Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Diagnosis and testing in bronchiolitis: a systematic review.

BACKGROUND: The diagnosis of bronchiolitis is based on typical history and results of a physical examination. The indications for and utility of diagnostic and supportive laboratory testing (eg, chest x-ray films, complete blood cell counts, and respiratory syncytial virus testing) are unclear. OBJECTIVES: To review systematically the data on diagnostic and supportive testing in the management of bronchiolitis and to assess the utility of such testing. DESIGN: In conjunction with an expert panel, we generated admissibility criteria and derived relevant terms to search the literature published from 1980 to November 2002 in MEDLINE and the Cochrane Collaboration Database of Controlled Clinical Trials. Trained abstractors completed detailed data collection forms for each article. We summarized the data in tables after performing data integrity checks. RESULTS: Of the 797 abstracts identified, we present evidence from 82 trials that met our inclusion criteria (17 are primary articles on diagnosis of bronchiolitis and 65are reports of treatment or prevention trials). Numerous studies demonstrate that rapid respiratory syncytial virus tests have acceptable sensitivity and specificity, but no data show that respiratory syncytial virus testing affects clinical outcomes in typical cases of the disease. Seventeen studies presented chest x-ray film data. Abnormalities on chest x-ray films ranged from 20% to 96%. Insufficient data exist to show that chest x-ray films reliably distinguish between viral and bacterial disease or predict severity of disease. Ten studies included complete blood cell counts, but most did not present specific results. In one study, white blood cell counts correlated with radiologically defined disease categories of bronchiolitis. CONCLUSIONS: A large number of studies include diagnostic and supportive testing data. However, these studies do not define clear indications for such testing or the impact of testing on relevant patient outcomes. Given the high prevalence of this disease, prospective studies of the utility of such testing are needed and feasible.

Pharmacologic treatment of bronchiolitis in infants and children: a systematic review.

BACKGROUND: Bronchiolitis is the most common lower respiratory tract infection in infants. Up to 3% of all children in their first year of life are hospitalized with bronchiolitis. Bronchodilators and corticosteroids are commonly used treatments, but little consensus exists about optimal management strategies. OBJECTIVE: To conduct a systematic review of the effectiveness of commonly used treatments for bronchiolitis in infants and children. DATA SOURCES: We searched MEDLINE and the Cochrane Controlled Trials Register for references to randomized controlled trials of bronchiolitis treatment published since 1980. STUDY SELECTION: Randomized controlled trials of interventions for bronchiolitis in infants and children were included if they were published in English between 1980 and November 2002 and had a minimum sample size of 10. DATA EXTRACTION: We abstracted data on characteristics of the study population, interventions used, and results of studies meeting entry criteria into evidence tables and analyzed them by drug category. DATA SYNTHESIS: Interventions were grouped by drug category and qualitatively synthesized. RESULTS: Of 797 abstracts identified in the literature search, we included 54 randomized controlled trials. This review includes 44 studies of the most common interventions: epinephrine (n = 8), beta2-agonist bronchodilators (n = 13), corticosteroids (n = 13), and ribavirin (n = 10). Studies were, in general, underpowered to detect statistically significant outcome differences between study groups. Few studies collected data on outcomes that are of great importance to parents and clinicians, such as the need for and duration of hospitalization. CONCLUSIONS: Overall, little evidence supports a routine role for any of these drugs in treating patients with bronchiolitis. A sufficiently large, well-designed pragmatic trial of the commonly used interventions for bronchiolitis is needed to determine the most effective treatment strategies for managing this condition.

Spine and pain clinics serving North Carolina patients with back and neck pain: what do they do, and are they multidisciplinary?

STUDY DESIGN: Cross-sectional survey. OBJECTIVE: Our primary objective was to describe spine and pain clinics serving North Carolina residents with respect to organizational characteristics. Our secondary objective was to assess the multidisciplinary nature of the clinics surveyed. SUMMARY OF BACKGROUND DATA: Pain clinics have become common in the United States, and patients with chronic back pain have increasingly been seeking services at these clinics. Little is known about the organizational characteristics of spine and pain clinics. METHODS: We identified and surveyed spine and pain clinics serving North Carolina residents with chronic back and neck pain. Practice managers at 46 clinics completed a 20-minute questionnaire about the characteristics of their clinic, including providers on staff and services offered. Descriptive and exploratory analyses were conducted to summarize the data. Several variables were constructed to assess the multidisciplinary nature of the clinics. RESULTS: The response rate was 75%. There was marked heterogeneity among the clinics surveyed. Fifty-nine percent of practices were free-standing (n = 27) and 61% were physician-owned (n = 28). Twenty-five clinics (54%) had an anesthesiologist. Other common physician providers were physiatrists and surgeons. Less than one third of sites had mental health providers (n = 12; 26%); only 26% employed physical therapists. Seventy-six percent of sites offered epidural injections, 74% long-term narcotic prescriptions, and 67% antidepressants. The majority of clinics (30 of 33) prescribing narcotics provided monitoring of therapy using periodic urine toxicology testing. Forty-eight percent of sites (n = 22) offered exercise instruction. Few clinics were multidisciplinary in nature. Only 3 (7%) met the criteria of having a medical physician, registered nurse, physical therapist, and mental health specialist. CONCLUSION: Clinics varied widely in their organizational characteristics, including providers and scope of services available. Few clinics were multidisciplinary in nature. This information should be used to determine how pain clinics can better serve patients and improve outcomes.

Comfortably numb? Exploring satisfaction with chronic back pain visits.

BACKGROUND CONTEXT: Chronic back pain is a condition characterized by high rates of disability, health-care service use, and costs. PURPOSE: The purpose of this study was to identify factors associated with patients' satisfaction with their last health-care provider visit for chronic low back pain (LBP). STUDY DESIGN/SETTING: A cross-sectional, state-level, telephone survey was administered to patients with chronic LBP. PATIENT SAMPLE: The sample consisted of 624 individuals with chronic LBP who reported seeing a health-care provider in the previous year. OUTCOME MEASURES: Dependent variables included satisfaction with last visit for LBP and intent to seek care from additional providers. Independent variables included the Roland-Morris Disability Questionnaire, 3-month pain ratings using a 0 to 10 Likert scale, the Medical Outcomes Survey Short Form 12, and self-reported health service utilization (provider type, number of visits to health-care providers, medication use during the previous month, and treatments and diagnostic tests during the previous year). METHODS: Bivariate and multivariate analyses were used to explore how demographic, insurance-related, and health-related characteristics were associated with patient satisfaction. RESULTS: Participants who were not satisfied with one or more aspects of their last clinic visit were younger (51.0 vs. 54.21 years), reported higher 3-month pain ratings (7.23 vs. 6.53), and were more commonly Hispanic (53.2% vs. 46.8% for other ethnicities) and uninsured (43.1% vs. 29.3% for other insurance groups). Those who intended to seek care from additional providers were younger (50.05 vs. 55.49 years), had higher 3-month pain ratings (7.20 vs. 6.46), had lower Short Form 12 mental health component scores (44.75 vs. 49.55) and physical component scores (30.07 vs. 31.55), and were more commonly black (54.6% vs. 45.4% for other racial groups) and uninsured (56.9% vs. 43.1% for other insurance groups). Narcotic use was associated with satisfaction (odds ratio=2.12, p=.01), whereas lack of insurance was associated with respondents' intent to seek care from additional providers (odds ratio=2.97, p<.01). CONCLUSIONS: Factors other than disability were associated with satisfaction with chronic LBP visits. Understanding the role of medication in satisfaction and its implications for the health behaviors of this highly disabled population may be particularly important.

Exercise prescription for chronic back or neck pain: who prescribes it? who gets it? What is prescribed?

OBJECTIVE: To describe exercise prescription in routine clinical practice for individuals with chronic back or neck pain because, although current practice guidelines promote exercise for chronic back and neck pain, little is known about exercise prescription in routine care. METHODS: We conducted a computer-assisted telephone survey of a representative sample of individuals (n = 684) with chronic back or neck pain who saw a physician, chiropractor, and/or physical therapist (PT) in the past 12 months. Individuals were asked about whether they were prescribed exercise, the amount of supervision received, and the type, duration, and frequency of the prescribed exercise. Descriptive and multivariable regression analyses were conducted. RESULTS: Of the 684 subjects, 48% were prescribed exercise. Of those prescribed exercise, 46% received the prescription from a PT, 29% from a physician, 21% from a chiropractor, and 4% from other. In multivariable analyses, seeing a PT or a chiropractor were the strongest predictors of exercise prescription. The likelihood of exercise prescription was increased in women, those with higher education, and those receiving worker's compensation. PTs were more likely to provide supervision and prescribe strengthening exercises compared with physicians and chiropractors, and were more likely to prescribe stretching exercises compared with physicians. CONCLUSION: Our findings suggest that exercise is being underutilized as a treatment for chronic back and neck pain and, to some extent, that the amount of supervision and types of exercises prescribed do not follow current practice guidelines. Exercise prescription provided by PTs appears to be most in line with current guidelines.

The rising prevalence of chronic low back pain.

BACKGROUND: National or state-level estimates on trends in the prevalence of chronic low back pain (LBP) are lacking. The objective of this study was to determine whether the prevalence of chronic LBP and the demographic, health-related, and health care-seeking characteristics of individuals with the condition have changed over the last 14 years. METHODS: A cross-sectional, telephone survey of a representative sample of North Carolina households was conducted in 1992 and repeated in 2006. A total of 4437 households were contacted in 1992 and 5357 households in 2006 to identify noninstitutionalized adults 21 years or older with chronic (>3 months), impairing LBP or neck pain that limits daily activities. These individuals were interviewed in more detail about their health and health care seeking. RESULTS: The prevalence of chronic, impairing LBP rose significantly over the 14-year interval, from 3.9% (95% confidence interval [CI], 3.4%-4.4%) in 1992 to 10.2% (95% CI, 9.3%-11.0%) in 2006. Increases were seen for all adult age strata, in men and women, and in white and black races. Symptom severity and general health were similar for both years. The proportion of individuals who sought care from a health care provider in the past year increased from 73.1% (95% CI, 65.2%-79.8%) to 84.0% (95% CI, 80.8%-86.8%), while the mean number of visits to all health care providers were similar (19.5 [1992] vs 19.4 [2006]). CONCLUSIONS: The prevalence of chronic, impairing LBP has risen significantly in North Carolina, with continuing high levels of disability and health care use. A substantial portion of the rise in LBP care costs over the past 2 decades may be related to this rising prevalence.