The use of EORTC measures in daily clinical practice-A synopsis of a newly developed manual.

Cancer has increasingly become a chronic condition and the routine collection of patient-reported outcomes (PROs) like quality of life is widely recommended for clinical practice. Nonetheless, the successful implementation of PROs is still a major challenge, although common barriers to and facilitators of their beneficial use are well known. To support health care professionals and other stakeholders in the implementation of the EORTC PRO measures, the EORTC Quality of Life Group provides guidance on issues considered important for their use in daily clinical practice. Herein, we present an outline of the newly developed "'Manual for the use of EORTC measures in daily clinical practice", covering the following issues: * a rationale for using EORTC measures in routine care *selection of EORTC measures, timing of assessments, scoring and presentation of results * aspects of a strategic implementation * electronic data assessment and telemonitoring, and * further use of EORTC measures and ethical considerations. Next to an extensive overview of currently available literature, the manual specifically focuses on knowledge about EORTC measures to give evidence-based recommendations whenever possible and to encourage readers and end-users of EORTC measures to contribute to further needed high-quality research. The manual will be accessible on the EORTC Quality of Life Group website's homepage and will be periodically updated to take into account any new knowledge due to medical, technical, regulatory and scientific advances

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.Conclusions: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT

Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR)

BACKGROUND: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. DESIGN: Phase I - realist review, survey and focus groups to develop the rehabilitation package. Phase II - parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. SETTING: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. PARTICIPANTS: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. INTERVENTIONS: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients' self-efficacy and increasing the amount and quality of patients' practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. MAIN OUTCOME MEASURES: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale - International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. RESULTS: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen's d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen's d = 0.31) and 1.3 (Cohen's d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information