Nivolumab plus ipilimumab shines as first-line in advanced NSCLC

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– The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News
Dr. Scott N. Gettinger
“Response rates seemed to go up as PD-L1 expression went up,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

Dr. Edward B. Garon
Discussant Edward B. Garon, MD, said that most observers believe the two-drug nivolumab/ipilimumab immunotherapy combination will sail through phase III studies. They think it will become the new standard approach to first-line therapy of advanced NSCLC, pushing aside pembrolizumab (Keytruda), a PD-1 receptor inhibitor that has been approved as first-line therapy in patients with advanced NSCLC, albeit with the restriction that they must have at least 50% tumor PD-L1 expression. But he is less certain of this scenario than are many of his colleagues.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

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– The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News
Dr. Scott N. Gettinger
“Response rates seemed to go up as PD-L1 expression went up,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

Dr. Edward B. Garon
Discussant Edward B. Garon, MD, said that most observers believe the two-drug nivolumab/ipilimumab immunotherapy combination will sail through phase III studies. They think it will become the new standard approach to first-line therapy of advanced NSCLC, pushing aside pembrolizumab (Keytruda), a PD-1 receptor inhibitor that has been approved as first-line therapy in patients with advanced NSCLC, albeit with the restriction that they must have at least 50% tumor PD-L1 expression. But he is less certain of this scenario than are many of his colleagues.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

– The combination of nivolumab and ipilimumab as first-line therapy in patients with advanced non–small cell lung cancer (NSCLC) doubled median progression-free survival time compared with nivolumab monotherapy in updated results from the CheckMate 012 trial, Scott N. Gettinger, MD, reported at the World Congress on Lung Cancer.

This doubling of progression-free survival (PFS) applied to all comers regardless of whether or not their tumor expressed programmed death-ligand 1 (PD-L1). In those patients with any degree of PD-L1 expression – even if just 1% of tumor cells stained positive – combination therapy didn’t just double median PFS, it tripled it, compared with nivolumab alone, added Dr. Gettinger of the Yale Cancer Center in New Haven, Conn.

Bruce Jancin/Frontline Medical News
Dr. Scott N. Gettinger
“Response rates seemed to go up as PD-L1 expression went up,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

CheckMate 012 is a phase I study of nivolumab as first-line therapy for advanced NSCLC with numerous treatment arms. Dr. Gettinger presented updated results for 52 patients who received intravenous nivolumab monotherapy at a dose of 3 mg/kg every 2 weeks, 36 patients on nivolumab plus intravenous ipilimumab at 1 mg/kg every 12 weeks, and 39 who received nivolumab plus ipilimumab every 6 weeks. None of the participants had prior chemotherapy for their advanced stage IIIb or IV NSCLC.

Median PFS in the overall study population was 3.6 months with nivolumab monotherapy and 8.0 months with combination therapy. In the roughly 70% of participants who had any degree of tumor PD-L1 expression, median PFS was 3.5 months with monotherapy, compared with 12.7 months in the combined dual therapy arms. And, in the roughly one-quarter of patients whose tumor showed at least 50% PD-L1 expression, median PFS rose to 8.3 months with nivolumab monotherapy and hasn’t yet been reached in patients on combination therapy.

The 1-year overall survival rate in patients on nivolumab monotherapy was 73% in all treated patients, 69% in those with any detectable tumor PD-L1 expression, and 83% in patients with at least 50% PD-L1 expression. In patients on combination therapy, the corresponding figures were higher at 76%, 87%, and 100%.

The clearly enhanced efficacy achieved with the combination of nivolumab plus ipilimumab was accomplished with only a modest increase in toxicity compared with nivolumab alone. At a median follow-up of 22 months in the nivolumab monotherapy group and 16 months for combination therapy, the rate of any treatment-related adverse event leading to study withdrawal was 12% with monotherapy and 18% with combination therapy.

The combination of nivolumab (Opdivo), a PD-L1 immune checkpoint inhibitor, and ipilimumab (Yervoy), a cytotoxic T-lymphocyte–associated protein 4 immune checkpoint inhibitor, is biologically attractive: “The ipilimumab primes the immune system by inducing tumor infiltration of effector T cells while depleting the number of myeloid-derived suppressor cells and suppressive regulatory T cells within the tumor microenvironment,” Dr. Gettinger explained.

Nivolumab is approved for treatment of advanced NSCLC that has progressed despite platinum-based chemotherapy. Of the various toxicities associated with the drug, only dermatologic and GI adverse events occurred more frequently with combination therapy than nivolumab alone.

There were five complete responses in the nivolumab monotherapy group and six with combination therapy. Of note, four of these complete responses occurred in patients without any measurable tumor PD-L1 expression.

Based upon these encouraging results from CheckMate 012, a phase III randomized clinical trial of nivolumab as first-line therapy in patients with advanced NSCLC is underway. In the CheckMate 227 trial, patients with any detectable PD-L1 expression are randomized to nivolumab at 3mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks, nivolumab monotherapy at 240 mg every 2 weeks, or standard platinum-based chemotherapy. Patients with no PD-L1 expression in their tumor are assigned to the nivolumab/ipilimumab combination, or nivolumab at 360 mg every 3 weeks plus chemotherapy, or chemotherapy alone.

Dr. Edward B. Garon
Discussant Edward B. Garon, MD, said that most observers believe the two-drug nivolumab/ipilimumab immunotherapy combination will sail through phase III studies. They think it will become the new standard approach to first-line therapy of advanced NSCLC, pushing aside pembrolizumab (Keytruda), a PD-1 receptor inhibitor that has been approved as first-line therapy in patients with advanced NSCLC, albeit with the restriction that they must have at least 50% tumor PD-L1 expression. But he is less certain of this scenario than are many of his colleagues.

“I think we should be cautious despite the excitement about the combination,” argued Dr. Garon, director of thoracic oncology at the University of California, Los Angeles.

He noted that various iterations of the large CheckMate 012 phase I program have been presented repeatedly at major meetings, and the shifting data have raised concerns in his mind about possible patient selection bias stemming from the study design.

“From my perspective, until we see randomized data that can control for these biases, I will remain hopeful but not yet extremely confident that this combination will be the new frontline therapy for metastatic non–small cell lung cancer,” Dr. Garon said.

Dr. Gettinger reported serving as a consultant to Bristol-Myers Squibb, which markets nivolumab.

Dr. Garon reported that his institution receives funding from Bristol-Myers Squibb as well as AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Mirati, Merck, Pfizer, and Novartis.

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Key clinical point: A combination of two immunotherapy agents with different mechanisms of action produced impressive efficacy and acceptable toxicities as first-line therapy in patients with chemotherapy-naive advanced non–small cell lung cancer.

Major finding: The combination of nivolumab and ipilimumab achieved threefold greater progression-free survival than nivolumab alone as first-line therapy for advanced NSCLC in patients with any detectable tumor PD-L1 expression.

Data source: This analysis from a larger phase I study included 127 patients with no prior chemotherapy for advanced NSCLC.

Disclosures: The study presenter is a consultant to Bristol-Myers Squibb, which sponsored the CheckMate 012 trial.

Using a Medical Interpreter with Persons of Limited English Proficiency

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Using a Medical Interpreter with Persons of Limited English Proficiency

From the Department of Medicine, Mayo Clinic, Rochester, MN.

 

Abstract

  • Objective: To provide an overview of important aspects of interpreting for medical visits for persons with limited English proficiency (LEP).
  • Methods: Literature review.
  • Results: When working with persons of LEP, providing a professional medical interpreter will facilitate optimal communication. Interpreters may work in different roles including as a conduit, cultural broker, clarifier, and advocate. In-person and remote (videoconferencing or telephonic) interpreting are available and one may be preferred depending on the medical visit. Clinicians should recognize that patients may have a preference for the interpreter’s gender and dialect and accommodations should be made if possible. Prior to the visit, the provider may want to clarify the goals of the medical encounter with the interpreter as some topics may be viewed differently in certain cultures. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient rather than to the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately to allow interpretation. Additionally, providers should assess patient understanding of what has been discussed. After the medical visit, providers should consider discussing with the interpreter any issues with communication or cultural factors noted to have affected the visit.
  • Conclusion: Providers should utilize a professional medical interpreter for visits with persons with LEP. Appropriate communication techniques, including talking in first and second tenses and maintaining eye contact with the patient rather than the interpreter, are important for a successful visit. Realizing patients may have interpreter preferences is also important to facilitate patient-centered-care.

Key words: language barriers; quality of care; physician-patient communication; interpreter services.

 

The United States is a diverse country that includes many persons whose first language is not English. According to the U.S. Census Bureau, more than 63 million persons age 5 and above (about 51 million adults) reported speaking a language other than English at home. Also, about 25.7 million of the population age 5 and up (around 10.6 million adults) noted speaking English less than “very well” [1]. Protecting people from discrimination based on the language they speak is highlighted in Title VI of the Civil Rights Act of 1964 (which focuses on those receiving federal funding). President Clinton, furthermore, in 2000 signed Executive Order 13166, which encouraged federal agencies to provide appropriate access of their services to those with limited English proficiency (LEP) [2,3].

The benefits of using professional interpreters is well-documented. In addition to increased satisfaction with communication when professional medical interpreters are used [4], they also make fewer clinically significant interpretation errors compared to ad hoc interpreters (ie, untrained individuals such as bilingual staff member, family member, or friend who are asked to interpret) [5–7]. LEP patients who do not have a professional interpreter have less understanding of their medical issues, have less satisfaction of their medical care, and may have more tests ordered and be hospitalized more often compared to those who do utilize professional medical interpreters [8]. In addition to improved satisfaction and understanding of medical diagnoses, hospitalized persons requiring interpreters who utilized a professional medical interpreter on admission and discharge were noted to have a shorter length of stay than persons who required an interpreter and did not receive one [9].

Despite the documented benefits of using professional interpreters, they are underutilized. Reasons include underfunded medical interpreting services [10,11], lack of awareness of the risks involved with using an ad hoc interpreter [2,12], providers using their own or another worker’s limited second language skills to communicate rather than using a professional medical interpreter [13,14], perceived delay in obtaining a professional medical interpreter, and judging a medical situation as minor rather than complex [13]. In this article, the roles, importance, and considerations of using a professional medical interpreter are explored.

Case Study

Initial Presentation

A 23-year-old married Somali-speaking female who moved to the United States recently called a local primary care provider’s office to schedule an appointment. When asked the reason for the visit, she said the reason was private. The clinical assistant scheduled her with the next available provider.

When the patient arrived for her clinic appointment, a clinical assistant roomed her and her mother and asked the patient the reason for the visit. The patient remained quiet and her mother replied that she needed to speak with the doctor. When the female medical provider entered, she observed that the patient appeared anxious. When the doctor initiated conversation with the patient, she noted that her English was limited. Her mother tried to explain the reason for the visit saying her daughter was having severe pain. She then pointed towards her daughter’s lower abdomen. The clinician noted the limited English abilities of the patient and mother and used the interpreter line to request a Somali interpreter and placed the first available interpreter available on speaker.

  • How can patients who need an interpreter be identified?

 

If a person does not speak any English, then an interpreter is necessary; however, sometimes whether a person from a non-English speaking background would benefit from an interpreter is unclear. If a patient is answering only in nods or yes/no responses or answering questions inconsistently, further evaluation should be done. Asking open-ended questions and/or having the patient repeat what is his or her understanding of the conversation will help determine if the person may benefit from an interpreter [12] (Table 1).

Health care systems can facilitate identifying patients in need of an interpreter by routinely collecting information on LEP status. The patient should be asked during registration if her or she speaks English and has a preferred language, and the answers should be recorded in the medical record [3]. If an interpreter is used during the hospital stay, it should be recorded to alert future providers to the need of an interpreter [15]. Patients may speak a dialect of a common language and this also should be noted, as an interpreter with a similar dialect to the patient should ideally be requested when necessary [16]. Furthermore, health care systems can measure rate of screening for language need at registration and rate of interpreter use during hospital stay to assess language need and adequacy of provision of interpreters to LEP patients [15].

It should be noted that patients may be wary about the presence of an interpreter. In one study involving pediatric oncologists and Spanish-speaking parents, the former reported concern regarding the accuracy of interpretation and the latter were concerned about missing out on important information even with the use of professional medical interpreters [17]. The concern for accuracy of interpreting was shared in a study by Chinese and Vietnamese Americans with LEP [18] as well as in a Swedish study involving Arabic-speaking persons. In the latter study, Arabic-speaking patients also felt uncomfortable speaking about bodily issues in the presence of interpreters [19]. In a study of Latina patients, there were concerns about confidentiality with interpreters [20].

  • What is the role of the interpreter? Should they offer emotional support to the patient?

Interpreter-as-conduit reflects a neutral, more literal information exchange and is preferred by certain medical providers who prioritize a more exact interpretation of the medical conversation. In this role, the interpreter assumes a more passive role and the emphasis is on the interpreter’s linguistic ability [21]. Providers need to be aware that word-for-word interpretation may not align with what is regarded as culturally sensitive care—such as when the term “cancer” is to be used. Also, word-for-word interpretation does not necessarily mean the patient will understand what is being interpreted if the terminology does not reflect the literacy level or dialect of the person with LEP [22].

Interpreters may also assume an active role, sometimes referred to as clarifier and cultural broker. Clarifying may be utilized, for example, when a medical provider is discussing complicated treatment options. This requires an interpreter to step out of a conduit role (if that is the preferred role) and confirm or clarify information to ensure accurate information exchange [21,23]. As a cultural broker, communication between provider and patient is exchanged in a manner that reflects consideration of the patient’s cultural background. Interpreters may explain, to the provider, the cultural reason for the patient’s perspective of what is causing or contributing to the illness. Cultural brokering may as well include communicating the medical terminology and disease explanation, given by the medical provider, in a way that the patient would understand. This role, additionally, can involve educating the provider about aspects of the culture that may influence the patient’s communication with him or her [22].

Furthermore, interpreters may fulfill an advocate role for patients by helping them understand the health care system and increasing patient empowerment by seeking information and services that the patient may not know to ask about [23].

The interpreter may offer emotional support during a medical visit, for example, where the diagnosis of cancer is conveyed. In such a case, an interpreter’s emotional support may be considered by providers to be appropriate. In contrast, with visits related to mental health evaluations, having the interpreter remain neutral, rather than being a more active participant by offering emotional support, may be preferred [24]. In addition to interpreters remaining more neutral during mental health visits, providers may prefer that interpreters not speak with the patient prior to the visit, depending on the mental health condition, as negative therapeutic consequences may occur [21]. Trust is an important element of the provider-patient relationship and, as such, there is concern on the part of some providers that if the trust of patients falls to the interpreter rather than to the provider, then therapeutic progress may be compromised [24]. In general, clarifying with interpreters the goals of the visit and expectations regarding speaking to the patient outside of the visit may ensure the provider-patient relationship is not diminished [21].

  • What are the disadvantages and caveats of using family members or bilingual staff as interpreters?

Although family members and other ad hoc interpreters may be present and willing to interpret, the risk of miscommunication is greater than with professional medical interpreters [5,6]. This risk of miscommunication extends to partially bilingual medical providers who do not utilize appropriate interpreter services [10,25]. Ad hoc interpreters may try to answer on behalf the patient [6,26] and may not have the appropriate medical terminology to correctly interpret what the provider is trying to communicate to the patient [6].

Professional medical interpreters are trained to facilitate communication of a spoken language in a medical setting [2,10]. Certification is offered by the National Board of Certification for Medical Interpreters and the Certification Commission for Healthcare Interpreters. In order to be certified certain requirements must be met which include a minimum of 40 hours of health care interpreter training (which includes medical terminology as well as roles and ethics involved in medical interpreting) as well as demonstrated oral proficiency in English as well as another chosen language (such as Spanish) [10].

In certain circumstances, patients may feel more comfortable disclosing personal details with a professional medical interpreter rather than in the presence of an ad hoc interpreter. For example, more details of traumatic events and psychological symptoms were spoken of in the presence of a professional, rather than an ad hoc, interpreter in medical interviews of asylum seekers requiring an interpreter in Switzerland. In the presence of ad hoc interpreters, more physical symptoms were disclosed rather than psychological [6].

Furthermore, in visits concerning sexuality or abuse issues, using family members as interpreters may violate privacy concerns of the patient [2,27]. Additionally, in certain cultures where respect for elders is very important, parents who use children as interpreters may feel that the structure of the family changes when he or she interprets on behalf of the parent [18]. Also, what children consider as embarrassing may not be interpreted to either the parent or to the care provider [8]. Furthermore, one should note there are ethical issues of using non-adult children as interpreters in situations involving confidentiality and privacy—by doing so, there may be resulting harmful effects on non-adult children [27,28].

Patients may at times decline the use of a professional medical interpreter and prefer to have a family member interpret; this preference should be documented in the patient’s medical chart [10]. Caution should be had using an ad hoc interpreter when obtaining informed consent [12].

 

 

 

  • What professional interpreting services are available to the clinician?

For the most part, access to interpreters via a telephone service is widely available [10]. The cost of providing interpreters in-person and/or remotely varies depending on the health care site [29–31] In general, considerations of using professional medical interpreters, whether remotely or in-person, involves accessibility and cost. There are certain sites that have explored having a shared network of interpreters available via the telephone and videoconference to reduce the cost of providing interpreters for individual hospitals [32]. While the costs of providing a person with LEP with interpretation varies depending on the health care site, the costs of not providing a professional medical interpreter should be considered as well, which include greater malpractice risk and potential medical errors [32]. In addition, the use of employees as interpreters takes time away from their respective jobs, which results in staff time lost [31].

In-person interpreting may be preferred for certain medical visits, as an in-person interpreter can interpret both verbal and nonverbal communication [16]. When emotional support is anticipated, in-person interpreting is usually preferred by providers [24]. There may be improved cultural competence when using an in-person interpreter, which may be important for certain visits such as those involving end-of life care discussions [4]. One concern may involve the comfort level of the patient if he or she personally knows the interpreter; this can occur in smaller ethnic communities [12]. Telephonic interpreting may be preferred in certain medical situations where confidentiality is desired [16].

Telephonic interpreting offers greater accessibility as it is not limited by time of the day or geographic location and less common language interpreters are available. Disadvantages of telephonic interpretation include lack of ability to interpret body language and, at times, problems with communication related to background noise [27]. Also, some providers feel that rapport building is more difficult with telephonic interpreting [13]. Using a double-headset telephone or speaker phone (in a private setting preferably), instead of passing the telephone headset between provider and patient, is recommended to optimize provider-patient communication [2]. Remote videoconference interpretation is also an option in many places. Videoconferencing offers the advantage of interpretation of nonverbal communication that would be absent in telephonic interpreting [33]. Also, accessibility to languages is improved, especially for languages not covered by in-person interpreters depending on the health care site [34]. Disadvantages of videoconferencing interpretation include technical problems due to wireless networking issues [33] (Table 2).

For providers working with persons who are deaf, options for interpreting include in-person sign language interpreters as well as remote videoconference interpretation [10].

  • Are in-person interpreting and remote interpreting comparable?

In general, using in-person or remote interpreters does not significantly change patient satisfaction. In a study involving Spanish-speaking patients in a clinic setting, persons requiring an interpreter rated satisfaction of interpreting between in-person, videoconferencing, and telephonic methods highly with no significant differences. Of note, though, medical providers and interpreters preferred in-person rather than the 2 remote interpreting options [33]. In a different study involving Spanish, Chinese, Russian, or Vietnamese interpreters, satisfaction of information exchange was considered equal among the 3 interpreting modalities, although in-person interpreting was felt to establish rapport between clinician and patient with LEP better than telephonic and videoconferencing interpreting [35]. Additionally, in a study of providers in a clinic setting who worked with persons with LEP, no significant differences were noted in provider satisfaction of the medical visit, or in the quality of interpretation or communication, when using in-person versus remote videoconferencing interpretation. Providers, though, noted improved knowledge of the patient’s cultural beliefs when using in-person interpreting [4].

Regarding the question of a difference in understanding when using in-person versus remote interpreters, a study was done in a pediatric emergency department (ED) that compared in-person and telephonic interpretation. Family understanding of the discharge diagnosis was high (about 95%) regardless of whether an in-person or telephonic interpreter was utilized [36]. In a different study comparing telephone and video interpretation in a pediatric ED, while quality of communication and interpretation were rated similarly, the parents who used video interpretation were more likely to name their child’s diagnosis correctly [29].

Case Continued

The physician proceeded with introductions and explained that all conversations would be interpreted. She further stated that if there were any questions, the patient and mother should feel free to ask them. Via the interpreter, who was male, the provider began by asking about the nature of the abdominal pain. The patient looked to her mother and then down without answering. The mother nodded, but did not say more. The provider wondered if their reticence might be due to discomfort with discussing the issue through a male interpreter. The physician asked the patient if she would prefer a female interpreter and, once that was confirmed, she asked if she wanted an in-person or telephonic interpreter. The mother requested a female in-person interpreter.

  • How might gender-specific issues impact working with an interpreter?

As gender concordance of patient and physician [37] at times is desired, gender concordance of patient and interpreter [16,18] may also be important to optimize communication of gender-specific issues [16,18,37]. For example, an Arabic-speaking man from the Middle East may prefer to discuss sexuality-related concerns in the presence of a male rather than female interpreter [16]. An Arabic-speaking female who has a preference for female providers may prefer a female interpreter when discussing sexuality and undergoing a physical examination [19]. In one study, the majority of Somali females preferred female interpreters as well as female providers for breast, pelvic, and abdominal examinations [38]. If a same-gender interpreter cannot be present, an option is to have the interpreter either leave the room or step behind a curtain or turn away from the patient during a sensitive part of the physical examination [39].

  • What are recommended strategies for using a medical interpreter?

It is often helpful to have a brief discussion with the interpreter prior to the medical visit with the patient to speak about the general topics that will be discussed (especially if the topics involve sensitive issues or news that could be upsetting to the patient) and the goal of the visit [2, 11]. Certain topics may be viewed dissimilarly in different cultures, thus approaching the interpreter from the view point of cultural broker or liaison [10] may bring to light cultural factors that may influence the medical visit [40,41]. the name of the interpreter should be noted for documentation purposes [10].

To start the visit, introductions of everyone involved should take place with a brief disclosure about the role of the interpreter and assurance of confidentiality on the part of the interpreter [2,11]. Also, the provider should set the expectation that all statements said in the room will be interpreted so that all persons can understand what it being spoken [10].

There are several options for where each person should be positioned. In some medical visits, a triangle is pursued where the interpreter sits lateral to the provider, but this may lead to challenges in maintaining eye contact between the patient and provider. Another option is have the interpreter sit next to [10] and slightly behind the patient to improve eye contact between provider-patient and to maintain the patient-provider relationship [2,41]. When seated, the medical provider should try to sit at the same level as the patient [16]. Seating is different with persons requiring the use of sign language interpreters as the interpreter needs to be visible to the patient for communications purposes. One possibility is having the interpreter sit beside and slightly behind the provider; this positioning allows the patient to understand what is being communicated and also allows the patient to understand what is being communicated and allows him or her to see the provider during the conversation [40].

There are 2 main communication styles used by interpreters: consecutive interpreting, where the interpreter exchanges what has been said by the clinician or patient after each one has finished speaking, and simultaneous interpreting, where the interpreter translates as the person is speaking. Interpreters and medical providers may have a preference and it is important to clarify, if needed, which method is preferred [21].

The provider should face the patient and direct conversation to him or her rather than to the interpreter. Third-person statements should not be used, such as “tell her,” as this directs the conversation to the interpreter rather than to the patient [10]. By using the first and second person (when addressing the patient) and making eye contact, the relationship between the provider and patient is emphasized [14,40].

 

 

Choosing the right word is important to have meaningful communication. Interpreters advise that providers should understand that medical concepts may be unfamiliar to patients with LEP. Providers should use simpler words rather than medical terminology to discuss medical issues [42]. In general, straightforward word choice is recommended [16]. Providers are advised to not use acronyms or idioms. It is important to note that humor may be difficult to convey as well [10].

Clinicians are advised to speak clearly and not quickly and to use shorter sentences with appropriate pauses to allow time for the interpreter to interpret (if consecutive rather than simultaneous interpreting style is being used) [2,41,43,44]. In addition to limiting speech to one to two sentences at a time, asking one question at a time is important for optimal communication [43]. To improve information gathering, patients may respond better to open-ended questions [42], which is an aspect of patient-centered communication, as directive questioning often leads to shorter answers [43].

Furthermore, the provider should be aware that persons with LEP may know some English, so statements that one would not say to an English-speaking patient should not be said in the room with a person with LEP [10].

Encouraging the interpreter to clarify certain concepts, if necessary, may provide for improved information exchange [21] as well as encouraging the patient to ask questions during the medical visit may help elucidate potential areas of confusion [22,40,44]. Summarizing important concepts [40] and limiting the number of concepts discussed may increase patient understanding [10]. Additionally, asking the patient to repeat what was discussed in his or her words [10], rather than directly asking if he or she understands, will allow for more meaningful assessment of patient understanding [43].

Finally, recognition that interpreters may experience distress after certain visits, such as an oncologic medical encounters, is important and debriefing may be desired by the interpreter [22,45]. Also, discussing any communication concerns may be helpful [40,42] in addition to discussing certain cultural beliefs that impacted the visit may be educational for the provider [45].

Case Continued

After the female translator arrived, the physician asked the patient if she felt comfortable with her mother in the room for this medical visit. After the patient confirmed that she wanted her mother present, the physician tried to further clarify the reason for the medical visit. Her mother, appearing very concerned, began speaking quickly to the interpreter without stopping for interpretation. When the mother did stop speaking, the interpreter, rather than informing the provider what was spoken of by the mother, dialoged with the mother and the back and forth conversation continued.

  • What are strategies to optimize the medical visit when the provider is not satisfied with the flow of conversation?

If there are conversations occurring between the patient and interpreter with the exclusion of the provider, the provider should request sentence-by-sentence interpretation by the interpreter. If the interpreter is answering on behalf of the patient, providers should redirect communication to the patient [10]. At times, patients may speak for longer periods without stopping for the interpreter to provide accurate information exchange. The provider in this case may need to interrupt conversation to allow the interpreter time to convey what is being said [14].

If there are family members who know English, but the patient and/or others do not know English, there may be a risk of miscommunication if the exchange of medical information is done by a combination of family members and the interpreter, as the medical information may not accurately reflect what the clinician is trying to convey. The provider may need to redirect the conversation flow through the interpreter to make sure there is consistent information being communicated [22].

Case Continued

Finally, the provider interrupted. She emphasized with the patient, mother, and the interpreter that all that was being said should be interpreted. She asked the interpreter to sit next to the patient and mother (rather than lateral to the physician) so that eye contact between the patient and mother and the provider could be maintained thus supporting the patient-provider relationship. She then asked one question at a time to the patient. She needed to interrupt the conversation again when the mother started to speak to the interpreter without waiting for interpretation. The doctor reemphasized the need to allow time for the interpreter to adequately convey the information. After this the medical visit progressed successfully. Soon the provider found out that the mother was concerned that something serious could be happening to her daughter, as her daughter previously had a miscarriage. After hearing the mother’s concern, the provider was able to clarify with the daughter that the pain was suprapubic and she was having burning when she urinated. After further evaluation, the provider diagnosed a urinary tract infection. She told the patient about the diagnosis and provided her with appropriate medication and instructions on how to take it and for how long. The provider then asked the patient to tell her what she understood about the diagnosis and how to take the medication. The doctor then asked if either had any further questions. After the medical visit, the provider made sure that the patient’s chart reflected the need for a Somali interpreter with the notation that a female interpreter was preferred.

Conclusion

When working with persons with LEP, providing a professional medical interpreter will facilitate optimal communication. In-person and remote (videoconferencing or telephonic) interpreting are options. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient not the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately. Clinicians should remember that patients may have a preference in the gender and dialect of the interpreter and accommodations should be made if available. Finally, asking the patient to repeat back in his or her own words what has been discussed is important to make sure the patient understood what was communicated during the medical visit [10,16].

 

Corresponding author: Kimberly Schoonover, MD, 200 First Street SW, Rochester, MN 55905, Schoonover.Kimberly@mayo.edu.

Financial disclosures: None.

References

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11. Schapira L, Vargas E, Hidalgo R, et al. Lost in translation: integrating medical interpreters into the multidisciplinary team. Oncologist 2008;13:586–92.

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13. Hsieh E. Not just “getting by”: factors influencing providers’ choice of interpreters. J Gen Intern Med 2015;30:75–82.

14. Philips C. Using interpreters--a guide for GPs. Austr Fam Physician 2010;39:188–95.

15. Boscolo-Hightower A, Rafton SA, Tolman M, et al. Identifying families with limited English proficiency using a capture-recapture approach. Hosp Pediatr 2014;4:16–22.

16. Hadziabdic E, Hjelm K. Working with interpreters: practical advice for use of an interpreter in healthcare. Int J Evid Based Healthc 2013;11:69–76.

17. Abbe M, Simon C, Angiolillo A, et al. A survey of language barriers from the perspective of pediatric oncologists, interpreters, and parents. Pediatr Blood Cancer 2006;47:819–24.

18. Ngo-Metzger Q, Massagli MP, Clarridge BR, et al. Linguistic and cultural barriers to care. J Gen Intern Med 2003;18:44–52.

19. Hadziabdic E, Hjelm K. Arabic-speaking migrants’ experiences of the use of interpreters in healthcare: a qualitative explorative study. Int J Equity Health 2014;13:49.

20. Julliard K, Vivar J, Delgado C, et al. What Latina patients don’t tell their doctors: a qualitative study. Ann Family Med 2008;6:543–9.

21. Hsieh E, Ju H, Kong H. Dimensions of trust: the tensions and challenges in provider--interpreter trust. Qual Health Res 2010;20:170–81.

22. Butow PN, Lobb E, Jefford M, et al. A bridge between cultures: interpreters’ perspectives of consultations with migrant oncology patients. Support Care Cancer 2012;20:235-44.

23. Hsieh E. “I am not a robot!” Interpreters’ views of their roles in health care settings. Qual Health Res 2008;18:1367–83.

24. Hsieh E, Hong SJ. Not all are desired: providers’ views on interpreters’ emotional support for patients. Patient Educ Couns 2010;81:192–7.

25. Elderkin-Thompson V, Silver RC, Waitzkin H. When nurses double as interpreters: a study of Spanish-speaking patients in a US primary care setting. Soc Sci Med 2001;52:1343–58.

26. Napoles AM, Santoyo-Olsson J, Karliner LS, et al. Inaccurate language interpretation and its clinical significance in the medical encounters of Spanish-speaking Latinos. Med Care 2015;53:940–7.

27. Gray B, Hilder J, Donaldson H. Why do we not use trained interpreters for all patients with limited English proficiency? Is there a place for using family members? Austr J Prim Health 2011;17:240–9.

28. Jacobs B, Kroll L, Green J, David TJ. The hazards of using a child as an interpreter. J Royal Soc Med 1995;88:474P–5P.

29. Lion KC, Brown JC, Ebel BE, et al. Effect of telephone vs video interpretation on parent comprehension, communication, and utilization in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr 2015;169:1117–25.

30. Wofford JL CC, Johnson DA, Brown MT. Providing a Spanish interpreter using low-cost videoconferencing in a community health centre: a pilot study using tablet computers. Inform Prim Care 2012;20:141–6.

31. Jacobs EA SL, Rathouz PJ. The impact of an enhanced interpreter service intervention on hospital costs and patient satisfaction. J Gen Intern Med 2007;22(Suppl 2):306–11.

32. Jacobs EA LG, Rathouz PJ, Fu P Jr. Shared networks of interpreter services, at relatively low cost, can help providers serve patients with limited english skills. Health Aff (Millwood) 2011;30:1930–8.

33. Locatis C, Williamson D, Gould-Kabler C, et al. Comparing in-person, video, and telephonic medical interpretation. J Gen Intern Med 2010;25:345–50.

34. Jones D, Gill P, Harrison R, et al. An exploratory study of language interpretation services provided by videoconferencing. J Telemed Telecare 2003;9:51–6.

35. Price EL, Perez-Stable EJ, Nickleach D, et al. Interpreter perspectives of in-person, telephonic, and videoconferencing medical interpretation in clinical encounters. Patient Educ Couns 2012;87:226–32.

36. Crossman KL, Wiener E, Roosevelt G, et al. Interpreters: telephonic, in-person interpretation and bilingual providers. Pediatrics 2010;125:e631–8.

37. Degni F, Suominen S, Essen B, et al. Communication and cultural issues in providing reproductive health care to immigrant women: health care providers’ experiences in meeting the needs of [corrected] Somali women living in Finland. J Immigr Minor Health 2012;14:330–43.

38. Odunukan OW, Abdulai RM, Hagi Salaad MF, et al. Provider and interpreter preferences among Somali women in a primary care setting. J Prim Care Comm Health 2015;6:105–10.

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From the Department of Medicine, Mayo Clinic, Rochester, MN.

 

Abstract

  • Objective: To provide an overview of important aspects of interpreting for medical visits for persons with limited English proficiency (LEP).
  • Methods: Literature review.
  • Results: When working with persons of LEP, providing a professional medical interpreter will facilitate optimal communication. Interpreters may work in different roles including as a conduit, cultural broker, clarifier, and advocate. In-person and remote (videoconferencing or telephonic) interpreting are available and one may be preferred depending on the medical visit. Clinicians should recognize that patients may have a preference for the interpreter’s gender and dialect and accommodations should be made if possible. Prior to the visit, the provider may want to clarify the goals of the medical encounter with the interpreter as some topics may be viewed differently in certain cultures. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient rather than to the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately to allow interpretation. Additionally, providers should assess patient understanding of what has been discussed. After the medical visit, providers should consider discussing with the interpreter any issues with communication or cultural factors noted to have affected the visit.
  • Conclusion: Providers should utilize a professional medical interpreter for visits with persons with LEP. Appropriate communication techniques, including talking in first and second tenses and maintaining eye contact with the patient rather than the interpreter, are important for a successful visit. Realizing patients may have interpreter preferences is also important to facilitate patient-centered-care.

Key words: language barriers; quality of care; physician-patient communication; interpreter services.

 

The United States is a diverse country that includes many persons whose first language is not English. According to the U.S. Census Bureau, more than 63 million persons age 5 and above (about 51 million adults) reported speaking a language other than English at home. Also, about 25.7 million of the population age 5 and up (around 10.6 million adults) noted speaking English less than “very well” [1]. Protecting people from discrimination based on the language they speak is highlighted in Title VI of the Civil Rights Act of 1964 (which focuses on those receiving federal funding). President Clinton, furthermore, in 2000 signed Executive Order 13166, which encouraged federal agencies to provide appropriate access of their services to those with limited English proficiency (LEP) [2,3].

The benefits of using professional interpreters is well-documented. In addition to increased satisfaction with communication when professional medical interpreters are used [4], they also make fewer clinically significant interpretation errors compared to ad hoc interpreters (ie, untrained individuals such as bilingual staff member, family member, or friend who are asked to interpret) [5–7]. LEP patients who do not have a professional interpreter have less understanding of their medical issues, have less satisfaction of their medical care, and may have more tests ordered and be hospitalized more often compared to those who do utilize professional medical interpreters [8]. In addition to improved satisfaction and understanding of medical diagnoses, hospitalized persons requiring interpreters who utilized a professional medical interpreter on admission and discharge were noted to have a shorter length of stay than persons who required an interpreter and did not receive one [9].

Despite the documented benefits of using professional interpreters, they are underutilized. Reasons include underfunded medical interpreting services [10,11], lack of awareness of the risks involved with using an ad hoc interpreter [2,12], providers using their own or another worker’s limited second language skills to communicate rather than using a professional medical interpreter [13,14], perceived delay in obtaining a professional medical interpreter, and judging a medical situation as minor rather than complex [13]. In this article, the roles, importance, and considerations of using a professional medical interpreter are explored.

Case Study

Initial Presentation

A 23-year-old married Somali-speaking female who moved to the United States recently called a local primary care provider’s office to schedule an appointment. When asked the reason for the visit, she said the reason was private. The clinical assistant scheduled her with the next available provider.

When the patient arrived for her clinic appointment, a clinical assistant roomed her and her mother and asked the patient the reason for the visit. The patient remained quiet and her mother replied that she needed to speak with the doctor. When the female medical provider entered, she observed that the patient appeared anxious. When the doctor initiated conversation with the patient, she noted that her English was limited. Her mother tried to explain the reason for the visit saying her daughter was having severe pain. She then pointed towards her daughter’s lower abdomen. The clinician noted the limited English abilities of the patient and mother and used the interpreter line to request a Somali interpreter and placed the first available interpreter available on speaker.

  • How can patients who need an interpreter be identified?

 

If a person does not speak any English, then an interpreter is necessary; however, sometimes whether a person from a non-English speaking background would benefit from an interpreter is unclear. If a patient is answering only in nods or yes/no responses or answering questions inconsistently, further evaluation should be done. Asking open-ended questions and/or having the patient repeat what is his or her understanding of the conversation will help determine if the person may benefit from an interpreter [12] (Table 1).

Health care systems can facilitate identifying patients in need of an interpreter by routinely collecting information on LEP status. The patient should be asked during registration if her or she speaks English and has a preferred language, and the answers should be recorded in the medical record [3]. If an interpreter is used during the hospital stay, it should be recorded to alert future providers to the need of an interpreter [15]. Patients may speak a dialect of a common language and this also should be noted, as an interpreter with a similar dialect to the patient should ideally be requested when necessary [16]. Furthermore, health care systems can measure rate of screening for language need at registration and rate of interpreter use during hospital stay to assess language need and adequacy of provision of interpreters to LEP patients [15].

It should be noted that patients may be wary about the presence of an interpreter. In one study involving pediatric oncologists and Spanish-speaking parents, the former reported concern regarding the accuracy of interpretation and the latter were concerned about missing out on important information even with the use of professional medical interpreters [17]. The concern for accuracy of interpreting was shared in a study by Chinese and Vietnamese Americans with LEP [18] as well as in a Swedish study involving Arabic-speaking persons. In the latter study, Arabic-speaking patients also felt uncomfortable speaking about bodily issues in the presence of interpreters [19]. In a study of Latina patients, there were concerns about confidentiality with interpreters [20].

  • What is the role of the interpreter? Should they offer emotional support to the patient?

Interpreter-as-conduit reflects a neutral, more literal information exchange and is preferred by certain medical providers who prioritize a more exact interpretation of the medical conversation. In this role, the interpreter assumes a more passive role and the emphasis is on the interpreter’s linguistic ability [21]. Providers need to be aware that word-for-word interpretation may not align with what is regarded as culturally sensitive care—such as when the term “cancer” is to be used. Also, word-for-word interpretation does not necessarily mean the patient will understand what is being interpreted if the terminology does not reflect the literacy level or dialect of the person with LEP [22].

Interpreters may also assume an active role, sometimes referred to as clarifier and cultural broker. Clarifying may be utilized, for example, when a medical provider is discussing complicated treatment options. This requires an interpreter to step out of a conduit role (if that is the preferred role) and confirm or clarify information to ensure accurate information exchange [21,23]. As a cultural broker, communication between provider and patient is exchanged in a manner that reflects consideration of the patient’s cultural background. Interpreters may explain, to the provider, the cultural reason for the patient’s perspective of what is causing or contributing to the illness. Cultural brokering may as well include communicating the medical terminology and disease explanation, given by the medical provider, in a way that the patient would understand. This role, additionally, can involve educating the provider about aspects of the culture that may influence the patient’s communication with him or her [22].

Furthermore, interpreters may fulfill an advocate role for patients by helping them understand the health care system and increasing patient empowerment by seeking information and services that the patient may not know to ask about [23].

The interpreter may offer emotional support during a medical visit, for example, where the diagnosis of cancer is conveyed. In such a case, an interpreter’s emotional support may be considered by providers to be appropriate. In contrast, with visits related to mental health evaluations, having the interpreter remain neutral, rather than being a more active participant by offering emotional support, may be preferred [24]. In addition to interpreters remaining more neutral during mental health visits, providers may prefer that interpreters not speak with the patient prior to the visit, depending on the mental health condition, as negative therapeutic consequences may occur [21]. Trust is an important element of the provider-patient relationship and, as such, there is concern on the part of some providers that if the trust of patients falls to the interpreter rather than to the provider, then therapeutic progress may be compromised [24]. In general, clarifying with interpreters the goals of the visit and expectations regarding speaking to the patient outside of the visit may ensure the provider-patient relationship is not diminished [21].

  • What are the disadvantages and caveats of using family members or bilingual staff as interpreters?

Although family members and other ad hoc interpreters may be present and willing to interpret, the risk of miscommunication is greater than with professional medical interpreters [5,6]. This risk of miscommunication extends to partially bilingual medical providers who do not utilize appropriate interpreter services [10,25]. Ad hoc interpreters may try to answer on behalf the patient [6,26] and may not have the appropriate medical terminology to correctly interpret what the provider is trying to communicate to the patient [6].

Professional medical interpreters are trained to facilitate communication of a spoken language in a medical setting [2,10]. Certification is offered by the National Board of Certification for Medical Interpreters and the Certification Commission for Healthcare Interpreters. In order to be certified certain requirements must be met which include a minimum of 40 hours of health care interpreter training (which includes medical terminology as well as roles and ethics involved in medical interpreting) as well as demonstrated oral proficiency in English as well as another chosen language (such as Spanish) [10].

In certain circumstances, patients may feel more comfortable disclosing personal details with a professional medical interpreter rather than in the presence of an ad hoc interpreter. For example, more details of traumatic events and psychological symptoms were spoken of in the presence of a professional, rather than an ad hoc, interpreter in medical interviews of asylum seekers requiring an interpreter in Switzerland. In the presence of ad hoc interpreters, more physical symptoms were disclosed rather than psychological [6].

Furthermore, in visits concerning sexuality or abuse issues, using family members as interpreters may violate privacy concerns of the patient [2,27]. Additionally, in certain cultures where respect for elders is very important, parents who use children as interpreters may feel that the structure of the family changes when he or she interprets on behalf of the parent [18]. Also, what children consider as embarrassing may not be interpreted to either the parent or to the care provider [8]. Furthermore, one should note there are ethical issues of using non-adult children as interpreters in situations involving confidentiality and privacy—by doing so, there may be resulting harmful effects on non-adult children [27,28].

Patients may at times decline the use of a professional medical interpreter and prefer to have a family member interpret; this preference should be documented in the patient’s medical chart [10]. Caution should be had using an ad hoc interpreter when obtaining informed consent [12].

 

 

 

  • What professional interpreting services are available to the clinician?

For the most part, access to interpreters via a telephone service is widely available [10]. The cost of providing interpreters in-person and/or remotely varies depending on the health care site [29–31] In general, considerations of using professional medical interpreters, whether remotely or in-person, involves accessibility and cost. There are certain sites that have explored having a shared network of interpreters available via the telephone and videoconference to reduce the cost of providing interpreters for individual hospitals [32]. While the costs of providing a person with LEP with interpretation varies depending on the health care site, the costs of not providing a professional medical interpreter should be considered as well, which include greater malpractice risk and potential medical errors [32]. In addition, the use of employees as interpreters takes time away from their respective jobs, which results in staff time lost [31].

In-person interpreting may be preferred for certain medical visits, as an in-person interpreter can interpret both verbal and nonverbal communication [16]. When emotional support is anticipated, in-person interpreting is usually preferred by providers [24]. There may be improved cultural competence when using an in-person interpreter, which may be important for certain visits such as those involving end-of life care discussions [4]. One concern may involve the comfort level of the patient if he or she personally knows the interpreter; this can occur in smaller ethnic communities [12]. Telephonic interpreting may be preferred in certain medical situations where confidentiality is desired [16].

Telephonic interpreting offers greater accessibility as it is not limited by time of the day or geographic location and less common language interpreters are available. Disadvantages of telephonic interpretation include lack of ability to interpret body language and, at times, problems with communication related to background noise [27]. Also, some providers feel that rapport building is more difficult with telephonic interpreting [13]. Using a double-headset telephone or speaker phone (in a private setting preferably), instead of passing the telephone headset between provider and patient, is recommended to optimize provider-patient communication [2]. Remote videoconference interpretation is also an option in many places. Videoconferencing offers the advantage of interpretation of nonverbal communication that would be absent in telephonic interpreting [33]. Also, accessibility to languages is improved, especially for languages not covered by in-person interpreters depending on the health care site [34]. Disadvantages of videoconferencing interpretation include technical problems due to wireless networking issues [33] (Table 2).

For providers working with persons who are deaf, options for interpreting include in-person sign language interpreters as well as remote videoconference interpretation [10].

  • Are in-person interpreting and remote interpreting comparable?

In general, using in-person or remote interpreters does not significantly change patient satisfaction. In a study involving Spanish-speaking patients in a clinic setting, persons requiring an interpreter rated satisfaction of interpreting between in-person, videoconferencing, and telephonic methods highly with no significant differences. Of note, though, medical providers and interpreters preferred in-person rather than the 2 remote interpreting options [33]. In a different study involving Spanish, Chinese, Russian, or Vietnamese interpreters, satisfaction of information exchange was considered equal among the 3 interpreting modalities, although in-person interpreting was felt to establish rapport between clinician and patient with LEP better than telephonic and videoconferencing interpreting [35]. Additionally, in a study of providers in a clinic setting who worked with persons with LEP, no significant differences were noted in provider satisfaction of the medical visit, or in the quality of interpretation or communication, when using in-person versus remote videoconferencing interpretation. Providers, though, noted improved knowledge of the patient’s cultural beliefs when using in-person interpreting [4].

Regarding the question of a difference in understanding when using in-person versus remote interpreters, a study was done in a pediatric emergency department (ED) that compared in-person and telephonic interpretation. Family understanding of the discharge diagnosis was high (about 95%) regardless of whether an in-person or telephonic interpreter was utilized [36]. In a different study comparing telephone and video interpretation in a pediatric ED, while quality of communication and interpretation were rated similarly, the parents who used video interpretation were more likely to name their child’s diagnosis correctly [29].

Case Continued

The physician proceeded with introductions and explained that all conversations would be interpreted. She further stated that if there were any questions, the patient and mother should feel free to ask them. Via the interpreter, who was male, the provider began by asking about the nature of the abdominal pain. The patient looked to her mother and then down without answering. The mother nodded, but did not say more. The provider wondered if their reticence might be due to discomfort with discussing the issue through a male interpreter. The physician asked the patient if she would prefer a female interpreter and, once that was confirmed, she asked if she wanted an in-person or telephonic interpreter. The mother requested a female in-person interpreter.

  • How might gender-specific issues impact working with an interpreter?

As gender concordance of patient and physician [37] at times is desired, gender concordance of patient and interpreter [16,18] may also be important to optimize communication of gender-specific issues [16,18,37]. For example, an Arabic-speaking man from the Middle East may prefer to discuss sexuality-related concerns in the presence of a male rather than female interpreter [16]. An Arabic-speaking female who has a preference for female providers may prefer a female interpreter when discussing sexuality and undergoing a physical examination [19]. In one study, the majority of Somali females preferred female interpreters as well as female providers for breast, pelvic, and abdominal examinations [38]. If a same-gender interpreter cannot be present, an option is to have the interpreter either leave the room or step behind a curtain or turn away from the patient during a sensitive part of the physical examination [39].

  • What are recommended strategies for using a medical interpreter?

It is often helpful to have a brief discussion with the interpreter prior to the medical visit with the patient to speak about the general topics that will be discussed (especially if the topics involve sensitive issues or news that could be upsetting to the patient) and the goal of the visit [2, 11]. Certain topics may be viewed dissimilarly in different cultures, thus approaching the interpreter from the view point of cultural broker or liaison [10] may bring to light cultural factors that may influence the medical visit [40,41]. the name of the interpreter should be noted for documentation purposes [10].

To start the visit, introductions of everyone involved should take place with a brief disclosure about the role of the interpreter and assurance of confidentiality on the part of the interpreter [2,11]. Also, the provider should set the expectation that all statements said in the room will be interpreted so that all persons can understand what it being spoken [10].

There are several options for where each person should be positioned. In some medical visits, a triangle is pursued where the interpreter sits lateral to the provider, but this may lead to challenges in maintaining eye contact between the patient and provider. Another option is have the interpreter sit next to [10] and slightly behind the patient to improve eye contact between provider-patient and to maintain the patient-provider relationship [2,41]. When seated, the medical provider should try to sit at the same level as the patient [16]. Seating is different with persons requiring the use of sign language interpreters as the interpreter needs to be visible to the patient for communications purposes. One possibility is having the interpreter sit beside and slightly behind the provider; this positioning allows the patient to understand what is being communicated and also allows the patient to understand what is being communicated and allows him or her to see the provider during the conversation [40].

There are 2 main communication styles used by interpreters: consecutive interpreting, where the interpreter exchanges what has been said by the clinician or patient after each one has finished speaking, and simultaneous interpreting, where the interpreter translates as the person is speaking. Interpreters and medical providers may have a preference and it is important to clarify, if needed, which method is preferred [21].

The provider should face the patient and direct conversation to him or her rather than to the interpreter. Third-person statements should not be used, such as “tell her,” as this directs the conversation to the interpreter rather than to the patient [10]. By using the first and second person (when addressing the patient) and making eye contact, the relationship between the provider and patient is emphasized [14,40].

 

 

Choosing the right word is important to have meaningful communication. Interpreters advise that providers should understand that medical concepts may be unfamiliar to patients with LEP. Providers should use simpler words rather than medical terminology to discuss medical issues [42]. In general, straightforward word choice is recommended [16]. Providers are advised to not use acronyms or idioms. It is important to note that humor may be difficult to convey as well [10].

Clinicians are advised to speak clearly and not quickly and to use shorter sentences with appropriate pauses to allow time for the interpreter to interpret (if consecutive rather than simultaneous interpreting style is being used) [2,41,43,44]. In addition to limiting speech to one to two sentences at a time, asking one question at a time is important for optimal communication [43]. To improve information gathering, patients may respond better to open-ended questions [42], which is an aspect of patient-centered communication, as directive questioning often leads to shorter answers [43].

Furthermore, the provider should be aware that persons with LEP may know some English, so statements that one would not say to an English-speaking patient should not be said in the room with a person with LEP [10].

Encouraging the interpreter to clarify certain concepts, if necessary, may provide for improved information exchange [21] as well as encouraging the patient to ask questions during the medical visit may help elucidate potential areas of confusion [22,40,44]. Summarizing important concepts [40] and limiting the number of concepts discussed may increase patient understanding [10]. Additionally, asking the patient to repeat what was discussed in his or her words [10], rather than directly asking if he or she understands, will allow for more meaningful assessment of patient understanding [43].

Finally, recognition that interpreters may experience distress after certain visits, such as an oncologic medical encounters, is important and debriefing may be desired by the interpreter [22,45]. Also, discussing any communication concerns may be helpful [40,42] in addition to discussing certain cultural beliefs that impacted the visit may be educational for the provider [45].

Case Continued

After the female translator arrived, the physician asked the patient if she felt comfortable with her mother in the room for this medical visit. After the patient confirmed that she wanted her mother present, the physician tried to further clarify the reason for the medical visit. Her mother, appearing very concerned, began speaking quickly to the interpreter without stopping for interpretation. When the mother did stop speaking, the interpreter, rather than informing the provider what was spoken of by the mother, dialoged with the mother and the back and forth conversation continued.

  • What are strategies to optimize the medical visit when the provider is not satisfied with the flow of conversation?

If there are conversations occurring between the patient and interpreter with the exclusion of the provider, the provider should request sentence-by-sentence interpretation by the interpreter. If the interpreter is answering on behalf of the patient, providers should redirect communication to the patient [10]. At times, patients may speak for longer periods without stopping for the interpreter to provide accurate information exchange. The provider in this case may need to interrupt conversation to allow the interpreter time to convey what is being said [14].

If there are family members who know English, but the patient and/or others do not know English, there may be a risk of miscommunication if the exchange of medical information is done by a combination of family members and the interpreter, as the medical information may not accurately reflect what the clinician is trying to convey. The provider may need to redirect the conversation flow through the interpreter to make sure there is consistent information being communicated [22].

Case Continued

Finally, the provider interrupted. She emphasized with the patient, mother, and the interpreter that all that was being said should be interpreted. She asked the interpreter to sit next to the patient and mother (rather than lateral to the physician) so that eye contact between the patient and mother and the provider could be maintained thus supporting the patient-provider relationship. She then asked one question at a time to the patient. She needed to interrupt the conversation again when the mother started to speak to the interpreter without waiting for interpretation. The doctor reemphasized the need to allow time for the interpreter to adequately convey the information. After this the medical visit progressed successfully. Soon the provider found out that the mother was concerned that something serious could be happening to her daughter, as her daughter previously had a miscarriage. After hearing the mother’s concern, the provider was able to clarify with the daughter that the pain was suprapubic and she was having burning when she urinated. After further evaluation, the provider diagnosed a urinary tract infection. She told the patient about the diagnosis and provided her with appropriate medication and instructions on how to take it and for how long. The provider then asked the patient to tell her what she understood about the diagnosis and how to take the medication. The doctor then asked if either had any further questions. After the medical visit, the provider made sure that the patient’s chart reflected the need for a Somali interpreter with the notation that a female interpreter was preferred.

Conclusion

When working with persons with LEP, providing a professional medical interpreter will facilitate optimal communication. In-person and remote (videoconferencing or telephonic) interpreting are options. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient not the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately. Clinicians should remember that patients may have a preference in the gender and dialect of the interpreter and accommodations should be made if available. Finally, asking the patient to repeat back in his or her own words what has been discussed is important to make sure the patient understood what was communicated during the medical visit [10,16].

 

Corresponding author: Kimberly Schoonover, MD, 200 First Street SW, Rochester, MN 55905, Schoonover.Kimberly@mayo.edu.

Financial disclosures: None.

From the Department of Medicine, Mayo Clinic, Rochester, MN.

 

Abstract

  • Objective: To provide an overview of important aspects of interpreting for medical visits for persons with limited English proficiency (LEP).
  • Methods: Literature review.
  • Results: When working with persons of LEP, providing a professional medical interpreter will facilitate optimal communication. Interpreters may work in different roles including as a conduit, cultural broker, clarifier, and advocate. In-person and remote (videoconferencing or telephonic) interpreting are available and one may be preferred depending on the medical visit. Clinicians should recognize that patients may have a preference for the interpreter’s gender and dialect and accommodations should be made if possible. Prior to the visit, the provider may want to clarify the goals of the medical encounter with the interpreter as some topics may be viewed differently in certain cultures. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient rather than to the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately to allow interpretation. Additionally, providers should assess patient understanding of what has been discussed. After the medical visit, providers should consider discussing with the interpreter any issues with communication or cultural factors noted to have affected the visit.
  • Conclusion: Providers should utilize a professional medical interpreter for visits with persons with LEP. Appropriate communication techniques, including talking in first and second tenses and maintaining eye contact with the patient rather than the interpreter, are important for a successful visit. Realizing patients may have interpreter preferences is also important to facilitate patient-centered-care.

Key words: language barriers; quality of care; physician-patient communication; interpreter services.

 

The United States is a diverse country that includes many persons whose first language is not English. According to the U.S. Census Bureau, more than 63 million persons age 5 and above (about 51 million adults) reported speaking a language other than English at home. Also, about 25.7 million of the population age 5 and up (around 10.6 million adults) noted speaking English less than “very well” [1]. Protecting people from discrimination based on the language they speak is highlighted in Title VI of the Civil Rights Act of 1964 (which focuses on those receiving federal funding). President Clinton, furthermore, in 2000 signed Executive Order 13166, which encouraged federal agencies to provide appropriate access of their services to those with limited English proficiency (LEP) [2,3].

The benefits of using professional interpreters is well-documented. In addition to increased satisfaction with communication when professional medical interpreters are used [4], they also make fewer clinically significant interpretation errors compared to ad hoc interpreters (ie, untrained individuals such as bilingual staff member, family member, or friend who are asked to interpret) [5–7]. LEP patients who do not have a professional interpreter have less understanding of their medical issues, have less satisfaction of their medical care, and may have more tests ordered and be hospitalized more often compared to those who do utilize professional medical interpreters [8]. In addition to improved satisfaction and understanding of medical diagnoses, hospitalized persons requiring interpreters who utilized a professional medical interpreter on admission and discharge were noted to have a shorter length of stay than persons who required an interpreter and did not receive one [9].

Despite the documented benefits of using professional interpreters, they are underutilized. Reasons include underfunded medical interpreting services [10,11], lack of awareness of the risks involved with using an ad hoc interpreter [2,12], providers using their own or another worker’s limited second language skills to communicate rather than using a professional medical interpreter [13,14], perceived delay in obtaining a professional medical interpreter, and judging a medical situation as minor rather than complex [13]. In this article, the roles, importance, and considerations of using a professional medical interpreter are explored.

Case Study

Initial Presentation

A 23-year-old married Somali-speaking female who moved to the United States recently called a local primary care provider’s office to schedule an appointment. When asked the reason for the visit, she said the reason was private. The clinical assistant scheduled her with the next available provider.

When the patient arrived for her clinic appointment, a clinical assistant roomed her and her mother and asked the patient the reason for the visit. The patient remained quiet and her mother replied that she needed to speak with the doctor. When the female medical provider entered, she observed that the patient appeared anxious. When the doctor initiated conversation with the patient, she noted that her English was limited. Her mother tried to explain the reason for the visit saying her daughter was having severe pain. She then pointed towards her daughter’s lower abdomen. The clinician noted the limited English abilities of the patient and mother and used the interpreter line to request a Somali interpreter and placed the first available interpreter available on speaker.

  • How can patients who need an interpreter be identified?

 

If a person does not speak any English, then an interpreter is necessary; however, sometimes whether a person from a non-English speaking background would benefit from an interpreter is unclear. If a patient is answering only in nods or yes/no responses or answering questions inconsistently, further evaluation should be done. Asking open-ended questions and/or having the patient repeat what is his or her understanding of the conversation will help determine if the person may benefit from an interpreter [12] (Table 1).

Health care systems can facilitate identifying patients in need of an interpreter by routinely collecting information on LEP status. The patient should be asked during registration if her or she speaks English and has a preferred language, and the answers should be recorded in the medical record [3]. If an interpreter is used during the hospital stay, it should be recorded to alert future providers to the need of an interpreter [15]. Patients may speak a dialect of a common language and this also should be noted, as an interpreter with a similar dialect to the patient should ideally be requested when necessary [16]. Furthermore, health care systems can measure rate of screening for language need at registration and rate of interpreter use during hospital stay to assess language need and adequacy of provision of interpreters to LEP patients [15].

It should be noted that patients may be wary about the presence of an interpreter. In one study involving pediatric oncologists and Spanish-speaking parents, the former reported concern regarding the accuracy of interpretation and the latter were concerned about missing out on important information even with the use of professional medical interpreters [17]. The concern for accuracy of interpreting was shared in a study by Chinese and Vietnamese Americans with LEP [18] as well as in a Swedish study involving Arabic-speaking persons. In the latter study, Arabic-speaking patients also felt uncomfortable speaking about bodily issues in the presence of interpreters [19]. In a study of Latina patients, there were concerns about confidentiality with interpreters [20].

  • What is the role of the interpreter? Should they offer emotional support to the patient?

Interpreter-as-conduit reflects a neutral, more literal information exchange and is preferred by certain medical providers who prioritize a more exact interpretation of the medical conversation. In this role, the interpreter assumes a more passive role and the emphasis is on the interpreter’s linguistic ability [21]. Providers need to be aware that word-for-word interpretation may not align with what is regarded as culturally sensitive care—such as when the term “cancer” is to be used. Also, word-for-word interpretation does not necessarily mean the patient will understand what is being interpreted if the terminology does not reflect the literacy level or dialect of the person with LEP [22].

Interpreters may also assume an active role, sometimes referred to as clarifier and cultural broker. Clarifying may be utilized, for example, when a medical provider is discussing complicated treatment options. This requires an interpreter to step out of a conduit role (if that is the preferred role) and confirm or clarify information to ensure accurate information exchange [21,23]. As a cultural broker, communication between provider and patient is exchanged in a manner that reflects consideration of the patient’s cultural background. Interpreters may explain, to the provider, the cultural reason for the patient’s perspective of what is causing or contributing to the illness. Cultural brokering may as well include communicating the medical terminology and disease explanation, given by the medical provider, in a way that the patient would understand. This role, additionally, can involve educating the provider about aspects of the culture that may influence the patient’s communication with him or her [22].

Furthermore, interpreters may fulfill an advocate role for patients by helping them understand the health care system and increasing patient empowerment by seeking information and services that the patient may not know to ask about [23].

The interpreter may offer emotional support during a medical visit, for example, where the diagnosis of cancer is conveyed. In such a case, an interpreter’s emotional support may be considered by providers to be appropriate. In contrast, with visits related to mental health evaluations, having the interpreter remain neutral, rather than being a more active participant by offering emotional support, may be preferred [24]. In addition to interpreters remaining more neutral during mental health visits, providers may prefer that interpreters not speak with the patient prior to the visit, depending on the mental health condition, as negative therapeutic consequences may occur [21]. Trust is an important element of the provider-patient relationship and, as such, there is concern on the part of some providers that if the trust of patients falls to the interpreter rather than to the provider, then therapeutic progress may be compromised [24]. In general, clarifying with interpreters the goals of the visit and expectations regarding speaking to the patient outside of the visit may ensure the provider-patient relationship is not diminished [21].

  • What are the disadvantages and caveats of using family members or bilingual staff as interpreters?

Although family members and other ad hoc interpreters may be present and willing to interpret, the risk of miscommunication is greater than with professional medical interpreters [5,6]. This risk of miscommunication extends to partially bilingual medical providers who do not utilize appropriate interpreter services [10,25]. Ad hoc interpreters may try to answer on behalf the patient [6,26] and may not have the appropriate medical terminology to correctly interpret what the provider is trying to communicate to the patient [6].

Professional medical interpreters are trained to facilitate communication of a spoken language in a medical setting [2,10]. Certification is offered by the National Board of Certification for Medical Interpreters and the Certification Commission for Healthcare Interpreters. In order to be certified certain requirements must be met which include a minimum of 40 hours of health care interpreter training (which includes medical terminology as well as roles and ethics involved in medical interpreting) as well as demonstrated oral proficiency in English as well as another chosen language (such as Spanish) [10].

In certain circumstances, patients may feel more comfortable disclosing personal details with a professional medical interpreter rather than in the presence of an ad hoc interpreter. For example, more details of traumatic events and psychological symptoms were spoken of in the presence of a professional, rather than an ad hoc, interpreter in medical interviews of asylum seekers requiring an interpreter in Switzerland. In the presence of ad hoc interpreters, more physical symptoms were disclosed rather than psychological [6].

Furthermore, in visits concerning sexuality or abuse issues, using family members as interpreters may violate privacy concerns of the patient [2,27]. Additionally, in certain cultures where respect for elders is very important, parents who use children as interpreters may feel that the structure of the family changes when he or she interprets on behalf of the parent [18]. Also, what children consider as embarrassing may not be interpreted to either the parent or to the care provider [8]. Furthermore, one should note there are ethical issues of using non-adult children as interpreters in situations involving confidentiality and privacy—by doing so, there may be resulting harmful effects on non-adult children [27,28].

Patients may at times decline the use of a professional medical interpreter and prefer to have a family member interpret; this preference should be documented in the patient’s medical chart [10]. Caution should be had using an ad hoc interpreter when obtaining informed consent [12].

 

 

 

  • What professional interpreting services are available to the clinician?

For the most part, access to interpreters via a telephone service is widely available [10]. The cost of providing interpreters in-person and/or remotely varies depending on the health care site [29–31] In general, considerations of using professional medical interpreters, whether remotely or in-person, involves accessibility and cost. There are certain sites that have explored having a shared network of interpreters available via the telephone and videoconference to reduce the cost of providing interpreters for individual hospitals [32]. While the costs of providing a person with LEP with interpretation varies depending on the health care site, the costs of not providing a professional medical interpreter should be considered as well, which include greater malpractice risk and potential medical errors [32]. In addition, the use of employees as interpreters takes time away from their respective jobs, which results in staff time lost [31].

In-person interpreting may be preferred for certain medical visits, as an in-person interpreter can interpret both verbal and nonverbal communication [16]. When emotional support is anticipated, in-person interpreting is usually preferred by providers [24]. There may be improved cultural competence when using an in-person interpreter, which may be important for certain visits such as those involving end-of life care discussions [4]. One concern may involve the comfort level of the patient if he or she personally knows the interpreter; this can occur in smaller ethnic communities [12]. Telephonic interpreting may be preferred in certain medical situations where confidentiality is desired [16].

Telephonic interpreting offers greater accessibility as it is not limited by time of the day or geographic location and less common language interpreters are available. Disadvantages of telephonic interpretation include lack of ability to interpret body language and, at times, problems with communication related to background noise [27]. Also, some providers feel that rapport building is more difficult with telephonic interpreting [13]. Using a double-headset telephone or speaker phone (in a private setting preferably), instead of passing the telephone headset between provider and patient, is recommended to optimize provider-patient communication [2]. Remote videoconference interpretation is also an option in many places. Videoconferencing offers the advantage of interpretation of nonverbal communication that would be absent in telephonic interpreting [33]. Also, accessibility to languages is improved, especially for languages not covered by in-person interpreters depending on the health care site [34]. Disadvantages of videoconferencing interpretation include technical problems due to wireless networking issues [33] (Table 2).

For providers working with persons who are deaf, options for interpreting include in-person sign language interpreters as well as remote videoconference interpretation [10].

  • Are in-person interpreting and remote interpreting comparable?

In general, using in-person or remote interpreters does not significantly change patient satisfaction. In a study involving Spanish-speaking patients in a clinic setting, persons requiring an interpreter rated satisfaction of interpreting between in-person, videoconferencing, and telephonic methods highly with no significant differences. Of note, though, medical providers and interpreters preferred in-person rather than the 2 remote interpreting options [33]. In a different study involving Spanish, Chinese, Russian, or Vietnamese interpreters, satisfaction of information exchange was considered equal among the 3 interpreting modalities, although in-person interpreting was felt to establish rapport between clinician and patient with LEP better than telephonic and videoconferencing interpreting [35]. Additionally, in a study of providers in a clinic setting who worked with persons with LEP, no significant differences were noted in provider satisfaction of the medical visit, or in the quality of interpretation or communication, when using in-person versus remote videoconferencing interpretation. Providers, though, noted improved knowledge of the patient’s cultural beliefs when using in-person interpreting [4].

Regarding the question of a difference in understanding when using in-person versus remote interpreters, a study was done in a pediatric emergency department (ED) that compared in-person and telephonic interpretation. Family understanding of the discharge diagnosis was high (about 95%) regardless of whether an in-person or telephonic interpreter was utilized [36]. In a different study comparing telephone and video interpretation in a pediatric ED, while quality of communication and interpretation were rated similarly, the parents who used video interpretation were more likely to name their child’s diagnosis correctly [29].

Case Continued

The physician proceeded with introductions and explained that all conversations would be interpreted. She further stated that if there were any questions, the patient and mother should feel free to ask them. Via the interpreter, who was male, the provider began by asking about the nature of the abdominal pain. The patient looked to her mother and then down without answering. The mother nodded, but did not say more. The provider wondered if their reticence might be due to discomfort with discussing the issue through a male interpreter. The physician asked the patient if she would prefer a female interpreter and, once that was confirmed, she asked if she wanted an in-person or telephonic interpreter. The mother requested a female in-person interpreter.

  • How might gender-specific issues impact working with an interpreter?

As gender concordance of patient and physician [37] at times is desired, gender concordance of patient and interpreter [16,18] may also be important to optimize communication of gender-specific issues [16,18,37]. For example, an Arabic-speaking man from the Middle East may prefer to discuss sexuality-related concerns in the presence of a male rather than female interpreter [16]. An Arabic-speaking female who has a preference for female providers may prefer a female interpreter when discussing sexuality and undergoing a physical examination [19]. In one study, the majority of Somali females preferred female interpreters as well as female providers for breast, pelvic, and abdominal examinations [38]. If a same-gender interpreter cannot be present, an option is to have the interpreter either leave the room or step behind a curtain or turn away from the patient during a sensitive part of the physical examination [39].

  • What are recommended strategies for using a medical interpreter?

It is often helpful to have a brief discussion with the interpreter prior to the medical visit with the patient to speak about the general topics that will be discussed (especially if the topics involve sensitive issues or news that could be upsetting to the patient) and the goal of the visit [2, 11]. Certain topics may be viewed dissimilarly in different cultures, thus approaching the interpreter from the view point of cultural broker or liaison [10] may bring to light cultural factors that may influence the medical visit [40,41]. the name of the interpreter should be noted for documentation purposes [10].

To start the visit, introductions of everyone involved should take place with a brief disclosure about the role of the interpreter and assurance of confidentiality on the part of the interpreter [2,11]. Also, the provider should set the expectation that all statements said in the room will be interpreted so that all persons can understand what it being spoken [10].

There are several options for where each person should be positioned. In some medical visits, a triangle is pursued where the interpreter sits lateral to the provider, but this may lead to challenges in maintaining eye contact between the patient and provider. Another option is have the interpreter sit next to [10] and slightly behind the patient to improve eye contact between provider-patient and to maintain the patient-provider relationship [2,41]. When seated, the medical provider should try to sit at the same level as the patient [16]. Seating is different with persons requiring the use of sign language interpreters as the interpreter needs to be visible to the patient for communications purposes. One possibility is having the interpreter sit beside and slightly behind the provider; this positioning allows the patient to understand what is being communicated and also allows the patient to understand what is being communicated and allows him or her to see the provider during the conversation [40].

There are 2 main communication styles used by interpreters: consecutive interpreting, where the interpreter exchanges what has been said by the clinician or patient after each one has finished speaking, and simultaneous interpreting, where the interpreter translates as the person is speaking. Interpreters and medical providers may have a preference and it is important to clarify, if needed, which method is preferred [21].

The provider should face the patient and direct conversation to him or her rather than to the interpreter. Third-person statements should not be used, such as “tell her,” as this directs the conversation to the interpreter rather than to the patient [10]. By using the first and second person (when addressing the patient) and making eye contact, the relationship between the provider and patient is emphasized [14,40].

 

 

Choosing the right word is important to have meaningful communication. Interpreters advise that providers should understand that medical concepts may be unfamiliar to patients with LEP. Providers should use simpler words rather than medical terminology to discuss medical issues [42]. In general, straightforward word choice is recommended [16]. Providers are advised to not use acronyms or idioms. It is important to note that humor may be difficult to convey as well [10].

Clinicians are advised to speak clearly and not quickly and to use shorter sentences with appropriate pauses to allow time for the interpreter to interpret (if consecutive rather than simultaneous interpreting style is being used) [2,41,43,44]. In addition to limiting speech to one to two sentences at a time, asking one question at a time is important for optimal communication [43]. To improve information gathering, patients may respond better to open-ended questions [42], which is an aspect of patient-centered communication, as directive questioning often leads to shorter answers [43].

Furthermore, the provider should be aware that persons with LEP may know some English, so statements that one would not say to an English-speaking patient should not be said in the room with a person with LEP [10].

Encouraging the interpreter to clarify certain concepts, if necessary, may provide for improved information exchange [21] as well as encouraging the patient to ask questions during the medical visit may help elucidate potential areas of confusion [22,40,44]. Summarizing important concepts [40] and limiting the number of concepts discussed may increase patient understanding [10]. Additionally, asking the patient to repeat what was discussed in his or her words [10], rather than directly asking if he or she understands, will allow for more meaningful assessment of patient understanding [43].

Finally, recognition that interpreters may experience distress after certain visits, such as an oncologic medical encounters, is important and debriefing may be desired by the interpreter [22,45]. Also, discussing any communication concerns may be helpful [40,42] in addition to discussing certain cultural beliefs that impacted the visit may be educational for the provider [45].

Case Continued

After the female translator arrived, the physician asked the patient if she felt comfortable with her mother in the room for this medical visit. After the patient confirmed that she wanted her mother present, the physician tried to further clarify the reason for the medical visit. Her mother, appearing very concerned, began speaking quickly to the interpreter without stopping for interpretation. When the mother did stop speaking, the interpreter, rather than informing the provider what was spoken of by the mother, dialoged with the mother and the back and forth conversation continued.

  • What are strategies to optimize the medical visit when the provider is not satisfied with the flow of conversation?

If there are conversations occurring between the patient and interpreter with the exclusion of the provider, the provider should request sentence-by-sentence interpretation by the interpreter. If the interpreter is answering on behalf of the patient, providers should redirect communication to the patient [10]. At times, patients may speak for longer periods without stopping for the interpreter to provide accurate information exchange. The provider in this case may need to interrupt conversation to allow the interpreter time to convey what is being said [14].

If there are family members who know English, but the patient and/or others do not know English, there may be a risk of miscommunication if the exchange of medical information is done by a combination of family members and the interpreter, as the medical information may not accurately reflect what the clinician is trying to convey. The provider may need to redirect the conversation flow through the interpreter to make sure there is consistent information being communicated [22].

Case Continued

Finally, the provider interrupted. She emphasized with the patient, mother, and the interpreter that all that was being said should be interpreted. She asked the interpreter to sit next to the patient and mother (rather than lateral to the physician) so that eye contact between the patient and mother and the provider could be maintained thus supporting the patient-provider relationship. She then asked one question at a time to the patient. She needed to interrupt the conversation again when the mother started to speak to the interpreter without waiting for interpretation. The doctor reemphasized the need to allow time for the interpreter to adequately convey the information. After this the medical visit progressed successfully. Soon the provider found out that the mother was concerned that something serious could be happening to her daughter, as her daughter previously had a miscarriage. After hearing the mother’s concern, the provider was able to clarify with the daughter that the pain was suprapubic and she was having burning when she urinated. After further evaluation, the provider diagnosed a urinary tract infection. She told the patient about the diagnosis and provided her with appropriate medication and instructions on how to take it and for how long. The provider then asked the patient to tell her what she understood about the diagnosis and how to take the medication. The doctor then asked if either had any further questions. After the medical visit, the provider made sure that the patient’s chart reflected the need for a Somali interpreter with the notation that a female interpreter was preferred.

Conclusion

When working with persons with LEP, providing a professional medical interpreter will facilitate optimal communication. In-person and remote (videoconferencing or telephonic) interpreting are options. When using an interpreter, the provider should maintain eye contact with and direct speech to the patient not the interpreter. The provider should speak clearly, avoid complex terminology, and pause appropriately. Clinicians should remember that patients may have a preference in the gender and dialect of the interpreter and accommodations should be made if available. Finally, asking the patient to repeat back in his or her own words what has been discussed is important to make sure the patient understood what was communicated during the medical visit [10,16].

 

Corresponding author: Kimberly Schoonover, MD, 200 First Street SW, Rochester, MN 55905, Schoonover.Kimberly@mayo.edu.

Financial disclosures: None.

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14. Philips C. Using interpreters--a guide for GPs. Austr Fam Physician 2010;39:188–95.

15. Boscolo-Hightower A, Rafton SA, Tolman M, et al. Identifying families with limited English proficiency using a capture-recapture approach. Hosp Pediatr 2014;4:16–22.

16. Hadziabdic E, Hjelm K. Working with interpreters: practical advice for use of an interpreter in healthcare. Int J Evid Based Healthc 2013;11:69–76.

17. Abbe M, Simon C, Angiolillo A, et al. A survey of language barriers from the perspective of pediatric oncologists, interpreters, and parents. Pediatr Blood Cancer 2006;47:819–24.

18. Ngo-Metzger Q, Massagli MP, Clarridge BR, et al. Linguistic and cultural barriers to care. J Gen Intern Med 2003;18:44–52.

19. Hadziabdic E, Hjelm K. Arabic-speaking migrants’ experiences of the use of interpreters in healthcare: a qualitative explorative study. Int J Equity Health 2014;13:49.

20. Julliard K, Vivar J, Delgado C, et al. What Latina patients don’t tell their doctors: a qualitative study. Ann Family Med 2008;6:543–9.

21. Hsieh E, Ju H, Kong H. Dimensions of trust: the tensions and challenges in provider--interpreter trust. Qual Health Res 2010;20:170–81.

22. Butow PN, Lobb E, Jefford M, et al. A bridge between cultures: interpreters’ perspectives of consultations with migrant oncology patients. Support Care Cancer 2012;20:235-44.

23. Hsieh E. “I am not a robot!” Interpreters’ views of their roles in health care settings. Qual Health Res 2008;18:1367–83.

24. Hsieh E, Hong SJ. Not all are desired: providers’ views on interpreters’ emotional support for patients. Patient Educ Couns 2010;81:192–7.

25. Elderkin-Thompson V, Silver RC, Waitzkin H. When nurses double as interpreters: a study of Spanish-speaking patients in a US primary care setting. Soc Sci Med 2001;52:1343–58.

26. Napoles AM, Santoyo-Olsson J, Karliner LS, et al. Inaccurate language interpretation and its clinical significance in the medical encounters of Spanish-speaking Latinos. Med Care 2015;53:940–7.

27. Gray B, Hilder J, Donaldson H. Why do we not use trained interpreters for all patients with limited English proficiency? Is there a place for using family members? Austr J Prim Health 2011;17:240–9.

28. Jacobs B, Kroll L, Green J, David TJ. The hazards of using a child as an interpreter. J Royal Soc Med 1995;88:474P–5P.

29. Lion KC, Brown JC, Ebel BE, et al. Effect of telephone vs video interpretation on parent comprehension, communication, and utilization in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr 2015;169:1117–25.

30. Wofford JL CC, Johnson DA, Brown MT. Providing a Spanish interpreter using low-cost videoconferencing in a community health centre: a pilot study using tablet computers. Inform Prim Care 2012;20:141–6.

31. Jacobs EA SL, Rathouz PJ. The impact of an enhanced interpreter service intervention on hospital costs and patient satisfaction. J Gen Intern Med 2007;22(Suppl 2):306–11.

32. Jacobs EA LG, Rathouz PJ, Fu P Jr. Shared networks of interpreter services, at relatively low cost, can help providers serve patients with limited english skills. Health Aff (Millwood) 2011;30:1930–8.

33. Locatis C, Williamson D, Gould-Kabler C, et al. Comparing in-person, video, and telephonic medical interpretation. J Gen Intern Med 2010;25:345–50.

34. Jones D, Gill P, Harrison R, et al. An exploratory study of language interpretation services provided by videoconferencing. J Telemed Telecare 2003;9:51–6.

35. Price EL, Perez-Stable EJ, Nickleach D, et al. Interpreter perspectives of in-person, telephonic, and videoconferencing medical interpretation in clinical encounters. Patient Educ Couns 2012;87:226–32.

36. Crossman KL, Wiener E, Roosevelt G, et al. Interpreters: telephonic, in-person interpretation and bilingual providers. Pediatrics 2010;125:e631–8.

37. Degni F, Suominen S, Essen B, et al. Communication and cultural issues in providing reproductive health care to immigrant women: health care providers’ experiences in meeting the needs of [corrected] Somali women living in Finland. J Immigr Minor Health 2012;14:330–43.

38. Odunukan OW, Abdulai RM, Hagi Salaad MF, et al. Provider and interpreter preferences among Somali women in a primary care setting. J Prim Care Comm Health 2015;6:105–10.

39. Poss JE, Beeman T. Effective use of interpreters in health care: guidelines for nurse managers and clinicians. Semin Nurse Manag 1999;7:166–71.

40. Phelan M, Parkman S. How to work with an interpreter. BMJ 1995;311:555–7.

41. Lubrano di Ciccone B, Brown RF, Gueguen JA, et al. Interviewing patients using interpreters in an oncology setting: initial evaluation of a communication skills module. Ann Oncol 2010;21:27–32.

42. Hudelson P. Improving patient-provider communication: insights from interpreters. Fam Pract 2005;22:311–6.

43. Hudelson P, Dao MD, Perron NJ, Bischoff A. Interpreter-mediated diabetes consultations: a qualitative analysis of physician communication practices. BMC Fam Pract 2013;14:163.

44. Green AR, Ngo-Metzger Q, Legedza AT, et al. Interpreter services, language concordance, and health care quality. Experiences of Asian Americans with limited English proficiency. J Gen Intern Med 2005;20:1050–6.

45. Schenker Y, Smith AK, Arnold RM, Fernandez A. “Her husband doesn’t speak much English”: conducting a family meeting with an interpreter. J Palliat Med 2012;15:494–8.

References

1. U.S. Census Bureau. American community survey. Accessed 11 Jul 2016 at www.census.gov/acs/www.

2. Wiener ESR, Ivonne M. Bridging language barriers: how to work with an interpreter. Clin Pediatr Emerg Med 2004;5:93–101.

3. Perez-Stable EJ, Karliner LS. What do we know about patient-clinician interactions with interpreters? J Gen Intern Med 2013;28:339–41.

4. Napoles AM, Santoyo-Olsson J, Karliner LS, et al. Clinician ratings of interpreter mediated visits in underserved primary care settings with ad hoc, in-person professional, and video conferencing modes. J Health Care Poor Underserved 2010;21:301–17.

5. Flores G, Abreu M, Barone CP, et al. Errors of medical interpretation and their potential clinical consequences: a comparison of professional versus ad hoc versus no interpreters. Ann Emerg Med 2012;60:545–53.

6. Bauer AM, Alegria M. Impact of patient language proficiency and interpreter service use on the quality of psychiatric care: a systematic review. Psychiatr Serv 2010;61:765–73.

7. Karliner LS, Jacobs EA, Chen AH, Mutha S. Do professional interpreters improve clinical care for patients with limited English proficiency? A systematic review of the literature. Health Serv Res 2007;42:727–54.

8. Flores G. The impact of medical interpreter services on the quality of health care: a systematic review. Med Care Res Rev 2005;62:255–99.

9. Lindholm M, Hargraves JL, Ferguson WJ, Reed G. Professional language interpretation and inpatient length of stay and readmission rates. J Gen Intern Med 2012;27:1294–9.

10. Juckett G, Unger K. Appropriate use of medical interpreters. Am Fam Physician 2014;90:476–80.

11. Schapira L, Vargas E, Hidalgo R, et al. Lost in translation: integrating medical interpreters into the multidisciplinary team. Oncologist 2008;13:586–92.

12. Gray B, Hilder J, Stubbe M. How to use interpreters in general practice: the development of a New Zealand toolkit. J Prim Health Care 2012;4:52–61, A1-8.

13. Hsieh E. Not just “getting by”: factors influencing providers’ choice of interpreters. J Gen Intern Med 2015;30:75–82.

14. Philips C. Using interpreters--a guide for GPs. Austr Fam Physician 2010;39:188–95.

15. Boscolo-Hightower A, Rafton SA, Tolman M, et al. Identifying families with limited English proficiency using a capture-recapture approach. Hosp Pediatr 2014;4:16–22.

16. Hadziabdic E, Hjelm K. Working with interpreters: practical advice for use of an interpreter in healthcare. Int J Evid Based Healthc 2013;11:69–76.

17. Abbe M, Simon C, Angiolillo A, et al. A survey of language barriers from the perspective of pediatric oncologists, interpreters, and parents. Pediatr Blood Cancer 2006;47:819–24.

18. Ngo-Metzger Q, Massagli MP, Clarridge BR, et al. Linguistic and cultural barriers to care. J Gen Intern Med 2003;18:44–52.

19. Hadziabdic E, Hjelm K. Arabic-speaking migrants’ experiences of the use of interpreters in healthcare: a qualitative explorative study. Int J Equity Health 2014;13:49.

20. Julliard K, Vivar J, Delgado C, et al. What Latina patients don’t tell their doctors: a qualitative study. Ann Family Med 2008;6:543–9.

21. Hsieh E, Ju H, Kong H. Dimensions of trust: the tensions and challenges in provider--interpreter trust. Qual Health Res 2010;20:170–81.

22. Butow PN, Lobb E, Jefford M, et al. A bridge between cultures: interpreters’ perspectives of consultations with migrant oncology patients. Support Care Cancer 2012;20:235-44.

23. Hsieh E. “I am not a robot!” Interpreters’ views of their roles in health care settings. Qual Health Res 2008;18:1367–83.

24. Hsieh E, Hong SJ. Not all are desired: providers’ views on interpreters’ emotional support for patients. Patient Educ Couns 2010;81:192–7.

25. Elderkin-Thompson V, Silver RC, Waitzkin H. When nurses double as interpreters: a study of Spanish-speaking patients in a US primary care setting. Soc Sci Med 2001;52:1343–58.

26. Napoles AM, Santoyo-Olsson J, Karliner LS, et al. Inaccurate language interpretation and its clinical significance in the medical encounters of Spanish-speaking Latinos. Med Care 2015;53:940–7.

27. Gray B, Hilder J, Donaldson H. Why do we not use trained interpreters for all patients with limited English proficiency? Is there a place for using family members? Austr J Prim Health 2011;17:240–9.

28. Jacobs B, Kroll L, Green J, David TJ. The hazards of using a child as an interpreter. J Royal Soc Med 1995;88:474P–5P.

29. Lion KC, Brown JC, Ebel BE, et al. Effect of telephone vs video interpretation on parent comprehension, communication, and utilization in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr 2015;169:1117–25.

30. Wofford JL CC, Johnson DA, Brown MT. Providing a Spanish interpreter using low-cost videoconferencing in a community health centre: a pilot study using tablet computers. Inform Prim Care 2012;20:141–6.

31. Jacobs EA SL, Rathouz PJ. The impact of an enhanced interpreter service intervention on hospital costs and patient satisfaction. J Gen Intern Med 2007;22(Suppl 2):306–11.

32. Jacobs EA LG, Rathouz PJ, Fu P Jr. Shared networks of interpreter services, at relatively low cost, can help providers serve patients with limited english skills. Health Aff (Millwood) 2011;30:1930–8.

33. Locatis C, Williamson D, Gould-Kabler C, et al. Comparing in-person, video, and telephonic medical interpretation. J Gen Intern Med 2010;25:345–50.

34. Jones D, Gill P, Harrison R, et al. An exploratory study of language interpretation services provided by videoconferencing. J Telemed Telecare 2003;9:51–6.

35. Price EL, Perez-Stable EJ, Nickleach D, et al. Interpreter perspectives of in-person, telephonic, and videoconferencing medical interpretation in clinical encounters. Patient Educ Couns 2012;87:226–32.

36. Crossman KL, Wiener E, Roosevelt G, et al. Interpreters: telephonic, in-person interpretation and bilingual providers. Pediatrics 2010;125:e631–8.

37. Degni F, Suominen S, Essen B, et al. Communication and cultural issues in providing reproductive health care to immigrant women: health care providers’ experiences in meeting the needs of [corrected] Somali women living in Finland. J Immigr Minor Health 2012;14:330–43.

38. Odunukan OW, Abdulai RM, Hagi Salaad MF, et al. Provider and interpreter preferences among Somali women in a primary care setting. J Prim Care Comm Health 2015;6:105–10.

39. Poss JE, Beeman T. Effective use of interpreters in health care: guidelines for nurse managers and clinicians. Semin Nurse Manag 1999;7:166–71.

40. Phelan M, Parkman S. How to work with an interpreter. BMJ 1995;311:555–7.

41. Lubrano di Ciccone B, Brown RF, Gueguen JA, et al. Interviewing patients using interpreters in an oncology setting: initial evaluation of a communication skills module. Ann Oncol 2010;21:27–32.

42. Hudelson P. Improving patient-provider communication: insights from interpreters. Fam Pract 2005;22:311–6.

43. Hudelson P, Dao MD, Perron NJ, Bischoff A. Interpreter-mediated diabetes consultations: a qualitative analysis of physician communication practices. BMC Fam Pract 2013;14:163.

44. Green AR, Ngo-Metzger Q, Legedza AT, et al. Interpreter services, language concordance, and health care quality. Experiences of Asian Americans with limited English proficiency. J Gen Intern Med 2005;20:1050–6.

45. Schenker Y, Smith AK, Arnold RM, Fernandez A. “Her husband doesn’t speak much English”: conducting a family meeting with an interpreter. J Palliat Med 2012;15:494–8.

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Journal of Clinical Outcomes Management - December 2016, Vol. 23, No. 12
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Younger age, greater anxiety, affect pain after breast reconstruction

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Younger age, bilateral procedure, and presurgery depression and anxiety are among the significant contributors to pain after breast reconstruction surgery, according to findings from a prospective study of 2,207 women who underwent several types of breast reconstruction procedures.

Although breast reconstruction is an important element of breast cancer treatment, and most acute postoperative pain resolves with time and pain management intervention, some patients suffer from persistent, severe postoperative pain that increases their risk for long-term pain and clinical morbidity, wrote Anita R. Kulkarni, MD, of Memorial Sloan-Kettering Cancer Center, New York, and her colleagues.

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To identify patients at increased risk for higher levels of acute postoperative pain, the researchers assessed pain, patient characteristics, and medical/surgical variables before surgery and 1 week after surgery. Pain was assessed using the McGill Pain Questionnaire (MPQ)–Short Form, Numerical Pain Rating Scale (NPRS), and BREAST-Q chest and upper body scale. Depression and anxiety were assessed using the Patient Health Questionnaire and Generalized Anxiety Disorders Scale (JPRAS Open 2016. doi: 10.1016/j.jpra.2016.08.005).

Overall, greater acute postoperative pain was significantly associated with younger age, bilateral procedures, higher levels of preoperative pain, and higher levels of preoperative anxiety and depression, the researchers said.

“Moreover, the degree of patients’ self-reported preoperative anxiety and depressive symptoms both appeared to bear a linear relationship with the magnitude of increased postoperative pain at 1 week” on the MPQ sensory pain rating, they noted.

Similarly, lower scores of physical well-being based on the BREAST-Q physical well-being scale were significantly associated with younger age, bilateral procedures, immediate reconstruction, and higher levels of preoperative pain, anxiety, and depression.

The average age of the women was 50 years, and 87% were white. Most patients (69%) had tissue expander (TE)/implant reconstruction procedures; 93% were immediate reconstruction; and 53% were bilateral reconstruction. The majority (90%) underwent surgery as part of breast cancer treatment.

“The comparative effect of procedure type on postoperative pain showed variable results across our multiple pain scales,” the researchers said.

The patients who underwent autologous flap reconstruction procedures – pedicled transverse rectus abdominis myocutaneous flap (PTRAMS), deep inferior epigastric perforator (DIEP), or superficial inferior epigastric artery (SIEA) – reported less-severe postoperative pain than did those who had TE/Implant procedures. Specifically, patients with SIEA and DIEP procedures reported significantly less pain 1 week after surgery than did those who had TE/Implant procedures, based on the MPQ sensory scale. In addition, patients with PTRAMS reported significantly less postoperative pain 1 week after surgery than did those who had TE/Implant procedures based on the NPRS scale. All three flap procedures were significantly associated with less-severe postoperative pain, compared with TE/Implant procedures.

The findings support data from previous studies that identified preoperative pain, mood disturbance, and age as factors for increased risk of acute postoperative pain, the researchers noted. In addition, “the findings have important implications for the identification of women who might be at risk for significant early postoperative pain following breast reconstruction, as acute postoperative pain is associated with poor functional outcomes, diminished quality of life, and the risk for development of persistent postsurgical pain,” they wrote.

The study results were limited by several factors, including the lack of standardization for postoperative pain treatment regimens, variability in the timing of preoperative assessment, and nonresponder bias, the researchers said.

However, “Once high-risk patients are identified, appropriate referrals can be considered to facilitate careful monitoring of postsurgical pain for selected patients,” they said. “Early intervention can give clinicians the opportunity to reduce postoperative morbidity and improve patients’ surgical experience and satisfaction with breast reconstruction outcome,” they added.

The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health/National Cancer Institute.

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Younger age, bilateral procedure, and presurgery depression and anxiety are among the significant contributors to pain after breast reconstruction surgery, according to findings from a prospective study of 2,207 women who underwent several types of breast reconstruction procedures.

Although breast reconstruction is an important element of breast cancer treatment, and most acute postoperative pain resolves with time and pain management intervention, some patients suffer from persistent, severe postoperative pain that increases their risk for long-term pain and clinical morbidity, wrote Anita R. Kulkarni, MD, of Memorial Sloan-Kettering Cancer Center, New York, and her colleagues.

Pradit_Ph/Thinkstock
To identify patients at increased risk for higher levels of acute postoperative pain, the researchers assessed pain, patient characteristics, and medical/surgical variables before surgery and 1 week after surgery. Pain was assessed using the McGill Pain Questionnaire (MPQ)–Short Form, Numerical Pain Rating Scale (NPRS), and BREAST-Q chest and upper body scale. Depression and anxiety were assessed using the Patient Health Questionnaire and Generalized Anxiety Disorders Scale (JPRAS Open 2016. doi: 10.1016/j.jpra.2016.08.005).

Overall, greater acute postoperative pain was significantly associated with younger age, bilateral procedures, higher levels of preoperative pain, and higher levels of preoperative anxiety and depression, the researchers said.

“Moreover, the degree of patients’ self-reported preoperative anxiety and depressive symptoms both appeared to bear a linear relationship with the magnitude of increased postoperative pain at 1 week” on the MPQ sensory pain rating, they noted.

Similarly, lower scores of physical well-being based on the BREAST-Q physical well-being scale were significantly associated with younger age, bilateral procedures, immediate reconstruction, and higher levels of preoperative pain, anxiety, and depression.

The average age of the women was 50 years, and 87% were white. Most patients (69%) had tissue expander (TE)/implant reconstruction procedures; 93% were immediate reconstruction; and 53% were bilateral reconstruction. The majority (90%) underwent surgery as part of breast cancer treatment.

“The comparative effect of procedure type on postoperative pain showed variable results across our multiple pain scales,” the researchers said.

The patients who underwent autologous flap reconstruction procedures – pedicled transverse rectus abdominis myocutaneous flap (PTRAMS), deep inferior epigastric perforator (DIEP), or superficial inferior epigastric artery (SIEA) – reported less-severe postoperative pain than did those who had TE/Implant procedures. Specifically, patients with SIEA and DIEP procedures reported significantly less pain 1 week after surgery than did those who had TE/Implant procedures, based on the MPQ sensory scale. In addition, patients with PTRAMS reported significantly less postoperative pain 1 week after surgery than did those who had TE/Implant procedures based on the NPRS scale. All three flap procedures were significantly associated with less-severe postoperative pain, compared with TE/Implant procedures.

The findings support data from previous studies that identified preoperative pain, mood disturbance, and age as factors for increased risk of acute postoperative pain, the researchers noted. In addition, “the findings have important implications for the identification of women who might be at risk for significant early postoperative pain following breast reconstruction, as acute postoperative pain is associated with poor functional outcomes, diminished quality of life, and the risk for development of persistent postsurgical pain,” they wrote.

The study results were limited by several factors, including the lack of standardization for postoperative pain treatment regimens, variability in the timing of preoperative assessment, and nonresponder bias, the researchers said.

However, “Once high-risk patients are identified, appropriate referrals can be considered to facilitate careful monitoring of postsurgical pain for selected patients,” they said. “Early intervention can give clinicians the opportunity to reduce postoperative morbidity and improve patients’ surgical experience and satisfaction with breast reconstruction outcome,” they added.

The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health/National Cancer Institute.

Younger age, bilateral procedure, and presurgery depression and anxiety are among the significant contributors to pain after breast reconstruction surgery, according to findings from a prospective study of 2,207 women who underwent several types of breast reconstruction procedures.

Although breast reconstruction is an important element of breast cancer treatment, and most acute postoperative pain resolves with time and pain management intervention, some patients suffer from persistent, severe postoperative pain that increases their risk for long-term pain and clinical morbidity, wrote Anita R. Kulkarni, MD, of Memorial Sloan-Kettering Cancer Center, New York, and her colleagues.

Pradit_Ph/Thinkstock
To identify patients at increased risk for higher levels of acute postoperative pain, the researchers assessed pain, patient characteristics, and medical/surgical variables before surgery and 1 week after surgery. Pain was assessed using the McGill Pain Questionnaire (MPQ)–Short Form, Numerical Pain Rating Scale (NPRS), and BREAST-Q chest and upper body scale. Depression and anxiety were assessed using the Patient Health Questionnaire and Generalized Anxiety Disorders Scale (JPRAS Open 2016. doi: 10.1016/j.jpra.2016.08.005).

Overall, greater acute postoperative pain was significantly associated with younger age, bilateral procedures, higher levels of preoperative pain, and higher levels of preoperative anxiety and depression, the researchers said.

“Moreover, the degree of patients’ self-reported preoperative anxiety and depressive symptoms both appeared to bear a linear relationship with the magnitude of increased postoperative pain at 1 week” on the MPQ sensory pain rating, they noted.

Similarly, lower scores of physical well-being based on the BREAST-Q physical well-being scale were significantly associated with younger age, bilateral procedures, immediate reconstruction, and higher levels of preoperative pain, anxiety, and depression.

The average age of the women was 50 years, and 87% were white. Most patients (69%) had tissue expander (TE)/implant reconstruction procedures; 93% were immediate reconstruction; and 53% were bilateral reconstruction. The majority (90%) underwent surgery as part of breast cancer treatment.

“The comparative effect of procedure type on postoperative pain showed variable results across our multiple pain scales,” the researchers said.

The patients who underwent autologous flap reconstruction procedures – pedicled transverse rectus abdominis myocutaneous flap (PTRAMS), deep inferior epigastric perforator (DIEP), or superficial inferior epigastric artery (SIEA) – reported less-severe postoperative pain than did those who had TE/Implant procedures. Specifically, patients with SIEA and DIEP procedures reported significantly less pain 1 week after surgery than did those who had TE/Implant procedures, based on the MPQ sensory scale. In addition, patients with PTRAMS reported significantly less postoperative pain 1 week after surgery than did those who had TE/Implant procedures based on the NPRS scale. All three flap procedures were significantly associated with less-severe postoperative pain, compared with TE/Implant procedures.

The findings support data from previous studies that identified preoperative pain, mood disturbance, and age as factors for increased risk of acute postoperative pain, the researchers noted. In addition, “the findings have important implications for the identification of women who might be at risk for significant early postoperative pain following breast reconstruction, as acute postoperative pain is associated with poor functional outcomes, diminished quality of life, and the risk for development of persistent postsurgical pain,” they wrote.

The study results were limited by several factors, including the lack of standardization for postoperative pain treatment regimens, variability in the timing of preoperative assessment, and nonresponder bias, the researchers said.

However, “Once high-risk patients are identified, appropriate referrals can be considered to facilitate careful monitoring of postsurgical pain for selected patients,” they said. “Early intervention can give clinicians the opportunity to reduce postoperative morbidity and improve patients’ surgical experience and satisfaction with breast reconstruction outcome,” they added.

The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health/National Cancer Institute.

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FROM THE JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY OPEN

 

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Key clinical point: Identifying women at increased risk for severe acute postoperative pain allows clinicians the opportunity to reduce postoperative morbidity and improve patients’ surgical experience.

Major finding: Younger age (P = .002), bilateral procedures (P less than .0001), higher levels of preoperative pain (P less than .0001), and higher levels of preoperative anxiety (P less than .01) were among the strongest factors significantly associated with acute postoperative pain.

Data source: A prospective study of 2,207 women who underwent several types of breast reconstruction procedures.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health/National Cancer Institute.

VIDEO: SPIN tests hydroxyurea to prevent pediatric stroke in sickle cell disease

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– Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Whether hydroxyurea can avert a first stroke in children with sickle cell disease is a question that may be answered by a soon-to-be-started trial in Nigeria.

An estimated 15,000 children with sickle cell anemia have strokes each year in Nigeria, which is considered to have the largest burden of sickle cell disease in the world. Without treatment, about half of those children will have a second stroke within 2 years.

With completion of its feasibility trial results, SPIN (Primary Stroke Prevention in Children With Sickle Cell Anemia in Nigeria) will begin to examine two doses of hydroxyurea therapy, 20 mg/kg per day and 10 mg/kg per day, to determine whether the drug can prevent a first stroke in high-risk children.

In a video interview, Najibah A. Galadanci, MBBS, MPH, of Aminu Kano (Nigeria) Teaching Hospital, discusses how SPIN is addressing the unresolved clinical issue of hydroxyurea’s risks and benefits in children, and how research in Nigeria may provide adequate patient numbers to address a wide range of clinical questions about sickle cell disease.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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ASCO and AHA: Maintain high suspicion for cardiac dysfunction

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Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.

The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.

To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?

Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.

“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.

The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).

A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

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Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.

The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.

To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?

Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.

“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.

The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).

A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

 

Maintain a high suspicion for cardiac dysfunction and a low threshold for cardiac assessment with any patients who are survivors of adult cancers and may have received cardiotoxic therapy, a new guideline suggests.

The guideline, released by the American Society of Clinical Oncology and endorsed by the American Heart Association, is intended to assist primary care physicians, oncologists, cardiologists, and any members of multidisciplinary cancer care teams in preventing and monitoring systolic cardiac dysfunction, which is “typically detected as low left ventricular ejection fraction,” said Saro H. Armenian, DO, and his associates on the expert panel that drafted the guidelines.

To develop the guidelines, the panel conducted a systematic review of 8 metaanalyses, 12 randomized clinical trials, 49 cohort studies, 32 before-and-after studies, and 3 cross-sectional studies published in 1999-2016. They addressed five key questions: Which cancer survivors are at increased risk for developing cardiac dysfunction? Which preventive strategies minimize that risk before cancer therapy is initiated? Which preventive strategies minimize that risk during administration of potentially cardiotoxic cancer therapies? Which cardiac monitoring approaches are preferred during cancer therapies? And which cardiac monitoring approaches are preferred after cancer therapy is completed?

Regarding the fifth question, the guideline advises clinicians to regularly assess and manage cardiovascular risk factors such as smoking, hypertension, diabetes, dyslipidemia, and obesity in survivors of adult cancers, as well as to complete careful histories and physical examinations regularly. Any signs or symptoms that raise the suspicion of cardiac dysfunction should prompt an ECG (or cardiac MRI or multigated acquisition if an ECG isn’t available or technically feasible), assays of serum cardiac biomarkers, and, depending on the findings of these assessments, referral to a cardiologist.

“Patients also need to be advised that cardiac dysfunction can be a progressive disorder and may initially be asymptomatic; therefore, early and late warning signs and symptoms should be discussed,” said Dr. Armenian, a pediatric hematologist/oncologist and director of outcomes research in the department of population sciences at City of Hope in Duarte, Calif., and his associates.

The guideline also includes a special section concerning health disparities. “Patients with cancer who are members of racial or ethnic minorities suffer disproportionately from comorbidities, experience more obstacles to receiving care, are more likely to be uninsured, and are at greater risk of receiving care of poor quality than other Americans. [They] may have a substantially higher burden of cardiovascular complications during and after cancer treatment, in part because of inequities in the management of cardiovascular risk factors,” the guidelines state (J Clin Oncol. 2016 Dec 5 [doi:10.1200/JCO.2016.70.5400]).

A copy of the guideline and further information, including a data supplement, a methodology supplement, slide sets, and clinical tools and resources, are available at www.asco.org/cardiac-guidelineThis guideline was supported by the American Society of Clinical Oncology. Dr. Armenian reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

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‘Active referrals’ boost HIV testing in Kenyan children

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Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.

“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.

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The purpose of the study was to determine whether HIV testing rates in these children could be increased through “active referral” for index testing – “actively asking every HIV-positive adult whether they had children of unknown status and offering HIV testing,” Wagner said (JAIDS. 2016 Dec 15;73[5]:e83-e9).

During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.

Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).

Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”

The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”

The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.

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Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.

“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.

xrender/thinkstockphotos.com
The purpose of the study was to determine whether HIV testing rates in these children could be increased through “active referral” for index testing – “actively asking every HIV-positive adult whether they had children of unknown status and offering HIV testing,” Wagner said (JAIDS. 2016 Dec 15;73[5]:e83-e9).

During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.

Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).

Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”

The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”

The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.

Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.

“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.

xrender/thinkstockphotos.com
The purpose of the study was to determine whether HIV testing rates in these children could be increased through “active referral” for index testing – “actively asking every HIV-positive adult whether they had children of unknown status and offering HIV testing,” Wagner said (JAIDS. 2016 Dec 15;73[5]:e83-e9).

During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.

Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).

Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”

The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”

The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.

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FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

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Key clinical point: An active referral program boosted HIV testing of Kenyan children of HIV-positive adults and turned up previously undetected HIV cases, but many parents refused to participate.

Major finding: Of 611 HIV-infected adults with children younger than age 12 years of unknown HIV status, 74 (14%) accepted referral and completed testing of their 108 children; 8 children (7.4%) were HIV positive.

Data source: 10,426 HIV-infected adults interviewed at Kenyatta National Hospital over 9 months during 2013-2014.

Disclosures: The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.

VIDEO: Novel, multi-arm trial aims to beat AML

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– A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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– A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 

 

– A new multi-arm clinical trial aims to transform the treatment of de novo acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially stagnant for 40 years.

Launched in October 2016, the multicenter BEAT AML Master Trial provides genomic results of bone marrow biopsies in just 7 days, according to Brian J. Druker, MD, director of the Knight Cancer Institute at Oregon Health and Science University, Portland. With results that fast, patients can quickly receive whichever therapy targets the mutation shared by most or all their leukemia cells, Dr. Druker and other researchers said at a press briefing at the annual meeting of the American Society of Hematology.

Patients who lack targetable markers will be offered investigational therapies that have shown broad activity in AML, the researchers said. The goal is for all participants to receive optimized treatment – whether or not that leads to an FDA approval, they emphasized.

Centers now participating in this trial include Memorial Sloan Kettering, Ohio State University, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Oregon Health and Science University. More centers will join soon, according to the Leukemia & Lymphoma Society, which is sponsoring the trial. Researchers designed the trial with input from the FDA and pharmaceutical companies, they said.

In a video interview, Dr. Druker discussed key aspects of the trial and how it could advance treatment options for AML. Dr. Druker, whose work on imatinib helped pioneer precision medicine in cancer, disclosed ties to a number of pharmaceutical companies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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Nomogram predicts conversion of first demyelinating event to definite MS

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Baseline and follow-up data from a prospective, multinational cohort of more than 3,000 patients with clinically isolated events allowed researchers to develop an accurate prognostic nomogram to calculate an individual’s risk for conversion to clinically definite multiple sclerosis at 12 months.

“Identification of patient, disease, and examination factors associated with higher probability of second attack in clinical practice may enable clinicians to flag patients that could benefit from more intensive follow-up and consideration of early DMD [disease-modifying drug] treatment intervention, facilitating more favorable patient outcomes,” wrote Tim Spelman, PhD, and his associates.

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The investigators followed 3,296 patients for a median of 2 years after they had been diagnosed with clinically isolated syndrome, and 1,953 experienced a second attack and moved to clinically definite multiple sclerosis. Patients who did not receive DMDs during the follow-up period were just over three times more likely to experience a relapse than were patients who received DMDs.

Risk of relapse was decreased when clinically isolated syndrome was diagnosed later, with an adjusted hazard ratio of 0.9 for every 5 additional years of age. Other risk factors for earlier relapse include higher Expanded Disability Status Scale score at the onset of the first demyelinating event, DMD exposure prior to the first attack, multiple brain and spinal MRI criteria, and oligoclonal bands.

“These results corroborate and extend prior, albeit smaller, studies observing similar sets of predictors of clinical conversion probability,” Dr. Spelman and his coauthors wrote.

The predictive nomogram had a concordance index of 0.81 between the 12-month estimated and observed conversion probabilities.

“While our own internal validation suggested good performance, both an additional training-validation approach and an external validation through the application of the nomogram to a separate MS data set or population are required to confirm the generalizability of the nomogram,” they wrote.

Read the full study in Multiple Sclerosis Journal (2016 Nov 24. doi: 10.1177/1352458516679893).

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Baseline and follow-up data from a prospective, multinational cohort of more than 3,000 patients with clinically isolated events allowed researchers to develop an accurate prognostic nomogram to calculate an individual’s risk for conversion to clinically definite multiple sclerosis at 12 months.

“Identification of patient, disease, and examination factors associated with higher probability of second attack in clinical practice may enable clinicians to flag patients that could benefit from more intensive follow-up and consideration of early DMD [disease-modifying drug] treatment intervention, facilitating more favorable patient outcomes,” wrote Tim Spelman, PhD, and his associates.

designer491/Thinkstock
The investigators followed 3,296 patients for a median of 2 years after they had been diagnosed with clinically isolated syndrome, and 1,953 experienced a second attack and moved to clinically definite multiple sclerosis. Patients who did not receive DMDs during the follow-up period were just over three times more likely to experience a relapse than were patients who received DMDs.

Risk of relapse was decreased when clinically isolated syndrome was diagnosed later, with an adjusted hazard ratio of 0.9 for every 5 additional years of age. Other risk factors for earlier relapse include higher Expanded Disability Status Scale score at the onset of the first demyelinating event, DMD exposure prior to the first attack, multiple brain and spinal MRI criteria, and oligoclonal bands.

“These results corroborate and extend prior, albeit smaller, studies observing similar sets of predictors of clinical conversion probability,” Dr. Spelman and his coauthors wrote.

The predictive nomogram had a concordance index of 0.81 between the 12-month estimated and observed conversion probabilities.

“While our own internal validation suggested good performance, both an additional training-validation approach and an external validation through the application of the nomogram to a separate MS data set or population are required to confirm the generalizability of the nomogram,” they wrote.

Read the full study in Multiple Sclerosis Journal (2016 Nov 24. doi: 10.1177/1352458516679893).

 

Baseline and follow-up data from a prospective, multinational cohort of more than 3,000 patients with clinically isolated events allowed researchers to develop an accurate prognostic nomogram to calculate an individual’s risk for conversion to clinically definite multiple sclerosis at 12 months.

“Identification of patient, disease, and examination factors associated with higher probability of second attack in clinical practice may enable clinicians to flag patients that could benefit from more intensive follow-up and consideration of early DMD [disease-modifying drug] treatment intervention, facilitating more favorable patient outcomes,” wrote Tim Spelman, PhD, and his associates.

designer491/Thinkstock
The investigators followed 3,296 patients for a median of 2 years after they had been diagnosed with clinically isolated syndrome, and 1,953 experienced a second attack and moved to clinically definite multiple sclerosis. Patients who did not receive DMDs during the follow-up period were just over three times more likely to experience a relapse than were patients who received DMDs.

Risk of relapse was decreased when clinically isolated syndrome was diagnosed later, with an adjusted hazard ratio of 0.9 for every 5 additional years of age. Other risk factors for earlier relapse include higher Expanded Disability Status Scale score at the onset of the first demyelinating event, DMD exposure prior to the first attack, multiple brain and spinal MRI criteria, and oligoclonal bands.

“These results corroborate and extend prior, albeit smaller, studies observing similar sets of predictors of clinical conversion probability,” Dr. Spelman and his coauthors wrote.

The predictive nomogram had a concordance index of 0.81 between the 12-month estimated and observed conversion probabilities.

“While our own internal validation suggested good performance, both an additional training-validation approach and an external validation through the application of the nomogram to a separate MS data set or population are required to confirm the generalizability of the nomogram,” they wrote.

Read the full study in Multiple Sclerosis Journal (2016 Nov 24. doi: 10.1177/1352458516679893).

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Lower analgesic use after robotic pelvic surgery

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Postoperative use of both opioid and nonopioid analgesics was lower after robotic surgery than after laparotomy for endometrial cancer, according to a report published in Gynecologic Oncology.

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Shown is minimally invasive robotic surgery with the da Vinci Surgical System.
Compared with an historical cohort of 59 women matched for age and cancer stage who underwent laparotomy at the same medical center in earlier years, the robotic cohort required significantly less opioids (12 mg vs. 71 mg), acetaminophen (2,151 mg vs. 4,810 mg), ibuprofen (377 mg vs. 1,892 mg), and naproxen (393 mg vs 1,470 mg). In addition, no patients who underwent robotic surgery required continuous epidural anesthesia, and only 2% used patient-controlled analgesia, compared with 9% and 90% of patients who underwent laparotomy.

This benefit in the use of pain medication occurred regardless of the patient’s obesity status or age, which is particularly helpful in view of the increased risk of adverse events in these two patient populations, Dr. Abitbol and his associates reported (Gynecol Oncol. 2016. doi: 10.1016/jgyno.2016.11.014).

The direct costs associated with postoperative analgesia also were commensurately lower for robotically assisted surgery ($2.52 per day) than for laparotomy ($7.89 per day).

This study was supported by grants from the Israel Cancer Research Foundation, the Gloria’s Girls Fund, the Levi Family Fund, and the Weekend to End Women’s Cancers. Dr. Abitbol reported having no relevant financial disclosures; one of his associates reported receiving a grant from Intuitive Surgical.

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Postoperative use of both opioid and nonopioid analgesics was lower after robotic surgery than after laparotomy for endometrial cancer, according to a report published in Gynecologic Oncology.

Master Video/Shutterstock
Shown is minimally invasive robotic surgery with the da Vinci Surgical System.
Compared with an historical cohort of 59 women matched for age and cancer stage who underwent laparotomy at the same medical center in earlier years, the robotic cohort required significantly less opioids (12 mg vs. 71 mg), acetaminophen (2,151 mg vs. 4,810 mg), ibuprofen (377 mg vs. 1,892 mg), and naproxen (393 mg vs 1,470 mg). In addition, no patients who underwent robotic surgery required continuous epidural anesthesia, and only 2% used patient-controlled analgesia, compared with 9% and 90% of patients who underwent laparotomy.

This benefit in the use of pain medication occurred regardless of the patient’s obesity status or age, which is particularly helpful in view of the increased risk of adverse events in these two patient populations, Dr. Abitbol and his associates reported (Gynecol Oncol. 2016. doi: 10.1016/jgyno.2016.11.014).

The direct costs associated with postoperative analgesia also were commensurately lower for robotically assisted surgery ($2.52 per day) than for laparotomy ($7.89 per day).

This study was supported by grants from the Israel Cancer Research Foundation, the Gloria’s Girls Fund, the Levi Family Fund, and the Weekend to End Women’s Cancers. Dr. Abitbol reported having no relevant financial disclosures; one of his associates reported receiving a grant from Intuitive Surgical.

 

Postoperative use of both opioid and nonopioid analgesics was lower after robotic surgery than after laparotomy for endometrial cancer, according to a report published in Gynecologic Oncology.

Master Video/Shutterstock
Shown is minimally invasive robotic surgery with the da Vinci Surgical System.
Compared with an historical cohort of 59 women matched for age and cancer stage who underwent laparotomy at the same medical center in earlier years, the robotic cohort required significantly less opioids (12 mg vs. 71 mg), acetaminophen (2,151 mg vs. 4,810 mg), ibuprofen (377 mg vs. 1,892 mg), and naproxen (393 mg vs 1,470 mg). In addition, no patients who underwent robotic surgery required continuous epidural anesthesia, and only 2% used patient-controlled analgesia, compared with 9% and 90% of patients who underwent laparotomy.

This benefit in the use of pain medication occurred regardless of the patient’s obesity status or age, which is particularly helpful in view of the increased risk of adverse events in these two patient populations, Dr. Abitbol and his associates reported (Gynecol Oncol. 2016. doi: 10.1016/jgyno.2016.11.014).

The direct costs associated with postoperative analgesia also were commensurately lower for robotically assisted surgery ($2.52 per day) than for laparotomy ($7.89 per day).

This study was supported by grants from the Israel Cancer Research Foundation, the Gloria’s Girls Fund, the Levi Family Fund, and the Weekend to End Women’s Cancers. Dr. Abitbol reported having no relevant financial disclosures; one of his associates reported receiving a grant from Intuitive Surgical.

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Key clinical point: Postoperative use of both opioid and nonopioid analgesics was lower after robotic surgery than after laparotomy for endometrial cancer.

Major finding: The robotic surgery cohort required significantly less opioids (12 mg vs. 71 mg), acetaminophen (2,151 mg vs. 4,810 mg), ibuprofen (377 mg vs. 1,892 mg), and naproxen (393 mg vs 1,470 mg), compared with an historical cohort of 59 women who underwent laparotomy.

Data source: A single-center retrospective cohort study involving 340 consecutive robotically assisted pelvic surgeries during a 6-year period.

Disclosures: This study was supported by grants from the Israel Cancer Research Foundation, the Gloria’s Girls Fund, the Levi Family Fund, and the Weekend to End Women’s Cancers. Dr. Abitbol reported having no relevant financial disclosures; one of his associates reported receiving a grant from Intuitive Surgical.

Few drug-resistant epilepsy patients recruitable for trials of new AEDs

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HOUSTON – Fewer than 8% of adult patients with drug-resistant epilepsy would have been recruitable for recent phase II and III trials of new antiepileptic drugs (AEDs), results from a single-center study showed.

The findings underscore a need to rethink how phase II and III trials of AEDs are conducted, Bernhard J. Steinhoff, MD, said in an interview prior to the annual meeting of the American Epilepsy Society. “In spite of the marketing of numerous new antiepileptic drugs, the percentage of drug-resistant epilepsies has remained almost unchanged,” said Dr. Steinhoff of the Kork (Germany) Epilepsy Center. “I am not aware that anybody involved in the issue of clinical trials with AEDs addressed the problem [of] whether the pivotal trials really cover the patients the new AEDs are developed for: namely, patients with drug-resistant epilepsies. Every time we start with a new drug after licensing, we realize that we have no clue whether this drug will be appropriate for our difficult-to-treat patients. We wondered whether the design of the usual phase II and III randomized controlled trials covers an acceptable percentage of AED-resistant epilepsy patients.”

Dr. Bernhard J. Steinhoff
To find out, he and his associates collected data on 216 consecutive adult outpatients with drug-resistant epilepsies as defined by the recent International League Against Epilepsy classification. They assessed whether these patients would have been recruitable for the last five phase II and III trials that have been performed at the Kork Epilepsy Center. Of the 216 patients, only 14 (7.4%) would have fulfilled the inclusion criteria of all five studies without meeting exclusion criteria. The five major reasons for exclusion were: treatment with enzyme-inducing AEDs (47.2%); too few seizures per definite periods in spite of AED resistance (46.3%); EEG signs for generalized epileptogenesis (31.5%); intellectual disability or legal representatives (29.6%); and long distance between home and center that prevents frequent visits as required by the study protocol (27.3%).

“The result was frightening because less than 10% [of patients] would have been covered by the trials,” Dr. Steinhoff said. “Therefore, we suggest that a bad trials strategy may be responsible for the fact that the percentage of drug-resistant patients has not been markedly reduced by more than 15 new AEDs that were introduced during the recent years.” He added that pivotal trials with new AEDs “show superiority over placebo as add-on in an extremely limited group of difficult-to-treat patients. After licensing and marketing, we start to learn whether a new AED is appropriate for our drug-resistant patients.”

Medical writing was funded by an unrestricted grant from UCB. Dr. Steinhoff reported having no financial conflicts.

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HOUSTON – Fewer than 8% of adult patients with drug-resistant epilepsy would have been recruitable for recent phase II and III trials of new antiepileptic drugs (AEDs), results from a single-center study showed.

The findings underscore a need to rethink how phase II and III trials of AEDs are conducted, Bernhard J. Steinhoff, MD, said in an interview prior to the annual meeting of the American Epilepsy Society. “In spite of the marketing of numerous new antiepileptic drugs, the percentage of drug-resistant epilepsies has remained almost unchanged,” said Dr. Steinhoff of the Kork (Germany) Epilepsy Center. “I am not aware that anybody involved in the issue of clinical trials with AEDs addressed the problem [of] whether the pivotal trials really cover the patients the new AEDs are developed for: namely, patients with drug-resistant epilepsies. Every time we start with a new drug after licensing, we realize that we have no clue whether this drug will be appropriate for our difficult-to-treat patients. We wondered whether the design of the usual phase II and III randomized controlled trials covers an acceptable percentage of AED-resistant epilepsy patients.”

Dr. Bernhard J. Steinhoff
To find out, he and his associates collected data on 216 consecutive adult outpatients with drug-resistant epilepsies as defined by the recent International League Against Epilepsy classification. They assessed whether these patients would have been recruitable for the last five phase II and III trials that have been performed at the Kork Epilepsy Center. Of the 216 patients, only 14 (7.4%) would have fulfilled the inclusion criteria of all five studies without meeting exclusion criteria. The five major reasons for exclusion were: treatment with enzyme-inducing AEDs (47.2%); too few seizures per definite periods in spite of AED resistance (46.3%); EEG signs for generalized epileptogenesis (31.5%); intellectual disability or legal representatives (29.6%); and long distance between home and center that prevents frequent visits as required by the study protocol (27.3%).

“The result was frightening because less than 10% [of patients] would have been covered by the trials,” Dr. Steinhoff said. “Therefore, we suggest that a bad trials strategy may be responsible for the fact that the percentage of drug-resistant patients has not been markedly reduced by more than 15 new AEDs that were introduced during the recent years.” He added that pivotal trials with new AEDs “show superiority over placebo as add-on in an extremely limited group of difficult-to-treat patients. After licensing and marketing, we start to learn whether a new AED is appropriate for our drug-resistant patients.”

Medical writing was funded by an unrestricted grant from UCB. Dr. Steinhoff reported having no financial conflicts.

HOUSTON – Fewer than 8% of adult patients with drug-resistant epilepsy would have been recruitable for recent phase II and III trials of new antiepileptic drugs (AEDs), results from a single-center study showed.

The findings underscore a need to rethink how phase II and III trials of AEDs are conducted, Bernhard J. Steinhoff, MD, said in an interview prior to the annual meeting of the American Epilepsy Society. “In spite of the marketing of numerous new antiepileptic drugs, the percentage of drug-resistant epilepsies has remained almost unchanged,” said Dr. Steinhoff of the Kork (Germany) Epilepsy Center. “I am not aware that anybody involved in the issue of clinical trials with AEDs addressed the problem [of] whether the pivotal trials really cover the patients the new AEDs are developed for: namely, patients with drug-resistant epilepsies. Every time we start with a new drug after licensing, we realize that we have no clue whether this drug will be appropriate for our difficult-to-treat patients. We wondered whether the design of the usual phase II and III randomized controlled trials covers an acceptable percentage of AED-resistant epilepsy patients.”

Dr. Bernhard J. Steinhoff
To find out, he and his associates collected data on 216 consecutive adult outpatients with drug-resistant epilepsies as defined by the recent International League Against Epilepsy classification. They assessed whether these patients would have been recruitable for the last five phase II and III trials that have been performed at the Kork Epilepsy Center. Of the 216 patients, only 14 (7.4%) would have fulfilled the inclusion criteria of all five studies without meeting exclusion criteria. The five major reasons for exclusion were: treatment with enzyme-inducing AEDs (47.2%); too few seizures per definite periods in spite of AED resistance (46.3%); EEG signs for generalized epileptogenesis (31.5%); intellectual disability or legal representatives (29.6%); and long distance between home and center that prevents frequent visits as required by the study protocol (27.3%).

“The result was frightening because less than 10% [of patients] would have been covered by the trials,” Dr. Steinhoff said. “Therefore, we suggest that a bad trials strategy may be responsible for the fact that the percentage of drug-resistant patients has not been markedly reduced by more than 15 new AEDs that were introduced during the recent years.” He added that pivotal trials with new AEDs “show superiority over placebo as add-on in an extremely limited group of difficult-to-treat patients. After licensing and marketing, we start to learn whether a new AED is appropriate for our drug-resistant patients.”

Medical writing was funded by an unrestricted grant from UCB. Dr. Steinhoff reported having no financial conflicts.

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Key clinical point: Only a small fraction of AED-resistant epilepsy patients meet eligibility requirements for clinical trials of new AEDs.

Major finding: Only 7.4% of patients would have fulfilled the inclusion criteria of five phase II and III trials of new AEDs.

Data source: A review of 216 outpatients with drug-resistant epilepsies.

Disclosures: Medical writing was funded by an unrestricted grant from UCB. Dr. Steinhoff reported having no financial disclosures.