Michitaka Honda1, Takafumi Wakita2, Yoshihiro Onishi3, Souya Nunobe4, Naoki Hiki4, Akinori Miura5, Tatsuto Nishigori6, Hiroshi Kusanagi7, Takatsugu Yamamoto8, Kenji Kobayashi9, Alexander Boddy10, Shunichi Fukuhara11. 1. Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: michitakahonda@jfcr.or.jp. 2. Department of Sociology, Kansai University, Osaka, Japan. 3. Institute for Health Outcomes & Process Evaluation Research (i-Hope international), Kyoto, Japan. 4. Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 5. Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan. 6. Department of Surgery, Tenri Hospital, Nara, Japan. 7. Department of Surgery, Kameda Medical Center, Chiba, Japan. 8. Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan. 9. Department of General Internal Medicine, St. Lukes MediLocus, Tokyo, Japan. 10. Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK. 11. Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan; Center for Innovation in Clinical Research, Fukushima Medical University, Fukushima, Japan.
Abstract
BACKGROUND: Postgastrectomy or esophagectomy symptoms can be a significant burden for patients. However, no standard scale for evaluating these symptoms has been established. We recently developed a postoperative symptom-specific scale. STUDY DESIGN: After a draft scale was prepared based on a pilot study, psychometric methods were used to assess its reliability and validity. This study involved specialized and multifaceted discussions by a team consisting of gastrointestinal surgeons, gastroenterologists, psychologists, and epidemiologic researchers. The draft questionnaire included 40 questions and 3 domains. A factor analysis was carried out to refine the items and subscale design. To assess the reliability, Cronbach's alpha and score distributions were estimated. To assess the criterion-related validity, the correlations with the Short Form (SF)-12, Gastrointestinal Symptom Rating Scale (GSRS), endoscopic findings, and nutritional indicators were analyzed. RESULTS: A total of 344 patients were enrolled in this study. In an exploratory factor analysis (principal factor method), the eigenvalue attenuation data showed 4 domains. The final scale, named the Esophagus and Stomach Surgery Symptom Scale (ES(4)), included 23 items and 4 domains; 7 items for cervico-thoracic symptoms, 6 for abdominal hypersensitivity symptoms, 4 for abdominal distention symptoms, and 6 items for systemic symptoms. Cronbach's alphas for these domains were 0.82, 0.81, 0.79, and 0.74, respectively. The scale scores were normally distributed, and there were significant associations with the endoscopic findings, nutritional indicators, the summary score of the SF-12, and the GSRS. CONCLUSIONS: The ES(4) scale has high psychometric validity and can evaluate the profiles and severity of postoperative symptoms. This scale is applicable as an outcomes measure for various interventional studies on esophagogastric surgery aimed at alleviating postoperative symptoms.
BACKGROUND: Postgastrectomy or esophagectomy symptoms can be a significant burden for patients. However, no standard scale for evaluating these symptoms has been established. We recently developed a postoperative symptom-specific scale. STUDY DESIGN: After a draft scale was prepared based on a pilot study, psychometric methods were used to assess its reliability and validity. This study involved specialized and multifaceted discussions by a team consisting of gastrointestinal surgeons, gastroenterologists, psychologists, and epidemiologic researchers. The draft questionnaire included 40 questions and 3 domains. A factor analysis was carried out to refine the items and subscale design. To assess the reliability, Cronbach's alpha and score distributions were estimated. To assess the criterion-related validity, the correlations with the Short Form (SF)-12, Gastrointestinal Symptom Rating Scale (GSRS), endoscopic findings, and nutritional indicators were analyzed. RESULTS: A total of 344 patients were enrolled in this study. In an exploratory factor analysis (principal factor method), the eigenvalue attenuation data showed 4 domains. The final scale, named the Esophagus and Stomach Surgery Symptom Scale (ES(4)), included 23 items and 4 domains; 7 items for cervico-thoracic symptoms, 6 for abdominal hypersensitivity symptoms, 4 for abdominal distention symptoms, and 6 items for systemic symptoms. Cronbach's alphas for these domains were 0.82, 0.81, 0.79, and 0.74, respectively. The scale scores were normally distributed, and there were significant associations with the endoscopic findings, nutritional indicators, the summary score of the SF-12, and the GSRS. CONCLUSIONS: The ES(4) scale has high psychometric validity and can evaluate the profiles and severity of postoperative symptoms. This scale is applicable as an outcomes measure for various interventional studies on esophagogastric surgery aimed at alleviating postoperative symptoms.
Authors: Nandita N Mahajan; Minji K Lee; Kathleen J Yost; Karlyn E Pierson; Jason K Viehman; Mark S Allen; Stephen D Cassivi; Francis C Nichols; Janani S Reisenauer; K Robert Shen; Dennis A Wigle; Shanda H Blackmon Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2019-11-22