Top

Quality of Life Research

Published in:

Open Access 01-02-2014

Validation of the SF-36 in patients with endometriosis

Authors: Donald E. Stull, Radek Wasiak, Noemi Kreif, Mireia Raluy, Antje Colligs, Christian Seitz, Christoph Gerlinger

Published in: Quality of Life Research | Issue 1/2014

Abstract

Objectives

Endometriosis presents with significant pain as the most common symptom. Generic health measures can allow comparisons across diseases or populations. However, the Medical Outcomes Study Short Form 36 (SF-36) has not been validated for this disease. The goal of this study was to validate the SF-36 (version 2) for endometriosis.

Methods

Using data from two clinical trials (N = 252 and 198) of treatment for endometriosis, a full complement of psychometric analyses was performed. Additional instruments included a pain visual analog scale (VAS); a physician-completed questionnaire based on patient interview (modified Biberoglu and Behrman—B&B); clinical global impression of change (CGI-C); and patient satisfaction with treatment.

Results

Bodily pain (BP) and the Physical Component Summary Score (PCS) were correlated with the pain VAS at baseline and over time and the B&B at baseline and end of study. In addition, those who had the greatest change in BP and PCS also reported the greatest change on CGI-C and patient satisfaction with treatment. Other subscales showed smaller, but significant, correlations with change in the pain VAS, CGI-C, and patient satisfaction with treatment.

Conclusions

The SF-36—particularly BP and the PCS—appears to be a valid and responsive measure for endometriosis and its treatment.

Available only for authorised users

Kennedy, S., Bergqvist, A., Chapron, C., D’Hooghe, T., Dunselman, G., Greb, R., et al. (2005). ESHRE guideline for the diagnosis and treatment of endometriosis. Human Reproduction, 20(10), 2698–2704.PubMedCrossRef

Barton-Smith, P., Ballard, K., & Kent, A. S. H. (2006). Endometriosis: A general review and rationale for surgical therapy. Reviews in Gynaecological and Perinatal Practice, 6(3–4), 168–176.CrossRef

Ling, F. W. (1999). Randomized controlled trial of depot leuprolide in patients with chronic pelvic pain and clinically suspected endometriosis. Pelvic Pain Study Group. Obstetrics and Gynecology, 93(1), 51–58.PubMedCrossRef

Ferrero, S., Esposito, F., Abbamonte, L. H., Anserini, P., Remorgida, V., & Ragni, N. (2005). Quality of sex life in women with endometriosis and deep dyspareunia. Fertility and Sterility, 83(3), 573–579.PubMedCrossRef

Plumb, K., Sinaii, N., Cotton, L., Zondervan, K., Treloar, S., Lambert, A., et al. (2005). Differences in characteristics of 1000 women with endometriosis based on disease severity. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 123(Suppl. 1), S5.

Sinaii, N., Cleary, S. D., Ballweg, M. L., Nieman, L. K., & Stratton, P. (2002). High rates of autoimmune and endocrine disorders, fibromyalgia, chronic fatigue syndrome and atopic diseases among women with endometriosis: A survey analysis. Human Reproduction, 17(10), 2715–2724.PubMedCrossRef

Gerety, E., & Harris, R. D. (2001). Endometriosis: Epidemiology, current pathophysiological concepts, and imaging considerations. Applied Radiology, 3, 11–18.CrossRef

Koninckx, P. R., Meuleman, C., Demeyere, S., Lesaffre, E., & Cornillie, F. J. (1991). Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertility and Sterility, 55(4), 759–765.PubMed

Missmer, S. A. & Cramer, D. W. (2003). The epidemiology of endometriosis. Obstetrics and Gynecology Clinics of North America, 30(1), 1–19, vii.

10.

Eskenazi, B., & Warner, M. L. (1997). Epidemiology of endometriosis. Obstetrics and Gynecology Clinics of North America, 24(2), 235–258.PubMedCrossRef

11.

Vigano, P., Parazzini, F., Somigliana, E., & Vercellini, P. (2004). Endometriosis: Epidemiology and aetiological factors. Best Practice & Research Clinical Obstetrics & Gynaecology, 18(2), 177–200.CrossRef

12.

Ozkan, S., Murk, W., & Arici, A. (2008). Endometriosis and infertility: Epidemiology and evidence-based treatments. Annals of the New York Academy of Sciences, 1127, 92–100.PubMedCrossRef

13.

Ozawa, Y., Murakami, T., Terada, Y., Yaegashi, N., Okamura, K., Kuriyama, S., et al. (2006). Management of the pain associated with endometriosis: An update of the painful problems. Tohoku Journal of Experimental Medicine, 210(3), 175–188.PubMedCrossRef

14.

Vessey, M. P., Villard-Mackintosh, L., & Painter, R. (1993). Epidemiology of endometriosis in women attending family planning clinics. BMJ, 306(6871), 182–184.PubMedCrossRef

15.

Mahmood, T. A., & Templeton, A. (1991). Prevalence and genesis of endometriosis. Human Reproduction, 6(4), 544–549.PubMed

16.

Carter, J. E. (1994). Combined hysteroscopic and laparoscopic findings in patients with chronic pelvic pain. The Journal of the American Association of Gynecologic Laparoscopists, 2(1), 43–47.PubMedCrossRef

17.

Rowe, M. K., Kanouse, D. E., Mittman, B. S., & Bernstein, S. J. (1999). Quality of life among women undergoing hysterectomies. Obstetrics and Gynecology, 93(6), 915–921.PubMedCrossRef

18.

Colwell, H. H., Mathias, S. D., Pasta, D. J., Henning, J. M., & Steege, J. F. (1998). A health-related quality-of-life instrument for symptomatic patients with endometriosis: A validation study. American Journal of Obstetrics and Gynecology, 179(1), 47–55.PubMedCrossRef

19.

Hummelshoj, L., Prentice, A., & Groothuis, P. (2006). Update on endometriosis. Womens Health (Lond Engl), 2(1), 53–56.CrossRef

20.

Ballweg, M. L. (2004). Impact of endometriosis on women’s health: Comparative historical data show that the earlier the onset, the more severe the disease. Best Practice & Research Clinical Obstetrics & Gynaecology, 18(2), 201–218.CrossRef

21.

Gao, X., Yeh, Y. C., Outley, J., Simon, J., Botteman, M., & Spalding, J. (2006). Health-related quality of life burden of women with endometriosis: A literature review. Current Medical Research and Opinion, 22(9), 1787–1797.PubMedCrossRef

22.

Jones, G. L., Kennedy, S. H., & Jenkinson, C. (2002). Health-related quality of life measurement in women with common benign gynecologic conditions: A systematic review. American Journal of Obstetrics and Gynecology, 187(2), 501–511.PubMedCrossRef

23.

Jones, G., Jenkinson, C., & Kennedy, S. (2004). The impact of endometriosis upon quality of life: A qualitative analysis. Journal of Psychosomatic Obstetrics and Gynaecology, 25(2), 123–133.PubMedCrossRef

24.

Marques, A., Bahamondes, L., Aldrighi, J. M., & Petta, C. A. (2004). Quality of life in Brazilian women with endometriosis assessed through a medical outcome questionnaire. Journal of Reproductive Medicine, 49(2), 115–120.PubMed

25.

Mathias, S. D., Kuppermann, M., Liberman, R. F., Lipschutz, R. C., & Steege, J. F. (1996). Chronic pelvic pain: Prevalence, health-related quality of life, and economic correlates. Obstetrics and Gynecology, 87(3), 321–327.PubMedCrossRef

26.

Acquadro, C., Berzon, R., Dubois, D., Leidy, N. K., Marquis, P., Revicki, D., et al. (2003). Incorporating the patient’s perspective into drug development and communication: An ad hoc task force report of the patient-reported outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health, 6(5), 522–531.PubMedCrossRef

27.

Turk, D. C., Dworkin, R. H., Burke, L. B., Gershon, R., Rothman, M., Scott, J., et al. (2006). Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations. Pain, 125(3), 208–215.PubMedCrossRef

28.

Bodner, C. H., Garratt, A. M., Ratcliffe, J., Macdonald, L. M., & Penney, G. C. (1997). Measuring health-related quality of life outcomes in women with endometriosis—results of the Gynaecology Audit Project in Scotland. Health Bulletin (Edinb), 55(2), 109–117.

29.

Burry, K. A. (1992). Nafarelin in the management of endometriosis: Quality of life assessment. American Journal of Obstetrics and Gynecology, 166(2), 735–739.PubMedCrossRef

30.

Schlaff, W. D., Carson, S. A., Luciano, A., Ross, D., & Bergqvist, A. (2006). Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain. Fertility and Sterility, 85(2), 314–325.PubMedCrossRef

31.

Garry, R., Clayton, R., & Hawe, J. (2000). The effect of endometriosis and its radical laparoscopic excision on quality of life indicators. BJOG, 107(1), 44–54.PubMedCrossRef

32.

Abbott, J. A., Hawe, J., Clayton, R. D., & Garry, R. (2003). The effects and effectiveness of laparoscopic excision of endometriosis: A prospective study with 2–5 year follow-up. Human Reproduction, 18(9), 1922–1927.PubMedCrossRef

33.

Dubernard, G., Piketty, M., Rouzier, R., Houry, S., Bazot, M., & Darai, E. (2006). Quality of life after laparoscopic colorectal resection for endometriosis. Human Reproduction, 21(5), 1243–1247.PubMedCrossRef

34.

Lyons, S. D., Chew, S. S., Thomson, A. J., Lenart, M., Camaris, C., Vancaillie, T. G., et al. (2006). Clinical and quality-of-life outcomes after fertility-sparing laparoscopic surgery with bowel resection for severe endometriosis. Journal of Minimally Invasive Gynecology, 13(5), 436–441.PubMedCrossRef

35.

Bergqvist, A., & Theorell, T. (2001). Changes in quality of life after hormonal treatment of endometriosis. Acta Obstetricia et Gynecologica Scandinavica, 80(7), 628–637.PubMedCrossRef

36.

Miller, J. D. (2000). Quantification of endometriosis-associated pain and quality of life during the stimulatory phase of gonadotropin-releasing hormone agonist therapy: A double-blind, randomized, placebo-controlled trial. American Journal of Obstetrics and Gynecology, 182(6), 1483–1488.PubMedCrossRef

37.

Jones, G., Kennedy, S., Barnard, A., Wong, J., & Jenkinson, C. (2001). Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstetrics and Gynecology, 98(2), 258–264.PubMedCrossRef

38.

Chassany, O., Le-Jeunne, P., Duracinsky, M., Schwalm, M. S., & Mathieu, M. (2006). Discrepancies between patient-reported outcomes and clinician-reported outcomes in chronic venous disease, irritable bowel syndrome, and peripheral arterial occlusive disease. Value Health, 9(1), 39–46.PubMedCrossRef

39.

Jones, G., Jenkinson, C., & Kennedy, S. (2004). Evaluating the responsiveness of the Endometriosis Health Profile Questionnaire: The EHP-30. Quality of Life Research, 13(3), 705–713.PubMedCrossRef

40.

Strowitzki, T., Marr, J., Gerlinger, C., Faustmann, T., & Seitz, C. (2010). Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: A 24-week, randomized, multicentre, open-label trial. Human Reproduction, 25(3), 633–641.PubMedCrossRef

41.

Strowitzki, T., Faustmann, T., Gerlinger, C., & Seitz, C. (2010). Dienogest in the treatment of endometriosis-associated pelvic pain: A 12-week, randomized, double-blind, placebo-controlled study. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 151(2), 193–198.PubMedCrossRef

42.

Reed, P. J., & Moore, D. D. (2000). SF-36 as a predictor of health states. Value Health, 3(3), 202–207.PubMedCrossRef

43.

Ware, J. E., Kosinski, M., & Keller, S. K. (1994). SF-36 ^® Physical and Mental Health Summary Scales: A User’s Manual. Boston, MA: The Health Institute.

44.

Biberoglu, K. O., & Behrman, S. J. (1981). Dosage aspects of danazol therapy in endometriosis: Short-term and long-term effectiveness. American Journal of Obstetrics and Gynecology, 139(6), 645–654.PubMed

45.

Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare.

46.

Ware, J. E., Kosinski, M., & Dewey, J. E. (2000). How to score version two of the SF-36 health survey. Lincoln, RI: QualityMetric, Incorporated.

47.

Stull, D. E. (2008). Analyzing growth and change: Latent variable growth curve modeling with an application to clinical trials. Quality of Life Research, 17(1), 47–59.PubMedCrossRef

48.

Kline, R. B. (2011). Principles and practice of structural equation modeling (3rd ed.). New York: The Guilford Press.

49.

Browne, M. W., & Cudeck, R. (1993). Alternative ways of assessing model fit. In K. A. Bollen & J. S. Long (Eds.), Testing structural equation models (pp. 136–162). Newbury Park, CA: Sage.

50.

Farrar, J. T., Young, J. P, Jr, LaMoreaux, L., Werth, J. L., & Poole, R. M. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 94(2), 149–158.PubMedCrossRef

51.

Beivik, E., & Olsson, U. H. (2001). Adding variables to improve fit: The effect of model size on fit assessment in LISREL. In R. Cudeck, S. du Toit, & D. Sörbom (Eds.), Structural equation modeling: Present and future (pp. 169–194). Lincolnwood, IL: Scientific Software International.

52.

Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, New Jersey: Erlbaum.

53.

Ware, J. E., Kosinski, M., & Gandek, B. (2004). SF-36 Health Survey: Manual and Interpretation Guide. Lincoln, RI: Quality Metric Incorporated.

54.

Busija, L., Osborne, R. H., Nilsdotter, A., Buchbinder, R., & Roos, E. M. (2008). Magnitude and meaningfulness of change in SF-36 scores in four types of orthopedic surgery. Health and Quality of Life Outcomes, 6, 55.PubMedCentralPubMedCrossRef

55.

Shikiar, R., Willian, M. K., Okun, M. M., Thompson, C. S., & Revicki, D. A. (2006). The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: Results of a phase II study. Health and Quality of Life Outcomes, 4, 71.PubMedCentralPubMedCrossRef

56.

Gerlinger, C., Schumacher, U., Faustmann, T., Colligs, A., Schmitz, H., & Seitz, C. (2010). Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: Analyses of two placebo-controlled, randomized trials. Health and Quality of Life Outcomes, 8, 138. http://www.hqlo.com/content/8/1/138.

57.

Yost, K. J., & Eton, D. T. (2005). Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation and the Health Professions, 28(2), 172–191.PubMedCrossRef

58.

Banks, P., Martin, C. R., & Petty, R. K. (2012). The factor structure of the SF-36 in adults with progressive neuromuscular disorders. Journal of Evaluation in Clinical Practice, 18(1), 32–36.PubMedCrossRef

59.

Butterworth, P., & Crosier, T. (2004). The validity of the SF-36 in an Australian National Household Survey: Demonstrating the applicability of the Household Income and Labour Dynamics in Australia (HILDA) Survey to examination of health inequalities. BMC Public Health, 4, 44.PubMedCentralPubMedCrossRef

60.

Beals, J., Welty, T. K., Mitchell, C. M., Rhoades, D. A., Yeh, J. L., Henderson, J. A., et al. (2006). Different factor loadings for SF36: The Strong Heart Study and the National Survey of Functional Health Status. Journal of Clinical Epidemiology, 59(2), 208–215.PubMedCrossRef

Title: Validation of the SF-36 in patients with endometriosis
Authors: Donald E. Stull
Radek Wasiak
Noemi Kreif
Mireia Raluy
Antje Colligs
Christian Seitz
Christoph Gerlinger
Publication date: 01-02-2014
Publisher: Springer International Publishing
Published in: Quality of Life Research / Issue 1/2014
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-013-0442-5

2024 ASCO Annual Meeting

Springer Medicine

Validation of the SF-36 in patients with endometriosis

Abstract

Objectives

Methods

Results

Conclusions

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Objectives

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 1/2014

Quality of life and emotional distress between patients on peritoneal dialysis versus community-based hemodialysis

Evaluation of a patient-reported continuity of care model for older adults

Effectiveness of psychoeducational support on quality of life in early-stage breast cancer patients: a systematic review and meta-analysis of randomized controlled trials

Should patients perception of health status be integrated in the prognostic assessment of heart failure patients? A prospective study

Depression and painful conditions: patterns of association with health status and health utility ratings in the general population

The use of focus groups to develop a culturally relevant quality of life tool for lymphatic filariasis in Bangladesh