A demonstration of using formal consensus methods within guideline development; a case study.
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ABSTRACT: Background
Recommendations within guidelines are developed by synthesising the best available evidence; when limited evidence is identified recommendations are generally based on informal consensus. However, there are potential biases in group decision making, and formal consensus methods may help reduce these.Methods
We conducted a case study using formal consensus, to develop one set of recommendations within the Neonatal Parenteral Nutrition guideline being produced for the National Institute for Health and Care Excellence. Statements were generated through identification of published guidelines on several topics relating to neonatal parenteral nutrition. Ten high quality guidelines were included, and 28 statements were generated; these statements were rated by the committee via two rounds of voting. The statements which resulted in agreement were then used to develop the recommendations.Results
The approach was systematic and provided transparency. Additionally, a number of lessons were learnt; including the value of selecting the appropriate topic, giving adequate time to the process, and ensuring methodologies are understood by the committee for their value and relevance.Conclusion
Formal consensus is a valuable option for use within guideline development when specific criteria are met. The approach provides transparent methodology, ensuring clarity on how recommendations are developed.
SUBMITTER: Carter P
PROVIDER: S-EPMC8052943 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThis feasibility study has the primary aim of capturing and comparing participant expectations and experiences of using a formal consensus method (FCM) and to explore whether these views change following participation within a guideline committee where FCM are used.MethodsTwelve healthcare committee members and associated technical team members participated in semi-structured qualitative interviews before and after using FCM during guideline committee meetings. Interviews also focused on past experiences and expectations of informal consensus methods.ResultsParticipants said formal consensus included a greater range of evidence. They described positive reactions and found it a useful way to encourage involvement by balancing group power dynamics. Group discussion time was identified as important to clarify ideas, supported by good group chairing. However, participants reported that undertaking FCM required additional resources and suggested targeting its use for low quality evidence, limited committee expertise, or where the evidence is controversial.ConclusionsFCM is an acceptable alternative to informal consensus methods that has qualities specifically helpful to healthcare guidelines such as encouraging participation, inclusivity of a broad range of evidence, and managing group dynamics. More research is required to better understand when using formal consensus is most appropriate and effective.
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Project description:BackgroundStructured, systematic methods to formulate consensus recommendations, such as the Delphi process or nominal group technique, among others, provide the opportunity to harness the knowledge of experts to support clinical decision making in areas of uncertainty. They are widely used in biomedical research, in particular where disease characteristics or resource limitations mean that high-quality evidence generation is difficult. However, poor reporting of methods used to reach a consensus - for example, not clearly explaining the definition of consensus, or not stating how consensus group panellists were selected - can potentially undermine confidence in this type of research and hinder reproducibility. Our objective is therefore to systematically develop a reporting guideline to help the biomedical research and clinical practice community describe the methods or techniques used to reach consensus in a complete, transparent, and consistent manner.MethodsThe ACCORD (ACcurate COnsensus Reporting Document) project will take place in five stages and follow the EQUATOR Network guidance for the development of reporting guidelines. In Stage 1, a multidisciplinary Steering Committee has been established to lead and coordinate the guideline development process. In Stage 2, a systematic literature review will identify evidence on the quality of the reporting of consensus methodology, to obtain potential items for a reporting checklist. In Stage 3, Delphi methodology will be used to reach consensus regarding the checklist items, first among the Steering Committee, and then among a broader Delphi panel comprising participants with a range of expertise, including patient representatives. In Stage 4, the reporting guideline will be finalised in a consensus meeting, along with the production of an Explanation and Elaboration (E&E) document. In Stage 5, we plan to publish the reporting guideline and E&E document in open-access journals, supported by presentations at appropriate events. Dissemination of the reporting guideline, including a website linked to social media channels, is crucial for the document to be implemented in practice.DiscussionThe ACCORD reporting guideline will provide a set of minimum items that should be reported about methods used to achieve consensus, including approaches ranging from simple unstructured opinion gatherings to highly structured processes.
| S-EPMC9171734 | biostudies-literature
Project description:ObjectiveIn epilepsy, early diagnosis, accurate determination of epilepsy type, proper selection of antiseizure medication, and monitoring are all essential. However, despite recent therapeutic advances and conceptual reconsiderations in the classification and management of epilepsy, serious gaps are still encountered in day-to-day practice in Egypt as well as several other resource-limited countries. Premature mortality, poor quality of life, socio-economic burden, cognitive problems, poor treatment outcomes, and comorbidities are major challenges that require urgent actions to be implemented at all levels. In recognition of this, a group of Egyptian epilepsy experts met through a series of consecutive meetings to specify the main concepts concerning the diagnosis and management of epilepsy, with the ultimate goal of establishing a nationwide Egyptian consensus.MethodsThe consensus was developed through a modified Delphi methodology. A thorough review of the most recent relevant literature and international guidelines was performed to evaluate their applicability to the Egyptian situation. Afterward, several remote and live rounds were scheduled to reach a final agreement for all listed statements.ResultsOf 278 statements reviewed in the first round, 256 achieved ≥80% agreement. Live discussion and refinement of the 22 statements that did not reach consensus during the first round took place, followed by final live voting then consensus was achieved for all remaining statements.SignificanceWith the implementation of these unified recommendations, we believe this will bring about substantial improvements in both the quality of care and treatment outcomes for persons with epilepsy in Egypt.Plain language summaryThis work represents the efforts of a group of medical experts to reach an agreement on the best medical practice related to people with epilepsy based on previously published recommendations while taking into consideration applicable options in resource-limited countries. The publication of this document is expected to minimize many malpractice issues and pave the way for better healthcare services on both individual and governmental levels.
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Project description:Ultrasound-based sensing of muscle deformation, known as sonomyography, has shown promise for accurately classifying the intended hand grasps of individuals with upper limb loss in offline settings. Building upon this previous work, we present the first demonstration of real-time prosthetic hand control using sonomyography to perform functional tasks. An individual with congenital bilateral limb absence was fitted with sockets containing a low-profile ultrasound transducer placed over forearm muscle tissue in the residual limbs. A classifier was trained using linear discriminant analysis to recognize ultrasound images of muscle contractions for three discrete hand configurations (rest, tripod grasp, index finger point) under a variety of arm positions designed to cover the reachable workspace. A prosthetic hand mounted to the socket was then controlled using this classifier. Using this real-time sonomyographic control, the participant was able to complete three functional tasks that required selecting different hand grasps in order to grasp and move one-inch wooden blocks over a broad range of arm positions. Additionally, these tests were successfully repeated without retraining the classifier across 3 hours of prosthesis use and following simulated donning and doffing of the socket. This study supports the feasibility of using sonomyography to control upper limb prostheses in real-world applications.
| S-EPMC9114778 | biostudies-literature
Project description:BackgroundHearing loss has been identified as a potential major modifiable risk factor for developing dementia. This study examined associations between formal behavioural pure-tone and speech audiometry assessed by an audiologist with development of dementia in the Mayo Clinic Study of Aging (MCSA).MethodsThe MCSA is a prospective population-based study examining the incidence, prevalence, and risk factors of mild cognitive impairment and dementia in Olmsted County, Minnesota, USA. Participants undergo clinical examinations with neuropsychological testing at enrolment and every 15 months. Participants were 50 years or older at enrolment between Nov 29, 2004, and Dec 23, 2019, who underwent formal behavioural audiometric evaluation by an audiologist due to concerns about hearing loss or as a part of annual comprehensive health assessments. Associations of pure-tone average (PTA) and word recognition scores (WRS) with the development of dementia were evaluated using Cox proportional hazards regression with age as the timescale, and associations with changes in cognitive testing scores over time were evaluated using linear mixed-effects models.FindingsAmong 1200 eligible participants, the mean age at enrolment was 79 years (SD 9), 593 (49%) were men, and 207 developed dementia during a mean of 7·0 years (SD 3·7) of follow-up. After adjusting for sex, years of education, smoking status, diabetes, hypertension, apolipoprotein E ε4 carriership, and hearing rehabilitation (defined as hearing aid or cochlear implant use), neither PTA (hazard ratio [HR] per 10-decibels hearing level increase of 0·99 (95% CI 0·89-1·12; p=0·91) nor WRS (HR per 10% decrease of 0·98, 95% CI 0·89-1 ·07; p=0·65) was significantly associated with the development of dementia. However, both PTA and WRS were significantly associated with poorer performance in cognitive testing over time: participants with a PTA higher than 25 decibels hearing level or a WRS lower than 100% had significantly worse declines in cognitive testing scores. Informant-based hearing difficulties assessed by the participant's study partner were significantly associated with the development of dementia (HR 1·95, 95% CI 1·45-2·62; p<0·0001).InterpretationIn this prospective population-based study, subjective informant-based hearing difficulties were associated with development of dementia, whereas objective measures on formal behavioural audiometry were predictive of poorer performance on cognitive testing over time but not the development of dementia. Other factors related to central processing might potentiate the effects of peripheral hearing loss detected on behavioural audiometric testing.FundingNational Institute of Health, the Alexander Family Alzheimer's Disease Research Professorship of the Mayo Clinic, the GHR Foundation, the Mayo Foundation for Medical Education and Research, the Liston Award, the Schuler Foundation, the Rochester Epidemiology Project medical records linkage system, and the National Institute on Aging.
| S-EPMC9831680 | biostudies-literature
Project description:BackgroundAccurate identification of perturbed signaling pathways based on differentially expressed genes between sample groups is one of the key factors in the understanding of diseases and druggable targets. Most pathway analysis methods prioritize impacted signaling pathways by incorporating pathway topology using simple graph-based models. Despite their relative success, these models are limited in describing all types of dependencies and interactions that exist in biological pathways.ResultsIn this work, we propose a new approach based on the formal modeling of signaling pathways. Signaling pathways are formally modeled, and then model checking tools are applied to find the likelihood of perturbation for each pathway in a given condition. By adopting formal methods, various complex interactions among biological parts are modeled, which can contribute to reducing the false-positive rate of the proposed approach. We have developed a tool named Formal model checking based pathway analysis (FoPA) based on this approach. FoPA is compared with three well-known pathway analysis methods: PADOG, CePa, and SPIA on the benchmark of 36 GEO datasets from various diseases by applying the target pathway technique. This validation technique eliminates the need for possibly biased human assessments of results. In the cases that, there is no apriori knowledge of all relevant pathways, simulated false inputs (permuted class labels and decoy pathways) are chosen as a set of negative controls to test the false positive rate of the methods. Finally, to further evaluate the efficiency of FoPA, it is applied to a list of autism-related genes.ConclusionsThe results obtained by the target pathway technique demonstrate that FoPA is able to prioritize target pathways as well as PADOG but better than CePa and SPIA. Also, the false-positive rate of finding significant pathways using FoPA is lower than other compared methods. Also, FoPA can detect more consistent relevant pathways than other methods. The results of FoPA on autism-related genes highlight the role of "Renin-angiotensin system" pathway. This pathway has been supposed to have a pivotal role in some neurodegenerative diseases, while little attention has been paid to its impact on autism development so far.
| S-EPMC6390332 | biostudies-literature
Project description:ObjectiveWe aim to describe an evidence synthesis approach using parallel streams of evidence that informed the development of the 2021 American College of Rheumatology (ACR) guideline for the management of rheumatoid arthritis (RA).MethodsWe developed the evidence synthesis approach using parallel streams of evidence in multiple rounds of discussion, piloting, feedback, and revisions. A number of working groups involving ACR staff, content experts, and methodologists coordinated to develop and implement the approach.ResultsWe used a major stream of evidence that identified evidence specific to the clinical questions being addressed in the guideline (ie, we were able to match relevant articles to specific questions). We also used additional streams that identified data that applied across multiple questions. We describe in this article the different steps of the major stream, ie, screening and tagging, matching articles to question clusters, matching articles to individual questions, data abstraction and analysis, and Grading of Recommendations Assessment, Development and Evaluation (GRADEing). We then describe how we packaged the parallel streams of evidence into standardized structured tables to facilitate formulating the recommendations. These tables included information for the following factors: desirable effects, undesirable effects, certainty of evidence, valuation of outcomes, cost of interventions, and cost-effectiveness of interventions. The approach allowed us to match eligible articles for 47 of 81 clinical questions. We identified no eligible articles that addressed the remaining 34 questions.ConclusionWe were successful in using parallel streams of evidence to inform the development of the 2021 ACR guideline for the management of RA.
| S-EPMC8449038 | biostudies-literature
Project description:ObjectiveTo identify evidence on the reporting quality of consensus methodology and to select potential checklist items for the ACcurate COnsensus Reporting Document (ACCORD) project to develop a consensus reporting guideline.DesignSystematic review.Data sourcesEmbase, MEDLINE, Web of Science, PubMed, Cochrane Library, Emcare, Academic Search Premier and PsycINFO from inception until 7 January 2022.Eligibility criteriaStudies, reviews and published guidance addressing the reporting quality of consensus methodology for improvement of health outcomes in biomedicine or clinical practice. Reports of studies using or describing consensus methods but not commenting on their reporting quality were excluded. No language restrictions were applied.Data extraction and synthesisScreening and data extraction of eligible studies were carried out independently by two authors. Reporting quality items addressed by the studies were synthesised narratively.ResultsEighteen studies were included: five systematic reviews, four narrative reviews, three research papers, three conference abstracts, two research guidance papers and one protocol. The majority of studies indicated that the quality of reporting of consensus methodology could be improved. Commonly addressed items were: consensus panel composition; definition of consensus and the threshold for achieving consensus. Items least addressed were: public patient involvement (PPI); the role of the steering committee, chair, cochair; conflict of interest of panellists and funding. Data extracted from included studies revealed additional items that were not captured in the data extraction form such as justification of deviation from the protocol or incentives to encourage panellist response.ConclusionThe results of this systematic review confirmed the need for a reporting checklist for consensus methodology and provided a range of potential checklist items to report. The next step in the ACCORD project builds on this systematic review and focuses on reaching consensus on these items to develop the reporting guideline.Protocol registrationhttps://osf.io/2rzm9.
| S-EPMC9462098 | biostudies-literature
Project description:BackgroundMany intervention development projects fail to bridge the gap from basic research to clinical practice. Instead of theory-based approaches to intervention development, co-design prioritizes the end users' perspective as well as continuous collaboration between stakeholders, designers, and researchers throughout the project. This alternative approach to the development of interventions is expected to promote the adaptation to existing treatment activities and to be responsive to the requirements of end users.ObjectiveThe first objective was to provide an overview of all activities that were employed during the course of a research project to develop a relapse prevention intervention for interdisciplinary pain treatment programs. The second objective was to examine how co-design may contribute to stakeholder involvement, generation of relevant insights and ideas, and incorporation of stakeholder input into the intervention design.MethodsWe performed an embedded single case study and used the double diamond model to describe the process of intervention development. Using all available data sources, we also performed deductive content analysis to reflect on this process.ResultsBy critically reviewing the value and function of a co-design project with respect to idea generation, stakeholder involvement, and incorporation of stakeholder input into the intervention design, we demonstrated how co-design shaped the transition from ideas, via concepts, to a prototype for a relapse prevention intervention.ConclusionsStructural use of co-design throughout the project resulted in many different participating stakeholders and stimulating design activities. As a consequence, the majority of the components of the final prototype can be traced back to the information that stakeholders provided during the project. Although this illustrates how co-design facilitates the integration of contextual information into the intervention design, further experimental testing is required to evaluate to what extent this approach ultimately leads to improved usability as well as patient outcomes in the context of clinical practice.
| S-EPMC7857944 | biostudies-literature
Project description:BackgroundQuality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development.MethodsWe systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables.ResultsFrom 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement.ConclusionsFurther research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork.
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