Co-producing Progression Criteria for Feasibility Studies: A Partnership between Patient Contributors, Clinicians and Researchers

Young, Hannah; Goodliffe, Samantha; Madhani, Meeta; Phelps, Kay; Regen, Emma; Locke, Anthony; Burton, James O.; Singh, Sally; Smith, Alice C.; Conroy, Simon

doi:10.3390/ijerph16193756

Cited by 23 publications

(19 citation statements)

References 39 publications

(87 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For recruitment and retention, 50% and 75% were selected, respectively, as we recognised that not all patients may want to participate in research while in hospital and that the intervention (being technology-based) may not appeal to some patients. The values selected are consistent with those developed for a similar randomised controlled feasibility study of a complex intervention to reduce frailty and falls among haemodialysis patients [27].…”

Section: Study Overview and Aimssupporting

confidence: 71%

Using Technology to Promote Patient Engagement in Nutrition Care: A Feasibility Study

et al. 2021

View full text Add to dashboard Cite

Empowering patients to participate in nutrition care during hospitalisation may improve their dietary intakes and associated outcomes. This study tested the acceptability and feasibility of a technology-based intervention to engage hospital patients in nutrition care at a tertiary teaching hospital in Australia. The hospital used an electronic foodservice system (EFS), by which patients ordered meals via bedside computers. Adults at nutritional risk received the nutrition technology (NUTRI-TEC) intervention, involving nutrition assessment, education on nutrition requirements and training on using the EFS to enter food intakes and monitor nutrition goals. Acceptability was assessed using patient satisfaction and engagement surveys. Feasibility was assessed by evaluating the intervention delivery/fidelity and patient recruitment/retention. Patients’ dietary intakes were observed daily to indicate the intervention’s effects and assess the accuracy of the patient-recorded intakes. Descriptive and inferential statistics were used to analyse the data. Of the 71 patients recruited, 49 completed the study (55% male; median (IQR) age 71 (65–78) years; length of stay 10 (7–14) days). Patient satisfaction with NUTRI-TEC was high. Intervention delivery and fidelity targets were met but recruitment (≥50%) and retention (≥75%) targets were not; only 31% of patients agreed to participate and 69% completed the study (mostly due to unexpected/early discharge). Patient- and researcher-recorded dietary intakes correlated strongly, indicating patients can record food intakes accurately using technology. This study highlights the important role technology is likely to play in facilitating patient engagement and improving care during hospitalisation.

show abstract

Section: Study Overview and Aimssupporting

confidence: 71%

Using Technology to Promote Patient Engagement in Nutrition Care: A Feasibility Study

et al. 2021

View full text Add to dashboard Cite

show abstract

“…For each criterion, the development of ‘stop’ (indicating when there are issues with the trial that cannot be resolved) and ‘go’ thresholds (when there are no issues that may impede the success of a trial) were co-produced by patients, clinicians and researchers. 19 20 Results falling between these thresholds indicated that adaptation to trial procedures may render a definitive RCT viable. 20 …”

Section: Methodsmentioning

confidence: 99%

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

et al. 2020

Self Cite

View full text Add to dashboard Cite

ObjectivesFrailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.DesignMixed-methods feasibility.Setting and participantsPrevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.InterventionsParticipants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).OutcomesPrimary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.Results124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.ConclusionsA definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.Trial registration numbersISRCTN11299707; ISRCTN12840463.

show abstract

“…Using this system, green “Go” indicated that all criteria has been met and a future, larger scale randomized trial should proceed, yellow “Amend” indicated that some changes should be made to the larger trial, and red “Stop” indicated that the investigators should not move forward with a larger trial. For our enrollment feasibility, an enrollment of ≥ 50% of qualifying patients was selected [ 19 ]. Progression criteria for cycling feasibility on eligible cycling days of ≥ 70% were chosen [ 19 ].…”

Section: Methodsmentioning

confidence: 99%

“…For our enrollment feasibility, an enrollment of ≥ 50% of qualifying patients was selected [ 19 ]. Progression criteria for cycling feasibility on eligible cycling days of ≥ 70% were chosen [ 19 ].…”

Section: Methodsmentioning

confidence: 99%

CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery

Newman

Kho

Harris

et al. 2021

Pilot Feasibility Stud

View full text Add to dashboard Cite

Background In-bed cycling is a novel modality for the initiation of early mobilization in the intensive care unit. No study has investigated its use in the critically ill, off-track post cardiac surgery population. Before conducting an effectiveness trial, feasibility data are needed. The aim of this study was to determine the feasibility of in-bed cycling in a population of off-track cardiac surgery patients. Methods We conducted a prospective feasibility study in a 16-bed adult cardiac surgery intensive care unit in Ontario, Canada. Previously ambulatory adults (≥ 18 years) who were mechanically ventilated for ≥ 72 h were enrolled within 3 to 7 days post cardiac surgery. Twenty minutes of in-bed cycling was delivered by ICU physiotherapists 5 days/week. The primary outcome, feasibility, was the percent of patient-cycling sessions that occurred when cycling was appropriate. The secondary outcome was cycling safety, measured as cycling discontinuation due to predetermined adverse events. Results We screened 2074 patients, 29 met eligibility criteria, and 23 (92%) consented. Patients were male (78.26%) with a median [IQR] age of 76 [11] years, underwent isolated coronary bypass (39.1%), and had a median EuroScore II of 5.4 [7.8]. The mean (SD) time post-surgery to start of cycling was 5.9 (1.4) days. Patients were cycled on 80.5% (136/169) of eligible days, with limited physiotherapy staffing accounting for 48.5% of the missed patient-cycling sessions. During 136 sessions of cycling, 3 adverse events occurred in 3 individual patients. The incidence of an adverse event was 2.2 per 100 patient-cycling sessions (95% CI 0.50, 6.4). Conclusions In-bed cycling with critically ill cardiac surgery patients is feasible with adequate physiotherapy staffing and appears to be safe. Future studies are needed to determine the effectiveness of this intervention in a larger sample. Trial registration This trial was registered with Clinicaltrials.gov (NCT02976415). Registered November 29, 2016.

show abstract

Co-producing Progression Criteria for Feasibility Studies: A Partnership between Patient Contributors, Clinicians and Researchers

Cited by 23 publications

References 39 publications

Using Technology to Promote Patient Engagement in Nutrition Care: A Feasibility Study

Using Technology to Promote Patient Engagement in Nutrition Care: A Feasibility Study

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery

Contact Info

Product

Resources

About