Delayed Diagnosis of Multiple Sclerosis, Treatment Initiation and Non-adherence in Upper Egypt
NCT ID: NCT05438693
Last Updated: 2022-06-30
Study Results
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Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2020-06-01
2022-06-01
Brief Summary
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However, significant delays can still occur between noticing the first symptoms and receiving a diagnosis even before a person with symptoms suggestive of MS sees a neurologist. Such delays could be due to heterogeneity of clinical and imaging manifestations, which not only differ between patients, but also vary in individual patients over time. Moreover, lack of awareness of the primary care physicians about MS presentations, the limited accessibility to specialized centers or the non-availability of diagnostic tools such as MRI scanners and lumbar puncture, may further add to this delay and increases the risk of disability.
There are also many factors that can contribute to delayed initiation of DMT after diagnosis like inadequate knowledge with DMT, their high coast and limited access to health care insurance services.
Like many chronic conditions, non- Adherence to drug therapies is estimated up to 50%, with associated increased morbidity, mortality, and health care costs.
To the best of our knowledge, this is the first study in upper Egypt that tries to address these factors. By conducting this study, we aim at identifying factors leading to delayed diagnosis of MS, initiation and adherence to DMT in order to translate recent advances in the diagnosis and treatment of MS into improved outcomes in the lives of people with MS and their families and to avoid many of the long-term economic and personal costs that result from unnecessary irreversible disability.
Detailed Description
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each patient was subjected to the following:
* Full history and neurological examination including EDSS scores.
* MRI brain and spine.
* Electrophysiologic study: VEP, ABR, SSEP.
* clinical scales:
1. The Arabic version of the eight-item Morisky Medication Adherence Scale (MMAS-8).
2. Treatment Satisfaction Questionnaire for Medication (TSQM-9).
3. Extended disability status scale (EDSS) measurement for MS patients
4. Hamilton depression rating-17-item version (HAM-D 17).
5. Fatigue Severity Scale (FSS) for determination of fatigue degree using the Arabic validated version
6. The Pittsburgh Sleep Quality Index (PSQI)
7. International Restless Legs Syndrome rating scale time to diagnosis and DMT initiation was calculated and the rate of adherence was determined this was followed be determining factors related to each Data analysis was done using the IBM Statistical Package for Social Sciences software package version 20.0. (Armonk, NY: IBM Corp). The qualitative variables were described with ratio and percentage. The Shapiro-Wilk test was used to verify the normality of distribution. Quantitative variables with normal distribution were reported with mean and SD, and those without normal distribution were described using median and range of mid-quartiles. The level of statistical significance was set at p \< 0.05.
The used tests were
1. \- Chi-square test: For categorical variables, to compare between different groups
2. \- Monte Carlo correction: Correction for chi-square when more than 20% of the cells have expected count less than 5
3. \- Mann Whitney test: For abnormally distributed quantitative variables, to compare between two studied categories
4. \- Kruskal-Wallis test: For abnormally distributed quantitative variables, to compare between more than two studied categories
5. \- Regression: univariate and multivariate logistic regression for factors related to delayed diagnosis, delayed treatment initiation and non-adherence
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of other systemic disease or being on long term treatment for any disease.
* Incomplete clinical or radiological data were provided.
* Subject declined to provide written informed consent.
18 Years
60 Years
ALL
No
Sponsors
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doaa mokhtar mahmoud
OTHER
Responsible Party
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doaa mokhtar mahmoud
lecturer
Locations
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South valley University
Qina, Qena Governorate, Egypt
Assiut University
Asyut, , Egypt
Countries
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References
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Koch-Henriksen N, Sorensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol. 2010 May;9(5):520-32. doi: 10.1016/S1474-4422(10)70064-8.
Giovannoni G, Butzkueven H, Dhib-Jalbut S, Hobart J, Kobelt G, Pepper G, Sormani MP, Thalheim C, Traboulsee A, Vollmer T. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016 Sep;9 Suppl 1:S5-S48. doi: 10.1016/j.msard.2016.07.003. Epub 2016 Jul 7.
Gaitan MI, Correale J. Multiple Sclerosis Misdiagnosis: A Persistent Problem to Solve. Front Neurol. 2019 May 7;10:466. doi: 10.3389/fneur.2019.00466. eCollection 2019. No abstract available.
Kaufmann M, Kuhle J, Puhan MA, Kamm CP, Chan A, Salmen A, Kesselring J, Calabrese P, Gobbi C, Pot C, Steinemann N, Rodgers S, von Wyl V; Swiss Multiple Sclerosis Registry (SMSR). Factors associated with time from first-symptoms to diagnosis and treatment initiation of Multiple Sclerosis in Switzerland. Mult Scler J Exp Transl Clin. 2018 Dec 6;4(4):2055217318814562. doi: 10.1177/2055217318814562. eCollection 2018 Oct-Dec.
McNicholas N, Hutchinson M, McGuigan C, Chataway J. 2017 McDonald diagnostic criteria: A review of the evidence. Mult Scler Relat Disord. 2018 Aug;24:48-54. doi: 10.1016/j.msard.2018.05.011. Epub 2018 Jun 21.
Ashur ST, Shamsuddin K, Shah SA, Bosseri S, Morisky DE. Reliability and known-group validity of the Arabic version of the 8-item Morisky Medication Adherence Scale among type 2 diabetes mellitus patients. East Mediterr Health J. 2015 Dec 13;21(10):722-8. doi: 10.26719/2015.21.10.722.
Vermersch P, Hobart J, Dive-Pouletty C, Bozzi S, Hass S, Coyle PK. Measuring treatment satisfaction in MS: Is the Treatment Satisfaction Questionnaire for Medication fit for purpose? Mult Scler. 2017 Apr;23(4):604-613. doi: 10.1177/1352458516657441. Epub 2016 Jul 11.
Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.
Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Shalash AS, Elrassas HH, Monzem MM, Salem HH, Abdel Moneim A, Moustafa RR. Restless legs syndrome in Egyptian medical students using a validated Arabic version of the Restless Legs Syndrome Rating Scale. Sleep Med. 2015 Dec;16(12):1528-31. doi: 10.1016/j.sleep.2015.07.032. Epub 2015 Sep 25.
Other Identifiers
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SVU MED NAP020 2 20 7 56
Identifier Type: -
Identifier Source: org_study_id