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Book: Dementia

Bowen, James D.

(The medical clinics of North America ; 86,3)

2002

Author's details	James D. Bowen, guest ed
Series title	The medical clinics of North America ; 86,3 Medical clinics of North America
Collection	Medical clinics of North America
Language	English
Size	XIII S., S. 455 - 685 : Ill.
Publisher	Saunders
Publishing place	Philadelphia u.a.
Publishing country	United States
Document type	Book
HBZ-ID	HT013431674
Database	Catalogue ZB MED Medicine, Health

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Ua VI Zs 158 -86,3-	verfügbar in Königswinter	Königswinter

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Article ; Online: Highly Aggressive Multiple Sclerosis.

Bowen, James D

Continuum (Minneapolis, Minn.)

2019 Volume 25, Issue 3, Page(s) 689–714

Abstract: Purpose of review: Newly introduced disease-modifying therapies offer greater efficacy than previous therapies but also have serious side effects. This article reviews factors useful in identifying those at risk of developing aggressive relapsing ... ...

Abstract	Purpose of review: Newly introduced disease-modifying therapies offer greater efficacy than previous therapies but also have serious side effects. This article reviews factors useful in identifying those at risk of developing aggressive relapsing multiple sclerosis (MS) and therapies available for treatment. Recent findings: Several factors predict aggressive MS, including demographic factors, relapses, symptom characteristics, MRI activity, and other biomarkers. These can be used to select patients for more aggressive therapies, including natalizumab, alemtuzumab, fingolimod, and ocrelizumab. Additional off-label treatments are available for patients with severe disease. The benefits and side effects of these treatments must be considered when making therapeutic decisions. Summary: Selecting patients who are most appropriate for aggressive therapy involves considering risk factors for poor outcomes, early recognition of treatment failure, balancing treatment efficacy and side effects, and sharing the decision with patients to assist them in making optimal treatment choices. Vigilance for signs of treatment failure and early switching to more aggressive therapy are important components in optimal care.
MeSH term(s)	Adult ; Age Factors ; Alemtuzumab/administration & dosage ; Female ; Fingolimod Hydrochloride ; Glatiramer Acetate/administration & dosage ; Humans ; Immunosuppressive Agents/administration & dosage ; Male ; Multiple Sclerosis/diagnostic imaging ; Multiple Sclerosis/drug therapy ; Natalizumab/administration & dosage ; Optic Neuritis/diagnostic imaging ; Optic Neuritis/drug therapy ; Sex Factors ; Treatment Failure
Chemical Substances	Immunosuppressive Agents ; Natalizumab ; Alemtuzumab (3A189DH42V) ; Glatiramer Acetate (5M691HL4BO) ; Fingolimod Hydrochloride (G926EC510T)
Language	English
Publishing date	2019-06-20
Publishing country	United States
Document type	Case Reports ; Journal Article ; Review
ISSN	1538-6899
ISSN (online)	1538-6899
DOI	10.1212/CON.0000000000000731
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Article ; Online: Threshold definitions for significant change on the timed 25-foot walk and nine-hole peg test in primary progressive multiple sclerosis.

Koch, Marcus W / Repovic, Pavle / Mostert, Jop / Bowen, James D / Comtois, Jacynthe / Strijbis, Eva / Uitdehaag, Bernard / Cutter, Gary

European journal of neurology

2023 Volume 30, Issue 9, Page(s) 2761–2768

Abstract: Background and purpose: The timed 25-foot walk (T25FW) and nine-hole peg test (NHPT) exhibit random variability in the short term. A threshold of ≥20% change from baseline has been used to indicate true disability change, but other threshold definitions ...

Abstract	Background and purpose: The timed 25-foot walk (T25FW) and nine-hole peg test (NHPT) exhibit random variability in the short term. A threshold of ≥20% change from baseline has been used to indicate true disability change, but other threshold definitions may be better suited to exclude false and include true change events. The aim of this study was to use patient-level original trial data to investigate the short-term variation in T25FW and NHPT, and to compare its extent with disability change at 12-month follow-up in people with primary progressive multiple sclerosis (PPMS). Methods: We used original patient-level data from PROMISE, a large PPMS trial. In this trial, three separate T25FW and NHPT measurements were performed 1 week apart during screening. We used these repeated measures to describe the extent of short-term variation. We used binary logistic regression models to investigate the association between screening characteristics and unacceptable short-term variation. Results: The traditional 20% threshold excluded a reasonable number of false change events, while also yielding a large number of change events at follow-up. Increasing index values on the T25FW and NHPT were associated with higher short-term variation. Conclusions: The traditional ≥20% change threshold for the T25FW and NHPT represents a reasonable compromise between reducing the number of false change events and achieving the largest number of change events in people with PPMS. Our analyses inform the design of clinical trials in PPMS.
MeSH term(s)	Humans ; Multiple Sclerosis ; Multiple Sclerosis, Chronic Progressive/diagnosis ; Multiple Sclerosis, Chronic Progressive/drug therapy ; Walking ; Research Design ; Disabled Persons ; Disability Evaluation
Language	English
Publishing date	2023-06-20
Publishing country	England
Document type	Journal Article
ZDB-ID	1280785-0
ISSN	1468-1331 ; 1351-5101 ; 1471-0552
ISSN (online)	1468-1331
ISSN	1351-5101 ; 1471-0552
DOI	10.1111/ene.15920
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Article ; Online: Longitudinal Changes in Cognitive Test Scores in Patients With Relapsing-Remitting Multiple Sclerosis: An Analysis of the DECIDE Dataset.

Castrogiovanni, Nina / Mostert, Jop / Repovic, Pavle / Bowen, James D / Uitdehaag, Bernard M J / Strijbis, Eva M M / Cutter, Gary R / Koch, Marcus W

Neurology

2023 Volume 101, Issue 1, Page(s) e1–e11

Abstract: Background and objectives: Cognitive impairment is a common and impactful symptom of relapsing-remitting multiple sclerosis (RRMS). Cognitive outcome measures are often used in cross-sectional studies, but their performance as longitudinal outcome ... ...

Abstract	Background and objectives: Cognitive impairment is a common and impactful symptom of relapsing-remitting multiple sclerosis (RRMS). Cognitive outcome measures are often used in cross-sectional studies, but their performance as longitudinal outcome measures in clinical trials is not widely researched. In this study, we used data from a large clinical trial to describe change on the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT) over up to 144 weeks of follow-up. Methods: We used the data set from DECIDE (clinicaltrials.gov identifier NCT01064401), a large randomized controlled RRMS trial to describe change on the SDMT and PASAT over 144 weeks of follow-up. We compared change on these cognitive outcomes with change on the timed 25-foot walk (T25FW), a well-established physical outcome measure. We investigated several definitions for clinically meaningful change: any change, 4-point change, 8-point change, and 20% change for the SDMT, any change, 4-point change, and 20% change for the PASAT, and 20% change for the T25FW. Results: DECIDE included 1,814 trial participants. SDMT and PASAT scores steadily improved throughout follow-up: the SDMT from a mean 48.2 (SD, 16.1) points at baseline to 52.6 (SD 15.2) at 144 weeks and the PASAT from 47.0 (SD 11.3) at baseline to 50.0 (SD 10.8) at 144 weeks. This improvement in scores is most likely due to a practice effect. Throughout the trial, participants were more likely to experience improvement than worsening of their SDMT and PASAT performance, whereas the number of worsening events on the T25FW steadily increased. Changing the definition of clinically meaningful change for the SDMT and PASAT or using a 6-month confirmation changed the overall number of worsening or improvement events but did not affect the overall behavior of these measures. Discussion: Our findings suggest that the SDMT and PASAT scores do not accurately reflect the steady cognitive decline that people with RRMS experience. Both outcomes show postbaseline increases in scores, which complicates the interpretation of these outcome measures in clinical trials. More research into the size of these changes is needed before recommending a general threshold for clinically meaningful longitudinal change.
MeSH term(s)	Humans ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis/complications ; Cross-Sectional Studies ; Cognitive Dysfunction/etiology ; Neuropsychological Tests
Language	English
Publishing date	2023-04-18
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	207147-2
ISSN	1526-632X ; 0028-3878
ISSN (online)	1526-632X
ISSN	0028-3878
DOI	10.1212/WNL.0000000000207301
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Article ; Online: Oral rather than intravenous corticosteroids should be used to treat MS relapses - No.

Bowen, James D / Qian, Peiqing

Multiple sclerosis (Houndmills, Basingstoke, England)

2017 Volume 23, Issue 8, Page(s) 1058–1060

MeSH term(s)	Administration, Intravenous ; Administration, Oral ; Adrenal Cortex Hormones/administration & dosage ; Humans ; Multiple Sclerosis/drug therapy ; Recurrence
Chemical Substances	Adrenal Cortex Hormones
Language	English
Publishing date	2017-02-01
Publishing country	England
Document type	Journal Article
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/1352458517696598
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Article ; Online: Is the Symbol Digit Modalities Test a useful outcome in secondary progressive multiple sclerosis?

Koch, Marcus W / Mostert, Jop / Repovic, Pavle / Bowen, James D / Uitdehaag, Bernard / Cutter, Gary

European journal of neurology

2021 Volume 28, Issue 6, Page(s) 2115–2120

Abstract: Background: It is unclear which cognitive outcome measure is the most useful for clinical trials in multiple sclerosis. To investigate the usefulness of the Symbol Digit Modalities Test (SDMT) as a clinical outcome measure in secondary progressive ... ...

Abstract	Background: It is unclear which cognitive outcome measure is the most useful for clinical trials in multiple sclerosis. To investigate the usefulness of the Symbol Digit Modalities Test (SDMT) as a clinical outcome measure in secondary progressive multiple sclerosis (SPMS), we describe the frequency of worsening and improvement events in a large randomized controlled trial (RCT) dataset. Methods: Using original trial data from the ASCEND trial (n = 889), a recent large RCT in SPMS, we describe worsening and similarly defined improvement with and without 3-month confirmation on the SDMT in the whole trial cohort and unconfirmed worsening and improvement on the Paced Auditory Serial Addition Test (PASAT) in a smaller subset (n = 107). Results: Somewhat unexpectedly, SDMT scores steadily increased throughout the 2 years of follow-up in this trial. There were overall few SDMT worsening events throughout the trial (generally fewer than 10% of participants), but improvement events steadily increased from around 50% of participants with improvement at 12 weeks to more than 70% at 84 weeks and beyond. PASAT scores followed a similar pattern. Conclusions: In this well-characterized clinical trial cohort, the SDMT does not reflect the steady cognitive decline that patients with SPMS experience. Both SDMT and PASAT scores improve throughout follow-up, possibly due to a practice effect. The SDMT may not be a useful outcome measure of disease progression in 2-year clinical trials in SPMS.
MeSH term(s)	Cohort Studies ; Disease Progression ; Humans ; Multiple Sclerosis/diagnosis ; Multiple Sclerosis, Chronic Progressive/drug therapy ; Neuropsychological Tests
Language	English
Publishing date	2021-01-24
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1280785-0
ISSN	1468-1331 ; 1351-5101 ; 1471-0552
ISSN (online)	1468-1331
ISSN	1351-5101 ; 1471-0552
DOI	10.1111/ene.14732
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Article ; Online: The MSIS-29 and SF-36 as outcomes in secondary progressive MS trials.

Strijbis, Eva Mm / Repovic, Pavle / Mostert, Jop / Bowen, James D / Uitdehaag, Bernard Mj / Cutter, Gary / Koch, Marcus W

Multiple sclerosis (Houndmills, Basingstoke, England)

2022 Volume 28, Issue 10, Page(s) 1606–1619

Abstract: Background: Patient-reported outcome measures (PROMs) are often used in clinical research, but little is known about their performance as longitudinal outcomes.: Methods: We used data from ASCEND, a large SPMS trial (: Results: PROM scores changed ...

Abstract	Background: Patient-reported outcome measures (PROMs) are often used in clinical research, but little is known about their performance as longitudinal outcomes. Methods: We used data from ASCEND, a large SPMS trial ( Results: PROM scores changed little over the 2 years of follow-up. In contrast to physical disability measures, there was no consistent trend in PROM change: significant worsening occurred about as often as improvement. Using a 6-month confirmation reduced the number of both worsening and improvement events without altering their relative balance. There was no clear difference in worsening events in groups based on population characteristics, nor was there a noticeable effect using different thresholds for clinically significant change. Conclusion: We found little consistent change in MSIS-29 and SF-36 over 2 years of follow-up in people with SPMS. Our findings show a disconnect between disability worsening and PROM change in this population. Our findings raise caution about the use of these PROMs as primary outcome measures in SPMS trials and call for a critical reappraisal of the longitudinal use of these measures in SPMS trials.
MeSH term(s)	Humans ; Multiple Sclerosis/therapy
Language	English
Publishing date	2022-08-11
Publishing country	England
Document type	Journal Article
ZDB-ID	1290669-4
ISSN	1477-0970 ; 1352-4585
ISSN (online)	1477-0970
ISSN	1352-4585
DOI	10.1177/13524585221105465
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Article: A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse.

Greenberg, Benjamin M / Bowen, James D / Alvarez, Enrique / Rodriguez, Moses / Caggiano, Anthony O / Warrington, Arthur E / Zhao, Ping / Eisen, Andrew

Multiple sclerosis journal - experimental, translational and clinical

2022 Volume 8, Issue 2, Page(s) 20552173221091475

Abstract: Background: Recombinant human immunoglobulin M22 (rHIgM22) has promoted remyelination in animal models and was well tolerated in people with clinically stable multiple sclerosis.: Objective: Safety/tolerability of a single rHIgM22 dose was ... ...

Abstract	Background: Recombinant human immunoglobulin M22 (rHIgM22) has promoted remyelination in animal models and was well tolerated in people with clinically stable multiple sclerosis. Objective: Safety/tolerability of a single rHIgM22 dose was investigated following an acute relapse and to determine whether this enhanced CNS/CSF concentrations. Methods: Adults (N = 27) with acute relapse were assigned to rHIgM22 (0.5 or 2.0 mg/kg) or placebo. Study included screening/steroid administration periods and 10 study visits over 6 months. rHIgM22 CSF concentrations were assessed on days 2 and 29. Pharmacokinetic and safety samples were taken for up to 60 days. Assessments included adverse events and other clinical measures. Brain magnetic resonance imaging was performed with/without gadolinium. Results: rHIgM22 CSF levels were consistent with dose-dependent concentration on both days 2 and 29. Infusion was generally well tolerated during an acute relapse. Immunogenicity was mild. Most adverse events did not appear to be dose dependent, were mild/moderate, and were events often associated with multiple sclerosis. Conclusion: Although limited by high variability and small sample size, the data suggest enhanced CNS uptake associated with a drop in CSF levels. This study demonstrated safety of an antibody directed to myelin and oligodendrocytes in the course of active demyelinating disease. Further research into rHIgM22 is warranted.
Language	English
Publishing date	2022-04-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2841884-0
ISSN	2055-2173 ; 2055-2173
ISSN (online)	2055-2173
ISSN	2055-2173
DOI	10.1177/20552173221091475
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Article ; Online: The nine hole peg test as an outcome measure in progressive MS trials.

Koch, Marcus W / Repovic, Pavle / Mostert, Jop / Bowen, James D / Comtois, Jacynthe / Strijbis, Eva / Uitdehaag, Bernard / Cutter, Gary

Multiple sclerosis and related disorders

2022 Volume 69, Page(s) 104433

Abstract: Background: The nine-hole peg test (NHPT) is the outcome measure with the least change in secondary and primary progressive MS (SPMS and PPMS) trials. The Standard NHPT is defined as the average of four measurements, two in each hand. Little is known ... ...

Abstract	Background: The nine-hole peg test (NHPT) is the outcome measure with the least change in secondary and primary progressive MS (SPMS and PPMS) trials. The Standard NHPT is defined as the average of four measurements, two in each hand. Little is known about the performance of alternative NHPT scoring methods as longitudinal outcome measures in progressive MS. Non-ambulatory people with progressive MS are now generally excluded from clinical trials, and there is little information on longitudinal NHPT change in this patient group. In this investigation, we used patient-level data from two large randomized controlled trials in progressive MS to explore alternative NHPT scoring methods and NHPT change in non-ambulatory people with progressive MS. Methods: We used patient-level data from the ASCEND (SPMS, n = 889) and PROMISE (PPMS, n = 943) clinical trials to compare significant change on the Standard NHPT with the alternatives dominant hand (DH), non-dominant hand (NDH), and either hand (EH) NHPT in ambulatory and non-ambulatory trial participants. Results: The Standard NHPT changed slowly and showed few worsening events, as did the DH and NDH alternatives. Using the EH NHPT resulted in a substantial increase of worsening events. Non-ambulatory trial participants with PPMS experienced more NHPT worsening than ambulatory participants, especially when using the EH NHPT. Conclusion: Using the EH NHPT yielded substantially more worsening events in people with progressive MS. Clinical trials in non-ambulatory people may be possible with the NHPT as the primary outcome measure. More research into the precision of these measures in this patient group is necessary.
MeSH term(s)	Humans ; Hand ; Multiple Sclerosis, Chronic Progressive/diagnosis ; Outcome Assessment, Health Care ; Upper Extremity
Language	English
Publishing date	2022-11-24
Publishing country	Netherlands
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2022.104433
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Article ; Online: The timed 25-foot walk is a more sensitive outcome measure than the EDSS for PPMS trials: an analysis of the PROMISE clinical trial dataset.

Koch, Marcus W / Mostert, Jop / Repovic, Pavle / Bowen, James D / Comtois, Jacynthe / Strijbis, Eva / Uitdehaag, Bernard / Cutter, Gary

Journal of neurology

2022 Volume 269, Issue 10, Page(s) 5319–5327

Abstract: Background: Clinical trials in primary progressive MS (PPMS) generally use the Expanded Disability Status Scale (EDSS) as their primary outcome measure, although different clinical outcomes may be more useful. Disability worsening in PPMS trials may be ... ...

Abstract	Background: Clinical trials in primary progressive MS (PPMS) generally use the Expanded Disability Status Scale (EDSS) as their primary outcome measure, although different clinical outcomes may be more useful. Disability worsening in PPMS trials may be influenced by baseline factors, such as age, sex, and contrast-enhancing lesions. Methods: We used the dataset of PROMISE, a large randomized controlled trial of glatiramer acetate (GA) versus placebo, to compare the clinical outcomes EDSS, timed 25-foot walk (T25FW), and nine-hole peg test (NHPT). We used Cox regression analyses to investigate the association of the baseline factors age, sex, treatment arm, contrast-enhancing lesions (CELs), and EDSS on the time to 3-month confirmed disability worsening (3MCDW) on the EDSS and the T25FW. Results: PROMISE included 943 participants. Worsening on the T25FW or EDSS or occurred much more frequently than on the NHPT. Having CELs at baseline was associated with a shorter time to 3MCDW on both the EDSS and T25FW. An additional resampling experiment using the PROMISE dataset showed that increasing representation of participants with CELs at baseline increases the likelihood of having a positive trial result in favor of GA treatment. Conclusion: Our investigation suggests that the T25FW may be a more useful primary outcome measure than the EDSS in PPMS trials, and that its use may shorten clinical trials. Our findings on the impact of CELs at baseline on disability outcomes inform the critical appraisal of clinical trials in PPMS.
MeSH term(s)	Disability Evaluation ; Disabled Persons ; Humans ; Multiple Sclerosis, Chronic Progressive/drug therapy ; Outcome Assessment, Health Care ; Walking
Language	English
Publishing date	2022-05-16
Publishing country	Germany
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	187050-6
ISSN	1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
ISSN (online)	1432-1459
ISSN	0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
DOI	10.1007/s00415-022-11171-2
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