Dataset Information

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

ABSTRACT:

Background

Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR).

Methods

Primary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC).

Results

It was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88.It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items.

Conclusions

The use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated.

Trial registration

Trial registration: ISRCTN22464643 Registered 21 July 2014.

SUBMITTER: Williams NH

PROVIDER: S-EPMC5937043 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Publications

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

Williams Nefyn H NH Mawdesley Kevin K Roberts Jessica L JL Din Nafees Ud NU Totton Nicola N Charles Joanna M JM Hoare Zoe Z Edwards Rhiannon T RT

Pilot and feasibility studies 20180507

<h4>Background</h4>Health economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those da ...[more]

PMID: 29760941

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Project description:IntroductionProximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.Methods and analysisProtocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.Ethics and disseminationNational Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.Trial registration numberISRCTN28376407; Pre-results registered on 23 November 2018.

Project description:BackgroundCardiac rehabilitation (CR), a multidisciplinary program consisting of exercise, risk factor modification and psychosocial intervention, forms an integral part of managing patients after myocardial infarction (MI), revascularization surgery and percutaneous coronary interventions, as well as patients with heart failure (HF). This systematic review seeks to examine the cost-effectiveness of CR for patients with MI or HF and inform policy makers in Singapore on published cost-effectiveness studies on CR.MethodsElectronic databases (EMBASE, MEDLINE, NHS EED, PEDro, CINAHL) were searched from inception to May 2010 for published economic studies. Additional references were identified through searching bibliographies of included studies. Two independent reviewers selected eligible publications based on the inclusion/exclusion criteria. Quality assessment of economic evaluations was undertaken using Drummond's checklist.ResultsA total of 22 articles were selected for review. However five articles were further excluded because they were cost-minimization analyses, whilst one included patients with stroke. Of the final 16 articles, one article addressed both centre-based cardiac rehabilitation versus no rehabilitation, as well as home-based cardiac rehabilitation versus no rehabilitation. Therefore, nine studies compared cost-effectiveness between centre-based supervised CR and no CR; three studies examined that between centre- and home based CR; one between inpatient and outpatient CR; and four between home-based CR and no CR. These studies were characterized by differences in the study perspectives, economic study designs and time frames, as well as variability in clinical data and assumptions made on costs. Overall, the studies suggested that: (1) supervised centre-based CR was highly cost-effective and the dominant strategy when compared to no CR; (2) home-based CR was no different from centre-based CR; (3) no difference existed between inpatient and outpatient CR; and (4) home-based programs were generally cost-saving compared to no CR.ConclusionsOverall, all the studies supported the implementation of CR for MI and HF. However, comparison across studies highlighted wide variability of CR program design and delivery. Policy makers need to exercise caution when generalizing these findings to the Singapore context.

Project description:To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.Mixed methods process evaluation in a randomised feasibility study.Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge.Sixty-one older adults (aged ?65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers.Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions.Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context.Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions.Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care.ISRCTN22464643; Post- results.

Project description:BackgroundA Rehabilitation Program for older adults with hip fracture (HIP-REP) based on Activity of Daily Living has been developed. The objectives of this study were to assess the feasibility and safety of the HIP-REP program to inform a future randomized controlled trial (RCT).MethodsA feasibility study Inspired by the Complex-intervention development (Medical Research Council framework phase II) design using quantitative and qualitative research methods were conducted. Eighteen participants (above 65 years) with hip fracture were recruited from the orthopedic wards. The setting was cross sectoral including Copenhagen University Hospital, Herlev and Gentofte and rehabilitation centers in Herlev, Gentofte and Lyngby-Taarbæk municipalities. A cross-sectoral rehabilitation intervention tailored to the needs of older adults with hip fracture highlighting systematic goal setting and strategies focused on activities of daily living was conducted. Pre-defined feasibility criteria: participants recruitment and retention, duration of measuring the outcome, adherence to intervention, and adverse events, along with self-reported outcomes and an objective measurement of performance in activity of daily living. Focus groups were analyzed using a deductive manifest content analysis approach. Descriptive statistical analysis and paired t-tests were performed for assessing change in outcome measures.ResultsRecruitment rate was 4.5/month. Outcome measures were performed but length and number of questionnaires were a burden. Thirteen out of eighteen participants completed the study three dropped out and two died. Adherence among the 13 was 100%. Focus group revealed issues regarding coordinating the intervention, ensuring procedural processes across sectors regarding recruitment of participants, and documentation in the database. Participants expressed satisfaction with the intervention and felt safe during intervention. Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability. No clear association between outcome improvements and intervention adherence.ConclusionsThe cross-sectoral intervention based on daily activities was feasible and safe for older adults with hip fracture. A future RCT, with an improved recruitment strategy and reduced number of outcome measures will evaluate the effectiveness in improving independence and safety performance of activity of daily living.Trial registrationClinicalTrials.gov ID: NCT03828240 . Registered on January 29, 2019.

Project description:BackgroundRandomised controlled trials (RCTs) are generally regarded as the "gold standard" for providing quantifiable evidence around the effectiveness and cost-effectiveness of new healthcare technologies. In order to perform the economic evaluations associated with RCTs, there is a need for accessible and good quality resource-use data; for the purpose of discussion here, data that best reflect the care received. Traditionally, researchers have developed questionnaires for resource-use data collection. However, the evolution of routinely collected electronic data within care services provides new opportunities for collecting data without burdening patients or caregivers (e.g. clinicians). This paper describes the potential strengths and limitations of each data collection method and then discusses aspects for consideration before choosing which method to use.Main textWe describe electronic data sources (large observational datasets, commissioning data, and raw data extraction) that may be suitable data sources for informing clinical trials and the current status of self-reported instruments for measuring resource-use. We assess the methodological risks and benefits, and compare the two methodologies. We focus on healthcare resource-use; however, many of the considerations have relevance to clinical questions. Patient self-report forms a pragmatic and cheap method that is largely under the control of the researcher. However, there are known issues with the validity of the data collected, loss to follow-up may be high, and questionnaires suffer from missing data. Routinely collected electronic data may be more accurate and more practical if large numbers of patients are involved. However, datasets often incur a cost and researchers are bound by the time for data approval and extraction by the data holders.ConclusionsOwing to the issues associated with electronic datasets, self-reported methods may currently be the preferred option. However, electronic hospital data are relatively more accessible, informative, standardised, and reliable. Therefore in trials where secondary care constitutes a major driver of patient care, detailed electronic data may be considered superior to self-reported methods; with the caveat of requiring data sharing agreements with third party providers and potentially time-consuming extraction periods. Self-reported methods will still be required when a 'societal' perspective (e.g. quantifying informal care) is desirable for the intended analysis.

Project description:BackgroundDelirium is a brain condition associated with poor outcomes in rehabilitation. It is therefore important to assess delirium incidence in rehabilitation.PurposeTo develop and validate a chart-based method to identify incident delirium episodes within the electronic database of a Swiss rehabilitation clinic, and to identify a study population of validated incident delirium episodes for further research purposes.DesignRetrospective validation study.SettingsRoutinely collected inpatient clinical data from ZURZACH Care.ParticipantsAll patients undergoing rehabilitation at ZURZACH Care, Rehaklinik Bad Zurzach between 2015 and 2018 were included.MethodsWithin the study population, we identified all rehabilitation stays for which ≥2 delirium-predictive key words (common terms used to describe delirious patients) were recorded in the medical charts. We excluded all prevalent delirium episodes and defined the remaining episodes to be potentially incident. At least two physicians independently confirmed or refuted each potential incident delirium episode by reviewing the patient charts. We calculated the positive predictive value (PPV) with 95% confidence interval (95% CI) for all potential incident delirium episodes and for specific subgroups.ResultsWithin 10,515 rehabilitation stays we identified 554 potential incident delirium episodes. Overall, 125 potential incident delirium episodes were confirmed by expert review. The PPV of the chart-based method varied from 0.23 (95% CI 0.19-0.26) overall to 0.69 (95% CI 0.56-0.79) in specific subgroups.ConclusionsOur chart-based method was able to capture incident delirium episodes with low to moderate accuracy. By conducting an additional expert review of the medical charts, we identified a study population of validated incident delirium episodes. Our chart-based method contributes towards an automated detection of potential incident delirium episodes that, supplemented with expert review, efficiently yields a validated population of incident delirium episodes for research purposes.

Dataset Information

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

Background

Methods

Results

Conclusions

Trial registration

Publications

Hip fracture in the elderly multidisciplinary rehabilitation (FEMuR) feasibility study: testing the use of routinely collected data for future health economic evaluations.

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