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Background Chronic pain patients increasingly seek treatment through mindfulness meditation. Purpose This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults. Method We conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use. Results Thirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life. Conclusions While mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.

In that spirit, I call out some of the major flaws of this research, using the population, interventions, comparators, outcomes, timing, setting, and study design framework of study characteristics. The time courses of treatment and follow-up varied widely across studies. Since baseline and follow-up nutrient status were seldom reported, who is to say what an appropriate duration would be for treatment and follow-up? [...]based on the quality of the included studies, the inconsistency and imprecision of findings across studies, and the small effect sizes, the strength of the evidence supporting any beneficial effects of individual or combination micronutrient supplements is low at best, although the review did not attempt to assess the strength of evidence for any of the micronutrients.

Homeopathy is a system of therapeutics that treats disease with highly diluted substances based on the Law of Similars, which holds that “like cures like.” Despite widespread use, homeopathy lacks a comprehensive and robust evidence base. We examined the state of homeopathic clinical research by critically assessing the overall quality of peer-reviewed, recently published, English-language, homeopathic clinical research in terms of internal, external, and model validity using standard and homeopathic-specific instruments. Further, we convened an international panel of nine experts in research methods and homeopathy to identify gaps in homeopathic research and prioritize areas for future study. We reviewed 99 clinical research studies targeting a wide range of populations and conditions. Studies were conducted in Western and Asian countries, with the largest number (30 percent) conducted in India. Of the 99 studies reviewed, 85 were controlled trials; 79 of these were randomized. There were many areas where the quality of the studies could be improved. About two-thirds of the 85 controlled trials had either high (42 percent) or unclear (24 percent) risk of bias according to internationally recognized standards for internal validity. Of the 14 observational (cohort) studies, over one-third did not control for important confounders in the outcome analyses. Regarding external validity, adherence was reported in less than a third of studies (n=31). Forty percent of studies (79 % of observational studies) did not report on safety. Regarding model validity, fewer than two-thirds of the studies were consistent with homeopathic principles. Our expert panel was mixed on whether the homeopathic research literature was missing important populations and/or conditions, and they suggested a variety of priority areas. Panelists also expressed a variety of opinions about the types of homeopathy that should be prioritized for future study but also noted that since homeopathic practice differs by country, each country may have different priorities. Panelists agreed with the findings of the literature review that the research literature was at least somewhat deficient in all three types of validity. Although our assessment of validity was [by necessity] based only on what was reported, this assessment suggests the need for both better reporting and higher quality research. They recommended the use of reporting guidelines to improve all types of validity, the identification of exemplar studies to help guide researchers to improve internal validity, and, given the limitations of the instruments available to measure external and model validity, that these instruments be validated and configured to provide summary scores. Finally, substantial discussion addressed the need to bring more research expertise into homeopathic studies, both by better training homeopathic researchers and by collaborating with experienced conventional medicine research groups. •The validity of homeopathic research studies is reasonable but can be improved.•Adherence to standard and homeopathic-specific reporting guidelines would help.•Identify and target a few populations and conditions for replication studies.•All homeopathy studies should proactively monitor and report on adverse events.•Increase homeopathic research expertise through better training and collaborations.

Latinas in the United States are more likely to be diagnosed with late-stage breast cancer (BC) compared to non-Latinas. Literacy-appropriate and culturally sensitive cancer communication interventions can help address existing racial/ethnic BC disparities. We formatively developed a new BC prevention brochure for Spanish-speaking Latinas (≥35 years). Eligible women (n = 240) from a large public hospital in California were randomly assigned to one of three study arms: Group 1 received the new brochure, Group 2 included a community health worker (CHW) who delivered the new brochure’s content, and a control group received a standard educational brochure. Participants completed three surveys (baseline, postintervention, 3-month follow-up) with a 100% completion rate for the first two surveys and 80.4% completion after 3 months. We assessed the difference in outcomes for BC risk knowledge, perceived BC susceptibility, and BC information self-efficacy between groups. Participant mean age was 52.3 years, and 82.1% reported low English proficiency. Mean knowledge scores increased and perceived BC susceptibility improved for all groups (p ≤ .05), yet treatment effects were not significant between groups for these outcomes. BC information self-efficacy also increased from baseline to postintervention for all groups to >80%. After 3 months, only Group 2 and the control group retained their increases and treatment effects were significant only for Group 2 compared to other groups in unadjusted and adjusted models. A CHW-delivered intervention may be more effective in improving BC information self-efficacy among Latinas compared to print material alone. More research is needed to examine the efficacy of CHW-delivered interventions.

As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review.

Groups such as the Institute of Medicine emphasize the importance of attention to financial conflicts of interest. Little guidance exists, however, on managing the risk of bias for systematic reviews from nonfinancial conflicts of interest. We sought to create practical guidance on ensuring adequate clinical or content expertise while maintaining independence of judgment on systematic review teams. Workgroup members built on existing guidance from international and domestic institutions on managing conflicts of interest. We then developed practical guidance in the form of an instrument for each potential source of conflict. We modified the Institute of Medicine's definition of conflict of interest to arrive at a definition specific to nonfinancial conflicts. We propose questions for funders and systematic review principal investigators to evaluate the risk of nonfinancial conflicts of interest. Once risks have been identified, options for managing conflicts include disclosure followed by no change in the systematic review team or activities, inclusion on the team along with other members with differing viewpoints to ensure diverse perspectives, exclusion from certain activities, and exclusion from the project entirely. The feasibility and utility of this approach to ensuring needed expertise on systematic reviews and minimizing bias from nonfinancial conflicts of interest must be investigated.

Background The prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverse events (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular viscosupplementation with HA in older individuals with knee osteoarthritis and account for differences in these conclusions from another systematic review. Methods We searched PubMed and eight other databases and gray literature sources from 1990 to December 12, 2014. Double-blind placebo-controlled randomized controlled trials (RCTs) reporting functional outcomes or quality-of-life; RCTs and observational studies on delay/avoidance of arthroplasty; RCTs, case reports, and large cohort studies and case series assessing safety; and systematic reviews reporting on knee pain were considered for inclusion. A standardized, pre-defined protocol was applied by two independent reviewers to screen titles and abstracts, review full text, and extract details on study design, interventions, outcomes, and quality. We compared our results with those of a prior systematic review and found them to be discrepant; our analysis of why this discrepancy occurred is the focus of this manuscript. Results Eighteen RCTs reported functional outcomes: pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of −0.23 (95 % confidence interval (CI) −0.45 to −0.01) favoring HA at 6 months. Studies reported few serious adverse events (SAEs) and no significant differences in non-serious adverse events (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93–1.15] or SAEs (RR [95 % CI] 1.39 [0.78–2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE inclusion and synthesis accounted for the disparate conclusions. Conclusions Trials show a small but significant effect of HA on function on which recent systematic reviews agree, but lack of AE synthesis standardization leads to opposite conclusions about the balance of benefits and harms. A limitation of the re-analysis of the prior systematic review is that it required imputation of missing data.

Background Systematic reviews are a cornerstone of evidence-based medicine but are useful only if up-to-date. Methods for detecting signals of when a systematic review needs updating have face validity, but no proposed method has had an assessment of predictive validity performed. Methods The AHRQ Comparative Effectiveness Review program had produced 13 comparative effectiveness reviews (CERs), a subcategory of systematic reviews, by 2009, 11 of which were assessed in 2009 using a surveillance system to determine the degree to which individual conclusions were out of date and to assign a priority for updating each report. Four CERs were judged to be a high priority for updating, four CERs were judged to be medium priority for updating, and three CERs were judged to be low priority for updating. AHRQ then commissioned full update reviews for 9 of these 11 CERs. Where possible, we matched the original conclusions with their corresponding conclusions in the update reports, and compared the congruence between these pairs with our original predictions about which conclusions in each CER remained valid. We then classified the concordance of each pair as good, fair, or poor. We also made a summary determination of the priority for updating each CER based on the actual changes in conclusions in the updated report, and compared these determinations with the earlier assessments of priority. Results The 9 CERs included 149 individual conclusions, 84% with matches in the update reports. Across reports, 83% of matched conclusions had good concordance, and 99% had good or fair concordance. The one instance of poor concordance was partially attributable to the publication of new evidence after the surveillance signal searches had been done. Both CERs originally judged as being low priority for updating had no substantive changes to their conclusions in the actual updated report. The agreement on overall priority for updating between prediction and actual changes to conclusions was Kappa = 0.74. Conclusions These results provide some support for the validity of a surveillance system for detecting signals indicating when a systematic review needs updating.

Apply and compare two methods that identify signals for the need to update systematic reviews, using three Evidence-based Practice Center reports on omega-3 fatty acids as test cases. We applied the RAND method, which uses domain (subject matter) expert guidance, and a modified Ottawa method, which uses quantitative and qualitative signals. For both methods, we conducted focused electronic literature searches of recent studies using the key terms from the original reports. We assessed the agreement between the methods and qualitatively assessed the merits of each system. Agreement between the two methods was “substantial” or better (kappa>0.62) in three of the four systematic reviews. Overall agreement between the methods was “substantial” (kappa=0.64, 95% confidence interval [CI] 0.45–0.83). The RAND and modified Ottawa methods appear to provide similar signals for the possible need to update systematic reviews in this pilot study. Future evaluation with a broader range of clinical topics and eventual comparisons between signals to update reports and the results of full evidence review updates will be needed. We propose a hybrid approach combining the best features of both methods, which should allow efficient review and assessment of the need to update.

OBJECTIVE:  To evaluate and synthesize the evidence on the effect of supplements of vitamin E on the prevention and treatment of cardiovascular disease. DESIGN:  Systematic review of placebo‐controlled randomized controlled trials; meta‐analysis where justified. MEASUREMENTS AND MAIN RESULTS:  Eighty‐four eligible trials were identified. For the outcomes of all‐cause mortality, cardiovascular mortality, fatal or nonfatal myocardial infarction, and blood lipids, neither supplements of vitamin E alone nor vitamin E given with other agents yielded a statistically significant beneficial or adverse pooled relative risk (for example, pooled relative risk of vitamin E alone = 0.96 [95% confidence interval (CI), 0.84 to 1.10]; 0.97 [95% CI, 0.80 to 1.90]; and 0.72 [95% CI, 0.51 to 1.02] for all‐cause mortality, cardiovascular mortality, and nonfatal myocardial infarction, respectively. CONCLUSIONS:  There is good evidence that vitamin E supplementation does not beneficially or adversely affect cardiovascular outcomes.