ISRCTN

A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020 - Pilot and Feasibility Studies

Background Pilot and feasibility studies provide information to be used when planning a full trial. A sufficient sample size within the pilot/feasibility study is required so this information can be extracted with suitable precision. This work builds upon previous reviews of pilot and feasibility studies to evaluate whether the target sample size aligns with recent recommendations and whether these targets are being reached. Methods A review of the ISRCTN registry was completed using the keywords “pilot” and “feasibility”. The inclusion criteria were UK-based randomised interventional trials that started between 2013 (end of the previous review) and 2020. Target sample size, actual sample size and key design characteristics were extracted. Descriptive statistics were used to present sample sizes overall and by key characteristics. Results In total, 761 studies were included in the review of which 448 (59%) were labelled feasibility studies, 244 (32%) pilot studies and 69 (9%) described as both pilot and feasibility studies. Over all included pilot and feasibility studies (n = 761), the median target sample size was 30 (IQR 20–50). This was consistent when split by those labelled as a pilot or feasibility study. Slightly larger sample sizes (median = 33, IQR 20–50) were shown for those labelled both pilot and feasibility (n = 69). Studies with a continuous outcome (n = 592) had a median target sample size of 30 (IQR 20–43) whereas, in line with recommendations, this was larger for those with binary outcomes (median = 50, IQR 25–81, n = 97). There was no descriptive difference in the target sample size based on funder type. In studies where the achieved sample size was available (n = 301), 173 (57%) did not reach their sample size target; however, the median difference between the target and actual sample sizes was small at just minus four participants (IQR −25–0). Conclusions Target sample sizes for pilot and feasibility studies have remained constant since the last review in 2013. Most studies in the review satisfy the earlier and more lenient recommendations however do not satisfy the most recent largest recommendation. Additionally, most studies did not reach their target sample size meaning the information collected may not be sufficient to estimate the required parameters for future definitive randomised controlled trials.

DIAMONDS—a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial

Introduction Type 2 diabetes mellitus (T2DM) is two to three times more common in people with severe mental illness (SMI) than in the general population. Supporting self-management in diabetes is fundamental to improving clinical outcomes. The DIAMONDS trial aims to evaluate the clinical and cost effectiveness of a novel, codesigned, supported diabetes self-management programme for people with T2DM and SMI. Methods and analysis This multicentre, two-armed, parallel, individually randomised controlled trial will be conducted in National Health Service mental health trusts across England. We will recruit 380 participants (≥18 years old) with a diagnosis of SMI (schizophrenia, bipolar disorder, schizoaffective disorder, psychosis and severe depression) and T2DM. Eligible and consenting participants will be randomised to the DIAMONDS intervention or treatment as usual. The intervention group will receive one-to-one sessions with a trained DIAMONDS Coach for six months. These sessions will focus on goal setting, action planning and diabetes self-management education, supported by a paper-based workbook and an optional digital application. Individuals allocated to the control group will continue to receive usual care and may be offered National Institute for Health and Care Excellence-recommended generic diabetes self-management education programmes in line with usual practice. The primary outcome is the difference in glycated haemoglobin (HbA1c) between both groups at 12 months postrandomisation. The secondary outcomes include measures of physical and mental health, diabetes complications and physical activity. Economic and process evaluations will also be performed. Outcomes will be collected at baseline and at six and 12 month post-randomisation. Ethics and dissemination This study received ethics approval by the West of Scotland Research Ethics Committee 3 (22/WS/0117). Findings will be published in peer-reviewed, academic and professional journals. We will also be producing plain language summaries, infographics and audio summaries on the website, as well as attending conferences and dissemination events. A summary of the results will be distributed to all participants and other relevant stakeholders, and we will use social media channels, websites and knowledge exchange events to communicate our findings beyond academic audiences. Trial registration number [ISRCTN22275538][1]. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN22275538

Effectiveness of a Multicomponent Group-Based Treatment in Patients with Medically Unexplained Physical Symptoms: A Multisite Naturalistic Study - Journal of Contemporary Psychotherapy

Abstract Psychotherapy is expected to be effective in the treatment of patients with medically unexplained physical symptoms (MUPS). However, evidence is scarce. The aim of this study was to examine the effectiveness of a multicomponent treatment based on group therapy in patients with MUPS in a naturalistic setting and to explore potential predictors of the outcomes. A multisite naturalistic uncontrolled effectiveness study. A total of 290 patients with MUPS participated in group psychotherapy across seven clinical sites. Somatic symptoms, depression, anxiety, general psychotherapy outcomes operationalized as the Outcome Rating Scale (ORS) score, well-being, role functioning interference, as well as a number of pretreatment predictors were measured using a battery of self-report measures. Multilevel modeling and lasso regression with bootstrapping were used for the analysis. Medium to large pre-post effects were found for somatic symptoms, ORS, depression, anxiety, well-being, role functioning interference found in completers after controlling for site and group effects, pretreatment outcome values, and treatment length. Changes reported at 6- and 12-month follow-up were higher for most variables. No substantial pretreatment predictors of the patients’ posttreatment status were found in addition to the pretreatment level of outcome variables. Somatic symptoms seem to be less malleable in psychotherapy than psychological outcome variables. However, there was a trend of further improvement after treatment completion. Registration This study was retrospectively registered with ISRCTN (Identifier 13532466).

Passport to Success

Passport to Success