Re: Published Research - General Sleep and RLS
Posted: Tue Oct 16, 2012 2:41 am
The Real Burden of Restless Legs Syndrome: Clinical and Economic Outcomes - Page 4
Rachel E. Salas, MD; and Anthony B. Kwan
PAGE 4 - CONTINUED FROM PRIOR POST
A study from Philipps-University Marburg in Germany, published in 2010, utilized expenditure figures from a relatively transparent public/private insurance system. It should be noted that the study included data collected via a validated questionnaire given to 519 participants with RLS at various disease stages who were being seen at 5 different treatment centers. Direct and indirect costs were calculated for a 3-month period of observation. Costs were reported in 2006 Euros, and are converted here at a rate of 1.25 dollars per Euro, which was the average exchange rate in 2006 and is the approximate exchange rate in September 2012.23 Total 3-month costs were found to be $2613, of which 37% was attributed to direct costs. Three-month direct medical and non-medical costs for the health insurance provider were $974. The largest proportion of this cost, $443, was attributable to hospitalization, which was necessary in 32 patients who had an average length of stay of 1 day. Mean drug costs, which amounted to $374, comprised the second-largest direct cost category. Physician/outpatient services accounted for another $63, and physical therapy, $57. Indirect cost calculations were based on 3 categories—working days lost, productivity lost, and early retirement costs— and amounted to a total of $1635 during the 3-month period. Both direct and indirect costs were found to be significantly associated with disease severity (P <.01).23
A separate cost-of-illness study from Germany employed the Markov model to estimate annual RLS-related expenditures. The annual direct costs to a “sickness fund” (a type of non-profit health insurance provider which most Germans are obliged to join) were estimated to be $1237, while $1607 in costs were incurred outside the sickness fund system. Drug costs represented roughly two-thirds of expenditures.24 It should be noted that treatment costs, and to some extent drug costs, are typically lower in Germany than in the United States.
RLS expenditures, while not extraordinarily high, certainly represent meaningful expenditures both directly and indirectly. This was confirmed by a systematic review of cost studies in RLS, which, although heterogeneous in design and results, was consistent in observing higher rates of expenditure for third-party payers for patients with RLS compared with average patients without RLS in the primary care setting. The review also found that pharmacologic treatment of RLS was consistently cost-effective across therapies.25
The full economic impact of not treating RLS has not been satisfactorily evaluated at present. Nevertheless, it seems highly likely that certain costs—for example, lost productivity, which already comprises a very substantial part of the total costs related to RLS—will increase when patients experience greater disease severity. It may also be the case that failure to treat RLS exacerbates comorbidities, requiring additional expenditures and healthcare resource utilization that might not otherwise be necessary.
Conclusions
RLS is an underdiagnosed condition with a relatively high prevalence and a negative effect on QoL. The deleterious impact of RLS on QoL is perhaps surprisingly large for a condition that may not appear particularly serious to those unfamiliar with it. The effects of RLS can be very serious indeed, and QoL among its sufferers is generally worse than that of other chronic diseases such as type 2 diabetes, depression, and osteoarthritis. Sleep disturbance, perhaps more than any other feature of RLS, is responsible for a large proportion of the deterioration in QoL associated with the condition and represents a cardinal feature of RLS. RLS is also associated with a spectrum of comorbidities, including renal disease, hypertension, and fibromyalgia. The costs, both direct and indirect, attributable to RLS are substantial, and although recent analyses of the economic impact of RLS do not address nationwide costs, they are likely to be significant considering both the measurable costs on an individual basis and the extent of the prevalence of RLS. Greater awareness among clinicians and managed care professionals about RLS has the potential to help improve rates of diagnosis and treatment, which will potentially reduce the impact of RLS on patient QoL and healthcare expenditures.
Affiliation
Author affiliation: Undergraduate Neuroscience Program, Johns Hopkins University, Baltimore, MD (ABK); Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD (RES).
Funding source: This supplement was supported by UCB, Inc.
Author disclosure: Anthony B. Kwan and Rachel E. Salas, MD, report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this supplement.
Authorship information: Concept and design (ABK); acquisition of data (ABK); drafting of the manuscript (ABK, RES); critical revision of the manuscript for important intellectual content (RES); and supervision (RES).
Address correspondence to: Rachel E. Salas, MD, Johns Hopkins School of Medicine, 601 N Wolfe, Meyer 6119, Baltimore, MD 21287. E-mail: rsalas3@jhmi.edu.
References
Allen RP, Bhamal M, Calloway M. Prevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United States. Movement Disorders. 2011;26(1):114-120.
Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact–REST general population study. Arch Intern Med. 2005;165:1286-1292.
Hening WA, Allen RP, Washburn M, Lesage SR, Earley CJ. The four diagnostic criteria for Restless Legs Syndrome are unable to exclude confounding conditions (“mimics”). Sleep Med. 2009;10(9):976-981.
Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. Sleep Med. 2003;4:101-119.
Ekbom K, Ulfberg J. Restless legs syndrome. J Intern Med. 2009;266:419-431.
Innes KE, Selfe TK, Agarwal P. Prevalence of restless legs syndrome in North American and Western European populations: a systematic review. Sleep Med. 2011;12(7):623-634.
Szentkiralyi A, Fendrich K, Hoffmann W, Happe S, Berger K. Socio-economic risk factors for incident restless legs syndrome in the general population [published online ahead of print February 27, 2012]. J Sleep Res.
Kushida C, Martin M, Nikam P, et al. Burden of restless legs syndrome on health-related quality of life. Qual Life Res. 2007;16:617-624.
Abetz L, Allen R, Follet A, et al. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther. 2004;26(6):925- 935.
Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med. 2004;5(3):237-246.
Lichstein KL, Durrence HH, Taylor DJ, et al. Quantitative criteria for insomnia. Behav Res Ther. 2003;41:427-445.
Winkelmann J, Wetter TC, Collado-Seidel V, et al. Clinical characteristics and frequency of the hereditary restless legs syndrome in a population of 300 patients. Sleep. 2000;23:597-602.
Salas RE, Rasquinha R, Gamaldo CE. All the wrong moves: a clinical review of restless legs syndrome, periodic limb movements of sleep and wake, and periodic limb movement disorder. Clin Chest Med. 2010;31(2):383-395.
Gamaldo CE, Earley CJ. Restless legs syndrome: a clinical update. Chest. 2006;130:1596-1604.
Angelini M, Negrotti A, Marchesi E, Bonavina G, Calzetti S. A study of the prevalence of restless legs syndrome in previously untreated Parkinson’s disease patients: absence of co-morbid association. J Neurol Sci. 2011;310(1-2):286-288.
Scholz H, Benes H, Happe S, et al. Psychological distress of patients suffering from restless legs syndrome: a cross-sectional study. Health Qual Life Outcomes. 2011;9:73-79.
Merlino G, Piani A, Dolso P, et al. Sleep disorders in patients with end-stage renal disease undergoing dialysis therapy. Nephrol Dial Transplant. 2006;21(1):184-190.
Giannaki CD, Sakkas GK, Karatzaferi C, et al. Evidence of increased muscle atrophy and impaired quality of life parameters in patients with uremic restless legs syndrome. PLoS One. 2011;6(10):e25180.
Batool-Anwar S, Malhotra A, Forman J, Winkelman J, Li Y, Gao X. Restless legs syndrome and hypertension in middle-aged women. Hypertension. 2011;58(5):791-796.
Viola-Saltzman M, Watson NF, Bogart A, Goldberg J, Buchwald D. High prevalence of restless legs syndrome among patients with fibromyalgia: a controlled cross-sectional study. J Clin Sleep Med. 2010;6(5):423-427.
Stehlik R, Arvidsson L, Ulfberg J. Restless legs syndrome is common among female patients with fibromyalgia. Eur Neurol. 2009;61(2):107-111.
Basu PP, Shah NJ, Krishnaswamy N, Pacana T. Prevalence of restless legs syndrome in patients with irritable bowel syndrome. World J Gastroenterol. 2011;17(39):4404-4407.
Dodel R, Happe S, Peglau I, et al. Health economic burden of patients with restless legs syndrome in a German ambulatory setting. Pharmacoeconomics. 2010;28(5):381-393.
Nelles S, Köberlein J, Grimm C, Pittrow D, Kirch W, Rychlik R. Socioeconomic relevance of the idiopathic restless legs syndrome (RLS) in Germany: cost-of-illness study. Med Klin (Munich). 2009;104(5):363-371.
Reinhold T, Müller-Riemenschneider F, Willich SN, Brüggenjürgen B. Economic and human costs of restless legs syndrome. Pharmacoeconomics. 2009;27(4):267-279.
Rachel E. Salas, MD; and Anthony B. Kwan
PAGE 4 - CONTINUED FROM PRIOR POST
A study from Philipps-University Marburg in Germany, published in 2010, utilized expenditure figures from a relatively transparent public/private insurance system. It should be noted that the study included data collected via a validated questionnaire given to 519 participants with RLS at various disease stages who were being seen at 5 different treatment centers. Direct and indirect costs were calculated for a 3-month period of observation. Costs were reported in 2006 Euros, and are converted here at a rate of 1.25 dollars per Euro, which was the average exchange rate in 2006 and is the approximate exchange rate in September 2012.23 Total 3-month costs were found to be $2613, of which 37% was attributed to direct costs. Three-month direct medical and non-medical costs for the health insurance provider were $974. The largest proportion of this cost, $443, was attributable to hospitalization, which was necessary in 32 patients who had an average length of stay of 1 day. Mean drug costs, which amounted to $374, comprised the second-largest direct cost category. Physician/outpatient services accounted for another $63, and physical therapy, $57. Indirect cost calculations were based on 3 categories—working days lost, productivity lost, and early retirement costs— and amounted to a total of $1635 during the 3-month period. Both direct and indirect costs were found to be significantly associated with disease severity (P <.01).23
A separate cost-of-illness study from Germany employed the Markov model to estimate annual RLS-related expenditures. The annual direct costs to a “sickness fund” (a type of non-profit health insurance provider which most Germans are obliged to join) were estimated to be $1237, while $1607 in costs were incurred outside the sickness fund system. Drug costs represented roughly two-thirds of expenditures.24 It should be noted that treatment costs, and to some extent drug costs, are typically lower in Germany than in the United States.
RLS expenditures, while not extraordinarily high, certainly represent meaningful expenditures both directly and indirectly. This was confirmed by a systematic review of cost studies in RLS, which, although heterogeneous in design and results, was consistent in observing higher rates of expenditure for third-party payers for patients with RLS compared with average patients without RLS in the primary care setting. The review also found that pharmacologic treatment of RLS was consistently cost-effective across therapies.25
The full economic impact of not treating RLS has not been satisfactorily evaluated at present. Nevertheless, it seems highly likely that certain costs—for example, lost productivity, which already comprises a very substantial part of the total costs related to RLS—will increase when patients experience greater disease severity. It may also be the case that failure to treat RLS exacerbates comorbidities, requiring additional expenditures and healthcare resource utilization that might not otherwise be necessary.
Conclusions
RLS is an underdiagnosed condition with a relatively high prevalence and a negative effect on QoL. The deleterious impact of RLS on QoL is perhaps surprisingly large for a condition that may not appear particularly serious to those unfamiliar with it. The effects of RLS can be very serious indeed, and QoL among its sufferers is generally worse than that of other chronic diseases such as type 2 diabetes, depression, and osteoarthritis. Sleep disturbance, perhaps more than any other feature of RLS, is responsible for a large proportion of the deterioration in QoL associated with the condition and represents a cardinal feature of RLS. RLS is also associated with a spectrum of comorbidities, including renal disease, hypertension, and fibromyalgia. The costs, both direct and indirect, attributable to RLS are substantial, and although recent analyses of the economic impact of RLS do not address nationwide costs, they are likely to be significant considering both the measurable costs on an individual basis and the extent of the prevalence of RLS. Greater awareness among clinicians and managed care professionals about RLS has the potential to help improve rates of diagnosis and treatment, which will potentially reduce the impact of RLS on patient QoL and healthcare expenditures.
Affiliation
Author affiliation: Undergraduate Neuroscience Program, Johns Hopkins University, Baltimore, MD (ABK); Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD (RES).
Funding source: This supplement was supported by UCB, Inc.
Author disclosure: Anthony B. Kwan and Rachel E. Salas, MD, report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this supplement.
Authorship information: Concept and design (ABK); acquisition of data (ABK); drafting of the manuscript (ABK, RES); critical revision of the manuscript for important intellectual content (RES); and supervision (RES).
Address correspondence to: Rachel E. Salas, MD, Johns Hopkins School of Medicine, 601 N Wolfe, Meyer 6119, Baltimore, MD 21287. E-mail: rsalas3@jhmi.edu.
References
Allen RP, Bhamal M, Calloway M. Prevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United States. Movement Disorders. 2011;26(1):114-120.
Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact–REST general population study. Arch Intern Med. 2005;165:1286-1292.
Hening WA, Allen RP, Washburn M, Lesage SR, Earley CJ. The four diagnostic criteria for Restless Legs Syndrome are unable to exclude confounding conditions (“mimics”). Sleep Med. 2009;10(9):976-981.
Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. Sleep Med. 2003;4:101-119.
Ekbom K, Ulfberg J. Restless legs syndrome. J Intern Med. 2009;266:419-431.
Innes KE, Selfe TK, Agarwal P. Prevalence of restless legs syndrome in North American and Western European populations: a systematic review. Sleep Med. 2011;12(7):623-634.
Szentkiralyi A, Fendrich K, Hoffmann W, Happe S, Berger K. Socio-economic risk factors for incident restless legs syndrome in the general population [published online ahead of print February 27, 2012]. J Sleep Res.
Kushida C, Martin M, Nikam P, et al. Burden of restless legs syndrome on health-related quality of life. Qual Life Res. 2007;16:617-624.
Abetz L, Allen R, Follet A, et al. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther. 2004;26(6):925- 935.
Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med. 2004;5(3):237-246.
Lichstein KL, Durrence HH, Taylor DJ, et al. Quantitative criteria for insomnia. Behav Res Ther. 2003;41:427-445.
Winkelmann J, Wetter TC, Collado-Seidel V, et al. Clinical characteristics and frequency of the hereditary restless legs syndrome in a population of 300 patients. Sleep. 2000;23:597-602.
Salas RE, Rasquinha R, Gamaldo CE. All the wrong moves: a clinical review of restless legs syndrome, periodic limb movements of sleep and wake, and periodic limb movement disorder. Clin Chest Med. 2010;31(2):383-395.
Gamaldo CE, Earley CJ. Restless legs syndrome: a clinical update. Chest. 2006;130:1596-1604.
Angelini M, Negrotti A, Marchesi E, Bonavina G, Calzetti S. A study of the prevalence of restless legs syndrome in previously untreated Parkinson’s disease patients: absence of co-morbid association. J Neurol Sci. 2011;310(1-2):286-288.
Scholz H, Benes H, Happe S, et al. Psychological distress of patients suffering from restless legs syndrome: a cross-sectional study. Health Qual Life Outcomes. 2011;9:73-79.
Merlino G, Piani A, Dolso P, et al. Sleep disorders in patients with end-stage renal disease undergoing dialysis therapy. Nephrol Dial Transplant. 2006;21(1):184-190.
Giannaki CD, Sakkas GK, Karatzaferi C, et al. Evidence of increased muscle atrophy and impaired quality of life parameters in patients with uremic restless legs syndrome. PLoS One. 2011;6(10):e25180.
Batool-Anwar S, Malhotra A, Forman J, Winkelman J, Li Y, Gao X. Restless legs syndrome and hypertension in middle-aged women. Hypertension. 2011;58(5):791-796.
Viola-Saltzman M, Watson NF, Bogart A, Goldberg J, Buchwald D. High prevalence of restless legs syndrome among patients with fibromyalgia: a controlled cross-sectional study. J Clin Sleep Med. 2010;6(5):423-427.
Stehlik R, Arvidsson L, Ulfberg J. Restless legs syndrome is common among female patients with fibromyalgia. Eur Neurol. 2009;61(2):107-111.
Basu PP, Shah NJ, Krishnaswamy N, Pacana T. Prevalence of restless legs syndrome in patients with irritable bowel syndrome. World J Gastroenterol. 2011;17(39):4404-4407.
Dodel R, Happe S, Peglau I, et al. Health economic burden of patients with restless legs syndrome in a German ambulatory setting. Pharmacoeconomics. 2010;28(5):381-393.
Nelles S, Köberlein J, Grimm C, Pittrow D, Kirch W, Rychlik R. Socioeconomic relevance of the idiopathic restless legs syndrome (RLS) in Germany: cost-of-illness study. Med Klin (Munich). 2009;104(5):363-371.
Reinhold T, Müller-Riemenschneider F, Willich SN, Brüggenjürgen B. Economic and human costs of restless legs syndrome. Pharmacoeconomics. 2009;27(4):267-279.