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Health state utility values and patient-reported outcomes before and after vertebral and non-vertebral fractures in an osteoporosis clinical trial

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Abstract

Summary

We assessed the health state utility value (HSUV) reductions associated with vertebral fractures using data collected in the Japanese Osteoporosis Intervention Trial-03 (JOINT-03). Our analysis revealed that assessment of HSUVs after morphometric vertebral fracture is important to capture the burden of vertebral fractures.

Introduction

Evaluation of the HSUV after fracture is important to calculate the quality-adjusted life years (QALYs) of osteoporosis patients, which is essential information in the context of health economic evaluation.

Methods

JOINT-03 study patients were aged ≥65 years and treated with risedronate and vitamin K2 or risedronate alone. Radiographic information and patient-reported outcomes measured by EQ-5D and a visual analogue scale (VAS) were assessed at registration and followed up after 6, 12, and 24 months. According to differences among the dates of these assessments and the radiographic information, we classified the follow-up HSUVs calculated based on EQ-5D results into before or after fracture categories regardless of clinical symptoms.

Results

Among 2922 follow-up HSUVs, 201 HSUVs were categorized as HSUVs that were observed after incident vertebral fractures on X-ray films. The median time from the detection of an incident vertebral fracture until the EQ-5D assessment was 53 days (25th percentile, 0 day; 75th percentile, 357 days). The impact of incident vertebral fractures on HSUVs was quantified as −0.03. Among the five health profile domains on the EQ-5D, an incident vertebral fracture had significant effects on anxiety/depression, self-care, and usual activities.

Conclusions

The results suggest that incident morphometric vertebral fracture was associated with impairment of the HSUV for patients with osteoporosis not only immediately but also several months after the fracture.

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Acknowledgments

The authors express thanks to the A-TOP Research Group and those who participated as clinical investigators in the JOINT-03. The JOINT study was sponsored by Public Health Research Foundation. The authors also thank the Japan Arteriosclerosis Prevention Fund; Teijin Pharma Limited; Asahi Kasei Corporation; Takeda Pharmaceutical Company Limited; GE Healthcare Japan; Toyo Medic Co., Ltd.; MSD Co., Ltd.; and Dainippon Sumitomo Pharma Co., Ltd., for their generous donations.

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Correspondence to K. Kawakami.

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Appendix. Rules for categorizing patient-reported outcomes

Appendix. Rules for categorizing patient-reported outcomes

Because radiographic assessments were conducted routinely at registration and at intervals of 6, 12, and 24 months in the JOINT-03 study, the date of the assessment did not necessarily correspond to the date of the vertebral fracture. Therefore, judgment of whether the date of the EQ-5D and VAS assessment was before or after the incident vertebral fracture was based on the following rules. If an incident vertebral fracture was detected and the date of EQ-5D and VAS assessments was the same or after the date of the radiographic assessment, all subsequent EQ-5D and VAS outcomes were categorized as outcomes that were obtained after the incident vertebral fracture. If no incident vertebral fracture was detected and the date of the EQ-5D and VAS assessment was the same or before the date of the radiographic assessment, EQ-5D and VAS outcomes were categorized as outcomes that were obtained before an incident vertebral fracture. These were the general procedures in the JOINT-03 study. However, in exceptional cases, the judgment process was not straightforward. For example, when an incident vertebral fracture was detected through radiographic assessment at 12 months, it had actually occurred at some time point between the 6- and 12-month radiographic assessment. In this case, if the EQ-5D and VAS assessment was conducted after the 6-month radiographic assessment but before the 12-month radiographic assessment, it could not be concluded whether the date of the assessment was before or after the incident vertebral fracture. In this situation, judgment was based on the radiographic result that was obtained proximate to the date of EQ-5D and VAS assessments. For example, if an incident vertebral fracture was detected by radiographic assessment and the EQ-5D and VAS assessment had been conducted a few weeks before the radiographic assessment, the EQ-5D and VAS outcomes were judged as having been obtained after the incident vertebral fracture. For the case of incident non-vertebral fracture, the judgment process was simpler because the information on the specific date of the occurrence was available.

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Imai, T., Tanaka, S., Kawakami, K. et al. Health state utility values and patient-reported outcomes before and after vertebral and non-vertebral fractures in an osteoporosis clinical trial. Osteoporos Int 28, 1893–1901 (2017). https://doi.org/10.1007/s00198-017-3966-7

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