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Correspondence

TO THE EDITOR:

I read with interest "Current Concepts Review. Methods for Locating Missing Patients for the Purpose of Long-Term Clinical Studies" (80-A: 431–438, March 1998), by Smith and Watts. The authors went to great lengths to provide the readership with a comprehensive analysis of the sources of information used to locate missing patients. I write to raise two related issues.

The authors stated: "In order for an investigator to evaluate the effectiveness of a medical treatment over the long term, patients must be located, interviewed, and often examined." The word investigator implies an individual who has carefully thought out the rationale for, and the specific hypotheses to be addressed by, a long-term clinical or functional outcome study. This responsibility, in my mind, mandates that the investigator think proactively about the issue of locating patients in the long term. If a protocol is developed for a long-term follow-up study, the patients are informed as to the purposes and mechanisms at the outset. Our specialty has been plagued by retrospective analyses performed without solid research plans and hypotheses. If the investigator takes the role seriously and performs these essential steps, many patients in the initial cohort may not be lost to follow-up.

A second issue relates to the function of the institutional review board. It is the policy of The Journal that all clinical studies be approved by the appropriate institutional review board from the investigators' institution. In my experience, some institutional review boards are hesitant to grant approval for the use of some of the methods outlined in this review for the purposes of conducting retrospective clinical or functional outcome studies. The issue of an individual patient's privacy cannot be de-emphasized. If the investigator outlines the methods that may be used to locate patients both to the institutional review board and to the patient whose consent is being requested at the time of enrollment in a study and identifies these methods in the informed-consent form, this issue can be avoided.

I found this review to be helpful and informative, but I hope that the authors are not misinterpreted as condoning retrospective reviews as has been the tradition in orthopaedic surgery.

Marc F. Swiontkowski, M.D.: Department of Orthopaedic Surgery, University of Minnesota, Box 492, 420 Delaware Street S.E., Minneapolis, Minnesota 55455

Dr. Smith and Dr. Watts reply:

Dr. Swiontkowski is concerned that our specialty has been plagued by retrospective analyses performed without solid research plans and hypotheses and implies that our Current Concepts Review encourages retrospective rather than prospective studies. That was certainly not our intent. By employing the techniques that were described in our report, investigators who are planning a study can make certain that sufficient information is obtained so that patients can be readily found later. For example, in our ongoing multi-institutional prospective trial on the treatment of Legg-Perthes disease, such information was not part of the initial demographic data. When the patients had to be located fifteen years later, use of the Internet greatly facilitated our search.

Concerning the issue of approval of the study by the institutional review board, we are in complete agreement with Dr. Swiontkowski that an individual patient's privacy cannot be de-emphasized. This requires a thorough understanding, both on the part of the patient and on the part of the members of the institutional review board, of the processes used to locate patients. Unfortunately, by the time some prospective trials come to fruition, the techniques and technologies that are available are totally different from those that were available years earlier when the study was begun.

J. Scott Smith, M.D.: 4304 Andrews Highway, Midland, Texas 79703

Hugh G. Watts, M.D.: Shriners Hospital for Children, 3160 Geneva Street, Los Angeles, California 90020

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This Article Extract Full Text (PDF) Free Letters to the Editor: Submit a response Alert me when this article is cited Alert me when Letters to the Editor are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Rights and Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Swiontkowski, M. F. Articles by Watts, H. G. Search for Related Content PubMed PubMed Citation Articles by Swiontkowski, M. F. Articles by Watts, H. G. Social Bookmarking                   What's this?

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