Hip injections are performed as diagnostic and therapeutic interventions across a variety of medical subspecialties, including but not limited to those practicing physical medicine and rehabilitation, pain medicine, sports medicine, orthopedic surgery, and radiology. Traditional image-guided intra-articular hip injection commonly uses an anterior-oblique approach from a starting point on the anterior groin traversing soft tissue anterior to the femoral neck to the target needle placement at the femoral head-neck junction.

In fluoroscopic procedures, a coaxial technique for needles placement is used for safe and precise insertion of needles. An X-ray beam is angled in line with the projected path of the needle from skin entry point to injection target. Coaxial, en face technique (also called EF, parallel, hub view, down the barrel, or barrel view) appears as a single radiopaque dot over the target injection site.¹ This technique minimizes needle redirection for correction of the injection path and minimal disturbance of surrounding tissue on the approach to the intended target.

Noncoaxial technique, as used in the anterior-oblique approach, intentionally directs the needle away from a skin entry point, the needle barrel traversing the X-ray beam toward an injection target. Clinical challenges to injection with the anterior-oblique approach include using a noncoaxial technique. Additional challenges to the anterior-oblique (also referred to as anterior) approach are body habitus and pannus, proximity to neurovascular structures, and patient positioning. By understanding the risks and benefits of varied technical approaches to accomplish a clinical goal and outcome, trainees are better able to select the technique most appropriate for a varied patient population.

Common risks to patients for all intra-articular interventions include bleeding, infection, and pain. Risk of damage to nearby structures is often mentioned as part of a standard informed consent process as it relates to the femoral vein, artery, and nerve that are in close anatomical proximity to the target injection site. When prior studies have examined the risk of complications resulting from intra-articular hip injections, a common conclusion is that despite a relatively low-risk profile for skilled interventionalists, efforts to avoid needle placement in the medial 50% of the femoral head on antero-posterior imaging is recommended.²

The anterior technique is a commonly described approach, and the same can be used for both ultrasound-guided and fluoroscopically guided hip injections.³ Using ultrasound guidance, the anterior technique can be performed with in-plane direct visualization of the needle throughout the procedure. With fluoroscopic guidance, the anterior approach is performed out-of-plane, using the noncoaxial technique. This requires the interventionalist to use tactile and anatomic guidance to the target injection site. The anterior approach for hip injection is one of few interventions where coaxial technique is not used for the procedure, making the instruction for a learner less concrete and potentially more challenging related to the needle path not under direct visualization in plane with the X-ray beam.

Technical guidance and detailed instruction for the lateral approach is infrequently described in fluoroscopic interventional texts. Reference to a lateral approach hip injection was made as early as the 1970s, without detail provided on the technique, with respect to the advantage of visualization of the hip joint for needle placement when hardware is in place.⁴ A more recent article described a lateral approach technique involving the patient in a decubitus (lateral) supine position, which presents limitations in consistent fluoroscopic imaging and can be a challenging static position for the patient to maintain.⁵

The retrospective review of anterior-oblique and lateral approach procedures in this study aims to demonstrate that there is no significant difference in radiation exposure, rate of successful intra-articular injection, or complication rate. If proven as a noninferior technique, the lateral approach may be a valuable interventional skill to those performing hip injections. Potential benefits to the patient and provider include options for the provider to access the joint using either technique. Additionally, the approach can be added to the instructional plan for those practitioners providing technical instruction to trainees within their health care system.

Methods

The institutional review board at the VA Ann Arbor Healthcare System reviewed and granted approval for this study. One of 5 interventional pain physician staff members at the VA Ann Arbor Healthcare System performed fluoroscopically guided hip injections. Interventional pain fellows under the direct supervision of board-certified physicians performed the procedures for the study cases. Supervising physicians included both physiatrists and anesthesiologists. Images were reviewed and evaluated without corresponding patient biographic data.

For cases using the lateral approach, the patients were positioned supine on the fluoroscopy table. In anterior-posterior and lateral views, trajectory lines are drawn using a long metal marking rod held adjacent to the patient. With pulsed low-dose fluoroscopy, transverse lines are drawn to identify midpoint of the femoral head in lateral view (Figure 1A, x-axis) and the most direct line from skin to lateral femoral head neck junction joint target (Figure 1B, z-axis). Also confirmed in lateral view, the z-axis marked line drawn on the skin is used to confirm that this transverse plane crosses the overlapping femoral heads (Figure 1A, y-axis).

Imaging reports, using the saved images and the associated procedure report, were classified for technical approach (anterior, lateral, or inconclusive), success of joint injection as evidenced by appropriate contrast enhancement within the joint space (successful, unsuccessful, or incomplete images), documented use of sedation (yes, no), patient positioning (supine, prone), radiation exposure dose, radiation exposure time, and additional comments, such as “notable pannus” or “hardware present” to annotate significant findings on imaging review.

Statistical Analysis

The distribution of 2 outcomes used to compare rates of complication, radiation dose, and exposure time was checked using the Shapiro-Wilk test. Power analysis determined that inclusion of 30 anterior and 30 lateral cases results in adequate power to detect a 1-point mean difference, assuming a standard deviation of 1.5 in each group. Both radiation dose and exposure time were found to be nonnormally distributed (W = 0.65, P < .001; W = 0.86, P < .001; respectively). Median and interquartile range (IQR) of dose and time in seconds for anterior and lateral approaches were computed. Median differences in radiation dose and exposure time between anterior and lateral approaches were assessed with the k-sample test of equality of medians. All analyses were conducted using Stata Version 14.1 (College Station, TX).

Results

Between June 2017 and January 2018, 88 cases were reviewed as performed, with 30 anterior and 30 lateral approach cases included in this retrospective comparison study. A total of 28 cases were excluded from the study for using an inconclusive approach, multiple or bilateral procedures, cases without recorded dose and time data, and inadequately saved images to provide meaningful data (Figure 3).

Rate of successful intervention with needle placement confirmed within the articular space on contrast enhancement was not significantly different in the study groups with 96.7% (29 of 30) anterior approach cases reported as successful, 100% (30 of 30) lateral approach cases reported as successful. Overhanging pannus in the viewing area was reported in 5 anterior approach cases and 4 lateral cases. Hardware was noted in 2 lateral approach cases, none in anterior approach cases. Sedation was used for 3 of the anterior approach cases and none of the lateral approach cases.

Discussion

Pain medicine fellows who have previously completed residency in a variety of disciplines, often either anesthesiology or physical medicine and rehabilitation, perform fluoroscopically guided procedures and benefit from increased experience with coaxial technique as this improves needle depth and location awareness. Once mastered, this skill set can be applied to and useful for multiple interventional pain procedures. Similar technical instruction with an emphasis on coaxial technique for hip injections as performed in the anterior or anterolateral approach can be used in both fluoroscopic and ultrasound-guided procedures, including facet injection, transforaminal epidural steroid injection, and myriad other procedures performed to ameliorate pain. There are advantages to pursuing a similar approach with all image-guided procedures. Evaluated in this comparison study is an alternative technique that has potential for risk reduction benefit with reduced proximity to neurovascular structures, which ultimately leads to a safer procedure profile.

Using a lateral approach, the interventionalist determines a starting point, entering the skin at a greater distance from any overlying pannus and the elevated concentration of gram-negative and gram-positive bacteria contained within the inguinal skin.⁶ A previous study demonstrated improved success of intra-articular needle tip placement without image guidance in patients with body mass index (BMI) < 30.⁷ A prior study of anterior approach using anatomic landmarks as compared to lateral approach demonstrated the anterior approach pierced or contacted the femoral nerve in 27% of anterior cases and came within 5 mm of 60% of anterior cases.² Use of image guidance, whether ultrasound, fluoroscopy, or computed tomography (CT) is preferred related to reduced risk of contact with adjacent neurovascular structures. Anatomic surface landmarks have been described as an alternative injection technique, without the use of fluoroscopy for confirmatory initial, intraprocedure, and final placement.⁸ Palpation of anatomic structures is required for this nonimage-guided technique, and although similar to the described technique in this study, the anatomically guided injection starting point is more lateral than the anterior approach but not in the most lateral position in the transverse plane that is used for this fluoroscopically guided lateral approach study.

Physiologic characteristics of subjects and technical aspects of fluoroscopy both can be factors in radiation dose and exposure times for hip injections. Patient BMI was not included in the data collection, but further study would seek to determine whether BMI is a significant risk for any increased radiation dose and exposure times using lateral approach injections. Use of lateral images for fluoroscopy requires penetration of X-ray beam through more tissue compared with that of anterior-posterior images. Further study of these techniques would benefit from comparing the pulse rate of fluoroscopic images and collimation (or focusing of the radiation beam over a smaller area of tissue) as factors in any observed increase in total radiation dose and exposure times.

Improving the safety profile of this procedure could have a positive impact on the patient population receiving fluoroscopic hip injections, both within the VA Ann Arbor Health System and elsewhere. While the study population was limited to the VA patient population seeking subspecialty nonsurgical joint care at a single tertiary care center, this technique is generalizable and can be used in most patients, as hip pain is a common condition necessitating nonoperative evaluation and treatment.

Radiation Exposures

As our analysis demonstrates, mean radiation dose exposure for each group was consistent with low (≤ 3 mSv) to moderate (> 3-20 mSv) annual effective doses in the general population.⁷ Both anterior and lateral median radiation dose of 1 mGy and 3 mGy, respectively, are within the standard exposure for radiographs of the pelvis (1.31 mGy).⁹ It is therefore reasonable to consider a lateral approach for hip injection, given the benefits of direct coaxial approach and avoiding needle entry through higher bacteria-concentrated skin.

The lateral approach did have increased radiation dose and exposure time, although it was not statistically significantly greater than the anterior approach. The difference between radiation dose and time to perform either technique was not clinically significant. One potential explanation for this is that the lateral technique has increased tissue to penetrate, which can be reduced with collimation and other fluoroscopic image adjustments. Additionally, as trainees progress in competency, fewer images should need to be obtained.⁷ We hypothesize that as familiarity and comfort with this technique increase, the number of images necessary for successful injection would decrease, leading to decreased radiation dose and exposure time. We would expect that in the hands of a board-certified interventionalist, radiation dose and exposure time would be significantly decreased as compared to our current dataset, and this is an area of planned further study. With our existing dataset, the majority of procedures were performed with trainees, with inadequate information documented for comparison of dose over time and procedural experience under individual physicians.

Notable strengths of this study are the direct comparison of the anterior approach when compared to the lateral approach with regard to radiation dose and exposure time, which we have not seen described in the literature. A detailed description of the technique may result in increased utilization by other providers. Data were collected from multiple providers, as board-certified pain physicians and board-eligible interventional pain fellows performed the procedures. This variability in providers increases the generalizability of the findings, with a variety of providers, disciplines, years of experiences, and type of training represented.

Limitations

Limitations include the retrospective nature of the study and the relatively small sample size. However, even with this limitation, it is notable that no statistically significant differences were observed in mean radiation dose or fluoroscopy exposure time, making the lateral approach, at minimum, a noninferior technique. Combined with the improved safety profile, this technique is a viable alternative to the traditional anterior-oblique approach. Further study should be performed, such as a prospective, randomized control trial investigating the 2 techniques and following pain scores and functional ability after the procedure.

Conclusion

Given the decreased procedural risk related to proximity of neurovascular structures and coaxial technique for needle advancement, lateral approach for hip injection should be considered by those in any discipline performing fluoroscopically guided procedures. Lateral technique may be particularly useful in technically challenging cases and when skin entry at the anterior groin is suboptimal, as a noninferior alternative to traditional anterior method.

Hip injections are performed as diagnostic and therapeutic interventions across a variety of medical subspecialties, including but not limited to those practicing physical medicine and rehabilitation, pain medicine, sports medicine, orthopedic surgery, and radiology. Traditional image-guided intra-articular hip injection commonly uses an anterior-oblique approach from a starting point on the anterior groin traversing soft tissue anterior to the femoral neck to the target needle placement at the femoral head-neck junction.

In fluoroscopic procedures, a coaxial technique for needles placement is used for safe and precise insertion of needles. An X-ray beam is angled in line with the projected path of the needle from skin entry point to injection target. Coaxial, en face technique (also called EF, parallel, hub view, down the barrel, or barrel view) appears as a single radiopaque dot over the target injection site.¹ This technique minimizes needle redirection for correction of the injection path and minimal disturbance of surrounding tissue on the approach to the intended target.

Noncoaxial technique, as used in the anterior-oblique approach, intentionally directs the needle away from a skin entry point, the needle barrel traversing the X-ray beam toward an injection target. Clinical challenges to injection with the anterior-oblique approach include using a noncoaxial technique. Additional challenges to the anterior-oblique (also referred to as anterior) approach are body habitus and pannus, proximity to neurovascular structures, and patient positioning. By understanding the risks and benefits of varied technical approaches to accomplish a clinical goal and outcome, trainees are better able to select the technique most appropriate for a varied patient population.

Common risks to patients for all intra-articular interventions include bleeding, infection, and pain. Risk of damage to nearby structures is often mentioned as part of a standard informed consent process as it relates to the femoral vein, artery, and nerve that are in close anatomical proximity to the target injection site. When prior studies have examined the risk of complications resulting from intra-articular hip injections, a common conclusion is that despite a relatively low-risk profile for skilled interventionalists, efforts to avoid needle placement in the medial 50% of the femoral head on antero-posterior imaging is recommended.²

The anterior technique is a commonly described approach, and the same can be used for both ultrasound-guided and fluoroscopically guided hip injections.³ Using ultrasound guidance, the anterior technique can be performed with in-plane direct visualization of the needle throughout the procedure. With fluoroscopic guidance, the anterior approach is performed out-of-plane, using the noncoaxial technique. This requires the interventionalist to use tactile and anatomic guidance to the target injection site. The anterior approach for hip injection is one of few interventions where coaxial technique is not used for the procedure, making the instruction for a learner less concrete and potentially more challenging related to the needle path not under direct visualization in plane with the X-ray beam.

Technical guidance and detailed instruction for the lateral approach is infrequently described in fluoroscopic interventional texts. Reference to a lateral approach hip injection was made as early as the 1970s, without detail provided on the technique, with respect to the advantage of visualization of the hip joint for needle placement when hardware is in place.⁴ A more recent article described a lateral approach technique involving the patient in a decubitus (lateral) supine position, which presents limitations in consistent fluoroscopic imaging and can be a challenging static position for the patient to maintain.⁵

The retrospective review of anterior-oblique and lateral approach procedures in this study aims to demonstrate that there is no significant difference in radiation exposure, rate of successful intra-articular injection, or complication rate. If proven as a noninferior technique, the lateral approach may be a valuable interventional skill to those performing hip injections. Potential benefits to the patient and provider include options for the provider to access the joint using either technique. Additionally, the approach can be added to the instructional plan for those practitioners providing technical instruction to trainees within their health care system.

Methods

The institutional review board at the VA Ann Arbor Healthcare System reviewed and granted approval for this study. One of 5 interventional pain physician staff members at the VA Ann Arbor Healthcare System performed fluoroscopically guided hip injections. Interventional pain fellows under the direct supervision of board-certified physicians performed the procedures for the study cases. Supervising physicians included both physiatrists and anesthesiologists. Images were reviewed and evaluated without corresponding patient biographic data.

For cases using the lateral approach, the patients were positioned supine on the fluoroscopy table. In anterior-posterior and lateral views, trajectory lines are drawn using a long metal marking rod held adjacent to the patient. With pulsed low-dose fluoroscopy, transverse lines are drawn to identify midpoint of the femoral head in lateral view (Figure 1A, x-axis) and the most direct line from skin to lateral femoral head neck junction joint target (Figure 1B, z-axis). Also confirmed in lateral view, the z-axis marked line drawn on the skin is used to confirm that this transverse plane crosses the overlapping femoral heads (Figure 1A, y-axis).

Imaging reports, using the saved images and the associated procedure report, were classified for technical approach (anterior, lateral, or inconclusive), success of joint injection as evidenced by appropriate contrast enhancement within the joint space (successful, unsuccessful, or incomplete images), documented use of sedation (yes, no), patient positioning (supine, prone), radiation exposure dose, radiation exposure time, and additional comments, such as “notable pannus” or “hardware present” to annotate significant findings on imaging review.

Statistical Analysis

The distribution of 2 outcomes used to compare rates of complication, radiation dose, and exposure time was checked using the Shapiro-Wilk test. Power analysis determined that inclusion of 30 anterior and 30 lateral cases results in adequate power to detect a 1-point mean difference, assuming a standard deviation of 1.5 in each group. Both radiation dose and exposure time were found to be nonnormally distributed (W = 0.65, P < .001; W = 0.86, P < .001; respectively). Median and interquartile range (IQR) of dose and time in seconds for anterior and lateral approaches were computed. Median differences in radiation dose and exposure time between anterior and lateral approaches were assessed with the k-sample test of equality of medians. All analyses were conducted using Stata Version 14.1 (College Station, TX).

Results

Between June 2017 and January 2018, 88 cases were reviewed as performed, with 30 anterior and 30 lateral approach cases included in this retrospective comparison study. A total of 28 cases were excluded from the study for using an inconclusive approach, multiple or bilateral procedures, cases without recorded dose and time data, and inadequately saved images to provide meaningful data (Figure 3).

Rate of successful intervention with needle placement confirmed within the articular space on contrast enhancement was not significantly different in the study groups with 96.7% (29 of 30) anterior approach cases reported as successful, 100% (30 of 30) lateral approach cases reported as successful. Overhanging pannus in the viewing area was reported in 5 anterior approach cases and 4 lateral cases. Hardware was noted in 2 lateral approach cases, none in anterior approach cases. Sedation was used for 3 of the anterior approach cases and none of the lateral approach cases.

Discussion

Pain medicine fellows who have previously completed residency in a variety of disciplines, often either anesthesiology or physical medicine and rehabilitation, perform fluoroscopically guided procedures and benefit from increased experience with coaxial technique as this improves needle depth and location awareness. Once mastered, this skill set can be applied to and useful for multiple interventional pain procedures. Similar technical instruction with an emphasis on coaxial technique for hip injections as performed in the anterior or anterolateral approach can be used in both fluoroscopic and ultrasound-guided procedures, including facet injection, transforaminal epidural steroid injection, and myriad other procedures performed to ameliorate pain. There are advantages to pursuing a similar approach with all image-guided procedures. Evaluated in this comparison study is an alternative technique that has potential for risk reduction benefit with reduced proximity to neurovascular structures, which ultimately leads to a safer procedure profile.

Using a lateral approach, the interventionalist determines a starting point, entering the skin at a greater distance from any overlying pannus and the elevated concentration of gram-negative and gram-positive bacteria contained within the inguinal skin.⁶ A previous study demonstrated improved success of intra-articular needle tip placement without image guidance in patients with body mass index (BMI) < 30.⁷ A prior study of anterior approach using anatomic landmarks as compared to lateral approach demonstrated the anterior approach pierced or contacted the femoral nerve in 27% of anterior cases and came within 5 mm of 60% of anterior cases.² Use of image guidance, whether ultrasound, fluoroscopy, or computed tomography (CT) is preferred related to reduced risk of contact with adjacent neurovascular structures. Anatomic surface landmarks have been described as an alternative injection technique, without the use of fluoroscopy for confirmatory initial, intraprocedure, and final placement.⁸ Palpation of anatomic structures is required for this nonimage-guided technique, and although similar to the described technique in this study, the anatomically guided injection starting point is more lateral than the anterior approach but not in the most lateral position in the transverse plane that is used for this fluoroscopically guided lateral approach study.

Physiologic characteristics of subjects and technical aspects of fluoroscopy both can be factors in radiation dose and exposure times for hip injections. Patient BMI was not included in the data collection, but further study would seek to determine whether BMI is a significant risk for any increased radiation dose and exposure times using lateral approach injections. Use of lateral images for fluoroscopy requires penetration of X-ray beam through more tissue compared with that of anterior-posterior images. Further study of these techniques would benefit from comparing the pulse rate of fluoroscopic images and collimation (or focusing of the radiation beam over a smaller area of tissue) as factors in any observed increase in total radiation dose and exposure times.

Improving the safety profile of this procedure could have a positive impact on the patient population receiving fluoroscopic hip injections, both within the VA Ann Arbor Health System and elsewhere. While the study population was limited to the VA patient population seeking subspecialty nonsurgical joint care at a single tertiary care center, this technique is generalizable and can be used in most patients, as hip pain is a common condition necessitating nonoperative evaluation and treatment.

Radiation Exposures

As our analysis demonstrates, mean radiation dose exposure for each group was consistent with low (≤ 3 mSv) to moderate (> 3-20 mSv) annual effective doses in the general population.⁷ Both anterior and lateral median radiation dose of 1 mGy and 3 mGy, respectively, are within the standard exposure for radiographs of the pelvis (1.31 mGy).⁹ It is therefore reasonable to consider a lateral approach for hip injection, given the benefits of direct coaxial approach and avoiding needle entry through higher bacteria-concentrated skin.

The lateral approach did have increased radiation dose and exposure time, although it was not statistically significantly greater than the anterior approach. The difference between radiation dose and time to perform either technique was not clinically significant. One potential explanation for this is that the lateral technique has increased tissue to penetrate, which can be reduced with collimation and other fluoroscopic image adjustments. Additionally, as trainees progress in competency, fewer images should need to be obtained.⁷ We hypothesize that as familiarity and comfort with this technique increase, the number of images necessary for successful injection would decrease, leading to decreased radiation dose and exposure time. We would expect that in the hands of a board-certified interventionalist, radiation dose and exposure time would be significantly decreased as compared to our current dataset, and this is an area of planned further study. With our existing dataset, the majority of procedures were performed with trainees, with inadequate information documented for comparison of dose over time and procedural experience under individual physicians.

Notable strengths of this study are the direct comparison of the anterior approach when compared to the lateral approach with regard to radiation dose and exposure time, which we have not seen described in the literature. A detailed description of the technique may result in increased utilization by other providers. Data were collected from multiple providers, as board-certified pain physicians and board-eligible interventional pain fellows performed the procedures. This variability in providers increases the generalizability of the findings, with a variety of providers, disciplines, years of experiences, and type of training represented.

Limitations

Limitations include the retrospective nature of the study and the relatively small sample size. However, even with this limitation, it is notable that no statistically significant differences were observed in mean radiation dose or fluoroscopy exposure time, making the lateral approach, at minimum, a noninferior technique. Combined with the improved safety profile, this technique is a viable alternative to the traditional anterior-oblique approach. Further study should be performed, such as a prospective, randomized control trial investigating the 2 techniques and following pain scores and functional ability after the procedure.

Conclusion

Given the decreased procedural risk related to proximity of neurovascular structures and coaxial technique for needle advancement, lateral approach for hip injection should be considered by those in any discipline performing fluoroscopically guided procedures. Lateral technique may be particularly useful in technically challenging cases and when skin entry at the anterior groin is suboptimal, as a noninferior alternative to traditional anterior method.

Hip injections are performed as diagnostic and therapeutic interventions across a variety of medical subspecialties, including but not limited to those practicing physical medicine and rehabilitation, pain medicine, sports medicine, orthopedic surgery, and radiology. Traditional image-guided intra-articular hip injection commonly uses an anterior-oblique approach from a starting point on the anterior groin traversing soft tissue anterior to the femoral neck to the target needle placement at the femoral head-neck junction.

In fluoroscopic procedures, a coaxial technique for needles placement is used for safe and precise insertion of needles. An X-ray beam is angled in line with the projected path of the needle from skin entry point to injection target. Coaxial, en face technique (also called EF, parallel, hub view, down the barrel, or barrel view) appears as a single radiopaque dot over the target injection site.¹ This technique minimizes needle redirection for correction of the injection path and minimal disturbance of surrounding tissue on the approach to the intended target.

Noncoaxial technique, as used in the anterior-oblique approach, intentionally directs the needle away from a skin entry point, the needle barrel traversing the X-ray beam toward an injection target. Clinical challenges to injection with the anterior-oblique approach include using a noncoaxial technique. Additional challenges to the anterior-oblique (also referred to as anterior) approach are body habitus and pannus, proximity to neurovascular structures, and patient positioning. By understanding the risks and benefits of varied technical approaches to accomplish a clinical goal and outcome, trainees are better able to select the technique most appropriate for a varied patient population.

Common risks to patients for all intra-articular interventions include bleeding, infection, and pain. Risk of damage to nearby structures is often mentioned as part of a standard informed consent process as it relates to the femoral vein, artery, and nerve that are in close anatomical proximity to the target injection site. When prior studies have examined the risk of complications resulting from intra-articular hip injections, a common conclusion is that despite a relatively low-risk profile for skilled interventionalists, efforts to avoid needle placement in the medial 50% of the femoral head on antero-posterior imaging is recommended.²

The anterior technique is a commonly described approach, and the same can be used for both ultrasound-guided and fluoroscopically guided hip injections.³ Using ultrasound guidance, the anterior technique can be performed with in-plane direct visualization of the needle throughout the procedure. With fluoroscopic guidance, the anterior approach is performed out-of-plane, using the noncoaxial technique. This requires the interventionalist to use tactile and anatomic guidance to the target injection site. The anterior approach for hip injection is one of few interventions where coaxial technique is not used for the procedure, making the instruction for a learner less concrete and potentially more challenging related to the needle path not under direct visualization in plane with the X-ray beam.

Technical guidance and detailed instruction for the lateral approach is infrequently described in fluoroscopic interventional texts. Reference to a lateral approach hip injection was made as early as the 1970s, without detail provided on the technique, with respect to the advantage of visualization of the hip joint for needle placement when hardware is in place.⁴ A more recent article described a lateral approach technique involving the patient in a decubitus (lateral) supine position, which presents limitations in consistent fluoroscopic imaging and can be a challenging static position for the patient to maintain.⁵

The retrospective review of anterior-oblique and lateral approach procedures in this study aims to demonstrate that there is no significant difference in radiation exposure, rate of successful intra-articular injection, or complication rate. If proven as a noninferior technique, the lateral approach may be a valuable interventional skill to those performing hip injections. Potential benefits to the patient and provider include options for the provider to access the joint using either technique. Additionally, the approach can be added to the instructional plan for those practitioners providing technical instruction to trainees within their health care system.

Methods

The institutional review board at the VA Ann Arbor Healthcare System reviewed and granted approval for this study. One of 5 interventional pain physician staff members at the VA Ann Arbor Healthcare System performed fluoroscopically guided hip injections. Interventional pain fellows under the direct supervision of board-certified physicians performed the procedures for the study cases. Supervising physicians included both physiatrists and anesthesiologists. Images were reviewed and evaluated without corresponding patient biographic data.

For cases using the lateral approach, the patients were positioned supine on the fluoroscopy table. In anterior-posterior and lateral views, trajectory lines are drawn using a long metal marking rod held adjacent to the patient. With pulsed low-dose fluoroscopy, transverse lines are drawn to identify midpoint of the femoral head in lateral view (Figure 1A, x-axis) and the most direct line from skin to lateral femoral head neck junction joint target (Figure 1B, z-axis). Also confirmed in lateral view, the z-axis marked line drawn on the skin is used to confirm that this transverse plane crosses the overlapping femoral heads (Figure 1A, y-axis).

Imaging reports, using the saved images and the associated procedure report, were classified for technical approach (anterior, lateral, or inconclusive), success of joint injection as evidenced by appropriate contrast enhancement within the joint space (successful, unsuccessful, or incomplete images), documented use of sedation (yes, no), patient positioning (supine, prone), radiation exposure dose, radiation exposure time, and additional comments, such as “notable pannus” or “hardware present” to annotate significant findings on imaging review.

Statistical Analysis

The distribution of 2 outcomes used to compare rates of complication, radiation dose, and exposure time was checked using the Shapiro-Wilk test. Power analysis determined that inclusion of 30 anterior and 30 lateral cases results in adequate power to detect a 1-point mean difference, assuming a standard deviation of 1.5 in each group. Both radiation dose and exposure time were found to be nonnormally distributed (W = 0.65, P < .001; W = 0.86, P < .001; respectively). Median and interquartile range (IQR) of dose and time in seconds for anterior and lateral approaches were computed. Median differences in radiation dose and exposure time between anterior and lateral approaches were assessed with the k-sample test of equality of medians. All analyses were conducted using Stata Version 14.1 (College Station, TX).

Results

Between June 2017 and January 2018, 88 cases were reviewed as performed, with 30 anterior and 30 lateral approach cases included in this retrospective comparison study. A total of 28 cases were excluded from the study for using an inconclusive approach, multiple or bilateral procedures, cases without recorded dose and time data, and inadequately saved images to provide meaningful data (Figure 3).

Rate of successful intervention with needle placement confirmed within the articular space on contrast enhancement was not significantly different in the study groups with 96.7% (29 of 30) anterior approach cases reported as successful, 100% (30 of 30) lateral approach cases reported as successful. Overhanging pannus in the viewing area was reported in 5 anterior approach cases and 4 lateral cases. Hardware was noted in 2 lateral approach cases, none in anterior approach cases. Sedation was used for 3 of the anterior approach cases and none of the lateral approach cases.

Discussion

Pain medicine fellows who have previously completed residency in a variety of disciplines, often either anesthesiology or physical medicine and rehabilitation, perform fluoroscopically guided procedures and benefit from increased experience with coaxial technique as this improves needle depth and location awareness. Once mastered, this skill set can be applied to and useful for multiple interventional pain procedures. Similar technical instruction with an emphasis on coaxial technique for hip injections as performed in the anterior or anterolateral approach can be used in both fluoroscopic and ultrasound-guided procedures, including facet injection, transforaminal epidural steroid injection, and myriad other procedures performed to ameliorate pain. There are advantages to pursuing a similar approach with all image-guided procedures. Evaluated in this comparison study is an alternative technique that has potential for risk reduction benefit with reduced proximity to neurovascular structures, which ultimately leads to a safer procedure profile.

Using a lateral approach, the interventionalist determines a starting point, entering the skin at a greater distance from any overlying pannus and the elevated concentration of gram-negative and gram-positive bacteria contained within the inguinal skin.⁶ A previous study demonstrated improved success of intra-articular needle tip placement without image guidance in patients with body mass index (BMI) < 30.⁷ A prior study of anterior approach using anatomic landmarks as compared to lateral approach demonstrated the anterior approach pierced or contacted the femoral nerve in 27% of anterior cases and came within 5 mm of 60% of anterior cases.² Use of image guidance, whether ultrasound, fluoroscopy, or computed tomography (CT) is preferred related to reduced risk of contact with adjacent neurovascular structures. Anatomic surface landmarks have been described as an alternative injection technique, without the use of fluoroscopy for confirmatory initial, intraprocedure, and final placement.⁸ Palpation of anatomic structures is required for this nonimage-guided technique, and although similar to the described technique in this study, the anatomically guided injection starting point is more lateral than the anterior approach but not in the most lateral position in the transverse plane that is used for this fluoroscopically guided lateral approach study.

Physiologic characteristics of subjects and technical aspects of fluoroscopy both can be factors in radiation dose and exposure times for hip injections. Patient BMI was not included in the data collection, but further study would seek to determine whether BMI is a significant risk for any increased radiation dose and exposure times using lateral approach injections. Use of lateral images for fluoroscopy requires penetration of X-ray beam through more tissue compared with that of anterior-posterior images. Further study of these techniques would benefit from comparing the pulse rate of fluoroscopic images and collimation (or focusing of the radiation beam over a smaller area of tissue) as factors in any observed increase in total radiation dose and exposure times.

Improving the safety profile of this procedure could have a positive impact on the patient population receiving fluoroscopic hip injections, both within the VA Ann Arbor Health System and elsewhere. While the study population was limited to the VA patient population seeking subspecialty nonsurgical joint care at a single tertiary care center, this technique is generalizable and can be used in most patients, as hip pain is a common condition necessitating nonoperative evaluation and treatment.

Radiation Exposures

As our analysis demonstrates, mean radiation dose exposure for each group was consistent with low (≤ 3 mSv) to moderate (> 3-20 mSv) annual effective doses in the general population.⁷ Both anterior and lateral median radiation dose of 1 mGy and 3 mGy, respectively, are within the standard exposure for radiographs of the pelvis (1.31 mGy).⁹ It is therefore reasonable to consider a lateral approach for hip injection, given the benefits of direct coaxial approach and avoiding needle entry through higher bacteria-concentrated skin.

The lateral approach did have increased radiation dose and exposure time, although it was not statistically significantly greater than the anterior approach. The difference between radiation dose and time to perform either technique was not clinically significant. One potential explanation for this is that the lateral technique has increased tissue to penetrate, which can be reduced with collimation and other fluoroscopic image adjustments. Additionally, as trainees progress in competency, fewer images should need to be obtained.⁷ We hypothesize that as familiarity and comfort with this technique increase, the number of images necessary for successful injection would decrease, leading to decreased radiation dose and exposure time. We would expect that in the hands of a board-certified interventionalist, radiation dose and exposure time would be significantly decreased as compared to our current dataset, and this is an area of planned further study. With our existing dataset, the majority of procedures were performed with trainees, with inadequate information documented for comparison of dose over time and procedural experience under individual physicians.

Notable strengths of this study are the direct comparison of the anterior approach when compared to the lateral approach with regard to radiation dose and exposure time, which we have not seen described in the literature. A detailed description of the technique may result in increased utilization by other providers. Data were collected from multiple providers, as board-certified pain physicians and board-eligible interventional pain fellows performed the procedures. This variability in providers increases the generalizability of the findings, with a variety of providers, disciplines, years of experiences, and type of training represented.

Limitations

Limitations include the retrospective nature of the study and the relatively small sample size. However, even with this limitation, it is notable that no statistically significant differences were observed in mean radiation dose or fluoroscopy exposure time, making the lateral approach, at minimum, a noninferior technique. Combined with the improved safety profile, this technique is a viable alternative to the traditional anterior-oblique approach. Further study should be performed, such as a prospective, randomized control trial investigating the 2 techniques and following pain scores and functional ability after the procedure.

Conclusion

Given the decreased procedural risk related to proximity of neurovascular structures and coaxial technique for needle advancement, lateral approach for hip injection should be considered by those in any discipline performing fluoroscopically guided procedures. Lateral technique may be particularly useful in technically challenging cases and when skin entry at the anterior groin is suboptimal, as a noninferior alternative to traditional anterior method.

The disputes about those who decline to vaccinate their children for communicable infectious diseases, especially measles, have been in the headlines of late. Those refusals are often done in the name of “medical freedom.”¹ Yet this is a much older debate for the military. It seems fitting in this month in which we celebrate the 243rd anniversary of the Declaration of Independence to reflect on the earliest history of the interaction between vaccinations and war in the US and what it tells us about the fight for religious and political freedom and individual liberty.

Go back in time with me to 1776, long before the Fourth of July was a day for barbecues and fireworks. We are in Boston, Philadelphia, and other important cities in colonial America. This time, concern was not about measles but the even more dreaded smallpox. In the first years of the Revolutionary War, General George Washington took command of a newly formed and named Continental Army. A catastrophic 90% of casualties in the Continental Army were from infectious diseases, with the lion’s share of these from smallpox, which at that time had a mortality rate of about 30%.^2,3

Early efforts to introduce inoculation into the colonies had failed for many of the same reasons parents across the US today refuse immunization: fear and anxiety. When the renowned New England Puritan minister and scientist Cotton Mather attempted in 1721 to introduce variolation, his house was firebombed and his fellow clergy and physicians alleged that his efforts at inoculation were challenging God’s will to send a plague.³ Variolation was the now antiquated and then laborious process in which a previously unexposed individual was inoculated with material from the vesicle of someone infected with the disease.^4,5 Variolation was practiced in parts of Africa and Asia and among wealthy Europeans but remained controversial in many colonies where few Americans had been exposed to smallpox or could afford the procedure.³

It is important to note that the use of variolation was practiced before Edward Jenner famously demonstrated that cowpox vaccine could provide immunity to smallpox in 1798. The majority of those inoculated would develop a mild case of smallpox that required a 5-week period of illness and recovery that provided lifelong immunity. However, during those 5 weeks, they remained a vector of disease for the uninoculated. Southern and New England colonies passed laws that prohibited variolation. Those anti-inoculation attitudes were the basis for the order given to the surgeons general of the Continental Army in 1776 that all inoculations of the troops were forbidden, despite the fact that perhaps only 25% of soldiers possessed any natural immunity.^2,3

There was yet another reason that many colonial Americans opposed government-sponsored preventative care, and it was the same reason that they were fighting a war of independence: distrust and resentment of authority. The modern antivaccine movement voices similar fears and suspicions regarding public health campaigns and especially legislative efforts to mandate vaccinations or remove extant exemptions.

In 1775 in Boston, a smallpox outbreak occurred at the same time the Americans laid siege to the British troops occupying the city. Greater natural immunity to the scourge of smallpox either through exposure or variolation provided the British with a stronger defense than the mere city fortifications. There are even some suspicions that the British used the virus as a proto-biologic weapon.

General Washington had initially been against inoculation until he realized that without it the British might win the war. This possibility presented him with a momentous decision: inoculate despite widespread anxiety that variolation would spread the disease or risk the virus ravaging the fighting force. Perhaps the most compelling reason to variolate was that new recruits refused to sign up, fearing not that they would die in battle but of smallpox. In 1777, Washington mandated variolation of the nonimmune troops and new recruits, making it the first large-scale military preventative care measure in history.

Recapitulating an ethical dilemma that still rages in the military nearly 3 centuries later, for British soldiers, inoculation was voluntary not compulsory as for the Americans. There was so much opposition to Washington’s order that communications with surgeons were secret, and commanding officers had to oversee the inoculations.^2,3

Washington’s policy not only contributed mightily to the American victory in the war, but also set the precedent for compulsory vaccination in the US military for the next 3 centuries. Currently, regulations require that service members be vaccinated for multiple infectious diseases. Of interest, this mandatory vaccination program has led to no reported cases of measles among military families to date, in part because of federal regulations requiring families of those service members to be vaccinated.⁶

Ironically, once General Washington made the decision for mass inoculation, he encountered little actual resistance among the troops. However, throughout military history some service members have objected to compulsory vaccination on medical, religious, and personal grounds. In United States v Chadwell, a military court ruled against 2 Marine Corps members who refused vaccination for smallpox, typhoid, paratyphoid, and influenza, citing religious grounds. The court opined that the military orders that ensure the health and safety of the armed forces and thereby that of the public override personal religious beliefs.⁷

The paradox of liberty—the liberty first won in the Revolutionary War—is that in a pluralistic representative democracy like ours to secure the freedom for all, some, such as the military, must relinquish the very choice to refuse. Their sacrifices grant liberty to others. On June 6, we commemorated the seventy-fifth anniversary of D-Day, remembering how great the cost of that eternal vigilance, which the patriot Thomas Paine said was the price of liberty. On Memorial Day, we remember all those men and women who died in the service of their country. And while they gave up the most precious gift, we must never forget that every person in uniform also surrenders many other significant personal freedoms so that their fellow civilians may exercise them.

The question General Washington faced is one that public health authorities and our legislators again confront. When should the freedom to refuse, which was won with the blood of many valiant heroes and has been defended since 1776, be curtailed for the greater good? We are the one nation in history that has made the defense of self-determination its highest value and in so doing, its greatest challenge.

The disputes about those who decline to vaccinate their children for communicable infectious diseases, especially measles, have been in the headlines of late. Those refusals are often done in the name of “medical freedom.”¹ Yet this is a much older debate for the military. It seems fitting in this month in which we celebrate the 243rd anniversary of the Declaration of Independence to reflect on the earliest history of the interaction between vaccinations and war in the US and what it tells us about the fight for religious and political freedom and individual liberty.

Go back in time with me to 1776, long before the Fourth of July was a day for barbecues and fireworks. We are in Boston, Philadelphia, and other important cities in colonial America. This time, concern was not about measles but the even more dreaded smallpox. In the first years of the Revolutionary War, General George Washington took command of a newly formed and named Continental Army. A catastrophic 90% of casualties in the Continental Army were from infectious diseases, with the lion’s share of these from smallpox, which at that time had a mortality rate of about 30%.^2,3

Early efforts to introduce inoculation into the colonies had failed for many of the same reasons parents across the US today refuse immunization: fear and anxiety. When the renowned New England Puritan minister and scientist Cotton Mather attempted in 1721 to introduce variolation, his house was firebombed and his fellow clergy and physicians alleged that his efforts at inoculation were challenging God’s will to send a plague.³ Variolation was the now antiquated and then laborious process in which a previously unexposed individual was inoculated with material from the vesicle of someone infected with the disease.^4,5 Variolation was practiced in parts of Africa and Asia and among wealthy Europeans but remained controversial in many colonies where few Americans had been exposed to smallpox or could afford the procedure.³

It is important to note that the use of variolation was practiced before Edward Jenner famously demonstrated that cowpox vaccine could provide immunity to smallpox in 1798. The majority of those inoculated would develop a mild case of smallpox that required a 5-week period of illness and recovery that provided lifelong immunity. However, during those 5 weeks, they remained a vector of disease for the uninoculated. Southern and New England colonies passed laws that prohibited variolation. Those anti-inoculation attitudes were the basis for the order given to the surgeons general of the Continental Army in 1776 that all inoculations of the troops were forbidden, despite the fact that perhaps only 25% of soldiers possessed any natural immunity.^2,3

There was yet another reason that many colonial Americans opposed government-sponsored preventative care, and it was the same reason that they were fighting a war of independence: distrust and resentment of authority. The modern antivaccine movement voices similar fears and suspicions regarding public health campaigns and especially legislative efforts to mandate vaccinations or remove extant exemptions.

In 1775 in Boston, a smallpox outbreak occurred at the same time the Americans laid siege to the British troops occupying the city. Greater natural immunity to the scourge of smallpox either through exposure or variolation provided the British with a stronger defense than the mere city fortifications. There are even some suspicions that the British used the virus as a proto-biologic weapon.

General Washington had initially been against inoculation until he realized that without it the British might win the war. This possibility presented him with a momentous decision: inoculate despite widespread anxiety that variolation would spread the disease or risk the virus ravaging the fighting force. Perhaps the most compelling reason to variolate was that new recruits refused to sign up, fearing not that they would die in battle but of smallpox. In 1777, Washington mandated variolation of the nonimmune troops and new recruits, making it the first large-scale military preventative care measure in history.

Recapitulating an ethical dilemma that still rages in the military nearly 3 centuries later, for British soldiers, inoculation was voluntary not compulsory as for the Americans. There was so much opposition to Washington’s order that communications with surgeons were secret, and commanding officers had to oversee the inoculations.^2,3

Washington’s policy not only contributed mightily to the American victory in the war, but also set the precedent for compulsory vaccination in the US military for the next 3 centuries. Currently, regulations require that service members be vaccinated for multiple infectious diseases. Of interest, this mandatory vaccination program has led to no reported cases of measles among military families to date, in part because of federal regulations requiring families of those service members to be vaccinated.⁶

Ironically, once General Washington made the decision for mass inoculation, he encountered little actual resistance among the troops. However, throughout military history some service members have objected to compulsory vaccination on medical, religious, and personal grounds. In United States v Chadwell, a military court ruled against 2 Marine Corps members who refused vaccination for smallpox, typhoid, paratyphoid, and influenza, citing religious grounds. The court opined that the military orders that ensure the health and safety of the armed forces and thereby that of the public override personal religious beliefs.⁷

The paradox of liberty—the liberty first won in the Revolutionary War—is that in a pluralistic representative democracy like ours to secure the freedom for all, some, such as the military, must relinquish the very choice to refuse. Their sacrifices grant liberty to others. On June 6, we commemorated the seventy-fifth anniversary of D-Day, remembering how great the cost of that eternal vigilance, which the patriot Thomas Paine said was the price of liberty. On Memorial Day, we remember all those men and women who died in the service of their country. And while they gave up the most precious gift, we must never forget that every person in uniform also surrenders many other significant personal freedoms so that their fellow civilians may exercise them.

The question General Washington faced is one that public health authorities and our legislators again confront. When should the freedom to refuse, which was won with the blood of many valiant heroes and has been defended since 1776, be curtailed for the greater good? We are the one nation in history that has made the defense of self-determination its highest value and in so doing, its greatest challenge.

The disputes about those who decline to vaccinate their children for communicable infectious diseases, especially measles, have been in the headlines of late. Those refusals are often done in the name of “medical freedom.”¹ Yet this is a much older debate for the military. It seems fitting in this month in which we celebrate the 243rd anniversary of the Declaration of Independence to reflect on the earliest history of the interaction between vaccinations and war in the US and what it tells us about the fight for religious and political freedom and individual liberty.

Go back in time with me to 1776, long before the Fourth of July was a day for barbecues and fireworks. We are in Boston, Philadelphia, and other important cities in colonial America. This time, concern was not about measles but the even more dreaded smallpox. In the first years of the Revolutionary War, General George Washington took command of a newly formed and named Continental Army. A catastrophic 90% of casualties in the Continental Army were from infectious diseases, with the lion’s share of these from smallpox, which at that time had a mortality rate of about 30%.^2,3

Early efforts to introduce inoculation into the colonies had failed for many of the same reasons parents across the US today refuse immunization: fear and anxiety. When the renowned New England Puritan minister and scientist Cotton Mather attempted in 1721 to introduce variolation, his house was firebombed and his fellow clergy and physicians alleged that his efforts at inoculation were challenging God’s will to send a plague.³ Variolation was the now antiquated and then laborious process in which a previously unexposed individual was inoculated with material from the vesicle of someone infected with the disease.^4,5 Variolation was practiced in parts of Africa and Asia and among wealthy Europeans but remained controversial in many colonies where few Americans had been exposed to smallpox or could afford the procedure.³

It is important to note that the use of variolation was practiced before Edward Jenner famously demonstrated that cowpox vaccine could provide immunity to smallpox in 1798. The majority of those inoculated would develop a mild case of smallpox that required a 5-week period of illness and recovery that provided lifelong immunity. However, during those 5 weeks, they remained a vector of disease for the uninoculated. Southern and New England colonies passed laws that prohibited variolation. Those anti-inoculation attitudes were the basis for the order given to the surgeons general of the Continental Army in 1776 that all inoculations of the troops were forbidden, despite the fact that perhaps only 25% of soldiers possessed any natural immunity.^2,3

There was yet another reason that many colonial Americans opposed government-sponsored preventative care, and it was the same reason that they were fighting a war of independence: distrust and resentment of authority. The modern antivaccine movement voices similar fears and suspicions regarding public health campaigns and especially legislative efforts to mandate vaccinations or remove extant exemptions.

In 1775 in Boston, a smallpox outbreak occurred at the same time the Americans laid siege to the British troops occupying the city. Greater natural immunity to the scourge of smallpox either through exposure or variolation provided the British with a stronger defense than the mere city fortifications. There are even some suspicions that the British used the virus as a proto-biologic weapon.

General Washington had initially been against inoculation until he realized that without it the British might win the war. This possibility presented him with a momentous decision: inoculate despite widespread anxiety that variolation would spread the disease or risk the virus ravaging the fighting force. Perhaps the most compelling reason to variolate was that new recruits refused to sign up, fearing not that they would die in battle but of smallpox. In 1777, Washington mandated variolation of the nonimmune troops and new recruits, making it the first large-scale military preventative care measure in history.

Recapitulating an ethical dilemma that still rages in the military nearly 3 centuries later, for British soldiers, inoculation was voluntary not compulsory as for the Americans. There was so much opposition to Washington’s order that communications with surgeons were secret, and commanding officers had to oversee the inoculations.^2,3

Washington’s policy not only contributed mightily to the American victory in the war, but also set the precedent for compulsory vaccination in the US military for the next 3 centuries. Currently, regulations require that service members be vaccinated for multiple infectious diseases. Of interest, this mandatory vaccination program has led to no reported cases of measles among military families to date, in part because of federal regulations requiring families of those service members to be vaccinated.⁶

Ironically, once General Washington made the decision for mass inoculation, he encountered little actual resistance among the troops. However, throughout military history some service members have objected to compulsory vaccination on medical, religious, and personal grounds. In United States v Chadwell, a military court ruled against 2 Marine Corps members who refused vaccination for smallpox, typhoid, paratyphoid, and influenza, citing religious grounds. The court opined that the military orders that ensure the health and safety of the armed forces and thereby that of the public override personal religious beliefs.⁷

The paradox of liberty—the liberty first won in the Revolutionary War—is that in a pluralistic representative democracy like ours to secure the freedom for all, some, such as the military, must relinquish the very choice to refuse. Their sacrifices grant liberty to others. On June 6, we commemorated the seventy-fifth anniversary of D-Day, remembering how great the cost of that eternal vigilance, which the patriot Thomas Paine said was the price of liberty. On Memorial Day, we remember all those men and women who died in the service of their country. And while they gave up the most precious gift, we must never forget that every person in uniform also surrenders many other significant personal freedoms so that their fellow civilians may exercise them.

The question General Washington faced is one that public health authorities and our legislators again confront. When should the freedom to refuse, which was won with the blood of many valiant heroes and has been defended since 1776, be curtailed for the greater good? We are the one nation in history that has made the defense of self-determination its highest value and in so doing, its greatest challenge.

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.

 With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.

Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.

Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.

The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”

The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.

 With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.

Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.

Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.

The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”

The “digital divide”: That is how the VA describes the situation of the 42% of veterans without reliable—or any—Internet access. The lack of access means they are effectively barred from participating in telehealth and other online services.

 With the goal of “digital inclusion,” the Veterans Health Administration (VHA) is partnering with a variety of nongovernmental businesses. VHA and T-Mobile, for instance, host the VA Video Connect application, which connects veterans to health care providers on a secure line on all devices with T-Mobile for free.

Walmart, Philips, and Veteran Service Organizations have set up remote clinics for veterans to access telehealth services closer to their home; with those partners, the VHA also lends Internet-connected iPads to veterans who do not have home computers.

Now, the VHA is working with Microsoft and Internet service providers to bring broadband access to rural areas with large populations of veterans.

The initiatives will not only improve access to health care, but also open other avenues. Dr. Kevin Galpin, executive director of VHA Telehealth Services, says, “We really want veterans to have the opportunities that come with being connected. There is lots of value in being able to maintain social relationships, conduct job searches online, and connect with VA. We know limited access is a problem and we’re exploring a multitude of options.”

Patients with gout who visit the emergency department are regularly prescribed opioids, based on a review of electronic medical records.

“In addition to regulatory changes, the burden of opioid prescription could be potentially reduced by creating prompts for providers in electronic record systems to avoid prescribing opioids in opioid-naive patients or using lower intensity and shorter duration of prescription,” wrote Deepan S. Dalal, MD, of Brown University, Providence, R.I., and coauthors. The study was published in Arthritis Care & Research.

To determine frequency, dose, and duration of opioid prescription at ED discharge, the researchers reviewed the records of 456 patients with acute gout who were discharged in Rhode Island between March 30, 2015, and Sept. 30, 2017. All data were gathered via electronic medical system records.

Of the 456 discharged patients, 129 (28.3%) were prescribed opioids; 102 (79%) were not on opioids at the time. A full prescription description was available for 119 of the 129 patients; 96 (81%) were prescribed oxycodone or oxycodone combinations. Hydrocodone was prescribed for 9 patients (8%) and tramadol was prescribed for 11 patients (9%).

The median duration of each prescription was 8 days (interquartile range, 5-14 days) and the average daily dose was 37.9 mg of morphine equivalent. Patients who were prescribed opioids tended to be younger and male. After multivariable analysis, diabetes, polyarticular gout attack, and prior opioid use were all associated with a more than 100% higher odds of receiving an opioid prescription.

The authors acknowledged their study’s limitations, including their inability to determine the physicians’ reasoning behind each prescription or the prescribing habits of each provider. In addition, they were only able to assess the prescriptions as being written and not the number of pills actually taken or not taken.

No conflicts of interest were reported.

SOURCE: Dalal DS et al. Arthritis Care Res. 2019 Jul 3. doi: 10.1002/acr.23928.

Patients with gout who visit the emergency department are regularly prescribed opioids, based on a review of electronic medical records.

“In addition to regulatory changes, the burden of opioid prescription could be potentially reduced by creating prompts for providers in electronic record systems to avoid prescribing opioids in opioid-naive patients or using lower intensity and shorter duration of prescription,” wrote Deepan S. Dalal, MD, of Brown University, Providence, R.I., and coauthors. The study was published in Arthritis Care & Research.

To determine frequency, dose, and duration of opioid prescription at ED discharge, the researchers reviewed the records of 456 patients with acute gout who were discharged in Rhode Island between March 30, 2015, and Sept. 30, 2017. All data were gathered via electronic medical system records.

Of the 456 discharged patients, 129 (28.3%) were prescribed opioids; 102 (79%) were not on opioids at the time. A full prescription description was available for 119 of the 129 patients; 96 (81%) were prescribed oxycodone or oxycodone combinations. Hydrocodone was prescribed for 9 patients (8%) and tramadol was prescribed for 11 patients (9%).

The median duration of each prescription was 8 days (interquartile range, 5-14 days) and the average daily dose was 37.9 mg of morphine equivalent. Patients who were prescribed opioids tended to be younger and male. After multivariable analysis, diabetes, polyarticular gout attack, and prior opioid use were all associated with a more than 100% higher odds of receiving an opioid prescription.

The authors acknowledged their study’s limitations, including their inability to determine the physicians’ reasoning behind each prescription or the prescribing habits of each provider. In addition, they were only able to assess the prescriptions as being written and not the number of pills actually taken or not taken.

No conflicts of interest were reported.

SOURCE: Dalal DS et al. Arthritis Care Res. 2019 Jul 3. doi: 10.1002/acr.23928.

Patients with gout who visit the emergency department are regularly prescribed opioids, based on a review of electronic medical records.

“In addition to regulatory changes, the burden of opioid prescription could be potentially reduced by creating prompts for providers in electronic record systems to avoid prescribing opioids in opioid-naive patients or using lower intensity and shorter duration of prescription,” wrote Deepan S. Dalal, MD, of Brown University, Providence, R.I., and coauthors. The study was published in Arthritis Care & Research.

To determine frequency, dose, and duration of opioid prescription at ED discharge, the researchers reviewed the records of 456 patients with acute gout who were discharged in Rhode Island between March 30, 2015, and Sept. 30, 2017. All data were gathered via electronic medical system records.

Of the 456 discharged patients, 129 (28.3%) were prescribed opioids; 102 (79%) were not on opioids at the time. A full prescription description was available for 119 of the 129 patients; 96 (81%) were prescribed oxycodone or oxycodone combinations. Hydrocodone was prescribed for 9 patients (8%) and tramadol was prescribed for 11 patients (9%).

The median duration of each prescription was 8 days (interquartile range, 5-14 days) and the average daily dose was 37.9 mg of morphine equivalent. Patients who were prescribed opioids tended to be younger and male. After multivariable analysis, diabetes, polyarticular gout attack, and prior opioid use were all associated with a more than 100% higher odds of receiving an opioid prescription.

The authors acknowledged their study’s limitations, including their inability to determine the physicians’ reasoning behind each prescription or the prescribing habits of each provider. In addition, they were only able to assess the prescriptions as being written and not the number of pills actually taken or not taken.

No conflicts of interest were reported.

SOURCE: Dalal DS et al. Arthritis Care Res. 2019 Jul 3. doi: 10.1002/acr.23928.

The consumption of some probiotic supplements appears linked to a reduced susceptibility to depressive symptoms, preliminary results of a randomized trial of 71 participants show.

“Results from the current study provide further evidence that some probiotic mixtures can influence thinking and cognition,” reported Bahia Chahwan of the University of Technology Sydney in New South Wales, Australia, and associates. “Although probiotics did not appear to have had a direct effect on depressive symptoms, our results suggest that probiotics potentially act on cognitive processes contributing to depression.” The study was published in the Journal of Affective Disorders.

To conduct the study, the investigators recruited 71 adults over a 12-month period. A nondepressed control group consisting of 20 adults was recruited over 2 months. Across both groups, about 70% of the participants were women, 67% were white, 80% had no abdominal conditions, 78% did not smoke, and 92% did not consume alcohol above the daily recommended intake. The participants were randomly assigned to either the probiotic or placebo group. Members of both groups received instructions on how to consume their respective product, which was a 2-g freeze-dried powder mixture, twice a day over 8 weeks, and were scheduled for weekly monitoring visits.

Several pre- and postintervention measures of depression were compared using several scales, including the MINI International Neuropsychiatric Interview, the Depression Anxiety Stress Scale-21, and the Beck Anxiety Inventory.

Participants in both groups experienced a reduction in depressive symptoms during the trial period. “This is in line with the evidence suggesting that routines and engagement in planned activities [are] beneficial for reducing symptoms of depression, which forms the basis of activity scheduling as a component for [cognitive-behavioral therapy] for depression,” they wrote.

However, in contrast to the investigators’ hypotheses, participants in the probiotics group did not experience a greater reduction in depressive symptoms than did those on placebo. Instead, the differences between the groups were seen on a measure for depression called cognitive reactivity. Specifically, people with mild/moderate depression who took the probiotics reported lower psychological test scores on cognitive reactivity, compared with controls (45.00 vs. 53.78).

Additional research is needed to look at the impact of differences in gut microbiota strains on people with depressive symptoms, the researchers said. In the meantime, clinicians might do well to consider probiotics as an adjunctive intervention. “Probiotics may be a useful adjunct to potentiate the effects of therapies, such as CBT, which changes cognitive patterns.”

One of the authors, Saskia van Hemert, is an employee of Winclove Probiotics. The other authors reported having no conflicts of interest.

ghenderson@mdedge.com

SOURCE: Chahwan B et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.04.97.

The consumption of some probiotic supplements appears linked to a reduced susceptibility to depressive symptoms, preliminary results of a randomized trial of 71 participants show.

“Results from the current study provide further evidence that some probiotic mixtures can influence thinking and cognition,” reported Bahia Chahwan of the University of Technology Sydney in New South Wales, Australia, and associates. “Although probiotics did not appear to have had a direct effect on depressive symptoms, our results suggest that probiotics potentially act on cognitive processes contributing to depression.” The study was published in the Journal of Affective Disorders.

To conduct the study, the investigators recruited 71 adults over a 12-month period. A nondepressed control group consisting of 20 adults was recruited over 2 months. Across both groups, about 70% of the participants were women, 67% were white, 80% had no abdominal conditions, 78% did not smoke, and 92% did not consume alcohol above the daily recommended intake. The participants were randomly assigned to either the probiotic or placebo group. Members of both groups received instructions on how to consume their respective product, which was a 2-g freeze-dried powder mixture, twice a day over 8 weeks, and were scheduled for weekly monitoring visits.

Several pre- and postintervention measures of depression were compared using several scales, including the MINI International Neuropsychiatric Interview, the Depression Anxiety Stress Scale-21, and the Beck Anxiety Inventory.

Participants in both groups experienced a reduction in depressive symptoms during the trial period. “This is in line with the evidence suggesting that routines and engagement in planned activities [are] beneficial for reducing symptoms of depression, which forms the basis of activity scheduling as a component for [cognitive-behavioral therapy] for depression,” they wrote.

However, in contrast to the investigators’ hypotheses, participants in the probiotics group did not experience a greater reduction in depressive symptoms than did those on placebo. Instead, the differences between the groups were seen on a measure for depression called cognitive reactivity. Specifically, people with mild/moderate depression who took the probiotics reported lower psychological test scores on cognitive reactivity, compared with controls (45.00 vs. 53.78).

Additional research is needed to look at the impact of differences in gut microbiota strains on people with depressive symptoms, the researchers said. In the meantime, clinicians might do well to consider probiotics as an adjunctive intervention. “Probiotics may be a useful adjunct to potentiate the effects of therapies, such as CBT, which changes cognitive patterns.”

One of the authors, Saskia van Hemert, is an employee of Winclove Probiotics. The other authors reported having no conflicts of interest.

ghenderson@mdedge.com

SOURCE: Chahwan B et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.04.97.

The consumption of some probiotic supplements appears linked to a reduced susceptibility to depressive symptoms, preliminary results of a randomized trial of 71 participants show.

“Results from the current study provide further evidence that some probiotic mixtures can influence thinking and cognition,” reported Bahia Chahwan of the University of Technology Sydney in New South Wales, Australia, and associates. “Although probiotics did not appear to have had a direct effect on depressive symptoms, our results suggest that probiotics potentially act on cognitive processes contributing to depression.” The study was published in the Journal of Affective Disorders.

To conduct the study, the investigators recruited 71 adults over a 12-month period. A nondepressed control group consisting of 20 adults was recruited over 2 months. Across both groups, about 70% of the participants were women, 67% were white, 80% had no abdominal conditions, 78% did not smoke, and 92% did not consume alcohol above the daily recommended intake. The participants were randomly assigned to either the probiotic or placebo group. Members of both groups received instructions on how to consume their respective product, which was a 2-g freeze-dried powder mixture, twice a day over 8 weeks, and were scheduled for weekly monitoring visits.

Several pre- and postintervention measures of depression were compared using several scales, including the MINI International Neuropsychiatric Interview, the Depression Anxiety Stress Scale-21, and the Beck Anxiety Inventory.

Participants in both groups experienced a reduction in depressive symptoms during the trial period. “This is in line with the evidence suggesting that routines and engagement in planned activities [are] beneficial for reducing symptoms of depression, which forms the basis of activity scheduling as a component for [cognitive-behavioral therapy] for depression,” they wrote.

However, in contrast to the investigators’ hypotheses, participants in the probiotics group did not experience a greater reduction in depressive symptoms than did those on placebo. Instead, the differences between the groups were seen on a measure for depression called cognitive reactivity. Specifically, people with mild/moderate depression who took the probiotics reported lower psychological test scores on cognitive reactivity, compared with controls (45.00 vs. 53.78).

Additional research is needed to look at the impact of differences in gut microbiota strains on people with depressive symptoms, the researchers said. In the meantime, clinicians might do well to consider probiotics as an adjunctive intervention. “Probiotics may be a useful adjunct to potentiate the effects of therapies, such as CBT, which changes cognitive patterns.”

One of the authors, Saskia van Hemert, is an employee of Winclove Probiotics. The other authors reported having no conflicts of interest.

ghenderson@mdedge.com

SOURCE: Chahwan B et al. J Affect Disord. 2019. doi: 10.1016/j.jad.2019.04.97.

SAN ANTONIO – Patients with obstructive sleep apnea who complain of feeling tired when they wake up, being sleepy during the day, and have a high score on the Epworth Sleepiness Scale face an increased risk for cardiovascular disease, results from a population-based analysis suggest.

Doug Brunk/MDedge News

“OSA is a highly heterogeneous disease, with multiple clinical presentations and consequences,” the study’s first author, Diego R. Mazzotti, PhD, said at the annual meeting of the Associated Professional Sleep Societies. “These patients also have diverse comorbidities, and there are arbitrary severity definitions and variable therapeutic responses. It’s difficult to lump these patients together.”

Symptom subtypes of OSA were originally described in the Icelandic Sleep Apnea Cohort, and defined as excessively sleepy, minimally symptomatic, and disturbed sleep (Eur Respir J. 2014; 44[6]:1600-7). These distinct clusters were identified based on symptom experiences and the existence of major comorbidities. “This concept is more popular today, trying to identify symptom clusters, or groups of individuals, that share similar polysomnographic data, and then compare differences in prevalence or incidence of cardiovascular disease,” said Dr. Mazzotti, a research associate at the University of Pennsylvania, Philadelphia. “That’s a concept that needs to be moving forward.”

Dr. Mazzotti and colleagues set out to determine if OSA symptom subtypes are present in the Sleep Heart Health Study, a multicenter, prospective, community-based cohort of individuals aged 40 years and older designed to assess the cardiovascular (CV) consequences of OSA. They also wanted to know if there is additional evidence of the relevance of OSA symptom subtypes, particularly with respect to cardiovascular disease .

Participant-reported symptoms, such as difficulty falling and staying asleep, snoring, fatigue, drowsy driving and daytime sleepiness, and responses to the Epworth Sleepiness Scale were used to determine the patient’s subtype. Assessments including questionnaires and in-home polysomnography were conducted at baseline (between 1995 and 1998) and follow-up (between 2001 and 2003), while CV outcomes were assessed until the end of follow-up (between 2008 and 2011).

In all, 1,207 patients from the Sleep Heart Health Study met criteria for moderate to severe OSA (apnea-hypopnea index, or AHI, of 15 or greater) and were included in the final analysis. They were followed for a mean of 12 years. Based on the clustering of symptoms, the researchers identified four OSA symptom subtypes: disturbed sleep (12%), minimally symptomatic (33%), excessively sleepy (17%), and moderately sleepy (38%) – proportions that were similar to those observed in prior studies.

The disturbed sleep subtype presented with increased prevalence of “insomnialike” symptoms, such as difficulty initiating or maintaining sleep, according to Dr. Mazzotti. “On the other hand, the excessively sleepy subtype presented with a very high prevalence of several symptoms related to excessive daytime sleepiness, while the moderately sleepy showed a moderately high prevalence of such symptoms, but not as much when compared to the excessively sleepy subtype,” he explained. “Finally, the minimally symptomatic subtype was found to have the lowest prevalence of all investigated symptoms, suggesting that these patients have low symptom burden. They do not complain as much, even though they have moderate-to-severe OSA.”

Next, Dr. Mazzotti and colleagues used Kaplan-Meier survival analysis and Cox proportional hazards models to evaluate whether subtypes were associated with incident coronary heart disease (CHD), heart failure, and CV disease, including CV mortality. Similar analyses were performed comparing each symptom subtype with 2,830 individuals without OSA (AHI less than 5).

Compared with other subtypes, the excessively sleepy group had a more than threefold increased odds of prevalent heart failure, after adjustment for other CV risk factors. They also had a 1.7- to 2.3-fold increased risk for incident CV disease (P less than .001), CHD (P = .015) and heart failure (P = 0.018), after adjustment for other CV risk factors.

“Compared to individuals without OSA, the excessively sleepy subtype is the only subtype with increased risk of incident CV disease and CHD,” Dr. Mazzotti said. “It is possible that excessively sleepy OSA patients are more likely to benefit from CPAP therapy in preventing CV disease.” These results were published online earlier this year (Am J Respir Crit Care Med. 2019 Feb 15. doi: 10.1164/rccm.201808-1509OC).

Dr. Mazzotti reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Mazzotti D et al. SLEEP 2019, Abstract 0586.

SAN ANTONIO – Patients with obstructive sleep apnea who complain of feeling tired when they wake up, being sleepy during the day, and have a high score on the Epworth Sleepiness Scale face an increased risk for cardiovascular disease, results from a population-based analysis suggest.

Doug Brunk/MDedge News

“OSA is a highly heterogeneous disease, with multiple clinical presentations and consequences,” the study’s first author, Diego R. Mazzotti, PhD, said at the annual meeting of the Associated Professional Sleep Societies. “These patients also have diverse comorbidities, and there are arbitrary severity definitions and variable therapeutic responses. It’s difficult to lump these patients together.”

Symptom subtypes of OSA were originally described in the Icelandic Sleep Apnea Cohort, and defined as excessively sleepy, minimally symptomatic, and disturbed sleep (Eur Respir J. 2014; 44[6]:1600-7). These distinct clusters were identified based on symptom experiences and the existence of major comorbidities. “This concept is more popular today, trying to identify symptom clusters, or groups of individuals, that share similar polysomnographic data, and then compare differences in prevalence or incidence of cardiovascular disease,” said Dr. Mazzotti, a research associate at the University of Pennsylvania, Philadelphia. “That’s a concept that needs to be moving forward.”

Dr. Mazzotti and colleagues set out to determine if OSA symptom subtypes are present in the Sleep Heart Health Study, a multicenter, prospective, community-based cohort of individuals aged 40 years and older designed to assess the cardiovascular (CV) consequences of OSA. They also wanted to know if there is additional evidence of the relevance of OSA symptom subtypes, particularly with respect to cardiovascular disease .

Participant-reported symptoms, such as difficulty falling and staying asleep, snoring, fatigue, drowsy driving and daytime sleepiness, and responses to the Epworth Sleepiness Scale were used to determine the patient’s subtype. Assessments including questionnaires and in-home polysomnography were conducted at baseline (between 1995 and 1998) and follow-up (between 2001 and 2003), while CV outcomes were assessed until the end of follow-up (between 2008 and 2011).

In all, 1,207 patients from the Sleep Heart Health Study met criteria for moderate to severe OSA (apnea-hypopnea index, or AHI, of 15 or greater) and were included in the final analysis. They were followed for a mean of 12 years. Based on the clustering of symptoms, the researchers identified four OSA symptom subtypes: disturbed sleep (12%), minimally symptomatic (33%), excessively sleepy (17%), and moderately sleepy (38%) – proportions that were similar to those observed in prior studies.

The disturbed sleep subtype presented with increased prevalence of “insomnialike” symptoms, such as difficulty initiating or maintaining sleep, according to Dr. Mazzotti. “On the other hand, the excessively sleepy subtype presented with a very high prevalence of several symptoms related to excessive daytime sleepiness, while the moderately sleepy showed a moderately high prevalence of such symptoms, but not as much when compared to the excessively sleepy subtype,” he explained. “Finally, the minimally symptomatic subtype was found to have the lowest prevalence of all investigated symptoms, suggesting that these patients have low symptom burden. They do not complain as much, even though they have moderate-to-severe OSA.”

Next, Dr. Mazzotti and colleagues used Kaplan-Meier survival analysis and Cox proportional hazards models to evaluate whether subtypes were associated with incident coronary heart disease (CHD), heart failure, and CV disease, including CV mortality. Similar analyses were performed comparing each symptom subtype with 2,830 individuals without OSA (AHI less than 5).

Compared with other subtypes, the excessively sleepy group had a more than threefold increased odds of prevalent heart failure, after adjustment for other CV risk factors. They also had a 1.7- to 2.3-fold increased risk for incident CV disease (P less than .001), CHD (P = .015) and heart failure (P = 0.018), after adjustment for other CV risk factors.

“Compared to individuals without OSA, the excessively sleepy subtype is the only subtype with increased risk of incident CV disease and CHD,” Dr. Mazzotti said. “It is possible that excessively sleepy OSA patients are more likely to benefit from CPAP therapy in preventing CV disease.” These results were published online earlier this year (Am J Respir Crit Care Med. 2019 Feb 15. doi: 10.1164/rccm.201808-1509OC).

Dr. Mazzotti reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Mazzotti D et al. SLEEP 2019, Abstract 0586.

SAN ANTONIO – Patients with obstructive sleep apnea who complain of feeling tired when they wake up, being sleepy during the day, and have a high score on the Epworth Sleepiness Scale face an increased risk for cardiovascular disease, results from a population-based analysis suggest.

Doug Brunk/MDedge News

“OSA is a highly heterogeneous disease, with multiple clinical presentations and consequences,” the study’s first author, Diego R. Mazzotti, PhD, said at the annual meeting of the Associated Professional Sleep Societies. “These patients also have diverse comorbidities, and there are arbitrary severity definitions and variable therapeutic responses. It’s difficult to lump these patients together.”

Symptom subtypes of OSA were originally described in the Icelandic Sleep Apnea Cohort, and defined as excessively sleepy, minimally symptomatic, and disturbed sleep (Eur Respir J. 2014; 44[6]:1600-7). These distinct clusters were identified based on symptom experiences and the existence of major comorbidities. “This concept is more popular today, trying to identify symptom clusters, or groups of individuals, that share similar polysomnographic data, and then compare differences in prevalence or incidence of cardiovascular disease,” said Dr. Mazzotti, a research associate at the University of Pennsylvania, Philadelphia. “That’s a concept that needs to be moving forward.”

Dr. Mazzotti and colleagues set out to determine if OSA symptom subtypes are present in the Sleep Heart Health Study, a multicenter, prospective, community-based cohort of individuals aged 40 years and older designed to assess the cardiovascular (CV) consequences of OSA. They also wanted to know if there is additional evidence of the relevance of OSA symptom subtypes, particularly with respect to cardiovascular disease .

Participant-reported symptoms, such as difficulty falling and staying asleep, snoring, fatigue, drowsy driving and daytime sleepiness, and responses to the Epworth Sleepiness Scale were used to determine the patient’s subtype. Assessments including questionnaires and in-home polysomnography were conducted at baseline (between 1995 and 1998) and follow-up (between 2001 and 2003), while CV outcomes were assessed until the end of follow-up (between 2008 and 2011).

In all, 1,207 patients from the Sleep Heart Health Study met criteria for moderate to severe OSA (apnea-hypopnea index, or AHI, of 15 or greater) and were included in the final analysis. They were followed for a mean of 12 years. Based on the clustering of symptoms, the researchers identified four OSA symptom subtypes: disturbed sleep (12%), minimally symptomatic (33%), excessively sleepy (17%), and moderately sleepy (38%) – proportions that were similar to those observed in prior studies.

The disturbed sleep subtype presented with increased prevalence of “insomnialike” symptoms, such as difficulty initiating or maintaining sleep, according to Dr. Mazzotti. “On the other hand, the excessively sleepy subtype presented with a very high prevalence of several symptoms related to excessive daytime sleepiness, while the moderately sleepy showed a moderately high prevalence of such symptoms, but not as much when compared to the excessively sleepy subtype,” he explained. “Finally, the minimally symptomatic subtype was found to have the lowest prevalence of all investigated symptoms, suggesting that these patients have low symptom burden. They do not complain as much, even though they have moderate-to-severe OSA.”

Next, Dr. Mazzotti and colleagues used Kaplan-Meier survival analysis and Cox proportional hazards models to evaluate whether subtypes were associated with incident coronary heart disease (CHD), heart failure, and CV disease, including CV mortality. Similar analyses were performed comparing each symptom subtype with 2,830 individuals without OSA (AHI less than 5).

Compared with other subtypes, the excessively sleepy group had a more than threefold increased odds of prevalent heart failure, after adjustment for other CV risk factors. They also had a 1.7- to 2.3-fold increased risk for incident CV disease (P less than .001), CHD (P = .015) and heart failure (P = 0.018), after adjustment for other CV risk factors.

“Compared to individuals without OSA, the excessively sleepy subtype is the only subtype with increased risk of incident CV disease and CHD,” Dr. Mazzotti said. “It is possible that excessively sleepy OSA patients are more likely to benefit from CPAP therapy in preventing CV disease.” These results were published online earlier this year (Am J Respir Crit Care Med. 2019 Feb 15. doi: 10.1164/rccm.201808-1509OC).

Dr. Mazzotti reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Mazzotti D et al. SLEEP 2019, Abstract 0586.

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

mzoler@mdedge.com

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

mzoler@mdedge.com

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

mzoler@mdedge.com

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)