scholarly journals Study protocol to develop a core outcome set for thyroid dysfunction to bridge the unmet needs of patient-centred care

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e050231
Author(s):  
Cheow Peng Ooi ◽  
Abdul Hanif Khan Yusof Khan ◽  
Rosliza Abdul Manaf ◽  
Norlaila Mustafa ◽  
Norlela Sukor ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Clinical Care ◽  
Core Outcome Set ◽  
Ethics Committee ◽  
Quality Data ◽  
Evidence Based ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Outcome Measures ◽  
Effectiveness Trials

AbstractIntroductionThyroid dysfunctions (TD) are common medical conditions affecting all global populations. Improved healthcare leading to increasing survival rates and delayed diagnosis rendered significant burden of the disease in the increasing number of patients with TD with comorbid illnesses. Therefore, reducing the burden of TD and improving the quality of care are crucial. Existing poor-quality data that guide evidence-based decisions only provide a fragmented picture of clinical care. The different outcomes across studies assessing the effectiveness of treatments impede our ability to synthesise results for determining the most efficient treatments. This project aims to produce a core outcome set (COS), which embeds the multiple complex dimensions of routine clinical care for the effectiveness studies and clinical care of adult patients with TD.Methods and analysisThis mixed-method project has two phases. In phase 1, we will identify a list of patient-reported and clinical outcomes through qualitative research and systematic reviews. In phase 2, we will categorise the identified outcomes using the Core Outcome Measures in Effectiveness Trials taxonomy of core domains and the International Classification of Functioning, Disability and Health. We will develop questionnaires from the list of outcomes identified from each domain for the two-round online Delphi exercise, aiming to reach a consensus on the COS. The Delphi process will include patients, carers, researchers and healthcare participants. We will hold an online consensus meeting involving representatives of all key stakeholders to establish the final COS.Ethics and disseminationThe study has been reviewed and approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia and the Research Ethics Committee, National University of Malaysia. This proposed COS in TD will improve the value of data, facilitate high-quality evidence synthesis and evidence-based decision-making. Furthermore, we will present the results to participants, in peer-reviewed academic journals and conferences.Registration detailsCore Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1371

scholarly journals A Systematic Review of Outcome Reporting, Definition and Measurement Heterogeneity in Non-Muscle Invasive Bladder Cancer Effectiveness Trials of Adjuvant, Prophylactic Treatment After Transurethral Resection

2021 ◽  
pp. 1-21
Author(s):  
Erik Veskimae ◽  
Selvarani Subbarayan ◽  
Riccardo Campi ◽  
Domitille Carron ◽  
Muhammad Imran Omar ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Evidence Based ◽  
Core Outcome ◽  
Muscle Invasive Bladder Cancer ◽  
Evidence Based Treatment ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Effectiveness Trials ◽  
Muscle Invasive ◽  
Meta Analyses

Abstract: BACKGROUND: Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant intervention after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians. OBJECTIVE: We aimed to systematically review the extent of reporting and definition heterogeneity. METHODS: We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000–2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another. RESULTS: We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials. CONCLUSIONS: Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity. PATIENT SUMMARY: This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions. Keywords:

scholarly journals Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e030146 ◽  
Author(s):  
Caroline Miller ◽  
Jane Cross ◽  
Dominic M Power ◽  
Derek Kyte ◽  
Christina Jerosch-Herold
Keyword(s):  
Systematic Review ◽  
Brachial Plexus ◽  
Clinical Outcomes ◽  
Clinical Care ◽  
Core Outcome Set ◽  
Evidence Based ◽  
Core Outcome ◽  
Permanent Disability ◽  
Outcome Set ◽  
Patient Reported

IntroductionTraumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Fifty per cent of injuries result in complete paralysis of the arm with many other individuals having little movement, sensation loss and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, with an estimated cost to the National Health Service and the economy of £35 million per annum. Advances in microsurgery have resulted in an increase in interventions aimed at reconstructing these injuries. However, data to guide evidence-based decisions is lacking. Different outcomes are used across studies to assess the effectiveness of treatments. This has impeded our ability to synthesise results to determine which treatments work best. Studies frequently report short-term clinical outcomes but rarely report longer term outcomes and those focused on quality of life. This project aims to produce a core outcome set (COS) for surgical and conservative management of TBPI. The TBPI COS will contain a minimum set of outcomes to be reported and measured in effectiveness studies and collected through routine clinical care.Methods and analysisThis mixed-methods project will be conducted in two phases. In phase 1 a long list of patient-reported and clinical outcomes will be identified through a systematic review. Interviews will then explore outcomes important to patients. In phase 2, the outcomes identified across the systematic review, and the interviews will be included in a three-round online Delphi exercise aiming to reach consensus on the COS. The Delphi process will include patient and healthcare participants. A consensus meeting will be held to achieve the final COS.Ethics and disseminationThe use of a COS in TBPI will increase the relevance of research and clinical care to all stakeholders, facilitate evidence synthesis and evidence-based decision making. The study has ethical approval.Trial registration numbersCRD42018109843.

scholarly journals Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Bateman ◽  
Jonathan P. Evans ◽  
Viana Vuvan ◽  
Val Jones ◽  
Adam C. Watts ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Health Care Professionals ◽  
Delphi Study ◽  
Evidence Synthesis ◽  
Core Outcome Set ◽  
Outcome Evaluation ◽  
Core Outcome ◽  
Outcome Set ◽  
Lateral Elbow ◽  
Lateral Elbow Tendinopathy

Abstract Background Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. Methods This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. Conclusions There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. Trial registration Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

scholarly journals Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need

2021 ◽  
Vol 8 (1) ◽  
pp. e000529
Author(s):  
Lisa N Guo ◽  
Lourdes M Perez-Chada ◽  
Robert Borucki ◽  
Vinod E Nambudiri ◽  
Victoria P Werth ◽  
...  
Keyword(s):  
Disease Activity ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Core Outcome Set ◽  
Cutaneous Lupus Erythematosus ◽  
Core Outcome ◽  
Outcome Set ◽  
Starting Point ◽  
Cutaneous Lupus

ObjectiveThe lack of standardised outcomes and outcome measures for cutaneous lupus erythematosus (CLE) represents a substantial barrier to clinical trial design, comparative analysis and approval of novel investigative treatments. We aimed to develop a working core outcome set (COS) for CLE randomised controlled trials and longitudinal observational studies.MethodsWe conducted a multistage literature review of CLE and SLE studies to generate candidate domains and outcome measures. Domains were narrowed to a working core domain set. Outcome measures for core domains were identified and examined.ResultsProposed core domains include skin-specific disease activity and damage, investigator global assessment (IGA) of disease activity, symptoms (encompassing itch, pain and photosensitivity), health-related quality of life (HRQoL) and patient global assessment (PtGA) of disease activity. Recommended physician-reported outcome measures include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and Cutaneous Lupus Activity IGA (CLA-IGA). For the domains of symptoms, HRQoL and PtGA of disease activity, we were unable to recommend one clearly superior instrument.ConclusionThis work represents a starting point for further refinement pending formal consensus activities and more rigorous evaluations of outcome measure quality. In the interim, the proposed working COS can serve as a much-needed guide for upcoming CLE clinical trials.

scholarly journals Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Anna N. Millar ◽  
◽  
Amrit Daffu-O’Reilly ◽  
Carmel M. Hughes ◽  
David P. Alldred ◽  
...  
Keyword(s):  
Older Adults ◽  
Core Outcome Set ◽  
Care Homes ◽  
Core Outcome ◽  
Outcome Set ◽  
Effectiveness Trials

scholarly journals Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

2019 ◽  
Vol 5 (2) ◽  
pp. 00072-2019 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Mia Moberg ◽  
Julie Janner ◽  
Pablo Alonso-Coello ◽  
Jørgen Vestbo
Keyword(s):  
Outcome Measures ◽  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Core Outcome ◽  
Copd Exacerbations ◽  
Outcome Set ◽  
Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

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