Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial

Table 1 Outcome measures and study instruments

Outcomes	Study instrument
Time to recover	Patient filled data sheet at 6 weeks
Operative time	Data sheet on operative period filled by research assistant.
Postoperative hospital stay	Postoperative data sheet filled by research assistant
Cost	Direct costs based on preoperative, operative, postoperative, 6-week and 6-month data sheets filled by research assistant Indirect costs based on preoperative, postoperative, 6-week and 6-month data sheets filled by patient
Complications	Data sheet on operative, postoperative, 6-weeks and 6-months period filled by research assistant
Anaesthesia time	Data sheet on operative period filled by research assistant
Pain scores and pain medication	Data sheet on postoperative period filled by research assistant
Blood loss/change in haematocrit	Data sheet on operative and postoperative period filled by research assistant
QALYs	Paper-based EQ-5D-3L (Sinhala/Tamil) [16]
Urinary function	ICIQ-FLUTS (Sinhala/Tamil) questionnaire [18, 19]
Vaginal and sexual function	ICIQ-VS (Sinhala/Tamil) questionnaire [20]
Bowel function	Bowel symptoms questionnaire [21]

EQ-5D-3L EuroQoL group questionnaire on health-related quality of life, ICIQ-FLUTS International Consultation on Incontinence modular Questionnaire on Female Lower Urinary Tract Symptoms, ICIQ-VS International Consultation on Incontinence modular Questionnaire on Vaginal Symptoms, QALYs Quality-adjusted life years

ISSN: 1745-6215