0
Articles   |    
Challenges in Evaluating Patients Lost to Follow-up in Clinical Studies of Rotator Cuff Tears*
Barbara M. Norquist, B.S.†; Benjamin A. Goldberg, M.D.†; Frederick A. MatsenIII, M.D.†
View Disclosures and Other Information
Investigation performed at the Department of Orthopaedics, University of Washington, Seattle, Washington
*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. Funds were received in total or partial support of the research or clinical study presented in this article. The funding sources were the Orthopaedic Research and Education Foundation, the Bristol-Myers Squibb/Zimmer Institutional Award for Excellence in Orthopaedics, and the E. A. Codman Research Fund at the University of Washington.
†Department of Orthopaedics, University of Washington, Box 356500, 1959 N.E. Pacific Street, Seattle, Washington 98195-6500. E-mail address for F. A. Matsen, III: matsen@u.washington.edu.

J Bone Joint Surg Am, 2000 Jun 01;82(6):838-838
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

Background: Long-term follow-up studies are necessary to critically evaluate the outcome of a treatment intervention for a specific disorder. However, patients may cease participating in a long-term study and become lost to follow-up; thus, their current condition is unknown. The underlying characteristics that predispose a patient to become lost to follow-up are difficult to identify and control. Patients who are lost to follow-up may be contacted by telephone; however, the effect of administering a functional assessment questionnaire by telephone compared with that of mailing a questionnaire is unknown. The purpose of this study was to compare patients who continued to respond to requests for follow-up with those who did not. A second purpose was to compare responses obtained by mail with those obtained by telephone interview.

Methods: Two hundred and twenty-four patients with a rotator cuff tear were enrolled in an ongoing study of shoulder function and general health. Self-assessment questionnaires were mailed to every patient at six-month intervals. Sixty-seven patients (30 percent) regularly responded to mailings (identified as responders in this study), fifty-five patients (25 percent) responded occasionally (these patients were not included in the analysis), and 102 patients (46 percent) ceased to respond and became lost to follow-up (identified as nonresponders in this study). This investigation was performed to determine: (1) the characteristics of nonresponders compared with those of responders, (2) the functional status of nonresponders as assessed with a questionnaire over the telephone, and (3) the effect of administering a self-assessment functional questionnaire by telephone compared with that of sending the same questionnaire by mail.

Results: Nonresponders tended to have lower initial scores for the mental health summary (p = 0.03) and for social function (p = 0.01), were less likely to have had surgery (p = 0.009), and were less likely to consume alcohol (p = 0.03). At the last known time when they completed the mailed questionnaire, nonresponders reported significantly worse shoulder function than responders (p = 0.0001). However, on telephone questioning the mean number of shoulder functions that the nonresponders indicated that they could perform was greater than the mean number documented on their last mailed questionnaire (p < 0.0001). In a random subgroup of responders, the mean number of functions that the patients indicated that they could perform when interviewed by telephone was significantly greater than the number indicated on their most recent mailed questionnaire (p < 0.01). The results obtained by telephone from this random subgroup of responders were similar to those obtained by telephone from the nonresponders.

Conclusions: There are differences between patients who continue to participate in a study and those who become lost to follow-up. Functional assessment questionnaires administered by telephone yield different results than the same questionnaires sent by mail. These considerations are relevant to the design, implementation, and interpretation of clinical studies in which functional questionnaires are used.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    PubMed Articles
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    11/15/2013
    Louisiana - Ochsner Health System
    04/16/2014
    Georgia - Choice Care Occupational Medicine & Orthopaedics
    12/31/2013
    SC - Department of Orthopaedic Surgery Medical Univerity of South Carlonina
    01/22/2014
    PA - Penn State Milton S. Hershey Medical Center