Angus McNair

The COMET Handbook: Version 1.0

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified.

A systematic review of outcome reporting in colorectal cancer surgery

Evaluation of surgery for colorectal cancer (CRC) is necessary to inform clinical decision‐making and healthcare policy. The standards of outcome reporting after CRC surgery have not previously been considered.

Health-related quality of life and survival in the 2 years after surgery for gastric cancer

BACKGROUND This prospective study examined health-related quality of life (HRQL) and survival in patients with potentially curable gastric cancer. METHODS Consecutive patients (n=58) selected for curative surgery completed a validated questionnaire (EORTC QLQ-C30) and site-specific module (QLQ-STO22) before surgery and regularly for 2 years afterwards. Changes of 10 or more points on a 0-100 scale were considered clinically significant. RESULTS Some 30 patients were alive after 2 years (52%). In the first 3 months after surgery, HRQL was significantly reduced across all dimensions except emotional and cognitive functioning (mean reduction of 10 or more points). Functional aspects of HRQL recovered by 6 months in patients who subsequently were alive at 2 years, although at least a third of patients experienced specific symptoms, even 6 months after surgery, especially diarrhoea. For those dying within 2 years, some postoperative functional HRQL recovery occurred, but many symptoms were common. CONCLUSIONS Potentially curative gastrectomy for cancer has a detrimental impact on HRQL that mostly recovers in patients surviving some 2 years. Patients who die within 2 years may experience limited postoperative recovery. It is recommended that patients receive HRQL information about the outcomes of surgery for gastric cancer.

Maximising recruitment into randomised controlled trials: the role of multidisciplinary cancer teams.

Multidisciplinary cancer teams offer many theoretical benefits, although few have been formally examined. This study evaluated the role of multidisciplinary team (MDT) meetings in recruitment into randomised controlled trials (RCTs). Consecutive MDT patient records were categorised into those with or without a recommendation for a national multicentre RCT. Clinical trial office records identified whether patients were subsequently screened and randomised. In 125 MDT meetings, 350 new patients were discussed, of whom 103 were potentially suitable for a RCT. The MDT recommended 68 patients for the trial, of whom 58 (85%) were screened for trial eligibility. Of the 35 without an MDT trial recommendation, only 23 (66%) were screened (p=0.022). This difference persisted and resulted in a greater proportion of MDT recommended patients being recruited (65% versus 49%; p=0.12). This study demonstrates that trial recommendation by an MDT significantly increases trial screening rates and may improve recruitment.

Core information set for oesophageal cancer surgery

Surgeons provide patients with information before surgery, although standards of information are lacking and practice varies. The development and use of a ‘core information set’ as baseline information before surgery may improve understanding. A core set is a minimum set of information to use in all consultations before a specific procedure. This study developed a core information set for oesophageal cancer surgery.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

Background Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard “core” set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). Conclusion This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

Synthesis and summary of patient‐reported outcome measures to inform the development of a core outcome set in colorectal cancer surgery

Patient‐reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum ‘core’ outcome set to be measured in all trials.

What surgeons should tell patients with oesophago-gastric cancer: A cross sectional study of information needs

BACKGROUND Evidence shows that patients with cancer have many information needs, but specific requirements of patients undergoing surgery for oesophago-gastric (OG) cancer have not been well explored. This study surveyed information needs of patients with OG cancer and explored associations between patient characteristics and information needs. PATIENTS A validated questionnaire assessing the importance of information about i) the nature, process and prognosis of the cancer, ii) tests, iii) treatments, and iv) physical and psychosocial outcomes (quality of life information) was completed by patients before and after OG cancer treatment. Items responses were transformed to a 0-100 score and linear regression explored associations between clinical and socio-demographic patient characteristics and patient information needs. RESULTS Questionnaires from 136 respondents were received (response rate 60%, 25% pre-operative, 77% men, mean age 66). Most types of information were rated as important, with information about prognosis and quality of life issues being scored as highly important by over 112 (82%) patients. Linear regression showed that women rated information relating to treatment and psychosocial effects as more important than men (p < 0.038), but no other associations were identified. CONCLUSIONS Most patients with OG cancer want detailed information, especially information about prognosis and quality of life. It is recommended that surgeons provide this for patients alongside information that the surgeon considers important.

What surgeons tell patients and what patients want to know before major cancer surgery: a qualitative study

BackgroundThe information surgeons impart to patients and information patients want about surgery for cancer is important but rarely examined. This study explored information provided by surgeons and patient preferences for information in consultations in which surgery for oesophageal cancer surgery was discussed.MethodsPre-operation consultations in which oesophagectomy was discussed were studied in three United Kingdom hospitals and patients were subsequently interviewed. Consultations and interviews were audio-recorded, transcribed in full and anonymized. Interviews elicited views about the information provided by surgeons and patients’ preferences for information. Thematic analysis of consultation-interview pairs was used to investigate similarities and differences in the information provided by surgeons and desired by patients.ResultsFifty two audio-recordings from 31 patients and 7 surgeons were obtained (25 consultations and 27 patient interviews). Six consultations were not recorded because of equipment failure and four patients declined an interview. Surgeons all provided consistent, extensive information on technical operative details and in-hospital surgical risks. Consultations rarely included discussion of the longer-term outcomes of surgery. Whilst patients accepted that information about surgery and risks was necessary, they really wanted details about long-term issues including recovery, impact on quality of life and survival.ConclusionsThis study demonstrated a need for surgeons to provide information of importance to patients concerning the longer term outcomes of surgery. It is proposed that “core information sets” are developed, based on surgeons’ and patients’ views, to use as a minimum in consultations to initiate discussion and meet information needs prior to cancer surgery.

Population-based cohort study of outcomes following cholecystectomy for benign gallbladder diseases

The aim was to describe the management of benign gallbladder disease and identify characteristics associated with all‐cause 30‐day readmissions and complications in a prospective population‐based cohort.