Initial List Of Outcomes Research Articles

Protocol for the development of a core outcome set for studies on centralisation of healthcare services

IntroductionCentralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while...

Expert Consensus Regarding Core Outcomes for Enhanced Recovery after Cesarean Delivery Studies: A Delphi Study

Heterogeneity among reported outcomes from enhanced recovery after cesarean delivery impact studies is high. This study aimed to develop a standardized enhanced recovery core outcome set for use in future enhanced recovery after cesarean delivery studies. An international consensus study involving physicians, patients, and a director of midwifery and nursing services was conducted using a three-round modified Delphi approach (two rounds of electronic questionnaires and a third-round e-discussion) to produce the core outcome set. An initial list of outcomes was based on a previously published systematic review. Consensus was obtained for the final core outcome set, including definitions for key terms and preferred units of measurement. Strong consensus was defined as 70% or greater agreement and weak consensus as 50 to 69% agreement. Of the 64 stakeholders who were approached, 32 agreed to participate. All 32, 31, and 26 stakeholders completed Rounds 1, 2 and 3, respectively. The number of outcomes in the final core outcome set was reduced from 98 to 15. Strong consensus (70% or greater stakeholder agreement) was achieved for 15 outcomes. The core outcome set included length of hospital stay; compliance with enhanced recovery protocol; maternal morbidity (hospital re-admissions or unplanned consultations); provision of optimal analgesia (maternal satisfaction, compliance with analgesia, opioid consumption or requirement and incidence of nausea or vomiting); fasting times; breastfeeding success; and times to mobilization and urinary catheter removal. The Obstetric Quality of Recovery-10 item composite measure was also included in the final core outcome set. Areas identified as requiring further research included readiness for discharge and analysis of cost savings. Results from an international consensus to develop a core outcome set for enhanced recovery after cesarean delivery are presented. These are outcomes that could be considered when designing future enhanced recovery studies.

Sjogren’s syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set

BackgroundSjogren’s syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medicine (TCM) for SS. However, there are generally some problems in these published clinical trials: lack of reporting primary or long-term outcomes and the heterogeneous in different clinical trials’ outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders and reach agreement on the COS and syndromes to be measured and reported in all future TCM trials in patients with SS.Methods and analysisA phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (I-a) identifying of a long initial list of outcomes through systematic literature review and semi-structured qualitative interviews and (I-b) identifying an initial list of TCM syndromes through (1) systematic literature review, (2) referencing ancient Chinese medical books, and (3) retrospective studies of medical records; (II) prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients; and (III) through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes.DiscussionWe summarized the actions of COS into three points: direct action, indirect action, and final action. After the final COSs is completed, we will publish this research in a journal to promote communication.Trial registrationCore Outcome Measures in Effectiveness Trials Initiative (COMET) number 1429. Registered on 01 December 2019.

RADIATE \u2013 Radial Dysplasia Assessment, Treatment and Aetiology: protocol for the development of a core outcome set using a Delphi survey

BackgroundRadial dysplasia (RD) is a disfiguring, potentially disabling congenital upper limb anomaly. Multiple surgical techniques are in current use, with little agreement on the optimal treatment approach. At present, no core outcome set exists specifically for RD, and the literature is dominated by retrospective case series. A recent systematic review by this group demonstrated significant heterogeneity on which outcomes are measured and how they are measured.Methods/designThe RADIATE study will conduct a three-round online Delphi process, involving adult RD patients, the parents of children with RD, hand surgeons and hand therapists. The initial list of outcomes was drawn from our recent systematic review and will be supplemented by suggestions from the stakeholder groups. Following the Delphi process, outcomes that meet the consensus in definition will be ratified at a final consensus meeting. We will then follow the COSMIN guidelines to select outcome measurement instruments. Where appropriate, these will overlap with the outcome measures specified in the forthcoming standard set for congenital upper limb anomalies published by the International Consortium for Health Outcomes Measurement.DiscussionThe Radial Dysplasia Assessment, Treatment and Aetiology (RADIATE) study aims to address the uncertainty in the treatment of RD, and to begin to answer the question ‘What is the most appropriate treatment of the forearm and hand for children with RD?’ by establishing a core outcome set.Trial registrationCOMET initiative study, 902. Registered in May 2016.

PP93 HTA Role In CoreHEM, A Multi-Stakeholder Core Outcome Set Project

Introduction:Hemophilia gene therapy trials demonstrate a “cure” could be achievable, thereby changing disease management. CoreHEM aims to develop multi-stakeholder consensus around a clearly defined, core outcome set (COS) - a minimum set of outcomes that should be measured and reported in all clinical trials of a specific condition - that will demonstrate and allow differentiation of the effectiveness and value of gene therapy relative to the current standard of care. Health technology assessment (HTA) frequently suffers from a lack of relevant, consistently reported outcomes. When uniformly implemented, COS increase the predictability and consistency of appraisals, coverage, and reimbursement decisions by payers and HTA agencies.Methods:A COS was developed using a modified Delphi process, including online surveys and an in-person consensus meeting. A literature review and key informant interviews were used to create an initial list of outcomes for voting. Participants (patients, including representatives from the National Hemophilia Foundation and the World Federation of Hemophilia, healthcare providers, payers, HTA agencies, regulators and industry representatives) condensed and prioritized the list by rating each outcome on a scale of 1 (not important to include) to 9 (essential). Participants could also suggest outcomes for voting. Outcomes were eliminated from consideration if <70 percent rated the outcome from 7–9, unless the patient stakeholder group average score was ≥7.Results:After two Delphi rounds, there was consensus on three outcomes: frequency of bleeds, factor activity level, and duration of expression. Additional outcomes included after an in-person consensus meeting were chronic pain, mental health status, and utilization of the healthcare system (direct costs). Adverse events of interest were evaluated and separately reported.Conclusions:Including the coreHEM COS in clinical development programs will ensure that relevant, consistent outcomes are available for decisions by HTA agencies, clinicians, and patients. This should result in faster access to novel, high-value therapies for appropriate patients.