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).

Perioperative management of antiplatelet therapy in patients undergoing non-cardiac surgery following coronary stent placement: a systematic review.

BACKGROUND: The correct perioperative management of antiplatelet therapy (APT) in patients undergoing non-cardiac surgery (NCS) is often debated by clinicians. American College of Cardiology (ACC) and American Heart Association (AHA) guidelines recommend postponing elective NCS at least 3 months after stent implantation. Regardless of the timing of surgery, ACC/AHA guidelines recommend continuing at least ASA throughout the perioperative period and ideally continuing dual APT (DAPT) therapy "unless surgery demands discontinuation." The objective of this review was to ascertain the risks and benefits of APT in the perioperative period, to assess how these risks and benefits vary by APT management, and the significance of length of time since stent implantation before operative intervention. METHODS: PubMed, Web of Science, and Scopus were searched from inception through October 2017. Articles were included if patients were post PCI with stent placement (bare metal [BMS] or drug eluting [DES]), underwent elective NCS, and had rates of major adverse cardiac events (MACE) or bleeding events associated with pre and perioperative APT therapy. RESULTS: Of 4882 screened articles, we included 16 studies in the review (1 randomized controlled trial and 15 observational studies). Studies were small (< 50: n = 5, 51-150: n = 5, >150: n = 6). All studies included DES with 7 of 16 also including BMS. Average time from stent to NCS was variable (< 6 months: n = 3, 6-12 months: n = 1, > 12 months: n = 6). At least six different APT strategies were described. Six studies further utilized bridging protocols using three different pharmacologic agents. Studies typically included multiple surgical fields with varying degrees of invasiveness. Across all APT strategies, rates of MACE/bleeding ranged from 0 to 21% and 0 to 22%. There was no visible trend in MACE/bleeding rates within a given APT strategy. Stratifying the articles by type of surgery, timing of discontinuation of APT therapy, bridging vs. no bridging, and time since stent placement did not help explain the heterogeneity. CONCLUSIONS: Evidence regarding perioperative APT management in patients with cardiac stents undergoing NCS is insufficient to guide practice. Other clinical factors may have a greater impact than perioperative APT management on MACE and bleeding events. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016036607.

Recruiting Rural Healthcare Providers Today: a Systematic Review of Training Program Success and Determinants of Geographic Choices.

BACKGROUND: Rural areas have historically struggled with shortages of healthcare providers; however, advanced communication technologies have transformed rural healthcare, and practice in underserved areas has been recognized as a policy priority. This systematic review aims to assess reasons for current providers' geographic choices and the success of training programs aimed at increasing rural provider recruitment. METHODS: This systematic review (PROSPERO: CRD42015025403) searched seven databases for published and gray literature on the current cohort of US rural healthcare practitioners (2005 to March 2017). Two reviewers independently screened citations for inclusion; one reviewer extracted data and assessed risk of bias, with a senior systematic reviewer checking the data; quality of evidence was assessed using the GRADE approach. RESULTS: Of 7276 screened citations, we identified 31 studies exploring reasons for geographic choices and 24 studies documenting the impact of training programs. Growing up in a rural community is a key determinant and is consistently associated with choosing rural practice. Most existing studies assess physicians, and only a few are based on multivariate analyses that take competing and potentially correlated predictors into account. The success rate of placing providers-in-training in rural practice after graduation, on average, is 44% (range 20-84%; N = 31 programs). We did not identify program characteristics that are consistently associated with program success. Data are primarily based on rural tracks for medical residents. DISCUSSION: The review provides insight into the relative importance of demographic characteristics and motivational factors in determining which providers should be targeted to maximize return on recruitment efforts. Existing programs exposing students to rural practice during their training are promising but require further refining. Public policy must include a specific focus on the trajectory of the healthcare workforce and must consider alternative models of healthcare delivery that promote a more diverse, interdisciplinary combination of providers.

Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis.

IMPORTANCE: Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. OBJECTIVE: To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. DATA SOURCES: Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. DATA EXTRACTION AND SYNTHESIS: Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. MAIN OUTCOMES AND MEASURES: Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. FINDINGS: Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, -9.95 [95% CI, -15.6 to -4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, -0.39 [95% CI, -0.71 to -0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT. CONCLUSIONS AND RELEVANCE: Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

A systematic review of modifiable risk factors in the progression of multiple sclerosis.

BACKGROUND: The presenting symptoms and rate of progression of multiple sclerosis (MS) are very heterogeneous. The diverse clinical manifestations and the clinical course of the disease may vary with modifiable risk factors. OBJECTIVE: To systematically review modifiable risk factors and exposures associated with MS progression. METHODS: We searched six databases till March 2015, reference-mined reviews, and consulted with experts (PROSPERO 2015:CRD42015016461). Two reviewers screened and extracted data. We used random meta-analysis models and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to assess the quality of evidence. RESULTS: In total, 59 studies met inclusion criteria. Lower vitamin D levels were associated with higher Expanded Disability Status Scale (EDSS) scores ( r = -0.22; confidence interval (CI) = -0.32, -0.12; 11 studies; I2 = 66%), smokers had an increased risk of MS progression (hazard ratio (HR) = 1.55; CI = 1.10, 2.19; I2 = 72%; seven studies), and there was no association of MS progression with the use of epidural analgesics during childbirth delivery (three studies). There was insufficient evidence to draw conclusions for 11 risk factors due to conflicting results or use of different predictor and outcome measures. CONCLUSION: MS progression was consistently associated with low vitamin D levels, and smoking was associated with a more rapid decline in MS disability. Studies used a variety of methods, predictors, and outcomes making it difficult to draw conclusions. Future studies should focus on prospective assessments.

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.

Mental Health Conditions Among Patients Seeking and Undergoing Bariatric Surgery: A Meta-analysis.

IMPORTANCE: Bariatric surgery is associated with sustained weight loss and improved physical health status for severely obese individuals. Mental health conditions may be common among patients seeking bariatric surgery; however, the prevalence of these conditions and whether they are associated with postoperative outcomes remains unknown. OBJECTIVE: To determine the prevalence of mental health conditions among bariatric surgery candidates and recipients, to evaluate the association between preoperative mental health conditions and health outcomes following bariatric surgery, and to evaluate the association between surgery and the clinical course of mental health conditions. DATA SOURCES: We searched PubMed, MEDLINE on OVID, and PsycINFO for studies published between January 1988 and November 2015. Study quality was assessed using an adapted tool for risk of bias; quality of evidence was rated based on GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. FINDINGS: We identified 68 publications meeting inclusion criteria: 59 reporting the prevalence of preoperative mental health conditions (65,363 patients) and 27 reporting associations between preoperative mental health conditions and postoperative outcomes (50,182 patients). Among patients seeking and undergoing bariatric surgery, the most common mental health conditions, based on random-effects estimates of prevalence, were depression (19% [95% CI, 14%-25%]) and binge eating disorder (17% [95% CI, 13%-21%]). There was conflicting evidence regarding the association between preoperative mental health conditions and postoperative weight loss. Neither depression nor binge eating disorder was consistently associated with differences in weight outcomes. Bariatric surgery was, however, consistently associated with postoperative decreases in the prevalence of depression (7 studies; 8%-74% decrease) and the severity of depressive symptoms (6 studies; 40%-70% decrease). CONCLUSIONS AND RELEVANCE: Mental health conditions are common among bariatric surgery patients-in particular, depression and binge eating disorder. There is inconsistent evidence regarding the association between preoperative mental health conditions and postoperative weight loss. Moderate-quality evidence supports an association between bariatric surgery and lower rates of depression postoperatively.

Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires : A Systematic Review of Surgical Never Events.

IMPORTANCE: Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts. OBJECTIVE: To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004. DATA SOURCES: We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts. STUDY SELECTION: Two independent reviewers identified relevant publications in June 2014. DATA EXTRACTION AND SYNTHESIS: One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015. MAIN OUTCOMES AND MEASURES: Incidence of wrong-site surgery, retained surgical items, and surgical fires. RESULTS: We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10,000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10,000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix-coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable. CONCLUSIONS AND RELEVANCE: Current estimates for wrong-site surgery and retained surgical items are 1 event per 100,000 and 1 event per 10,000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.

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).

Electronic patient portals: evidence on health outcomes, satisfaction, efficiency, and attitudes: a systematic review.

BACKGROUND: Patient portals tied to provider electronic health record (EHR) systems are increasingly popular. PURPOSE: To systematically review the literature reporting the effect of patient portals on clinical care. DATA SOURCES: PubMed and Web of Science searches from 1 January 1990 to 24 January 2013. STUDY SELECTION: Hypothesis-testing or quantitative studies of patient portals tethered to a provider EHR that addressed patient outcomes, satisfaction, adherence, efficiency, utilization, attitudes, and patient characteristics, as well as qualitative studies of barriers or facilitators, were included. DATA EXTRACTION: Two reviewers independently extracted data and addressed discrepancies through consensus discussion. DATA SYNTHESIS: From 6508 titles, 14 randomized, controlled trials; 21 observational, hypothesis-testing studies; 5 quantitative, descriptive studies; and 6 qualitative studies were included. Evidence is mixed about the effect of portals on patient outcomes and satisfaction, although they may be more effective when used with case management. The effect of portals on utilization and efficiency is unclear, although patient race and ethnicity, education level or literacy, and degree of comorbid conditions may influence use. LIMITATION: Limited data for most outcomes and an absence of reporting on organizational and provider context and implementation processes. CONCLUSION: Evidence that patient portals improve health outcomes, cost, or utilization is insufficient. Patient attitudes are generally positive, but more widespread use may require efforts to overcome racial, ethnic, and literacy barriers. Portals represent a new technology with benefits that are still unclear. Better understanding requires studies that include details about context, implementation factors, and cost.