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Unspoken Challenges: Sexual Health in Sexual and Gender Minority People With Multiple Sclerosis

Assessing motor functioning is important to monitor the disease course of multiple sclerosis (MS). Video-assisted rating of classic neurologic tests and activities of daily living may improve the detection of changes in motor functioning. We investigated the value of using video-assisted composite measures for the detection of changes in mobility and upper extremity function (UEF).

 Forty-three patients with MS were recorded performing motor function tests before and during treatment with fampridine. Patients were classified as improved or not improved on mobility composite (MOB-COM) and UEF composite (UEF-COM) measures based on neurologists’ ratings of the tests. The proportional agreements between the composite measures and the conventional measures—the Timed 25-Foot Walk test (T25FW) and the Nine-Hole Peg Test (NHPT)—were determined and compared with patient-perceived improvement, which was determined using patient-reported ratings of changes in mobility and UEF.

Agreement between MOB-COM and T25FW was 79.5%, and agreement between UEF-COM and NHPT was 82.1%. Twenty-six of 39 patients (66.7%) reported mobility improvement; 6 of these reports were confirmed by both T25FW and MOB-COM, 4 were confirmed by T25FW only, and 2 were confirmed by MOB-COM only. For UEF, 13 of 39 patients (33.3%) reported improvement; 3 of these were confirmed by the NHPT and 3 were confirmed by the UEF-COM.

Compared with the conventional NHPT measure, the video-assisted composite measure of UEF detected additional patient-perceived improvement. This was less evident for mobility measures. Video-assisted composite measures may enhance the detection of treatment effects in MS clinical practice and trials.

From the Department of Neurology, MS Center Amsterdam, Amsterdam Neuroscience, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands (K-HL, CEPvM, JB, JK, BU); Neurologic Clinic and Polyclinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland (MD, LK); Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland (SS, CPK); Department of Neurology, Neurology and Neurorehabilitation Center, Luzerner Kantonsspital, Lucerne, Switzerland (CPK); Microsoft Research UK, Cambridge, UK (MJ, YZ); Novartis Pharma AG, Basel, Switzerland (JD, FD). 

: Caspar E.P. van Munster, MD, PhD, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands; email: c.vanmunster@amsterdamumc.nl.

*Ka-Hoo Lam, MD, and Caspar E.P. van Munster, MD, PhD, contributed equally to this paper.

 Caspar E.P. van Munster, MD, PhD, has received travel support from Novartis Pharma AG, Sanofi Genzyme, and Teva Pharmaceuticals and honoraria for lecturing and consulting from Biogen Idec and Merck Serono. Marcus D’Souza, MD, has received travel support from Bayer AG, Teva, and Genzyme and research support from the University Hospital Basel. Saskia Steinheimer, MD, has received travel support from Bayer and Merck and honoraria for consulting from Bayer, Merck, Roche, and Teva. Christian P. Kamm, MD, has received honoraria for lectures as well as research support from Biogen, Novartis, Almirall, Bayer Schweiz AG, Teva, Lilly, Merck, Genzyme, Roche, and the Swiss MS Society. Jessica Burggraaff, MD, has received travel support from Novartis Pharma AG. Messrs Johnson and Zaykov are employees of Microsoft Research. Jonas Dorn, PhD; and Frank Dahlke, MD, PhD, are employees of Novartis Pharma AG. The institution of Ludwig Kappos, MD, PhD, University Hospital Basel, has received funding for research support during the past 3 years from the Department of Neurology steering committee and advisory board; consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, df-mp, Excemed, GeNeuro SA, Genzyme, Merck, Minoryx, Mitsubishi Pharma, Novartis, Receptos, Roche, Sanofi-Aventis, Santhera, Teva, and Vianex; and royalties from Neurostatus. The hospital also received funding for departmental educational activities and honoraria from Allergan, Almirall, Bayer, Biogen, Excemed, Genzyme, Merck, Novartis, Pfizer, Sanofi-Aventis, Teva, and UCB. Joep Killestein, MD, PhD, has received speaker and consultancy fees from Merck, Biogen, Teva, Genzyme, Roche, and Novartis. Bernard Uitdehaag, MD, PhD, has received consultancy fees from Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, and Teva. Ka-Hoo Lam, MD, has disclosed no relevant financial relationships.

 This research was funded by Novartis Pharma AG.

 Data from this study were presented as a poster presentation at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 10-12, 2018; Berlin, Germany.

Clinical assessment of patients with multiple sclerosis (MS) is notoriously difficult largely due to the heterogeneous clinical symptoms.

 With the availability of increasing numbers of effective disease-modifying therapies and expanding treatment targets, selecting appropriate outcome measures is increasingly important.

 For example, in a large phase 3 trial of patients with secondary progressive MS, the effect of natalizumab on progression was assessed using various measures. Although no treatment effect was found on Expanded Disability Status Scale (EDSS) score progression, a reduction in progression of upper extremity function (UEF) impairment was detected.

 The accurate assessment of disability is also relevant in the evaluation of symptomatic treatment options such as fampridine (also called dalfampridine).

 Fampridine improves walking speed and UEF in a subset of patients with MS, albeit patient-perceived improvement does not fully correspond with improvement measured using clinical instruments.

The EDSS is the most widely used outcome measure in MS trials, although it has several limitations (eg, high interrater and intrarater variability, disproportional impact of ambulation on the total score).

 To improve the assessment of commonly affected functional domains in MS, the Multiple Sclerosis Functional Composite is used to assess ambulation (Timed 25-Foot Walk test [T25FW]), UEF (Nine-Hole Peg Test [NHPT]), and cognition.

 Despite generally good psychometric properties, the individual components have several shortcomings.

 The T25FW and the NHPT measure only certain aspects of ambulation and UEF (walking speed and manual dexterity, respectively), which do not fully capture the broader aspects of functioning. Also, the T25FW may not be sensitive enough to detect abnormalities in patients with mild ambulatory impairment.

 Because of these shortcomings, clinically relevant treatment effects might be missed.

Video-assisted assessment of motor functioning has the potential to improve disability evaluation. Recording patients’ movements on video may improve certain psychometric properties, such as intrarater and interrater variability, and promotes data quality by allowing a visual check on compliance relative to the standardization of performance.

 Also, standardized activities of daily living (ADLs) can be added to the assessment and are valuable in measuring patients’ functioning.

We investigated the additional value of video-assisted composite measures, consisting of classic neurologic tests and ADLs, in relation to conventional measures and aimed to enhance the detection of changes in mobility and UEF in patients with MS.

Written informed consent was obtained from all patients before study participation, and the study was approved by the respective ethics committees. Data used in this study were part of a multicenter project to develop the ASSESS MS system, performed in 4 large European MS centers located in Amsterdam, the Netherlands, and in Basel, Bern, and Lucerne, Switzerland.

 Patients with MS were recorded using a three-dimensional depth-sensing and color camera (Kinect, Microsoft Corp) with the aim of training machine learning algorithms to automatically quantify motor functioning.

Patients were recruited at the Amsterdam University Medical Center, Vrije Universiteit Medical Center between August 1, 2017, and April 30, 2018. Patients initiating treatment with fampridine were eligible for study participation because fampridine can have positive treatment effects on mobility and UEF.

 Inclusion criteria conformed to the official treatment label of fampridine, a diagnosis of MS according to the revised 2010 McDonald criteria,

 age older than 18 years, ambulatory impairment defined as an estimated EDSS score between 4.0 and 7.0, and no additional diseases that contributed to disability. Contraindications as stated in the fampridine product label were handled as exclusion criteria.

 Patients were assessed at baseline before fampridine treatment and at follow-up after a minimum of 2 weeks of fampridine treatment. Patient and disease characteristics were collected during the baseline visit: age, sex, EDSS score,

The T25FW was used to measure mobility, and the NHPT was used to measure UEF. Each test was performed twice during each visit, as implemented in the Multiple Sclerosis Functional Composite.

 For each visit, 2 trials were averaged for each patient. A decrease of at least 20% in baseline walking time was used to indicate significant improvement in mobility function.

 For the NHPT, trial results of the dominant and nondominant hands were averaged. Similar to the T25FW, a decrease in completion time of at least 20% between visits was used as the determinant of significant UEF improvement.

In addition to the conventional measures, the mobility composite (MOB-COM) consisted of 3 traditional neurologic tests and 4 ADLs (

). The UEF composite (UEF-COM) consisted of 3 classic neurologic tests and 2 ADLs. The MOB-COM and UEF-COM movements were recorded using the Microsoft Kinect camera (

). Each color video was rated by 2 neurologists (of C.E.P.vM., M.D.S., S.S.), who were blinded to the visit type (ie, before or during fampridine treatment) and to the patients’ performance on the conventional measures. The classic neurologic tests were quantified according to predetermined rating scales based on the Neurostatus EDSS functional system scoring definitions.

 A 5-point Likert scale was created ranging from 0 (normal) to 4 (unable to perform due to disability) for the ADLs. Videos were rated using reference videos.

 A reference video displays a person performing a test according to the predefined scale, the gold standard. A consensus score was calculated based on the video ratings of the 2 neurologists using an algorithm similar to that described by Sarkar et al,

 which takes into account individual rater bias. These scores were used in the statistical analyses. Videos of insufficient quality or inaccurately performed movements were excluded from the analysis. A more comprehensive description of the standardized movements, video rating, and score calculation can be found elsewhere.

 During follow-up visits, significant improvement on the MOB-COM and the UEFCOM was defined as improvement on 2 or more tests (ie, ≥1-point decrease) and a decline on no more than 1 test (ie, ≥1-point increase) compared with baseline.

Clinically relevant improvement was determined with the Global Rating of Change (GRC) scales.

 At the follow-up visit, patients rated their perceived change in mobility and in UEF. Patients with positive GRC scales scores were classified as having clinically relevant improvement, whereas negative GRC scales scores or scores of 0 were classified as no clinically relevant improvement.

All statistical analyses were performed using IBM SPSS Statistics for Windows, version 24.0 (IBM Corp). Categorical variables are summarized as frequencies with percentages. The mean and SD are used to summarize continuous variables that were normally distributed; the median and interquartile range are used to summarize irregular distributions. The proportional agreement between the video-assisted composite and conventional measures was determined using 2×2 contingency tables for mobility (T25FW and MOB-COM) and UEF (NHPT and UEFCOM). The added value of the composite measures was determined and visualized using Venn diagrams showing the overlap in patients who improved on the various outcomes for mobility and UEF.

A total of 43 patients with MS initiating fampridine treatment were included and completed baseline measurements. Two patients discontinued treatment prematurely due to adverse effects, and 2 patients refused follow-up assessment because of time constraints. The baseline characteristics of the 39 patients who completed the study are summarized in 

 (all supplemental tables are available in a PDF at the bottom of this article). No adverse events occurred while performing the tests.

 shows the proportions of patients with significant mobility and UEF improvement, as assessed using the GRC scales, conventional measures, and video-assisted composite measures. The proportions of patients who improved on the classic neurologic tests and ADLs were similar to patients with improved MOB-COM (both 50.0%) and UEF-COM (54.5% and 45.5%, respectively).

Comparison of Conventional and Video-Assisted Composite Measures

 shows the distribution of improved mobility on the conventional and video-assisted composite measures. Three patients (7.7%) improved on the MOB-COM without improvement on the T25FW. Conversely, 5 patients (12.8%) improved on the T25FW without improvement on the MOB-COM. For the remaining patients (31 [79.5%]), the MOB-COM and T25FW outcomes were congruent.

Results of the UEF-COM and the NHPT, shown in 

, are congruent for 32 patients (82.1%). Four patients (10.3%) improved on the UEF-COM with no improvement on the NHPT. Conversely, 3 patients (7.7%) did not improve on the UEF-COM but improved on the NHPT.

Detection of Clinically Relevant Improvement 

The overlap between improvement on the GRC scale and the conventional and video-assisted composite measures is depicted in 

. In total, 26 of 39 patients (66.7%) reported improvement in mobility on the GRC scales. Of these patients, the number also showing improvement on the T25FW and the MOB-COM was similar (10 and 8 patients, respectively) and largely overlapped (6 of 12 patients). Concerning UEF, 13 patients (33.3%) reported improvement on the GRC scales. Although no overlap could be detected between these patients and those showing improvement on the NHPT (n = 3), an improved UEF-COM largely concurred with GRC scales improvement (n = 3 of 4).

In this study we investigated the value of adding 2 video-assisted composite measures to conventional measures to improve detection of change in motor functioning. We found that the composite measures detected additional clinical improvement, as perceived relevant by the patient. The additional clinical value was most evident for UEF assessment.

The present findings suggest the importance of multidimensional assessment to detect changes in motor functioning. The composite measures used herein consisted of several classic neurologic tests and ADLs. In contrast, the conventional T25FW primarily tests walking speed which results in both ceiling and floor effects in patients who are more or less severely disabled, respectively.

 Similarly, a floor effect has been reported for the NHPT.

 In the present cohort, a ceiling effect is unlikely to have occurred because patients had relatively mild disabilities (highest EDSS score of 6.5).

The potential value of composite measures was most clearly present for UEF, as some overlap existed between the UEF-COM and the GRC scales. The inclusion of several ADLs in the composite measures might have contributed to this finding. In the present cohort, approximately 50% of all tests that contributed to improvement of the composite measure were ADLs. A previous study with similar methods also found that ADLs may be more valuable than classic neurologic tests.

 The NHPT and the T25FW also correlate to the ability to perform ADLs.

 However, these correlations are based on patient-reported outcome measures (ie, questionnaires), which differ from the performance tests used in the present study.

Video-assisted assessment of motor functioning has the potential to improve disability evaluation in several ways. By using reference videos,

 it may improve psychometric properties of outcome measures, such as intraobserver and interobserver variability. Digital video data could be used to build machine learning algorithms that automatically quantify motor performance. Video-assisted assessment could also shorten administration times and associated administrative burdens relative to other assessments, particularly the EDSS, which takes up to 30 minutes to obtain, including administration time. The tasks that made up the composite scores were shown on a screen integrated into the system and took 10 to 20 minutes to perform, depending on the level of disability. Ultimately, once determined safe for the patient, automated, video-assisted disability assessment has the potential to be performed by patients themselves at their preferred location and time instead of in a hospital or research clinic. To achieve this, machine learning algorithms of sufficient quality need to be developed.

This study has several limitations. The first is the small sample size. Another is, for the assessment of clinically relevant change, that potential placebo effects are not accounted for because no control group was available. Nevertheless, the goal of this study was not to assess the efficacy of fampridine but to detect change in performance. The present findings also provide limited insight into patients in the lower and upper ranges of EDSS scores because disability in this cohort of patients ranged from 3.5 to 6.5.

Another limitation is that the clinometric properties of the GRC scales scores as an assessment tool for clinically significant change are less established than those of the T25FW and the NPHT. Therefore, despite its use to determine relevant change from the clinicians’ or patients’ perspective, it is unclear whether the improvement of mobility on the GRC scale and the UEF truly reflects (subjective) improvement at the group level. Nonetheless, we believe that this 1-item patient-reported outcome stands more closely to the perceived treatment effect on the individual patient level.

Last, potential learning effects in performing the video-assisted composite at follow-up were not studied, although we assume that this is not a major bias because the composite measures were assessed once each visit with an interval of at least 2 weeks. Further improvement of the composite measures to detect changes in motor functioning might be achieved by adding ADLs with various difficulty levels to decrease floor effects or increase ceiling effects.

In this study, we demonstrated that the use of video-assisted composite measures may enhance the detection of motor functioning changes in patients with MS. This was most evident for the assessment of UEF. Using video-assisted composite measures as outcome measures in MS clinical practice and trials may enhance the detection of treatment effects, but further exploration is needed in a larger cohort of patients.

Improving Detection of Change in Motor Functioning in Multiple Sclerosis Using Video-Assisted Composite Measures

People with multiple sclerosis (MS) frequently report implementing dietary strategies as part of their personal wellness programs; however, little is known about the perceived themes of healthy behavior change in people with MS.

Semistructured one-on-one interviews were conducted with 20 women with MS enrolled in 2 different restrictive dietary intervention studies and their 18 self-identified support persons consisting of partners and adult children. Interviews were transcribed, coded, categorized, and then grouped into summative themes. The frequency of issues being mentioned as facilitators of or barriers to diet adherence was evaluated to identify possible differences in perceived experiences between women with MS and their support persons during the studies.

Five qualitative themes were identified: (1) personal motivation, (2) diet components, (3) time, (4) support, and (5) resource access. Major facilitators of dietary adherence were positive support from support persons and study staff, access to resources, symptom improvement, and personal motivation. Major barriers included the novelty of the study diet, lack of cooking skills, no change in or worsening of symptoms, lack of diet knowledge, and food preferences and temptations. Symptom severity was more frequently reported as a barrier to study diet adherence among participants with secondary progressive MS.

Methods to enhance personal motivation and ensure positive support from support persons and study staff may improve study diet adherence. Due to the unique challenges faced by people with MS, future studies should tailor interventions to their unique MS cohort to increase diet adherence.

From the Department of Internal Medicine, Carver College of Medicine (CD, SP, TJT, AA, PM, NG, MAE, BB, TLW), Department of Epidemiology, College of Public Health (TJT, LGS), and College of Nursing (SD-H), University of Iowa, Iowa City, IA, USA; and the Department of Exercise Science (SSF), Central College, Pella, IA, USA. 

: Terry L. Wahls, MD, University of Iowa, 200 Hawkins Dr, Iowa City, IA 52242, USA; 

*CD and SP contributed equally to this paper.

We thank the students who supported the parent trials and the present study.

 Terry L. Wahls, MD, personally follows and promotes the Wahls diet. She has equity interest in the following companies: Terry Wahls, LLC; TZ Press, LLC; The Wahls Institute, PLC; FBB Biomed, Inc; and the website http://www.terrywahls.com. She also owns the copyright to the books 

, and the trademarks The Wahls Protocol, Wahls diet, Wahls Paleo diet, and Wahls Paleo Plus diet (the Wahls elimination diet is not trademarked). She has completed grant funding from the National Multiple Sclerosis Society for the Dietary Approaches to Treating Multiple Sclerosis Related Fatigue Study. She has financial relationships with BioCeuticals; MCG Health, LLC; Genova Diagnostics; and the Institute for Functional Medicine. She receives royalty payments from Penguin Random House. She has conflict of interest management plans in place with the University of Iowa and the Iowa City VA Health Care System. The other authors have disclosed no relevant financial relationships.

 This study was supported in part by the National Multiple Sclerosis Society (grant RG-1506-04312 to Terry L. Wahls, MD), the Direct-MS Charity of Canada, and University of Iowa institutional funds. The University of Iowa Summer Research Fellowship for Medical Students provided support for Cassidy Dean, BS; Samantha Parks, BS; and Andrea Arthofer, BA. Tyler J. Titcomb, PhD, RD, is a research trainee of the University of Iowa Fraternal Order of Eagles Diabetes Research Center (grant T32DK112751-01) and is supported by the Carter Chapman Shreve Family Foundation and the Carter Chapman Shreve Fellowship Fund for diet and lifestyle research conducted by the Wahls Research Team at the University of Iowa. In-kind support was provided by the University of Iowa College of Public Health Preventive Intervention Center.

Multiple sclerosis (MS) is a progressive neurodegenerative disease that can severely impact an individual’s quality of life with many debilitating symptoms.

 Surveys consistently report that approximately half of people with MS modify their diet as a nonpharmacologic method to improve overall well-being and reduce symptom burden.

 Consequently, the focus on nonpharmacologic interventions, such as diet and lifestyle, as adjunct therapies to reduce symptom burden has increased.

Emerging epidemiologic evidence suggests that diet quality is inversely associated with risk of relapse and disability among people with MS.

 Similarly, several preliminary trials have shown the benefit of dietary interventions in reducing MS-related fatigue and improving quality of life.

 However, due to the overall lack of scientific rigor in the preliminary trials, the current state of evidence does not support any specific dietary strategies for MS.

 Thus, better-designed randomized trials are needed to determine the efficacy of dietary interventions on MS-related symptoms.

Participant adherence to study intervention diets is an important consideration when evaluating the efficacy of dietary intervention studies. People with MS often experience pain, fatigue, and changes in vision, cognition, and motor function,

 which may present people with MS unique challenges in adhering to dietary interventions. A qualitative interview study by Plow and Golding

 identified symptoms of fatigue and mobility problems as major barriers to engaging in healthy behaviors among people with MS; however, in the same study, improvements in these symptoms were also described by participants as major motivators to engaging in healthy behaviors. Thus, it is possible that disease and symptom severity impacts how people with MS perceive adaptation to dietary interventions.

In agreement with our previous experience, expert recommendations suggest that adaptation of study diets by partners of people with MS facilitates diet adherence and study completion.

 The “we” approach is suggested for people with MS and their partners in coping with MS.

 reported that partners who engage in healthy behaviors with their spouse with MS feel a sense of “togetherness” and are better able to provide support to their partner with MS. This coengagement in healthy behaviors also leads to increased perceived hope for the future among partners of people with MS.

 In addition to practical barriers to diet adaptation, such as eating out, traveling, and major life events, partners of people with MS report that disease progression is a major barrier because the rewards of healthy behaviors may become less obvious or occur over an extended period.

 Understanding facilitators of and barriers to diet adaptation among people with MS and their support persons may provide important information to better design future clinical trials. Thus, the objective of this study was to identify themes of perceived experiences in adapting to study diet interventions among people with MS and their support persons.

This is a qualitative descriptive study. Semistructured one-on-one telephone or video interviews were conducted with participants with MS from 2 different dietary intervention studies conducted by our group

 and their self-identified support person, defined as any adult companion (partner, family member, friend, adult child) who supported the participant throughout the dietary intervention studies. The interviews were designed to gather details about adherence to the restrictive study diets (modified paleo and low–saturated fat diets, both of which lead to symptom improvement in MS

 and the present study protocol were approved by the University of Iowa institutional review board.

Participants with relapsing-remitting MS (RRMS; n = 13) were recruited from a cohort of 55 individuals who met the following criteria: completed a trial comparing 2 specialized dietary approaches (modified paleo and low–saturated fat diets) on MS symptoms

 and voluntarily enrolled in a long-term observational follow-up study. Participants were contacted regarding interviews via email and, if they agreed to participate, were asked to nominate a support person. Partners were the preferred support person, but to avoid discrimination against those without partners, friends or other family members were also included. Two participants declined to nominate a support person but were interviewed and included in this study. In all instances, the support person was either a spouse (n = 9) or an adult child (n = 2). In addition, as part of a previous 12-month multimodal safety and feasibility study that included a dietary intervention component, interviews were requested by email from the first 10 participants with secondary progressive MS (SPMS) to tell the study team about participant experiences with the intervention before recruitment of the complete cohort.

 Interviews were completed with participants with SPMS (n = 7) near the end of follow-up during the previous trial, and each participant’s partner was also interviewed. Participants in both studies received dietary education and support from registered dietitians (RDs) or RD-trained study staff. The RDs provided coaching using motivational interviewing and self-determination theory

 to improve adherence to the study diet intervention and reviewed 10% of coaching sessions to ensure fidelity to the dietary interventions.

The participants and their support persons were interviewed individually once by authors Cassidy Dean and Samantha Parks for study 1 and by Paul Meirick and Nicole Grogan for study 2. The semistructured interviews were conducted in person (32%), by telephone (15%), or by video call (53%) using (1) open-ended questions regarding attitudes and experiences with food and diets before, during, and after the dietary intervention trials and (2) scaled questions regarding perceived sense of hope before and after the study and perceived adherence to the diet rated on a Likert-type scale. Questions in the semistructured interview guide were based on the primary investigator’s clinical experience and were designed to elicit participants’ experiences that affected their adherence to their assigned diet. Additional questions were developed during interim analyses, allowing us to elaborate on possible themes emerging from the interviews. Interviews typically lasted 30 to 60 minutes.

To further elucidate issues related to diet adherence, participants and their support persons were asked about their attitude toward and experience with healthy food and diets before the study to assess their knowledge and skill and how that may have impacted dietary adherence. In addition, they were also asked about previous knowledge they had of the study diets and whether that had any impact on their motivation to adhere to the diet.

Questions regarding their feelings about their (loved one’s) illness before the study and what they expected their (loved one’s) health status to be after another year of MS without the study provided insight into the feelings of each participant and their support person before the dietary intervention. Asking these same questions regarding their feelings after the study concluded provided evidence of the perceived effect of the dietary intervention and the impact that it had on their motivation to adhere to the study diets. The participants were also asked to rate their sense of hope on a scale from 1 (no hope for the future) to 10 (very hopeful for the future) before and after the dietary intervention for a quantitative evaluation. In addition, they were asked to rate their dietary adherence on a scale from 1 (minimally following diet goals) to 10 (meeting all the study diet goals each day) and discuss any challenges they may have faced in meeting the study diet goals, as well as anything that helped them succeed in meeting the goals. Finally, participants in both studies were asked how their respective study could be improved and if there was anything specific that the study team could do or provide that would make it easier to meet the study diet goals each day.

The interviews were recorded and transcribed verbatim. MAXQDA software (VERBI Software) was used to store and organize the data and to facilitate coding. The procedure, reviewed by Graneheim and Lundman,

 was adapted for the qualitative content analysis of the transcribed interviews. The transcripts were independently evaluated to identify codes regarding study diet adherence by 2 investigators (C.D. and S.P.). Any disagreements were discussed until consensus was reached; however, when an agreement could not be reached, discrepancies were settled by a third investigator (T.J.T.). Each code was recorded in a frequency count (ie, how many participants said something consistent with that category). Codes were then condensed and aggregated into content areas describing the specific facilitator or barrier. After final verification, the content areas were deductively grouped together into 2 predefined categories as facilitators of or barriers to diet adherence and then inductively evaluated to identify major themes that prevent or facilitate adherence to study diets as perceived by study participants and their support persons.

The demographic characteristics of the study participants (n = 20 women with MS) from both studies are reported in 

. Using data obtained from one-on-one interviews of study participants and their support persons, we identified 5 themes that were described as having a major impact on their ability to adhere to their assigned study diet. The themes are (1) personal motivation, (2) diet components, (3) time, (4) support, and (5) resource access (

). The following sections summarize each theme using illustrative quotes from study participants and their support persons. Names of participants have been replaced with pseudonyms for confidentiality. Differences in the frequency of facilitator and barrier reports between MS participants and their support persons are given in 

, which is available in a PDF at the end of this article.

Participants and their support persons attributed finding an inner source of personal motivation as key to diet adherence; however, the reported sources of motivation (eg, family, physical ability, MS community, etc) varied widely, suggesting that the source of motivation is not the key factor. Participants in both groups described an innate drive to comply with study procedures because they felt a sense of duty to the study or a sense of obligation to the ‘greater good’ of the MS community as their motivation. “I have felt from the beginning that I can’t let [MS] beat me … being a part of the study … knowing that it was for the greater good, was motivation,” said Jill when asked why she chose to participate in the study. Conversely, an inability to find or maintain motivation was a frequently reported barrier, especially among the participants (65%) compared with their support persons (17%).

Improvement in MS symptoms was another frequently reported facilitator of diet adherence. Most participants with RRMS (77%) and all with SPMS noted an improvement in MS symptoms and attributed their perceived symptom improvement as a major motivation to continue with the study diet. Elizabeth said, “After the first couple weeks, I started feeling better and was feeling stronger.” Symptom severity at the beginning of the study was a significant barrier reported by participants with SPMS (43%) but not by participants with RRMS (0%), and overall, study participants reported worsening of symptoms as a barrier more frequently than their support persons (40% vs 11%, respectively). Stacey said, “I was mostly after the physical improvement and there was [no improvement]. I would still be on it 100% if I saw both physical and fatigue improvements.”

Both intervention diets required considerable effort to follow, a major barrier for some participants. When asked about her experience following the study diet, Karen said, “It hasn’t been anywhere near like swallowing a magic pill; it’s a lot of work.” Among the most significant barriers to diet adherence among participants was the novelty of the study diet. The participants indicated significant struggle at the beginning of the diet intervention as they were learning the study diet protocol and how to prepare new foods. “The first week was tough … information overload … I just want to know what to eat and when to eat,” said Rebecca. “Some of the information that is given can be a little, a little daunting to grasp,” echoed Jim, a support person.

Despite all the study participants receiving diet education from the intervention dietitians, learning the study diet was frequently reported as a barrier. Michelle said, “We have the book and know what we’re going to do, but we have no idea how to do that.” In fact, many participants wished they were given more time to adjust before the study truly began. “My house wasn’t prepared for that type of diet to be implemented that day … it should have been a 2-week progression towards the diet,” said Sally. Conversely, perceived previous knowledge about nutrition and its effects on health were reported as facilitators of diet adherence. “The foods were normal … it’s how I eat normally … I know that each component has its own specific task when it comes to giving nutrients and energy and support to my body,” said Elizabeth.

The restrictive diets were perceived as a major burden for several support persons. John stated, “I don’t think food is medicine; I think of it as something that is the highlight of the day so if it doesn’t taste good, I’m definitely not going to do it, even if it’s healthy for me.” Several support persons chose to not follow the same diet as the loved one with MS who was enrolled in the study. “I guess … my desire [was] to have things other than what she wanted. I had a different view of what I should eat and what she should eat,” said Paul. However, a few support persons appeared to enjoy the study diets. Kirk emphasized, “We like fresh fruits and vegetables, [and] the ingredients are pretty good.”

Among the 5 themes identified in this study, participants and support persons alike described time only as a barrier to and in no way as a facilitator of study diet adherence. It was directly mentioned by Ashley that “time was the biggest thing” when asked during the interview what may have hindered her dietary adherence. “It was a lot of work initially because you had to research everything you ate … everything you did,” Ashley continued. The time-consuming aspects of the diet included preparing the food and grocery shopping. Jill said, “You had to spend a lot more time … planning out the meals for the week … [and] cooking.” This point is further highlighted by Michelle, who said, “I really feel like I could have a time and a half job just trying to figure out my food, which is at times overwhelming.” The burden of time spent planning and purchasing food was also noted by support persons. Paul stated, “Grocery shopping was a big challenge because you had to spend a lot more time researching ingredients on your purchases.”

Study procedures were frequently reported as a perceived barrier by study participants (65%), but not as frequently by their support persons (28%). “The data-keeping was a bit overwhelming,” said Rebecca. The burden of food log documentation was also noticed by support person John, who said, “Another barrier is just like [the] documentation part of this diet. Like, knowing what to record or how often to record … it takes so much time.”

Throughout the study, perceived support or lack thereof contributed greatly to participants’ ability to adhere to the diet. It was a challenge for the participants who had family members who were not supportive of them taking part in the study and thus hindered their success. “My husband liked to cheat [on the diet] … if it was just me it probably would have been different … but it’s the family element, both child and husband,” said Elizabeth. In addition, children were frequently reported as a challenge. “My child was preteen … it was hard to bring him along with what I was eating … it was difficult trying to fix him one meal and me another,” said Sally. Ben, a support person, also noted, “When you’ve got kids it’s really tough because then you [have to] cook two separate entrees.”

Alternatively, when support persons assisted in food preparation and household tasks, providing positive support, it facilitated study diet adherence among the study participants. Jennifer said, “My husband does a lot of the chopping of fruits and vegetables to get them ready to grab … he has picked up a lot more things at home that I used to do.” Positive family support was among the strongest facilitators identified. Lexi said, “What made [the diet] easier was that we did it as a family, not just [me] individually.” This is highlighted by support person Kirk, who stated, “Because we were doing the study, we might fall back a few days and then say, ‘Okay, we got to get back on [the diet].’” Study participants more frequently reported support from the study staff (ie, the dietitians) as a facilitator to study adherence compared with their support persons (75% vs 39%, respectively). Carol said, “For me, the biggest perk was being able to work with the [study] nutritionist … if I had any questions, they were answered.”

Access to resources, including online support groups, recipe books, public transit, and well-stocked local supermarkets, was one of the most frequently referenced facilitators. Stacy said, “I did join one of the [online support] groups and we found it’s not as expensive as we thought it would be. … Once you make a couple different recipes, that gives you an idea of the trends and how to cook.” Access to resources was also perceived as a facilitator by Stanley, a support person, who said, “The biggest help was finding [a] more appetizing variety [of] recipe books that were [study diet] friendly.”

Cost was not frequently reported as a barrier to the study diet; however, it was a barrier for some. Stanley, a support person, said, “For a family that has one working parent … financially, I just didn’t feel like I could because it’s kind of expensive.” This was further emphasized by the support person Kirk, “The price of foods, the right … foods is tough, you know, for a family that has one working parent.” Location was another barrier to diet adherence for the participants and support persons who lived in areas perceived to be food deserts. As described by Mike, a support person, “We live in a small town and the grocery store where we live didn’t have a lot of the things that were in the study … and fatigue is a huge issue for [her]. There’s a lot of times where it’s not really safe for her to drive further.”

Perceived hope for the future slightly increased after the study for the participants with RRMS or their support persons, and there were larger increases among participants with SPMS and their support persons. On a scale from 1 to 10 (1 = no hope, 10 = extremely hopeful), mean ± SD perceived hope for the future among participants with RRMS was 8.2 ± 2.2 before the study and 9.0 ± 1.9 after the study. Similarly, mean ± SD perceived hope for the future was 6.7 ± 2.2 before the study and 7.7 ± 2.4 after the study for RRMS support persons. Among participants with SPMS, mean ± SD hope for the future was 4.6 ± 1.8 before the study and 7.4 ± 2.0 after the study, and for SPMS support persons, it went from 5.0 ± 1.7 before the study to 7.5 ± 1.9 after the study. One quote from Rhonda, a participant with SPMS, illustrates this change: “I never expected to walk without assistance again [or] be able to finish the training with my dog and walk her further. I mean, I’m babysitting for a coworker now. I never thought I [would again].”

An increased interest in lifestyle modification among people with MS has led to an increased interest in nonpharmacologic interventions among MS researchers. Emerging evidence suggests that lifestyle modification, including diet changes, can improve quality of life in people with MS. However, to develop MS-specific dietary approaches, well-designed studies with adequate sample sizes and high levels of diet adherence are urgently needed.

 The themes identified in this study provide insight into facilitators of and barriers to study diet adherence that can be used by future dietary intervention studies to improve the accuracy and reliability of their results.

We observed that participants often noted the importance of a positive mindset, maintaining study engagement, positive support from family members and study staff, and planning ahead to adhering to their assigned study diet. Having a positive mindset and motivation was mentioned by 100% of participants with MS and 78% of their support persons. These findings are similar to those from Plow and Golding,

 who observed that participants who prioritized diet adherence often felt a sense of duty because of their MS and felt that participating in wellness programs provided them a sense of control over their MS. In this study, support from family and study staff proved to be an invaluable resource, with 80% of participants mentioning positive family support and/or study dietitians as a facilitator. Simultaneous adoption of lifestyle changes is viewed as a method to provide practical and emotional support and increases perceived hope for the future by the partners of people with MS.

 In this light, it is alarming that 39% of support persons identified themselves as being guilty of negative support in the present study.

Improving access to study dietitians may additionally help mitigate the barrier of the novelty of study diets and facilitate active dietary adherence. People with MS are likely to prefer making active, shared decisions with health care professionals.

 Study dietitians can help accommodate study participant food preferences and provide diet education to help foster autonomy and desirability, which, in turn, could promote intrinsic motivation to follow the study diet. In the present study, 80% of participants referenced unfamiliarity with the new diet as a barrier to successful adherence. Previous perceived knowledge about diet/nutrition was mentioned as a facilitator to diet adherence by 77% of participants with RRMS and 29% with SPMS. Although it was not frequently referenced, access and cost were significant barriers for several participants. Addressing resource disparities among participants and reducing the cost of study interventions are critical for improving adherence.

People with MS often report symptoms as a barrier to healthy behavior change.

 In the present study, symptom severity at the beginning of the study was a major perceived barrier to study diet adherence for only the participants with SPMS. This discrepancy may be due to the progressive nature of SPMS, which leads to higher symptom burden over time.

 In this study, improvement in MS symptoms was frequently reported as a facilitator of diet adherence among both participants with MS and their support persons. Plow and Golding

 found that engaging in healthy behavior change was viewed as a means to maintain independence for people with MS, and coengagement in healthy behaviors by partners of people with MS increases their ability to support them.

 Taken together, these observations highlight the complex interaction between symptom severity and the desire to engage in healthy behaviors among people with MS.

This study has several limitations. First, due to the small sample size and the lack of male participants, these findings have limited application to the entire MS population and need to be confirmed by additional studies. Second, because the data from participants with RRMS and SPMS are from 2 different studies, differences between these 2 groups should be viewed only as hypotheses. Third, there is the potential for selection bias in these results because individuals with particularly extreme responses to the dietary intervention may have been more likely to agree to be interviewed for the present study. Fourth, some of the participants with RRMS and their support persons interviewed had completed the study more than 1 year earlier, which may have impaired recall. Finally, the intervention among participants with RRMS was only 24 weeks, whereas participants with SPMS were interviewed between 26 and 52 weeks into their intervention, and this discrepancy in the duration of the intervention may have caused differences in the perceived outcomes of the study interventions. Nonetheless, this study provides awareness to perceived themes of dietary intervention adherence that may be addressed by health care providers at the time of diagnosis.

The findings from this study provide insight into modifiable factors that can be used to better design future dietary intervention studies among people with MS. These results suggest that study participants with MS and their support persons perceive many similar themes to study diet adherence, which may improve the ability to engage support persons and ultimately lead to better study diet adherence. Enhancing personal motivation and ensuring positive support from study staff and family members seem to be major opportunities for future dietary intervention studies among people with MS. These interventions may enhance study diet adherence and reduce attrition. In addition, devising strategies to adapt the study diets to the preferences of not only the study participants with MS but also other people in the household, such as spouses and children, may reduce feelings of burden toward the study diet and enhance adherence. The themes of diet adherence identified in this study may be used by clinicians working with people with MS to improve their diet and by future researchers to design more rigorous studies to determine the effectiveness of dietary interventions on MS disease activity.

Facilitators of and Barriers to Adherence to Dietary Interventions Perceived by Women With Multiple Sclerosis and Their Support Persons

Multiple sclerosis (MS) causes motor, cognitive, and sensory impairments that result in injurious falls. Current fall risk measures in MS (ie, forward walking [FW] speed and balance) are limited in their sensitivity. Backward walking (BW) velocity is a sensitive marker of fall risk and correlates with information processing speed (IPS) and visuospatial memory (VSM) in persons with MS. Backward walking is a complex motor task that requires increased cognitive demands, which are negatively affected by MS; however, whether cognitive function modifies the sensitivity of BW as a fall risk assessment in MS remains unknown. This study examines the influence of cognition on the relationship between BW and falls in persons with MS.

Measures of BW, FW, IPS, VSM, and retrospective falls were collected. Hierarchical regression tested moderation and included an interaction term predicting number of falls. Covariates for all analyses included age and disease severity.

Thirty-eight persons with MS participated. Although BW, IPS, and covariates significantly predicted the number of falls (

 = .016), there was no evidence of moderation. Backward walking, VSM, and covariates also significantly predicted number of falls (

 = .008), but there was no evidence of moderation. The FW models generated comparable results.

The relationship between BW velocity and falls was not conditional on IPS or VSM in this sample. Larger-scale studies examining additional cognitive domains commonly affected by MS and prospective falls are needed to characterize neurobiological processes relevant to BW and its clinical application in the assessment of fall risk.

From the Translational Neuroscience Program (EME, AMD, NEF), Department of Health Care Sciences (EME, NEF), Department of Psychology (AMD), Institute of Gerontology (AMD), and Department of Neurology (NEF), Wayne State University, Detroit, MI, USA. 

Erin M. Edwards, BS, 259 Mack Ave, #2305, Detroit, MI 48201, USA; 

 Nora E. Fritz, PhD, PT, DPT, NCS, serves on the MS scientific advisory board for Helius Medical. The other authors declare no conflicts of interest.

 Preliminary data from this manuscript were presented as a poster at the Consortium of Multiple Sclerosis Centers Annual Meeting; October 2021; Orlando, Florida.

Multiple sclerosis (MS) is a progressive neurologic disease associated with inflammation, demyelination and axonal damage that leads to debilitating motor and cognitive impairments.

 Consequently, injurious falls are common in persons with MS, with more than 50% of individuals experiencing a fall in a 3-month period.

 Falls in MS are associated with decreased quality of life (activity curtailment and social isolation)

 and greater cost to society (increased demand on health care resources).

Current fall risk measures rely on forward walking (FW) speed,

; however, these measures exhibit limited sensitivity to predict fall risk,

 which may be attributed to their inability to detect subtle underlying impairments that are linked to falls, including motor and cognitive dysfunction. At present, a simple and sensitive fall detection measure remains unidentified for persons with MS.

Substantial evidence supports backward walking (BW) velocity as a reliable fall prediction measure in the elderly and other neurologic populations.

 Recently, our laboratory examined the relationship between BW and falls in persons with MS to determine what clinical measures of walking and disability most strongly and uniquely differentiate those with MS who fall from those with MS who do not fall.

 Velocity of BW exhibited the highest effect magnitude and specificity in differentiating the 2 groups compared with standard clinical methods. The present findings emphasize the importance of examining BW as a quick, simple, and sensitive fall prediction tool in persons with MS. However, critical gaps in knowledge remain in our understanding of BW’s ability to sensitively detect falls in persons with MS, and it remains unclear whether functional domains commonly affected by MS may modify the sensitivity of BW as a fall risk assessment in MS.

Backward walking is a complex, novel task requiring increased postural control, lower extremity strength, and sensory and cognitive demands,

 all of which are negatively affected by and related to falls in MS.

 The relationships between BW, motor function, and falls in persons with MS are established,

 yet the relationship between BW, cognitive function, and falls in persons with MS is unknown. Previous MS research demonstrates connections between complex motor task performance and the function of specific cognitive domains, namely, information processing speed (IPS) and visuospatial memory (VSM).

 Similarly, our laboratory has shown that BW correlates with IPS

 and VSM (N. Fritz, PhD, DPT, PT, NCS; M. Atalla, BS; M. Nitta, BS; unpublished data; 2018). However, the aforementioned cognitive studies did not examine falls. Thus, the relationship between BW, cognitive function, and falls remains unknown in persons with MS. This leaves a critical gap in knowledge regarding cognitive mechanisms underlying BW’s ability to detect falls.

Based on published preliminary data, we hypothesized that the relationship between BW velocity and falls is conditional on an individual’s IPS, and a secondary hypothesis tested VSM (

). Evidence in support of these hypotheses is the critical first step in establishing a cognitive framework aimed at characterizing neurobiological processes relevant to BW and its clinical application in the assessment of fall risk and targeted fall prevention therapies for persons with MS.

A convenience sample of 38 participants with a neurologist-confirmed diagnosis of relapsing-remitting MS was recruited from the MS clinic at Wayne State University in Detroit, Michigan, and from local MS support groups of the greater Detroit area. All participants provided written informed consent, and the research protocol was approved by the Wayne State University institutional review board. Individuals with MS were eligible to participate if they were between 18 and 75 years old, stable on immunomodulatory therapy (if applicable) for at least 3 months before the beginning of the study, ambulatory with or without physical assistance, and able to follow study-related commands. Exclusion criteria included MS exacerbation within the past 8 weeks, corticosteroid use within the past 30 days, and acute orthopedic or other neurologic conditions that would interfere with walking.

Demographic data were collected, including age, sex, body mass index, disease severity (using the Patient-Determined Disease Steps [PDDS] scale), and symptom duration.

The FW and BW performance was evaluated using a 16-ft GAITRite electronic walkway (CIR Systems, Inc). The GAITRite electronic walkway is equipped with sensors organized in a gridlike pattern that record footfalls in real time and is reliable and valid for use in MS.

 The GAITRite calculates spatiotemporal measures of gait and individual step parameters. Participants were instructed to walk at their quickest and safest speed for FW trials, which mimics the conditions of the Timed 25-Foot Walk test. Participants were instructed to walk at a comfortable, safe pace for BW trials, following the methods of our laboratory and others.

 Four trials were recorded for each condition, and the data were averaged. Participants received instruction to look ahead rather than at their feet, wore a gait belt, and were accompanied by a research assistant to ensure safety and minimize path deviations on all trials.

Processing speed was assessed using the Symbol Digit Modalities Test (SDMT). Participants received a key with 9 numbers each corresponding to a symbol and were asked to determine the number belonging with a series of symbols using this key. The score is the number of correct answers in 90 seconds. The SDMT is validated and reliable in MS to analyze IPS.

 Visuospatial memory was assessed using the Brief Visuospatial Memory Test–Revised (BVMT-R). Participants are shown 6 simple figures arranged in a 2×3 matrix on 8×11 paper for 3 consecutive 10-second trials. After each trial, participants were asked to draw as many shapes as accurately as possible and in the correct location. The BVMT-R demonstrates good psychometric properties and high reliability in MS.

Falls were measured retrospectively: Participants were asked, “How many times have you fallen in the last month?” and answered with a number. Falls were defined as “unexpected events that resulted in an unintentional landing on the ground or a lower surface.”

All statistical analyses were performed using IBM SPSS Statistics for Windows version 25.0 (IBM Corp). We chose, a priori, to evaluate IPS and VSM because both domains are primarily affected by MS and have been linked to BW velocity and falls, separately, in persons with MS.

 To evaluate the hypothesis that the relationship between BW velocity and falls is moderated by cognition, we used hierarchical regression modeling. The model’s first step used the main effects of BW and cognitive function to predict the number of falls, and significantly increased variance was used in the second step with the addition of an interaction term to test the moderation hypothesis. Continuous predictors were mean centered before model estimation. For each cognitive domain tested, we ran 1 model for BW and 1 model for FW, resulting in 4 total models; all significance testing was adjusted for multiple comparisons (Bonferroni corrected α = 0.01). Covariates for all analyses included age and disease severity as measured using the PDDS scale.

Thirty-eight participants (4 men and 34 women) with relapsing-remitting MS participated in this study. The mean ± SD patient age was 50.4 ± 9.2 years, symptom duration was 16.9 ± 11.8 years, and PDDS scale score was 3.2 ± 4 Most of the participants (86.8%) were taking disease-modifying therapies, and 39.5% used walking devices during testing (

). There was no statistical evidence to suggest that IPS or VSM moderates the relationship between BW velocity and falls (

). In the first BW model (A1–2), BW velocity, IPS, and covariates (age and disease severity) significantly predicted the number of falls (

). However, IPS did not change the relationship to BW velocity (Δ

). In the second BW model (B1–2), BW velocity, VSM, and covariates also significantly predicted the number of falls (

Maya Behn, MD

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