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.
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).
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.
Background : : Increasingly interventional radiology has been used to stop uncontrolled gastrointestinal (GI) bleeding leading to a reduction in the requirement for surgical intervention. To examine ...the safety and efficacy of angiography and embolisation for the treatment of GI bleeding in a United Kingdom tertiary hospital. Methods : : This was a single-centre retrospective study of 112 procedures performed on 105 patients who underwent catheter angiography for GI bleeding over 7 years. Fifty procedures were for upper GI bleeding and 62 were for lower GI bleeding. Primary outcome was clinical success rate. Other measures were re-bleeding rates and 30-day mortality. Results : : In patients with upper GI bleeds, 71.6% of cases had a bleeding point that was identified at the time of initial catheter angiogram. Overall, the clinical success rate was 70.4% with a 20% 30-day mortality. Technical success with embolisation was 98% with no major complications. In patients with lower GI bleeds, 50% of cases had a bleeding point that was identified at the time of initial catheter angiogram. Overall clinical success rate was 83.0% with a 13.6% 30-day mortality. Technical success with embolisation was 100% with no major complications. Conclusion : : Catheter directed angiography and embolisation is safe and efficacious in patients with GI bleeding who have a positive computed tomography angiogram and should be considered as an alternative to surgery.
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).
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.
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).
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.
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.
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.
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.
There were 276 admissions, of whom 235 (85.1 %) were eligible. Reasons for ineligibility were the following: age under 18 years old (
= 5, 1.8 %), non-surgical presenting complaint (
= 6, 2.2 %) and clinical instability (
= 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 (
= 29, 12.3 %) or declining participation because they felt unwell (
= 15, 6.4 %). The most common reason for admission to the hospital was abdominal pain (
= 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.
Collection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.
NHS England has mandated use of the National Early Warning Score (NEWS), more recently NEWS2, in acute settings, and suggested its use in primary care. However, there is reluctance from GPs to adopt ...NEWS/NEWS2.
To assess whether NEWS calculated at the point of GP referral into hospital is associated with outcomes in secondary care.
An observational study using routinely collected data from primary and secondary care.
NEWS values were prospectively collected for 13 047 GP referrals into acute care between July 2017 and December 2018. NEWS values were examined and multivariate linear and logistic regression used to assess associations with process measures and clinical outcomes.
Higher NEWS values were associated with faster conveyance for patients travelling by ambulance, for example, median 94 minutes (interquartile range IQR 69-139) for NEWS ≥7; median 132 minutes, (IQR 84-236) for NEWS = 0 to 2); faster time from hospital arrival to medical review (54 minutes IQR 25-114 for NEWS ≥7; 78 minutes IQR 34-158 for NEWS = 0 to 2); as well as increased length of stay (5 days IQR 2-11 versus 1 day IQR 0-5); intensive care unit admissions (2.0% versus 0.5%); sepsis diagnosis (11.7% versus 2.5%); and mortality, for example, 30-day mortality 12.0% versus 4.1% for NEWS ≥7 versus NEWS = 0 to 2, respectively. On average, for patients referred without a NEWS value (NEWS = NR), most clinical outcomes were comparable with patients with NEWS = 3 to 4, but ambulance conveyance time and time to medical review were comparable with patients with NEWS = 0 to 2.
This study has demonstrated that higher NEWS values calculated at GP referral into hospital are associated with a faster medical review and poorer clinical outcomes.
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