Theme aim

Theme 4 has focused on improving clinical and patient-reported outcome assessment, reporting and integration in RCTs and clinical decision-making.

Major achievements

1. Facilitate the ongoing development of core outcome sets (COSs), core information sets (CISs) and methods for their integration and reporting in trials.

Projects have included the development of COSs and CISs for multiple health conditions including oesophageal, colorectal, and head and neck cancer, bariatric surgery, breast reconstruction and burn care.

We have undertaken studies to improve methods for developing core sets to explore the impact of feedback from different stakeholder groups, the selection and integration of stakeholder views and the impact of question order on prioritisation of outcomes.

The theme has been involved in producing the following methodological guidance for future COS researchers:

• The COMET Handbook: version 1.0
• Core Outcome Set-STAndards for Development: The COS-STAD recommendations
• CoreOutcomeSet–STAndards for Reporting: TheCOS-STAR Statement
• Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

2. Incorporate patient views into the development of COSs and CISs. We have developed methods for identifying and including patient-reported outcomes (PROs) to include in core outcome sets. We have undertaken a comparison of health professionals’ and patients’ views of the importance of outcomes of bariatric surgery to explore whether different stakeholders prioritise outcomes differently. 

3. Establish methods to better integrate clinical and patient-reported outcomes into clinical consultations and decision-making.

We conducted a systematic review to explore methods for synthesizing clinical and patient reported outcome (PRO) data in trials to inform clinical practice.

4. Develop innovative methods to ensure blinding of outcome assessors and patients in RCTs in surgery.

The ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study has piloted methods to blind patients and outcome assessors to the type of surgery by using large adhesive dressing positioned similarly on all trial paticipants regardless of the type of surgery.

We held a workshop on ‘Methods for placebo comparator group selection and use in surgical trials’ Oxford, December 2018 and have conducted a systematic review of surgical trials using placebos.

Other major outputs from theme 4 have included:

1. Guidelines for incorporating patient-reported outcomes in trial design and reporting:

• Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension
• Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

2. Development of methods for monitoring symptoms and adverse events after cancer surgery: the Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) study

3. Development and validation of an outcome measure for surgical site infection for patient or healthcare professional completion: The Bluebelle Wound Healing Questionnaire (WHQ)

4. Development and validation of European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires and facilitation of their use in multinational RCTs