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.

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

BACKGROUND: Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information). METHODS: Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories. RESULTS: Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively). CONCLUSIONS: Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.

Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study.

BACKGROUND: Randomised controlled trials (RCTs) in surgery can be challenging to conduct, and trials in the emergency surgical setting when patients have unplanned hospital admissions are particularly difficult. One area of challenge is capturing baseline patient-reported outcome (PRO) data. This study examined the feasibility and optimal methods for the collection of baseline and follow-up PRO data in the setting of unplanned surgical hospital admissions. METHODS: Clinically stable adult patients with unplanned admissions through the day and night under the care of general surgeons at two acute NHS trusts were approached during working week days and asked to complete validated PRO measures (European Quality of Life-5 Dimension, Short Form-12, and Gastrointestinal Quality of Life Index) on admission and 6 weeks following discharge. Feasibility of PRO data collection was determined by the proportions of admitted patients eligible and recruited and by questionnaire-response rates at baseline and follow up. Reasons for non-recruitment and non-completion of questionnaires were sought and recorded. RESULTS: There were 276 admissions, of whom 235 (85.1 %) were eligible. Reasons for ineligibility were the following: age under 18 years old (n = 5, 1.8 %), non-surgical presenting complaint (n = 6, 2.2 %) and clinical instability (n = 30, 10.9 %). One hundred and sixty-six patients (70.6 %) were recruited (98 female, 59.0 %); median age 53, range 19-100). Common reasons for non-recruitment included patients being discharged home before approached by researchers (n = 29, 12.3 %) or declining participation because they felt unwell (n = 15, 6.4 %). The most common reason for admission to the hospital was abdominal pain (n = 120, 72.3 % recruited patients), of whom 50 (30.1 %) required operative intervention. Baseline PRO data was obtained from 153 patients (93.3 %), and 74 (48.4 %) returned follow-up questionnaires. CONCLUSIONS: Collection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.

Laparoscopic assisted right hemicolectomy for caecal volvulus.

A case of acute caecal volvulus is presented where laparoscopy was used to avoid a major laparotomy. A technique is described for safe deflation of the caecum, which allowed a small incision for resection and anastomosis.