What are important outcomes of bariatric surgery? An in-depth analysis to inform the development of a core outcome set and a comparison between the views of surgeons and other health professionals (the BARIACT study)

BackgroundMany completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the ‘right’ outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important.ObjectivesTo develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies.ResultsThe literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes.ConclusionsThis study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS ‘long’ list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.

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ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations

European Respiratory Journal ◽

10.1183/13993003.02006-2021 ◽

2021 ◽

pp. 2102006

Author(s):

Alexander G. Mathioudakis ◽

Fekri Abroug ◽

Alvar Agusti ◽

Sachin Ananth ◽

Per Bakke ◽

...

Keyword(s):

Clinical Trials ◽

Systematic Reviews ◽

Health Professionals ◽

Core Outcome Set ◽

Core Outcome ◽

Measurement Instruments ◽

Copd Exacerbations ◽

The Core ◽

Arterial Blood ◽

Outcome Set

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.

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558 Summarising the Reporting of Outcomes in Studies of Robot Assisted Cholecystectomy: A Systematic Review

British Journal of Surgery ◽

10.1093/bjs/znab258.037 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

C S Jones ◽

E Kirkham ◽

L Gourbault ◽

F Hollowood ◽

M Dada ◽

...

Keyword(s):

Evidence Synthesis ◽

Core Outcome Set ◽

Significant Heterogeneity ◽

Core Outcome ◽

Robot Assisted ◽

Outcome Set ◽

Depth Analysis ◽

Outcome Selection ◽

Outcome Domain

Abstract Background Robot-assisted cholecystectomy (RC) has seen increasing adoption into clinical practice despite a lack of evidence to demonstrate superiority over conventional methods. Consistency in outcome selection, definition and reporting between studies is required for effective evidence synthesis and to minimise research waste. The aim of this study was to conduct an in-depth analysis of the outcomes reported in studies of RC. This work will inform the need for a core outcome set (COS). Method Systematic searches identified all published studies reporting RC, from inception to February 2020. Outcomes reported in each manuscript were recorded verbatim and categorised into domains. All outcomes were coded in duplicate. Where reported, the follow up period of each study was documented. Results Of 1425 abstracts screened, ninety studies met the criteria for inclusion. A total of 878 outcomes were reported. Each study included a median of 8 outcomes (range 3-26). Outcome selection was heterogeneous, with those relating to technical/operative factors (n = 383, 88 studies), complications (n = 245, 81 studies) and health economics (n = 139, 72 studies) used most frequently. No single outcome, or outcome domain, was reported in all studies. Only 30 studies reported a follow-up period, which ranged from 14 days to 46 months. In thirteen, the follow-up was for less than or equal to one month. Conclusions We identified significant heterogeneity in the selection and reporting of outcomes in studies of RC and support calls for standardisation and development of a COS.

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1158 Summarising the Reporting of Study Outcomes in Robotic Oesophagectomy: A Systematic Review

British Journal of Surgery ◽

10.1093/bjs/znab259.795 ◽

2021 ◽

Vol 108 (Supplement_6) ◽

Author(s):

J Ramirez ◽

C Jones ◽

L Gourbault ◽

W Hurst ◽

A Abbas ◽

...

Keyword(s):

Oesophageal Cancer ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Significant Heterogeneity ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set ◽

Depth Analysis ◽

Outcome Domain

Abstract Introduction There is an increasing adoption of robotic oesophagectomy in place of standard techniques for oesophageal cancer resection. This is potentially due to its perceived technical benefits and improved short-term outcomes. Consistency in outcome selection, definition and reporting between studies is required for effective evidence synthesis and prevention of research waste. The aim of this review is to perform an in-depth analysis of outcome reporting in robotic oesophagectomy. Method Systematic searches were conducted using key words for robotic surgery and oesophageal cancer, from inception to February 2020. Studies reporting any outcome for robotic oesophagectomy were included. Outcomes in each study were recorded verbatim and categorised into twelve domains. Outcomes were independently categorised by two reviewers. Where reported, the follow-up period was also recorded. Results Of 954 abstracts screened, 226 full texts were reviewed and 102 included. Only one study was a RCT. A total of 1422 outcomes were reported. Each study had a median of 14 reported outcomes (range 1-25). Outcomes related to complications (n = 578, 99 studies), technical/operative factors (n = 290, 90 studies), and pathology (e.g., resection margin) (n = 197, 83 studies) were reported most frequently. No single outcome, or outcome domain was reported in all studies. No studies used a core outcome set for reporting. Forty-five studies stated a follow-up period, ranging from <1 month to 58 months. Conclusions There is significant heterogeneity in the selection and reporting of outcomes in robotic oesophagectomy. This calls for the use of a core outcome set to allow standardisation and transparency of outcome reporting.

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Triangulated perspectives on outcomes of pulmonary rehabilitation in patients with COPD: a qualitative study to inform a core outcome set

Clinical Rehabilitation ◽

10.1177/0269215518821405 ◽

2018 ◽

Vol 33 (4) ◽

pp. 805-814 ◽

Cited By ~ 6

Author(s):

Sara Souto-Miranda ◽

Alda Marques

Keyword(s):

Health Professionals ◽

Pulmonary Rehabilitation ◽

Functional Performance ◽

Core Outcome Set ◽

Chronic Obstructive ◽

Core Outcome ◽

Structured Interviews ◽

Obstructive Pulmonary Disease ◽

Outcome Set ◽

Informal Carers

Introduction: Pulmonary rehabilitation implies a comprehensive assessment. Although several outcomes are commonly measured, those are selected mainly by health professionals and researchers, with the voice of patients and informal caregivers being minimally captured. Qualitative studies are fundamental to enhance our knowledge on perspectives of different stakeholders involved in pulmonary rehabilitation. Objective: This study aimed to explore the views of different stakeholders on outcomes of pulmonary rehabilitation, contributing to one of the stages of a core outcome set for pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). Methods: Semi-structured interviews were conducted with 12 patients with COPD, 11 informal carers and 10 health professionals. Data were analysed with content analysis, followed by thematic analysis to gain deeper understanding of the different perspectives. Results: A total of 44 outcomes were identified, being the most reported ‘improving functional performance’ (67%) and ‘reducing and taking control over dyspnoea’ (64%). Five relevant themes across stakeholders were generated: having a healthy mind in a healthy body; I can(’t) do it; feeling fulfilled; knowing more, doing better and avoiding doctors and expenses. Although perspectives were mostly consensual, some outcomes were only valued by health professionals (e.g. pulmonary function) or by patients and informal carers (e.g. quality of sleep). Conclusion: Views of the different stakeholders on outcomes of pulmonary rehabilitation were similar although, some specificities existed. Comprehensive assessments are needed to reflect what is valued by the different stakeholders in pulmonary rehabilitation. This study contributed to a future core outcome set in this field.

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Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

Frontiers in Medicine ◽

10.3389/fmed.2021.677068 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ruijin Qiu ◽

Songjie Han ◽

Xuxu Wei ◽

Changming Zhong ◽

Min Li ◽

...

Keyword(s):

Heart Failure ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Adverse Events ◽

Health Professionals ◽

Core Outcome Set ◽

Essential Medicines ◽

Core Outcome ◽

Outcome Set

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine.Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting.Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences.Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

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Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy

Trials ◽

10.1186/s13063-021-05574-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Nicole Evangelidis ◽

Benedicte Sautenet ◽

Magdalena Madero ◽

Allison Tong ◽

Gloria Ashuntantang ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Kidney Disease ◽

Replacement Therapy ◽

Health Professionals ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Kidney Replacement Therapy ◽

Randomised Controlled ◽

Stakeholder Consensus

Abstract Background Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacement therapy. The burden of symptoms and impaired quality of life in CKD may be compounded by comorbidities and treatment side effects. However, patient-important outcomes remain inconsistently and infrequently reported in trials in patients with CKD, which can limit evidence-informed decision-making. The Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers and health professionals are consistently reported in trials. Methods SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and stakeholder consensus workshops to review and finalise the set of core outcome domains for trials in CKD. Discussion Establishing a core outcome set to be reported in trials in patients with CKD will enhance the relevance, transparency and impact of research to improve the lives of people with CKD. Trial registration Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/Studies/Details/1653.

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