title: Development and validation of a symptom scale to evaluate postoperative patients with esophagogastric cancer.
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.
  
  
  METHODS
  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.affiliation: Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: michitakahonda@jfcr.or.jp.
authors.forename: Michitaka
authors.initials: M
authors.lastname: Honda
authors.affiliation: Department of Sociology, Kansai University, Osaka, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Wakita
authors.affiliation: Institute for Health Outcomes & Process Evaluation Research (i-Hope international), Kyoto, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Onishi
authors.affiliation: Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Souya
authors.initials: S
authors.lastname: Nunobe
authors.affiliation: Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiki
authors.affiliation: Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Miura
authors.affiliation: Department of Surgery, Tenri Hospital, Nara, Japan.
authors.forename: Tatsuto
authors.initials: T
authors.lastname: Nishigori
authors.affiliation: Department of Surgery, Kameda Medical Center, Chiba, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kusanagi
authors.affiliation: Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Takatsugu
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Department of General Internal Medicine, St. Lukes MediLocus, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK.
authors.forename: Alexander
authors.initials: A
authors.lastname: Boddy
authors.affiliation: 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.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Fukuhara
mesh_terms: D000328:Adult; D000368:Aged; D004938:Esophageal Neoplasms / Q000601:surgery*; D016629:Esophagectomy; D005163:Factor Analysis, Statistical; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000175:diagnosis*; D011594:Psychometrics; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013274:Stomach Neoplasms / Q000601:surgery*; D011795:Surveys and Questionnaires