Main Article Content
Sarcoidosis, Fatigue Assessment Scale, Short Form 6-Dimension
Background and aim: Patient related outcomes are important in sarcoidosis but the medium-term repeatability of the key patient reported outcome measure is not known. We aimed to test the repeatability of the Fatigue Assessment Scale (FAS), Short Form 6-Dimension (SF-6D), and King’s Sarcoidosis Questionnaire (KSQ) in free living people with sarcoidosis associated fatigue. Methods: Twelve people with sarcoidosis associated fatigue completed the FAS, short form 36 questionnaire (SF-36) and the KSQ at baseline and 12 weeks. The SF-6D utility was calculated from the SF-36. The difference between baseline and 12 week assessments was measured. Results: The interclass correlation (95% confidence interval) showed good agreement between the baseline and 3 months measurements: FAS 0.91 (0.74, 0.71), SF-36 0.98 (0.94, 1), KSQ 0.98 (0.93, 0.99), SF-6D utility 0.98 (0.93, 0.99). The baseline (standard deviation) FAS was 27.83 (5.86) and at 12 weeks was 27.25 (7.55) representing 0.58 difference (95% CI for difference (-1.89, 3.06)), SF-6D utility was 0.69 (0.16) at baseline and 0.68 (0.17) after 3 months representing at 0.00 (-0.03, 0.03) difference and corresponding values for KSQ were 59.12 (18.68) and 56.91 (27.26) with a difference of -1.87 (5.49,1.76). Conclusions: There was good repeatability of FAS, SF-36, SF-6D and KSQ in free living people with sarcoidosis associated fatigue. Fatigue, general and disease specific health related quality of life showed no significant change over a 12 week period. Studies identifying changes in these outcomes can confidently report a true change and not measurement error or regression to the mean.
2. Judson MA. Quality of Life Assessment in Sarcoidosis. Clin Chest Med. 2015;36(4):739-50.
3. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-36.
4. Brazier J, Usherwood T, Harper R, Thomas K. Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol. 1998;51(11):1115-28.
5. du Bois RM, Greenhalgh PM, Southcott AM, Johnson NM, Harris TA. Randomized trial of inhaled fluticasone propionate in chronic stable pulmonary sarcoidosis: a pilot study. Eur Respir J. 1999;13(6):1345-50.
6. Atkins C, Fordham R, Clark AB, Stockl A, Jones AP, Wilson AM. Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol. BMJ Open. 2017;7(12):e018532.
7. Patel AS, Siegert RJ, Creamer D, et al. The development and validation of the King's Sarcoidosis Questionnaire for the assessment of health status. Thorax. 2013;68(1):57-65.
8. Marcellis RG, Lenssen AF, Elfferich MD, et al. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011;38(3):628-34.
9. Michielsen HJ, Drent M, Peros-Golubicic T, De Vries J. Fatigue is associated with quality of life in sarcoidosis patients. Chest. 2006;130(4):989-94.
10. Marcellis R, Lenssen A, Drent M, De Vries J. Association between physical functions and quality of life in sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2014;31(2):117-28
11. De Vries J, Michielsen H, Van Heck GL, Drent M. Measuring fatigue in sarcoidosis: the Fatigue Assessment Scale (FAS). Br J Health Psychol. 2004;9(Pt 3):279-91.
12. de Kleijn WPE, De Vries J, Wijnen PAHM, Drent M. Minimal (clinically) important differences for the Fatigue Assessment Scale in sarcoidosis. Respir Med. 2011;105(9):1388-95.
13. Atkins CJ, A.P.; Wilson, A. M.;. The feasibility of investigating methylphenidate for the treatment of sarcoidosis-associated fatigue (the FaST-MP study) – a double-blind, parallel-arm randomised controlled-trial. Thorax. 2019;74 (Suppl 2).
14. Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? Bmj. 1993;306(6890):1440-4.
15. 36-Item Short Form Survey (SF-36) Scoring Instructions [Available from: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html.
16. 1. Finniss DG, Kaptchuk TJ, Miller F, Benedetti F. Biological, clinical, and ethical advances of placebo effects. The Lancet. 2010;375(9715):686–95.
17. Franke RHK, J. D. The Hawthorne Experiments: First Statistical Interpretation. Am Sociol Rev. 1978;43(5):623-43.
18. Opiyo RO, Nyasulu PS, Koigi RK, Obondo A, Ogoyi D, Kogi-Makau W. Effect of fish oil omega-3 fatty acids on reduction of depressive symptoms among HIV-seropositive pregnant women: a randomized, double-blind controlled trial. Ann Gen Psychiatry. 2018;17:49.
19. McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P. The Hawthorne Effect: a randomised, controlled trial. BMC Med Res Methodol. 2007;7:30.
20. Hoenemeyer TW, Kaptchuk TJ, Mehta TS, Fontaine KR. Open-label placebo treatment for cancer-related fatigue: A randomized-controlled clinical trial. Scientific Reports. 2018;8(1).
21. Yennurajalingam S, Azhar A, Lu Z, et al. Open-label Placebo for the treatment of cancer-related fatigue in patients with advanced cancer: A randomized controlled trial. The Oncologist. 2022;27(12):1081–9.
22. Holden JD. Hawthorne effects and research into professional practice. J Eval Clin Pract. 2001;7(1):65-70.
23. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344(21):1594-602.
24. De Boer S, Wilsher ML. Validation of the Sarcoidosis Health Questionnaire in a non-US population. Respirology. 2012;17(3):519-24.