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ObjectiveFor large, integrated healthcare delivery systems, coordinating patient care across delivery systems with providers external to the system presents challenges. We explored the domains and requirements for care coordination by professionals across healthcare systems and developed an agenda for research, practice and policy.DesignThe modified Delphi approach convened a 2-day stakeholder panel with moderated virtual discussions, preceded and followed by online surveys.SettingThe work addresses care coordination across healthcare systems. We introduced common care scenarios and differentiated recommendations for a large (main) healthcare organisation and external healthcare professionals that contribute additional care.ParticipantsThe panel composition included health service providers, decision makers, patients and care community, and researchers. Discussions were informed by a rapid review of tested approaches to fostering collaboration, facilitating care coordination and improving communication across healthcare systems.Outcome measuresThe study planned to formulate a research agenda, implications for practice and recommendations for policy.ResultsFor research recommendations, we found consensus for developing measures of shared care, exploring healthcare professionals’ needs in different care scenarios and evaluating patient experiences. Agreed practice recommendations included educating external professionals about issues specific to the patients in the main healthcare system, educating professionals within the main healthcare system about the roles and responsibilities of all involved parties, and helping patients better understand the pros and cons of within-system and out-of-system care. Policy recommendations included supporting time for professionals with high overlap in patients to engage regularly and sustaining support for care coordination for high-need patients.ConclusionsRecommendations from the stakeholder panel created an agenda to foster further research, practice and policy innovations in cross-system care coordination.

BACKGROUND: 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. OBJECTIVE: The purpose of this review is to characterize methods conducted or supported by research funding organizations to identify health research gaps, needs, or priorities. METHOD: We searched MEDLINE, PsycINFO, and the Web of Science up to September 2019. Eligible studies reported on methods to identify health research gaps, needs, and priorities that had been conducted or supported by research funding organizations. Using a published protocol, we extracted data on the method, criteria, involvement of stakeholders, evaluations, and whether the method had been replicated (i.e., used in other studies). RESULTS: Among 10,832 citations, 167 studies were eligible for full data extraction. More than half of the studies employed methods to identify both needs and priorities, whereas about a quarter of studies focused singularly on identifying gaps (7%), needs (6%), or priorities (14%) only. The most frequently used methods were the convening of workshops or meetings (37%), quantitative methods (32%), and the James Lind Alliance approach, a multi-stakeholder research needs and priority setting process (28%). The most widely applied criteria were importance to stakeholders (72%), potential value (29%), and feasibility (18%). Stakeholder involvement was most prominent among clinicians (69%), researchers (66%), and patients and the public (59%). Stakeholders were identified through stakeholder organizations (51%) and purposive (26%) and convenience sampling (11%). Only 4% of studies evaluated the effectiveness of the methods and 37% employed methods that were reproducible and used in other studies. DISCUSSION: To ensure optimal targeting of funds to meet the greatest areas of need and maximize outcomes, a much more robust evidence base is needed to ascertain the effectiveness of methods used to identify research gaps, needs, and priorities. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-021-07064-1.

Although transitions between health care systems are common when patients move between jobs or insurers, they are especially difficult to navigate when patients with mental health conditions leave an integrated system, such as the Military Health System (MHS). The authors synthesize evidence from studies of interventions that facilitate transitions between mental health care systems, such as the transition from the MHS to the Veterans Health Administration (VHA). The authors searched multiple research databases, reference-mined bibliographies of existing reviews, and consulted with experts to identify existing evaluations of transition support interventions. Key informants helped identify pertinent populations of interest who are transitioning between health care systems. Seventeen studies evaluating different approaches met inclusion criteria. Studies reported on different outcomes, and few could be combined in aggregated analyses. Analyses showed that care transition interventions can increase outpatient mental health service use, but the overall body of evidence is limited.

Background Quality improvement (QI) initiatives often reflect approaches based on anecdotal evidence, but it is unclear how initiatives can best incorporate scientific literature and methods into the QI process. Review of studies of QI initiatives that aim to systematically incorporate evidence review (termed evidence-based quality improvement (EBQI)) may provide a basis for further methodological development. Methods In this scoping review (registration: https://osf.io/hr5bj) of EBQI, we searched the databases PubMed, CINAHL, and SCOPUS. The review addressed three central questions: How is EBQI defined? How is evidence used to inform evidence-informed QI initiatives? What is the effectiveness of EBQI? Results We identified 211 publications meeting inclusion criteria. In total, 170 publications explicitly used the term “EBQI.” Published definitions emphasized relying on evidence throughout the QI process. We reviewed a subset of 67 evaluations of QI initiatives in primary care, including both studies that used the term “EBQI” with those that described an evidence-based initiative without using EBQI terminology. The most frequently reported EBQI components included use of evidence to identify previously tested effective QI interventions; engaging stakeholders; iterative intervention development; partnering with frontline clinicians; and data-driven evaluation of the QI intervention. Effectiveness estimates were positive but varied in size in ten studies that provided data on patient health outcomes. Conclusions EBQI is a promising strategy for integrating relevant prior scientific findings and methods systematically in the QI process, from the initial developmental phase of the IQ initiative through to its evaluation. Future QI researchers and practitioners can use these findings as the basis for further development of QI initiatives.

Background Understanding the safety of vaccines is critical to inform decisions about vaccination. Our objective was to conduct a systematic review of the safety of vaccines recommended for children, adults, and pregnant women in the United States. Methods We searched the literature in November 2020 to update a 2014 Agency for Healthcare Research and Quality review by integrating newly available data. Studies of vaccines that used a comparator and reported the presence or absence of key adverse events were eligible. Adhering to Evidence-based Practice Center methodology, we assessed the strength of evidence (SoE) for all evidence statements. The systematic review is registered in PROSPERO (CRD42020180089). Results Of 56,603 reviewed citations, 338 studies reported in 518 publications met inclusion criteria. For children, SoE was high for no increased risk of autism following measles, mumps, and rubella (MMR) vaccine. SoE was high for increased risk of febrile seizures with MMR. There was no evidence of increased risk of intussusception with rotavirus vaccine at the latest follow-up (moderate SoE), nor of diabetes (high SoE). There was no evidence of increased risk or insufficient evidence for key adverse events for newer vaccines such as 9-valent human papillomavirus and meningococcal B vaccines. For adults, there was no evidence of increased risk (varied SoE) or insufficient evidence for key adverse events for the new adjuvanted inactivated influenza vaccine and recombinant adjuvanted zoster vaccine. We found no evidence of increased risk (varied SoE) for key adverse events among pregnant women following tetanus, diphtheria, and acellular pertussis vaccine, including stillbirth (moderate SoE). Conclusions Across a large body of research we found few associations of vaccines and serious key adverse events; however, rare events are challenging to study. Any adverse events should be weighed against the protective benefits that vaccines provide.

ObjectiveOne potential barrier to optimal healthcare may be provider burnout or occupational-related stress in the workplace. The objective of this study is to conduct a systematic review to identify the predictors of burnout among US. healthcare providers.DesignSystematic review using in-depth critical appraisal to assess risk of bias and present the quality of evidence in synthesised results from the prognostic studies.Data sourcesWe searched 11 databases, registries, existing reviews and contacted experts through 4 October 2021.Eligibility criteria for selecting studiesWe included all studies evaluating potential predictors and documenting the presence and absence of associations with burnout assessed as a multidimensional construct. We excluded studies that relied solely on a single continuous subscale of burnout. Data were abstracted from eligible studies and checked for accuracy by a content expert and a methodologist.Data extraction and synthesisTwo reviewers independently screened citations and full-text publications using predetermined eligibility criteria.ResultsThe 141 identified studies evaluated a range of burnout predictors. Findings for demographic characteristics were conflicting or show no association. Workplace factors, such as workload, work/life balance, job autonomy and perceived support from leadership, had stronger associations with risk for burnout. Mental health factors, such as anxiety, and physical health risks may increase the risk, although the direction of these associations is unclear as few prospective studies exist to address this question. Factors such as social support appear to have a protective effect.ConclusionWe found the most evidence for workplace, mental health and psychosocial factors in predicting burnout but limited evidence for other potential predictors. However, more prospective studies are needed to improve our understanding about how to prevent provider burnout.PROSPERO registration numberCRD4202014836.

Despite longstanding efforts to improve health care quality for patients with complex needs who are at highest risk for hospitalization or death, to our knowledge, no guidance exists on what constitutes measurable high-quality care for this heterogeneous population. Identifying quality measures that are cross-cutting (ie, relevant to multiple chronic conditions and disease states) may enable health care professionals and health care systems to better design and report on quality improvement efforts for this patient population.To identify quality measures of care and prioritize quality-of-care concepts in the ambulatory primary care setting for patients in the Veterans Health Administration (VHA) who have complex care needs and are at high risk for adverse outcomes, such as hospitalization or death.In this expert panel assessment and prioritization, relevant measure concepts for future quality measure development in 3 care categories (assessment, management, and other features of health care) were extracted from a systematic review, conducted from June 2020 to June 2021, of published studies that suggested, evaluated, or used indicators of quality care for patients at high risk of adverse outcomes. Measure concepts associated with single conditions, surgical or other specialty care settings, and inpatient care were excluded. A panel of 14 experts (10 VHA leaders and staff, 2 non-VHA physician investigators, and 2 veterans) discussed and rated the importance of the remaining set of potentially relevant measure concepts using a modified RAND/UCLA Appropriateness Method on January 15, 2021. Measure concepts were rated on a scale of 1 to 9, with 9 being the highest priority. A median rating of 7.5 or greater was used as the cutoff to identify the highest-priority items.The systematic review identified 519 measure concepts, from which 15 domains and 49 measure concepts were proposed for expert panel consideration. After panel discussions and changes to measure concepts, the expert panel rated 63 measure concepts in 13 domains. The measure concepts with the highest median ratings focused on caregiver availability and support, COVID-19 vaccination, and pneumonia vaccination (all rated 9.0); housing instability (rated 8.5); and physical function, depression symptoms, cognitive impairment, prescription regimen, primary care follow-up after an emergency department visit or hospitalization, and timely transmission of discharge information to primary care (all rated 8.0). Recommendations to improve care included timely assessment of housing instability, caregiver support, physical function, depression symptoms, and cognitive impairment; annual prescription regimen review; coordinated transitions in care; and preventive care including vaccinations.The expert panelists identified a parsimonious set of high-priority, evidence-based, cross-cutting quality measure concepts for improving care of patients at high risk for adverse health outcomes in the VHA. These quality measures may inform both future research for patients at high risk and health care system quality improvement.

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.

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.

Objective In pandemics like COVID-19, the need for medical resources quickly outpaces available supply. policymakers need strategies to inform decisions about allocating scarce resources. Study design and setting We updated a systematic review on evidence-based approaches and searched databases through May 2020 for evaluation of strategies for policymakers. Results The 201 identified studies evaluated reducing demand for healthcare, optimizing existing resources, augmenting resources, and adopting crisis standards of care. Most research exists to reduce demand (n = 149); 39 higher quality studies reported benefits of contact tracing, school closures, travel restrictions, and mass vaccination. Of 28 strategies to augment resources, 6 higher quality studies reported effectiveness of establishing temporary facilities, use of volunteers, and decision support software. Of 23 strategies to optimize existing resources, 12 higher quality studies reported successful scope of work expansions and building on existing interagency agreements. Of 15 COVID-19 studies, 5 higher quality studies reported on combinations of policies and benefits of community-wide mask policies. Conclusion Despite the volume, the evidence base is limited; few strategies were empirically tested in robust study designs. The review provides a comprehensive overview of the effects of strategies to allocate resources and provides critical appraisal to identify the best available evidence.

BACKGROUND: The U.S. health care system is the most expensive in the world, but it lags many other industrialized nations on multiple measures of effectiveness and quality. This poor performance may have played a role in the push to incentivize health care organizations to achieve high performance over a range of domains. Research is needed to understand the determinants of health system performance. METHODS: In order to identify key attributes of health systems associated with performance, we conducted a literature review. The characteristics we identified were compiled into a web-based rating instrument for use with a technical expert panel (TEP) composed of leaders in health systems and health services research. A modified Delphi process was initiated using three “rounds” to develop group consensus. RESULTS: The expert panel discussed and rated the importance of nine broad areas in relation to health system performance. Panelists also rated which specific attributes within those domains were predictive of performance. Panelists tended to rate the kind of characteristics used in past research (such as size, ownership and profit status) as only somewhat or not at all important, while rating aspects of culture, leadership and business execution as very important. CONCLUSION: There is limited empirical evidence or understanding of factors associated with health system performance. We have illustrated the value of using a modified Delphi process to bring experiential evidence to the task. These findings may help researchers refine their data collection efforts, policymakers craft better policies to incentivize high performance, and health leaders build better systems.

IntroductionThere is strong global commitment to eliminate HIV-related stigma. Wide variation exists in frameworks and measures, and many strategies to prevent, reduce or mitigate stigma have been proposed but critical factors determining success or failure remain elusive.Methods and analysisBuilding on existing knowledge syntheses, we designed a systematic review to identify frameworks, measures and intervention evaluations aiming to address internalised stigma, stigma and discrimination in healthcare, and stigma and discrimination at the legal or policy level. The review addresses four key questions (KQ): KQ1: Which conceptual frameworks have been proposed to assess internal stigma, stigma and discrimination experienced in healthcare settings, and stigma and discrimination entrenched in national laws and policies? KQ2: Which measures of stigma have been proposed and what are their descriptive properties? KQ3: Which interventions have been evaluated that aimed to reduce these types of stigma and discrimination or mitigate their adverse effects and what are the effectiveness and unintended consequences? KQ4: What common ‘critical factors for success or failure’ can be identified across interventions that have been evaluated? We will search PubMed, PsycINFO, Web of Science, Universal Human Rights Index, HeinOnline, PAIS, HIV Legal Network, CDSR, Campbell Collaboration, PROSPERO and Open Science Framework. Critical appraisal will assess the source, processes and consensus finding for frameworks; COnsensus-based Standards for the selection of health Measurement Instruments criteria for measures; and risk of bias for interventions. Quality of evidence grading will apply . A gap analysis will provide targeted recommendations for future research. We will establish a compendium of frameworks, a comprehensive catalogue of available measures, and a synthesis of intervention characteristics to advance the science of HIV-related stigma.PROSPERO registration numberCRD42021249348.

There is strong global commitment to eliminate HIV-related stigma, and work in this area continues to evolve. Wide variation exists in frameworks and measures used.Building on the existing knowledge syntheses, we carried out a systematic review to identify frameworks and measures aiming to understand or assess internalized stigma, stigma and discrimination in healthcare, and in law and policy. The review addressed two questions: Which conceptual frameworks have been proposed to assess internalized stigma, stigma and discrimination experienced in healthcare settings, and stigma and discrimination entrenched in national laws and policies? Which measures of these different types of stigma and discrimination have been proposed and what are their descriptive properties? Searches, completed on 6 May 2021, cover publications from 2008 onwards. The review is registered in PROSPERO (CRD42021249348), the protocol incorporated stakeholder input, and the data are available in the Systematic Review Data Repository.Sixty-nine frameworks and 50 measures met the inclusion criteria. Critical appraisal figures and detailed evidence tables summarize these resources. We established a compendium of frameworks and a catalogue of measures of HIV-related stigma and discrimination. Seventeen frameworks and 10 measures addressed at least two of our focus domains, with least attention to stigma and discrimination in law and policy. The lack of common definitions and variability in scope and structure of HIV-related frameworks and measures creates challenges in understanding what is being addressed and measured, both in relation to stigma and efforts to mitigate or reduce its harmful effects. Having comparable data is essential for tracking change over time within and between interventions.This systematic review provides an evidence base of current understandings of HIV-related stigma and discrimination and how further conceptual clarification and increased adaptation of existing tools might help overcome challenges across the HIV care continuum. With people living with HIV at the centre, experts from different stakeholder groups could usefully collaborate to guide a more streamlined approach for the field. This can help to achieve global targets and understand, measure and help mitigate the impact of different types of HIV-related stigma on people's health and quality of life.

Objective. This evidence report synthesizes the available evidence on radiation therapy for brain metastases. Data sources. We searched PubMed®, Embase®, Web of Science, Scopus, CINAHL®, clinicaltrials.gov, and published guidelines in July 2020; assessed independently submitted data; consulted with experts; and contacted authors. Review methods. The protocol was informed by Key Informants. The systematic review was supported by a Technical Expert Panel and is registered in PROSPERO (CRD42020168260). Two reviewers independently screened citations; data were abstracted by one reviewer and checked by an experienced reviewer. We included randomized controlled trials (RCTs) and large observational studies (for safety assessments), evaluating whole brain radiation therapy (WBRT) and stereotactic radiosurgery (SRS) alone or in combination, as initial or postoperative treatment, with or without systemic therapy for adults with brain metastases due to non-small cell lung cancer, breast cancer, or melanoma. Results. In total, 97 studies, reported in 190 publications, were identified, but the number of analyses was limited due to different intervention and comparator combinations as well as insufficient reporting of outcome data. Risk of bias varied; 25 trials were terminated early, predominantly due to poor accrual. Most studies evaluated WBRT, alone or in combination with SRS, as initial treatment; 10 RCTs reported on post-surgical interventions. The combination treatment SRS plus WBRT compared to SRS alone or WBRT alone showed no statistically significant difference in overall survival (hazard ratio [HR], 1.09; confidence interval [CI], 0.69 to 1.73; 4 RCTs; low strength of evidence [SoE]) or death due to brain metastases (relative risk [RR], 0.93; CI, 0.48 to 1.81; 3 RCTs; low SoE). Radiation therapy after surgery did not improve overall survival compared with surgery alone (HR, 0.98; CI, 0.76 to 1.26; 5 RCTs; moderate SoE). Data for quality of life, functional status, and cognitive effects were insufficient to determine effects of WBRT, SRS, or post-surgical interventions. We did not find systematic differences across interventions in serious adverse events radiation necrosis, fatigue, or seizures (all low or moderate SoE). WBRT plus systemic therapy (RR, 1.44; CI, 1.03 to 2.00; 14 studies; moderate SoE) was associated with increased risks for vomiting compared to WBRT alone. Conclusion. Despite the substantial research literature on radiation therapy, comparative effectiveness information is limited. There is a need for more data on patient-relevant outcomes such as quality of life, functional status, and cognitive effects.

Objective Ductal carcinoma in situ (DCIS) has the potential to progress to invasive carcinoma. The optimal management of DCIS and methods for individualizing treatment of DCIS are still being determined. This evidence map depicts the robustness and topical span of research on DCIS management choice on patient-centered and clinical outcomes. Methods We searched PubMed, EMBASE, PsycINFO, PubMed Health, PROSPERO, and clinical practice guideline sites to identify systematic reviews of DCIS management options and consulted with topic experts. A bubble plot visualizes the literature volume and research content for patient-centered outcomes. An online decision tree facilitates discussions with patients and guides through the available evidence. Results In total, 40 systematic reviews met inclusion criteria. The research syntheses addressed DCIS management options, including the role of magnetic resonance imaging, axillary surgery/sentinel lymph node biopsy, and excisional biopsy. The map shows existing evidence for mutually exclusive treatment options including active surveillance, breast-conserving surgery, nipple sparing mastectomy, and simple mastectomy. Research findings for intraoperative radiation, adjuvant radiation therapy, adjuvant hormone therapy, hypofractionation radiotherapy, accelerated partial breast irradiation, radiation therapy plus boost, and combined radiation and hormone therapy, as well as for breast reconstruction after mastectomy and surveillance mammography postsurgery are also displayed. The evidence map highlights a scarcity of robust evidence on patient-centered outcomes. Conclusions The evidence map provides an overview of DCIS research showing the range of management options and remaining decisional dilemmas that follow a diagnosis of DCIS. It maps the evidence in accessible tools to guide practice and future research. : Video Summary:http://links.lww.com/MENO/A448.

Background Mindfulness interventions aim to foster greater attention and awareness of present moment experiences. Uptake of mindfulness programs in the workplace has grown as organizations look to support employee health, wellbeing, and performance. Objective In support of evidence-based decision making in workplace contexts, we created an evidence map summarizing physical and mental health, cognitive, affective, and interpersonal outcomes from systematic reviews of randomized controlled trials (RCTs) of mindfulness interventions. Methods We searched nine electronic databases to July 2017, dually-screened all reviews, and consulted topic experts to identify systematic reviews on mindfulness interventions. The distribution of evidence is presented as an evidence map in a bubble plot. Results In total, 175 systematic reviews met inclusion criteria. Reviews included a variety of mindfulness-based interventions. The largest review included 109 randomized controlled trials. The majority of these addressed general health, psychological conditions, chronic illness, pain, and substance use. Twenty-six systematic reviews assessed studies conducted in workplace settings and with healthcare professionals, educators, and caregivers. The evidence map shows the prevalence of research by the primary area of focus. An outline of promising applications of mindfulness interventions is included. Conclusions The evidence map provides an overview of existing mindfulness research. It shows the body of available evidence to inform policy and organizational decision-making supporting employee wellbeing in work contexts.

Objective. To conduct a systematic review of the literature on the safety of vaccines recommended for routine immunization in the United States, updating the 2014 Agency for Healthcare Research and Quality (AHRQ) report on the topic. Data sources. We searched MEDLINE®, Embase®, CINAHL®, Cochrane CENTRAL, Web of Science, and Scopus through November 9, 2020, building on the prior 2014 report; reviewed existing reviews, trial registries, and supplemental material submitted to AHRQ; and consulted with experts. Review methods. This report addressed three Key Questions (KQs) on the safety of vaccines currently in use in the United States and included in the Centers for Disease Control and Prevention’s (CDC) recommended immunization schedules for adults (KQ1), children and adolescents (KQ2), and pregnant women (KQ3). The systematic review was supported by a Technical Expert Panel that identified key adverse events of particular concern. Two reviewers independently screened publications; data were extracted by an experienced subject matter expert. Studies of vaccines that used a comparator and reported the presence or absence of adverse events were eligible. We documented observed rates and assessed the relative risks for key adverse events. We assessed the strength of evidence (SoE) across the existing findings from the prior 2014 report and the new evidence from this update. The systematic review is registered in PROSPERO (CRD42020180089). Results. A large body of evidence is available to evaluate adverse events following vaccination. Of 56,608 reviewed citations, 189 studies met inclusion criteria for this update, adding to data in the prior 2014 report, for a total of 338 included studies reported in 518 publications. Regarding vaccines recommended for adults (KQ1), we found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence in this update, including for newer vaccines such as recombinant influenza vaccine, adjuvanted inactivated influenza vaccine, and recombinant adjuvanted zoster vaccine. The prior 2014 report noted a signal for anaphylaxis for hepatitis B vaccines in adults with yeast allergy and for tetanus, diphtheria, and acellular pertussis vaccines. Regarding vaccines recommended for children and adolescents (KQ2), we found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence, including for newer vaccines such as 9-valent human papillomavirus vaccine and meningococcal B vaccine. The prior 2014 report noted signals for rare adverse events—such as anaphylaxis, idiopathic thrombocytopenic purpura, and febrile seizures—with some childhood vaccines. Regarding vaccines recommended for pregnant women (KQ3), we found no evidence of increased risk for key adverse events with varied SoE among either pregnant women or their infants following administration of tetanus, diphtheria, and acellular pertussis vaccines during pregnancy. Conclusion. Across this large body of research, we found no new evidence of increased risk since the prior 2014 report for key adverse events following administration of vaccines that are routinely recommended. Signals from the prior report remain unchanged for rare adverse events, which include anaphylaxis in adults and children, and febrile seizures and idiopathic thrombocytopenic purpura in children. There is no evidence of increased risk of adverse events for vaccines currently recommended in pregnant women. There remains insufficient evidence to draw conclusions about some rare potential adverse events.

Purpose This evidence report synthesizes the available evidence on radiation therapy for brain metastases. Methods and Materials The literature search included PubMed, EMBASE, Web of Science, Scopus, CINAHL, clinicaltrials.gov, and published guidelines in July 2020; independently submitted data, expert consultation, and contacting authors. Included studies were randomized controlled trials (RCTs) and large observational studies (for safety assessments), evaluating whole brain radiation therapy (WBRT) and stereotactic radiosurgery (SRS) alone or in combination, as initial or postoperative treatment, with or without systemic therapy for adults with brain metastases due to lung cancer, breast cancer, or melanoma. Results Ninety-seven studies reported in 189 publications were identified, but the number of analyses was limited owing to different intervention and comparator combinations as well as insufficient reporting of outcome data. Risk of bias varied, and 25 trials were terminated early, predominantly owing to poor accrual. The combination of SRS plus WBRT compared with SRS alone or WBRT alone showed no statistically significant difference in overall survival (hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.69%-1.73%; 4 RCTs) or death owing to brain metastases (relative risk [RR], 0.93; 95% CI, 0.48%-1.81%; 3 RCTs). Radiation therapy after surgery did not improve overall survival compared with surgery alone (HR, 0.98; 95% CI, 0.76%-1.26%; 5 RCTs). Data for quality of life, functional status, and cognitive effects were insufficient to determine effects of WBRT, SRS, or postsurgery interventions. We did not find systematic differences across interventions in serious adverse events, number of adverse events, radiation necrosis, fatigue, or seizures. WBRT plus systemic therapy (RR 1.44; 95% CI, 1.03%-2.00%; 14 studies) was associated with increased risks for vomiting compared with WBRT alone. Conclusions Despite the substantial research literature on radiation therapy, comparative effectiveness information is limited. There is a need for more data on patient-relevant outcomes such as quality of life, functional status, and cognitive effects.

Introduction Military personnel must prepare for and respond to life-threatening crises on a daily basis. This lifestyle places stress on personnel, and particularly so on deployed service members who are isolated from support systems and other resources. As part of a larger systematic review on the acceptability, efficacy, and comparative effectiveness of interventions designed to prevent, identify, and manage stress reactions, we assessed posttraumatic stress disorder (PTSD) outcomes. Materials and Methods We searched the electronic databases PsycINFO, PubMed, PTSDPubs, the Defense Technical Information Center, and Cochrane Central, as well as bibliographies of existing systematic reviews, to identify English-language studies evaluating the efficacy or comparative effectiveness of stress control interventions published since 1990. Controlled trials and cohort comparisons of interventions with military, law enforcement, and first responders were included. Two independent reviewers screened literature using predetermined eligibility criteria. Researchers individually abstracted study-level information and outcome data and assessed the risk of bias of included studies; data were reviewed for accuracy by the project leader. Changes in PTSD symptom scores from baseline to post-intervention were converted to standardized mean differences for comparison across studies. Risk ratios were calculated for PTSD case rates post-deployment. When several studies that compared an intervention group with a similar control/comparator reported the same outcome category and measure type, we conducted meta-analysis. We conducted meta-regression by adding a categorical variable, representing setting (i.e., in theater) or population (military vs. law enforcement or first responders) to the meta-analysis model to assess whether this variable was associated with the outcome across studies. The quality of the body of evidence (QoE) was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which considers study limitations (risk of bias), directness, consistency, precision, and publication bias. Results Sixteen controlled trials and 13 cohort comparisons reporting PTSD outcomes met inclusion criteria. Eight controlled trials and two cohort studies had high risk of bias, primarily due to poor, differential, or unknown response rate at follow-up. Twenty-four of the 29 studies included military personnel. Interventions included Acceptance-based Skills training, Attention Bias Modification training, stress inoculation with biofeedback, Critical Incident Stress Debriefing, group psychological debriefing, Eye Movement Desensitization and Reprocessing for sub-clinical stress, embedding mental health providers in theater, Third Location Decompression, reintegration programs, and a 3-week post-deployment residential program for psychological resource strengthening. Meta-analyses of studies comparing a group that received a stress control intervention to a group that did not receive an intervention found no significant difference in reduction in PTSD symptom scores (moderate QoE) or PTSD case rate post-deployment (low QoE). A meta-analysis of studies comparing a specific stress control intervention to an active comparator (usually standard stress management education) found no significant effect on PTSD symptom scores (moderate QoE). Conclusion Although combat and operational stress control (COSC) interventions may play a valuable role in decreasing stress, decreasing absenteeism, and enabling return to duty, a systematic review of 29 studies that included a control/comparison group found little evidence that COSC is effective in preventing PTSD or decreasing PTSD symptom scores in military personnel.

Objectives. Survival rates for pediatric cancer have dramatically increased since the 1970s, and the population of childhood cancer survivors (CCS) exceeds 500,000 in the United States. Cancer during childhood and related treatments lead to long-term health problems, many of which are poorly understood. These problems can be amplified by suboptimal survivorship care. This report provides an overview of the existing evidence and forthcoming research relevant to disparities and barriers for pediatric cancer survivorship care, outlines pending questions, and offers guidance for future research. Data sources. This Technical Brief reviews published peer-reviewed literature, grey literature, and Key Informant interviews to answer five Guiding Questions regarding disparities in the care of pediatric survivors, barriers to cancer survivorship care, proposed strategies, evaluated interventions, and future directions. Review methods. We searched research databases, research registries, and published reviews for ongoing and published studies in CCS to October 2020. We used the authors’ definition of CCS; where not specified, CCS included those diagnosed with any cancer prior to age 21. The grey literature search included relevant professional and nonprofit organizational websites and guideline clearinghouses. Key Informants provided content expertise regarding published and ongoing research, and recommended approaches to fill identified gaps. Results. In total, 110 studies met inclusion criteria. We identified 26 studies that assessed disparities in survivorship care for CCS. Key Informants discussed subgroups of CCS by race or ethnicity, sex, socioeconomic status, and insurance coverage that may experience disparities in survivorship care, and these were supported in the published literature. Key Informants indicated that major barriers to care are providers (e.g., insufficient knowledge), the health system (e.g., availability of services), and payers (e.g., network adequacy); we identified 47 studies that assessed a large range of barriers to survivorship care. Sixteen organizations have outlined strategies to address pediatric survivorship care. Our searches identified only 27 published studies that evaluated interventions to alleviate disparities and reduce barriers to care. These predominantly assessed approaches that targeted patients. We found only eight ongoing studies that evaluated strategies to address disparities and barriers. Conclusions. While research has addressed disparities and barriers to survivorship care for childhood cancer survivors, evidence-based interventions to address these disparities and barriers to care are sparse. Additional research is also needed to examine less frequently studied disparities and barriers and to evaluate ameliorative strategies in order to improve the survivorship care for CCS.

Cost, distance, and stigma may present barriers to face-to-face treatment for anxiety disorders. Technology can help overcome these barriers. The evidence map presented here provides an overview of technology use in clinical care for anxiety.Searches in three databases from their inception dates to June 2019 identified published randomized controlled trials (RCTs) examining technology use in anxiety disorder management. Reviewers screened 4,061 records, included 128 RCTs, and extracted data on study characteristics and technology type, function, and effectiveness.In 88% of the 128 RCTs, the authors reported reduced anxiety symptoms postintervention. Studies of computer technology (66%) and patient self-directed psychotherapy (31%) were most common. Many interventions were studied by only a few RCTs, and many studies had small sample sizes.Almost all interventions reported improved anxiety symptoms, with computer applications having the largest evidence base. More information is needed to evaluate the role of technology in clinical care for anxiety.

Chimeric antigen receptor (CAR)-T cell therapies appear to be promising treatments for non-Hodgkin's and B-cell lymphoma. However, several CAR-T therapies approved by the US Food and Drug Administration have only been tested for efficacy in relatively few single-arm clinical trials with small sample sizes. We sought to examine the differences between patients in these trials and the general population of patients with non-Hodgkin's and B-cell lymphoma. Five hundred and twenty-two patients from 15 CAR-T trials found in a systematic review and 417,492 patients from the Surveillance, Epidemiology, and End Results (SEER) Program database were compared. CAR-T study participants appeared to be younger (46.7% under 70 years old vs. 42.2%), more male (68.0% vs. 55.7%), and followed for a shorter period of time compared to patients in the SEER population (mean [M] 45.6 months, 95% confidence interval [CI] 17.7 to 63.3 months follow-up vs. M 57.1 months, 95% CI 57.0 to 57.3 months survival). CAR-T study participants may differ significantly from the general population of patients with non-Hodgkin's and B-cell lymphoma. Effectiveness of CAR-T therapies in the general population of lymphoma patients may differ from effectiveness demonstrated in trials. Newly created CAR-T patient registries are essential to establishing population-level effectiveness of the therapies.

Caring for women with gynecologic malignancies requires multidisciplinary communication and coordination across multiple providers. This article discusses a rapid review of the literature on characteristics of care coordination for gynecologic malignancies. Five electronic databases (from inception through March 2015) were searched for empirical studies on coordinated care models for female adults with gynecologic malignancies. A single reviewer extracted and synthesized information on how care was coordinated, how care teams made decisions, who performed what tasks, how care teams communicated information to coordinate care, and potential impact of the characteristic on delivering coordinated care. From 26 included studies, predominant characteristics of coordinated care were identified: multidisciplinary teams, patient navigators, scheduled follow-ups, survivorship care plans, and colocated services. Decision-making was best documented for studies that utilized teams that had periodic scheduled meetings with set agendas and consistent procedures. Providers' roles in coordinating care were numerous, reflecting professional backgrounds: oncologists had most authority in making treatment decisions; radiologists and pathologists shared vital biomedical information; and nurses coordinated care and communicated with patients. Communication tools and strategies across studies included having shared medical records, integrated treatment plans, and telephone-based or teleconferencing communication. There was limited information available on the impact of characteristics and accompanying strategies or tools. Several characteristics of care coordination models for gynecologic cancers have been published in the literature. Further investigation is needed to understand the relative effectiveness of these ways to coordinate care.

Acupuncture has been suggested as a treatment for posttraumatic stress disorder (PTSD), yet its clinical effects are unclear. This review aims to estimate effects of acupuncture on PTSD symptoms, depressive symptoms, anxiety symptoms, and sleep quality for adults with PTSD. We searched 10 databases in January 2016 to identify eligible randomized controlled trials (RCTs). We performed random effects meta-analyses and examined quality of the body of evidence (QoE) using the GRADE approach to rate confidence in meta-analytic effect estimates. Seven RCTs with 709 participants met inclusion criteria. We identified very low QoE indicating significant differences favoring acupuncture (versus any comparator) at post-intervention on PTSD symptoms (standardized mean difference [SMD] = -0.80, 95% confidence interval [CI] [-1.59, -0.01], 6 RCTs), and low QoE at longer follow-up on PTSD (SMD = -0.46, 95% CI [-0.85, -0.06], 4 RCTs) and depressive symptoms (SMD = -0.56; 95% CI [-0.88, -0.23], 4 RCTs). No significant differences were observed between acupuncture and comparators at post-intervention for depressive symptoms (SMD = -0.58, 95% CI [-1.18, 0.01], 6 RCTs, very low QoE), anxiety symptoms (SMD = -0.82, 95% CI [-2.16, 0.53], 4 RCTs, very low QoE), and sleep quality (SMD = -0.46, 95% CI [-3.95, 3.03], 2 RCTs, low QoE). Safety data (7 RCTs) suggest little risk of serious adverse events, though some participants experienced minor/moderate pain, superficial bleeding, and hematoma at needle insertion sites. To increase confidence in findings, sufficiently powered replication trials are needed that measure all relevant clinical outcomes and dedicate study resources to minimizing participant attrition.

Background Uncertainty remains regarding the effectiveness of treatments for patients diagnosed with both an alcohol use disorder (AUD) and depressive disorder. This study aimed to compare the effectiveness of clinical interventions for improving symptoms of adults with co-occurring AUDs and depressive disorders. Methods and findings We searched CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Excerpta Medica Database, International Clinical Trials Registry Platform (ICTRP), PubMed, PsycINFO, and Web of Science from inception to December 2020. We included randomized controlled trials (RCTs) evaluating clinical interventions for adults with co-occurring AUDs and depressive disorders. Two independent reviewers extracted study-level information and outcome data. We assessed risk of bias using the Cochrane Risk of Bias tool, used frequentist random effects models for network meta-analyses, and rated our confidence in effect estimates using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Primary outcomes were remission from depression and alcohol use. Secondary outcomes were depressive symptoms, alcohol use, heavy drinking, health-related quality of life, functional status, and adverse events. We used standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes to estimate intervention effects. Overall, 36 RCTs with 2,729 participants evaluated 14 pharmacological and 4 psychological interventions adjunctive to treatment as usual (TAU). Studies were published from 1971 to 2019, conducted in 13 countries, and had a median sample size of 50 participants (range: 14 to 350 participants). We have very low confidence in all estimates of intervention effects on our primary outcomes (i.e., remission from depression and remission from alcohol use). We have moderate confidence that cognitive behavioral therapies (CBTs) demonstrated greater benefit than no additional treatment (SMD = −0.84; 95% confidence interval [CI], −1.05 to −0.63; p < 0.001) for depressive symptoms and low confidence (SMD = −0.25; 95% CI, −0.47 to −0.04; p = 0.021) for alcohol use. We have low confidence that tricyclic antidepressants (TCAs) demonstrated greater benefit than placebo (SMD = −0.37; 95% CI, −0.72 to −0.02, p = 0.038) for depressive symptoms. Compared with placebo, we have moderate confidence that selective serotonin reuptake inhibitors (SSRIs) demonstrated greater benefit for functional status (SMD = −0.92; 95% CI, −1.36 to −0.47, p < 0.001) and low confidence for alcohol use (SMD = −0.30; 95% CI, −0.59 to −0.02, p = 0.039). However, we have moderate confidence that patients receiving SSRIs also were more likely to experience an adverse event (OR = 2.20; 95% CI, 0.94 to 5.16, p = 0.07). We have very low confidence in all other effect estimates, and we did not have high confidence in any effect estimates. Limitations include the sparsity of evidence on intervention effects over the long term, risks of attrition bias, and heterogeneous definitions of adverse events in the evidence base. Conclusions We are very uncertain about the existence (or not) of any non-null effects for our primary outcomes of remission from depression and remission from alcohol use. The available evidence does suggest that CBTs likely reduced, and TCAs may have resulted in a slight reduction of depressive symptoms. SSRIs likely increased functional status, and SSRIs and CBTs may have resulted in a slight reduction of alcohol use. However, patients receiving SSRIs also likely had an increased risk of experiencing an adverse event. In addition, these conclusions only apply to postintervention and are not against active comparators, limiting the understanding of the efficacy of interventions in the long term as well as the comparative effectiveness of active treatments. As we did not have high confidence in any outcomes, additional studies are warranted to provide more conclusive evidence., Sean Grant and co-workers report on pharmacological and psychological treatments for patients with both alcohol-use and depressive disorders., Author summary Why was this study done? Alcohol use disorders (AUDs) and depressive disorders are prevalent behavioral health conditions among adult populations, often co-occur, and have significant personal, societal, and economic consequences. Existing systematic reviews and clinical practice guidelines often focus on either AUDs or depressive disorders, despite the prevalence and significance of their co-occurrence. The objective of this review is to examine the available evidence on the effectiveness of clinical interventions for adult patients with co-occurring AUD and depressive disorders. What did the researchers do and find? We conducted a systematic review and network meta-analysis (NMA) of 36 randomized controlled trials (RCTs) with 2,729 participants evaluating 14 pharmacological and 4 psychological interventions for adults with co-occurring AUDs and depressive disorders. We have very low confidence in all estimates of intervention effects on our primary outcomes (i.e., remission from depression and remission from alcohol use). We found that cognitive behavioral therapies (CBTs) likely reduced, and tricyclic antidepressants (TCAs) may have resulted in a slight reduction of depressive symptoms, selective serotonin reuptake inhibitors (SSRIs) likely increased functional status, SSRIs and CBTs may have resulted in a slight reduction of alcohol use, and SSRIs also likely resulted in an increased risk of experiencing an adverse event. We have very low confidence in all other effect estimates, and we did not have high confidence in any effect estimates. What do these findings mean? We did not have high confidence in any effect estimates, and we have very low confidence in the vast majority of estimates of intervention effects across all outcomes. For policy and practice, we are very uncertain about the existence (or not) of any non-null effects for our primary outcomes of remission from depression and remission from alcohol use. The available evidence does suggest potentially actionable benefits at postintervention of CBTs for depressive symptoms and alcohol use, TCAs for depressive symptoms, and SSRIs for alcohol use and functional status—although SSRIs also likely have higher risks of adverse events (including serious adverse events). For research, future trials are needed that are prospectively registered, adequately powered, fit for pragmatic purposes, comprehensively report study information and outcomes, and evaluate interventions discussed in clinical practice guidelines yet missing from the current body of evidence.

Men and women might respond differently to some treatments for alcohol use disorder. If so, this would be important to consider when selecting treatment. The purpose of this systematic review was to synthesize evidence for gender differences in effects of treatments. While researchers did not identify systematic differences across studies, a paucity of reporting on treatment effects according to gender hindered analysis.

This evidence map provides an overview of the existing research evaluating technology in depression and anxiety care and documents upcoming research to evaluate the role of technology to support clinical care. It documents the volume, nature, and characteristics of research in this field and should be of interest to health policymakers and practitioners who oversee or implement treatment for those conditions.

Objective Obesity is preventable and yet continues to be a major risk factor for chronic disease. Multiple prevention approaches have been proposed across multiple settings where people live, work, learn, worship, and play. This review searched the vast literature on obesity prevention interventions to assess their effects on daily energy consumed and energy expended. Methods This systematic review (PROSPERO registration CRD42017077083) searched seven databases for systematic reviews and studies reporting energy intake and expenditure. Two independent reviewers screened 5,977 citations; data abstraction supported an evidence map, comprehensive evidence tables, and meta-analysis; critical appraisal assessed risk of bias; and the quality of evidence was evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results Hundreds of published reviews were identified. However, few studies reported on energy intake and expenditure to determine intervention success. Ninety-nine studies across all intervention domains were identified. Few areas demonstrated statistically significant effects across studies; school-based approaches and health care initiatives reduced energy consumed, education reduced energy consumed and increased energy expended, and social-group approaches increased energy expenditure. Conclusions Despite the amount of research on obesity prevention interventions, very few studies have provided relevant information on energy intake and expenditure, two factors determining weight gain. Future research needs to fill this gap to identify successful public health policies.

ImportanceEvidence supports palliative care effectiveness. Given workforce constraints and the costs of new services, payers and providers need help to prioritize their investments. They need to know which patients to target, which personnel to hire, and which services best improve outcomes.ObjectiveTo inform how payers and providers should identify patients with "advanced illness" and the specific interventions they should implement, we reviewed the evidence to identify (1) individuals appropriate for palliative care and (2) elements of health service interventions (personnel involved, use of multidisciplinary teams, and settings of care) effective in achieving better outcomes for patients, caregivers, and the healthcare system.Evidence reviewSystematic searches of MEDLINE, EMBASE, PsycINFO, Web of Science, and Cochrane Database of Systematic Reviews databases (1/1/2001-1/8/2015).ResultsRandomized controlled trials (124) met inclusion criteria. The majority of studies in cancer (49%, 38 of 77 studies) demonstrated statistically significant patient or caregiver outcomes (e.g., p

ObjectivesGenetic therapies replace or inactivate disease-causing genes or introduce new or modified genes. These therapies have the potential to cure in a single application rather than treating symptoms through repeated administrations. This evidence map provides a broad overview of the genetic therapies that have been evaluated in randomised controlled trials (RCTs) for efficacy and safety.Eligibility criteriaTwo independent reviewers screened publications using predetermined eligibility criteria. Study details and data on safety and efficacy were abstracted from included trials. Results were visualised in an evidence map.Information sourcesWe searched PubMed, EMBASE, Web of Science, ClinicalTrials.gov and grey literature to November 2018.Risk of biasOnly RCTs were included in this review to reduce the risk of selection bias in the evaluation of genetic therapy safety and efficacy.Included studiesWe identified 119 RCTs evaluating genetic therapies for a variety of clinical conditions.Synthesis of resultsOn average, samples included 107 participants (range: 1–1022), and were followed for 15 months (range: 0–124). Interventions using adenoviruses (40%) to treat cardiovascular diseases (29%) were the most common.Description of the effectIn RCTs reporting safety and efficacy outcomes, in the majority (60%) genetic therapies were associated with improved symptoms but in nearly half (45%) serious adverse event (SAEs) were also reported. Improvement was reported in trials treating cancer, cardiovascular, ocular and muscular diseases. However, only 19 trials reported symptom improvement for at least 1 year.Strengths and limitations of evidenceThis is the first comprehensive evidence map of RCTs evaluating the safety and efficacy of genetic therapies. Evidence for long-term effectiveness and safety is still sparse. This lack of evidence has implications for the use, ethics, pricing and logistics of genetic therapies.InterpretationThis evidence map provides a broad overview of research studies that allow strong evidence statements regarding the safety and efficacy of genetic therapies. Most interventions improve symptoms, but SAE are also common. More research is needed to evaluate genetic therapies with regard to the potential to cure diseases.

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.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.MEDLINE; Cochrane Central; Cochrane Database of Systematic Reviews; and the Health Technology Assessments; search limited to English-language articles on humans.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.A standardized protocol with predefined criteria was used to extract details on study design, interventions, outcomes, and study quality.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.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.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.

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.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.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.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.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.

Context Palliative care continues to be a rapidly growing field aimed at improving quality of life for patients and their caregivers. Objectives The purpose of this review was to provide a synthesis of the evidence in palliative care to inform the fourth edition of the National Consensus Project Clinical Practice Guidelines for Quality Palliative Care. Methods Ten key review questions addressing eight content domains guided a systematic review focused on palliative care interventions. We searched eight databases in February 2018 for systematic reviews published in English from 2013, after the last edition of National Consensus Project guidelines was published, to present. Experienced literature reviewers screened, abstracted, and appraised data per a detailed protocol registered in PROSPERO. The quality of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations criteria. The review was supported by a technical expert panel. Results We identified 139 systematic reviews meeting inclusion criteria. Reviews addressed the structure and process of care (interdisciplinary team care, 13 reviews; care coordination, 18 reviews); physical aspects (48 reviews); psychological aspects (26 reviews); social aspects (two reviews); spiritual, religious, and existential aspects (11 reviews); cultural aspects (three reviews); care of the patient nearing the end of life (grief/bereavement programs, six reviews; final days of life, two reviews); ethical and legal aspects (36 reviews). Conclusion A substantial body of evidence exists to support clinical practice guidelines for quality palliative care, but the quality of evidence is limited.

Background Depression is a common mental health disorder for which clinical practice guidelines have been developed. Prior systematic reviews have identified complex organizational interventions, such as collaborative care, as effective for guideline implementation; yet, many healthcare delivery organizations are interested in less resource-intensive methods to increase provider adherence to guidelines and guideline-concordant practices. The objective of this systematic review was to assess the effectiveness of healthcare provider interventions that aim to increase adherence to evidence-based treatment of depression in routine clinical practice. Methods We searched five databases through August 2017 using a comprehensive search strategy to identify English-language randomized controlled trials (RCTs) in the quality improvement, implementation science, and behavior change literature that evaluated outpatient provider interventions, in the absence of practice redesign efforts, to increase adherence to treatment guidelines or guideline-concordant practices for depression. We used meta-analysis to summarize odds ratios, standardized mean differences, and incidence rate ratios, and assessed quality of evidence (QoE) using the GRADE approach. Results Twenty-two RCTs promoting adherence to clinical practice guidelines or guideline-concordant practices met inclusion criteria. Studies evaluated diverse provider interventions, including distributing guidelines to providers, education/training such as academic detailing, and combinations of education with other components such as targeting implementation barriers. Results were heterogeneous and analyses comparing provider interventions with usual clinical practice did not indicate a statistically significant difference in guideline adherence across studies. There was some evidence that provider interventions improved individual outcomes such as medication prescribing and indirect comparisons indicated more complex provider interventions may be associated with more favorable outcomes. We did not identify types of provider interventions that were consistently associated with improvements across indicators of adherence and across studies. Effects on patients’ health in these RCTs were inconsistent across studies and outcomes. Conclusions Existing RCTs describe a range of provider interventions to increase adherence to depression guidelines. Low QoE and lack of replication of specific intervention strategies across studies limited conclusions that can be drawn from the existing research. Continued efforts are needed to identify successful strategies to maximize the impact of provider interventions on increasing adherence to evidence-based treatment for depression. Trial registration PROSPERO record CRD42017060460 on 3/29/17 Electronic supplementary material The online version of this article (10.1186/s13012-018-0788-8) contains supplementary material, which is available to authorized users.

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.

The objective of this systematic review was to synthesize the effectiveness of health care provider interventions that aim to increase the uptake of evidence-based treatment of depression in routine clinical practice. This study summarizes results of comprehensive searches in the quality improvement, implementation science, and behavior change literature. Studies evaluated diverse provider interventions such as sending out depression guidelines to providers, education and training such as academic detailing, and combinations of education with other components such as targeting implementation barriers. A detailed critical appraisal process assessed risk of bias and study quality. The body of evidence was graded using established evidence synthesis criteria. Twenty-two randomized controlled trials promoting uptake of clinical practice guidelines and guideline-concordant practices met inclusion criteria. Results were heterogeneous and analyses comparing interventions with usual clinical practice did not indicate a statistically significant difference in guideline adherence across studies. There was some evidence that interventions improved individual outcomes such as medication prescribing and indirect comparisons indicated that more complex interventions may be associated with more favorable outcomes. However, we did not identify types of interventions that were consistently associated with improvements across indicators of guideline adherence and across studies. Due to the small number of studies reporting team interventions or approaches tested in specialty care we did not identify robust evidence that effects vary by provider group or setting. Low quality of evidence and lack of replication of specific intervention strategies limited conclusions that can be drawn from the existing research.