A novel method for the translation and cross-cultural adaptation of health-related quality of life patient-reported outcome measurements.

BACKGROUND: This paper presents a novel methodology for translation and cross-cultural adaptation of health-related quality-of-life patient-reported outcome measures, incorporating the Delphi method. Specifically, we describe the process of translating the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 from English to Norwegian using this method. METHODS: The multistep translation method combined the European Organization for Research and Treatment of Cancer Quality of Life guidelines, an Expert Panel review, and the Delphi method. It comprised two independent forward- and back-translations. While the bilingual pelvic floor Expert Panel ensured rigorous cross-checking and effective cross-cultural adaptation, the addition of the Delphi method (comprising the attributes of anonymity, controlled feedback, and statistical group response) further established consensus on translated items. OUTCOMES: The application of the Delphi method in the Expert Panel phase proved adequate in producing comprehensible intermediate Norwegian versions ready for pilot testing. The Expert Panel reviewed the comments made by patients completing the instruments and offered advice to allow final translated versions to be produced and tested for measurement properties. This iterative approach, internal logic, and anonymity between rounds improved the evaluations that the panel members provided, which in turn enhanced the final translated Patient Reported Outcome Measures (PROMs). CONCLUSIONS: To our knowledge, this work represents the first demonstration of the application of an Expert Panel review incorporating a Delphi method to assess health-related quality-of-life instruments. The controlled feedback approach, iterative nature, internal logic, and anonymity of the Delphi consensus method appeared to ensure a good cross-cultural adaptation of these PROMs.

Norwegian translation, and validation, of the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7).

INTRODUCTION AND HYPOTHESIS: The goal was to translate into Norwegian, and validate, short versions of the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7) using a sample of women with symptomatic pelvic organ prolapse and pelvic floor dysfunction. METHODS: Modified European Organization for Research and Treatment of Cancer Guidelines were used for translation and cultural adaptation. Of 212 eligible Norwegian women who consented to participate, 205 completed the questionnaires, of whom 50 were retested after 1 - 3 weeks, and 76 were tested 6 months after surgery. Reliability, validity and responsiveness were evaluated. Additionally, interpretability, the smallest detectable change, the standard error of measurement, floor and ceiling effects, and the percentages of missing items are reported. RESULTS: Reliability ranged from 0.66 to 0.93 and intraclass correlation coefficients from 0.85 to 0.94. Both construct validity and responsiveness were found to be adequate. The responsiveness of the PFDI-20 was further supported by areas under the curve above 0.70. Estimates were lower for the PFIQ-7. The smallest detectable changes at the individual level were 15 - 21 % and 17 - 27 % for the PFDI-20 and PFIQ-7, respectively. The absolute values of the minimal important changes in the total scores were 48 and 47, respectively. No floor or ceiling effects were evident in the distributions of the PFDI-20 and PFIQ-7 total scores. CONCLUSIONS: The translated questionnaires provided adequate reliability, validity and good responsiveness to change. These short versions of the PFDI and PFIQ are robust measuring instruments that will enable symptom severity and health-related quality of life to be evaluated in the Norwegian context.

Perioperative course and long term outcome after vaginal sacrospinous colpopexy for vaginal vault prolapse post hysterectomy: comparison of three different suture methods.

AIM: To compare long-term results of the vaginal sacrospinous colpopexy (VSC) procedure for the treatment of vaginal vault prolapse after previous hysterectomy with the use of either of the three most commonly used devices (the Deschamps ligature carrier, the Shutt Suture Punch System, or an ordinary straight needle holder). METHOD: The study group consisted of 73 women (out of 84; response rate 86%) who had undergone VSC for vaginal vault prolapse in between January 1994 and April 2005. All these patients were contacted with a mailed questionnaire and asked about symptoms related to prolapse, possible complications, any subsequent surgical repair and their satisfaction with results of the surgery. All data concerning the patients' characteristics at the time of surgery and perioperative events were retrospectively collected using the patient records (charts). RESULTS: There were no significant differences in age, parity, body mass index, or in proportion of previous prolapse or incontinence surgery between groups. The operation time was similar in all groups, with a median duration around 60 min. There was a wide distribution of the estimated blood loss in the groups, but without significant differences between groups. The rate of complications was low in all groups. Most of the patients were 'very satisfied' with the results of the surgery and rated their satisfaction as 8 to 10. The proportions of patients being very satisfied with the results of the surgery were 84%, 80% and 87% in the Deschamps, Shutt and needle holder groups, respectively. CONCLUSION: In the present study we could not see any major differences in perioperative data when comparing usage of the three instruments. Operation time, complications rate, perioperative blood loss and the patient's satisfaction with the surgery were equal between the three groups. This indicates that the type of instrument used in VSC is of no importance.

Bishop score and the outcome of labor induction with misoprostol.

BACKGROUND: The aim of the study was to retrospectively identify possible factors for predicting the outcome of induction with misoprostol. METHODS: Fifty micrograms of misoprostol were administered intravaginally every 6 h during the first 2 days of induction, up to a maximum of 4 doses. The Bishop score, indication for induction, gestational length, maternal age, and parity were analyzed. The study involved 99 patients (47 primiparous and 52 multiparous) at term (>36 weeks of gestation) with unripe cervices. RESULTS: Forty-five per cent of the patients achieved ripening of cervix and went into labor after a single dose of misoprostol; a further 45% required 2 doses. Nine patients received more than 2 tablets. Ninety-seven per cent of all vaginal deliveries occurred within the first 2 days of induction. Ninety-five per cent of the patients delivered vaginally when the Bishop score was >3, compared with 75% of those with a Bishop score of < or =3 (p=0.003). Among factors creating the Bishop scoring system, in logistic regression analysis effacement of the cervix was the only independent, significant predictor of cesarean section (p=0.003, OR = 0.16) even after adjusting for maternal age, which also was a significant predictor in the regression analysis. Eleven patients had previously had a cesarean section; one of them had a uterine rupture with a fatal outcome for the fetus. All women with a previously scarred uterus are now excluded from misoprostol treatment. CONCLUSION: Misoprostol 50 microg administered intravaginally every 6 h according to this protocol is highly effective for inducing labor in carefully selected patients with unripe cervices.