Evidence map›Paper›PMID 26888986›Full record

SynthesisNeurology2016

The challenge of comorbidity in clinical trials for multiple sclerosis.

Ruth Ann Marrie, Aaron Miller, Maria Pia Sormani, Alan Thompson, Emmanuelle Waubant, Maria Trojano, Paul O'Connor, Stephen Reingold, Jeffrey A Cohen, attendees of the International Workshop on Comorbidity in Multiple Sclerosis

Abstract readConsensus StatementSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Enhancing diversity of clinical trial populations in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Review
  16. CNS Ageing in Health and Neurodegenerative Disorders.Journal of clinical medicine · 2023
    Review
  17. Multiple Sclerosis and Autoimmune Comorbidities.Journal of personalized medicine · 2022
    Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ruth Ann MarrieFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH. rmarrie@hsc.mb.ca.
Aaron MillerFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Maria Pia SormaniFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Alan ThompsonFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Emmanuelle WaubantFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Maria TrojanoFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Paul O'ConnorFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Stephen ReingoldFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
Jeffrey A CohenFrom the Departments of Internal Medicine (R.A.M.) and Community Health Sciences (R.A.M.), University of Manitoba, Winnipeg, Canada; Icahn School of Medicine at Mount Sinai (A.M.), New York, NY; Biostatistic Unit (M.P.S.), Department of Health Sciences, University of Genova, Italy; Faculty of Brain Sciences (A.T.), University College London, UK; University of California San Francisco (E.W.); Department of Basic Medical Sciences, Neurosciences and Sense Organs (M.T.), University of Bari, Italy; St. Michael's Hospital (P.O.), Toronto, Canada; Scientific and Clinical Review Associates, LLC (S.R.), Salisbury, CT; and Mellen Center for MS Treatment and Research (J.A.C.), Cleveland Clinic, OH.
attendees of the International Workshop on Comorbidity in Multiple Sclerosis

Funding

Medical Research Council MC_PC_12024
6 · The paper itself

Abstract

objectiveWe aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS).

methodsWe held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS.

resultsWe recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies.

conclusionOur recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to "real world" settings where the MS population commonly has comorbid conditions.

Indexed as

Clinical Trials as TopicComorbidityHumansMultiple Sclerosis

Identifiers

PMID26888986
PMCPMC4831041

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.