Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.

BackgroundSensitivity analyses play a crucial role in assessing the robustness of the findings or conclusions based on primary analyses of data in clinical trials. They are a critical way to assess the impact, effect or influence of key assumptions or variations—such as different methods of analysis, definitions of outcomes, protocol deviations, missing data, and outliers—on the overall conclusions of a study.The current paper is the second in a series of tutorial-type manuscripts intended to discuss and clarify aspects related to key methodological issues in the design and analysis of clinical trials.DiscussionIn this paper we will provide a detailed exploration of the key aspects of sensitivity analyses including: 1) what sensitivity analyses are, why they are needed, and how often they are used in practice; 2) the different types of sensitivity analyses that one can do, with examples from the literature; 3) some frequently asked questions about sensitivity analyses; and 4) some suggestions on how to report the results of sensitivity analyses in clinical trials.SummaryWhen reporting on a clinical trial, we recommend including planned or posthoc sensitivity analyses, the corresponding rationale and results along with the discussion of the consequences of these analyses on the overall findings of the study.

The Canadian Society for Exercise Physiology assembled a Consensus Panel representing national organizations, content experts, methodologists, stakeholders, and end-users and followed an established guideline development procedure to create the Canadian 24-Hour Movement Guidelines for Adults aged 18–64 years and Adults aged 65 years or older: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. These guidelines underscore the importance of movement behaviours across the whole 24-h day. The development process followed the strategy outlined in the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. A large body of evidence was used to inform the guidelines including 2 de novo systematic reviews and 4 overviews of reviews examining the relationships among movement behaviours (physical activity, sedentary behaviour, sleep, and all behaviours together) and several health outcomes. Draft guideline recommendations were discussed at a 4-day in-person Consensus Panel meeting. Feedback from stakeholders was obtained by survey (n = 877) and the draft guidelines were revised accordingly. The final guidelines provide evidence-based recommendations for a healthy day (24-h), comprising a combination of sleep, sedentary behaviours, and light-intensity and moderate-to-vigorous-intensity physical activity. Dissemination and implementation efforts with corresponding evaluation plans are in place to help ensure that guideline awareness and use are optimized. Novelty First ever 24-Hour Movement Guidelines for Adults aged 18–64 years and Adults aged 65 years or older with consideration of a balanced approach to physical activity, sedentary behaviour, and sleep Finalizes the suite of 24-Hour Movement Guidelines for Canadians across the lifespan

BackgroundPhysical inactivity and sedentary behavior increase the risk of chronic illness and death. The newest generation of “wearable” activity trackers offers potential as a multifaceted intervention to help people become more active.ObjectiveTo examine the usability and usefulness of wearable activity trackers for older adults living with chronic illness.MethodsWe recruited a purposive sample of 32 participants over the age of 50, who had been previously diagnosed with a chronic illness, including vascular disease, diabetes, arthritis, and osteoporosis. Participants were between 52 and 84 years of age (mean 64); among the study participants, 23 (72%) were women and the mean body mass index was 31 kg/m2. Participants tested 5 trackers, including a simple pedometer (Sportline or Mio) followed by 4 wearable activity trackers (Fitbit Zip, Misfit Shine, Jawbone Up 24, and Withings Pulse) in random order. Selected devices represented the range of wearable products and features available on the Canadian market in 2014. Participants wore each device for at least 3 days and evaluated it using a questionnaire developed from the Technology Acceptance Model. We used focus groups to explore participant experiences and a thematic analysis approach to data collection and analysis.ResultsOur study resulted in 4 themes: (1) adoption within a comfort zone; (2) self-awareness and goal setting; (3) purposes of data tracking; and (4) future of wearable activity trackers as health care devices. Prior to enrolling, few participants were aware of wearable activity trackers. Most also had been asked by a physician to exercise more and cited this as a motivation for testing the devices. None of the participants planned to purchase the simple pedometer after the study, citing poor accuracy and data loss, whereas 73% (N=32) planned to purchase a wearable activity tracker. Preferences varied but 50% felt they would buy a Fitbit and 42% felt they would buy a Misfit, Jawbone, or Withings. The simple pedometer had a mean acceptance score of 56/95 compared with 63 for the Withings, 65 for the Misfit and Jawbone, and 68 for the Fitbit. To improve usability, older users may benefit from devices that have better compatibility with personal computers or less-expensive Android mobile phones and tablets, and have comprehensive paper-based user manuals and apps that interpret user data.ConclusionsFor older adults living with chronic illness, wearable activity trackers are perceived as useful and acceptable. New users may need support to both set up the device and learn how to interpret their data.