Anita Slade

Assessing and adjusting for cross-cultural validity of impairment and activity limitation scales through differential item functioning within the framework of the Rasch model the pro-esor project

IntroductionIn Europe it is common for outcome measures to be translated for use in other languages. This adaptation may be complicated by culturally specific approaches to certain tasks; for example, bathing. In this context the issue of cross-cultural validity becomes paramount. ObjectiveTo facilitate the pooling of data in international studies, a project set out to evaluate the cross-cultural validity of impairment and activity limitation measures used in rehabilitation from the perspective of the Rasch measurement model. MethodsCross-cultural validity is assessed through an analysis of Differential Item Functioning (DIF) within the context of additive conjoint measurement expressed through the Rasch model. Data from patients undergoing rehabilitation for stroke was provided from 62 centers across Europe. Two commonly used outcome measures, the Mini-Mental State Examination (MMSE) and the Functional Independence Measure (FIM) motor scale are used to illustrate the approach. ResultsPooled data from 3 countries for the MMSE were shown to fit the Rasch model with only 1 item displaying DIF by country. In contrast, many items from the FIM expressed DIF and misfit to the model. Consequently they were allowed to be unique across countries, so resolving the lack of fit to the model. ConclusionsWhere data are to be pooled for international studies, analysis of DIF by culture is essential. Where DIF is observed, adjustments can be made to allow for cultural differences in outcome measurement.

A randomised controlled trial to determine the effect of intensity of therapy upon length of stay in a neurological rehabilitation setting.

A randomised single-blind controlled trial was designed to determine whether intensity of therapy (physiotherapy and occupational therapy) shortened length of stay for patients in a rehabilitation unit. Patients were under 65, primarily with stroke, but also with other conditions such as traumatic brain injury, and multiple sclerosis. The experimental group were timetabled to receive 67% more therapy in any given week, than the control group. After controlling for confounders and case mix (as expressed by type of therapy required) patients in the experimental group showed a significant 14-day reduction in length of stay (<0.01). Concurrently average length of stay was increased for both groups by 16 days due to delays in discharge.

MUltiple Sclerosis and Extract of Cannabis: results of the MUSEC trial

Objective Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. Patients and methods Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. Results The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. Conclusion The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. Trial registration number NCT00552604.

Cross-cultural validity of functional independence measure items in stroke: A study using Rasch analysis

OBJECTIVE To analyse cross-cultural validity of the Functional Independence Measure (FIM) in patients with stroke using the Rasch model. SETTINGS Thirty-one rehabilitation facilities within 6 different countries in Europe. PARTICIPANTS A total of 2546 in-patients at admission, median age 63 years. METHODS Data from the FIM were evaluated with the Rasch model, using the Rasch analysis package RUMM2020. A detailed analysis of scoring functions of the 7 categories of the FIM items was undertaken prior to testing fit to the model. Categories were re-scored where necessary. Analysis of Differential Item Functioning was undertaken in pooled data for each of the FIM motor and social-cognitive scales, respectively. RESULTS Disordered thresholds were found on most items when using 7 categories. Fit to the Rasch model varied between countries. Differential Item Functioning was found by country for most items. Adequate fit to the Rasch model was achieved when items were treated as unique for each country and after a few country-specific items were removed. CONCLUSION Clinical collected data from FIM for patients with stroke cannot be pooled in its raw form, or compared across countries. Comparisons can be made after adjusting for country-specific Differential Item Functioning, though the adjustments for Differential Item Functioning and rating scales may not generalize to other samples.

Cross-cultural validity of FIM in spinal cord injury

Objective:To analyse cross-culture validity of the Functional Independence Measure (FIM™) in patients with a spinal cord injury using a modern psychometric approach.Settings:A total of 19 rehabilitation facilities from four countries in Europe.Participants:A total of 647 patients at admission, median age 46 years, 69% male.Methods:Data from the FIM™, collected on inpatient admission, was fitted to the Rasch model. A detailed analysis of scoring functions of the seven categories of the FIM™ items was undertaken before to testing fit to the model. Categories were rescored where necessary. Fit to the model was assessed initially within country, and then in the pooled data. Analysis of differential item functioning (DIF) was undertaken in the pooled data for each of the FIM™ motor and social cognitive scales, respectively. Final fit to the model was tested for breach of local independence by principle components analysis (PCA).Results:The present scoring system for the FIM™ motor and cognitive scales, that is a seven category scale, was found to be invalid, necessitating extensive rescoring. Following this, DIF was found in a number of items within the motor scale, requiring a complex solution of splitting items by country to allow for the valid pooling of data. Five country-specific items could not be retained within this solution. The FIM cognitive scale fitted the Rasch model after rescoring, but there was a substantial ceiling effect.Conclusions:Data from the FIM™ motor scale for patients with spinal cord injury should not be pooled in its raw form, or compared from country to country. Only after fit to the Rasch model and necessary adjustments could such a comparison be made, but with a loss of clinical important items. The FIM cognitive scale works well following rescoring, and data may be pooled, but many patients were at the maximum score.

Walking as a Meaningful Leisure Occupation: The Implications for Occupational Therapy

Introduction: In response to growing interest in leisure in occupational therapy and the importance of understanding how occupations maintain, enhance and promote health and wellbeing, a qualitative phenomenological study was conducted to explore the experiences of walking for leisure. Method: Six healthy student participants, identified as regular walkers, were interviewed using a semi-structured format. Data were analysed following interpretative phenomenological analysis methodology. Findings: Participants expressed how and why walking was meaningful to them; the four main themes were social connectedness, wellbeing, connection to nature and achievement from a challenge. Findings suggest that occupational therapists could use walking and leisure occupations in intervention, and that there is scope for an occupational therapy perspective in health promotion. Conclusion: Determining the subjective meaning of engaging in walking as a leisure occupation has implications for occupational science and health promotion in helping to explain why people do what they do.

1000 fieldwork hours: : Analysis of multi-site evidence

Background. Internationally, the World Federation of Occupational Therapists has established a minimum of 1,000 hours as the fieldwork standard. Purpose. To examine student development in fieldwork across placements to determine if students achieve entry-level competence after completion of 1,000 hours of fieldwork. Methods. Archival data (N=400) from six occupational therapy programs were analyzed to examine the acquisition of fieldwork competency over time as measured by the Competency Based Fieldwork Evaluation Scale. Findings. Competency scores increased with each fieldwork placement, the majority of students achieved entry-level scores upon completion of their final fieldwork placement. While, on average, some competency scores exceeded entry level by 1,000 hours, Practice Knowledge, Clinical Reasoning, and Facilitating Change fell just short. Implications. The identification of a plan for addressing the lower ratings in these three competencies should be considered.

Identifying patients at risk of nursing home admission: The Leeds Elderly Assessment Dependency Screening tool (LEADS)

BackgroundDischarge from hospital to a nursing home represents a major event in the life of an older person and should only follow a comprehensive functional and medical assessment. A previous study identified 3 dependency scales able to discriminate across outcomes for older people admitted to an acute setting. We wished to determine if a single dependency scale derived from the 3 scales could be created. In addition could this new scale with other predictors be used as a comprehensive tool to identify patients at risk of nursing home admission.MethodsItems from the 3 scales were combined and analysed using Rasch Analysis. Sensitivity and specificity analysis and ROC curves were applied to identify the most appropriate cut score. Binary logistic regression using this cut-off, and other predictive variables, were used to create a predictive algorithm score. Sensitivity, specificity and likelihood ratio scores of the algorithm scores were used to identify the best predictive score for risk of nursing home placement.ResultsA 17-item (LEADS) scale was derived, which together with four other indicators, had a sensitivity of 88% for patients at risk of nursing home placement, and a specificity of 85% for not needing a nursing home placement, within 2 weeks of admission.ConclusionA combined short 17-item scale of dependency plus other predictive variables can assess the risk of nursing home placement for older people in an acute care setting within 2 weeks of admission. This gives an opportunity for either early discharge planning, or therapeutic intervention to offset the risk of placement.

EVALUATION OF THE PSyCHOMETRIC PROPERTIES OF THE UPPER LIMB SUBSCALES OF THE MOTOR ASSESSMENT SCALE USING A RASCH ANALySIS MODEL

OBJECTIVES To apply Rasch analysis to evaluate the psychometric properties of the composite score of the 3 upper limb subscales of the Motor Assessment Scale (UL-MAS) when administered in the acute/subacute phase post-stroke. DESIGN Prospective data collection of UL-MAS scores. PARTICIPANTS Eighty Eighty individuals a mean of 64.8 days (standard deviation 53.3; range 4-193 days) following the onset of unilateral stroke. METHODS All UL-MAS test items were administered in 30 participants assessed longitudinally over 3 occasions, and in 50 participants assessed on a single occasion. These 140 observations were pooled to be evaluated using Rasch analysis. RESULTS With the elimination of the wrist radial deviation test item, the UL-MAS demonstrated uni-dimensionality with no significant test item response bias. The test item difficulty hierarchy was validated in the Upper Arm and Hand Movements subscales, but not in the Advanced Hand Activities subscale. The acceptable floor (14%) and ceiling (9%) effects and the high Person Separation Reliability Index (0.96) indicated that the scale was appropriately targeted to discriminate statistically between groups of acute/subacute stroke participants with differing upper limb motor recovery. CONCLUSION The findings support the psychometric properties of the composite UL-MAS score in this clinical population.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols:: the SPIRIT-PRO Extension

Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.