Perioperative Risk Assessment in Humanitarian Settings: A Scoping Review.

BACKGROUND: No validated perioperative risk assessment models currently exist for use in humanitarian settings. To inform the development of a perioperative mortality risk assessment model applicable to humanitarian settings, we conducted a scoping review of the literature to identify reports that described perioperative risk assessment in surgical care in humanitarian settings and LMICs. METHODS: We conducted a scoping review of the literature to identify records that described perioperative risk assessment in low-resource or humanitarian settings. Searches were conducted in databases including: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Web of Science, World Health Organization Catalog, and Google Scholar. RESULTS: Our search identified 1582 records. After title/abstract and full text screening, 50 reports remained eligible for analysis in quantitative and qualitative synthesis. These reports presented data from over 37 countries from public, NGO, and military facilities. Data reporting was highly inconsistent: fewer than half of reports presented the indication for surgery; less than 25% of reports presented data on injury severity or prehospital data. Most elements of perioperative risk models designed for high-resource settings (e.g., vital signs, laboratory data, and medical comorbidities) were unavailable. CONCLUSION: At present, no perioperative mortality risk assessment model exists for use in humanitarian settings. Limitations in consistency and quality of data reporting are a primary barrier, however, can be addressed through data-driven identification of several key variables encompassed by a minimum dataset. The development of such a score is a critical step toward improving the quality of care provided to populations affected by conflict and protracted humanitarian crises.

Operative Trauma Courses: A Scoping Review to Inform the Development of a Trauma Surgery Course for Low-Resource Settings.

BACKGROUND: A multitude of operative trauma courses exist, most of which are designed for and conducted in high-resource settings. There are numerous barriers to adapting such courses to low- and low-middle-income countries (LMICs), including resource constraints and contextual variations in trauma care. Approaches to implementing operative trauma courses in LMICs have not been evaluated in a structured manner. METHODS: We conducted a scoping review of the literature including databases (e.g., PubMed, Web of Science, EMBASE), grey literature repositories, and structured queries of publicly available course materials to identify records that described operative trauma courses offered since 2000. RESULTS: The search identified 3,518 non-duplicative records, of which 48 relevant reports were included in analysis. These reports represented 23 named and 11 unnamed operative trauma courses offered in 12 countries. Variability existed in course format and resource requirements, ranging from USD 40 to 3,000 per participant. Courses incorporated didactic and laboratory components, which utilized simulations, cadavers, or live animals. Course content overlapped significantly but was not standardized. Data were lacking on course implementation and promulgation, credentialing of instructors, and standardized evaluation metrics. CONCLUSIONS: While many operative trauma courses have been described, most are not directly relatable to LMICs. Barriers include cost-prohibitive fees, lack of resources, limited data collection, and contextual variability that renders certain surgical care inappropriate in LMICs. Gaps exist in standardization of course content as well as transparency of credentialing and course implementation strategies. These issues can be addressed through developing an open-access operative trauma course for low-resource settings.

Successful ingredients of effective Collaborative Care programs in low- and middle-income countries: A rapid review.

Integrating mental health care in primary healthcare settings is a compelling strategy to address the mental health treatment gap in low- and middle-income countries (LMICs). Collaborative Care is the integrated care model with the most evidence supporting its effectiveness, but most research has been conducted in high-income countries. Efforts to implement this complex multi-component model at scale in LMICs will be enhanced by understanding the model components that have been effective in LMIC settings. Following Cochrane Rapid Reviews Methods Group recommendations, we conducted a rapid review to identify studies of the effectiveness of Collaborative Care for priority adult mental disorders of mhGAP (mood and anxiety disorders, psychosis, substance use disorders and epilepsy) in outpatient medical settings in LMICs. Article screening and data extraction were performed using Covidence software. Data extraction by two authors utilized a checklist of key components of effective interventions. Information was aggregated to examine how frequently the components were applied. Our search yielded 25 articles describing 20 Collaborative Care models that treated depression, anxiety, schizophrenia, alcohol use disorder or epilepsy in nine different LMICs. Fourteen of these models demonstrated statistically significantly improved clinical outcomes compared to comparison groups. Successful models shared key structural and process-of-care elements: a multi-disciplinary care team with structured communication; standardized protocols for evidence-based treatments; systematic identification of mental disorders, and a stepped-care approach to treatment intensification. There was substantial heterogeneity across studies with respect to the specifics of model components, and clear evidence of the importance of tailoring the model to the local context. This review provides evidence that Collaborative Care is effective across a range of mental disorders in LMICs. More work is needed to demonstrate population-level and longer-term outcomes, and to identify strategies that will support successful and sustained implementation in routine clinical settings.

Surrogate Endpoints as Predictors of Overall Survival in Metastatic Urothelial Cancer: A Trial-level Analysis.

Background: Surrogate endpoints (SEs), such as progression-free survival (PFS) and objective response rate (ORR), are frequently used in clinical trials. The relationship between SEs and overall survival (OS) has not been well described in metastatic urothelial cancer (MUC). Objective: We evaluated trial-level data to assess the relationship between SEs and OS. We hypothesize a moderate surrogacy relationship between both PFS and ORR with OS. Design setting and participants: We systematically reviewed phase 2/3 trials in MUC with two or more treatment arms, and report PFS and/or ORR, and OS. Outcome measurements and statistical analysis: Linear regression was performed, and the coefficient of determination (R2) and surrogate threshold effect (STE) estimate were determined between PFS/ORR and OS. Results and limitations: Of 3791 search results, 59 trials and 62 comparisons met the inclusion criteria. Of the 53 trials that reported PFS, 31 (58%) reported proportional hazard regression for PFS and OS. Linear regression across trials demonstrated an R2 of 0.60 between hazard ratio (HR) for PFS (HRPFS) and HR for OS (HROS), and an STE of 0.41. Linear regression of ΔPFS (median PFS in months of the treatment arm - that of the control arm) and ΔOS demonstrated an R2 of 0.12 and an STE of 14.1 mo. Thirty trials reported ORRs. Linear regression for ORRratio and HROS among all trials found an R2 of 0.08; an STE of 95% was not reached at any value and ΔORR and HROS similarly demonstrated a poor correlation with an R2 value of 0.03. Conclusions: PFS provides only a moderate level of surrogacy for OS; An HRPFS of ≤0.41 provides 95% confidence of OS improvement. ORR is weakly correlated with OS and should be de-emphasized in MUC clinical trials. When PFS is discussed, proportional hazard regression should be reported. Patient summary: We examined the relationship between surrogate endpoints, common outcomes in clinical trials, with survival in urothelial cancer trials. Progression-free survival is moderately correlated, while objective response rate had a poor correlation with survival and should be de-emphasized as a primary endpoint.

Should anti-TNF therapy be discontinued in rheumatoid arthritis patients undergoing elective orthopaedic surgery? A systematic review of the evidence.

Anti-tumour necrosis factor (TNF) therapies have revolutionized the management of rheumatoid arthritis (RA). A high proportion of RA patients are now established users of anti-TNF agents. Unfortunately, many RA patients with longstanding disease still require elective orthopaedic procedures. Published studies on the influence of TNF antagonist on infection rates in RA patients undergoing surgery are conflicting. However, national registries of RA patients on anti-TNF reported an increased risk of infection. The risk of anti-TNF-related infection is highest at the start of treatment with frequent involvement of the skin and subcutaneous tissue. Infection at these sites could negatively influence the healing of surgical wound. Current guidelines suggest that treatment with biologics should be discontinued prior to surgery. Patients with established disease are more likely to flare compared to those with early disease on stopping treatment. Consequently, TNF blockers need to be reinstated promptly after surgery to avoid the risk of RA flare.

Use of Race in Pediatric Clinical Practice Guidelines: A Systematic Review.

Importance: National clinical practice guidelines (CPGs) guide medical practice. The use of race in CPGs has the potential to positively or negatively affect structural racism and health inequities. Objective: To review the use of race in published pediatric CPGs. Evidence Review: A literature search of PubMed, Medscape, Emergency Care Research Institute Guidelines Trust, and MetaLib.gov was performed for English-language clinical guidelines addressing patients younger than 19 years of age from January 1, 2016, to April 30, 2021. The study team systematically identified and evaluated all articles that used race and ethnicity terms and then used a critical race theory framework to classify each use according to the potential to either positively or negatively affect structural racism and racial inequities in health care. Findings: Of 414 identified pediatric clinical practice guidelines, 126 (30%) met criteria for full review because of the use of race or ethnicity terms and 288 (70%) did not use race or ethnicity terms. The use of a race term occurred 175 times in either background, clinical recommendations, or future directions. A use of race with a potential negative effect occurred 87 times (49.7%) across 73 CPGs and a positive effect 50 times (28.6%) across 45 CPGs. Conclusions and Relevance: In this systematic review of US-based pediatric CPGs, race was frequently used in ways that could negatively affect health care inequities. Many opportunities exist for national medical organizations to improve the use of race in CPGs to positively affect health care, particularly for racial and ethnic minoritized communities.

Estimating the global health impact of gender-based violence and violence against children: a systematic review and meta-analysis protocol.

INTRODUCTION: Exposure to gender-based violence (GBV) and violence against children (VAC) can result in substantial morbidity and mortality. Previous reviews of health outcomes associated with GBV and VAC have focused on limited definitions of exposure to violence (ie, intimate partner violence) and often investigate associations only with predefined health outcomes. In this protocol, we describe a systematic review and meta-analysis for a comprehensive assessment of the impact of violence exposure on health outcomes and health-related risk factors across the life-course. METHODS AND ANALYSIS: Electronic databases (PubMed, Embase, CINAHL, PsycINFO, Global Index Medicus, Cochrane and Web of Science Core Collection) will be searched from 1 January 1970 to 30 September 2021 and searches updated to the current date prior to final preparation of results. Reviewers will first screen titles and abstracts, and eligible articles will then be full-text screened and accepted should they meet all inclusion criteria. Data will be extracted using a standardised form with fields to capture study characteristics and estimates of association between violence exposure and health outcomes. Individual study quality will be assessed via six risk of bias criteria. For exposure-outcome pairs with sufficient data, evidence will be synthesised via a meta-regression-Bayesian, regularised, trimmed model and confidence in the cumulative evidence assessed via the burden of proof risk function. Where possible, variations in associations by subgroup, that is, age, sex or gender, will be explored. ETHICS AND DISSEMINATION: Formal ethical approval is not required. Findings from this review will be used to inform improved estimation of GBV and VAC within the Global Burden of Disease Study. The review has been undertaken in conjunction with the Lancet Commission on GBV and the Maltreatment of Young People with the aim of providing new data insights for a report on the global response to violence. PROSPERO REGISTRATION NUMBER: CRD42022299831.

Mental health problems and service gaps experienced by pregnant adolescents and young women in Sub-Saharan Africa: A systematic review.

BACKGROUND: Pregnant adolescent girls and young women (AGYW, aged 12-24 years) are at high risk for mental health problems, particularly in the Sub-Saharan African (SSA) region. METHODS: We performed a systematic review of mental health studies among pregnant AGYW in SSA published between January 1, 2007 and December 31, 2020 in PubMed, Embase, CINAHL, PsycInfo, and Global Index Medicus following PRISMA guidelines (PROSPERO: CRD42021230980). We used Bronfenbrenner's bioecological model to frame and synthesize results from included studies. FINDINGS: Our search yielded 945 articles from which 18 studies were included (N = 8 quantitative, N = 9 qualitative, N = 1 case report). The most frequently studied mental health problem was depression (N = 9 studies); the most frequently utilized measurement tool was the Edinburgh Postnatal Depression Scale (N = 3). Studies reported life course factors, individual, microsystem, exosystem, macrosystem, and chronosystem-level factors associated with mental health problems. Gaps in mental health service delivery for pregnant AGYW included lack of confidentiality, judgmental healthcare worker attitudes, and lack of services tailored to their unique needs. INTERPRETATION: Gaps remain in research and services for mental health among pregnant AGYW in SSA. Integration of mental health services within school, community, and healthcare settings that are tailored to pregnant AGYW could strengthen health systems within SSA. FUNDING: Author contributions were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (F31HD101149 to AL) and the Fogarty International Center (K43TW010716 to MK). The funding agencies had no role in the writing of the manuscript or the decision to submit it for publication. The project itself was not funded.

A systematic review of the influence of anti-TNF on infection rates in patients with rheumatoid arthritis.

OBJECTIVE: The present article aims to provide a systematic review of the influence of antitumor necrosis factor (TNF) on infection rates in patients with rheumatoid arthritis (RA). METHOD: Medline was searched to obtain quality control information on infection rates in RA patients treated with anti-TNF. RESULTS: A high proportion of RA patients are now established users of anti-TNF agents. Data from national registries in European countries of patients with RA treated with anti-TNF suggest that biological therapies are closely linked to sepsis. Although previous studies reported a higher risk of infections, there are now emerging data with longer duration of follow-up that suggested an adjusted hazard risk of 1.2. Elderly patients and those with longstanding disease may have a higher rate of serious infections compared to their counterparts who were younger with early disease. There are now emerging data to suggest that anti-TNF therapy is associated with the development of neutropenia shortly after the commencement of treatment. The biologic registries found that RA patients treated with monoclonal antibodies are at increased risk of tuberculosis (TB) compared to those on TNF receptor blockers. This risk of infection needs to be weighed against the established benefits of TNF blockers. CONCLUSION: Current evidence suggests that anti-TNF treatment in RA is closely linked to infection. Patients need to be aware of the risk of infection together with the established benefits of TNF blockers in order to give informed consent for treatment.

Análise sistemática da influência do antifator de necrose tumoral [anti-TNF] sobre as taxas de infecção em pacientes com artrite reumatoide / A systematic review of the influence of anti-TNF on infection rates in patients with rheumatoid arthritis

OBJETIVO: O presente trabalho tem como objetivo fornecer uma análise sistemática da influência do anti-TNF sobre as taxas de infecção em pacientes com artrite reumatoide (AR). MÉTODO: Pesquisamos na Medline para obter informações de controle de qualidade sobre as taxas de infecção em pacientes com AR tratados com anti-TNF. RESULTADOS: Atualmente, uma proporção elevada de pacientes com AR é usuária de agentes anti-TNF. Dados de registros nacionais em países da Europa de pacientes com AR tratados com anti-TNF sugerem que terapias biológicas estão intimamente ligadas à sepse. Apesar de estudos anteriores terem relatado um maior risco de infecções, atualmente há dados emergentes com maior duração de acompanhamento que sugerem um risco ajustado de 1,2. Os pacientes idosos e os com doença de longa data poderão apresentar uma taxa mais elevada de infecções graves em comparação às suas contrapartes mais novas com doença inicial. Hoje, há dados emergentes que sugerem que a terapia com anti-TNF está associada ao desenvolvimento de neutropenia logo após o início do tratamento. Os registros biológicos constataram que os pacientes com ARES tratados com anticorpos monoclonais apresentam aumento no risco de tuberculose (TB), em comparação aos tratados com bloqueadores dos receptores de TNF. Esse risco de infecção precisa ser ponderado em relação aos benefícios estabelecidos dos bloqueadores de TNF. CONCLUSÃO: A evidência atual sugere que o tratamento com anti-TNF na AR está intimamente associado à infecção. Os pacientes precisam estar cientes do risco de infecção, assim como dos benefícios estabelecidos dos bloqueadores de TNF, para que possam fornecer o consentimento informado para o tratamento.

OBJECTIVE: The present article aims to provide a systematic review of the influence of antitumor necrosis factor (TNF) on infection rates in patients with rheumatoid arthritis (RA). METHOD: Medline was searched to obtain quality control information on infection rates in RA patients treated with anti-TNF. RESULTS: A high proportion of RA patients are now established users of anti-TNF agents. Data from national registries in European countries of patients with RA treated with anti-TNF suggest that biological therapies are closely linked to sepsis. Although previous studies reported a higher risk of infections, there are now emerging data with longer duration of follow-up that suggested an adjusted hazard risk of 1.2. Elderly patients and those with longstanding disease may have a higher rate of serious infections compared to their counterparts who were younger with early disease. There are now emerging data to suggest that anti-TNF therapy is associated with the development of neutropenia shortly after the commencement of treatment. The biologic registries found that RA patients treated with monoclonal antibodies are at increased risk of tuberculosis (TB) compared to those on TNF receptor blockers. This risk of infection needs to be weighed against the established benefits of TNF blockers. CONCLUSION: Current evidence suggests that anti-TNF treatment in RA is closely linked to infection. Patients need to be aware of the risk of infection together with the established benefits of TNF blockers in order to give informed consent for treatment.