Open Access Study protocol

Measuring health-related quality of life in men with osteoporosis or osteoporotic fracture

Marta Zwart12*, Rafael Azagra234, Gloria Encabo5, Amada Aguye6, Genís Roca7, Sílvia Güell8, Núria Puchol3, Emili Gene29, Francesc López-Expósito10, Silvia Solà11, Sergio Ortiz12, Pilar Sancho13, Liz Abado3, Milagros Iglesias3, Jesus Pujol-Salud15 and Adolf Diez-Perez142

Author Affiliations

1 EAP Can Gibert del Plà- Girona-2 Health Centre, Catalan Health Institute. Carrer Sant Sebastià 50, 17005 Girona, Spain

2 Department of Medicine, Universitat Autònoma de Barcelona. Passeig Vall d'Hebrón 119-129, 08035 Barcelona, Spain

3 EAP Badia del Vallès Health Centre, Catalan Health Institute. Carrer Bética, 08214 Badia del Vallès, Barcelona, Spain

4 Primary Healthcare Research Support Unit Metropolitana Nord. Catalan Health Institute-IDIAP Jordi Gol. Rambla 227, 08223 Sabadell, Barcelona, Spain

5 Nuclear Medicine Service, Vall d'Hebron University Hospital. Passeig Vall d'Hebrón 119-129, 08035 Barcelona, Spain

6 EAP Granollers-Centre Health Centre, Catalan Health Institute. Carrer Museu 19, 08400 Granollers, Barcelona, Spain

7 EAP Sant Llatzer Health Centre. Consorci Sanitari de Terrassa. Carrer de la Riba, 62, 08221 Terrassa, Barcelona, Spain

8 EAP Montcada i Reixach Health Centre, Catalan Health Institute. Passeig de Jaume I, 08110 Montcada i Reixac, Barcelona, Spain

9 Emergency Service, Hospital of Sabadell, Sanitary Consortium of Parc Taulí. Parc Tauli, 08208 Sabadell, Barcelona, Spain

10 EAP Bon Pastor Health Centre, Catalan Health Institute. Carrer de Mollerussa, 08030 Barcelona, Spain

11 Emergency Service, University Hospital of Bellvitge, Catalan Health Institute. University of Barcelona. Carrer de la Feixa Llarga, 08907 L'Hospitalet de Llobregat, Barcelona, Spain

12 EAP Serraparera Health Centre, Avda Diagonal, 08290 Cerdanyola del Vallès, Barcelona, Spain

13 EAP Corbera de Llobregat Health Centre, Catalan Health Institute. c/Buenos Aires, 9, 08757 Corbera de Llobregat, Barcelona, Spain

14 Internal Medicine Service, IMIM-Hospital del Mar. Department of Medicine. Psg Marítim 25, 08003 Barcelona. Spain

15 EAP Balaguer Health Centre, Catalan Health Institute. Passeig Àngel Guimerà, 22, 25600 Balaguer. Lleida. Spain

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BMC Public Health 2011, 11:775  doi:10.1186/1471-2458-11-775

Published: 9 October 2011

Abstract

Background

Osteoporosis is a serious health problem that worsens the quality of life and the survival rate of individuals with this disease on account the osteoporotic fractures. Studies have long focused on women, and its presence in men has been underestimated. While many studies conducted in different countries mainly assess health-related quality of life and identify fracture risks factors in women, few data are available on a Spanish male population.

Methods/Design

Observational study.

Study population

Men ≥ 40 years of age with/without diagnosed osteoporosis and with/without osteoporotic fracture included by their family doctor.

Measurements

The relationship between customary clinical risk factors for osteoporotic fracture and health-related quality of life in a Spanish male population. A telephone questionnaire on health-related quality of life is made.

Statistical analysis

The association between qualitative variables will be assessed by the Chi-square test. The distribution of quantitative variables by Student's t-test. If the conditions for using this test are not met, the non-parametric Mann-Whitney's U test will be used.

The validation of the results obtained by the FRAX™ tool will be performed by way of the Hosmer-Lemeshow test and by calculating the area under the Receiver Operating Characteristic (ROC) curve (AUC). All tests will be performed with a confidence intervals set at 95%.

Discussion

The applicability and usefulness of Health-related quality of life (HRQOL) studies are well documented in many countries. These studies allow implementing cost-effective measures in cases of a given disease and reducing the costly consequences derived therefrom. This study attempts to provide objective data on how quality of life is affected by the clinical aspects involved in osteoporosis in a Spanish male population and can be useful as well in cost utility analyses conducted by health authorities.

The sample selected is not based on a high fracture risk group. Rather, it is composed of men in the general population, and accordingly comparisons should not lead to erroneous interpretations.

A possible bias correction will be ensured by checking reported fractures against healthcare reports and X-rays, or by consulting health care centers as applicable.