Assistive devices among people living at home with advanced cancer: Use, non-use and who have unmet needs for assistive devices?

OBJECTIVE: To investigate which assistive devices people with advanced cancer have and whether they are in use. In addition, to explore the characteristics of people with advanced cancer who have unmet needs for assistive devices. METHODS: This descriptive cross-sectional study used data from a randomised controlled trial evaluating efficacy of an occupational therapy-based intervention. Participants were 237 people with advanced cancer. Data were collected by means of instruments about demography, functioning and assistive devices. RESULTS: The most frequent assistive devices possessed by the participants were as follows: (1) small aids for dressing (47%), (2) Pillow for positioning (40%) and (3) electrically operated adjustable bed (39%). The prevalence of assistive devices was 92% (95% confidence interval [CI]: 88%-95%) with 14.2% non-use, largest for trolley tables (50%). In all, 27.4% of the participants were found to have unmet needs for assistive devices. These participants had similar characteristics to the other participants except from lower activity of daily living (ADL) ability (p values = <0.001). CONCLUSION: The assistive devices possessed by the participants were primarily for positioning and resting, and most were in use. More than a fourth of the participants had unmet needs for assistive devices and were characterised by lower ADL ability.

Measurement Properties of Isokinetic Dynamometry for Assessment of Shoulder Muscle Strength: A Systematic Review.

OBJECTIVE: To investigate the evidence of measurement properties of isokinetic dynamometry (ID) for assessment of shoulder muscle strength in healthy individuals and patients with nonneurologic shoulder pathology. DATA SOURCES: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Physiotherapy Evidence Database were searched up to February 2020 without restrictions. Reference lists and citations were hand-searched. STUDY SELECTION: Two review authors independently included studies that met the following criteria: (1) evaluated measurement properties of ID when used on the glenohumeral joint and (2) included individuals 18 years and older. Studies including patients with neurologic, neuromuscular, or systemic diseases or critical illness were excluded. DATA EXTRACTION: The quality assessment and data synthesis were performed according to the COnsensus-based Standards for the selection of health Measurement INstruments methodology. DATA SYNTHESIS: Twenty-one studies with a total of 597 participants were included. The results were combined separately for isometric, concentric, and eccentric test mode; for the velocities 30°/s-60°/s, 90°/s, 120°/s, and 240°/s; for the seated, supine, and standing position; and for internal rotation (IR), external rotation (ER), and the ER/IR ratio. The reliability of ID was overall sufficient with the majority of intraclass correlation coefficients ≥0.70. The quality of evidence was moderate or low for 20 of 30 strata examined. The measurement error results were rated as insufficient for all strata. The SEM ranged from 4%-28%. The quality of evidence varied depending of strata examined. CONCLUSIONS: The reliability of ID for measurement of shoulder strength was overall sufficient for all positions, velocities, and modes of strength. The measurement error was not sufficient. Because most studies used the seated position, the velocities 30°/s-60°/s or 120°/s, and the concentric test mode, the quality of evidence was highest for these conditions.

Measurement properties of handheld dynamometry for assessment of shoulder muscle strength: A systematic review.

Like any assessment tool, handheld dynamometry (HHD) must be valid and reliable in order to be meaningful in clinical practice and research. To summarize the evidence of measurement properties of HHD for the assessment of shoulder muscle strength. Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, and PEDro were searched up to February 2020. Inclusion criteria were studies (a) evaluating HHD used on the glenohumeral joint, (b) evaluating measurement properties, and (c) included individuals ≥ 18 years old with or without shoulder symptoms. Exclusion criteria were studies (a) including patients with neurologic, neuromuscular, systemic diseases, or critical illness or bed-side patients and (b) that did not report the results separately for each movement. In total, 28 studies with 963 participants were included. The reliability results showed that 98% of the intraclass correlation coefficient (ICC) values were ≥0.70. The measurement error showed that the minimal detectable change in percent varied from 0% to 51.0%. The quality of evidence was high or moderate for the majority of movements and type of reliability examined. Based on the evidence of low or very low quality of evidence, the convergent validity and discriminative validity of HHD were either sufficient, indeterminate, or insufficient. The reliability of HHD was overall sufficient, and HHD can be used to distinguish between individuals on the group level. The measurement error was not sufficient, and evaluation of treatment effect on the individual level should be interpreted with caution.

Identifying elderly patients at risk of readmission after discharge from a short-stay unit in the emergency department using performance-based tests of daily activities.

BACKGROUND: Readmission is a serious and adverse event for elderly patients. Despite efforts, predicting the risk of readmission remains imprecise. The objective of this study is to examine if performance-based tests of daily activities can identify elderly patients at risk of readmission within 26 weeks after discharge from a short-stay unit in the emergency department. METHODS: The current study is an observational study based on data from 144 elderly patients included in a previous non-randomised controlled trial. Before discharge, patients were assessed for limitations in performing daily activities using three performance-based tests with predetermined cut-off values: the Assessment of Motor and Process Skills, Timed Up and Go and the 30s-Chair Stand Test. Outcome was risk of readmission within 26 weeks after discharge. RESULTS: Limitations in performing daily activities were associated with risk of readmission as measured by the Assessment of Motor and Process Skills motor scale (Crude OR = 4.38 [1.36; 14.12]), (Adjusted OR = 4.17 [1.18; 14.75]) and the 30s-Chair Stand Test (Adjusted OR = 3.36 [1.42; 7.93]). No significant associations were found in regards to other measures. CONCLUSION: The Assessment of Motor and Process Skills motor scale and the age, gender and comorbidity adjusted 30s-Chair Stand Test can identify elderly patients at increased risk of readmission after discharge from the emergency department. The results were limited by one-third of the patients did not perform the Assessment of Motor and Process Skills and the association between 30s-Chair Stand Test and risk of readmission were only positive when adjusted for age, gender and comorbidity.

A comparison of high versus low dose of exercise training in exercise-based cardiac rehabilitation: a randomized controlled trial with 12-months follow-up.

OBJECTIVE: To assess if a higher dose of exercise training in exercise-based cardiac rehabilitation could affect improvements in aerobic capacity and muscle strength. DESIGN: Assessor-blinded randomized controlled trial with 12-months follow-up. SETTING: Aarhus University Hospital, Aarhus, Denmark. SUBJECTS: A total of 164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited. INTERVENTIONS: Patients were randomized to 1-hour exercise sessions either three times weekly for 12 weeks (36 sessions, high-dose group) or twice weekly for 8 weeks (16 sessions, low-dose group). The same standardized exercise and intensity protocol including aerobic and muscle strength training was used in all participants. MAIN MEASURES: Primary outcome was changes in VO2peak. Secondary outcomes were changes in maximal workload, muscle strength and power. Measures were obtained at baseline, after termination of the rehabilitation programme and at follow-up after 6 and 12 months. RESULTS: After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO2peak 2.6 (mL kg-1 min-1) (95% confidence interval (CI): 0.4-4.8), maximal workload 0.3 W kg-1 (95%CI: 0.02-0.5), isometric muscle strength 0.7 N m kg-1 (95%CI: 0.1-1.2) and muscle power 0.3 W kg-1 (95%CI: 0.04-0.6). After 12 months, a significant between-group difference only persisted in VO2peak and maximal workload. CONCLUSION: A higher dose of exercise training had a small effect on all outcomes at termination of intervention. A long-term effect persisted in VO2peak and maximal workload. Although the effect was small, it is an important finding because VO2peak is the most important predictor of all-cause mortality in cardiac patients.

Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data. DESIGN: Economic evaluation alongside a randomized controlled trial with two-year follow-up. SETTING: Patients from the outpatient clinics of a university hospital and a general hospital. SUBJECTS: A total of 82 lumbar spinal fusion patients. INTERVENTIONS: Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation. MAIN MEASURES: Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects. RESULTS: No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion. CONCLUSION: This case manager-assisted rehabilitation programme was unlikely to be cost-effective.

Does adding case management to standard rehabilitation affect functional ability, pain, or the rate of return to work after lumbar spinal fusion? A randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the effect of a case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation in patients undergoing lumbar spinal fusion. DESIGN: A randomized controlled trial with a two-year follow-up. SETTINGS: Outpatient clinics of a university hospital and a general hospital. SUBJECTS: In total, 82 patients undergoing lumbar spinal fusion. INTERVENTIONS: The patients were randomized one-to-one to case manager-assisted rehabilitation (case manager group) or no case manager-assisted rehabilitation (control group). Both groups received usual physical rehabilitation. The case manager-assisted rehabilitation programme included a preoperative meeting with a case manager to determine a rehabilitation plan, postsurgical meetings, phone meetings, and voluntary workplace visits or roundtable meetings. MAIN MEASURES: Primary outcome was the Oswestry Disability Index. Secondary outcomes were back pain, leg pain, and return to work. RESULTS: Of the 41 patients in the case manager group, 49% were men, with the mean age of 46.1 (±8.7 years). In the control group, 51% were male, with the mean age of 47.4 (±8.9 years). No statistically significant between-group differences were found regarding any outcomes. An overall group effect of 4.1 points (95% confidence interval (CI): -1.8; 9.9) was found on the Oswestry Disability Index, favouring the control group. After two years, the relative risk of return to work was 1.18 (95% CI: 0.8; 1.7), favouring the case manager group. CONCLUSION: The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation. The study lacked power to evaluate the impact on return to work.

Development of a complex intervention aimed at reducing the risk of readmission of elderly patients discharged from the emergency department using the intervention mapping protocol.

BACKGROUND: Limitations in performing daily activities and a incoherent discharge are risk factors for readmission of elderly patients after discharge from the emergency department. This paper describes the development and design of a complex intervention whose aim was to reduce the risk of readmission of elderly patients discharged from the emergency department. METHODS: The intervention was described using the Intervention Mapping approach. In step 1, a needs assessment was conducted to analyse causes of readmission. In steps 2 and 3, expected improvements in terms of intervention outcomes, performance objectives and change objectives were specified and linked to selected theory- and evidence-based methods. In step 4, the specific intervention components were developed; and in step 5, an implementation plan was described. Finally, in step 6, a plan for evaluating the effectiveness of the intervention was described. The intervention was informed by input from a literature search, informal interviews and an expert steering group. RESULTS: A three-phased theory- and evidence-based intervention was developed. The intervention consisted of 1) assessment of performance of daily activities, 2) defining a rehabilitation plan and 3) a follow-up home visit the day after discharge with focus on enhancing the patients' performance of daily activities. CONCLUSION: The intervention mapping protocol was found to be a useful method to describe and systemize this theory- and evidence-based intervention.

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients.

BACKGROUND: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF). METHODS: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records. RESULTS: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention. CONCLUSION: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention. TRIAL REGISTRATION: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.

BACKGROUND: The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. METHODS/DESIGN: The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. DISCUSSION: It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42281022.

Prognostic factors for high societal costs: a register-based study on 561,665 patients with shoulder disorders.

ABSTRACT: Shoulder disorders are common and associated with high societal costs, especially for a small group of patients. Prognostic factors can help identify high-cost patients, which is crucial to optimize early identification and develop tailored interventions. We aimed to identify prognostic factors for high societal costs, to examine whether the prognostic factors were similar for high healthcare costs and high costs of sick leave, and to investigate the model's robustness across 4 diagnostic categories. Using national Danish registers, potential prognostic factors (age, sex, educational level, long-term sick leave, admission, visits to general practitioner and physiotherapist, comorbidity, diabetes, low back pain, and neck pain) were included in a logistic regression model with high societal costs, defined by the top 10th percentile, as the main outcome. The model's prognostic accuracy was assessed using the Nagelkerke R2 and its discriminative ability using area under the receiver operating curve (AUC). Data on 80% of the patients (n = 449,302) were used to develop the model and 20% (n = 112,363) to validate the model. By far the strongest prognostic factor for high societal costs and high costs of sick leave was sick leave at the time of diagnosis (OR: 20.2, 95% CI: 19.5-20.9). Prognostic factors for high healthcare costs were high age, comorbidity, and hospital admission the year before diagnosis. The model was robust across diagnostic categories and sensitivity analyses. In the validation sample, the primary model's discriminative ability was good (AUC = 0.80) and the model explained 28% of the variation in the outcome (Nagelkerke R2 ).

Telephone consultation for cancer survivors with unclarified need for rehabilitation in a primary healthcare setting: a mixed methods process evaluation.

PURPOSE: To evaluate the implementation of telephone consultations to assess cancer patients' needs for rehabilitation, with focus on patients' acceptance, health professionals' experience and contextual factors. METHODS: A mixed methods process evaluation was conducted at a primary healthcare rehabilitation clinic. Cancer survivors above 18 years of age with an unclarified rehabilitation need at discharge from hospital, was offered a telephone consultation provided by health professionals. Data on implementation and acceptability were collected using medical records systems, data collection forms and semi-structured interviews with six patients and two health professionals. RESULTS: Eighty-one cancer survivors were referred to the intervention, and 54% continued to further rehabilitation. The telephone consultations were executed approximately eight days after referral and took on average 44 min to deliver. Overall, the patients found that the telephone consultation addressed what they considered the most important topics, and the health professionals found the intervention to be acceptable. Both patients and health professionals reported challenges regarding the referral process. CONCLUSION: Patient acceptance of the intervention was high, and the telephone consultation was implemented to a high degree, resulting in more than half of the patients continuing to further rehabilitation. Patients' and health professionals' perspectives provided valuable insights about contextual factors.

Bridging Inequity Gaps in Healthcare Systems While Educating Future Healthcare Professionals-The Social Health Bridge-Building Programme.

Social inequity in healthcare persists even in countries with universal healthcare. The Social Health Bridge-Building Programme aims to reduce healthcare inequities. This paper provides a detailed description of the programme. The Template for Intervention Description and Replication (TIDieR) was used to structure the description. The programme theory was outlined using elements from the British Medical Research Council's framework, including identifying barriers to healthcare, synthesising evidence, describing the theoretical framework, creating a logic model, and engaging stakeholders. In the Social Health Bridge-Building Programme, student volunteers accompany individuals to healthcare appointments and provide social support before, during, and after the visit. The programme is rooted in a recovery-oriented approach, emphasising personal resources and hope. The programme finds support in constructs within the health literacy framework. Student volunteers serve as health literacy mediators, supporting individuals in navigating the healthcare system while gaining knowledge and skills. This equips students for their forthcoming roles as healthcare professionals, and potentially empowers them to develop and implement egalitarian initiatives within the healthcare system, including initiatives that promote organisational health literacy responsiveness. The Social Health Bridge-Building Programme is a promising initiative that aims to improve equity in healthcare by addressing individual, social, and systemic barriers to healthcare. The programme's description will guide forthcoming evaluations of its impact.

The Canadian Occupational Performance Measure's semi-structured interview: its applicability to lumbar spinal fusion patients. A prospective randomized clinical study.

BACKGROUND: Although lumbar spinal fusion has been performed for more than 70 years, few studies have examined rehabilitation strategies for spinal fusion patients, and there is only sparse information about the patient's activity level after surgery. The Canadian Occupational Performance Measure (COPM) is a standardized semi-structured interview, developed to identify patients' problems in relation to activities of daily living (ADL). The COPM has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients. We aimed to examine whether or not the use of the semi-structured interview COPM during in-hospital rehabilitation could: (1) identify more ADL-related problems of importance to the patients after discharge from the hospital, (2) enhance the patients' ADL performance after discharge from hospital METHOD: Eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the COPM or to standard treatment. RESULTS AND CONCLUSION: Use of the COPM during hospitalization helped in identifying more ADL problems encountered by patients during the first 3 months post-discharge period as COPM served to identify more treatment goals and plans of action. Use of the COPM had no impact on the patients' ADL performance, and the difference is so small that COPM may be of little clinical consequence.

Costs of shoulder disorders in Denmark: a nationwide cost-of-illness study investigating 617,334 patients and matched controls.

ABSTRACT: Shoulder disorders are very common musculoskeletal conditions. Few studies have focused on the costs associated with shoulder disorders, and the economic burden has never been established in a nationwide cost-of-illness study. We aimed to evaluate the healthcare costs and costs of productivity loss (sick leave) and to evaluate if costs were higher for specific subgroups. Using national Danish registers, we identified individuals with shoulder disorders (subacromial pain, stiffness, fracture, or dislocation) diagnosed between 2005 and 2017 and controls matched on age and gender without shoulder disorders. Health care usage, sick leave, and related costs were estimated. During the 13-year inclusion period, 617,334 unique individuals were identified and the incidence rate was 1215 per 100,000 person-years in 2017. The expected additional societal costs were €1.21 billion annually. The mean additional total costs for the 6-year period were €11,334 (11,014-11,654) for individuals aged ≥65 years and €25,771 (25,531-26,012) for individuals aged <65 years. For individuals in the working age, the costs of sick leave accounted for approximately 70% of the total costs. Individuals aged ≥65 years had healthcare costs that were twice as high as individuals aged <65 years. Additionally, the 20% of cases accruing the highest costs accounted for 66% of the total costs. In conclusion, incidence rates of shoulder disorders were high and costs of sick leave accounted for a large proportion of total costs associated with illness in working age people. Furthermore, a minority of patients accounted for a substantial share of the total costs.

Mental Fatigue, Activities of Daily Living, Sick Leave and Functional Status among Patients with Long COVID: A Cross-Sectional Study.

Studies suggest that persistent symptoms after COVID-19 (long COVID) influence functioning and activities of daily living (ADL). However, it is still uncertain how and to what extent. This study aimed to describe patient-reported mental fatigue, ADL problems, ADL ability, sick leave and functional status among patients with long COVID. In this cross-sectional study, 448 patients, ≥18 years old and referred to occupational therapy at a Danish Post-COVID-19 Clinic, were included. Mental fatigue was measured by the Mental Fatigue Scale, ADL problems and ability were measured by the Canadian Occupational Performance Measure, sick leave was self-reported and functional status was evaluated by the Post-COVID-19 Functional Status Scale. Mean age was 46.8 years, 73% of the patients were female, and 75% suffered from moderate to severe mental fatigue. The majority reported difficulties performing productive and leisure activities. The median performance and satisfaction scores were 4.8 and 3, respectively. In total, 56% of the patients were on sick leave, and 94% were referred to rehabilitation. A decrease in functional status was found between pre-COVID-19 and assessment. Conclusively, the patients were highly affected in their everyday life and had distinct rehabilitation needs. Future research is needed to address causalities and rehabilitation for this patient group.

Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial).

INTRODUCTION: Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation. METHODS AND ANALYSIS: In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors. ETHICS AND DISSEMINATION: The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences. TRIAL REGISTRATION NUMBER: NCT04795843.

Construct Validity and Clinical Utility of World Health Organization Disability Assessment Schedule 2.0 in Older Patients Discharged From Emergency Departments.

Introduction: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is designed to measure functioning and disability in six domains. It is included in the International Classification of Diseases 11th revision (ICD-11). The objective of the study was to examine the construct validity of WHODAS 2.0 and describe its clinical utility for the assessment of functioning and disability among older patients discharged from emergency departments (EDs). Material and Methods: This cross-sectional study is based on data from 129 older patients. Patients completed the 36-item version of WHODAS 2.0 together with the Barthel-20, the Assessment of Motor and Process Skills (AMPS), Timed Up and Go (TUG), and the 30-Second Chair Stand Test (30 s-CST). Construct validity was examined through hypothesis testing by correlating the WHODAS with the other instruments and specifically the mobility domain in WHODAS 2.0 with the TUG and 30 s-CST tests. The clinical utility of WHODAS 2.0 was explored through floor/ceiling effect and missing item responses. Results: WHODAS 2.0 correlated fair with Barthel-20 (r = -0.49), AMPS process skills (r = -0.26) and TUG (r=0.30) and correlated moderate with AMPS motor skills (r = -0.58) and 30s-CST (r = -0.52). The WHODAS 2.0 mobility domain correlated fair with TUG (r = 0.33) and moderate with 30s-CST (r = -0.60). Four domains demonstrated floor effect: D1 "Cognition," D3 "Self-care," D4 "Getting along," and D5 "Household." Ceiling effect was not identified. The highest proportion of missing item responses were present for Item 3.4 (Staying by yourself for a few days), Item 4.4 (Making new friends), and Item 4.5 (Sexual activities). Conclusion: WHODAS 2.0 had fair-to-moderate correlations with Barthel-20, AMPS, TUG, and 30s-CST and provides additional aspects of disability compared with commonly used instruments. However, the clinical utility of WHODAS 2.0 applied to older patients discharged from EDs poses some challenges due to floor effect and missing item responses. Accordingly, patient and health professional perspectives need further investigation.

Evaluating a complex intervention addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a randomised controlled trial (ABLE).

INTRODUCTION: The need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council's guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme. METHODS AND ANALYSIS: The evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers. ETHICS AND DISSEMINATION: Danish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT04295837.

Subgroup effects of occupational therapy-based intervention for people with advanced cancer.

Background: Many people with advanced cancer have decreased ability to perform activities of daily living (ADL). We recently performed a randomized, controlled trial (RCT) assessing the efficacy of an occupational therapy-based program, the 'Cancer Home-Life Intervention' in people with advanced cancer (N = 242) and found no overall effects on ADL ability. However, heterogeneity of treatment effect may disguise subgroup differences.Objective: To investigate whether subgroups of people with advanced cancer gain positive effects from the 'Cancer Home-Life Intervention' on ADL ability.Material and method: An exploratory subgroup analysis including 191 participants from a RCT. The outcome was ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS). Subgroups were defined by age, gender, years of education, type of primary tumor, functional level, and activity problems.Results: The 'Cancer Home-Life Intervention' had no statistically significant effect in the six subgroups. Modifying effects of age (0.30 [95% CI: -0.05 to 0.64]) and gender (0.23 [95% CI: -0.11 to 0.57]) were not found.Conclusion: There were no subgroup effects of the 'Cancer Home-Life Intervention'on ADL motor ability. Some indications suggest greater effects for those aged below 69 years; however, this result should be interpreted with caution.