The British journal of surgery
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Heterogeneity of outcomes is a problem for assessing intervention effectiveness when considering treatments for uncomplicated symptomatic gallstone disease. The value to all stakeholders of outcomes that have been measured and reported to date is also unclear. The aim of this study was to develop a core outcome set for symptomatic uncomplicated gallstone disease. ⋯ A core outcome set for symptomatic uncomplicated gallstone disease has been developed with patients and healthcare professionals. Eleven outcomes across four key domains have been identified. These represent the minimum set of outcomes that should be reported in trials evaluating interventions for gallstone disease.
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Randomized Controlled Trial
Antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis (APPAC III): randomized double-blind superiority trial.
Non-operative management of uncomplicated acute appendicitis is an option, but omission of antibiotics from the regimen has not been tested. ⋯ The lack of antibiotic superiority statistically suggests that a non-inferiority trial against placebo is warranted in adults with CT-confirmed mild appendicitis. Registration number: EudraCT 2015-003634-26 (https://eudract.ema.europa.eu/eudract-web/index.faces), NCT03234296 (http://www.clinicaltrials.gov).
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The IDEAL Framework is a scheme for safe implementation and assessment of surgical innovation. The transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a new innovation in thyroid surgery that eliminates the need for a cervical incision. Despite considerable interest and adoption worldwide, significant scepticism remains regarding the outcomes and cost-effectiveness for healthcare systems. The aim of this narrative review was to appraise the available literature and examine whether TOETVA has progressed in line with the IDEAL Framework. ⋯ There is need for multi-institutional collaborations and international registry studies to plan high-quality randomized trials comparing TOETVA with other remote-access approaches and collect long-term follow-up data. In countries where TOETVA has yet to be adopted, the IDEAL Framework will be a useful roadmap for government regulators and professional societies to evaluate, regulate, and provide best practice recommendations for the adoption of this technique.