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• W2079427451 abstract "Walter Rosser (Feb 20, p 661)1Rosser WW Application of evidence from randomised controlled trials to general practice.Lancet. 1999; 353: 661-664Summary Full Text Full Text PDF PubMed Scopus (83) Google Scholar raises two key issues in his article—namely patients' preferences2McPherson K Britton AR Wennberg JE Are randomised controlled trials controlled? Patient preferences and unblind trials.J R Soc Med. 1997; 90: 652-656PubMed Google Scholar, 3Solomon MJ McLeod RS Should we be performing more randomised controlled trials evaluating surgical operations?.Surgery. 1995; 118: 459-467Summary Full Text PDF PubMed Scopus (237) Google Scholar and putting the clinical importance of randomised controlled trials (RCTs) into perspective. These can be illustrated very simply as follows.Three studies were carried out in which either Nuits St Georges 1er cru 1991 (red wine) or Meursault 1er cru 1992 (white wine) was given to a non-random unrepresentative sample of ten participants attending a seminar of evidence-based medicine.Study one was an opinion survey asking, “Do you prefer red or white wine?”. Study two was a single-blind RCT. The blindfolded participants were offered three glasses of wine in random order (ie, any one of eight combinations: red/red/red, red/red/white, red/white/red, etc) and were asked, “which glass of wine (1, 2, or 3) do you prefer?” (more than one answer was possible), then, “Which glass contains white wine and which contains red wine?”. The study was not double-blind (blindfolding the barman) because no external observer was available. Study three was a non-randomised open controlled study. A glass of red and a glass of white wine were offered at the same time to unmasked participants who were then asked, “Which glass of wine do you prefer?”.Response rate was 100% in the survey. Compliance was excellent in the controlled studies. Results (table) were obtained in under an hour. Seven (70%) participants in the survey and RCT (opinion or truth) and six (60%) in the open study preferred white wine. These apparently similar results are rather deceptive because the same individuals did not necessarily prefer white wine in all three studies. Agreement between studies (participants giving the same answer in different studies) was 80% between the opinion survey and RCT-truth (increasing to 90% for RCT-opinion), and 70% between the open controlled study and either the opinion survey or RCT-truth (80% for RCT-opinion). Concordance between RCT-truth and RCT-opinion was 70%.TableParticipants' preferences and ability to distinguish the red and white winesParticipantsOpinion survey preferenceRCTOpen controlled preferenceOpinion*What the participants thought they were drinking.PreferenceTruth†What they actually drank.1231231WWWR1-2RRWW2WRWR2RWRW3RRRW1-2RRWR4RWRW2WRWR5WWRR1WRRW6RWRW2RWRW7WWWW1-2-3WWWR8WWWR3RRWR9WRWR2RWRW10WWWW1-2-3WWWWW=white wine. R=-red wine. 1 2 3=order of tasting.* What the participants thought they were drinking.† What they actually drank. Open table in a new tab Although virtually the same question was asked each time, each study had a different aim. The survey gives the absolute preferences of an unrepresentative sample of individuals for red or white wine irrespective of the wines' other properties. The single-blind RCT is no objective measure of preference but a test of taste in the absence of visual information. Its results cannot be generalised because likes and dislikes for foods are also determined by sight. The open controlled study seems to assess preference best but must be repeated with other vintages. Overall agreement was encountered just 60% of the time.These studies confirm that the RCT can answer only specific types of questions and that patients' preferences are a key factor in clinical-trial design.4Schmoor C Olschewski M Schumacher M Randomized and non-randomized patients in clinical trials: experiences with comprehensive cohort studies.Stat Med. 1996; 15: 263-271Crossref PubMed Scopus (125) Google Scholar Investigators should consider with care whether the chosen design can answer the true issue behind their question. Why not ponder the point over a glass of wine (red or white) or, if you prefer, a glass of whisky or brandy?5Campbell EJ Campbell DM Roberts RS Ability to distinguish whisky (uisge beatha) from brandy (cognac).BMJ. 1994; 309: 1686-1688Crossref PubMed Scopus (5) Google Scholar Walter Rosser (Feb 20, p 661)1Rosser WW Application of evidence from randomised controlled trials to general practice.Lancet. 1999; 353: 661-664Summary Full Text Full Text PDF PubMed Scopus (83) Google Scholar raises two key issues in his article—namely patients' preferences2McPherson K Britton AR Wennberg JE Are randomised controlled trials controlled? Patient preferences and unblind trials.J R Soc Med. 1997; 90: 652-656PubMed Google Scholar, 3Solomon MJ McLeod RS Should we be performing more randomised controlled trials evaluating surgical operations?.Surgery. 1995; 118: 459-467Summary Full Text PDF PubMed Scopus (237) Google Scholar and putting the clinical importance of randomised controlled trials (RCTs) into perspective. These can be illustrated very simply as follows. Three studies were carried out in which either Nuits St Georges 1er cru 1991 (red wine) or Meursault 1er cru 1992 (white wine) was given to a non-random unrepresentative sample of ten participants attending a seminar of evidence-based medicine. Study one was an opinion survey asking, “Do you prefer red or white wine?”. Study two was a single-blind RCT. The blindfolded participants were offered three glasses of wine in random order (ie, any one of eight combinations: red/red/red, red/red/white, red/white/red, etc) and were asked, “which glass of wine (1, 2, or 3) do you prefer?” (more than one answer was possible), then, “Which glass contains white wine and which contains red wine?”. The study was not double-blind (blindfolding the barman) because no external observer was available. Study three was a non-randomised open controlled study. A glass of red and a glass of white wine were offered at the same time to unmasked participants who were then asked, “Which glass of wine do you prefer?”. Response rate was 100% in the survey. Compliance was excellent in the controlled studies. Results (table) were obtained in under an hour. Seven (70%) participants in the survey and RCT (opinion or truth) and six (60%) in the open study preferred white wine. These apparently similar results are rather deceptive because the same individuals did not necessarily prefer white wine in all three studies. Agreement between studies (participants giving the same answer in different studies) was 80% between the opinion survey and RCT-truth (increasing to 90% for RCT-opinion), and 70% between the open controlled study and either the opinion survey or RCT-truth (80% for RCT-opinion). Concordance between RCT-truth and RCT-opinion was 70%. W=white wine. R=-red wine. 1 2 3=order of tasting. Although virtually the same question was asked each time, each study had a different aim. The survey gives the absolute preferences of an unrepresentative sample of individuals for red or white wine irrespective of the wines' other properties. The single-blind RCT is no objective measure of preference but a test of taste in the absence of visual information. Its results cannot be generalised because likes and dislikes for foods are also determined by sight. The open controlled study seems to assess preference best but must be repeated with other vintages. Overall agreement was encountered just 60% of the time. These studies confirm that the RCT can answer only specific types of questions and that patients' preferences are a key factor in clinical-trial design.4Schmoor C Olschewski M Schumacher M Randomized and non-randomized patients in clinical trials: experiences with comprehensive cohort studies.Stat Med. 1996; 15: 263-271Crossref PubMed Scopus (125) Google Scholar Investigators should consider with care whether the chosen design can answer the true issue behind their question. Why not ponder the point over a glass of wine (red or white) or, if you prefer, a glass of whisky or brandy?5Campbell EJ Campbell DM Roberts RS Ability to distinguish whisky (uisge beatha) from brandy (cognac).BMJ. 1994; 309: 1686-1688Crossref PubMed Scopus (5) Google Scholar" @default.
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