Endoscopic therapies for patients with obesity: a systematic review and meta-analysis.

BACKGROUND: Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS: A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS: Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION: This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.

Veterans Health Administration (VA) vs. Non-VA Healthcare Quality: A Systematic Review.

BACKGROUND: The Veterans Health Administration (VA) serves Veterans in the nation's largest integrated healthcare system. VA seeks to provide high quality of healthcare to Veterans, but due to the VA Choice and MISSION Acts, VA increasingly pays for care outside of its system in the community. This systematic review compares care provided in VA and non-VA settings, and includes published studies from 2015 to 2023, updating 2 prior systematic reviews on this topic. METHODS: We searched PubMed, Web of Science, and PsychINFO from 2015 to 2023 for published literature comparing VA and non-VA care, including VA-paid community care. Records were included at the abstract or full-text level if they compared VA medical care with care provided in other healthcare systems, and included clinical quality, safety, access, patient experience, efficiency (cost), or equity outcomes. Data from included studies was abstracted by two independent reviewers, with disagreements resolved by consensus. Results were synthesized narratively and via graphical evidence maps. RESULTS: Thirty-seven studies were included after screening 2415 titles. Twelve studies compared VA and VA-paid community care. Most studies assessed clinical quality and safety, and studies of access were second most common. Only six studies assessed patient experience and six assessed cost or efficiency. Clinical quality and safety of VA care was better than or equal to non-VA care in most studies. Patient experience in VA care was better than or equal to experience in non-VA care in all studies, but access and cost/efficiency outcomes were mixed. DISCUSSION: VA care is consistently as good as or better than non-VA care in terms of clinical quality and safety. Access, cost/efficiency, and patient experience between the two systems are not well studied. Further research is needed on these outcomes and on services widely used by Veterans in VA-paid community care, like physical medicine and rehabilitation.

Use of Acupuncture for Adult Health Conditions, 2013 to 2021: A Systematic Review.

Importance: Acupuncture is a popular treatment that has been advocated for dozens of adult health conditions and has a vast evidence base. Objective: To map the systematic reviews, conclusions, and certainty or quality of evidence for outcomes of acupuncture as a treatment for adult health conditions. Evidence Review: Computerized search of PubMed and 4 other databases from 2013 to 2021. Systematic reviews of acupuncture (whole body, auricular, or electroacupuncture) for adult health conditions that formally rated the certainty, quality, or strength of evidence for conclusions. Studies of acupressure, fire acupuncture, laser acupuncture, or traditional Chinese medicine without mention of acupuncture were excluded. Health condition, number of included studies, type of acupuncture, type of comparison group, conclusions, and certainty or quality of evidence. Reviews with at least 1 conclusion rated as high-certainty evidence, reviews with at least 1 conclusion rated as moderate-certainty evidence, and reviews with all conclusions rated as low- or very low-certainty evidence; full list of all conclusions and certainty of evidence. Findings: A total of 434 systematic reviews of acupuncture for adult health conditions were found; of these, 127 reviews used a formal method to rate certainty or quality of evidence of their conclusions, and 82 reviews were mapped, covering 56 health conditions. Across these, there were 4 conclusions that were rated as high-certainty evidence, and 31 conclusions that were rated as moderate-certainty evidence. All remaining conclusions (>60) were rated as low- or very low-certainty evidence. Approximately 10% of conclusions rated as high or moderate-certainty were that acupuncture was no better than the comparator treatment, and approximately 75% of high- or moderate-certainty evidence conclusions were about acupuncture compared with a sham or no treatment. Conclusions and Relevance: Despite a vast number of randomized trials, systematic reviews of acupuncture for adult health conditions have rated only a minority of conclusions as high- or moderate-certainty evidence, and most of these were about comparisons with sham treatment or had conclusions of no benefit of acupuncture. Conclusions with moderate or high-certainty evidence that acupuncture is superior to other active therapies were rare.

Measuring the Appropriateness of Spinal Manipulation for Chronic Low Back and Chronic Neck Pain in Chiropractic Patients.

STUDY DESIGN: RAND/UCLA Appropriateness Method (RUAM) applied to chiropractic manipulation for patients with chronic low-back pain (CLBP) and chronic neck pain (CNP). OBJECTIVE: Determine the rate of appropriate care provided by US chiropractors. SUMMARY OF BACKGROUND DATA: Spinal manipulation has been shown effective for CLBP and CNP but may not be appropriate for all patients with these conditions. METHODS: Ratings of the appropriateness of spinal and cervical manipulation previously developed by two RUAM expert panels were applied to data abstracted from random samples of patient charts from chiropractors in six US regions to determine the appropriateness of manipulation for each patient. RESULTS: Of 125 chiropractors sampled, 89 provided charts that could be abstracted. Of the 2128 charts received, 1054 were abstracted. Charts received but not abstracted included 460 that were unusable (e.g., illegible), and 555 did not have CLBP or CNP. Across the abstracted charts 72% had CLBP, 57% had CNP, and 29% had both; 84% of patients with CLBP and 86% with CNP received manipulation. Patients with CLBP who had minor neurologic findings, sciatic nerve irritation, or no joint dysfunction were significantly less likely to receive manipulation. Patients with CNP who had substantial trauma etiology, no joint dysfunction, or no radiographs were significantly less likely to receive manipulation. Most manipulation for CLBP (64%) was appropriate and most manipulation for CNP (93%) was for patients where appropriateness was uncertain or equivocal. The proportions of patients receiving inappropriate manipulation for either condition were low (1%-3%) as were the numbers of patients presenting to these chiropractors for which manipulation was inappropriate. CONCLUSION: Chiropractors in this US sample tend to provide manipulation to very few patients with CLBP or CNP for which it is inappropriate. However, more research is needed to determine which patients with CNP benefit from manipulation.Level of Evidence: 4.

Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis.

Importance: Inadequate access to food is a risk factor for poor health and the effectiveness of federal programs targeting food insecurity, such as the Supplemental Nutrition Assistance Program (SNAP), are well-documented. The associations between other types of interventions to provide adequate food access and food insecurity status, health outcomes, and health care utilization, however, are unclear. Objective: To review evidence on the association between food insecurity interventions and food insecurity status, clinically-relevant health outcomes, and health care utilization among adults, excluding SNAP. Data Sources: A systematic search for English-language literature was performed in PubMed Central and Cochrane Trials databases (inception to January 23, 2020), the Social Interventions Research and Evaluation Network database (December 10, 2019); and the gray literature using Google (February 1, 2021). Study Selection: Studies of any design that assessed the association between food insecurity interventions for adult participants and food insecurity status, health outcomes, and health care utilization were screened for inclusion. Studies of interventions that described addressing participants' food needs or reporting food insecurity as an outcome were included. Interventions were categorized as home-delivered food, food offered at a secondary site, monetary assistance in the form of subsidies or income supplements, food desert interventions, and miscellaneous. Data Extraction and Synthesis: Data extraction was performed independently by 3 reviewers. Study quality was assessed using the Cochrane Risk of Bias Tool, the ROBINS-I (Risk of Bias in Non-Randomized Studies of Interventions) tool, and a modified version of the National Institutes of Health's Quality Assessment Tool for Before-After Studies With No Control. The certainty of evidence was based on GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria and supplemented with mechanistic and parallel evidence. For outcomes within intervention categories with at least 3 studies, random effects meta-analysis was performed. Main Outcomes and Measures: Food insecurity (measured through surveys; eg, the 2-item Hunger Vital Sign), health outcomes (eg, hemoglobin A1c), and health care utilization (eg, hospitalizations, costs). Results: A total of 39 studies comprising 170 605 participants were included (8 randomized clinical trials and 31 observational studies). Of these, 14 studies provided high-certainty evidence of an association between offering food and reduced food insecurity (pooled random effects; adjusted odds ratio, 0.53; 95% CI, 0.33-0.67). Ten studies provided moderate-certainty evidence of an association between offering monetary assistance and reduced food insecurity (pooled random effects; adjusted odds ratio, 0.64; 95% CI, 0.49-0.84). There were fewer studies of the associations between interventions and health outcomes or health care utilization, and the evidence in these areas was of low or very low certainty that any food insecurity interventions were associated with changes in either. Conclusions and Relevance: This systematic review with meta-analysis found that providing food and monetary assistance was associated with improved food insecurity measures; however, whether it translated to better health outcomes or reduced health care utilization was unclear.

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain.

BACKGROUND: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. DESIGN: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. SUMMARY: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 5: Using Patient Records: Selection, Protection, and Abstraction.

OBJECTIVES: The purpose of this paper is to describe the 4-step process (consent, selection, protection, and abstraction) of acquiring a large sample of chiropractic patient records from multiple practices and subsequent data abstraction. METHODS: From April 2017 to December 2017, RAND acquired patient records from 99 chiropractic practices across the United States. The records included patients enrolled in a survey e-study (prospective sample) and a random sample of all clinic patients (retrospective sample) with chronic back or neck pain. Clinic staff were trained to collect the sample, scan, and transfer the records. We designed an online data collection tool for abstraction. Protocols were instituted to protect patient confidentiality. Doctors of chiropractic were selected and trained as abstractors, and a system was established to monitor data collection. RESULTS: In compliance with data protection protocols, 3603 patient records were scanned, including 1475 in the prospective sample and 2128 in the random sample. A total of 1716 patients (prospective sample) consented to having their records scanned, but only 1475 could be retrieved. Of records scanned, 19% were unusable owing to illegibility, no care during the period of interest, or poor scanning. The abstractor interrater reliability for appropriateness of care decisions was fair to moderate (κ .38-.48). CONCLUSION: The acquisition, handling, and abstraction of a large sample of chiropractic records was a complex task with challenges that necessitated adapting planned approaches. Of the records abstracted, many revealed incomplete provider documentation regarding the details of and rationale for care. Better documentation and more standardized record keeping would facilitate future research using patient records.

Massage for Pain: An Evidence Map.

Objectives: Massage therapy has been proposed for painful conditions, but it can be difficult to understand the breadth and depth of evidence, as various painful conditions may respond differently to massage. The authors conducted an evidence mapping process and generated an "evidence map" to visually depict the distribution of evidence available for massage and various pain indications to identify gaps in evidence and to inform future research priorities. Design: The authors searched PubMed, Embase, and Cochrane for systematic reviews reporting pain outcomes for massage therapy. The authors assessed the quality of each review using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) criteria. The authors used a bubble plot to depict the number of included articles, pain indication, effect of massage for pain, and strength of findings for each included systematic review. Results: The authors identified 49 systematic reviews, of which 32 were considered high quality. Types of pain frequently included in systematic reviews were cancer pain, low back pain, and neck pain. High quality reviews concluded that there was low strength of evidence of potential benefits of massage for labor, shoulder, neck, low back, cancer, arthritis, postoperative, delayed onset muscle soreness, and musculoskeletal pain. Reported attributes of massage interventions include style of massage, provider, co-interventions, duration, and comparators, with 14 high-quality reviews reporting all these attributes in their review. Conclusion: Prior reviews have conclusions of low strength of evidence because few primary studies of large samples with rigorous methods had been conducted, leaving evidence gaps about specific massage type for specific pain. Primary studies often do not provide adequate details of massage therapy provided, limiting the extent to which reviews are able to draw conclusions about characteristics such as provider type.

Benefits and Harms of Cranial Electrical Stimulation for Chronic Painful Conditions, Depression, Anxiety, and Insomnia: A Systematic Review.

Background: Cranial electrical stimulation (CES) is increasingly popular as a treatment, yet its clinical benefit is unclear. Purpose: To review evidence about the benefits and harms of CES for adult patients with chronic painful conditions, depression, anxiety, and insomnia. Data Sources: Several databases from inception to 10 October 2017 without language restrictions and references from experts, prior reviews, and manufacturers. Study Selection: Randomized controlled trials of CES versus usual care or sham CES that reported pain, depression, anxiety, or sleep outcomes in any language. Data Extraction: Single-reviewer extraction checked by another; dual independent quality assessment; strength-of-evidence grading by the first author with subsequent group discussion. Data Synthesis: Twenty-eight articles from 26 randomized trials met eligibility criteria. The 2 trials that compared CES with usual care were small, and neither reported a statistically significant benefit in pain or anxiety outcomes for patients with fibromyalgia or anxiety, respectively. Fourteen trials with sham or placebo controls involving patients with painful conditions, such as headache, neuromuscular pain, or musculoskeletal pain, had conflicting results. Four trials done more than 40 years ago and 1 from 2014 provided low-strength evidence of a possible modest benefit compared with sham treatments in patients with anxiety and depression. Trials in patients with insomnia (n = 2), insomnia and anxiety (n = 1), or depression (n = 3) had inconclusive or conflicting results. Low-strength evidence suggested that CES does not cause serious side effects. Limitation: Most trials had small sample sizes and short durations; all had high risk of bias due to inadequate blinding. Conclusion: Evidence is insufficient that CES has clinically important effects on fibromyalgia, headache, neuromusculoskeletal pain, degenerative joint pain, depression, or insomnia; low-strength evidence suggests modest benefit in patients with anxiety and depression. Primary Funding Source: Veterans Affairs Quality Enhancement Research Initiative. (PROSPERO: CRD42016023951).

A systematic review of the effects of modifiable risk factor interventions on the progression of multiple sclerosis.

BACKGROUND: Several risk factors are associated with multiple sclerosis (MS) progression and may be amenable to intervention. OBJECTIVE: To systematically review the evidence for interventions targeting risk factors for MS progression. METHODS: We searched six databases and existing reviews till March 2015 and consulted with experts to identify randomized controlled trials (RCTs) of interventions targeting MS risk factors (PROSPERO 2015:CRD42015016461). RESULTS: In total, 37 RCTs met inclusion criteria. Expanded Disability Status Scale (EDSS) scores after exercise interventions did not differ compared with untreated controls (standardized mean differences (SMDs): 0.02; confidence interval (CI): -0.40, 0.44; I2: 0%; seven RCTs; very low quality of evidence (QoE)). Dietary interventions did not show a statistically significant effect on the relative risk (RR) of progression (RR: 0.86; CI: 0.67, 1.05; I2: 0%; four RCTs; moderate QoE) compared to placebo. EDSS scores after vitamin D supplementation were not significantly different from placebo (SMD: -0.15; CI: -0.33, 0.02; I2: 0%; five RCTs; very low QoE). CONCLUSION: We did not identify any risk factor interventions with significant effects on MS progression, but the overall QoE was limited. More adequately powered trials are needed on vitamin D supplementation, long-term exercise, and smoking cessation.

An evidence map of the effect of Tai Chi on health outcomes.

BACKGROUND: This evidence map describes the volume and focus of Tai Chi research reporting health outcomes. Originally developed as a martial art, Tai Chi is typically taught as a series of slow, low-impact movements that integrate the breath, mind, and physical activity to achieve greater awareness and a sense of well-being. METHODS: The evidence map is based on a systematic review of systematic reviews. We searched 11 electronic databases from inception to February 2014, screened reviews of reviews, and consulted with topic experts. We used a bubble plot to graphically display clinical topics, literature size, number of reviews, and a broad estimate of effectiveness. RESULTS: The map is based on 107 systematic reviews. Two thirds of the reviews were published in the last five years. The topics with the largest number of published randomized controlled trials (RCTs) were general health benefits (51 RCTs), psychological well-being (37 RCTs), interventions for older adults (31 RCTs), balance (27 RCTs), hypertension (18 RCTs), fall prevention (15 RCTs), and cognitive performance (11 RCTs). The map identified a number of areas with evidence of a potentially positive treatment effect on patient outcomes, including Tai Chi for hypertension, fall prevention outside of institutions, cognitive performance, osteoarthritis, depression, chronic obstructive pulmonary disease, pain, balance confidence, and muscle strength. However, identified reviews cautioned that firm conclusions cannot be drawn due to methodological limitations in the original studies and/or an insufficient number of existing research studies. CONCLUSIONS: Tai Chi has been applied in diverse clinical areas, and for a number of these, systematic reviews have indicated promising results. The evidence map provides a visual overview of Tai Chi research volume and content. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009907.

Omega-3 Fatty Acids and Maternal and Child Health: An Updated Systematic Review.

OBJECTIVES: To update a prior systematic review on the effects of omega-3 fatty acids (n-3 FA) on maternal and child health and to assess the evidence for their effects on, and associations with, additional outcomes. DATA SOURCES: MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Centre for Agriculture and Biosciences (CAB) Abstracts from 2000 to August 2015; eligible studies from the original report; and relevant systematic reviews. REVIEW METHODS: We included randomized controlled trials (RCTs) of any defined dose of n-3 FA (or combination) compared to placebo, any other n-3 FA, or alternative dose with an outcome of interest conducted in pregnant or breastfeeding women or neonates (preterm or term). We also included prospective observational studies that analyzed the association between baseline n-3 FA intake or biomarker level and followup outcomes. Postnatal interventions began within a week of birth for term infants and within a week of beginning enteral or oral feeding for preterm infants. Standard methods were used for data abstraction and analysis, according to the Evidence-based Practice Center Methods Guide. RESULTS: We identified 4,275 potentially relevant titles from our searches, of which 95 RCTs and 48 observational studies met the inclusion criteria. Risk of bias was a concern with both RCTs and observational studies. Outcomes for which evidence was sufficient to draw a conclusion are summarized here with the Strength of Evidence (SoE). (Outcomes for which the evidence was insufficient to draw a conclusion are summarized in Appendix G of the report.).Maternal Exposures and Outcomes: Gestational length and risk for preterm birth: Prenatal algal docosahexaenoic acid (DHA) or DHA-enriched fish oil supplementation had a small positive effect on length of gestation (moderate SoE), but no effect on risk for preterm birth (low SoE). Prenatal EPA (eicosapentaenoic acid) plus DHA-containing fish oil supplementation has no effect on length of gestation (low SoE). Supplementation with DHA, or EPA plus DHA-, or DHA-enriched fish oil does not decreaserisk for preterm birth (low SoE).Birth weight and risk for low birth weight: Changes in maternal n-3 FA biomarkers were significantly associated with birth weight. Prenatal algal DHA or DHA-enriched fish oil supplementation had a positive effect on birth weight among healthy term infants (moderate SoE), but prenatal DHA supplementation had no effect on risk for low birth weight (low SoE). Prenatal EPA plus DHA or alpha-linolenic acid (ALA) supplementation had no effect on birth weight (low SoE).Risk for peripartum depression: Maternal n-3 FA biomarkers had no association with risk for peripartum depression. Maternal DHA, EPA, or DHA-enriched fish oil supplementation had no effect on risk for peripartum depression (low SoE).Risk for gestational hypertension/preeclampsia: Prenatal DHA supplementation among high-risk pregnant women had no effect on the risk for gestational hypertension or preeclampsia (moderate SoE). Prenatal supplementation of any n-3 FA in normal-risk women also had no significant effect on risk for gestational hypertension or preeclampsia (low SoE).Fetal, Infant, and Child Exposures and Outcomes: Postnatal growth patterns: Maternal fish oil or DHA plus EPA supplementation had no effect on postnatal growth patterns (attainment of weight, length, and head circumference) when administered prenatally (moderate SoE) or both pre- and postnatally (low SoE). Fortification of infant formulas with DHA plus arachidonic acid (AA, an n-6 FA) had no effect on growth patterns of preterm or term infants (low SoE).Visual acuity: Prenatal supplementation with DHA had no effect on development of visual acuity (low SoE). Supplementing or fortifying preterm infant formula with any n-3 FA had no significant effect on visual acuity assessed by visual evoked potentials (VEP) at 4 or 6 months corrected age (low SoE). Data conflicted on the effectiveness of supplementing infant formula for term infants with n-3 FA depending on when and how visual acuity was assessed (i.e. by VEP or by behavioral methods) and the type of essential FA provided (low SoE).Neurological development: Prenatal or postnatal n-3 FA supplementation had no consistent effect on neurological development (low SoE).Cognitive development: Prenatal DHA supplementation with AA or EPA had no effect on cognitive development (moderate SoE). Supplementing breastfeeding women with DHA plus EPA also had no effect on cognitive development in infants and children (low SoE). Supplementing or fortifying preterm infants' formula with DHA plus AA had a positive effect on infant cognition at some short-term followup times (moderate SoE). Supplementing or fortifying infant formula for term infants with any n-3 FA had no effect on cognitive development (low SoE). Evidence is insufficient to support any effect of n-3 FA infant supplementation on long-term cognitive outcomes.Autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), and learning disorders: Maternal or infant n-3 FA supplementation had no effect on risk for autism spectrum disorders or ADHD (low SoE). No studies on other learning disorders were identified.Atopic dermatitis (AD), allergies, and respiratory disorders: Pre- and postnatal (maternal and infant) n-3 FA supplementation had no consistent effect on the risk for AD/eczema, allergies, asthma, and other respiratory illnesses (moderate SoE). Biomarkers and intakes had no consistent association with the risk for AD, allergies, and respiratory disorders (low SoE).Adverse events: Prenatal and infant supplementation with n-3 FA or fortification of foods with n-3 FA did not result in any serious or nonserious adverse events (moderate SoE); with the exception of an increased risk for mild gastrointestinal symptoms. CONCLUSIONS: Most studies in this report examined the effects of fish oil (or other combinations of DHA and EPA) supplements on pregnant or breastfeeding women or the effects of infant formula fortified with DHA plus AA. As with the original report, with the exception of small increases in birth weight and length of gestation,n-3 FA supplementation or fortification has no consistent evidence of effects on peripartum maternal or infant health outcomes. No effects of n-3 FA were seen on gestational hypertension, peripartum depression, or postnatal growth. Apparent effects of n-3 FA supplementation were inconsistent across assessment methods and followup times for outcomes related to infant visual acuity, cognitive development and prevention of allergy and asthma. Future RCTs need to assess standardized preparations of n-3 and n-6 FA, using a select group of clinically important outcomes, on populations with baseline n-3 FA intakes typical of those of most western populations.

Development of the Quality Improvement Minimum Quality Criteria Set (QI-MQCS): a tool for critical appraisal of quality improvement intervention publications.

OBJECTIVE: Valid, reliable critical appraisal tools advance quality improvement (QI) intervention impacts by helping stakeholders identify higher quality studies. QI approaches are diverse and differ from clinical interventions. Widely used critical appraisal instruments do not take unique QI features into account and existing QI tools (eg, Standards for QI Reporting Excellence) are intended for publication guidance rather than critical appraisal. This study developed and psychometrically tested a critical appraisal instrument, the QI Minimum Quality Criteria Set (QI-MQCS) for assessing QI-specific features of QI publications. METHODS: Approaches to developing the tool and ensuring validity included a literature review, in-person and online survey expert panel input, and application to empirical examples. We investigated psychometric properties in a set of diverse QI publications (N=54) by analysing reliability measures and item endorsement rates and explored sources of disagreement between reviewers. RESULTS: The QI-MQCS includes 16 content domains to evaluate QI intervention publications: Organisational Motivation, Intervention Rationale, Intervention Description, Organisational Characteristics, Implementation, Study Design, Comparator Description, Data Sources, Timing, Adherence/Fidelity, Health Outcomes, Organisational Readiness, Penetration/Reach, Sustainability, Spread and Limitations. Median inter-rater agreement for QI-MQCS items was κ 0.57 (83% agreement). Item statistics indicated sufficient ability to differentiate between publications (median quality criteria met 67%). Internal consistency measures indicated coherence without excessive conceptual overlap (absolute mean interitem correlation=0.19). The critical appraisal instrument is accompanied by a user manual detailing What to consider, Where to look and How to rate. CONCLUSIONS: We developed a ready-to-use, valid and reliable critical appraisal instrument applicable to healthcare QI intervention publications, but recognise scope for continuing refinement.

Electronic health record-based interventions for improving appropriate diagnostic imaging: a systematic review and meta-analysis.

BACKGROUND: One driver of increasing health care costs is the use of radiologic imaging procedures. More appropriate use could improve quality and reduce costs. PURPOSE: To review interventions that use the computerized clinical decision-support (CCDS) capabilities of electronic health records to improve appropriate use of diagnostic radiologic test ordering. DATA SOURCES: English-language articles in PubMed from 1995 to September 2014 and searches in Web of Science and PubMed of citations related to key articles. STUDY SELECTION: 23 studies, including 3 randomized trials, 7 time-series studies, and 13 pre-post studies that assessed the effect of CCDS on diagnostic radiologic test ordering in adults. DATA EXTRACTION: 2 independent reviewers extracted data on functionality, study outcomes, and context and assessed the quality of included studies. DATA SYNTHESIS: Thirteen studies provided moderate-level evidence that CCDS improves appropriateness (effect size, -0.49 [95% CI, -0.71 to -0.26]) and reduces use (effect size, -0.13 [CI, -0.23 to -0.04]). Interventions with a "hard stop" that prevents a clinician from overriding the CCDS without outside consultation, as well as interventions in integrated care delivery systems, may be more effective. Harms have rarely been assessed but include decreased ordering of appropriate tests and physician dissatisfaction. LIMITATION: Potential for publication bias, insufficient reporting of harms, and poor description of context and implementation. CONCLUSION: Computerized clinical decision support integrated with the electronic health record can improve appropriate use of diagnostic radiology by a moderate amount and decrease use by a small amount. Before widespread adoption can be recommended, more data are needed on potential harms. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs. (PROSPERO registration number: CRD42014007469).

Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update).

BACKGROUND: In 2009, the Institute of Medicine/Food and Nutrition Board constituted a Dietary Reference Intakes (DRI) committee to undertake a review of the evidence that had emerged (since the 1997 DRI report) on the relationship of vitamin D and calcium, both individually and combined, to a wide range of health outcomes, and potential revision of the DRI values for these nutrients. To support that review, several United States and Canadian Federal Government agencies commissioned a systematic review of the scientific literature for use during the deliberations by the committee. The intent was to support a transparent literature review process and provide a foundation for subsequent reviews of the nutrients. The committee used the resulting literature review in their revision of the DRIs.In 2013, in preparation for a project the National Institutes of Health Office of Dietary Supplements (NIH/ODS) was undertaking related to evidence-based decisionmaking for vitamin D in primary care, based on the updated DRI report, the ODS and AHRQ requested an update to the 2009 systematic review to incorporate the findings of studies conducted since the 2009 evidence review on the relationship between vitamin D alone or vitamin D plus calcium to selected health outcomes and to report on the methods used to assay vitamin D in the included trials. PURPOSE: To systematically summarize the evidence on the relationship between vitamin D alone or in combination with calcium on selected health outcomes included in the earlier review: primarily those related to bone health, cardiovascular health, cancer, immune function, pregnancy, all-cause mortality, and vitamin D status; and to identify the vitamin D assay methods and procedures used for the interventional studies that aimed to assess the effect of vitamin D administration on serum 25(OH)D concentrations, and to stratify key outcomes by methods used to assay serum 25(OH)D concentrations. DATA SOURCES: MEDLINE; Cochrane Central; Cochrane Database of Systematic Reviews; and the Health Technology Assessments; search limited to English-language articles on humans. STUDY SELECTION: Primary interventional or prospective observational studies that reported outcomes of interest in human subjects in relation to vitamin D alone or in combination with calcium, as well as systematic reviews that met the inclusion and exclusion criteria. DATA EXTRACTION: A standardized protocol with predefined criteria was used to extract details on study design, interventions, outcomes, and study quality. DATA SYNTHESIS: We summarized 154 newly identified primary articles and two new systematic reviews that incorporated more than 93 additional primary articles. Available evidence focused mainly on bone health, cardiovascular diseases, or cancer outcomes. Findings were inconsistent across studies for bone health; breast, colorectal, and prostate cancer; cardiovascular disease and mortality; immune function; and pregnancy-related outcomes. Few studies assessed pancreatic cancer and birth outcomes. One new systematic review of observational studies found that circulating 25(OH)D was generally inversely associated with risk for cardiovascular disease. Methods used to assay serum 25(OH)D in studies reporting on key outcomes diverged widely. The current report also identified one new systematic review published since the original report that addressed whether a dose response relationship exists between dietary and supplemental vitamin D intake and serum 25(OH)D concentrations. The systematic review, based on 76 RCTs, reported widely varying increases in serum concentrations of 25(OH)D for similar doses of vitamin D, with a general increase in serum concentration with dietary intake. The RCTs identified for the current report found increases in serum 25(OH)D with supplementation; however, the findings varied by age group and health status of participants, baseline vitamin D status, dose, duration, and assay used to assess serum 25(OH)D. LIMITATIONS: Studies on vitamin D and calcium were not specifically targeted at life stages (except for pregnant and postmenopausal women) specified for the determination of DRI and were often underpowered for their intended outcomes. Studies vary widely in methodological quality and in the assays used to measure vitamin D status. CONCLUSIONS: In solid agreement with the findings of the original report, the majority of the findings concerning vitamin D, alone or in combination with calcium, on the health outcomes of interest were inconsistent. Associations observed in prospective cohort and nested case-control studies were inconsistent, or when consistent, were rarely supported by the results of randomized controlled trials. Clear dose-response relationships between intakes of vitamin D and health outcomes were rarely observed. Although a large number of new studies (and longer followups to older studies) were identified, particularly for cardiovascular outcomes, all-cause mortality, several types of cancer, and intermediate outcomes for bone health, no firm conclusions can be drawn. Studies identified for the current report suggest a possible U-shaped association between serum 25(OH)D concentrations and both all-cause mortality and hypertension and also suggest that the level of supplemental vitamin D and calcium administered in the Women's Health Initiative Calcium-Vitamin D Trial are not associated with an increased risk for cardiovascular disease or cancer among postmenopausal women who are not taking additional supplemental vitamin D and calcium. Studies suggest the method used to assay 25(OH)D may influence the outcomes of dose-response assessments. Beyond these observations, it is difficult to make any substantive statements on the basis of the available evidence concerning the association of either serum 25(OH)D concentration, vitamin D supplementation, calcium intake, or the combination of both nutrients, with the various health outcomes because most of the findings were inconsistent.

WITHDRAWN: Spinal manipulative therapy for low-back pain.

BACKGROUND: Low-back pain is a costly illness for which spinal manipulative therapy is commonly recommended. Previous systematic reviews and practice guidelines have reached discordant results on the effectiveness of this therapy for low-back pain. OBJECTIVES: To resolve the discrepancies related to the use of spinal manipulative therapy and to update previous estimates of effectiveness, by comparing spinal manipulative therapy with other therapies and then incorporating data from recent high-quality randomized, controlled trials (RCTs) into the analysis. SEARCH METHODS: The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL were electronically searched from their respective beginning to January 2000, using the Back Group search strategy; references from previous systematic reviews were also screened. SELECTION CRITERIA: Randomized, controlled trials (RCT) that evaluated spinal manipulative therapy for patients with low-back pain, with at least one day of follow-up, and at least one clinically-relevant outcome measure. DATA COLLECTION AND ANALYSIS: Two authors, who served as the authors for all stages of the meta-analysis, independently extracted data from unmasked articles. Comparison treatments were classified into the following seven categories: sham, conventional general practitioner care, analgesics, physical therapy, exercises, back school, or a collection of therapies judged to be ineffective or even harmful (traction, corset, bed rest, home care, topical gel, no treatment, diathermy, and minimal massage). MAIN RESULTS: Thirty-nine RCTs were identified. Meta-regression models were developed for acute or chronic pain and short-term and long-term pain and function. For patients with acute low-back pain, spinal manipulative therapy was superior only to sham therapy (10-mm difference [95% CI, 2 to 17 mm] on a 100-mm visual analogue scale) or therapies judged to be ineffective or even harmful. Spinal manipulative therapy had no statistically or clinically significant advantage over general practitioner care, analgesics, physical therapy, exercises, or back school. Results for patients with chronic low-back pain were similar. Radiation of pain, study quality, profession of manipulator, and use of manipulation alone or in combination with other therapies did not affect these results. AUTHORS' CONCLUSIONS: There is no evidence that spinal manipulative therapy is superior to other standard treatments for patients with acute or chronic low-back pain.

Design of a continuous quality improvement program to prevent falls among community-dwelling older adults in an integrated healthcare system.

BACKGROUND: Implementing quality improvement programs that require behavior change on the part of health care professionals and patients has proven difficult in routine care. Significant randomized trial evidence supports creating fall prevention programs for community-dwelling older adults, but adoption in routine care has been limited. Nationally-collected data indicated that our local facility could improve its performance on fall prevention in community-dwelling older people. We sought to develop a sustainable local fall prevention program, using theory to guide program development. METHODS: We planned program development to include important stakeholders within our organization. The theory-derived plan consisted of 1) an initial leadership meeting to agree on whether creating a fall prevention program was a priority for the organization, 2) focus groups with patients and health care professionals to develop ideas for the program, 3) monthly workgroup meetings with representatives from key departments to develop a blueprint for the program, 4) a second leadership meeting to confirm that the blueprint developed by the workgroup was satisfactory, and also to solicit feedback on ideas for program refinement. RESULTS: The leadership and workgroup meetings occurred as planned and led to the development of a functional program. The focus groups did not occur as planned, mainly due to the complexity of obtaining research approval for focus groups. The fall prevention program uses an existing telephonic nurse advice line to 1) place outgoing calls to patients at high fall risk, 2) assess these patients' risk factors for falls, and 3) triage these patients to the appropriate services. The workgroup continues to meet monthly to monitor the progress of the program and improve it. CONCLUSION: A theory-driven program development process has resulted in the successful initial implementation of a fall prevention program.

Randomized controlled trial of mindfulness-based therapy for dyspnea in chronic obstructive lung disease.

OBJECTIVES: Patients with chronic obstructive lung disease (COPD) suffer from significant dyspnea and may benefit from complementary and alternative medicine (CAM) therapies aimed at mitigating symptoms. The objective of this study was to test the efficacy of a mindfulness-based breathing therapy (MBBT) on improving symptoms and health-related quality of life in those with COPD. DESIGN: We conducted a randomized controlled trial of 8-week mindfulness-based breathing therapy (MBBT) compared to support groups to test efficacy on improving symptoms and health-related quality of life in those with COPD. SETTING: The setting for this study was an academic-affiliated veterans healthcare system. SUBJECTS: The subjects consisted of 86 patients with COPD. INTERVENTIONS: MBBT included weekly meetings practicing mindfulness mediation and relaxation response. OUTCOME MEASURES: The main outcome measure was a post 6-minute-walk test (6MWT) Borg dyspnea assessment. Other outcome measures included health-related quality of life measures, 6MWT distance, symptom scores, exacerbation rates, and measures of stress and mindfulness. Analysis of covariance compared differences in outcomes between groups; paired t test evaluated changes within groups. RESULTS: Participants were predominantly elderly men with moderate to severe COPD. We found no improvements in dyspnea (post 6MWT Borg difference between the MBBT and support group was 0.3 (95% confidence interval [CI]: -1.1, 1.7). We found no differences between groups in almost all other outcome measures by either intention-to-treat analysis or within the subset that completed assigned group sessions. For the physical summary scale of the generic Short Form-36 for Veterans, the difference between outcomes favored the support group (4.3, 95% CI: 0.4, 8.1). Participant retention was low compared to mind-body trials that randomize from CAM wait lists. CONCLUSIONS: This trial found no measurable improvements in patients with COPD receiving a mindfulness-based breathing CAM therapy compared to a support group, suggesting that this intervention is unlikely to be an important therapeutic option for those with moderate-to-severe COPD.

Bariatric surgery in women of reproductive age: special concerns for pregnancy.

CONTEXT: The use of bariatric surgery for treating severe obesity has increased dramatically over the past 10 years; about half of patients who undergo these procedures are women of reproductive age. This report was commissioned to measure the incidence of bariatric surgery in this population and review the evidence on the impact of bariatric surgery on fertility and subsequent pregnancy. OBJECTIVES: To measure the incidence of contemporary bariatric surgery procedures in women age 18-45 and to assess its impact on fertility, contraception, prepregnancy risk factors, and pregnancy outcomes, including those of neonates. DATA SOURCES AND STUDY SELECTION: Nationwide Inpatient Sample (NIS), a national sample of over 1,000 hospitals, to measure the trend in the number of women of reproductive age who underwent bariatric procedures from 1998-2005. We searched numerous electronic databases, including MEDLINE and Embase, for potentially relevant studies involving bariatric surgery (gastric bypass, laparoscopic adjustable gastric band, vertical-banded gastroplasty, biliopancreatic diversion), and consequent fertility, contraception, pregnancy, weight management, maternal and neonatal outcomes, and nutritional deficiencies. We scanned reference lists for additional relevant articles and contacted experts in the fields of bariatric surgery and obstetrics/gynecology (OB/GYN). Of 223 screened articles, we accepted 57 that reported on fertility following surgery (19 articles), contraception use/recommendations (11), maternal weight or nutrition management (28), maternal outcomes including morbidity and mortality (48), cesarean-section rates (16), and neonatal outcomes (44). These articles included reports on gastric bypass, both open and laparoscopic (27 articles), laparoscopic adjustable band (15), biliopancreatic diversion (16), and vertical-banded gastroplasty (6). Studies could contribute to one or more analyses. We found one case-control study and the observational data accepted included 12 cohort studies, 21 case series, and 23 individual case reports. DATA EXTRACTION: We abstracted information about study design, fertility history, fertility outcomes, prepregnancy weight loss, nutritional management, outcomes following pregnancy, and adverse events (during pregnancy) related to surgery. DATA SYNTHESIS: Nationally representative data showed a six-fold increase in bariatric surgery inpatient procedures from 1998 to 2005. Women age 18-45 accounted for about half of the patients undergoing bariatric surgery; over 50,000 have these procedures as inpatients annually. An unknown number have outpatient bariatric procedures. We identified one case-control study that directly addressed some of the key questions, but no randomized controlled trials or prospective cohort studies, which would be the strongest study designs to answer questions about effectiveness, risk and prognosis. Consequently, all of our conclusions are limited by the available data, and are cautious.The evidence suggests that bariatric surgery results in improved fertility; the strongest evidence is in women with the polycystic ovarian syndrome, where biochemical studies showing normalization of hormones after surgery support case series data. Observational studies (retrospective cohorts and case series) suggest that fertility improves following bariatric procedures and weight loss; similar to that seen when obese women lose weight through nonsurgical means. There is almost no evidence on post-surgical contraceptive efficacy or use. Research is needed to determine whether differences in absorption, particularly for oral contraceptives, affect contraceptive efficacy. Nutrient deficiencies were reported in infants born to women who underwent procedures that resulted in malabsorption, as well as women who did not take prenatal vitamins or had difficulty with their own nutrition (i.e., from chronic vomiting). Literature suggests that gastric bypass and laparoscopic adjustable band procedures confer only minimal, if any, increased risk of nutritional or congenital problems if supplemental vitamins are taken and maternal nutrition is otherwise adequate. Biliopancreatic diversion has an appreciable risk for nutritional problems in some patients. Women who have undergone bariatric surgery may have less risk than obese women for certain pregnancy complications such as gestational diabetes, preeclampsia, and pregnancy induced hypertension. There is no evidence that cesarean section rates and delivery complications are higher in the post-surgery group, but data are limited. CONCLUSIONS: Weight loss procedures are being performed more frequently to treat morbid obesity, with a six-fold increase over a recent 7-year time span; almost half of all patients are women of reproductive age. The level of evidence on fertility, contraception, and pregnancy outcomes is limited to observational studies. Data suggest that fertility improves after bariatric surgical procedures, nutritional deficiencies for mother and child are minimal, and maternal and neonatal outcomes are acceptable with laparoscopic adjustable band and gastric bypass as long as adequate maternal nutrition and vitamin supplementation are maintained. There is no evidence that delivery complications are higher in post-surgery pregnancies.