Mortality of patients during trial period in trials with verapamil. No of dcaths/No randomised. Observed minus. Verapamil Control expected Variance. Bussman et ...
Mortality of patients during trial period in trials with verapamil No of dcaths/No randomised
Observed minus Verapamil Control expected Variance
DAVITI
0/29 0/8 3/28 92/717
0/25 2/9 4/33 100/719
0-0 -0 9 -0-2 -3-9
0.0 0-5 1-6 41-6
Total
95/782
106/786
-5-0
43-7
Bussman et al Crca etalt Danish pilot"
Pooled odds ratio 0-89. 95% Confidence interval 0-66 to 1 20.
care units do not have an acute myocardial infarction; but to be sure that all patients with an infarct were treated, treatment should start immediately in all patients-without exclusion criteriaadmitted with a suspicion of acute myocardial infarction. Treatment should then stop if a diagnosis of acute myocardial infarction was ruled out. This means that we did not intend to treat the 3447 patients in coronary care units but only the 1436 with acute myocardial infarction. Naturally the effect of verapamil in patients who were treated but did not fulfil the inclusion criteria should be reported from a trial with such a design. We find it impossible, however, to evaluate the effect of verapamil on death and reinfarction after an infarct in the 2011 patients without acute myocardial infarction, most of whom were treated for only two or three days and none for more than a week. Based on the intention to treat principle and including all available trials with verapamil, which are all early intervention trials, an analysis shows a reduction in pooled odds ratio of 0 11 of mortality (table) and not an increased pooled odds ratio. The number of patients in verapamil trials (n= 1568) is still small compared with the numbers included in nifedipine (n=9464) and diltiazem (n=3151) trials, and a beneficial effect of verapamil on mortality and reinfarction cannot be excluded. A report of the results ofa further multicentre Danish verapamil infarction trial (DAVIT II) with late intervention is in preparation. J FISCHER HANSEN Department of Cardiology,
Ram's second point, that the "various clinical baseline variables were not equally distributed" (presumably between those randomised to the active group compared with the control group), is not substantiated as most of the trials published data on baseline characteristics that seem to be well balanced within each trial. Therefore it is reasonable to expect that, overall, the two treatment groups (active and control) were similar. The populations chosen in the various trials (or for that matter within each trial) are not "homogeneous" (whatever that may mean). Homogeneity, however, is not a requisite for the conduct of randomised clinical trials or for the conduct of an appropriate overview. The methods that we used compare patients randomised to the active and control groups with each other only within a trial and not between trials. The methods are standard, widely accepted, and prospectively validated in a number of different situations. We had extensive correspondence with Dr Fischer-Hansen regarding his trials before the publication of our paper. The pilot study was not included in our overview because treatment allocation was based on the date of admission (odd or even) and was therefore not random.4 We recognise that by design in DAVIT F a large number of patients were withdrawn after randomisation because of lack of confirmation of the infarct. This was pointed out in table III of our paper. We believe that the only unbiased analysis of DAVIT I should be based on an intention to treat principle that includes all randomised patients (that is, all 3447 patients). It is possible that some high risk patients may have died after randomisation but before clinical confirmation of infarction was obtained; others may have suffered death due to infarction some time after the initial clinical episode was not diagnosed as an infarct. In others the drug may have prevented or precipitated an infarct. Therefore confining analysis to only a subset of patients in the table that Dr FischerHansen provides in his letter could be potentially biased and misleading. We look forward to the publication of DAVIT II and hope that the data will be presented based on all patients randomised (irrespective of subsequent diagnosis, compliance with treatment, or outcome).
Hvidovre Hospital, SALIM YUSUF P HELD
t)K-2650 Hvidovre, Denmark 1 Held PH, Y'usuf S, Furberg Cl). Calcium channel blockers in acute myocardial infarction and unstable angina: an overview. Br Medj 1989;299: 1187-92. ( 11 November.) 2 Danish Study Group on Verapamil in Myocardial Infarction. Verapamil in acute myocardial infarction. Eur Heartj 1984;5: 516-28. 3 Hansen JF, Sigurd B, Mellemgaard K, Lyngbve J. Verapamil in acute myocardial infarction. Danish Med Bull 1980;27:105-9. 4 Hansen JF, Sigurd B, Mellemgaard K, Lyngbve J. Verapamil in acute myocardial infarction. Clin Invest Med 1980;3:159-63. 5 Bussmann WD, Seher W, (irungras M. Reduktion der CK und CK-MB Infarktgrosse durch Verapamil. Deutsche Medizinische Wochenschrift 1983;108: 1047-53. 6 Crea F, Deanfield J, Crean P, Sharom M, Davies G, Maseri A. Effects of verapamil in preventing early post-infarction angina and reinfarction. Am] Cardiol 1985;55:900-4.
National Heart, Lung and Blond Institute, Bethesda, Maryland 20892, United States
CURT FURBERG
Bowman-Gray School of Medicine, Winston-Salem, North Carolina 27013. United States 1 Held PH, Yusuf S, Furberg CD. Calcium channel blockers in acute myocardial infarction and unstable angina. Br Med 7 1989;229:1187-92. (11 November.) 2 Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Betablockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 1985;17:335-71. 3 Antiplatelet Trialists Collaboration. Secondary prevention of sascular disease by prolonged antiplatelet treatment. Br MedJ
1988;2%:320-31.
AUTHORS' REPLY,-Dr Ram suggests that none of the studies included in our overview were intended to examine the effects of calcium channel blockers on survival or recurrence of myocardial infarction. His position is incorrect. At least eight studies that we reviewed were conducted with the explicit aim of exploring whether or not calcium channel blockers reduced mortality or recurrent infarction (see table I of Held et al'). Indeed some authors have claimed that these drugs are useful in this regard. We agree that coronary artery disease is multifactorial. Despite this a number of other drug interventions such as P blockers' and antiplatelet agents' have been clearly shown to reduce mortality and recurrent infarction in trials where risk factors were not modified. Therefore, it is reasonable to continue to explore whether various drugs reduce the risk of infarction or death. Dr
260
4 Hansen JF, Sigurd B, MNellemgaard K, Lyngbe J. Verapamil in acute mvocardial infarction. Clin Invest Med 1980;3:159-63. 5 Danish Study Group on Verapamil in Myocardial Infarction. Verapamil in acute myocardial infarction. Eur Heartj 1984;5: 5 16-28.
Demoralised doctors SIR,-Dr Debbie Parker spoils a persuasive piece' by massaging the findings of some research. She quotes a study of young doctors by Isobel Allen as reporting that "44% of the men and 49% of the women who qualified in 1981 wished that they had never become doctors." Whatever the level of demoralisation, it was certainly not as catastrophic as these figures suggest. The percentages given are of doctors who responded affirmatively to the question "Have you
ever regretted your decision to become a doctor?" -the final question of a lengthy interview. RICHARD WAKEFORD Cambridge CB I 2EWC I I'arker DF. Demoraliscd doctors. Br Med 7 1990;300:56-7. (6 J anuary.)
Psychiatric discharge summaries SIR,-I would like to add my findings to those of Drs Nick Craddock and Bridget Craddock on the subject of psychiatric discharge summaries for general practitioners.' I conducted a similar postal survey of the 34 general practice surgeries (115 general practitioners) in South Warwickshire Health Authority (catchment population 223 000). Each surgery received three sample discharge summaries describing the same case (an acute psychotic episode in a 40 year old woman) and containing details of the reason for admission, diagnosis, prognosis, discharge medication, and follow up. Summary A (half a side of A4 paper) was in note form. Summary B (one side of A4) was in prose style and added brief details of mental state and progress. Summary C (two and a quarter sides of A4) followed Institute of Psychiatry guidelines.2 A question sheet asked practices' opinions on each summary, whether they would favour receiving lengthier summaries for first admissions and short summaries thereafter, and their opinion of the most important information required in a discharge summary. A prepaid envelope was included. The response rate was poor (15 out of 34 practices), but the preferences expressed agree with Drs Craddocks' findings (16% found summary A "just right," 67% summary B, 26% summary C). Summary A was considered lacking in detail, and the note format was considered unprofessional. Summary B was favoured for being in prose style while remaining clear and concise. Summary C "gives the GP the information he thought he knew but didn't!"-which was good for first admissions but excessive subsequently. All of the practices favoured the "two tier" system, 67% preferring to receive summary C first. The vital details in a discharge summary, in order of importance, were treatment on discharge (including arrangements for its administration); future management (including details of all the agencies concerned, dates of appointments, the nomination of a case manager for patients likely to be unreliable, and a clear delineation of the general practitioner's role in the case in relation to the other professionals); and diagnosis (including the evidence for it). Of lesser importance were background history, presenting problems, and course of admission. The need for promptness was stressed. These findings carry forward Drs Craddocks' comment: "Our results show clearly that separate summaries are required for the general practitioner and for hospital notes." A possible solution might be to prepare a detailed "clinical summary" following Institute of Psychiatry guidelines for the notes and the general practitioner after the patient's first admission in the catchment area. Thereafter the general practitioner's needs will be met by a concise communication of diagnosis, treatment, and management issues, with only brief details of the circumstances of admission and mental state enough to give a rationale for the decisions made. The needs of the psychiatric records (to record information that may be required in future discussions of diagnosis, prognosis, and management issues) can be met by a concise update of the clinical summary, including information such as mental state and management and progress, as well as a note of any changes in personal circumstances and possibly a summary of "psychiatric dis-
BMJ
VOLUME
300
27 JANUARY 1990
