Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol

Abstract

Background: The conventional view that participants in randomised controlled trials sacrifice themselves for the good of future patients is challenged by increasing evidence to suggest that individual patients benefit from participation in trials. Objective: To test the hypothesis that trial participants receive higher quality care and, as a consequence, have better outcomes than patients receiving guideline driven routine care. Methods: Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol. Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia (Magpie Trial); 322 non-participants formed the control group. Indicators of the process of care and clinical outcomes were compared between the two groups. Results: Trial participants were significantly more likely to have received daily blood tests (odds ratio (OR) 6.82, 95% CI 1.62 to 28.72) and had their respiration rate measured hourly (OR 3.42, 95% CI 1.69 to 6.92) than control patients. There were no significant differences in other markers of clinical process and no significant difference in clinical outcomes. Conclusion: This study shows minor differences in process markers and no difference in clinical outcomes between patients in a clinical trial and patients receiving protocol driven care. The benefits of improved clinical care that have previously been associated with being in a trial may be explained by the use of clear clinical protocols. In routine practice, patients may be well advised to insist on treatment as part of a protocol.

Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?

“…Our main results aligned with those of the most recent published studies [14,15,16], although the concept of an ‘inclusion benefit' differs in various ways between well-informed adults and very preterm infants. First, in addition to the study treatment, all procedures were the same in our placebo and eligible NR groups.…”

Primary stroke prevention in Nigerian children with sickle cell disease (SPIN): Challenges of conducting a feasibility trial

“…These benefits of being in a clinical trial are consistent with findings by others that clinical trials may improve the clinical care of patients not part of the trial through improvement in clinical protocols. 17 …”

Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

“…However, inadequate data are available on the actual outcomes of non-participants compared with those participating in RCTs (Schmoor et al, 1996;Braunholtz et al, 2001;Burgers et al, 2002;Peppercorn et al, 2004;West et al, 2005). Although several reports and their review (Braunholtz et al, 2001) have suggested the existence of a 'trial effect', in which participants enjoy favourable outcomes, others, especially those which attempted to exclude the confounding factors, have refuted this finding (Schmoor et al, 1996;Burgers et al, 2002;Peppercorn et al, 2004;West et al, 2005).…”

“…Several investigations have reported a favourable overall trend with trial entry (Braunholtz et al, 2001;Peppercorn et al, 2004;West et al, 2005). This 'trial effect' could derive from several factors, such as protocol effect (the way treatments are delivered), care effect (extra care related to data gathering), Hawthorne effect (changes in doctor or patient behaviour on the basis of the knowledge that they are under observation) or placebo effect (psychologically mediated benefits) (Braunholtz et al, 2001;Peppercorn et al, 2004).…”

“…Although several reports and their review (Braunholtz et al, 2001) have suggested the existence of a 'trial effect', in which participants enjoy favourable outcomes, others, especially those which attempted to exclude the confounding factors, have refuted this finding (Schmoor et al, 1996;Burgers et al, 2002;Peppercorn et al, 2004;West et al, 2005).…”