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INTRODUCTION: The GRADE-ADOLOPMENT methodology has been widely used to adopt, adapt or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. This guidance refines the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings and email communications, the GRADE-ADOLOPMENT Project Group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned Adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE Working Group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people) and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing EtDs when available or developing new EtDs if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over six years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.
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OBJECTIVES: To define the minimum knowledge required for guideline panel members (healthcare professionals and consumers) involved in developing recommendations about healthcare related testing. STUDY DESIGN AND SETTING: A developmental study with a multistaged approach. We derived a first set of knowledge components from literature and subsequently performed semistructured interviews with 9 experts. We refined the set of knowledge components and checked it with the interviewees for final approval. RESULTS: Understanding the test-management pathway, for example, how test results should be used in context of decisions about interventions, is the key knowledge component. The final list includes 26 items on the following topics: health question, test-management pathway, target population, test, test result, interpretation of test results and subsequent management, and impact on people important outcomes. For each item, the required level of knowledge is defined. CONCLUSION: We developed a list of knowledge components required for guideline panels to formulate recommendations on healthcare related testing. The list could be used to design specific training programs for guideline panel members when developing recommendations about tests and testing strategies in healthcare.
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BACKGROUND: Prognostic models incorporate multiple prognostic factors to estimate the likelihood of future events for individual patients based on their prognostic factor values. Evaluating these models crucially involves conducting studies to assess their predictive performance, like discrimination. Systematic reviews and meta-analyses of these validation studies play an essential role in selecting models for clinical practice. METHODS: In this paper, we outline 3 thresholds to determine the target for certainty rating in the discrimination of prognostic models, as observed across a body of validation studies. RESULTS AND CONCLUSION: We propose 3 thresholds when rating the certainty of evidence about a prognostic model's discrimination. The first threshold amounts to rating certainty in the model's ability to classify better than random chance. The other 2 approaches involve setting thresholds informed by other mechanisms for classification: clinician intuition or an alternative prognostic model developed for the same disease area and outcome. The choice of threshold will vary based on the context. Instead of relying on arbitrary discrimination cut-offs, our approach positions the observed discrimination within an informed spectrum, potentially aiding decisions about a prognostic model's practical utility.
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Estudios de Validación como Asunto , Humanos , Pronóstico , Enfoque GRADE , Modelos Estadísticos , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVES: To provide guidance on rating imprecision in a body of evidence assessing the accuracy of a single test. This guide will clarify when Grading of Recommendations Assessment, Development and Evaluation (GRADE) users should consider rating down the certainty of evidence by one or more levels for imprecision in test accuracy. STUDY DESIGN AND SETTING: A project group within the GRADE working group conducted iterative discussions and presentations at GRADE working group meetings to produce this guidance. RESULTS: Before rating the certainty of evidence, GRADE users should define the target of their certainty rating. GRADE recommends setting judgment thresholds defining what they consider a very accurate, accurate, inaccurate, and very inaccurate test. These thresholds should be set after considering consequences of testing and effects on people-important outcomes. GRADE's primary criterion for judging imprecision in test accuracy evidence is considering confidence intervals (i.e., CI approach) of absolute test accuracy results (true and false, positive, and negative results in a cohort of people). Based on the CI approach, when a CI appreciably crosses the predefined judgment threshold(s), one should consider rating down certainty of evidence by one or more levels, depending on the number of thresholds crossed. When the CI does not cross judgment threshold(s), GRADE suggests considering the sample size for an adequately powered test accuracy review (optimal or review information size [optimal information size (OIS)/review information size (RIS)]) in rating imprecision. If the combined sample size of the included studies in the review is smaller than the required OIS/RIS, one should consider rating down by one or more levels for imprecision. CONCLUSION: This paper extends previous GRADE guidance for rating imprecision in single test accuracy systematic reviews and guidelines, with a focus on the circumstances in which one should consider rating down one or more levels for imprecision.
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Enfoque GRADE , Procesos de Grupo , Humanos , Juicio , Tamaño de la MuestraRESUMEN
BACKGROUND: The role of serologic testing for SARS-CoV-2 has evolved during the pandemic as seroprevalence in global populations has increased. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct updated best practice guidance related to SARS-CoV-2 serologic testing. This guideline is an update to the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. OBJECTIVE: To develop evidence-based recommendations and identify unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, decisions related to vaccination and administration of monoclonal antibodies or convalescent plasma in immunocompromised patients, and identification of a serologic correlate of immunity. METHODS: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature reviewed, identified, and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. RESULTS: The panel recommends against serologic testing to diagnose SARS-CoV-2 infection in the first two weeks after symptom onset (strong recommendations, low certainty of evidence). Serologic testing should not be used to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative nucleic acid amplification test results (strong recommendation, very low certainty of evidence). Serologic testing may assist with the diagnosis of multisystem inflammatory syndrome in children (strong recommendation, very low certainty of evidence). To seek evidence for prior SARS-CoV-2 infection, the panel suggests testing for IgG, IgG/IgM, or total antibodies to nucleocapsid protein three to five weeks after symptom onset (conditional recommendation, low certainty of evidence). In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence.) The panel acknowledges further that a negative spike antibody test may be a useful metric to identify immunocompromised patients who are candidates for immune therapy. CONCLUSIONS: The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. Future studies should use serologic assays calibrated to a common reference standard.
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Ninety percent of people with chronic kidney disease (CKD) remain undiagnosed, most people at risk do not receive guideline-concordant testing, and disparities of care and outcomes exist across all stages of the disease. To improve CKD diagnosis and management across primary care, the National Kidney Foundation launched a collective impact (CI) initiative known as Show Me CKDintercept. The initiative was implemented in Missouri, USA from January 2021 to June 2022, using a data strategy, stakeholder engagement and relationship mapping, learning in action working groups (LAWG), and a virtual leadership summit. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to evaluate success. The initiative united 159 stakeholders from 81 organizations (Reach) to create an urgency for change and engage new CKD champions (Effectiveness). The adoption resulted in 53% of participants committed to advancing the roadmap (Adoption). Short-term results reported success in laying a foundation for CI across Missouri. The long-term success of the CI initiative in addressing the public health burden of kidney disease remains to be determined. The project reported the potential use of a CI initiative to build leadership consensus to drive measurable public health improvements nationwide.
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BACKGROUND: Assessing certainty of evidence is a key element of any systematic review. The aim of this meta-epidemiology study was to understand the frequency and ways with which certainty of evidence is assessed in contemporary systematic reviews published in high-impact sports science journals. METHODS: We searched PubMed and relevant journal web sites from 1 August 2016 to 11 October 2022 for systematic reviews published in the top-ten highest-impact journals within the 2020 Journal Citation Report for the Sports Sciences category. Pairs of independent reviewers screened items using a priori established criteria. RESULTS: Of 1250 eligible documents, 258 (20.6%) assessed the certainty of evidence, defined as using two or more distinct domains to provide an overall rating of the trustworthiness of findings across studies. Nine methods were cited for assessing certainty, with the most common being the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach (61.6%). The proportion of systematic reviews assessing certainty of evidence appeared to increase over the 6-year timeframe analyzed. Across all reviews analyzed, a large majority addressed the domains of risk of bias, imprecision, and inconsistency of the results. Other certainty domains including indirectness/applicability were less commonly assessed. DISCUSSION: Only one in five recent contemporary systematic reviews in the field of exercise and sports science assessed certainty of evidence. Organizational and institutional education on methods for assessing evidence may help further increase uptake of these methods and improve both the quality and clinical impact of systematic reviews in the field.
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Publicaciones Periódicas como Asunto , Deportes , Humanos , Revisiones Sistemáticas como Asunto , Sesgo , Estudios EpidemiológicosRESUMEN
Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches.
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Prueba de Ácido Nucleico para COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , COVID-19/diagnóstico , SARS-CoV-2/genética , SARS-CoV-2/aislamiento & purificación , Prueba de Ácido Nucleico para COVID-19/normas , Prueba de Ácido Nucleico para COVID-19/métodos , Estados Unidos , Técnicas de Diagnóstico Molecular/normas , Técnicas de Diagnóstico Molecular/métodos , Prueba de COVID-19/métodos , Prueba de COVID-19/normas , Técnicas de Amplificación de Ácido Nucleico/normas , Técnicas de Amplificación de Ácido Nucleico/métodosRESUMEN
Background: Despite efforts to provide evidence-based care for people living with kidney disease, health care provider goals and priorities are often misaligned with those of individuals with lived experience of disease. Coupled with competing interests of time, resources, and an abundance of suitable guideline topics, identifying and prioritizing areas of focus for the Canadian nephrology community with a patient-oriented perspective is necessary and important. Similar priority-setting exercises have been undertaken to establish research priorities for kidney disease and to standardize outcomes for kidney disease research and clinical care; however, research priorities are distinct from priorities for guideline development. Inclusion of people living with health conditions in the selection and prioritization of guideline topics is suggested by patient engagement frameworks, though the process to operationalizing this is variable. We propose that the Canadian Society of Nephrology Clinical Practice Guideline Committee (CSN CPGC) takes the opportunity at this juncture to incorporate evidence-based prioritization exercises with involvement of people living with kidney disease and their caregivers to inform future guideline activities. In this protocol, we describe our planned research methods to address this. Objective: To establish consensus-based guideline topic priorities for the CSN CPGC using a modified Delphi survey with involvement of multidisciplinary stakeholders, including people living with kidney disease and their caregivers. Study design: Protocol for a Modified Delphi Survey. Setting: Pilot-tested surveys will be distributed via email and conducted using the online platform SurveyMonkey, in both French and English. Participants: We will establish a group of multidisciplinary clinical and research stakeholders (both within and outside CSN membership) from Canada, in addition to people living with kidney disease and/or their caregivers. Methods: A comprehensive literature search will be conducted to generate an initial list of guideline topics, which will be organized into three main categories: (1) International nephrology-focused guidelines that may require Canadian commentary, (2) Non-nephrology specific guidelines from Canada that may require CSN commentary, and (3) Novel topics for guideline development. Participants will engage in a multi-round Modified Delphi Survey to prioritize a set of "important guideline topics." Measures: Consensus will be reached for an item based on both median score on the Likert-type scale (≥ 7) and the percentage agreement (≥ 75%); the Delphi process will be complete when consensus is reached on each item. Guideline topics will then be given a priority score calculated from the total Likert ratings across participants, adjusted for the number of participants. Limitations: Potential limitations include participant response rates and compliance to survey completion. Conclusions: We propose to incorporate evidence-based prioritization exercises with the engagement of people living with kidney disease and their caregivers to establish consensus-based guideline topics and inform future guidelines activities of the CSN CPGC.
Contexte: Malgré les efforts déployés pour fournir aux personnes atteintes de néphropathies des soins fondés sur les données probantes, il s'avère que les objectifs et priorités des prestataires de soins de santé sont souvent mal alignés avec ceux des personnes qui ont une expérience concrète de la maladie. Compte tenu des intérêts concurrents en matière de temps et de ressources, et de l'abondance de sujets pertinents pour l'élaboration de lignes directrices, il est nécessaire et important d'identifier et de hiérarchiser les domaines prioritaires pour la communauté néphrologique canadienne dans une perspective orientée vers le patient. Des exercices semblables pour la définition des priorités ont été entrepris afin d'établir les priorités de la recherche sur les maladies rénales et normaliser les soins cliniques et les résultats de la recherche sur les maladies rénales. Or, les priorités de la recherche diffèrent des priorités pour l'élaboration des lignes directrices. Bien que les façons de procéder varient, les cadres d'engagement des patients suggèrent que des personnes vivant avec des problèmes de santé soient incluses dans la sélection et la hiérarchisation des sujets des lignes directrices. À cet égard, nous proposons que le Comité sur les lignes directrices de pratique clinique de la Société canadienne de néphrologie (CSN CPGC Canadian Society of Nephrology Clinical Practice Guideline Committee) profite de l'occasion pour intégrer des exercices d'établissement des priorités fondés sur des données probantes et impliquer des personnes vivant avec une néphropathie et des soignants afin de guider les futures activités d'élaboration de lignes directrices. Dans ce protocole, nous décrivons la méthodologie de recherche que nous suivrons pour y remédier. Objectif: Établir des priorités consensuelles en matière de sujets de lignes directrices pour le CSN CPGC à l'aide d'une enquête Delphi modifiée et avec la participation d'intervenants multidisciplinaires, notamment des personnes vivant avec une néphropathie et leurs soignants. Conception: Protocole pour une enquête Delphi modifiée. Cadre: Des sondages pilotes, en anglais et en français, seront distribués par courriel et réalisés à l'aide de la plateforme en ligne SurveyMonkey. Participants: Nous créerons un groupe d'intervenants multidisciplinaires canadiens Åuvrant en clinique et en recherche (à la fois des membres et des non membres de la SCN) auquel s'ajouteront des personnes atteintes d'une néphropathie et/ou leurs soignants. Méthodologie: Une recherche exhaustive sera effectuée dans la littérature afin de constituer une première liste de sujets de lignes directrices, laquelle sera divisée en trois catégories principales: (1) lignes directrices internationales axées sur la néphrologie et pouvant nécessiter des commentaires canadiens, (2) lignes directrices canadiennes non spécifiquement liées à la néphrologie et pouvant nécessiter des commentaires de la SCN, (3) nouveaux sujets pour l'élaboration de lignes directrices. Les participants s'engageront dans une enquête Delphi modifiée à plusieurs tours afin de hiérarchiser un ensemble de « sujets importants pour l'élaboration de lignes directrices ¼. Mesures: Un consensus sera atteint pour un énoncé s'il atteint à la fois un score médian (≥7) sur l'échelle de Likert et le pourcentage d'accord établi (≥ 75 %); le processus Delphi sera terminé lorsque le consensus sera atteint pour chaque énoncé. Les sujets pour l'élaboration de lignes directrices recevront ensuite une cote de priorité calculée à partir du total des scores des participants sur l'échelle Likert et ajustée en fonction du nombre de participants. Limites: L'étude pourrait être limitée par le taux de réponse des participants et leur engagement à compléter toutes les étapes de l'enquête. Conclusion: Nous proposons d'intégrer des exercices de définition des priorités fondés sur des données probantes et impliquant la participation de personnes vivant avec une néphropathie et de leurs soignants afin de déterminer des sujets consensuels pour l'élaboration de lignes directrices et de guider les futures activités du CSN CPGC en lien avec ce processus.
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People with metastatic breast cancer (MBC) have diverse medical, physical, and psychosocial needs that require multidimensional care. Understanding patient preferences is crucial to tailor treatments, services, and foster patient-centered care. A scoping review was performed to summarize the current evidence on the preferences of people with MBC regarding their care to identify knowledge gaps and key areas for future research. The Embase, MEDLINE, CINAHL and PsycInfo databases were searched. Twenty studies enrolling 3354 patients met the study eligibility criteria. Thirteen quantitative studies, four mixed methods studies, and three qualitative studies were included. Seven studies captured healthcare provider perspectives; thirteen studies evaluated patient preferences relating specifically to cancer treatments; three studies evaluated preferences relating to supportive care; and four studies evaluated communication and decision-making preferences. The current literature evaluating MBC patient preferences is heterogeneous with a focus on cancer treatments. Future research should explore patient preferences relating to multidisciplinary, multi-modal care that aims to improve quality of life. Understanding MBC patient preferences regarding their comprehensive care can help tailor healthcare delivery, enhance the patient experience, and improve outcomes.
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INTRODUCTION: This updated guidance from the Grading of Recommendations Assessment, Development, and Evaluation addresses rating up certainty of evidence due to a dose-response gradient (DRG) observed in synthesis of intervention and exposure studies. STUDY DESIGN AND SETTING: This guidance was developed using iterative discussions and consensus in multiple meetings and was presented to attendees of the Grading of Recommendations Assessment, Development, and Evaluation Working Group meeting for feedback in November 2022 and for final approval in May 2023. RESULTS: The guidance consists of two steps. The first is to determine whether the DRG is credible. We describe five items for assessing credibility: a) is DRG identified using a proper analytical approach; b) is confounding the cause of the DRG; c) is there serious concern about ecological bias; d) is the DRG consistent across studies; and e) is there indirect evidence supporting the DRG. The first two of these items are the most critical. If the DRG was judged to be credible, then the second step is to apply the DRG domain and consider rating up, but only by one level due to the concern about residual confounding. CONCLUSION: Systematic review authors should only rate up certainty in evidence when a DRG is deemed credible.
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Sesgo , Humanos , ConsensoRESUMEN
OBJECTIVES: We describe how consideration of external evidence may play an important role in judging certainty in the process of establishing the certainty of the evidence. Our example is a network meta-analysis (NMA) addressing treatment for Ebola virus disease, which informed a World Health Organization guideline. STUDY DESIGN AND SETTING: Through Grading of Recommendations Assessment, Development, and Evaluations (GRADE) project group iterative online, in-person and email discussions, we developed this GRADE concept and obtained approval from the GRADE working group. Using the null as a threshold, we rated our certainty for network estimates in mortality, including consideration of evidence external to the NMA (i.e., did not meet eligibility criteria) and formal logical construction. RESULTS: Based on the existing GRADE guidance, we rated the network estimate for one indirect comparison as low certainty. The formal logical construction that lead us reevaluate the certainty of the evidence is as follows: if A is superior to B, and B is not inferior to C, then A must be superior to C. After considering the logic and the external indirect evidence, we concluded at least moderate certainty for the comparison. CONCLUSION: Systematic review authors and guideline developers should apply the fundamental logical construction for indirect comparisons and consider compelling external evidence in NMA certainty ratings.
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Enfoque GRADE , Humanos , Metaanálisis en Red , Metaanálisis como AsuntoRESUMEN
BACKGROUND: Misinformation poses a serious challenge to clinical and policy decision-making in the health field. The COVID-19 pandemic amplified interest in misinformation and related terms and witnessed a proliferation of definitions. OBJECTIVE: We aim to assess the definitions of misinformation and related terms used in health-related literature. METHODS: We conducted a scoping review of systematic reviews by searching Ovid MEDLINE, Embase, Cochrane, and Epistemonikos databases for articles published within the last 5 years up till March 2023. Eligible studies were systematic reviews that stated misinformation or related terms as part of their objectives, conducted a systematic search of at least one database, and reported at least 1 definition for misinformation or related terms. We extracted definitions for the terms misinformation, disinformation, fake news, infodemic, and malinformation. Within each definition, we identified concepts and mapped them across misinformation-related terms. RESULTS: We included 41 eligible systematic reviews, out of which 32 (78%) reviews addressed the topic of public health emergencies (including the COVID-19 pandemic) and contained 75 definitions for misinformation and related terms. The definitions consisted of 20 for misinformation, 19 for disinformation, 10 for fake news, 24 for infodemic, and 2 for malinformation. "False/inaccurate/incorrect" was mentioned in 15 of 20 definitions of misinformation, 13 of 19 definitions of disinformation, 5 of 10 definitions of fake news, 6 of 24 definitions of infodemic, and 0 of 2 definitions of malinformation. Infodemic had 19 of 24 definitions addressing "information overload" and malinformation had 2 of 2 definitions with "accurate" and 1 definition "used in the wrong context." Out of all the definitions, 56 (75%) were referenced from other sources. CONCLUSIONS: While the definitions of misinformation and related terms in the health field had inconstancies and variability, they were largely consistent. Inconstancies related to the intentionality in misinformation definitions (7 definitions mention "unintentional," while 5 definitions have "intentional"). They also related to the content of infodemic (9 definitions mention "valid and invalid info," while 6 definitions have "false/inaccurate/incorrect"). The inclusion of concepts such as "intentional" may be difficult to operationalize as it is difficult to ascertain one's intentions. This scoping review has the strength of using a systematic method for retrieving articles but does not cover all definitions in the extant literature outside the field of health. This scoping review of the health literature identified several definitions for misinformation and related terms, which showed variability and included concepts that are difficult to operationalize. Health practitioners need to exert caution before labeling a piece of information as misinformation or any other related term and only do so after ascertaining accurateness and sometimes intentionality. Additional efforts are needed to allow future consensus around clear and operational definitions.
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COVID-19 , Humanos , Pandemias , Revisiones Sistemáticas como Asunto , Consenso , ComunicaciónRESUMEN
BACKGROUND: Sensitivity and specificity are characteristics of a diagnostic test and are not expected to change as the prevalence of the target condition changes. We sought to evaluate the association between prevalence and changes in sensitivity and specificity. METHODS: We retrieved data from meta-analyses of diagnostic test accuracy published in the Cochrane Database of Systematic Reviews (2003-2020). We used mixed-effects random-intercept linear regression models to evaluate the association between prevalence and logit-transformed sensitivity and specificity. The model evaluated all meta-analyses as nested within each systematic review. RESULTS: We analyzed 6909 diagnostic test accuracy studies from 552 meta-analyses that were included in 92 systematic reviews. For sensitivity, compared with the lowest quartile of prevalence, the second, third and fourth quartiles were associated with significantly higher odds of identifying a true positive case (odds ratio [OR] 1.17, 95% confidence interval [CI] 1.09-1.26; OR 1.32, 95% CI 1.23-1.41; OR 1.47, 95% CI 1.37-1.58; respectively). For specificity, compared with the lowest quartile of prevalence, the second, third and fourth quartiles were associated with significantly lower odds of identifying a true negative case (OR 0.74, 95% CI 0.69-0.80; OR 0.65, 95% CI 0.60-0.70; OR 0.47, 95% CI 0.44-0.51; respectively). Pooled regression coefficients from bivariate models conducted within each meta-analysis showed that prevalence was positively associated with sensitivity and negatively associated with specificity. Findings were consistent across subgroups. INTERPRETATION: In this large sample of diagnostic studies, higher prevalence was associated with higher estimated sensitivity and lower estimated specificity. Clinicians should consider the implications of disease prevalence and spectrum when interpreting the results from studies of diagnostic test accuracy.
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Pruebas Diagnósticas de Rutina , Humanos , Sensibilidad y Especificidad , Revisiones Sistemáticas como Asunto , Metaanálisis como AsuntoRESUMEN
OBJECTIVE: Universally acknowledged standards for trustworthy guidelines include the necessity to ground recommendations in patient values and preferences. When information is limited-which is typically the case-guideline panels often find it difficult to explicitly integrate patient values and preferences into their recommendations. Our objective was to develop and evaluate a framework for systematically navigating guideline panels in incorporating patient values and preferences in making recommendations. STUDY DESIGN AND SETTING: In the context of developing a guideline for colorectal cancer screening, we generated an initial framework for creating panel surveys to elicit guideline panelists' views of patient values and preferences and to inform panel discussions on recommendations. With further applications in guidelines of diverse topic areas, we dynamically refined the framework through iterative discussions and consensus. RESULTS: The finial framework consists of five steps for creating and implementing panel surveys. The surveys can serve three objectives following from the quantitative information regarding patient values and preferences that guideline panels usually require. An accompanying video provides detailed instructions of the survey. CONCLUSION: The framework for creating and implementing panel surveys offers explicit guidance for guideline panels considering transparently and systematically incorporating patient values and preferences into guideline recommendations.
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Neoplasias Colorrectales , Humanos , Encuestas y Cuestionarios , Consenso , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/terapiaRESUMEN
OBJECTIVES: To explore guideline panelists' understanding of panel surveys for eliciting panels' inferences regarding patient values and preferences, and the influence of the surveys on making recommendations. STUDY DESIGN AND SETTING: We performed sampling and data collection from all four guideline panels that had conducted the surveys through October 2020. We collected the records of all panel meetings and interviewed some panelists in different roles. We applied inductive thematic analysis for analyzing and interpreting data. RESULTS: We enrolled four guideline panels with 99 panelists in total and interviewed 25 of them. Most panelists found the survey was easy to follow and facilitated the incorporation of patient values and preferences in the tradeoffs between benefits and harms or burdens. The variation of patient preferences and uncertainty regarding patient values and preferences reflected in the surveys helped the panels ponder the strength of recommendations. In doing so, the survey results enhanced a rationale for panels' decision on the recommendations. CONCLUSION: The panel surveys have proved to help guideline panels explicitly consider and incorporate patient values and preferences in making recommendations. Guideline panels would benefit from widespread use of the panel surveys, particularly when primary evidence regarding patient values and preferences is scarce.
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Medicina Basada en la Evidencia , Prioridad del Paciente , Humanos , Incertidumbre , Investigación Cualitativa , Encuestas y CuestionariosRESUMEN
OBJECTIVES: This article describes considerations for addressing intransitivity when assessing the certainty of the evidence from network meta-analysis (NMA) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Intransitivity is induced by effect modification, that is, when the magnitude of the effect between an intervention and outcome differs depending on the level of another factor. STUDY DESIGN AND SETTING: To develop this GRADE concept paper, the lead authors conducted iterative discussions, computer simulations, and presentations to the GRADE project group and at GRADE working group meetings. The GRADE Working Group formally approved the article in July 2022. RESULTS: NMA authors can have a higher or a lower threshold to rate down the certainty of the evidence due to intransitivity, which depends on the extent of their concerns regarding the trustworthiness of indirect comparisons, and their view of the relative problems with rating down excessively or insufficiently. NMA authors should consider three main factors when addressing intransitivity: the credibility of effect modification, the strength of the effect modification, and the distribution of effect modifiers across the direct comparisons. To avoid double counting limitations of the evidence, authors should consider the relationship between intransitivity and other GRADE domains. CONCLUSION: NMA authors face theoretic and pragmatic challenges and in most situations need to assess intransitivity without the availability of empirical data. Thus, explicitness regarding perspective is crucial.