Background: The purpose of our study was to develop a quality-of-life (QoL) questionnaire for patients with gastroesophageal reflux disease (GERD) who have undergone laparoscopic fundoplication. This questionnaire was developed to be more comprehensive than existing measures.
Methods: Between 1994 and 2002, 252 patients underwent laparoscopic fundoplication for GERD in the 1st Department of Surgery, Semmelweis University. We undertook a retrospective analysis: each of 252 operated patients was given a questionnaire and was requested to complete it and return it in an enclosed envelope. A total of 116 patients returned completed questionnaires. The patients included 55 men and 61 women, with a mean age of 46 years (range 14-77). These patients were used in the psychometric evaluation. The questionnaire consisted of 50 questions (including the Visick score, EORTC-QLQ-C30, and a modified GERD-HRQL).
Results: Internal consistency reliability was high (alpha value overall, 0.95, range, 0.74-0.96). Using convergent and divergent validity, construct validity was evaluated by examining Pearson correlation coefficients between items and scales. Construct validity was demonstrated based on observed correlations. Known groups validity was upheld because patients who experienced more symptoms and patients who has higher Visick scores reported worse QoL than those with less symptoms or lower Visick scores.
Conclusions: Our questionnaire is a short and user-friendly instrument with excellent psychometric properties. It has been found to be valid and reliable.