Abstract
Purpose
Clinical trials in Parkinson’s disease commonly employ outcome measures of disability and quality of life. Responsiveness of these outcomes measures to symptomatic decline versus improvement has not been studied. We wanted to study the responsiveness of Schwab & England Activities of Daily Living Scale (SE) and Short Form-12 (SF-12) to symptomatic decline versus improvement in Parkinson’s disease over a 4-year period among a naturalistic cohort of patients.
Methods
Parkinson’s disease patients (N = 228, disease duration 6.1 years) were followed for 4 years with assessments of disease severity, Unified Parkinson’s Disease Rating Scale (UPDRS), health-related quality of life (SF-12 physical/mental health), and disability (SE). The sample was subdivided into those who declined (N = 118) or improved (N = 102) on total-UPDRS. Responsiveness was assessed with Cohen’s effect size and standardized response mean.
Results
At baseline, patients who improved over 4 years had greater disease severity and worse quality of life than decliners (p < .05). Decliners had a 13.5-point worsening on total-UPDRS, 26.3–39.8; p < .001) associated with concomitant decline on the SF-12 (physical health 42.9–39.2, mental health 50.0–46.6; both p < .001) and the SE (85–74 %; p < .001). Improvers had a 13.0-point improvement on total-UPDRS (39.8–26.8; p < .001) associated with minimal change on the SF-12 (physical health 40.8–39.5, mental health 47.1–46.3) and SE (79–79 %). Based on effect size, the rank order of responsiveness of measures for decliners from high to low was SE (−0.78), Short Form-12 mental health (−0.45), and SF-12 physical health (−0.34). Rank order of responsiveness for improvers was Short Form-12 physical health (−0.11), SF-12 mental health (−0.10), and SE (−0.03).
Conclusions
Among decliners, measures of disability and quality of life were moderate to highly responsive to change in disease severity. Among improvers, both disability and quality of life were poorly responsive despite UPDRS improvement of comparable magnitude.
![](http://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs11136-016-1351-1/MediaObjects/11136_2016_1351_Fig1_HTML.gif)
Similar content being viewed by others
References
Shulman, L. M. (2010). Understanding disability in Parkinson’s disease. Movement Disorders, 25(S1), S131–S135. doi:10.1002/mds.22789.
Cella, D. F. (1995). Measuring quality of life in palliative care. Seminars in Oncology, 22(2 Suppl 3), 73–81.
Forsaa, E. B., Larsen, J. P., Wentzel-Larsen, T., Herlofson, K., & Alves, G. (2008). Predictors and course of health-related quality of life in Parkinson’s disease. Movement Disorders, 23(10), 1420–1427. doi:10.1002/mds.22121.
Karlsen, K. H., Tandberg, E., Arsland, D., & Larsen, J. P. (2000). Health related quality of life in Parkinson’s disease: A prospective longitudinal study. Journal of Neurology, Neurosurgery and Psychiatry, 69(5), 584–589.
Hely, M. A., Morris, J. G. L., Traficante, R., Reid, W. G. J., O’Sullivan, D. J., & Williamson, P. M. (1999). The Sydney multicentre study of Parkinson’s disease: Progression and mortality at 10 years. Journal of Neurology, Neurosurgery and Psychiatry, 67(3), 300–307. doi:10.1136/jnnp.67.3.300.
Hely, M. A., Morris, J. G. L., Reid, W. G. J., & Trafficante, R. (2005). Sydney Multicenter Study of Parkinson’s disease: Non-L-dopa-responsive problems dominate at 15 years. Movement Disorders, 20(2), 190–199. doi:10.1002/mds.20324.
Hely, M. A., Reid, W. G. J., Adena, M. A., Halliday, G. M., & Morris, J. G. L. (2008). The Sydney multicenter study of Parkinson’s disease: The inevitability of dementia at 20 years. Movement Disorders, 23(6), 837–844. doi:10.1002/mds.21956.
Williams-Gray, C. H., Foltynie, T., Brayne, C. E. G., Robbins, T. W., & Barker, R. A. (2007). Evolution of cognitive dysfunction in an incident Parkinson’s disease cohort. Brain, 130(7), 1787–1798. doi:10.1093/brain/awm111.
Vu, T. C., Nutt, J. G., & Holford, N. H. G. (2012). Progression of motor and nonmotor features of Parkinson’s disease and their response to treatment. British Journal of Clinical Pharmacology, 74(2), 267–283. doi:10.1111/j.1365-2125.2012.04192.x.
Evans, J. R., Mason, S. L., Williams-Gray, C. H., Foltynie, T., Brayne, C., Robbins, T. W., & Barker, R. A. (2011). The natural history of treated Parkinson’s disease in an incident, community based cohort. Journal of Neurology, Neurosurgery and Psychiatry, 82(10), 1112–1118. doi:10.1136/jnnp.2011.240366.
Ware, J. E., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care, 30(6), 473–483.
Hauser, R. A., Hsu, A., Kell, S., Espay, A. J., Sethi, K., Stacy, M., et al. (2013). Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson’s disease and motor fluctuations: A phase 3 randomised, double-blind trial. The Lancet Neurology, 12(4), 346–356. doi:10.1016/S1474-4422(13)70025-5.
Stocchi, F., Hsu, A., Khanna, S., Ellenbogen, A., Mahler, A., Liang, G., et al. (2014). Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients. Parkinsonism and Related Disorders, 20(12), 1335–1340. doi:10.1016/j.parkreldis.2014.08.004.
Fahn, S., Elton, R., & Members of the UPDRS Development Committee. (1987). Unified Parkinson’s Disease Rating Scale. In S. Fahn, C. D. Marsden, D. B. Calne & M. Goldstein (Eds.), Recent developments in Parkinson’s disease (Vol. 2, pp. 153–164). Forest Park, NJ: Macmillan Health Care Information.
Martínez-Martín, P., Gil-Nagel, A., Gracia, L. M., Gómez, J. B., Martínez-Sarriés, J., & Bermejo, F. (1994). Unified Parkinson’s Disease Rating Scale characteristics and structure. The Cooperative Multicentric Group. Movement Disorders, 9(1), 76–83. doi:10.1002/mds.870090112.
Schwab, R. S., & England, A. C. (1969). Projection technique for evaluating surgery in Parkinson’s disease. In F. J. Gillingham & I. M. L. Danoldson (Eds.), Third symposium on Parkinson’s disease (pp. 152–157). Edinburgh: Churchill Livingstone.
Ware, J., Kosinski, M., & Keller, S. D. (1996). A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220–233.
Pelle, A. J., Kupper, N., Mols, F., & de Jonge, P. (2013). What is the use? Application of the short form (SF) questionnaires for the evaluation of treatment effects. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 22(6), 1225–1230. doi:10.1007/s11136-012-0266-8.
Martinez-Martin, P., Jeukens-Visser, M., Lyons, K. E., Rodriguez-Blazquez, C., Selai, C., Siderowf, A., et al. (2011). Health-related quality-of-life scales in Parkinson’s disease: Critique and recommendations. Movement Disorders, 26(13), 2371–2380. doi:10.1002/mds.23834.
Martinez-Martin, P., Prieto, L., & Forjaz, M. J. (2006). Longitudinal metric properties of disability rating scales for Parkinson’s disease. Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research, 9(6), 386–393. doi:10.1111/j.1524-4733.2006.00131.x.
Hoehn, M. M., & Yahr, M. D. (1967). Parkinsonism: Onset, progression and mortality. Neurology, 17(5), 427–442.
Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975). “Mini-mental state”: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189–198.
Pahwa, R., Lyons, K. E., Hauser, R. A., Fahn, S., Jankovic, J., Pourcher, E., et al. (2014). Randomized trial of IPX066, carbidopa/levodopa extended release, in early Parkinson’s disease. Parkinsonism Related Disorders, 20(2), 142–148. doi:10.1016/j.parkreldis.2013.08.017.
Linn, B. S., Linn, M. W., & Gurel, L. (1968). Cumulative illness rating scale. Journal of the American Geriatrics Society, 16(5), 622–626.
Cohen, J. (1998). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale: Lawrence Earlbaum Associates.
Liang, M. H. (1995). Evaluating measurement responsiveness. The Journal of Rheumatology, 22(6), 1191–1192.
Shulman, L. M., Gruber-Baldini, A. L., Anderson, K. E., Fishman, P. S., Reich, S. G., & Weiner, W. J. (2010). The clinically important difference on the unified Parkinson’s disease rating scale. Archives of Neurology, 67(1), 64–70. doi:10.1001/archneurol.2009.295.
Schrag, A., Sampaio, C., Counsell, N., & Poewe, W. (2006). Minimal clinically important change on the unified Parkinson’s disease rating scale. Movement Disorders, 21(8), 1200–1207. doi:10.1002/mds.20914.
Hauser, R. A., Gordon, M. F., Mizuno, Y., Poewe, W., Barone, P., Schapira, A. H., et al. (2014). Minimal clinically important difference in Parkinson’s disease as assessed in pivotal trials of pramipexole extended release. Parkinson’s Disease, 2014(2014), e467131. doi:10.1155/2014/467131.
Merola, A., Zibetti, M., Angrisano, S., Rizzi, L., Ricchi, V., Artusi, C. A., et al. (2011). Parkinson’s disease progression at 30 years: A study of subthalamic deep brain-stimulated patients. Brain, 134(Pt 7), 2074–2084. doi:10.1093/brain/awr121.
Zibetti, M., Merola, A., Rizzi, L., Ricchi, V., Angrisano, S., Azzaro, C., et al. (2011). Beyond nine years of continuous subthalamic nucleus deep brain stimulation in Parkinson’s disease. Movement Disorders, 26(13), 2327–2334. doi:10.1002/mds.23903.
Duarte, J., García Olmos, L. M., Mendoza, A., & Clavería, L. E. (2013). The natural history of Parkinson’s disease in the province of Segovia: Mortality in a longitudinal study (20-year follow-up). Acta Neurologica Scandinavica, 127(5), 295–300. doi:10.1111/ane.12003.
Ringash, J., O’Sullivan, B., Bezjak, A., & Redelmeier, D. A. (2007). Interpreting clinically significant changes in patient-reported outcomes. Cancer, 110(1), 196–202. doi:10.1002/cncr.22799.
Cella, D., Hahn, E. A., & Dineen, K. (2002). Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening. Quality of Life Research, 11(3), 207–221.
Sprangers, M. A., & Schwartz, C. E. (1999). Integrating response shift into health-related quality of life research: A theoretical model. Social Science and Medicine (1982), 48(11), 1507–1515.
Tubach, F., Dougados, M., Falissard, B., Baron, G., Logeart, I., & Ravaud, P. (2006). Feeling good rather than feeling better matters more to patients. Arthritis Care and Research, 55(4), 526–530. doi:10.1002/art.22110.
Lang, A. E., Eberly, S., Goetz, C. G., Stebbins, G., Oakes, D., Marek, K., et al. (2013). Movement disorder society unified Parkinson disease rating scale experiences in daily living: Longitudinal changes and correlation with other assessments. Movement Disorders, 28(14), 1980–1986. doi:10.1002/mds.25671.
Middel, B., & van Sonderen, E. (2002). Statistical significant change versus relevant or important change in (quasi) experimental design: Some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research. International Journal of Integrated Care, 2, e15.
Funding
This study was funded by The Rosalyn Newman Foundation.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
Authors have no conflict of interests.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Rights and permissions
About this article
Cite this article
Lamichhane, D., Gruber-Baldini, A.L., Reich, S.G. et al. Asymmetric responsiveness of disability and health-related quality of life to improvement versus decline in Parkinson’s disease. Qual Life Res 25, 3139–3145 (2016). https://doi.org/10.1007/s11136-016-1351-1
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11136-016-1351-1