ABSTRACT

Cervical myelopathy is the most common cause of acquired spinal cord dysfunction in people aged >55 years. Advanced age and duration of symptoms have been implicated in the literature as negative prognostic indicators for postoperative functional improvement, but very few studies have evaluated the interaction of these factors. We retrospectively reviewed 125 patients who underwent surgery for cervical myelopathy. Patients were stratified according to age greater or less than 65 years and duration of symptoms of greater or less than 12 and 24 months. Functional outcomes were assessed using the Nurick score. Simple regression and multiple regression analyses were done, controlling for sex, preoperative Nurick score, surgical approach, smoking status, diabetes status, prior surgery, number of levels fused, ethanol use, and signal change on preoperative magnetic resonance imaging. The average change in Nurick score in all patients was 1.36, with a significant difference between patients with symptoms for <24 months and those with symptoms for >24 months (1.54 vs 0.98, P = .03). Multiple regression analysis revealed that older patients had a significant difference at 24 months (1.69 vs 1.25, P = .01), whereas younger patients showed slightly lower improvement overall and a change in Nurick score at both thresholds that was statistically nonsignificant.

Continue to: Cervical spondylotic myelopathy...

Cervical spondylotic myelopathy (CSM) is the most common acquired cause of spinal cord dysfunction in people aged >55 years.¹ It is a slowly progressive disorder usually caused by spinal cord compression and ischemia due to age-related changes in the spine and is characterized by neck pain, radicular arm pain, paresthesia, weakness, lower extremity hyperreflexia, and gait and balance abnormalities and may also present with bowel and bladder dysfunction. The majority of cases progress in a stepwise manner, but about 5% of cases decline rapidly, and the prognosis of nonoperative treatment is poor once the patient is truly myelopathic. The objective of surgery is to decompress the spinal cord before permanent damage has set in.^2-4

Several studies have attempted to describe the prognostic significance of duration of symptoms in surgical decompression of CSM. Some studies have found that there is no association with outcomes,^5-7 but most of the studies have concluded that there is an association. Several of these studies specify that duration of symptoms is significant beyond particular time points, typically of 12 months^8-12 or 24 months.^13,14 At least 2 review studies have found low evidence for the influence of symptom duration on postoperative outcomes.^15,16

Age has also been cited as an important prognostic factor in surgical decompression of CSM by some of these same studies. Only a few studies have concluded that age itself does not affect outcomes.^17-19 However, most of the studies conclude that advanced age is a significant factor. Most of these cite a cutoff of 60 years of age,^14,20 65 years of age,²¹ or 70 years of age,¹⁰ but at least 1 study has cited a cutoff as young as 40 years of age,⁹ and at least 1 other has cited 50 years of age.⁸

Most of the available literature has evaluated the effects of age and duration of symptoms separately. However, at least 2 studies have discussed the interplay between these variables, and both found that outcomes are associated with duration of symptoms only in the elderly, defined as above either 65 or 70 years of age.^5,19 This study is an attempt to clarify this relationship.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

Institutional Review Board approval was obtained for this study. Informed consent was waived due to the retrospective nature of the work. The medical records of 212 patients who underwent surgery for CSM by the senior author were reviewed. All surgeries were performed at the University Hospital or the Veterans Administration (VA) between March 2005 and July 2012. CSM was diagnosed by magnetic resonance imaging (MRI) and based on the presence of upper motor signs, clonus, gait abnormalities, or difficulty with fine motor movements such as buttoning a shirt. Nurick score (Table 1) was assessed at presentation and at follow-up, and was the only outcome measure recorded in this cohort. Inclusion criteria were the diagnosis of CSM with a Nurick score, surgical intervention, and at least 2 years of follow-up. Age at presentation, sex, preoperative Nurick score, postoperative Nurick score, duration of symptoms preoperatively, duration of follow-up, procedure performed, approach (anterior vs posterior vs anterior and posterior), prior surgery, number of levels fused, diabetes status, cocaine use, ethanol use, tobacco use, signal change on preoperative MRI, and whether the patient belonged to the VA were recorded. Posterior cervical surgery was performed in patients who had ossification of the posterior longitudinal ligament, had multiple prior anterior cervical procedures, or had involvement of 3 or more levels with anatomy that would make an extensive exposure difficult. Surgeries were performed anteriorly for cases of 1- or 2-level stenosis in the absence of ossification of the posterior longitudinal ligament.

Anterior surgery was also considered in patients with 3-level disease who did not have anatomy that precluded a more extensive exposure.

Patients were stratified according to duration of symptoms by cutoffs of 12 or 24 months and according to age <65 years or >65 years. The age cutoff was chosen because this was the youngest cohort in which stratification revealed a significant difference in change in the Nurick score according to duration of symptoms, and because this age is consistent with the literature. Data were blinded, and outcomes according to duration of symptoms and age were analyzed. The analysis was conducted using simple linear regression and multiple regression.

SURGICAL TECHNIQUE

Patients were evaluated through a complete neurological examination and Nurick scores preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter. Decompression procedures performed included single or multilevel corpectomy, anterior decompression with strut grafting and instrumentation, posterior cervical laminoplasty, and posterior cervical laminectomy and fusion. Patients were placed in a Miami J collar (Össur) postoperatively and sent to physical and occupational therapy when able. All procedures were performed by the senior author with the assistance of residents and fellows.

RESULTS

Of the 125 patients who met all the inclusion criteria, 44 were females and 81 were males. The average follow-up duration was 30.9 months (standard deviation [SD], 13.23). The average age of all patients was 55.2 years (range, 27-89 years), and there was no difference in age according to gender (55.0 years for females vs 55.2 years for males). The average preoperative Nurick score was 2.61 (SD, 1.16), and there was no difference in preoperative Nurick score according to cutoff of duration of symptoms. Males had a higher preoperative Nurick score than females (2.73 vs 2.41, P = .12) and a longer but statistically nonsignificant duration of symptoms (25.7 vs 16.9 months, P = .1). There were 97 patients aged ≤65 years (average, 49.6 years) and 28 patients aged >65 years (average, 73.7 years). The younger cohort had a lower preoperative Nurick score than the older cohort, but this difference was not statistically significant (2.52 vs 3.0, P = .06). The younger cohort also had a longer duration of symptoms, but this difference was not significant (21.8 vs 26.2 months, P > .1). The initial analysis of the change in Nurick score in all patients according to duration of symptoms revealed an average change of 1.36 points (SD, 1.13) and a difference in postoperative change in Nurick score for the duration of symptom cutoffs of 12 and 24 months. This pattern was also present when patients were stratified according to age (Tables 2 and 3). The most common procedures performed were anterior cervical discectomy and fusion (ACDF) (58) and corpectomy (49). Data according to the procedure performed are recorded in Table 4. No significant complications were recorded. Simple regression and multiple regression analyses were undertaken to further evaluate these relationships.

Table 1. Nurick Score

Table 2. Change in Nurick According to Threshold of Duration of Symptoms

Abbreviation: SD, standard deviation.

Table 3. Change in Nurick According to Threshold of Duration of Symptoms, by Age

Abbreviation: SD, standard deviation.

Abbreviations: ACDF, anterior cervical discectomy and fusion; SD, standard deviation.

Continue to: Simple regression analysis of data...

Simple regression analysis of data of all patients revealed a statistically significant negative relationship between duration of symptoms and postoperative change in Nurick score (P = .044). There was no relationship between duration of symptoms and preoperative Nurick score (P = .482). When stratified according to duration of preoperative symptoms by 12 or 24 months, the relationship between duration of symptoms and change in Nurick score was statistically significant for cutoffs of 12 months (P = .03) and 24 months (P = .007). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration. When these results were stratified according to age, patients aged ≤65 years showed a statistically significant association between duration of preoperative symptoms and change in Nurick score for cutoffs of 12 months (P = .016) and 24 months (P = .019). However, patients aged >65 years did not show a statistically significant association for cutoffs of 12 or 24 months (P = .85 and .29, respectively). There was also no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

Multiple regression analysis of the previously described findings was undertaken to assess the influence of potential confounding variables. These included age, gender, diabetes, cocaine use, alcohol use, tobacco use, signal change on preoperative MRI, severity of myelopathy, total levels fused, prior surgery, surgical approach (anterior vs posterior), and procedure performed (Table 4). Analysis of the relationship between duration of symptoms and change in Nurick score for all patients initially revealed a statistically nonsignificant correlation (P = .22). Significant factors in this model included diabetes status and tobacco use that correlated with decreasing change in Nurick score (P = .02 and .0001, respectively) and severity of myelopathy that correlated with increasing change in Nurick score (P = .0002). Notably, combined procedures also correlated with decreasing change in Nurick score (P = .03), but the performance of individual procedures did not correlate with change in Nurick score. There was no association between duration of symptoms and preoperative Nurick score (P = .76). When stratified according to duration of symptoms of 12 or 24 months, only 24 months was found to be statistically significant (P = .03). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of symptom duration. When further stratified according to age, the younger cohort did not show a statistically significant association between duration of preoperative symptoms and change in Nurick score for either threshold of symptom duration (P = .15 and .43, respectively). Diabetes status, tobacco use, number of levels fused, severity of myelopathy, and combined procedures remained significant predictors of change in Nurick score for both thresholds of symptom duration. In contrast, the older cohort showed a statistically significant association between duration of symptoms and postoperative change in Nurick score only for a threshold of 24 months (P = .01). In contrast to the younger cohort, the only other significant predictors in this group were preoperative severity of myelopathy, anterior approach (all ACDF procedures), and signal change on preoperative MRI (P = .02, .04, and .03, respectively). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

DISCUSSION

Several studies have attempted to describe the prognostic influence of preoperative symptom duration on surgical outcomes for CSM. Few studies suggest that duration of symptoms does not correlate with functional outcomes. For example, Naderi and colleagues⁶ concluded in a retrospective study of 27 patients that there is no correlation as assessed by the modified Japanese Orthopedic Association scale. Handa and colleagues⁵ similarly concluded in a retrospective study of 61 patients that duration of symptoms was not significant, but only in patients aged <70 years. Furlan and colleagues⁷ conducted a prospective study of 81 patients with a mean follow-up of 10 months and concluded that there is no association as assessed using the modified Japanese Orthopedic Association (mJOA) and Nurick score. In contrast, the majority of studies support the notion that duration of symptoms adversely affects outcomes. Several of these studies do not provide a clear cutoff beyond which outcomes are significantly affected.^17-19,22

Of the studies that provide a cutoff, a fair number of studies suggest a limit of 12 months and a few suggest 24 months. In a retrospective study of 109 patients with cervical radiculopathy and 55 with cervical myelopathy, Bertalanffy and Eggert⁸ found that duration of symptoms beyond 12 months significantly correlated with worse outcomes as assessed by the evaluation criteria set forth by Roosen and Grote.²³ Using the more common European Myelopathy Score, Heidecke and colleagues⁹ arrived at the same conclusion from a retrospective review of 106 patients. In a large retrospective review of 248 patients, Pumberger and colleagues¹¹ found that patients who did not improve following surgical decompression for CSM, where improvement was defined as a reduction of at least 1 Nurick grade, had an average of 17.85 months of preoperative symptoms, whereas those who did improve had symptoms for an average of 11.21 months. In a prospective study of 98 patients, Suzuki and colleagues¹⁰ found that recovery rate of the JOA scale was significantly decreased in those with >1 year of preoperative symptoms. Both Chagas and colleagues¹⁴ and Suri and colleagues¹³ conducted prospective studies that revealed a significant difference in Nurick score improvement in patients with >2 years of symptoms. In reviews of the literature, both Holly and colleagues¹⁵ and Yoon and colleagues¹⁶ found a low level of evidence for the significance of symptom duration on outcomes. Similarly, Tetreault and colleagues²⁴ found that duration of symptoms was predictive of outcomes as assessed by both mJOA and Nurick score.

Continue to: Our results in all patients showed...

Our results in all patients showed a clear difference in outcomes at the 12-month cutoff as revealed by the simple regression and a trend that reached significance at the 24-month cutoff as assessed by the multiple regression. These results are consistent with those discussed, especially those that specifically used the Nurick score. We further showed that the influence of duration of symptoms on outcomes is dependent on age. Our simple regression analysis suggested that this dependence was evident for symptom durations of 12 and 24 months only in the younger cohort. However, our multiple regression analysis showed that the effect of symptom duration on outcomes is evident only in patients aged >65 years who have had symptoms for 24 months. The stark difference in results between the simple and multiple regressions is probably due to the several potentially confounding variables that were controlled for in the multiple regression analysis. Of course, it should be noted that a statistically nonsignificant difference does not necessarily translate into a clinically nonsignificant difference.  

Our results are consistent with the few studies that describe the influence of the interplay between age and duration of symptoms on postoperative outcomes in CSM. For example, Handa and colleagues⁵ retrospectively reviewed 61 patients who underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 70 years. Compared with the younger patients, duration of symptoms in the 22 elderly patients correlated with a significant difference in outcomes as assessed by the mJOA, with a cutoff of 1 year.⁵ Similarly, Yamazaki and colleagues¹⁹ evaluated 64 patients who also underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 65 years. Duration of symptoms in 35 elderly patients significantly correlated with outcomes as assessed by the JOA scale, such that those considered to have an excellent outcome had a mean duration of symptoms of 11.1 months compared to the 39 months of symptoms in those considered to have a fair outcome.¹⁹ In contrast to those studies, we found that 24 months rather than 12 months was significant. However, we also evaluated outcomes using the Nurick score rather than the JOA. The JOA is a more detailed instrument, and this may be the reason for the discrepancy. Nonetheless, our results are consistent with the extant literature and add to the limited number of studies that have commented on the combined interactions of symptom duration and age in postoperative outcomes for CSM.

There are several strengths and limitations to this study. One strength is the relatively large sample size of patients. However, there was an uneven distribution in the number of patients in each age cohort. Ideally, there would have been an equal number of patients in each age group. The fact that all patients were operated on by the same surgeon minimizes variability in outcomes due to surgeon skill. We also controlled for multiple variables that are known to affect CSM outcomes, but we did not have quantitative data with respect to degree of compression or cross-sectional area of the affected spinal cord, which have been described as significant variables in outcomes of CSM. Furthermore, we did not evaluate the results using several outcome measures such as the JOA in addition to the Nurick score, and this limits the comparability of our work to some of the existing literature. This study also suffers from the inherent biases and shortcomings of retrospective studies, and the fact that this was not a multicenter study may limit generalizability of the results. However, given the dearth of literature on this topic, our work adds to the literature. Further studies will be needed to more clearly elucidate this topic.

CONCLUSION

This study demonstrated that duration of symptoms may be a significant factor in the recovery of patients undergoing surgical decompression for CSM, but only in patients aged >65 years who have had symptoms for 24 months.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Cervical myelopathy is the most common cause of acquired spinal cord dysfunction in people aged >55 years. Advanced age and duration of symptoms have been implicated in the literature as negative prognostic indicators for postoperative functional improvement, but very few studies have evaluated the interaction of these factors. We retrospectively reviewed 125 patients who underwent surgery for cervical myelopathy. Patients were stratified according to age greater or less than 65 years and duration of symptoms of greater or less than 12 and 24 months. Functional outcomes were assessed using the Nurick score. Simple regression and multiple regression analyses were done, controlling for sex, preoperative Nurick score, surgical approach, smoking status, diabetes status, prior surgery, number of levels fused, ethanol use, and signal change on preoperative magnetic resonance imaging. The average change in Nurick score in all patients was 1.36, with a significant difference between patients with symptoms for <24 months and those with symptoms for >24 months (1.54 vs 0.98, P = .03). Multiple regression analysis revealed that older patients had a significant difference at 24 months (1.69 vs 1.25, P = .01), whereas younger patients showed slightly lower improvement overall and a change in Nurick score at both thresholds that was statistically nonsignificant.

Continue to: Cervical spondylotic myelopathy...

Cervical spondylotic myelopathy (CSM) is the most common acquired cause of spinal cord dysfunction in people aged >55 years.¹ It is a slowly progressive disorder usually caused by spinal cord compression and ischemia due to age-related changes in the spine and is characterized by neck pain, radicular arm pain, paresthesia, weakness, lower extremity hyperreflexia, and gait and balance abnormalities and may also present with bowel and bladder dysfunction. The majority of cases progress in a stepwise manner, but about 5% of cases decline rapidly, and the prognosis of nonoperative treatment is poor once the patient is truly myelopathic. The objective of surgery is to decompress the spinal cord before permanent damage has set in.^2-4

Several studies have attempted to describe the prognostic significance of duration of symptoms in surgical decompression of CSM. Some studies have found that there is no association with outcomes,^5-7 but most of the studies have concluded that there is an association. Several of these studies specify that duration of symptoms is significant beyond particular time points, typically of 12 months^8-12 or 24 months.^13,14 At least 2 review studies have found low evidence for the influence of symptom duration on postoperative outcomes.^15,16

Age has also been cited as an important prognostic factor in surgical decompression of CSM by some of these same studies. Only a few studies have concluded that age itself does not affect outcomes.^17-19 However, most of the studies conclude that advanced age is a significant factor. Most of these cite a cutoff of 60 years of age,^14,20 65 years of age,²¹ or 70 years of age,¹⁰ but at least 1 study has cited a cutoff as young as 40 years of age,⁹ and at least 1 other has cited 50 years of age.⁸

Most of the available literature has evaluated the effects of age and duration of symptoms separately. However, at least 2 studies have discussed the interplay between these variables, and both found that outcomes are associated with duration of symptoms only in the elderly, defined as above either 65 or 70 years of age.^5,19 This study is an attempt to clarify this relationship.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

Institutional Review Board approval was obtained for this study. Informed consent was waived due to the retrospective nature of the work. The medical records of 212 patients who underwent surgery for CSM by the senior author were reviewed. All surgeries were performed at the University Hospital or the Veterans Administration (VA) between March 2005 and July 2012. CSM was diagnosed by magnetic resonance imaging (MRI) and based on the presence of upper motor signs, clonus, gait abnormalities, or difficulty with fine motor movements such as buttoning a shirt. Nurick score (Table 1) was assessed at presentation and at follow-up, and was the only outcome measure recorded in this cohort. Inclusion criteria were the diagnosis of CSM with a Nurick score, surgical intervention, and at least 2 years of follow-up. Age at presentation, sex, preoperative Nurick score, postoperative Nurick score, duration of symptoms preoperatively, duration of follow-up, procedure performed, approach (anterior vs posterior vs anterior and posterior), prior surgery, number of levels fused, diabetes status, cocaine use, ethanol use, tobacco use, signal change on preoperative MRI, and whether the patient belonged to the VA were recorded. Posterior cervical surgery was performed in patients who had ossification of the posterior longitudinal ligament, had multiple prior anterior cervical procedures, or had involvement of 3 or more levels with anatomy that would make an extensive exposure difficult. Surgeries were performed anteriorly for cases of 1- or 2-level stenosis in the absence of ossification of the posterior longitudinal ligament.

Anterior surgery was also considered in patients with 3-level disease who did not have anatomy that precluded a more extensive exposure.

Patients were stratified according to duration of symptoms by cutoffs of 12 or 24 months and according to age <65 years or >65 years. The age cutoff was chosen because this was the youngest cohort in which stratification revealed a significant difference in change in the Nurick score according to duration of symptoms, and because this age is consistent with the literature. Data were blinded, and outcomes according to duration of symptoms and age were analyzed. The analysis was conducted using simple linear regression and multiple regression.

SURGICAL TECHNIQUE

Patients were evaluated through a complete neurological examination and Nurick scores preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter. Decompression procedures performed included single or multilevel corpectomy, anterior decompression with strut grafting and instrumentation, posterior cervical laminoplasty, and posterior cervical laminectomy and fusion. Patients were placed in a Miami J collar (Össur) postoperatively and sent to physical and occupational therapy when able. All procedures were performed by the senior author with the assistance of residents and fellows.

RESULTS

Of the 125 patients who met all the inclusion criteria, 44 were females and 81 were males. The average follow-up duration was 30.9 months (standard deviation [SD], 13.23). The average age of all patients was 55.2 years (range, 27-89 years), and there was no difference in age according to gender (55.0 years for females vs 55.2 years for males). The average preoperative Nurick score was 2.61 (SD, 1.16), and there was no difference in preoperative Nurick score according to cutoff of duration of symptoms. Males had a higher preoperative Nurick score than females (2.73 vs 2.41, P = .12) and a longer but statistically nonsignificant duration of symptoms (25.7 vs 16.9 months, P = .1). There were 97 patients aged ≤65 years (average, 49.6 years) and 28 patients aged >65 years (average, 73.7 years). The younger cohort had a lower preoperative Nurick score than the older cohort, but this difference was not statistically significant (2.52 vs 3.0, P = .06). The younger cohort also had a longer duration of symptoms, but this difference was not significant (21.8 vs 26.2 months, P > .1). The initial analysis of the change in Nurick score in all patients according to duration of symptoms revealed an average change of 1.36 points (SD, 1.13) and a difference in postoperative change in Nurick score for the duration of symptom cutoffs of 12 and 24 months. This pattern was also present when patients were stratified according to age (Tables 2 and 3). The most common procedures performed were anterior cervical discectomy and fusion (ACDF) (58) and corpectomy (49). Data according to the procedure performed are recorded in Table 4. No significant complications were recorded. Simple regression and multiple regression analyses were undertaken to further evaluate these relationships.

Table 1. Nurick Score

Table 2. Change in Nurick According to Threshold of Duration of Symptoms

Abbreviation: SD, standard deviation.

Table 3. Change in Nurick According to Threshold of Duration of Symptoms, by Age

Abbreviation: SD, standard deviation.

Abbreviations: ACDF, anterior cervical discectomy and fusion; SD, standard deviation.

Continue to: Simple regression analysis of data...

Simple regression analysis of data of all patients revealed a statistically significant negative relationship between duration of symptoms and postoperative change in Nurick score (P = .044). There was no relationship between duration of symptoms and preoperative Nurick score (P = .482). When stratified according to duration of preoperative symptoms by 12 or 24 months, the relationship between duration of symptoms and change in Nurick score was statistically significant for cutoffs of 12 months (P = .03) and 24 months (P = .007). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration. When these results were stratified according to age, patients aged ≤65 years showed a statistically significant association between duration of preoperative symptoms and change in Nurick score for cutoffs of 12 months (P = .016) and 24 months (P = .019). However, patients aged >65 years did not show a statistically significant association for cutoffs of 12 or 24 months (P = .85 and .29, respectively). There was also no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

Multiple regression analysis of the previously described findings was undertaken to assess the influence of potential confounding variables. These included age, gender, diabetes, cocaine use, alcohol use, tobacco use, signal change on preoperative MRI, severity of myelopathy, total levels fused, prior surgery, surgical approach (anterior vs posterior), and procedure performed (Table 4). Analysis of the relationship between duration of symptoms and change in Nurick score for all patients initially revealed a statistically nonsignificant correlation (P = .22). Significant factors in this model included diabetes status and tobacco use that correlated with decreasing change in Nurick score (P = .02 and .0001, respectively) and severity of myelopathy that correlated with increasing change in Nurick score (P = .0002). Notably, combined procedures also correlated with decreasing change in Nurick score (P = .03), but the performance of individual procedures did not correlate with change in Nurick score. There was no association between duration of symptoms and preoperative Nurick score (P = .76). When stratified according to duration of symptoms of 12 or 24 months, only 24 months was found to be statistically significant (P = .03). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of symptom duration. When further stratified according to age, the younger cohort did not show a statistically significant association between duration of preoperative symptoms and change in Nurick score for either threshold of symptom duration (P = .15 and .43, respectively). Diabetes status, tobacco use, number of levels fused, severity of myelopathy, and combined procedures remained significant predictors of change in Nurick score for both thresholds of symptom duration. In contrast, the older cohort showed a statistically significant association between duration of symptoms and postoperative change in Nurick score only for a threshold of 24 months (P = .01). In contrast to the younger cohort, the only other significant predictors in this group were preoperative severity of myelopathy, anterior approach (all ACDF procedures), and signal change on preoperative MRI (P = .02, .04, and .03, respectively). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

DISCUSSION

Several studies have attempted to describe the prognostic influence of preoperative symptom duration on surgical outcomes for CSM. Few studies suggest that duration of symptoms does not correlate with functional outcomes. For example, Naderi and colleagues⁶ concluded in a retrospective study of 27 patients that there is no correlation as assessed by the modified Japanese Orthopedic Association scale. Handa and colleagues⁵ similarly concluded in a retrospective study of 61 patients that duration of symptoms was not significant, but only in patients aged <70 years. Furlan and colleagues⁷ conducted a prospective study of 81 patients with a mean follow-up of 10 months and concluded that there is no association as assessed using the modified Japanese Orthopedic Association (mJOA) and Nurick score. In contrast, the majority of studies support the notion that duration of symptoms adversely affects outcomes. Several of these studies do not provide a clear cutoff beyond which outcomes are significantly affected.^17-19,22

Of the studies that provide a cutoff, a fair number of studies suggest a limit of 12 months and a few suggest 24 months. In a retrospective study of 109 patients with cervical radiculopathy and 55 with cervical myelopathy, Bertalanffy and Eggert⁸ found that duration of symptoms beyond 12 months significantly correlated with worse outcomes as assessed by the evaluation criteria set forth by Roosen and Grote.²³ Using the more common European Myelopathy Score, Heidecke and colleagues⁹ arrived at the same conclusion from a retrospective review of 106 patients. In a large retrospective review of 248 patients, Pumberger and colleagues¹¹ found that patients who did not improve following surgical decompression for CSM, where improvement was defined as a reduction of at least 1 Nurick grade, had an average of 17.85 months of preoperative symptoms, whereas those who did improve had symptoms for an average of 11.21 months. In a prospective study of 98 patients, Suzuki and colleagues¹⁰ found that recovery rate of the JOA scale was significantly decreased in those with >1 year of preoperative symptoms. Both Chagas and colleagues¹⁴ and Suri and colleagues¹³ conducted prospective studies that revealed a significant difference in Nurick score improvement in patients with >2 years of symptoms. In reviews of the literature, both Holly and colleagues¹⁵ and Yoon and colleagues¹⁶ found a low level of evidence for the significance of symptom duration on outcomes. Similarly, Tetreault and colleagues²⁴ found that duration of symptoms was predictive of outcomes as assessed by both mJOA and Nurick score.

Continue to: Our results in all patients showed...

Our results in all patients showed a clear difference in outcomes at the 12-month cutoff as revealed by the simple regression and a trend that reached significance at the 24-month cutoff as assessed by the multiple regression. These results are consistent with those discussed, especially those that specifically used the Nurick score. We further showed that the influence of duration of symptoms on outcomes is dependent on age. Our simple regression analysis suggested that this dependence was evident for symptom durations of 12 and 24 months only in the younger cohort. However, our multiple regression analysis showed that the effect of symptom duration on outcomes is evident only in patients aged >65 years who have had symptoms for 24 months. The stark difference in results between the simple and multiple regressions is probably due to the several potentially confounding variables that were controlled for in the multiple regression analysis. Of course, it should be noted that a statistically nonsignificant difference does not necessarily translate into a clinically nonsignificant difference.  

Our results are consistent with the few studies that describe the influence of the interplay between age and duration of symptoms on postoperative outcomes in CSM. For example, Handa and colleagues⁵ retrospectively reviewed 61 patients who underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 70 years. Compared with the younger patients, duration of symptoms in the 22 elderly patients correlated with a significant difference in outcomes as assessed by the mJOA, with a cutoff of 1 year.⁵ Similarly, Yamazaki and colleagues¹⁹ evaluated 64 patients who also underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 65 years. Duration of symptoms in 35 elderly patients significantly correlated with outcomes as assessed by the JOA scale, such that those considered to have an excellent outcome had a mean duration of symptoms of 11.1 months compared to the 39 months of symptoms in those considered to have a fair outcome.¹⁹ In contrast to those studies, we found that 24 months rather than 12 months was significant. However, we also evaluated outcomes using the Nurick score rather than the JOA. The JOA is a more detailed instrument, and this may be the reason for the discrepancy. Nonetheless, our results are consistent with the extant literature and add to the limited number of studies that have commented on the combined interactions of symptom duration and age in postoperative outcomes for CSM.

There are several strengths and limitations to this study. One strength is the relatively large sample size of patients. However, there was an uneven distribution in the number of patients in each age cohort. Ideally, there would have been an equal number of patients in each age group. The fact that all patients were operated on by the same surgeon minimizes variability in outcomes due to surgeon skill. We also controlled for multiple variables that are known to affect CSM outcomes, but we did not have quantitative data with respect to degree of compression or cross-sectional area of the affected spinal cord, which have been described as significant variables in outcomes of CSM. Furthermore, we did not evaluate the results using several outcome measures such as the JOA in addition to the Nurick score, and this limits the comparability of our work to some of the existing literature. This study also suffers from the inherent biases and shortcomings of retrospective studies, and the fact that this was not a multicenter study may limit generalizability of the results. However, given the dearth of literature on this topic, our work adds to the literature. Further studies will be needed to more clearly elucidate this topic.

CONCLUSION

This study demonstrated that duration of symptoms may be a significant factor in the recovery of patients undergoing surgical decompression for CSM, but only in patients aged >65 years who have had symptoms for 24 months.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Cervical myelopathy is the most common cause of acquired spinal cord dysfunction in people aged >55 years. Advanced age and duration of symptoms have been implicated in the literature as negative prognostic indicators for postoperative functional improvement, but very few studies have evaluated the interaction of these factors. We retrospectively reviewed 125 patients who underwent surgery for cervical myelopathy. Patients were stratified according to age greater or less than 65 years and duration of symptoms of greater or less than 12 and 24 months. Functional outcomes were assessed using the Nurick score. Simple regression and multiple regression analyses were done, controlling for sex, preoperative Nurick score, surgical approach, smoking status, diabetes status, prior surgery, number of levels fused, ethanol use, and signal change on preoperative magnetic resonance imaging. The average change in Nurick score in all patients was 1.36, with a significant difference between patients with symptoms for <24 months and those with symptoms for >24 months (1.54 vs 0.98, P = .03). Multiple regression analysis revealed that older patients had a significant difference at 24 months (1.69 vs 1.25, P = .01), whereas younger patients showed slightly lower improvement overall and a change in Nurick score at both thresholds that was statistically nonsignificant.

Continue to: Cervical spondylotic myelopathy...

Cervical spondylotic myelopathy (CSM) is the most common acquired cause of spinal cord dysfunction in people aged >55 years.¹ It is a slowly progressive disorder usually caused by spinal cord compression and ischemia due to age-related changes in the spine and is characterized by neck pain, radicular arm pain, paresthesia, weakness, lower extremity hyperreflexia, and gait and balance abnormalities and may also present with bowel and bladder dysfunction. The majority of cases progress in a stepwise manner, but about 5% of cases decline rapidly, and the prognosis of nonoperative treatment is poor once the patient is truly myelopathic. The objective of surgery is to decompress the spinal cord before permanent damage has set in.^2-4

Several studies have attempted to describe the prognostic significance of duration of symptoms in surgical decompression of CSM. Some studies have found that there is no association with outcomes,^5-7 but most of the studies have concluded that there is an association. Several of these studies specify that duration of symptoms is significant beyond particular time points, typically of 12 months^8-12 or 24 months.^13,14 At least 2 review studies have found low evidence for the influence of symptom duration on postoperative outcomes.^15,16

Age has also been cited as an important prognostic factor in surgical decompression of CSM by some of these same studies. Only a few studies have concluded that age itself does not affect outcomes.^17-19 However, most of the studies conclude that advanced age is a significant factor. Most of these cite a cutoff of 60 years of age,^14,20 65 years of age,²¹ or 70 years of age,¹⁰ but at least 1 study has cited a cutoff as young as 40 years of age,⁹ and at least 1 other has cited 50 years of age.⁸

Most of the available literature has evaluated the effects of age and duration of symptoms separately. However, at least 2 studies have discussed the interplay between these variables, and both found that outcomes are associated with duration of symptoms only in the elderly, defined as above either 65 or 70 years of age.^5,19 This study is an attempt to clarify this relationship.

Continue to: MATERIALS AND METHODS...

MATERIALS AND METHODS

Institutional Review Board approval was obtained for this study. Informed consent was waived due to the retrospective nature of the work. The medical records of 212 patients who underwent surgery for CSM by the senior author were reviewed. All surgeries were performed at the University Hospital or the Veterans Administration (VA) between March 2005 and July 2012. CSM was diagnosed by magnetic resonance imaging (MRI) and based on the presence of upper motor signs, clonus, gait abnormalities, or difficulty with fine motor movements such as buttoning a shirt. Nurick score (Table 1) was assessed at presentation and at follow-up, and was the only outcome measure recorded in this cohort. Inclusion criteria were the diagnosis of CSM with a Nurick score, surgical intervention, and at least 2 years of follow-up. Age at presentation, sex, preoperative Nurick score, postoperative Nurick score, duration of symptoms preoperatively, duration of follow-up, procedure performed, approach (anterior vs posterior vs anterior and posterior), prior surgery, number of levels fused, diabetes status, cocaine use, ethanol use, tobacco use, signal change on preoperative MRI, and whether the patient belonged to the VA were recorded. Posterior cervical surgery was performed in patients who had ossification of the posterior longitudinal ligament, had multiple prior anterior cervical procedures, or had involvement of 3 or more levels with anatomy that would make an extensive exposure difficult. Surgeries were performed anteriorly for cases of 1- or 2-level stenosis in the absence of ossification of the posterior longitudinal ligament.

Anterior surgery was also considered in patients with 3-level disease who did not have anatomy that precluded a more extensive exposure.

Patients were stratified according to duration of symptoms by cutoffs of 12 or 24 months and according to age <65 years or >65 years. The age cutoff was chosen because this was the youngest cohort in which stratification revealed a significant difference in change in the Nurick score according to duration of symptoms, and because this age is consistent with the literature. Data were blinded, and outcomes according to duration of symptoms and age were analyzed. The analysis was conducted using simple linear regression and multiple regression.

SURGICAL TECHNIQUE

Patients were evaluated through a complete neurological examination and Nurick scores preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter. Decompression procedures performed included single or multilevel corpectomy, anterior decompression with strut grafting and instrumentation, posterior cervical laminoplasty, and posterior cervical laminectomy and fusion. Patients were placed in a Miami J collar (Össur) postoperatively and sent to physical and occupational therapy when able. All procedures were performed by the senior author with the assistance of residents and fellows.

RESULTS

Of the 125 patients who met all the inclusion criteria, 44 were females and 81 were males. The average follow-up duration was 30.9 months (standard deviation [SD], 13.23). The average age of all patients was 55.2 years (range, 27-89 years), and there was no difference in age according to gender (55.0 years for females vs 55.2 years for males). The average preoperative Nurick score was 2.61 (SD, 1.16), and there was no difference in preoperative Nurick score according to cutoff of duration of symptoms. Males had a higher preoperative Nurick score than females (2.73 vs 2.41, P = .12) and a longer but statistically nonsignificant duration of symptoms (25.7 vs 16.9 months, P = .1). There were 97 patients aged ≤65 years (average, 49.6 years) and 28 patients aged >65 years (average, 73.7 years). The younger cohort had a lower preoperative Nurick score than the older cohort, but this difference was not statistically significant (2.52 vs 3.0, P = .06). The younger cohort also had a longer duration of symptoms, but this difference was not significant (21.8 vs 26.2 months, P > .1). The initial analysis of the change in Nurick score in all patients according to duration of symptoms revealed an average change of 1.36 points (SD, 1.13) and a difference in postoperative change in Nurick score for the duration of symptom cutoffs of 12 and 24 months. This pattern was also present when patients were stratified according to age (Tables 2 and 3). The most common procedures performed were anterior cervical discectomy and fusion (ACDF) (58) and corpectomy (49). Data according to the procedure performed are recorded in Table 4. No significant complications were recorded. Simple regression and multiple regression analyses were undertaken to further evaluate these relationships.

Table 1. Nurick Score

Table 2. Change in Nurick According to Threshold of Duration of Symptoms

Abbreviation: SD, standard deviation.

Table 3. Change in Nurick According to Threshold of Duration of Symptoms, by Age

Abbreviation: SD, standard deviation.

Abbreviations: ACDF, anterior cervical discectomy and fusion; SD, standard deviation.

Continue to: Simple regression analysis of data...

Simple regression analysis of data of all patients revealed a statistically significant negative relationship between duration of symptoms and postoperative change in Nurick score (P = .044). There was no relationship between duration of symptoms and preoperative Nurick score (P = .482). When stratified according to duration of preoperative symptoms by 12 or 24 months, the relationship between duration of symptoms and change in Nurick score was statistically significant for cutoffs of 12 months (P = .03) and 24 months (P = .007). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration. When these results were stratified according to age, patients aged ≤65 years showed a statistically significant association between duration of preoperative symptoms and change in Nurick score for cutoffs of 12 months (P = .016) and 24 months (P = .019). However, patients aged >65 years did not show a statistically significant association for cutoffs of 12 or 24 months (P = .85 and .29, respectively). There was also no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

Multiple regression analysis of the previously described findings was undertaken to assess the influence of potential confounding variables. These included age, gender, diabetes, cocaine use, alcohol use, tobacco use, signal change on preoperative MRI, severity of myelopathy, total levels fused, prior surgery, surgical approach (anterior vs posterior), and procedure performed (Table 4). Analysis of the relationship between duration of symptoms and change in Nurick score for all patients initially revealed a statistically nonsignificant correlation (P = .22). Significant factors in this model included diabetes status and tobacco use that correlated with decreasing change in Nurick score (P = .02 and .0001, respectively) and severity of myelopathy that correlated with increasing change in Nurick score (P = .0002). Notably, combined procedures also correlated with decreasing change in Nurick score (P = .03), but the performance of individual procedures did not correlate with change in Nurick score. There was no association between duration of symptoms and preoperative Nurick score (P = .76). When stratified according to duration of symptoms of 12 or 24 months, only 24 months was found to be statistically significant (P = .03). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of symptom duration. When further stratified according to age, the younger cohort did not show a statistically significant association between duration of preoperative symptoms and change in Nurick score for either threshold of symptom duration (P = .15 and .43, respectively). Diabetes status, tobacco use, number of levels fused, severity of myelopathy, and combined procedures remained significant predictors of change in Nurick score for both thresholds of symptom duration. In contrast, the older cohort showed a statistically significant association between duration of symptoms and postoperative change in Nurick score only for a threshold of 24 months (P = .01). In contrast to the younger cohort, the only other significant predictors in this group were preoperative severity of myelopathy, anterior approach (all ACDF procedures), and signal change on preoperative MRI (P = .02, .04, and .03, respectively). There was no relationship between duration of symptoms and preoperative Nurick score for any threshold of preoperative symptom duration in either age cohort.

DISCUSSION

Several studies have attempted to describe the prognostic influence of preoperative symptom duration on surgical outcomes for CSM. Few studies suggest that duration of symptoms does not correlate with functional outcomes. For example, Naderi and colleagues⁶ concluded in a retrospective study of 27 patients that there is no correlation as assessed by the modified Japanese Orthopedic Association scale. Handa and colleagues⁵ similarly concluded in a retrospective study of 61 patients that duration of symptoms was not significant, but only in patients aged <70 years. Furlan and colleagues⁷ conducted a prospective study of 81 patients with a mean follow-up of 10 months and concluded that there is no association as assessed using the modified Japanese Orthopedic Association (mJOA) and Nurick score. In contrast, the majority of studies support the notion that duration of symptoms adversely affects outcomes. Several of these studies do not provide a clear cutoff beyond which outcomes are significantly affected.^17-19,22

Of the studies that provide a cutoff, a fair number of studies suggest a limit of 12 months and a few suggest 24 months. In a retrospective study of 109 patients with cervical radiculopathy and 55 with cervical myelopathy, Bertalanffy and Eggert⁸ found that duration of symptoms beyond 12 months significantly correlated with worse outcomes as assessed by the evaluation criteria set forth by Roosen and Grote.²³ Using the more common European Myelopathy Score, Heidecke and colleagues⁹ arrived at the same conclusion from a retrospective review of 106 patients. In a large retrospective review of 248 patients, Pumberger and colleagues¹¹ found that patients who did not improve following surgical decompression for CSM, where improvement was defined as a reduction of at least 1 Nurick grade, had an average of 17.85 months of preoperative symptoms, whereas those who did improve had symptoms for an average of 11.21 months. In a prospective study of 98 patients, Suzuki and colleagues¹⁰ found that recovery rate of the JOA scale was significantly decreased in those with >1 year of preoperative symptoms. Both Chagas and colleagues¹⁴ and Suri and colleagues¹³ conducted prospective studies that revealed a significant difference in Nurick score improvement in patients with >2 years of symptoms. In reviews of the literature, both Holly and colleagues¹⁵ and Yoon and colleagues¹⁶ found a low level of evidence for the significance of symptom duration on outcomes. Similarly, Tetreault and colleagues²⁴ found that duration of symptoms was predictive of outcomes as assessed by both mJOA and Nurick score.

Continue to: Our results in all patients showed...

Our results in all patients showed a clear difference in outcomes at the 12-month cutoff as revealed by the simple regression and a trend that reached significance at the 24-month cutoff as assessed by the multiple regression. These results are consistent with those discussed, especially those that specifically used the Nurick score. We further showed that the influence of duration of symptoms on outcomes is dependent on age. Our simple regression analysis suggested that this dependence was evident for symptom durations of 12 and 24 months only in the younger cohort. However, our multiple regression analysis showed that the effect of symptom duration on outcomes is evident only in patients aged >65 years who have had symptoms for 24 months. The stark difference in results between the simple and multiple regressions is probably due to the several potentially confounding variables that were controlled for in the multiple regression analysis. Of course, it should be noted that a statistically nonsignificant difference does not necessarily translate into a clinically nonsignificant difference.  

Our results are consistent with the few studies that describe the influence of the interplay between age and duration of symptoms on postoperative outcomes in CSM. For example, Handa and colleagues⁵ retrospectively reviewed 61 patients who underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 70 years. Compared with the younger patients, duration of symptoms in the 22 elderly patients correlated with a significant difference in outcomes as assessed by the mJOA, with a cutoff of 1 year.⁵ Similarly, Yamazaki and colleagues¹⁹ evaluated 64 patients who also underwent expansive laminoplasty for CSM and stratified them according to age greater or less than 65 years. Duration of symptoms in 35 elderly patients significantly correlated with outcomes as assessed by the JOA scale, such that those considered to have an excellent outcome had a mean duration of symptoms of 11.1 months compared to the 39 months of symptoms in those considered to have a fair outcome.¹⁹ In contrast to those studies, we found that 24 months rather than 12 months was significant. However, we also evaluated outcomes using the Nurick score rather than the JOA. The JOA is a more detailed instrument, and this may be the reason for the discrepancy. Nonetheless, our results are consistent with the extant literature and add to the limited number of studies that have commented on the combined interactions of symptom duration and age in postoperative outcomes for CSM.

There are several strengths and limitations to this study. One strength is the relatively large sample size of patients. However, there was an uneven distribution in the number of patients in each age cohort. Ideally, there would have been an equal number of patients in each age group. The fact that all patients were operated on by the same surgeon minimizes variability in outcomes due to surgeon skill. We also controlled for multiple variables that are known to affect CSM outcomes, but we did not have quantitative data with respect to degree of compression or cross-sectional area of the affected spinal cord, which have been described as significant variables in outcomes of CSM. Furthermore, we did not evaluate the results using several outcome measures such as the JOA in addition to the Nurick score, and this limits the comparability of our work to some of the existing literature. This study also suffers from the inherent biases and shortcomings of retrospective studies, and the fact that this was not a multicenter study may limit generalizability of the results. However, given the dearth of literature on this topic, our work adds to the literature. Further studies will be needed to more clearly elucidate this topic.

CONCLUSION

This study demonstrated that duration of symptoms may be a significant factor in the recovery of patients undergoing surgical decompression for CSM, but only in patients aged >65 years who have had symptoms for 24 months.

This paper will be judged for the Resident Writer’s Award.

This story was co-published with Stat.

It’s a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro (ixazomib), it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical, one patient even hailed Ninlaro as “my savior.”

The U.S. Food and Drug Administration approved it in 2015 after patients in a clinical trial gained an average of 6 months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the United States is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer.

Yet, of the 722 participants in the trial, only 13 – or 1.8% – were black.

The scarcity of black patients in Ninlaro’s testing left unanswered the vital question of whether the drug would work equally well for them. “Meaningful differences may exist” in how multiple myeloma affects black patients, what symptoms they experience, and how they respond to medications, FDA scientists wrote in a 2017 journal article.

The racial disparity in the Ninlaro study isn’t unusual. Reflecting the reluctance of the FDA to force drugmakers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark underrepresentation of blacks is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them. A ProPublica analysis of data recently made public by the FDA found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of the patients were black. African Americans make up 13.4% of the U.S. population.

As a result, desperately ill black patients who have exhausted other treatment options aren’t getting early access to experimental drugs that could extend their life spans or improve their quality of life. While unapproved treatments also carry a risk of setbacks or side effects, new cancer drugs have dramatically shifted outcomes for some patients.

Recently approved lung cancer treatments are “revolutionary,” said Karen Kelly, MD, associate director for research at UC Davis Comprehensive Cancer Center. Even in the first phase of clinical testing, which is aimed at making sure a drug is safe, 20% of cancer patients now see their tumors shrink or disappear, up from 5% in the early 1990s, Dr. Kelly said.

Kashif Ali, MD, research head at Maryland Oncology Hematology, has spent 7 years recruiting patients for about 30 cancer and blood disease trials a year. He said he’s often seen minorities, including African Americans, miss out on trials because of financial hurdles, logistical challenges, and their lingering distrust of the medical community because of a history of being victimized by medical experimentation.

“They’re potentially losing out on life-extending opportunities because it’s one more option they no longer have,” Dr. Ali said. “Especially when patients are in advanced stages of cancer, treatments are like stepping-stones: When one stops working, you move on to the next.”

Not joining a trial can mean “you’ve lost life expectancy,” he said.

Patients who can’t afford to travel long distances to a trial, take time off work, or find child care are at a disadvantage. They are usually reimbursed for travel and food costs, but drugmakers are careful not to pay too much because they do not want to appear to be enticing patients to join when it isn’t in their medical interests, said Laurie Halloran, founder and CEO of a consulting firm for the drug industry.

While the experimental drug used in a study is free, any approved treatments that are part of the trial typically need to be covered by a patient’s own insurance, according to Dr. Ali.

He recalled one black patient who was eligible for a study that entailed taking an already approved drug in combination with a new treatment. The approved drug cost $10,000 a month and the patient’s insurance charged 20% as his copay, Dr. Ali recalled. The patient decided that joining the trial would be too expensive. He instead underwent chemotherapy, which was cheaper, but he didn’t tolerate it well. The patient is now considering hospice, Dr. Ali said.

Criteria for admission to clinical trials have become more stringent over the years, Mass. General’s Dr. Jackson said, and patients of color increasingly are excluded. They are more likely than white people are to have other conditions such as stroke, hypertension, and diabetes, which could complicate research results. Trials often want to enroll “the healthiest sick people they can find” and preclude patients with other conditions. “The wall basically gets taller and taller,” he said.

Aredia Taylor didn’t qualify for a clinical trial on other grounds. A former U.S. Department of Agriculture supervisor for food-safety inspections, she was diagnosed with multiple myeloma in 2014 and had undergone a gamut of treatment including various chemotherapy drugs and a stem cell transplant.

While the transplant drove her cancer into remission, she still needs to take Revlimid (lenalidomide) – a standard treatment – daily to keep the cancer at bay. The drug has given her side effects that she describes as devastating to her daily life, including diarrhea, muscle spasms, and an inability to concentrate. She said she wants to stop taking Revlimid and would be willing to try an experimental treatment.

Ms. Taylor, 58, said she saw pamphlets at her doctor’s office encouraging patients to ask about clinical trials, so she asked her oncologist, Larry Anderson, MD, at the University of Texas Southwestern Medical Center in Dallas, whether she should join a study. He told her that she “wasn’t a fit,” she said. Dr. Anderson told ProPublica that most trials are seeking patients with either newly diagnosed or relapsed multiple myeloma, and since Ms. Taylor is currently in remission, she wouldn’t be accepted.

Ms. Taylor was disappointed. Knowing that blacks like herself are especially susceptible to multiple myeloma, she’d like to be a part of developing more effective treatments.

“I want to pay it forward and be a blessing to somebody else,” she said. “I want to be one of the people that they try to do a clinical trial for, so they find a way to a cure.”

Spurred by Congress, the FDA began in January 2015 to regularly publish a “Drug Trials Snapshot” for every new drug approved, delineating the demographic breakdown for clinical trial participants by sex, race and age subgroups. ProPublica’s analysis focused on participants in trials for the 31 cancer drugs approved since then, comparing their demographics with data from the National Cancer Institute on the incidence of various cancers by race.

Eighteen of those drugs targeted cancers that are at least as likely to afflict black Americans as white Americans. On average, only 4.1% of patients in those trials were black. Trials for four multiple myeloma drugs, including Ninlaro, averaged 5% black participation.

An FDA study over a longer time period corroborated ProPublica’s findings. In a 2017 article in the journal Blood coauthored by Richard Pazdur, the FDA’s cancer chief, the agency reported that black patients on average made up 4.5% of participants in trials for multiple myeloma drugs since 2003. Higher enrollment of minorities in myeloma trials would have “multiple benefits,” the FDA scientists noted. Not only would “underserved populations” gain access to new therapies, but additional data could help researchers identify subtypes of the blood cancer and develop targeted treatments.

A similar pattern emerges for treatments of non–small cell lung cancer. It occurs in 56 out of 100,000 black Americans, versus 49 out of 100,000 white Americans. Yet ProPublica found that in trials for two recently approved drugs for a type of non–small cell lung cancer driven by a mutation in what is known as the ALK gene, less than 2% of participants were black.

Those drugs, Takeda’s Alunbrig (brigatinib) and Genentech’s Alecensa (alectinib), are approved for patients whose lung cancer has spread to other parts of the body. In trials, both drugs were able to shrink tumors, including lesions in the brain. Patients taking Alecensa lived without the disease progressing for an average of 25.7 months, more than double the 10.4 months for patients on another treatment.

“We believe that we must consider differences across all populations to deliver on the promise of personalized health care,” said Meghan Cox, a Genentech spokeswoman, adding that the drugmaker is “continuing to study patient response to Alecensa across populations in the postmarketing setting.”

Similarly, prostate cancer affects 178 out of every 100,000 African Americans, more than for any other race in the United States, compared with 106 out of every 100,000 white Americans. Black Americans are twice as likely as white Americans to die from prostate cancer.

Yet during 2009-2015, in seven trials conducted for five new prostate cancer therapies, only 3% of participants were black, according to a study conducted by Daniel Spratt, MD, vice chair of research in the department of radiation oncology at the University of Michigan, Ann Arbor. More recently, 11 times as many white as black participants, or 66% – compared with 6% – joined trials for Johnson & Johnson’s new prostate cancer treatment, Erleada (apalutamide).

To understand how a small minority group responds to a drug, researchers might have to enroll more patients than what would be a nationally representative sample. In a trial of 100 people, two Native American or Alaska Native patients would reflect those groups’ proportion of the U.S. population but wouldn’t give doctors enough information about race-related impacts.

Linda Burhansstipanov, DrPH, founder of the Native American Cancer Research Corp., estimated that 85% of Native Americans want to participate in clinical trials when informed of the opportunity. She knows several Native American patients who drove 3 hours each way to participate in a trial, despite losing an entire day of work.

Still, trial protocols are rarely designed with minority communities in mind, Dr. Burhansstipanov said. It has long been rumored among Native Americans, she said, that a clinical trial in the 1990s required patients to take a medication upon rising in the morning. In many Native American tribes, the first thing people do when they wake up is greet the sun with morning prayers. For some tribes, prayers can take more than half an hour. Because of the delay, the tale goes, Native American patients were kicked out of the clinical trial for violating the protocol. “The story spread and became a barrier for people to take part in clinical trials,” she said.

In addition, the history of unscrupulous medical experimentation on minorities feeds wariness of clinical trials. Angela M. Marshall, MD, an internal medicine doctor and board member of Black Women’s Health Imperative, said she sees a “lack of excitement among minority communities for clinical trials, coming from a mistrust of the medical community.”

Her black patients often cite the infamous Tuskegee study, conducted from 1932 to 1972 by the U.S. Public Health Service, in which researchers knowingly withheld treatment from African American sharecroppers with syphilis in order to study the progression of the disease. Some Native Americans are similarly suspicious of the medical community, Dr. Burhansstipanov said, because the Indian Health Service (a unit of the U.S. Department of Health and Human Services) sterilized thousands of Native American women in the 1970s without their consent.

“The medical community has to engage in some serious trust-building initiatives,” Dr. Marshall said.

That trust is what has helped to keep Thomas Goode alive. An African American diagnosed with multiple myeloma in 2005 when he was 34 years old, Mr. Goode has endured three stem cell transplants. Between each transplant, he participated in clinical trials, where he gained access to drug cocktails that helped bridge him to the next procedure. He counted himself lucky that he lived close to Durham, North Carolina, which is a research hub, so he was able to see specialists and take part in trials.

“I never knew anything about clinical trials, but a lot of my trust and faith was in the doctor,” he said. “I said, ‘I trust you, doctor, whatever you say.’ ”

Now, Mr. Goode has gone 6 years without a relapse. “I’m in a good place right now,” he said, “But if I didn’t try a trial, who’s to say I would still be here?”



ProPublica is a Pulitzer Prize–winning investigative newsroom. Stat is a news organization reporting from the frontiers of health and medicine.

This story was co-published with Stat.

It’s a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro (ixazomib), it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical, one patient even hailed Ninlaro as “my savior.”

The U.S. Food and Drug Administration approved it in 2015 after patients in a clinical trial gained an average of 6 months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the United States is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer.

Yet, of the 722 participants in the trial, only 13 – or 1.8% – were black.

The scarcity of black patients in Ninlaro’s testing left unanswered the vital question of whether the drug would work equally well for them. “Meaningful differences may exist” in how multiple myeloma affects black patients, what symptoms they experience, and how they respond to medications, FDA scientists wrote in a 2017 journal article.

The racial disparity in the Ninlaro study isn’t unusual. Reflecting the reluctance of the FDA to force drugmakers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark underrepresentation of blacks is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them. A ProPublica analysis of data recently made public by the FDA found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of the patients were black. African Americans make up 13.4% of the U.S. population.

As a result, desperately ill black patients who have exhausted other treatment options aren’t getting early access to experimental drugs that could extend their life spans or improve their quality of life. While unapproved treatments also carry a risk of setbacks or side effects, new cancer drugs have dramatically shifted outcomes for some patients.

Recently approved lung cancer treatments are “revolutionary,” said Karen Kelly, MD, associate director for research at UC Davis Comprehensive Cancer Center. Even in the first phase of clinical testing, which is aimed at making sure a drug is safe, 20% of cancer patients now see their tumors shrink or disappear, up from 5% in the early 1990s, Dr. Kelly said.

Kashif Ali, MD, research head at Maryland Oncology Hematology, has spent 7 years recruiting patients for about 30 cancer and blood disease trials a year. He said he’s often seen minorities, including African Americans, miss out on trials because of financial hurdles, logistical challenges, and their lingering distrust of the medical community because of a history of being victimized by medical experimentation.

“They’re potentially losing out on life-extending opportunities because it’s one more option they no longer have,” Dr. Ali said. “Especially when patients are in advanced stages of cancer, treatments are like stepping-stones: When one stops working, you move on to the next.”

Not joining a trial can mean “you’ve lost life expectancy,” he said.

Patients who can’t afford to travel long distances to a trial, take time off work, or find child care are at a disadvantage. They are usually reimbursed for travel and food costs, but drugmakers are careful not to pay too much because they do not want to appear to be enticing patients to join when it isn’t in their medical interests, said Laurie Halloran, founder and CEO of a consulting firm for the drug industry.

While the experimental drug used in a study is free, any approved treatments that are part of the trial typically need to be covered by a patient’s own insurance, according to Dr. Ali.

He recalled one black patient who was eligible for a study that entailed taking an already approved drug in combination with a new treatment. The approved drug cost $10,000 a month and the patient’s insurance charged 20% as his copay, Dr. Ali recalled. The patient decided that joining the trial would be too expensive. He instead underwent chemotherapy, which was cheaper, but he didn’t tolerate it well. The patient is now considering hospice, Dr. Ali said.

Criteria for admission to clinical trials have become more stringent over the years, Mass. General’s Dr. Jackson said, and patients of color increasingly are excluded. They are more likely than white people are to have other conditions such as stroke, hypertension, and diabetes, which could complicate research results. Trials often want to enroll “the healthiest sick people they can find” and preclude patients with other conditions. “The wall basically gets taller and taller,” he said.

Aredia Taylor didn’t qualify for a clinical trial on other grounds. A former U.S. Department of Agriculture supervisor for food-safety inspections, she was diagnosed with multiple myeloma in 2014 and had undergone a gamut of treatment including various chemotherapy drugs and a stem cell transplant.

While the transplant drove her cancer into remission, she still needs to take Revlimid (lenalidomide) – a standard treatment – daily to keep the cancer at bay. The drug has given her side effects that she describes as devastating to her daily life, including diarrhea, muscle spasms, and an inability to concentrate. She said she wants to stop taking Revlimid and would be willing to try an experimental treatment.

Ms. Taylor, 58, said she saw pamphlets at her doctor’s office encouraging patients to ask about clinical trials, so she asked her oncologist, Larry Anderson, MD, at the University of Texas Southwestern Medical Center in Dallas, whether she should join a study. He told her that she “wasn’t a fit,” she said. Dr. Anderson told ProPublica that most trials are seeking patients with either newly diagnosed or relapsed multiple myeloma, and since Ms. Taylor is currently in remission, she wouldn’t be accepted.

Ms. Taylor was disappointed. Knowing that blacks like herself are especially susceptible to multiple myeloma, she’d like to be a part of developing more effective treatments.

“I want to pay it forward and be a blessing to somebody else,” she said. “I want to be one of the people that they try to do a clinical trial for, so they find a way to a cure.”

Spurred by Congress, the FDA began in January 2015 to regularly publish a “Drug Trials Snapshot” for every new drug approved, delineating the demographic breakdown for clinical trial participants by sex, race and age subgroups. ProPublica’s analysis focused on participants in trials for the 31 cancer drugs approved since then, comparing their demographics with data from the National Cancer Institute on the incidence of various cancers by race.

Eighteen of those drugs targeted cancers that are at least as likely to afflict black Americans as white Americans. On average, only 4.1% of patients in those trials were black. Trials for four multiple myeloma drugs, including Ninlaro, averaged 5% black participation.

An FDA study over a longer time period corroborated ProPublica’s findings. In a 2017 article in the journal Blood coauthored by Richard Pazdur, the FDA’s cancer chief, the agency reported that black patients on average made up 4.5% of participants in trials for multiple myeloma drugs since 2003. Higher enrollment of minorities in myeloma trials would have “multiple benefits,” the FDA scientists noted. Not only would “underserved populations” gain access to new therapies, but additional data could help researchers identify subtypes of the blood cancer and develop targeted treatments.

A similar pattern emerges for treatments of non–small cell lung cancer. It occurs in 56 out of 100,000 black Americans, versus 49 out of 100,000 white Americans. Yet ProPublica found that in trials for two recently approved drugs for a type of non–small cell lung cancer driven by a mutation in what is known as the ALK gene, less than 2% of participants were black.

Those drugs, Takeda’s Alunbrig (brigatinib) and Genentech’s Alecensa (alectinib), are approved for patients whose lung cancer has spread to other parts of the body. In trials, both drugs were able to shrink tumors, including lesions in the brain. Patients taking Alecensa lived without the disease progressing for an average of 25.7 months, more than double the 10.4 months for patients on another treatment.

“We believe that we must consider differences across all populations to deliver on the promise of personalized health care,” said Meghan Cox, a Genentech spokeswoman, adding that the drugmaker is “continuing to study patient response to Alecensa across populations in the postmarketing setting.”

Similarly, prostate cancer affects 178 out of every 100,000 African Americans, more than for any other race in the United States, compared with 106 out of every 100,000 white Americans. Black Americans are twice as likely as white Americans to die from prostate cancer.

Yet during 2009-2015, in seven trials conducted for five new prostate cancer therapies, only 3% of participants were black, according to a study conducted by Daniel Spratt, MD, vice chair of research in the department of radiation oncology at the University of Michigan, Ann Arbor. More recently, 11 times as many white as black participants, or 66% – compared with 6% – joined trials for Johnson & Johnson’s new prostate cancer treatment, Erleada (apalutamide).

To understand how a small minority group responds to a drug, researchers might have to enroll more patients than what would be a nationally representative sample. In a trial of 100 people, two Native American or Alaska Native patients would reflect those groups’ proportion of the U.S. population but wouldn’t give doctors enough information about race-related impacts.

Linda Burhansstipanov, DrPH, founder of the Native American Cancer Research Corp., estimated that 85% of Native Americans want to participate in clinical trials when informed of the opportunity. She knows several Native American patients who drove 3 hours each way to participate in a trial, despite losing an entire day of work.

Still, trial protocols are rarely designed with minority communities in mind, Dr. Burhansstipanov said. It has long been rumored among Native Americans, she said, that a clinical trial in the 1990s required patients to take a medication upon rising in the morning. In many Native American tribes, the first thing people do when they wake up is greet the sun with morning prayers. For some tribes, prayers can take more than half an hour. Because of the delay, the tale goes, Native American patients were kicked out of the clinical trial for violating the protocol. “The story spread and became a barrier for people to take part in clinical trials,” she said.

In addition, the history of unscrupulous medical experimentation on minorities feeds wariness of clinical trials. Angela M. Marshall, MD, an internal medicine doctor and board member of Black Women’s Health Imperative, said she sees a “lack of excitement among minority communities for clinical trials, coming from a mistrust of the medical community.”

Her black patients often cite the infamous Tuskegee study, conducted from 1932 to 1972 by the U.S. Public Health Service, in which researchers knowingly withheld treatment from African American sharecroppers with syphilis in order to study the progression of the disease. Some Native Americans are similarly suspicious of the medical community, Dr. Burhansstipanov said, because the Indian Health Service (a unit of the U.S. Department of Health and Human Services) sterilized thousands of Native American women in the 1970s without their consent.

“The medical community has to engage in some serious trust-building initiatives,” Dr. Marshall said.

That trust is what has helped to keep Thomas Goode alive. An African American diagnosed with multiple myeloma in 2005 when he was 34 years old, Mr. Goode has endured three stem cell transplants. Between each transplant, he participated in clinical trials, where he gained access to drug cocktails that helped bridge him to the next procedure. He counted himself lucky that he lived close to Durham, North Carolina, which is a research hub, so he was able to see specialists and take part in trials.

“I never knew anything about clinical trials, but a lot of my trust and faith was in the doctor,” he said. “I said, ‘I trust you, doctor, whatever you say.’ ”

Now, Mr. Goode has gone 6 years without a relapse. “I’m in a good place right now,” he said, “But if I didn’t try a trial, who’s to say I would still be here?”



ProPublica is a Pulitzer Prize–winning investigative newsroom. Stat is a news organization reporting from the frontiers of health and medicine.

This story was co-published with Stat.

It’s a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro (ixazomib), it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical, one patient even hailed Ninlaro as “my savior.”

The U.S. Food and Drug Administration approved it in 2015 after patients in a clinical trial gained an average of 6 months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the United States is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer.

Yet, of the 722 participants in the trial, only 13 – or 1.8% – were black.

The scarcity of black patients in Ninlaro’s testing left unanswered the vital question of whether the drug would work equally well for them. “Meaningful differences may exist” in how multiple myeloma affects black patients, what symptoms they experience, and how they respond to medications, FDA scientists wrote in a 2017 journal article.

The racial disparity in the Ninlaro study isn’t unusual. Reflecting the reluctance of the FDA to force drugmakers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark underrepresentation of blacks is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them. A ProPublica analysis of data recently made public by the FDA found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of the patients were black. African Americans make up 13.4% of the U.S. population.

As a result, desperately ill black patients who have exhausted other treatment options aren’t getting early access to experimental drugs that could extend their life spans or improve their quality of life. While unapproved treatments also carry a risk of setbacks or side effects, new cancer drugs have dramatically shifted outcomes for some patients.

Recently approved lung cancer treatments are “revolutionary,” said Karen Kelly, MD, associate director for research at UC Davis Comprehensive Cancer Center. Even in the first phase of clinical testing, which is aimed at making sure a drug is safe, 20% of cancer patients now see their tumors shrink or disappear, up from 5% in the early 1990s, Dr. Kelly said.

Kashif Ali, MD, research head at Maryland Oncology Hematology, has spent 7 years recruiting patients for about 30 cancer and blood disease trials a year. He said he’s often seen minorities, including African Americans, miss out on trials because of financial hurdles, logistical challenges, and their lingering distrust of the medical community because of a history of being victimized by medical experimentation.

“They’re potentially losing out on life-extending opportunities because it’s one more option they no longer have,” Dr. Ali said. “Especially when patients are in advanced stages of cancer, treatments are like stepping-stones: When one stops working, you move on to the next.”

Not joining a trial can mean “you’ve lost life expectancy,” he said.

Patients who can’t afford to travel long distances to a trial, take time off work, or find child care are at a disadvantage. They are usually reimbursed for travel and food costs, but drugmakers are careful not to pay too much because they do not want to appear to be enticing patients to join when it isn’t in their medical interests, said Laurie Halloran, founder and CEO of a consulting firm for the drug industry.

While the experimental drug used in a study is free, any approved treatments that are part of the trial typically need to be covered by a patient’s own insurance, according to Dr. Ali.

He recalled one black patient who was eligible for a study that entailed taking an already approved drug in combination with a new treatment. The approved drug cost $10,000 a month and the patient’s insurance charged 20% as his copay, Dr. Ali recalled. The patient decided that joining the trial would be too expensive. He instead underwent chemotherapy, which was cheaper, but he didn’t tolerate it well. The patient is now considering hospice, Dr. Ali said.

Criteria for admission to clinical trials have become more stringent over the years, Mass. General’s Dr. Jackson said, and patients of color increasingly are excluded. They are more likely than white people are to have other conditions such as stroke, hypertension, and diabetes, which could complicate research results. Trials often want to enroll “the healthiest sick people they can find” and preclude patients with other conditions. “The wall basically gets taller and taller,” he said.

Aredia Taylor didn’t qualify for a clinical trial on other grounds. A former U.S. Department of Agriculture supervisor for food-safety inspections, she was diagnosed with multiple myeloma in 2014 and had undergone a gamut of treatment including various chemotherapy drugs and a stem cell transplant.

While the transplant drove her cancer into remission, she still needs to take Revlimid (lenalidomide) – a standard treatment – daily to keep the cancer at bay. The drug has given her side effects that she describes as devastating to her daily life, including diarrhea, muscle spasms, and an inability to concentrate. She said she wants to stop taking Revlimid and would be willing to try an experimental treatment.

Ms. Taylor, 58, said she saw pamphlets at her doctor’s office encouraging patients to ask about clinical trials, so she asked her oncologist, Larry Anderson, MD, at the University of Texas Southwestern Medical Center in Dallas, whether she should join a study. He told her that she “wasn’t a fit,” she said. Dr. Anderson told ProPublica that most trials are seeking patients with either newly diagnosed or relapsed multiple myeloma, and since Ms. Taylor is currently in remission, she wouldn’t be accepted.

Ms. Taylor was disappointed. Knowing that blacks like herself are especially susceptible to multiple myeloma, she’d like to be a part of developing more effective treatments.

“I want to pay it forward and be a blessing to somebody else,” she said. “I want to be one of the people that they try to do a clinical trial for, so they find a way to a cure.”

Spurred by Congress, the FDA began in January 2015 to regularly publish a “Drug Trials Snapshot” for every new drug approved, delineating the demographic breakdown for clinical trial participants by sex, race and age subgroups. ProPublica’s analysis focused on participants in trials for the 31 cancer drugs approved since then, comparing their demographics with data from the National Cancer Institute on the incidence of various cancers by race.

Eighteen of those drugs targeted cancers that are at least as likely to afflict black Americans as white Americans. On average, only 4.1% of patients in those trials were black. Trials for four multiple myeloma drugs, including Ninlaro, averaged 5% black participation.

An FDA study over a longer time period corroborated ProPublica’s findings. In a 2017 article in the journal Blood coauthored by Richard Pazdur, the FDA’s cancer chief, the agency reported that black patients on average made up 4.5% of participants in trials for multiple myeloma drugs since 2003. Higher enrollment of minorities in myeloma trials would have “multiple benefits,” the FDA scientists noted. Not only would “underserved populations” gain access to new therapies, but additional data could help researchers identify subtypes of the blood cancer and develop targeted treatments.

A similar pattern emerges for treatments of non–small cell lung cancer. It occurs in 56 out of 100,000 black Americans, versus 49 out of 100,000 white Americans. Yet ProPublica found that in trials for two recently approved drugs for a type of non–small cell lung cancer driven by a mutation in what is known as the ALK gene, less than 2% of participants were black.

Those drugs, Takeda’s Alunbrig (brigatinib) and Genentech’s Alecensa (alectinib), are approved for patients whose lung cancer has spread to other parts of the body. In trials, both drugs were able to shrink tumors, including lesions in the brain. Patients taking Alecensa lived without the disease progressing for an average of 25.7 months, more than double the 10.4 months for patients on another treatment.

“We believe that we must consider differences across all populations to deliver on the promise of personalized health care,” said Meghan Cox, a Genentech spokeswoman, adding that the drugmaker is “continuing to study patient response to Alecensa across populations in the postmarketing setting.”

Similarly, prostate cancer affects 178 out of every 100,000 African Americans, more than for any other race in the United States, compared with 106 out of every 100,000 white Americans. Black Americans are twice as likely as white Americans to die from prostate cancer.

Yet during 2009-2015, in seven trials conducted for five new prostate cancer therapies, only 3% of participants were black, according to a study conducted by Daniel Spratt, MD, vice chair of research in the department of radiation oncology at the University of Michigan, Ann Arbor. More recently, 11 times as many white as black participants, or 66% – compared with 6% – joined trials for Johnson & Johnson’s new prostate cancer treatment, Erleada (apalutamide).

To understand how a small minority group responds to a drug, researchers might have to enroll more patients than what would be a nationally representative sample. In a trial of 100 people, two Native American or Alaska Native patients would reflect those groups’ proportion of the U.S. population but wouldn’t give doctors enough information about race-related impacts.

Linda Burhansstipanov, DrPH, founder of the Native American Cancer Research Corp., estimated that 85% of Native Americans want to participate in clinical trials when informed of the opportunity. She knows several Native American patients who drove 3 hours each way to participate in a trial, despite losing an entire day of work.

Still, trial protocols are rarely designed with minority communities in mind, Dr. Burhansstipanov said. It has long been rumored among Native Americans, she said, that a clinical trial in the 1990s required patients to take a medication upon rising in the morning. In many Native American tribes, the first thing people do when they wake up is greet the sun with morning prayers. For some tribes, prayers can take more than half an hour. Because of the delay, the tale goes, Native American patients were kicked out of the clinical trial for violating the protocol. “The story spread and became a barrier for people to take part in clinical trials,” she said.

In addition, the history of unscrupulous medical experimentation on minorities feeds wariness of clinical trials. Angela M. Marshall, MD, an internal medicine doctor and board member of Black Women’s Health Imperative, said she sees a “lack of excitement among minority communities for clinical trials, coming from a mistrust of the medical community.”

Her black patients often cite the infamous Tuskegee study, conducted from 1932 to 1972 by the U.S. Public Health Service, in which researchers knowingly withheld treatment from African American sharecroppers with syphilis in order to study the progression of the disease. Some Native Americans are similarly suspicious of the medical community, Dr. Burhansstipanov said, because the Indian Health Service (a unit of the U.S. Department of Health and Human Services) sterilized thousands of Native American women in the 1970s without their consent.

“The medical community has to engage in some serious trust-building initiatives,” Dr. Marshall said.

That trust is what has helped to keep Thomas Goode alive. An African American diagnosed with multiple myeloma in 2005 when he was 34 years old, Mr. Goode has endured three stem cell transplants. Between each transplant, he participated in clinical trials, where he gained access to drug cocktails that helped bridge him to the next procedure. He counted himself lucky that he lived close to Durham, North Carolina, which is a research hub, so he was able to see specialists and take part in trials.

“I never knew anything about clinical trials, but a lot of my trust and faith was in the doctor,” he said. “I said, ‘I trust you, doctor, whatever you say.’ ”

Now, Mr. Goode has gone 6 years without a relapse. “I’m in a good place right now,” he said, “But if I didn’t try a trial, who’s to say I would still be here?”



ProPublica is a Pulitzer Prize–winning investigative newsroom. Stat is a news organization reporting from the frontiers of health and medicine.

Postpartum psychosis is extremely rare, but when it does occur, the consequences can prove catastrophic.

An article in The Atlantic chronicles the nightmare suffered by mothers driven to kill their children.

Cara Angelotta, MD, a forensic psychiatrist affiliated with Northwestern University in Chicago, says the presence of postpartum psychosis also puts mothers’ lives at risk. “Suicide is a major contributor to maternal death in the first year postpartum. [And] postpartum psychosis increases the risk of suicide,” she says.

“People don’t get it,” says Susan Benjamin Feingold, PsyD, a psychologist at the Illinois School of Professional Psychology in Chicago and an expert in postpartum disorders. “They see baby killers. These women are really sick and need treatment, not punishment.”

On June 1, Illinois became the first state to implement a law that allows judges to consider postpartum psychosis during sentencing. When left untreated, postpartum psychosis might raise the risk of infanticide by about 4%, the article in The Atlantic noted.
 

Thank you for being a friend

Some senior adults are benefiting from the friendship, security, and invigoration provided by an initiative of several universities in which they share living spaces with students. The arrangement, according to the Canadian Broadcasting Corporation, saves the student on housing costs and provides the senior with companionship and assistance with household chores.

But these arrangements have deeper and more enriching benefits.

About 25% of older adults lack family assistance with everyday tasks and live without the companionship that is a hallmark of multiperson households. “It actually gives some peace of mind to that older person,” says Samir Sinha, MD, director of geriatrics at Toronto’s Mount Sinai Hospital. 

“It gives them a greater sense of security and the ability to feel like they can maintain their independence for that much longer.”
 

Jobs and the deaf community

Hearing loss can cause a retreat from the world. But in one San Francisco neighborhood, it is not a barrier to work. As reported by National Public Radio (NPR), every staff member at Mozzeria is partly or fully deaf. Using pen-and-paper ordering or the tried and true pointing at the menu that eases the interchange between hearing-enabled patrons not versed in American Sign Language and hearing-challenged staff, Mozzeria owners Melody and Russ Stein provide solid employment for people for whom a job could otherwise be elusive. Only about 48% of the deaf community is employed in the United States (compared with 72% of hearing individuals), according to the National Deaf Center.

“We envision that each Mozzeria location will be looked at as a source of both local and national pride,” Melody Stein wrote in a recent article.
 

An alternative to opioids?

Jelena M. Janjic, PhD, a pain researcher at Duquesne University in Pittsburgh, is drawing on her expertise in nanotechnology and her personal experience to develop a means of delivering nonopioid drugs directly to cells in the body. If successful in humans, as it has been in rats, the method would free people from using addictive opioids for pain relief.

As reported by NPR, a motivation for the tact is Dr. Janjic’s own decades-long battle with chronic pain. Personal introspection and literature searches led her to the view that chronic pain can be rooted in inflammation. Quelling the inflammation without disabling the good that the immune system does in fighting infections and other harms might help ease the pain.

“As a patient, I want an answer,” Dr. Janjic says in the interview. “I want to figure out this.”
 

Marshmallows and self-control

The world recently bid goodbye to Walter Mischel, PhD, who died on Sept. 12. Dr. Mischel is chiefly remembered for his ionic marshmallow test.

In the test of delayed gratification, children were presented with a treat (sometimes the famous marshmallow) then asked to hold off gobbling down the treat in exchange for an even more treats later.

As described in The New Yorker, an inspiration for Dr. Mischel was his repeated attempts to quit his prodigious smoking addiction. His research was one of the first glimpses into the role of self-control as a beneficial strategy in life. Learning to mentally temper that got-to-have-it moment is, according to Dr. Mischel, key to self-control.

“If we have the skills to allow us to make discriminations about when we do or don’t do something, when we do or don’t drink something, and when we do and when we don’t wait for something, we are no longer victims of our desires,” he said in the New Yorker interview.

Postpartum psychosis is extremely rare, but when it does occur, the consequences can prove catastrophic.

An article in The Atlantic chronicles the nightmare suffered by mothers driven to kill their children.

Cara Angelotta, MD, a forensic psychiatrist affiliated with Northwestern University in Chicago, says the presence of postpartum psychosis also puts mothers’ lives at risk. “Suicide is a major contributor to maternal death in the first year postpartum. [And] postpartum psychosis increases the risk of suicide,” she says.

“People don’t get it,” says Susan Benjamin Feingold, PsyD, a psychologist at the Illinois School of Professional Psychology in Chicago and an expert in postpartum disorders. “They see baby killers. These women are really sick and need treatment, not punishment.”

On June 1, Illinois became the first state to implement a law that allows judges to consider postpartum psychosis during sentencing. When left untreated, postpartum psychosis might raise the risk of infanticide by about 4%, the article in The Atlantic noted.
 

Thank you for being a friend

Some senior adults are benefiting from the friendship, security, and invigoration provided by an initiative of several universities in which they share living spaces with students. The arrangement, according to the Canadian Broadcasting Corporation, saves the student on housing costs and provides the senior with companionship and assistance with household chores.

But these arrangements have deeper and more enriching benefits.

About 25% of older adults lack family assistance with everyday tasks and live without the companionship that is a hallmark of multiperson households. “It actually gives some peace of mind to that older person,” says Samir Sinha, MD, director of geriatrics at Toronto’s Mount Sinai Hospital. 

“It gives them a greater sense of security and the ability to feel like they can maintain their independence for that much longer.”
 

Jobs and the deaf community

Hearing loss can cause a retreat from the world. But in one San Francisco neighborhood, it is not a barrier to work. As reported by National Public Radio (NPR), every staff member at Mozzeria is partly or fully deaf. Using pen-and-paper ordering or the tried and true pointing at the menu that eases the interchange between hearing-enabled patrons not versed in American Sign Language and hearing-challenged staff, Mozzeria owners Melody and Russ Stein provide solid employment for people for whom a job could otherwise be elusive. Only about 48% of the deaf community is employed in the United States (compared with 72% of hearing individuals), according to the National Deaf Center.

“We envision that each Mozzeria location will be looked at as a source of both local and national pride,” Melody Stein wrote in a recent article.
 

An alternative to opioids?

Jelena M. Janjic, PhD, a pain researcher at Duquesne University in Pittsburgh, is drawing on her expertise in nanotechnology and her personal experience to develop a means of delivering nonopioid drugs directly to cells in the body. If successful in humans, as it has been in rats, the method would free people from using addictive opioids for pain relief.

As reported by NPR, a motivation for the tact is Dr. Janjic’s own decades-long battle with chronic pain. Personal introspection and literature searches led her to the view that chronic pain can be rooted in inflammation. Quelling the inflammation without disabling the good that the immune system does in fighting infections and other harms might help ease the pain.

“As a patient, I want an answer,” Dr. Janjic says in the interview. “I want to figure out this.”
 

Marshmallows and self-control

The world recently bid goodbye to Walter Mischel, PhD, who died on Sept. 12. Dr. Mischel is chiefly remembered for his ionic marshmallow test.

In the test of delayed gratification, children were presented with a treat (sometimes the famous marshmallow) then asked to hold off gobbling down the treat in exchange for an even more treats later.

As described in The New Yorker, an inspiration for Dr. Mischel was his repeated attempts to quit his prodigious smoking addiction. His research was one of the first glimpses into the role of self-control as a beneficial strategy in life. Learning to mentally temper that got-to-have-it moment is, according to Dr. Mischel, key to self-control.

“If we have the skills to allow us to make discriminations about when we do or don’t do something, when we do or don’t drink something, and when we do and when we don’t wait for something, we are no longer victims of our desires,” he said in the New Yorker interview.

Postpartum psychosis is extremely rare, but when it does occur, the consequences can prove catastrophic.

An article in The Atlantic chronicles the nightmare suffered by mothers driven to kill their children.

Cara Angelotta, MD, a forensic psychiatrist affiliated with Northwestern University in Chicago, says the presence of postpartum psychosis also puts mothers’ lives at risk. “Suicide is a major contributor to maternal death in the first year postpartum. [And] postpartum psychosis increases the risk of suicide,” she says.

“People don’t get it,” says Susan Benjamin Feingold, PsyD, a psychologist at the Illinois School of Professional Psychology in Chicago and an expert in postpartum disorders. “They see baby killers. These women are really sick and need treatment, not punishment.”

On June 1, Illinois became the first state to implement a law that allows judges to consider postpartum psychosis during sentencing. When left untreated, postpartum psychosis might raise the risk of infanticide by about 4%, the article in The Atlantic noted.
 

Thank you for being a friend

Some senior adults are benefiting from the friendship, security, and invigoration provided by an initiative of several universities in which they share living spaces with students. The arrangement, according to the Canadian Broadcasting Corporation, saves the student on housing costs and provides the senior with companionship and assistance with household chores.

But these arrangements have deeper and more enriching benefits.

About 25% of older adults lack family assistance with everyday tasks and live without the companionship that is a hallmark of multiperson households. “It actually gives some peace of mind to that older person,” says Samir Sinha, MD, director of geriatrics at Toronto’s Mount Sinai Hospital. 

“It gives them a greater sense of security and the ability to feel like they can maintain their independence for that much longer.”
 

Jobs and the deaf community

Hearing loss can cause a retreat from the world. But in one San Francisco neighborhood, it is not a barrier to work. As reported by National Public Radio (NPR), every staff member at Mozzeria is partly or fully deaf. Using pen-and-paper ordering or the tried and true pointing at the menu that eases the interchange between hearing-enabled patrons not versed in American Sign Language and hearing-challenged staff, Mozzeria owners Melody and Russ Stein provide solid employment for people for whom a job could otherwise be elusive. Only about 48% of the deaf community is employed in the United States (compared with 72% of hearing individuals), according to the National Deaf Center.

“We envision that each Mozzeria location will be looked at as a source of both local and national pride,” Melody Stein wrote in a recent article.
 

An alternative to opioids?

Jelena M. Janjic, PhD, a pain researcher at Duquesne University in Pittsburgh, is drawing on her expertise in nanotechnology and her personal experience to develop a means of delivering nonopioid drugs directly to cells in the body. If successful in humans, as it has been in rats, the method would free people from using addictive opioids for pain relief.

As reported by NPR, a motivation for the tact is Dr. Janjic’s own decades-long battle with chronic pain. Personal introspection and literature searches led her to the view that chronic pain can be rooted in inflammation. Quelling the inflammation without disabling the good that the immune system does in fighting infections and other harms might help ease the pain.

“As a patient, I want an answer,” Dr. Janjic says in the interview. “I want to figure out this.”
 

Marshmallows and self-control

The world recently bid goodbye to Walter Mischel, PhD, who died on Sept. 12. Dr. Mischel is chiefly remembered for his ionic marshmallow test.

In the test of delayed gratification, children were presented with a treat (sometimes the famous marshmallow) then asked to hold off gobbling down the treat in exchange for an even more treats later.

As described in The New Yorker, an inspiration for Dr. Mischel was his repeated attempts to quit his prodigious smoking addiction. His research was one of the first glimpses into the role of self-control as a beneficial strategy in life. Learning to mentally temper that got-to-have-it moment is, according to Dr. Mischel, key to self-control.

“If we have the skills to allow us to make discriminations about when we do or don’t do something, when we do or don’t drink something, and when we do and when we don’t wait for something, we are no longer victims of our desires,” he said in the New Yorker interview.

Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.

©Karen Winton/iStockphoto

“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.

To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.

The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.

The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.

The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.

Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.

Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.

The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.

The researchers had no financial conflicts to disclose.

SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.

Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.

©Karen Winton/iStockphoto

“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.

To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.

The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.

The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.

The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.

Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.

Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.

The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.

The researchers had no financial conflicts to disclose.

SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.

Patients with chronic pain who took opioids reported significantly more difficulty falling asleep, compared with those who didn’t use opioids, a study of 144 adults has found.

©Karen Winton/iStockphoto

“Identification of factors that influence insomnia symptoms among adults with chronic pain may inform prevention and treatment efforts for both disorders,” wrote Mary Beth Miller, PhD, of the University of Missouri School of Medicine, Columbia, and her colleagues.

To identify the potential impact of opioid use on sleep among chronic pain patients, the researchers recruited adults reporting symptoms of both insomnia and fibromyalgia. The average age of the participants was 52 years, and 95% were women. The study findings were published in Sleep Medicine.

The participants completed sleep diaries for 14 days, during which they recorded data including when they went to bed, how long it took them to fall asleep (SOL), how often they woke up during the night and how long they stayed awake (WASO), what time they woke up, and what time they got out of bed. Patients also reported “yes” or “no” on opioid use and their dosage each day and rated their pain on a scale of 0-100 each night before retiring.

The study participants wore wrist actigraphy devices for baseline assessment and underwent 1 night of ambulatory polysomnography.

The researchers used a multiple regression model to examine how pain intensity affected the association between opioid use and insomnia.

Overall, “opioid use was not associated with improvements in insomnia symptoms across any level of pain intensity, and was associated with worse insomnia symptoms among those reporting less intense pain,” the researchers said.

Opioid use was associated with significantly longer time to sleep onset in participants with low levels of pain (P = .02) but not among those with moderate to high levels; average sleep onset latency appeared unaffected by pain level among participants who did not use opioids.

The study findings were limited by several factors including the small number of male participants, the use of paper forms for the sleep diaries, which prevented confirmation of timely reporting, and the cross-sectional nature of the analysis, the researchers noted. However, from a clinical perspective, the “findings suggest that it may be important to advise patients reporting symptoms of insomnia about the risks of extending time in bed when providing them with opioid pain medication and that the use of behavioral or cognitive-behavioral treatment for insomnia may be recommended,” they said. The researchers also recommended that future studies address the longitudinal associations between opioid use and insomnia.

The researchers had no financial conflicts to disclose.

SOURCE: Miller M et al., Sleep Med. 2018; doi: 10.1016/j.sleep.2018.08.015.

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

WASHINGTON – Among HIV-infected women, those aged 18-29 years had the highest rates of gonorrhea and chlamydia. These results suggest that screening for these sexually transmitted infections (STIs) should be based on age and risk in HIV-infected women, said Jodie Dionne-Odom, MD, of the University of Alabama at Birmingham.

Courtesy CDC

Annual screening for gonorrhea and chlamydia is recommended for all sexually active adults with HIV, but prevalence varies by gender, age, and risk behavior, Dr. Dionne-Odom said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Odom and her colleagues calculated annual testing and positivity rates during 2007-2016 for chlamydia and gonorrhea among women engaged in HIV care in eight U.S. cities as part of the Centers for AIDS Research (CFAR) Clinical Networks and Integrated Clinical Services (CNICS) longitudinal cohort.

They assessed demographic data based on the most recent year the patient was in care and used validated surveys (AUDIT-C and ASSIST) to assess risk behaviors in the past 3-6 months. They collected information from 5,084 women and 158,745 HIV primary care and women’s health visits.

The median patient age was 47 years; 62.1% of the patients were black; 70% had CD4 counts greater than 350; and 73.6% had HIV viral loads of less than 500 copies/mL. In terms of reported risk, 60.6% of the women were sexually active, (85.5% of whom reported monogamy); 13.1% had problem alcohol use, and 11.6% had active drug use.

Sampling for gonorrhea and chlamydia were mostly from urogenital sites (86.6%), 6.6% were extragenital, and 6.8% were “other.” Nearly all (98.5%) of 23,492 chlamydia tests and 95.7% of 23,324 gonorrhea tests used nucleic acid amplification, Dr. Dionne-Odom said.

During the most recent year in care, 42.7% of women were tested for gonorrhea and chlamydia, and 3.4% were positive, with the annual positivity rates over the study ranging from 1.5% to 3.2% for chlamydia and 0.9% to 1.5% for gonorrhea. However, Dr. Dionne-Odom and her colleagues found that the prevalence of STIs was inversely related to patient age, with gonorrhea and chlamydia positivity in 2016 being 16% for chlamydia and 3.9% for gonorrhea among women aged 18-24 years, compared with 1.1% and 0.7%, respectively, for women older than 50 years.

“As with national data on women, HIV-infected women aged 18-29 years had the highest rates of gonorrhea and chlamydia. Our results show that targeted screening for chlamydia and gonorrhea in women with HIV based on age and risk is warranted,” Dr. Dionne-Odom concluded.

Dr. Dionne-Odom reported that she had no relevant disclosures.

[email protected]

Most in-hospital deaths from community-acquired pneumonia are not preventable with current medical therapy, according to an analysis of deaths at five U.S. hospitals with expertise in pneumonia care.

©marcosmartinezromero/iStockphoto.com

Adults who are hospitalized with community-acquired pneumonia (CAP) are at high risk for short-term mortality but it is unclear whether an improvement in care could lower this risk, noted the study authors led by Grant W. Waterer, MBBS, PhD, of Northwestern University, Chicago.

“Understanding the circumstances in which CAP patients die could facilitate improvements in the management of CAP by enabling future improvement efforts to focus on common preventable causes of death,” they wrote. Their report was published in CHEST^®.

They therefore performed a secondary analysis of the Etiology of Pneumonia in the Community (EPIC) study involving adults hospitalized with CAP between January 2010 and June 2012 across five tertiary-care hospitals in the United States.

The clinical characteristics of patients who died in the hospital were compared with those of patients who survived to hospital discharge. Chronic heart failure, chronic obstructive pulmonary disease, coronary artery disease, chronic liver disease, cerebrovascular disease, cancer (excluding skin cancer), and diabetes were considered as severe chronic comorbidities based on their association with increased mortality and ICU admission in CAP severity scores.

Deaths caused by septic shock, respiratory failure, multisystem organ failure, cardiopulmonary arrest prior to stabilization of CAP, and endocarditis, were considered to be directly related to CAP.

Conversely, causes of death indirectly related to CAP included acute cardiovascular disease, stroke, acute renal failure, and secondary infections developed after hospitalization. Deaths caused by cancer, cirrhosis, and chronic neurologic conditions were considered unrelated to CAP.

Medical notes were assessed to determine whether the patient received management consistent with current recommendations; for example, antibiotics consistent with guidelines from the Infectious Diseases Society of America.

End-of-life limitations in care, such as patient/family decision not to proceed with full medical treatment, also were considered by the research team.

Results showed that among the 2,320 patients with radiographically confirmed CAP, 52 died during initial hospitalization, 33 of whom were aged 65 years or older, and 32 of whom had two or more chronic comorbidities.

Most of the in-hospital deaths occurred early in the hospitalization: 35 within the first 10 days of admission, and 5 after 30 days in hospital.

CAP was judged by an expert physician review panel to be the direct cause of death in 27 of the patients, 10 with CAP having an indirect role with major contribution, 9 with CAP having an indirect role with minor contribution, and 6 with CAP having no role in death.

Do-not-resuscitate orders were present at the time of death for 21 of the patients.

Forty-five of the patients were admitted to an ICU, with 37 dying in the ICU. The eight patients who died on the ward after transfer out of the ICU had end-of-life limitations of care in place.

The researchers noted that the number of patients dying in the ICU was greater in the United States, possibly because in Europe fewer patients are admitted to an ICU.

“This discrepancy likely reflects cultural differences between the U.S. and Europe in the role of intensive care for patients with advanced age and/or advanced comorbid conditions,” they noted.

Overall, the physician review panel identified nine patients who had a lapse in quality of in-hospital CAP care, with four of the deaths potentially linked to this lapse in care.

However, two of the patients had end-of-life limitations of care in place, which according to the authors meant that “only two patients undergoing full medical treatment without end-of-life limitations of care had an identified lapse in quality of in-hospital pneumonia care potentially contributing to in-hospital death, including one with a delay in antibiotics for over an hour in the presence of shock and one with initial antibiotics not consistent with IDSA/ATS guidelines.”

The research team concluded that most in-hospital deaths among adult patients admitted with CAP in their study would not have been preventable with higher quality in-hospital pneumonia care.

“Many of the in-hospital deaths among patients admitted with CAP occurred in older patients with severe comorbidities and end-of-life limitations in care,” they noted.

They said the influence of end-of-life limitations on care short of full palliation was an important finding, with all patients who died outside the ICU having end-of-life limitations in care.

“Current diagnostic related group (DRG) and international classification of diseases (ICD) coding systems do not have the necessary nuances to capture these limitations of care, yet they are clearly important factors in determining whether patients experience in-hospital death,” they added.

Dr. Waterer reported no conflicts. Two coauthors reported potential conflicts of interest in relation to consulting fees from several pharmaceutical companies.
 

SOURCE: Waterer G. et al. CHEST 2018;154(3):628-35. doi: 10.1016/j.chest.2018.05.021.

Most in-hospital deaths from community-acquired pneumonia are not preventable with current medical therapy, according to an analysis of deaths at five U.S. hospitals with expertise in pneumonia care.

©marcosmartinezromero/iStockphoto.com

Adults who are hospitalized with community-acquired pneumonia (CAP) are at high risk for short-term mortality but it is unclear whether an improvement in care could lower this risk, noted the study authors led by Grant W. Waterer, MBBS, PhD, of Northwestern University, Chicago.

“Understanding the circumstances in which CAP patients die could facilitate improvements in the management of CAP by enabling future improvement efforts to focus on common preventable causes of death,” they wrote. Their report was published in CHEST^®.

They therefore performed a secondary analysis of the Etiology of Pneumonia in the Community (EPIC) study involving adults hospitalized with CAP between January 2010 and June 2012 across five tertiary-care hospitals in the United States.

The clinical characteristics of patients who died in the hospital were compared with those of patients who survived to hospital discharge. Chronic heart failure, chronic obstructive pulmonary disease, coronary artery disease, chronic liver disease, cerebrovascular disease, cancer (excluding skin cancer), and diabetes were considered as severe chronic comorbidities based on their association with increased mortality and ICU admission in CAP severity scores.

Deaths caused by septic shock, respiratory failure, multisystem organ failure, cardiopulmonary arrest prior to stabilization of CAP, and endocarditis, were considered to be directly related to CAP.

Conversely, causes of death indirectly related to CAP included acute cardiovascular disease, stroke, acute renal failure, and secondary infections developed after hospitalization. Deaths caused by cancer, cirrhosis, and chronic neurologic conditions were considered unrelated to CAP.

Medical notes were assessed to determine whether the patient received management consistent with current recommendations; for example, antibiotics consistent with guidelines from the Infectious Diseases Society of America.

End-of-life limitations in care, such as patient/family decision not to proceed with full medical treatment, also were considered by the research team.

Results showed that among the 2,320 patients with radiographically confirmed CAP, 52 died during initial hospitalization, 33 of whom were aged 65 years or older, and 32 of whom had two or more chronic comorbidities.

Most of the in-hospital deaths occurred early in the hospitalization: 35 within the first 10 days of admission, and 5 after 30 days in hospital.

CAP was judged by an expert physician review panel to be the direct cause of death in 27 of the patients, 10 with CAP having an indirect role with major contribution, 9 with CAP having an indirect role with minor contribution, and 6 with CAP having no role in death.

Do-not-resuscitate orders were present at the time of death for 21 of the patients.

Forty-five of the patients were admitted to an ICU, with 37 dying in the ICU. The eight patients who died on the ward after transfer out of the ICU had end-of-life limitations of care in place.

The researchers noted that the number of patients dying in the ICU was greater in the United States, possibly because in Europe fewer patients are admitted to an ICU.

“This discrepancy likely reflects cultural differences between the U.S. and Europe in the role of intensive care for patients with advanced age and/or advanced comorbid conditions,” they noted.

Overall, the physician review panel identified nine patients who had a lapse in quality of in-hospital CAP care, with four of the deaths potentially linked to this lapse in care.

However, two of the patients had end-of-life limitations of care in place, which according to the authors meant that “only two patients undergoing full medical treatment without end-of-life limitations of care had an identified lapse in quality of in-hospital pneumonia care potentially contributing to in-hospital death, including one with a delay in antibiotics for over an hour in the presence of shock and one with initial antibiotics not consistent with IDSA/ATS guidelines.”

The research team concluded that most in-hospital deaths among adult patients admitted with CAP in their study would not have been preventable with higher quality in-hospital pneumonia care.

“Many of the in-hospital deaths among patients admitted with CAP occurred in older patients with severe comorbidities and end-of-life limitations in care,” they noted.

They said the influence of end-of-life limitations on care short of full palliation was an important finding, with all patients who died outside the ICU having end-of-life limitations in care.

“Current diagnostic related group (DRG) and international classification of diseases (ICD) coding systems do not have the necessary nuances to capture these limitations of care, yet they are clearly important factors in determining whether patients experience in-hospital death,” they added.

Dr. Waterer reported no conflicts. Two coauthors reported potential conflicts of interest in relation to consulting fees from several pharmaceutical companies.
 

SOURCE: Waterer G. et al. CHEST 2018;154(3):628-35. doi: 10.1016/j.chest.2018.05.021.

Most in-hospital deaths from community-acquired pneumonia are not preventable with current medical therapy, according to an analysis of deaths at five U.S. hospitals with expertise in pneumonia care.

©marcosmartinezromero/iStockphoto.com

Adults who are hospitalized with community-acquired pneumonia (CAP) are at high risk for short-term mortality but it is unclear whether an improvement in care could lower this risk, noted the study authors led by Grant W. Waterer, MBBS, PhD, of Northwestern University, Chicago.

“Understanding the circumstances in which CAP patients die could facilitate improvements in the management of CAP by enabling future improvement efforts to focus on common preventable causes of death,” they wrote. Their report was published in CHEST^®.

They therefore performed a secondary analysis of the Etiology of Pneumonia in the Community (EPIC) study involving adults hospitalized with CAP between January 2010 and June 2012 across five tertiary-care hospitals in the United States.

The clinical characteristics of patients who died in the hospital were compared with those of patients who survived to hospital discharge. Chronic heart failure, chronic obstructive pulmonary disease, coronary artery disease, chronic liver disease, cerebrovascular disease, cancer (excluding skin cancer), and diabetes were considered as severe chronic comorbidities based on their association with increased mortality and ICU admission in CAP severity scores.

Deaths caused by septic shock, respiratory failure, multisystem organ failure, cardiopulmonary arrest prior to stabilization of CAP, and endocarditis, were considered to be directly related to CAP.

Conversely, causes of death indirectly related to CAP included acute cardiovascular disease, stroke, acute renal failure, and secondary infections developed after hospitalization. Deaths caused by cancer, cirrhosis, and chronic neurologic conditions were considered unrelated to CAP.

Medical notes were assessed to determine whether the patient received management consistent with current recommendations; for example, antibiotics consistent with guidelines from the Infectious Diseases Society of America.

End-of-life limitations in care, such as patient/family decision not to proceed with full medical treatment, also were considered by the research team.

Results showed that among the 2,320 patients with radiographically confirmed CAP, 52 died during initial hospitalization, 33 of whom were aged 65 years or older, and 32 of whom had two or more chronic comorbidities.

Most of the in-hospital deaths occurred early in the hospitalization: 35 within the first 10 days of admission, and 5 after 30 days in hospital.

CAP was judged by an expert physician review panel to be the direct cause of death in 27 of the patients, 10 with CAP having an indirect role with major contribution, 9 with CAP having an indirect role with minor contribution, and 6 with CAP having no role in death.

Do-not-resuscitate orders were present at the time of death for 21 of the patients.

Forty-five of the patients were admitted to an ICU, with 37 dying in the ICU. The eight patients who died on the ward after transfer out of the ICU had end-of-life limitations of care in place.

The researchers noted that the number of patients dying in the ICU was greater in the United States, possibly because in Europe fewer patients are admitted to an ICU.

“This discrepancy likely reflects cultural differences between the U.S. and Europe in the role of intensive care for patients with advanced age and/or advanced comorbid conditions,” they noted.

Overall, the physician review panel identified nine patients who had a lapse in quality of in-hospital CAP care, with four of the deaths potentially linked to this lapse in care.

However, two of the patients had end-of-life limitations of care in place, which according to the authors meant that “only two patients undergoing full medical treatment without end-of-life limitations of care had an identified lapse in quality of in-hospital pneumonia care potentially contributing to in-hospital death, including one with a delay in antibiotics for over an hour in the presence of shock and one with initial antibiotics not consistent with IDSA/ATS guidelines.”

The research team concluded that most in-hospital deaths among adult patients admitted with CAP in their study would not have been preventable with higher quality in-hospital pneumonia care.

“Many of the in-hospital deaths among patients admitted with CAP occurred in older patients with severe comorbidities and end-of-life limitations in care,” they noted.

They said the influence of end-of-life limitations on care short of full palliation was an important finding, with all patients who died outside the ICU having end-of-life limitations in care.

“Current diagnostic related group (DRG) and international classification of diseases (ICD) coding systems do not have the necessary nuances to capture these limitations of care, yet they are clearly important factors in determining whether patients experience in-hospital death,” they added.

Dr. Waterer reported no conflicts. Two coauthors reported potential conflicts of interest in relation to consulting fees from several pharmaceutical companies.
 

SOURCE: Waterer G. et al. CHEST 2018;154(3):628-35. doi: 10.1016/j.chest.2018.05.021.

CHICAGO – Consider 24-hour ambulatory blood pressure monitoring when patients complain about not getting enough sleep. You might catch hypertension early, according to researchers from the University of Pennsylvania, Philadelphia, and elsewhere.

M. Alexander Otto/MDedge News

They found a strong association between elevated 24-hour systolic blood pressure and short sleep duration, less than 7 hours a night and a mean in the study of 5.5 hours. Every 2-2.5 minutes of lost sleep was associated with an increase of 1 mm Hg in 24-hour mean systolic blood pressure and a increase of 1 beat per minute in heart rate.

The relationship was independent of office BP, nocturnal dipping status, and BP variability. It held in both the obese and nonobese, and in patients with and without obstructive sleep apnea (OSA). However, the relationship was found only among subjects who were not on antihypertensive medications.

“Adults with shorter sleep duration may benefit from screening with 24-hour ambulatory BP monitoring to promote earlier detection of hypertension and potentially mitigate the” the risk of cardiovascular disease. “This may be particularly important in screening for masked hypertension,” meaning normal pressures in the office, but elevated pressures at home, said investigators led by Jordana Cohen, MD, of the department of medicine at the University of Pennsylvania in a presentation at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

Dr. Cohen suggested that perhaps the sympathetic and endothelial derangements that drive hypertension in OSA also affect people with insufficient sleep. It may be that the normal morning surge in blood pressure persists longer into the day, she suggested. The investigative team analyzed data from two studies. The first, LIMBS (Lifestyle Modification in BP Lowering Study), was a phase 2 trial assessing yoga for blood pressure lowering. It was conducted in West Philadelphia and excluded people with diabetes, hypertension, OSA, and kidney or cardiovascular disease. The new analysis included 66 LIMBS subjects who had 24-hour blood pressure monitoring and kept sleep diaries to record their sleep duration (J Clin Hypertens (Greenwich). 2016 Aug;18[8]:809-16).

The team also analyzed 153 subjects from the PISA (Penn Icelandic Sleep Apnea) cohort, an ongoing project assessing continuous positive airway pressure for OSA, among other things. PISA includes patients with OSA, diabetes, hypertension, and kidney or cardiovascular disease. Sleep duration in the 153 subjects was again self-reported, but corroborated by actigraphy (J Sleep Res. 2015 Jun;24[3]:328-38).

The new findings were driven mostly by higher daytime systolic BP among short sleepers in LIMBS, and higher systolic pressures during both day and night among short sleepers in PISA, compared with subjects who slept at least 7 hours, and a mean of 8.5 hours, with napping included in overall sleep duration assessment.

In LIMBS, the mean 24-hour systolic BP was 12.7 mm Hg higher and the average heart rate 8 bpm faster among short sleepers; in PISA, the mean 24-hour systolic BP was 4.7 mm Hg higher and the heart rate 2 bpm faster.

Every 2.57 minutes of sleep lost in LIMBS and every 1.99 minute of lost sleep in PISA was associated with a 1–mm Hg gain in mean systolic BP and about a 1-bpm increase in heart rate. The findings were statistically significant and adjusted for age, race, body mass index, nocturnal dipping status, and office systolic blood pressure.

Baseline characteristics were generally well matched between short and long sleepers in both studies. However, while mean office systolic BP in LIMBS was the same in both sleep groups at about 139 mm Hg, the mean office systolic BP among long sleepers in PISA was 130 mm Hg versus 136 mm Hg among short sleepers, a significant difference.

It’s unclear why some people slept less, Dr. Cohen said, and the use of sleeping pills wasn’t considered in the analysis. Patients were an average of about 50 years old, with a body mass index of about 30 mg/m². The same model of 24-hour blood pressure monitor was used in both studies.

The work was funded by the National Institutes of Health. The investigators had no disclosures.
 

CHICAGO – Consider 24-hour ambulatory blood pressure monitoring when patients complain about not getting enough sleep. You might catch hypertension early, according to researchers from the University of Pennsylvania, Philadelphia, and elsewhere.

M. Alexander Otto/MDedge News

They found a strong association between elevated 24-hour systolic blood pressure and short sleep duration, less than 7 hours a night and a mean in the study of 5.5 hours. Every 2-2.5 minutes of lost sleep was associated with an increase of 1 mm Hg in 24-hour mean systolic blood pressure and a increase of 1 beat per minute in heart rate.

The relationship was independent of office BP, nocturnal dipping status, and BP variability. It held in both the obese and nonobese, and in patients with and without obstructive sleep apnea (OSA). However, the relationship was found only among subjects who were not on antihypertensive medications.

“Adults with shorter sleep duration may benefit from screening with 24-hour ambulatory BP monitoring to promote earlier detection of hypertension and potentially mitigate the” the risk of cardiovascular disease. “This may be particularly important in screening for masked hypertension,” meaning normal pressures in the office, but elevated pressures at home, said investigators led by Jordana Cohen, MD, of the department of medicine at the University of Pennsylvania in a presentation at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

Dr. Cohen suggested that perhaps the sympathetic and endothelial derangements that drive hypertension in OSA also affect people with insufficient sleep. It may be that the normal morning surge in blood pressure persists longer into the day, she suggested. The investigative team analyzed data from two studies. The first, LIMBS (Lifestyle Modification in BP Lowering Study), was a phase 2 trial assessing yoga for blood pressure lowering. It was conducted in West Philadelphia and excluded people with diabetes, hypertension, OSA, and kidney or cardiovascular disease. The new analysis included 66 LIMBS subjects who had 24-hour blood pressure monitoring and kept sleep diaries to record their sleep duration (J Clin Hypertens (Greenwich). 2016 Aug;18[8]:809-16).

The team also analyzed 153 subjects from the PISA (Penn Icelandic Sleep Apnea) cohort, an ongoing project assessing continuous positive airway pressure for OSA, among other things. PISA includes patients with OSA, diabetes, hypertension, and kidney or cardiovascular disease. Sleep duration in the 153 subjects was again self-reported, but corroborated by actigraphy (J Sleep Res. 2015 Jun;24[3]:328-38).

The new findings were driven mostly by higher daytime systolic BP among short sleepers in LIMBS, and higher systolic pressures during both day and night among short sleepers in PISA, compared with subjects who slept at least 7 hours, and a mean of 8.5 hours, with napping included in overall sleep duration assessment.

In LIMBS, the mean 24-hour systolic BP was 12.7 mm Hg higher and the average heart rate 8 bpm faster among short sleepers; in PISA, the mean 24-hour systolic BP was 4.7 mm Hg higher and the heart rate 2 bpm faster.

Every 2.57 minutes of sleep lost in LIMBS and every 1.99 minute of lost sleep in PISA was associated with a 1–mm Hg gain in mean systolic BP and about a 1-bpm increase in heart rate. The findings were statistically significant and adjusted for age, race, body mass index, nocturnal dipping status, and office systolic blood pressure.

Baseline characteristics were generally well matched between short and long sleepers in both studies. However, while mean office systolic BP in LIMBS was the same in both sleep groups at about 139 mm Hg, the mean office systolic BP among long sleepers in PISA was 130 mm Hg versus 136 mm Hg among short sleepers, a significant difference.

It’s unclear why some people slept less, Dr. Cohen said, and the use of sleeping pills wasn’t considered in the analysis. Patients were an average of about 50 years old, with a body mass index of about 30 mg/m². The same model of 24-hour blood pressure monitor was used in both studies.

The work was funded by the National Institutes of Health. The investigators had no disclosures.
 

CHICAGO – Consider 24-hour ambulatory blood pressure monitoring when patients complain about not getting enough sleep. You might catch hypertension early, according to researchers from the University of Pennsylvania, Philadelphia, and elsewhere.

M. Alexander Otto/MDedge News

They found a strong association between elevated 24-hour systolic blood pressure and short sleep duration, less than 7 hours a night and a mean in the study of 5.5 hours. Every 2-2.5 minutes of lost sleep was associated with an increase of 1 mm Hg in 24-hour mean systolic blood pressure and a increase of 1 beat per minute in heart rate.

The relationship was independent of office BP, nocturnal dipping status, and BP variability. It held in both the obese and nonobese, and in patients with and without obstructive sleep apnea (OSA). However, the relationship was found only among subjects who were not on antihypertensive medications.

“Adults with shorter sleep duration may benefit from screening with 24-hour ambulatory BP monitoring to promote earlier detection of hypertension and potentially mitigate the” the risk of cardiovascular disease. “This may be particularly important in screening for masked hypertension,” meaning normal pressures in the office, but elevated pressures at home, said investigators led by Jordana Cohen, MD, of the department of medicine at the University of Pennsylvania in a presentation at the joint scientific sessions of AHA Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.

Dr. Cohen suggested that perhaps the sympathetic and endothelial derangements that drive hypertension in OSA also affect people with insufficient sleep. It may be that the normal morning surge in blood pressure persists longer into the day, she suggested. The investigative team analyzed data from two studies. The first, LIMBS (Lifestyle Modification in BP Lowering Study), was a phase 2 trial assessing yoga for blood pressure lowering. It was conducted in West Philadelphia and excluded people with diabetes, hypertension, OSA, and kidney or cardiovascular disease. The new analysis included 66 LIMBS subjects who had 24-hour blood pressure monitoring and kept sleep diaries to record their sleep duration (J Clin Hypertens (Greenwich). 2016 Aug;18[8]:809-16).

The team also analyzed 153 subjects from the PISA (Penn Icelandic Sleep Apnea) cohort, an ongoing project assessing continuous positive airway pressure for OSA, among other things. PISA includes patients with OSA, diabetes, hypertension, and kidney or cardiovascular disease. Sleep duration in the 153 subjects was again self-reported, but corroborated by actigraphy (J Sleep Res. 2015 Jun;24[3]:328-38).

The new findings were driven mostly by higher daytime systolic BP among short sleepers in LIMBS, and higher systolic pressures during both day and night among short sleepers in PISA, compared with subjects who slept at least 7 hours, and a mean of 8.5 hours, with napping included in overall sleep duration assessment.

In LIMBS, the mean 24-hour systolic BP was 12.7 mm Hg higher and the average heart rate 8 bpm faster among short sleepers; in PISA, the mean 24-hour systolic BP was 4.7 mm Hg higher and the heart rate 2 bpm faster.

Every 2.57 minutes of sleep lost in LIMBS and every 1.99 minute of lost sleep in PISA was associated with a 1–mm Hg gain in mean systolic BP and about a 1-bpm increase in heart rate. The findings were statistically significant and adjusted for age, race, body mass index, nocturnal dipping status, and office systolic blood pressure.

Baseline characteristics were generally well matched between short and long sleepers in both studies. However, while mean office systolic BP in LIMBS was the same in both sleep groups at about 139 mm Hg, the mean office systolic BP among long sleepers in PISA was 130 mm Hg versus 136 mm Hg among short sleepers, a significant difference.

It’s unclear why some people slept less, Dr. Cohen said, and the use of sleeping pills wasn’t considered in the analysis. Patients were an average of about 50 years old, with a body mass index of about 30 mg/m². The same model of 24-hour blood pressure monitor was used in both studies.

The work was funded by the National Institutes of Health. The investigators had no disclosures.
 

Overdose death rates for individual drugs show no particular patterns since the turn of the century, but the exponential growth of overall drug mortality actually started before the opioid epidemic, according to an analysis of almost 600,000 unintentional overdose deaths since 1979.

“The current epidemic of overdose deaths due to prescription opioids, heroin, and fentanyl appears to be the most recent manifestation of a more fundamental, longer-term process,” senior author Donald S. Burke, MD, of the University of Pittsburgh, said in a written statement.

Overdose mortality from all types of drugs rose from 1.13 per 100,000 population in 1979 to 16.96 per 100,000 in 2016, based on data for 599,255 deaths from unintentional drug overdoses in the National Vital Statistics System, they reported in Science.

When the investigators plotted annual drug overdose mortality over that 38-year period, they saw a smooth upward exponential curve with a doubling time of about 9 years. “This remarkably smooth, long-term epidemic growth pattern really caught our attention,” Dr. Burke said. “If we can figure it out, we should be able to bend that curve downward.”

The individual drug types that make up the whole, however, are a different story. “There is no regular or predictable pattern to the overdose rates for any of these drugs. Cocaine overdose death rates curved down and up and down and back up over the past 20 years. Methadone deaths have been on a downturn since the mid-2000s. Prescription opioids have been on a fairly steady, steep climb. Heroin deaths shot up in 2010, followed in 2013 by synthetic opioids, such as fentanyl,” lead author Hawre Jalal, MD, PhD, also of the university, said in the statement.

Geographic and demographic analyses produced the same absence of patterns. “Indeed, these findings add to the paradox by revealing how disparate the individual drug epidemics are,” the researchers wrote.

The study was supported by grants from the Centers for Disease Control and Prevention and the Robert Wood Johnson Foundation. The investigators said they have no competing interests.
 

[email protected]

SOURCE: Jalal H et al. Science 2018 Sep 20. doi: 10.1126/science.aau1184.

Overdose death rates for individual drugs show no particular patterns since the turn of the century, but the exponential growth of overall drug mortality actually started before the opioid epidemic, according to an analysis of almost 600,000 unintentional overdose deaths since 1979.

“The current epidemic of overdose deaths due to prescription opioids, heroin, and fentanyl appears to be the most recent manifestation of a more fundamental, longer-term process,” senior author Donald S. Burke, MD, of the University of Pittsburgh, said in a written statement.

Overdose mortality from all types of drugs rose from 1.13 per 100,000 population in 1979 to 16.96 per 100,000 in 2016, based on data for 599,255 deaths from unintentional drug overdoses in the National Vital Statistics System, they reported in Science.

When the investigators plotted annual drug overdose mortality over that 38-year period, they saw a smooth upward exponential curve with a doubling time of about 9 years. “This remarkably smooth, long-term epidemic growth pattern really caught our attention,” Dr. Burke said. “If we can figure it out, we should be able to bend that curve downward.”

The individual drug types that make up the whole, however, are a different story. “There is no regular or predictable pattern to the overdose rates for any of these drugs. Cocaine overdose death rates curved down and up and down and back up over the past 20 years. Methadone deaths have been on a downturn since the mid-2000s. Prescription opioids have been on a fairly steady, steep climb. Heroin deaths shot up in 2010, followed in 2013 by synthetic opioids, such as fentanyl,” lead author Hawre Jalal, MD, PhD, also of the university, said in the statement.

Geographic and demographic analyses produced the same absence of patterns. “Indeed, these findings add to the paradox by revealing how disparate the individual drug epidemics are,” the researchers wrote.

The study was supported by grants from the Centers for Disease Control and Prevention and the Robert Wood Johnson Foundation. The investigators said they have no competing interests.
 

[email protected]

SOURCE: Jalal H et al. Science 2018 Sep 20. doi: 10.1126/science.aau1184.

Overdose death rates for individual drugs show no particular patterns since the turn of the century, but the exponential growth of overall drug mortality actually started before the opioid epidemic, according to an analysis of almost 600,000 unintentional overdose deaths since 1979.

“The current epidemic of overdose deaths due to prescription opioids, heroin, and fentanyl appears to be the most recent manifestation of a more fundamental, longer-term process,” senior author Donald S. Burke, MD, of the University of Pittsburgh, said in a written statement.

Overdose mortality from all types of drugs rose from 1.13 per 100,000 population in 1979 to 16.96 per 100,000 in 2016, based on data for 599,255 deaths from unintentional drug overdoses in the National Vital Statistics System, they reported in Science.

When the investigators plotted annual drug overdose mortality over that 38-year period, they saw a smooth upward exponential curve with a doubling time of about 9 years. “This remarkably smooth, long-term epidemic growth pattern really caught our attention,” Dr. Burke said. “If we can figure it out, we should be able to bend that curve downward.”

The individual drug types that make up the whole, however, are a different story. “There is no regular or predictable pattern to the overdose rates for any of these drugs. Cocaine overdose death rates curved down and up and down and back up over the past 20 years. Methadone deaths have been on a downturn since the mid-2000s. Prescription opioids have been on a fairly steady, steep climb. Heroin deaths shot up in 2010, followed in 2013 by synthetic opioids, such as fentanyl,” lead author Hawre Jalal, MD, PhD, also of the university, said in the statement.

Geographic and demographic analyses produced the same absence of patterns. “Indeed, these findings add to the paradox by revealing how disparate the individual drug epidemics are,” the researchers wrote.

The study was supported by grants from the Centers for Disease Control and Prevention and the Robert Wood Johnson Foundation. The investigators said they have no competing interests.
 

[email protected]

SOURCE: Jalal H et al. Science 2018 Sep 20. doi: 10.1126/science.aau1184.

Men who have sex with men (MSM) were younger at HIV diagnosis in 2016 than in 2008, but those living with the disease were older, according to the Centers for Disease Control and Prevention.

Among MSM aged 13-29 years, the number diagnosed with HIV increased by 2.9% per year from 2008 to 2016 but dropped 3.5% per year for those aged 30-49 and rose just 0.1% annually among those aged 50 and older. Over the period from 2008 to 2015, the number of MSM aged 50 and older who were living with HIV increased by 10.8% per year, compared with an annual percent change of 7.7% for those aged 13-29 and –0.4% for those aged 30-49, Andrew Mitsch, MPH, and his associates at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention reported in Morbidity and Mortality Weekly Report.

The size of the population of MSM living with HIV went from 384,000 in 2008 to 523,000 in 2016, with 13- to 29-year-olds going from 10.7% of the population to 13.3%, 30- to 49-year-olds dropping from 61% to 44%, and the 50-and-older group increasing from 28.3% to 42.7%, they said.

“The increase in annual diagnosis of HIV infections among younger MSM might reflect increased HIV testing, in addition to ongoing transmission,” they suggested, and increased prevalence among older men is probably the “result of increased survival associated with widespread use of antiretroviral therapy, surviving middle age, and advancing to the older group.”

The investigators also noted the persistence of racial/ethnic disparities over the course of the study. Among the three largest groups, whites had the smallest increase in new diagnoses for 13- to 29-year-olds and the largest decrease for 30- to 49-year-olds, and they were second to blacks in the less-than-or-equal-to-50-years-of-age group, according to data from the National HIV Surveillance System.

“Promotion of care and treatment by public health agencies and private sector partners to achieve viral suppression among MSM with diagnosed HIV infection will improve health outcomes and reduce transmission to others, particularly if prevention efforts are tailored to specific age groups,” the researchers wrote.

[email protected]

SOURCE: Mitsch A et al. MMWR 2018 Sep 21;67(37):1025-31.

Men who have sex with men (MSM) were younger at HIV diagnosis in 2016 than in 2008, but those living with the disease were older, according to the Centers for Disease Control and Prevention.

Among MSM aged 13-29 years, the number diagnosed with HIV increased by 2.9% per year from 2008 to 2016 but dropped 3.5% per year for those aged 30-49 and rose just 0.1% annually among those aged 50 and older. Over the period from 2008 to 2015, the number of MSM aged 50 and older who were living with HIV increased by 10.8% per year, compared with an annual percent change of 7.7% for those aged 13-29 and –0.4% for those aged 30-49, Andrew Mitsch, MPH, and his associates at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention reported in Morbidity and Mortality Weekly Report.

The size of the population of MSM living with HIV went from 384,000 in 2008 to 523,000 in 2016, with 13- to 29-year-olds going from 10.7% of the population to 13.3%, 30- to 49-year-olds dropping from 61% to 44%, and the 50-and-older group increasing from 28.3% to 42.7%, they said.

“The increase in annual diagnosis of HIV infections among younger MSM might reflect increased HIV testing, in addition to ongoing transmission,” they suggested, and increased prevalence among older men is probably the “result of increased survival associated with widespread use of antiretroviral therapy, surviving middle age, and advancing to the older group.”

The investigators also noted the persistence of racial/ethnic disparities over the course of the study. Among the three largest groups, whites had the smallest increase in new diagnoses for 13- to 29-year-olds and the largest decrease for 30- to 49-year-olds, and they were second to blacks in the less-than-or-equal-to-50-years-of-age group, according to data from the National HIV Surveillance System.

“Promotion of care and treatment by public health agencies and private sector partners to achieve viral suppression among MSM with diagnosed HIV infection will improve health outcomes and reduce transmission to others, particularly if prevention efforts are tailored to specific age groups,” the researchers wrote.

[email protected]

SOURCE: Mitsch A et al. MMWR 2018 Sep 21;67(37):1025-31.

Men who have sex with men (MSM) were younger at HIV diagnosis in 2016 than in 2008, but those living with the disease were older, according to the Centers for Disease Control and Prevention.

Among MSM aged 13-29 years, the number diagnosed with HIV increased by 2.9% per year from 2008 to 2016 but dropped 3.5% per year for those aged 30-49 and rose just 0.1% annually among those aged 50 and older. Over the period from 2008 to 2015, the number of MSM aged 50 and older who were living with HIV increased by 10.8% per year, compared with an annual percent change of 7.7% for those aged 13-29 and –0.4% for those aged 30-49, Andrew Mitsch, MPH, and his associates at the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention reported in Morbidity and Mortality Weekly Report.

The size of the population of MSM living with HIV went from 384,000 in 2008 to 523,000 in 2016, with 13- to 29-year-olds going from 10.7% of the population to 13.3%, 30- to 49-year-olds dropping from 61% to 44%, and the 50-and-older group increasing from 28.3% to 42.7%, they said.

“The increase in annual diagnosis of HIV infections among younger MSM might reflect increased HIV testing, in addition to ongoing transmission,” they suggested, and increased prevalence among older men is probably the “result of increased survival associated with widespread use of antiretroviral therapy, surviving middle age, and advancing to the older group.”

The investigators also noted the persistence of racial/ethnic disparities over the course of the study. Among the three largest groups, whites had the smallest increase in new diagnoses for 13- to 29-year-olds and the largest decrease for 30- to 49-year-olds, and they were second to blacks in the less-than-or-equal-to-50-years-of-age group, according to data from the National HIV Surveillance System.

“Promotion of care and treatment by public health agencies and private sector partners to achieve viral suppression among MSM with diagnosed HIV infection will improve health outcomes and reduce transmission to others, particularly if prevention efforts are tailored to specific age groups,” the researchers wrote.

[email protected]

SOURCE: Mitsch A et al. MMWR 2018 Sep 21;67(37):1025-31.

I have nothing to disclose.

That is the first line on my second slide in just about every talk I give. I have no financial conflicts of interest. I no longer accept meals from pharmaceutical companies, I no longer conduct pharmaceutical company sponsored research, and I no longer give talks that include honoraria from pharmaceutical companies. I turn down payments from pharmaceutical companies when I participate in drug-monitoring safety boards and advisory committees. I do not have a financial conflict of interest.

Or do I?

I almost gave up when they asked me to provide a Physician Taxonomy Code. It took me a long time to find it. For those interested, the code for Hematology is 207RH0000X. With that code entered in the right box, I was only two pages away from being registered and ready to open the dispute. Failure hit me like a lake effect snow storm. Despite my diligence, I was not “vetted” and could not file a dispute. I must have done something wrong and cannot seem to investigate the payment further, but I’m sure the New York Times could.

Now, I don’t know if I have anything to disclose or not. I do know that I have to investigate my payment the best I can, that I have to disclose it if it is real, and that I have to check Open Payments every so often to make sure I am not surprised by an investigative journalist’s report in the future. Add these to the pantheon of onerous requirements for a successful academic career.

Onerous or not, we have an obligation to disclose our financial ties to industry no matter how entangled we are. Many wear their entanglements as a badge of honor on slides highlighting a long list of conflicts. One speaker joked that she had so many conflicts that she had no conflicts. Clearly, much like alarm fatigue, the constant display of financial conflict of interest disclosures rarely raises red flags in an audience of peers. To an audience of interested lay persons, though, those conflicts may be very important and relevant.

It is our duty to accurately account for and report them no matter the difficulty in doing so. Failure to do so can carry tragic consequences.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

I have nothing to disclose.

That is the first line on my second slide in just about every talk I give. I have no financial conflicts of interest. I no longer accept meals from pharmaceutical companies, I no longer conduct pharmaceutical company sponsored research, and I no longer give talks that include honoraria from pharmaceutical companies. I turn down payments from pharmaceutical companies when I participate in drug-monitoring safety boards and advisory committees. I do not have a financial conflict of interest.

Or do I?

I almost gave up when they asked me to provide a Physician Taxonomy Code. It took me a long time to find it. For those interested, the code for Hematology is 207RH0000X. With that code entered in the right box, I was only two pages away from being registered and ready to open the dispute. Failure hit me like a lake effect snow storm. Despite my diligence, I was not “vetted” and could not file a dispute. I must have done something wrong and cannot seem to investigate the payment further, but I’m sure the New York Times could.

Now, I don’t know if I have anything to disclose or not. I do know that I have to investigate my payment the best I can, that I have to disclose it if it is real, and that I have to check Open Payments every so often to make sure I am not surprised by an investigative journalist’s report in the future. Add these to the pantheon of onerous requirements for a successful academic career.

Onerous or not, we have an obligation to disclose our financial ties to industry no matter how entangled we are. Many wear their entanglements as a badge of honor on slides highlighting a long list of conflicts. One speaker joked that she had so many conflicts that she had no conflicts. Clearly, much like alarm fatigue, the constant display of financial conflict of interest disclosures rarely raises red flags in an audience of peers. To an audience of interested lay persons, though, those conflicts may be very important and relevant.

It is our duty to accurately account for and report them no matter the difficulty in doing so. Failure to do so can carry tragic consequences.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

I have nothing to disclose.

That is the first line on my second slide in just about every talk I give. I have no financial conflicts of interest. I no longer accept meals from pharmaceutical companies, I no longer conduct pharmaceutical company sponsored research, and I no longer give talks that include honoraria from pharmaceutical companies. I turn down payments from pharmaceutical companies when I participate in drug-monitoring safety boards and advisory committees. I do not have a financial conflict of interest.

Or do I?

I almost gave up when they asked me to provide a Physician Taxonomy Code. It took me a long time to find it. For those interested, the code for Hematology is 207RH0000X. With that code entered in the right box, I was only two pages away from being registered and ready to open the dispute. Failure hit me like a lake effect snow storm. Despite my diligence, I was not “vetted” and could not file a dispute. I must have done something wrong and cannot seem to investigate the payment further, but I’m sure the New York Times could.

Now, I don’t know if I have anything to disclose or not. I do know that I have to investigate my payment the best I can, that I have to disclose it if it is real, and that I have to check Open Payments every so often to make sure I am not surprised by an investigative journalist’s report in the future. Add these to the pantheon of onerous requirements for a successful academic career.

Onerous or not, we have an obligation to disclose our financial ties to industry no matter how entangled we are. Many wear their entanglements as a badge of honor on slides highlighting a long list of conflicts. One speaker joked that she had so many conflicts that she had no conflicts. Clearly, much like alarm fatigue, the constant display of financial conflict of interest disclosures rarely raises red flags in an audience of peers. To an audience of interested lay persons, though, those conflicts may be very important and relevant.

It is our duty to accurately account for and report them no matter the difficulty in doing so. Failure to do so can carry tragic consequences.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].