Clinical Trials

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❘❙❚■ 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
Clinical Trials: A Practical Guide ■❚❙❘References1. Moher D, Schulz KF, Altman DG; for the CONSORT group. The Consort Statement: Revisedrecommendations for improving the quality of reports of parallel-group randomized trials.Available from: www.consort-statement.org. Accessed April 1, 2005.2. Altman DG, Dore CJ. Randomisation and baseline comparisons in clinical trials.Lancet 1990;335:149–53.3. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of publishedrandomised controlled trials. BMJ 1999;319:670–4.4. European Coronary Surgery Study Group. Coronary-artery bypass surgery in stable anginapectoris: survival at two years. Lancet 1979;1:889–93.5. Horton R. Medical editors trial amnesty. Lancet 1997;350:756.6. The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidenceof coronary heart disease. JAMA 1984;251:351–64.7. Fox KA, Poole-Wilson PA, Henderson RA, et al. for the Randomized Intervention Trialof unstable Angina (RITA) investigators. Interventional versus conservative treatmentfor patients with unstable angina or non-ST-elevation myocardial infarction: the BritishHeart Foundation RITA 3 randomised trial. Lancet 2002;360:743–51.8. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials.A survey of three medical journals. N Engl J Med 1987;317:426–32.9. Rothwell PM. External validity of randomised controlled trials: “to whom do the resultsof this trial apply?” Lancet 2005;365:82–93.10. Australia–New Zealand Heart Failure Research Collaborative Group. Effects of carvedilol,a vasodilator-beta-blocker, in patients with congestive heart failure due to ischemic heart disease.Circulation 1995;92:212–18.11. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality inpatients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med1996;334:1349–55.12. Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortalityin patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators.N Engl J Med 1999;341:709–17.13. Juurlink DN, Mamdani MM, Lee DS, et al. Rates of hyperkalemia after publication of theRandomized Aldactone Evaluation Study. N Engl J Med 2004;351:543–51.375
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❘❙❚■ ContributorsStephen L
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Clinical Trials: A Practical Guide
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■■❚❙❘Part IIIBasics ofSta
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■■❚❙❘Chapter 20Comparison
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■■❚❙❘Part IVSpecial Trial
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■■❚❙❘GlossaryGlossary453
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■■❚❙❘IndexIndex467
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