The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis

© 2022 Published by Elsevier B.V.Background A valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed. Methods A mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening. Results Factor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (≥ 0.97) and intraclass correlation coefficient (≥ 0.97) of test-retest scores (5–27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3–2.7 points are proposed as MID criteria for minimal worsening in PF. Conclusion PROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. Input from patients and clinicians ensured the content is comprehensive and relevant for people with MS.Peer reviewe

Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program

<div><p>Background</p><p>Dietary factors have been discussed to influence risk or disease course of multiple sclerosis (MS). Specific diets are widely used among patients with MS.</p><p>Objective</p><p>To design and pilot-test an evidence based patient education program on dietary factors in MS.</p><p>Methods</p><p>We performed a systematic literature search on the effectiveness of dietary interventions in MS. A web-based survey among 337 patients with MS and 136 healthy controls assessed knowledge, dietary habits and information needs. An interactive group education program was developed and pilot-tested.</p><p>Results</p><p>Fifteen randomised-controlled trials (RCTs) were included in the systematic review. Quality of evidence was low and no clear benefit could be seen. Patients with MS significantly more often adhered to a `Mediterranean Diet`(29.7% versus 14.0%, p<0.001) compared to controls. 143 (42%) of the patients with MS had tried special MS diets. Important information needs addressed effectiveness of MS diets (44%) and relation between nutrition and MS (43%). A pilot test of our newly developed patient education program with 13 participants showed excellent comprehensibility and the MS-specific content was judged as very important. However, the poor evidence base for dietary approaches in MS was perceived disappointing.</p><p>Conclusions</p><p>Development and pilot-testing of an evidence-based patient education program on nutrition and MS is feasible. Patient satisfaction with the program suffers from the lack of evidence. Further research should focus on generating evidence for the potential influence of lifestyle habits (diet, physical activity) on MS disease course thus meeting the needs of patients with MS.</p></div

Eligibility criteria used for literature search and screening.

<p>Eligibility criteria used for literature search and screening.</p

Patients’ goals of using specific diets.

<p>(n = 143) (Multiple answers possible).</p

Characteristics of included studies–trials modifying fatty acid intake by supplementation.

<p>Characteristics of included studies–trials modifying fatty acid intake by supplementation.</p

Content of the education program.

<p>Content of the education program.</p

Influence of different factors on disease course in the perception of PwMS.

<p>Patients could attribute 0 to 100 points to the different factors, 0 meaning no influence, 100 meaning maximum influence. n = 337 DMD = Disease Modifying Drugs.</p

Importance of different topics in a patient education program.

<p>Percentage of PwMS assigning rank 1 or 2 to the topic (n = 113).</p

Type of diet among PwMS and controls in % (n = 473).

<p>* = significant difference (p<0.001) PwMS = Patients with MS.</p

Pilot evaluation of the program by 11 PwMS; Median and Range (0–10) are displayed.

<p>Pilot evaluation of the program by 11 PwMS; Median and Range (0–10) are displayed.</p