Self‐management interventions for people with multiple sclerosis: A systematic review and meta‐analysis protocol

Abstract Background and Aims Educational self‐management interventions (SMI) have an important role in improving symptom management, preventing relapse of multiple sclerosis (MS) and promoting quality of life (QoL) of these patients; since there is little knowledge about overall effectiveness of MS self‐management programs and which types of SMI improves the outcomes, this research aims to assess the efficacy of structured SMI in improving health outcomes in people with MS (PwMS) by synthesizing and compare outcomes from related randomized controlled trials. Methods In the present systematic review protocol, the keywords related to self‐management and MS will be searched in electronic databases including (PubMed, Web of Science, Scopus, EMBASE, Cochrane Central Register of Controlled Trials [CENTRAL]), gray literature resources and key journals from 2000 to July 2023. Research‐related articles will be collected and after removing duplicate articles, will be included in the study. In the screening step, titles and abstracts of articles will be reviewed and after deleting irrelevant articles, the full text of related articles will be evaluated independently by two researchers and data will be extracted from final articles and the findings will be categorized in an extraction table. Risk of bias will be assessed by using the Cochrane collaboration's tool. If possible, the data will be analyzed using random effect models and the statistical analysis will be performed using STATA software (version 14.2) developed by StataCorp. Discussion Comparative effectiveness of SMI is currently unknown. We will analyze outcome measures used to assess effectiveness of self‐management education in improving QoL, depression, self‐efficacy, pain, and fatigue. These findings will help identify the most promising components of SMIs, guiding targeted interventions for specific subpopulations, and facilitating the design of better interventions.


| INTRODUCTION
Multiple sclerosis (MS) is a demyelinating disease in which the sheaths of nerve cells in the brain and spinal cord are damaged.2][3] The inflammatory and pathological conditions that lead to this disease affect women about four times more than men. 4,5The prevalence of this disease in the world is 2.3 million people. 6The signs and symptoms of the disease are unpredictable and uncertain, leading to various physical and psychological outcomes.[9] MS often occurs during the years when a person expects good health, and the onset of this disease can distort both their body image and overall health. 10,11Many studies today have expressed the need for comprehensive self-management programs and preventive strategies such as educational programs to improve well-being and reduce the symptoms of chronic diseases. 12,13Self-management can be defined as "the individual's ability to manage the symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent in living with a chronic condition." 14This program is a set of regular activities to help patients with chronic diseases that lead to active participation and control of factors involved in the disease and includes self-control of symptoms and physiological process of the disease, decision-making, and management of the disease and its complications. 15,16Nurses have consistently fulfilled a crucial role in patient education.Numerous studies have highlighted the nurse as one of the foremost, highly effective, and essential educators for patients.8][19] The nurse plays an important role in self-management programs due to their direct contact with patients.This role offers an opportunity to alleviate the burden of the disease on patients, families, and healthcare systems by preventing disease recurrence and reducing the severity of complications. 20,21During the search across different databases, several clinical trial studies were conducted to investigate the effect of self-management interventions (SMIs) in improving the health outcomes of people with MS (PwMS).3][24][25][26] SMIs have been implemented in various ways, such as educational interventions delivered through face-to-face interactions, digital-based education, and webbased platforms.The findings suggest the positive impact of SMIs on enhancing certain outcomes for PwMS.8][29] The most recent review study in this field is from 2017, which highlighted the need for a systematic review with well-defined inclusion criteria and an expanded search approach.Additionally, the study emphasized the importance of exploring further outcomes to enhance our understanding in this area. 30The purpose of this systematic review is to determine the effectiveness of SMIs on health-related outcomes of PwMS by reviewing the relevant randomized controlled trials (RCTs) and also identifying the limitations and future research needs.

| Aims
The objective of this review is to conduct a systematic review and meta-analysis to estimate the effectiveness of SMIs on outcomes of PwMS such as fatigue, depression, pain, self-efficacy, and QoL.

| Methodology
This systematic review will be performed according to the procedures outlined in the Cochrane Handbook 31 and also Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), 32 as well as Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). 33,34This protocol has also been registered at the Open Science Framework with the registration link as https://osf.io/92xdq.

| Criteria for study selection
Inclusion criteria for this study are as follows: We will include RCTs that describe the effectiveness of SMIs on outcomes of PwMS, such as fatigue, depression, pain, self-efficacy, and QoL, without any restrictions on the age and sex of patients.

Key points
• The effectiveness of self-management interventions (SMIs) for multiple sclerosis (MS) remains uncertain, underscoring the importance of this study in providing clarity about their impact.
• The insights gained from this research will contribute to the creation of more effective SMIs for MS patients.By understanding which components are impactful, future interventions can be better designed and optimized.
Published articles in any language will be considered, as long as they Exclusion criteria for this study are as follows: 1. Duplicate publications of the same material will be excluded.If a study has been published in multiple journals or conferences, the most recent and comprehensive version will be selected for inclusion.
2. Non-RCTs and non-interventional articles such as observational studies, narrative reviews, opinion pieces, letters, and any other publications lacking primary data and/or explicit method descriptions will be excluded.
3. Studies on SMIs that do not include the three key tasks of selfmanagement (medical, emotional, and role management) will be excluded.
4. Trials that include populations other than MS patients or have mixed populations will be excluded.

| Data sources and search strategy
Electronic searches: We will conduct a search using relevant keywords such as "MS" and "self-management" in databases including PubMed, SCOPUS, EMBASE, ISI Web of Science, PsyINFO, and the Cochrane Central Register of Controlled Trials (CENTRAL).The search will encompass the period from 2000 to July 2023, with no restrictions on language.

| Medline search strategy
MeSH tags were found in Medline.The search strategies have been conducted based on the PICOS framework.The details of the Medline database search syntax are provided below (Table 1).

| Screening procedures of eligible studies
After the initial systematic search, results will be imported into Endnote software version X8.All duplicate articles will be identified and finally removed. in the screening phase, the titles and abstracts of the articles will be screened by two reviewers (R. H. S. and A. R.) independently according to the inclusion criteria.In the screening phase; for the eligible titles and abstracts, corresponding articles will be obtained in full text and also independently assessed to select the articles which meet all the inclusion criteria.Any discrepancies will be resolved by consensus and if the disagreement is not resolved a third author (A.N. N.) will do the final assessment.The plan of study screening and selection is available in Figure 1 (adapted from an updated guideline for reporting systematic reviews).

| Assessment of risk of bias
The methodological quality of all full-text manuscripts included in the review will be assessed by two authors independently according to the up-to-date guidelines from the Cochrane Handbook for evaluating the risk of bias of included RCTs. 31,35RCTs quality will be assessed for five domains: selection bias, performance bias, detection bias, attrition bias, reporting bias, and other bias.Any inconsistencies will be resolved by consensus if the disagreement is not resolved, the How effective are SMIs in reducing depression of PwMS?How effective are SMIs in improving the QoL of PwMS?How effective are SMIs in improving the self-efficacy of PwMS?How effective are SMIs in reducing pain of PwMS?How effective are SMIs in reducing fatigue of PwMS?
have full English abstracts.The components of the PICO based on the questions in the present study are: P (population): PwMS whose diagnosis has been confirmed; I (intervention): The intervention includes a variety of SMIs, including face-to-face training, mobile-based training, telephone, digital, and so forth which includes all three key tasks of selfmanagement (medical, emotional, and role management) 14,21 ; C (comparison): The control group includes patients who have not received any interventions or not SMIs; O (outcome): The main outcomes include fatigue, depression, QoL, pain, and self-efficacy.

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Reference lists of relevant primary studies, reviews, and key journals • Gray literature resources include: Google Scholar, Open Gray, ProQuest, Scopus, contact with experts, conferences, protocol databases like ClinicalTrials.gov,International Standard Randomized Controlled Trial Number (ISRCTN), and The WHO International Clinical Trials Registry Platform (ICTRP).