Reliability of interview-based ADL ability measures in older adults obtained by occupational therapists, physical therapists, and nursing staff.

Purpose: To examine the reliability of ADL interview (ADL-I) ability measures when administered by different health professionals (HPs).Materials and methods:Older adults with stable ADL ability were invited to participate in three ADL-I interviews, administered by occupational therapists (OTs), physical therapists (PTs), and nursing staff (NS), respectively. Methods based on classic and modern test theory were applied.Results:Overall, n = 36 older adults and n = 11 HPs participated. Intraclass Correlation Coefficients were acceptable for research purposes (> 0.7), but not for clinical use. Mean differences in ADL ability measures were significant when comparing measures based on interviews by OTs to measures based on interviews by PTs and NS. Further, in 25 to 47% of the individuals, ADL-I ability measures differed significantly across HPs. Limits of Agreement revealed that measures based on interviews by OTs were systematically lower compared to measures based on interviews by PTs and NS. Four ADL-I items displayed Differential Item Functioning based on HP.Conclusion:When using the ADL-I, it is recommended to only involve one profession, to increase the reliability of measures. Results highlight the importance of evaluating reliability of measures based on instruments administered across HPs before implementation in rehabilitation practice and research.

Evaluations of activities of daily living (ADL) ability conducted in rehabilitation practice by different health professionals may not generate comparable results.When using the ADL-Interview, it is recommended to only involve one profession, to increase reliability of measures.The results of the present study highlight the importance of evaluating if ADL instruments can produce reliable measures in terms of both interrater reliability and measurement error.

Qualitative realist evaluation of an occupational therapy intervention programme (ABLE), addressing ability to perform activities of daily living among persons with chronic conditions.

BACKGROUND: Chronic conditions are associated with problems related to performance of activities of daily living (ADL) stressing a need to develop and evaluate intervention programmes addressing such problems. Hence, the ABLE programme was developed, and its feasibility evaluated. Implementing intervention programmes in community-based rehabilitation settings requires understanding of how the programme works in various contexts. Applying a realist evaluation approach, the aim of this study was to identify and evaluate interactions between contexts, mechanisms, and outcomes in the ABLE 2.0, to confirm, refine, or reject aspects of the initial programme theory. METHODS: Realist evaluation using qualitative data collected in the ABLE 2.0 randomised controlled trial (n = 78). Based on the ABLE 2.0 initial programme theory, qualitative realist interviews were conducted among receivers (n = 8) and deliverers (n = 3) of the ABLE 2.0 in a Danish municipality. Transcripts were coded, and context-mechanism-outcome configurations were extracted and grouped into contiguous themes. Results were then held up against the initial programme theory. RESULTS: Four contiguous themes were identified including a total of n = 28 context-mechanism-outcome configurations: building a foundation for the entire intervention; establishing the focus for further intervention; identifying and implementing relevant compensatory solutions; and re-evaluating ADL ability to finalise intervention. Overall, the ABLE 2.0 initial programme theory was confirmed. The evaluation added information on core facilitating mechanisms including active involvement of the client in the problem-solving process, a collaborative working relationship, mutual confidence, and a consultative occupation-based process using compensatory solutions. Several contextual factors were required to activate the desired mechanisms in terms of supportive management, referral procedures encouraging the problem-solving process, delivery in the client's home, skilled occupational therapists, and clients feeling ready for making changes. CONCLUSIONS: The ABLE 2.0 represents a coherent problem-solving occupational therapy process, applicable across sex, age, and diagnoses with the potential to enhance ADL ability among persons with chronic conditions, when delivered as part of community-based rehabilitation services. Knowledge about the interactions between contextual factors, mechanisms, and outcomes in the ABLE 2.0 is central in case of future implementation of the programme in community-based rehabilitation settings. TRIAL REGISTRATION: The trial was prospectively registered on www. CLINICALTRIALS: gov (registration date: 05/03/2020; identifier: NCT04295837 ) prior to data collection that occurred between August 2020 and October 2021.

Barriers for why pregnant women do not visit a dentist on a regular basis: using group concept mapping methodology.

OBJECTIVES: Periodontitis in pregnancy represents a significant, but often overlooked challenge due to its association to adverse pregnancy (preeclampsia and gestational diabetes) and birth related outcomes (preterm birth and low birth weight). The overall study aim was to identify, organize, and prioritize barriers influencing dental visits among Danish pregnant women not seeing a dentist on a regularly basis. MATERIALS AND METHODS: Participants were pregnant women screened at weeks 11-13 of gestation, and were recruited if they were not seeing a dentist regularly. The study was conducted at Holbæk and Nykøbing Falster Hospital in Region Zealand, Denmark. The Group Concept Mapping (GCM) approach was applied. The pregnant women participated in brainstorming (n = 18), sorting (n = 20), and rating (n = 17) the seating question 'Thinking as broadly as you can, please list all barriers of importance to you for not seeing a dentist on a regular basis'. RESULTS: A total of 38 unique barriers were identified, organized, and prioritized online. The multidimensional scaling analysis involved 10 iterations and revealed a low stress value of 0.21. A cluster solution with five clusters including 'economic reasons', 'lack of priority', 'lack of time and energy', 'no problems with teeth', and 'dental fear', was discussed and interpreted at a validation meeting. CONCLUSIONS: Five overall clusters explaining barriers for not seeing a dentist regularly were revealed. Of the five clusters, 'economic reasons' and 'lack of priority' were rated as the most important clusters. Accordingly, such barriers should be considered in the planning of future strategies of dental care during pregnancy.

International consensus on occupational therapy interventions for people with palliative care needs: A European Association for Palliative Care Group Concept Mapping study.

BACKGROUND: While evidence shows that occupational therapists can play a key role in the care of people with palliative care needs, more knowledge about effective occupational therapy interventions for this group is needed. AIM: To identify, organise and prioritise intervention components considered to be effective within occupational therapy for people with palliative care needs from the perspective of occupational therapy clinicians, managers and researchers. DESIGN: Group Concept Mapping utilising a mixed methods participatory approach. Using a focus prompt, participants brainstormed, sorted, labelled and rated generated statements about effective occupational therapy intervention components. Multidimensional scaling analysis and cluster analysis were conducted. SETTING/PARTICIPANTS: Snowball recruitment was used to recruit participants. Participants included occupational therapists worldwide who were able to read and write in English and were working as clinicians, managers and/or researchers with occupational therapy interventions for people with palliative care needs. RESULTS: Seventy-two occupational therapists from 15 countries participated in the study representing Asia (n = 3, 20%), Europe (n = 8, 53%), Oceania (n = 2, 13%) and North America (n = 2, 13%). A total of 117 statements were identified and organised into five clusters: (1) being client-centred, (2) promoting occupational engagement to optimise quality of life, (3) involving the social and relational environment, (4) enabling occupations and (5) facilitating occupational adaptation. CONCLUSIONS: Five clusters of core occupational therapy intervention components were considered to be effective when supporting people with palliative care needs. Research should use this knowledge to inform future occupational therapy interventions for this group of people.

How a group-based occupational therapy program works in woman with fibromyalgia: A process evaluation of the ADAPT program.

BACKGROUND: The ADAPT Program have improved activities of daily living (ADL) in women with fibromyalgia. To understand the functioning of the program, it is relevant to evaluate how program theory components are linked to outcomes (mechanisms) and how the randomised controlled trial (RCT) context, influenced delivery and outcomes. OBJECTIVE: To evaluate ADAPT in terms of dose, mechanisms of change and contextual factors. MATERIAL/METHODS: Dose was recorded on the n = 21 participants receiving ADAPT in the IMPROvE trial (NCT01352052). A subsample of n = 16 attended one of three 2-hour focusgroups, evaluating mechanisms of change and contextual factors. Interview questions explored participants' interaction with four program components, i.e. how the 'client-centred approach', 'group-based peer-exchange format', 'teaching-learning strategies' and 'long-term program format' triggered mechanisms facilitating/hindering outcomes. Moreover, how randomisation procedures influenced delivery and outcomes. RESULTS: Attending a long-term educational peer-exchange program, in which participants experienced met by a health professional that legitimised difficulties, facilitated participants knowledge, insights and motivation for changing habits. With time and support, participants experienced increased acceptance of their situation and began to implement more effective ways to perform ADL tasks. CONCLUSIONS/SIGNIFICANCE: Results support previous findings of improved ADL ability post-ADAPT and provide initial evidence to support the ADAPT Program theory.

Assessment of motor and process skills in Danish occupational therapy practice.

BACKGROUND: The demand for employment of standardized evaluations is increasing. In Denmark, approximately 25% of all occupational therapists (OTs) are trained to use the standardized occupational therapy instrument Assessment of Motor and Process Skills (AMPS). AIMS: To investigate the use of AMPS within Danish occupational therapy practice and determine factors supporting or hindering the use. MATERIAL AND METHODS: An online cross-sectional survey was conducted among OTs from various settings. RESULTS: Overall, 844 calibrated OTs participated in the survey. Of these, 540 (64%) met the inclusion criteria and 486 (90%) completed the questionnaire. Forty percent of the participants used the AMPS in a standardized way during a one-month period and 56% reported being dissatisfied with the low number of AMPS evaluations completed. Five supporting and nine hindering factors were found to significantly influence the use of standardized AMPS evaluations. CONCLUSIONS/SIGNIFICANCE: Despite demands for standardized evaluations, the AMPS is not regularly used in a standardized way within Danish occupational therapy practice. Use of AMPS in clinical practice seems to be facilitated by an acknowledgement from the management and the OT's ability to develop habits and routines. Time restraints were reported, however, time to conduct evaluations was not a statistically significant influencing factor.

Effectiveness of an individualised occupational therapy intervention programme (ABLE) using adaptational strategies on activities of daily living among persons with chronic conditions: A randomised controlled trial (RCT).

OBJECTIVE: Compare the effectiveness of a problem-solving, individualised, home-based occupational therapy intervention (ABLE 2.0), to usual occupational therapy, on activities of daily living (ADL) ability in persons with chronic conditions. DESIGN: A single-centre, double-blinded, randomised controlled trial with 10- and 26-week follow-up. SETTING: A Danish municipality. SUBJECTS: Persons with chronic conditions experiencing problems performing ADL tasks (n = 80). INTERVENTIONS: ABLE 2.0 was compared with usual occupational therapy. MAIN MEASURES: Coprimary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 10. Secondary outcomes were self-reported ADL ability (ADL-Interview Performance) and observed ADL motor ability (Assessment of Motor and Process Skills) at Week 26, and perceived satisfaction with ADL ability (ADL-Interview Satisfaction) and observed ADL process ability (Assessment of Motor and Process Skills) at Weeks 10 and 26. RESULTS: In total, 78 persons were randomly assigned: 40 to usual occupational therapy and 38 to ABLE 2.0. No statistically significant nor clinically relevant difference between group mean changes in primary outcomes was identified from baseline to Week 10 (ADL-Interview Performance [-0.16; 95% CI: -0.38 to 0.06] and Assessment of Motor and Process Skills ADL motor ability [-0.1; 95% CI: -0.3 to 0.1]). At Week 26, a statistically significant and clinically relevant difference was found in Assessment of Motor and Process Skills ADL motor ability (LS mean change: -0.3; 95% CI: -0.5 to -0.1) between groups. CONCLUSION: ABLE 2.0 was effective in improving observed ADL motor ability at 26 weeks.

Clinical utility of the Danish version of the Self-Assessment of Modes Questionnaire (D-SAMQ).

BACKGROUND: The the Self-Assessment of Modes Questionnaire (SAMQ) has been translated into Danish and culturally adapted (D-SAMQ), and aspects of validity and reliability have also been evaluated. However, no knowledge about the clinical utility of the D-SAMQ exists. AIMS/OBJECTIVES: The aims were to investigate the clinical utility of the D-SAMQ among Danish occupational therapists (OTs) and occupational therapy students (OTSs), and to determine differences in perceived clinical utility between the two groups. MATERIAL AND METHODS: Data was collected using an online survey consisting of 17 questions related to four dimensions of clinical utility; appropriateness, accessibility, practicability, and acceptability. RESULTS: A total of 25 OTs and 41 OTSs participated. The clinical utility was perceived to be high across all questions related to the four dimensions. No statistically significant differences were found between OTs and OTSs in any of the four dimensions. CONCLUSIONS AND SIGNIFICANCE: The D-SAMQ is ready for use in occupational therapy practice, education, and research. D-SAMQ can be used to gain insight into own therapeutic style. This insight serves as a basis for facilitating therapeutic relationships with the clients during the process of enabling engagement in occupation.

Quality of ADL task performance in persons with schizophrenia: Looking beyond independence.

BACKGROUND: Persons with schizophrenia may experience decreased ability to perform activities of daily living (ADL) indicated by need for assistance in everyday life. Others are independent, but their quality of ADL task performance in terms of effort and efficiency may still be impacted. AIMS/OBJECTIVES: The overall purpose of this study was to explore the quality of ADL task performance in subgroups with schizophrenia (independent/needing assistance). MATERIALS AND METHODS: Participants were in- and outpatients at a Psychiatric Hospital diagnosed with schizophrenia (n = 83). Their quality of ADL task performance was evaluated using the Assessment of Motor and Process Skills (AMPS). Evaluations were conducted at the hospital. Two subgroups (A: independent and B: needing assistance) were created based on AMPS ADL ability measures. RESULTS: The majority in both subgroups had AMPS ADL ability measures within the risk zones. Further, the majority in subgroup A had ADL ability measures within age expectations but below mean for well persons of the same age. Both ineffective motor and process skills were identified in both subgroups. CONCLUSIONS/SIGNIFICANCE: Occupational therapy is indicated for persons with schizophrenia, both for independent persons and for persons needing assistance. This is to prevent decline in or to enhance ADL ability.

Reliability and validity of the Danish version of the Self-Assessment of Modes Questionnaire.

BACKGROUND: The Self-Assessment of Modes Questionnaire (SAMQ) is developed to help therapists identify their preferred use of modes when interacting with clients in clinical practice. A Danish translation of the SAMQ has been developed (D-SAMQ). To provide a robust instrument for occupational therapy practice and research, evaluation of the psychometric properties of the D-SAMQ is needed. OBJECTIVES: The study aims to evaluate test-retest reliability, measurement error and content validity in terms of cultural relevance of the D-SAMQ. MATERIAL AND METHODS: Danish occupational therapists were recruited to represent diverse clinical settings and to work with various age groups. The D-SAMQ consists of 20 clinical cases. A repeated measures design was employed with evaluation of content validity at the second timepoint. The Content Validity Index and Kappa statistics were employed. RESULTS: In most cases (n = 12, 60%) agreement (test-retest reliability and measurement error) was moderate or strong. Also, there was a moderate (n = 6 cases, 30%), strong (n = 4 cases, 20%) or almost perfect agreement (n = 10 cases, 50%) on the cultural relevance of the cases. CONCLUSIONS: Acceptable test-retest reliability, measurement error and content validity were found. The SAMQ may support occupational therapists to adapt their therapeutic style to meet the needs of the clients.

Danish translation, adaptation and initial validation of the clinical assessment of modes questionnaires.

BACKGROUND: The Clinical Assessment of Modes questionnaires (CAMQs) determine clients' preferential modes for therapy (CAM-C1), clients' perception of modes used by the occupational therapist (OTs) during therapy (CAM-C2), or modes the OTs believed to have used (CAM-T). Access to valid CAMQs for Danish OTs and clients required a rigorous translation and cultural adaptation process. OBJECTIVES: To translate and culturally adapt the CAMQs into Danish, examining face validity in a Danish context. MATERIAL AND METHODS: A 10-step guideline for the process of translating and culturally adapting questionnaires was followed. Steps 1-6 included translation into Danish, steps 7-8 involved cognitive debriefing interviews and validation based on the Content Validity Index (CVI) analyzed using Kappa statistics. Steps 9-10 finalized the process. RESULTS: CAMQs were translated into Danish. Based on cognitive debriefing interviews and CVIs involving 15 clients and 7 OTs, modifications regarding titles, layouts, instructions, wording and response categories were performed in all Danish CAMQs. The Item CVI and the modified kappa revealed that most participants had a high level of agreement on the cultural relevance. CONCLUSIONS AND SIGNIFICANCE: Translated versions of the CAMQs have been culturally adapted into Danish. The current Danish versions seem culturally relevant and useable in Danish occupational therapy.

Working from home during COVID-19 in a Danish hospital research setting: experiences of researchers and healthcare providers, explored by Group Concept Mapping.

OBJECTIVES: The COVID-19 pandemic has changed the working environment, how we think of it and how it stands to develop into the future. Knowledge about how people have continued to work on-site and adjusted to working from home during the COVID-19 lockdown will be vital for planning work arrangements in the post-pandemic period. Our primary objective was to investigate experiences of working from home or having colleagues working from home during a late stage of the COVID-19 lockdown among researchers and healthcare providers in a hospital research setting. Second, we aimed to investigate researchers' productivity through changes in various proxy measures during lockdown as compared with pre-lockdown. DESIGN: Mixed-method participatory Group Concept Mapping (GCM). SETTING AND PARTICIPANTS: GCM, based on a mixed-method participatory approach, was applied involving researchers' and healthcare providers' online sorting and rating experiences working from home during the COVID-19 pandemic. At a face-to-face meeting, participants achieved consensus on the number and labelling of domains-the basis for developing a conceptual model. RESULTS: Through the GCM approach, 47 participants generated 125 unique statements of experiences related to working from home, which were organised into seven clusters. Using these clusters, we developed a conceptual model that illustrated the pros and cons of working from home. CONCLUSION: The future work setting, the role of the office and the overall work environment need to respond to workers' increased wish for flexible work arrangements and co-decision.

Fostering Change Through Occupation-Based Intervention: An International Joint Group Concept Mapping Study.

Further consolidation and clarity regarding occupation as a means to foster change in interventions are needed. The study aimed to utilize the knowledge of occupational scholars to systematically determine what is required to use occupation as means to foster change within occupation-based interventions and to generate a conceptual model from those results. Group Concept Mapping involved the following: preparation, generation of ideas, structuring of statements, data analysis, interpretation of maps, and development of conceptual model. Fifty-two international occupational scholars brainstormed 125 ideas. A cluster rating map with nine clusters posed the foundation for a conceptual model with seven themes, namely, artful use of occupation, evidence-based use of occupation, collaboration to promote occupation, coordinating intervention fit, client factors, sociocultural context, and structural influences. The conceptual model, capturing dimensions and dynamics required for using occupation to foster change, may guide future research into occupation-based interventions.

Participation and engagement in family activities among girls and young women with Rett syndrome living at home with their parents - a cross-sectional study.

PURPOSE: To describe the extent of participation and engagement in family activities and explore variables potentially impacting on these factors in family activities among girls and young women with Rett syndrome (RTT) under the age of 21. MATERIALS AND METHODS: The Child Participation in Family Activities (Child-PFA) questionnaire was sent to parents in the target group (n = 42). Additionally, age, number of siblings at home, ambulation level, clinical severity and level of hand function were recorded to explore possible impact. Data were analyzed using descriptive statistics, Fishers exact test and cross-tables. RESULTS: 23 families participated. Highest degrees of participation and engagement were seen in social and stationary family activities. Indoor activities were frequent and showed high levels of participation and engagement, Outdoor activities were infrequent and showed low levels of participation despite a high degree of engagement. Routine activities were frequent but showed moderate to low participation and engagement. A negative association was found between participation in watching a movie and number of siblings living at home, and positive associations between engagement and age in three family activities. CONCLUSION: Therapists working with this target group may benefit from focusing on engagement in routine activities and modification of family activities.IMPLICATIONS FOR REHABILITATIONTherapists may benefit from focusing on engagement in routine activities in the goal setting process and intervention as they occur on a daily basis, giving the opportunity for development of new skills.Therapists may benefit from focusing on assistive devices or other compensatory strategies for outdoor activities and activities that require a certain amount of hand function.Therapists may benefit from modifying the family's activities so that they require more social and mental participation and focus on experiencing different types of sensory input e.g., sound, tactile, visual or vestibular input rather than taking part in the activity by using their hands.

Prognostic factors for work disability in patients with chronic widespread pain and fibromyalgia: protocol for a cohort study.

INTRODUCTION: The association between chronic widespread pain (CWP) and disability is well established. Although research support large interindividual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3 years from baseline, that is, at referral for specialist care. METHODS AND ANALYSES: Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1000 patients ≥18 years of age registered in a clinical research database (DANFIB registry) with CWP either 'employed and working' or 'not working' will be enrolled. Participants must meet the American College of Rheumatology 1990 definition of CWP, that is, pain in all four body quadrants and axially for more than 3 months and are additionally screened for fulfilment of criteria for fibromyalgia. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3 years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable. ETHICS AND DISSEMINATION: Sensitive personal data will be anonymised according to regulations by the Danish Data Protection Agency, and informed consent are obtained from all participants. Understanding and improving the prognosis of a health condition like CWP should be a priority in clinical research and practice. Results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04862520.

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.

Measuring self-reported ability to perform activities of daily living: a Rasch analysis.

BACKGROUND: Since the number of persons diagnosed with multi-morbidity is increasing, there is a need for generic instruments to be able to assess, measure and compare ADL ability across diagnoses. Accordingly, the ADL-Interview (ADL-I) was developed to be used in rehabilitation research and clinical practice. The aim of this study was to investigate if the ADL-I can be used to provide valid and reliable ADL ability measures across gender and diagnostic groups. METHODS: ADL-I data were extracted from an existing research database on persons with chronic conditions including medical, rheumatological, oncological, neurological, geriatric and psychiatric diagnoses. Data were analysed based on Rasch Measurement methods to examine: the psychometric properties of the rating scale; ADL item and person fit to the Rasch model; if the difficulty of the ADL tasks differs across gender and diagnostic groups, and if the ADL-I provides precise and reliable measures of ADL ability. RESULTS: Data on n = 2098 persons were included in the final analysis. Initial evaluation of the 0-3 rating scale revealed threshold disordering between categories 1 and 2. After removal of 16 underfitting items, the variance explained by the Rasch dimension increased from 54.3 to 58.0%, thresholds were ordered, but the proportion of persons with misfitting ADL-I measures increased slightly from 8.7 to 9.1%. The person separation index improved slightly from 2.75 to 2.99 (reliability = 0.90). Differential test function analysis, however, supported that the 16 underfitting items did not represent a threat to the measurement system. Similarly, ADL items displaying differential item functioning across gender and diagnoses did not represent a threat to the measurement system. The ADL items and participants were well distributed along the scale, with item and person measures well targeted to each other, indicating a small ceiling effect and no floor effect. CONCLUSIONS: The study results overall suggest that the ADL-I is producing valid and reliable measures across gender and diagnostic groups among persons within a broad range of ADL ability, providing evidence to support generic use of the ADL-I. TRIAL REGISTRATION: N/A.

Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0.

BACKGROUND: The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. In this pilot study, the remaining feasibility aspects of a randomised controlled trial including (i) trial procedures (recruitment and retention), (ii) randomisation, (iii) adherence to program, (iv) feasibility of additional outcome measurements, and (iv) access to information on usual occupational therapy were evaluated. METHODS: The study was conducted in a Danish municipality, using a two-armed parallel randomised controlled design, planning a recruitment strategy including 20 persons living with one/more chronic conditions and experiencing problems performing ADL. The following progression criteria were used to determine if a future full-scale randomised controlled trial was feasible: (i) recruitment (50% met the eligibility criteria) and retention (80%), (ii) randomisation (80% accepted randomisation, procedure was executed as planned), (iii) adherence to program (100% followed the treatment protocol), (iv) outcome measurements (80% of the participants delivered relevantly and fully answered questionnaires), and (v) usual occupational therapy (extraction of needed information was successful). RESULTS: Due to the COVID-19 pandemic, the study was truncated resulting in limited but sufficient data to answer most of the study questions. (i) Eighteen of 37 eligible persons (48.6%) were recruited; of those treated (n = 6), all remained (100%); (ii) 18 accepted randomisation (100%), and procedure was effective; (iii) ABLE was delivered with adherence (100%); (iv) 92.3-100% of the participants gave relevant and complete answers in two of three questionnaires; and (v) needed information on usual occupational therapy was extractable in seven of nine aspects. CONCLUSIONS: Proceeding to full-scale trial is recommendable; however, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual occupational therapy are needed. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT04295837 ) on December 5th, 2019. Retrospectively registered.

Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions.

BACKGROUND: The "A Better everyday LifE" (ABLE) intervention was developed to accommodate the need of a program addressing ability to perform activities of daily living (ADL) in persons with chronic conditions living at home. During intervention development, it is necessary to evaluate relevant aspects of the feasibility of a program. Thus, the aim was to evaluate the feasibility of content and delivery of ABLE version 1.0. METHODS: A one group pre- and post-test design was applied. Thirty persons with chronic conditions, two occupational therapists (OTs), and five occupational therapy students (OTSs) participated. ABLE 1.0 is an 8-week program consisting of ADL evaluation (session 1); goal setting and reasons for ADL problems (session 2); intervention (sessions 3-7); and re-evaluation (final session), conducted in the clients' home-setting and local area. Sessions 1-4 and the final session was mandatory. To evaluate the feasibility of content and delivery, the OTs, after each session, reported on applied intervention component(s), time-use, needed equipment, adjustments, meaningfulness, confidence, progress toward goal attainment, and side effects using registration forms. The clients reported on progress toward goal attainment, meaningfulness, and satisfaction. Clinically relevant improvements in ADL ability were identified using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Goal attainment was evaluated using the Goal Attainment Scaling (GAS). RESULTS: Twenty clients (67%) completed ABLE 1.0 and received four sessions (median = 4, range 4-7) each lasting between 30 and 94 min. Most frequently applied component was "Changing habits related to task performance". Generally, OTs reported having the needed equipment. Deviations from the manual were made by omission of GAS and AMPS and less than mandatory number of sessions per client. The OTs reported confidence in delivering the program and the clients perceived the program as meaningful and satisfying, and experienced progress toward goal attainment. Goal attainment was found in 52% of the goals. Sixteen (80%) clients obtained clinically relevant improvements in self-reported or observed ADL ability. CONCLUSIONS: The content and delivery of ABLE 1.0 was feasible. However, the study revealed a need to adjust the recruitment procedure and make minor changes in the intervention manual. A pilot randomized controlled trial (RCT) study is recommended. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with registration no. NCT03335709 on November 8, 2017.

Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial.

BACKGROUND: Weight loss is critical for preventing and managing obesity-related diseases. There is a notable lack of valid and reliable means to manage patients with overweight/obesity and knee osteoarthritis (KOA). OBJECTIVE: To determine the efficacy and safety of liraglutide in a 30 mg/d dosing in patients with overweight/obesity and KOA. METHODS: The trial was designed as a randomized controlled trial including patients between the age of 18 and 74 y with KOA and a BMI ≥27 (measured in kg/m2).Patients underwent a pre-random assignment diet intervention (week -8 to 0). At week 0, patients having lost >5% of their body weight were randomly assigned to liraglutide 3 mg/d or placebo for 52 wk. The coprimary outcomes were changes in body weight and the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale from week 0 to 52. RESULTS: In total, 168 patients enrolled and 156 were randomly assigned to receive liraglutide or placebo. Patients experienced a significant reduction in body weight and KOOS pain during the pre-random assignment dietary intervention period (week -8 to 0). From week 0 to 52 there was a significant difference in body weight between the liraglutide and placebo group (mean changes: -2.8 and +1.2 kg, respectively; group difference, 3.9 kg; 95% CI: -6.9, -1.0; P = 0.008). There was, however, no group difference in KOOS pain (mean changes: 0.4 and -0.6 points, respectively; group difference, 0.9 points; 95% CI: -3.9, 5.7; P = 0.71). Treatment-emergent adverse events related to the gastrointestinal system were experienced by 50.2% and 39.2% of patients in the liraglutide and placebo groups, respectively. CONCLUSIONS: In patients with KOA and overweight/obesity liraglutide added after an 8-wk pre-random assignment diet induced a significant weight loss at >52 wk but did not reduce knee pain compared to placebo. This trial was registered at clinicaltrials.gov as NCT02905864.