“…Non-responding health professionals and patients providing consent but not returning the questionnaire were sent one reminder. In the absence of agreed methodology to determine a sample size for Delphi surveys, the target sample was 100 professionals and 100 patients [22,23]. …”
BackgroundBariatric and metabolic surgery is used as a treatment for patients with severe and complex obesity. However, there is a need to improve outcome selection and reporting in bariatric surgery trials. A Core Outcome Set (COS), an agreed minimum set of outcomes reported in all studies of a specific condition, may achieve this. Here, we present the development of a COS for BARIAtric and metabolic surgery Clinical Trials—the BARIACT Study.Methods and FindingsOutcomes identified from systematic reviews and patient interviews informed a questionnaire survey. Patients and health professionals were surveyed three times and asked to rate the importance of each item on a 1–9 scale. Delphi methods provided anonymised feedback to participants. Items not meeting predefined criteria were discarded between rounds. Remaining items were discussed at consensus meetings, held separately with patients and professionals, where the COS was agreed. Data sources identified 2,990 outcomes, which were used to develop a 130-item questionnaire. Round 1 response rates were moderate but subsequently improved to above 75% for other rounds. After rounds 2 and 3, 81 and 14 items were discarded, respectively, leaving 35 items for discussion at consensus meetings. The final COS included nine items: “weight,” “diabetes status,” “cardiovascular risk,” “overall quality of life (QOL),” “mortality,” “technical complications of the specific operation,” “any re-operation/re-intervention,” “dysphagia/regurgitation,” and “micronutrient status.” The main limitation of this study was that it was based in the United Kingdom only.ConclusionsThe COS is recommended to be used as a minimum in all trials of bariatric and metabolic surgery. Adoption of the COS will improve data synthesis and the value of research data. Future work will establish methods for the measurement of the outcomes in the COS.
“…Non-responding health professionals and patients providing consent but not returning the questionnaire were sent one reminder. In the absence of agreed methodology to determine a sample size for Delphi surveys, the target sample was 100 professionals and 100 patients [22,23]. …”
BackgroundBariatric and metabolic surgery is used as a treatment for patients with severe and complex obesity. However, there is a need to improve outcome selection and reporting in bariatric surgery trials. A Core Outcome Set (COS), an agreed minimum set of outcomes reported in all studies of a specific condition, may achieve this. Here, we present the development of a COS for BARIAtric and metabolic surgery Clinical Trials—the BARIACT Study.Methods and FindingsOutcomes identified from systematic reviews and patient interviews informed a questionnaire survey. Patients and health professionals were surveyed three times and asked to rate the importance of each item on a 1–9 scale. Delphi methods provided anonymised feedback to participants. Items not meeting predefined criteria were discarded between rounds. Remaining items were discussed at consensus meetings, held separately with patients and professionals, where the COS was agreed. Data sources identified 2,990 outcomes, which were used to develop a 130-item questionnaire. Round 1 response rates were moderate but subsequently improved to above 75% for other rounds. After rounds 2 and 3, 81 and 14 items were discarded, respectively, leaving 35 items for discussion at consensus meetings. The final COS included nine items: “weight,” “diabetes status,” “cardiovascular risk,” “overall quality of life (QOL),” “mortality,” “technical complications of the specific operation,” “any re-operation/re-intervention,” “dysphagia/regurgitation,” and “micronutrient status.” The main limitation of this study was that it was based in the United Kingdom only.ConclusionsThe COS is recommended to be used as a minimum in all trials of bariatric and metabolic surgery. Adoption of the COS will improve data synthesis and the value of research data. Future work will establish methods for the measurement of the outcomes in the COS.
“…The overall methodological approach is outlined in the next four sub-sections. A more detailed description of the application of the methods have been published elsewhere [13], so the emphasis here is on explaining how a pragmatic scientific approach can be applied to our theoretical model for informed consent. Development of core information sets involves four main phases, as shown in Fig.…”
Section: Introductionmentioning
confidence: 99%
“…Where possible, therefore, we have identified alternative methods that may better suit researchers with different expertise and/or resources.Fig. 1Phases in the development of a core information set for consent to oesophagectomy [13]
…”
Section: Introductionmentioning
confidence: 99%
“…Duplicated items can be combined into broader ‘domains’ of healthcare information [13]. Thirty- and 90-day mortality would, for example, be included in a ‘mortality’ domain.…”
BackgroundConsent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals.Main bodyThe model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient.ConclusionThe application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice.
“…We commend the efforts of Blazeby et al in establishing core information sets for cancer surgery, which have been formulated with the involvement of key stakeholders in surgical decision-making, and which can serve as an indicator of “complete” communication. 2 These core information sets are an important step toward addressing inconsistencies and inaccuracies in patient-surgeon communication. How best to implement these or similar frameworks for information delivery is an area of great interest to us and others.…”
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