Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing-Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative.

Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. Recent examples include the approval of palbociclib in combination with endocrine therapy for male breast cancer and the inclusion of RWE in the label of paliperidone palmitate for schizophrenia. This interest has created an urgency to develop processes that promote trust in the evidence-generation process. Key stakeholders and decision-makers include patients and their healthcare providers; learning health systems; health technology assessment bodies and payers; pharmacoepidemiologists and other clinical reseachers, and policy makers interested in bioethical and regulatory issues. A key to optimal uptake of RWE is transparency of the research process to enable decision-makers to evaluate the quality of the methods used and the applicability of the evidence that results from the RWE studies. Registration of RWE studies-particularly for hypothesis evaluating treatment effectiveness (HETE) studies-has been proposed to improve transparency, trust, and research replicability. Although registration would not guarantee better RWE studies would be conducted, it would encourage the prospective disclosure of study plans, timing, and rationale for modifications. A joint task force of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) recommended that investigators preregister their RWE studies and post their study protocols in a publicly available forum before starting studies to reduce publication bias and improve the transparency of research methods. Recognizing that published recommendations alone are insufficient, especially without accessible registration options and with no incentives, a group of experts gathered on February 25 and 26, 2019, in National Harbor, Maryland, to explore the structural and practical challenges to the successful implementation of the recommendations of the ISPOR/ISPE task force for preregistration. This positioning article describes a plan for making registration of HETE RWE studies routine. The plan includes specifying the rationale for registering HETE RWE studies, the studies that should be registered, where and when these studies should be registered, how and when analytic deviations from protocols should be reported, how and when to publish results, and incentives to encourage registration. Table 1 summarizes the rationale, goals, and potential solutions that increase transparency, in addition to unique concerns about secondary data studies. Definitions of terms used throughout this report are provided in Table 2.

Improving transparency to build trust in real-world secondary data studies for hypothesis testing-Why, what, and how: recommendations and a road map from the real-world evidence transparency initiative.

Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. Recent examples include the approval of palbociclib in combination with endocrine therapy for male breast cancer and the inclusion of RWE in the label of paliperidone palmitate for schizophrenia. This interest has created an urgency to develop processes that promote trust in the evidence-generation process. Key stakeholders and decision-makers include patients and their healthcare providers; learning health systems; health technology assessment bodies and payers; pharmacoepidemiologists and other clinical reseachers, and policy makers interested in bioethical and regulatory issues. A key to optimal uptake of RWE is transparency of the research process to enable decision-makers to evaluate the quality of the methods used and the applicability of the evidence that results from the RWE studies. Registration of RWE studies-particularly for hypothesis evaluating treatment effectiveness (HETE) studies-has been proposed to improve transparency, trust, and research replicability. Although registration would not guarantee better RWE studies would be conducted, it would encourage the prospective disclosure of study plans, timing, and rationale for modifications. A joint task force of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) recommended that investigators preregister their RWE studies and post their study protocols in a publicly available forum before starting studies to reduce publication bias and improve the transparency of research methods. Recognizing that published recommendations alone are insufficient, especially without accessible registration options and with no incentives, a group of experts gathered on February 25 and 26, 2019, in National Harbor, Maryland, to explore the structural and practical challenges to the successful implementation of the recommendations of the ISPOR/ISPE task force for preregistration. This positioning article describes a plan for making registration of HETE RWE studies routine. The plan includes specifying the rationale for registering HETE RWE studies, the studies that should be registered, where and when these studies should be registered, how and when analytic deviations from protocols should be reported, how and when to publish results, and incentives to encourage registration. Table 1 summarizes the rationale, goals, and potential solutions that increase transparency, in addition to unique concerns about secondary data studies. Definitions of terms used throughout this report are provided in Table 2.

Perceived occupational balance and well-being among people with mental illness living in two types of supported housing.

Background: People with psychiatric disabilities often struggle with maintaining a satisfying occupational balance. Knowledge about factors of relevance for occupational balance in this group is therefore vital for improving their support.Aim: The aim was to describe perceptions of occupational balance among people with psychiatric disabilities living in supported housing (SH) or in own flat/house with housing support (OHS). Potential importance of housing context and socio-demographic, well-being and recovery factors for occupational balance was also explored.Methods: Participants from SH (N = 155) and OHS (N = 111) responded to questionnaires about sociodemographic situation, well-being (self-rated health, life satisfaction and self-mastery), personal recovery and occupational balance (work, leisure, home chores, self-care and general balance assessed by SDO-OB).Results: A majority in both groups reported being in balance regarding all five domains of occupational balance. The OHS group reported being more under-occupied for home chores and self-care. Self-mastery was the most important contributor in both groups in the domains of work, domestic chores and self-care. Day center attendance was vital for general occupational balance.Conclusion: Both groups generally perceived occupational balance. Control over one's life situation and possibilities for regularly participating in occupations outside the home environment should receive high priority in housing support.

Health-Related Quality of Life in Patients with Idiopathic Pulmonary Fibrosis.

PURPOSE: Idiopathic pulmonary fibrosis (IPF) produces symptoms and activity limitations that impair health-related quality of life (HRQOL). The Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) includes measures of self-reported health and HRQOL for a range of conditions. This study evaluated the HRQOL of individuals with IPF using PROMIS measures and examined associations between HRQOL and key symptoms or supplemental oxygen need. METHODS: Individuals who reported being told by a doctor that they have IPF completed an online battery of measures at baseline and 7-10 days later (for test-retest reliability). Measures included a brief survey of demographic and health-related questions, the PROMIS-29 profile, the Modified Medical Research Council Dyspnea Scale (MMRC), PROMIS dyspnea severity short form, A Tool to Assess Quality of life in IPF (ATAQ-IPF) and one cough item from the Functional Assessment of Chronic Illness Therapy (FACIT). RESULTS: 220 individuals were included in the final sample. Except for sleep disturbance, all PROMIS domain scores significantly (p < .01) differed by MMRC level. Supplemental oxygen users were more impaired than non-users in fatigue, physical function, and social role participation (p < 0.01). The test-retest reliability was acceptable to excellent (>0.7) for all scales, but was lower for sleep disturbance (0.64). CONCLUSIONS: People with IPF report substantial deficits in HRQOL across a range of PROMIS domains, and deficits vary by dyspnea and cough severity. These deficits warrant monitoring in clinical practice and consideration when investigating new therapies. Further research is required to further evaluate the psychometric performance of the PROMIS-29 in IPF.

Towards a more liveable life for close relatives of individuals diagnosed with bipolar disorder.

The life of close relatives of persons with bipolar disorder (BD) is associated with emotional distress, depression, and a high level of use of mental health care. Illness-related changes of their life situation endanger relationships, social life, finances, and occupational functioning. Understanding of facilitating conditions for close relatives is still a neglected research area. The aim of the present study thus was to explore what makes the life of close relatives of persons with BD more liveable. A lifeworld phenomenological approach was used. The findings reveal that keeping distance, having stability in everyday life, and strengthening equality through transparent communication are conditions that enable close relatives to influence the unpredictable and its consequences and thus make life more liveable. This implies contributions from close relatives, the person with BD, and the caring services. We propose that health-care support should not be divided in support for the patient and/or the close relatives but instead be designed as support for the 'patient and close relatives' as a unit. Professional caregivers need to take responsibility for creating intersubjective settings for the person with BD and their close relatives to share their needs and make joint plans for how to influence the illness-related life issues.

The paradox of being both needed and rejected: the existential meaning of being closely related to a person with bipolar disorder.

The aim of this study was to elucidate the existential meaning of being closely related to a person with bipolar disorder. A qualitative, descriptive, and explorative design with a phenomenological meaning-oriented analysis was used. The findings reveal a paradoxical, existential exposure of close relatives to a person with bipolar disorder, being both needed and rejected whilst being overshadowed by the specific changeable nature of bipolar disorder. Psychiatric health care services are recommended to consider changes in attitudes and structures that may facilitate close relatives' participation in the care and treatment of persons with bipolar disorder.

A suggested revision of the Community Oriented Program Environmental Scale (COPES) for measuring the psychosocial environment of supported housing facilities for persons with psychiatric disabilities.

The aim of the present study is to address issues of construct validity and reliability of a revised short version of the COPES instrument to measure the psychosocial environment of supported housing facilities for persons with psychiatric disabilities. The results revealed that the division into subscales is not sufficiently reliable for use in measuring the psychosocial environment, although the three higher order dimensions can possibly be used for the descriptive and comparative purposes. A factor analysis based on the revised short version generated new factor solutions, differing from the COPES subscales, but with sufficient psychometric properties.

Medication costs to private insurers of diversion of medications for attention-deficit hyperactivity disorder.

BACKGROUND: The diversion of prescription stimulants for misuse, particularly those used in the treatment of attention-deficit hyperactivity disorder (ADHD), is potentially a significant problem for public health and for healthcare funding and delivery. Most prior research on the diversion of prescription stimulants for misuse, particularly those used in the treatment of ADHD, has focused on the 'end users' of diverted medications rather than the suppliers. Furthermore, little is known about the direct costs of diversion for third-party insurance payers in the US. OBJECTIVES: The objectives of this study were to estimate the prevalence in the US of people whose private insurance paid costs for ADHD prescriptions that they gave or sold to another person (diversion), and to estimate medication costs of diversion to private insurers. METHODS: Estimates are from a cross-sectional survey of respondents from two Internet survey panels targeting individuals aged 18-49 years in the civilian, noninstitutionalized US population, principally for those who filled prescriptions for ADHD medications in the past 30 days that were covered by private health insurance. Analysis weights were post-stratified to control totals from the Current Population Survey and National Health Interview Survey. Weighted prevalence rates and standard errors for diversion are reported, as are the costs of diverted pills using drug prices reported in the 2008 Thomson Reuters RED BOOK™. Sensitivity analyses were conducted that varied the cost assumptions for medications. RESULTS: Among individuals aged 18-49 years whose private insurance paid some costs for ADHD medications in the past 30 days, 16.6% diverted medications from these prescriptions. Men aged 18-49 years for whom private insurance paid some costs of ADHD drugs in the past 30 days were more than twice as likely as their female counterparts to divert medications from these prescriptions (22.5% vs 9.1%; p = 0.03). After a pro-rated co-payment share was subtracted, the estimated value of diverted medications in a 30-day period was $US8.0 million. Lower- and upper-bound estimates were $US6.9 million to $US17 million, for a range of $US83 million to $US204 million annually. Overall, diversion accounted for about 3.6% of the total costs that private insurers paid for ADHD medications (range: 3.5-4.5%). The percentages varied by medication category, although relative differences were sensitive to inclusion of a pro-rated co-payment. A higher percentage of the costs of extended-release (XR) medications was lost to diversion compared with that for immediate-release (IR) medications. CONCLUSIONS: Costs of ADHD medications paid for by private insurers that were lost to diversion were small relative to the total estimated medication costs and relative to total estimated healthcare costs for treating ADHD. Nevertheless, there may be significant cost savings for insurers if diversion can be reduced, particularly for XR medications. These findings represent a first step to informing policies to reduce diversion both in the interest of public health and for direct and indirect cost savings to insurers.

Validity and reliability of a Swedish version of the Relationship Assessment Scale (RAS): a pilot study.

BACKGROUND: There is a need for a short and easily administered scale, in the Swedish language, for assessing partner relationships in the health care of persons with cardiac disease. PURPOSE: To establish the reliability and validity of the Swedish version of the Relationship Assessment Scale (RAS). DESIGN: The present pilot study has a methodological design. FINDINGS: Content validity has been tested for relevance, clarity and readability. The scale was tested for construct validity with explorative factor analysis. The reliability was tested by internal consistency and test-retest analysis. The result showed a two-factor solution, which does not correspond to the original proposed one-factor solution. The factor analyses revealed two quite distinct factors of RAS, labelled "Relationship built on expectations and satisfaction of needs" and "Relationship built on love and devotion". CONCLUSIONS: The scale has satisfactory psychometric properties in terms of content validity, construct validity, homogeneity and stability in a population of persons with cardiac disease. Wider evaluations of the RAS for other populations and settings are recommended.

A retrospective claims analysis of combination therapy in the treatment of adult attention-deficit/hyperactivity disorder (ADHD).

BACKGROUND: Combination therapy in managing psychiatric disorders is not uncommon. While combination therapy has been documented for depression and schizophrenia, little is known about combination therapy practices in managing attention-deficit/hyperactivity disorder (ADHD). This study seeks to quantify the combination use of ADHD medications and to understand predictors of combination therapy. METHODS: Prescription dispensing events were drawn from a U.S. national claims database including over 80 managed-care plans. Patients studied were age 18 or over with at least 1 medical claim with a diagnosis of ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 314.0), a pharmacy claim for ADHD medication during the study period July 2003 to June 2004, and continuous enrollment 6 months prior to and throughout the study period. Dispensing events were grouped into 6 categories: atomoxetine (ATX), long-acting stimulants (LAS), intermediate-acting stimulants (IAS), short-acting stimulants (SAS), bupropion (BUP), and Alpha-2 Adrenergic Agonists (A2A). Events were assigned to calendar months, and months with combined use from multiple categories within patient were identified. Predictors of combination therapy for LAS and for ATX were modeled for patients covered by commercial plans using logistic regression in a generalized estimating equations framework to adjust for within-patient correlation between months of observation. Factors included age, gender, presence of the hyperactive component of ADHD, prior diagnoses for psychiatric disorders, claims history of recent psychiatric visit, insurance plan type, and geographic region. RESULTS: There were 18,609 patients identified representing a total of 11,886 months of therapy with ATX; 40,949 months with LAS; 13,622 months with IAS; 38,141 months with SAS; 22,087 months with BUP; and 1,916 months with A2A. Combination therapy was present in 19.7% of continuing months (months after the first month of therapy) for ATX, 21.0% for LAS, 27.4% for IAS, 23.1% for SAS, 36.9% for BUP, and 53.0% for A2A.For patients receiving LAS, being age 25-44 or age 45 and older versus being 18-24 years old, seeing a psychiatrist, having comorbid depression, or having point-of-service coverage versus a Health Maintenance Organization (HMO) resulted in odds ratios significantly greater than 1, representing increased likelihood for combination therapy in managing adult ADHD.For patients receiving ATX, being age 25-44 or age 45 and older versus being 18-24 years old, seeing a psychiatrist, having a hyperactive component to ADHD, or having comorbid depression resulted in odds ratios significantly greater than 1, representing increased likelihood for combination therapy in managing adult ADHD. CONCLUSION: ATX and LAS are the most likely drugs to be used as monotherapy. Factors predicting combination use were similar for months in which ATX was used and for months in which LAS was used except that a hyperactive component to ADHD predicted increased combination use for ATX but not for LAS.

Validity of the World Health Organization Adult ADHD Self-Report Scale (ASRS) Screener in a representative sample of health plan members.

The validity of the six-question World Health Organization Adult ADHD Self-Report Scale (ASRS) Screener was assessed in a sample of subscribers to a large health plan in the US. A convenience subsample of 668 subscribers was administered the ASRS Screener twice to assess test-retest reliability and then a third time in conjunction with a clinical interviewer for DSM-IV adult ADHD. The data were weighted to adjust for discrepancies between the sample and the population on socio-demographics and past medical claims. Internal consistency reliability of the continuous ASRS Screener was in the range 0.63-0.72 and test-retest reliability (Pearson correlations) in the range 0.58-0.77. A four-category version The ASRS Screener had strong concordance with clinician diagnoses, with an area under the receiver operating characteristic curve (AUC) of 0.90. The brevity and ability to discriminate DSM-IV cases from non-cases make the six-question ASRS Screener attractive for use both in community epidemiological surveys and in clinical outreach and case-finding initiatives.

Ward atmosphere - the Scarlet Pimpernel of psychiatric settings?

Patients and staff in a forensic psychiatric setting were requested to name three distinguishing characteristics of the ward atmosphere. The manifest content analysis of the responses revealed the following categories: interpersonal relations and pre-conditions for interpersonal relations; organization; staff; treatment; daily activities; physical environment; and feeling good and secure. The patients appeared to have a peripheral role as contributors to the ward atmosphere in the views of the respondents. The easily administered single question format provided valuable information about an intangible element of psychiatric settings - the ward atmosphere.

Factors associated with initiation with atomoxetine versus stimulants in the treatment of adults with ADHD: retrospective analysis of administrative claims data.

OBJECTIVE: To determine which factors are associated with use of atomoxetine (ATX) relative to stimulant medications (STIMs) for treatment initiation in adults with attention-deficit/hyperactivity disorder (ADHD). A similar exploratory analysis of the use of ATX versus STIMs in children has been published previously. METHODS: This was an exploratory analysis using a retrospective observational cohort design applied to administrative pharmacy and medical claims from an integrated managed care database. Patients were identified if they had at least 1 administrative claim with a diagnosis for ADHD. Treatment .initiation. was defined as a new prescription for an ADHD medication preceded by 3 months without similar therapy. Two separate analyses were done, one comparing medication starts for ATX with those of any STIM, the other comparing starts of ATX with long-acting stimulants (LA-STIMs). Logistic regression analyses of prior-year administrative claims were used to compare the frequencies of differential predictors of the use of medication. RESULTS: There were 10,359 patients aged >18 years who initiated ATX or a STIM between April and December of 2003 and had at least 1 claim with a diagnosis for ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification codes 314.0x). Approximately one third (28 of 82) of the comparisons related to patient demographics, diagnostic history, and previous treatment history was found to be related to the use of ATX versus STIMs and/or LA-STIMs. Patients were more likely to have received ATX than a STIM if they had prior diagnoses of bipolar disorder (odds ratio [OR] 1.47; 95% confidence interval [CI], 1.16-1.87), alcohol dependence (OR 1.80; 95% CI, 1.26-2.58), anxiety (OR 1.21; 95% CI, 1.05-1.40), previous use of antipsychotic medication (OR 1.55; 95% CI, 1.22-1.96), or previous antidepressant use (OR 1.14; 95% CI, 1.01-1.28). Prior use of behavioral services greater than 12 visits was associated with the use of ATX relative to STIMs (OR 1.46; 95% CI, 1.20-1.77) but not for ATX relative to LA-STIMs. Conversely, ATX was used less often than STIMs for initiation in younger adults aged 18 to 24 years (OR 0.66; 95% CI, 0.58-0.74), female patients (OR 0.89, 95% CI, 0.80-0.99), patients with personality disorders (OR 0.53; 95% CI, 0.34-0.82), and those with prior use of STIMs (OR 0.62; 95% CI, 0.56-0.69). The majority of comparisons (54 of 82) related to demographics, diagnostic history, and previous treatment history did not show statistically significant associations. CONCLUSIONS: During the first year of ATX.s market introduction, some differences in the frequency of various clinical factors were found in adults treated with ATX compared with those patients who received STIMs. This association may suggest that STIMs and ATX are used to address different treatment needs in adults with ADHD. Future studies will need to determine the significance of the practice pattern differences inferred here and if they persist after ATX has been on the market longer.

Predictors of selecting atomoxetine therapy for children with attention-deficit-hyperactivity disorder.

STUDY OBJECTIVE: To investigate predictors of beginning treatment with atomoxetine, a new attention-deficit-hyperactivity disorder (ADHD) drug, shortly after it was introduced into the marketplace compared with well-established stimulants for children in a managed care setting. DESIGN: Retrospective cohort analysis. DATA SOURCE: Managed care claims database. PATIENTS: A total of 45,144 patients aged 18 years or younger who filled a prescription for an ADHD-specific drug. MEASUREMENTS AND MAIN RESULTS: For each patient, the most recent start of therapy between April 1 and December 31, 2003, was categorized by drug: atomoxetine; any stimulant; or short-, intermediate-, or long-acting stimulant. The categories were based on the first use of the drug without use of a drug in that same category in the previous 3 months. Logistic regression analysis of past-year administrative claims was applied to determine predictors of the start of specific pharmacotherapy. Patients with a claim of ADHD with hyperactivity were 1.50 times more likely to begin therapy with atomoxetine than with any stimulant (95% confidence interval [CI] 1.42-1.58). Patients with a history of tics (odds ratio [OR] 3.11, 95% CI 2.54-3.82), anxiety (OR 1.35, 95% CI 1.24-1.48), pervasive developmental disorders (OR 2.00, 95% CI 1.69-2.37), or frequent use of behavioral care services (OR 1.34, 95% CI 1.21-1.48) were predisposed to starting treatment with atomoxetine relative to any stimulant, but patients with obesity were not (OR 0.68, 95% CI 0.53-0.87). A short-acting stimulant was specifically preferred for patients with narcolepsy or hypersomnolence (OR 0.33, 95% CI 0.20-0.56). Alcohol dependence, but not drug dependence or drug abuse, was predictive of the selection of atomoxetine over a short-acting stimulant (OR 2.98, 95% CI 1.25-7.09). CONCLUSION: Atomoxetine therapy was systematically preferred for patients with psychiatric comorbidities, contraindications to stimulants, or relatively heavy use of behavioral health care.

Impact of a statewide Medicaid managed care system on healthcare utilization and outcomes for people living with HIV.

BACKGROUND: Medicaid managed care (MMC) systems provide insurance for many persons living with HIV and AIDS (PLWH). This study sought to assess the impact of a statewide MMC system (TennCare) on healthcare utilization and outcomes for PLWH. METHODS: A retrospective longitudinal analysis of trends in population characteristics was performed. The study population included all Tennessee PLWH identified by State Health Department, enrolled for 1 year or longer in Medicaid (1992-1993) or TennCare (1994-1997). Main outcome measures included health care utilization, incidence of opportunistic infections, and mortality. RESULTS: From 1992 to 1997, the following decreased: average number of hospitalizations for HIV (0.72 to 0.37) and AIDS (1.27 to 0.52); emergency visits for HIV (1.70 to 1.12) and AIDS (1.65 to 1.02); outpatient visits for HIV (5.94 to 5.00) and AIDS (8.37 to 7.35), percentage of persons diagnosed with Pneumocystis carinii pneumonia for AIDS (10% to 6%) and percentage of persons diagnosed with community-acquired pneumonia for HIV (14% to 9%) and AIDS (27% to 12%), annual incidence of AIDS in the HIV population (33% to 10%), and annual mortality for HIV (3% to 1%) and AIDS (16% to 3%). The average number of antiretroviral medication prescriptions filled increased for HIV (1.27 to 2.45) and AIDS (1.31 to 3.34). CONCLUSIONS: This study documents improvements in utilization patterns, morbidity, and mortality in a statewide MMC system. These findings suggest that MMC patients are benefiting from recent advances in therapy.

Improvements in access to care for HIV and AIDS in a statewide Medicaid managed care system.

BACKGROUND: Some experimental Medicaid managed care systems have expanded eligibility criteria for chronically ill persons, but these systems' impact on access to care remains unknown. OBJECTIVE: To determine whether initiating a statewide Medicaid managed care system (TennCare) guaranteeing universal access for persons living with HIV or AIDS (PLWHs) increased their enrollment in public sector insurance. DESIGN, SETTING, AND PARTICIPANTS: A retrospective longitudinal descriptive analysis of trends in population characteristics during the study period was performed. The study population included all PLWHs in Tennessee (1992-1997) identified by the State Health Department. These data linked with Medicaid/TennCare enrollment files identified percentages of Tennessee's HIV/AIDS population enrolled in Medicaid (1993) or TennCare (1994-1997) and eligi-bility/demographics changes during program initiation. MAIN OUTCOME MEASURE: Annual percentage of PLWHs enrolled in Medicaid/TennCare. RESULTS: Absolute numbers of PLWHs served by Medicaid/TennCare increased 475% from 1992 (n = 593) to 1997 (n = 2818). Similar increases in Tennessee's overall HIV-positive population occurred. Percentages of PLWHs enrolled in Medicaid/TennCare increased (1993 to 1997): HIV (28% to 34%) and AIDS (32% to 44%). The largest percentage of PLWHs added to the program were uninsured/uninsurable. CONCLUSIONS: Absolute numbers of PLWHs covered by Medicaid/TennCare substantially increased. Percentages of PLWHs covered increased more modestly, partly owing to large increases in overall numbers of HIV-positive Tennesseans during the study period. Increases in coverage were greatest for the AIDS population. Tennessee's broad expansion of eligibility for PLWHs resulted in improved access, but did not result in enrollment of most PLWHs. States contemplating similar Medicaid expansions should not expect all PLWHs to crowd into public sector insurance programs.