Commentary on 'disability outcome measures in multiple sclerosis clinical trials'.

In order to fully understand and explore the effectiveness of any intervention for the management of multiple sclerosis (MS), it is important to have robust, valid, reliable, and universally applied measures. The recent article, 'Disability outcome measures in multiple sclerosis clinical trials' by Cohen, Reingold, Polman and Wolinsky (2012), explores this issue in regards to the effective measurement of MS-related disability, and the utilisation of patient-reported outcome measures, whilst highlighting the need for collaboration between the academic and clinical communities. Although it is important to examine disability measures, it is also equally important to recognise that physical function is only one aspect of a person's experience; for example, quality of life and psychological well-being are also important aspects to assess. The application of e-health technologies and patient registers could be a useful method of gaining additional information, using patient-reported outcomes. This commentary explores these issues in relation to points raised by the Cohen et al. paper.

Therapeutic ultrasound: the effects upon cutaneous blood flow in humans.

The premise of the current crossover, randomised, double-blinded and controlled study was to ascertain the physiologic effects of pulsed and continuous ultrasound (US) upon cutaneous blood flow in humans as measured by laser Doppler flowmetry. Ten healthy volunteers (5 male, 5 female; aged 18 to 36 y) were assigned to undergo four experimental conditions in a predetermined random order: (i) control, (ii) placebo, (iii) pulsed US and (iv) continuous US. US was applied at a frequency of 3 MHz at an intensity of 1 W/cm(2) for a total of 6 min over the lateral aspect of the forearm. Ambient and skin temperatures were measured concomitantly. Statistical analysis indicated that there were significant differences in blood perfusion units between pulsed US and continuous application of US compared with the control condition for cutaneous blood flow at 2 min (p < or = 0.05), 4 min (p < or = 0.03) and 6 min (p < or = 0.05). Additionally, the placebo group was found only significantly to be different from the control condition at 6 min (p = 0.02), indicating that the movement of the transducer head can produce an additional massage effect. There were no significant differences found for ambient or skin temperature recordings. These findings suggest that active US produces significant increases in cutaneous blood flow.

Physical disability, anxiety and depression in people with MS: an internet-based survey via the UK MS Register.

INTRODUCTION: People with Multiple Sclerosis are known to have a relatively high prevalence of both anxiety and depression. Studies of the relationship between physical disability and mental health in people with MS have reported mixed results, showing the need for further work. METHODS: Between May 2011 and April 2012, 4516 people completed the MSIS-29 (v.1) and HADS scales via the dedicated internet site of the UK MS Register within a 7 day time window. These responses were linked with basic demographic and descriptive data and analysed in SPSS (v.20). RESULTS: The proportions of people experiencing anxiety or depression increased with physical disability such that 38.0% of respondents with low, and 66.7% with high disability reported at least mild anxiety, and 17.1% of people with low, and 71.7% with high disability experienced at least mild depression. The multiple regression model explained 18.4% of the variance in anxiety with MSIS-29-PHYS score being the strongest predictor of anxiety. The model for depression explained 37.8% of the variance with MSIS-29-PHYS score being the strongest predictor. Some of the other variables included showed negative associations with anxiety and depression, indicating that the influence of physical disability on mental wellbeing could be underestimated. CONCLUSIONS: This study indicates that there is a positive relationship between physical disability and anxiety and depression, that physical disability impacts on anxiety and depression to differing extents, and that the effects vary with gender, age, disease course and disease duration. We have shown that physical disability is a predictor of anxiety and depression, and that other factors may mask the extent of this effect. Whether the causes of anxiety and depression are reactive, organic or a combination, it is essential that mental wellbeing is given due attention in caring for people with MS so that all their health needs can be met.

Desirability and expectations of the UK MS Register: views of people with MS.

BACKGROUND: Internet-based health registers are increasingly commonly used for health promotion and medical research, yet little is known about what the patient groups who help form the basis of such registers expect from these tools. Mismatches between patient expectations and the register design may limit the long-term utility of such registers. OBJECTIVE: This study elicited the views of people with Multiple Sclerosis (PwMS) on the desirability and expectations regarding a UK Register for MS. METHODS: Participants were recruited through a range of traditional means (newsletters, adverts, word of mouth), as well as via the Internet, to obtain a broad sample of PwMS. Semi-structured interviews were conducted over the telephone, and the questions asked about: the desirability of the Register; what the participants envisaged the Register actually being used for; and what they hoped the Register could be used for. RESULTS: The majority of individuals' points postulated that a UK MS Register would be useful, but a range of potential concerns were identified by the sample, such as security, accessibility for all PwMS, and the validity of self-report data. Analysis of the responses revealed a difference between what PwMS thought the Register would be used for, and how they wanted it to be used, particularly in relation to a desired social contact, exchange, and networking function. CONCLUSIONS: The security and accessibility of the website, the validity of the data, and mismatches between the expected and actual uses, are all issues of importance in the development of e-health tools, if PwMS are to be successfully engaged over time.

The physical and psychological impact of multiple sclerosis using the MSIS-29 via the web portal of the UK MS Register.

INTRODUCTION: The MSIS-29 was developed to assess the physical and psychological impact of MS. The aims of this study were to use the responses to the MSIS-29 via the web portal of the UK MS Register to: examine the internal properties of the scale delivered via the internet, profile the cohort, and assess how well the scale measures impact of disability on the potential workforce. METHODS: Between May 2011 and April 2012, 4558 people with MS completed the MSIS-29(v.1). The responses were collated with basic demographic and descriptive MS data and the resulting dataset was analysed in SPSS(v.20). RESULTS: Internal consistency was high (Cronbach's alpha 0.97 MSIS-29-PHYS, 0.92 MSIS-29-PSYCH). The mean MSIS-29-PHYS score was 60.5 (50.6%) with a median of 62 and the mean MSIS-29-PSYCH score was 24.8 (43.8%) with a median of 24. Physical scores increased with age and disease duration (p<0.001, p<0.001), but there was a weak negative relationship between psychological scores and age (p<0.001). The odds of people having an employment status of sick/disabled were 7.2 (CI 5.5, 9.4, p<0.001) for people with a moderate physical score, and 22.3 (CI 17.0, 29.3, p<0.001) for people with a high physical score (relative to having a low physical score). CONCLUSIONS: This largest known study of its kind has demonstrated how the MSIS-29 can be administered via the internet to characterise a cohort, and to predict the likely impact of disability on taking an active part in the workforce, as a reasonable proxy for the effects of MS on general activities. The findings examining MSIS-29-PHYS and MSIS-29-PSYCH scores against age support the use of two sub-scales, not a combined score. These results underline the importance of using a scale such as this to monitor disability levels regularly in guiding MS care to enable people to be as active as possible.

How people with multiple sclerosis rate their quality of life: an EQ-5D survey via the UK MS register.

INTRODUCTION: The EQ-5D is a widely-used, standardised, quality of life measure producing health profiles, indices and states. The aims of this study were to assess the role of various factors in how people with Multiple Sclerosis rate their quality of life, based on responses to the EQ-5D received via the web portal of the UK MS Register. METHODS: The 4516 responses to the EQ-5D (between May 2011 and April 2012) were collated with basic demographic and descriptive MS data and the resulting dataset was analysed in SPSS (v.20). RESULTS: The mean health state for people with MS was 59.73 (SD 22.4, median 61), compared to the UK population mean of 82.48 (which is approximately 1SD above the cohort mean). The characteristics of respondents with high health states (at or above +1SD) were: better health profiles (most predictive dimension: Usual Activities), higher health indices, younger age, shorter durations of MS, female gender, relapsing-remitting MS, higher educational attainment and being in paid employment (all p-values<0.001). Conversely, the characteristics of respondents with low health states (at or below -1SD) were: poorer health profiles (most predictive dimension: Mobility), lower health indices, older age, longer durations of MS, male gender, progressive MS, lower educational attainment and having an employment status of sick/disabled (p = 0.0014 for age, all other p-values<0.001). Particular living arrangements were not associated with either the high or low health status groups. CONCLUSIONS: This large-scale study has enabled in-depth analyses on how people with MS rate their quality of life, and it provides new knowledge on the various factors that contribute to their self-assessed health status. These findings demonstrate the impact of MS on quality of life, and they can be used to inform care provision and further research, to work towards enhancing the quality of life of people with MS.

Changes in the key areas of quality of life associated with age and time since diagnosis of long-term conditions.

This study examined whether quality of life areas, that were considered to be important by people with long-term and chronic conditions, altered as a function of their age ('maturational') and time since diagnosis ('adaptational'). Seventy-one individuals from two age groups (31-40 and 41-50 years), who had been diagnosed for different lengths of time (<1 year and 10-20 years), creating four groups, were asked to say what quality of life meant to them, and the results were qualitatively analysed. The key theme in determining the quality of life across the entire sample was 'independence and normality' in the participants' lives. However, the other key themes differed across the groups, suggesting that both 'maturation' and 'adaptation' play a role in determining the key areas that people consider, relating to their quality of life. The younger newly diagnosed group made more mention of 'involvement' than the other three groups, all of which mentioned different forms of wellbeing (social-emotional, physical and psychological) as the second most important aspect of their quality of life. These findings have implications for the assessment of quality of life.

A large-scale study of anxiety and depression in people with Multiple Sclerosis: a survey via the web portal of the UK MS Register.

INTRODUCTION: Studies have found that people with Multiple Sclerosis experience relatively high rates of anxiety and depression. Although methodologically robust, many of these studies had access to only modest sample sizes (N<200). The aims of this study were to use responses gained via the web portal of the UK MS Register (N>4000) to: describe the depression and anxiety profiles of people with MS; to determine if anxiety and depression are related to age or disease duration; and to assess whether the levels of anxiety and depression differ between genders and types of MS. METHODS: From its launch in May 2011 to the end of December 2011, 7786 adults with MS enrolled to take part in the UK MS Register via the web portal. The responses to the Hospital Anxiety and Depression Scale (HADS) were collated with basic demographic and descriptive MS data provided at registration and the resulting dataset was analysed in SPSS (v.16). RESULTS: The mean HADS score among the 4178 respondents was 15.7 (SE 0.117, SD 7.55) with a median of 15.0 (IQR 11). Anxiety and depression rates were notably high, with over half (54.1%) scoring ≥ 8 for anxiety and 46.9% scoring ≥ 8 for depression. Women with relapsing-remitting MS were more anxious than men with this type (p<0.001), and than women with other types of MS (p = 0.017). Within each gender, men and women with secondary progressive MS were more depressed than men or women with other types of MS (p<0.001, p<0.001). CONCLUSIONS: This largest known study of its kind has shown that anxiety and depression are highly prevalent in people with MS, indicating that their mental health needs could be better addressed. These findings support service planning and further research to provide the best care for people with MS to help alleviate these debilitating conditions.