Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

Joel Tay; Jane Blazeby; Adam O'Neill; Yoon Loke; Aoife Lowery; Catherine Robinson; Bilal Alkhaffaf; Jamie Kirkham

doi:10.12688/hrbopenres.14058.1

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Study Protocol

Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

[version 1; peer review: 1 approved]

Joel Tay ¹, Jane Blazeby², Adam O'Neill³, [...] Yoon Loke⁴, Aoife Lowery⁵, Catherine Robinson³, Bilal Alkhaffaf^6,7, Jamie Kirkham¹

Joel Tay ¹, Jane Blazeby², [...] Adam O'Neill³, Yoon Loke⁴, Aoife Lowery⁵, Catherine Robinson³, Bilal Alkhaffaf^6,7, Jamie Kirkham¹

PUBLISHED 31 Jan 2025

Author details Author details

¹ Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
² NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, England, UK
³ Social Care and Society, School of Health Sciences, The University of Manchester, Manchester, England, UK
⁴ Norwich Medical School, University of East Anglia, Norwich, England, UK
⁵ Discipline of Surgery, University of Galway, Galway, Ireland
⁶ Department of Oesophago-Gastric and Bariatric Surgery, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK
⁷ Division of Cancer Sciences, School of Medical Sciences, The University of Manchester, Manchester, England, UK

Joel Tay
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Jane Blazeby
Roles: Writing – Review & Editing

Adam O'Neill
Roles: Project Administration, Writing – Review & Editing

Yoon Loke
Roles: Writing – Review & Editing

Aoife Lowery
Roles: Formal Analysis, Funding Acquisition, Project Administration, Resources, Writing – Review & Editing

Catherine Robinson
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Bilal Alkhaffaf
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Jamie Kirkham
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the HRB-TMRN gateway.

Abstract

Background

Understanding outcomes of surgery performed with curative intent for different cancer types allows comparisons to be made provided consistent outcomes are selected and measured. At present core outcome sets (COS) that represent the minimum outcomes measured and reported in any clinical trial for a given condition exists for six of the ten most prevalent cancer types but it is uncertain whether this can be used to inform the development of a meta-COS (core outcome set) for any cancer type requiring a surgical operation with curative intent. This paper describes our study protocol to develop a meta-COS for surgical oncology.

Methods

Three stages of work will be conducted : (1) identification of a long list of outcomes including adverse events from previously published COS, a review of outcomes from trials registered with ClinicalTrials.gov, and focus groups with key stakeholders (inclusive of cancer patients having undergone surgery with curative intent for cancer or carers of such patients); (2) a two-round online Delphi survey including clinicians, patients or carers, and allied health professionals (such as dietitians, specialist nurses, physiotherapists, occupational health workers) to prioritise the outcomes; (3) an online consensus meeting using to agree on the final meta-COS.

Discussion

The meta-COS for surgical oncology trials will ensure that a selection of relevant outcomes will be available for use in all research studies for any cancer type requiring a surgical intervention.

Registration

This study titled “A meta-Core Outcome Set (COS) for surgical oncology” is registered on the COMET (Core Outcome Measures in Effectiveness Trials) Initiative database. (https://www.comet-initiative.org/Studies/Details/3252).

Keywords

Adverse events, Cancer, Core Outcome set, Consensus, Oncology, Surgery, Meta-COS

Corresponding author: Joel Tay

Competing interests: Professor Jamie Kirkham and Professor Jane Blazeby are members of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. There are no conflicts of interest to disclose from the other authors.

Grant information: Health Research Board [HRB-TMRN-2021-001]. This work was also supported by Professor Aoife Lowery in this project by funding from Irish Cancer Society [CRLALOW22].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Tay J et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Tay J, Blazeby J, O'Neill A et al. Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology [version 1; peer review: 1 approved]. HRB Open Res 2025, 8:19 (https://doi.org/10.12688/hrbopenres.14058.1) First published: 31 Jan 2025, 8:19 (https://doi.org/10.12688/hrbopenres.14058.1) Latest published: 31 Jan 2025, 8:19 (https://doi.org/10.12688/hrbopenres.14058.1)

Introduction

Surgical oncology is a branch of medicine that treats cancer using surgery. Cancer remains the leading cause of death worldwide (https://www.who.int/news-room/fact-sheets/detail/cancer) and surgery remains the single independent treatment modality most commonly required to treat cancer (Supplementary Figure 1 – Extended Data). In the UK, Public Health England’s official statistics also revealed that cancer diagnoses who received at least one type of treatment, surgery remains the single most common type of treatment (45%) compared to chemotherapy (28%) and radiotherapy (27%). As many as 76% of younger patients (under 50 years old) with cancer in the UK were treated with surgery (Fraser et al., 2020).

The primary and secondary outcomes used in clinical trials of surgical oncology can be heterogeneous. Consistency of these trial outcomes may be improved by the use of a core outcome set (COS), which represents the minimum set of outcomes that should be measured and reported in any clinical trial for a given condition (Williamson et al., 2012). A search of the COMET (Core Outcome Measures in Effectiveness Trials) database (https://www.comet-initiative.org) (accessed 2^nd February 2023) indicate that six of the ten commonest (WCRF, 2024) surgical cancers already have a COS with a further two developed for less common cancer types (Table 1). These surgical oncology COS can often be categorised into three key domains: survival, adverse outcome and the impact on health-related quality of life (Alkhaffaf & Kirkham, 2022). The remaining four commonest cancer types (breast, thyroid, liver and cervical) lack an available COS for use in trials and clinical settings with surgery as the main intervention type.

Table 1. Summary of existing COS in Surgical Oncology.

Cancer type	Rank by global incidence	No. of core outcomes	Outcomes in the COS
Cancer type	Rank by global incidence	No. of core outcomes	Survival core outcomes	Impact of surgery outcomes	Adverse event/Harm outcomes	Other outcomes
Lung[(De Rooij et al.*, 2022)	2	37	1. Overall survival 2. Progression-Free Survival 3. Cause of death	4. Financial impact 5. Difficulty swallowing (dysphagia) 6. Anorexia 7. Nausea 8. Gastric problems 9. Vomiting 10. Constipation 11. Diarrhoea 12. Pain 13. Fatigue 14. Shortness of breath/chest tightness 15. Coughing problems 16. Health Related Quality Of Life Outcomes (General) 17. Subjective wellbeing/health-related quality of life 18. Physical Function 19. Physical activity 20. Anxiety 21. Depression 22. Insomnia 23. Mobility 24. Cognitive functioning 25. Emotional functioning	26. Treatment discontinuation due to side effects 27. Treatment-related complications 28. Lung infection 29. Deep vein thrombosis 30. Haemoptysis	31. Medication compliance/ adherence 32. Patients’ personal beliefs and expectations about their illness 33. Social support 34. Tumour response 35. Duration of tumour Response (DoR) 36. Brain metastases 37. Localization of metastases
Colorectal(Mcnair et al., 2016)	3	12	1. Long-term survival 2. Perioperative survival	3. Physical function 4. Sexual function 5. Faecal incontinence 6. Faecal urgency	7. Stoma rates and complications 8. Anastomotic leak 9. Surgical Site infection	10. Conversion to open operation (where appropriate) 11. Cancer recurrence 12. Resection margins
Prostate(Maclennan et al., 2017)	4	12 universal + 4 surgery specific	1. Death from prostate cancer 2. Death from any cause 3. Perioperative deaths	4. Faecal incontinence 5. Bowel function 6. Stress incontinence 7. Urinary function 8. Sexual function 9. Overall quality of life	10. Bothersome or symptomatic urethral or anastomotic stricture 11. Thromboembolic disease	12. Positive surgical margin 13. Need for salvage therapy 14. Local disease recurrence 15. Distant disease recurrence/metastases 16. Disease progression
Stomach(Alkhaffaf et al., 2021)	5	8	1. Disease-free survival 2. Disease-specific survival 3. Surgery-related death	4. Overall quality of life 5. Nutritional effects	6. Serious adverse events	7. Recurrence of cancer 8. Completeness of tumour removal
Oesophagus(Avery et al., 2018)	8	10	1. Overall survival 2. In-hospital mortality	3. Severe nutritional problems 4. The ability to eat and drink 5. Problems with acid indigestion or heartburn 6. Overall quality of life	7. Respiratory complications 8. Conduit necrosis and anastomotic leak 9. The need for another operation related to their primary oesophageal cancer resection surgery	10. Inoperability
*Bladder(Reesink et al.*, 2021)	10	11	1. Survival (cause) 2. Bladder cancer-free survival	3. Urinary symptoms 4. Fatigue 5. Quality of life 6. Pain 7. Activities of Daily living 8. Physical functioning	9. Complications after treatment (using severity grading scales Clavien-Dindo or CTCAE)	10. Health-status in palliative setting 11. Readmissions after treatment
**Pancreas(van Rijssen et al.*, 2019)	12	8		1. Physical ability 2. Ability to work/do usual activities 3. General quality of life 4. General health 5. Abdominal complaints (pain/discomfort)		6. Relationship with partner/family 7. Fear of recurrence 8. Satisfaction with services/care organization
Oral cavity, Larynx, Nasopharynx (ENT) (Íde Waters, 2018)	16, 20, 22 respectively	8	Disease-specific survival1. 2. Death related to treatment	3. Dysphagia 4. HR-QOL		5. Interventions for the management of treatment-related morbidity 6. Local control 7. Regional control 8. Distant metastatic control

*Only includes outcomes in the lung cancer COS, information variables are excluded here.

**Radiation related complications in bladder cancer COS were excluded here.

***Pancreas COS was a Core Set of Patient-Reported Outcomes (COPRAC); Full representative pancreatic COS is currently being developed for April 2025

The development of a COS for each individual cancer type is resource intensive. Financial and time constraints become increasingly important considerations for researchers and is one of the most commonly cited barriers for standardising outcomes (Williamson et al., 2020). The recent examination (Alkhaffaf & Kirkham, 2022) of available COS for surgical oncology demonstrated overlapping outcomes across the three aforementioned outcome domains (see also Table 1), supporting the feasibility of an efficient approach to develop a COS across cancer types involving surgical treatment (a meta-COS) as a starting point for use in all surgical oncology trials.

The overall aim of this work is to determine a surgical oncology meta-COS for any cancer type that involves a surgical operation with curative intent and, is intended to describe endpoints to be reported as a minimum in future effectiveness trials. Specific objectives are to:

1) Identify suitable outcomes that have relevance in surgical oncology for the most prevalent cancer types through a review and discussion of previously published surgical oncology COS, a review of a clinical trials registry and focus groups with key stakeholders;
2) Assess the importance of these identified outcomes among key stakeholders (surgical and oncology consultants, cancer specialist nurses, patients, carers, and researchers) using a two-round Delphi survey technique;
3) Conduct a consensus-building process to determine which outcomes (including harm outcomes) should be included in the final surgical oncology meta-COS;

Study oversight

A Study Steering Committee (SSC) comprising three healthcare professionals (HCPs), an expert methodologist in COS development and one patient representative has been established. The three healthcare professionals consist of consultant oncological surgeons with track records as established academic researchers, two of whom had previous experience with COS development. The role of the SSC is to oversee the COS development study, provide feedback on the study protocol and list of outcomes, contribute to the dissemination of the online Delphi survey and to contribute to the final consensus meeting and dissemination of the COS.

Methods

The development of this COS protocol will follow the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement (Kirkham et al., 2019), and the minimum standards for planning a COS development study (Kirkham et al., 2017). A checklist of COS-STAP items is included in the extended data for this protocol. The study is registered with the COMET Initiative (https://www.comet-initiative.org/Studies/Details/3252). The COS process will involve three steps in Figure 1. Each of these steps is described below:

Figure 1. Study overview of a traditional COS development process.

Stage 1: Identification of outcomes

The list of outcomes from the ten most common surgical cancers reported globally will be identified (lung, breast, colorectal, prostate, gastric, liver, thyroid, cervical, bladder, oesophageal (WCRF, 2024)) for use in an online Delphi survey. These outcomes will be generated from the following sources:

1) Outcomes that were identified in existing published surgery oncology COS which were identified from a previous COMET database search (https://www.comet-initiative.org/Studies). From Table 1, we have identified eight previously published COS within scope which included two cancer types outside the top 10 (pancreatic and oropharyngeal (ENT) cancers), which the SSC decided to also include.
2) For cancer types within the top ten commonest ones where there is no existing COS (breast, thyroid, liver and cervical), outcomes will be identified from a review of open and recruiting trials registered on a trials registry (https://clinicaltrials.gov/). The search was carried out on 20^th March 2024 and will capture all records on the database. The search strategy is described in Table 2.
3) Three separate focus groups will be undertaken (one group for each type of stakeholders – patients/carers, consultant clinicians, and allied healthcare professionals) to capture any additional outcomes not already identified. Language of the outcomes and their definitions will also be checked in these group work. For each focus group meeting, the aim will be to capture participants representing as many of the different cancer types as possible.

Table 2. Search strategy for each cancer type on ClinicalTrials.gov.

	BREAST	THYROID	LIVER	CERVICAL
CONDITION	Breast cancer	Thyroid cancer	Hepatocellular carcinoma/Liver cancer	Cervix cancer
OTHER TERMS, IF ANY		Thyroid gland, thyroid carcinoma, thyroid neoplasm
INTERVENTION	Surgery	Surgery	Surgery	Surgery
FILTERS	Phase 3 and 4 trials only	*Interventional trials only	Phase 3 and 4 trials only	Phase 3 and 4 trials only
	Interventional trials only		Interventional trials only	Interventional trials only
EXCLUSION CRITERIA	Non-surgical trials, Oopherectomy-only trials	Non-surgical trials, Metastatic thyroid cancers	Non-surgical trials,	Non-surgical trials, Different cervical (head & neck) cancer trials.,

*No additional results returned for phase 3 and 4 filter for thyroid cancer(s) on the trial registry used.

Review of the final outcome list

The resulting list of outcomes from Stage 1 will undergo a series of independent iterative reviews and discussion between the lead investigator and the SSC. The aim of these reviews will be to remove all duplicate outcomes and to retain only outcomes that would be deemed to be relevant for inclusion across all cancer types. As an example, ‘residual shoulder abduction deficit’ following breast cancer surgery would not be relevant for all cancer types, thereby would not be suitable for consideration in a surgical oncology meta-COS. Conversely, disease-free survival following cervical cancer surgery would be relevant across all cancer types, and thus would be included as a candidate outcome for the meta-COS. If there is uncertainty in the decision-making process, then the outcome will be retained for consideration in Stage 2. All decisions made will be documented with rationale for why that decision was made.

The final list of outcomes from all sources will be reviewed by the SSC to group similar outcomes together and categorise each according to a 38-item taxonomy (Dodd et al., 2018). Outcome descriptors will be ensured by patient and public representatives to be clear and using appropriate plain language. Particular attention will be paid to the adverse events core domain in order to capture important individual harms (Tay et al., 2024). The SSC will also discuss the level of granularity of the outcome domains and will consider options for merging and dropping outcomes to ensure it was practically feasible for participants to score all outcomes in the Delphi survey phase in Stage 2 (Kottner et al., 2024).

Stage 2: Outcome prioritisation

Stakeholder recruitment

Stakeholders representing health care professionals (HCPs), researchers and patients will be invited to participate in the consensus building process. Healthcare professionals will include consultant surgeons, consultant oncologists, cancer specialist nurses, dietitians, and physiotherapists. They will be divided into 3 broad stakeholder groups – consultants (surgeons or oncologists), allied health professionals (nurses, therapists and dietitians) and patients (or carers of). We will look to include at least two participants from each of these stakeholder group for each of the ten most commonest cancer types.

Participants will be invited through professional networks and charities via email and social media

For example, HCPs will be identified through national societies, regional cancer networks, and regional trial units. Examples of these include, but not exhaustive of:

Greater Manchester Cancer Alliance
North West Surgical Trials Unit
Association of Surgeons of Great Britain
British Association of Surgical Oncology
National Breast Cancer Research Institute Ireland
National Surgical Research Support Centre (RCSI)
Cancer Research UK

We do not intend to recruit a separate stakeholder group of non-clinical academic researchers or triallists. Instead, HCPs with experience in trials, cancer research, or experience with COS development will be preferred. The SSC will assist in screening interested HCPs based on their research outputs and any prior COS development involvement.

Patient and carer participants will be identified through charity and cancer support networks both regionally and nationally. Examples of these include, but not exhaustive of:

Independent Cancer Patients’ Voice (ICPV)
The Patients Association (PA)
Greater Manchester Cancer Alliance
National Breast Cancer Research Institute Ireland
Irish Cancer Society
Patient and Public Involvement (PPI) Ignite Ireland

For patients or carers of patients, only those who have completed their treatment of the cancer diagnosis will be invited to participate. We anticipate the perceived priority of outcomes whilst still undergoing treatment will differ to those having completed. The stage of the cancer will not be specified in the recruitment due to the breadth of cancer types being targeted. Instead patients who have had cancer surgery with the intention to cure will be recruited.

Online delphi survey

A list of outcomes identified from the sources described in Stage 1 will be prioritised in a two-round online Delphi survey. The outcomes will be presented in terms of the core areas identified by the taxonomy: survival, physiological or clinical, life impact, resource use or adverse events (AE), and subsequently ordered into the relevant domains underpinning the core areas (for example the domain “global quality of life” falls under the core area of ‘life impact’; and ‘surgical site infections’ under ‘adverse events’.

Due to the importance of reporting AEs (Cornelius & Phillips, 2022; Junqueira et al., 2023; Zorzela et al., 2016), AEs will be presented as a domain separate to the other outcomes for consideration. They will not be mandated for inclusion into the final COS but participants will be encouraged to consider them by their own merits.

Participants will be asked to rate the importance of each outcome on a 9-point Likert scale (1–3 limited importance, 4–5 important but not critical and, 7–9 critical) following the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) (Guyatt et al., 2011) guidelines. An option of ‘unsure’ will be included where participants feel they are unable to score an outcomes importance. Participants will also be invited to voluntarily comment on each outcome should they wish to do so. At the end of the first round, participants will have the option of adding in additional outcomes that they think are important but have not been included in the original list. Any additional outcomes will be reviewed by the SCC to consider whether these outcomes are relevant and not duplicated, and if agreed, these outcomes will be included in round two of the Delphi survey. All outcomes scored in round one will be carried forward to round two.

In the second round of the Delphi survey, participants will be presented with their individual ratings from round one and the distribution of scores for each outcome according to a) each stakeholder group and b) overall across all stakeholder groups. Participants will have the opportunity to re-review outcomes and re-score the outcomes based on this information presented using the same 1–9 scale should they wish too. Newly added outcomes will be presented in round two and participants will be asked to score these new outcomes without reflection. Retention of participants between the two rounds will be monitored and several reminders will be sent to encourage continued engagement and completion of both rounds of the survey. Attrition bias between rounds will be assessed by looking at the average distribution of scores between rounds across all outcomes for each stakeholder group. Final responses from the second round will be analysed using descriptive statistics and summarised according to predefined consensus criteria (Table 3). The Delphi survey will be administered and managed using REDCap (Harris et al., 2009; Harris et al., 2019).

Table 3. Consensus criteria.

Consensus Classification	Description	Definition
Consensus in	Consensus that the outcome should be included in the final meta-core outcome set	80% or more participants scoring as 7–9 (critical) in each stakeholder groups
Consensus out	Consensus that the outcome should not be included in the final meta-core outcome set	50% or fewer participants scoring 7–9 (critical) in each stakeholder group
No consensus	Uncertainty about the importance of the outcome	All other responses

Stage 3: Consensus meeting

The recruitment for the consensus meeting will be aimed at individual participants who have completed both rounds of the Delphi survey. The estimated number for recruitment into this meeting would be no more than 15 with an equal breakdown of five consultant clinicians (surgeons or oncologists), five allied health professionals and five patients or carers.

Less importance will be placed on the cancer type each stakeholder represents at this stage, as the scope for this meta-COS is for all cancer involving surgery. The recruitment of this will be a direct email invitation following the completion of the Delphi survey.

The consensus meeting will be conducted interactively via Zoom under the guidance of an experienced independent facilitator. The meeting will be organised around the results to the final round of the Delphi survey. Outcomes will be prioritised for discussion if they met the consensus criteria by at least one stakeholder group and/or outcomes were scored as critically important by at least 50% of participants in each stakeholder group. Participants will be invited to briefly discuss the importance of each outcome if they wish before an anonymous vote on whether to include the outcome in the final meta-COS. For the outcome to be preliminary included in the final meta-core set, 80% or more of the participants needed to vote the outcome as critical.

Final meta-COS for surgical oncology

At the end of the consensus meeting, the consensus meeting panel will review the proposed outcomes to be included in the meta-COS following the discussions and voting. A final reflective discussion will be undertaken to ensure the outcomes included are pragmatic and feasible to measure for the COS’ intended purpose of use. If a final meta-COS is not agreed on at the end of the consensus meeting, subsequent online meetings will be considered in order to ratify the final meta-COS.

Discussion

The aim of this work is to standardise the collection of core outcomes in surgical oncology. It does not replace existing COS in the field, but forms an overarching minimum set that underpins these available COS and provides a starting point for trials involving cancer types lacking a COS. This novel approach will minimise the need for researchers developing a COS for individual cancer types to traditionally perform a comprehensive literature review for a list of cancer outcomes as shown in Figure 1. This expedited focussed approach will save significant amount of resources and time.

Adverse event (AE) outcomes are important to be collected and reported. This is already advocated by regulating bodies (Health Research Authority), World Health Organisation (WHO) (WHO, 2023), and the Cochrane Collaboration (Peryer et al., 2023). Recommendations for COS development exist (Kirkham et al., 2017), albeit with little guidance to ensure important harms are included in COS when appropriate (Tay et al., 2024). The need to improve the way these cancer COS are developed have already been recognised (Gargon et al., 2019).

Whilst the inclusion of AE outcomes in trials and COS is variable (Tay et al., 2024), information on AEs is crucial so that safety is not misrepresented in any particular cancer intervention. Our approach in presenting a separate AE domain to be considered in the meta-COS development process will ensure that stakeholders have time to consider the important of each AE outcome, even if they do not result in inclusion in the final meta-COS.

One limitation of this study is by selecting only the commonest 10 cancer types for surgical oncology as representation for all cancer types we could potentially miss certain outcomes. However this is estimated to be low risk given the focus of most of the surgical oncology COS has been on survival and life impact. Another limitation is that the majority of recruitment networks engaged are in the North West of England due to the location of the research team. Efforts will be made to recruit using national charities and in Ireland according to requirements of the grant body for this project.

The uptake of core outcome sets vary widely across health conditions (Hughes et al., 2021). One of the common barriers of uptake often relates to the lack of consensus on the instruments that should be used to assess each core outcome. A formal assessment of appropriate instruments for measuring each core outcome was beyond the scope of this study. Future work will be needed to reach a consensus on these outcome measures.

Dissemination

The results of this study will be disseminated via presentations to charity and network groups, presentations at scientific meetings and publications in open access journals.

Ethics and consent

This consensus study has been granted for approval by the Proportionate University Research Ethics Committee (UREC) on the 29^th October 2024. Reference: 2024-21348-37826. The focus group in the earlier stage was granted a separate full ethics approval by the UREC on the 7^th March 2024. Reference: 2024-18269-33406.

Written consent will be obtained from all participants in this consensus study after they have read the participant information sheet. The consent statements participants need to agree to are embedded into the beginning of the survey and mandatory for proceeding. All data will be anonymised in the reporting of this study. Transcripts of the consensus meeting will also be anonymised. Consent can be withdrawn at any time however any entered data will not be possible to be removed.

Data availability

Underlying data

No data are associated with this article.

Extended data

Open Science Framework: Protocol for developing a single pan-specialty 'meta-core outcome set': an example in surgical oncology, https://doi.org/10.17605/OSF.IO/CSZ9X (Tay et al., 2025).

This project contains the following extended data:

1. COS-STAP checklist for this protocol
2. Consent form for Delphi survey
3. Example PDF of Delphi survey Round 1
4. Participation Information Sheet for Healthcare Professionals
5. Participation Information Sheet for patients and carers
6. Supplementary Figure 1 - Taken from Cancer Research UK digital app.

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Faculty Opinions recommended

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Tay J: Protocol for developing a single pan-specialty meta-core outcome set: an example in surgical oncology. OSF. 2025. http://www.doi.org/10.17605/OSF.IO/CSZ9X
Tay J, Robinson C, Blazeby J, et al.: Inclusion of harm outcomes in Core Outcome Sets requires careful consideration. J Clin Epidemiol. 2024; 174: 111474. PubMed Abstract | Publisher Full Text
van Rijssen LB, Gerritsen A, Henselmans I, et al.: Core Set of Patient-reported Outcomes in Pancreatic Cancer (COPRAC): an International Delphi Study among patients and health care providers. Ann Surg. 2019; 270(1): 158–164. PubMed Abstract | Publisher Full Text
WHO: Patient safety. 2023; (Accessed: 11/10/2024). Reference Source
Williamson PR, Altman DG, Blazeby JM, et al.: Developing Core Outcome Sets for clinical trials: issues to consider. Trials. 2012; 13(1): 132. PubMed Abstract | Publisher Full Text | Free Full Text
Williamson PR, de Ávila Oliveira R, Clarke M, et al.: Assessing the relevance and uptake of Core Outcome Sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review. BMJ Open. 2020; 10(9): e036562. PubMed Abstract | Publisher Full Text | Free Full Text
World Cancer Research Fund (WCRF): Global cancer incidence. 2024; (Accessed: 17/07/2024). Reference Source
Zorzela L, Loke YK, Ioannidis JP, et al.: PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016; 352: i157. PubMed Abstract | Publisher Full Text

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Author details Author details

¹ Centre for Biostatistics, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
² NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, England, UK
³ Social Care and Society, School of Health Sciences, The University of Manchester, Manchester, England, UK
⁴ Norwich Medical School, University of East Anglia, Norwich, England, UK
⁵ Discipline of Surgery, University of Galway, Galway, Ireland
⁶ Department of Oesophago-Gastric and Bariatric Surgery, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK
⁷ Division of Cancer Sciences, School of Medical Sciences, The University of Manchester, Manchester, England, UK

Joel Tay
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Jane Blazeby
Roles: Writing – Review & Editing

Adam O'Neill
Roles: Project Administration, Writing – Review & Editing

Yoon Loke
Roles: Writing – Review & Editing

Aoife Lowery
Roles: Formal Analysis, Funding Acquisition, Project Administration, Resources, Writing – Review & Editing

Catherine Robinson
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Bilal Alkhaffaf
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Jamie Kirkham
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Competing interests

Professor Jamie Kirkham and Professor Jane Blazeby are members of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. There are no conflicts of interest to disclose from the other authors.

Grant information

Health Research Board [HRB-TMRN-2021-001]. This work was also supported by Professor Aoife Lowery in this project by funding from Irish Cancer Society [CRLALOW22].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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https://doi.org/10.12688/hrbopenres.14058.1

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Tay J, Blazeby J, O'Neill A et al. Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology [version 1; peer review: 1 approved]. HRB Open Res 2025, 8:19 (https://doi.org/10.12688/hrbopenres.14058.1)

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Reviewer Report 02 Jun 2025

Wasay Nizam, Howard University College of Medicine, Washington, USA

Approved

https://doi.org/10.21956/hrbopenres.15437.r47411

This is an appropriate undertaking. Surgical oncology is an evolving field and adding this will streamline future research endeavors. Interpretation of existing studies is limited by the heterogeneity of outcomes described. Harmonizing these will suitably improve future studies. I look ... Continue reading

This is an appropriate undertaking. Surgical oncology is an evolving field and adding this will streamline future research endeavors. Interpretation of existing studies is limited by the heterogeneity of outcomes described. Harmonizing these will suitably improve future studies. I look forward to the results of this meeting and wish the authors well.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Surgical oncology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Wasay Nizam, Howard University College of Medicine, Washington, USA

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Reviewer Report

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02 Jun 2025 | for Version 1

Wasay Nizam, Howard University College of Medicine, Washington, USA

3 Views Cite this report Responses(0)

Approved

This is an appropriate undertaking. Surgical oncology is an evolving field and adding this will streamline future research endeavors. Interpretation of existing studies is limited by the heterogeneity of outcomes described. Harmonizing these will suitably improve future studies. I look forward to the results of this meeting and wish the authors well.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Surgical oncology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

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[1] Alkhaffaf B, Kirkham J: Meeting the ongoing challenges of outcome selection in surgical oncology trials. Br J Surg. 2022; 109(7): 563–565. PubMed Abstract | Publisher Full Text | Free Full Text

[2] Alkhaffaf B, Metryka A, Blazeby JM, et al.: Core Outcome Set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus. Br J Surg. 2021; 108(10): 1216–1224. PubMed Abstract | Publisher Full Text | Free Full Text

[3] Avery KNL, Chalmers KA, Brookes ST, et al.: Development of a Core Outcome Set for clinical effectiveness trials in esophageal cancer resection surgery. Ann Surg. 2018; 267(4): 700–710. PubMed Abstract | Publisher Full Text | Free Full Text

[4] Cornelius VR, Phillips R: Improving the analysis of adverse event data in Randomized Controlled Trials. J Clin Epidemiol. 2022; 144: 185–192. PubMed Abstract | Publisher Full Text

[5] de Rooij BH, van den Hurk C, Smaardijk V, et al.: Development of an updated, standardized, patient-centered outcome set for lung cancer. Lung Cancer. 2022; 173: 5–13. PubMed Abstract | Publisher Full Text

[6] Dodd S, Clarke M, Becker L, et al.: A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol. 2018; 96: 84–92. PubMed Abstract | Publisher Full Text | Free Full Text

[7] Fraser J, Hope E, Anderson J, et al.: Chemotherapy, Radiotherapy and Surgical Tumour Resections in England. Official Statistics, 2020; (Accessed: 26/09/2024). Reference Source

[8] Gargon E, Williamson PR, Blazeby JM, et al.: Improvement was needed in the standards of development for cancer Core Outcome Sets. J Clin Epidemiol. 2019; 112: 36–44. PubMed Abstract | Publisher Full Text

[9] Guyatt GH, Oxman AD, Vist G, et al.: GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of bias). J Clin Epidemiol. 2011; 64(4): 407–415. PubMed Abstract | Publisher Full Text

[10] Harris PA, Taylor R, Minor BL, et al.: The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019; 95: 103208. PubMed Abstract | Publisher Full Text | Free Full Text

[11] Harris PA, Taylor R, Thielke R, et al.: Research Electronic Data Capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009; 42(2): 377–381. PubMed Abstract | Publisher Full Text | Free Full Text

[12] Hughes KL, Clarke M, Williamson PR: A systematic review finds Core Outcome Set uptake varies widely across different areas of health. J Clin Epidemiol. 2021; 129: 114–123. PubMed Abstract | Publisher Full Text | Free Full Text

[13] Íde Waters AM: A Core Outcome Set for clinical trials in Oropharyngeal cancer. Ph.D., The University of Liverpool (United Kingdom), Ann Arbor, 2018. Available at: https://manchester.idm.oclc.org/login?url=https://www.proquest.com/dissertations-theses/core-outcome-set-clinical-trials-oropharyngeal/docview/2499878063/se-2?accountid=12253. Reference Source

[14] Junqueira DR, Zorzela L, Golder S, et al.: CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials. BMJ. 2023; 381: e073725. PubMed Abstract | Publisher Full Text

[15] Kirkham JJ, Davis K, Altman DG, et al.: Core Outcome Set-STAndards for development: the COS-STAD recommendations. PLoS Med. 2017; 14(11): e1002447. PubMed Abstract | Publisher Full Text | Free Full Text

[16] Kirkham JJ, Gorst S, Altman DG, et al.: Core Outcome Set-STAndardised Protocol items: the COS-STAP statement. Trials. 2019; 20(1): 116. PubMed Abstract | Publisher Full Text | Free Full Text

[17] Kottner J, Beaton D, Clarke M, et al.: Core Outcome Set developers should consider and specify the level of granularity of outcome domains. J Clin Epidemiol. 2024; 169: 111307. PubMed Abstract | Publisher Full Text

[18] MacLennan S, Williamson PR, Bekema H, et al.: A Core Outcome Set for localised prostate cancer effectiveness trials. BJU Int. 2017; 120(5B): E64–E79. PubMed Abstract | Publisher Full Text

[19] McNair AGK, Whistance RN, Forsythe RO, et al.: Core outcomes for colorectal cancer surgery: a consensus study. PLoS Med. 2016; 13(8): e1002071. PubMed Abstract | Publisher Full Text | Free Full Text

[20] Peryer G, Golder S, Junqueira DR, et al.: Chapter 19: Adverse effects. In: Higgins JPT, T. J., Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors) (ed.) Cochrane Handbook for Systematic Reviews of Interventions. 2023. Reference Source

[21] Reesink DJ, van de Garde EMW, Somford DM, et al.: Development of the first patient-centred set of outcomes for Muscle-invasive and Metastatic Bladder Cancer: a multicentre initiative. Eur Urol Open Sci. 2021; 26: 18–26. PubMed Abstract | Publisher Full Text | Free Full Text

[22] Tay J: Protocol for developing a single pan-specialty meta-core outcome set: an example in surgical oncology. OSF. 2025. http://www.doi.org/10.17605/OSF.IO/CSZ9X

[23] Tay J, Robinson C, Blazeby J, et al.: Inclusion of harm outcomes in Core Outcome Sets requires careful consideration. J Clin Epidemiol. 2024; 174: 111474. PubMed Abstract | Publisher Full Text

[24] van Rijssen LB, Gerritsen A, Henselmans I, et al.: Core Set of Patient-reported Outcomes in Pancreatic Cancer (COPRAC): an International Delphi Study among patients and health care providers. Ann Surg. 2019; 270(1): 158–164. PubMed Abstract | Publisher Full Text

[25] WHO: Patient safety. 2023; (Accessed: 11/10/2024). Reference Source

[26] Williamson PR, Altman DG, Blazeby JM, et al.: Developing Core Outcome Sets for clinical trials: issues to consider. Trials. 2012; 13(1): 132. PubMed Abstract | Publisher Full Text | Free Full Text

[27] Williamson PR, de Ávila Oliveira R, Clarke M, et al.: Assessing the relevance and uptake of Core Outcome Sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review. BMJ Open. 2020; 10(9): e036562. PubMed Abstract | Publisher Full Text | Free Full Text

[28] World Cancer Research Fund (WCRF): Global cancer incidence. 2024; (Accessed: 17/07/2024). Reference Source

[29] Zorzela L, Loke YK, Ioannidis JP, et al.: PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016; 352: i157. PubMed Abstract | Publisher Full Text

Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

Abstract

Background

Methods

Discussion

Registration

Keywords

Introduction

Table 1. Summary of existing COS in Surgical Oncology.

Study oversight

Methods

Figure 1. Study overview of a traditional COS development process.

Stage 1: Identification of outcomes

Table 2. Search strategy for each cancer type on ClinicalTrials.gov.

Stage 2: Outcome prioritisation

Table 3. Consensus criteria.

Stage 3: Consensus meeting

Discussion

Dissemination

Ethics and consent

Data availability

Underlying data

Extended data

References

Comments on this article Comments (0)

Open Peer Review

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Open Peer Review

Reviewer Status

Reviewer Reports

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Are you a HRB-funded researcher?

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Protocol for a novel approach to developing a single pan-specialty ‘meta-core outcome set’: An example from the field of surgical oncology

Abstract

Background

Methods

Discussion

Registration

Keywords

Introduction

Table 1. Summary of existing COS in Surgical Oncology.

Study oversight

Methods

Figure 1. Study overview of a traditional COS development process.

Stage 1: Identification of outcomes

Table 2. Search strategy for each cancer type on ClinicalTrials.gov.

Stage 2: Outcome prioritisation

Table 3. Consensus criteria.

Stage 3: Consensus meeting

Discussion

Dissemination

Ethics and consent

Data availability

Underlying data

Extended data

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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Are you a HRB-funded researcher?

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