The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.

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Development of a core outcome set for trials investigating the long-term management of bronchiectasis

Chronic Respiratory Disease ◽

10.1177/1479972318804167 ◽

2018 ◽

Vol 16 ◽

pp. 147997231880416 ◽

Cited By ~ 2

Author(s):

Maureen Spargo ◽

Cristín Ryan ◽

Damian Downey ◽

Carmel Hughes

Keyword(s):

Core Outcome Set ◽

Delphi Panel ◽

Core Outcome ◽

Outcome Set ◽

Overview Of Systematic Reviews ◽

Outcome Selection ◽

Accurate Comparison ◽

Initial List ◽

Selection Of

Heterogeneity in outcomes measured in trials limits accurate comparison of bronchiectasis studies. A core outcome set (COS) is an agreed, standardized set of outcomes that should be measured in trials for specific clinical areas. A COS for bronchiectasis could encourage consistency in future studies. An overview of systematic reviews and qualitative study on outcome selection in bronchiectasis informed an initial list of outcomes. A Delphi panel ( n = 86) rated the importance of each outcome from 1 to 9 in 3 sequential questionnaires, as a means to achieve consensus: 1–3 = ‘of limited importance’; 4–6 = ‘important, but not critical’; and 7–9 = ‘critical’. Outcomes rated ‘critical’ by ≥70% of the panel were added to the COS. Eighty-two participants responded to the first questionnaire. Attrition between each questionnaire was 5%. After 3 rounds of questioning, 18 outcomes exceeded the threshold for consensus and were included in the COS. This study has achieved consensus on 18 outcomes that should be measured in trials of interventions for bronchiectasis. Selection of the highest ranked outcomes may represent a pragmatic means for comparison. Further research is required to condense the number of outcomes selected and to determine its relevance to interventions.

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Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL‐D studies to inform development of a core outcome set

BJS Open ◽

10.1002/bjs5.50358 ◽

2020 ◽

Vol 4 (6) ◽

pp. 1072-1083

Author(s):

R. C. Macefield ◽

N. Wilson ◽

C. Hoffmann ◽

J. M. Blazeby ◽

A. G. K. McNair ◽

...

Keyword(s):

Systematic Review ◽

Surgical Procedures ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Outcome Selection

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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)

The Lancet ◽

10.1016/s0140-6736(15)60358-0 ◽

2015 ◽

Vol 385 ◽

pp. S43 ◽

Cited By ~ 7

Author(s):

James Hopkins ◽

Noah Howes ◽

Katy Chalmers ◽

Katie Whale ◽

Jelena Savovic ◽

...

Keyword(s):

Bariatric Surgery ◽

Health Professionals ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set ◽

Depth Analysis

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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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Outcomes and measures of delirium interventional studies in palliative care to inform a core outcome set: A systematic review

Palliative Medicine ◽

10.1177/02692163211040186 ◽

2021 ◽

pp. 026921632110401

Author(s):

Meera R Agar ◽

Najma Siddiqi ◽

Annmarie Hosie ◽

Jason W Boland ◽

Miriam J Johnson ◽

...

Keyword(s):

Systematic Review ◽

Palliative Care ◽

Core Outcome Set ◽

Core Outcome ◽

Time Points ◽

Outcome Set ◽

Delirium Prevention ◽

Outcome Selection ◽

Specific Outcome ◽

Meta Analyses

Background: Trials of interventions for delirium in various patient populations report disparate outcomes and measures but little is known about those used in palliative care trials. A core outcome set promotes consistency of outcome selection and measurement. Aim: To inform core outcome set development by examining outcomes, their definitions, measures and time-points in published palliative care studies of delirium prevention or treatment delirium interventions. Design: Prospectively registered systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Data sources: We searched six electronic databases (1980–November 2020) for original studies, three for relevant reviews and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We included randomised, quasi-randomised and non-randomised intervention studies of pharmacological and non-pharmacological delirium prevention and/or treatment interventions. Results: From 13/3244 studies (2863 adult participants), we identified 9 delirium-specific and 13 non-delirium specific outcome domains within eight Core Outcome Measures in Effectiveness Trials (COMET) taxonomy categories. There were multiple and varied outcomes and time points in each domain. The commonest delirium specific outcome was delirium severity ( n = 7), commonly using the Memorial Delirium Assessment Scale (6/8 studies, 75%). Four studies reported delirium incidence. Non-delirium specific outcomes included mortality, agitation, adverse events, other symptoms and quality of life. Conclusion: The review identified few delirium interventions with heterogeneity in outcomes, their definition and measurement, highlighting the need for a uniform approach. Findings will inform the next stage to develop consensus for a core outcome set to inform delirium interventional palliative care research.

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Important research outcomes for treatment studies of perinatal depression: systematic overview and development of a core outcome set

10.22541/au.160801147.70898783/v1 ◽

2020 ◽

Author(s):

Christel Hellberg ◽

Marie Österberg ◽

AnnKristine Jonsson ◽

Sara Fundell ◽

Frida Trönnberg ◽

...

Keyword(s):

Perinatal Depression ◽

Core Outcome Set ◽

Nominal Group Technique ◽

Antenatal Depression ◽

Delphi Survey ◽

Nominal Group ◽

Core Outcome ◽

Systematic Overview ◽

Outcome Set ◽

Outcome Selection

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS

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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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