Clinical Trials

❘❙❚■ Chapter 32 | Overview of Reportingestimate of the overall prevalence or incidence of the condition of the study, andthe possible public health impact of the trial’s results, but this should avoidextrapolation from the study population to the population at large. Finally, thetitle of a press release must always reflect the key findings of the trial.The danger of over-simplified information cannot be over-estimated. An examplehighlighting the problem of imprecise global information uptake by health careproviders and patients can be found in RALES (Randomized Aldactone EvaluationStudy) [12,13]. This study published beneficial findings of spironolactone inheart failure. Spironolactone was used prior to this trial, mainly in dosages of100–300 mg/day in patients with liver cirrhosis. In contrast to patients with heartfailure, patients with liver cirrhosis are unlikely to receive angiotensin-convertingenzyme (ACE) inhibitors concomitant with spironolactone, and are therefore at amuch lower risk of developing hyperkalemia with large doses of spironolactone.When the results of RALES became available, large doses of spironolactone wereprescribed to heart failure patients in conjunction with ACE inhibitors withoutadequate monitoring of potassium, despite the fact that the spironolactone dosagein the trial ranged from 25 to 50 mg/day with close potassium monitoringaccording to the trial protocol. Hospitalizations of patients due to life-threateninghyperkalemias rose massively and, in contrast to the predicted effects of theRALES trial, the rates of readmission for heart failure or death from all causesdid not decrease after publication of the trial results.ConclusionClinical trial reports should be concise and understandable. They are usuallytargeted at a medically trained reader, which implies that the reader may not bean expert on statistical issues that are implicit in trial design and analysis, howeverthe report should clarify the assumptions and methods behind these issues. TheCONSORT statement is helpful in outlining the main points of a report that haveto be covered in order to ensure a correct and critical interpretation andpresentation of the results.By following such international guidance on publications, reports providesufficient information in a concise manner, allowing the presented results to bescrutinized fully, and helping clinicians to decide how best to translate the findingsinto practice.374