Integrated Geriatric Assessment and Treatment Effectiveness (INTEGERATE) in older people with cancer starting systemic anticancer treatment in Australia: a multicentre, open-label, randomised controlled trial.

BACKGROUND: The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear. We evaluated whether CGA can improve health-related quality of life (HRQOL) in older people with cancer who are starting systemic anticancer treatment. METHODS: INTEGERATE is a multicentre, open-label, pragmatic, parallel-group, randomised controlled trial that was done at three hospitals in Australia. Participants aged 70 years and older with solid cancer or diffuse large B-cell lymphoma planned for chemotherapy, targeted therapy, or immunotherapy, were randomly assigned (1:1; using a central computer-generated minimisation algorithm with a random element, balancing treatment intent, cancer type, age, sex, and performance status) to receive CGA integrated into oncology care (integrated oncogeriatric care) or usual care only. Group assignment was not concealed from the participants and clinicians. The primary outcome was HRQOL over 24 weeks, assessed at baseline, week 12, week 18, and week 24, using the Elderly Functional Index (ELFI; score range 0-100). Analyses were by intention to treat. The trial is registered with ANZCTR.org.au, ACTRN12614000399695, and is completed. FINDINGS: Between Aug 18, 2014, and Sept 5, 2018, 154 participants were randomly assigned to integrated oncogeriatric care (n=76) or usual care (n=78). 13 participants died by week 12 and 130 (92%) of the remaining 141 participants completed two or more ELFI assessments. Participants assigned to integrated oncogeriatric care reported better adjusted ELFI change scores over 24 weeks compared with those in the usual care group (overall main effect of group: t=2·1, df=213, p=0·039; effect size=0·38), with maximal between-group differences at week 18 (mean difference in change 9·8 [95% CI 2·4-17·2]; p=0·010, corrected p=0·030, effect size=0·48). The integrated oncogeriatric care group also had significantly fewer unplanned hospital admissions at 24 weeks (multivariable-adjusted incidence rate ratio 0·60 [95% CI 0·42-0·87]; p=0·0066). No statistically significant between-group difference was observed in overall survival. INTERPRETATION: CGA led to better quality of life and health-care delivery in older people receiving systemic anticancer treatment. Routine CGA-based interventions should be considered in at-risk older people starting systemic anticancer treatment. FUNDING: National Health and Medical Research Council (Australia), Monash University, and Eastern Health.

The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation study.

BACKGROUND: Functional assessment of patients with cancer can be challenging and is often undertaken by the clinician with minimal direct input from the patient. We developed and aimed to validate the Elderly Functional Index (ELFI), a composite measure of self-reported functioning in older patients with cancer. METHODS: In this multicentre, prospective validation study, we validated ELFI in adult patients attending five oncology practices in Australia. ELFI is a 12-item composite measure of self-reported functioning derived from functional scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ): physical, role, and social functioning, and mobility. For evaluation of validity and internal consistency, participants self-completed ELFI, cognitive functioning and emotional functioning scales of the EORTC QLQ Core-30, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), instrumental activities of daily living (IADL), and Clinical Frailty Scale (CFS) at baseline. For evaluation of test-retest reliability, participants opted in to repeat ELFI, cognitive functioning scale, emotional functioning scale, and ECOG-PS 1 week later, as well as completing the Global Rating of Change. Internal consistency reliability was assessed using Cronbach's α and test-retest reliability was assessed using intraclass correlation (ICC). We assessed ELFI for convergent and discriminant validity (Spearman's r), known-groups validity (ANOVA), and structural validity (exploratory factor analysis). FINDINGS: Between May 6 and Dec 15, 2017, 877 participants with cancer returned a total of 869 baseline questionnaires and 482 retest questionnaires. 621 (71%) participants (192 [31%] aged ≥70 years) were included in evaluations of validity and internal consistency and 278 (32%) participants (106 [38%] aged ≥70 years) in evaluations of test-retest reliability. ELFI demonstrated excellent internal consistency reliability (Cronbach's α=0·93 for all participants; p<0·0001) and test-retest reliability (overall ICC 0·90, 95% CI 0·87-0·92; p<0·0001). Hypotheses regarding convergent and discriminant validity were confirmed, with all item-scale correlations exceeding 0·40 except for one on the physical functioning scale. ELFI was better than its component scales and other function measures at differentiating between groups with different function and frailty scores (known-groups validity). Exploratory factor analysis provided empirical support to the structural validity of ELFI. Strong correlation was observed between ELFI and its component scales (r ranging from 0·67 to 0·79), ECOG-PS (-0·79), IADL (0·69), and CFS (-0·73). INTERPRETATION: ELFI is a validated and simple person-reported multidimensional measure of functional status, which captures broad dimensions of functioning. ELFI has enhanced statistical efficiency relative to its components, reducing the sample size required to detect a given effect. ELFI could be used as a clinical trial endpoint to assess functional domains of health-related quality of life. FUNDING: National Health and Medical Research Council, Monash University, Eastern Health.

Direct supervision of physiotherapists improves compliance with clinical practice guidelines for patients with hip fracture: a controlled before-and-after study.

Purpose: To determine if the addition of direct supervision to usual clinical supervision practice of physiotherapists can improve compliance with clinical practice guidelines and post-surgical outcomes for inpatients with hip fracture.Methods: A controlled before-and-after study was conducted on two acute orthopedic wards. Junior and mid-level physiotherapists on one ward were provided with direct supervision during their post-operative management of patients with hip fracture. Physiotherapists on the comparison ward received usual reflective supervision. The primary outcome was patient compliance with the hip fracture guideline to mobilize on the day following surgery. Secondary patient outcomes included physical function on the fifth post-operative day.Results: Data were collected from 290 patients with acute hip fracture. Patients at the direct supervision site were more likely to mobilize on the day after surgery [OR 3.14, 95% confidence interval (CI) 1.41-7.01; p = 0.005] and by the second post-operative day (OR 4.62, 95% CI 2.31-9.23; p < 0.001) compared to patients at the comparison site. Patients walked further on the fifth post-operative day (p < 0.001) with less assistance from therapists (p = 0.044).Conclusions: The addition of direct supervision improved physiotherapists' compliance with hip fracture guidelines and walking endurance and independence in hospitalized patients with hip fracture.Implications for rehabilitationThe addition of a direct supervision model, where physiotherapists are directly observed in their management of patients with hip fracture, to usual practice supervision improved early mobilization of patients with hip fractureDirect supervision appears to be an effective guideline implementation strategy that can improve care and outcomes for hospitalized patients with hip fracture.