Outcomes in pulmonary sarcoidosis: results of a newly implemented prednisone protocol. Results of newly implemented prednisone protocol.
Main Article Content
Quality improvement, Healthcare quality improvement, Pulmonary sarcoidosis, Implementation science
Background and aim Prednisone is used as first-line therapy for patients with pulmonary sarcoidosis. There is however no clear association between prednisone dose and FVC change in patients with pulmonary sarcoidosis. In order to improve our standard of care we introduced a more conservative prednisone protocol.
Methods This study is a single centre observational study, applying value-based healthcare (VBHC) and quality improvement (QI) principles. Prednisone intake was reduced from a starting dose of 40 mg to a starting dose of 20 mg. Primary outcomes evaluated were FVC, FEV1 and DLCO % predicted. The secondary outcome measure was BMI.
Results 369 patients were included in the old-cohort and 215 in the new-cohort. In the old-cohort, 182 (49.0%) of the patients were treated with prednisone. In total, 114 patients (62.6%) were treated according to the old protocol with a mean initial prednisone dose of 32.1 ±14.2 mg. In the new-cohort, 93 patients (45.0%) were treated with prednisone of which 53 patients (57.0%) received prednisone according to the new protocol. The mean initial prednisone dose in the new-cohort was 21.4 ±9.8 mg. Changes in FVC and FEV1 % predicted did not vary. Change in % predicted DLCO was 2.4 ±9.3 for the old-cohort and -1.3 ±11.4 for the new-cohort (p = 0.01). No statistically significant changes in BMI were observed.
Conclusions Our results indicate that in more than half of the patients the new protocol was followed. Data support the observation that a more conservative prednisone regimen might be equally effective, looking at changes in pulmonary function and BMI.
2 Kampstra, N. A., van der Nat, P. B., Dijksman, L. M., van Beek, F. T., Culver, D. A., Baughman, R. P., ... & Wijsenbeek MS. Results of the standard set for pulmonary sarcoidosis: feasibility and multicentre outcomes. ERJ Open Res 2019;5.
3 Daeter EJ, Timmermans MJC, Hirsch A, et al. Defining and Measuring a Standard Set of Patient-Relevant Outcomes in Coronary Artery Disease. Am J Cardiol 2018.
4 Kim AH, Roberts C, Feagan BG, et al. Developing a standard set of patient-centred outcomes for inflammatory bowel disease—an international, cross-disciplinary consensus. J Crohn’s Colitis 2017;12:408–18.
5 Michelotti M, de Korne DF, Weizer JS, et al. Mapping standard ophthalmic outcome sets to metrics currently reported in eight eye hospitals. BMC Ophthalmol 2017;17:269.
6 Morgans AK, van Bommel ACM, Stowell C, et al. Development of a standardized set of patient-centered outcomes for advanced prostate cancer: an international effort for a unified approach. Eur Urol 2015;68:891–8.
7 Porter ME. What is value in health care? N Engl J Med 2010;363:2477–81.
8 Van Veghel D, Daeter EJ, Bax M, et al. Organization of outcome-based quality improvement in Dutch heart centres. Eur Hear Journal-Quality Care Clin Outcomes 2019.
9 Costabel U, Hunninghake GW, Committee SS. ATS/ERS/WASOG statement on sarcoidosis. Eur Respir J 1999;14:735–7.
10 Schutt AC, Bullington WM, Judson MA. Pharmacotherapy for pulmonary sarcoidosis: a Delphi consensus study. Respir Med 2010;104:717–23.
11 Paramothayan NS, Lasserson TJ, Jones P. Corticosteroids for pulmonary sarcoidosis. Cochrane Libr 2005.
12 Wijsenbeek MS, Culver DA. Treatment of sarcoidosis. Clin Chest Med 2015;36:751–67.
13 Baughman RP, Costabel U, du Bois RM. Treatment of sarcoidosis. Clin Chest Med 2008;29:533–48.
14 Grunewald J, Grutters JC, Arkema E V, et al. Publisher Correction: Sarcoidosis. Nat Rev Prim 2019;5:49-019-0107-y.
15 Broos CE, Poell LHC, Looman CWN, et al. No evidence found for an association between prednisone dose and FVC change in newly-treated pulmonary sarcoidosis. Respir Med 2017.
16 Baughman RP, Drent M, Culver DA. Endpoints for clinical trials of sarcoidosis. Sarcoidosis Vasc Diffus lung Dis 2012;29:90–8.
17 Grol R, Wensing M, Eccles M, et al. Improving patient care; the implementation of change in health care. 2013.
18 Zipfel N, Van Der Nat PB, Rensing BJWM, et al. The implementation of change model adds value to value-based healthcare: A qualitative study. BMC Health Serv Res Published Online First: 2019.
19 Deming WE. Out of the Crisis: Quality, Productivity and Competitive Position. Massachusetts Inst Technol Cent Adv Eng study Published Online First: 1986.
20 Quanjer PH, Tammeling GJ, Cotes JE, et al. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur. Respir. J. Suppl. 1993.
21 Wensing M, Grol R. Knowledge translation in health: How implementation science could contribute more. BMC Med. 2019.
22 Peterson A, Gudbjornsdottir S, Lofgren UB, et al. Collaboratively Improving Diabetes Care in Sweden Using a National Quality Register: Successes and Challenges-A Case Study. Qual Manag Health Care 2015;24:212–21.
23 Portela MC, Pronovost PJ, Woodcock T, et al. How to study improvement interventions: A brief overview of possible study types. BMJ Qual. Saf. 2015.
24 Benn J, Burnett S, Parand A, et al. Studying large-scale programmes to improve patient safety in whole care systems: Challenges for research. Soc Sci Med Published Online First: 2009.
25 van Deen WK, Spiro A, Burak Ozbay A, et al. The impact of value-based healthcare for inflammatory bowel diseases on healthcare utilization: a pilot study. Eur J Gastroenterol Hepatol 2017;29:331–7.
26 Grol R, Wensing M. Effective implementation of change in healthcare: A systematic approach. Improv Patient Care Implement Chang Heal care 2013;40–63.
27 Kahlmann, V., Moor, C. C., Veltkamp, M., & Wijsenbeek, M. S. Patient reported side-effects of prednisone and methotrexate in a real-world sarcoidosis population. Chronic respiratory disease 2021 18;1-4. 5.