A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus

Fish, Rebecca; Sanders, Caroline; Adams, Rachel; Brewer, Julie; Brookes, Sara; DeNardo, Jill; Kochhar, Rohit; Saunders, Mark; Sebag‐Montefiore, David; Williamson, Paula; Renehan, Andrew G.

doi:10.1016/s2468-1253(18)30264-4

Cited by 61 publications

(48 citation statements)

References 34 publications

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“…Lastly, there are significant difficulties in comparison across trials stemming from the varying outcome definitions. We defined our clinical outcomes with advice from the CORMAC team, who recently published a core set of outcomes in ASCC 42 with the inclusion of the additional outcome colostomy-free survival due to international interest in this outcome. The CORMAC group undertook a systematic review of anal cancer trials, identifying 1192 different anal cancer outcomes.…”

Section: Discussionmentioning

confidence: 99%

Patterns and Predictors of Relapse Following Radical Chemoradiation Therapy Delivered Using Intensity Modulated Radiation Therapy With a Simultaneous Integrated Boost in Anal Squamous Cell Carcinoma

Shakir

Adams

Cooper

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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To inform intensity modulated radiation therapy delivery and future trials in anal squamous cell Purpose: Our purpose was to describe the patterns and predictors of treatment failure in patients receiving definitive chemoradiation therapy (CRT) for anal squamous cell carcinoma (ASCC), delivered using intensity modulated radiation therapy (IMRT). Methods and Materials: Our study was a retrospective cohort analysis of consecutive patients treated with curative intent for ASCC using CRT delivered with a standardized IMRT technique in 5 UK cancer centers. Patients were included from the start

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Section: Discussionmentioning

confidence: 99%

Patterns and Predictors of Relapse Following Radical Chemoradiation Therapy Delivered Using Intensity Modulated Radiation Therapy With a Simultaneous Integrated Boost in Anal Squamous Cell Carcinoma

Shakir

Adams

Cooper

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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“…The results of the Delphi survey will inform a consensus meeting to finalise the COS. While other COS studies in the field of cancer17–19 may have identified similar important outcomes such as survival, it was important to consider our participants separately given the unique problems which arise with gastrectomy. These include distinctive short-term and long-term problems related to surgery such as anastomotic leak and reactive hypoglycaemia (dumping syndrome) which would not be relevant in other COS.…”

Section: Discussionmentioning

confidence: 99%

Patient priorities in relation to surgery for gastric cancer: qualitative interviews with gastric cancer surgery patients to inform the development of a core outcome set

et al. 2020

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ObjectiveThe reporting of outcomes in surgical trials for gastric cancer is inconsistent. The GASTROS study (GAstric CancerSurgeryTRialsReportedOutcomeStandardisation) aims to address this by developing a core outcome set (COS) for use in all future trials within this field. A COS should reflect the views of all stakeholders, including patients. We undertook a series of interviews to identify outcomes important to patients which would be considered for inclusion in a COS.SettingAll interviews took place within the UK. Interviews were carried out face-to-face at hospitals and cancer support centres or via the telephone.ParticipantsTwenty participants at varying stages of recovery following surgery for gastric cancer with curative intent.DesignQualitative design using semistructured interviews, supported by an interview guide which was iteratively modified; thematic analysis was used to explore patient priorities.ResultsSix themes enveloping 38 outcomes were identified; surviving and controlling cancer, technical aspects of surgery, adverse events from surgery, recovering from surgery, long-term problems following surgery and long-term life impact of surgery. The ‘most important’ patient priority was to be ‘cured of cancer’.ConclusionSurgical trials for gastric cancer should consider broader priorities of patients when choosing which outcomes to report. This study highlighted the importance of longer-term outcomes such as cancer survival. Outcomes identified in this study will be used to inform an international Delphi survey to develop a COS in this field.

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“…For the CESCOS Delphi, HCPs (82%) had a better response rate compared to the patients (55%) in round 2. This may be a reflection that most HCPs were recruited from professional organisations and patients were recruited openly from social media [21]. The importance of completing both rounds of the Delphi may not have been emphasised enough through social media.…”

Section: Discussionmentioning

confidence: 99%

“…We have adopted the "70/15" consensus definition in the protocol, which was used successfully in other COS studies [20,21] for inclusion of an outcome in the COS. However, it was partially revised for "consensus out" due to the study team's experience from other studies where outcomes were rarely voted 1-3 not important and reach criteria for exclusion after the Delphi survey [21]. This revision was done without reference to the identity of the outcomes.…”

Section: Consensus Definitionmentioning

confidence: 99%

Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies

Srikandarajah¹,

Noble²,

Clark³

et al. 2020

PLoS ONE

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Background Cauda Equina Syndrome (CES) is an emergency condition that requires acute intervention and can lead to permanent neurological deficit in working age adults. A Core Outcome Set (COS) is the minimum set of outcomes that should be reported by a research study within a specific disease area. There is significant heterogeneity in outcome reporting for CES, which does not allow data synthesis between studies. The hypothesis is that a COS for CES can be developed for future research studies using patients and healthcare professionals (HCPs) as key stakeholders. Methods and findings Qualitative semi-structured interviews with CES patients were audio-recorded, transcribed and analysed using NVivo to identify the outcomes of importance. These were combined with the outcomes obtained from a published systematic literature review of CES patients. The outcomes were grouped into a list of 37, for rating through two rounds of an international Delphi survey according to pre-set criteria. The Delphi survey had an overall response rate of 63% and included 172 participants (104 patients, 68 HCPs) from 14 countries who completed both rounds. Thirteen outcomes reached consensus at the end of the Delphi survey and there was no attrition bias detected. The results were discussed at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 HCPs) from 8 countries. A further three outcomes were agreed to be included. There was no selection bias detected at the consensus meeting. There are 16 outcomes in total in the CESCOS.

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A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus

Abstract: This is a repository copy of A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus..

Cited by 61 publications

References 34 publications

Patterns and Predictors of Relapse Following Radical Chemoradiation Therapy Delivered Using Intensity Modulated Radiation Therapy With a Simultaneous Integrated Boost in Anal Squamous Cell Carcinoma

Patterns and Predictors of Relapse Following Radical Chemoradiation Therapy Delivered Using Intensity Modulated Radiation Therapy With a Simultaneous Integrated Boost in Anal Squamous Cell Carcinoma

Patient priorities in relation to surgery for gastric cancer: qualitative interviews with gastric cancer surgery patients to inform the development of a core outcome set

Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies

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