a protocol for developing a patient-reported outcome measurement instrument

Introduction: There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions. Methods and analysis: We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established through the use of focus groups. If patients deem necessary, we will develop new items based on the patients' input. We will examine whether it is valid to score all selected and developed items on the same scale as the original items from the PROMIS PF item bank. Our analyses will follow the methods used for calibrating the original PROMIS PF item bank in US samples, which were largely based on the general PROMIS approach. Ethics and dissemination: This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained where necessary, and signed informed consent will be obtained from all participants. We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences

Measuring quality of occupational performance based on self-report and observation : development and validation of instruments to evaluate ADL task performance

Background People with rheumatic or neurologic conditions are commonly referred for occupational therapy because of decreased ability to perform ADL tasks. Upon referral, occupational therapists use a client-centred, occupationfocused approach when evaluating a person's perceived and observed quality of ADL task performance to clarify the nature and extent of the person’s problems, plan interventions and determine effectiveness of interventions. Evaluation of the extent of problems and change following intervention require the use of linear measures of ADL. The aim of this doctoral thesis was to develop and validate linear measures of perceived and observed quality of ADL task performance for occupational therapy clinical praxis and research. Methods To develop linear measures of observed quality of ADL task performance based on Rasch measurement methods, clients with ABI (n=70) were evaluated using a 3-category rating scale and the ADL Taxonomy. Similarly, to develop linear measures of perceived quality of ADL task performance women with rheumatic diseases (n=118) reported their ability on a questionnaire and in an interview based on the ADL Taxonomy and a 4- category rating scale. To further validate the ADL ability measures of the Assessment of Motor and Process Skills (AMPS) data were collected in two samples. In a sample of women with chronic widespread pain (CWP) or fibromyalgia (FM) (n=50) the ADL ability measures were validated with regard to discrimination, stability and sensitivity to changes. Discrimination was examined by comparing AMPS data from women with CWP/FM to those of healthy women. Stability and sensitivity to change were examined based on repeated AMPS observations pre and post intervention. In addition, sensitivity to change was examined in a sample of clients with ABI (n=36) using a pre- and post-test design. Finally, the validity of the AMPS ADL ability measures in relation to perceived ADL ability was examined in women with rheumatic diseases (n=118) and women with CWP/FM (n=50). Results Based on the results of the four studies in this thesis, we were able to conclude that it was possible to obtain linear measures of observed quality of ADL task performance based on a revised version of the ADL Taxonomy (ADL-O). It was also possible to obtain linear measures of perceived quality of ADL task performance based on revised versions of the ADL Taxonomy using the formats of questionnaires (ADL-Q) and interviews (ADL-I). Moreover, it was possible to establish further evidence of validity of the ADL ability measures of the AMPS. Thus, the AMPS ADL ability measures could discriminate between women with CWP/FM and healthy women. The ADL ability measures of remained stable when no intervention was provided and the ADL motor ability measures were sensitive to change among women with CWP/FM. Moreover, the ADL ability measures were sensitive to change among clients with low ADL ability following ABI. Finally, only low to moderate correlations were found between measures of perceived and observed ADL ability. Conclusions Rasch analyses of revised versions of the ADL Taxonomy suggest that the majority of the ADL tasks and rating scales focused on quality of ADL task performance can be used to obtain linear measures of quality of ADL task performance based on methods of questionnaire, interview or observation. Furthermore, the studies provided evidence of validity of the ADL ability measures of the AMPS in relation to discrimination, stability and sensitivity to change and relation to perceived ADL ability. The results may, therefore, enhance the use of ADL instruments that provide linear measures of perceived and observed quality of ADL task performance in occupational therapy clinical praxis and research

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

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 (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: NCT0429583