[Joint study of seclusion, mechanical restraint and chemical restraint: Pilot study in three French psychiatric hospitals]. / Étudier conjointement l'isolement, la contention mécanique et la contention chimique : étude pilote dans trois établissements psychiatriques français.

Psychiatric wards that only exceptionally use isolation and mechanical restraint may be suspected of using "chemical restraint". However, in the case of these services, the hypothesis of a reduction in the general level of restraint can also be formulated. Prior to a comprehensive study to test these hypotheses, the current research aims to assess indicators which define high levels of the use of these measures and a relevant sample. The study was conducted in three facilities with 254 hospitalized patients over a week. Five per cent experienced isolation, 2% mechanical restraint, and 13% received high doses of medication (including "as needed" treatments). These figures are below literature data and national averages. Variances exist among centers, with one showing higher percentages for all three measures. While confirming the feasibility of studying these measures together, the study suggests the need for longer observations and continuous evaluation of prescription practices to better reflect yearly isolation and restraint trends. Future studies should involve more centers and include case studies for a nuanced understanding of administration practices in relation to prescriptions.

Feasibility and constraints of Bragg peak FLASH proton therapy treatment planning.

Introduction: FLASH proton therapy (FLASH-PT) requires ultra-high dose rate (≥ 40 Gy/s) protons to be delivered in a short timescale whilst conforming to a patient-specific target. This study investigates the feasibility and constraints of Bragg peak FLASH-PT treatment planning, and compares the in silico results produced to plans for intensity modulated proton therapy (IMPT). Materials and method: Bragg peak FLASH-PT and IMPT treatment plans were generated for bone (n=3), brain (n=3), and lung (n=4) targets using the MIROpt research treatment planning system and the Conformal FLASH library developed by Applications SA from the open-source version of UCLouvain. FLASH-PT beams were simulated using monoenergetic spot-scanned protons traversing through a conformal energy modulator, a range shifter, and an aperture. A dose rate constraint of ≥ 40 Gy/s was included in each FLASH-PT plan optimisation. Results: Space limitations in the FLASH-PT adapted beam nozzle imposed a maximum target width constraint, excluding 4 cases from the study. FLASH-PT plans did not satisfy the imposed target dose constraints (D95% ≥ 95% and D2%≤ 105%) but achieved clinically acceptable doses to organs at risk (OARs). IMPT plans adhered to all target and OAR dose constraints. FLASH-PT plans showed a reduction in both target homogeneity (p < 0.001) and dose conformity (non-significant) compared to IMPT. Conclusion: Without accounting for a sparing effect, IMPT plans were superior in target coverage, dose conformity, target homogeneity, and OAR sparing compared to FLASH-PT. Further research is warranted in treatment planning optimisation and beam delivery for clinical implementation of Bragg peak FLASH-PT.

Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients with Chronic Low Back Pain at High Risk of Poor Prognosis: A Pilot and Feasibility Randomized Controlled Trial.

Purpose: To determine the feasibility of a randomized controlled trial (RCT) testing the efficacy of psychologically-informed physiotherapy (PIPT), which includes usual physiotherapy (UP) interventions, compared with UP, and to explore the preliminary effectiveness of the interventions. Method: People with chronic low back pain at high risk of poor prognosis (using the STarT Back screening tool) were recruited and allocated to PIPT or UP. Effectiveness of recruitment strategies, adherence to intervention, risk of contamination, and specific challenges were assessed. Functional capacity, pain, quality of life, kinesiophobia, catastrophization, central sensitization, and self-efficacy were measured at baseline, 6-, 12- and 24-week follow-ups. Results: Forty participants were recruited mainly by diffusing through Laval University's email list, and 10 physiotherapists treated the participants recruited. The retention rate of participants at 24 weeks was 72.5%. Adherence to treatment by participants and physiotherapists was very good. The risk of contamination was low, and the specific challenges identified were modifiable. Significant improvement over time in all clinical variables of interest, except self-efficacy, was observed with no difference between groups. Conclusions: As most success criteria were met, conducting an RCT evaluating PIPT and PU is feasible with modifications. PIPT and UP appear to be similarly effective.

Objectif: déterminer la faisabilité d'une étude randomisée et contrôlée (ÉRC) évaluant l'efficacité de la physiothérapie fondée sur la psychologie (PTFP), qui inclut les interventions de physiothérapie conventionelle (PC), par rapport à la PC, et explorer l'efficacité préliminaire des interventions. Méthodologie: les chercheurs ont recruté des personnes qui souffrent de douleurs lombaires chroniques, ayant une probabilité élevée de mauvais pronostic (au moyen de l'outil de dépistage STarT Back) et les ont réparties entre la PTFP et la PC. Ils ont évalué l'efficacité des stratégies de recrutement, l'adhésion à l'intervention, le risque de contamination et les difficultés particulières. Ils ont également mesuré la capacité fonctionnelle, la douleur, la qualité de vie, la kinésiophobie, la catastrophisation, la sensibilisation centrale et l'autoefficacité en début d'étude ainsi que lors des suivis à six, 12 et 24 semaines. Résultats: les chercheurs ont recruté 40 participants, principalement en diffusant le projet par courriel à la communauté de l'Université Laval, et dix physiothérapeutes les ont traités. Le taux de rétention des participants était de 72,5 % à 24 semaines. Les participants et les physiothérapeutes ont démontré une très bonne adhésion au traitement. Le risque de contamination était faible, et les difficultés particulières constatées pouvaient être modifiées. Les chercheurs ont observé une amélioration considérable au fil du temps pour toutes les variables cliniques d'intérêt, sauf l'autoefficacité, sans différence entre les groupes. Conclusions: puisque la plupart des critères de succès étaient respectés, il est faisable de réaliser une ÉRC pour évaluer la PTFP et la PU, sous réserve de modifications. La PTFP et la PC semblent avoir une efficacité similaire.

Feasibility of the ERAS (Enhanced Recovery After Surgery) Protocol in Patients Undergoing Gastrointestinal Cancer Surgeries in a Tertiary Care Hospital-A Prospective Interventional Study.

Enhanced Recovery After Surgery (ERAS) protocols have emerged as a promising approach to optimize perioperative care and improve outcomes in various surgical specialties. Despite feasibility studies on ERAS in various surgeries, there remains a paucity of research focusing on gastrointestinal cancer surgeries in the Indian context. The primary objective is to evaluate the compliance rate of the ERAS protocol and secondary objectives include the compliance rate of individual components of the protocol, the complications, the length of hospital stay, and the challenges faced during implementation in patients undergoing gastrointestinal cancer surgeries in our tertiary care cancer center. In this prospective interventional study (CTRI/2022/04/041657; registered on 05/04/2022), we evaluated 50 patients aged 18 to 70 years undergoing surgery for gastrointestinal malignancies and implemented a refined ERAS protocol tailored to our institutional resources and conditions based on standard ERAS society recommendations for gastrointestinal surgeries and specific recommendations for colorectal, pancreatic, and esophageal surgeries.Our study's mean overall compliance rate with the ERAS protocol was 88.54%. We achieved a compliance rate of 91.98%, 81.66%, and 92.00% for pre-operative, intraoperative, and post-operative components respectively. Fourteen (28%) patients experienced complications during the study. The median length of stay was 6.5 days (5.25-8). Challenges were encountered during the preoperative, intraoperative, and postoperative phases. The study highlighted the feasibility of implementing the ERAS protocol in a cancer institute, but specific challenges need to be addressed for its optimal success in gastrointestinal cancer surgeries. Supplementary Information: The online version contains supplementary material available at 10.1007/s13193-024-01897-y.

Protocol for a pragmatic randomised controlled feasibility study of MS WorkSmart: an online intervention for Australians with MS who are employed.

INTRODUCTION: Multiple sclerosis (MS) causes a wide variety of symptoms. Loss of income due to sickness and early retirement comprise one-third of the total cost of MS in Australia. An intervention that maximises work productivity and keeps people with MS in the workforce for longer could provide a large societal cost saving and improve quality of life. The aim is to test the feasibility of delivering and evaluating a 10-week digitally delivered intervention called 'MS WorkSmart'. Findings will provide insights into participant profiles and address key methodological and procedural uncertainties (recruitment, retention, intervention adherence and engagement, and selection of primary outcome) in preparation for a subsequent definitive trial. METHODS AND ANALYSIS: A parallel-arm randomised controlled feasibility study, comparing those randomised to receive the MS WorkSmart package plus usual care (n=20) to those receiving usual care only (n=20). Australians with MS, aged 18-60 years, who are employed, and self-report work instability will be recruited from the Australian MS Longitudinal Study. Online surveys, at baseline and 1-month postintervention, will include MS-related work productivity loss and risk of job loss, MS work behaviour self-efficacy, health-related quality of life, fatigue severity, MS symptom impact on work, intention to retire due to MS, MS-related work difficulties, and awareness and readiness for change at work. Qualitative feedback will be obtained via a semistructured survey following the intervention (for participants) and via interviews (coaches). Analyses will be primarily descriptive and focus on the feasibility and acceptability of the intervention and study procedures. Progression criteria will guide decisions around whether to progress to a full trial. ETHICS AND DISSEMINATION: The study has been approved by the University of Tasmania Human Research Ethics Committee (H0024544). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and community presentations. TRIAL REGISTRATION NUMBER: ACTRN12622000826741.

Assessing early feasibility of a novel innovation to increase consumer partnership capability within an Australian health innovation organisation using a mixed-method approach.

OBJECTIVE: Engagement-capable health organisations recognise that consumer engagement (also known as patient engagement, consumer engagement, patient and public involvement) must occur at every level of the organisation if it is to be meaningful and genuine. Despite this aspiration, health organisations struggle to adopt, implement, and embody consumer engagement capability in a way that has yielded impact. The Partner Ring (PR) is an embedded model for building staff capability for consumer partnerships. It is hosted by an employed Patient Partner. PR was implemented at the Agency for Clinical Innovation in New South Wales, Australia. The aim of this study was to assess the feasibility (acceptability, demand and practicality) of this innovation to increase consumer engagement capability. DESIGN: One-group post-intervention mixed methods approach to assess feasibility. PARTICIPANTS: ACI staff engaged in the PR (n=40 of 89 members). DATA COLLECTION AND ANALYSIS: Qualitative data was collected through an artificial intelligence (AI)-driven interactive interview, with 40 responses received between 29 June and 12 July 2023. A framework analysis and Generative AI causal mapping were conducted to identify and visualise causal claims within the texts. Cost and session attendance collected from the same point in time supplemented the analysis. FINDINGS: Findings were categorised by the following feasibility constructs: acceptability, demand and practicality. Almost all the respondents indicated their intent to continue using the PR and outlined personal benefits and professional benefits. For example, (n=23, 57%) reacted positively to the psychological safety of the PR, and professionally people identified attendance increased their knowledge and skills (n=23, 57%). CONCLUSION: The PR is feasible and likely to be an acceptable innovation for building staff capability and consumer engagement skills across a large health system or organisation. It could be adopted or adapted by other jurisdictions.

Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinson's disease in Egypt: a mixed-methods feasibility study protocol.

BACKGROUND: Falls are common in older people and individuals with neurological conditions. Parkinson's disease (PD) is known for postural instability causing mobility disabilities, falls and reduced quality of life. The fear of falling (FOF), a natural response to unstable balance, can worsen postural control problems. Evaluating FOF relies largely on affected persons' subjective accounts due to limited objective assessment methods available. The aim of this mixed-methods feasibility study is to develop an assessment method for FOF while in motion and walking within virtual environments. This study will assess a range of FOF-related responses, including cognitive factors, neuromuscular response and postural stability. METHODS AND ANALYSIS: This feasibility study will consist of four phases: the first two phases will include people without PD, while the other two will include people diagnosed with PD. Participants will be assessed for direct and indirect responses to real life, as well as virtual environment walking scenarios that may induce FOF. Data from questionnaires, different neurophysiological assessments, movement and gait parameters, alongside evaluations of usability and acceptability, will be collected. Semistructured interviews involving both participants and research assistants shall take place to elicit their experiences throughout different phases of the assessments undertaken. Demographic data, the scores of assessment scales, as well as feasibility, usability and acceptability of the measurement methods, will be illustrated via descriptive statistics. Movement and gait outcomes, together with neurophysiological data, will be extracted and calculated. Exploring relationships between different factors in the study will be achieved using a regression model. Thematic analysis will be the approach used to manage qualitative data. ETHICS AND DISSEMINATION: This feasibility study was approved by the Ethics Committee of the Faculty of Physical Therapy, Kafr El Sheikh University, Egypt (number: P.T/NEUR/3/2023/46). The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05931692).

Australian trial of behavioural activation for people with schizophrenia experiencing negative symptoms: a feasibility randomised controlled trial protocol.

INTRODUCTION: Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive-behavioural therapy results in a modest reduction in negative symptoms. Behavioural activation may be an effective alternative treatment for negative symptoms.The study aims to examine the feasibility and acceptability of implementing a behavioural activation trial delivered in three community mental health services in South Australia to support adult consumers experiencing negative symptoms of schizophrenia. METHOD AND ANALYSIS: This randomised controlled study will recruit a total of 60 consumers aged 18 years or above with mild-moderate negative symptoms of schizophrenia. The consumers will be randomly allocated to receive behavioural activation plus usual mental healthcare or usual mental healthcare alone. The intervention group will receive twelve 30 min sessions of behavioural activation, which will be delivered twice weekly over 6 weeks. In addition, we aim to recruit nine mental health workers from the three rural mental health services who will complete a 10-week online training programme in behavioural activation. Changes in negative symptoms of schizophrenia and depressive symptoms will be assessed at three time points: (a) at baseline, at 6 weeks and 3 month follow-ups. Changes in health-related quality of life (Short Form F36; secondary outcome) will be assessed at two time points: (a) at baseline and (b) immediately at postintervention after 6 weeks. At the end of the trial, interviews will be conducted with purposively selected mental health workers and consumers. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability. ETHICS AND DISSEMINATION: The findings from our feasibility study will inform the design of a fully powered randomised controlled trial to test the effectiveness of behavioural activation as a treatment for negative symptoms in schizophrenia. The study protocol was approved by the Central Adelaide Local Health Network Human Research Ethics Committee. The findings from this study will be disseminated through peer-reviewed scientific journals and conferences. TRIAL REGISTRATION NUMBER: ACTRN12623000348651p.

Optimizing shoulder elevation assist rate in exoskeletal rehabilitation based on muscular activity indices: a clinical feasibility study.

BACKGROUND: Restoring shoulder function is critical for upper-extremity rehabilitation following a stroke. The complex musculoskeletal anatomy of the shoulder presents a challenge for safely assisting elevation movements through robotic interventions. The level of shoulder elevation assistance in rehabilitation is often based on clinical judgment. There is no standardized method for deriving an optimal level of assistance, underscoring the importance of addressing abnormal movements during shoulder elevation, such as abnormal synergies and compensatory actions. This study aimed to investigate the effectiveness and safety of a newly developed shoulder elevation exoskeleton robot by applying a novel optimization technique derived from the muscle synergy index. METHODS: Twelve chronic stroke participants underwent an intervention consisting of 100 robot-assisted shoulder elevation exercises (10 × 10 times, approximately 40 min) for 10 days (4-5 times/week). The optimal robot assist rate was derived by detecting the change points using the co-contraction index, calculated from electromyogram (EMG) data obtained from the anterior deltoid and biceps brachii muscles during shoulder elevation at the initial evaluation. The primary outcomes were the Fugl-Meyer assessment-upper extremity (FMA-UE) shoulder/elbow/forearm score, kinematic outcomes (maximum angle of voluntary shoulder flexion and elbow flexion ratio during shoulder elevation), and shoulder pain outcomes (pain-free passive shoulder flexion range of motion [ROM] and visual analogue scale for pain severity during shoulder flexion). The effectiveness and safety of robotic therapy were examined using the Wilcoxon signed-rank sum test. RESULTS: All 12 patients completed the procedure without any adverse events. Two participants were excluded from the analysis because the EMG of the biceps brachii was not obtained. Ten participants (five men and five women; mean age: 57.0 [5.5] years; mean FMA-UE total score: 18.7 [10.5] points) showed significant improvement in the FMA-UE shoulder/elbow/forearm score, kinematic outcomes, and pain-free passive shoulder flexion ROM (P < 0.05). The shoulder pain outcomes remained unchanged or improved in all patients. CONCLUSIONS: The study presents a method for deriving the optimal robotic assist rate. Rehabilitation using a shoulder robot based on this derived optimal assist rate showed the possibility of safely improving the upper-extremity function in patients with severe stroke in the chronic phase.

Doppler ultrasound surveillance of recently formed haemodialysis arteriovenous fistula: the SONAR observational cohort study.

Background: Arteriovenous fistulas are considered the best option for haemodialysis provision, but as many as 30% fail to mature or suffer early failure. Objective: To assess the feasibility of performing a randomised controlled trial that examines whether, by informing early and effective salvage intervention of fistulas that would otherwise fail, Doppler ultrasound surveillance of developing arteriovenous fistulas improves longer-term arteriovenous fistula patency. Design: A prospective multicentre observational cohort study (the 'SONAR' study). Setting: Seventeen haemodialysis centres in the UK. Participants: Consenting adults with end-stage renal disease who were scheduled to have an arteriovenous fistula created. Intervention: Participants underwent Doppler ultrasound surveillance of their arteriovenous fistulas at 2, 4, 6 and 10 weeks after creation, with clinical teams blinded to the ultrasound surveillance findings. Main outcome measures: Fistula maturation at week 10 defined according to ultrasound surveillance parameters of representative venous diameter and blood flow (wrist arteriovenous fistulas: ≥ 4 mm and > 400 ml/minute; elbow arteriovenous fistulas: ≥ 5 mm and > 500 ml/minute). Mixed multivariable logistic regression modelling of the early ultrasound scan data was used to predict arteriovenous fistula non-maturation by 10 weeks and fistula failure at 6 months. Results: A total of 333 arteriovenous fistulas were created during the study window (47.7% wrist, 52.3% elbow). By 2 weeks, 37 (11.1%) arteriovenous fistulas had failed (thrombosed), but by 10 weeks, 219 of 333 (65.8%) of created arteriovenous fistulas had reached maturity (60.4% wrist, 67.2% elbow). Persistently lower flow rates and venous diameters were observed in those fistulas that did not mature. Models for arteriovenous fistulas' non-maturation could be optimally constructed using the week 4 scan data, with fistula venous diameter and flow rate the most significant variables in explaining wrist fistula maturity failure (positive predictive value 60.6%, 95% confidence interval 43.9% to 77.3%), whereas resistance index and flow rate were most significant for elbow arteriovenous fistulas (positive predictive value 66.7%, 95% confidence interval 48.9% to 84.4%). In contrast to non-maturation, both models predicted fistula maturation much more reliably [negative predictive values of 95.4% (95% confidence interval 91.0% to 99.8%) and 95.6% (95% confidence interval 91.8% to 99.4%) for wrist and elbow, respectively]. Additional follow-up and modelling on a subset (n = 192) of the original SONAR cohort (the SONAR-12M study) revealed the rates of primary, assisted primary and secondary patency arteriovenous fistulas at 6 months were 76.5, 80.7 and 83.3, respectively. Fistula vein size, flow rate and resistance index could identify primary patency failure at 6 months, with similar predictive power as for 10-week arteriovenous fistula maturity failure, but with wide confidence intervals for wrist (positive predictive value 72.7%, 95% confidence interval 46.4% to 99.0%) and elbow (positive predictive value 57.1%, 95% confidence interval 20.5% to 93.8%). These models, moreover, performed poorly at identifying assisted primary and secondary patency failure, likely because a subset of those arteriovenous fistulas identified on ultrasound surveillance as at risk underwent subsequent successful salvage intervention without recourse to early ultrasound data. Conclusions: Although early ultrasound can predict fistula maturation and longer-term patency very effectively, it was only moderately good at identifying those fistulas likely to remain immature or to fail within 6 months. Allied to the better- than-expected fistula patency rates achieved (that are further improved by successful salvage), we estimate that a randomised controlled trial comparing early ultrasound-guided intervention against standard care would require at least 1300 fistulas and would achieve only minimal patient benefit. Trial Registration: This trial is registered as ISRCTN36033877 and ISRCTN17399438. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR135572) and is published in full in Health Technology Assessment; Vol. 28, No. 24. See the NIHR Funding and Awards website for further award information.

For people with advanced kidney disease, haemodialysis is best provided by an 'arteriovenous fistula', which is created surgically by joining a vein onto an artery at the wrist or elbow. However, these take about 2 months to develop fully ('mature'), and as many as 3 out of 10 fail to do so. We asked whether we could use early ultrasound scanning of the fistula to identify those that are unlikely to mature. This would allow us to decide whether it would be practical to run a large, randomised trial to find out if using early ultrasound allows us to 'rescue' fistulas that would otherwise fail. We invited adults to undergo serial ultrasound scanning of their fistula in the first few weeks after it was created. We then analysed whether we could use the data from the early scans to identify those fistulas that were not going to mature by week 10. Of the 333 fistulas that were created, about two-thirds reached maturity by week 10. We found that an ultrasound scan 4 weeks after fistula creation could reliably identify those fistulas that were going to mature. However, of those fistulas predicted to fail, about one-third did eventually mature without further intervention, and even without knowing what the early scans showed, another third were successfully rescued by surgery or X-ray-guided treatment at a later stage. Performing an early ultrasound scan on a fistula can provide reassurance that it will mature and deliver trouble-free dialysis. However, because scans are poor at identifying fistulas that are unlikely to mature, we would not recommend their use to justify early surgery or X-ray-guided treatment in the expectation that this will improve outcomes.

Cognitive stimulation for people with dementia in nursing homes: a protocol for a feasibility study examining a new 24/7 approach (CogStim24).

INTRODUCTION: Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, '24/7') has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes. METHODS AND ANALYSIS: The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed. ETHICS AND DISSEMINATION: Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00024381.

Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial.

BACKGROUND: For every critically ill adult receiving invasive mechanical ventilation, clinicians must select a mode of ventilation. The mode of ventilation determines whether the ventilator directly controls the tidal volume or the inspiratory pressure. Newer hybrid modes allow clinicians to set a target tidal volume; the ventilator controls and adjusts the inspiratory pressure. A strategy of low tidal volumes and low plateau pressure improves outcomes, but the optimal mode to achieve these targets is not known. RESEARCH QUESTION: Can a cluster-randomized trial design be used to assess whether the mode of mandatory ventilation affects the number of days alive and free of invasive mechanical ventilation among critically ill adults? STUDY DESIGN AND METHODS: The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot trial being conducted in the medical ICU at an academic center. The MODE trial compares the use of volume control, pressure control, and adaptive pressure control. The study ICU is assigned to a single-ventilator mode (volume control vs pressure control vs adaptive pressure control) for continuous mandatory ventilation during each 1-month study block. The assigned mode switches every month in a randomly generated sequence. The primary outcome is ventilator-free days to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of mechanical ventilation to 28 days after enrollment. Enrollment began November 1, 2022, and will end on July 31, 2023. RESULTS: This manuscript describes the protocol and statistical analysis plan for the MODE trial of ventilator modes comparing volume control, pressure control, and adaptive pressure control. INTERPRETATION: Prespecifying the full statistical analysis plan prior to completion of enrollment increases rigor, reproducibility, and transparency of the trial results. CLINICAL TRIAL REGISTRATION: The trial was registered with clinicaltrials.gov on October 3, 2022, before initiation of patient enrollment on November 1, 2022 (ClinicalTrials.gov identifier: NCT05563779).

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

BACKGROUND: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. METHODS: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. RESULTS: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. CONCLUSION: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.

Preliminary feasibility assessment of a targeted, pharmacist-led intervention for older adults with polypharmacy: a mixed-methods study.

BACKGROUND: Polypharmacy is associated with the prescription of inappropriate medications and avoidable medication-related harm. A novel pharmacist-led intervention aims to identify and resolve inappropriate medication prescriptions in older adults with polypharmacy. AIM: To conduct a preliminary feasibility assessment of the intervention in primary care, testing whether specific components of the intervention procedures and processes can be executed as intended. METHOD: The mixed-methods study was approved by the New Zealand Health and Disability Ethics Committees and public health agency. Patients from a New Zealand general practice clinic were recruited over 4 weeks to receive the intervention. The preliminary feasibility assessment included measures of intervention delivery, patient-reported outcome measures, and perspectives from ten patients and six clinicians. Data were analysed quantitatively and qualitatively to determine if a full-scale intervention trial is warranted. The study's progression criteria were based on established research and guided the decision-making process. RESULTS: The intervention met the study's progression criteria, including patient recruitment, retention, and adherence to the intervention procedures. However, several modifications were identified, including: (1) enhancing patient recruitment, (2) conducting a preliminary meeting between the patient and pharmacist, (3) supporting pharmacists in maintaining a patient-centred approach, (4) reviewing the choice of patient-reported outcome measure, (5) extending the 8-week follow-up period, (6) allocating more time for pharmacists to conduct the intervention. CONCLUSION: The study found the intervention feasible; however, additional development is required before progressing to a full-scale trial. This intervention has the potential to effectively reduce medication-related harm and improve outcomes for older adults with polypharmacy. TRIAL REGISTRATION NUMBER: ACTRN12621000268842 Date registered: 11/03/2021.

Life, death, and statins: association of statin prescriptions and survival in older general practice patients.

AIMS: This study serves as an exemplar to demonstrate the scalability of a research approach using survival analysis applied to general practice electronic health record data from multiple sites. Collection of these data, the subsequent analysis, and the preparation of practice-specific reports were performed using a bespoke distributed data collection and analysis software tool. BACKGROUND: Statins are a very commonly prescribed medication, yet there is a paucity of evidence for their benefits in older patients. We examine the relationship between statin prescriptions for general practice patients over 75 and all-cause mortality. METHODS: We carried out a retrospective cohort study using survival analysis applied to data extracted from the electronic health records of five Australian general practices. FINDINGS: The data from 8025 patients were analysed. The median duration of follow-up was 6.48 years. Overall, 52 015 patient-years of data were examined, and the outcome of death from any cause was measured in 1657 patients (21%), with the remainder being censored. Adjusted all-cause mortality was similar for participants not prescribed statins versus those who were (HR 1.05, 95% CI 0.92-1.20, P = 0.46), except for patients with diabetes for whom all-cause mortality was increased (HR = 1.29, 95% CI: 1.00-1.68, P = 0.05). In contrast, adjusted all-cause mortality was significantly lower for patients deprescribed statins compared to those who were prescribed statins (HR 0.81, 95% CI 0.70-0.93, P < 0.001), including among females (HR = 0.75, 95% CI: 0.61-0.91, P < 0.001) and participants treated for secondary prevention (HR = 0.72, 95% CI: 0.60-0.86, P < 0.001). This study demonstrated the scalability of a research approach using survival analysis applied to general practice electronic health record data from multiple sites. We found no evidence of increased mortality due to statin-deprescribing decisions in primary care.

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study.

Objectives: Posttraumatic stress disorder (PTSD) is a prevalent mental health condition, and techniques using sensory stimulation in processing traumatic memories have gained attention. The Emotional Freedom Techniques (EFT) is a psychotherapy that combines tapping on acupoints with exposure to cognitive reframing. This pilot study aimed to assess the feasibility of EFT as a treatment for PTSD by answering the following research questions 1) What is the compliance and completion rate of patients with PTSD with regard to EFT protocol? Is the dropout rate reasonable? 2) Is the effect size of EFT protocol for PTSD sufficient to justify a future trial? Methods: Thirty participants diagnosed with PTSD were recruited. They received weekly EFT sessions for five weeks, in which they repeated a statement acknowledging the problem and accepting themselves while tapping the SI3 acupoint on the side of their hand. PTSD symptoms were evaluated using the PTSD Checklist for DSM-5 (PCL-5) before and after the intervention. Results: Of the 30 PTSD patients (mean age 34.1 ± 9.1, 80% female), 96.7% showed over 80% compliance to the EFT sessions, and 86.7% completed the entire study process. The mean PCL-5 total score decreased significantly after the intervention, with a large effect size (change from baseline -14.33 [95% CI -19.79, -8.86], p < 0.0001, d = 1.06). Conclusion: The study suggests that EFT is a feasible treatment for PTSD, with high session compliance and low dropout rates. The effect size observed in this study supports the need for a larger trial in the future to further investigate EFT as a treatment for PTSD. However, the lack of a control group and the use of a self-rated questionnaire for PTSD symptoms are limitations of this study. The findings of this pilot study can be used to plan a future trial.

Implementing and evaluating resources to support good maternity care for parents with learning disabilities: A qualitative feasibility study in England.

PROBLEM: Parents with learning disabilities are often disadvantaged and their needs not well understood in maternity services. BACKGROUND: Despite a global vision to improve maternity care, current evidence confirms poor pre- and post-natal care for parents with learning disabilities and their families. Midwives have expressed a need for support in the delivery of good care to this population of parents. AIM: To test the feasibility of implementing and evaluating two evidence-based and values-based resources - the Together Toolkit and Maternity Passport - to support good maternity care for people with learning disabilities. METHODS: A qualitative feasibility study employing semi-structured interviews with 17 midwives and 6 parents who had used the resources in practice in four NHS Trusts in the south of England. FINDINGS: Midwives and parents described how the resources positively impacted maternity care by enabling midwives, connecting networks and empowering parents. Factors affecting effective implementation of the resources were reported at an individual and setting level. DISCUSSION: Staff training to raise awareness and confidence in supporting parents with learning disabilities, and improved systems for recording parent's individual needs are required to enable the delivery of personalised care. CONCLUSION: Reasonable adjustments need to be prioritised to facilitate implementation of resources to support personalised maternity care and to address inequity for parents with learning disabilities. Aspirations for equity suggested commitment from midwives to challenge and overcome barriers to implementation. Recommendations were made to improve the resources and their implementation. These resources are free and accessible for use [www.surrey.ac.uk/togetherproject].

Implementation of home 'finger-prick' carcino-embryonic antigen testing for colorectal cancer follow-up - A pilot study of user acceptability.

Aim: Routine carcino-embryonic antigen blood testing is required after colorectal cancer resection, requiring face-to-face appointments. This has workforce implications, and impacts patients' lives. We assessed feasibility and acceptability of self-taken blood tests. Methods: 50 colorectal cancer patients with experience of face-to-face phlebotomy surveillance agreed to self-testing finger-prick kits. Follow-up questionnaires assessed perspectives and preferences. Results: 68% (50/74) of patients agreed to participate. 76% (38/50) successfully completed samples. 62% (29/47) felt it was no worse than their previous experience. Regarding future testing, 47% (22/47) preferred finger-prick testing. 19% (9/47) expressed no preference. This was unaffected by patient age. Qualitative assessment showed difficulties with pain, discomfort, and sample collection, but was more convenient and saved time for patients. Conclusions: Many preferred finger-prick assessment, but some found it challenging, unnecessary or less preferable. This may reduce burden of follow-up blood tests but currently would only be acceptable to a limited patient cohort.

Metformin for sepsis-associated AKI: a protocol for the Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis-associated AKI (LiMiT AKI).

INTRODUCTION: Acute kidney injury (AKI) is a common complication of sepsis associated with increased risk of death. Preclinical data and observational human studies suggest that activation of AMP-activated protein kinase, an ubiquitous master regulator of energy that can limit mitochondrial injury, with metformin may protect against sepsis-associated AKI (SA-AKI) and mortality. The Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis-associated AKI (LiMiT AKI) aims to evaluate the safety and feasibility of enteral metformin in patients with sepsis at risk of developing SA-AKI. METHODS AND ANALYSIS: Blind, randomised, placebo-controlled clinical trial in a single-centre, quaternary teaching hospital in the USA. We will enrol adult patients (18 years of age or older) within 48 hours of meeting Sepsis-3 criteria, admitted to intensive care unit, with oral or enteral access. Patients will be randomised 1:1:1 to low-dose metformin (500 mg two times per day), high-dose metformin (1000 mg two times per day) or placebo for 5 days. Primary safety outcome will be the proportion of metformin-associated serious adverse events. Feasibility assessment will be based on acceptability by patients and clinicians, and by enrolment rate. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board. All patients or surrogates will provide written consent prior to enrolment and any study intervention. Metformin is a widely available, inexpensive medication with a long track record for safety, which if effective would be accessible and easy to deploy. We describe the study methods using the Standard Protocol Items for Randomized Trials framework and discuss key design features and methodological decisions. LiMiT AKI will investigate the feasibility and safety of metformin in critically ill patients with sepsis at risk of SA-AKI, in preparation for a future large-scale efficacy study. Main results will be published as soon as available after final analysis. TRIAL REGISTRATION NUMBER: NCT05900284.

Recommendations for optimising pilot and feasibility work in surgery.

BACKGROUND: Surgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. METHODS: The findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS. RESULTS: The synthesis informed the development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS is not currently optimised. The four root causes identified include issues relating to (i) understanding the full scope of PAFS; (ii) design and conduct of PAFS; (iii) reporting of PAFS; and (iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform the development of a practical guidance tool for surgeons and study teams to improve research practice. CONCLUSIONS: Optimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our 'Top Tips' guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.