The use of invasive life support in patients with a prolonged critical illness clearly saves lives but carries substantial risks, including intensive care unit-acquired weakness (ICUAW) and long-term disability. Early mobilisation might improve outcomes, yet the evidence is conflicting and complicated by the lack of a responsive outcome measurement to detect change in critically ill patients’ physical function and activity. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for patients at risk of ICUAW. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated.

The primary objective of this prospective, international, multicentre, longitudinal cohort study is to investigate responsiveness and to establish the MCID of the CPAx during the ‘intensive care unit (ICU) period’, from ICU baseline to ICU discharge, and ‘hospital period’, from ICU to hospital discharge. Adults with any critical illness who are mechanically ventilated for at least 72 hours, expected to remain in ICU (≥48 hours) and being treated by a physiotherapist are eligible for study inclusion. Functional measurements, including the CPAx and a global rating of change (GRC) scale, will be collected during routine physiotherapy. Responsiveness will be evaluated primarily using the GRC as an anchor to distinguish changed from unchanged/deteriorated patients (criterion validity). As such, the magnitude of change will be analysed with receiver operating characteristics. Additionally, construct validity will be explored with correlation coefficients and effect sizes to confirm/reject a priori formulated hypotheses. MCID will be investigated with anchor-based and distribution-based methods. We plan to recruit 120 patients across three sites in Australia and Switzerland.

Ethical approval has been obtained from each local ethics committee (Canton of Bern, Switzerland (2024-00346), Monash Health, Australia (HREC/106143/MonH-2024-438474(v3)), the Alfred, Australia (490/24)). The results will be disseminated through international/national conferences, peer-reviewed journals and social media. The high quality, rigorous testing of the CPAx could benefit researchers, clinicians and patients.

NCT06419699.

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures.

Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ~36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected.

Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.

NCT03887988.

This study aims to inform the development of a patient-reported symptom questionnaire for head and neck cancer and outline the requirements for a patient-reported symptom-based risk stratification system. The study objectives are to explore how clinicians ask questions and decide subsequent steps for patients referred with suspected head and neck cancer; the language patients and clinicians use to describe symptoms; how clinicians reassure and discharge low-risk patients; and identify clinician and patient experiences of the head and neck cancer diagnostic pathway and their views on a novel diagnostic pathway using patient-reported symptom-based risk stratification.

The study employed qualitative methods including observation and recordings of clinic consultations and semistructured interviews with clinicians and patients. Analysis proceeded concurrently with data collection using a rapid qualitative analysis approach.

Three acute UK National Health Service Trusts with variation in service delivery models. Data collection took place between April and October 2023.

One hundred and fifty-six adults referred for suspected head and neck cancer, and 21 clinicians from different subspecialties were recruited. A subset of recruited patients (n=16) and clinicians (n=13) were interviewed. One observation of a general head and neck clinic was conducted.

The findings highlight types of symptoms and the language used by patients and clinicians to describe these symptoms in clinic consultations. During interviews, patients described the need for in-person support and human clinical decision-making, an accessible system for reporting their symptoms and reassurance regarding the security of patient data. Clinicians discussed the need for risk scores to be sufficiently validated to be trusted, the potential clinical usefulness of a risk score-based system, for example, to support triage by discriminating symptoms, and accessibility for patients. The observation highlighted inconsistent and sometimes unclear referral information and the limited time clinicians have to read referral information.

The findings have implications for the development of a patient-reported symptom-based risk stratification system. As well as ensuring patients can understand the language used, it will be important to consider how their emotional needs can be met. The findings also have wider implications for understanding the impact of language on emotionally evocative healthcare interactions.