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Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using electronic health records, we sequentially monitored a real-world population of adults aged ≥50 years who received care in multiple US Vaccine Safety Datalink health systems to identify potentially increased risks of 10 prespecified health outcomes, including stroke, anaphylaxis, and Guillain-Barré syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative to either historical (2013–2017) recipients of zoster vaccine live, a live attenuated virus vaccine (Zostavax; Merck & Co. Inc. Kenilworth, New Jersey), or contemporary non-RZV vaccine recipients who had an annual well-person visit during the 2018–2019 study period. We confirmed prelicensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed. [ABSTRACT FROM AUTHOR]

A study was conducted to determine a new model's effectiveness, which uses patient Web services, home blood pressure (BP) monitoring and pharmacist-assisted care in improving BP control. Findings conclude with the note that pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension.

Abstract Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836

Abstract Background Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. Methods/Design A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. Conclusions This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT00447668.

Abstract Background Chronic back pain is a major public health problem and the primary reason patients seek massage treatment. Despite the growing use of massage for chronic low back pain, there have been few studies of its effectiveness. This trial will be the first evaluation of the effectiveness of relaxation massage for chronic back pain and the first large trial of a focused structural form of massage for this condition. Methods and Design A total of 399 participants (133 in each of three arms) between the ages of 20 and 65 years of age who have low back pain lasting at least 3 months will be recruited from an integrated health care delivery system. They will be randomized to one of two types of massage ("focused structural massage" or "relaxation massage"), or continued usual medical care. Ten massage treatments will be provided over 10 weeks. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline and after 10, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, perceived stress, and use and costs of healthcare services for back pain will also be measured. Outcomes across assigned treatment groups will be compared using generalized estimating equations, accounting for participant correlation and adjusted for baseline value, age, and sex. For both primary outcome measures, this trial will have at least 85% power to detect the presence of a minimal clinically significant difference among the three treatment groups and 91% power for pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount. Conclusion Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain. Trial registration Clinical Trials.gov NCT 00371384.

We consider the critical problem of pharmacosurveillance for adverse events once a drug or medical product is incorporated into routine clinical care. When making inference on comparative safety using large‐scale electronic health records, we often encounter an extremely rare binary adverse outcome with a large number of potential confounders. In this context, it is challenging to offer flexible methods to adjust for high‐dimensional confounders, whereas use of the propensity score (PS) can help address this challenge by providing both confounding control and dimension reduction. Among PS methods, regression adjustment using the PS as a covariate in an outcome model has been incompletely studied and potentially misused. Previous studies have suggested that simple linear adjustment may not provide sufficient control of confounding. Moreover, no formal representation of the statistical procedure and associated inference has been detailed. In this paper, we characterize a three‐step procedure, which performs flexible regression adjustment of the estimated PS followed by standardization to estimate the causal effect in a select population. We also propose a simple variance estimation method for performing inference. Through a realistic simulation mimicking data from the Food and Drugs Administration's Sentinel Initiative comparing the effect of angiotensin‐converting enzyme inhibitors and beta blockers on incidence of angioedema, we show that flexible regression on the PS resulted in less bias without loss of efficiency, and can outperform other methods when the PS model is correctly specified. In addition, the direct variance estimation method is a computationally fast and reliable approach for inference. [ABSTRACT FROM AUTHOR]

Brooks Brown, the author of No Easy Answers: The Truth Behind Death at Columbine High School, spoke at the 11th annual Reclaiming Youth International No Disposable Kids conference at Rushmore Plaza Holiday Inn. Brown, who worked with Michael Moore on his Academy Award winning documentary, "Bowling for Columbine," said the letters he received from children and adults after the Columbine shootings prompted him to become involved in trying to make a difference in the lives of kids. Brown was a senior at Columbine High School on April 20, 1999, when his classmates Dylan Klebold and Eric Harris entered the school and killed 12 students and a teacher. They wounded 21 others before they killed themselves. Junior high and high school were the worst years for anyone who wasn't "just right," Brown said, relating how he was bullied in junior high. The bullying increased in high school for Brown when he became involved in drama and debate. After the Columbine killings, Brown said he received letters from kids and adults all over the country who said, "I went through it." He decided to make a difference--that and because of Rachel Scott, one of the students who died at Columbine, he said. "She was a very compassionate person," he said. "One of the things she taught me is that every day should be a good day to die." The learning experiences I suffered through taught me more about life than anything," Brown said. "I wouldn't go back and change it because it gives me the opportunity to go out and be someone who changes things."