Apr 1, 1996 - doctors see more than 44 patients a day. The decision is a result of a province-wide BC Medical Associa- tion referendum in which doctors.
services plan for anything above the 62nd or the 59th visit respectively. * The limit on GP office visits per day does not apply to communities in the "northern and isolation allowance" categories, of which there are 82 in British Columbia. * The volume limit does not apply to any work done in the office relating to cases involving the Workers' Compensation Board or the Insurance Company of British Columbia (the provincially run motor-vehicle insurance plan). * The volume limit does not apply to house calls, hospital calls, deliveries or full-time work in an emergency department by a family physician. * A premium of 15% will be added to the fee for an office visit when the service is provided to a patient 75 years of age or older. * The funding for the augmented fee for office visits for patients 75 years of age and older will be derived from savings from the volume limits; this measure is to be revenue neutral - that is, if there are insufficient funds from the savings from volume limits, then the premium for office visits for these patients will have to be scaled back. The Medical Services Commission of British Columbia has been asked to accept and implement these policies concerning HV-LIPs, and it is hoped that this can be done by Apr. 1, 1996. At the most recent meeting of the Board of Directors, the BCMA directed its executive to establish a committee to review the effects of the HV-LIPs program and the need (if any) for any modifications concerning further exemptions, additional inclusions and the application of time aspects to the volume limits. This committee will also survey the Society of Specialist Physicians to determine whether such a program 1708
can be applied to specialty office Canada. Walter Cronkite was the practice as well. moderator and Dr. Jane Fulton one of the panelists. When one of the seVictor Dirnfeld, MD, FRCPC nior Americans gave a lengthy list President of faults in the Canadian system, British Columbia Medical Association Cronkite asked Fulton to reply. The Vancouver, BC bright Fulton then said, "Is it all right to say 'bullshit' on public broadcast[The news and features editor replies:] ing?" She seems to have changed her opinion. he information in the news item cited by Dr. Gregory was taken Alvin Cohen from a BCMA news release dated Vancouver, BC July 27, 1995. The release stated: "Value for service: this is the out-. come of a recent decision by British EPISIOTOMY RESULTS Columbia doctors to impose limits STAND DESPITE LACK on the fee-for-service payment if doctors see more than 44 patients a OF COMPLIANCE day. The decision is a result of a province-wide BC Medical Associae are pleased that the assocition referendum in which doctors W ate editor-in-chief of CAMAJ were asked to approve changes in ('The pursuit of objectivity; La the way physicians will charge for recherche de l'objectivit6," by Patriseeing patients. The decision means cia Huston, Can Med Assoc J 1995; that for the first 44 patients in a 153: 735) and the author of the edigiven day, a doctor will receive full torial ("Unbiased research and the medical Services Plan fee. Between human spirit: the challenges of ranthe 45th and 62nd patient, physi- domized controlled trials," by Kencians will receive 50% of the fee. Af- neth F. Schulz, 153: 783-786) acter 62 patients, they will not be reim- companying our article,, "Physician bursed at all. Nearly 3000 physicians beliefs and behaviour during a ranvoted, with 62.2% voting in favour domized controlled trial of epiand 34.7% opposing the restric- siotomy: consequences for women in their care" (153: 769-779), apprecitions.` ate our study and draw attention to Patrick Sullivan the methodologic problems and pitEditor falls associated with randomized News and Features controlled trials (RCTs). Although the editor's page and the editorial focus appropriately on the methodologic issues, some comFULTON DEFENDS OUR ments about the results of the trial HEALTH CARE SYSTEM may be misunderstood. Drs. Huston and Schulz suggest the validity of the trial was unthat Cat Fulton: The article "Jane dermined Med by the noncompliance of among the pigeons?" (Can Assoc J 1995; 153: 819-821), by the study physicians. We discovered Charlotte Gray, brought back an serious problems with compliance, and this issue is one of the themes of amusing memory. A few years ago I watched a tele- our article. However, it would be a vision program on the US Public mistake to minimize what the trial Broadcasting System that compared actually shows. Although the nonhealth care in the United States and compliant physicians almost sub-
CAN MED ASSOC J * 15 DEC. 1995; 153 (12)
verted the trial, we had a sufficient number of compliant physicians to show strong evidence that routine episiotomy cannot be justified. The original trial shows no difference in a whole range of outcomes involving perineal pain and pelvic-floor relaxation between primiparous patients treated with routine episiotomy and those subjected to a more restrictive approach.' With greater compliance, the kind of information concerning outcomes among primiparous patients that emerged from the secondary cohort analysis2 could well have appeared in the original analysis. However, the positive effect of restricting episiotomy among multiparous patients is evident in the original RCT. Multiparous patients received less stitching and had intact perineums more often. In the secondary cohort analysis, the best outcomes are shown among women who had not had an episiotomy. Of 53 extensions that occurred, 52 happened after an episiotomy. In our article in CMAJ, we collapse both arms of the trial and examine the results not on the basis of allocation group but on the basis of the belief system of the physicians attending study participants. This kind of analysis of an RCT is unusual: RCTs can normally provide answers only to simple questions (what works, what does not and which treatment is better). Investigators do not normally look inside trials to examine the underlying reasons why the results turn out the way they do. In another unpublished analysis, we examined what the physicians actually did within the trial, rather than what they believed. In that analysis the link between those who used episiotomy liberally and a whole range of poor perineal outcomes and other interventions (such as cesarean section) was even clearer. Thus, although our RCT has some serious compliance problems, through careful analysis we have understood the reasons for the problems and man-
aged to salvage the trial, producing consistent information that shows clearly the adverse effects of routine episiotomy. Schulz has written an eloquent analysis of the reasons why RCTs may go astray, but in so doing he has raised questions about some of our methods, notably the process of random assignment. He suggests that selection bias could have been introduced through manipulations of assignments if physicians were able to figure out allocations ahead of time. Although this is an interesting hypothesis, this was not where the problem occurred. Our random assignments were done in large blocks, which were produced by a randomnumber generator. The envelopes were sealed and opaque. On-site supervision by study nurses assured that manipulation of assignments or "peeking" into opaque envelopes did not happen. All envelopes were accounted for, and there was no possibility that a physician could select one envelope and, if he or she did not like the assignment contained in it, discard it and select another. The problems affecting the study physicians were much more subtle. Most participating physicians joined the trial genuinely believing that they could comply with the study manoeuvre, yet they had trouble doing so. Why? Most believed (even when their rate of episiotomy was as high as 90% among primiparous women) that they used episiotomy only for specific clinical indications, not routinely. The noncompliant physicians were not trying to subvert the trial. They were not trying to show that routine episiotomy was good or that limiting it was bad. They were simply unable to change their behaviour from their usual clinical practice, although they thought that they would be able to. The power to rationalize such a practice pattern is at the heart of the difficulty in changing clinical practice.
Thus, the problems we encountered were not rooted in methods as much as in human nature, as Schulz pointed out. Although the noncompliant physicians in our trial have given us a few grey hairs, we are grateful to them for allowing us to look inside an RCT and to understand the difficulties of mounting trials and the nature of belief systems in the practice of medicine. Michael C. Klein, MD Principal investigator McCill University-Universite de Montreal Episiotomy Trial University of British Columbia Departments of Family Practice and Pediatrics Vancouver, BC
References 1. Klein MC, Gauthier RC, Jorgensen SH et al: Does episiotomy prevent perineal trauma and pelvic floor relaxation? [article] Online J Curr Clin Trials 1992; July I (doc 10) [6019 words] 2. Klein M, Gauthier R, Robbins J et al: Relation of episiotomy to perineal trauma and morbidity, sexual dysfunction and pelvic floor relaxation. Am J Obstet Gynecol 1994; 171: 59-58 3. Klein M, Gauthier R, Kaczorowski J et al: Physician beliefs about episiotomy and perineal management: consequences for primiparas under their care. Further results from the McGill/Universite de Montreal Episiotomy Trial. [abstract] North American Primary Care Research Group Annual Meeting, Richmond, Va, Apr 14, 1992
[Dr. Schulz responds:] r. Klein has clarified many points. His letter and the studies he carried out with his colleagues have greatly increased our understanding of episiotomy and RCTs. Obviously, I have a particular interest in the methodologic aspects of such trials, as I showed in my editorial. Nevertheless, if my wife has another child and faces a possible episiotomy, I hope she will take the work of Klein and colleagues into consideration.
CAN MED ASSOC J * DEC. 15, 1995; 153 (12)
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