Interventions That Support or Involve Caregivers or Families of Patients with Traumatic Injury: a Systematic Review.

BACKGROUND: Almost 40 million family caregivers care for a loved one with severe physical or cognitive impairments. The purpose of this review is to summarize evidence about the benefits of interventions to support or involve family members/caregivers of patients with trauma-related injury on caregiver, patient, and household outcomes. METHODS: English-language peer-reviewed publications in MEDLINE, CINAHL, and PsycINFO from 1995 through December 2016 were identified. Eligible studies included RCT or quasi-experimental studies evaluating interventions designed to support or involve caregivers or family members of patients with TBI, PTSD, or polytrauma. Abstractions were completed by one reviewer and checked by a second; two reviewers independently assessed risk of bias using the Cochrane Effective Practice and Organization of Care Review Criteria. RESULTS: Thirteen studies (n = 9 TBI; n = 4 PTSD, n = 0 polytrauma) evaluated psychological or rehabilitation interventions involving caregivers. Interventions did not improve TBI patients' functional status (standardized mean difference [SMD], 0.29 [95% confidence interval [CI], - 0.51 to 1.08]) or psychological symptoms (SMD - 0.25, CI - 0.62 to 0.12). Qualitative analysis shows potential intervention benefit for TBI symptoms. Interventions did not improve TBI caregiver psychological symptoms (SMD - 0.26, CI - 0.57 to 0.05); however, qualitative analysis suggests mixed effects for caregiver burden and quality of life. Positive intervention effects on patients' PTSD symptoms, mental health service use, and PTSD caregivers' psychological symptoms were identified with certain interventions. Strength of evidence ranged from moderate to very low. DISCUSSION: Studies showed mixed patterns of intervention effects on caregiver and patient outcomes; evidence about intervention impact is inconclusive. This review is the first to identify caregiving interventions for patients with TBI and polytrauma and extends past reviews about patients with PTSD. Limitations include a small evidence base, low study quality, disparate methods, varied outcome measures, and high heterogeneity. PROSPERO Registration CRD42017053516.

Telehealth Interventions Designed for Women: an Evidence Map.

BACKGROUND: Telehealth employs technology to connect patients to the right healthcare resources at the right time. Women are high utilizers of healthcare with gender-specific health issues that may benefit from the convenience and personalization of telehealth. Thus, we produced an evidence map describing the quantity, distribution, and characteristics of evidence assessing the effectiveness of telehealth services designed for women. METHODS: We searched MEDLINE® (via PubMed®) and Embase® from inception through March 20, 2018. We screened systematic reviews (SRs), randomized trials, and quasi-experimental studies using predetermined eligibility criteria. Articles meeting inclusion criteria were identified for data abstraction. To assess emerging trends, we also conducted a targeted search of ClinicalTrials.gov . RESULTS: Two hundred thirty-four primary studies and three SRs were eligible for abstraction. We grouped studies into focused areas of research: maternal health (n = 96), prevention (n = 46), disease management (n = 63), family planning (n = 9), high-risk breast cancer assessment (n = 10), intimate partner violence (n = 7), and mental health (n = 3). Most interventions focused on phone as the primary telehealth modality and featured healthcare team-to-patient communication and were limited in duration (e.g., < 12 weeks). Few interventions were conducted with older women (≥ 60 years) or in racially/ethnically diverse populations. There are few SRs in this area and limited evidence regarding newer telehealth modalities such as mobile-based applications or short message service/texting. Targeted search of clinical.trials.gov yielded 73 ongoing studies that show a shift in the use of non-telephone modalities. DISCUSSION: Our systematic evidence map highlights gaps in the existing literature, such as a lack of studies in key women's health areas (intimate partner violence, mental health), and a dearth of relevant SRs. With few existing SRs in this literature, there is an opportunity for examining effects, efficiency, and acceptability across studies to inform efforts at implementing telehealth for women.

Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review.

BACKGROUND: Recent changes to the U.S. Food and Drug Administration boxed warning for metformin will increase its use in persons with historical contraindications or precautions. Prescribers must understand the clinical outcomes of metformin use in these populations. PURPOSE: To synthesize data addressing outcomes of metformin use in populations with type 2 diabetes and moderate to severe chronic kidney disease (CKD), congestive heart failure (CHF), or chronic liver disease (CLD) with hepatic impairment. DATA SOURCES: MEDLINE (via PubMed) from January 1994 to September 2016, and Cochrane Library, EMBASE, and International Pharmaceutical Abstracts from January 1994 to November 2015. STUDY SELECTION: English-language studies that: 1) examined adults with type 2 diabetes and CKD (with estimated glomerular filtration rate less than 60 mL/min/1.73 m2), CHF, or CLD with hepatic impairment; 2) compared diabetes regimens that included metformin with those that did not; and 3) reported all-cause mortality, major adverse cardiovascular events, and other outcomes of interest. DATA EXTRACTION: 2 reviewers abstracted data and independently rated study quality and strength of evidence. DATA SYNTHESIS: On the basis of quantitative and qualitative syntheses involving 17 observational studies, metformin use is associated with reduced all-cause mortality in patients with CKD, CHF, or CLD with hepatic impairment, and with fewer heart failure readmissions in patients with CKD or CHF. LIMITATIONS: Strength of evidence was low, and data on multiple outcomes of interest were sparse. Available studies were observational and varied in follow-up duration. CONCLUSION: Metformin use in patients with moderate CKD, CHF, or CLD with hepatic impairment is associated with improvements in key clinical outcomes. Our findings support the recent changes in metformin labeling. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs. (PROSPERO: CRD42016027708).

Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic Pain.

Systematic reviews (SRs) have the potential to contribute uniquely to the evaluation of sex and gender differences (termed "sex effects"). This article describes the reporting of sex effects by SRs on interventions for depression, type 2 diabetes mellitus, and chronic pain conditions (chronic low back pain, knee osteoarthritis, and fibromyalgia). It includes SRs published since 1 October 2009 that evaluate medications, behavioral interventions, exercise, quality improvement, and some condition-specific treatments. The reporting of sex effects by primary randomized, controlled trials is also examined. Of 313 eligible SRs (86 for depression, 159 for type 2 diabetes mellitus, and 68 for chronic pain), few (n = 29) reported sex effects. Most SRs reporting sex effects used metaregression, whereas 9 SRs used subgroup analysis or individual-patient data meta-analysis. The proportion of SRs reporting the sex distribution of primary studies varied from a low of 31% (n = 8) for low back pain to a high of 68% (n = 23) for fibromyalgia. Primary randomized, controlled trials also infrequently reported sex effects, and most lacked an adequate sample size to examine them. Therefore, all SRs should report the proportion of women enrolled in primary studies and evaluate sex effects using appropriate methods whenever power is adequate.

Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical Patients: A Systematic Review.

BACKGROUND: Thromboprophylaxis regimens include pharmacologic and mechanical options such as intermittent pneumatic compression devices (IPCDs). There are a wide variety of IPCDs available, but it is uncertain if they vary in effectiveness or ease of use. This is a systematic review of the comparative effectiveness of IPCDs for selected outcomes (mortality, venous thromboembolism [VTE], symptomatic or asymptomatic deep vein thrombosis, major bleeding, ease of use, and adherence) in postoperative surgical patients. METHODS: We searched MEDLINE (via PubMed), Embase, CINAHL, and Cochrane CENTRAL from January 1, 1995, to October 30, 2014, for randomized controlled trials, as well as relevant observational studies on ease of use and adherence. RESULTS: We identified 14 eligible randomized controlled trials (2633 subjects) and 3 eligible observational studies (1724 subjects); most were conducted in joint arthroplasty patients. Intermittent pneumatic compression devices were comparable to anticoagulation for major clinical outcomes (VTE: risk ratio, 1.39; 95% confidence interval, 0.73-2.64). Limited data suggest that concurrent use of anticoagulation with IPCD may lower VTE risk compared with anticoagulation alone, and that IPCD compared with anticoagulation may lower major bleeding risk. Subgroup analyses did not show significant differences by device location, mode of inflation, or risk of bias elements. There were no consistent associations between IPCDs and ease of use or adherence. CONCLUSIONS: Intermittent pneumatic compression devices are appropriate for VTE thromboprophylaxis when used in accordance with current clinical guidelines. The current evidence base to guide selection of a specific device or type of device is limited.

Effects of nurse-managed protocols in the outpatient management of adults with chronic conditions: a systematic review and meta-analysis.

BACKGROUND: Changes in federal health policy are providing more access to medical care for persons with chronic disease. Providing quality care may require a team approach, which the American College of Physicians calls the "medical home." One new model may involve nurse-managed protocols. PURPOSE: To determine whether nurse-managed protocols are effective for outpatient management of adults with diabetes, hypertension, and hyperlipidemia. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, and CINAHL from January 1980 through January 2014. STUDY SELECTION: Two reviewers used eligibility criteria to assess all titles, abstracts, and full texts and resolved disagreements by discussion or by consulting a third reviewer. DATA EXTRACTION: One reviewer did data abstractions and quality assessments, which were confirmed by a second reviewer. DATA SYNTHESIS: From 2954 studies, 18 were included. All studies used a registered nurse or equivalent who titrated medications by following a protocol. In a meta-analysis, hemoglobin A1c level decreased by 0.4% (95% CI, 0.1% to 0.7%) (n = 8); systolic and diastolic blood pressure decreased by 3.68 mm Hg (CI, 1.05 to 6.31 mm Hg) and 1.56 mm Hg (CI, 0.36 to 2.76 mm Hg), respectively (n = 12); total cholesterol level decreased by 0.24 mmol/L (9.37 mg/dL) (CI, 0.54-mmol/L decrease to 0.05-mmol/L increase [20.77-mg/dL decrease to 2.02-mg/dL increase]) (n = 9); and low-density-lipoprotein cholesterol level decreased by 0.31 mmol/L (12.07 mg/dL) (CI, 0.73-mmol/L decrease to 0.11-mmol/L increase [28.27-mg/dL decrease to 4.13-mg/dL increase]) (n = 6). LIMITATION: Studies had limited descriptions of the interventions and protocols used. CONCLUSION: A team approach that uses nurse-managed protocols may have positive effects on the outpatient management of adults with chronic conditions, such as diabetes, hypertension, and hyperlipidemia. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Evidence-based risk communication: a systematic review.

BACKGROUND: Effective communication of risks and benefits to patients is critical for shared decision making. PURPOSE: To review the comparative effectiveness of methods of communicating probabilistic information to patients that maximize their cognitive and behavioral outcomes. DATA SOURCES: PubMed (1966 to March 2014) and CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials (1966 to December 2011) using several keywords and structured terms. STUDY SELECTION: Prospective or cross-sectional studies that recruited patients or healthy volunteers and compared any method of communicating probabilistic information with another method. DATA EXTRACTION: Two independent reviewers extracted study characteristics and assessed risk of bias. DATA SYNTHESIS: Eighty-four articles, representing 91 unique studies, evaluated various methods of numerical and visual risk display across several risk scenarios and with diverse outcome measures. Studies showed that visual aids (icon arrays and bar graphs) improved patients' understanding and satisfaction. Presentations including absolute risk reductions were better than those including relative risk reductions for maximizing accuracy and seemed less likely than presentations with relative risk reductions to influence decisions to accept therapy. The presentation of numbers needed to treat reduced understanding. Comparative effects of presentations of frequencies (such as 1 in 5) versus event rates (percentages, such as 20%) were inconclusive. LIMITATION: Most studies were small and highly variable in terms of setting, context, and methods of administering interventions. CONCLUSION: Visual aids and absolute risk formats can improve patients' understanding of probabilistic information, whereas numbers needed to treat can lessen their understanding. Due to study heterogeneity, the superiority of any single method for conveying probabilistic information is not established, but there are several good options to help clinicians communicate with patients. PRIMARY FUNDING SOURCE: None.

Management of Menopause Symptoms with Acupuncture: An Umbrella Systematic Review and Meta-Analysis.

OBJECTIVES: Vasomotor symptoms (VMSs) are the most common symptoms reported during menopause. Although hormone therapy is effective for reducing VMSs, its use is restricted in some women. Many women with VMSs thus seek nonhormonal, nonpharmacologic treatment options such as acupuncture. DESIGN: An umbrella systematic review (SR) was conducted, supplemented by a search of published randomized controlled trials (RCTs), that assessed the effectiveness of acupuncture for VMSs, health-related quality of life (HRQOL), and adverse effects of treatment in perimenopausal or postmenopausal women. Meta-analyses were conducted using a random-effects model when data were sufficient. RESULTS: Three SRs and four new RCTs were identified that met eligibility criteria. Meta-analyses of this study revealed statistically significant standardized mean differences (SMDs) associated with acupuncture compared with no acupuncture at reducing VMS frequency (SMD -0.66, 95% confidence interval [CI] -1.06 to -0.26, I2 = 61.7%, 5 trials) and VMS severity (SMD -0.49, 95% CI -0.85 to -0.13, I2 = 18.1%, 4 trials) and improving HRQOL outcomes (SMD -0.93, 95% CI -1.20 to -0.67, I2 = 0.0%, 3 trials). SMDs were smaller or not statistically significant when acupuncture was compared with sham acupuncture. CONCLUSIONS: Evidence from RCTs supports the use of acupuncture as an adjunctive or stand-alone treatment for reducing VMSs and improving HRQOL outcomes, with the caveat that observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects. The safety of acupuncture in the treatment of VMSs has not been rigorously examined, but there is no clear signal for a significant potential for harm.

Evidence Map of Yoga for Depression, Anxiety, and Posttraumatic Stress Disorder.

BACKGROUND: This study describes evidence of yoga's effectiveness for depressive disorders, general anxiety disorder (GAD), panic disorder (PD), and posttraumatic stress disorder (PTSD) in adults. We also address adverse events associated with yoga. METHODS: We searched multiple electronic databases for systematic reviews (SRs) published between 2008 and July 2014, randomized controlled trials (RCTs) not identified in eligible SRs, and ongoing RCTs registered with ClincalTrials.gov. RESULTS: We identified 1 SR on depression, 1 for adverse events, and 3 addressing multiple conditions. The high-quality depression SR included 12 RCTs (n = 619) that showed improved short-term depressive symptoms (standardized mean difference, -0.69, 95% confidence interval, -0.99 to -0.39), but there was substantial variability (I2 = 86%) and a high risk of bias for 9 studies. Three SRs addressing multiple conditions identified 4 nonrandomized studies (n = 174) for GAD/PD and 1 RCT (n = 8) and 2 nonrandomized studies (n = 22) for PTSD. We separately found 1 RCT (n = 13) for GAD and 2 RCTs (n = 102) for PTSD. Collectively, these studies were inconclusive for the effectiveness of yoga in treating GAD/PD and PTSD. The high-quality SR for adverse events included 37 primary reports (n = 76) in which inversion postures were most often implicated. We found 5 ongoing trials (3 for PTSD). CONCLUSIONS: Yoga may improve short-term depressive symptoms, but evidence for GAD, PD, and PTSD remain inconclusive.

An evidence map of yoga for low back pain.

OBJECTIVE: Yoga is being increasingly studied as a treatment strategy for a variety of different clinical conditions, including low back pain (LBP). We set out to conduct an evidence map of yoga for the treatment, prevention and recurrence of acute or chronic low back pain (cLBP). METHODS: We searched Medline, Cochrane Database of Systematic Reviews, EMBASE, Allied and Complementary Medicine Database and ClinicalTrials.gov for randomized controlled trials (RCT), systematic reviews or planned studies on the treatment or prevention of acute back pain or cLBP. Two independent reviewers screened papers for inclusion, extracted data and assessed the quality of included studies. RESULTS: Three eligible systematic reviews were identified that included 10 RCTs (n=956) that evaluated yoga for non-specific cLBP. We did not identify additional RCTs beyond those included in the systematic reviews. Our search of ClinicalTrials.gov identified one small (n=10) unpublished trial and one large (n=320) planned clinical trial. The most recent good quality systematic review indicated significant effects for short- and long-term pain reduction (n=6 trials; standardized mean difference [SMD] -0.48; 95% CI, -0.65 to -0.31; I(2)=0% and n=5; SMD -0.33; 95% CI, -0.59 to -0.07; I(2)=48%, respectively). Long-term effects for back specific disability were also identified (n=5; SMD -0.35; 95% CI, -0.55 to -0.15; I(2)=20%). No studies were identified evaluating yoga for prevention or treatment of acute LBP. CONCLUSION: Evidence suggests benefit of yoga in midlife adults with non-specific cLBP for short- and long-term pain and back-specific disability, but the effects of yoga for health-related quality of life, well- being and acute LBP are uncertain. Without additional studies, further systematic reviews are unlikely to be informative.

Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol).

BACKGROUND: Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation? METHODS: We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs. DISCUSSION: Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016029335.

An evidence synthesis of care models to improve general medical outcomes for individuals with serious mental illness: a systematic review.

OBJECTIVE: To conduct a systematic review of studies of interventions that integrated medical and mental health care to improve general medical outcomes in individuals with serious mental illness. DATA SOURCES: English-language publications in MEDLINE (via PubMed), EMBASE, PsycINFO, and the Cochrane Library, from database inception through January 18, 2013, were searched using terms for our diagnoses of interest, a broad set of terms for care models, and a set of terms for randomized controlled trials (RCTs) or quasi-experimental design. Bibliographies of included articles were examined for additional sources. ClinicalTrials.gov was searched using the terms for our diagnoses of interest (serious mental illness,SMI,bipolar disorder,schizophrenia,orschizoaffective disorder) to assess for evidence of publication bias and ongoing studies. STUDY SELECTION: 4 RCTs were included from 1,729 articles reviewed. Inclusion criteria were RCT or quasi-experimental design; adult outpatient population with 25% or greater carrying a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; intervention with a stated goal to improve medical outcomes through integration of care, using a comparator of usual care or other quality improvement strategy; and outcomes assessing process of care, clinical outcomes, or physical functioning. DATA EXTRACTION: A trained researcher abstracted the following data from the included articles: study design, funding source, setting, population characteristics, eligibility and exclusion criteria, number of subjects and providers, intervention(s), comparison(s), length of follow-up, and outcome(s). These abstracted data were then overread by a second reviewer. RESULTS: Of the 4 studies reviewed, 2 good-quality studies (according to the guidelines of the Agency for Healthcare Research and Quality) that evaluated processes of preventive and chronic disease care demonstrated positive effects of integrated care. Specifically, integrated care interventions were associated with increased rates of immunization and screening. All 4 RCTs evaluated changes in physical functioning, with mixed results: 2 studies demonstrated small improvements in the physical health component of the 36-Item Short-Form Health Survey (SF-36) and the 12-Item Short-Form Health Survey, and 2 studies demonstrated no significant difference in SF-36 scores. No studies reported on clinical outcomes related to preventive care or chronic medical care. CONCLUSIONS: Integrated care models have positive effects on processes of preventive and chronic disease care but have inconsistent effects on physical functioning for individuals with serious mental illness. The relatively small number of trials and limited range of treatment models tested and outcomes reported point to the need for additional study in this important area.