Strontium ranelate prevents quality of life impairment in post-menopausal women with established vertebral osteoporosis.

UNLABELLED: Strontium ranelate reduces the risk of fracture in post-menopausal osteoporotic women with prevalent fractures for whom quality of life is severely impaired. The SOTI study, which used the SF-36 questionnaire and disease-specific QUALIOST module, demonstrated that treatment with strontium ranelate improved osteoporotic women's quality of life compared with placebo. INTRODUCTION: The Spinal Osteoporosis Therapeutic Intervention (SOTI) study demonstrated the effect of orally administered strontium ranelate versus placebo on the incidence of new vertebral fractures and compared impact on quality of life (QoL). METHODS: QoL was assessed 6 monthly over 3 years using the QUALIOST and SF-36 questionnaires in post-menopausal osteoporotic women with prevalent fracture taking strontium ranelate or placebo 2 g/day. A total of 1,240 women were included (strontium ranelate: n=618 and placebo: n=622). RESULTS: The QUALIOST total score decreased in the strontium ranelate group, indicating preserved QoL compared with a deterioration in the placebo group (P=0.016). Strontium ranelate patients had reduced QUALIOST emotional and physical dimension scores (P=0.019 and 0.032, respectively, versus placebo), indicating beneficial effects on emotional and physical functioning. There was a trend towards better SF-36 scores in the strontium ranelate group, although there were no significant between-group differences. More strontium ranelate patients (+31%) were free from back pain over 3 years versus placebo (P=0.005), with a significant effect from the first year of treatment (P=0.023). CONCLUSION: Strontium ranelate has beneficial effects on QoL in women with post-menopausal osteoporosis compared with placebo.

Development of a revised version of the Women's Health Questionnaire.

OBJECTIVES: The Women's Health Questionnaire (WHQ) includes 36 items assessing nine domains of physical and emotional experiences of mid-aged women. The primary aim of the current research was to examine the psychometric properties of the WHQ across linguistic versions in view of the increased need for reliable health-related quality of life (HRQL) measures in multinational studies. METHODS: In this paper, we examine the hypothesized structure of the questionnaire in a UK sample, to develop and verify a revised model to be used in multicenter, international studies. RESULTS AND CONCLUSIONS: Content analysis and evaluation of missing data led to exclusion of 'Menstrual symptoms' and 'Sexual behavior' domains, retaining these as optional modules of the core questionnaire. Additionally, item 13 was excluded because it does not investigate the same concepts as other domains and the deletion of five additional items appeared to improve the questionnaire's factor structure. The revised WHQ comprises 23 items, investigating six domains. The cross-sectional psychometric properties of the 23-item WHQ were good and better than those of the 36-item version. The 23-item WHQ was assessed with multinational data, to evaluate cross-cultural equivalence of linguistically adapted versions. In addition, its reproducibility and responsiveness need to be documented.

Construction and validation of a photographic guide for assessing severity of chronic hand dermatitis.

BACKGROUND: A standardized instrument is needed to rate the overall severity of chronic hand dermatitis (CHD), in particular during clinical trials. OBJECTIVES: To design and validate a photographic guide. METHODS: Initially, five experts were asked to grade 50 photographs of CHD, first individually, then as a consensus-building group, in order to select the photographs included in the guide. Then, a validation session with 11 different dermatologists evaluating 28 patients was conducted to assess the interrater reliability and test-retest reproducibility of the assessment of disease severity, relying on the photographic guide, on two consecutive days. Patient order was randomized, and only diseased hands were visible to prevent any bias in evaluation. RESULTS: The experts reached a consensus for development of a photographic guide composed of five severity levels and four photographs per severity level. Results of the validation session showed a high level of interrater reliability and test-retest reproducibility. CONCLUSIONS: The photographic guide is a reliable tool for assessing the morphological severity of hand dermatitis, and can be used as part of a comprehensive evaluation of disease in international multicentre clinical trials.

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders.

OBJECTIVE: Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis. METHODS: Recruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores. RESULTS: The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days. CONCLUSIONS: Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability.

The acceptability of the combined contraceptive vaginal ring, NuvaRing, was assessed during two trials conducted in North America and Europe. Women completed a questionnaire about the ring's clarity of instructions, ease of use, sexual comfort, cycle-related characteristics and satisfaction after 3, 6 and 13 cycles of use. A total of 1,950 women (82% of those recruited) completed a questionnaire at cycle 3. At baseline, 66% of participants preferred oral contraceptives, but after three cycles of ring use 81% preferred the ring. On study completion, 97% agreed that the instructions for use were clear; 85% of women and 71% of their partners never/rarely felt the ring during intercourse and 94% of partners never/rarely minded that the woman was using the ring. Overall acceptance was high, 96% were satisfied with the ring and 97% would recommend the ring. Similar responses were seen for women who prematurely discontinued from the studies, except that slightly fewer women were satisfied (60%) and would recommend the ring (75%). Reasons for liking the ring included 'not having to remember anything' (45%) and 'ease of use' (27%). In conclusion, there is a high level of user and partner acceptability for the contraceptive ring.

Development and validation of a specific quality of life module in post-menopausal women with osteoporosis: the QUALIOST.

Established post-menopausal osteoporosis (PMO) has serious consequences on health related quality of life (HRQL), as long-term back and joint pain can severely limit normal activities. The quality of life questionnaire in osteoporosis (QUALIOST), a self-administered module consisting of 23 questions which complements the SF-36, was specifically designed to evaluate the repercussions of PMO on patient HRQL. The QUALIOST was developed simultaneously in French and English after discussion with 45 patients. A validation study in France and the UK included 140 women with PMO, with at least one osteoporotic vertebral fracture. Patients completed the SF-36 and QUALIOST twice, 7 days apart. Factorial analysis revealed a physical and emotional component. Three scores were calculated: physical repercussions (10 items), emotional repercussions (13 items) and the global score (23 items). Internal reliability and stability over time were excellent. Concurrent validity with the SF-36 physical and mental fields was satisfactory. A deterioration in clinical state, as measured by pain severity, hospital admission and walking stick use, increased the repercussions on HRQL for all three scores, demonstrating the clinical validity of the questionnaire. The QUALIOST, combined with the SF-36, is a valid rating scale for measuring HRQL in clinical trials for established PMO, providing both general and specific data on the effects of PMO on patient HRQL.