Study reports that stroke patients in Australia who participate in clinical research studies receive better care that leads to reduced mortality outcomes.
Clinical research studies are conducted to develop safe and effective interventions and to improve health outcomes. Research participation can involve both risks and benefits to the patient, such as adverse reactions or positive therapeutic effects from a drug. The belief that participation in a research study will yield benefits is called the ‘trial effect’. Although many studies have examined this phenomenon, the results still remain inconclusive. The stroke population is a group of patients that has yet to be studied regarding the trial effect. An observational study reported in the journal Neurology recently explored the differences between outcomes of in-hospital-based stroke patients participating in research compared to those not participating in research.
Data was analyzed from hospitals that participated in the Australian National Stroke Foundation’s acute services audit program in 2009, 2011, and 2013. The audits were voluntary and composed of a survey to be completed by a representative clinician from each hospital on general information (bed numbers, admissions per year, organizational aspects of stroke services), the type of current stroke research studies being conducted, and the number of studies. A total of 240 hospitals provided 571 audit surveys over the course of the three audit years.
Almost all (98%) of the hospitals that participated in the audit surveys were public institutions. Stroke research occurred more frequently in hospitals located in an urban area with a stroke unit and more than 200 stroke admissions per year. The majority of stroke research studies conducted focused on acute stroke care (54%), stroke prevention (18%), and stroke rehabilitation (13%). Patient medical records showed that of 9,537 patients, only 469 (5%) consented to participate in a research study when admitted into hospital. Research participation consent was simply recorded as a “yes” or “no”, and based on medical records, it was not clear to the researchers whether the patient participated in observational or interventional studies.
Research participants were younger and more independent prior to their stroke compared to non-research participants. Within 48 hours of admission, participants were more likely to receive stroke unit care, have a swallow screen/assessment prior to oral intake, receive thrombolysis treatment, and see a physiotherapist or a speech therapist. Surprisingly, patient enrollment in research was correlated with a reduction in in-hospital mortality and being discharged to patient rehabilitation, regardless of whether their hospital had access to stroke unit care.
The researchers of this study conclude that stroke patients who participate in research studies receive better quality of care and are less likely to die in-hospital compared to non-participants. As this observational study was conducted in Australia, these results are representative of the Australian stroke population, research activities, and hospitals.
The observed positive trial effect may have been influenced by both patients and clinicians knowing that they were involved in research – regular and intensive monitoring of patients often occurs in studies and clinicians involved in specific disease research may be better informed or following strict research protocols.
It remains to be seen as to whether the trial effect is transferable to other diseases such as HIV, multiple sclerosis or diabetes based on the results of this study, since there are many differences between conditions, studies, hospitals, and countries. The conclusions from this study, however, contribute additional evidence to a potential positive effect with research participation. In any case, the potential for improved outcomes and better treatment with research participation could improve patient motivation and trial recruitment, reduce dropout rates, and increase the involvement of hospital teams in research.
Written By: Fiona Wong, PhD