Holger J Schünemann

McMaster University | McMaster

Background Intranasal antihistamines (INAH), corticosteroids (INCS), and their fixed combinations (INAH+INCS) are one of the cornerstones of the treatment of allergic rhinitis (AR). We performed a systematic review and network‐meta‐analysis comparing the efficacy and safety of INAH, INCS, and INAH+INCS in patients with AR. Methods We searched four...

Background Given the colonial connotations of the term “stakeholder”, its continued use may be perceived as disrespectful to Indigenous Peoples. While several groups have introduced alternative terms, each has its own limitations. The objective of this article is to introduce “interest‐holders” as an alternative term to “stakeholders” and describe...

COVID-19-related critical and acute illness are associated with an increased risk of venous thromboembolism (VTE). These evidence-based recommendations of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other healthcare professionals in decisions about the use of anticoagulation for thromboprophylaxis in p...

Background Cow's milk allergy (CMA) is the most complex and common food allergy in infants. Elimination of cow's milk from the diet and replacement with a specialized formula for infants with cow's milk allergy who cannot be breastfed is an established approach to minimize the risk of severe allergic reactions while avoiding nutritional deficiencie...

The first version of the World Health Organization Model list of essential medicines contained 186 medicines in 1977 and has evolved to include 502 medicines in 2023. Over time, different articles criticized the methods and process for decisions; however, the list holds global relevance as a model list to over 150 national lists. Given the global u...

The World Health Organization (WHO) plays an important role in developing evidence-based and ethically sound guidelines to assist health workers, programme managers and policy-makers, particularly in countries with limited capacities to create their own. While the development of these guidelines follows rigorous methods, contextualizing recommendat...

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...

People’s values are an important driver in healthcare decision making. The certainty of an intervention’s effect on benefits and harms relies on two factors: the certainty in the measured effect on an outcome in terms of risk difference and the certainty in its value, also known as utility or importance. The GRADE (Grading of Recommendations, Asses...

Recommendations for or against the use of interventions need to consider both desirable and undesirable effects as well as patients' values and preferences (V&P). In the decision‐making context, patients' V&P represent the relative importance people place on the outcomes resulting from a decision. Therefore, the balance between desirable and undesi...

Background: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. Objective: To develop an extension of the Reporting Items for pra...

Background Cow's milk allergy (CMA) is the most common food allergy in infants. The replacement with specialized formulas is an established clinical approach to ensure adequate growth and minimize the risk of severe allergic reactions when breastfeeding is not possible. Still, given the availability of multiple options, such as extensively hydrolyz...

Background There is insufficient systematised evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR). Objective To perform a systematic review to compare the efficacy of individual intranasal corticosteroids and antihistamines against placebo in improving the nasal and ocular symptoms and the rhinoconjunctivit...

Background Allergic rhinitis (AR) impacts patients' physical and emotional well‐being. Assessing patients' values and preferences (V&P) related to AR is an essential part of patient‐centered care and of the guideline development process. We aimed to systematically summarize the information about patients' V&P on AR and its symptoms and impact on da...

Health guidelines impact clinical, public health and policy practice, but there is no regulation for their development, often leading to variability in quality and trustworthiness. The International Guideline Training and Certification Programme (INGUIDE), established by faculty at McMaster University in partnership and under the auspice of the Gui...

Objectives: Guidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided pri-oritization of essential medicines globally for nearly 50 years, and national EMLs (...

Essential medicine lists (EMLs) are important medicine prioritization tools used by the World Health Organization (WHO) EML and over 130 countries. The criteria used by WHO’s Expert Committee on the Selection and Use of Essential Medicines has parallels to the GRADE Evidence-to-Decision (EtD) frameworks. In this study, we explored the EtD framework...

The quality of reporting practice guidelines is often poor, and there is no widely accepted ­guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines fo...

Introduction Intranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist among different intranasal specific medications. This systematic review aims to analyse and synthesise all evidence from r...

Background COVID-19 and antimicrobial resistance (AMR) are two intersecting public health crises. Antimicrobial overuse in patients with COVID-19 threatens to worsen AMR. Guidelines are fundamental in encouraging antimicrobial stewardship. We sought to assess the quality of antibiotic prescribing guidelines and recommendations in the context of COV...

Background Collaboration between guideline development groups has the potential to strengthen guideline rigor and reduce redundancies in research and discordance in practice. However, a recent needs assessment and subsequent qualitative study identified a lack of materials to structure and facilitate collaboration on guideline development. Objecti...

Background Guideline development can be a lengthy and resource consuming process. Also, duplication of efforts contributes to research waste. Adoption of guidelines, while an efficient alternative, fails to consider contextual factors which may impact the final recommendations. Therefore, adaptation of developed guidelines provides an alternative s...

Background Guideline adaptation allows for developing trustworthy recommendations using rigorous processes while limiting intensive use of resources. New frameworks, tools, and experience papers are continuously emerging to better inform the adaptation process. Objective To assess and map adaptation methods and processes through a scoping review, a...

GIN 2023 Hybrid Conference | 19 – 22 September | Abstract Book P a g e | 303 The development of GIN-McMaster checklist extension for guideline adaptation Dr Yang Song1, Yuan Zhang2, Yasser Amer3, Andrea J. Darzi2, Elie A Akl2,4, Pablo Alonso-Coello1,5, Holger J Schünemann2 1Iberoamerican Cochrane Centre (CCIb) - Biomedical Research Institute Sant P...

Trustworthy evidence syntheses using systematic review methodology are essential to make trustworthy decisions. To assess the certainty of a body of evidence included in a systematic review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group has developed an approach that is used by over 110 organizations, i...

Importance: To ensure that youths can make informed decisions about their health, it is important that health recommendations be presented for understanding by youths. Objective: To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of youths provided with a digital plain language recommendation...

Background: This is the 23rd in a series of articles describing the GRADE approach to grading the certainty of evidence and strength of recommendations for systematic reviews, health technology assessments, and clinical guideline development. Objectives: We outline how resource utilization and cost-effectiveness analyses (CEAs) are integrated in...

Objective: To assess the effectiveness of plain language compared with standard language versions of COVID-19 recommendations specific to child health. Study design and setting: Pragmatic, allocation-concealed, blinded, superiority randomized controlled trial (RCT) with nested qualitative component. Trial was conducted online, internationally. P...

Diese Ausgabe des Versorgungs-Reports widmet sich schwerpunktmäßig der Bedeutung von medizinischen Leitlinien in der Gesundheitsversorgung. Leitlinien geben den Behandelnden diagnostische und therapeutische Empfehlungen an die Hand. Sie werden nach systematischen und evidenzbasierten Kriterien entwickelt und zielen darauf ab, die Versorgungsqualitä...

There are concerns about bias arising from the interests that stakeholder representatives may bring into the process of health research. In this article we distinguish between the non-conflicting interests of stakeholder groups and the conflicting interests of their representatives. Non-conflicting interests of a stakeholder group (also referred to...

Purpose: To evaluate the reporting of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rating the certainty of evidence in systematic reviews (SRs) published in the urological literature. Materials and methods: Based on a predefined protocol we identified all SRs published in 5 major urological journals f...

Background: Hereditary and acquired thrombophilia are risk factors for venous thromboembolism (VTE). Whether testing helps in guiding management decisions is controversial. Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision-making about thrombophilia testing. Methods: ASH formed...

Objectives: This GRADE concept article offers systematic reviewers, guideline authors and other users of evidence assistance in addressing randomized trial situations in which interventions or comparators differ from those in the target people, interventions, comparators, outcomes (PICO). To clarify what GRADE considers under indirectness of inter...

One of the aims of the GRADE Working Group has been to develop a single system that would reduce confusion arising from a legion of multiple conflicting systems for grading evidence and recommendations and serve as unifying lingua franca. Although GRADE has been widely endorsed, the way it is being used is not infrequently inconsistent with GRADE g...

LINKED CONTENT This article is linked to Piovani et al papers. To view these articles, visit https://doi.org/10.1111/apt.17360 and https://doi.org/10.1111/apt.17461.

This paper is part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group. Rapid reviews (RRs) use modified systematic review methods to accelerate the review process while maintaining systematic, transparent and reproducible methods. This paper addresses considerations for rating the certainty of evidence (COE) in RRs...

Biomarkers for the diagnosis, treatment and follow-up of patients with rhinitis and/or asthma are urgently needed. Although some biologic biomarkers exist in specialist care for asthma, they cannot be largely used in primary care. There are no validated biomarkers in rhinitis or allergen immunotherapy (AIT) that can be used in clinical practice. Th...

Nonrandomized studies (NRS) on allergen immunotherapy (AIT) particularly lend themselves to evaluate outcomes that are insufficiently addressed in randomized controlled studies (RCTs). However, NRS are prone to several sources of bias, which limit their validity. We aimed at comparing AIT effects between RCTs and NRS and evaluate the reasons for di...

Objective: Clinical practice guidelines are often created through collaboration among organizations. Use of inconsistent terminology may cause poor communication and delays. This study aimed to develop a glossary of terms related to collaboration in guideline development. Study design and setting: A literature review of collaborative guidelines...

Background: Implementation of international guidelines in Latin American settings requires additional considerations (i.e., values and preferences, resources, accessibility, feasibility, and impact on health equity). Objective: To provide evidence-based guidelines about diagnosis of VTE and management in children and during pregnancy. Methods:...

Objective: To highlight how using the GRADE approach to understand the certainty in the evidence about the impact of climate change in health outcomes increases transparency. Also, how GRADE can enhance communication and decisions about adaptation and mitigation strategies. Study design: We developed a narrative review based on an assessment of...

Introduction The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public’s understanding, usability, satisfaction, intention to implement, and preference for dif...

Objectives: To evaluate alternative formats of summary of findings (SoF) tables for single comparison with multiple outcomes. Study design and setting: We conducted a three-arm randomized controlled non-inferiority trial (RCT) in the following systematic review (SR) users: researchers, clinical practice guideline developers, healthcare providers...

Background: Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks are well-known tools that enable guideline panels to structure the process of developing recommendations and making decisions in healthcare and public health. To date, they have not regularly been used for health policy-maki...

Introduction Data from mHealth apps can provide valuable information on rhinitis control and treatment patterns. However, in MASK‐air®, these data have only been analyzed cross‐sectionally, without considering the changes of symptoms over time. We analyzed data from MASK‐air® longitudinally, clustering weeks according to reported rhinitis symptoms....

Best practices for the dissemination of global health guidelines has not undergone rigorous research. We used a new approach to digitizing World Health Organization (WHO) global tuberculosis guideline recommendations (eTB RecMap) and compared its usability to the conventional method of accessing TB recommendations using the WHO website. We conducte...

Objectives Randomized controlled trials (RCTs) are the preferred source of evidence for the relative effect of healthcare interventions summarized in knowledge syntheses. Non-randomized studies of interventions (NRSI) may provide replacement, sequential, or complementary evidence to RCTs. The Grading of Recommendations, Assessment, Development and...

Background As systematically developed statements regarding possible courses of action, health system guidance (HSG) can assist with making decisions about addressing problems or achieving goals in health systems. However, there are conceptual and methodological challenges in HSG implementation due to the complexity of health-system policy-making,...

Background Allergy to cow's milk is the most common food allergy in infants and it is usually outgrown by 5 years of age. In some individuals it persists beyond early childhood. Oral immunotherapy (OIT, oral desensitization, specific oral tolerance induction) has been proposed as a promising therapeutic strategy for persistent IgE-mediated cow's mi...

Objective To provide updated guidance on when GRADE users should consider rating down more than one level for imprecision using a minimally contextualized approach. Study design and setting Based on the first GRADE guidance addressing imprecision rating in 2011, a project group within the GRADE Working Group conducted iterative discussions and pre...

Introduction GRADE guidance to rate the certainty domain of imprecision is presently not fully operationalized for rating down by two levels and when different or uncertainty in baseline risks are considered. In addition, there are scenarios in which lowering the certainty of evidence by three levels for imprecision is more appropriate than lowerin...

Background: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. Objective: To develop a framework that characterizes the processes of development of living practice guidelines in health care. Design: First, 3 background reviews were conducted: a scoping review of me...

Background: COVID-19 related critical illness is associated with an increased risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation in patients with...

Background Different treatments exist for allergic rhinitis (AR), including pharmacotherapy and allergen immunotherapy (AIT), but they have not been compared using direct patient data (i.e., “real‐world data”). We aimed to compare AR pharmacological treatments on (i) daily symptoms, (ii) frequency of use in co‐medication, (iii) visual analogue scal...

In an effort to enhance the trustworthiness of its clinical practice guidelines, the Endocrine Society has recently adopted new policies and more rigorous methodologies for its guideline program. In this Clinical Practice Guideline Communication, we describe these recent enhancements—many of which reflect greater adherence to the Grading of Recomme...

Objectives: Analytical frameworks are graphical representation of the key questions answered by a systematic review and can support the development of guideline recommendations. Our objectives were to a) conduct a systematic review to identify, describe and compare all analytical frameworks published as part of a systematic and guideline developme...

Introduction The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to the public’s (youth, parents, and adult populations) understanding, usability, satisfaction,...

Background: COVID-19 related acute illness is associated with an increased risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians and other health care professionals in decisions about the use of anticoagulation in patients with COV...

Objectives To evaluate the development and quality of actionable statements that qualify as good practice statements (GPS) reported in COVID-19 guidelines. Design and setting Systematic review . We searched MEDLINE, MedSci, China National Knowledge Infrastructure (CNKI), databases of Grading of Recommendations Assessment, Development and Evaluatio...

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendation...

Background “Biological plausibility” is a concept frequently referred to in environmental and public health when researchers are evaluating how confident they are in the results and inferences of a study or evidence review. Biological plausibility is not, however, a domain of one of the most widely-used approaches for assessing the certainty of evi...

Clinicians, patients, policy makers, funders, programme managers, regulators, and science communities invest considerable amounts of time and energy in influencing or making decisions at various levels, using systematic reviews, health technology assessments, guideline recommendations, coverage decisions, selection of essential medicines and diagno...

Objective There is little empirical evidence of the impact of pooling randomized controlled trials (RCTs) and cohort studies (CSs) on the certainty-of-evidence. To evaluate the hypothetical-scenario of pooling bodies-of-evidence from RCTs with matched bodies-of-evidence from CSs on the certainty-of-evidence. Study design and setting We extracted G...

Objective Our objective was to develop an extension of the widely used GIN-McMaster Guideline Development Checklist and Tool for the integration of quality assurance and improvement (QAI) schemes with guideline development. Study Design and Setting We used a mixed-methods approach incorporating evidence from a systematic review, an expert workshop...

Objective GRADE practice guideline developers often perform systematic reviews of potential economic evaluations to inform recommendation decision-making. We aimed to identify indirectness characteristics of economic evaluations, related to GRADE evidence-to-decision (EtD) theoretical frameworks, that influence selection of these articles. Study D...

Background The prevalence of cow's milk allergy (CMA) is approximately 2–4.5% in infants and less than 0.5% in adults. Most children outgrow cow's milk allergy in early childhood, particularly that to the baked milk products. Immunotherapy with unheated cow's milk has been used as a treatment option for those who have not yet outgrown CMA, but the...

Objective To develop a digital communication tool to improve the implementation of up-to-date COVID-19 recommendations. Specifically, to improve patient, caregiver and public understanding of healthcare recommendations on prevention, diagnoses and treatment. Study Design and Setting Multi-stakeholder engagement design. In conjunction with the COVI...

Systematic reviews are essential to produce trustworthy guidelines. To assess the body of evidence included in a systematic review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group has developed an approach that is used by over 100 organizations, including the World Health Organization and Cochrane. GRADE...