Improving bladder cancer outcomes: The impact of initiating a phase IV randomised controlled clinical trial

Summary 

Objective

The aim of this study was to determine if patients newly diagnosed with bladder cancer and included in a clinical trial had better outcomes than similar patients treated in the same department before initiation of the trial.

Methods

Forty patients presenting with bladder cancer in 2005 and recruited into a randomised trial of photodynamic-assisted tumour resection were compared with a cohort of 40 non-trial patients from 2004. Quality of care was measured by assessing near-miss criteria.

Results

There were fewer near-misses in the Trial Group (TG) than in the Control Group (CG) (52 versus 151) (p<0.001). There were 15 surgical near-misses in the TG compared with 90 in the CG (p=0.025). Adjuvant intravesical chemotherapy was given within 6h of resection in 26/31(84%) of the TG and 1/23(4%) of the CG. There were 37 process near-misses in the TG compared with 61 in the CG (p=0.002). The times to first outpatient appointment, diagnostic flexible cystoscopy, and outpatient follow-up were shorter in the TG (median 10.5/25/17.5 days) than the CG (median 17/32.5/26 days).

Conclusions

Patients in the trial had better outcomes than non-trial patients the previous year. The recruitment of patients into trials is a valuable driver of quality improvement.

Keywords: Quality of care, Bladder cancer, Clinical trial