Scientific paperInfluence of follow-up methodology and completeness on apparent clinical outcome of fundoplication
Section snippets
Methods
The Department of Surgery at the Royal Adelaide Hospital has conducted five randomized clinical trials of laparoscopic antireflux surgery techniques [5], [6], [7]. One of these trials, Nissen versus anterior fundoplication [5], [6], [7], [8], recently reached the 5-year follow-up point and an attempt was made to contact every patient enrolled in the trial, and to interview each patient by telephone 5 years after surgery. One hundred and three patients were potentially available for follow-up at
Results
The first 75 patients from our clinical trial of laparoscopic Nissen fundoplication versus anterior fundoplication who were interviewed by telephone were used for this analysis. The time interval between returning a mail-out questionnaire and telephone interview was less than 6 months for all of these patients (mean 1 month, range 0 to 6). Forty-nine of 75 patients (65%) returned a mail-out questionnaire.
Table 1compares the symptom scores obtained from the 49 patients who returned the mail-out
Comments
Accurate measurements of clinical outcomes are critical in medicine and medical research. Unfortunately, objective outcomes cannot always be determined and when that is the case, subjective outcomes must be assessed. An example of this is the outcome of antireflux surgery. Many clinical studies have been conducted to assess the efficacy of the laparoscopic approach to antireflux surgery [2], [4], [9], [10], and outcomes for these patients are usually obtained using subjective questionnaires
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