Overcoming recruitment challenges in patients with multiple sclerosis: Results from an Italian survey

Simona Maida, Gloria Dalla Costa, Mariaemma Rodegher, Monica Falautano, Giancarlo Comi, Vittorio Martinelli

Research output: Contribution to journalArticle

Abstract

Conclusion: Multiple sclerosis patients' willingness to participate in a randomized trial is mainly related to both altruistic and individual considerations, as well as to a greater chance of specialist/improved care. More effective information flow and an effective, long-standing patient-physician relationship may improve recruitment overall.

Methods: This is a single-center, observational study involving 352 consecutive outpatients followed at one site in Italy. Patients completed the Enrollment Problems Questionnaire and Beck Depression Inventory.

Background: Recruiting patients for randomized clinical trials is still extremely difficult. While there has been much research in oncology patients, no previous studies have consistently addressed specific factors affecting the willingness to enroll in multiple sclerosis trials from the patient's perspective. To this end, we conducted an exploratory study to assess the related factors and to find ways to improve recruitment.

Results: Over 50% of the patients would consider participating in a randomized trial. Willing patients are frequently older, with no children, have a diagnosis of secondary progressive multiple sclerosis, and have already participated in clinical trials. Patients' choices were positively influenced by expectations of having (a) a greater chance of cure, (b) an unavailable drug, (c) a specialist's care, and (d) the chance to contribute to medical research. Willingness was significantly increased by the use of optimistic language and practical/psychological assistance during the decision-making process.

Original languageEnglish
Pages (from-to)667-672
Number of pages6
JournalClinical Trials
Volume11
Issue number6
DOIs
Publication statusPublished - Dec 20 2014

Keywords

  • Multiple sclerosis
  • Observational study
  • Randomized clinical trial
  • Recruitment

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

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