Patient, Family Member and Physician Perspectives and Experiences with AML Treatment Decision-Making.

INTRODUCTION: Treatment decisions in older adults with acute myeloid leukemia (AML) are challenging, particularly for those who are not candidates for intensive chemotherapy (IC), and the trade-offs patients, their families and physicians consider when choosing a treatment option are not well understood. This qualitative research explored the value of extending survival and the treatment decision-making process from a multi-stakeholder perspective. METHODS: Overall, 28 patients with AML (≥ 65 years old, unsuitable for IC), 25 of their relatives and 10 independent physicians from the US, UK and Canada took part in one-on-one, 60-minute qualitative interviews. RESULTS: Across all stakeholders, improved health-related quality of life (HRQoL), extended survival and relief of AML symptoms were recognized as most important in AML treatment decision-making. However, extending survival in 'good health' was more important than extending survival alone, particularly because of the extra time it gives patients and their relatives together, and allows patients to achieve important goals. Patients' limited understanding of available treatment options, paired with incorrect perceptions of treatment side effects, impacted their involvement in the treatment decision-making process. Patients and physicians perceived physicians to have the most influence in the decision-making process despite their priorities not always aligning. CONCLUSION: These findings illustrate the importance of having structured discussions which explicitly assess patients' goals and their understanding and expectations of treatments and also the need for patient friendly resources about the lived experience of AML and available treatment options. These measures will help to ensure that patients are fully involved in the shared decision-making process.

Environmental and Management Effects on Demographic Processes in the U.S. Threatened Platanthera leucophaea (Nutt.) Lindl. (Orchidaceae).

Populations of the U.S. threatened orchid, Platanthera leucophaea, are restricted to fragmented grassland and wetland habitats. We address the long-term (1998-2020) interactive effects of habitat (upland prairie vs. wetland), fire management (burned vs. unburned) and climatic variation, as well as pollination crossing effects, on population demography in 42 populations. Our analysis revealed the consistent interactive effects of habitat, dormant season burning, and climatic variation on flowering, reproduction, and survival. Burning increased flowering and population size under normal or greater than normal precipitation but may have a negative effect during drought years apparently if soil moisture stress reduces flowering and increases mortality. Trends in the number of flowering plants in populations also correspond to precipitation cycles. As with flowering and fecundity, survival is significantly affected by the interactive effects of habitat, fire, and climate. This study supports previous studies finding that P. leucophaea relies on a facultative outcrossing breeding system. Demographic modeling indicated that fire, normal precipitation, and outcrossing yielded greater population growth, and that greater fire frequency increased population persistence. It also revealed an ecologically driven demographic switch, with wetlands more dependent upon survivorship than fecundity, and uplands more dependent on fecundity than survivorship. Our results facilitate an understanding of environmental and management effects on the population demography of P. leucophaea in the prairie region of its distribution. Parallel studies are needed in the other habitats such as wetlands, especially in the eastern part of the range of the species, to provide a more complete picture.

A quality-adjusted survival time without symptoms or toxicities analysis of glasdegib plus low-dose cytarabine versus low-dose cytarabine as initial therapy for acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy.

BACKGROUND: In a randomized study, glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC) significantly prolonged survival in comparison with LDAC in patients with acute myeloid leukemia (AML). A quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) approach was used to evaluate comparative quality-adjusted survival. METHODS: Overall survival was partitioned into the following: time with any treatment-emergent grade 3 or higher adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL). Q-TWiST was calculated by multiplying the restricted mean time in each state by respective utilities and then summing up the utility-adjusted time. RESULTS: At 20 months of follow-up, the survival probabilities for the glasdegib-LDAC arm and the LDAC arm were 28.2% and 7.9%, respectively. Glasdegib-LDAC patients (n = 78), in comparison with LDAC patients (n = 38), had significantly longer mean TWiST (+3.4 months; 95% confidence interval [CI], 1.8-5.2 months) and TOX (+0.8 months; 95% CI, 0.1-1.6 months) and longer but nonsignificant REL (+0.3 months; 95% CI, -1.9 to 2.3 months). Q-TWiST was 4.0 months (95% CI, 2.1-5.8 months) longer with glasdegib plus LDAC, and this translated into a 75% relative improvement in quality-adjusted survival with respect to LDAC. Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included. CONCLUSIONS: These results suggest that most of the survival benefit from glasdegib plus LDAC versus LDAC alone is TWiST, and this represents added time in relatively "good" health. These results support the clinical value of glasdegib plus LDAC as initial therapy for AML in patients for whom intensive chemotherapy is not an option.

Overall survival of glasdegib in combination with low-dose cytarabine, azacitidine, and decitabine among adult patients with previously untreated AML: comparative effectiveness using simulated treatment comparisons.

BACKGROUND: Until recently, treatments for older patients with AML ineligible to receive intensive chemotherapies were limited to hypomethylating agents, low-dose cytarabine (LDAC), or clinical trials. In 2018, the FDA approved combination glasdegib (GLAS) plus LDAC based on Phase II results demonstrating improved overall survival (OS) versus LDAC alone in previously untreated AML. However, no randomized clinical trials have directly compared GLAS + LDAC with other AML treatments. OBJECTIVE: Using both indirect treatment comparison (ITC) and simulated treatment comparison (STC), which adjusts for baseline differences between trials, the comparative effectiveness of GLAS + LDAC was compared with hypomethylating agent azacitidine (AZA) or decitabine (DEC). METHODS: A systematic literature review identified published trials of AZA or DEC versus LDAC among older AML patients ineligible for high-intensity chemotherapy. In addition to standard and covariate-adjusted ITC, STC was performed following guidance from the NICE Decision Support Unit (DSU). Using individual patient data from the Phase II GLAS + LDAC study, population-specific OS hazard ratios (HR) for GLAS + LDAC versus AZA or DEC were compared. Furthermore, covariate-adjusted ITC (Cox multivariate models) and STC were repeated using GLAS + LDAC versus LDAC data propensity-weighted for within-trial mean cytogenetic risk. As this initial step was not specified in the DSU, results from this second method were compared to the first STC following DSU guidance only. RESULTS: Standard ITC and STC both demonstrated significantly improved OS for GLAS + LDAC versus either AZA or DEC. Adjusting for key covariates, STC stepwise exponential models demonstrated GLAS + LDAC superiority to both AZA (HR=0.424; 95% CI: 0.228, 0.789) and DEC (HR=0.505; 95% CI: 0.269, 0.949). These significant results held using full or step-wise approaches, following DSU guidance only or the weighted STC approach. CONCLUSION: Using ITC and STC, GLAS + LDAC demonstrated superior OS to AZA or DEC in an adult population with previously untreated AML for whom intensive chemotherapy is not an option.

Risk Factors of QTc Prolongation in Women With Hormone Receptor‒positive/Human Epidermal Growth Factor Receptor 2‒negative Metastatic Breast Cancer: A Retrospective Analysis of Health Care Claims Data.

PURPOSE: In addition to biomarker status, treatment selection for metastatic breast cancer (mBC) includes individual patient and clinical characteristics such as tumor burden, timing of disease recurrence, and comorbidities. Women with mBC may take medications that can increase the risk of drug-induced toxicities, including prolongation of cardiac repolarization (prolongation of QT interval). Corrected QT (QTc) prolongation, a toxicity associated with many cancer treatments, can lead to potentially life-threatening ventricular arrhythmias. As such, it is important to identify patients at risk for QTc prolongation due to comorbid conditions, concomitant medications, or electrolyte abnormalities. This real-world study estimated the proportion of women with hormone receptor‒positive (HR+)/human epidermal growth factor receptor 2‒negative (HER2‒) mBC who may be at risk of developing QTc prolongation. Results in the elderly are also included. METHODS: This retrospective, cross-sectional cohort study used the Truven Health MarketScan and Optum Clinformatics administrative claims databases. Patients' medical and pharmacy data were evaluated to assess the risk of QTc prolongation. Prescription and medication administration claims were evaluated during the 7-day period before the index date (ie, first secondary neoplasm diagnosis). In addition, International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification, codes were evaluated 12 months before the index date to describe congenital long QT syndrome, cardiac disease, and electrolyte abnormalities. FINDINGS: A cohort of 24,340 women with HR+/HER2‒ mBC were identified, including 5059 women aged 65-74 years and 4851 aged ≥75 years. Based on an overall analysis of risk factors (congenital long QT syndrome, cardiovascular disease, electrolyte abnormalities, or concomitant medications), 29.5% of all patients, 33.2% of patients aged 65-74 years, and 40.5% of patients aged ≥75 years had risk factors for QTc prolongation. IMPLICATIONS: This analysis of real-world data indicates that almost 1 in 3 women with HR+/HER2‒ mBC had congenital long QT syndrome, cardiovascular disease, and/or electrolyte abnormalities or received a concomitant medication that could increase the risk of developing QTc prolongation. The risk factors for congenital long QT syndrome, cardiovascular disease, or electrolyte abnormalities were more common in older patients. This analysis emphasizes the importance of individualized benefit/risk assessment during treatment decisions, especially when considering drugs with known or possible QTc prolongation risk.

Effects of life history and reproduction on recruitment time lags in reintroductions of rare plants.

Reintroductions are important components of conservation and recovery programs for rare plant species, but their long-term success rates are poorly understood. Previous reviews of plant reintroductions focused on short-term (e.g., ≤3 years) survival and flowering of founder individuals rather than on benchmarks of intergenerational persistence, such as seedling recruitment. However, short-term metrics may obscure outcomes because the unique demographic properties of reintroductions, including small size and unstable stage structure, could create lags in population growth. We used time-to-event analysis on a database of unusually well-monitored and long-term (4-28 years) reintroductions of 27 rare plant species to test whether life-history traits and population characteristics of reintroductions create time-lagged responses in seedling recruitment (i.e., recruitment time lags [RTLs]), an important benchmark of success and indicator of persistence in reintroduced populations. Recruitment time lags were highly variable among reintroductions, ranging from <1 to 17 years after installation. Recruitment patterns matched predictions from life-history theory with short-lived species (fast species) exhibiting consistently shorter and less variable RTLs than long-lived species (slow species). Long RTLs occurred in long-lived herbs, especially in grasslands, whereas short RTLs occurred in short-lived subtropical woody plants and annual herbs. Across plant life histories, as reproductive adult abundance increased, RTLs decreased. Highly variable RTLs were observed in species with multiple reintroduction events, suggesting local processes are just as important as life-history strategy in determining reintroduction outcomes. Time lags in restoration outcomes highlight the need to scale success benchmarks in reintroduction monitoring programs with plant life-history strategies and the unique demographic properties of restored populations. Drawing conclusions on the long-term success of plant reintroduction programs is premature given that demographic processes in species with slow life-histories take decades to unfold.

Efectos de la Historia de Vida y la Reproducción sobre las Demoras en el Tiempo de Reclutamiento en la Reintroducción de Plantas Raras Resumen Las reintroducciones son componentes importantes de los programas de conservación y recuperación de especies raras de plantas, pero las tasas de éxito a largo plazo cuentan con muy poco entendimiento. Las revisiones previas de las reintroducciones de plantas se han enfocado en la supervivencia a corto plazo (p. ej.: ≤ 3 años) y en el florecimiento de individuos fundadores en lugar de enfocarse en puntos de referencia para la persistencia inter-generacional, como el reclutamiento de plántulas. Sin embargo, las medidas a corto plazo pueden ocultar los resultados ya que las propiedades demográficas únicas de las reintroducciones, incluyendo el menor tamaño y la estructura inestable de estadio, podrían crear demoras en el crecimiento poblacional. Usamos un análisis de tiempo-para-evento en una base de datos de reintroducciones inusualmente bien monitoreadas y de largo plazo (4-28 años) de 27 especies raras de plantas para probar si los atributos de la historia de vida y las características poblacionales de la reintroducción crean respuestas con demoras temporales en el reclutamiento de plántulas (es decir, demoras temporales en el reclutamiento), un punto de referencia importante para el éxito y un indicador de la persistencia en poblaciones reintroducidas. Las demoras temporales de reclutamiento (RTLs, en inglés) fueron muy variables entre las reintroducciones, abarcando desde <1 hasta 17 años después de la instalación. Los patrones de reclutamiento se acoplaron a las predicciones de la teoría de historias de vida, donde las especies de vida corta (especies rápidas) exhibieron RTLs consistentemente más cortas y menos variables que las especies de vida larga (especies lentas). Las RTLs largas ocurrieron en hierbas de vida larga, especialmente en los pastizales, mientras que las RTLs cortas ocurrieron en plantas leñosas subtropicales de vida corta y en hierbas anuales. En todas las historias de vida de las plantas, conforme incrementó la abundancia de adultos reproductivos, las RTLs disminuyeron. Se observaron RTLs altamente variables en las especies con eventos de reintroducción múltiples, lo que sugiere que los procesos locales son igual de importantes que la estrategia de historia de vida para determinar los resultados de las reintroducciones. Las demoras temporales en los resultados de restauración resaltan la necesidad de poner a escala los puntos de referencia de éxito en los programas de monitoreo de reintroducciones que tengan estrategias de historia de vida de las plantas y las propiedades demográficas únicas de las poblaciones restauradas. La obtención de conclusiones sobre el éxito a largo plazo de los programas de reintroducción de plantas es algo prematuro ya que los procesos demográficos de especies con historias de vida lentas tardan décadas en desarrollarse.

Clinical and economic outcomes by first-line treatment among women with HR+/HER2- metastatic breast cancer in a large US health plan database.

BACKGROUND: Guidelines recommend that women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. METHODS: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008-April 30, 2013. Subjects had evidence of a HR+/HER2- tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. RESULTS: Three hundred and twenty-four women with HR+/HER2- mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82-3.46; adjusted IRR = 0.64, 95% CI = 0.32-1.27). Adjusted average total all-cause healthcare costs were $11 090 for women with CT-1L and $6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36-1.99). CONCLUSIONS: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2- mBC population.

Hospital costs, length of stay and mortality associated with childhood, adolescent and young adult meningococcal disease in the US.

BACKGROUND: Assessments of vaccination programmes should account for several important factors, including efficacy, safety and costs of preventing and treating the disease. Because patients with invasive meningococcal disease (IMD) are managed primarily in an inpatient setting, hospital costs and outcomes are central endpoints in health economic evaluations of IMD. OBJECTIVE: The aim of the study was to estimate hospital costs, length of stay (LOS) and mortality associated with IMD among children, adolescents and young adults in the US. METHODS: The study design was a retrospective analysis of discharges from the 2006 Healthcare Cost and Utilization Project Kids' Inpatient Database. Infant (<1 year), childhood (1-10 years), adolescent (11-18 years) and young adult (19-20 years) IMD-related hospitalizations (International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] code 036) were selected. Regression-adjusted costs ($US, year 2009 values), LOS and mortality risk were compared between IMD hospitalizations and demographically matched (5 : 1) controls. RESULTS: A weighted total of 735 IMD admissions were identified. Among children, adjusted mean LOS and cost per admission was highest for infants (9.0 days and $US36 454 among cases vs 1.9 days and $US5041 for controls; all p < 0.0001). Adjusted costs and case fatality was highest among infants with meningococcal sepsis ($US49 626 and 11.6%, respectively). Versus controls, adjusted risks of death in IMD cases were 4.6- and 10.3-fold higher, respectively, for infants and adolescents (both p < 0.05). CONCLUSIONS: While the advent of vaccines for Haemophilus influenzae and Streptococcus pneumoniae has curtailed invasive bacterial infection rates, IMD continues to be a public health concern that presents greatly increased hospital costs, LOS and mortality risk, particularly for infants and adolescents.

Cost of acute hospitalization and post-discharge follow-up care for meningococcal disease in the US.

The combined costs of acute hospitalization and post-discharge follow-up care in patients with meningococcal disease have not been widely documented. In this study, data were retrospectively analyzed from three large databases of hospital discharge records and commercial insurance claims in the US. Cases of meningococcal disease were defined as admissions with an ICD-9-CM diagnosis code in the range of 036.x. From the 2005 HCUP Nationwide Inpatient Sample, 349 (weighted N=1,710) meningococcal-related hospitalizations were identified with a mean facility cost (in 2009 dollars) of $19,526 per admission. Similar estimates ($18,119 and $20,066, respectively) were obtained from 268 admissions identified in the LifeLink (formerly PharMetrics) database during 1999-2007 and from 1,058 hospitalizations in the Perspective Comparative Database (PCD) during 2000-2007. Using insurance claims from LifeLink, we estimated that payers incur an additional $26,178 in non-facility (professional and other ancillary) costs during the course of a meningococcal admission, as well as $22,230 in additional medical and pharmacy expenses for post-discharge care during the ensuing year. The majority of follow-up costs ($14,637) were attributed to repeat hospitalizations. Mean length of stay for meningococcal disease was consistently estimated across databases at 8 to 9 days. Data from the PCD further suggested that meningococcal disease carries, on average, nearly 2 days of intensive care unit utilization. In conclusion, hospital admissions for meningococcal disease are costly to payers. These costs are heightened when non-facility services and post-discharge care are also considered. Awareness of the full cost burden of meningococcal disease is needed when evaluating vaccination programs targeting the disease.

Medical care costs among patients with established cardiovascular disease.

OBJECTIVE: To estimate direct medical costs among patients with established cardiovascular disease (CVD). STUDY DESIGN: Observational longitudinal cohort study. METHODS: We identified 12,278 patients who were added to the Kaiser Permanente Northwest CVD registry from 2000 to 2005. We observed patients until they died or left the health plan or until June 30, 2008. Total direct medical costs were calculated over an individual's entire follow-up and were then annualized by dividing by the months of follow-up. We also calculated and compared age- and sex-adjusted incidence rates per 1000 person-years of secondary CVD hospitalization and all-cause mortality and a composite outcome of both. RESULTS: The total mean (SD) annual direct medical costs for the entire sample were $18,953 ($39,036). With approximately 22 million US residents having prevalent CVD or stroke, this extrapolates to direct costs of more than $400 billion. Inpatient costs accounted for 42.8% of total costs (mean [SD], $8114 [$25,410]). The greatest differences in costs were found when comparing patients who did versus did not experience a secondary CVD hospitalization ($62,755 vs $13,509, P <.001). Other large differences were found in comparisons of patients with versus without diabetes ($27,258 vs $17,210), an estimated glomerular filtration rate of less than 60 mL/min/1.73 m(2) ($29,498 vs $16,326), depression ($26,681 vs $17,303), and death ($28,689 vs $17,779) (P <.001 for all). CONCLUSIONS: The economic burden of providing care to patients with CVD may be substantially greater than current American Heart Association estimates. Although several comorbid conditions undoubtedly contribute to these costs, avoidance of secondary CVD hospitalization may be the key to substantially reducing healthcare consumption.

Economic analysis of alvimopan in North American Phase III efficacy trials.

PURPOSE: The economic effect of the use of alvimopan in four randomized, double-blind, placebo-controlled, Phase III, North American efficacy trials was analyzed. METHODS: Patients were eligible for the study if they were 18 years or older, were undergoing laparotomy for partial small or large bowel resection with primary anastomosis, and were scheduled for postoperative pain management with opioid-based i.v. patient-controlled analgesia. Patients analyzed in the North American Phase III trials received placebo or alvimopan 12 mg orally before surgery. Doses were administered twice daily beginning the day after surgery until hospital discharge or for a maximum of 15 doses. RESULTS: Compared with placebo, alvimopan was associated with a significantly shorter mean time to gastrointestinal (GI) recovery and a significantly shorter mean time to a written discharge order. Alvimopan was also associated with a mean hospital length of stay (LOS) of one full day less than placebo. The mean cost of alvimopan based on a mean of 8.9 12-mg doses was $558.00; the alvimopan cost at the upper limit of allowed dosing was $937.50. Combining the alvimopan and hospital costs for each patient, total costs for the alvimopan group were estimated to be lower than for the placebo group. CONCLUSION: In a post hoc analysis, alvimopan was associated with significantly faster upper and lower GI recovery after bowel resection and a mean LOS reduction of one day compared with placebo. The mean estimated hospital cost was $879-$977 less for patients who received alvimopan compared with placebo. The base-case and sensitivity analyses suggest that, on average, the use of alvimopan compared with placebo may have a cost-saving effect in the hospital setting.

The prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1).

OBJECTIVE: This multinational, Internet-based survey was designed to assess the prevalence, frequency, severity, and impact of opioid-induced bowel dysfunction (OBD) in patients receiving opioid therapy for chronic pain and taking laxatives. DESIGN: In total, 322 patients taking daily oral opioids and laxatives completed the 45-item questionnaire. At the time of the survey, 45% of patients reported <3 bowel movements per week. The most prevalent opioid-induced side effects were constipation (81%) and straining to pass a bowel movement (58%). Those side effects considered most bothersome by patients were (in order of rank) constipation, straining, fatigue, small or hard bowel movements, and insomnia. RESULTS: Most of the OBD symptoms specified in the questionnaire were experienced by the majority of patients >or=4 times a week. Constipation was the OBD symptom that was most often reported as severe. Most patients reported that their OBD symptoms had at least a moderate negative impact on their overall quality of life and activities of daily living. A third of patients had missed, decreased or stopped using opioids in order to make it easier to have a bowel movement. CONCLUSION: The survey findings confirm that OBD occurs frequently, despite the use of laxatives, in individuals taking daily oral opioids for chronic pain. These gastrointestinal symptoms add to the burden already experienced by chronic pain patients, negatively impacting quality of life and, in some cases, affecting opioid treatment itself.

Restless legs syndrome prevalence and impact: REST general population study.

BACKGROUND: Restless legs syndrome (RLS), a common sensorimotor disorder, has a wide range of severity from merely annoying to affecting sleep and quality of life severely enough to warrant medical treatment. Previous epidemiological studies, however, have failed to determine the prevalence of those with clinically significant RLS symptoms and to examine the life effects and medical experiences of this group. METHODS: A total of 16 202 adults (aged >/=18 years) were interviewed using validated diagnostic questions to determine the presence, frequency, and severity of RLS symptoms; respondents reporting RLS symptoms were asked about medical diagnoses and the impact of the disorder and completed the Short Form-36 Health Survey (SF-36). Criteria determined by RLS experts for medically significant RLS (frequency at least twice a week, distress at least moderate) defined "RLS sufferers" as a group most likely to warrant medical treatment. RESULTS: In all, 15 391 fully completed questionnaires were obtained; in the past year, RLS symptoms of any frequency were reported by 1114 (7.2%). Symptoms occurred at least weekly for 773 respondents (5.0%); they occurred at least 2 times per week and were reported as moderately or severely distressing by 416 (2.7%). Of those 416 (termed RLS sufferers), 337 (81.0%) reported discussing their symptoms with a primary care physician, and only 21 (6.2%) were given a diagnosis of RLS. The SF-36 scores for RLS sufferers were significantly below population norms, matching those of patients with other chronic medical conditions. CONCLUSION: Clinically significant RLS is common (prevalence, 2.7%), is underdiagnosed, and significantly affects sleep and quality of life.