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.

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.

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.

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.

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.

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.

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.

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.

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.