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Development and Validation of Pgsas-45, an Integrated Questionnaire to Assess Postgastrectomy Syndrome
Koji Nakada*1,12, Masami Ikeda2,12, Masazumi Takahashi3,12, Shinichi Kinami4,12, Masashi Yoshida5,12, Yoshikazu Uenosono6,12, Yoshiyuki Kawashima7,12, Atsushi Oshio8, Yoshimi Suzukamo9, Masanori Terashima10,12, Yasuhiro Kodera11,12
1Surgery, The Jikei University School of Medicine, Tokyo, Japan; 2Asama General Hospital, Saku, Japan; 3Yokohama Municipal Citizen`s Hospital, Yokohama, Japan; 4Kanazawa Medical School, Kanazawa, Japan; 5International University of Health and Welfare, Mita Hospital, Tokyo, Japan; 6Kagoshima University Graduate School of Medicine, Kagoshima, Japan; 7Saitama Cancer Center, Saitama, Japan; 8Waseda University, Tokyo, Japan; 9Tohoku University Graduate School of Medicine, Sendai, Japan; 10Shizuoka Cancer Center, Shizuoka, Japan; 11Nagoya University Graduate School of Medicine, Nagoya, Japan; 12Japan Postgastrectomy Syndrome Working Party, Tokyo, Japan
BACKGROUND:
Postgastrectomy syndrome (PGS) is common after gastrectomy. Information regarding actual details of the PGS and their relation to surgical procedures, however, is limited possibly due to the fact that optimal instrument to assess PGS is lacking. A questionnaire, Postgastrectomy Syndrome Assessment Scale (PGSAS)-45, was therefore developed by a voluntary group, Japan Postgastrectomy Syndrome Working Party. PGSAS-45 was designed to assess severity of the PGS, the status of oral food intake and degree of recovery in terms of social roles, and impact of these factors on patients' well-being.
METHODS:
PGSAS-45 is an integrated questionnaire consisting of 45 items including items selectively taken with permission from the standardized generic QOL questionnaire SF-8 (8 items) and the symptom-specific QOL questionnaire gastrointestinal symptom rating scale (GSRS; 15 items). Items selected from an item pool as being clinical relevant by 47 gastric surgeons were added to these to constitute the PGSAS-45. In the current study, 52 institutions were involved in "Postgastrectomy Syndrome Assessment Study (PGSAS)", a nation-wide study to validate PGSAS-45, in which a total of 2520 PGSAS-45 questionnaires (86% of those that were originally sent out) were retrieved from the patients who received either of the six different types of gastrectomy procedures. Of these, 1516 questionnaires retrieved from the patients who received conventional gastrectomy (total with Roux-en-Y [n=393], distal with Billroth-I [n=909], distal with Roux-en-Y [n=475]) were statistically analyzed.
RESULTS:
The 23 symptom items of PGSAS-45 was composed of seven symptom subscales (SS), 'esophageal reflux SS', 'abdominal pain SS', 'meal-related distress SS', 'indigestion SS', 'diarrhea SS', 'constipation SS' and 'dumping SS' by factor analysis. The seven symptom subscales and other two domains, 'quality of ingestion SS' and 'dissatisfaction for daily life SS', had good internal consistency in terms of Cronbach's alpha (.65-.88).
Multiple regression analysis demonstrated that the sum of newly added 8 symptoms had larger impact [Beta] compared to the sum of 15 symptoms of GSRS, in ingestion (.32, .02), ability for working (.35, .09), loss in body weight (.24, .07), physical component summary (PCS) (.35, .17) and dissatisfaction for daily life SS (.60, .11).
The associations between patient's condition (symptoms, ingestion, ability for working) and HRQOL (PCS and mental component summary [MCS] of SF-8, dissatisfaction for daily life SS) was evident. The effect size [Beta, R2] was medium to large for all domains (.32 to .60, all p<0.0001).
CONCLUSIONS:
The results indicated that the PGSAS-45 provides a valid and reliable integrated measurement of QOL in gastrectomized patients.
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