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Disaster Preparation for People With Multiple Sclerosis: A Scoping Review of Resources

From the Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA (SLD, MP). 

Sara L. Douglas, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44104, USA; email: SLD4@case.edu.

Caregivers of persons with multiple sclerosis (MS) report high levels of distress. The National Comprehensive Cancer Network Distress Thermometer (DT) is used extensively with patients with cancer and their caregivers but has not been tested in nononcology caregivers. The purpose of this study was to examine the psychometric properties and clinical utility of the barometer portion of the DT in caregivers of persons with MS.

A secondary analysis was performed of data from a randomized trial comparing the effectiveness of 2 interventions aimed at reducing psychological outcomes associated with caregiving. The DT and the 4-item Patient-Reported Outcomes Measurement Information System Anxiety and Depression scales, which were administered at baseline, were used for all analyses. Construct validity (known groups) and convergent validity (interscale correlations) were evaluated. Receiver operating characteristic curve analysis was used to evaluate clinical diagnostic test evaluation.

 The DT had good construct validity supported by strong correlations for known-groups analyses and good convergent validity (

 = 0.70–0.72). The DT also demonstrated good discrimination for anxiety (area under the curve [AUC] = 0.83) and depression (AUC = 0.80). The optimal screening cut point on the DT was 4 for anxiety and 5 for depression.

The barometer portion of the DT demonstrates good psychometric properties and clinical utility in caregivers of persons with MS. This is the first examination of the DT in MS care partners.

 The authors declare no conflicts of interest.

 This study was supported by the Patient-Centered Outcomes Research Institute (grant MS-1610-37015-Enhancement).

Psychological distress has been conceptualized as a “state of emotional suffering characterized by symptoms of anxiety and depression,”

 and research has demonstrated its effect not only on a patient’s quality of life but also on their adherence to treatment, satisfaction with care, and survival.

 Distress and negative emotional outcomes have also been documented in caregivers. Rates of distress and psychiatric disorders for caregivers have ranged from 15% to 60%,

 and caregiver distress has been shown to contribute to the delivery of lower-quality patient care and to poorer quality of life for the patient.

 Therefore, caregiver distress has been shown to impact not only the caregiver but also the patient.

To date, the most common tool used to measure distress in patients with cancer has been the National Comprehensive Cancer Network Distress Thermometer (DT).

 It has good psychometric properties and clinical utility in oncology care

 and consists of a visual analog scale (resembling a thermometer) that ranges from 0 (no distress) to 10 (extreme distress).

 There is also a list of 42 problems representing 5 different categories (practical, family, emotional, spiritual, physical) where individuals identify sources of distress from the list of problems. In the clinical setting, the single-item thermometer is often used to identify individuals who display elevated distress (score >4) and who should be referred for additional evaluation. The DT has high acceptability among patients, caregivers, and clinicians, primarily because of its brevity.

In oncology, the DT is recommended as a quick screening measure to identify individuals with psychological distress who may present with symptoms of depression and/or anxiety.

 In addition, its use in the clinical setting is recommended because patients and caregivers do not stigmatize it like standard anxiety and depression tools.

 Finally, the DT is recommended because of the numerous validation studies (using depression and anxiety as reference measures)

 that have yielded cut points at which to make referrals for further psychological assessments.

Although the DT has been used with some populations of patients without cancer, information about its psychometric properties and clinical utility with these populations is minimal.

 In a recent scoping review of the clinical utility of the DT for those without cancer,

 of the 53 studies identified, 37 included patients, 14 included parents of children with various illnesses, and only 2 included caregivers who were not parents of children with illness. Given the recognition of the important role that caregivers play in the support and care of all patients—especially those with long trajectories of care—there is a need to identify reliable and valid tools that can quickly identify elevated caregiver distress—especially in caregivers of nonchildren.

One such group is caregivers of persons with multiple sclerosis (MS); MS is a chronic demyelinating neurologic disorder that is often progressive in nature and results in problems with mobility and cognition as well as a variety of other physical and emotional outcomes.

 An estimated 46% to 58% of persons with MS receive informal, unpaid care not routinely provided through the established health care system over the course of their illness.

 Caregivers of persons with MS are reported to have low health-related quality of life and high levels of anxiety (68%), depression (44%), and distress (51%).

 As screening of cancer caregivers for distress has begun to be incorporated into outpatient clinics, MS caregivers should be screened as well, given the prevalence of anxiety, depression, and distress identified in this population, and health care providers should make referrals for further evaluation and treatment if needed.

 The first step in this process is to determine the psychometric properties and clinical utility of the DT for use in this caregiver population.

Baseline (prerandomization) data used for psychometric testing came from a randomized trial comparing the efficacy of 2 interventions aimed at reducing distress in caregivers of persons with MS.

 The study was conducted from April 2021 to February 2022 and included a national sample of MS caregivers. A caregiver was defined as someone (family or friend) who provides any type of support (eg, physical, emotional, or administrative support, such as paying bills) to the person with MS, who is not a professional caregiver, and who is not paid for their efforts.

 Convenience sampling was applied using social media and direct email to persons with MS who had participated in a previous study. Inclusion criteria for caregivers were as follows: (1) an adult family member or friend (≥18 years old) of a person with MS, (2) self-identified as an unpaid caregiver for a person with MS, (3) access to the internet, and (4) capable of providing informed consent in English. After initial screening, electronic informed consent was obtained using REDCap (Research Electronic Data Capture).

 Approval was obtained from Case Western Reserve’s institutional review board before data collection.

Distress was measured using the barometer portion of the DT.

 The barometer tool is a single-item, self-report measure of psychological distress and has excellent psychometric properties for both patients with cancer

 Instructions for completion of the barometer tool defines distress as an “unpleasant experience of a mental, physical, social, or spiritual nature which can affect the way one thinks, feels, or acts.”

 Instructions also state that distress may make it harder to cope with disease, its symptoms, or its treatment.

 Individuals are asked to rate their distress in the past 7 days on an 11-point visual analog scale ranging from 0 (no distress) to 10 (extreme distress), with higher scores indicating higher levels of distress.

Receiver operating characteristic (ROC) curves have demonstrated that the DT has good diagnostic utility for cancer caregivers relative to anxiety and depression reference measures.

 Area under the curve (AUC) analyses indicate that the DT has good overall discrimination (AUC = 0.85 for the Patient-Reported Outcomes Measurement Information System [PROMIS] Anxiety scale and AUC = 0.81 for the PROMIS Depression scale),

 and ROC curves also indicate that using a cut point of 4/5 maximizes sensitivity (86.2% Hospital Anxiety and Depression Scale [HADS]-Anxiety; 88.2% HADS-Depression) and specificity (71.2% HADS-Anxiety; 67.6% HADS-Depression).

 Scores of 4 or greater represent clinically elevated levels of distress for caregivers of those with cancer, and the DT is deemed appropriate to use as a clinical screening tool for patients with cancer and their caregivers.

The PROMIS Anxiety and PROMIS Depression short-version instruments

 were used as reference measures for validation of the DT. Standardized anxiety and depression tools have been the most frequently used reference measures for validation of the DT in cancer populations.

 The PROMIS Anxiety instrument consists of 4 items, has a 7-day recall period, and uses a 5-point Likert scale ranging from 1 to 5, with higher scores representing more anxiety severity. Raw scores are converted to standardized 

 scores for analysis using PROMIS guidelines (mean ± SD = 50 ± 10). General population cut points that classify scores as normal, mild, moderate, or severe anxiety have been validated.

 The short version has demonstrated excellent psychometric properties in several patient populations,

 with good internal reliability (Cronbach α = 0.89–0.95)

 = 0.71–0.79) between the PROMIS short version and other established measures of anxiety.

 In the present study, the Cronbach α for this scale at baseline was 0.85.

In previous research, ROC curve analyses demonstrated that the PROMIS Anxiety short version has good diagnostic utility in patients with pain and poststroke, with AUCs greater than 0.80

 and a cut point of 8 maximizing sensitivity (64.6%) and specificity (86.3%).

 Based on these studies, the PROMIS Anxiety short version has been deemed appropriate for use as a brief measure for screening patients for anxiety severity.

The PROMIS Depression short-version instrument

 has the same number of items, recall period, and Likert scale as the PROMIS Anxiety short version, and 

 scores are converted using the same methods as outlined previously herein (mean ± SD = 50 ± 10), with higher scores indicating greater depression severity. General cut points that classify 

 scores as normal, mild, moderate, or severe depression have been validated.

 The short version has demonstrated excellent psychometric properties in orthopedic outpatients and outpatients with musculoskeletal pain,

 with good internal reliability (Cronbach α = 0.89–0.93)

 In the present study, baseline Cronbach α was 0.85.

In previous research, ROC curve analysis demonstrated that the PROMIS Depression short version has good diagnostic utility in patients with pain and poststroke, with AUCs greater than 0.80.

 Cut points of 8 have been shown to maximize sensitivity (89.8%) and specificity (79.5%).

 Based on this research, the PROMIS Depression short version has been deemed appropriate for use as a brief measure for screening patients for depression severity.

After participant consent and before randomization, baseline data were collected remotely using REDCap. Baseline surveys included a demographic data form, the single-item DT tool, the PROMIS Anxiety short version, and the PROMIS Depression short version.

All data were checked and analyzed using IBM SPSS Statistics for Windows, version 28.0 (IBM Corp). The DT, PROMIS Anxiety, and PROMIS Depression 

 scores all followed a normal distribution as determined by Q-Q plots and 95% CIs around the mean skew and kurtosis values. All assumptions of test statistics were evaluated and met before the analyses were performed.

The known-groups approach was used to evaluate the construct validity of the DT.

 Participants were classified into 2 groups known to differ regarding their baseline depression and baseline anxiety (with the focal construct being distress). Because anxiety and depression were the reference measures for validation of the DT, we examined construct validity using both reference measures. Anxiety and depression scores were categorized (following PROMIS normed cut points) into normal, mild, moderate, severe, and extremely severe categories. Based on these baseline categories, we constructed 2 groups for anxiety and 2 groups for depression: those with scores categorized as “normal” and those with scores categorized as “severe” or “extremely severe.” We then compared the mean baseline DT scores for those 2 groups. These mean differences needed to be statistically significant in the expected direction for the instrument to be considered valid.

 We hypothesized that the mean DT scores for the 2 groups would differ significantly, with those in the “severe” or “extremely severe” category (anxiety, depression) having statistically significantly higher DT scores than those in the “normal” group.

Next, to evaluate convergent validity we tested the correlations between the focal measure (ie, the DT) and the measures of constructs with which conceptual convergence is expected. Previous validation studies for the DT have used measures of anxiety and depression in assessing convergent validity because research has shown strong relationships between the concepts of distress and anxiety and depression.

 Correlations less than 0.20 were considered low, 0.20 to 0.50 were considered moderate, and greater than 0.50 were considered large.

 It was hypothesized that there would be significant direct correlations between DT and each of the 2 PROMIS scales (anxiety, depression). To establish convergent validity, correlations needed to be statistically significant and demonstrate moderate to high correlations (≥0.45).

Given the general use of the DT in the clinical environment to screen individuals who need referral for treatment and management of elevated levels of distress,

 we also evaluated the diagnostic performance of the DT in a sample of caregivers of persons with MS. Using established, normed cut points for above-normal levels of anxiety and depression (for each PROMIS scale), we created dichotomous variables representing the standard criterion for presence or absence of anxiety and depression. The ROC curve analyses were conducted for each of the dichotomized PROMIS scales (anxiety, depression) against DT scores. The AUC values were examined to determine the validity of the DT as a diagnostic test for the PROMIS scales. The AUC values ranging from 0.90 to 1.0 indicated an excellent test, 0.80 to 0.89 a good test, 0.70 to 0.79 a fair test, 0.60 to 0.69 a poor test, and less than 0.60 a test of no diagnostic value.

 Finally, the best cut point DT score for each dichotomized PROMIS scale was determined by evaluating sensitivity, specificity, and Youden index scores for all values of the DT (0–10). The Youden index is a measure of a diagnostic test’s ability to balance sensitivity (detect disease) and specificity (detect no disease); values greater than 0.50 indicate a better-performing diagnostic test.

There were 151 caregivers enrolled in the study who provided data at baseline. Caregivers were, on average, middle aged (mean ± SD age, 52.5 ± 13.9 years), White (n =134; 89.3%), and the spouse of the person with MS (n = 122; 80.8%%). Slightly more than half of the caregivers were female, and 53% had DT scores of 4 or greater (the cut point for caregivers of patients with cancer).

 Patients with MS, were, on average, female (65.6%) and middle aged (mean ± SD age, 50.3 ± 12.6 years), with a moderate level of disability (median Patient-Determined Disease Steps scale score = 4.0).

For construct validity evaluation, independent-samples 

 tests were used to examine known groups for anxiety and depression measures. Mean DT scores for those with PROMIS Anxiety 

 scores <55) were compared with those that were moderate-severe (

 scores >60). For anxiety, there was a significant difference in DT group means between the 2 groups (

 = 0.66). Those with anxiety within normal limits had a mean ± SD DT score of 2.54 ± 2.09 compared with a mean ± SD score of 6.56 ± 2.24 for those with moderate-severe anxiety. Next, mean DT scores for those with PROMIS Depression 

 scores >60). There was a significant difference in DT group means between the 2 groups (

 = 0.63). Those with depression within normal limits had a mean ± SD DT score of 2.74 ± 2.18 compared with a mean ± SD score of 6.77 ± 2.25 for those with moderate-severe depression.

Correlations between DT, PROMIS Anxiety, and PROMIS Depression scores demonstrated strong and significant correlations (all with 

 < .001). Relationships were as follows: DT and PROMIS Anxiety (

 = 0.70). These relationships demonstrate good convergent validity.

Established cut points for each PROMIS scale were used as the standard criteria for presence or absence of anxiety or depression. The ROC curve analysis against each criterion score revealed that the best DT cut point score for anxiety was 4 and for depression was 5. Both cut point scores yielded the highest Youden index. The 

 displays the sensitivity, specificity, Youden index, positive predictive value, and negative predictive value for all DT scores in each criterion. As seen in the 

, the DT showed significant and strong discrimination, with an AUC of 0.83 (SE = 0.03; 95% CI, 0.77–0.90; 

 < .001) for PROMIS Anxiety and 0.80 (SE = 0.04; 95% CI, 0.73–0.87; 

This study provides initial preliminary psychometric findings regarding the DT in caregivers of persons with MS. First, the DT demonstrated strong convergent validity with other established criterion measures (PROMIS Anxiety and Depression scales), with all correlations exceeding the benchmark of 0.45 needed to demonstrate sufficient validity.

 In addition, the DT demonstrated an ability to discriminate between those with moderate-severe anxiety and depression and those with scores within normal limits. As hypothesized, mean differences were statistically significant, in the expected direction, and clinically significant with large effect sizes. Second, the AUCs indicate that the DT discriminates reasonably well between caregivers with and without anxiety and depression, with AUC values falling within the “good test” range.

 Finally, optimal screening cut points on the DT seem to be 4 for the anxiety measure and 5 for the depression measure. The cut points in the present sample varied from those recommended for caregivers of patients with chronic pain (cut point of 8 for anxiety and depression),

 caregivers of adolescents with schizophrenia (cut point of 7 for anxiety and depression),

 and caregivers of persons with cancer (cut point of 4).

 Given the variability of cut points by population, further research examining the psychometric properties of the DT for screening is needed. Psychometric testing should also be conducted in a larger sample of caregivers of persons with MS, a sample that has more variability in race, income, and relationship to persons with MS. Replication of the present findings will enhance confidence in recommending use of the DT for screening purposes and the cut points for anxiety and depression.

Although the need to assess distress in caregivers of persons with MS has been articulated,

 there are no reports of such screening being conducted in the outpatient setting to date. In the oncology outpatient (or chemotherapy infusion) setting, systematic distress screening of caregivers has been studied and implemented without difficulty.

 As with patients, caregivers with elevated DT scores are told of their findings and encouraged to meet with either the facility’s psycho-oncology services (eg, social workers, psychologists) or to meet with other psychosocial providers. In a recent study where this approach was used, 80% of caregivers were interested in meeting with the institutional psycho-oncology professional.

 This procedure is also feasible for caregivers of persons with MS. The DT, which takes 3 to 5 minutes to complete when incorporating the problem list,

 can be administered in the outpatient setting while waiting for an appointment with the patient’s physician. Either the physician or another health care provider can inform the caregiver when their distress score is elevated and provide contact information for professionals for further evaluation. Caregivers can share the information from the DT screening and problem list with current psychosocial professionals (if they have current therapists) or future professionals whom they see for further evaluation.

There are some areas of limitation in the present study. First, psychometric testing was applied solely to the DT barometer without including the list of problems. The original intent of the DT screening tool was to use both the barometer and the list of problems to identify not only those who have elevated distress scores but also the problems most related to their distress.

 In a scoping review of the clinical utility of the DT in nononcologic contexts

 it was noted that most studies (66%) in their review used the DT barometer only and did not include the problem list portion of the tool. The present study, similar to others, is limited in its ability to draw conclusions regarding the tool’s clinical utility because the entire tool was not tested. Future research evaluating the DT tool in a sample of caregivers of persons with MS should include the problem list component.

Second, no comprehensive testing regarding acceptability was conducted. Although few studies examining acceptability of the DT in populations of patients without cancer have been conducted,

 such testing can be very beneficial in terms of ensuring that the tool is clear and understandable to the individuals using it. The DT was originally designed for use with patients with cancer, and its extension into areas such as caregivers and patients without cancer means that it is possible that terminology or types of problems listed are not as relevant to those populations. Such testing and information could lead to modifications of the tool to include different types of problems on the problem list based on the intended population. It is recommended that future testing of the DT in caregivers for those without cancer include acceptability testing.

In summary, preliminary testing shows that the DT barometer is a valid measure of distress in caregivers of persons with MS and performs well as a screening tool for assessing those at risk for anxiety and/or depression. Based on the present findings, it is reasonable to use the DT barometer as a screening tool with caregivers of persons with MS and, given its brevity, is likely to have better clinical utility than longer validated measures. Additional testing of the full DT tool, including the problem list, in a more diverse sample is recommended to see whether these findings can be replicated. Given the importance of screening caregivers of persons with MS for psychological distress, use of the DT is reasonable, and further testing will potentially increase confidence in its use.

Psychometric Properties and Clinical Utility of the Distress Thermometer in Caregivers of Persons With Multiple Sclerosis

From the Department of Clinical Neuropsychology, Free University, Amsterdam, the Netherlands (RJS, CvK, IC); Tante Louise, Bergen op Zoom, the Netherlands (MJvD);Atlant, Kuiltjesweg, Beekbergen, the Netherlands (AJP); Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands (JK); and Department of Neurology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (HW). 

Rogier J. Scherder, MD,Department of Clinical Neuropsychology,Free University, Van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands;email: rogierscherder@hotmail.com.

Although the relationships among physical disability, mood disorders, and pain are well described in multiple sclerosis (MS), little is known about whether those symptoms are associated with sleep disturbances.

Forty-six patients with MS experiencing pain participated. Sleep was indirectly measured by assessing rest-activity rhythm via actigraphy: interdaily stability, intradaily variability, and relative amplitude. Pain was assessed using visual and verbal analog scales, mood by the Beck Depression Inventory and Symptom Checklist-90, and physical disability by the Expanded Disability Status Scale.

Incorporating mood, pain, and physical disability into 1 regression model resulted in a significant association with interdaily stability.

Compared with intradaily variability and relative amplitude, interdaily stability seems to be the most vulnerable actigraphy variable for mood disturbances, pain, and physical disabilities.

The authors are most grateful to all the study participants and to the team at Nieuw Unicum, Zandvoort, the Netherlands.

Major symptoms of multiple sclerosis (MS) include motor dysfunction, cognitive impairment, mood disturbances, and pain.

 The relationships between those symptoms have been extensively examined, more specifically those between physical disability and pain,

 between pain and mood (anxiety, depression),

Sleep disturbances are also highly prevalent (42%–65%) in patients with MS.

 49% of participants reported insomnia, characterized by problems such as difficulty falling asleep or getting up in the morning and nighttime awakenings. In another study,

 32.7% of participants complained of sleep-related movement disorders such as restless legs syndrome. Sleep-related breathing disorders, such as obstructive sleep apnea, have similarly been observed, reported by 37.8% of participants in 1 study.

Considering the close relationship between pain, mood, and physical disability in patients with MS, how do each of these comorbidities contribute to sleep problems in MS? It is known that pain and mood disorders, ie, depression and anxiety, may cause sleep disturbances.

 One study observed an association between pain and sleep in patients with MS, but pain was not included as an independent variable in a regression analysis.

 Consequently, there was no information about how much of the sleep variance was explained by pain. In the same study, pain had a significant relationship with mood when sleep was assessed by means of the Pittsburgh Sleep Quality Index (PSQI), a self-report covering sleep-related issues and daytime functioning. In another study,

 patients with MS who self-reported sleep disturbances had significantly higher scores on anxiety and depression than those who indicated sleeping well. Sarraf and colleagues

 observed a relationship between physical disability, measured by the Expanded Disability Status Scale (EDSS), and sleep, assessed by the PSQI. Vitkova et al

 suggested that such a relationship might also be indirect, mediated by depression. They also assessed sleep by means of the PSQI.

Although the studies noted previously herein, and many more, use the PSQI, a more objective method to assess sleep is actigraphy. Actigraphy assesses the rest-activity rhythm, an indirect measure of the sleep-wake rhythm.

 Actigraphy facilitates insight into 3 clinically relevant variables: interdaily stability (IS), intradaily variability (IV), and relative amplitude (RA) (for further details, see the Methods section). One study found no differences in those 3 variables between patients with MS (n = 16) and controls (n = 16).

 In another study, 3 of 15 patients with MS had a circadian rhythm disturbance: Two patients had a delayed sleep phase and 1 patient displayed an irregular sleep phase.

 These findings might suggest that circadian rhythm disturbances are not a clinical hallmark of MS. On the other hand, the number of participants in each study is relatively small and, overall, there is a dearth of studies assessing the rest-activity rhythm in MS. Moreover, the 3 actigraphy variables–IS, IV, and RA–have not been examined in relation to pain, mood disturbances, or physical disability in MS. The goal of the present cross-sectional study is to investigate whether there is a positive relationship between pain, mood, physical disability, and the rest-activity rhythm—IS, IV, and RA—in patients with MS.

The original total sample consisted of 61 patients with MS, 26 men and 35 women. Twenty-eight patients lived in a center that specialized in MS and other neurodegenerative disorders (ie, Nieuw Unicum, Zandvoort, the Netherlands), and 33 patients lived in their own homes. Of these 61 patients with MS, 46 (17 men, 29 women) experienced pain and 15 (9 men, 6 women) did not. Of the 46 patients with pain, 19 were from Nieuw Unicum and 27 were still living in their own homes. For each patient, a diagnosis of MS and the specific subtype, according to the criteria of either Poser et al

 was made by an MS neurologist. The Mini-Mental State Examination (MMSE)

 was used to assess patients’ global cognitive functioning (maximum score = 30). Level of education was scored as follows

: elementary school not finished (score = 1), elementary school finished (score = 2), more than 6 classes elementary school (score = 3), education but did not complete secondary school (score = 4), secondary school (score = 5), higher secondary school (score = 6), higher vocational training for age 18 years and older/university (score = 7).

From the medical records, we registered chronic comorbidities that existed in the 6 months before the time of assessment and actual comorbidities that existed at the assessment. Conditions causing pain for the cohort were, among others, arthrosis/rheumatoid arthritis, musculoskeletal disorders (eg, neck-shoulder pain), osteoporosis, and peripheral neuropathy.

We listed the following analgesics in the study: baclofen, paracetamol, diclofenac, naproxen, ibuprofen, and cannabis. Medication that could be prescribed for sleep enhancement was registered.

Patients were excluded from the study if they had a history of neoplasms, cerebral traumata, alcoholism, normal pressure hydrocephalus, and/or psychiatric and neurologic disorders with an etiology other than MS.

The local medical ethics committee approved the present study. After being extensively informed about the study’s processes and goals, the patients were asked to provide oral and written consent. We emphasized that the patient was completely free to withdraw from the study at any point.

Rest-activity rhythm was assessed by means of actigraphy. Participants wore an Actiwatch (Cambridge Neurotechnology Ltd) around their wrist like a watch. The Actiwatch objectively records the intensity, amount, and duration of arm movements in episodes of 1 minute, during at least 5 consecutive days and nights, ie, at least 120 hours. The total time that participants wore the Actiwatch ranged from 141 to 193 hours.

The following dependent variables were assessed: (1) IV, which measures the fragmentation of the rhythm within 24 hours, ie, the transitions between periods of activity and rest continuity; a high value means an unstable rhythm within a single day; (2) IS, which assesses the (in)stability of the rhythm between days; the higher the value the more the stability between the days; and (3) RA, which assesses the relative difference between a participant’s maximal rest (normally at night) and maximal activity (normally during the day).

During testing, various scales were used to assess pain according to 4 domains: pain intensity, pain affect, mood, and physical disability.

 The color analog scale (CAS) was used to assess pain intensity (CAS Intensity) and the affective aspects of pain (CAS Affect) (0 = no pain, 10 = severe pain).

 The Faces Pain Scale is composed of 7 faces expressing different levels of pain, ranging from no pain (score 0) to severe pain (score 7). The scores of the 2 scales were converted to 

 scores. This resulted in a Cronbach α of 0.79. Subsequently, we added the 

 scores and to create a pain intensity domain.

 The McGill Pain Questionnaire (Dutch version) also encompasses an affective pain scale, reflected in 5 groups of words that appeal to the affective aspects of pain (0 = no suffering, 15 = high suffering). The scores of the 2 scales were converted to 

 scores. This resulted in a Cronbach α of 0.68. Subsequently, we added the 

 was administered to assess depression (minimum score = 0, maximum score = 63), and the Symptom Checklist-90 (SCL-90) was used to assess anxiety (minimum score = 0, maximum score = 40)

 and depression (minimum score = 0, maximum score = 52).

 The scores of these 3 subscales were converted to 

 scores. This resulted in a Cronbach α of 0.87. Subsequently, we added the 

Physical disability was assessed using the EDSS.

 The EDSS score ranges from 0 (no disability) to 10 (death due to MS).

 The EDSS addresses physical disabilities and is not a suitable tool for assessing cognitive functioning.

The principal investigator (R.J.S.) taught 2 students the study protocol and trained them to administer the EDSS, the BDI, and the pain scales and to use the Actiwatch.

IBM SPSS-PC Statistics, version 26.0 (IBM Corp) was used for data analysis. Because only 1 group of patients with MS was studied, we compared the mean MMSE, education, pain, depressive symptom, and EDSS scores with the maximum score of each scale. Pain medication use is presented as a percentage, and the relationship between pain and pain medication as a correlation (partial 

The main research question, ie, the relationships among pain, motor abilities, mood, and the rest-activity rhythm, was analyzed by 4 hierarchical regression analyses. The dependent variables were IS, IV, and RA. Four models were applied: mood (model 1), pain intensity (model 2), pain affect (model 3), and EDSS (model 4). The level of significance was set at 

Of 61 patients with MS (26 men, 35 women) who participated in the study, 6 had relapsing-remitting diagnoses, 25 had primary progressive diagnoses, 28 had secondary progressive diagnoses, and 2 had undetermined courses. The mean ± SD age of the participants was 55.54 ± 9.33 years, with the range from 29 to 71 years. The mean ± SD MMSE score of the patients was 27.15 ± 3.24 (range, 16–30), and the mean ± SD level of education was 5.41 ± 0.97 (range, 2–7).

We listed comorbidities that were present in the 6 months before the assessment (chronic) (

 available online at IJMSC.org) and at the assessment (actual). At the time of assessment, 1 patient had a urinary tract infection and 1 patient had a pressure ulcer.

The cohort’s mean ± SD scores on the various pain scales are presented in 

. The mean scores on each of the separate pain scales suggest that the patients with MS had mild pain (

). The number and percentage of the group using analgesics are presented in 

. After controlling for mood, the relationship between total pain (adding the 

 scores of all separate pain scales) and total pain medication (adding all pain medications) was not significant (partial 

 = .32). Concerning the relationship between separate pain medications and pain, a significant positive relationship was observed between total pain and cannabis, once controlled for mood (partial 

One patient each used temazepam (a benzodiazepine) combined with melatonin, temazepam combined with modafinil (treatment for narcolepsy), zopiclone, and zopiclone combined with melatonin.

The cohort had mean ± SD mood scores of 10.26 ± 6.60 (range, 1–29) on the BDI, 13.07 ± 3.97 (range, 10–26) on the SCL-90 Anxiety, and 24.82 ± 9.13 (range, 14–51) on the SCL-90 Depression; the mean ± SD EDSS score was 7.00 ± 1.23, with a range from 3 to 9 (maximum score = 10). The 3 main variables (IS, IV, RA) had mean ± SD values as follows: IS, 0.67 ± 0.25 (range, 0.08–0.95); IV, 0.58 ± 0.31 (range, 0.10–1.60); and RA, 0.71 ± 0.20 (range, 0.04–1.00).

Relationship Between Pain, Motor Abilities, Mood, and Rest-Activity Rhythm

The percentage of explained variance of the scores on IS by model 4, including mood, pain intensity, pain affect, and the EDSS as predictors, was 12% and showed a trend (

 = .06). None of the separate predictors significantly contributed to the explained variance of 12% (

None of the models significantly explained variance of the scores on IV (

None of the models significantly explained variance of the scores on RA (

Subgroup Analysis Including Only Patients With MS With Pain 

Considering that only the whole-group IS data (including 15 patients without pain) showed a trend (

Diana Walker, PhD

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