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BACKGROUND: Primary sclerosing cholangitis (PSC) is a progressive immune-mediated liver disease, for which no medical therapy has been shown to slow disease progression. However, the horizon for new therapies is encouraging, with several innovative clinical trials in progress. Despite these advancements, there is considerable heterogeneity in the outcomes studied, with lack of consensus as to what outcomes to measure, when to measure and how to measure. Furthermore, there has been a paradigm shift in PSC treatment targets over recent years, moving from biochemistry-based endpoints to histological assessment of liver fibrosis, imaging-based biomarkers and patient-reported outcome measures. The abundance of new interventional trials and evolving endpoints pose opportunities for all stakeholders involved in evaluating novel therapies. To this effect, there is a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). METHODS AND ANALYSIS: Synthesis of a PSC-specific COS will be conducted in four stages. Initially, a systematic literature review will be performed to identify outcomes previously used in PSC trials, followed by semistructured qualitative interviews conducted with key stakeholders. The latter may include patients, clinicians, researchers, pharmaceutical industry representatives and healthcare payers and regulatory agencies, to identify additional outcomes of importance. Using the outcomes generated from the literature review and stakeholder interviews, an international two-round Delphi survey will be conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting will be convened to ratify the COS and disseminate findings for application in future PSC trials. ETHICS AND DISSEMINATION: Ethical approval has been granted by the East Midlands-Leicester Central Research Ethics Committee (Ref: 24/EM/0126) for this study. The COS from this study will be widely disseminated including publication in peer-reviewed journals, international conferences, promotion through patient-support groups and made available on the Core Outcomes Measurement in Effectiveness Trials (COMET) database. TRIAL REGISTRATION NUMBER: 1239.

BACKGROUND: Hematopoietic stem cell transplantation (HSCT) is a life-saving treatment for adolescents and young adults (ages 15-39) with hematologic malignancy. Given the significant developmental milestones usually achieved during this unique life stage, this population is especially vulnerable to the interruption caused by a cancer diagnosis and its treatment. HSCT is a particularly invasive form of cancer therapy with many negative physical, social, and psychological sequelae. The long-term impact of HSCT in adolescents and young adults with hematologic malignancies warrants a systematic investigation of its effects to best shape clinical care and health policy. METHODS: This protocol for a systematic review will focus on the long-term physical, psychological, social, spiritual, and health behavior effects experienced by adolescents and young adults who undergo HSCT for hematologic malignancy. We have constructed a specific search strategy that queries these five domains, which will be applied to five databases-Embase, PubMed, Cochrane Trials and Reviews, PsychInfo, and CINAHL-to identify the key literature. Two independent reviewers will perform a title/abstract screen followed by a full-text screen using standard screening templates to ensure the inclusion of outcomes in the post-acute HSCT period. Risk of bias will be assessed using the University of Adelaide Joanna Briggs Institute Collaboration Critical Appraisal Tools. Data from included studies will be abstracted on study characteristics, study setting, sample characteristics, and outcomes. Given the broad scope of the research question, data synthesis will focus on qualitative methods in accordance with Institute of Medicine standards. DISCUSSION: While adolescents and young adults undergoing hematopoietic stem cell transplantation for hematologic malignancy are understood to have a unique survivorship experience, the sequelae of this treatment approach in this population have not been previously aggregated. This systematic review intends to expand insight into the adolescent and young adult experiences with HSCT in order to inform age-appropriate survivorship care and deliver this life-saving intervention with the best possible outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022361663.

Background Aims Materials and Methods Results Conclusions Cannabis use during pregnancy is becoming more prevalent. While numerous studies have explored the relationship of cannabis use during pregnancy and outcomes for mothers and infants, uncertainty remains regarding the impact of cannabis use on pregnancy complications and later‐life outcomes for offspring.To produce a summary of the short and long‐term effects of prenatal cannabis exposure on fetal growth and development, neonatal conditions, later‐life, and maternal outcomes.An overview of systematic reviews, an evidence and gap map, targeted updates of previous reviews, and de novo evidence synthesis was conducted. The databases searched include PubMed (National Center for Biotechnology Information); MEDLINE (Ovid); Embase (Ovid) and CINAHL with Full Text (EBSCO). Assessment of risk of bias was conducted in duplicate for all studies. Relevant studies were coded and are presented as an evidence and gap map. Where possible, meta‐analyses were conducted with a narrative synthesis of the results. Primary studies and systematic reviews examining the relationship between cannabis consumption in pregnancy and the effect on fetal/child development, antenatal, and obstetric outcomes during pregnancy were eligible for inclusion.There were 89 studies/reviews eligible for inclusion in this review. There was a potentially harmful impact of prenatal cannabis exposure on all fetal growth and development outcomes, some neonatal outcomes, some later‐life outcomes, and some maternal outcomes. The evidence regarding other neonatal conditions, later‐life, and maternal outcomes was mixed.The evidence suggests cannabis should be avoided during pregnancy. [ABSTRACT FROM AUTHOR]

Background: The relationship between dietary fiber intake and cancer outcomes, including incidence, recurrence, and mortality, is crucial for understanding cancer prevention strategies. Methods: An umbrella review was conducted, analyzing existing systematic reviews and meta-analyses from PubMed, Embase, and the Cochrane Database of Systematic Reviews. This included data from 26 meta-analyses based on 2,107 unique articles, covering 52 observational study outcomes. The quality of the studies was assessed using the AMSTAR 2 tool. Results: High fiber intake significantly lowers the risk of cancers affecting the digestive, reproductive, and urinary systems, including esophageal adenoma, squamous cell carcinoma, gastric, pancreatic, colon, rectal, colorectal adenoma, breast, ovarian, endometrial, prostate, renal cell, and bladder cancers. Findings estimated that the risk of Colon cancer between total dietary fiber (TDF) was 0.74 (95% confidence interval [CI]: 0.67–0.82), and the risk of Colorectal cancer between TDF was 0.88 (95% CI: 0.82–0.94). TDF was also found to be protective against Barrett’s esophagus and esophagus cancer, esophageal adenomas, and esophagus squamous cell carcinoma, with effect sizes of 0.52 (95% CI: 0.43–0.64), 0.50 (95% CI: 0.37–0.67), and 0.53 (95% CI: 0.31–0.90), respectively. Conversely, increased intake of cereal fiber was associated with a higher incidence of renal cell carcinoma and endometrial cancer. Dose–response analyses revealed that increments of 2.5, 5, or 10 g per day in dietary fiber could lead to different levels of risk reduction for these cancers. Meta-regression suggested an optimal fiber intake range of 7–36 g per day for colon cancer prevention. However, the overall study quality was predominantly rated as ‘very low’. Conclusions: Higher dietary fiber intake is linked to reduced cancer risk and improved outcomes. These findings highlight dietary fiber’s importance in cancer prevention and care.

ImportancePolypharmacy is associated with mortality, falls, hospitalizations, and functional and cognitive decline. The study of polypharmacy-related interventions has increased substantially, prompting the need for an updated, more focused systematic overview.ObjectiveTo systematically evaluate and summarize evidence across multiple systematic reviews (SRs) examining interventions addressing polypharmacy.Evidence reviewA search was conducted of MEDLINE, the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects for articles published from January 2017-October 2022, as well as those identified in a previous overview (January 2004-February 2017). Systematic reviews were included regardless of study design, setting, or outcome. The evidence was summarized by 4 categories: (1) medication-related process outcomes (eg, potentially inappropriate medication [PIM] and potential prescribing omission reductions), (2) clinical and functional outcomes, (3) health care use and economic outcomes, and (4) acceptability of the intervention.FindingsFourteen SRs were identified (3 from the previous overview), 7 of which included meta-analyses, representing 179 unique published studies. Nine SRs examined medication-related process outcomes (low to very low evidence quality). Systematic reviews using pooled analyses found significant reductions in the number of PIMs, potential prescribing omissions, and total number of medications, and improvements in medication appropriateness. Twelve SRs examined clinical and functional outcomes (very low to moderate evidence quality). Five SRs examined mortality; all mortality meta-analyses were null, but studies with longer follow-up periods found greater reductions in mortality. Five SRs examined falls incidence; results were predominantly null save for a meta-analysis in which PIMs were discontinued. Of the 8 SRs examining quality of life, most (7) found predominantly null effects. Ten SRs examined hospitalizations and readmissions (very low to moderate evidence quality) and 4 examined emergency department visits (very low to low evidence quality). One SR found significant reductions in hospitalizations and readmissions among higher-intensity medication reviews with face-to-face patient components. Another meta-analysis found a null effect. Of the 7 SRs without meta-analyses for hospitalizations and readmissions, all had predominantly null results. Two of 4 SRs found reductions in emergency department visits. Two SRs examined acceptability (very low evidence quality), finding wide variation in the adoption of polypharmacy-related interventions.Conclusions and relevanceThis updated systematic overview noted little evidence of an association between polypharmacy-related interventions and reduced important clinical and health care use outcomes. More evidence is needed regarding which interventions are most useful and which populations would benefit most.

OBJECTIVE: Advances in amyotrophic lateral sclerosis (ALS) gene discovery, ongoing gene therapy trials, and patient demand have driven increased use of ALS genetic testing. Despite this progress, the offer of genetic testing to persons with ALS is not yet standard of care. Our primary goal is to develop clinical ALS genetic counseling and testing guidelines to improve and standardize genetic counseling and testing practice among neurologists, genetic counselors or any provider caring for persons with ALS. METHODS: Core clinical questions were identified and a rapid review performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-P) 2015 method. Guideline recommendations were drafted and the strength of evidence for each recommendation was assessed by combining two systems: the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) System and the Evaluation of Genomic Applications in Practice and Prevention (EGAPP). A modified Delphi approach was used to reach consensus among a group of content experts for each guideline statement. RESULTS: A total of 35 guideline statements were developed. In summary, all persons with ALS should be offered single-step genetic testing, consisting of a C9orf72 assay, along with sequencing of SOD1, FUS, and TARDBP, at a minimum. The key education and genetic risk assessments that should be provided before and after testing are delineated. Specific guidance regarding testing methods and reporting for C9orf72 and other genes is provided for commercial laboratories. INTERPRETATION: These evidence-based, consensus guidelines will support all stakeholders in the ALS community in navigating benefits and challenges of genetic testing.

Vasomotor symptoms (VMS) are the hallmark of menopause and negatively affect a large proportion of women over many years. However, studies evaluating the overall impact of VMS are limited. This systematic review (SR) aimed to examine epidemiological, clinical, humanistic, and economic outcomes of VMS among perimenopausal women and among women aged ≥65 years in the US. A systematic search of the MEDLINE and Embase databases was conducted to identify observational studies (2010–2022) reporting on these populations. Data reporting outcomes of interest were extracted and analyzed descriptively. Of 7,613 studies identified, 34 met inclusion criteria, of which 30 reported on perimenopausal women and 4 reported on VMS in women aged ≥ 65 years. VMS and severe/moderate-to-severe VMS were reported by 48.4–70.6 percent and 13.0–63.1 percent, respectively, of perimenopausal women. Mean VMS duration was 2.6 years, and median duration ranged from 7.4 to 10.1 years among women with onset in early perimenopause and from 3.8 to 6.1 years among those with onset in late perimenopause. Among women aged ≥65 years, 20.9–45.1 percent reported VMS; 2.0 percent reported severe symptoms, and 17.6 percent reported moderate symptoms. No studies reported VMS frequency and duration or the economic or humanistic burden among women aged ≥65 years. In conclusion, high VMS frequency and severity were observed among perimenopausal women and women aged ≥65 years in the US in this SR, highlighting the need for (1) better management of VMS to reduce frequency and severity and (2) further research to clarify the impact of VMS on disease burden, quality of life, and economic impact. [ABSTRACT FROM AUTHOR]

Background and Aims: Alternative therapies, such as zinc supplementation, have been explored as potential interventions for sleep disorders. However, the efficacy of zinc supplementation in improving sleep quality remains uncertain. This systematic review aims to examine the impacts of zinc supplementation on sleep quality in humans. Methods: The Web of Science, Medline, Scopus, and Google Scholar databases were comprehensively searched to find studies investigating the effect of zinc supplementation on sleep quality. After identifying relevant studies by screening, relevant data were extracted from them. The quality assessment was conducted using the Cochrane quality assessment tool. Results: This systematic review included eight studies. The interventions ranged from 4 to 48 weeks, with a daily dose of zinc supplementation varying between 10 and 73.3 mg. The majority of the evidence examined in this review pointed to the significant improvement effect of zinc supplementation on sleep quality in adults compared to the control groups. Furthermore, zinc supplementation did not have a significant effect on sleep disorders. However, there was no consensus about these findings. Also, the effect of supplementation on sleep duration in nonadults was contradictory. Conclusions: This systematic review suggests that zinc supplementation may lead to improvements in sleep quality. However, more research, primarily clinical trials, is needed to clarify the beneficial effects of zinc supplementation on sleep quality with consideration of dietary zinc intake and the Recommended Dietary Allowances of zinc (RDA) in the different populations. It is also recommended to investigate the effect of zinc supplementation on sleep quality in people with zinc deficiency in future studies. [ABSTRACT FROM AUTHOR]

We conducted a content analysis of the literature underlying the Centers for Disease Control and Prevention (CDC) Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children (i.e., the Guideline) to determine the extent to which social determinants of health (SDoH) were examined or addressed. The systematic review forming the basis for the Guideline included 37 studies addressing diagnosis, prognosis, and treatment/rehabilitation. We examined those studies to identify SDoH domains derived from the U.S. Department of Health and Human Services Healthy People 2020 and 2030 websites. No study explicitly mentioned social determinants of health, by name, and few studies addressed SDoH domains as a primary focus (ranging from 0% to 27% of studies across SDoH domains). The most frequently represented SDoH domains, described in an inferential or a descriptive manner, were Education Access and Quality (29.7% of studies), Social and Community Context (27.0% of studies), and Economic Stability (21.6% of studies). Health Care Access (13.5% of studies) was less well represented and no studies (0%) examined Neighborhood and Built Environment. In terms of the CDC clinical questions, SDoH were only examined as predictors of outcome (prognosis) and no studies examined SDoH in relation to diagnosis or treatment/rehabilitation. The Guideline includes some commentary on health literacy and socioeconomic status. Overall, social determinants of health are largely unrepresented as important or meaningful variables influencing the Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children, or in the studies that informed the Guideline.

CONTEXT: Poor diet has been implicated in a range of noncommunicable diseases. Fiscal and pricing policies (FPs) may offer a means by which consumption of food and non-alcoholic beverages with links to such diseases can be influenced to improve public health. OBJECTIVE: To examine the acceptability of FPs to reduce diet-related noncommunicable disease, based on systematic review evidence. DATA SOURCES: MEDLINE, EMBASE, PsychInfo, SCI, SSCI, Web of Science, Scopus, EconLit, the Cochrane Library, Epistemonikos, and the Campbell Collaboration Library were searched for relevant studies published between January 1, 1990 and June 2021. DATA EXTRACTION: The studies included systematic reviews of diet-related FPs and: used real-world evidence; examined real or perceived barriers/facilitators; targeted the price of food or non-alcoholic beverages; and applied to entire populations within a jurisdiction. A total of 9996 unique relevant records were identified, which were augmented by a search of bibliographies and recommendations from an external expert advisory panel. Following screening, 4 systematic reviews remained. DATA ANALYSIS: Quality appraisal was conducted using the AMSTAR 2 tool. A narrative synthesis was undertaken, with outcomes grouped according to the WHO-INTEGRATE criteria. The findings indicated a paucity of high-quality systematic review evidence and limited public support for the use of FPs to change dietary habits. This lack of support was related to a number of factors that included: their perceived potential to be regressive; a lack of transparency, ie, there was mistrust around the use of revenues raised; a paucity of evidence around health benefits; the deliberate choice of rates that were lower than those considered necessary to affect diet; and concerns about the potential of such FPs to harm economic outcomes such as employment. CONCLUSION: The findings underscore the need for high-quality systematic review evidence on this topic, and the importance of responding to public concerns and putting in place mechanisms to address these when implementing FPs. This study was funded by Safefood [02A-2020]. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42021274454.

Given the key role of systematic reviews in informing clinical decision making and guidelines, it is important for individuals to have equitable access to quality instructional materials on how to design, conduct, report, and evaluate systematic reviews. In response to this need, Vanderbilt University Medical Center’s Center for Knowledge Management (CKM) created an open-access systematic review instructional video series. The educational content was created by experienced CKM information scientists, who worked together to adapt an internal training series that they had developed into a format that could be widely shared with the public. Brief videos, averaging 10 minutes in length, were created addressing essential concepts related to systematic reviews, including distinguishing between literature review types, understanding reasons for conducting a systematic review, designing a systematic review protocol, steps in conducting a systematic review, web-based tools to aid with the systematic review process, publishing a systematic review, and critically evaluating systematic reviews. Quiz questions were developed for each instructional video to allow learners to check their understanding of the material. The systematic review instructional video series launched on CKM’s Scholarly Publishing Information Hub (SPI-HubTM) website in Fall 2023. From January through August 2024, there were 1,662 international accesses to the SPI-HubTM systematic review website, representing 41 countries. Initial feedback, while primarily anecdotal, has been positive. By adapting its internal systematic review training into an online video series format suitable for asynchronous instruction, CKM has been able to widely disseminate its educational materials.

IntroductionUnhealthy alcohol use is associated with a range of adverse outcomes among people with HIV (PWH). Testing the efficacy and promoting the availability of effective interventions to address unhealthy alcohol use among PWH is thus a priority. Alcohol use outcomes in intervention studies are often measured by self-report alone, which can lead to spurious results due to information biases (eg, social desirability). Measuring alcohol outcomes objectively through biomarkers, such as phosphatidylethanol (PEth), in addition to self-report has potential to improve the validity of intervention studies. This protocol outlines the methods for a systematic review and individual participant data meta-analysis that will estimate the efficacy of interventions to reduce alcohol use as measured by a combined categorical self-report/PEth variable among PWH and compare these estimates to those generated when alcohol is measured by self-report or PEth alone.Methods and analysisWe will include randomised controlled trials that: (A) tested an alcohol intervention (behavioural and/or pharmacological), (B) enrolled participants 15 years or older with HIV; (C) included both PEth and self-report measurements, (D) completed data collection by 31 August 2023. We will contact principal investigators of eligible studies to inquire about their willingness to contribute data. The primary outcome variable will be a combined self-report/PEth alcohol categorical variable. Secondary outcomes will include PEth alone, self-report alone and HIV viral suppression. We will use a two-step meta-analysis and random effects modelling to estimate pooled treatment effects; I2 will be calculated to evaluate heterogeneity. Secondary and sensitivity analyses will explore treatment effects in adjusted models and within subgroups. Funnel plots will be used to explore publication bias.Ethics and disseminationThe study will be conducted with deidentified data from completed randomised controlled trials and will be considered exempt from additional ethical approval. Results will be disseminated through peer-reviewed publications and international scientific meetings.Prospero registration numberCRD42022373640.

Background: Theoretical models are characterized as a guiding thread for research. However, they are rarely used and reported in depth by researchers, which can negatively impact scientific quality and re-producibility. Objective: Identify the use profile and level of depth of theories and/or theoretical models, methodological and reporting qualities of systematic reviews (SR) with or without meta-analysis, and to correlate the use of theories/models with the methodological and reporting qualities. Method: Crosssectional study, carried out from May to December 2019, composed of RS from the journals Revista de Saúde Pública (RSP) and Cadernos de Saúde Pública (CSP). There were no language restrictions. The selection of articles and data extraction was carried out in duplicate. To assess the use of theories, the questionnaire developed by Cabrera was used; to assess methodological quality, the Assessment of Multiple Systematic Reviews (AMSTAR-2); and for the report, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Analysis was performed using statistical tests, at the level of significance p<0.05. Results: Forty-five SR were included (22 RSP and 23 CSP). Only 24.4% of SR used theories/models and, of these, 54.5% only mentioned (Level 1) and 45.5% described (Level 2), there was no use in depth (Levels 3 and 4). The SRs presented limitations in methodological and reporting quality: only 37.5% of the items in AMSTAR-2 were attended by most of the SRs, and 66.6% of those in PRISMA. Positive correlations were observed between the use of theories and methodological and reporting qualities. Conclusion: The use of theories/theoretical models may reflect better methodological and reporting quality of SR. [ABSTRACT FROM AUTHOR]

Background: Key performance indicators (KPIs) are quantifiable measures used to monitor the quality of health services. Implementation guidelines for clinical pharmacy services (CPS) do not specify KPIs. Aim: To assess the quality of the studies that have developed KPIs for CPS in inpatient hospital settings. Method: A systematic review was conducted by searching in Web of Science, Scopus, and PubMed, supplemented with citation analyses and grey literature searches, to retrieve studies addressing the development of KPIs in CPS for hospital inpatients. Exclusions comprised drug- or disease-specific studies and those not written in English, French, Portuguese, or Spanish. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument assessed methodological quality. Domain scores and an overall score were calculated using an equal-weight principle. KPIs were classified into structure, process, and outcome categories. The protocol is available at https://doi.org/10.17605/OSF.IO/KS2G3. Results: We included thirteen studies that collectively developed 225 KPIs. Merely five studies scored over 50% on the AIRE instrument, with domains #3 (scientific evidence) and #4 (formulation and usage) displaying low scores. Among the KPIs, 8.4% were classified as structure, 85.8% as process, and 5.8% as outcome indicators. The overall methodological quality did not exhibit a clear association with a major focus on outcomes. None of the studies provided benchmarking reference values. Conclusion: The KPIs formulated for evaluating CPS in hospital settings primarily comprised process measures, predominantly suggested by pharmacists, with inadequate evidence support, lacked piloting or validation, and consequently, were devoid of benchmarking reference values. [ABSTRACT FROM AUTHOR]

Abstract Background and Aims Alternative therapies, such as zinc supplementation, have been explored as potential interventions for sleep disorders. However, the efficacy of zinc supplementation in improving sleep quality remains uncertain. This systematic review aims to examine the impacts of zinc supplementation on sleep quality in humans. Methods The Web of Science, Medline, Scopus, and Google Scholar databases were comprehensively searched to find studies investigating the effect of zinc supplementation on sleep quality. After identifying relevant studies by screening, relevant data were extracted from them. The quality assessment was conducted using the Cochrane quality assessment tool. Results This systematic review included eight studies. The interventions ranged from 4 to 48 weeks, with a daily dose of zinc supplementation varying between 10 and 73.3 mg. The majority of the evidence examined in this review pointed to the significant improvement effect of zinc supplementation on sleep quality in adults compared to the control groups. Furthermore, zinc supplementation did not have a significant effect on sleep disorders. However, there was no consensus about these findings. Also, the effect of supplementation on sleep duration in nonadults was contradictory. Conclusions This systematic review suggests that zinc supplementation may lead to improvements in sleep quality. However, more research, primarily clinical trials, is needed to clarify the beneficial effects of zinc supplementation on sleep quality with consideration of dietary zinc intake and the Recommended Dietary Allowances of zinc (RDA) in the different populations. It is also recommended to investigate the effect of zinc supplementation on sleep quality in people with zinc deficiency in future studies.

The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk.

ABSTRACT Purpose: Penile fracture (PF) affects 1,14 to 10,48 men in every 100.000 men in East Asia, and the primary aetiology is sexual intercourse, but the knowledge regarding the most dangerous sexual position is not well explained. This study compares three sexual positions: man on top position (MTP), woman on top position (WTP), and doggy style position (DSP), leading to PF potential. Materials and methods: A search of sexual position-related PF in Google Scholar, PubMed, Cochrane, and PMC Europe was performed. Criteria inclusion was the full text of relevant articles which describ the number of sexual positions. It was analyzed by odds ratio, random model effect, and the OR and 95%CI were calculated. Results: Twelve relevant papers involving 490 patients comprised 169 MTP, 120 WTP, 158 DSP, and 43 no intercourse cases. Meta-analysis of all sexual positions was a MTP P= 0,04, WTP P=0,49, and DSP P=0,0005. Conclusions: The man-dominant positions (MTP and DSP) were significantly potential for PF, which speculated that when a man is dominant and very excited, intercourse may become highly vigorous and impact trauma. This study found that man's dominant position consists of DSP and the MTP significantly lead to PF.

Abstract Background Organizations face diverse contexts and requirements when updating and maintaining their portfolio, or pool, of systematic reviews or clinical practice guidelines they need to manage. We aimed to develop a comprehensive, theoretical framework that might enable the design and tailoring of maintenance strategies for portfolios containing systematic reviews and guidelines. Methods We employed a conceptual approach combined with a literature review. Components of the diagnostic test-treatment pathway used in clinical healthcare were transferred to develop a framework specifically for systematic review and guideline portfolio maintenance strategies. Results We developed the Portfolio Maintenance by Test-Treatment (POMBYTT) framework comprising diagnosis, staging, management, and monitoring components. To illustrate the framework’s components and their elements, we provided examples from both a clinical healthcare test-treatment pathway and a clinical practice guideline maintenance scenario. Additionally, our literature review provided possible examples for the elements in the framework, such as detection variables, detection tests, and detection thresholds. We furthermore provide three example strategies using the framework, of which one was based on living recommendations strategies. Conclusions The developed framework might support the design of maintenance strategies that could contain multiple options besides updating to manage a portfolio (e.g. withdrawing and archiving), even in the absence of the target condition. By making different choices for variables, tests, test protocols, indications, management options, and monitoring, organizations might tailor their maintenance strategy to suit specific contexts and needs. The framework’s elements could potentially aid in the design by being explicit about the operational aspects of maintenance strategies. This might also be helpful for end-users and other stakeholders of systematic reviews and clinical practice guidelines.

BACKGROUND: Patients presenting with acute abdominal pain that occurs after months or years following bariatric surgery may present for assessment and management in the local emergency units. Due to the large variety of surgical bariatric techniques, emergency surgeons have to be aware of the main functional outcomes and long-term surgical complications following the most performed bariatric surgical procedures. The purpose of these evidence-based guidelines is to present a consensus position from members of the WSES in collaboration with IFSO bariatric experienced surgeons, on the management of acute abdomen after bariatric surgery focusing on long-term complications in patients who have undergone laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. METHOD: A working group of experienced general, acute care, and bariatric surgeons was created to carry out a systematic review of the literature following the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) and to answer the PICO questions formulated after the Operative management in bariatric acute abdomen survey. The literature search was limited to late/long-term complications following laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. CONCLUSIONS: The acute abdomen after bariatric surgery is a common cause of admission in emergency departments. Knowledge of the most common late/long-term complications (> 4 weeks after surgical procedure) following sleeve gastrectomy and Roux-en-Y gastric bypass and their anatomy leads to a focused management in the emergency setting with good outcomes and decreased morbidity and mortality rates. A close collaboration between emergency surgeons, radiologists, endoscopists, and anesthesiologists is mandatory in the management of this group of patients in the emergency setting.

BACKGROUND: A crisis in pain management persists, as does the epidemic of opioid overdose deaths, addiction, and diversion. Pain medicine is meeting these challenges by returning to its origins: the Bonica model of multidisciplinary pain care. The 2018 Academic Consortium White Paper detailed the historical context and magnitude of the pain crisis and the evidence base for nonpharmacologic strategies. More than 50% of chronic opioid use begins in the acute pain care setting. Acupuncture may be able to reduce this risk. OBJECTIVE: This article updates the evidence base for acupuncture therapy for acute pain with a review of systematic reviews and meta-analyses on postsurgical/perioperative pain with opioid sparing and acute nonsurgical/trauma pain, including acute pain in the emergency department. METHODS: To update reviews cited in the 2018 White Paper, electronic searches were conducted in PubMed, MEDLINE, CINAHL, and the Cochrane Central Register of Controlled Trials for acupuncture and acupuncture therapy and acute pain, surgery, peri-operative, trauma, emergency department, urgent care, review(s) , systematic review, meta-analysis, with additional manual review of titles, links, and reference lists. RESULTS: There are 22 systematic reviews, 17 with meta-analyses of acupuncture in acute pain settings, and a review for acute pain in the intensive care unit. There are additional studies of acupuncture in acute pain settings. CONCLUSION: The majority of reviews found acupuncture therapy to be an efficacious strategy for acute pain, with potential to avoid or reduce opioid reliance. Future multicenter trials are needed to clarify the dosage and generalizability of acupuncture for acute pain in the emergency department. With an extremely low risk profile, acupuncture therapy is an important strategy in comprehensive acute pain care.

A comprehensive and reproducible search strategy for systematic reviews especially about COVID-19 plays a pivotal role in conducting a reliable and unbiased review. The primary aim of this study was to investigate the quality of the search strategy reporting in systematic reviews conducted on the role of telehealth during COVID-19. The secondary aim of study was to explore some affecting factor in the quality of search strategy. The study evaluated the quality of the search strategy reporting with PRISMA-S checklist. The search was performed in MEDLINE, Embase, CINAHL, and other related databases. Systematic reviews were included. There was no language restriction. The correlation of the PRISMA-S scores with journal impact factor, CiteScore, and librarians' role were evaluated using Spearman's rank correlation coefficient. A total of 85 articles were included in the review. The overall mean score of PRISMA-S checklist was 6.12 ± 1.46. PubMed was the most popular database for search. More than half of the studies did not provide a full search strategy. There was a significant positive correlation between PRISMA-S score and the journal impact factor (Spearman's rho = 0.217; P = 0.46) and CiteScore (Spearman's rho = 0.235; P = 0.03). The quality of literature search was poor in the included studies. Using the PRISMA-S as a search reporting guideline can be a helpful tool for authors. A professional librarian can be beneficial in improving the quality of the search. It is recommended to use a new pattern in COVID-19-related searches, such as preprint sources. [ABSTRACT FROM AUTHOR]

Background: Organizations face diverse contexts and requirements when updating and maintaining their portfolio, or pool, of systematic reviews or clinical practice guidelines they need to manage. We aimed to develop a comprehensive, theoretical framework that might enable the design and tailoring of maintenance strategies for portfolios containing systematic reviews and guidelines. Methods: We employed a conceptual approach combined with a literature review. Components of the diagnostic test-treatment pathway used in clinical healthcare were transferred to develop a framework specifically for systematic review and guideline portfolio maintenance strategies. Results: We developed the Portfolio Maintenance by Test-Treatment (POMBYTT) framework comprising diagnosis, staging, management, and monitoring components. To illustrate the framework's components and their elements, we provided examples from both a clinical healthcare test-treatment pathway and a clinical practice guideline maintenance scenario. Additionally, our literature review provided possible examples for the elements in the framework, such as detection variables, detection tests, and detection thresholds. We furthermore provide three example strategies using the framework, of which one was based on living recommendations strategies. Conclusions: The developed framework might support the design of maintenance strategies that could contain multiple options besides updating to manage a portfolio (e.g. withdrawing and archiving), even in the absence of the target condition. By making different choices for variables, tests, test protocols, indications, management options, and monitoring, organizations might tailor their maintenance strategy to suit specific contexts and needs. The framework's elements could potentially aid in the design by being explicit about the operational aspects of maintenance strategies. This might also be helpful for end-users and other stakeholders of systematic reviews and clinical practice guidelines. [ABSTRACT FROM AUTHOR]

IntroductionWhile there are guidelines for reporting on observational studies (eg, Strengthening the Reporting of Observational Studies in Epidemiology, Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement), estimation of causal effects from both observational data and randomised experiments (eg, A Guideline for Reporting Mediation Analyses of Randomised Trials and Observational Studies, Consolidated Standards of Reporting Trials, PATH) and on prediction modelling (eg, Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis), none is purposely made for deriving and validating models from observational data to predict counterfactuals for individuals on one or more possible interventions, on the basis of given (or inferred) causal structures. This paper describes methods and processes that will be used to develop a Reporting Guideline for Causal and Counterfactual Prediction Models (PRECOG).Methods and analysisPRECOG will be developed following published guidance from the Enhancing the Quality and Transparency of Health Research (EQUATOR) network and will comprise five stages. Stage 1 will be meetings of a working group every other week with rotating external advisors (active until stage 5). Stage 2 will comprise a systematic review of literature on counterfactual prediction modelling for biomedical sciences (registered in Prospective Register of Systematic Reviews). In stage 3, a computer-based, real-time Delphi survey will be performed to consolidate the PRECOG checklist, involving experts in causal inference, epidemiology, statistics, machine learning, informatics and protocols/standards. Stage 4 will involve the write-up of the PRECOG guideline based on the results from the prior stages. Stage 5 will seek the peer-reviewed publication of the guideline, the scoping/systematic review and dissemination.Ethics and disseminationThe study will follow the principles of the Declaration of Helsinki. The study has been registered in EQUATOR and approved by the University of Florida's Institutional Review Board (#202200495). Informed consent will be obtained from the working groups and the Delphi survey participants. The dissemination of PRECOG and its products will be done through journal publications, conferences, websites and social media.

INTRODUCTION: Improved treatment regimens have led to increased survival rates among childhood cancer survivors (CCS), and more than 84% of all children diagnosed with cancer will experience long-term survival or cure. Survivors are susceptible to late effects of cancer treatment often requiring lifelong follow-up care, as many of these conditions can be prevented or mitigated with surveillance. Integrating primary care (PC) and childhood cancer survivorship care can improve follow-up for survivors, however, little integrative research exists. This scoping review aims to: identify and describe existing models of care that integrate PC and childhood cancer survivorship care, examine the effectiveness of these models of care, and characterise the barriers and facilitators for the integration of PC for CCS. METHODS AND ANALYSIS: A comprehensive empirical literature search of three electronic databases (PubMed, CINAHL, and Embase) was employed to identify potentially relevant citations on 1 October 2020. The population, independent variables/intervention, comparator, outcomes, timing, setting and study design/other limiters (PICOTSS) framework was used to inform protocol development. The Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist and explanation will be used to report study findings. The search strategy will be completed again prior to publication to ensure recent empirical research is accounted for. ETHICS AND DISSEMINATION: This research is exempt from Institutional Review Board (IRB) review. Approval from a research ethics board for this study was not required as it does not involve human participants or unpublished secondary data. The findings from this scoping review will be disseminated through peer-reviewed scientific manuscripts, clinical conference presentations, professional networks and digital communications using social media platforms such as Twitter. This study has been registered with Open Science Framework: https://osf.io/92xbg.

Context.—The diagnosis and clinical management of patients with diffuse gliomas (DGs) have evolved rapidly over the past decade with the emergence of molecular biomarkers that are used to classify, stratify risk, and predict treatment response for optimal clinical care.Objective.—To develop evidence-based recommendations for informing molecular biomarker testing for pediatric and adult patients with DGs and provide guidance for appropriate laboratory test and biomarker selection for optimal diagnosis, risk stratification, and prediction.Design.—The College of American Pathologists convened an expert panel to perform a systematic review of the literature and develop recommendations. A systematic review of literature was conducted to address the overarching question, "What ancillary tests are needed to classify DGs and sufficiently inform the clinical management of patients?" Recommendations were derived from quality of evidence, open comment feedback, and expert panel consensus.Results.—Thirteen recommendations and 3 good practice statements were established to guide pathologists and treating physicians on the most appropriate methods and molecular biomarkers to include in laboratory testing to inform clinical management of patients with DGs.Conclusions.—Evidence-based incorporation of laboratory results from molecular biomarker testing into integrated diagnoses of DGs provides reproducible and clinically meaningful information for patient management.

IntroductionMeningioma is the most common primary intracranial tumour in adults. The majority are non-malignant, but a proportion behave more aggressively. Incidental/minimally symptomatic meningioma are often managed by serial imaging. Symptomatic meningioma, those that threaten neurovascular structures, or demonstrate radiological growth, are usually resected as first-line management strategy. For patients in poor clinical condition, or with inoperable, residual or recurrent disease, radiotherapy is often used as primary or adjuvant treatment. Effective pharmacotherapy treatments do not currently exist. There is heterogeneity in the outcomes measured and reported in meningioma clinical studies. Two 'Core Outcome Sets' (COS) will be developed: (COSMIC: Intervention) for use in meningioma clinical effectiveness trials and (COSMIC: Observation) for use in clinical studies of incidental/untreated meningioma.Methods and analysisTwo systematic literature reviews and trial registry searches will identify outcomes measured and reported in published and ongoing (1) meningioma clinical effectiveness trials, and (2) clinical studies of incidental/untreated meningioma. Outcomes include those that are clinician reported, patient reported, caregiver reported and based on objective tests (eg, neurocognitive tests), as well as measures of progression and survival. Outcomes will be deduplicated and categorised to generate two long lists. The two long lists will be prioritised through two, two-round, international, modified eDelphi surveys including patients with meningioma, healthcare professionals, researchers and those in caring/supporting roles. The two final COS will be ratified through two 1-day online consensus meetings, with representation from all stakeholder groups.Ethics and disseminationInstitutional review board (University of Liverpool) approval was obtained for the conduct of this study. Participant eConsent will be obtained prior to participation in the eDelphi surveys and consensus meetings. The two systematic literature reviews and two final COS will be published and freely available.Trial registration numberCOMET study ID 1508.

INTRODUCTION: There are limited available research and guidance regarding the use of spinal manipulative therapy (SMT) in patients with low back-related symptoms following lumbar spine surgery, a condition called persistent spinal pain syndrome type 2 (PSPS-2). This publication outlines a review protocol to identify and synthesise individual participant data (IPD) to examine associations between patient, clinical and surgical variables and SMT application in adults with PSPS-2. METHODS AND ANALYSIS: PubMed, OVID, Web of Science, Scopus, PEDro, Index to Chiropractic Literature and KoreaMed will be searched from inception to 1 January 2022 without language restrictions. Case reports, series, observational studies and cases from grey literature of adults receiving SMT for PSPS-2 will be included. Two investigators will independently screen citations, abstracts and full-text articles. A risk-of-bias assessment will be performed in duplicate to rate cases according to exposure and outcome ascertainment and data completeness. Data extraction will be performed in duplicate and missing IPD will be requested from corresponding authors. Multiple binary logistic regression will be used to identify independent predictors of the use of lumbar-SMT, lumbar-manual-thrust SMT and SMT within 1-year postsurgery. Patient, clinical and surgical variables will be summarised using descriptive statistics, while SMT-related outcomes (lumbar-SMT, lumbar-manual-thrust SMT and 1-year surgery-to-SMT interval) will be described using adjusted ORs with 95% CIs. ETHICS AND DISSEMINATION: This study was deemed not human subjects research by the University Hospitals institutional review board. The results of this review will be disseminated at conferences and/or published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021250039.

BackgroundCare coordination tools and toolkits can be challenging to implement. Practice facilitation, an active but expensive strategy, may facilitate toolkit implementation. We evaluated the comparative effectiveness of distance coaching, a form of practice facilitation, for improving the implementation of care coordination quality improvement (QI) projects.MethodsWe conducted a mixed methods evaluation of the Coordination Toolkit and Coaching (CTAC) initiative. Twelve matched US Veterans Health Administration primary care clinics were randomized to receive coaching and an online care coordination toolkit ("coached"; n = 6) or access to the toolkit only ("non-coached"; n = 6). We did interviews at six, 12, and 18 months. For coached sites, we'ly collected site visit fieldnotes, prospective coach logs, retrospective coach team debriefs, and project reports. We employed matrix analysis using constructs from the Consolidated Framework for Implementation Research and a taxonomy of outcomes. We assessed each site's project(s) using an adapted Complexity Assessment Tool for Systematic Reviews.ResultsEleven sites implemented a local CTAC project. Eight sites (5 coached, 3 non-coached) used at least one tool from the toolkit. Coached sites implemented significantly more complex projects than non-coached sites (11.5 vs 7.5, 95% confidence interval 1.75-6.25, p

BackgroundEvidence-to-decision (EtD) frameworks provide a structured and transparent approach for groups of experts to use when formulating recommendations or making decisions. While extensively used for clinical and public health recommendations, EtD frameworks are not in widespread use in environmental health. This review sought to identify, compare and contrast key EtD frameworks for decisions on interventions used in clinical medicine, public health or environmental health. This information can be used to develop an EtD framework suitable for formulating recommendations for interventions in environmental health.MethodsWe identified a convenience sample of EtD frameworks used by a range of organizations. We searched Medline for systematic reviews of frameworks. We summarized the decision criteria in the selected frameworks and reviews in a qualitative manner.FindingsFourteen organizations provided 18 EtD frameworks; most frameworks focused on clinical medicine or public health interventions; four focused on environmental health and three on economic considerations. Harms of interventions were examined in all frameworks and benefits in all but one. Other criteria included certainty of the body of evidence (15 frameworks), resource considerations (15), feasibility (13), equity (12), values (11), acceptability (11), and human rights (2). There was variation in how specific criteria were defined. The five identified systematic reviews reported a similar spectrum of EtD criteria.InterpretationThe EtD frameworks examined encompassed similar criteria, with tailoring to specific audience needs. Existing frameworks are a useful starting point for development of one tailored to decision-making in environmental health.FunderJPB Foundation.

ObjectiveTo develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials.Study designWe extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings.ResultsWe entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity).ConclusionUsing robust consensus science methods we have developed a core outcome set for future abortion research.ImplicationsStandardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

Abstract Background Evidence-based medicine requires synthesis of research through rigorous and time-intensive systematic literature reviews (SLRs), with significant resource expenditure for data extraction from scientific publications. Machine learning may enable the timely completion of SLRs and reduce errors by automating data identification and extraction. Methods We evaluated the use of machine learning to extract data from publications related to SLRs in oncology (SLR 1) and Fabry disease (SLR 2). SLR 1 predominantly contained interventional studies and SLR 2 observational studies. Predefined key terms and data were manually annotated to train and test bidirectional encoder representations from transformers (BERT) and bidirectional long-short-term memory machine learning models. Using human annotation as a reference, we assessed the ability of the models to identify biomedical terms of interest (entities) and their relations. We also pretrained BERT on a corpus of 100,000 open access clinical publications and/or enhanced context-dependent entity classification with a conditional random field (CRF) model. Performance was measured using the F1 score, a metric that combines precision and recall. We defined successful matches as partial overlap of entities of the same type. Results For entity recognition, the pretrained BERT+CRF model had the best performance, with an F1 score of 73% in SLR 1 and 70% in SLR 2. Entity types identified with the highest accuracy were metrics for progression-free survival (SLR 1, F1 score 88%) or for patient age (SLR 2, F1 score 82%). Treatment arm dosage was identified less successfully (F1 scores 60% [SLR 1] and 49% [SLR 2]). The best-performing model for relation extraction, pretrained BERT relation classification, exhibited F1 scores higher than 90% in cases with at least 80 relation examples for a pair of related entity types. Conclusions The performance of BERT is enhanced by pretraining with biomedical literature and by combining with a CRF model. With refinement, machine learning may assist with manual data extraction for SLRs.

Objective: Cinnamon is extracted from the inner bark of Cinnamomum trees. Recent studies have indicated that cinnamon is a safe and cost-effective treatment for improving body weight, lipid profiles, insulin resistance, and blood pressure. This systematic review aimed to summarize the effect of cinnamon supplementation on adipokines and appetite-regulating hormones.Materials and Methods: This comprehensive literature search was conducted using databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar up to March 2022 without any limitation. The quality of eligible studies was evaluated through the Cochrane Collaboration’s tool for assessing the risk of bias.Results: This systematic review included six clinical trial studies (363 participants), among which, only one study was performed on children, and two investigations were conducted on obese participants. A decreasing effect was found in the level of leptin and visfatin after cinnamon supplementation. Two out of three studies examined adiponectin levels and revealed non-significant effects of cinnamon consumption on this parameter. Two studies evaluated ghrelin levels and found an increase after cinnamon supplementation. The result of cinnamon supplementation on other biomarkers such as glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and resistin was inconsistent.Conclusion: The result of this systematic review indicated the increasing effect of cinnamon supplementation on ghrelin levels and decreasing effect on leptin and visfatin levels. However, more clinical data are required to clarify the beneficial effects of cinnamon on adipokines levels due to the controversial findings of the studies.

Objective: With exponential growth in the publication of interprofessional education (IPE) research studies, it has become more difficult to find relevant literature and stay abreast of the latest research. To address this gap, we developed, evaluated, and validated search strategies for IPE studies in PubMed, to improve future access to and synthesis of IPE research. These search strategies, or search hedges, provide comprehensive, validated sets of search terms for IPE publications. Methods: The search strategies were created for PubMed using relative recall methodology. The research methods followed the guidance of previous search hedge and search filter validation studies in creating a gold standard set of relevant references using systematic reviews, having expert searchers identify and test search terms, and using relative recall calculations to validate the searches' performance against the gold standard set. Results: The three recommended search hedges for IPE studies presented had recall of 71.5%, 82.7%, and 95.1%; the first more focused for efficient literature searching, the last with high recall for comprehensive literature searching, and the remaining hedge as a middle ground between the other two options. Conclusion: These validated search hedges can be used in PubMed to expedite finding relevant scholarships, staying up to date with IPE research, and conducting literature reviews and evidence syntheses. [ABSTRACT FROM AUTHOR]

BackgroundDue to a large variety in treatment outcomes reported in therapeutic trials and lacking patient-relevant outcomes, it is hard to adequately compare and improve current therapies for patients with capillary malformations (CMs). The Core Outcome Set for Capillary Malformations (COSCAM) project aims to develop a core outcome set (COS) for use in future CM trials, in which we will first develop a core outcome (sub)domain set (CDS). Here, we describe the methods for the development of a CDS and present the results of the first development stage.MethodsThe COSCAM project is carried out according to the recommendations of the Cochrane Skin Core OUtcomes Set INitiative (CS-COUSIN) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative. During the first stage, we identified all potentially relevant outcome subdomains based on a systematic review, two focus group sessions and input from patient representatives of Dutch patient organizations and the COSCAM-founding group. In stage two, we will present the subdomains in a three-round e-Delphi study and online consensus meeting, in which CM patients, parents/caregivers and CM experts worldwide rate the importance of the proposed subdomains, hereby finalizing the core outcome (sub)domains of the CDS.ResultsA total of 67 potential outcome subdomains were included; sixteen were previously used in the literature, 20 were proposed by Dutch patients and their parents/caregivers (n = 13) in focus group sessions and 38 were suggested by the experts of the COSCAM-founding group. Seven were excluded because of overlap.ConclusionThe final CDS may serve as a minimum standard in future CM trials, thereby facilitating adequate comparison of treatment outcomes. After this CDS development, we will select appropriate outcome measurement instruments to measure the core outcome subdomains.

BackgroundAccumulating evidence links paternal adiposity in the periconceptional period to offspring health outcomes. DNA methylation has been proposed as a mediating mechanism, but very few studies have explored this possibility in humans.MethodsIn the Pregnancy And Childhood Epigenetics (PACE) consortium, we conducted a meta-analysis of coordinated epigenome-wide association studies (EWAS) of paternal prenatal body mass index (BMI) (with and without adjustment for maternal BMI) in relation to DNA methylation in offspring blood at birth (13 data sets; total n = 4894) and in childhood (6 data sets; total n = 1982).ResultsWe found little evidence of an association at either time point: at all CpGs, the false-discovery-rate-adjusted P-values were >0.05. In secondary sex-stratified analyses, we found just four CpGs for which there was robust evidence of an association in female offspring. To compare our findings to those of other studies, we conducted a systematic review, which identified seven studies, including five candidate gene studies showing associations between paternal BMI/obesity and offspring or sperm DNA methylation at imprinted regions. However, in our own study, we found very little evidence of enrichment for imprinted genes.ConclusionOur findings do not support the hypothesis that paternal BMI around the time of pregnancy is associated with offspring-blood DNA methylation, even at imprinted regions.

BackgroundSynthesizing environmental health science is crucial to taking action to protect public health. Procedures for evidence evaluation and integration are transitioning from "expert-based narrative" to "systematic" review methods. However, little is known about the methodology being utilized for either type of review.ObjectivesTo appraise the methodological strengths and weaknesses of a sample of "expert-based narrative" and "systematic" reviews in environmental health.MethodsWe conducted a comprehensive search of multiple databases and identified relevant reviews using pre-specified eligibility criteria. We applied a modified version of the Literature Review Appraisal Toolkit (LRAT) to three environmental health topics that assessed the utility, validity and transparency of reviews.ResultsWe identified 29 reviews published between 2003 and 2019, of which 13 (45%) were self-identified as systematic reviews. Across every LRAT domain, systematic reviews received a higher percentage of "satisfactory" ratings compared to non-systematic reviews. In eight of these domains, there was a statistically significant difference observed between the two types of reviews and "satisfactory" ratings. Non-systematic reviews performed poorly with the majority receiving an "unsatisfactory" or "unclear" rating in 11 of the 12 domains. Systematic reviews performed poorly in six of the 12 domains; 10 (77%) did not state the reviews objectives or develop a protocol; eight (62%) did not state the roles and contribution of the authors, or evaluate the internal validity of the included evidence consistently using a valid method; and only seven (54%) stated a pre-defined definition of the evidence bar on which their conclusions were based, or had an author disclosure of interest statement.DiscussionSystematic reviews produced more useful, valid, and transparent conclusions compared to non-systematic reviews, but poorly conducted systematic reviews were prevalent. Ongoing development and implementation of empirically based systematic review methods are required in environmental health to ensure transparent and timely decision making to protect the public's health.

IntroductionEconomic groups, such as microfinance or self-help groups are widely implemented in low-income and middle-income countries (LMICs). Women's groups are voluntary groups, which aim to improve the well-being of members through activities, such as joint savings, credit, livelihoods development and/or health activities. Health interventions are increasingly added on to existing women's economic groups as a public health intervention for women and their families. Here, we present the protocol for a mixed-methods systematic review we will conduct of the evidence on integrated economic and health interventions on women's groups to assess whether and how they improve health-related knowledge, behaviour and outcomes in LMICs.Methods and analysisWe will search seven electronic databases for published literature, along with manual searches and consultation. The review will include (1) randomised trials and non-randomised quasiexperimental studies of intervention effects of integrated economic and health interventions delivered through women's groups in LMICs, and (2) sibling studies that examine factors related to intervention content, context, implementation processes and costs. We will appraise risk of bias and study quality using standard tools. High and moderate quality studies will be grouped by health domain and synthesised without meta-analysis. Qualitative evidence will be thematically synthesised and integrated into the quantitative synthesis using a matrix approach.Ethics and disseminationThis protocol was reviewed and deemed exempt by the institutional review board at the American Institutes for Research. Findings will be shared through peer-reviewed publication and disseminated with programme implementers and policymakers engaged with women's groups.Prospero registration numberCRD42020199998.

Approximately 1·5 billion people worldwide live with a physical, mental, sensory, or intellectual disability, about 80% of which are in low-income and middle-income countries. This Series paper provides a global overview of the prevalence, benefits, and promotion policies for physical activity for people living with disabilities (PLWD). PLWD are 16-62% less likely to meet physical activity guidelines and are at higher risk of serious health problems related to inactivity than people without disabilities. Meta-analyses have shown that physical activity has beneficial effects on cardiovascular fitness (average standardised mean difference [SMD] 0·69 [95% CI 0·31-1·01]), musculoskeletal fitness (0·59 [0·31-0·87]), cardiometabolic risk factors (0·39 [0·04-0·75]), and brain and mental health outcomes (0·47 [0·21-0·73]). These meta-analyses also show that health benefits can be achieved even with less than 150 min of physical activity per week, and suggest that some physical activity is better than none. Meta-analyses of interventions to increase physical activity for PLWD have reported effect sizes ranging from SMD 0·29 (95% CI 0·17-0·41, k=10) to 1·00 (0·46-1·53, k=10). There is increasing awareness among policy makers of the needs of PLWD for full participation in physical activity. Physical activity action plans worldwide must be adequately resourced, monitored, and enforced to truly advance the fundamental rights of PLWD to fully participate in physical activity.

IntroductionWhile the need for palliative care for people living with dementia has widely been recognised, they continue to be a disadvantaged group when it comes to timely initiation, and controversies remain regarding appropriate timing, or what elements constitute high quality palliative care early in the disease trajectory. To date, no literature review has summarised this debate or offered insights. The aim of this scoping review is to provide a general overview of research regarding palliative care in mild or moderate dementia, to identify existing controversies, and to examine what are key components of palliative care in dementia, specifically when initiated earlier in the disease trajectory.Methods and analysisConsistent with recent guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews, we carried out a search for academic literature in PubMed, CINAHL, EMBASE, Cochrane Library, PsycINFO, Web of Science; on 5 November 2019 and an updated search on 2 February 2021. We will include studies with different study designs published in English over the last decade that focused on palliative care in early stages of dementia. We will include models targeting at least one outcome domain of palliative care (physical, psychological, social or spiritual) and advance care planning, and will exclude hospice models with limited prognosis similar to the requirements in the USA. We will report study characteristics and quality. We aim to apply narrative synthesis techniques to develop a theoretical model of how, for whom and why palliative care can be relevant in early stages of dementia, and what are facilitators and barriers. We anticipate to also describe if and how the concept of (early) palliative care in dementia changed across time and studies.Ethics and disseminationNo ethical review required. Results will identify research gaps and lay out basic principles for conceptualising palliative care in early stages of dementia.

PURPOSE: To develop guideline recommendations concerning optimal neoadjuvant therapy for breast cancer. METHODS: ASCO convened an Expert Panel to conduct a systematic review of the literature on neoadjuvant therapy for breast cancer and provide recommended care options. RESULTS: A total of 41 articles met eligibility criteria and form the evidentiary basis for the guideline recommendations. RECOMMENDATIONS: Patients undergoing neoadjuvant therapy should be managed by a multidisciplinary care team. Appropriate candidates for neoadjuvant therapy include patients with inflammatory breast cancer and those in whom residual disease may prompt a change in therapy. Neoadjuvant therapy can also be used to reduce the extent of local therapy or reduce delays in initiating therapy. Although tumor histology, grade, stage, and estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) expression should routinely be used to guide clinical decisions, there is insufficient evidence to support the use of other markers or genomic profiles. Patients with triple-negative breast cancer (TNBC) who have clinically node-positive and/or at least T1c disease should be offered an anthracycline- and taxane-containing regimen; those with cT1a or cT1bN0 TNBC should not routinely be offered neoadjuvant therapy. Carboplatin may be offered to patients with TNBC to increase pathologic complete response. There is currently insufficient evidence to support adding immune checkpoint inhibitors to standard chemotherapy. In patients with hormone receptor (HR)-positive (HR-positive), HER2-negative tumors, neoadjuvant chemotherapy can be used when a treatment decision can be made without surgical information. Among postmenopausal patients with HR-positive, HER2-negative disease, hormone therapy can be used to downstage disease. Patients with node-positive or high-risk node-negative, HER2-positive disease should be offered neoadjuvant therapy in combination with anti-HER2-positive therapy. Patients with T1aN0 and T1bN0, HER2-positive disease should not be routinely offered neoadjuvant therapy.Additional information is available at www.asco.org/breast-cancer-guidelines.

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher's Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

Background: Evidence-based medicine requires synthesis of research through rigorous and time-intensive systematic literature reviews (SLRs), with significant resource expenditure for data extraction from scientific publications. Machine learning may enable the timely completion of SLRs and reduce errors by automating data identification and extraction. Methods: We evaluated the use of machine learning to extract data from publications related to SLRs in oncology (SLR 1) and Fabry disease (SLR 2). SLR 1 predominantly contained interventional studies and SLR 2 observational studies. Predefined key terms and data were manually annotated to train and test bidirectional encoder representations from transformers (BERT) and bidirectional long-short-term memory machine learning models. Using human annotation as a reference, we assessed the ability of the models to identify biomedical terms of interest (entities) and their relations. We also pretrained BERT on a corpus of 100,000 open access clinical publications and/or enhanced context-dependent entity classification with a conditional random field (CRF) model. Performance was measured using the F1 score, a metric that combines precision and recall. We defined successful matches as partial overlap of entities of the same type. Results: For entity recognition, the pretrained BERT+CRF model had the best performance, with an F1 score of 73% in SLR 1 and 70% in SLR 2. Entity types identified with the highest accuracy were metrics for progression-free survival (SLR 1, F1 score 88%) or for patient age (SLR 2, F1 score 82%). Treatment arm dosage was identified less successfully (F1 scores 60% [SLR 1] and 49% [SLR 2]). The best-performing model for relation extraction, pretrained BERT relation classification, exhibited F1 scores higher than 90% in cases with at least 80 relation examples for a pair of related entity types. Conclusions: The performance of BERT is enhanced by pretraining with biomedical literature and by combining with a CRF model. With refinement, machine learning may assist with manual data extraction for SLRs. [ABSTRACT FROM AUTHOR]

Objective: Cinnamon is extracted from the inner bark of Cinnamomum trees. Recent studies have indicated that cinnamon is a safe and cost-effective treatment for improving body weight, lipid profiles, insulin resistance, and blood pressure. This systematic review aimed to summarize the effect of cinnamon supplementation on adipokines and appetite-regulating hormones. Materials and Methods: This comprehensive literature search was conducted using databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar up to March 2022 without any limitation. The quality of eligible studies was evaluated through the Cochrane Collaboration’s tool for assessing the risk of bias. Results: This systematic review included six clinical trial studies (363 participants), among which, only one study was performed on children, and two investigations were conducted on obese participants. A decreasing effect was found in the level of leptin and visfatin after cinnamon supplementation. Two out of three studies examined adiponectin levels and revealed non-significant effects of cinnamon consumption on this parameter. Two studies evaluated ghrelin levels and found an increase after cinnamon supplementation. The result of cinnamon supplementation on other biomarkers such as glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and resistin was inconsistent. Conclusion: The result of this systematic review indicated the increasing effect of cinnamon supplementation on ghrelin levels and decreasing effect on leptin and visfatin levels. However, more clinical data are required to clarify the beneficial effects of cinnamon on adipokines levels due to the controversial findings of the studies. [ABSTRACT FROM AUTHOR]

The expansion and consolidation of evidence-based clinical practice has led, among other things, to the need to carry out an increasing variety of types of literature reviews, which allows advancing in knowledge and understanding the breadth of research on a topic of interest. However, the diversity of the terminology used generates confusion of terms and concepts. The aim of this manuscript was to provide a list of the most frequently used review types with their characteristics and some examples. Qualitative review. PubMed, WoS and Scopus databases were examined in a directed way, searching for terms associated with types of reviews and syntheses of the scientific literature. Twenty-one types of review, and 29 variants and associated synonymies were found; those that illustrate the processes of each of them. An overview of the characteristics of each is given, along with perceived strengths and weaknesses. However, it was verified that only some types of review have their own explicit methodologies. This approach, provides a point of reference for those who perform or interpret reviews in the health field and suggests two classification proposals. [ABSTRACT FROM AUTHOR]

BACKGROUND:Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. METHODS/DESIGN:A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of asthma severity. We will then identify practice differences in tne clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in acute paediatric asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with acute severe asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. DISCUSSION:The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

IntroductionUnderuse of high-value clinical practices and overuse of low-value practices are major sources of inefficiencies in modern healthcare systems. Injuries are second only to cardiovascular disease in terms of acute care costs but data on the economic impact of clinical practices for injury admissions are lacking. This study aims to summarise evidence on the economic value of intrahospital clinical practices for injury care.Methods and analysisWe will perform a systematic review to identify research articles in economic evaluation of intrahospital clinical practices in acute injury care. We will search MEDLINE and databases such as Embase, Web of Science, NHS Economic Evaluation Database, Cochrane CENTRAL, BIOSIS and CINAHL for randomised or non-randomised controlled trials and observational studies using a combination of keywords and controlled vocabulary. We will consider the following outcomes relative to economic evaluations: incremental cost-effectiveness ratio, incremental cost-utility ratio, incremental net health benefit, incremental net monetary benefit (iNMB) and incremental cost-benefit ratio. Pairs of independent reviewers will evaluate studies that meet eligibility criteria and extract data from included articles using an electronic data extraction form. All outcomes will be converted into iNMB. We will report iNMB for practices classified by type of practice (hospitalisation, consultation, diagnostic, therapeutic-surgical, therapeutic-drugs, therapeutic-other). Results obtained with a ceiling ratio of $50 000 per quality-adjusted life year gained for identified clinical practices will be summarised by charting forest plots. In line with Cochrane recommendations for systematic reviews of economic evaluations, meta-analyses will not be conducted.Ethics and disseminationEthics approval is not required as original data will not be collected. This study will summarise existing evidence on the economic value of clinical practices in injury care. Results will be used to advance knowledge on value-based care for injury admissions and will be disseminated through a peer-reviewed article, international scientific meetings and clinical and healthcare quality associations.

BACKGROUND AND OBJECTIVES:Although most people have some experience as caregivers, the nature and context of care are highly variable. Caregiving, socioeconomic factors, and health are all interrelated. For these reasons, caregiver interventions must consider these factors. This review examines the degree to which caregiver intervention research has reported and considered social determinants of health. RESEARCH DESIGN AND METHODS:We examined published systematic reviews and meta-analyses of interventions for older adults with age-related chronic conditions using the PRISMA and AMSTAR 2 checklists. From 2,707 papers meeting search criteria, we identified 197 potentially relevant systematic reviews, and selected 33 for the final analysis. RESULTS:We found scant information on the inclusion of social determinants; the papers lacked specificity regarding race/ethnicity, gender, sexual identity, socioeconomic status, and geographic location. The majority of studies focused on dementia, with other conditions common in later life vastly underrepresented. DISCUSSION AND IMPLICATIONS:Significant gaps in evidence persist, particularly for interventions targeting diverse conditions and populations. To advance health equity and improve the effectiveness of interventions, research should address caregiver heterogeneity and improve assessment, support, and instruction for diverse populations. Research must identify aspects of heterogeneity that matter in intervention design, while recognizing opportunities for common elements and strategies.

Abstract Objective Meta-analyses of analgesic medicines for low back pain often rescale measures of pain intensity to use mean difference (MD) instead of standardised mean difference for pooled estimates. Although this improves clinical interpretability, it is not clear whether this method is justified. Our study evaluated the justification for this method. Methods We identified randomised clinical trials of analgesic medicines for adults with low back pain that used two scales with different ranges to measure the same construct of pain intensity. We transformed all data to a 0–100 scale, then compared between-group estimates across pairs of scales with different ranges. Results Twelve trials were included. Overall, differences in means between pain intensity measures that were rescaled to a common 0–100 scale appeared to be small and randomly distributed. For one study that measured pain intensity on a 0–100 scale and a 0–10 scale; when rescaled to 0–100, the difference in MD between the scales was 0.8 points out of 100. For three studies that measured pain intensity on a 0–10 scale and 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.2 points out of 100 (range 5.5 points lower to 2.7 points higher). For two studies that measured pain intensity on a 0–100 scale and a 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points out of 100 (range 6.2 points lower to 12.1 points higher). Finally, for six studies that measured pain intensity on a 0–100 scale and a 0–4 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points (range 5.4 points lower to 8.3 points higher). Conclusion Rescaling pain intensity measures may be justified in meta-analyses of analgesic medicines for low back pain. Systematic reviewers may consider this method to improve clinical interpretability and enable more data to be included. Study registration/data availability Open Science Framework (osf.io/8rq7f).

Optimal clinical decision-making requires understanding of evidence regarding benefits, harms, and burdens of alternative management options. Rigorously conducted systematic reviews and meta-analyses offer accurate summaries of the evidence. However, such summaries may review only low-certainty evidence, in the process highlighting that no single decision is likely to be best for all patients. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach offers a systematic and transparent method for rating certainty of evidence in systematic reviews. In this paper, we will address the importance of assessing the certainty associated with bodies of evidence; explain how the GRADE system rates the certainty of evidence from systematic reviews; and present the GRADE evidence to decision framework for moving from evidence to strong or weak recommendations in clinical practice guidelines. [ABSTRACT FROM AUTHOR]