Factors influencing clinical trial participation of women with fibromyalgia across the United States: a cross-sectional survey.

Although fibromyalgia is a widespread chronic pain condition where 90 percent of patients are women, they are underrepresented in Randomized Clinical Trials (RCTs). We aim to describe the willingness to participate, assess different factors, and explore the impact of sociodemographic and clinical ch...

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Publicado en:Women & Health Vol. 64; no. 5; pp. 369 - 380
Autores principales: Cardenas-Rojas, A., Pacheco-Barrios, K., Castelo-Branco, L., Gonzalez-Mego, P., Marduy, A., Vásquez-Ávila, K., Caumo, W., Fregni, F.
Formato: Artículo
Publicado: Taylor & Francis Ltd May/Jun2024
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Acceso en línea:Ver este registro en EBSCOhost
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      dt: May/Jun2024
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        10.1080/03630242.2024.2334700
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        atl: Factors influencing clinical trial participation of women with fibromyalgia across the United States: a cross-sectional survey.
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          Cardenas-Rojas, A.
          Pacheco-Barrios, K.
          Castelo-Branco, L.
          Gonzalez-Mego, P.
          Marduy, A.
          Vásquez-Ávila, K.
          Caumo, W.
          Fregni, F.
        affil:
          Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, USA
          Laboratory of Pain and Neuromodulation, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil
      su:
        United States
        Cross-sectional method
        Income
        Human research subjects
        Psychology of women
        Randomized controlled trials
        Age distribution
        Patient participation
        Educational attainment
        Pain measurement
        Patient selection
        Research funding
        Fibromyalgia
        Multiple regression analysis
        Questionnaires
        Multivariate analysis
        Statistics
      sug:
        subj:
          Cross-sectional method
          Income
          Human research subjects
          Psychology of women
          Randomized controlled trials
          Age distribution
          Patient participation
          Educational attainment
          United States
          Pain measurement
          Patient selection
          Research funding
          Fibromyalgia
          Multiple regression analysis
          Questionnaires
          Multivariate analysis
          Statistics
      keyword:
        Clinical trials participation
        fibromyalgia
        questionnaire
        recruitment
        Clinical trials participation
        fibromyalgia
        questionnaire
        recruitment
      ab: Although fibromyalgia is a widespread chronic pain condition where 90 percent of patients are women, they are underrepresented in Randomized Clinical Trials (RCTs). We aim to describe the willingness to participate, assess different factors, and explore the impact of sociodemographic and clinical characteristics on perceived barriers to trial participation. This is a cross-sectional survey targeting women with fibromyalgia. Univariate and multivariate logistic regression were performed. Of the 436 women with fibromyalgia, 56 percent were very likely to participate in RCTs. Minorities expressed less interest than non-minorities, while higher pain scores, previous participation, and younger patients reported a higher interest. Barriers significantly associated with a reduced willingness were: the participant's perception (side effects, distance, potential negative impact), the center (reputation), the trial protocol (number of visits, placebo), and trial awareness by their physician. In a multivariate analysis, older age, low education, lower income, and higher pain scores were associated with perceived barriers to RCT participation. Despite the high interest to participate, factors such as side effects, the center's distance, number of visits, placebo treatments, and the institution's reputation must be considered in clinical trials for women with fibromyalgia.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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