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1.  Validity of Diagnostic Codes and Prevalence of Psoriasis and Psoriatic Arthritis in a Managed Care Population, 1996–2009 
Background
Few population-based studies have reported the prevalence of psoriatic disease.
Objective
We validated computerized diagnoses to estimate the prevalence of psoriasis and psoriatic arthritis.
Method
We identified adults with ≥1 ICD-9 diagnosis codes of 696.0 (psoriatic arthritis) or 696.1 (psoriasis) in clinical encounter data during 1996–2009, and used chart review to confirm the diagnoses in random samples of patients. We then used the best performing case-finding algorithms to estimate the point prevalence of psoriasis and psoriatic arthritis.
Results
The number of persons with a diagnosis for psoriasis (ICD-9 code 696.1) was 87,827. Chart review of a random sample of 101 cases with at least one dermatologist-rendered psoriasis code revealed a positive predictive value (PPV) of 90% (95% CI, 83–95) with sensitivity 88% (95% CI, 80–93). Psoriatic arthritis (code 696.0) was recorded for 5,187 patients, with the best performing algorithm requiring ≥2 diagnoses recorded by a rheumatologist or ≥1 diagnosis recorded by a rheumatologist together with ≥1 psoriasis diagnoses recorded by a dermatologist; the PPV was 80% (95% CI, 70–88) with sensitivity 73% (95% CI, 63–82). Among KPNC adults, the point prevalence of psoriasis, with or without psoriatic arthritis, was 939 (95% CI, 765–1142) per 100,000, and the overall prevalence of psoriatic arthritis, with or without psoriasis, was 68 (95% CI, 54–84) per 100,000.
Conclusion
Within an integrated health care delivery system, the use of computerized diagnoses rendered by relevant disease specialists is a valid method for identifying individuals with psoriatic disease.
doi:10.1002/pds.3447
PMCID: PMC3720770  PMID: 23637091
Psoriasis; Psoriatic Arthritis; Epidemiology; Incidence; Prevalence; Health Maintenance Organizations; Computerized Medical Information
2.  Association Between Anti-TNF-α Therapy and Interstitial Lung Disease 
Background
Anti-TNF-α agents have been hypothesized to increase the risk of interstitial lung disease (ILD), including its most severe manifestation, pulmonary fibrosis.
Methods
We conducted a cohort study among autoimmune disease patients who were members of Kaiser Permanente Northern California, 1998–2007. We obtained therapies from pharmacy data and diagnoses of ILD from review of X-ray and computed tomography reports. We compared new users of anti-TNF-α agents to new users of non-biologic therapies using Cox proportional hazards analysis to adjust for baseline propensity scores and time-varying use of glucocorticoids. We also made head-to-head comparisons between anti-TNF-α agents.
Results
Among the 8,417 persons included in the analysis, 38 (0.4%) received a diagnostic code for ILD by the end of follow-up, including 23 of 4,200 (0.5%) who used anti-TNF-α during study follow-up, and 15 of 5,423 (0.3%) who used only non-biologic therapies. The age- and gender-standardized incidence rate of ILD, per 100 person-years, was 0.21 (95% CI 0–0.43) for rheumatoid arthritis and appreciably lower for other autoimmune diseases. Compared to use of non-biologic therapies, use of anti-TNF-α therapy was not associated with a diagnosis of ILD among RA patients (adjusted hazard ratio, 1.03; 95% CI 0.51–2.07). Nor did head-to-head comparisons across anti-TNF-α agents suggest important differences in risk, although the number of cases available for analysis was limited.
Conclusion
The study provides evidence that compared to non-biologic therapies anti-TNF-α therapy does not increase the occurrence of ILD among patients with autoimmune diseases, and informs research design of future safety studies of ILD.
doi:10.1002/pds.3409
PMCID: PMC3618622  PMID: 23359391
Rheumatoid arthritis; psoriatic arthritis; psoriasis; Crohn’s Disease; ulcerative colitis; inflammatory bowel disease; pharmacoepidemiology; drug safety; drug toxicity; adverse events; cohort studies; propensity scores; automated healthcare data; interstitial lung disease; pulmonary fibrosis
3.  Non-viral Opportunistic Infections in New Users of TNF Inhibitor Therapy: Results of the SAfety Assessment of Biologic ThERapy (SABER) Study 
Annals of the rheumatic diseases  2013;73(11):1942-1948.
Objectives
To determine among patients with autoimmune diseases in the United States whether the risk of non-viral opportunistic infections (OIs) was increased among new users of tumor necrosis factor-alpha inhibitors (TNFI), when compared to users of non-biologic agents used for active disease.
Methods
We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis-psoriatic arthritis-ankylosing spondylitis (PsO-PsA-AS) patients during 1998–2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programs for the elderly, Tennessee Medicaid, and US Medicaid/Medicare programs. We compared incidence of non-viral OIs among new TNFI users and patients initiating non-biologic disease modifying drugs (DMARDs) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biologic DMARD users.
Results
Within a cohort of 33,324 new TNFI users we identified 80 non-viral OIs, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OIs among new users of TNFI as compared to those initiating non-biologic DMARDs was 2.7 verus 1.7 per 1000-person years[adjusted hazard ratio (aHR): 1.6, 95% CI: 1.0, 2.6)]. Baseline corticosteroid use was associated with non-viral OIs (aHR 2.5, 95% CI: 1.5, 4.0). In the RA cohort, rates of non-viral OIs among new users of infliximab were higher when compared to patients newly starting non-biologic DMARDs (aHR 2.6, 95% CI 1.2, 5.6) or new etanercept users (aHR 2.9, 95% CI: 1.5, 5.4).
Conclusions
In the US, the rate of non-viral OIs was higher among new users of TNFI with autoimmune diseases as compared to non-biologic DMARD users.
doi:10.1136/annrheumdis-2013-203407
PMCID: PMC4273901  PMID: 23852763
opportunistic infection; tumor necrosis factor-alpha; Pneumocystis; tuberculosis; rheumatoid arthritis
4.  Association Between Anti-TNF-α Therapy and All-Cause Mortality 
Pharmacoepidemiology and drug safety  2012;21(12):1311-1320.
Purpose
To compare mortality among patients with selected autoimmune diseases treated with anti-tumor necrosis factor alpha (TNF-α) agents with similar patients treated with non-biologic therapies.
Methods
Cohort study set within several large health care programs, 1998–2007. Autoimmune disease patients were identified using diagnoses from computerized healthcare data. Use of anti-TNF-α agents and comparison non-biologic therapies were identified from pharmacy data and mortality was identified from vital records and other sources. We compared new users of anti-TNF-α agents to new users of non-biologic therapies using propensity scores and Cox proportional hazards analysis to adjust for baseline differences. We also made head-to-head comparisons among anti-TNF-α agents.
Results
Among the 46,424 persons included in the analysis, 2,924 (6.3%) had died by the end of follow-up, including 1,754 (6.1%) of the 28,941 with a dispensing of anti-TNF-α agent and 1,170 (6.7%) of the 17,483 who used non-biologic treatment alone. Compared to use of non-biologic therapies, use of anti-TNF-α therapy was not associated with an increased mortality in patients with rheumatoid arthritis (adjusted hazard ratio [aHR] 0.93 with 95% CI 0.85–1.03); psoriasis, psoriatic arthritis, or ankylosing spondylitis (combined aHR 0.81 with CI 0.61–1.06; or inflammatory bowel disease (aHR 1.12 with CI 0.85–1.46). Mortality rates did not differ to an important degree between patients treated with etanercept, adalimumab, or infliximab.
Conclusion
Anti-TNF-α therapy was not associated with increased mortality among patients with autoimmune diseases.
doi:10.1002/pds.3354
PMCID: PMC3565563  PMID: 23065964
Rheumatoid arthritis; psoriatic arthritis; psoriasis; Crohn’s Disease; ulcerative colitis; inflammatory bowel disease; pharmacoepidemiology; drug safety; drug toxicity; adverse events; cohort studies; propensity scores; automated healthcare data; mortality
5.  Study Design for a Comprehensive Assessment of Biologic Safety Using Multiple Healthcare Data Systems 
Pharmacoepidemiology and Drug Safety  2011;20(11):1199-1209.
Background
Although biologic treatments have excellent efficacy for many autoimmune diseases, safety concerns persist. Understanding the absolute and comparative risks of adverse events in patient and disease subpopulations is critical for optimal prescribing of biologics.
Purpose
The Safety Assessment of Biologic Therapy collaborative was federally funded to provide robust estimates of rates and relative risks of adverse events among biologics users using data from national Medicaid and Medicare plus Medicaid dual-eligible programs, Tennessee Medicaid, Kaiser Permanente, and state pharmaceutical assistance programs supplementing New Jersey and Pennsylvania Medicare programs. This report describes the organizational structure of the collaborative, and the study population and methods.
Methods
This retrospective cohort study (1998–2007) examined risks of 7 classes of adverse events in relation to biologic treatments prescribed for 7 autoimmune diseases. Propensity scores were used to control for confounding and enabled pooling of individual level data across data systems while concealing personal health information. Cox proportional hazard modeling was used to analyze study hypotheses.
Results
The cohort comprised 159,000 subjects with rheumatic diseases, 33,000 with psoriasis, and 46,000 with inflammatory bowel disease. This reports summarizes demographic characteristics and drug exposures. Separate reports will provide outcome definitions and estimated hazard ratios for adverse events.
Conclusion
This comprehensive research will improve understanding of the safety of these treatments. The methods described may be useful to others planning similar evaluations.
doi:10.1002/pds.2196
PMCID: PMC3312584  PMID: 21919113
Rheumatoid arthritis; juvenile idiopathic arthritis; psoriatic arthritis; psoriasis; Crohns Disease; ulcerative colitis; inflammatory bowel disease; ankylosing spondylitis; adverse events; pharmacoepidemiology; drug safety; drug toxicity; adverse events; cohort studies; propensity scores; computerized data; administrative data; Medicaid; Medicare
6.  IRRIGATION PRACTICES IN LONG-TERM SURVIVORS OF COLORECTAL CANCER (CRC) WITH COLOSTOMIES 
Creation of a colostomy in colorectal (CRC) cancer patients results in a loss of control over bowel evacuation. The only way to re-establish some control is through irrigation, a procedure that involves instilling fluid into the bowel to allow for gas and fecal output. This article reports on irrigation practices of participants in a large, multi-site, multi-investigator study of health-related quality of life (HR-QOL) in long term CRC survivors. Questions about irrigation practices were identified in open-ended questions within a large HR-QOL survey and in focus groups of men and women with high and low HR-QOL. Descriptive data on survivors were combined with content analysis of irrigation knowledge and practices. Patient education and use of irrigation in the United States has decreased over the years, with no clear identification of why this change in practice has occurred. Those respondents who used irrigation had their surgery longer ago, and spent more time in colostomy care than those that did not irrigate. Reasons for the decrease in colostomy irrigation are unreported and present priorities for needed research.
doi:10.1188/12.CJON.514-519
PMCID: PMC3951489  PMID: 23022935
Colostomy; colorectal cancer; irrigation; bowel control
7.  Tumor Necrosis Factor Alpha Inhibitor Therapy and Cancer Risk In Chronic Immune Mediated Diseases 
Arthritis and rheumatism  2013;65(1):10.1002/art.37740.
Background
We compared the incidence of cancer following tumor necrosis factor alpha antagonists (TNF-I) therapy to that with commonly used alternative therapies across multiple immune mediated diseases.
Methods
The Safety Assessment of Biologic thERapy (SABER) study used data from national Medicaid & Medicare, Kaiser Permanente Northern California, TennCare, and pharmacy benefits plans for Medicare beneficiaries in New Jersey and Pennsylvania. Propensity score adjusted hazard ratios (HR) and 95% confidence intervals (CI) were computed to estimate the relative rates of cancer, comparing TNF-I users to alternative disease modifying therapies. The cancer finding algorithm had a positive predictive value ranging from 31% for any leukemia to 89% for female breast cancer.
Results
We included 29,555 patients with rheumatoid arthritis (13,102 person-years), 6,357 patients with inflammatory bowel disease (1,508 person-years), 1,298 patients with psoriasis (371 person-years), and 2,498 patients with psoriatic arthritis (618 person-years). The incidence of any solid cancer was not elevated in rheumatoid arthritis (HR 0.80, CI 0.59-1.08), inflammatory bowel disease (HR 1.42, CI 0.47-4.26), psoriasis (HR 0.58, CI 0.10-3.31) or psoriatic arthritis (HR 0.74, CI 0.20-2.76) during TNF-I therapy compared to disease specific alternative therapy. Among patients with rheumatoid arthritis, the incidence of any of the ten most common cancers in the United States and nonmelanoma skin cancer was not increased with TNF-I therapy compared to methotrexate failure.
Conclusions
Short-term cancer risk was not elevated among patients treated with TNF-I therapy relative to commonly used therapies for immune mediated chronic inflammatory diseases in this study.
doi:10.1002/art.37740
PMCID: PMC3778442  PMID: 23055441
rheumatoid arthritis; inflammatory bowel disease; psoriasis; psoriatic arthritis; ankylosing spondylitis; tumor necrosis factor alpha
8.  Surviving Colorectal Cancer: Long-Term, Persistent Ostomy-Specific Concerns and Adaptations 
Purpose
The purpose of this paper is to describe persistent ostomy-specific concerns and adaptations in long-term (> 5 years) colorectal cancer survivors with ostomies.
Subjects and Settings
Thirty three colorectal cancer survivors who participated in eight gender- and health related Quality of life (HRQOL) stratified focus groups and 130 colorectal cancer survivors who provided written comments to two open-ended questions on ostomy location and pouch problems participated in the study. Data were collected on health maintenance organization members in Oregon, southwestern Washington and northern California.
Methods
Qualitative data were analyzed for the 8 focus groups and written comments from 2 open-ended survey questions. Discussions from the focus groups were recorded, transcribed and analyzed using content analysis. Written content from the open-ended questions was derived from a mailed questionnaire on health related quality of life in survivors with ostomies and analyzed using content analysis.
Results
Discussions related to persistent ostomy-related issues more than 5 years after formation were common. Persistent ostomy-related issues were focused on clothing restrictions and adaptations, dietary concerns, issues related to ostomy equipment and self-care, and the constant need to find solutions to adjust and re-adjust to living with an ostomy.
Conclusions
Ostomy-specific concerns persist 5 years and more for long-term colorectal cancer survivors after initial ostomy formation. Adaptations tend to be individualized and based on trial and error. Findings underscore the need to develop long-term support mechanisms that survivors can access to promote better coping and adjustment to living with an ostomy.
doi:10.1097/WON.0b013e3182750143
PMCID: PMC3536890  PMID: 23222968
9.  Changes in Body Mass Index and Stoma Related Problems in the Elderly 
Journal of geriatric oncology  2012;4(1):84-89.
Objectives
Weight gain can cause retraction of an intestinal stoma, possibly resulting in difficulty with wafer and pouch fit, daily care challenges, and discomfort. This cross-sectional study examined the association between body mass index (BMI) and ostomy-related problems among long-term (>5 years post-diagnosis) colorectal cancer (CRC) survivors.
Materials and Methods
CRC survivors from three Kaiser Permanente Regions completed a mailed survey. The response rate for those with an ostomy was 53% (283/529). Questions included stoma-related problems and time to conduct daily ostomy care. Poisson regression evaluated associations between report of problems and change in BMI. Our analysis sample included 235 survivors.
Results
Sample was 76% ≥65 years of age. Since their surgeries, BMI remained stable in 44% (ST), decreased in 20% (DE), and increased in 35% (IN) of survivors. Compared to ST, male IN (RR 2.15 [1.09–4.25]) and female DE (RR 5.06 [1.26–25.0]) were more likely to spend more than 30 minutes per day on stoma care. IN (vs. ST) were more likely to report interference with clothing (RR 1.51 [1.06–2.17]) and other stoma-related problems (RR 2.32 [1.30–4.14]). Survivors who were obese at time of survey were more likely to report interference with clothing (RR 1.88 [1.38–2.56]) and other stoma-related problems (RR 1.68 [1.07–2.65]).
Conclusion
A change in BMI is associated with ostomy-related problems among long-term CRC survivors. Equipment and care practices may need to be adapted for changes in abdominal shape. Health care providers should caution that a significant increase or decrease in BMI may cause ostomy-related problems.
doi:10.1016/j.jgo.2012.10.172
PMCID: PMC3564631  PMID: 24071496
Colorectal cancer; ostomy; stoma; BMI; body mass index
10.  Association between the initiation of anti-TNF therapy and the risk of herpes zoster 
Importance
Herpes zoster (HZ) reactivation disproportionately affects patients with rheumatoid arthritis (RA). It is unclear whether anti-tumor necrosis factor (anti-TNF) therapy elevates HZ risk, and whether monoclonal antibodies carry greater risk than etanercept.
Objectives
To ascertain whether initiation of anti-TNF therapy compared with non-biologic comparators is associated with increased HZ risk
Design, Setting, and Patients
We identified new users of anti-TNF therapy among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis-psoriatic arthritis-ankylosing spondylitis (PsO-PsA-AS) patients during 1998–2007 within a large US multi-institutional collaboration combining data from Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and national Medicaid/Medicare programs. We compared HZ incidence between new anti-TNF users and patients initiating non-biologic disease modifying drugs (DMARDs) within each inflammatory disease cohort (last participant follow-up Dec 31, 2007). Within these cohorts, we used Cox regression models to compare propensity-score adjusted HZ incidence between new anti-TNF and non-biologic DMARD users while controlling for baseline corticosteroid use.
Main Outcome Measure
Incidence of herpes zoster cases occurring after initiation of new anti- TNF or non-biologic DMARD therapy
Results
Among 32,208 new users of anti-TNF therapy, we identified 310 HZ cases. Crude incidence rates among anti-TNF users for RA, IBD, and PsO-PsA-AS were 12.1/1000 pt-yrs, (95% CI 10.7–13.6), 11.3/1000 (95% CI 7.7–16.7), and 4.4/1000 (95% CI 2.8–7.0) respectively. Baseline use of corticosteroids of > 10mg/day was associated with elevated risk [adjusted HR 2.13 (1.64, 2.75) compared with no baseline use. For RA patients, adjusted incidence rates were similar between anti-TNF and nonbiologic DMARD initiators [adjusted HR 1.00 (95% CI 0.77–1.29) and comparable between all three anti-TNF therapies studied.
Conclusions and Relevance
Among patients with RA and other select inflammatory diseases, those who initiated anti-TNF therapies were not at higher risk for HZ compared to patients who initiated non-biologic treatment regimens.
doi:10.1001/jama.2013.1099
PMCID: PMC3773213  PMID: 23462785
shingles; zoster; herpes; biologic therapy; tumor necrosis factor-alpha; rheumatoid arthritis; adverse events; psoriasis
11.  Comparative safety of infliximab and etanercept on the risk of serious infections – Does the association vary by patient characteristics? 
Purpose
Infliximab, a chimeric monoclonal anti-TNFα antibody, has been found to increase the risk of serious infections compared with the TNF receptor fusion protein etanercept in some studies. It is unclear whether the risk varies by patient characteristics. We conducted a study to address this question.
Methods
We identified members of Kaiser Permanente Northern California who initiated infliximab (n=793) or etanercept (n=2,692) in 1997–2007. Using a Cox model, we estimated the propensity score-adjusted hazard ratio (HR) and 95% confidence interval (CI) of serious infections requiring hospitalization or opportunistic infections comparing infliximab with etanercept following treatment initiation. We tested whether the adjusted HR differed by age, sex, race/ethnicity, body mass index, and smoking status.
Results
The crude incidence rate of serious infections per 100 person-years was 5.4 (95% CI: 3.8, 7.5) in patients <65 years and 16.0 (10.4, 23.4) in patients ≥65 years during the first three months following treatment initiation. Compared with etanercept, the adjusted HR during this period was elevated for infliximab in patients <65 years (HR 3.01; 95% CI: 1.49, 6.07), but not in those ≥65 years (HR 0.94; 0.41, 2.13). Findings did not suggest that the HR varied by other patient characteristics examined.
Conclusions
An increased risk of serious infections associated with infliximab relative to etanercept did not appear to be modified by patients’ sex, race/ethnicity, body mass index, or smoking status. There was an indication that the increased risk might be limited to patients <65 years. Additional studies are warranted to verify or refute this finding.
doi:10.1002/pds.3238
PMCID: PMC3330193  PMID: 22411435
Anti-TNF agents; Database; Pharmacoepidemiology; Propensity score; Serious infections
12.  COMPLICATIONS AMONG COLORECTAL CANCER SURVIVORS: SF-6D PREFERENCE-WEIGHTED QUALITY OF LIFE SCORES 
Medical care  2011;49(3):321-326.
Background
Societal preference-weighted health-related quality of life (HRQOL) scores enable comparing multi-dimensional health states across diseases and treatments for research and policy.
Objective
To assess the effects of living with a permanent intestinal stoma, compared to a major bowel resection, among colorectal cancer (CRC) survivors.
Research Design
Cross-sectional multivariate linear regression analysis to explain preference-weighted HRQOL scores.
Subjects
Six-hundred-forty CRC survivors (≥5 years) from three group-model HMOs; ostomates and non-ostomates with colorectal resections for CRC were matched on gender, age (±5 years), time since diagnosis, and tumor site (rectum vs. colon).
Measures
SF-6D scoring system applied to Medical Outcomes Study Short Form-36 version 2 (SF-36v2); City of Hope Quality of Life-Ostomy (mCOH-QOL-O); Charlson-Deyo comorbidity index.
Methods
Survey of CRC survivors linked to respondents’ clinical data extracted from HMO files.
Results
Response rate was 52%. Ostomates and non-ostomates had similar sociodemographic characteristics. Mean SF-6D score was 0.69 for ostomates, compared to 0.73 for non-ostomates (p <.001), but other factors explained this difference. Complications of initial cancer surgery, and prior-year comorbidity burden and hospital use were negatively associated with SF-6D scores, while household income was positively associated.
Conclusions
CRC survivors’ SF-6D scores were not associated with living with a permanent ostomy after other factors were taken into account. Surgical complications, comorbidities, and metastatic disease lowered the preference-weighted HRQOL of CRC survivors with and without ostomies. Further research to understand and reduce late complications from CRC surgeries as well as associated depression is warranted.
doi:10.1097/MLR.0b013e31820194c8
PMCID: PMC3503529  PMID: 21224741
colorectal cancer; survivorship; HRQOL; stomas; ostomies; utilities
13.  GENDER DIFFERENCES IN QUALITY OF LIFE AMONG LONG-TERM COLORECTAL CANCER SURVIVORS WITH OSTOMIES 
Oncology nursing forum  2011;38(5):587-596.
Objective
To describe how gender shapes the concerns and adaptations of long-term (> 5 years) colorectal cancer (CRC) survivors with ostomies.
Design
Qualitative study using content analysis of focus group content.
Setting
Member of Kaiser Permanente, residing in either Oregon, Southwest Washington State, or Northern California.
Sample
Four female and four male focus groups selected from quantitative survey participants with health-related quality of life (HRQOL) scores in the highest or lowest quartile.
Methods
Eight focus groups, discussed challenges of living with an ostomy. Content was recorded, transcribed, and analyzed using directive and summative content analysis.
Main Research Variables
HRQOL domains of physical, psychological, social and spiritual well being.
Findings
All groups reported avoiding foods that cause gas or rapid transit, and discussed how limiting the amount of food eaten controlled the output. All groups discussed physical activities, getting support from friends and family, and the importance of being resilient. Both genders identified challenges with sexuality/intimacy. Coping and adjustment difficulties were discussed by women with men only discussing these issues to a small extent. Difficulties with sleep were primarily identified by Low HRQOL women. Problems with body image and depression were discussed only by Low HRQOL women.
Conclusions
Common issues included diet management, physical activity, social support and sexuality. Women with low HRQOL discussed problems with depression, body image, and sleep.
Implications for Nursing
Application of these gender-based differences can inform educational interventions for CRC survivors with ostomies.
doi:10.1188/11.ONF.587-596
PMCID: PMC3251903  PMID: 21875846
Ostomy; Colorectal Cancer; Quality of Life; Gender; Focus Groups
14.  Initiation of tumor necrosis factor-α antagonists and the risk of hospitalization for infection in patients with autoimmune diseases 
Context
Although tumor necrosis factor alpha (TNF-α) antagonists are increasingly used in place of non-biologic comparator medications, their safety profile remains incomplete.
Objectives
To determine whether initiation of TNF-α antagonists compared with non-biologic comparators is associated with an increased risk of serious infections.
Design, setting and patients
Within a US multi-institutional collaboration, we assembled retrospective cohorts (1998–2007) of patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, psoriatic arthritis or ankylosing spondylitis (PsO-PsA-AS) combining data from Kaiser Permanente Northern California, New Jersey and Pennsylvania Pharmaceutical Assistance programs, Tennessee Medicaid and National Medicaid/Medicare. TNF-α antagonists and non-biologic regimens were compared in disease specific-propensity score (PS) matched cohorts using Cox regression models with non-biologics as reference. Baseline glucocorticoid use was evaluated as a separate covariate.
Main outcome measure
Infections requiring hospitalization (serious infections) during the first 12 months after initiation of TNF-α antagonists or non-biologic regimens.
Results
Study cohorts included 10484 RA, 2323 IBD and 3213 PsO-PsA-AS PS-matched pairs using TNF-α antagonists and comparator medications. Overall, we identified 1171 serious infections, most of which (53%) were pneumonia and skin and soft tissue infections. Among RA patients, serious infection hospitalization rates were 8.16 (TNF-α antagonists) and 7.78 (comparator regimens) per 100 person-years (adjusted hazard ratio [aHR]: 1.07 (95% CI: 0.93–1.23)). Among IBD patients, rates were 10.91 and 9.60 per 100 person-years (aHR: 1.13, (0.85–1.50)). Among PsO-PsA-AS patients, rates were 5.41 and 5.19 per 100 person-years (aHR: 1.10, (0.80–1.53)). Among RA patients, infliximab was associated with a significant increase in serious infections compared with etanercept and adalimumab (aHRs: 1.27 (1.08–1.49) and 1.23 (1.02–1.48)). Baseline glucocorticoid use was associated with a dose-dependent increase in infections.
Conclusions
Among patients with autoimmune diseases, compared to treatment with non-biologic regimens, initiation of TNF-α antagonists was not associated with an increased risk of hospitalizations for serious infections.
doi:10.1001/jama.2011.1692
PMCID: PMC3428224  PMID: 22056398
Rheumatoid arthritis; inflammatory bowel disease; psoriasis; psoriatic arthritis; ankylosing spondylitis; infliximab; etanercept; adalimumab; safety; infection
15.  EARLY AND LATE COMPLICATIONS AMONG LONG-TERM COLORECTAL CANCER SURVIVORS WITH OSTOMY OR ANASTOMOSIS 
Diseases of the Colon and Rectum  2010;53(2):200-212.
Purpose
Among long-term (≥5 years) colorectal cancer survivors with permanent ostomy or anastomosis, we compared the incidence of medical and surgical complications and examined the relationship of complications with health-related quality of life.
Background
The incidence and effects of complications on long-term health-related quality of life among colorectal cancer survivors are not adequately understood.
Methods
Participants (284 ostomy/395 anastomosis) were long-term colorectal cancer survivors enrolled in an integrated health plan. Health-related quality of life was assessed via mailed survey questionnaire in 2002–2005. Information on colorectal cancer, surgery, co-morbidities, and complications was obtained from computerized data and analyzed using survival analysis and logistic regression.
Results
Ostomy and anastomosis survivors were followed an average 12.1 and 11.2 years, respectively. Within 30 days of surgery, 19% of ostomy and 10% of anastomosis survivors experienced complications (p<0.01). From 31 days on, the percentages were 69% and 67% (after adjustment, p<0.001). Bleeding and post-operative infection were common early complications. Common long-term complications included hernia, urinary retention, hemorrhage, skin conditions, and intestinal obstruction. Ostomy was associated with long-term fistula (odds ratio 5.4; 95% CI 1.4–21.2), and among ostomy survivors, fistula was associated with reduced health-related quality of life (p<0.05).
Conclusions
Complication rates remain high despite recent advances in surgical treatment methods. Survivors with ostomy have more complications early in their survivorship period, but complications among anastomosis survivors catch up after 20 years, when the two groups have convergent complication rates. Among colorectal cancer survivors with ostomy, fistula has especially important implications for health-related quality of life.
doi:10.1007/DCR.0b013e3181bdc408
PMCID: PMC3320086  PMID: 20087096
16.  Health-Related Quality of Life Among Long-Term Rectal Cancer Survivors With an Ostomy: Manifestations by Sex 
Journal of Clinical Oncology  2009;27(28):4664-4670.
Purpose
Intestinal stomas can pose significant challenges for long-term (≥ 5 years) rectal cancer (RC) survivors. Specifying common challenges and sociodemographic or clinical differences will further the development of tailored interventions to improve health-related quality of life (HRQOL).
Patients and Methods
This was a matched cross-sectional study of long-term RC survivors conducted in three Kaiser Permanente regions. The mailed questionnaire included the modified City of Hope Quality of Life-Ostomy (mCOH-QOL-Ostomy) and Medical Outcomes Study 36-Item Short-Form Health Survey, version 2 (SF-36v2). Groups surveyed were permanent ostomates (cases) and those who did not require an ostomy (controls). RC survivors were matched on sex, age, and time since diagnosis. Comparisons between groups used regression analysis with adjustment for age, comorbidity score, history of radiation therapy, income, and work status.
Results
Response rate was 54% (491 of 909). Cases and controls had similar demographic characteristics. On the basis of the mCOH-QOL-Ostomy, both male and female cases had significantly worse social well-being compared with controls, while only female cases reported significantly worse overall HRQOL and psychological well-being. For younger females (< age 75 years), ostomy had a greater impact on physical well-being compared with older females. Based on the SF-36v2, statistically significant and meaningful differences between female cases and controls were observed for seven of the eight scales and on the physical and mental component summary scores.
Conclusion
Men and women report a different profile of challenges, suggesting the need for targeted or sex-specific interventions to improve HRQOL in this population. This may include focus on physical HRQOL for female ostomy survivors younger than age 75.
doi:10.1200/JCO.2008.20.9502
PMCID: PMC2754912  PMID: 19720920
17.  The Health-Related Quality of Life in Long-Term Colorectal Cancer Survivors Study: objectives, methods, and patient sample 
Current medical research and opinion  2008;24(7):2059-2070.
Objectives
The objective of this paper is to describe the complex mixed-methods design of a study conducted to assess health-related quality of life (HRQOL) outcomes and ostomy-related obstacles and adjustments among long-term (>five years) colorectal cancer (CRC) survivors with ostomies (cases) and without ostomies (controls). In addition, details are provided regarding the study sample and the psychometric properties of the quantitative data collection measures used. Subsequent manuscripts will present the study findings.
Research Design and Methods
The study design involved a cross-sectional mail survey for collecting quantitative data and focus groups for collecting qualitative data. The study subjects were individuals identified as long-term CRC survivors within a community-based health maintenance organization's enrolled population. Focus groups comprised of cases and divided by gender and HRQOL high and low quartile contrasts (based on the mail survey data) were conducted.
Main Outcome Measures
The modified City of Hope Quality of Life (mCOH-QOL)-Ostomy and SF-36v2 questionnaires were used in the mail survey. An abridged version of the mCOH-QOL-Ostomy was used for the control subjects. Focus groups explored ostomy-related barriers to self-care, adaptation methods/skills, and advice for others with an ostomy.
Results
The survey response rate was 52% (679/1308) and 34 subjects participated in focus groups. The internal consistency reliability estimates for the mCOH-QOL-Ostomy and SF-36v2 questionnaires were very acceptable for group comparisons. In addition, evidence supports the construct validity of the abridged version of the mCOH-QOL-Ostomy. Study limitations include potential non-response bias and limited minority participation.
Conclusions
We were able to successfully recruit long-term CRC survivors into this study and the psychometric properties of the quantitative measures used were quite acceptable. Mixed-methods designs, such as the one used in this study, may be useful in identification and further elucidation of common problems, coping strategies, and HRQOL outcomes among long-term cancer survivors.
doi:10.1185/03007990802118360
PMCID: PMC2575021  PMID: 18544186
Colorectal cancer; Health-related quality of life; Ostomy; Patient-reported outcomes; Stomas, Qualitative research
18.  Specificity of Clinical Breast Examination in Community Practice 
Background
Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (∼94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity.
Objective
To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity.
Design
Retrospective cohort study.
Subjects
Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484).
Measurements
Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered “average-risk” if they had neither a family history of breast cancer nor a prior breast biopsy and “increased-risk” otherwise.
Results
Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8–99.7%] and 97.1% (95% CI: 95.7–98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7–76.5%) and 57.1% (95% CI: 51.1–63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10–0.46).
Conclusions
Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.
doi:10.1007/s11606-006-0062-7
PMCID: PMC1824753  PMID: 17356964
breast cancer; sensitivity and specificity; screening; physical examination
19.  Specificity of Clinical Breast Examination in Community Practice 
Background
Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (∼94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity.
Objective
To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity.
Design
Retrospective cohort study.
Subjects
Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484).
Measurements
Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered “average-risk” if they had neither a family history of breast cancer nor a prior breast biopsy and “increased-risk” otherwise.
Results
Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8–99.7%] and 97.1% (95% CI: 95.7–98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7–76.5%) and 57.1% (95% CI: 51.1–63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10–0.46).
Conclusions
Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.
doi:10.1007/s11606-006-0062-7
PMCID: PMC1824753  PMID: 17356964
breast cancer; sensitivity and specificity; screening; physical examination

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