Evaluation of the Effectiveness of Lifestyle Interventions in theprimary prevention of diabetes mellitus type II in high-riskindividuals

Background/research question: The increasing prevalence of type II diabetes mellitus (T2DM) raises the question as to whether lifestyle interventions (diet/exercise) can delay or prevent the manifestation of T2DM and reduce the risk of micro- and macrovascular complications and premature death in high-risk individuals. The primary aim of this thesis was to determine whether systematic reviews exist that are able to answer the research question and thus provide a basis for the production of evidence-based health information (EBHI). Secondly, evidence on patient relevant outcomes like cardiovascular disease and mortality on the basis of individual RCTs and epidemiological studies was to be collected. Methods: PubMed, the Cochrane Library and DARE have systematically been searched for systematic reviews of controlled trials (CTs) in June 2013. The DIMDI, NICE and AHRQ websites were manually searched. Systematic reviews were included if they met predefined inclusion criteria and achieved an Oxman & Gyuatt Index ≥ 5. Two researchers independently screened 710 titles/abstracts and the resulting 48 full-text articles. Results: 9 relevant systematic reviews have been identified, of which 4 had the required quality. They differed in terms of the populations, interventions and outcomes included, as well as the search date. The most appropriate review included 11 randomized CTs in a meta-analysis: The pooled hazard ratio versus controls was 0.51 (95% CI 0.43-0.62). Assuming an annual diabetes incidence of 11% as in the US Diabetes Prevention Program the calculated absolute risk of diabetes in the intervention groups would be 5.61% (95% CI 4.73- 6.82). Significant reductions in long term adverse health outcomes like CVD risk, CVD or all-cause mortality could neither be found in the 4 identified reviews nor in the individual RCTs. However, long term follow-up data of individual RCTs indicated benefits of lifestyle interventions in terms of microvascular complications like diabetic retinopathy and HRQoL. Conclusions: Lifestyle interventions can prevent or delay the diagnosis of T2DM in high-risk individuals. The findings translate into an estimated effect of about 5 out of 100 individuals by reducing an assumed annual diabetes progression rate of 11 out of 100 to about 6 out of 100 individuals. The systematic procedure to find the best available external evidence resulted in a suitable basis for the production of EBHI on diabetes prevention in high-risk individuals. Whether the applied evaluation method is the most suitable for creating EBHI is worth consideration

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study

Abstract Background Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application “levidex” was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health. Objectives A previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention’s impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored. Methods levidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6. Results Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13–16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes. Conclusion This pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability. Trial registration German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered

Patients experiences with multiple sclerosis disease-modifying therapies in daily life – a qualitative interview study

Background!#!Besides coping with a disease with many uncertainties, people with relapsing-remitting multiple sclerosis face complex decisions concerning disease-modifying therapies (DMTs). In an interview study, we aimed to assess patients' experiences with DMTs.!##!Methods!#!Problem-centred interviews were conducted with 50 people with relapsing-remitting multiple sclerosis in Germany using maximum variation sampling and covering all licensed DMTs. Data were analysed thematically using deductive and inductive categories.!##!Results!#!47 of 50 patients had treatment with at least one of the approved DMTs. The main themes were: (1) starting a DMT, (2) switching to another DMT, (3) discontinuing a DMT, and (4) multiple sclerosis without starting a DMT. Different intercorrelated factors influenced the decision-making processes for or against a DMT. Individual experiences with DMTs in daily life contained the effort in administration, success, and failure of DMTs, coping strategies and well-being without DMTs. The decision-making process for or against a DMT and the use of those treatments can be understood as a constant, continually shifting process, complicated by different factors, which change over time. Experiences with DMTs were characterized by attempts to handle uncertainty and to (re)gain control and integrate adaptivity into one's life.!##!Conclusions!#!The study provides a rich and nuanced amount of patients' experiences with DMTs. The findings demonstrate the importance for practitioners to look at current life circumstances of patients with multiple sclerosis when recommending a DMT and to promote and enable patients to make informed decisions

Health behaviors of people with multiple sclerosis and its associations with MS related outcomes: a German clinical cohort

Background: Health behaviors in persons with multiple sclerosis (pwMS) have been associated with MS-related disease outcomes. Objective: The aim of the study was to gain knowledge about current patient health behaviors in a convenience sample representative for pwMS presenting to a large university-based outpatient clinic and to investigate associations between modifiable risk factors with physical impairment, quality of life (QoL) and cardiovascular comorbidities. Methods: A questionnaire was administered at the MS Outpatient Clinic of the University Medical Center Hamburg Eppendorf asking for health behaviors regarding dietary habits assessed with the German adaptation of the validated Spanish short Diet Quality Screener (sDQS), level of physical activity assessed with the Godin Leisure Time Questionnaire (GLTEQ) and tobacco smoking. Participants were asked to report cardiovascular comorbidities using items from the Self-Report Comorbidity Questionnaire for Multiple Sclerosis. Additionally, cardiovascular risk factors like blood pressure, height and weight (to calculate BMI) and waist circumference were measured. MS specific clinical data, e.g., disease course, duration, disability and MS-specific QoL were collected from the clinical database. Descriptive analyses were performed and multivariate regression analyses for complete cases were carried out for each of the three outcome variables including all mentioned modifiable risk factors (dietary behavior, smoking, physical activity and BMI) as independent variables. Results: In this sample of 399 pwMS the mean age was 42 years (SD 12.8) with a mean disease duration since diagnosis of 7.4 years (SD 8.4) and a mean EDSS of 2.8 (SD 1.9). 24% were current smokers, 44% were insufficiently physically active and 54% did not follow a healthy dietary pattern. 49% of this relatively young clinical population was overweight and 27% reported one or more cardiovascular comorbidities. Most modifiable risk factors showed no convincing associations with MS-related disease outcomes in the multiple regression analyses. Conclusion: This clinical cohort of pwMS shows a high prevalence of critical health behaviors and comorbidities and emphasizes the need for monitoring, education and assistance for behavior change in this population

Mobile health interventions in multiple sclerosis: A systematic review.

BACKGROUND Persons with multiple sclerosis (pwMS) might be particularly well suited to benefit from digital health applications because they are, on average, younger and less severely disabled than patients with many other chronic diseases. Many digital health applications for pwMS have been developed. OBJECTIVES Analysis of the evidence of digital health applications to improve health outcomes from a patient perspective. METHODS A systematic review was performed on all randomized controlled trials (RCTs) that have studied mobile health interventions for pwMS, that is, which can be applied with a smartphone, tablet, or laptop to improve patient-reported outcomes. RESULTS Of the 1127 articles identified in the literature search, 13 RCTs fit the inclusion criteria. Two trials studied messaging systems, two depression interventions, one addressed MS fatigue, five cognition, and three mobility issues, of which two focused on spasticity management. One trial aimed to enhance physical activity. Most were pilot studies that cannot yield definitive conclusions regarding efficacy. One depression intervention and one fatigue intervention showed significant results across several outcomes. CONCLUSION Several mobile self-guided digital health applications for pwMS have been tested in RCTs, and two interventions targeting depression and fatigue have demonstrated significant effects. Challenges remain regarding implementation into routine care

Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months

International audienceBackground: People with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA. Objective: To investigate feasibility of a smartphone app providing EBPI about the benefit of PA and a simple activity feedback to enhance PA in people with CPMS in a pilot randomized controlled trial over 3 months. Methods: Thirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0) were 1:1 randomized into either a control group (n = 20) or an intervention group (n = 18). The intervention group received access to a multimedia EBPI app including activity feedback, texts, figures and videos. In the control group, participants received a leaflet with unspecific information about exercising in general. The EPBI itself was designed based on a systematic review. At baseline and after 3 months, all participants underwent clinical performance tests, filled in questionnaires and received an activity monitor (Actigraph Ò) for 7 days. The primary endpoint was the rate of responders defined as participants with a 20% increase of physical acitivity (time of moderate or vigiorous PA-MVPA) or 20% increase of the number of steps, both assessed with the activity monitor. As secondary endpoints, we compared accelerometry, performance and questionnaires adjusted for baseline measurments between the groups (ANCOVA). Moreover, we used questionnaires to compare knowledge about exercise (activity requiring physical effort, carried out to improve or improve health and fitness) i

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

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

Patients’ goals of using specific diets.

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

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

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

Sociodemographic data of PwMS and controls.

<p>Sociodemographic data of PwMS and controls.</p