Predictors of malignancy development in patients with chronic pruritus.

BACKGROUND: Patients with pruritus have been shown to have an increased incidence of certain subtypes of malignancy. OBJECTIVE: To assess predictors of malignancy in patients with chronic pruritus without prior dermatologic diagnoses. METHODS: Case-control study of 398 patients with chronic pruritus who developed a malignancy were compared with 8346 patients with chronic pruritus who did not develop a malignancy. Primary outcomes were odds of developing incident malignancy. RESULTS: Age greater than 60 years (OR 4.04, 95% CI 3.08, 5.31), male sex (OR 1.39, 95% CI 1.13, 1.71) and liver disease (OR 2.37, 95% CI 1.00, 5.65) were predictors of malignancy development in patients with chronic pruritus and non-diseased skin. In an exploratory analysis with multiple imputation via chained equations, age greater than 60 years (OR 4.13, 95% CI 3.15, 5.42), male sex (OR 1.26, 95% CI 1.02, 1.55), and current or prior smoking (OR 2.02, 95% CI 1.42, 2.88) were predictors of malignancy development in patients with chronic pruritus and non-diseased skin. LIMITATIONS: Potential for misclassification and detection biases. Missing data. CONCLUSIONS AND RELEVANCE: In patients with chronic pruritus without concomitant dermatologic diagnoses, older age, male sex, liver disease and tobacco abuse increase the odds of an underlying malignancy.

Field survey of health perception and complaints of Pennsylvania residents in the Marcellus Shale region.

Pennsylvania Marcellus Shale region residents have reported medical symptoms they believe are related to nearby Unconventional Natural Gas Development (UNGD). Associations between medical symptoms and UNGD have been minimally explored. The objective of this descriptive study is to explore whether shale region Pennsylvania residents perceive UNGD as a health concern and whether they attribute health symptoms to UNGD exposures. A questionnaire was administered to adult volunteers with medical complaints in a primary-care medical office in a county where UNGD was present. Participants were asked whether they were concerned about health effects from UNGD, and whether they attributed current symptoms to UNGD or to some other environmental exposure. There were 72 respondents; 22% perceived UNGD as a health concern and 13% attributed medical symptoms to UNGD exposures. Overall, 42% attributed one or more of their medical symptoms to environmental causes, of which UNGD was the most frequent. A medical record review conducted on six participants who attributed their medical symptoms to UNGD revealed that only one of these records documented both the symptoms in question and the attribution to UNGD. The results of this pilot study suggest that there is substantial concern about adverse health effects of UNGD among Pennsylvania Marcellus Shale residents, and that these concerns may not be adequately represented in medical records. Further efforts to determine the relationship between UNGD and health are recommended in order to address community concerns.

Five-year malignancy incidence in patients with chronic pruritus: a population-based cohort study aimed at limiting unnecessary screening practices.

BACKGROUND: The incidence of malignancy in patients with chronic pruritus and nondiseased skin is unknown. OBJECTIVE: We sought to assess the hazard ratio (HR) of incident overall malignancy and incident malignancy by subtype in patients with chronic pruritus during the 5 years after diagnosis. METHODS: A population-based cohort study was performed in the Health Improvement Network. In all, 8744 patients with chronic pruritus were matched with 31,580 patients without chronic pruritus based on sex, age, and practice. Primary outcomes were HR of incident malignancy and HR of malignancy subtypes. RESULTS: The fully adjusted HR for incident malignancy in patients with chronic pruritus was 1.14 (95% confidence interval 0.98-1.33). The fully adjusted HR for incident hematologic malignancy and incident bile duct malignancy in patients with chronic pruritus was 2.02 (95% confidence interval 1.48-2.75) and 3.73 (95% confidence interval 1.55-8.97), respectively. The incidence of hematologic malignancy and cholangiocarcinoma in patients with chronic pruritus was 0.0016 and 0.0003 per person-year, respectively. LIMITATIONS: Potential for misclassification and detection biases is a limitation. CONCLUSIONS: Chronic pruritus without concomitant skin changes is a risk factor for having undiagnosed hematologic and bile duct malignancies, but not other malignancies. The overall incidence of these malignancies in patients with chronic pruritus is very low.

Investigating the magnetic susceptibility properties of fresh human blood for noninvasive oxygen saturation quantification.

Quantification of blood oxygen saturation on the basis of a measurement of its magnetic susceptibility demands knowledge of the difference in volume susceptibility between fully oxygenated and fully deoxygenated blood (Δχ(do) ). However, two very different values of Δχ(do) are currently in use. In this work we measured Δχ(do) as well as the susceptibility of oxygenated blood relative to water, Δχ(oxy) , by MR susceptometry in samples of freshly drawn human blood oxygenated to various levels, from 6 to 98% as determined by blood gas analysis. Regression analysis yielded 0.273 ± 0.006 and -0.008 ± 0.003 ppm (cgs) respectively, for Δχ(do) and Δχ(oxy) , in excellent agreement with previous work by Spees et al. (Magn Reson Med 2001;45:533-542).

Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo.

PURPOSE: We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a randomized clinical trial. MATERIALS AND METHODS: Patients with interstitial cystitis who responded positively to treatment with bacillus Calmette-Guerin or placebo after 34 weeks of followup in a double-blind clinical trial were followed for an additional 34 weeks in an observational study to assess response durability. Outcomes at 68 weeks included a patient reported global response assessment, 24-hour voiding diary, and pain, urgency and validated interstitial cystitis symptom indexes. RESULTS: Of responders to bacillus Calmette-Guerin or placebo in the clinical trial 38 continued extended followup in the observational study. A total of 12 (75%) responders who received placebo and 19 (86%) who received bacillus Calmette-Guerin considered themselves to remain moderately or markedly improved at week 68. Improved symptom outcomes were also generally maintained during followup in the 2 groups. CONCLUSIONS: Most patients who respond to therapy with intravesical bacillus Calmette-Guerin or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy. However, initial response rates are low and placebo responders demonstrated essentially the same durability of response as bacillus Calmette-Guerin responders. These results argue against the routine use of bacillus Calmette-Guerin in this patient group.

Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus Calmette-Guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus Calmette-Guerin?

PURPOSE: We evaluated safety and efficacy outcomes in a case series of subjects who received open label intravesical bacillus Calmette-Guerin after failing to respond to bacillus Calmette-Guerin or intravesical placebo in a randomized clinical trial. MATERIALS AND METHODS: Subjects who met National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency were initially randomized to 6 weekly intravesical instillations of bacillus Calmette-Guerin or placebo and followed for a total of 34 weeks. At 34 weeks subjects who reported that they had not responded to treatment were offered treatment with open label bacillus Calmette-Guerin, using the same course of treatment and followup. Outcomes included a patient reported global response assessment, a 24-hour voiding diary, pain, urgency, validated interstitial cystitis symptom indexes and adverse events. RESULTS: A total of 156 subjects elected open label bacillus Calmette-Guerin, of whom 18 (12%) withdrew during the open label series. The response rate based on the global response assessment was 18% and it was identical between those initially randomized to placebo (first course of bacillus Calmette-Guerin in the open label series) and those initially randomized to bacillus Calmette-Guerin (second course). Small improvements were observed for most secondary efficacy outcomes. Most participants reported at least 1 adverse event, primarily pain, genitourinary symptoms and gastrointestinal disturbances. However, there was no difference in adverse events between those who received the first course of bacillus Calmette-Guerin in this series compared to those who received 2 courses. CONCLUSIONS: The low response rate for bacillus Calmette-Guerin in this open label case series further argues against the routine use of bacillus Calmette-Guerin as treatment for interstitial cystitis.

A prospective study of symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome: the National Institutes of Health Chronic Prostatitis Cohort study.

PURPOSE: We present the results of 2 years of symptom and quality of life followup of men with CP/CPPS enrolled in the CPC. MATERIALS AND METHODS: We followed 445 subjects from 6 clinical centers across North America for 2 years with outcome measures that included the NIH-CPSI, quality of life, and GRA. All subjects were treated according to usual care practices at each clinical site. RESULTS: Of the 445 subjects 293 had complete data at 2 years. Withdrawals were younger, had been diagnosed more recently and had higher baseline symptoms. Among the 293 men the mean improvement at 2 years was 5 points on the 43-point NIH-CPSI total score. Most of the observed improvement occurred in the first 3 months of followup. Among all 445 subjects, retaining withdrawals in the denominator, 31% considered themselves moderately or markedly improved at 2 years. Although group mean symptom scores were stable and improved slightly over time, some individual subjects reported large fluctuations. No baseline demographic or clinical factors significantly predicted changes in symptom scores over time. CONCLUSIONS: CP/CPPS is a chronic disease characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of followup, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period.

A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.

PURPOSE: We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC). MATERIALS AND METHODS: Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC, and reported at least moderate pain and frequency for a minimum of 6 months before study entry, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively. RESULTS: A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates. CONCLUSIONS: Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.

Relationship between Alzheimer's disease severity and patient participation in decisions about their medical care.

To examine the relationships between Alzheimer's disease (AD) severity and patient participation in decisions about their medical care, we performed a cross-sectional study of 74 caregivers' ratings of the degree to which AD patients participate in making decisions about their medical care. The majority of the caregivers reported that they made the final decisions about medical care (n = 48, 64%), one-quarter (n = 19, 26%) reported an equal role, and a small proportion (n = 7, 9%) reported that the patient made the final decisions. Multivariate models showed that the significant predictors of the patient's participation in decisions about medical care were measures of dementia severity: Mini-Mental State Examination (MMSE) and Clinical Dementia Rating (CDR). Patients with mild-stage disease (CDR = 1 or MMSE > or = 20) are involved in decision making largely in a collaborative role with the caregiver. Beyond mild-stage disease, the clinician can largely expect that the caregiver is making the final decisions. These results illustrate how and when caregivers can expect changes in their decision making role.

Effect of blood collection technique in mice on clinical pathology parameters.

A study was conducted in normal healthy C57BL/6 mice to determine the effect of method of blood collection on clinical pathology parameters and to provide value ranges for these parameters. Males and females were used and were randomly assigned to treatment groups based upon phlebotomy method. The blood was collected using one of four methods: intracardiac (IC), a single attempt at collection from the caudal vena cava (VC), collection from the caudal vena cava with collection of any extravasated blood from the peritoneum (MC), or retroorbital phlebotomy (RO). Evaluation of blood and serum samples was conducted for a number of serum biochemistries including liver function tests and complete blood count with differentials and platelet counts. Female mice demonstrated higher values for red blood cell number, hemoglobin (p < 0.002), hematocrit, alkaline phosphatase, albumin, total protein, and creatinine. Males demonstrated higher values for platelet counts, specific white blood cell numbers (total, neutrophil, lymphocyte, and eosinophil counts), globulin, amylase, and the BUN/creatinine ratio. Overall, the VC method was associated with the least variation in both sexes and appeared slightly better than the IC method for the parameters evaluated. The largest difference between groups was noted for the transaminase levels. While alanine aminotransferase (ALT) values were similar between the IC and VC groups, aspartate aminotransferase (AST) values were associated with less variation for the VC method. Transaminase levels for the MC and RO groups were associated with relatively large ranges and variation. ALT results from the RO method, the only method amenable to repetitive sample collection used in this evaluation, indicate that this is an acceptable method. The results demonstrate the substantial impact that phlebotomy method has on the assay results and that the VC or IC methods provide the most consistent results. The ranges by collection method and sex provided here can be used to select the preferred method of collection when designing a study and for comparison of data obtained with reference ranges. The authors recommend establishment of normal ranges based upon methods employed within an investigator's laboratory.