The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study.

Background: Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available.

Exploring General Practitioners' Management of Self-Harm in Young People: A Qualitative Study.

Background: General practitioners (GPs) are key to the frontline assessment and treatment of young people after self-harm. Young people value GP-led self-harm care, but little is known about how GPs manage young people after self-harm.

Aim: This study aimed to understand the approaches of GPs to self-harm in young people and explore their perspectives on ways they might help young people avoid repeat self-harm.

Scalable Transdiagnostic Early Assessment of Mental Health (STREAM): a study protocol.

Introduction: Early childhood development forms the foundations for functioning later in life. Thus, accurate monitoring of developmental trajectories is critical. However, such monitoring often relies on time-intensive assessments which necessitate administration by skilled professionals.

Development and validation of a short form psychometric tool assessing the caregiving Challenge of Living with Cystic Fibrosis (CLCF-SF) in a child.

Objective: Caring for a child with cystic fibrosis (CF) is a rigorous daily commitment for caregivers and treatment burden is a major concern. We aimed to develop and validate a short form version of a 46-item tool assessing the Challenge of Living with Cystic Fibrosis (CLCF) for clinical or research use.

Design: A novel genetic algorithm based on 'evolving' a subset of items from a pre-specified set of criteria, was applied to optimise the tool, using data from 135 families.

Pilot and feasibility studies: extending the conceptual framework.

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies.

Protocol for validation of the Global Scales for Early Development (GSED) for children under 3 years of age in seven countries.

Introduction: Children's early development is affected by caregiving experiences, with lifelong health and well-being implications. Governments and civil societies need population-based measures to monitor children's early development and ensure that children receive the care needed to thrive. To this end, the WHO developed the Global Scales for Early Development (GSED) to measure children's early development up to 3 years of age.

Baseline and Peak Cortisol Response to the Low-Dose Short Synacthen Test Relates to Indication for Testing, Age, and Sex.

Context: Meta-analyses report that the low dose short Synacthen test (LDSST) is more sensitive but less specific than the standard dose test for the diagnosis of adrenal insufficiency, and there are concerns regarding the accuracy of dosing in the LDSST.

Objective: Perform a retrospective, observational study to review the outcomes of LDSSTs performed in a tertiary endocrine service from 2008 to 2014 (N = 335) and 2016 to 2020 (N = 160), and examine for relationships between cortisol measurements and indication for testing, age and sex.

Methods: LDSST were performed by endocrine nurses.

Development and preliminary validation of the challenges of living with cystic fibrosis (CLCF) questionnaire: a 46-item measure of treatment burden for parent/carers of children with CF.

Objective: Treatments for cystic fibrosis (CF) are complex, labour-intensive, and perceived as highly burdensome by caregivers of children with CF. An instrument assessing burden of care is needed.

Design: A stepwise, qualitative design was used to create the CLCF with caregiver focus groups, participant researchers, a multidisciplinary professional panel, and cognitive interviews.

Pilot and feasibility studies for pragmatic trials have unique considerations and areas of uncertainty.

Background And Objective: Feasibility studies are increasingly being used to support the development of, and investigate uncertainties around, future large-scale trials. The future trial can be designed with either a pragmatic or explanatory mindset. Whereas pragmatic trials aim to inform the choice between different care options and thus, are designed to resemble conditions outside of a clinical trial environment, explanatory trials examine the benefit of a treatment under more controlled conditions.

Validation of the Infant and Young Child Development (IYCD) Indicators in Three Countries: Brazil, Malawi and Pakistan.

Background: The early childhood years provide an important window of opportunity to build strong foundations for future development. One impediment to global progress is a lack of population-based measurement tools to provide reliable estimates of developmental status. We aimed to field test and validate a newly created tool for this purpose.

Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.

Objectives: Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.

Study Design: Methodological review.

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study.

Background: Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies.

Methods: Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies.

Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

Introduction: Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.

Guidelines for reporting non-randomised pilot and feasibility studies.

As the number of submissions to increases, there is a need for good quality reporting guidelines to help researchers tailor their reports in a way that is consistent and helpful to other readers. The publication in 2016 of the CONSORT extension to pilot and feasibility trials filled a much-needed gap, but there still remains some uncertainty as to how to report pilot and feasibility studies that are not randomised. This editorial aims to provide some general guidance on how to report the most common types of non-randomised pilot and feasibility studies that are submitted to the journal.

A guide to the reporting of protocols of pilot and feasibility trials.

Publishing protocols of trials including protocols of pilot and feasibility trials-designed to inform the designs of main trials-has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials. This editorial aims to provide some general guidance on how to report protocols of pilot and feasibility trials, drawing upon two available resources-the CONSORT extension to pilot trials and the SPIRIT guideline for main trials. We describe how these might be adapted for the reporting of protocol manuscripts of pilot and feasibility trials for submission in journal.

Creation of the WHO Indicators of Infant and Young Child Development (IYCD): metadata synthesis across 10 countries.

Background: Renewed global commitment to the improvement of early child development outcomes, as evidenced by the focus of the United Nations Sustainable Development Goal 4, highlights an increased need for reliable and valid measures to evaluate preventive and interventional efforts designed to affect change. Our objective was to create a new tool, applicable across multicultures, to measure development from 0 to 3 years through metadata synthesis.

Methods: Fourteen cross-sectional data sets were contributed on 21 083 children from 10 low/middle-income countries (LMIC), assessed using seven different tools (caregiver reported or directly assessed).

Pilot trials in physical activity journals: a review of reporting and editorial policy.

Background: Since the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: a conceptual framework for defining feasibility studies and an extension to the CONSORT 2010 statement to include pilot trials. It was hoped that these publications would educate researchers, leading to better use of pilot trials and thus more rigorously planned and informed randomised controlled trials.

Progress in clinical research in surgery and IDEAL.

The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm.

Sample size re-estimation in paired comparative diagnostic accuracy studies with a binary response.

Background: The sample size required to power a study to a nominal level in a paired comparative diagnostic accuracy study, i.e. studies in which the diagnostic accuracy of two testing procedures is compared relative to a gold standard, depends on the conditional dependence between the two tests - the lower the dependence the greater the sample size required.

Improving the efficiency of trials using innovative pilot designs: the next phase in the conduct and reporting of pilot and feasibility studies.

With continuously increasing costs of conducting trials, use of innovative approaches-such as pragmatic trials, registry-based randomised trials, adaptive trials, personalised medicine trials, platform trials, and basket trials-to the design and conduct of clinical trials has been advocated as one of the most promising solutions. In this editorial, we propose that the next wave of feasibility or pilot studies should focus on assessing the feasibility of trials using these designs, which we see as an imperative in order to unleash their potential to reduce trial costs and accelerate the drug development process and the search for best treatments, so that the right treatments can be delivered as soon as possible to the right patients.

A mixed methods study to evaluate the feasibility of using the Adolescent Diabetes Needs Assessment Tool App in paediatric diabetes care in preparation for a longitudinal cohort study.

Background: An evaluation study was carried out to determine the feasibility of integrating the Adolescent Diabetes Needs Assessment Tool (ADNAT) App into UK paediatric diabetes care, to ascertain best practice standards and to determine methodological recommendations for a future cohort study.

Methods: A non-randomised, cohort, mixed methods study design was used to ensure equality of access to ADNAT for all participants at three sites in the North West of England. Following UK Medical Research Council guidance, the RE-AIM (reach, effectiveness (potential and perceived), adoption, implementation, maintenance) framework was used to guide study objectives and feasibility outcomes.

Laparoscopic Excision Versus Ablation for Endometriosis-associated Pain: An Updated Systematic Review and Meta-analysis.

The aim of this study was to update the evidence on the surgical management of endometriosis-associated pain. Does laparoscopic excision offer any benefits over laparoscopic ablation? This is a systematic review and meta-analysis in which we searched MEDLINE, Embase, Institute for Scientific Information conference proceedings, the International Standard Randomised Controlled Trial Number registry, the Register and Meta-register for randomized controlled trials, the World Health Organization trials search portal, the Cochrane Library, and the British Library of electronic theses. Three randomized controlled trials were included, which enrolled 335 participants with a sample size per study ranging from 24 to 178 participants.

Erratum to: Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials.

[This corrects the article DOI: 10.1186/s40814-016-0065-z.].