"Going into the black box": a policy analysis of how the World Health Organization uses evidence to inform guideline recommendations.

Background: The World Health Organization (WHO) plays a crucial role in producing global guidelines. In response to previous criticism, WHO has made efforts to enhance the process of guideline development, aiming for greater systematicity and transparency. However, it remains unclear whether these changes have effectively addressed these earlier critiques. This paper examines the policy process employed by WHO to inform guideline recommendations, using the update of the WHO Consolidated HIV Testing Services (HTS) Guidelines as a case study. Methods: We observed guideline development meetings and conducted semi-structured interviews with key participants involved in the WHO guideline-making process. The interviews were recorded, transcribed, and analysed thematically. The data were deductively coded and analysed in line with the main themes from a published conceptual framework for context-based evidence-based decision making: introduction, interpretation, and application of evidence. Results: The HTS guideline update was characterized by an inclusive and transparent process, involving a wide range of stakeholders. However, it was noted that not all stakeholders could participate equally due to gaps in training and preparation, particularly regarding the complexity of the Grading Recommendations Assessment Development Evaluation (GRADE) framework. We also found that WHO does not set priorities for which or how many guidelines should be produced each year and does not systematically evaluate the implementation of their recommendations. Our interviews revealed disconnects in the evidence synthesis process, starting from the development of systematic review protocols. While GRADE prioritizes evidence from RCTs, the Guideline Development Group (GDG) heavily emphasized "other" GRADE domains for which little or no evidence was available from the systematic reviews. As a result, expert judgements and opinions played a role in making recommendations. Finally, the role of donors and their presence as observers during GDG meetings was not clearly defined. Conclusion: We found a need for a different approach to evidence synthesis due to the diverse range of global guidelines produced by WHO. Ideally, the evidence synthesis should be broad enough to capture evidence from different types of studies for all domains in the GRADE framework. Greater structure is required in formulating GDGs and clarifying the role of donors through the process.

Enablers and barriers to a quaternary prevention approach: a qualitative study of field experts.

OBJECTIVE: There is a growing concern about the sustainability of healthcare and the impacts of 'overuse' on patients and systems. Quaternary prevention (P4), a concept promoting the protection of patients from medical interventions in which harms outweigh benefits, is well positioned to stimulate reflection and inspire solutions, yet has not been widely adopted. We sought to identify enablers and barriers to a P4 approach, according to field experts and advocates in one health system. DESIGN: Qualitative methodology, using semistructured interviews and a grounded theory approach facilitated thematic analysis and development of a conceptual model. SETTING: Virtual interviews, conducted in British Columbia, Canada. PARTICIPANTS: 12 field experts, recruited based on their interest and work related to P4 and related concepts. RESULTS: Four factors were seen as promoting or hindering P4 efforts depending on context: relationship between patient and clinician, education of clinicians and the public, health system design and influencers. We extracted four broad enablers of P4: evidence-based medicine, personal experiences and questioning attitude, public P4 campaigns and experience in resource-poor contexts. There were six barriers: peer pressure between clinicians, awareness and screening campaigns, cognitive biases, cultural factors, complexity of the problem and industry influence. CONCLUSIONS: Elicited facilitators and impediments to the application of P4 were similar to those seen in existing literature but framed uniquely; our findings place increased emphasis on the clinician-patient relationship as central to decision-making and position other drivers as influencing this relationship. A transition to a model of care that explicitly integrates conscious protection of patients by reducing overtesting, overdiagnosis and overtreatment will require changes across health systems and society.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Transfusion of blood components in pediatric age groups: an evidence-based clinical practice guideline adapted for the use in Egypt using 'Adapted ADAPTE'.

Pediatric transfusion is a complex area of medicine covering a wide age range, from neonates to young adults. Compared to adult practice, there is a relative lack of high-quality research to inform evidence-based guidelines. We aimed to adapt the pre-existing high-quality practice guidelines for the transfusion of blood components in different pediatric age groups to be available for national use by general practitioners, pediatricians, and other health care professionals. The guideline panel included 17 key leaders from different Egyptian institutions. The panel used the Adapted ADAPTE methodology. The panel prioritized the health questions and recommendations according to their importance for clinicians and patients. The procedure included searching for existing guidelines, quality appraisal, and adaptation of the recommendations to the target context of use. The guideline covered all important aspects of the indications, dosing, and administration of packed red cells, platelets, and fresh frozen plasma. It also included transfusion in special situations, e.g., chronic hemolytic anemia and aplastic anemia, management of massive blood loss, malignancies, surgery, recommendations for safe transfusion practices, and recommendations for modifications of cellular blood components. The final version of the adapted clinical practice guideline (CPG) has been made after a thorough review by an external review panel and was guided by their official recommendations and modifications. A set of implementation tools included algorithms, tables, and flow charts to aid decision-making in practice. This adapted guideline serves as a tool for safe transfusion practices in different pediatric age groups.

A Study Never Proves Anything: Contemporary Interpretation of the Levels of Clinical Evidence and Statistical Significance.

Critical analysis of the medical literature and an evidence-based approach to clinical practice and medical decision-making is of vital importance in contemporary podiatric practice. This article reviews the levels of clinical evidence and their application within this paradigm. This includes determining which level of evidence is most appropriate for a given methodology, as well as an appreciation of inherent limitations within each level of evidence. The article concludes with a discussion on the difference between statistical significance and clinical significance.

Surgical treatment of nasopharyngeal cancer - a consensus recommendation from two Chinese associations.

BACKGROUND: Surgical treatment is playing an increasingly important role in the management of nasopharyngeal carcinoma (NPC). This consensus focuses on the indications for optimal surgery, and surgical methods in the whole process of treatment for NPC to provide a useful reference to assist these difficult clinical decisions. METHODOLOGY: A thorough review of available literature on NPC and surgery was conducted by the Association for the prevention and treatment of nasopharyngeal carcinoma in China, international exchange and promotion Association for medicine and healthcare, and the Committee on nasopharyngeal cancer of Guangdong provincial anticancer association. A set of questions and a preliminary draft guideline was circulated to a panel of 1096 experienced specialists on this disease for voting on controversial areas and comments. A refined second proposal, based on a summary of the initial voting and different opinions expressed, was recirculated to the experts in two authoritative medical science and technology academic groups in the prevention and treatment of NPC in China for review and reconsideration. RESULTS: The initial round of questions showed variations in clinical practice even among similar specialists, reflecting the lack of high-quality supporting data and resulting difficulties in formulating clinical decisions. Through exchange of comments and iterative revisions, recommendations with high-to-moderate agreement were formulated on general treatment strategies and details of surgery, including indications and surgical approaches. CONCLUSION: By standardizing the surgical indications and practice, we hope not only to improve the surgical outcomes, but also to highlight the key directions of future clinical research in the surgical management of NPC.

Patterns and Pitfalls of Short-cuts Used in Environmental Management Rapid Reviews.

Environmental managers and policy-makers need reliable evidence to make effective decisions. Systematic reviews are one way to provide this information but are time-consuming and may not meet the needs of decision-makers when faced with rapidly changing management requirements or transient policy-windows. Rapid reviews are one type of knowledge synthesis that follow simplified or truncated methods compared to systematic reviews. Rapid reviews on environmentally-relevant topics are growing in prevalence, but it is unclear if rapid reviews use similar short-cuts or follow available guidelines. In this methodological review, we assess 26 rapid reviews published between 2002 and 2023. Numerous rapid review short-cuts and approaches were identified, with few consistencies among studies. Short-cuts were present in all stages of the review process, with some of the most common short-cuts including not developing an a priori review protocol, not including stakeholder involvement, or not conducting critical appraisal of study validity. Poor quality in reporting of methods was observed. Fewer than half of assessed rapid reviews reported using available guidelines when developing their methods. Future rapid reviews should aim for improved reporting and adherence to published guidelines to help increase the useability and evidence-user confidence. This will also enable readers to understand where short-cuts were made and their potential consequences for the conclusions of the review.

A guide to conducting systematic reviews of clinical laboratory tests.

Clinical laboratory professionals have an instrumental role in supporting clinical decision making with the optimal use of laboratory testing for screening, risk stratification, diagnostic, prognostic, treatment selection and monitoring of different states of health and disease. Delivering evidence-based laboratory medicine relies on review of available data and literature. The information derived, supports many national policies to improve patient care through clinical practice guidelines or best practice recommendations. The quality, validity and bias of this literature is variable. Hence, there is a need to collate similar studies and data and analyse them critically. Systematic review, thus, becomes the most important source of evidence. A systematic review, unlike a scoping or narrative review, involves a thorough understanding of the procedure involved and a stepwise methodology. There are nuances that need some consideration for laboratory medicine systematic reviews. The purpose of this article is to describe the process of performing a systematic review in the field of laboratory medicine, describing the available methodologies, tools and software packages that can be used to facilitate this process.

How Systematic Review Can Shape Clinical Practice in Radiology.

Systematic reviews offer radiologists a comprehensive synthesis of all relevant evidence pertaining to a specific question, aiding them in shaping their clinical practices. It is crucial for radiologists to familiarize themselves with the methods used in systematic reviews and meta-analyses and to understand the limitations. By doing so, they can effectively appraise and interpret results, enabling them to make informed decisions based on the evidence provided in systematic reviews and meta-analyses.

Planetary health in medical guidelines - A workshop report from the conference of the evidence-based medicine network 2023.

INTRODUCTION: Guidelines may play an important role in the process of adopting a planetary health perspective in clinical medicine. Current issues relating to the integration of planetary health aspects in guidelines were discussed during a workshop at the German Network for Evidence-Based Medicine conference in 2023. METHODS: In a multidisciplinary workshop, 25 persons with an interest in guideline development selected important planetary health dimensions that could be promptly included in guidelines. Group discussions addressed the challenges of integrating planetary health aspects in guidelines and feasible solutions. RESULTS: Participants recommended to first integrate the dimensions Environmental impacts, Prevention & co-benefits and Choosing wisely and provided corresponding rationales. Updating evidence to decision frameworks and including relevant climate outcomes (e.g., CO2 equivalents) in clinical trials were regarded as crucial. Pragmatic steps to integrate planetary health aspects such as an adapted guideline layout and prioritization of recommendations were proposed. DISCUSSION: Changes in the guideline development processes are necessary to incorporate the planetary health perspective into guidelines. Capacity building for guideline developers and modifications to frameworks are important next steps. Public discussion and cooperation between guideline developing bodies are therefore essential to move beyond the results of this workshop. CONCLUSION: The aforementioned workshop underpins the strong interest to integrate planetary health aspects into guideline frameworks to eventually promote planetary health in clinical medicine.

A tailored approach to horizon scanning for cancer medicines.

BACKGROUND: Horizon scanning (HS) is the systematic identification of emerging therapies to inform policy and decision-makers. We developed an agile and tailored HS methodology that combined multi-criteria decision analysis weighting and Delphi rounds. As secondary objectives, we aimed to identify new medicines in melanoma, non-small cell lung cancer and colorectal cancer most likely to impact the Australian government's pharmaceutical budget by 2025 and to compare clinician and consumer priorities in cancer medicine reimbursement. METHOD: Three cancer-specific clinician panels (total n = 27) and a consumer panel (n = 7) were formed. Six prioritisation criteria were developed with consumer input. Criteria weightings were elicited using the Analytic Hierarchy Process (AHP). Candidate medicines were identified and filtered from a primary database and validated against secondary and tertiary sources. Clinician panels participated in a three-round Delphi survey to identify and score the top five medicines in each cancer type. RESULTS: The AHP and Delphi process was completed in eight weeks. Prioritisation criteria focused on toxicity, quality of life (QoL), cost savings, strength of evidence, survival, and unmet need. In both curative and non-curative settings, consumers prioritised toxicity and QoL over survival gains, whereas clinicians prioritised survival. HS results project the ongoing prevalence of high-cost medicines. Since completion in October 2021, the HS has identified 70 % of relevant medicines submitted for Pharmaceutical Benefit Advisory Committee assessment and 60% of the medicines that received a positive recommendation. CONCLUSION: Tested in the Australian context, our method appears to be an efficient and flexible approach to HS that can be tailored to address specific disease types by using elicited weights to prioritise according to incremental value from both a consumer and clinical perspective. POLICY SUMMARY: Since HS is of global interest, our example provides a reproducible blueprint for adaptation to other healthcare settings that integrates consumer input and priorities.

A Primer on Systematic Review and Meta-analysis in Diabetes Research.

A systematic review is a rigorous process that involves identifying, selecting, and synthesizing available evidence pertaining to an a priori-defined research question. The resulting evidence base may be summarized qualitatively or through a quantitative analytic approach known as meta-analysis. Systematic review and meta-analysis (SRMAs) have risen in popularity across the scientific realm including diabetes research. Although well-conducted SRMAs are an indispensable tool in informing evidence-based medicine, the proliferation of SRMAs has led to many reviews of questionable quality and misleading conclusions. The objective of this article is to provide up-to-date knowledge and a comprehensive understanding of strengths and limitations of SRMAs. We first provide an overview of the SRMA process and offer ways to identify common pitfalls at key steps. We then describe best practices as well as evolving approaches to mitigate biases, improve transparency, and enhance rigor. We discuss several recent developments in SRMAs including individual-level meta-analyses, network meta-analyses, umbrella reviews, and prospective meta-analyses. Additionally, we outline several strategies that can be used to enhance quality of SRMAs and present key questions that authors, editors, and readers should consider in preparing or critically reviewing SRMAs.

Chinese guidelines for the rehabilitation treatment of knee osteoarthritis: An CSPMR evidence-based practice guideline.

BACKGROUND: Knee osteoarthritis (KOA) is the most common degenerative joint disease in China, causing a huge economic burden on patients, families, and society. Standardized KOA rehabilitation treatment is an important means to prevent and treat the disease and promote the development of high-quality medical services. This guideline is updated on the basis of the 2016 and 2019 editions. METHODS: Clinical questions regarding rehabilitation assessment and treatment were selected through clinical questions screening and deconstruction, and multiple rounds of Delphi questionnaire consultation. The International Classification of Functioning, Disability and Health (ICF) was used as the theoretical framework, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was used to grade the quality of evidence and recommendations. RESULTS: The reporting of this guideline followed the standard of Reporting Items for Practice Guidelines in Healthcare (RIGHT). Taking into account patients' preferences and values and the needs of Chinese clinical practice, a total of 11 clinical questions and 28 recommendations were established. The clinical questions were grouped into two categories: KOA assessment (body function, body structure, activity and participation, quality of life, and environmental factors and clinical outcomes assessment, resulting in 9 recommendations) and KOA treatment (health education, therapeutic exercise, therapeutic modalities, occupational therapy, assistive devices, and regenerative rehabilitation approaches, resulting in 19 recommendations). CONCLUSION: This is the first evidence-based guideline for KOA rehabilitation in China utilizing the ICF framework. This guideline provides key guidance for developing systematic, standardized, and precise rehabilitation protocols for KOA across various healthcare settings.

Evidence-based Medicine and Mechanistic Evidence: The Case of the Failed Rollout of Efavirenz in Zimbabwe.

Evidence-based medicine (EBM) has long deemphasized mechanistic reasoning and pathophysiological rationale in assessing the effectiveness of interventions. The EBM+ movement has challenged this stance, arguing that evidence of mechanisms and comparative studies should both be seen as necessary and complementary. Advocates of EBM+ provide a combination of theoretical arguments and examples of mechanistic reasoning in medical research. However, EBM+ proponents have not provided recent examples of how downplaying mechanistic reasoning resulted in worse medical results than would have occurred otherwise. Such examples are necessary to make the case that EBM+ responds to a problem in clinical practice that urgently demands a solution. In light of this, we examine the failed rollout of efavirenz as a first-line HIV treatment in Zimbabwe as evidence of the importance of mechanistic reasoning in improving clinical practice and public health policy decisions. We suggest that this case is analogous to examples commonly given to support EBM.

Challenges in developing national orthopedic health research agendas in the Netherlands: process overview and recommendations.

Growing demand for clinical research to improve evidence-based medicine in daily medical practice led to healthcare evaluation, which assesses the effectiveness of the existing care. The first step is identifying and prioritizing the most important evidence uncertainties. A health research agenda (HRA) can be valuable and helps determine funding and resource allocation, aiding researchers and policymakers to design successful research programs and implement the results in daily medical practice. We provide an overview of the development process of the first 2 HRAs within orthopedic surgery in the Netherlands and the following research process. In addition, we developed a checklist with recommendations for the future development of an HRA. This perspective guides the development of highquality and widely supported nationwide HRAs, including preparatory actions. This improves the uptake of evidence uncertainties in a successful research program and disseminates evidence-based literature in daily medical practice to improve patient care.

Evidence-Based Intervention Adaptations Within the Veterans Health Administration: a Scoping Review.

BACKGROUND: Veterans receiving care within the Veterans Health Administration (VA) are a unique population with distinctive cultural traits and healthcare needs compared to the civilian population. Modifications to evidence-based interventions (EBIs) developed outside of the VA may be useful to adapt care to the VA healthcare system context or to specific cultural norms among veterans. We sought to understand how EBIs have been modified for veterans and whether adaptations were feasible and acceptable to veteran populations. METHODS: We conducted a scoping review of EBI adaptations occurring within the VA at any time prior to June 2021. Eligible articles were those where study populations included veterans in VA care, EBIs were clearly defined, and there was a comprehensive description of the EBI adaptation from its original context. Data was summarized by the components of the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME). FINDINGS: We retrieved 922 abstracts based on our search terms. Following review of titles and abstracts, 49 articles remained for full-text review; eleven of these articles (22%) met all inclusion criteria. EBIs were adapted for mental health (n = 4), access to care and/or care delivery (n = 3), diabetes prevention (n = 2), substance use (n = 2), weight management (n = 1), care specific to cancer survivors (n = 1), and/or to reduce criminal recidivism among veterans (n = 1). All articles used qualitative feedback (e.g., interviews or focus groups) with participants to inform adaptations. The majority of studies (55%) were modified in the pre-implementation, planning, or pilot phases, and all were planned proactive adaptations to EBIs. IMPLICATIONS FOR D&I RESEARCH: The reviewed articles used a variety of methods and frameworks to guide EBI adaptations for veterans receiving VA care. There is an opportunity to continue to expand the use of EBI adaptations to meet the specific needs of veteran populations.

Guidelines for implementing and adapting evidence-based interventions with marginalized youth in schools.

With growing diversity within the U.S. population and notable barriers to accessing behavioral health care, marginalized youth are placed at risk for developing psychosocial and mental health problems. Promoting evidence-based interventions (EBIs) through school-based mental health services may improve accessibility and quality of care for marginalized youth facing mental health disparities. Culturally sensitive interventions (CSIs) may further improve engagement with and effectiveness of EBIs with marginalized youth. In this article, we provide guidelines for advancing CSIs when implementing and adapting EBIs with marginalized youth in schools. First, we emphasize inclusive strategies for advancing CSIs with marginalized youth in schools, focusing on antiracist adaptations to interventions and using a community-based participatory research approach when implementing EBIs. Following, we discuss techniques for tailoring CSIs to more effectively support marginalized youth and their families with school-based prevention and treatment. Specifically, we recommend using the Adapting Strategies for Promoting Implementation Reach and Equity framework as a guide to promote equitable implementation as well as key strategies for engaging marginalized youth and their families with school-based EBIs. Ultimately, we offer these guidelines to address disparities and inform more equitable practice in youth mental health care-and to motivate future studies advancing culturally responsive services with marginalized youth in schools. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

User experience of applying AMSTAR 2 to appraise systematic reviews of healthcare interventions: a commentary.

BACKGROUND: 'A Measurement Tool to Assess Systematic Reviews, version 2' (AMSTAR 2) is a validated 16-item scale designed to appraise systematic reviews (SRs) of healthcare interventions and to rate the overall confidence in their results. This commentary aims to describe the challenges with rating of the individual items and the application of AMSTAR 2 from the user perspective. DISCUSSION: A group of six experienced users (methodologists working in different clinical fields for at least 10 years) identified and discussed the challenges in rating of each item and the general use of AMSTAR 2 to appraise SRs. A group discussion was used to develop recommendations on how users could deal with the identified challenges. We identified various challenges with the content of items 2-16 and with the derivation of the overall confidence ratings on AMSTAR 2. These challenges include the need (1) to provide additional definitions (e.g., what constitutes major deviations from SR protocol on item 2), (2) to choose a rating strategy for multiple conditions on single items (e.g., how to rate item 5 if studies were selected in duplicate, but consensus between two authors was not reported), and (3) to determine rules for deriving the confidence ratings (e.g., what items are critical for such ratings). Based on these challenges we formulated specific recommendations for items 2-16 that AMSTAR 2 users could consider before applying the tool. Our commentary adds to the existing literature by providing the first in-depth examination of the AMSTAR 2 tool from the user perspective. The identified challenges could be addressed by additional decision rules including definitions for ambiguous items and guidance for rating of complex items and derivation of confidence ratings. We recommend that a team consensus regarding such decision rules is required before appraisal procedure begins. TRIAL REGISTRATION: Not applicable.

American Society of Hematology, ABHH, ACHO, Grupo CAHT, Grupo CLAHT, SAH, SBHH, SHU, SOCHIHEM, SOMETH, Sociedad Panamena de Hematología, Sociedad Peruana de Hematología, and SVH 2023 guidelines for diagnosis of venous thromboembolism and for its management in special populations in Latin America.

Implementation of international guidelines in Latin American settings requires additional considerations (ie, values and preferences, resources, accessibility, feasibility, and impact on health equity). The purpose of this guideline is to provide evidence-based recommendations about the diagnosis of venous thromboembolism (VTE) and its management in children and during pregnancy. We used the GRADE ADOLOPMENT method to adapt recommendations from 3 American Society of Hematology (ASH) VTE guidelines (diagnosis of VTE, VTE in pregnancy, and VTE in the pediatric population). ASH and 12 local hematology societies formed a guideline panel comprising medical professionals from 10 countries in Latin America. Panelists prioritized 10 questions about the diagnosis of VTE and 18 questions about its management in special populations that were relevant for the Latin American context. A knowledge synthesis team updated evidence reviews of health effects conducted for the original ASH guidelines and summarized information about factors specific to the Latin American context. In comparison with the original guideline, there were significant changes in 2 of 10 diagnostic recommendations (changes in the diagnostic algorithms) and in 9 of 18 management recommendations (4 changed direction and 5 changed strength). This guideline ADOLOPMENT project highlighted the importance of contextualizing recommendations in other settings based on differences in values, resources, feasibility, and health equity impact.