Don Robinson

Cardiovascular Disease and Risk Factors among Psoriasis Patients in Two US Healthcare Databases, 2001–2002

Background: Cardiovascular diseases or risk factors (CVDR) seem to be more common in psoriasis patients than in the general population. Objective: We assessed the relationship of psoriasis with CVDR by analysis of healthcare claims data using a cross-sectional, prevalence-based study design. Patients and Methods: The IMS Health and MarketScan® claims databases were used to identify adults with psoriasis diagnostic codes. Non-psoriasis controls were matched 3:1 based on age, gender, census region and previous medical insurance coverage. Odds ratios evaluated the relative prevalence of CVDR, and Mantel-Haenszel confidence intervals were estimated. Results: CVDR prevalence was generally higher in psoriasis patients than controls in both datasets. Odds ratios for atherosclerosis, congestive heart failure, type 2 diabetes, and peripheral vascular disease were ≧1.20 for psoriasis patients. Elevated disease severity was associated with a higher rate of CVDR, but varied somewhat by dataset and condition. Conclusions: Elevated CVDR rates were found in psoriasis patients compared with controls. This pattern merits further examination.

Autoimmune disease concomitance among inflammatory bowel disease patients in the United States, 2001-2002

Background: Recent studies suggest that inflammatory bowel disease (IBD) may share an underlying pathogenesis with other autoimmune diseases. Methods: Two United States data sets with patient‐level medical and drug claims were used to explore the occurrence of autoimmune diseases in patients with IBD, particularly Crohns disease (CD) and ulcerative colitis (UC), with that in controls. From 2001 to 2002 IBD patients were identified using International Classification of Diseases, 9th revision, diagnosis codes in the IMS Health Integrated Administration Claims Database and the Market Scan Commercial Claims and Encounters Database. Controls were selected by matching on sex, age, Census Bureau region, and length of previous medical insurance coverage. Odds ratios (ORs) evaluated the risk relationship between IBD patients and controls within an estimated Mantel‐Haenszel 95% confidence interval. Sensitivity analysis tested the case identification method used to select IBD patients. Results: The risk for ankylosing spondylitis (AS) was substantially increased across both data sets: OR (95% confidence interval [CI]) of 7.8 (5.6–10.8) in IMS Health and 5.8 (3.9–8.6) in MarketScan. The risk for rheumatoid arthritis (RA) was 2.7 (2.4–3.0) and 2.1 (1.8–2.3), respectively; for multiple sclerosis (MS); the ORs were 1.5 (1.2–1.9) and 1.6 (1.2–2.1), respectively. There was no increased risk for type 1 diabetes mellitus, and the results for psoriatic arthritis (PsA) were inconsistent. The sensitivity analysis supported these findings. Conclusions: A much higher risk for RA, AS, PsA, and MS was observed in IBD patients compared with controls. Prospective epidemiologic studies are needed to confirm these findings and explore the pathogenic mechanism of this relationship.

Co-occurrence and comorbidities in patients with immune-mediated inflammatory disorders: an exploration using US healthcare claims data, 2001-2002.

ABSTRACT Objective: Research in immune-mediatedinflammatory disorders (IMIDs) suggests that several diseases share disruptions in key cytokines. A common pathogenesis may present as similar patterns of disease co-occurrence and comorbidity, which could be observed through the analysis of healthcare claims datasets. Methods: Adult patients continuously enrolled from 2001–2002 were identified in two US healthcare datasets containing medical and drug claims from health plans and self-insured employers. Patients with treatment records indicating an IMID were selected (e.g., rheumatoid arthritis, psoriasis, Crohns disease); controls for each disorder were matched 3:1 based on age, gender, region, and previous insurance coverage. IMID cohorts and comorbidities were identified using International Classification of Diseases, 9th revision codes. Prevalence relative risk was used to assess co-occurrence and comorbidity rates in IMID cohorts and controls. Medical and drug utilization patterns were also explored. Results: Findings were similar across the two datasets. IMID patients represented about 4% of the population; specific IMID prevalence matched the epidemiology literature. Patients with at least one IMID had a higher risk for another IMID when compared to controls. The risk for infectious, renal, liver, and ulcerative comorbidities was also elevated. Selected drug utilization patterns confirmed comorbidity findings. IMID patients used more healthcare resources compared to controls; findings were robust under sensitivity analyses. Conclusions: IMID patients were generally more likely than controls to have another IMID, supporting the concept that the diseases are related. These patients also had higher comorbidity rates. Findings may be limited by the nature of claims datasets and the confounding effect of current treatments. Prospective studies are needed to determine whether IMIDs have a common pathogenesis.

The burden of autoimmune disease: A comparison of prevalence ratios in patients with psoriatic arthritis and psoriasis

BACKGROUNDnCurrent research has confirmed that many inflammatory autoimmune (AI) diseases are due to derangements in multiple cytokine pathways. Some of these cytokines appear to play comparable key roles across diseases, suggesting that a similar underlying systemic inflammatory cascade could be responsible for various disease states. A recent study supports the hypothesis of a common cytokine-based pathology by showing that having one AI disease significantly increased the risk of having another AI disease. Psoriasis is an AI, manifesting as a chronic inflammatory skin condition and is clearly associated with other conditions, most obviously psoriatic arthritis (PsA).nnnOBJECTIVEnWe sought to examine whether patients with PsA enrolled in managed health care plans carry a higher AI disease burden than patients with cutaneous psoriasis only (PsO).nnnMETHODSnPatients 18 years or older enrolled in a health claims database were classified by two clinical subtypes: PsA and PsO. Control subjects were matched 3:1 to patients with psoriasis on age, sex, census region, and length of previous medical insurance coverage. AI disease diagnoses were identified through International Classification of Diseases, Ninth Revision codes. The association of other AI diseases with each psoriasis cohort was assessed using a prevalence ratio.nnnRESULTSnPsO was associated with a higher prevalence ratio for the 3 gastrointestinal diseases: Crohn disease (1.6 [confidence interval {CI} 1.4-2.0]), ulcerative colitis (1.3 [CI 1.1-1.6]), and inflammatory bowel disease (1.4 [CI 1.2-1.6]). PsA was also associated with a higher prevalence ratio for the gastrointestinal diseases: Crohn disease (2.1 [CI 1.3-3.3]), ulcerative colitis (2.0 [CI 1.3-3.1]), and inflammatory bowel disease (1.8 [CI 1.3-2.5]). Patients with PsA had an increased prevalence ratio associated with giant cell arteritis (4.8 [CI 1.5-15.7]) and pulmonary fibrosis (1.9 [CI 1.2-3.0]).nnnLIMITATIONSnDetection and misclassification biases may have affected these findings.nnnCONCLUSIONSnThese findings support the hypothesis that PsA and PsO are associated with development of other AI diseases. The data suggest that evaluating patients with psoriasis for other associated disorders in a prospective manner may be important, because they may be more likely to experience the onset of another AI disease. Treatment planning for these patients could, therefore, require the medical management of more than one AI disease. Further, our data suggest that PsA and PsO may be divergent in ways previously not described that could inform future research.

Impact of systemic lupus erythematosus on health, family, and work: the patient perspective.

Qualitative research among patients with systemic lupus erythematosus (SLE) can identify aspects of the disease relevant to clinical research and practice. A phenomenological, mixed‐method approach was used to investigate these disease‐driven health issues.

Systemic sclerosis prevalence and comorbidities in the US, 2001–2002

ABSTRACT Objective: Large, population-based assessments of systemic sclerosis (SSc) prevalence and comorbidity in the United States (US) are rare. We explored autoimmune disease and other comorbidity patterns among SSc patients in the US from 2001 to 2002 and compared these with controls. Research design and methods: Two US datasets with patient-level medical and drug claims were used to assess SSc prevalence and comorbidity: IMS Health Integrated Administrative Claims Database (IMS Health) and the MarketScan Commercial Claims and Encounters Database (MarketScan). SSc patients and comorbidities were identified by International Classification of Diseases (ICD), 9th revision diagnostic codes appearing on medical claims. Patients without SSc diagnostic codes (controls) were selected and matched 4u2009:u20091 to SSc patients based on sex, age, Census Bureau region, and previous insurance coverage. The prevalence relative risk (RR) statistic compared comorbidity occurrence between SSc patients and controls, with 95% confidence intervals estimated using the Mantel–Haenszel method. Several sensitivity analyses tested methods used for identifying SSc cases and the prevalence of comorbidities. Results: In both databases, SSc prevalence was 0.05% using the standard population model, 0.03% under sensitivity analysis. Among SSc patients the risks for inflammatory bowel disease (IBD) and multiple sclerosis (MS) were notably higher across datasets than for those without SSc: RR 3.2–6.6 for MS, RR 2.1–2.2 for IBD, in MarketScan and IMS Health, respectively (u2009p < 0.05 for all). The chronic disease burden of SSc patients was much higher than that of controls, as confirmed by two chronicity measures (Chronic Disease Score, Elixhauser Comorbidity Index). The risks for cardiovascular, renal, liver and several neuropsychiatric diseases were higher for SSc patients across both datasets. Sensitivity analyses supported these findings. Conclusions: These data provide a population-based estimate of US prevalence of SSc and document the higher risk for certain other autoimmune diseases among SSc patients when compared to controls. Patients with SSc also had a higher chronic disease burden than those without SSc. These findings are limited by the unknown validity of ICD-9 codes for SSc case identification, unbalanced regional representation, and a likely ‘healthy worker’ effect in these databases.

Content Development for the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM): Use of Qualitative and Quantitative Methods for Scale Construction

CONTEXTnMultiple myeloma (MM) is a common hematologic malignancy and is associated with symptom burden and impairments in health-related quality of life (HRQL).nnnOBJECTIVESnTo develop a disease-specific, patient-reported outcome (PRO) measure for the assessment of HRQL among patients with MM as part of the Functional Assessment of Cancer Therapy (FACT) measurement system.nnnMETHODSnHRQL concerns and symptoms associated with MM were tabulated based on a literature review, and 52 candidate PRO items were identified. Expert clinicians (n=13) rated 52 items on relevance to HRQL for MM patients (0-3 scale). Experts added 11 items for comprehensive PRO assessment in MM. A list of 63 candidate items was rated (0-3 scale) by 13 MM patients enrolled through the International Myeloma Foundation website. Qualitative data and quantitative item ratings were reviewed to select FACT-MM scale items.nnnRESULTSnExpert clinicians provided the highest HRQL relevance ratings for bone pain, bodily pain, difficulty walking (2.9), tiring easily (2.6), feeling discouraged (2.5), interference with activities and difficulty with self-care as a result of bone pain (2.5), and fatigue (2.5). Mean age of patients was 57 years; Eastern Cooperative Oncology Group performance status was 0 (38%), 1 (31%), or 2 (31%). Quantitative ratings by patients identified sexual function (1.3), uncertainty about health (1.2), fatigue (1.0), weight gain (1.0), and emotional concerns, such as worry about new symptoms and difficulty planning for the future (1.0) as most relevant to HRQL.nnnCONCLUSIONnThe 14-item FACT-MM PRO measure was developed based on expert clinician and patient data, ensuring relevance to HRQL for MM patients.

A Comparison of the Renal Cell Carcinoma―Symptom Index (RCC-SI) and the Functional Assessment of Cancer Therapy―Kidney Symptom Index (FKSI)

The development and validation of measures that provide disease-specific, patient-reported outcomes have become increasingly relevant in the care of cancer patients, especially for assessing symptoms from the patients perspective. Recently, two patient symptom questionnaires were developed for kidney cancer patients, the Renal Cell Carcinoma-Symptom Index (RCC-SI) and the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). This article describes the development of the revised FKSI scale (FKSI-19) and reconciles its use with the RCC-SI. Fifty participants with advanced kidney cancer commented on their symptoms and concerns about kidney cancer and this input was used to revise FKSI items. These patients also completed the RCC-SI, the Functional Assessment of Cancer Therapy-General (FACT-G), and an older version of the FKSI scale. We qualitatively reviewed item wording and content coverage across the two instruments, examined correlations between the scales, and calculated basic psychometrics on each scale. We found that the FKSI-19 and the RCC-SI addressed similar symptoms. Qualitative and descriptive statistical analyses demonstrated considerable overlap between the two instruments (rho=0.88, P<0.001). Cronbachs alpha for the FKSI-19 and RCC-SI were both good, at 0.86 and 0.92, respectively. The FKSI-19 has some advantages over the RCC-SI. The FKSI-19 has more clarity in item phrasing, is shorter in length, and covers a similar breadth of disease-based symptoms when compared to the RCC-SI.

Health perceptions and clinical characteristics of relapsing- remitting multiple sclerosis patients: baseline data from an international clinical trial

ABSTRACT Objective: Baseline clinical and health-related quality of life (HRQoL) data from a phase 2, multi-site, international, randomized, controlled trial were analyzed to: (1) characterize the health status of patients with relapsing-remitting multiple sclerosis (RRMS), (2) explore cross-sectional relationships between HRQoL and clinical measures, and (3) evaluate differences in HRQoL scores for subsequent validation as minimally important differences (MID). Clinical Trial Registration: www.clinicaltrials.gov, NCT00207727. Research design and methods: Baseline clinical and HRQoL data were selected and analyzed. HRQoL questionnaires included the Short Form-36 (SF-36), Fatigue Severity Scale (FSS), a Patient Assessment of multiple sclerosis (MS) Impact (PAMSI), and MS-specific symptom scales for Bladder and Bowel Control, Cognition, and Sexual Satisfaction. Standard summary statistics described the population while Pearson and Spearman correlations evaluated the baseline association between HRQoL and clinical measures. Cross-sectional estimates of MID in HRQoL scores were derived using several clinical anchors, the PAMSI, and two tests: Tukey multiple comparisons and adjacent mean difference. Results: Patients (nu2009=u2009249) had a mean age of 39.0 (Standard deviation, SDu2009=u200910.5), 70% were female, 63% resided in Europe, and 96% were Caucasian. Baseline median Expanded Disability Severity Scale (EDSS) was 2.5 (rangeu2009=u20090.0–6.5); median disease duration was 1.9 years (rangeu2009=u20090.1–33.6). The worst baseline mean (normalized) SF-36 scores were for General Health (39.9), Role Physical (40.4), Physical Functioning (41.0), and Vitality (42.7). The worst MS symptom mean scores were for Cognition (6.3) and FSS (4.4). Fatigue scores indicated substantial burden and were consistent with SF-36 Vitality results. Baseline HRQoL scores (SF-36, FSS, MS symptom scales) correlated most with EDSS, Multiple Sclerosis Functional Composite (MSFC), age and disease duration. Lesion count and pre-baseline relapse rate had no meaningful association with HRQoL or other clinical measures. The MID for several HRQoL measures are proposed for confirmation in longitudinal patient datasets. Conclusion: Clinical and HRQoL assessments documented health impairments in physical functioning, fatigue, and cognition among these RRMS patients with relatively short disease duration. HRQoL data varied with clinical measures and contributed new information regarding disease burden. The association between clinical and HRQoL measures was limited to cross-sectional analysis and requires confirmation in longitudinal datasets. These findings reflect an ambulatory, early-stage RRMS population that was mostly European in location or descent. The PAMSI also requires further validation as a measure of patient health status.