Exploring kidney dialysis costs in the United States: a scoping review.

AIMS: The increasing prevalence of end-stage renal disease (ESRD) in the United States (US) represents a considerable economic burden due to the high cost of dialysis treatment. This review examines data from real-world studies to identify cost drivers and explore areas where dialysis costs could be reduced. METHODS: We identified and synthesized evidence published from 2016-2023 reporting direct dialysis costs in adult US patients from a comprehensive literature search of MEDLINE, Embase, and grey literature sources (e.g. US Renal Data System reports). RESULTS: Most identified data related to Medicare expenditures. Overall Medicare spending in 2020 was $29B for hemodialysis and $2.8B for peritoneal dialysis (PD). Dialysis costs accounted for almost 80% of total Medicare expenditures on ESRD beneficiaries. Private insurance payers consistently pay more for dialysis; for example, per person per month spending by private insurers on outpatient dialysis was estimated at $10,149 compared with Medicare spending of $3,364. Dialysis costs were higher in specific high-risk patient groups (e.g. type 2 diabetes, hepatitis C). Spending on hemodialysis was higher than on PD, but the gap in spending between PD and hemodialysis is closing. Vascular access costs accounted for a substantial proportion of dialysis costs. LIMITATIONS: Insufficient detail in the identified studies, especially related to outpatient costs, limits opportunities to identify key drivers. Differences between the studies in methods of measuring dialysis costs make generalization of these results difficult. CONCLUSIONS: These findings indicate that prevention of or delay in progression to ESRD could have considerable cost savings for Medicare and private payers, particularly in patients with high-risk conditions such as type 2 diabetes. More efficient use of resources is needed, including low-cost medication, to improve clinical outcomes and lower overall costs, especially in high-risk groups. Widening access to PD where it is safe and appropriate may help to reduce dialysis costs.

Previous papers have studied the cost of treating patients who need dialysis for kidney failure. We reviewed these costs and looked for patterns. Dialysis was the most expensive part of treatment for people with kidney disease who have Medicare. Dialysis with private insurance was much more expensive than with Medicare. People with diabetes experienced higher costs of dialysis than those without diabetes. Dialysis in a hospital costs more than dialysis at home. There are opportunities to reduce the cost of dialysis that should be explored further, such as more use of low-cost medication that can prevent the worsening of kidney disease and reduce the need for dialysis.

Poor adherence to clinical practice guidelines: A call to action for increased albuminuria testing in patients with type 2 diabetes.

We describe the substantial shortfall in adherence to guideline-recommended albumin-to-creatinine ratio (uACR) testing for people in the United States with type 2 diabetes. Poor compliance with current guidelines leads to delays in diagnosis-and treatment- of chronic kidney disease, which adversely affects clinical outcomes and contributes to incremental economic burden.

Identifying Patients with Group 3 Pulmonary Hypertension Associated with COPD or ILD Using an Administrative Claims Database.

BACKGROUND: Group 3 pulmonary hypertension (PH) describes a subpopulation of patients with PH due to chronic lung disease and/or hypoxia, with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) being two large subgroups. Claims database studies provide insights into the real-world treatment patterns and outcomes among these patients. However, claims data do not provide sufficient detail to assign the clinical subtype of PH required for identifying these patients. METHODS: A panel of PH clinical experts and researchers was convened to discuss methodologies to identify patients with Group 3 PH associated with COPD or ILD in retrospective claims databases. To inform the discussion, a literature review was conducted to identify claims-based studies of Group 3 PH associated with COPD or ILD published from 2010 through June 2020. RESULTS: Targeted title and abstract review identified 11 claims-based studies and two conference abstracts (eight based in the United States [US] and five conducted outside the US) that met search criteria. Based on insights from the panel and literature review, the following components were detailed across studies in the identification of Group 3 PH associated with COPD and ILD: (a) COPD or ILD identification, (b) PH identification, (c) defining the sequence between COPD/ILD and PH, and (d) other PH Group and Group 3 PH exclusions. CONCLUSION: This article provides recommended approaches and considerations for identifying and studying patients with Group 3 PH associated with COPD or ILD using administrative claims data that provide the foundation for future validation studies.

CKD Prevalence Among Patients With and Without Type 2 Diabetes: Regional Differences in the United States.

RATIONALE & OBJECTIVE: Regional variation in chronic kidney disease (CKD) prevalence in patients with or without type 2 diabetes mellitus (T2DM) has not been well characterized. STUDY DESIGN: Spatial and temporal comparative analysis. SETTING & PARTICIPANTS: MarketScan databases were used to identify patients with CKD overall and subgroups of patients with CKD with and without T2DM in the United States. OUTCOMES: Spatial patterns in CKD prevalence based on year, regional clusters of CKD between years, and characteristics of patients in high-prevalence states. ANALYTICAL APPROACH: Geomapping was used to visualize the state-level data of CKD prevalence generated from 2013 to 2018. We used univariate local indicators of spatial association (LISA) to evaluate geographic differences in prevalence, differential LISA for changes in CKD prevalence over time, and the χ2 test to identify patient characteristics in the top-20th percentile states for the prevalence of CKD. RESULTS: In univariate LISA, low-low clusters, in which a state has a low CKD prevalence and the surrounding states have a below-average CKD prevalence, were observed in the northwest region throughout the study period, regardless of the T2DM status, indicating a consistently low prevalence of CKD clustered in these areas. High-high clusters were observed, regardless of the T2DM status, in the southeast region in more recent years, suggesting an increased CKD prevalence in this region. LIMITATIONS: Health care insurance enrollment might not have been representative of the United States; the estimates were based on claims data that likely underestimated the true prevalence. CONCLUSIONS: Geographic disparities in CKD prevalence appear increasingly magnified, with an increase in the southeastern region of the United States. This increase is especially problematic because patients with CKD in high-prevalence states experience a greater likelihood of chronic conditions than those in the rest of the United States.

Correction to: Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

Changes within text are indicated in bold.

Medication Adherence and Healthcare Costs Among Patients with Pulmonary Arterial Hypertension Treated with Oral Prostacyclins: A Retrospective Cohort Study.

BACKGROUND: Given the improved convenience of oral prostacyclins, there is a shift toward their use in treating pulmonary arterial hypertension (PAH). OBJECTIVES: Our objective was to compare patient characteristics, medication adherence, healthcare resource use (HCRU), and costs among patients receiving oral treprostinil or selexipag. METHODS: We used Truven Health MarketScan Commercial and Medicare databases to identify patients with PAH with a diagnosis code for pulmonary hypertension (PH) plus a prescription for oral treprostinil or selexipag from July 2013 to September 2017. Medication adherence, persistence, and all-cause and PAH-related HCRU and costs were compared between cohorts during the 6-month follow-up. Adjusted healthcare costs were obtained using recycled predictions and bootstrapped samples. RESULTS: A total of 256 (130 oral treprostinil, 126 selexipag) patients fulfilled the study criteria. The oral treprostinil cohort was more likely to be male, to have previously used parenteral prostacyclins, and to have higher outpatient costs at baseline than the selexipag cohort. During follow-up, both cohorts had similar proportions of patients who were adherent to and persistent with their respective therapies. All-cause and PAH-related medical utilization was generally similar between cohorts. The oral treprostinil cohort had 66.9% lower total PAH-related healthcare costs (mean difference - $75,183; 95% confidence interval [CI] - 102,584 to - 49,771) and 70.6% lower PAH-related pharmacy costs (mean difference - $76,439; 95% CI - 104,512 to - 51,458) than the selexipag cohort, with similar differences in all-cause healthcare and pharmacy costs. CONCLUSIONS: Lower all-cause and PAH-related total healthcare and pharmacy costs were observed in patients receiving oral treprostinil compared with those receiving selexipag. It will be important to study longer-term costs and clinical outcomes.

Identifying Patients with Pulmonary Arterial Hypertension Using Administrative Claims Algorithms.

Retrospective administrative claims database studies provide real-world evidence about treatment patterns, healthcare resource use, and costs for patients and are increasingly used to inform policy-making, drug formulary, and regulatory decisions. However, there is no standard methodology to identify patients with pulmonary arterial hypertension (PAH) from administrative claims data. Given the number of approved drugs now available for patients with PAH, the cost of PAH treatments, and the significant healthcare resource use associated with the care of patients with PAH, there is a considerable need to develop an evidence-based and systematic approach to accurately identify these patients in claims databases. A panel of pulmonary hypertension clinical experts and researchers experienced in retrospective claims database studies convened to review relevant literature and recommend best practices for developing algorithms to identify patients with PAH in administrative claims databases specific to a particular research hypothesis.

Sexually Transmitted Disease Testing of Human Immunodeficiency Virus-Infected Men Who Have Sex With Men: Room for Improvement.

BACKGROUND: In the United States, sexually transmitted infection (STI) testing is recommended at least annually for sexually active men who have sex with men (MSM). We evaluated human immunodeficiency virus (HIV) providers' STI testing practices and frequency of positive test results. METHODS: We analyzed data from HIV Outpatient Study (HOPS) participants who, from 2007 to 2014, completed a confidential survey about risk behaviors. Using medical records data, we assessed the frequency of gonorrhea, chlamydia, and syphilis testing and positive results during the year after the survey for MSM who reported sex without a condom in the prior 6 months. We compared testing frequency and positivity for men having 1, 2 to 3, and 4 or more sexual partners. Correlates of STI testing were assessed using general linear model to derive relative risks (RR) with associated 95% confidence intervals (CI). RESULTS: Among 719 MSM, testing frequency was 74.5%, 74.3%, and 82.9% for gonorrhea, chlamydia, and syphilis, respectively, and was higher in those men who reported more sexual partners (P < 0.001 for all). In multivariable analysis, testing for gonorrhea was significantly more likely among non-Hispanic black versus white men (RR, 1.17; 95% CI, 1.03-1.33), among men seen in private versus public clinics (RR, 1.16; 95% CI, 1.05-1.28), and among men with 2 to 3 and 4 or more sexual partners versus 1 partner (RR, 1.12; 95% CI, 1.02-1.23, and RR, 1.18; 95% CI, 1.08-1.30, respectively). Correlates of chlamydia and syphilis testing were similar. Test positivity was higher among men with more sexual partners: for gonorrhea 0.0%, 3.0%, and 6.7% for men with 1, 2 to 3, and 4 or more partners, respectively (P < 0.001, syphilis 3.7%, 3.8% and 12.5%, P < 0.001). CONCLUSIONS: Among HIV-infected MSM patients in HIV care who reported sex without a condom, subsequent testing was not documented in clinic records during the following year for up to a quarter of patients. Exploring why STI testing did not occur may improve patient care.

Computerized Clinical Decision Support to Prevent Venous Thromboembolism Among Hospitalized Patients: Proximal Outcomes from a Multiyear Quality Improvement Project.

Despite venous thromboembolism (VTE) policy initiatives, gaps exist between guidelines and practice. In response, hospitals implement clinical decision support (CDS) systems to improve VTE prophylaxis. To assess the impact of a VTE CDS on reducing incidence of VTE, this study used a pretest/posttest, longitudinal, cohort design incorporating electronic health record (EHR) data from one urban tertiary and level 1 trauma center, and one suburban hospital. VTE CDS was embedded into the EHR system. The study included 45,046 admissions; 171,753 patient days; and 110 VTE events. The VTE rate declined from 0.954 per 1,000 patient days to 0.434 comparing baseline to full VTE CDS. Compared to baseline, patients benefitting from VTE CDS were 35% less likely to have a VTE. VTE CDS utilization achieved 78.4% patients assessed within 24 hr from admission, 64.0% patients identified at risk, and 47.7% patients at risk for VTE with an initiated VTE interdisciplinary plan of care. CDS systems with embedded algorithms, alerts, and notification capabilities enable physicians at the point of care to utilize guidelines and make impactful decisions to prevent VTE. This study demonstrates a phased-in implementation of VTE CDS as an effective approach toward VTE prevention. Implications for future research and quality improvement are discussed as well.

HIV laboratory monitoring reliably identifies persons engaged in care.

BACKGROUND: Attendance at biannual medical encounters has been proposed as a minimum national standard for adequate engagement in HIV care. Using data from the HIV Outpatient Study, we analyzed how well dates of HIV-related laboratory testing correlated with attendance at biannual medical encounters. METHODS: HIV Outpatient Study is an open prospective cohort study of HIV-infected patients receiving outpatient care in the United States. The data set included dates for laboratory measurements and medical encounters. We included patients with at least 1 HIV laboratory test (CD4 cell count or plasma HIV RNA viral load) during 2010-2011. An HIV laboratory test was defined as associated with a medical encounter if it occurred within 3 weeks of the encounter. We assessed the predictive value of HIV laboratory tests as a proxy for adequate engagement in clinical care, defined as having had ≥2 HIV laboratory tests within 1 year and performed >90 days apart. RESULTS: A total of 10,321 HIV laboratory tests were recorded from 2909 patients. Adequate engagement in clinical care based on medical encounters was 88.2% and 77.3% when based on laboratory tests. Using HIV laboratory tests to assess engagement had a sensitivity of 85.7%, specificity of 86.0%, and positive and negative predictive values of 97.9% and 44.5%, respectively. Of the 22.7% classified as not engaged in care by the proxy measure, over half (55.5%) were actually engaged. CONCLUSIONS: Using laboratory monitoring reliably classified persons as engaged in care. Of the 22.7% of patients classified as not engaged in care, most were actually engaged.

Healthe Kids: an assessment of program performance and participation.

Many states in the United States have mandated school health screenings for early identification and referral to professional services for a set of health conditions. Healthe Kids, a community-based program, began offering school-based health screenings to Missouri elementary schools in March 2007. The purpose of the article is to provide a description of the Healthe Kids program, including the team members, screening process, and the program's underlying technology. Further, we present data gathered during the first 5 years of the Healthe Kids program in Kansas City, Missouri, and describe improvements to the program from lessons learned and implications to school nurses and health care delivery.

Transparency in evidence evaluation and formulary decision-making: from conceptual development to real-world implementation.

OBJECTIVE: Establishing a better understanding of the relationship between evidence evaluation and formulary decision-making has important implications for patients, payers, and providers. The goal of our study was to develop and test a structured approach to evidence evaluation to increase clarity, consistency, and transparency in formulary decision-making. STUDY DESIGN: The study comprised three phases. First, an expert panel identified key constructs to formulary decision-making and created an evidence-assessment tool. Second, with the use of a balanced incomplete block design, the tool was validated by a large group of decision-makers. Third, the tool was pilot-tested in a real-world P&T committee environment. METHODS: An expert panel identified key factors associated with formulary access by rating the level of access that they would give a drug in various hypothetical scenarios. These findings were used to formulate an evidence-assessment tool that was externally validated by surveying a larger sample of decision-makers. Last, the tool was pilot-tested in a real-world environment where P&T committees used it to review new drugs. RESULTS: Survey responses indicated that a structured approach in the formulary decision-making process could yield greater clarity, consistency, and transparency in decision-making; however, pilot-testing of the structured tool in a real-world P&T committee environment highlighted some of the limitations of our structured approach. CONCLUSION: Although a structured approach to formulary decision-making is beneficial for patients, health care providers, and other stakeholders, this benefit was not realized in a real-world environment. A method to improve clarity, consistency, and transparency is still needed.

Uncontrolled asthma: assessing quality of life and productivity of children and their caregivers using a cross-sectional Internet-based survey.

BACKGROUND: Results of a national survey of asthmatic children that evaluated management goals established in 2004 by the National Asthma Education and Prevention Program (NAEPP) indicated that asthma symptom control fell short on nearly every goal. METHODS: An Internet-based survey was administered to adult caregivers of children aged 6-12 years with moderate to severe asthma. Asthma was categorized as uncontrolled when the caregiver reported pre-specified criteria for daytime symptoms, nighttime awakening, activity limitation, or rescue medication based on the NAEPP guidelines. Children's health-related quality of life (HRQOL) and caregivers' quality of life (QOL) were assessed using the Child Health Questionnaire Parent Form 28 (CHQ-PF28) and caregiver's work productivity using a modified Work Productivity and Activity Impairment Questionnaire. Children with uncontrolled vs. controlled asthma were compared. RESULTS: 360 caregivers of children with uncontrolled asthma and 113 of children with controlled asthma completed the survey. Children with uncontrolled asthma had significantly lower CHQ-PF28 physical (mean 38.1 vs 49.8, uncontrolled vs controlled, respectively) and psychosocial (48.2 vs 53.8) summary measure scores. They were more likely to miss school (5.5 vs 2.2 days), arrive late or leave early (26.7 vs 7.1%), miss school-related activities (40.6 vs 6.2%), use a rescue inhaler at school (64.2 vs 31.0%), and visit the health office or school nurse (22.5 vs 8.8%). Caregivers of children with uncontrolled asthma reported significantly greater work and activity impairment and lower QOL for emotional, time-related and family activities. CONCLUSIONS: Poorly controlled asthma symptoms impair HRQOL of children, QOL of their caregivers, and productivity of both. Proper treatment and management to improve symptom control may reduce humanistic and economic burdens on asthmatic children and their caregivers.

Pattern of clopidogrel use in hospitalized patients receiving percutaneous coronary interventions.

PURPOSE: The pattern of clopidogrel loading in patients who had undergone percutaneous coronary intervention (PCI) was studied in a retrospective analysis of clinical records. METHODS: A database of deidentified electronic medical records from hospitals and hospital-affiliated outpatient facilities throughout the United States was analyzed for PCI patients with or without a diagnosis of acute coronary syndrome (ACS) who received clopidogrel loading doses of > or =300 mg between 48 hours before and 6 hours after PCI. A high dose was defined as > or =600 mg, and pretreatment was defined as more than 6 hours before PCI for 300-599 mg and 2 or more hours before PCI for > or =600 mg. RESULTS: Among 6253 PCI patients who met the criteria, there were 2331 with a diagnosis of ACS (ACS-PCI) and 3922 without an ACS diagnosis (elective PCI). Of the ACS-PCI patients, 1359 had ST-segment elevation myocardial infarction (STEMI) and 972 had unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI). A majority of ACS-PCI patients (57%) received a > or =600-mg loading dose, 34% received a 300-mg loading dose, and the rest received a loading dose between 300 and 600 mg. Loading consisted of a single bolus in 75% of patients, two doses in 21.5%, and three or more doses in 3.1%. The first dose was during or after PCI in 56% of the UA/NSTEMI group and in 71% of both the elective PCI and STEMI groups. Among the UA/NSTEMI group, only 33% met criteria for pretreatment. CONCLUSION: Reported practice patterns of clopidogrel administration before PCI for UA/NSTEMI were not consistent with evidence generated from published clinical trials and guidelines. Recommended pre-treatment with clopidogrel was frequently not practiced.

Uncontrolled asthma among children: impairment in social functioning and sleep.

OBJECTIVE: To evaluate asthma symptom frequency, severity, and control among children with asthma and to evaluate the impact on social functioning and sleep impairment. PATIENTS AND METHODS: Using a cross-sectional design, adult caregivers of children aged 6-12 years with moderate to severe asthma (severity based on National Asthma Education and Prevention Program guidelines) were surveyed about the child's symptoms, treatment, activity limitation, and sleep impairment. Asthma was categorized as uncontrolled if the caregiver reported any of the following of the child: experienced >2 days/week with symptoms, were awakened at night by symptoms during the preceding 4 weeks, had activity limited by a health problem, or used short-acting beta-agonist for rescue >5 times/week. Asthma not meeting any of these criteria was categorized as controlled. Social functioning and sleep impairment were assessed using questions adapted from the SleepLearnPlay instrument. Children with uncontrolled and controlled asthma were compared using t tests for continuous variables and Fisher's exact test for categorical variables. Multiple comparison adjustment using the Bonferroni procedure was made for social functioning and sleep impairment measures. RESULTS: A total of 473 caregivers completed the survey; 360 were caregivers of children with uncontrolled asthma and 113 of children with controlled asthma. Compared with controlled asthma, a greater proportion of children with uncontrolled asthma showed avoidance across all nine social activities assessed. Children with uncontrolled asthma were significantly more likely to wake up at night with symptoms (p <.0001) and use a rescue inhaler at night (p <.0001), experience difficulty waking up in the morning (p = .0001) and getting out of bed (p = .0039), and be overly tired all day (p <.0001). CONCLUSIONS: Uncontrolled asthma impacted functioning and sleep of children to a significantly greater degree than well-controlled asthma. Proper treatment and disease management to improve symptom control can reduce this impact on the lives of children.

The relationship between the prevalence of nighttime gastroesophageal reflux disease and disease severity.

BACKGROUND: Nighttime gastrointestinal reflux disease (GERD) prevalence and severity estimates vary substantially across studies. METHODS: We assessed nighttime GERD (NTG) prevalence and symptom frequency and severity through a web survey of US adults, using the GERD Symptom and Medication Questionnaire (GERD-SMQ), a validated symptom questionnaire. NTG was based on episodes of nighttime heartburn per week and time of occurrence. Symptom severity and impact were assessed and compared for GERD cases with and without NTG. RESULTS: GERD prevalence among respondents (n = 2,603) was 27%. Forty-five percent of symptomatic GERD respondents had NTG. Among respondents with both daytime and nighttime symptoms, 51% reported that nighttime symptoms were more bothersome. NTG respondents reported greater disease severity compared with those without (P < 0.0001). CONCLUSIONS: NTG symptoms are very common among those identified with GERD. People with nighttime symptoms have greater disease severity than those with exclusively or primarily daytime symptoms.

The impact of uncontrolled asthma on absenteeism and health-related quality of life.

OBJECTIVE: To evaluate the impact of uncontrolled asthma on the absenteeism and health-related quality of life (HRQOL) of adults and children with asthma and the caregivers of pediatric patients. PATIENTS AND METHODS: Patient information was obtained from datasets maintained by National Jewish Health for this cross-sectional study. Participants in the study were 12 years of age or older. Participants younger than 18 years had their information provided by caregivers. Caregivers also provided 6 months of absenteeism and QOL data. Participants were classified as having uncontrolled asthma based on a treatment and symptom guideline-based algorithm. Absenteeism was assessed from the self-reported number of work or school days missed due to asthma during the previous 6 months. HRQOL among adults was measured using the validated Marks Asthma Quality of Life Questionnaire (Marks-AQLQ) and among caregivers using the validated Pediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ). To account for the positive skew in absenteeism data, a zero-inflated Poisson regression model was used to compare group differences. HRQOL was analyzed for adults and caregivers using the Wilcoxon-Mann-Whitney test. RESULTS: A total of 15,149 patients met the inclusion criteria for the study and were included in the analysis. Adults with uncontrolled asthma and caregivers of children with uncontrolled asthma reported significantly higher absenteeism than their controlled counterparts: 43% vs 24% adults reported missing days of work, with a median 6 days vs 3 days missed; 31% vs 16% of caregivers reported missing days of work, with 4 days vs 2 days missed; and caregivers reported that more than 70% vs 45% pediatric patients missed school, with a median of 6 days vs 4 days missed (uncontrolled vs controlled asthma, respectively). Adult uncontrolled asthmatics and caregivers of uncontrolled pediatric patients had significantly lower HRQOL as indicated by the Marks-AQLQ (scores 1.5 points higher, p < 0.001) and PACQLQ (scores < 0.5 points lower, p < 0.001), respectively. CONCLUSIONS: Uncontrolled asthma has far-reaching impact on the productivity and quality of life of asthma patients and their caregivers. Proper assessment, treatment, and disease management to improve asthma control may reduce the impact of uncontrolled asthma on asthmatic adults, children, and the caretakers of pediatric asthmatic patients.

Review: use of electronic medical records for health outcomes research: a literature review.

This review assessed the use of electronic medical record (EMR) systems in outcomes research. We systematically searched PubMed to identify articles published from January 2000 to January 2007 involving EMR use for outpatient-based outcomes research in the United States. EMR-based outcomes research studies (n = 126) have increased sixfold since 2000. Although chronic conditions were most common, EMRs were also used to study less common diseases, highlighting the EMRs' flexibility to examine large cohorts as well as identify patients with rare diseases. Traditional multi-variate modeling techniques were the most commonly used technique to address confounding and potential selection bias. Data validation was a component in a quarter of studies, and many evaluated the EMR's ability to achieve similar results previously achieved using other data sources. Investigators using EMR data should aim for consistent terminology, focus on adequately describing their methods, and consider appropriate statistical methods to control for confounding and treatment-selection bias.

Differences in symptom scores and health outcomes in premenstrual syndrome.

BACKGROUND: In studies of premenstrual syndrome (PMS), a significant response to treatment is commonly defined as a 50% reduction in symptom scores, but empirical support for this definition is lacking. We compared healthcare utilization in women with and without PMS according to the Daily Record of Severity of Problems (DRSP) scores in order to determine the degree of symptomatic variation in premenstrual symptoms associated with differences in the burden of illness. METHODS: Participants were women aged 18-45 years enrolled in a medical group in southern California. Respondents completed the Medical Outcomes Study Short Form-36 (SF-36) at baseline and the DRSP symptom and occupational productivity items daily. Luteal phase DRSP scores were averaged over two consecutive cycles. Respondents were categorized as having mild/no and moderate/severe PMS or premenstrual dysphoric disorder (PMDD) using a previously published, validated algorithm. Medical costs were estimated from medical claims data over the 2 years prior to study entry. RESULTS: Compared with women with moderate/severe PMS/PMDD (n = 117), those with mild/no PMS/PMDD (n = 271) had 43% lower DRSP scores (29.7 and 52.4, p < 0.05), higher SF-36 mental component summary (49.9 and 40.5, p < 0.0001) and physical component summary (52.6 and 50.8, p = 0.04) scores, and fewer workdays per month with reduced productivity (13.3 and 22.0, p < 0.0001) and workdays missed due to health reasons (1.2 and 2.7, p = 0.001). Women with moderate/severe PMS/PMDD had greater odds of having >10 office visits (OR = 1.80, 95% CI 1.01, 3.22) and of accumulating >$500 in medical charges (OR = 1.9, 95% CI 1.2, 3.0). CONCLUSIONS: A 43% difference in premenstrual vs. postmenstrual symptom scores is associated with a significant difference in healthcare burden. These data support the use of a 50% reduction in symptom ratings as a clinically relevant improvement in PMS/PMDD treatment trials, although smaller differences may also be meaningful.