Guideline Development Group Research Articles

Evidence synthesis summary formats for clinical guideline development group members: a mixed-methods systematic review protocol.

Introduction: Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods: This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion: The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries.

Physical Therapist Management of Patients With Suspected or Confirmed Osteoporosis: A Clinical Practice Guideline From the Academy of Geriatric Physical Therapy.

A clinical practice guideline on physical therapist management of patients with suspected or confirmed osteoporosis was developed by a volunteer guideline development group (GDG) that was appointed by the Academy of Geriatric Physical Therapy (APTA Geriatrics). The GDG consisted of an exercise physiologist and 6 physical therapists with clinical and methodological expertise. The guideline was based on a systematic review of existing clinical practice guidelines, followed by application of the ADAPTE methodological process described by Guidelines International Network for adapting guidelines for cultural and professional utility. The recommendations contained in this guideline are derived from the 2021 Scottish Intercollegiate Guideline Network (SIGN) document: Management of Osteoporosis and the Prevention of Fragility Fractures. These guidelines are intended to assist physical therapists practicing in the United States, and implementation in the context of the US health care system is discussed.

Evidence synthesis summary formats for clinical guideline development group members: a mixed-methods systematic review protocol

Introduction: Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods: This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion: The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries.

Clinical practice guideline for the prevention and management of hypertensive disorders of pregnancy

RESUMENObjetivos: Proveer recomendaciones clínicas basadas en evidencia para la prevención y el manejo de la enfermedad hipertensiva del embarazo (EHE) en el Seguro Social de Salud (EsSalud) del Perú. Materiales y métodos: se conformó un grupo elaborador de la guía (GEG) que incluyó médicos especialistas y metodólogos. El GEG formuló ocho preguntas clínicas para ser respondidas por la presente Guía de Práctica Clínica (GPC). Se realizaron búsquedas sistemáticas de revisiones sistemáticas y, cuando se consideró pertinente, estudios primarios en PubMed y Central durante 2021. Se seleccionó la evidencia para responder cada una de las preguntas clínicas planteadas . En reuniones de trabajo periódicas, el GEG usó la metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE) para calificar la evidencia y formular las recomendaciones. Además se resentan los puntos de buenas prácticas clínicas (BPC) y los flujogramas de prevención, manejo y seguimiento. Finalmente, la GPC fue aprobada por Resolución 112-IETSI-ESSALUD-2021.Resultados: En la presente GPC se formularon 11 recomendaciones (6 fuertes y 5 condicionales) que respondieron las preguntas clínicas definidas en el alcance de la GPC, acompañadas de 32 puntos de BPC y 3 flujogramas que abordan temas de prevención, tratamiento y seguimiento de la EHE. Conclusiones: Como recomendaciones centrales de la guía se dan el uso de sulfato de magnesio para el tratamiento de la preeclampsia severa y la eclampsia. La guía deberá ser actualizada en tres años.

Mandibular advancement device: prescription in adult dental sleep medicine — guideline of the German Society of Dental Sleep Medicine

PurposeObstructive sleep apnea (OSA) may result in severe health onditions, reduces quality of live, and affects high percentages of the adult population. Due to recent changes in the German health care regulations, mandibular advancement devices (MAD) will become available as a treatment option for OSA to a greater extent for general dentists and their patients.MethodsA guideline development group consisting of nine members representing four German dental and medical organizations was formed, in order to provide critical information and orientation to the main stakeholders (dentists and patients), regarding the use of MAD for the treatment of OSA within dental sleep medicine.ResultsThis guideline aims to inform physicians and dentists, particularly those with acquired qualification/specialization in sleep medicine (or in the diagnosis and treatment of sleep-related breathing disorders), as well as experts, payers, and patients. It delivers recommendations on technical requirements for MAD prescription and fabrication, clinical procedures, maintenance, and follow-up procedures.ConclusionA MAD should be designed for long-term therapy and must be a custom made, adjustable, bimaxillary retained two-splint system equipped with adjustable protrusive elements. The fabrication in a dental laboratory should be based on dental impressions or scans and three-dimensional registrations of the starting position taken with a bite gauge.

Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.

IntroductionThe goal of this project was to create an up‐to‐date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI.MethodsThese guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher‐level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus.ResultsThese guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients.ConclusionThese multidisciplinary European guidelines provide an up‐to‐date comprehensive evidence‐based framework with recommendations on the diagnosis and management of adult patients who suffer from FI.

Physical Therapist Management of Patients With Suspected or Confirmed Osteoporosis: A Clinical Practice Guideline From the Academy of Geriatric Physical Therapy.

A clinical practice guideline on physical therapist management of patients with suspected or confirmed osteoporosis was developed by a volunteer guideline development group (GDG) that was appointed by the Academy of Geriatric Physical Therapy (APTA Geriatrics). The GDG consisted of an exercise physiologist and 6 physical therapists with clinical and methodological expertise. The guideline was based on a systematic review of existing clinical practice guidelines, followed by application of the ADAPTE methodological process described by Guidelines International Network for adapting guidelines for cultural and professional utility. The recommendations contained in this guideline are derived from the 2021 Scottish Intercollegiate Guideline Network (SIGN) document: Management of Osteoporosis and the Prevention of Fragility Fractures. These guidelines are intended to assist physical therapists practicing in the United States, and implementation in the context of the US health care system is discussed.

Clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer.

The Japanese Psycho-Oncology Society and the Japanese Association of Supportive Care in Cancer developed evidence-based clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer. The guideline development group formulated two clinical questions. A systematic literature review was conducted. The level of evidence and the strength of the recommendations were graded and recommendation statements validated using the modified Delphi method. The recommendations were as follows: non-pharmacological interventions were indicated for serious psychological distress (depression and grief); antidepressants were indicated for depression; however, psychotropic medications including antidepressants were not recommended for ‘complicated’ grief. These guidelines will facilitate the provision of appropriate care to distressed bereaved family members and highlight areas where further research is needed.

Guidelines for diagnosis, prevention, and treatment of hand eczema.

Hand eczema is a common inflammatory skin disorder. Health care providers need continuously updated information about the management of hand eczema to ensure best treatment for their patients. To update the European Society of Contact Dermatitis guideline on the diagnosis, prevention, and treatment on of hand eczema. The Guideline Development Group (GDG) was established on behalf of the ESCD. A call for interest was launched via the ESCD website and via the ESCD members' mailing list. Appraisal of the evidence for therapeutic and preventive interventions was applied and a structured method of developing consensus was used and moderated by an external methodologist. The final guideline was approved by the ESCD executive committee and was in external review on the ESCD webpage for 1 month. Consensus was achieved for several statements and management strategies. The updated guideline should improve management of hand eczema.

Guidelines, guidelines and more guidelines for haemorrhoid treatment: A review to sort the wheat from the chaff.

AimGuidelines benefit patients and clinicians by distilling evidence into easy‐to‐read recommendations. The literature around the management of haemorrhoids is immense and guidelines are invaluable to improve treatment integrity and patient outcomes. We identified current haemorrhoid guidelines and assessed them for quality and consistency.MethodsA systematic search of the literature from January 2011 to October 2021 was carried out. Guidelines identified were assessed for quality using the AGREE II instrument and for consistency in terms of tabulated treatment recommendations.ResultsDuring this period nine guidelines were identified worldwide. The general quality was poor with only one guideline considered of high enough quality for use. In general, expert selection criteria for guideline development groups were vaguely defined. There were inconsistencies in the interpretation of the published evidence leading to variation in treatment recommendations.DiscussionFewer, higher quality guidelines, with more consistent results, are needed. Particular attention should be given to defining the selection of experts involved.

Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD)

IntroductionThe Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable...

ESHRE guideline: endometriosis.

ESHRE guideline: endometriosis.

Consensus on methods of development of clinical practice guidelines in oncology under the auspices of Maria Sklodowska-Curie National Research Institute of Oncology and the Agency for Health Technology Assessment and Tariff System

Introduction. As the changes leading to improvement of cancer care in Poland have shown the need to introduce clinical practice guidelines into the health care system, it has become clear that no methodological standard of the process for guidelines preparation has been established so far. The following process aims to present a unified and comprehensive clinical practice guidelines (CPGs) development methodology. Materials and methods. A review of globally recognised methods used by guideline development groups was prepared, informing the discussion during three plenary meetings and extensive consultations in writing. The resulting document was unanimously approved by a group of 24 methodologists and clinical experts, and has been formally recognized as a standard for CPGs development by the management of the National Institute of Oncology and the Agency for Health Technology Assessment and Tariff System. Results. Within the process, 43 recommendations were formulated to create unified and comprehensive rules for guideline development within the Polish healthcare system. Conclusions. The presented methods are consistent with the globally recognized tools and methods of guideline development, such as GRADE and ADAPTE, and follow quality criteria described by AGREE II. The process supports the development of high-quality guidelines within a resource-constrained setting by allowing to choose between adoption, adaptation, or de novo development of either the whole document of guidelines or particular recommendations.

Clinical practice guidelines and consensus statements for antenatal oral healthcare: An assessment of their methodological quality and content of recommendations.

ObjectivesTo review the content of recommendations within antenatal oral healthcare guidance documents and appraise the quality of their methodology to inform areas of development, clinical practice, and research focus.MethodA systematic search of five electronic databases, Google search engine, and databases from relevant professional and guideline development groups published in English, developed countries, and between 2010 and 2020 was undertaken to identify guidance documents related to antenatal oral healthcare. Quality of documents was appraised using the Appraisal of Guidelines Research and Evaluation II tool, and a 3-step quality cut-off value was used. Inductive thematic analysis was employed to categories discreet recommendations into themes.ResultsSix guidelines and one consensus statement were analysed. Two documents developed within Australia scored ≥60% across five of the six domains of the quality appraisal tool and were recommended for use. Four documents (developed in the United States and Canada) were recommended for use with modifications, whilst one document (developed in Europe) was not recommended. A total of 98 discreet recommendations were identified and demonstrated considerable unanimity but differed in scope and level of information. The main content and number of recommendations were inductively categorised within the following clinical practice points: risk factor assessments (n = 2), screening and assessment (n = 10), pre-pregnancy care (referral, n = 1), antenatal care (health education and advice, n = 14; management of nausea and vomiting, n = 7; referral, n = 2), postnatal care (health education and advice, n = 1; anticipatory guidance, n = 6), documentation (n = 4), coordinated care (n = 4), capacity building (n = 6), and community engagement (n = 1).ConclusionThe methodological rigour of included guidance documents revealed areas of strengths and limitations and posit areas for improvement. Further research could centre on adapting antenatal oral healthcare guidelines and consensus statements to local contexts. More high-quality studies examining interventions within antenatal oral healthcare are needed to support the development of recommendations.

Evidence based Acupuncture-Moxibustion Key questions and outcomes for the clinical practice guideline on acupuncture and moxibustion for allergic rhinitis: 《过敏性鼻炎针灸临床实践指南》关键临床问题和结局指标的研究

ObjectiveFormulating critical clinical questions and outcomes is essential for developing clinical practice guidelines (CPGs). This study aims to formulate the key clinical questions and outcomes for the CPG on acupuncture and moxibustion for allergic rhinitis (AR). MethodsPICO (patient, intervention, comparator, and outcome) question survey, Delphi survey, and consensus conference of the guideline development group (GDG) were employed. PICO questionnaires were used to gather and analyze the target users' key demands and interests. The GDG then selected the critical clinical questions and outcomes via a mixed method of Delphi survey and consensus conference. ResultsFifteen potential clinical questions and ten types of outcomes were formulated based on the analysis of 123 responses from seventeen countries on five continents. After two rounds of the Delphi survey and complete discussions, a consensus was reached by the GDG that all potential questions were included. After three rounds of the Delphi survey and complete debate, the consensus was reached that nine outcomes were considered important. ConclusionFifteen key clinical questions and nine important outcomes were formulated for the CPG. These covered issues elicited the most attention from global users in acupuncture therapy and AR. The results will contribute to the CPGs development and future clinical studies.

Trends in the development process of clinical practice guidelines: a questionnaire survey for the guideline development groups in Japan

BackgroundClinical practice guidelines (CPGs) are representative methods for promoting healthcare standardization and improving its quality. Previous studies on the CPG (published by 2006) development process in Japan reported that the involvement of experts and patients, efficient evidence collection and appraisal, and paucity of evidence on Japanese patients should be improved for the efficient CPG development. This study aimed to clarify the trends of CPG development process in Japan, focusing on the involvement of experts and patients, efficient evidence collection and appraisal, and paucity of Japanese evidence.MethodsA cross-sectional questionnaire survey was conducted for CPG development groups to collect information on the development activities of the CPGs published from 2012 to 2019. These CPGs were identified from the Japanese guideline clearinghouse. The questionnaire included the questions on composing the group, securing funding sources, collecting and appraising the research evidence, and the difficulties in the CPG development process. The questionnaires were distributed to the chairpersons of the CPG development groups through postal mail from November 2020 to January 2021. Combining the data from the current survey with those of previous studies reporting the development process of CPGs published by 2011, we analyzed the trend in the CPG development process.ResultsOf the total 265 CPGs included in the analysis, 164 (response rate: 41.4%) were from the current survey and 101 (response rate: 44.5%) were from previous studies. Among these, 40 (15.1%) were published by 2005, 47 (17.7%) in 2006–2010, 77 (29.1%) in 2011–2015, and 101 (38.1%) in 2016–2019. The proportion of CPGs involving methodologists did not increase through the publication periods. The proportion of CPGs involving patients almost doubled from the first period (15.9%) to the fourth period (32.4%). The yield rates of the articles did not change through the publication periods. The difficulty in “Coping with the paucity of Japanese evidence” has been improving consistently (69.2% in the first period to 37.4% in the fourth period).ConclusionsOur results suggest the need for methodological improvement in the efficient collection and appraisal of evidence and in the system assigning experts to the CPG development groups.

Strategic universality in the making of global guidelines for mental health.

Based on interviews with members of the Guideline Development Group (GDG) of the World Health Organization's (WHO) Mental Health Gap Action Programme (mhGAP) Guidelines for Mental, Neurological and Substance Use Disorders, this article adds empirical depth to understanding the contingent and strategic nature of universality in relation to mental health. Differently from debating whether or not mental health is global, the article outlines the people, ideas, and processes involved in making it global. Thematic analysis of interviews carried out with nine (out of 21) members of the original mhGAP GDG identified six intersecting strategies that enable the construction of universality in global mental health (GMH): 1) processes and practices of assembling expertise; 2) decisions on what counts as evidence; 3) framing cultural relativism as nihilistic; 4) the delaying of complexity to prioritize action; 5) the narration of tensions as technical rather than epistemological; and 6) the ascription of messiness to local contexts rather than to processes of standardization. Interviews showed that differently from the public-facing consensus often presented in GMH, GDG members hold contrasting and contingent understandings of the nature of universality in relation to mental health diagnoses and interventions. Thus, the universality of mental health achieved through the mhGAP Guidelines is partial and temporary, requiring continuous (re)iteration. The article uses empirical data to show nuance, complexity, and multi-dimensionality where binary thinking sometimes dominates, and to make links across arguments 'for' and 'against' global mental health.

A collaborative approach to adopting/adapting guidelines. The Australian 24-hour movement guidelines for children (5-12 years) and young people (13-17 years): An integration of physical activity, sedentary behaviour, and sleep

BackgroundIn 2018, the Australian Government updated the Australian Physical Activity and Sedentary Behaviour Guidelines for Children and Young People. A requirement of this update was the incorporation of a 24-hour approach to movement, recognising the importance of adequate sleep. The purpose of this paper was to describe how the updated Australian 24-Hour Movement Guidelines for Children and Young People (5 to 17 years): an integration of physical activity, sedentary behaviour and sleep were developed and the outcomes from this process.MethodsThe GRADE-ADOLOPMENT approach was used to develop the guidelines. A Leadership Group was formed, who identified existing credible guidelines. The Canadian 24-Hour Movement Guidelines for Children and Youth best met the criteria established by the Leadership Group. These guidelines were evaluated based on the evidence in the GRADE tables, summaries of findings tables and recommendations from the Canadian Guidelines. We conducted updates to each of the Canadian systematic reviews. A Guideline Development Group reviewed, separately and in combination, the evidence for each behaviour. A choice was then made to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. We then conducted an online survey (n=237) along with three focus groups (n=11 in total) and 13 key informant interviews. Stakeholders used these to provide feedback on the draft guidelines.ResultsBased on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Guideline Development Group agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, maintain the wording of the guidelines, preamble, and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-hours), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for children (5-12 years) and young people (13-17 years).ConclusionsTo our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used to develop movement behaviour guidelines. The judgments of the Australian Guideline Development Group did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian Guidelines were adopted with only very minor alterations. This allowed the Australian Guidelines to be developed in a shorter time frame and at a lower cost. We recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines that was developed using the GRADE approach is available with all supporting materials. Other countries may consider this approach when developing and/or revising national movement guidelines.

Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative.

Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative.

Korean guideline of desmopressin for the treatment of nocturia in men.

PurposeNocturia is the most bothersome of lower urinary tract symptoms in men. Desmopressin, a synthetic analog of the human hormone vasopressin, has been used for the treatment of nocturia. However, the guidelines include varying recommendations for the use of desmopressin for the management of nocturia in men. Therefore, the Korean Urological Association (KUA) developed recommendations for desmopressin for the treatment of nocturia in men.Materials and MethodsA rigorous systematic review was performed and Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to rate the certainty of evidence for patient outcomes and to develop the evidence into recommendations. The steering group, guidelines development group, systematic review team, and external review group consisted of members of the Korean Continence Society, Korean Society of Geriatric Urological Care, and KUA, respectively, who were involved in the guidelines development process.ResultsThe guidelines address the benefits, harms, patients’ values and preferences, costs, and resources related to desmopressin by using a single clinical question: What is the effectiveness of desmopressin compared to that of placebo, behavior modification, or other pharmacological therapies?ConclusionsThe guidelines development panel suggests desmopressin for men with nocturia instead of placebo, behavior modification, or alpha-blocker monotherapy (low certainty of evidence, weak recommendation). Additionally, the panel suggests desmopressin combination therapy with alpha-blockers for men with nocturia instead of alpha-blocker monotherapy or alpha-blocker combination therapy with anticholinergic agents (low certainty of evidence, weak recommendation).