"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.

Use of qualitative research in World Health Organisation guidelines: a document analysis.

BACKGROUND: Guidelines depend on effect estimates, usually derived from randomised controlled trials, to inform their decisions. Qualitative research evidence may improve decisions made but where in the process and the methods to do this have not been so clearly established. We sought to describe and appraise how qualitative research has been used to inform World Heath Organization guidance since 2020. METHODS: We conducted a document analysis of WHO guidelines from 2020 to 2022. We purposely sampled guidelines on the topics of maternal and newborn health (MANH) and infectious diseases, as most of the qualitative synthesis to date has been conducted on these topics, likely representing the 'best case' scenario. We searched the in-built repository feature of the WHO website and used standardised search terms to identify qualitative reporting. Using deductive frameworks, we described how qualitative evidence was used to inform guidelines and appraised the standards of this use. RESULTS: Of the 29 guidelines, over half used qualitative research to help guide decisions (18/29). A total of 8 of these used qualitative research to inform the guideline scope, all 18 to inform recommendations, and 1 to inform implementation considerations. All guidelines drew on qualitative evidence syntheses (QES), and five further supplemented this with primary qualitative research. Qualitative findings reported in guidelines were typically descriptive, identifying people's perception of the benefits and harms of interventions or logistical barriers and facilitators to programme success. No guideline provided transparent reporting of how qualitative research was interpreted and weighed used alongside other evidence when informing decisions, and only one guideline reported the inclusion of qualitative methods experts on the panel. Only a few guidelines contextualised their recommendations by indicating which populations and settings qualitative findings could be applied. CONCLUSIONS: Qualitative research frequently informed WHO guideline decisions particularly in the field of MANH. However, the process often lacked transparency. We identified unmet potential in informing implementation considerations and contextualisation of the recommendations. Use in these areas needs further methods development.

Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study.

INTRODUCTION: Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. OBJECTIVE: We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway. METHODS AND ANALYSIS: This is a prospective, pragmatic, observational cohort study. Children (aged 0-17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9-15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value. ETHICS AND DISSEMINATION: The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective. TRIAL REGISTRATION NUMBER: NCT05964764.

An evaluation of the quality, suitability and impact on equity of clinical practice guidelines relevant to preterm birth for use in Aotearoa New Zealand.

BACKGROUND: Preterm birth is a leading cause of perinatal morbidity and mortality and a defining event for pregnant people, infants, and whanau (extended families). Recommendations have been made for a national preterm birth prevention initiative focusing on equity in Aotearoa New Zealand, including the development of a national best practice guide. An understanding of the number and quality of guidelines, and consideration of their suitability and impact on equity is required. METHODS: Guidelines were identified through a systematic literature search, search of professional bodies websites, and invitation to regional health services in Aotearoa New Zealand. Obstetric and midwifery clinical directors were invited to report on guideline use. Identified guidelines were appraised by a 23-member trans-disciplinary Review Panel; quantitatively using the AGREE-II instrument and qualitatively using modified ADAPTE questions. The quality of guidelines available but not in use was compared against those in current use, and by health services by level of maternity and neonatal care. Major themes affecting implementation and impact on equity were identified using Braun and Clarke methodology. RESULTS: A total of 235 guidelines were included for appraisal. Guidelines available but not in use by regional health services scored higher in quality than guidelines in current use (median domain score Rigour and Development 47.5 versus 18.8, p < 0.001, median domain score Overall Assessment 62.5 versus 44.4, p < 0.001). Guidelines in use by regional health services with tertiary maternity and neonatal services had higher median AGREE II scores in several domains, than those with secondary level services (median domain score Overall Assessment 50.0 versus 37.5, p < 0.001). Groups identified by the Review Panel as experiencing the greatest constraints and limitations to guideline implementation were rural, provincial, low socioeconomic, Maori, and Pacific populations. Identified themes to improve equity included a targeted approach to groups experiencing the least advantage; a culturally considered approach; nationally consistent guidance; and improved funding to support implementation of guideline recommendations. CONCLUSIONS: We have systematically identified and assessed guidelines on preterm birth. High-quality guidelines will inform a national best practice guide for use in Taonga Tuku Iho, a knowledge translation project for equity in preterm birth care and outcomes in Aotearoa.

Appraising the quality standard of clinical practice guidelines related to central venous catheter-related thrombosis prevention: a systematic review of clinical practice guidelines.

OBJECTIVE: To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it. DESIGN: Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales. DATA SOURCES: Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022. ELIGIBILITY CRITERIA: Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022. DATA EXTRACTION AND SYNTHESIS: Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines. RESULTS: Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended. CONCLUSION: The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.

Enhanced recovery after surgery (ERAS® ) Society abdominal and thoracic surgery recommendations: A systematic review and comparison of guidelines for perioperative and pharmacotherapy core items.

INTRODUCTION: Worldwide, ERAS® Society guidelines have ushered in a new era of perioperative care. The purpose of this systematic review is to compare published core elements and pharmacotherapy recommendations embedded within ERAS® Society abdominal and thoracic surgery (ATS) guidelines. Determining whether a consensus exists for pharmacological core items would make future guideline preparation for similar surgeries more standardized and could improve patient care by reducing unnecessary protocol variations. METHODS: From the ERAS® Society website as of May 2023, 16 current ERAS® published ATS guidelines were included in the analysis to determine consensus and differing statements regarding each ERAS® perioperative and pharmacotherapy-related item. The aims were to (a) determine whether a consensus for each item could be derived, (b) identify gaps in ERAS® protocol development, and (c) propose potential research directions for addressing the identified gaps in the literature. RESULTS: Core items with consensus included: preoperative smoking and alcohol cessation; avoiding bowel reparation and fasting; multimodal preanesthetic, perioperative analgesia, and postoperative nausea and vomiting regimens; low molecular weight heparins for in-hospital and at-home venous thromboembolism prophylaxis; antibiotic prophylaxis; skin preparation; goal-directed perioperative fluid management with balanced crystalloids; perioperative nutrition care; ileus prevention with peripherally-acting mu receptor antagonists; and glucose control. CONCLUSION: While consensus was found for aspects of 21 current ERAS® guideline core items related to pharmacotherapy choice, details related to doses, regimen, timing of administration as well as unique aspects pertaining to specific surgeries remain to be researched and harmonized to promote guideline consistency and further optimize patient outcomes.

Understanding New Recommendations for Respiratory Syncytial Virus Prevention in Pregnancy.

Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy.

Barreras y facilitadores para el uso de las guías de práctica clínica por residentes de Medicina Familiar y Comunitaria: estudio cualitativo con grupos focales / Barriers and facilitators for the use of clinical practice guidelines by Family and Community Medicine residents: qualitative study with focus groups

Objetivo: identificar barreras y facilitadores para el uso de las guías de práctica clínica (GPC) por residentes de Medicina Familiar y Comunitaria.Métodos: metodología cualitativa. Se formaron tres grupos focales, total 28 residentes de tercer y cuarto año de las siete unidades docentes multiprofesionales de Atención Familiar y Comunitaria de Madrid. Los temas explorados fueron: conocimiento, comprensión, utilidad y uso de GPC. Las categorías elegidas para agrupar el discurso se elaboraron siguiendo el Manual metodológico de GuíaSalud. Análisis sociológico bajo la perspectiva fenomenológica.Resultados: las barreras relacionadas con la formación fueron el modelo de formación recibida para adquirir las habilidades necesarias, la falta de conocimientos para evaluar la calidad de las guías y un limitado conocimiento de los buscadores. Entre las barreras del contexto social y del sistema sanitario, se identificaron el conflicto con las expectativas del paciente, con las recomendaciones de otros especialistas, las características de los pacientes que consultan en Atención Primaria (AP) y la limitación de tiempo en las consultas. Como facilitadores se identificaron la motivación personal, los conocimientos y el modelo de práctica profesional del tutor y que las GPC fueran claras, breves y en diversos formatos.Conclusiones: los residentes dan valor a las GPC como herramientas docentes, de ayuda a la toma de decisiones y para desempeñar un mejor ejercicio profesional, aunque encuentran dificultades y limitaciones en su uso. El papel del tutor se identifica como clave; la formación, motivación y el modelo de práctica del tutor son considerados como los mayores facilitadores.(AU)

Aim: to identify barriers and facilitators for the use of Clinical Practice Guidelines (CPG) by Family and Community Medicine residents.Method: qualitative methodology. Three focus groups were set up, with a total of 28 participants, 3rd and 4th year residents of the 7 Multiprofessional Family and Community Care Teaching Units of Madrid. The topics explored were based on knowledge, understanding, usefulness and use of CPG. The categories chosen for discussion were drawn up according to the GuiaSalud Methodological Manual. Sociological analysis was performed using a phenomenological approach.Results: the barriers related to training were the training model received to acquire the necessary skills, the lack of knowledge to evaluate the quality of guidelines and a limited knowledge of the search engines. Among the barriers related to social context and health system, conflict with the patient's expectations or with the recommendations of other specialists, the characteristics of patients who consult in primary care and the limited time available for consultations were all identified. Personal motivation, the tutor’s knowledge and professional practice model and clear, brief CPGs and in various formats were all identified as facilitators. Conclusions: residents value CPGs as teaching and decision-making tools, as well as a tool to improve their professional practice. However, they detect difficulties and limitations in their use. Training, motivation and the tutor's practice model are considered to be among the greatest facilitators.(AU)