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CoreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment.

ABSTRACT: The increasing prevalence and burden of nonalcoholic steatohepatitis (NASH) has spurred the development of new treatments and a need to consider outcomes used for NASH treatment decision making. Development of a NASH core outcome set (COS) can help prioritize outcomes of highest importance by incorporating the perspectives from a variety of decision makers. coreNASH was an initiative to develop a COS for NASH using a modified Delphi consensus process with a multi-stakeholder voting panel. A candidate outcome list was created based on a literature review and key informant interviews. The candidate outcome list was then condensed and prioritized through three rounds of online voting and through discussion at an in-person meeting. Outcomes were retained or eliminated based on predetermined consensus criteria, which included special weighting of patients' opinions in the first two voting rounds. The coreNASH Delphi panel included 53 participants (7 patients, 10 clinicians and researchers, 7 health technology assessors, 22 industry representatives, 2 regulators, and 5 payers) who considered outcomes for two NASH-related COS: one for NASH without cirrhosis (F2-F3) and one for NASH with cirrhosis (F4). The initial candidate outcome list for both disease stages included 86 outcomes. The panel agreed on including two core outcomes for NASH without cirrhosis and nine core outcomes for NASH with cirrhosis in the COS. Conclusion: A consensus-based COS has been developed that can be used across the life cycle of NASH treatments. Outcomes included can contribute to decision making for regulatory, market access, and on-market decision making. Including the coreNASH COS in clinical development programs will facilitate improved comparisons and help decision makers assess the value of new products.

SUBMITTER: Clearfield E

PROVIDER: S-EPMC8122373 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundClinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study.ObjectiveThis study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol.MethodsThe study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome.ResultsOverall, 98% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day.ConclusionsSharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs.

Project description:BACKGROUND:Chronic pain is one of the most common complaints of cancer patients. There are many pharmacological and non-pharmacological treatment modalities used for the treatment of pain. Nonetheless, non-pharmacological interventions are preferred because of potential side effects in cases resistant to medical therapy that require a dose increase or potent drug use. In most real-life situations, the decision on which technique to choose is based on the clinical but subjective decisions of the practitioners. This study aimed to find out the best non-pharmacological treatment option for patients with chronic cancer pain by following a rational and reasonable approach. METHODS:Since the evaluation of treatment options requires to make a comparison between a number of alternatives in the light of certain criteria, we utilize the order relation analysis (G1-method) which is a method for determining the weights based on the improved Analytic Hierarchy Process (AHP). The method uses the relative importances on prioritizing the four criteria and eight sub-criteria defined by the experts of three pain physicians, one oncologist, and one oncologic surgeon. Four alternatives are then compared according to the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) using the verbal subjective judgments of the practitioners. RESULTS:Obtained results indicate that the general medical condition of the patient and the stage of the cancer are the essential factors in the selection of the treatment method. It is followed by the extent of the pain and the level of evidence, respectively. According to the evaluations performed, spinal port and splanchnic nerve radiofrequency thermocoagulation treatments are the first and second priority methods for pain treatment, respectively, compared to lumbar epidural catheter and celiac plexus block. CONCLUSIONS:The results of this study emphasize the need to integrate critical criteria into the decision-making process objectively. This is the first study in which multi-criteria decision-making tools are used in the evaluation and selection of pain management methods in cancer patients.

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CoreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment.

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