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Importance: Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.Objective: To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.Design, Setting, and Participants: Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113).Interventions: CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.Main Outcomes and Measures: Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.Results: There were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.Conclusions and Relevance: Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.Trial Registration: clinicaltrials.gov Identifier: NCT01467843. [ABSTRACT FROM AUTHOR]

Background Context: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments.Purpose: The aim was to determine the optimal dose of massage for neck pain.Study Design/setting: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage.Patient Sample: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included.Outcome Measures: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline.Methods: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs.Results: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups.Conclusions: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain. [ABSTRACT FROM AUTHOR]

Objectives. We examined whether supermarket choice, conceptualized as a proxy for underlying personal factors, would better predict access to supermarkets and fruit and vegetable consumption than mere physical proximity. Methods. The Seattle Obesity Study geocoded respondents' home addresses and locations of their primary supermarkets. Primary supermarkets were stratified into low, medium, and high cost according to the market basket cost of 100 foods. Data on fruit and vegetable consumption were obtained during telephone surveys. Linear regressions examined associations between physical proximity to primary supermarkets, supermarket choice, and fruit and vegetable consumption. Descriptive analyses examined whether supermarket choice outweighed physical proximity among lower-income and vulnerable groups. Results. Only one third of the respondents shopped at their nearest supermarket for their primary food supply. Those who shopped at low-cost supermarkets were more likely to travel beyond their nearest supermarket. Fruit and vegetable consumption was not associated with physical distance but, with supermarket choice, after adjusting for covariates. Conclusions. Mere physical distance may not be the most salient variable to reflect access to supermarkets, particularly among those who shop by car. Studies on food environments need to focus beyond neighborhood geographic boundaries to capture actual food shopping behaviors. [ABSTRACT FROM AUTHOR]

To address gaps in traditional postlicensure vaccine safety surveillance and to promote rapid signal identification, new prospective monitoring systems using large health-care database cohorts have been developed. We newly adapted clinical trial group sequential methods to this observational setting in an original safety study of a combination diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) conjugate vaccine (DTaP-IPV-Hib) among children within the Vaccine Safety Datalink population. For each prespecified outcome, we conducted 11 sequential Poisson-based likelihood ratio tests during September 2008–January 2011 to compare DTaP-IPV-Hib vaccinees with historical recipients of other DTaP-containing vaccines. No increased risk was detected among 149,337 DTaP-IPV-Hib vaccinees versus historical comparators for any outcome, including medically attended fever, seizure, meningitis/encephalitis/myelitis, nonanaphylactic serious allergic reaction, anaphylaxis, Guillain-Barré syndrome, or invasive Hib disease. In end-of-study prespecified subgroup analyses, risk of medically attended fever was elevated among 1- to 2-year-olds who received DTaP-IPV-Hib vaccine versus historical comparators (relative risk = 1.83, 95% confidence interval: 1.34, 2.50) but not among infants under 1 year old (relative risk = 0.83, 95% confidence interval: 0.73, 0.94). Findings were similar in analyses with concurrent comparators who received other DTaP-containing vaccines during the study period. Although lack of a controlled experiment presents numerous challenges, implementation of group sequential monitoring methods in observational safety surveillance studies is promising and warrants further investigation. [ABSTRACT FROM PUBLISHER]

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 FROM AUTHOR]

Abstract: Objective: To assess the impact of women''s breast cancer risk factors (use of hormone therapy, family history of breast cancer, previous breast biopsy) on radiologists'' mammographic interpretive performance and whether the influence of risk factors varies according to radiologist characteristics. Study Design and Setting: Screening mammograms (n =638,947) performed from 1996 to 2005 by 134 radiologists from three Breast Cancer Surveillance Consortium registries was linked to cancer outcomes, radiologist surveys, and patient questionnaires. Interpretive performance measures were modeled using marginal and conditional logistic regression. Results: Having one or more clinical risk factors was associated with higher recall rates (1 vs. 0 risk factors: odds ratio [OR]=1.17, 95% confidence interval [CI]=1.15–1.19; ≥2 vs. 0: OR=1.43, 95% CI=1.40–1.47) and lower specificity (1 vs. 0: OR=0.86 [95% CI=0.84–0.88]; ≥2 vs. 0: OR=0.70 [95% CI=0.68–0.72]) without a corresponding improvement in sensitivity and only a small increase in positive predictive value (1 vs. 0: OR=1.08 [95% CI=0.99–1.19]; ≥2 vs. 0: OR=1.12 [95% CI=0.99–1.26]). There was no indication that influence of risk factors varied by radiologist characteristics. Conclusion: Women with clinical risk factors who undergo screening mammography are more likely recalled for false-positive evaluation without an associated increase in cancer detection. Radiologists and patients with risk factors should be aware of this increased risk of adverse screening events. [Copyright &y& Elsevier]

Background: Little attention has been paid to quality improvement (QI) capacity within smaller primary care practices which comprise nearly half of all primary care settings. Strategies for external support to build such capacity include practice facilitation (PF), shared learning opportunities, and educational outreach. Although PF has proven effectiveness, little is known about the comparative effectiveness of combining these strategies. Here, we describe the protocol of the "Healthy Hearts Northwest" (H2N) study, a randomized trial designed to address these questions while improving risk factors for cardiovascular disease.Methods/design: The targeted enrollment is 250 smaller primary care practices across Washington, Oregon, and Idaho. The study is utilizing a two-by-two factorial design to assess four different combinations of practice support: PF alone, PF with educational outreach, PF with shared learning opportunities, or PF with both. A mixed methods approach is being used for evaluation and will include data from (1) baseline and follow-up practice and staff surveys; (2) baseline and quarterly clinical performance measurement from each practice on four cardiovascular risk factors: appropriate aspirin use, blood pressure control, lipid management and smoking cessation support; and (3) a quality improvement capacity assessment (QICA) survey used by external practice facilitators to guide improvement efforts.Discussion: Results from this study will inform future large-scale practice improvement initiatives by providing comparisons of promising external practice support strategies and advance our understanding of how to build QI capacity in primary care.Trial Registration: ClinicalTrials.gov, NCT02839382. [ABSTRACT FROM AUTHOR]

Background: Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonic saline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients.Study Design: Two multicenter, randomized, clinical trials were designed to compare hypertonic saline resuscitation with or without dextran with conventional isotonic resuscitation in patients with hypovolemic shock or traumatic brain injury. During a 3-year period, 5,848 patients will be randomized, with a primary end point of 28-day survival in the hypovolemic shock cohort and 6-month neurologic outcomes in the traumatic brain injury cohort.Results: This is a report of the study design and implementation of 2 large-scale prehospital intervention trials from the Resuscitation Outcomes Consortium that qualify for exception from informed consent required for emergency research outlined in FDA regulation 21CFR50.24 and the Canadian Tri-Council Agreement for research in emergency health situations (Article 2.8).Conclusions: We have successfully designed and implemented two prehospital intervention trials. The proc-ess has helped define the numerous challenges that must be overcome to pursue exception from informed consent resuscitation research in the prehospital setting. The results of these studies will hopefully advance and improve the early care of the severely injured patient. [ABSTRACT FROM AUTHOR]

Cognitive behavioral therapy (CBT) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain. Mindfulness-based stress reduction (MBSR) is believed to benefit patients with chronic pain by increasing mindfulness and pain acceptance. However, little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR vs CBT. In a randomized controlled trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with chronic low back pain (N = 342), we examined (1) baseline relationships among measures of catastrophizing, self-efficacy, acceptance, and mindfulness and (2) changes on these measures in the 3 treatment groups. At baseline, catastrophizing was associated negatively with self-efficacy, acceptance, and 3 aspects of mindfulness (nonreactivity, nonjudging, and acting with awareness; all P values <0.01). Acceptance was associated positively with self-efficacy (P < 0.01) and mindfulness (P values <0.05) measures. Catastrophizing decreased slightly more posttreatment with MBSR than with CBT or UC (omnibus P = 0.002). Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks (omnibus P = 0.001). In both the entire randomized sample and the subsample of participants who attended ≥6 of the 8 MBSR or CBT sessions, differences between MBSR and CBT at up to 52 weeks were few, small in size, and of questionable clinical meaningfulness. The results indicate overlap across measures of catastrophizing, self-efficacy, acceptance, and mindfulness and similar effects of MBSR and CBT on these measures among individuals with chronic low back pain. [ABSTRACT FROM AUTHOR]