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Mixed-methods study protocol to develop and pilot a Competency Assessment Tool to support therapists in the care of patients with blunt CHest trauma (CATCh study)

Por: Battle · C. · Barnett · J. · Driscoll · T. · Hutchings · H. A. · ONeill · C. · Toghill · H. · Whelan · R. · Baker · E.
Introduction

Competency assessment tools are well-recognised as a method to achieve a standardised level of practice for a group of healthcare professionals with similar characteristics. The aim of this study is to develop and pilot a new competency assessment tool to support therapists caring for patients with blunt chest trauma from prehospital care through to long-term follow-up following hospital discharge.

Methods and analysis

A mixed-methods study will be undertaken, with three distinct phases: (1) an integrative narrative review to examine the literature regarding therapist competencies; (2) focus groups with patients, therapists and key stakeholders to explore opinions regarding important aspects of care (phases I and II will inform the content of the tool), followed by final tool development by an international expert panel; and (3) a multicentre pilot study using questionnaires and elicitation interviews, in which final tool acceptability to therapists will be tested. The total sample size will be between 40 and 50 participants for the focus groups. For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity. We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists. A mixed qualitative and quantitative data analysis approach will be used.

Ethics and dissemination

Proportionate ethics approval has been granted (South Yorkshire Research Ethics Committee, reference number: 24/YH/0231). We will publish the work in an open-access peer-reviewed journal to ensure equitable access and present at relevant conferences. Webinars will be used to achieve a wide audience. The results will be shared with the research participants via an infographic which will be designed and developed with the public research partners.

Trial registration number

Integrative review is registered at the Open Science Framework: https://doi.org/10.17605/OSF.IO/CEXNR

Surgery or radiotherapy for early-stage cancer study (SORT) target trial protocol: stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for early-stage non-small cell lung cancer (NSCLC)

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Hutchings · A. · Aggarwal · A. · ONeill · S. · Rachet · B. · Edwards · J. · Faivre-Finn · C. · Grieve · R. · Surgery or Radiotherapy Study (SORT) group · Choudhury · Vohra · Cresswell · Charlton · Chuter · Nolte · Gravenhorst · Alencar · Mon
Introduction

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

Methods and analysis

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethics and dissemination

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

Lymphoedema Development Following a Cancer Diagnosis: An Anonymised Data Linkage Study in Wales, United Kingdom

ABSTRACT

This observational cohort study explored lymphoedema development following a cancer diagnosis and whether demographic factors impacted the time to lymphoedema development. We identified cases through the Secure Anonymised Information Linkage (SAIL) Databank. We used cancer diagnostic codes to identify a cohort of six broad cancer ‘types’. We independently used lymphoedema diagnostic codes to identify a cohort who developed lymphoedema. We linked these two cohorts to develop a single cohort of cases and describe the number of cases who went on to develop lymphoedema after a cancer diagnosis, and the time to lymphoedema diagnosis. We used Cox regression models to calculate hazard ratios and produced survival curves to explore whether pre-defined factors (gender, age, deprivation, cancer type) had any impact on time to lymphoedema development. We identified 7538 cases of lymphoedema development after a cancer diagnosis, relating to 7279 people. There was considerable variation in the time to diagnosis, with a mean and standard deviation of 483.3 (701.8) days. Cancer type was the single most important factor in explaining time to lymphoedema diagnosis. Time to lymphoedema was shortest in breast cancer. A large number of breast cancer cases have undergone surgery, and this may account for the earlier development of lymphoedema. Consideration should be made of risk factors for lymphoedema development in order to allow for more targeted treatment plans that could improve health-related quality of life for patients.

STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection

Por: Delfino · C. · Carcel · C. · Lin · X. · Munoz-Venturelli · P. · Naismith · S. L. · Woodward · M. · Peters · R. · Wijesuriya · N. · Law · M. · Harding · I. H. · Wang · X. · Elliott · J. · Leder · K. · Hutchings · O. · Stecher · X. · Zoungas · S. · Anderson · C. S.
Introduction

Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.

Methods and analysis

The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.

Ethics and dissemination

This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.

Trial registration number

The study protocol is registered at Clinicaltrials.gov (NCT04904536).

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