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Is it any good? The evaluation of therapy by participants in a clinical trial
1Brunel-ARMS Research Unit, Department of Human Sciences, Brunel University, Uxbridge, Middlesex, England.
Abstract:
Research into patients' perspectives on treatments, in concentrating on their compliance with medically prescribed regimens, have taken bio-medicine's evaluation of therapeutic efficacy and benefit for granted. This paper suggests that the clinical trial, the predominant method of evaluation, should become the object of research attention. Clinical trials of hyperbaric oxygen therapy for multiple sclerosis have failed to show any therapeutic benefit: people who themselves have the disease have however continued to employ it, arranging its delivery for themselves. This study focuses on the decision by a small number of participants in one such clinical trial whether or not to continue using the therapy afterwards. On the basis of in-depth interviews, concerning how the participants evaluated the therapy and came to their decision, it is suggested that at least in the case of this therapy and this condition, the assumptions inherent in the trial method, and its concept of genuine therapeutic benefit, structures the conclusions of the trial in a way that is profoundly at variance with the participants' own methodological assumptions and concept of benefit. Inter alia, the study challenges the view of patients as being inevitably driven by their disregard of proper scientific method to an unreasoning optimism in their assessments of possible treatments.
Insights
Patients
Area of Science:
- Biomedical research methodology
- Patient-reported outcomes
- Qualitative health research
Background:
- Traditional clinical trials often overlook patient perspectives on treatment efficacy and benefit.
- Patient compliance with prescribed regimens is frequently assumed rather than investigated.
- Existing research paradigms may not fully capture the nuances of patient experiences with therapies.
Purpose of the Study:
- To examine patient decision-making regarding continued use of hyperbaric oxygen therapy (HOT) for multiple sclerosis (MS) post-clinical trial.
- To investigate the discrepancies between clinical trial conclusions and patients' own evaluations of therapeutic benefit.
- To challenge the assumption that patients lack scientific rigor in assessing treatments.
Main Methods:
- In-depth interviews with a small cohort of multiple sclerosis patients who participated in a hyperbaric oxygen therapy clinical trial.
- Qualitative analysis of patient narratives concerning their decision-making process and evaluation of HOT.
- Comparative analysis of patient-defined benefit versus trial-defined therapeutic efficacy.
Main Results:
- Patients who continued using hyperbaric oxygen therapy for multiple sclerosis post-trial did so based on their own evaluations of benefit, diverging from trial outcomes.
- The assumptions embedded in clinical trial methodologies may not align with patients' understanding and experience of therapeutic benefit.
- Patient decision-making regarding treatment continuation is influenced by factors not captured by standard clinical trial metrics.
Conclusions:
- The study highlights a significant divergence between clinical trial assessments of hyperbaric oxygen therapy and the lived experiences and benefit evaluations of multiple sclerosis patients.
- Clinical trial designs may need to incorporate patient-centered methodologies to better understand and validate therapeutic benefit from the patient's perspective.
- Patients' decisions to continue therapies like hyperbaric oxygen therapy are informed by their own rigorous, albeit different, evaluative frameworks, challenging notions of unreasoning optimism.