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More than a decade ago, it was clear that conceptually, extensible Business Reporting Language, known as XBRL, was the wave of the future for financial reporting. Many in the field [...]

Outcomes research typically assesses three major health care outcomes, including quantity of life, quality of life (QOL), and health care cost. This article highlights the impact of treatment-associated mucositis on health care costs and QOL. After a background description of the economic analyses of overall cancer treatment costs and of the incremental costs associated with other treatment side effects, data from a retrospective study of mucositis-specific costs are presented. The second half of this article reviews current knowledge about the effect that mucositis has on QOL. Because the empirical work that specifically evaluates mucositis and QOL is quite limited, studies examining proxies for mucositis grading are described. These include studies comparing the QOL of patients currently undergoing treatment, in which symptoms likely to be associated with mucositis are worse, with that of patients who have completed treatment. Also discussed are investigations examining both the relationship between specific mucositis-associated symptoms, such as pain and difficulty swallowing, and QOL and the weighting of different domains of mucositis-associated problems. Finally, several future research directions are suggested, with the intent of expanding knowledge about the economic and QOL impact of mucositis in patients treated for head and neck cancer.

Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo.

Successful management of complex conditions such as systemic lupus erythematosus (SLE) and comorbid conditions benefit from patient-reported outcomes (PRO). Measuring health-related quality of life with PROs provides SLE patients with an opportunity to participate in their treatment and to facilitate better communication with the multidisciplinary team involved in their care. Health outcomes research has produced well-validated instruments that can be used across diseases; others have been specifically developed for SLE. The use of generic and SLE-specific PROs depends on needs, including population monitoring, treatment decision making, clinical trials research, and for evaluating and comparing the effect of therapies.

One of the PROMIS (Patient-Reported Outcome Measurement Information System) network’s primary goals is the development of a comprehensive item bank for patient-reported outcomes of chronic diseases. For its first set of item banks, PROMIS chose to focus on pain, fatigue, emotional distress, physical function, and social function. An essential step for the development of an item pool is the identification, evaluation, and revision of extant questionnaire items for the core item pool. In this work, we also describe the systematic process wherein items are classified for subsequent statistical processing by the PROMIS investigators. Six phases of item development are documented: identification of extant items, item classification and selection, item review and revision, focus group input on domain coverage, cognitive interviews with individual items, and final revision before field testing. Identification of items refers to the systematic search for existing items in currently available scales. Expert item review and revision was conducted by trained professionals who reviewed the wording of each item and revised as appropriate for conventions adopted by the PROMIS network. Focus groups were used to confirm domain definitions and to identify new areas of item development for future PROMIS item banks. Cognitive interviews were used to examine individual items. Items successfully screened through this process were sent to field testing and will be subjected to innovative scale construction procedures.

The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years.

OBJECTIVE: This study validated a brief measure of fatigue in rheumatoid arthritis (RA), the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. METHODS: The FACIT Fatigue was tested along with measures previously validated in RA: the Multidimensional Assessment of Fatigue (MAF) and Medical Outcomes Study Short-Form 36 (SF-36) Vitality. The sample included 636 patients with RA enrolled in a 24 week double blind, randomized clinical trial (RCT) of adalimumab versus placebo. RESULTS: The FACIT Fatigue showed good internal consistency (alpha = 0.86 to 0.87), strong association with SF-36 Vitality (r = 0.73 to 0.84) and MAF (r = –0.84 to –0.88), and the ability to differentiate patients according to clinical change using the American College of Rheumatology (ACR) response criteria (ACR 20/50/70). Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures. A minimally important difference in FACIT Fatigue change score of 3–4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo. CONCLUSION: The FACIT Fatigue is a brief, valid measure for monitoring this important symptom and its effects on patients with RA.

Summary We assessed the reliability, validity, and responsiveness to change of the 6-item Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) in a sample of 615 metastatic breast cancer patients. The FBSI is a brief, clinically relevant, and psychometrically sound instrument that can be used to measure symptoms in patients with breast cancer.

Anemia is a common disorder in patients with cancer and can be caused by the disease itself or by cancer-related therapy. The cardinal symptom of anemia, fatigue, is the most commonly reported symptom in patients with cancer and has profound effects on patient well-being and quality of life. Until recently, blood transfusions were the mainstay of management of cancer-related anemia, despite attendant risks of transfusion-related reactions and transmission of infection. Recombinant human erythropoietin (epoetin-), an effective alternative to blood transfusion, has been shown to improve hematologic parameters, including hemoglobin levels, Hematocrit, and transfusion requirements. Clinical trials have also suggested that this intervention has a positive impact on the quality of life of patients with cancer. The literature published between November 2000 and October 2001 continues to support a positive effect of epoetin- therapy on the quality of life of patients with cancer and includes investigations of dosing schedules more convenient for patients and trials of longer-acting versions of epoetin-, such as the novel erythropoiesis-stimulating protein. Future studies that incorporate measures of patient-reported outcomes and rigorous methodologic designs are needed to strengthen and elucidate this association between these pharmacologic therapies for cancer-related anemia and quality of life.

This study examined the neurocognitive functioning of 554 end-stage renal disease (ESRD) patients to determine the underlying factor structure of tests of attention and memory and to assess the differential impact of psychosocial and biomedical variables on these factors. Analysis revealed three underlying factors: Sustained Attention, Focused Attention, and Memory Recall. Hierarchical regression analyses revealed that psychosocial and biomedical variables were most strongly related to the Focused Attention factor. Education, vocabulary score, age, race, age by creatinine, creatinine, and renal replacement therapy accounted for 30% of variance in Focused Attention; sex, depression, and hypertension were unrelated. After controlling for demographic and medical variables, type of renal replacement therapy was a statistically, but not clinically, significant predictor of Focused Attention, with peritoneal dialysis associated with better attentional performance relative to hemodialysis. The potential relationship between focused attention and compliance is discussed.

Noncompliance to treatment regimen after kidney transplantation is a threat to health outcomes and cost containment. Although there are methodological challenges to obtaining reliable compliance data, the results of noncompliance are increased morbidity and mortality in posttransplant patients. In addition, recent research suggests that patients who incur repeated rejection episodes leading to graft failure have higher levels of medical utilization. Some psychosocial factors related to compliance and medical utilization are potentially modifiable through cognitive-behavioral intervention.

Stringent long-term control of blood glucose concentration in patients with insulin-dependent diabetes mellitus (IDDM) can decrease albuminuria, presumably forestalling development of renal insufficiency. Personality characteristics may influence a diabetic patient's ability and willingness to follow a prescribed regimen to achieve glycemic control. This study investigated the relationship of 2 personality factors to renal deterioration time (from initiation of insulin therapy to renal failure) in 85 patients with IDDM and end-stage renal disease. Persons moderate in the personality trait of neuroticism and high in conscientiousness had renal deterioration times that were 12 years longer than persons with either high or low neuroticism and low conscientiousness, presumably because of better self-care. The implications of this study's findings are discussed.

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Presents the poem "When Chickens Die," by Susan Yount. First Line: A scrawny-eight-year-old; Last Line: Especially me at scrawny eight.

There are several advantages to including comprehensive health-related quality of life (HRQL) in symptom trials in oncology. The most obvious is to test the hypothesis that HRQL will be improved in addition to the symptom benefit. We should not “require,” however, that a successful symptom intervention also improve other dimensions of HRQL. On the other hand, we should expect that it will not make other dimensions worse through side effects or exacerbation of disease, even if it improves the symptom. HRQL assessment in the trial helps evaluate the competing risks of any therapy. Furthermore, assessment of HRQL is now accomplished with very brief assessment (usually 30 questions or less), and the knowledge gained is valuable. With HRQL, one can compare cancer patients with those with other conditions and can determine the contribution of symptoms and side effects to the more broadly defined HRQL. Examples using the Functional Assessment of Cancer Therapy measurement system will demonstrate how HRQL assessment has contributed to our understanding of common cancer symptoms and their place in the conceptualization of HRQL. The prevalence of clinically significant symptoms is greatest in poor performance status (PS) patients compared with patients with good PS. Symptom improvement trials specifically designed for these patients should be encouraged, particularly with interventions that can provide symptomatic relief and improve multidimensional HRQL.

Presents the poem "Leota," by Susan Yount. First Line: In Leota, Indiana; Last Line: a damned-flooded creek.

During the past year, researchers published several trials supporting the efficacy of cognitive-behavioral therapy in the prevention and treatment of a variety of medical disorders. Applications and advances in cancer, chronic pain, cardiovascular disorders, HIV and AIDS, and obesity are presented. Future directions for further establishing the use and cost-effectiveness of cognitive-behavioral interventions are discussed.