This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. We include a glossary of terms, and explore the key properties of the SW-CRT which require special consideration in their reporting.

In clinical trials it is not uncommon to face a multiple testing problem which can have an impact on both type I and type II error rates, leading to inappropriate interpretation of trial results. Multiplicity issues may need to be considered at the design, analysis and interpretation stages of a trial. The proportion of trial reports not adequately correcting for multiple testing remains substantial. The purpose of this article is to provide an introduction to multiple testing issues in clinical trials, and to reduce confusion around the need for multiplicity adjustments. We use a tutorial, question-and-answer approach to address the key issues of why, when and how to consider multiplicity adjustments in trials. We summarize the relevant circumstances under which multiplicity adjustments ought to be considered, as well as options for carrying out multiplicity adjustments in terms of trial design factors including Population, Intervention/Comparison, Outcome, Time frame and Analysis (PICOTA). Results are presented in an easy-to-use table and flow diagrams. Confusion about multiplicity issues can be reduced or avoided by considering the potential impact of multiplicity on type I and II errors and, if necessary pre-specifying statistical approaches to either avoid or adjust for multiplicity in the trial protocol or analysis plan.

The quick Sequential Organ Failure Assessment (qSOFA) has been proposed for prediction of mortality in patients with suspected infection. To summarize and compare the prognostic accuracy of qSOFA and the systemic inflammatory response syndrome (SIRS) criteria for prediction of mortality in adult patients with suspected infection. Four databases from inception through November 2017. English-language studies using qSOFA for prediction of mortality (in-hospital, 28-day, or 30-day) in adult patients with suspected infection in the intensive care unit (ICU), emergency department (ED), or hospital wards. Two investigators independently extracted data and assessed study quality using standard criteria. Thirty-eight studies were included (n = 385 333). qSOFA was associated with a pooled sensitivity of 60.8% (95% CI, 51.4% to 69.4%) and a pooled specificity of 72.0% (CI, 63.4% to 79.2%) for mortality. The SIRS criteria were associated with a pooled sensitivity of 88.1% (CI, 82.3% to 92.1%) and a pooled specificity of 25.8% (CI, 17.1% to 36.9%). The pooled sensitivity of qSOFA was higher in the ICU population (87.2% [CI, 75.8% to 93.7%]) than the non-ICU population (51.2% [CI, 43.6% to 58.7%]). The pooled specificity of qSOFA was higher in the non-ICU population (79.6% [CI, 73.3% to 84.7%]) than the ICU population (33.3% [CI, 23.8% to 44.4%]). Potential risk of bias in included studies due to qSOFA interpretation and patient selection. qSOFA had poor sensitivity and moderate specificity for short-term mortality. The SIRS criteria had sensitivity superior to that of qSOFA, supporting their use for screening of patients and as a prompt for treatment initiation. Canadian Association of Emergency Physicians. (PROSPERO: CRD42017075964)

The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.

Objective: To compare the accuracy of the modified Fried Index (mFI) and the Clinical Frailty Scale (CFS) to predict death or patient-reported new disability 90 days after major elective surgery. Background: The association of frailty with patient-reported outcomes, and comparisons between preoperative frailty instruments are poorly described. Methods: This was a prospective multicenter cohort study. We determined frailty status in individuals ≥65 years having elective noncardiac surgery using the mFI and CFS. Outcomes included death or patient-reported new disability (primary); safety incidents, length of stay (LOS), and institutional discharge (secondary); ease of use, usefulness, benefit, clinical importance, and feasibility (tertiary). We measured the adjusted association of frailty with outcomes using regression analysis and compared true positive and false positive rates (TPR/FPR). Results: Of 702 participants, 645 had complete follow up. The CFS identified 297 (42.3%) with frailty, the mFI 257 (36.6%); 72 (11.1%) died or experienced a new disability. Frailty was significantly associated with the primary outcome (CFS adjusted odds ratio, OR, 2.51, 95% confidence interval, CI, 1.50–4.21; mFI adjusted-OR 2.60, 95% CI 1.57–4.31). TPR and FPR were not significantly different between instruments. Frailty was the only significant predictor of death or new disability in a multivariable analysis. Need for institutional discharge, costs and LOS were significantly increased in individuals with frailty. The CFS was easier to use, required less time and had less missing data. Conclusions: Older people with frailty are significantly more likely to die or experience a new patient-reported disability after surgery. Clinicians performing frailty assessments before surgery should consider the CFS over the mFI as accuracy was similar, but ease of use and feasibility were higher.