Progestogens in women with threatened miscarriage or recurrent miscarriage: A meta-analysis.

INTRODUCTION: Clinical practice guidelines provide inconsistent recommendations regarding progestogen supplementation for threatened and recurrent miscarriage. We conducted a systematic review and meta-analysis to assess the effectiveness and safety of progestogens for these patients. MATERIAL AND METHODS: We searched Medline, Embase, and Cochrane Central Registry of Controlled Trials up to October 6, 2023 for randomized control trials (RCTs) comparing progestogen supplementation to placebo or no treatment for pregnant women with threatened or recurrent miscarriage. We assessed the risk of bias using a modified version of the Cochrane risk-of-bias tool and the certainty of evidence using the GRADE approach. RESULTS: Of 15 RCTs (6616 pregnancies) reporting on threatened or recurrent miscarriage, 12 (5610 pregnancies) reported on threatened miscarriage with or without a prior history of miscarriage. Results indicated that progesterone probably increases live births (relative risk (RR) 1.04, 95% confidence interval (CI) 0.99-1.10, absolute increase 3.1%, moderate certainty). Of these RCTs, three (1973 pregnancies) reporting on threatened miscarriage with a prior history of miscarriage indicated that progesterone possibly increases live births (RR 1.06, 95% CI: 0.97-1.16, absolute increase 4.4%; low certainty), while four (2540 pregnancies) reporting on threatened miscarriage and no prior miscarriage left the effect very uncertain (RR 1.02, 95% CI: 0.96-1.10, absolute increase 1.7%; very low certainty). Three trials reporting on 1006 patients with a history of two or more prior miscarriages indicated progesterone probably increases live births (RR 1.08, 95% CI: 0.98-1.19, absolute increase 5.7%, moderate certainty). Six RCTs that reported on 2979 patients with at least one prior miscarriage indicated that progesterone probably increases live births (RR 1.07, 95% CI: 1.01-1.13, absolute increase 5.0%; moderate certainty). Progesterone probably has little or no effect on congenital anomalies (RR 1.06, 95% CI: 0.76-1.48, absolute increase 0.1%; moderate certainty), and other serious adverse pregnancy events (RR 1.07, 95% CI: 0.83-1.40, absolute increase 0.2%, moderate certainty). CONCLUSIONS: In women at increased risk of pregnancy loss, progestogens probably increase live births without increasing adverse maternal and neonatal events. It remains possible that the benefit is restricted to those with prior miscarriages.

INTENTION TO TREAT ANALYSIS IN CLINICAL RESEARCH: BASIC CONCEPTS FOR CLINICIANS.

ABSTRACT: This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. Additionally, we included studies from manual searches that were already cataloged within the first author's personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.

Global Indigenous gender concepts, gender-based violence and resilience: A scoping review.

BACKGROUND & OBJECTIVE: The legacy of colonialism includes ongoing trauma and disruption of traditional teachings on relationality, which has contributed to Indigenous populations being disproportionately exposed to gender-based violence (GBV). GBV in Indigenous populations is explored to consider gender-specific findings and points of resilience in relational networks. PARTICIPANTS & SETTING: Included articles sampled Indigenous groups in Canada, US, Mexico, Guatemala, and Israel. All participants self-identified as Indigenous, and were either GBV survivors or service providers working in GBV contexts. METHODS: A scoping review was conducted in OVID Medline, Embase, APA Psycinfo, and Informit Indigenous Collection, using keywords for Indigenous peoples, gender concepts, and GBV. Articles were screened and extracted by two reviewers; a third reviewer resolved conflicts. RESULTS: Our search yielded one mixed-method study and seven qualitative studies, all published since 2016. North American studies identified colonial, patriarchal disruptions (e.g. residential schools) to positive pre-contact gender norms (e.g. non-hierarchical roles) that contribute to emerging GBV. Studies conducted in Guatemala and Israel also described local patriarchal cultures contributing to GBV. Lack of understanding of the Two-Spirit identity (i.e. supra-binary gender identity used by Indigenous persons) led to harmful attitudes and stigma. Interpersonal support and return to traditional matriarchal practices were identified as key resilience processes. CONCLUSIONS: There is limited literature on Indigenous gender concepts and GBV, particularly regarding GBV against males and Two-Spirit persons. Colonization-related violence and/or patriarchal gender norms were identified as precursors for GBV. Decolonization processes should be further explored to address GBV in Indigenous populations.

Saturated fat, the estimated absolute risk and certainty of risk for mortality and major cancer and cardiometabolic outcomes: an overview of systematic reviews.

OBJECTIVE: To assess the impact of reducing saturated fat or fatty foods, or replacing saturated fat with unsaturated fat, carbohydrate or protein, on the risk of mortality and major cancer and cardiometabolic outcomes in adults. METHODS: We searched MEDLINE, EMBASE, CINAHL, and references of included studies for systematic reviews and meta-analyses (SRMAs) of randomized controlled trials (RCTs) and observational studies in adults published in the past 10 years. Eligible reviews investigated reducing saturated fat or fatty foods or replacing saturated fat with unsaturated fat, carbohydrate or protein, on the risk of cancer and cardiometabolic outcomes and assessed the certainty of evidence for each outcome using, for example, the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. We assessed the quality of SRMAs using a modified version of AMSTAR-2. Results were summarized as absolute estimates of effect together with the certainty of effects using a narrative synthesis approach. RESULTS: We included 17 SRMAs (13 reviews of observational studies with follow-up 1 to 34 years; 4 reviews of RCTs with follow-up 1 to 17 years). The quality of two-thirds of the SRMAs was critically low to moderate; the main limitations included deficient reporting of study selection, absolute effect estimates, sources of funding, and a priori subgroups to explore heterogeneity. Our included reviews reported > 100 estimates of effect across 11 critically important cancer and cardiometabolic outcomes. High quality SRMAs consistently and predominantly reported low to very low certainty evidence that reducing or replacing saturated fat was associated with a very small risk reduction in cancer and cardiometabolic endpoints. The risk reductions where approximately divided, some being statistically significant and some being not statistically significant. However, based on 2 moderate to high quality reviews, we found moderate certainty evidence for a small but important effect that was statistically significant for two outcomes (total mortality events [20 fewer events per 1000 followed] and combined cardiovascular events [16 fewer per 1000 followed]). Conversely, 4 moderate to high quality reviews showed very small effects on total mortality, with 3 of these reviews showing non-statistically significant mortality effects. CONCLUSION: Systematic reviews investigating the impact of SFA on mortality and major cancer and cardiometabolic outcomes almost universally suggest very small absolute changes in risk, and the data is based primarily on low and very low certainty evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020172141.

Saturated fat and human health: a protocol for a methodologically innovative systematic review and meta-analysis to inform public health nutrition guidelines.

BACKGROUND: The health effects of dietary fats are a controversial issue on which experts and authoritative organizations have often disagreed. Care providers, guideline developers, policy-makers, and researchers use systematic reviews to advise patients and members of the public on optimal dietary habits, and to formulate public health recommendations and policies. Existing reviews, however, have serious limitations that impede optimal dietary fat recommendations, such as a lack of focus on outcomes important to people, substantial risk of bias (RoB) issues, ignoring absolute estimates of effects together with comprehensive assessments of the certainty of the estimates for all outcomes. OBJECTIVE: We therefore propose a methodologically innovative systematic review using direct and indirect evidence on diet and food-based fats (i.e., reduction or replacement of saturated fat with monounsaturated or polyunsaturated fat, or carbohydrates or protein) and the risk of important health outcomes. METHODS: We will collaborate with an experienced research librarian to search MEDLINE, EMBASE, CINAHL, and the Cochrane Database of Systematic Reviews (CDSR) for randomized clinical trials (RCTs) addressing saturated fat and our health outcomes of interest. In duplicate, we will screen, extract results from primary studies, assess their RoB, conduct de novo meta-analyses and/or network meta-analysis, assess the impact of missing outcome data on meta-analyses, present absolute effect estimates, and assess the certainty of evidence for each outcome using the GRADE contextualized approach. Our work will inform recommendations on saturated fat based on international standards for reporting systematic reviews and guidelines. CONCLUSION: Our systematic review and meta-analysis will provide the most comprehensive and rigorous summary of the evidence addressing the relationship between saturated fat modification for people-important health outcomes. The evidence from this review will be used to inform public health nutrition guidelines. TRIAL REGISTRATION: PROSPERO Registration: CRD42023387377 .

What are the ways in which social media is used in the context of complementary and alternative medicine in the health and medical scholarly literature? a scoping review.

BACKGROUND: Despite the increased use of social media to share health-related information and the substantial impact that complementary and alternative medicine (CAM) can have on individuals' health and wellbeing, currently, to our knowledge, there is no review that compiles research on how social media is used in the context of CAM. The objective of this study was to summarize what are the ways in which social media is used in the context of CAM. METHODS: A scoping review was conducted, following Arksey and O'Malley's five-stage methodological framework. MEDLINE, EMBASE, PsycINFO, AMED, and CINAHL databases were systematically searched from inception until October 3, 2020, in addition to the Canadian Agency for Drugs and Technology in Health (CADTH) website. Eligible studies had to have investigated how at least one social media platform is used in the context of a single or multiple types of CAM treatments. RESULTS: Searches retrieved 1714 items following deduplication, of which 1687 titles and abstracts were eliminated, leaving 94 full-text articles to be considered. Of those, 65 were not eligible, leaving a total of 29 articles eligible for review. Three themes emerged from our analysis: 1) social media is used to share user/practitioner beliefs, attitudes, and experiences about CAM, 2) social media acts as a vehicle for the spread of misinformation about CAM, and 3) there are unique challenges with social media research in the context of CAM. CONCLUSIONS: In addition to social media being a useful tool to share user/practitioner beliefs, attitudes, and experiences about CAM, it has shown to be accessible, effective, and a viable option in delivering CAM therapies and information. Social media has also been shown to spread a large amount of misleading and false information in the context of CAM. Additionally, this review highlights the challenges with conducting social media research in the context of CAM, particularly in collecting a representative sample.

Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: a systematic review and meta-analysis.

BACKGROUND: Atopic dermatitis is a prevalent condition in children and can be effectively managed with medications such as topical calcineurin inhibitors (pimecrolimus or tacrolimus). A key unresolved safety concern is whether use of topical calcineurin inhibitors is associated with cancer. We systematically reviewed the risk of cancer in patients with atopic dermatitis exposed to topical calcineurin inhibitors. METHODS: As part of the 2022 American Academy of Allergy, Asthma and Immunology and American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters atopic dermatitis guidelines, we searched MEDLINE, Embase, the Latin American and Caribbean Health Sciences Literature database, the Índice Bibliográfico Espanhol de Ciências da Saúde database, the Global Resource of Eczema Trials database, WHO's International Clinical Trials Registry Platform, the US Food and Drug Administration database, the European Medicines Agency database, company registers, and relevant citations from inception to June 6, 2022. We included randomised controlled trials and comparative and non-comparative non-randomised studies in any language addressing cancer risk in patients with atopic dermatitis using topical calcineurin inhibitors. We excluded split-body studies and studies with less than 3 weeks of follow-up. Paired reviewers independently screened records, extracted data, and assessed risk of bias in duplicate. We used Bayesian models to estimate the probability for cancer due to topical calcineurin inhibitor exposure and the GRADE approach to determine the certainty of the evidence. Patients, advocacy groups, and care providers set a priori thresholds of important effects. This study is registered with Open Science Framework, https://osf.io/v4bfc. FINDINGS: We identified and analysed 110 unique studies (52 randomised controlled trials and 69 non-randomised studies [11 were non-randomised study extensions of randomised controlled trials]) including 3·4 million patients followed up for a mean of 11 months (range 0·7-120). The absolute risk of any cancer with topical calcineurin inhibitor exposure was not different from controls (absolute risk 4·70 per 1000 with topical calcineurin inhibitors vs 4·56 per 1000 without; odds ratio 1·03 [95% credible interval 0·94-1·11]; moderate certainty). For all age groups and using data from observational studies and randomised controlled trials, the use of pimecrolimus (OR 1·05 [95% credible interval 0·94-1·15]) or tacrolimus (0·99 [0·89-1·09]) is likely to have had little to no association with cancer compared with no topical calcineurin inhibitor exposure. For pimecrolimus versus tacrolimus, the finding was similar (0·95 [95% credible interval 0·83-1·07]). Findings were similar in infants, children, and adults, and robust to trial sequential, subgroup, and sensitivity analyses. INTERPRETATION: Among individuals with atopic dermatitis, moderate-certainty evidence shows that topical calcineurin inhibitors do not increase the risk of cancer. These findings support the safe use of topical calcineurin inhibitors in the optimal treatment of patients with atopic dermatitis. FUNDING: American Academy of Allergy, Asthma and Immunology and American College of Allergy, Asthma and Immunology via the Joint Task Force on Practice Parameters.

Neck pain clinical practice guidelines: a systematic review of the quality and quantity of complementary and alternative medicine recommendations.

BACKGROUND: Individuals with neck pain frequently turn to complementary and alternative medicine (CAM) to seek relief. However, conventional healthcare providers often lack adequate CAM therapy knowledge to deliver informed recommendations to patients. The purpose of this study was to identify mention of CAM in neck pain clinical practice guidelines (CPG) and assess the quality of CAM recommendations using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument. METHODS: MEDLINE, EMBASE and CINAHL were systematically searched from 2009 to 2020 in addition to the Guidelines International Network and National Center for Complementary and Integrative Health websites. Eligible CPGs providing CAM recommendations were assessed twice with the AGREE II instrument, once to assess the overall CPG and then once to assess the CAM sections specifically. RESULTS: From 643 unique search results, 15 CPGs on the treatment and/or management of neck pain were identified, and 8 made recommendations on CAM therapy. Regarding scaled domain percentages, the overall CPG scored higher than the CAM section for 5 of 6 domains (overall, CAM): (1) scope and purpose (93.4%, 93.1%), (2) stakeholder involvement (81.6%, 81.9%), (3) rigour of development (70.8%, 66.3%), (4) clarity of presentation (64.9%, 60.8%), (5) applicability (39.3%, 33.6%), and (6) editorial independence (47.9%, 45.3%). CONCLUSIONS: Most neck pain CPGs made CAM recommendations. The quality of CAM recommendations is lower than overall recommendations across all domains with the exception of stakeholder involvement. This disparity highlights the need for CAM recommendations quality improvement. Although many patients with neck pain seek CAM therapies, few CPGs are available for healthcare providers and patients.

The Incidence and Prevalence of Uveitis in Psoriasis: A Systematic Review and Meta-Analysis.

BACKGROUND: The systemic effects and comorbidities of psoriasis include ocular disorders, such as uveitis. Patients with psoriatic arthritis in particular have been demonstrated to have an elevated risk for developing uveitis. Presently, the risk of uveitis in psoriasis has yet to be fully elucidated and this systematic review seeks to address this gap. OBJECTIVE: To examine the prevalence and incidence of uveitis in psoriasis patients compared to non-psoriasis patients. METHODS: We conducted a systematic review search on MEDLINE, Embase, and CENTRAL electronic databases with no lower limit on year of publication. RESULTS: Fourteen articles met our inclusion criteria, with a total of 234 143 psoriasis subjects. Two studies found that participants with severe psoriasis were at a greater risk of uveitis than those with mild psoriasis. A random-effects meta-analysis of the 3 studies, which reported risk of incidence of uveitis in psoriasis patients compared to non-psoriasis controls, found a pooled risk ratio of 1.29 (95% CI, 1.10-1.51), indicating an increased risk of uveitis in psoriasis. Three studies compared risk of uveitis in psoriatic arthritis with psoriasis-only participants, all finding that psoriatic arthritis was associated with a greater risk of uveitis. CONCLUSIONS: In summary, our findings suggest that psoriasis is associated with an increased risk of uveitis, with or without psoriatic arthritis.