Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting.

BACKGROUND AND OBJECTIVES: Treatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient-centered approach. To better support patient autonomy in the decision-making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended-release naltrexone (XR-NTX). METHODS: The posthoc analysis included adults with OUD currently receiving BUP (≤8 mg/day) and seeking transition to XR-NTX (N = 101) in a residential setting. Baseline participant characteristics and OUD treatment history were reviewed. All patients completed a screening questionnaire that asked about their reasons for seeking transition to XR-NTX and for choosing BUP. RESULTS: The most common reasons for initiating a transition to XR-NTX were "Seeking to be opioid-free" (63.4%) and "Tired of daily pill taking" (25.7%). Positive predictors of transition included a more extensive BUP treatment history and a history of prescription opioid abuse. Most participants stated they were not aware of XR-NTX as a treatment option when initiating BUP (78.2%). DISCUSSIONS AND CONCLUSIONS: Patients' reasons for seeking XR-NTX transition, more extensive BUP treatment history, and a history of prescription opioid abuse, may positively predict outcomes. SCIENTIFIC SIGNIFICANCE: These findings may assist clinicians in optimizing outcomes of the BUP to XR-NTX transition and supporting patients to make better informed MOUD decisions.

Handwriting Kinematics in Patients with Schizophrenia Treated with Long-Acting Injectable Atypical Antipsychotics: Results From the ALPINE Study.

Handwriting kinematics (HWKs) were assessed in the randomized controlled ALPINE study of 2 long-acting injectable antipsychotics started during an acute exacerbation of schizophrenia. This exploratory analysis examined the relationship between baseline HWKs and response to acute antipsychotic treatment. Adults with acute schizophrenia were assigned to aripiprazole lauroxil or paliperidone palmitate (groups combined for this analysis). Treatment response was defined as ≥20% reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total score at week 4. Two HWK measures, peak velocity (decreases with greater dysfunction) and percentage of nonballistic movements (%NBM; increases with greater dysfunction), were captured in 4 handwriting tasks (complex loops, maximum speed circles, overlay circles, and left-right loops). Peak velocity and %NBM at baseline were compared between responders and nonresponders. The analysis included 143 patients (mean baseline PANSS total score, 94.5). PANSS responders (n = 67 [46.9%]) had a lower mean peak velocity (i.e., slower pen movements) on all HWK tasks at baseline compared with nonresponders (n = 76): complex loops, 8.8 versus 12.1 cm/s; maximum speed circles, 18.0 versus 23.7 cm/s; overlay circles, 12.6 versus 17.2 cm/s; and left-right loops, 11.2 versus 14.6 cm/s. PANSS responders had a greater %NBM on 3 tasks compared with nonresponders: complex loops, 57.1% versus 47.4%; overlay circles, 30.6% versus 24.3%; and left-right loops, 58.7% versus 47.0%. In this exploratory analysis, PANSS responders to aripiprazole lauroxil or paliperidone palmitate treatment at week 4 had lower baseline HWK movement velocities and greater baseline %NBM versus nonresponders, suggesting that baseline HWKs might predict response to these antipsychotic drugs.

Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone.

BACKGROUND: Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience. OBJECTIVES: To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine. METHODS: We performed a post hoc, cross-study comparison of the temporal pattern of opioid withdrawal during 1-week induction onto extended-release naltrexone by similar protocols enrolling two participant populations: participants with OUD entering a study with untreated opioid use (N = 378, NCT02537574) or on stable buprenorphine (BUP) treatment (N = 101, NCT02696434). RESULTS: The temporal pattern of withdrawal from induction day 1 through day 7 differed between the two participant populations for Clinical Opiate Withdrawal Score (COWS) and Subjective Opiate Withdrawal Score (SOWS): participants with untreated OUD prior to study entry were more likely to experience an earlier relative peak in opioid withdrawal followed by a gradual decline, whereas participants on stable BUP treatment prior to study entry were more likely to experience a relatively later, though still mild, peak opioid withdrawal. The peak COWS was reached at a mean (standard deviation) of 1.9 (1.5) days for participants with untreated OUD and 5.0 (1.5) days for participants on stable BUP. Daily peak cravings were generally higher for participants with untreated OUD than participants on stable BUP. CONCLUSION: Awareness of population-specific variations in the patient experience of opioid withdrawal may help clinicians anticipate the expected course of withdrawal.

Evaluating more naturalistic outcome measures: A 1-year smartphone study in multiple sclerosis.

OBJECTIVE: In this cohort of individuals with and without multiple sclerosis (MS), we illustrate some of the novel approaches that smartphones provide to monitor patients with chronic neurologic disorders in their natural setting. METHODS: Thirty-eight participant pairs (MS and cohabitant) aged 18-55 years participated in the study. Each participant received an Android HTC Sensation 4G smartphone containing a custom application suite of 19 tests capturing participant performance and patient-reported outcomes (PROs). Over 1 year, participants were prompted daily to complete one assigned test. RESULTS: A total of 22 patients with MS and 17 cohabitants completed the entire study. Among patients with MS, low scores on PROs relating to mental and visual function were associated with dropout (p < 0.05). We illustrate several novel features of a smartphone platform. First, fluctuations in MS outcomes (e.g., fatigue) were assessed against an individual's ambient environment by linking responses to meteorological data. Second, both response accuracy and speed for the Ishihara color vision test were captured, highlighting the benefits of both active and passive data collection. Third, a new trait, a person-specific learning curve in neuropsychological testing, was identified using spline analysis. Finally, averaging repeated measures over the study yielded the most robust correlation matrix of the different outcome measures. CONCLUSIONS: We report the feasibility of, and barriers to, deploying a smartphone platform to gather useful passive and active performance data at high frequency in an unstructured manner in the field. A smartphone platform may therefore enable large-scale naturalistic studies of patients with MS or other neurologic diseases.

A randomized, double-blind, placebo-controlled, twelve-week, dose-ranging study of decernotinib, an oral selective JAK-3 inhibitor, as monotherapy in patients with active rheumatoid arthritis.

OBJECTIVE: To assess the efficacy and safety of oral decernotinib (VX-509; Vertex Pharmaceuticals) monotherapy in a 12-week, randomized, double-blind, placebo-controlled, dose-ranging study of patients with rheumatoid arthritis (RA). METHODS: Two hundred four adults with active RA who had been unsuccessfully treated with ≥1 disease-modifying antirheumatic drug were administered placebo tablets or decernotinib twice a day at dosages of 25 mg, 50 mg, 100 mg, or 150 mg. Primary measures of efficacy at week 12 were the response rate according to the American College of Rheumatology 20% improvement criteria (ACR20) and mean change from baseline in the Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP). RESULTS: At week 12, the ACR20 response rates were 39.0%, 61.0%, 65.0%, and 65.9% in the 25-mg, 50-mg, 100-mg, and 150-mg groups, respectively, and were significantly higher in the 50-mg group (P = 0.007) and the 100-mg and 150-mg groups (P = 0.002) as compared to the response rates in the placebo group (29.3%). The mean change from baseline in DAS28-CRP was greater in the 50-mg, 100-mg, and 150-mg groups as compared to the placebo group (P < 0.001). Decernotinib treatment resulted in higher ACR50 and ACR70 response rates, more patients with DAS28-CRP scores <2.6, and improvements in the Health Assessment Questionnaire disability index as compared to placebo. The most common adverse events in any decernotinib group were nausea (6.1%), headache (4.3%), an increase in levels of alanine aminotransferase (4.3%), and hypercholesterolemia (3.7%). In the groups receiving decernotinib, there was an increased risk of infections and increased liver transaminase levels. CONCLUSION: Decernotinib was efficacious in improving clinical signs and symptoms of RA at week 12 at dosages of 50-150 mg twice a day. Infections and increases in liver transaminase and lipid levels were noted as potential safety signals.

Willingness to participate in clinical trials among African Americans and whites previously exposed to clinical research.

The objective of this study was to identify racial differences in willingness to participate in a population with previous exposure to clinical research. A survey instrument was administered to community-dwelling whites and African Americans who were voluntarily receiving a lay research and health education newsletter from a local Boston geriatric clinical research institution. The survey instrument assessed willingness to participate in 3 hypothetical clinical trials (diet trial for obesity, medication trial for hypertension [HTN], chemotherapy trial for cancer). Surveys were received from 473 whites and 279 African Americans (53% response rate) with mean age 74 (SD +/- 9). In multivariate models, race was not significantly related to willingness to participate in the multivariate models for any of the 3 trials. Previous trial participation was related to a higher odds of willingness to participate in the diet trial only (OR 1.8, 95% CI 1.2, 2.6). Lower levels of trust in one's primary care physician were associated with a lower odds of willingness to participate in clinical trials for the diet and HTN trials (OR 0.5, 95% CI 0.3, 0.8 and OR 0.6, 95% CI 0.3, 0.9, respectively). These findings suggest that, within populations previously exposed to clinical research, African Americans are no less willing to participate in clinical trials compared to whites.

Different types of distrust in clinical research among whites and African Americans.

BACKGROUND: African Americans are thought to be more distrustful of clinical research compared to elderly whites, but it is unknown whether specific types of distrust in clinical research, such as interpersonal or societal distrust, vary according to race. The primary objective was to identify racial differences in interpersonal or societal distrust in clinical research among African Americans and whites. METHODS: Seven hundred seventy-six older African Americans and whites were surveyed about their interpersonal and societal distrust using a 7-item index of distrust in clinical research. We combined the 2 societal distrust items into a societal distrust subscale. We also assessed trust in primary care physicians, access to care, health/functional status, previous exposure to clinical research, awareness of the Tuskegee Syphilis Study, perceived discrimination in health care, and sociodemographic characteristics. RESULTS: High societal distrust was more common among African Americans compared to whites (21% vs 7% in the top quartile of the societal distrust, p < .0001), but there were no racial differences in responses to the individual interpersonal distrust index items. In sequentially built multivariable analyses, the relationship between African American race and societal distrust (odds ratio, 2.2; 95% CI, 1.2-3.7) was not completely explained by other factors such as trust in one's physician, previous discrimination, or awareness of the Tuskegee Syphilis Study. CONCLUSIONS: Racial differences according to the type of distrust in clinical research may warrant assessing specific types of distrust separately among racially diverse populations in future studies.

Perceived benefit of Complementary and Alternative Medicine (CAM) for back pain: a national survey.

BACKGROUND: Complementary and alternative medicine (CAM) is commonly used to treat back pain, but little is known about factors associated with improvement. METHODS: We used data from the 2002 National Health Interview Survey to examine the associations between the perceived helpfulness of various CAM therapies for back pain. RESULTS: Approximately 6% of the US population used CAM to treat their back pain in 2002. Sixty percent of respondents who used CAM for back pain perceived a "great deal" of benefit. Using multivariable logistic regression, the factor associated with perceived benefit from CAM modalities was reporting that a reason for using CAM was that "conventional medical treatment would not help" (odds ratio [OR], 1.46; 95% CI, 1.14-1.86). The 2 factors associated with less perceived benefit from CAM modalities were fair to poor self-reported health status (OR, 0.58; 95% CI, 0.41-0.82) and referral by a conventional medical practitioner for CAM (OR, 0.7; 95% CI, 0.54-0.92). Using chiropractic as a reference, massage (OR, 0.62; 95% CI, 0.46-0.83), relaxation techniques (OR, 0.25; 95% CI, 0.14-0.45), and herbal therapy (OR, 0.3; 95% CI, 0.19-0.46) were all associated with less perceived benefit whereas those with similar perceived benefit included yoga/tai chi/qi gong (OR, 0.71; 95% CI, 0.41-1.22) and acupuncture (OR, 0.71; 95% CI, 0.37-1.38). CONCLUSIONS: The majority of respondents who used CAM for back pain perceived benefit. Specific factors and therapies associated with perceived benefit warrant further investigation.

Injury thresholds after motor vehicle crash--important factors for patient triage and vehicle design.

INTRODUCTION: The Committee on Trauma recommends that older motor vehicle crash (MVC) victims or victims of crashes with significant vehicle intrusion of more than 12 in. be transferred to a trauma center since those older than 55 have an increased risk of death after injury. Yet, the precise injury thresholds as they relate to age, gender and velocity remain ill-defined. To maintain a low rate of under triage, reliable methods to identify patients at moderate injury risk are needed. We therefore characterized the likelihood of moderate to severe injury in MVC victims to determine the influence of age, gender and velocity. METHODS: An analysis of drivers from the National Automotive Sampling System (1993-2001) was performed. Weighted logistic regression models were developed to predict the probability of head, leg, and torso injuries as a function of vehicle speed, age, and gender while controlling for confounders. A 10% probability of injury threshold was set and differences in velocity, gender and age were identified in terms of reaching this probability of injury threshold. RESULTS: The analysis yielded 56,459 drivers which is equivalent to a population of 28,877,696 drivers nationwide. Restraint use, steering away prior to impact, breaking maneuver, gender, delta velocity, driver height and age were independent predictors of injury. Women had a higher velocity injury threshold than men for the 10% probability of injury cut-off to the torso or head which disappeared with increasing age. Conversely, men had a higher velocity injury threshold than women for the 10% probability of injury cut-off to the extremity which persisted even in older victims. CONCLUSIONS: Our data indicate that age and gender must be considered in addition to crash velocity when making triage decisions. Furthermore, Federal Motor Vehicle Safety Standards may need to be modified to address the increased risk of injury among older adults at lower velocities given the increasing number of elderly drivers in the US.

Acculturation and cardiovascular risk factor control among Hispanic adults in the United States.

OBJECTIVES: We sought to determine whether low acculturation, based on language measures, leads to disparities in cardiovascular risk factor control in U.S. Hispanic adults. METHODS: We studied 4729 Hispanic adults aged 18 to 85 years from the National Health and Nutrition Examination Survey, 1999-2004. We examined the association between acculturation and control of low-density lipoprotein (LDL) cholesterol, blood pressure, and hemoglobin A1c based on national guidelines among participants with hypercholesterolemia, hypertension, and diabetes, respectively. We used weighted logistic regression adjusting for age, gender, and education. We then examined health insurance, having a usual source of care, body mass index, fat intake, and leisure-time physical activity as potential mediators. RESULTS: Among participants with hypercholesterolemia, Hispanic adults with low acculturation were significantly more likely to have poorly controlled LDL cholesterol than Hispanic adults with high acculturation after multivariable adjustment (odds ratio [OR] = 3.4, 95% confidence interval [CI] 1.2, 9.5). Insurance status mildly attenuated the difference in LDL cholesterol control. After adjusting for diet and physical activity, the magnitude of the association increased. Other covariates had little influence on the observed relationship. Among those with diabetes and hypertension, we did not observe statistically significant associations between low acculturation and control of hemoglobin A1c (OR = 0.5, 95% CI 0.2, 1.2), and blood pressure (OR = 1.1, 95% CI 0.6, 1.7), respectively. CONCLUSIONS: Low levels of acculturation may be associated with increased risk of inadequate LDL cholesterol control among Hispanic adults with hypercholesterolemia. Further studies should examine the mechanisms by which low acculturation might adversely impact lipid control among Hispanic adults in the U.S.

The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill.

OBJECTIVES: To explore to what extent psychological factors such as expectation, depression, anxiety and belief in alternative medicine impact placebo response and differential responses to separate placebo interventions. METHODS: We analysed data from a randomized controlled trial designed to compare the clinical response of two distinct placebo treatments (sham acupuncture device and placebo pill) in 119 participants with persistent distal upper arm pain due to repetitive stress injury. We used a multivariable linear regression model to identify potential correlates of self-reported upper extremity pain at the end of treatment in both placebo arms of the study combined. We also performed stratified analyses by placebo treatment. RESULTS: We did not find any of the psychological factors of interest to be associated with pain at the end of treatment in our combined analysis. We found higher baseline pain score and pain for longer than 1 year's duration to be significantly associated with higher pain scores at the end of treatment for the placebo treatments combined. In stratified analyses, for the sham acupuncture group, we found higher baseline depression score, higher baseline pain score and younger age to be independently correlated with higher pain score at the end of treatment. For the placebo pill group, only baseline pain was significantly correlated to pain score at the end of treatment. CONCLUSION: In this trial, neither expectancy nor psychological states were associated with response to placebo, with the exception of baseline depression score for the sham acupuncture arm.

An overview of practical approaches for handling missing data in clinical trials.

For a variety of reasons including poorly designed case report forms (CRFs), incomplete or invalid CRF data entries, and premature treatment or study discontinuations, missing data is a common phenomenon in controlled clinical trials. With the widely accepted use of the intent-to-treat (ITT) analysis dataset as the primary analysis dataset for the analysis of controlled clinical trial data, the presence of missing data could lead to complicated data analysis strategies and subsequently to controversy in the interpretation of trial results. In this article, we review the mechanisms of missing data and some common approaches to analyzing missing data with an emphasis on study dropouts. We discuss the importance of understanding the reasons for study dropouts with ways to assess the mechanisms of missingness. Finally, we discuss the results of a comparative Monte Carlo investigation of the performance characteristics of commonly utilized statistical methods for the analysis of clinical trial data with dropouts. The methods investigated include the mixed effects model for repeated measurements (MMRM), weighted and unweighted generalized estimating equations (GEE) method for the available case data, multiple-imputation-based GEE (MI-GEE), complete case (CC) analysis of covariance (ANCOVA), and last observation carried forward (LOCF) ANCOVA. Simulation experiments for the repeated measures model with missing at random (MAR) dropout, under varying dropout rates and intrasubject correlation, show that the LOCF, ANCOVA, and weighted GEE methods perform poorly in terms of percent relative bias for estimating a difference in means effect, while the MI-GEE and weighted GEE methods both have less power for rejecting a zero difference in means hypothesis.

Association between language and risk factor levels among Hispanic adults with hypertension, hypercholesterolemia, or diabetes.

BACKGROUND: The association of acculturation and cardiovascular risk factor control among populations with high proportions of immigrants has not been well studied. METHODS: We studied 1,492 Hispanic participants in the Multi-Ethnic Study of Atherosclerosis (MESA) with hypertension, hypercholesterolemia, and/or diabetes. We used linear regression to examine the cross-sectional relationships between acculturation measures and cardiovascular risk factor levels. Outcome measures included systolic blood pressure (mm Hg), fasting low-density lipoprotein (LDL) cholesterol (mg/dL), and fasting blood glucose (mg/dL). Covariates included education, income, health insurance, physical activity, dietary factors, risk factor-specific medication use, duration of medication use, smoking, and body mass index. RESULTS: There were 580 Hispanics with hypertension, 539 with hypercholesterolemia, and 248 with diabetes. After adjustment for age and gender, Spanish-speaking Hispanics with cardiovascular risk factors had higher systolic blood pressure, fasting LDL cholesterol, and fasting blood glucose compared to English-speaking Hispanics. Differences in systolic blood pressure were accounted for mainly by education, whereas differences in LDL cholesterol were almost entirely accounted for by cholesterol-lowering medication use. Differences in fasting glucose were partly accounted for by socioeconomic variables but were augmented after adjustment for dietary factors. Similar associations were observed between proportion of life in the United States and risk factor levels. CONCLUSIONS: Among those with cardiovascular risk factors, Hispanics who spoke Spanish at home and lived less time in the United States had worse control of cardiovascular risk factors. Treatment strategies that focus on Hispanics with low levels of acculturation may improve cardiovascular risk factor control.

Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: results of a randomized sham-controlled trial.

STUDY OBJECTIVE: To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis. DESIGN: Randomized, sham-controlled trial. SETTINGS: Tertiary-referral hospital. PARTICIPANTS: Eighteen young women (13-22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain. INTERVENTIONS: A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks. MAIN OUTCOME MEASURES: Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation. RESULTS: Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points (P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported. CONCLUSION: Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.

Primary care for low-income populations: comparing health care delivery systems.

Amidst recent policy discussions about the health care safety net there has been relatively little information about whether the actual site of care affects care quality. We therefore used National Health Interview Survey data to describe low-income adults seeking primary care at different types of sites and the quality of access and preventive care at these sites. After adjusting for sociodemographic characteristics and illness burden, hospital-outpatient- department patients were more likely to receive vaccinations for influenza (adjusted odds ratio [AOR] 1.3, 95% confidence interval [CI] 1.0-1.6) and pneumococcus (AOR 1.4, 95% CI 1.1-1.8) than were those at clinics or health centers. Hospital-clinic patients were more likely to report delays in care due to office administrative difficulties (AOR 1.3, 95% CI 1.1-1.7) and more likely to have more than one emergency room visit (AOR 1.9, 95% CI 1.5-2.3). Physicians' office or HMO patients were less likely to report administrative delays in care than those at clinics or health centers, but there were no other differences in quality between these two site types. Policymakers and health care services analysts and providers must monitor quality as they decide how best to deliver care to vulnerable populations.

Joint replacement surgery in elderly patients with severe osteoarthritis of the hip or knee: decision making, postoperative recovery, and clinical outcomes.

BACKGROUND: Osteoarthritis (OA) of the hip and knee is a common cause of pain and disability in elderly patients. Joint replacement surgery can alleviate pain and restore function but is associated with risks and discomfort. METHODS: We conducted a prospective cohort study to examine decision making and clinical outcomes for elderly patients (age >or=65 years) with severe OA of the hip or knee with symptoms inadequately controlled with conservative treatments. Osteoarthritis symptoms and functional status were assessed at baseline and at 12 months. Postoperative symptoms and function were assessed 6 weeks, 6 months, and 12 months after surgery. RESULTS: For the 174 patients studied (mean age, 75 years; 76% were female, 17% were nonwhite, 69% had knee OA, and 31% had hip OA), the mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score was 56 on a 100-point scale. During a 12-month follow-up, 29% had joint replacement surgery. Of patients who had surgery, no patients died, 17% had postoperative complications, and 38% had postoperative pain lasting more than 4 weeks. The median time to recovery of independence in walking was 12 days and to ability to perform household chores was 49 days, with similar times for patients 65 to 74 years old and those 75 years or older. At 12 months, WOMAC scores improved by 24 points in the patients who had surgery and 0.5 point in the patients who did not have surgery (P < .001); improvements were 19 and 0.3 points in patients 75 or older (P < .001). Among patients who did not have surgery, 45% reported that surgery was not offered as a potential treatment option. CONCLUSIONS: Elderly patients who had hip or knee replacements for severe OA took several weeks to recover but experienced excellent long-term outcomes. Physicians often do not discuss joint replacement surgery with elderly patients who might benefit.

Characteristics of yoga users: results of a national survey.

BACKGROUND: There are limited data on the characteristics of yoga users in the U.S. OBJECTIVE: To characterize yoga users, medical reasons for use, perceptions of helpfulness, and disclosure of use to medical professionals. METHODS: Utilizing cross-sectional survey data from the 2002 National Health Interview Survey (NHIS) Alternative Medicine Supplement (n = 31044), we examined correlates of yoga use for health. The estimated prevalence from 2002 NHIS of yoga for health was 5.1% corresponding to over 10 million adults. RESULTS: In 2002, yoga users were predominately Caucasian (85%) and female (76%) with a mean age of 39.5 years. Compared to non-yoga users, yoga users were more likely female (OR 3.76, 95% CI 3.11-4.33); less likely black than white (OR 0.65, 95% CI 0.53-0.80); tended to be younger; and more likely college educated (OR 2.70, 95% CI 2.37-3.08). Musculoskeletal conditions (OR 1.61, 95% CI 1.42-1.83), mental health conditions (OR 1.43, 95% CI 1.22-1.67), severe sprains in the last 12 months (OR 1.49, 95% CI 1.22-1.81), and asthma (OR 1.27, 95% CI 1.05-1.54) were independently associated with higher yoga use, while hypertension (OR 0.78, 95% CI 0.64-0.95) and chronic obstructive lung disease (OR 0.69, 95% CI 0.48-1.00) were associated with lower use. Yoga was most commonly used to treat musculoskeletal or mental health conditions, and most users reported yoga to be helpful for these conditions. A majority of yoga users (61%) felt yoga was important in maintaining health, though only 25% disclosed yoga practice to their medical professional. CONCLUSIONS: We found that yoga users are more likely to be white, female, young and college educated. Yoga users report benefit for musculoskeletal conditions and mental health, indicating that further research on the efficacy of yoga for the treatment and/or prevention of these conditions is warranted.

Dietary supplements: inpatient policies in US children's hospitals.

BACKGROUND: Variations in hospital policies and practices regarding the use of vitamins, minerals, herbs, and other dietary supplements could compromise patient safety and quality of care. We undertook this study to describe pediatric hospital policies regarding dietary supplements. METHODS: We administered a cross-sectional survey of a sample of National Association of Children Hospitals and Related Institutions members. Pharmacy personnel were asked about the following: written policies addressing dietary supplements; how such policies are made; and responsibilities for storage, administration, documentation, and checking for potential interactions. We created a 10-point hospital policy and practices quality score to assess the quality of each policy. RESULTS: Of the 186 eligible National Association of Children Hospitals and Related Institutions hospitals, 109 responded (59%). Forty-four percent reported having written policies on vitamins and minerals, herbs, and other dietary supplements. Few hospitals had herbs (2%) or other dietary supplements (38%) on formulary. However, most (81%) allowed patients to use their home supply of dietary supplements under defined circumstances, and 64% allowed staff to make recommendations about dietary supplement use. In 70% of hospitals, nurses stored and administered the home supply of dietary supplements. Less than half (46%) required documentation of a check for drug or dietary supplements interactions. One third (32%) had surgical preoperative recommendations regarding dietary supplements. Only 11% of 109 hospitals satisfied the 10 criteria necessary for a perfect hospital policy and practices quality score indicative of quality practices regarding patient use of dietary supplements. CONCLUSION: Even among those hospitals that have written policies about dietary supplements, there is a wide range in policy quality, which may compromise the safety of patients.

Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.

OBJECTIVE: To compare true and sham acupuncture in their abilities to relieve arm pain and improve arm function in individuals with arm pain due to repetitive use. METHODS: Participants with persistent arm pain (N=123) were randomly assigned to true or sham acupuncture groups and received 8 treatments over 4 weeks. The primary outcome was intensity of pain (10-point scale) and secondary outcomes were arm symptoms, arm function, and grip strength. Outcomes were measured during treatment (at 2 and 4 wk) and 1 month after treatment ended. RESULTS: Arm pain scores improved in both groups during the treatment period, but improvements were significantly greater in the sham group than in the true acupuncture group. This difference disappeared by 1 month after treatment ended. The true acupuncture group experienced more side effects, predominantly mild pain at time of treatments. DISCUSSION: Sham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use.

Patient expectations as predictors of outcome in patients with acute low back pain.

BACKGROUND: Few studies have evaluated the association between patient expectations for recovery and clinical outcomes, and no study has evaluated whether asking patients to choose their therapy modifies such an association. OBJECTIVE: To evaluate the association between patients' expectations and functional recovery in patients with acute low back pain (LBP), and to determine whether that association is affected by giving patients choice of therapy. DESIGN AND PARTICIPANTS: A secondary analysis of a randomized controlled trial comparing usual care alone to usual care plus choice of chiropractic, acupuncture, or massage in 444 adults with acute LBP, lasting less than 21 days. MEASUREMENTS AND MAIN RESULTS: Primary outcome was functional disability (Roland score) at 5 and 12 weeks. Patients' general expectations for improvement were associated with improvement in functional status (beta = 0.96, 95% CI = 0.56, 1.36). A 1-point increase in general expectations was associated with a 0.96-point improvement in Roland score. The association of expectation with outcome was 2-3 times greater in the usual care group than the choice group. However, these differences did not reach statistical significance. CONCLUSIONS: In patients with acute LBP, higher expectations for recovery are associated with greater functional improvement. Eliciting patient expectations for improvement may be a simple way to identify patients with the highest (or lowest) likelihood of experiencing functional improvement. Incorporating questions about patient expectations in future trials may clarify the role of this important correlate of clinical outcomes.