Gender Affirming Surgery: A Comprehensive, Systematic Review of All Peer-reviewed Literature and Methods of Assessing Patient-centered Outcomes (Part 1: Breast/Chest, Face, and Voice).

OBJECTIVE: To perform the first systematic review of all available gender-affirming surgery (GAS) publications across all procedures to assess both outcomes reported in the literature and the methods used for outcome assessment. SUMMARY OF BACKGROUND DATA: Rapidly increasing clinical volumes of gender-affirming surgeries have stimulated a growing need for high-quality clinical research. Although some procedures have been performed for decades, each individual procedure has limited data, necessitating synthesis of the entire literature to understand current knowledge and guide future research. METHODS: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify all outcomes measures in GAS cohorts, including PCOs, complications, and functional outcomes. Outcome data were pooled to assess currently reported complication, satisfaction, and other outcome rates. RESULTS: Overall, 15,186 references were identified, 4162 papers advanced to abstract review, and 1826 underwent full-text review. After review, there were 406 GAS cohort publications. Of non-genitoplasty titles, 35 were mastectomy, 6 mammoplasty, 21 facial feminization, and 31 voice/cartilage. Although 59.1% of non-genitoplasty papers addressed PCOs in some form, only 4.3% used instruments partially-validated in transgender patients. Overall, data were reported heterogeneously and were biased towards high-volume centers. CONCLUSIONS: This study represents the most comprehensive review of GAS literature. By aggregating all previously utilized measurement instruments, this study offers a foundation for discussions about current methodologic limitations and what dimensions must be included in assessing surgical success. We have assembled a comprehensive list of outcome instruments; this offers an ideal starting basis for emerging discussions between patients and providers about deficiencies which new, better instruments and metrics must address. The lack of consistent use of the same outcome measures and validated GAS-specific instruments represent the 2 primary barriers to high-quality research where improvement efforts should be focused.

Gender Affirming Surgery: A Comprehensive, Systematic Review of All Peer-reviewed Literature and Methods of Assessing Patient-centered Outcomes (Part 2: Genital Reconstruction).

OBJECTIVE: To perform the first systematic review of all available GAS publications across all procedures to assess outcomes reported in the literature and the methods used for outcome assessment. SUMMARY OF BACKGROUND DATA: Assessment of GAS results is complex and multidimensional, involving not only complication rates but also anatomic (eg, vaginal depth), functional (eg, urinary), and psychosocial outcomes. A fully comprehensive aggregation of all prior research would offer an essential cornerstone for continued progress. METHODS: A systematic review was performed after PRISMA guidelines to identify all outcomes measures in GAS cohorts, including patient-centered outcomes, complications, and functional outcomes. Data were aggregated to assess pooled rates of complications, satisfaction, and other outcomes. RESULTS: Overall, 15,186 references were identified, 4162 papers advanced to abstract review, and 1826 underwent full-text review. After review, there were 406 GAS cohort publications, including 171 vaginoplasty, 82 phalloplasty, 16 metoidioplasty, 23 oophorectomy/vaginectomy, and 21 with multiple procedures.Although 68.7% of genitoplasty papers addressed patient-centered outcomes, only 1.0% used metrics validated in the transgender population. Forty-three different outcome instruments were used. No instrument was used in more than 15% of published series and 38 were used in only 1 or 2 publications. CONCLUSIONS: Our review found high patient satisfaction for genital procedures but little concordance between study methods, with almost 90% of patient-focused outcome metrics appearing only once or twice. Standardization of outcome instruments and measurement methods through patient-inclusive, multidisciplinary consensus efforts is the essential next step for quality improvement. As GAS continues to mature, building on current foundations with the goal of improving both surgical and patient-reported outcomes is essential.

Non-pharmacological interventions for sleep promotion in hospitalized children.

BACKGROUND: Healthy sleep is an important component of childhood development. Changes in sleep architecture, including sleep stage composition, quantity, and quality from infancy to adolescence are a reflection of neurologic maturation. Hospital admission for acute illness introduces modifiable risk factors for sleep disruption that may negatively affect active brain development during a period of illness and recovery. Thus, it is important to examine non-pharmacologic interventions for sleep promotion in the pediatric inpatient setting. OBJECTIVES: To evaluate the effect of non-pharmacological sleep promotion interventions in hospitalized children and adolescents on sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, three other databases, and three trials registers to December 2021. We searched Google Scholar, and two websites, handsearched conference abstracts, and checked reference lists of included studies. SELECTION CRITERIA: Randomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, investigating the effects of any non-pharmacological sleep promotion intervention on the sleep quality or sleep duration (or both) of children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility, evaluated risk of bias, extracted and synthesized data, and used the GRADE approach to assess certainty of evidence. The primary outcomes were changes in both objective and subjective validated measures of sleep in children; secondary outcomes were child and parent satisfaction, cost-effectiveness ratios, delirium incidence or delirium-free days at time of hospital discharge, duration of mechanical ventilation, length of hospital stay, and mortality. MAIN RESULTS: We included 10 trials (528 participants; aged 3 to 22 years) in inpatient pediatric settings. Seven studies were conducted in the USA, two in Canada, and one in Brazil. Eight studies were funded by government, charity, or foundation grants. Two provided no information on funding. Eight studies investigated behavioral interventions (massage, touch therapy, and bedtime stories); two investigated physical activity interventions. Duration and timing of interventions varied widely. All studies were at high risk of performance bias due to the nature of the intervention, as participants, parents, and staff could not be masked to group assignment. We were unable to perform a quantitative synthesis due to substantial clinical heterogeneity. Behavioral interventions versus usual care Five studies (145 participants) provided low-certainty evidence of no clear difference between multicomponent relaxation interventions and usual care on objective sleep measures. Overall, evidence from single studies found no clear differences in daytime or nighttime sleep measures (33 participants); any sleep parameter (48 participants); or daytime or nighttime sleep or nighttime arousals (20 participants). One study (34 participants) reported no effect of massage on nighttime sleep, sleep efficiency (SE), wake after sleep onset (WASO), or total sleep time (TST) in adolescents with cancer. Evidence from a cross-over study in 10 children with burns suggested touch therapy may increase TST (391 minutes, interquartile range [IQR] 251 to 467 versus 331 minutes, IQR 268 to 373; P = 0.02); SE (76, IQR 53 to 90 versus 66, IQR 55 to 78; P = 0.04); and the number of rapid eye movement (REM) periods (4.5, IQR 2 to 5 versus 3.5, IQR 2 to 4; P = 0.03); but not WASO, sleep latency (SL), total duration of REM, or per cent of slow wave sleep. Four studies (232 participants) provided very low-certainty evidence on subjective measures of sleep. Evidence from single studies found that sleep efficiency may increase, and the percentage of nighttime wakefulness may decrease more over a five-day period following a massage than usual care (72 participants). One study (48 participants) reported an improvement in Children's Sleep Habits Questionnaire scores after discharge in children who received a multicomponent relaxation intervention compared to usual care. In another study, mean sleep duration per sleep episode was longer (23 minutes versus 15 minutes), and time to fall asleep was shorter (22 minutes versus 27 minutes) following a bedtime story versus no story (18 participants); and children listening to a parent-recorded story had longer SL than when a parent was present (mean 57.5 versus 43.5 minutes); both groups reported longer SL than groups who had a stranger-recorded story, and those who had no story and absent parents (94 participants; P < 0.001). In one study (34 participants), 87% (13/15) of participants felt they slept better following massage, with most parents (92%; 11/12) reporting they wanted their child to receive a massage again. Another study (20 participants) reported that parents thought the music, touch, and reading components of the intervention were acceptable, feasible, and had positive effects on their children (very low-certainty evidence). Physical activity interventions versus usual care One study (29 participants) found that an enhanced physical activity intervention may result in little or no improvement in TST or SE compared to usual care (low-certainty evidence). Another study (139 participants), comparing play versus no play found inconsistent results on subjective measures of sleep across different ages (TST was 49% higher for the no play groups in 4- to 7-year olds, 10% higher in 7- to 11-year olds, and 22% higher in 11- to 14-year olds). This study also found inconsistent results between boys and girls (girls in the first two age groups in the play group slept more than the no play group). No study evaluated child or parent satisfaction for behavioral interventions, or cost-effectiveness, delirium incidence or delirium-free days at hospital discharge, length of mechanical ventilation, length of hospital stay, or mortality for either behavioral or physical activity intervention. AUTHORS' CONCLUSIONS: The included studies were heterogeneous, so we could not quantitatively synthesize the results. Our narrative summary found inconsistent, low to very low-certainty evidence. Therefore, we are unable to determine how non-pharmacologic sleep promotion interventions affect sleep quality or sleep duration compared with usual care or other interventions. The evidence base should be strengthened through design and conduct of randomized trials, which use validated and highly reliable sleep assessment tools, including objective measures, such as polysomnography and actigraphy.

How, when and where? A systematic review on abortion decision making in legally restricted settings in sub-Saharan Africa, Latin America, and the Caribbean.

BACKGROUND: With increasing global availability of medication abortion drugs, a safer option exists for many women to terminate a pregnancy even in legally restrictive settings. However, more than 22,000 women die each year from unsafe abortion, most often in developing countries where abortion is highly legally restricted. We conducted a systematic review to compile existing evidence regarding factors that influence women's abortion-related decision making in countries where abortion is highly legally restricted. METHODS: We searched ten databases in two languages (English and Spanish) for relevant literature published between 2000 and 2019 that address women's decision-making regarding when, where and how to terminate a pregnancy in sub-Saharan African, Latin American and the Caribbean countries where abortion is highly legally restricted. RESULTS: We identified 46 articles that met the review's inclusion criteria. We found four primary factors that influenced women's abortion-related decision-making processes: (1) the role of knowledge, including of laws, methods and sources; (2) the role of safety, including medical, legal and social safety; (3) the role of social networks and the internet, and; (4) cost affordability and convenience. CONCLUSIONS: The choices women make after deciding to terminate a pregnancy are shaped by myriad factors, particularly in contexts where abortion is highly legally restricted. Our review catalogued the predominant influences on these decisions of when, where and how to abort. More research is needed to better understand how these factors work in concert to best meet women's abortion needs to the full limit of the law and within a harm reduction framework for abortions outside of legal indications.

The persistence of clinical questions across shifts on an intensive care unit: an observational pilot study.

How do clinical questions emerge and move toward resolution in the intensive care setting over the course of 24 hours? In a 20-bed surgical intensive care unit in a large, tertiary-care teaching hospital, informationists shadowed clinicians for 2 48-hour periods to record questions, noting when they were asked and whether they were answered. Thirty-eight percent of 112 recorded questions remained unanswered. Some unanswered questions persisted across shifts, and clinicians' information-seeking behaviors changed over time. Clinical information services can be improved and integrated more fully into clinical workflows based on a fuller understanding of the life cycle of clinical inquiry.

How Can Community Data Be Leveraged to Advance Primary Health Care? A Scoping Review of Community-Based Health Information Systems.

BACKGROUND: Community-based health information systems (CBISs) can provide critical insights into how community health systems function, and digitized CBISs may improve the quality of community-level data and facilitate integration and use of CBISs within the broader health system. This scoping review aims to understand how CBISs have been implemented, integrated, and used to support community health outcomes in low- and middle-income countries (LMICs). METHODS: Both peer-reviewed and gray literature were included; relevant articles were identified using key terms and controlled vocabulary related to community/primary health care, health information systems, digital health, and LMICs. A total of 11,611 total records were identified from 5 databases and the gray literature. After deduplication, 6,985 peer-reviewed/gray literature were screened, and 95 articles/reports were included, reporting on 105 CBIS implementations across 38 countries. RESULTS: Findings show that 55% of CBISs included some level of digitization, with just 28% being fully digitized (for data collection and reporting). Data flow from the community level into the health system varied, with digitized CBISs more likely to reach national-level integration. National-level integration was primarily seen among vertical CBISs. Data quality challenges were present in both paper-based and digitized CBISs, exacerbated by fragmentation of the community health landscape with often parallel reporting systems. CBIS data use was constrained to mostly vertical and digitized (partially or fully) CBISs at national/subnational levels. CONCLUSION: Digitization can play a pivotal role in strengthening CBIS use, but findings demonstrate that CBISs are only as effective as the community health systems they are embedded within. Community-level data are often not being integrated into national/subnational health information systems, undermining the ability to understand what the community health needs are. Furthermore, stronger investments within community health systems need to be in place broadly to reduce fragmentation and provide stronger infrastructural and systemic support to the community health workforce.

Sociodemographics of Patient Populations Undergoing Gender-Affirming Surgery: A Systematic Review of All Cohort Studies.

Importance: Sociodemographic and health characteristics of patients undergoing gender-affirming surgery (GAS) are currently unknown. Understanding these patient characteristics is vital to optimizing patient-centered care for transgender patients. Objective: To determine sociodemographic characteristics for the transgender population undergoing GAS. Collected sociodemographic information included the following: age, race/ethnicity, body metrics, hormone replacement therapy administration and duration, substance use, psychiatric comorbidities, and medical comorbidities. Evidence Review: A search of seven electronic databases (PubMed, PsycINFO, Embase, CINAHL, Web of Science, Cochrane, and Gender Studies) was used to find all articles on GAS from inception through May 2019. The 15,190 articles were then subjected to two levels of screening, and articles unrelated to gender-affirming care, unavailable in English, n<5, and with no outcomes reporting were excluded. Textbook chapters and letters were also excluded. Findings: A total of 406 studies were fully extracted, with 307 studies reporting age (n=22,727 patients), 19 reporting race/ethnicity (n=1184), 74 reporting body metrics (body mass index [BMI] n=6852, height n=416, and weight n=475), 58 reporting hormone therapies (n=5104), 56 reporting substance use (n=1146), 44 reporting psychiatric comorbidities (n=574), and 47 reporting medical comorbidities (n=573). From the 406 studies, 80 were done in the United States. Regarding U.S. studies, 59 studies reported age (n=5365), 10 reported race/ethnicity (n=709), 22 reported body metrics (BMI n=2519), 18 reported hormone therapies (n=3285), 15 reported substance use (n=478), 44 reported psychiatric comorbidities (n=394), and 47 reported medical comorbidities (n=293). Age was the most reported characteristic, reported in 75.62% of studies (73.75% of U.S. studies). Race/ethnicity was the least commonly reported data, reported in 4.68% of studies (12.50% of U.S. studies). Conclusions and Relevance: The type of sociodemographic information reported by GAS studies is inconsistently reported. To improve patient-centered care for transgender patients, further work is needed to create a standardization of collected sociodemographic information.

Experiences, Enablers, and Challenges in Service Delivery and Integration of COVID-19 Vaccines: A Rapid Systematic Review.

The COVID-19 vaccination is a crucial public health intervention for controlling the spread and severity of the SARS-CoV2 virus. COVID-19 vaccines have been developed in record time, but their deployment has varied across countries, owing to differences in health system capacity, demand for the vaccine, and purchasing power of countries. The aim of this rapid review is to summarize and synthesize experiences on COVID-19 vaccine service delivery and integration to inform future COVID-19 vaccination programming and contribute to the knowledge base for future pandemic management. A systematic search was conducted in PubMed, Scopus, and Global Index Medicus databases. Twenty-five studies were included in the analysis. Included studies spanned nine countries where COVID-19 vaccines were delivered through mass, mobile, and fixed-post vaccination service delivery models. There was limited evidence of integrating COVID-19 vaccines into routine services for pregnant women, people who inject drugs, and leveraging existing health programs to deliver COVID-19 vaccines to the general population. Common challenges reported were vaccine skepticism, lack of adequate health workers, and linguistic barriers to access. Partnerships with a variety of stakeholders and the involvement of volunteers were vital in overcoming barriers and contributed to the efficient functioning of COVID-19 vaccination programs.

Brain-based correlates of antidepressant response to ketamine: a comprehensive systematic review of neuroimaging studies.

Ketamine is an effective antidepressant, but there is substantial variability in patient response and the precise mechanism of action is unclear. Neuroimaging can provide predictive and mechanistic insights, but findings are limited by small sample sizes. This systematic review covers neuroimaging studies investigating baseline (pre-treatment) and longitudinal (post-treatment) biomarkers of responses to ketamine. All modalities were included. We performed searches of five electronic databases (from inception to April 26, 2022). 69 studies were included (with 1751 participants). There was substantial methodological heterogeneity and no well replicated biomarker. However, we found convergence across some significant results, particularly in longitudinal biomarkers. Response to ketamine was associated with post-treatment increases in gamma power in frontoparietal regions in electrophysiological studies, post-treatment increases in functional connectivity within the prefrontal cortex, and post-treatment increases in the functional activation of the striatum. Although a well replicated neuroimaging biomarker of ketamine response was not identified, there are biomarkers that warrant further investigation.

Neuroimaging Correlates of Depression after Traumatic Brain Injury: A Systematic Review.

Depression is the most frequent neuropsychiatric complication after traumatic brain injury (TBI) and is associated with poorer outcomes. Neuroimaging has the potential to improve our understanding of the neural correlates of depression after TBI and may improve our capacity to accurately predict and effectively treat this condition. We conducted a systematic review of structural and functional neuroimaging studies that examined the association between depression after TBI and neuroimaging measures. Electronic searches were conducted in four databases and were complemented by manual searches. In total, 2035 citations were identified and, ultimately, 38 articles were included, totaling 1793 individuals (median [25-75%] sample size of 38.5 [21.8-54.3] individuals). The most frequently used modality was structural magnetic resonance imaging (MRI) (n = 17, 45%), followed by diffusion tensor imaging (n = 11, 29%), resting-state functional MRI (n = 10, 26%), task-based functional MRI (n = 4, 8%), and positron emission tomography (n = 2, 4%). Most studies (n = 27, 71%) were cross-sectional. Overall, depression after TBI was associated with lower gray matter measures (volume, thickness, and/or density) and greater white matter damage. However, identification of specific brain areas was somewhat inconsistent. Findings that were replicated in more than one study included reduced gray matter in the rostral anterior cingulate cortex, pre-frontal cortex, and hippocampus, and damage in five white matter tracts (cingulum, internal capsule, superior longitudinal fasciculi, and anterior and posterior corona radiata). This systematic review found that the available data did not converge on a clear neuroimaging biomarker for depression after TBI. However, there are promising targets that warrant further study.

Prenatal Environmental Metal Exposure and Preterm Birth: A Scoping Review.

Preterm birth (PTB) and its complications are the leading causes of under-five year old child deaths, accounting worldwide for an estimated one million deaths annually. The etiology of PTB is complex and multifactorial. Exposures to environmental metals or metalloids are pervasive and prenatal exposures to them are considered important in the etiology of PTB. We conducted a scoping review to determine the extent of prenatal exposures to four metals/metalloids (lead, mercury, cadmium and arsenic) and their association with PTB. We reviewed original research studies published in PubMed, Embase, the Cochrane Library, Scopus, POPLINE and the WHO regional indexes from 2000 to 2019; 36 articles were retained for full text review. We documented a higher incidence of PTB with lead and cadmium exposures. The findings for mercury and arsenic exposures were inconclusive. Metal-induced oxidative stress in the placenta, epigenetic modification, inflammation, and endocrine disruptions are the most common pathways through which heavy metals and metalloids affect placental functions leading to PTB. Most of the studies were from the high-income countries, reflecting the need for additional data from low-middle-income countries, where PTB rates are higher and prenatal exposure to metals are likely to be just as high, if not higher.

In the shadow of academic medical centers: a systematic review of urban health research in Baltimore City.

The city of Baltimore is a typical, large, urban center in the United States with several major academic medical institutions surrounded by disadvantaged neighborhoods with multiple poor health indices. In order to understand the extent to which academic research agendas reflect the health concerns of Baltimore's local population, a systematic review was conducted to identify research about four key, health-related topic areas. We classified papers on: disease prevalence and health status, utilization of health services, population-based interventions, and the unmet health needs of Baltimore City residents. Approximately 4,150 citations were identified in the search and two levels of screening yielded a total of 288 papers. The majority of articles (n = 189) examined prevalence of health conditions such as Human Immunodeficiency Virus (HIV), mental health and mental disorders, and sexually transmitted diseases. Papers about specific target populations focused primarily on adults, African Americans, and females. Despite a significant body of research concerning several health conditions and priority populations, significant gaps in knowledge about health services utilization, community interventions, unmet health needs, and the prevalence of specific health issues remain. This review provides valuable insight into the extent of health research conducted about the city of Baltimore and whether community health priorities have been investigated. It provides a basis for examining the potential directions of academic research centers to effectively identify and address collective, urban health priorities of the communities in which they reside.

Evaluation of Systematic Reviews of Interventions for Retina and Vitreous Conditions.

Importance: Patient care and clinical practice guidelines should be informed by evidence from reliable systematic reviews. The reliability of systematic reviews related to forthcoming guidelines for retina and vitreous conditions is unknown. Objectives: To summarize the reliability of systematic reviews on interventions for 7 retina and vitreous conditions, describe characteristics of reliable and unreliable systematic reviews, and examine the primary area in which they appeared to be lacking. Design, Setting, and Participants: A cross-sectional study of systematic reviews was conducted. Systematic reviews of interventions for retina- and vitreous-related conditions in a database maintained by the Cochrane Eyes and Vision United States Satellite were identified. Databases that the reviewers searched, whether any date or language restrictions were applied, and bibliographic information, such as year and journal of publication, were documented. The initial search was conducted in March 2007, and the final update was performed in July 2018. The conditions of interest were age-related macular degeneration; diabetic retinopathy; idiopathic epiretinal membrane and vitreomacular traction; idiopathic macular hole; posterior vitreous detachment, retinal breaks, and lattice degeneration; retinal and ophthalmic artery occlusions; and retinal vein occlusions. The reliability of each review was evaluated using prespecified criteria. Data were extracted by 2 research assistants working independently, with disagreements resolved through discussion or by 1 research assistant with verification by a senior team member. Main Outcomes and Measures: Proportion of reviews that meet all of the following criteria: (1) defined eligibility criteria for study selection, (2) described conducting a comprehensive literature search, (3) reported assessing risk of bias in included studies, (4) described using appropriate methods for any meta-analysis performed, and (5) provided conclusions consistent with review findings. Results: A total of 327 systematic reviews that addressed retina and vitreous conditions were identified; of these, 131 reviews (40.1%) were classified as reliable and 196 reviews (59.9%) were classified as not reliable. At least 1 reliable review was found for each of the 7 retina and vitreous conditions. The most common reason that a review was classified as not reliable was lack of evidence that a comprehensive literature search for relevant studies had been conducted (149 of 196 reviews [76.0%]). Conclusion and Relevance: The findings of this study suggest that most systematic reviews that addressed interventions for retina and vitreous conditions were not reliable. Systematic review teams and guideline developers should work with information professionals who can help navigate sophisticated and varied syntaxes required to search different resources.

Bringing evidence to practice: a team approach to teaching skills required for an informationist role in evidence-based clinical and public health practice.

OBJECTIVE: The objectives were (1) to develop an academic, graduate-level course designed for information professionals seeking to bring evidence to clinical medicine and public health practice and to address, in the course approach, the "real-world" time constraints of these domains and (2) to further specify and realize identified elements of the "informationist" concept. SETTING: The course took place at the Division of Health Sciences Informatics, School of Medicine, Johns Hopkins University. PARTICIPANTS: A multidisciplinary faculty, selected for their expertise in the course core competencies, and three students, two post-graduate National Library of Medicine (NLM) informationist fellows and one NLM second-year associate, participated in the research. INTERVENTION: A 1.5-credit, graduate-level course, "Informationist Seminar: Bringing the Evidence to Practice," was offered in October to December 2006. In this team-taught course, a series of lectures by course faculty and panel discussions involving outside experts were combined with in-class discussion, homework exercises, and a major project that involved choosing and answering, in both oral and written form, a real-world question based on a case scenario in clinical or public health practice. CONCLUSION: This course represents an approach that could be replicated in other academic health centers with similar pools of expertise. Ongoing journal clubs that reiterate the question-and-answer process with new questions derived from clinical and public health practice and incorporate peer review and faculty mentoring would reinforce the skills acquired in the seminar.

Dietary Alteration of the Gut Microbiome and Its Impact on Weight and Fat Mass: A Systematic Review and Meta-Analysis.

Dietary alteration of the gut microbiome is an important target in the treatment of obesity. Animal and human studies have shown bidirectional weight modulation based on the probiotic formulation used. In this study, we systematically reviewed the literature and performed a meta-analysis to assess the impact of prebiotics, probiotics and synbiotics on body weight, body mass index (BMI) and fat mass in adult human subjects. We searched Medline (PubMed), Embase, the Cochrane Library and the Web of Science to identify 4721 articles, of which 41 were subjected to full-text screening, yielding 21 included studies with 33 study arms. Probiotic use was associated with significant decreases in BMI, weight and fat mass. Studies of subjects consuming prebiotics demonstrated a significant reduction in body weight, whereas synbiotics did not show an effect. Overall, when the utilization of gut microbiome-modulating dietary agents (prebiotic/probiotic/synbiotic) was compared to placebo, there were significant decreases in BMI, weight and fat mass. In summary, dietary agents for the modulation of the gut microbiome are essential tools in the treatment of obesity and can lead to significant decreases in BMI, weight and fat mass. Further studies are needed to identify the ideal dose and duration of supplementation and to assess the durability of this effect.

Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.

The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol".

Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review.

CORRECTION: The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review.

Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy.

OBJECTIVES: The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic sources (clinical study reports [CSRs] and individual participant data [IPD]). RESULTS: We found 21 gabapentin RCTs (74 reports, 6 IPD) and 7 quetiapine RCTs (50 reports, 1 IPD); most were reported in journal articles (18/21 [86%] and 6/7 [86%], respectively). When available, CSRs contained the most trial design and risk of bias information. CSRs and IPD contained the most results. For the outcome domains "pain intensity" (gabapentin) and "depression" (quetiapine), we found single trials with 68 and 98 different meta-analyzable results, respectively; by purposefully selecting one meta-analyzable result for each RCT, we could change the overall result for pain intensity from effective (standardized mean difference [SMD] = -0.45; 95% confidence interval [CI]: -0.63 to -0.27) to ineffective (SMD = -0.06; 95% CI: -0.24 to 0.12). We could change the effect for depression from a medium effect (SMD = -0.55; 95% CI: -0.85 to -0.25) to a small effect (SMD = -0.26; 95% CI: -0.41 to -0.1). CONCLUSIONS: Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta-analyses.

Community Health Workers' Provision of Family Planning Services in Low- and Middle-Income Countries: A Systematic Review of Effectiveness.

This systematic review evaluates the strength of the evidence that community health workers' (CHW) provision of family planning (FP) services in low- and middle-income countries is effective. In a search of eight databases, articles were screened by study design and outcome measure and ranked by strength of evidence. Only randomized trials, longitudinal studies with a comparison group, and pre-test/post-test studies met inclusion criteria. A total of 56 studies were included. Of those studies with relevant data, approximately 93 percent indicated that CHW FP programs effectively increased the use of modern contraception, while 83 percent reported an improvement in knowledge and attitudes concerning contraceptives. Based on these findings, strong evidence exists for promoting CHW programs to improve access to FP services. We recommend a set of best practice guidelines that researchers and program managers can use to report on CHW FP programs to facilitate the translation of research to practice across a wide range of settings.