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

A change in the NICE guidelines on antibiotic prophylaxis

Since 2008, NICE clinical guidelines have stated: ‘Antibiotic prophylaxis against infective endocarditis is not recommended for people undergoing dental procedures’. This put UK guidance at odds with guidance in the rest of the world, where antibiotic prophylaxis is recommended for patients at high-risk of infective endocarditis undergoing invasive dental procedures. Many dentists also felt this wording prohibited the use of antibiotic prophylaxis, regardless of the wishes of the patient or their personal risk of infective endocarditis and made it difficult for them to use their clinical judgment to deliver individualised care in the best interests of their patients. NICE have now changed this guidance to ‘Antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures.’ This article examines the implications of this small but important change

Guidelines on prophylaxis to prevent infective endocarditis

Infective endocarditis is a devastating disease with high morbidity and mortality. The link to oral bacteria has been known for many decades and has caused ongoing concern for dentists, patients and cardiologists. Since 2008, the UK has been out of step with the rest of the world where antibiotic prophylaxis is recommended for high-risk patients undergoing invasive dental procedures. Recent evidence that identified an increase in endocarditis incidence prompted a guideline review by NICE and the European Society for Cardiology – which produces guidance for the whole of Europe. Despite reviewing the same evidence they reached completely opposing conclusions. The resulting conflict of opinions and guidance is confusing and poses difficulties for dentists, cardiologists and their patients. Recent changes in the law on consent, however, may provide a patient-centred and pragmatic solution to these problems. This Opinion piece examines the evidence and opposing guidance on antibiotic prophylaxis in the context of the recent changes in the law on consent and provides a framework for how patients at risk of endocarditis might be managed in practice

Term elective induction of labour and perinatal outcomes in obese women: retrospective cohort study

ObjectiveTo compare perinatal outcomes between elective induction of labour (eIOL) and expectant management in obese women.DesignRetrospective cohort study.SettingDeliveries in California in 2007.PopulationTerm, singleton, vertex, nonanomalous deliveries among obese women (n = 74 725).MethodsWomen who underwent eIOL at 37 weeks were compared with women who were expectantly managed at that gestational age. Similar comparisons were made at 38, 39, and 40 weeks. Results were stratified by parity. Chi-square tests and multivariable logistic regression were used for statistical comparison.Main outcome measuresMethod of delivery, severe perineal lacerations, postpartum haemorrhage, chorioamnionitis, macrosomia, shoulder dystocia, brachial plexus injury, respiratory distress syndrome.ResultsThe odds of caesarean delivery were lower among nulliparous women with eIOL at 37 weeks [odds ratio (OR) 0.55, 95% confidence interval (CI) 0.34-0.90] and 39 weeks (OR 0.77, 95% CI 0.63-0.95) compared to expectant management. Among multiparous women with a prior vaginal delivery, eIOL at 37 (OR 0.39, 95% CI 0.24-0.64), 38 (OR 0.65, 95% CI 0.51-0.82), and 39 weeks (OR 0.67, 95% CI 0.56-0.81) was associated with lower odds of caesarean. Additionally, eIOL at 38, 39, and 40 weeks was associated with lower odds of macrosomia. There were no differences in the odds of operative vaginal delivery, lacerations, brachial plexus injury or respiratory distress syndrome.ConclusionsIn obese women, term eIOL may decrease the risk of caesarean delivery, particularly in multiparas, without increasing the risks of other adverse outcomes when compared with expectant management

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

BACKGROUND: More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients' perspectives on conflicts of interest? METHODS: We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. RESULTS: Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. LIMITATIONS: Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. CONCLUSIONS: The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery