Methods for Identifying Health Research Gaps, Needs, and Priorities: A Scoping Review.

Well-defined, systematic, and transparent processes to identify health research gaps, needs, and priorities are vital to ensuring that available funds target areas with the greatest potential for impact. This study documents a scoping review of published methods used for identifying health research gaps, establishing research needs, and determining research priorities and provides relevant information on 362 studies. Of the 362 studies, 167 were linked to funding decisionmaking and underwent a more detailed data abstraction process. The authors noted that most studies focused on physical health conditions, but few addressed psychological health conditions. The most frequent method for identifying research gaps, needs, and priorities was to convene workshops or conferences. One-third of studies employed quantitative methods, and nearly as many used the James Lind Alliance Priority Setting Partnerships approach. Other methods included literature reviews, qualitative methods, consensus methods, and reviews of source materials. The criterion most widely applied to determine health research gaps, needs, and priorities was the importance to stakeholders, followed by the potential value and feasibility of carrying out the research. The two largest stakeholder groups were researchers and clinicians. More than one-half the studies involved patients and the public as stakeholders. Very few studies have evaluated the impact of methods used to identify research gaps, needs, and priorities. This study provides a roadmap of methods used for identifying health research gaps, needs, and priorities, which may help accelerate progress toward validating methods that ensure the effective targeting of funds to meet the greatest areas of need and to maximize impact.

Sleep Management in Posttraumatic Stress Disorder (PTSD): A Systematic Review.

Posttraumatic stress disorder (PTSD) is a condition that can emerge after exposure to a traumatic event. It involves several symptoms, including distressing memories or dreams and/or dissociative reactions; psychological distress at exposure to trauma cues; physiologic reactions to cues; avoidance of stimuli associated with the event; negative alterations in cognitions and mood associated with the trauma; and alterations in arousal and reactivity, including sleep disturbance. The purpose of this systematic review is to synthesize the evidence from randomized controlled trials on the effects that interventions for adults with PTSD have on sleep outcomes. The authors searched research databases and bibliographies of existing systematic reviews to identify pertinent trials published in English; literature was identified by the searches using predetermined eligibility criteria. The primary outcome domain included sleep quality, insomnia, and nightmares. Secondary outcomes were PTSD symptoms and adverse events. Risk of bias and the quality of evidence were assessed for each outcome. The identified interventions addressed pharmacological, psychological, behavioral, complementary, and integrative medicine treatments aimed at improving sleep or lessening other PTSD symptoms. Interventions in general showed an effect on sleep. Interventions explicitly targeting sleep-particularly psychotherapy targeting sleep-showed larger effects on sleep than did interventions not targeting sleep. Heterogeneity was considerable, but sleep effect estimates were not systematically affected by trauma type, setting, or modality. Comparative effectiveness studies are needed to support the findings.

Sleep management in posttraumatic stress disorder: a systematic review and meta-analysis.

OBJECTIVE: Post-traumatic stress disorder (PTSD) can lead to many negative secondary outcomes for patients, including sleep disturbances. The objective of this meta-analysis is (1) to evaluate the effect of interventions for adults with PTSD on sleep outcomes, PTSD outcomes, and adverse events, and (2) to evaluate the differential effectiveness of interventions aiming to improve sleep compared to those that do not. METHODS: Nine databases were searched for relevant randomized controlled trials (RCTs) in PTSD from January 1980 to October 2019. Two independent reviewers screened 7176 records, assessed 2139 full-text articles, and included 89 studies in 155 publications for this review. Sleep, PTSD, and adverse event outcomes were abstracted and meta-analyses were performed using the Hartung-Knapp-Sidik-Jonkman method for random effects. RESULTS: Interventions improved sleep outcomes (standardized mean difference [SMD] -0.56; confidence interval [CI] -0.75 to -0.37; 49 RCTs) and PTSD symptoms (SMD -0.48; CI -0.67 to -0.29; 44 RCTs) across studies. Adverse events were not related to interventions overall (RR 1.17; CI 0.91 to 1.49; 15 RCTs). Interventions targeting sleep improved sleep outcomes more than interventions that did not target sleep (p = 0.03). Improvement in PTSD symptoms did not differ between intervention types. CONCLUSIONS: Interventions for patients with PTSD significantly improve sleep outcomes, especially interventions that specifically target sleep. Treatments for adults with PTSD directed towards sleep improvement may benefit patients who suffer from both ailments.

The Use of Technology in the Clinical Care of Depression: An Evidence Map.

OBJECTIVE: Depression is a highly prevalent clinical condition. The use of technologies in the clinical care of depressive disorders may increase the reach of clinical services for these disorders and support more comprehensive treatment. The objective of this evidence map is to provide an overview of the use of technology in the clinical care of depression. DATA SOURCES: We searched PubMed, PsycINFO, and the Web of Science from inception to June 2017 to identify published randomized controlled trials (RCTs). STUDY SELECTION: Two reviewers used predetermined eligibility criteria to review 4,062 records and include 161 RCTs that met our inclusion criteria. We include studies evaluating any type of treatment-related technology in the clinical care of depression. DATA EXTRACTION: We extracted data on sample sizes, the type of technology examined, the function of that technology, the effectiveness of the technology, and publication year. RESULTS: Out of 161 RCTs, we found the greatest amount of research for psychotherapy by computer (51 RCTs). The majority of studies were published after 2012 (94 RCTs; 58%). Few published studies involved videoconferences or smartphones, or provider feedback or auto-reminders. 145 studies (90%) reported that the intervention had a positive outcome of symptom improvement compared to baseline. CONCLUSIONS: This evidence map provides a broad overview of the existing research evaluating technology in depression care. Computer applications are still most common. Almost all applications yield symptom improvement. More information is needed to evaluate the role of technology in clinical care.

Efficacy of mindfulness meditation for smoking cessation: A systematic review and meta-analysis.

BACKGROUND: Smokers increasingly seek alternative interventions to assist in cessation or reduction efforts. Mindfulness meditation, which facilitates detached observation and paying attention to the present moment with openness, curiosity, and acceptance, has recently been studied as a smoking cessation intervention. AIMS: This review synthesizes randomized controlled trials (RCTs) of mindfulness meditation (MM) interventions for smoking cessation. METHODS: Five electronic databases were searched from inception to October 2016 to identify English-language RCTs evaluating the efficacy and safety of MM interventions for smoking cessation, reduction, or a decrease in nicotine cravings. Two independent reviewers screened literature using predetermined eligibility criteria, abstracted study-level information, and assessed the quality of included studies. Meta-analyses used the Hartung-Knapp-Sidik-Jonkman method for random-effects models. The quality of evidence was assessed using the GRADE approach. FINDINGS: Ten RCTs of MM interventions for tobacco use met inclusion criteria. Intervention duration, intensity, and comparison conditions varied considerably. Studies used diverse comparators such as the American Lung Association's Freedom from Smoking (FFS) program, quitline counseling, interactive learning, or treatment as usual (TAU). Only one RCT was rated as good quality and reported power calculations indicating sufficient statistical power. Publication bias was detected. Overall, mindfulness meditation did not have significant effects on abstinence or cigarettes per day, relative to comparator groups. The small number of studies and heterogeneity in interventions, comparators, and outcomes precluded detecting systematic differences between adjunctive and monotherapy interventions. No serious adverse events were reported. CONCLUSIONS: MM did not differ significantly from comparator interventions in their effects on tobacco use. Low-quality evidence, variability in study design among the small number of existing studies, and publication bias suggest that additional, high-quality adequately powered RCTs should be conducted.

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis.

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.

Meditation for posttraumatic stress: Systematic review and meta-analysis.

OBJECTIVE: We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. METHOD: Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. CONCLUSIONS: Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes. (PsycINFO Database Record

St. John's Wort for Major Depressive Disorder: A Systematic Review.

RAND researchers conducted a systematic review that synthesized evidence from randomized controlled trials of St. John's wort (SJW)-used adjunctively or as monotherapy-to provide estimates of its efficacy and safety in treating adults with major depressive disorder. Outcomes of interest included changes in depressive symptomatology, quality of life, and adverse effects. Efficacy meta-analyses used the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. In total, 35 studies met inclusion criteria. There is moderate evidence, due to unexplained heterogeneity between studies, that depression improvement based on the number of treatment responders and depression scale scores favors SJW over placebo, and results are comparable to antidepressants. The existing evidence is based on studies testing SJW as monotherapy; there is a lack of evidence for SJW given as adjunct therapy to standard antidepressant therapy. We found no systematic difference between SJW extracts, but head-to-head trials are missing; LI 160 (0.3% hypericin, 1-4% hyperforin) was the extract with the greatest number of studies. Only two trials assessed quality of life. SJW adverse events reported in included trials were comparable to placebo, and were fewer compared with antidepressant medication; however, adverse event assessments were limited, and thus we have limited confidence in this conclusion.

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.

Bariatric surgery for weight loss and glycemic control in nonmorbidly obese adults with diabetes: a systematic review.

IMPORTANCE: Bariatric surgery is beneficial in persons with a body mass index (BMI) of 35 or greater with obesity-related comorbidities. There is interest in using these procedures in persons with lower BMI and diabetes. OBJECTIVE: To assess the association between bariatric surgery vs nonsurgical treatments and weight loss and glycemic control among patients with diabetes or impaired glucose tolerance and BMI of 30 to 35. EVIDENCE REVIEW: PubMed, EMBASE, and Cochrane Library databases were searched from January 1985 through September 2012. Of 1291 screened articles, we included 32 surgical studies, 11 systematic reviews on nonsurgical treatments, and 11 large nonsurgical studies published after those reviews. Weight loss, metabolic outcomes, and adverse events were abstracted by 2 independent reviewers. FINDINGS: Three randomized clinical trials (RCTs) (N = 290; including 1 trial of 150 patients with type 2 diabetes and mean BMI of 37, 1 trial of 80 patients without diabetes [38% with metabolic syndrome] and BMI of 30 to 35, and 1 trial of 60 patients with diabetes and BMI of 30 to 40 [13 patients with BMI <35]) found that surgery was associated with greater weight loss (range, 14.4-24 kg) and glycemic control (range, 0.9-1.43 point improvements in hemoglobin A1c levels) during 1 to 2 years of follow-up than nonsurgical treatment. Indirect comparisons of evidence from observational studies of bariatric procedures (n ≈ 600 patients) and meta-analyses of nonsurgical therapies (containing more than 300 RCTs) support this finding at 1 or 2 years of follow-up. However, there are no robust surgical data beyond 5 years of follow-up on outcomes of diabetes, glucose control, or macrovascular and microvascular outcomes. In contrast, some RCT data of nonsurgical therapies show benefits at 10 years of follow-up or more. Surgeon-reported adverse events were low (eg, hospital deaths of 0.3%-1.0%), but data were from select centers and surgeons. Long-term adverse events are unknown. CONCLUSIONS AND RELEVANCE: Current evidence suggests that, when compared with nonsurgical treatments, bariatric surgical procedures in patients with a BMI of 30 to 35 and diabetes are associated with greater short-term weight loss and better intermediate glucose outcomes. Evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this population until more data are available about long-term outcomes and complications of surgery.

Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis.

CONTEXT: Atypical antipsychotic medications are commonly used for off-label conditions such as agitation in dementia, anxiety, and obsessive-compulsive disorder. OBJECTIVE: To perform a systematic review on the efficacy and safety of atypical antipsychotic medications for use in conditions lacking approval for labeling and marketing by the US Food and Drug Administration. DATA SOURCES AND STUDY SELECTION: Relevant studies published in the English language were identified by searches of 6 databases (PubMed, EMBASE, CINAHL, PsycInfo, Cochrane DARE, and CENTRAL) from inception through May 2011. Controlled trials comparing an atypical antipsychotic medication (risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, or paliperidone) with placebo, another atypical antipsychotic medication, or other pharmacotherapy for adult off-label conditions were included. Observational studies with sample sizes of greater than 1000 patients were included to assess adverse events. DATA EXTRACTION: Independent article review and study quality assessment by 2 investigators. DATA SYNTHESIS: Of 12 228 citations identified, 162 contributed data to the efficacy review. Among 14 placebo-controlled trials of elderly patients with dementia reporting a total global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effects sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, a pooled analysis of 3 trials showed that quetiapine was associated with a 26% greater likelihood of a favorable response (defined as at least 50% improvement on the Hamilton Anxiety Scale) compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of a favorable response (defined as a 25% improvement on the Yale-Brown Obsessive Compulsive Scale) compared with placebo. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH] = 87), stroke (NNH = 53 for risperidone), extrapyramidal symptoms (NNH = 10 for olanzapine; NNH = 20 for risperidone), and urinary tract symptoms (NNH range = 16-36). In nonelderly adults, adverse events included weight gain (particularly with olanzapine), fatigue, sedation, akathisia (for aripiprazole), and extrapyramidal symptoms. CONCLUSIONS: Benefits and harms vary among atypical antipsychotic medications for off-label use. For global behavioral symptom scores associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder; however, adverse events were common.