Search

Sequential multiple assignment randomized trial (SMART) designs tailor individual treatment by re-randomizing participants to subsequent therapies based on their response to initial treatment. Misc...

Background The usefulness of laboratory tests in the decision-making process with regard to early identification of dengue virus infection has not been widely reported, particularly the aspartate aminotransferase (AST)/platelet count ratio index during a patient's days of illness. The aim of this study was to examine the pattern of the ratio index over the course of illness and identify whether it is a marker of dengue virus infection in dengue patients, as well as to assess the role of other laboratory tests. Methods A chart review of 205 dengue patients was analyzed using available records of 845 laboratory results within different time intervals or exam dates during the course of illness. We used repeated measures mixed binary logistic regression analyses to model the dengue virus infection, defined as giving at least one positive antibody test (yes/no). Results The high risk of dengue virus infection in dengue patients was found in the male gender (adjusted OR = 4.316, 95% CI: 1.285–14.498, P = 0.018), in patients with a high AST/platelet count ratio index (adjusted OR = 1.438, 95% CI: 1.057–1.957, P = 0.021), in patients with a low MCV level (adjusted OR = 0.815, 95% CI: 0.679–0.978, P = 0.028), and in patients with a low ALT level (adjusted OR = 0.996, 95% CI: 0.993–0.999, P = 0.010). Conclusion Laboratory markers, in particular the AST/platelet count ratio index, can be useful for clinicians to strengthen the decision-making process in primary care settings. Furthermore, our model revealed that low MCV and low ALT are predictors of the dengue virus infection, while being a male increases the risk of dengue virus infection. More studies are needed to evaluate the impact of the AST/platelet count ratio index on the severity of dengue fever infection during the onset of symptoms and course of treatment.

Hydroxyurea (hydroxycarbamide) (HU) for sickle cell anaemia (SCA) is underutilised. Case management is an evidence-based health management strategy and in this regard patient navigators (PNs) may provide case management for SCA. We hypothesised that HU-eligible patients exposed to PNs would have improved indicators of starting HU and HU adherence. We randomised 224 HU-eligible SCA adults into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Trial. All patients received care from trained physicians using standardised HU prescribing protocols. Patients in the Experimental arm received case management and education from PNs through multiple contacts. All other patients were regarded as the Control arm and received specialty care alone. Study physicians were blinded to the study arms and did not interact with PNs. At baseline, 6 and 12 months we assessed and compared laboratory parameters and HU adherence indicators. Experimental patients had higher 6-month mean fetal haemoglobin (HbF) levels than controls. But at 12 months, mean HbF was similar, as were white blood cell count, absolute neutrophil count, total haemoglobin, platelet count and mean corpuscular volume. At 12 months there were fewer experimental patients missing HU doses than controls (mean 1·8 vs. 4·5, P = 0·0098), and more recent HU prescriptions filled than for controls (mean 53·8 vs. 92 days, median 27·5 vs. 62 days, P = 0·0082). Mean HU doses were largely similar. We detected behavioural improvements in HU adherence but no haematological improvements by adding PNs to specialty care.

Sickle cell disease (SCD) pain is often acute-on-chronic, likening it to other chronic acute-on-chronic pain conditions. Pain treatment of SCD was already reported as inadequate prior to the current opioid epidemic, but attitudes underlying treatment were understudied. Understanding these attitudes prior to the current epidemic would be revealing. Therefore in 1997, before the current opioid epidemic, we surveyed physicians' attitudes toward pain management and treatment preferences for acute pain exacerbations in the Emergency Department in SCD versus those of chronic pancreatitis and chronic low back pain, two other acute-on-chronic pain diseases. Thirty-nine residency trainees were surveyed in a level one triage hospital. Resident estimates of the rate of opioid addiction in SCD were higher than estimates in both chronic pancreatitis and chronic low back pain. Most residents relied on their personal clinical experience rather than external sources of data or knowledge as the most important driver when they managed chronic pain. This survey research shows that, predating the current opioid epidemic, there was both a backdrop of opioid-phobia and a bias against treating SCD pain compared to other chronic pain conditions among our sample. Repeating this survey research among current training physicians, along with surveys of other attitudes, would provide useful comparisons.

Objective: To develop a survey instrument to identify adult sickle cell disease (SCD) patients on chronic opioid therapy who are at-risk for opioid abuse. Design: Prospective survey and interview.Setting: Adult SCD clinic in a large urban teaching facility.Patients/participants: Convenience sampling of adult patients presenting to the sickle cell clinic.Interventions: None.Main outcome: Primary outcome was “at-risk for opioid misuse,” defined as at least 3/8 “yes” answers (a positive composite score) on the Prescription Opioid Misuse Index (POMI) questionnaire. Secondary outcome was DSM-IV criteria for substance abuse using the DSM IV Diagnostic Interview Schedule.Results: Of the 99 patients who completed the POMI, the mean age was 36 years; 58.6 percent were female, 48 percent were hemoglobin SS (47/99), and 26 percent were SC (26/99). Twenty-four percent (24/99) were identified as at-risk for opioid misuse using the POMI. There were no differences in demographic, SCD genotype, or socioeconomic variables for at-risk versus not-at-risk patients.Conclusion: Twenty-four percent of unselected adult SCD patients on opioids were identified as at-risk for opioid misuse using a quick survey. This may represent as much as 2.5-7 times the national misuse rate. This group of patients may benefit from additional diagnostic and therapeutic interventions to help understand and manage their opioid usage.

Background Despite the continuing increase in the breast cancer incidence rate among Saudi Arabian women, no breast cancer risk-prediction model is available in this population. The aim of this research was to develop a risk-assessment tool to distinguish between high risk and low risk of breast cancer in a sample of Saudi women who were screened for breast cancer. Methods A retrospective chart review was conducted on symptomatic women who underwent breast mass biopsies between September 8, 2015 and November 8, 2017 at King Abdulaziz Medical City, Riyadh, Saudi Arabia. Results A total of 404 (63.8%) malignant breast biopsies and 229 (36.2%) benign breast biopsies were analyzed. Women ≥40 years old (aOR: 6.202, CI 3.497-11.001, P=0.001), hormone-replacement therapy (aOR 24.365, 95% CI 8.606-68.987, P=0.001), postmenopausal (aOR 3.058, 95% CI 1.861-5.024, P=0.001), and with a family history of breast cancer (aOR 2.307, 95% CI 1.142-4.658, P=0.020) were independently associated with an increased risk of breast cancer. This model showed an acceptable fit and had area under the receiver-operating characteristic curve of 0.877 (95% CI 0.851-0.903), with optimism-corrected area under the curve of 0.865. Conclusion The prediction model developed in this study has a high ability in predicting increased breast cancer risk in our facility. Combining information on age, use of hormone therapy, postmenopausal status, and family history of breast cancer improved the degree of discriminatory accuracy of breast cancer prediction. Our risk model may assist in initiating population-screening programs and prompt clinical decision making to manage cases and prevent unfavorable outcomes.

Anwar E Ahmed,1,2 Faris S Alzahrani,2 Ahmed M Gharawi,2 Salman A Alammary,2 Fahad H Almijmaj,2 Fahad M Alhusayni,2 Donna K McClish,3 Hamdan Al-Jahdali,1,2 Ashwaq A Al Olayan,4 Abdul Rahman Jazieh4 1King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia; 2King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 3Department of Biostatistics, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA; 4King Abdulaziz Medical City, National Guards Health Affairs, Riyadh, Saudi Arabia Background: Imaging tests used in our center are usually inadequate to confirm the high risk for pancreatic cancer. We aimed to use a combination of potential predictors including imaging tests to quantify the risk of pancreatic cancer and evaluate its utility. Methods: This was a retrospective cohort study of patients who were suspected as having pancreatic cancer and underwent biopsy examination of pancreatic mass at King Abdulaziz Medical City, Riyadh, Saudi Arabia, between January 1, 2013, and December 31, 2016. We retrieved data on demographics, clinical history, imaging tests, and final pancreatic diagnosis from medical records. Results: Of the 206 who underwent pancreatic biopsies, the mean age was 63.6 years; 54.4% were male. Of all the biopsies, 57.8% were malignant and 42.2% were benign masses. Nine factors contributed significantly to the risk of pancreatic cancer and were noted: older age (adjusted odds ratio [aOR] =1.048; P=0.010), male gender (aOR =4.670;P=0.008), weight loss (aOR =14.810;P=0.001), abdominal pain (aOR =7.053;P=0.0.001), blood clots (aOR =20.787;P=0.014), pancreatitis (aOR =4.473;P=0.021), jaundice (aOR =7.446;P=0.003), persistent fatigue (aOR =22.015;P=0.015), and abnormal imaging tests (aOR =67.124;P=0.001). The model yielded powerful calibration (P=0.953), excellent predictive utility (area under the receiver operating characteristic curve 96.3%; 95% CI =94.1, 98.6), with optimism-corrected area under the curve bootstrap resampling of 94.9%. An optimal cut-off risk probability of 0.513 yielded a sensitivity of 94% and specificity of 84.7% for risk classification. Conclusion: The study developed and validated a risk model for quantifying the risk of pancreatic cancer. Nine characteristics were associated with increased risk of pancreatic cancer. This risk assessment model is feasible and highly sensitive and could be useful to improve screening performance and the decision-making process in clinical settings in Saudi Arabia. Keywords: pancreas, cancer, fatigue, weight loss, blood clots, jaundice, Saudi Arabia

Background. Patients with SCD now usually live well into adulthood. Whereas transitions into adulthood are now often studied, little is published about aging beyond the transition period. We therefore studied age-associated SCD differences in utilization, pain, and psychosocial variables.Methods. Subjects were 232 adults in the Pain in Sickle Cell Epidemiology Study (PiSCES). Data included demographics, comorbidity, and psychosocial measures. SCD-related pain and health care utilization were recorded in diaries. We compared 3 age groups: 16–25 (transition), 26–36 (younger adults), and 37–64 (older adults) years.Results. Compared to the 2 adult groups, the transition group reported fewer physical challenges via comorbidities, somatic complaints, and pain frequency, though pain intensity did not differ on crisis or noncrisis pain days. The transition group utilized opioids less often, made fewer ambulatory visits, and had better quality of life, but these differences disappeared after adjusting for pain and comorbidities. However, the transition group reported more use of behavioral coping strategies.Conclusion. We found fewer biological challenges, visits, and better quality of life, in transition-aged versus older adults with SCD, but more behavioral coping. Further study is required to determine whether age-appropriate health care, behavioral, or other interventions could improve age-specific life challenges of patients with SCD.

Background Despite the continuing increase in the breast cancer incidence rate among Saudi Arabian women, no breast cancer risk-prediction model is available in this population. The aim of this research was to develop a risk-assessment tool to distinguish between high risk and low risk of breast cancer in a sample of Saudi women who were screened for breast cancer. Methods A retrospective chart review was conducted on symptomatic women who underwent breast mass biopsies between September 8, 2015 and November 8, 2017 at King Abdulaziz Medical City, Riyadh, Saudi Arabia. Results A total of 404 (63.8%) malignant breast biopsies and 229 (36.2%) benign breast biopsies were analyzed. Women ≥40 years old (aOR: 6.202, CI 3.497–11.001, P=0.001), hormone-replacement therapy (aOR 24.365, 95% CI 8.606–68.987, P=0.001), postmenopausal (aOR 3.058, 95% CI 1.861–5.024, P=0.001), and with a family history of breast cancer (aOR 2.307, 95% CI 1.142–4.658, P=0.020) were independently associated with an increased risk of breast cancer. This model showed an acceptable fit and had area under the receiver-operating characteristic curve of 0.877 (95% CI 0.851–0.903), with optimism-corrected area under the curve of 0.865. Conclusion The prediction model developed in this study has a high ability in predicting increased breast cancer risk in our facility. Combining information on age, use of hormone therapy, postmenopausal status, and family history of breast cancer improved the degree of discriminatory accuracy of breast cancer prediction. Our risk model may assist in initiating population-screening programs and prompt clinical decision making to manage cases and prevent unfavorable outcomes.

Summary Background A case control study to better characterize the clinical features, laboratory, and radiological abnormalities associated with MERS-CoV infection in order to help with early identification of this syndrome from other respiratory infections. Methods Eighty patients admitted to a hospital in Riyadh, diagnosed with MERS-CoV infection based on RT-PCR were matched on age, sex, and the presence of a co-morbid condition on a basis of 1:2 to other patients admitted with respiratory symptoms and tested negative for MERS-CoV on RT-PCR. Results None of the reported MERS-CoV presenting symptoms was significantly associated with being infected with MERS-CoV. On the other hand, WBC count was significantly lower in patients with confirmed MERS-CoV infection (median 5.7 vs 9.3, P: 0.0004). Neutrophil count was as well significantly lower in MERS-CoV patients (median 3.7 vs 6.7, P: 0.0001). Both AST, and ALT values were significantly higher in MERS-CoV infected group (AST median 42 vs 36, P: 0.03, and ALT median 33 vs 28, P: 0.003). Overall our MERS-CoV mortality rate was (10%) below the national figure of (40%). Conclusions None of the presenting symptoms are specific for MERS-CoV infection. And out of all the investigations WBC, neutrophil counts, AST and ALT values have some predictive utility.

Objectives To evaluate the nonclinical outcomes of a proactive palliative care program funded and operated by a health system for Medicare Advantage plan beneficiaries. Design Observational, retrospective study using propensity-based matching. Setting A health system in southern California. Participants Individuals who received the intervention between 2007 and 2014 (n = 368) were matched with 1,075 comparison individuals within each of four disease groups: cancer, chronic obstructive pulmonary disease, heart failure, and dementia. All were known to be dead at the time of the retrospective study, were Medicare Advantage beneficiaries, and had 2 years of usage data before death. Median age at death for each disease group was older than 80. Intervention Home- and clinic-based palliative care (PC) services provided by a multidisciplinary team. Measurements Outcomes included hospital costs, other healthcare costs, readmission rates, hospital admissions and bed days, intensive care unit use in final 30 days of life, and death within 30 days of an admission. Results Intervention participants in all four disease groups had less hospital use and lower hospital costs nonintervention participants, which drove lower overall healthcare costs. In the final 6 months of life, healthcare costs for the intervention groups stayed largely the same from month to month, whereas costs for comparison participants increased dramatically. Conclusion In the context of an alternative payment model in which the provider was “at risk” of bearing the costs of care, a proactive PC program helped to avoid the escalation in hospital use and costs commonly seen in the final months of life.

25 Background: There have been reports implicating underweight status as well as obesity with lower survival in colorectal cancer patients, but data has been inconsistent. Methods: In this retrospective observational study, we gathered pre-treatment data on BMI and other co-morbidities from 423 colon cancer patients who underwent surgical resection (stages I to III) or were metastatic at diagnosis (stage IV) at VCU Medical Center from 2005 to 2018 and analyzed their survival outcomes. Results: Compared to patients with a normal BMI, patients with underweight status (BMI < 18.5) have a trend towards higher all-cause mortality (HR 1.66, 95% CI 0.67-4.12). Patients with overweight BMI (25-29.9) and obese BMI ( > 30) have a trend towards improved mortality (HR 0.67, 95% CI 0.46-0.98) (HR 0.75, 95% CI 0.53-1.07) respectively. The p-value was 0.0675. We also found that pre-existing diabetes mellitus is associated with increased all-cause mortality (HR 1.43, CI 1.03 to 1.98, p < 0.05), as well as the use of aspirin at diagnosis (HR 1.60, CI 1.16 to 2.21, p < 0.05). Conclusions: Our results are similar to previous findings that patients with underweight status have worse mortality outcome, suggesting the importance of nutritional status prior to starting treatment. We also found that overweight and obese patients have trends towards improved survival compared to normal weight patients. Future focus can be directed to see whether overweight or obesity status past diagnosis affect survival trends. Aspirin use at diagnosis in our study population is associated with worse mortality outcome; literature is conflicting with outcomes and pre-diagnosis aspirin use. Our findings are similar for both locoregional colon cancers as well as metastatic disease. Research should be directed at seeing what kind of interventions such as nutrition or rehabilitation can be used to ameliorate the increased mortality trend in the underweight status group of patients.

Acute pain episodes are the most common complication in patients with sickle cell disease (SCD). Classically attributed to vaso-occlusion, recent insights suggest that chronic pain may also contribute to the pathogenesis of acute pain episodes, which adds complexity to their diagnosis and management. A taxonomy, or classification system, for acute pain in patients with SCD would aid research efforts and enhance clinical care. To meet this need, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the U.S. Food and Drug Administration, the American Pain Society, and the American Academy of Pain Medicine formed the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks-American Pain Society-American Academy of Pain Medicine Pain Taxonomy initiative. One of the goals of this initiative was to develop taxonomies for acute pain disorders, including SCD. To accomplish this, a working group of experts in SCD and pain was convened. Based on available literature and expert opinion, the working group used a 5-dimenional structure (diagnostic criteria, common features, modulating factors, impact/functional consequences, and putative mechanisms) to develop an acute pain taxonomy that is specific to SCD. As part of this, a set of 4 diagnostic criteria, with 2 modifiers to account for the influence of chronic pain, are proposed to define the types of acute pain observed in patients with SCD. PERSPECTIVE: This article presents a taxonomy for acute pain in patients with SCD. This taxonomy could help to standardize definitions of acute pain in clinical studies of patients with SCD.

Background Emergency Department (ED) revisits have often been used as an indicator of medical care quality. This study aimed to quantify the frequency of ED revisits within 72 h of discharge and identify its factors among children with chronic diseases. Methods We designed a retrospective cohort study of children with at least one chronic disease who were also under 18 years of age and had attended and were discharged from the ED at King Abdullah Specialist Children’s Hospital (KASCH-RD), Riyadh, Saudi Arabia between April 19, 2015 and July 29, 2017. The outcome measure was the frequency of ED revisits during a period of 72 h after discharge. Results The study included 11,057 ED discharges of children with at least one chronic disease. Their revisit rate was 1211 (11%), with 83 (6.9%) having had a second ED revisit within 72 h of ED discharge. According to ICD-10 codes, the most common causes of ED revisits were respiratory, digestive, genitourinary, symptoms, and external causes. Factors of frequent ED revisits within 72 h were young age, institutional health insurance coverage, year of new health information system (2015), external causes, and genitourinary. Conclusion The rate of 72-h ED revisits after discharge of children with chronic diseases treated at KASCH-RD was relatively high, and was associated with young age, institutional health insurance coverage, year of a new health information system implementation, and external causes of ED visit. These study findings amplify the need for intervention to reduce the rate of early ED revisits among children with chronic diseases.

Cost and burden of diagnostic testing may be reduced if fewer tests can be applied. Sequential testing involves selecting a sequence of tests, but only administering subsequent tests dependent on results of previous tests. This research provides guidance to choosing between single tests or the believe the positive (BP) and believe the negative (BN) sequential testing strategies, using accuracy (as measured by the Youden Index) as the primary determinant. Approximately 75% of the parameter combinations examined resulted in either BP or BN being recommended based on a higher accuracy at the optimal point. In about half of the scenarios BP was preferred, and the other half, BN, with the choice often a function of the value of the ratio of standard deviations of those without and with disease (b). Large values of b for the first test of the sequence tended to be associated with preference for BN as opposed to BP, while small values of b appear to favor BP. When there was no preference between sequences and/or single tests based on the Youden Index, cost of the sequence was considered. In this case, disease prevalence plays a large role in the selection of strategies, with lower values favoring BN and sometimes higher values favoring BP. The cost threshold for the sequential strategy to be preferred over a single, more accurate test, was often quite high. It appears that while sequential strategies most often increase diagnostic accuracy over a single test, sequential strategies are not always preferred.

Background: If and how much dural penetration influences long-term outcome after traumatic brain injury (TBI) is understudied, especially within the civilian population. Objectives: Using the large TBI Model Systems cohort, this study assessed and compared penetrating TBI (PTBI) and closed TBI with respect to global outcome and late seizures 2 years after injury. Methods: After performing unadjusted PTBI versus closed TBI comparisons, multivariate regression models were built and analyzed for both outcomes by including the following additional predictors: length of unconsciousness, posttraumatic amnesia duration, hospital length of stay, age, gender, race, marital status, education level, problem substance abuse, and preinjury employment status. Results: The collapsed Glasgow Outcome Scale model (n = 6111) showed significant secondary effects of PTBI with employment status. When employed before injury, individuals with PTBI were 2.62 times more likely (95% confidence interval, 1.92-3.57) to have a lower Glasgow Outcome Scale category. The final model for late seizures (n = 6737) showed a significant main effect for PTBI. Adjusting for other predictors, individuals with PTBI were 2.78 times more likely (95% confidence interval, 1.93-3.99) than those with closed TBI to be rehospitalized for a seizure. Conclusion: This study empirically demonstrates that penetrating injury mechanism has important prognostic implications.

Background: Although opioid prescribing in sickle cell disease (SCD) can be controversial, little is published about patterns of opioid use. Objective: To report on home opioid use among adults with SCD. Design: Cohort study. Participants: Adults with SCD (n = 219) who completed daily pain diaries for up to 6 months and had at least one home pain day. Main measures: Use of long-acting or short-acting opioids, other analgesics, or adjuvants; the proportion of home days, home pain days, and home crisis days with opioid use; these two outcomes according to patient characteristics. Key results: Patients used opioids on 12,311 (78 percent) of 15,778 home pain days. Eighty-five patients (38.8 percent) used long-acting opioids with or without short-acting opioids and 103 (47.0 percent) used only short-acting opioids. Twenty-one (9.6 percent) patients used only non-opioid analgesics and 10 (4.6 percent) used no analgesics. Both pain intensity and pain frequency were higher among opioid users (analysis of variance [ANOVA], p < 0.0001). Opioid users used hydroxyurea more often than nonusers, even when controlling for mean pain on pain days. Among all patients, significant relationships were found between any opioid use and somatic symptom burden, SCD stress, negative coping, and physical and mental quality of life (QOL); the relationship with SCD stress and physical QOL remained when controlled for mean pain. Among opioid users, similar associations were found between frequency of opioid use and some disease-related and psychosocial variables. Conclusions: In this adult SCD sample, opioids were used by the majority of patients. Pain was the overwhelming characteristic associated with use, but disease-related and psychosocial variables were also associated.

Anwar E Ahmed,1 Yosra Z Ali,2 Ahmad M Al-Suliman,3 Jafar M Albagshi,3 Majid Al Salamah,1 Mohieldin Elsayid,1 Wala R Alanazi,4 Rayan A Ahmed,5 Donna K McClish,6 Hamdan AL-Jahdali,1,2 1College of Public Health and Health Informatics, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 2King Abdulaziz Medical City, Riyadh, Saudi Arabia; 3King Fahad Hospital, Hofuf, Saudi Arabia; 4Al-Maarefa College for Science and Technology, Riyadh, Saudi Arabia; 5Dar Al Uloom University, Riyadh, Saudi Arabia; 6Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA Introduction: High white blood cell (WBC) count is an indicator of sickle cell disease (SCD) severity, however, there are limited studies on WBC counts in Saudi Arabian patients with SCD. The aim of this study was to estimate the prevalence of abnormal leukocyte count (either low or high) and identify factors associated with high WBC counts in a sample of Saudi patients with SCD. Methods: A cross-sectional and retrospective chart review study was carried out on 290 SCD patients who were routinely treated at King Fahad Hospital in Hofuf, Saudi Arabia. An interview was conducted to assess clinical presentations, and we reviewed patient charts to collect data on blood test parameters for the previous 6 months. Results: Almost half (131 [45.2%]) of the sample had abnormal leukocyte counts: low WBC counts 15 (5.2%) and high 116 (40%). High WBC counts were associated with shortness of breath (P=0.022), tiredness (P=0.039), swelling in hands/feet (P=0.020), and back pain (P=0.007). The mean hemoglobin was higher in patients with normal WBC counts (P=0.024), while the mean hemoglobin S was high in patients with high WBC counts (P=0.003). After adjustment for potential confounders, predictors of high WBC counts were male gender (adjusted odds ratio [aOR]=3.63) and patients with cough (aOR=2.18), low hemoglobin (aOR=0.76), and low heart rate (aOR=0.97). Conclusion: Abnormal leukocyte count was common: approximately five in ten Saudi SCD patients assessed in this sample. Male gender, cough, low hemoglobin, and low heart rate were associated with high WBC count. Strategies targeting high WBC count could prevent disease complication and thus could be beneficial for SCD patients.Keywords: white blood cell, leukocyte, SCD, Saudi, hemoglobin, low heart rate, Saudi Arabia

Background Pain diary assessment in sickle cell disease (SCD) may be expensive and impose a high respondent burden. Objective To report whether intermittent assessment could substitute for continuous daily pain assessment in SCD. Design Prospective cohort study. Setting Academic and community practices in Virginia. Patients. A total of 125 SCD patients age 16 years or older in the Pain in Sickle Cell Epidemiology Study. Measurements. Using pain measures that summarized all diaries as the gold standard, we tested the statistical equivalence of four alternative strategies that summarized diaries only from the week prior or the month prior to study completion; one week per month; or one day per week (random day). Summary measures included percent pain days, percent crisis days (self-defined), mean pain (0-9 Likert scale) on all days, and mean pain on pain days. Equivalence tests included comparisons of means, regression intercepts, and slopes, as well as measurement of R2. Results Compared with the gold standard, the one-day-per-week and one-week-per-month strategies yielded statistically equivalent means of six summary pain measures, and the week prior and month prior yielded equivalent means as some of the measures. Regression showed statistically equivalent slopes and intercepts to the gold standard using one-day-per-week and one-week-per-month strategies for percent pain days and percent crisis days, but almost no other equivalence. R2 values ranged from 0.64 to 0.989. Conclusions It is possible to simulate five- to six-month daily assessment of pain in SCD. Either one-day-per-week or one-week-per-month assessment yields an equivalent mean and fair regression equivalence.

Objective To determine whether response to a dietary intervention is greater among people with family history of colorectal cancer (CRC) compared with a general population. Design Cohort study examining participants from 2 related studies. Setting Rural Virginia. Participants Seventy people with first-degree relatives with CRC and 113 participants from the intervention arm of a trial in the general population. Intervention Both studies implemented a low-intensity intervention delivered via telephone and mail, including low-literacy self-help booklets and personalized dietary feedback. Main Outcome Measures Fat, fiber, and fruit and vegetable behavior. Analysis Propensity score matching controlled for confounders. Mixed-model ANOVAs compared samples; mediation by perceived cancer risk was assessed. Results Participants in both groups significantly improved fat, fiber, and fruit and vegetable behavior at 1-month follow-up; there was significantly greater improvement in the general population sample. Cancer risk perception did not mediate the relationship between study sample and dietary change. Conclusions and Implications Contrary to expectations, first-degree relatives of CRC patients did not respond better to a dietary intervention than the general population, nor was risk perception related to dietary change. Given the role of diet in CRC risk, additional research should investigate targeted strategies to improve dietary intakes of people at higher cancer risk.

Background: Hydroxyurea (HU) therapy in sickle cell anemia (SCA) improves health care utilization, slows organ failure, and prolongs life. Implementation of evidence-based, comprehensive care has been shown to improve health-related quality of life (HRQOL). Case management by community health workers (CHWs) is an evidence-based health management strategy. We therefore hypothesized that HU-eligible SCA adults exposed to patient navigators (PN), CHWs specially trained as case managers for SCA, would have improved HRQOL compared with controls. Methods: We enrolled 224 patients eligible for HU into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Randomized Controlled Trial. All patients received care from trained physicians who implemented use of a standardized HU prescribing protocol using NIH guidelines. Pateints were randomized to either PN intervention (which included case management and education through home, telephone, and/or other visits from PNs) plus standard care by their treating physician (Experimental, E), or standard care by their physician alone (Control, C). Study physicians were blinded to study arm. At baseline, 6 and 12 months we assessed 4 psychosocial HRQOL variables-- ASCQ-Me emotional impact (EMOT), social impact (SOCI), PROMIS global mental (GMENT) and satisfaction with social roles (ROLE); 6 Physical HRQOL variables-- ASCQ-Me Sleep impact (SLEP) and Stiffness (STIFF), PROMIS global physical (GPHYS), Physical health (PHYS), Fatigue (FATG), and sleep/Wake disturbance (WAKE), and 4 pain HRQOL variables-- PROMIS pain behavior (PAINB), and ASCQ-ME-Pain crisis frequency (PAINF), Pain crisis severity (PAINS), and Pain impact (PAIN). Main analyses consisted of mixed model analysis of variance of follow-up visits, controlling for site and baseline value of outcome variable. Any missing baseline values for subjects were imputed. Results: 181 of 224 randomized patients had at least one HRQOL measure at follow-up. Patients had mean age 30.3, 45.3% were male, 81.2% were on HU at baseline. No HRQOL measures were different between groups E and C in any domain (Table, variables grouped by domain). Conclusions: In our sample, there were no differences in HRQOL among patients who were exposed to PNs vs those who weren't. These findings require further analyes before firm conclusions can be made about the isolated effect of PNs on HRQOL. PN dose of intervention was likely variable. HU use and adherence has been associated with higher HRQOL, and we did not predict high baseline HU uptake and adherence which may have led to minimal improvement despite adequate PN intervention. PNs were not allowed to work with MDs, nor did they work with the remainder of the health care team to improve HRQOL. Analyses are underway to examine these and other possible influences on HRQOL. Table. Disclosures Smith: Novartis: Consultancy, Honoraria. Villella:Emmaus: Membership on an entity's Board of Directors or advisory committees; Pfizer: Other: Site PI for the Rivipansel Clinical Trial. Liles:Novartis: Other: PI on clinical trial Sickle cell ; Shire: Other: PI on clinical trial Sickle cell ; Imara: Other: PI on Clinical trial- Sickle cell .

Background: Hydroxyurea (HU) therapy in adults with sickle cell anemia (SCA) increases total hemoglobin (Hb) and percent fetal hemoglobin (HbF) levels, reduces total white cell (WBC) and neutrophil (ANC) count, and increases the mean corpuscular volume (MCV). Case management and community health workers are both evidence-based health management strategies. Patient navigators (PN) are community health workers trained specifically in case management for patients with SCA. We therefore hypothesized that HU-eligible patients exposed to patient navigators (PN) would have improved laboratory characteristics reflecting improved uptake and adherence to HU. Methods: We enrolled 224 adult patients eligible for HU into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Randomized Controlled Trial. All patients received care from trained physicians who implemented use of a standardized HU prescribing protocol using NIH guidelines. Pateints were randomized to either PN intervention (which included case management and education through home, telephone, and/or other visits from PNs) plus standard care by their treating physician (Experimental, E), or standard care by their physician alone (Control, C). Study physicians were blinded to study arm. At baseline, 6 months and 12 months we assessed: Complete Blood Count including WBC, ANC, total hemoglobin (Hb), platelet count (plt), mean corpuscular volume (MCV), and; HbF via HPLC and electrophoresis. Main analyses consisted of comparisons of the hematological variables between arms. Mixed model analysis of variance was used to analyze follow-up visits, controlling for site and baseline value of outcome variable. Any missing baseline values for subjects were imputed. Results: 206 of 224 patients had at least one lab value at follow-up. Patients had mean age 30.1, 45.6% were male, 82.5% had been prescribed HU at baseline. HbF was higher at the 6 month visit for group E vs. group C when controlled for baseline values. Neither WBC, ANC, Hb, Hb F, Plt, nor MCV were different between groups E and C at any other time point (Table). Conclusions: In our sample, there were no differences in hematological variables among patients who were exposed to PNs vs those who weren't. Several factors may have impacted these outcomes. HU was prescribed to 82.5% of enrolled patients at baseline, with higher % HbF than anticipated in study design. The intention to study change in % HbF as a singular marker for HU uptake and adherence did not assume high utilization of HU at baseline. We are currently analyzing data to enable comparisons between patients who were on HU at baseline and those who were not, which we believe will be able to speak to the true impact of the PN intervention. Future analyses will examine these and other factors influencing outcomes. Table Disclosures Smith: Novartis: Consultancy, Honoraria. Villella:Pfizer: Other: Site PI for the Rivipansel Clinical Trial; Emmaus: Membership on an entity's Board of Directors or advisory committees. Liles:Novartis: Other: PI on clinical trial Sickle cell ; Shire: Other: PI on clinical trial Sickle cell ; Imara: Other: PI on Clinical trial- Sickle cell.

In noninferiority studies, a limit of indifference is used to express a tolerance in results such that the clinician would regard such results as being acceptable or ‘not worse’. We applied this concept to a measure of accuracy, the Receiver Operating Characteristic (ROC) curve, for a sequence of tests. We expressed a limit of indifference for the range of acceptable sensitivity values and examined the associated cost of testing within this range. In doing so, we generated the minimum cost maximum ROC (MCMROC) curve, which reflects the reduced sensitivity and cost of testing. We compared the MCMROC and its associated cost curve between limits of indifference set to 0.999 [a 0.1% reduction in true positive rate (TPR)], 0.95 (a 5% reduction in TPR), and 1 (no reduction in TPR). The limit of indifference tended to have less of an effect on the MCMROC curves than on the associated cost curves that were greatly affected. Cost was reduced at high false positive rates (FPRs) at higher limit of indifference (0.999) and at small FPRs as the limit of indifference decreased (0.95). These patterns were also observed as applied to sequential strategies used to diagnose diabetes in the Pima Indians. Copyright © 2013 John Wiley & Sons, Ltd.

Context: The literature provides limited evidence of the quality of life (QoL) distinctions between Saudi Arabian male and female patients with sickle cell disease (SCD). Objectives: To compare SCD complications, symptoms, and individual items in the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) between Saudi adult males and females. Methods: A multi-center, cross-sectional study was conducted on 629 Saudi adults with SCD who attended King Fahad Hospital in Hofuf and King Fahad Central Hospital in Jazan. Results: Gender differences were noted in terms of SCD-related complications, symptoms, daily activity, and pain. Saudi females with SCD reported significantly more fever (66.8% vs. 54.8%, P=0.003), more swelling (59.2% vs. 38.9%, P=0.001), and more frequent blood transfusion (88.5% vs. 80.6%, P=0.009). Males reported more physical exercising than females (41% vs. 23%, P=0.001), and having less family support (89.6% vs. 96.3%, P=0.001). Saudi females with SCD reported significantly higher percentages of daily activity limitations in lifting or carrying groceries (66.7% vs. 58%, P=0.031), climbing one flight of stairs (63.5% vs. 53.6%, P=0.016), and walking the length of one block (59.2% vs. 42.5%, P=0.001). Saudi females with SCD reported a higher percentage of bodily pain (94.3% vs. 87.1%, P=0.004). Conclusion: The study reveals that Saudi females with SCD experience SCD-related complications, symptoms, and pain differently than Saudi males with SCD. According to our data, females reported more limitations in daily activity, more pain, and less physical activity, than males. An interventional program is needed to address QoL among Saudi females with SCD.

Rationale and Objectives The accuracy of medical tests is often assessed using the area under the entire receiver-operating characteristic (ROC) curve. However, this includes values that might be of no clinical importance. Evaluation of a portion of the curve, or a single point, requires identifying a range of clinical interest, which may not be obvious. The author suggests evaluating the accuracy of medical tests in the vicinity of the optimal point. Materials and Methods Assuming binormality, the author estimated the optimal threshold as the value that maximizes the generalized Youden index. The confidence interval around the optimal point defined a region of clinical interest; the accuracy of the medical test was assessed using the partial area index (PAI) and standardized partial area (sPA). Bootstrapping was used to estimate variances and construct confidence intervals. Coverage probabilities for the PAI and sPA were assessed, as was the size of the test to compare measures. An example using biomechanical measures from radiographic images of the pelvis and lumbar spine to detect disk hernia and spondylolisthesis is presented. Results Coverage probabilities of confidence intervals for the partial area measures were good. The size of the test to compare partial area measures was appropriate. Values of PAI and sPA varied with the cost/prevalence ratio. In the example, the biomechanical measures were not found to have significantly different accuracy around the optimal point. Conclusions The PAI and sPA associated with the optimal point were found to be reasonable and useful measures of accuracy.

The practice of sequential testing is followed by the evaluation of accuracy, but not by the evaluation of cost. This paper focuses on three logic rules for combining two sequences of tests: believe the positive (BP), which diagnoses disease if any of two tests is positive, believe the negative (BN), which diagnoses disease if any of two tests is negative, and believe the extreme (BE), which diagnoses disease if the first test is positive or, after a first inconclusive test, a second test is positive for disease. Comparisons of these strategies are provided in terms of accuracy using false positive rate, sensitivity pairs that make up the maximum receiver operating characteristic curve, and cost of testing, defined as the proportion of subjects needing two tests to diagnose disease. A method to incorporate the cost of testing into the definition of the optimal operating point is also presented. The performance of the testing strategies is examined with respect to the ratio of standard deviations and the correlation between test results under the bivariate normal assumptions. Under all parameter settings, the maximum receiver operating characteristic curve of the BE strategy never performed worse than the BN and BP strategies; the BE strategy also had the lowest cost. The use of body mass index and plasma glucose concentration to diagnose diabetes in Pima Indians was presented as a real-world application. The optimal operating points found by the BN and BE strategies produce lower false positive rate values than the BP strategy for these data.

Studies show that daughters of mothers with breast cancer may be at increased risk for developing the disease. However, daughters' adherence to health behavior and screening recommendations, compared to the general population, is unknown.Telephone interviews explored characteristics of adult daughters (n=147), including primary and secondary preventive behaviors, body mass index (BMI, kg/m(2)), physical activity, fruit/vegetable intake, alcohol intake, smoking, and mammography. Daughters of mothers with breast cancer were recruited from the community and were compared with Virginia women (n=2528) from the 2005 Behavioral Risk Factor Surveillance System (BRFSS) survey. Differences were examined using logistic regression, adjusting for demographic covariates.Daughters were younger (p0.001), more highly educated (p0.001), and more likely to never have been married (p0.001) than BRFSS participants, but groups were similar by race. In adjusted analyses, daughters were significantly more likely to have ever had a mammogram (p0.001) and to have had one recently (p=0.001). Daughters also were significantly less likely to consume3 fruit/vegetable servings daily (p=0.032) compared to BRFSS results. There were no differences in BMI, smoking rates, alcohol consumption, or level of physical activity at work.Daughters with familial breast cancer risk were more likely to receive mammography screening than BRFSS participants, but they were no different in BMI, physical activity at work, exercise, or smoking than BRFSS participants and were less likely to consume more fruits and vegetables. More research is needed to explore group differences in screening practices compared to modifiable health behaviors in daughters of mothers with breast cancer.

Somatic symptoms have been extensively studied in primary care, but infrequently in diseases causing pain in multiple sites. We therefore examined the impact of somatic symptom burden (SSB) on pain, depression, anxiety, health-care utilization, and quality-of-life in adults with sickle cell disease (SCD).Subjects were 230 adults in the prospective Pain in Sickle Cell Epidemiology Study (PiSCES). Baseline data included demographics, genotype, Patient Health Questionnaire (PHQ), and SF-36 health-related quality of life (HRQOL). In daily diaries for 6 months, patients recorded SCD pain and SCD health-care utilization. To exclude common SCD pain sites, we abridged the PHQ's 15 somatic symptoms to 11 (PHQscd). We divided subjects into two groups: PHQscd≥11 (high SSB), and PHQscd11 (low SSB).High SSB occurred in 18.3% of subjects and was more frequent in women than men (24.6% vs. 9.1%, p=0.0033). Sixty percent of subjects with anxiety and 37.5% of those with depression had comorbid high SSB. Percentage of pain days not in crisis pain was significantly higher in somatizers, but crisis pain did not differ between groups. The high SSB group's hospitalization, scheduled doctor visits, and overall utilization, particularly on non-crisis days were significantly higher than the low SSB group's (p values0.05). All SF-36 subscales were significantly negatively correlated with PHQscd (p0.0001).Even after excluding common SCD pain complaints, high somatic symptom burden was 1.5 to 2 times more prevalent in SCD patients than in primary care. High SSB in SCD predicts more non-crisis pain and healthcare utilization for pain, and is associated with depression, anxiety, and poorer HRQOL.

Background: For research purposes, painful crises in sickle cell disease (SCD) have either been self-defined by patients, or adjudicated by research experts, most often based on whether urgent care or hospital care was sought for pain related to SCD. The Pain in Sickle Cell Epidemiology Study (PiSCES) determined that three-fourths of self-defined crises days were not managed in urgent or hospital care. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (AAPT) published a taxonomy of chronic SCD pain, defined as pain on most days of 6 months duration, along with at least one clinical sign, and no better explanation for the pain. We served on a similar SCD consensus panel to propose a more expansive taxonomy of acute sickle cell pain or painful episodes, informed by the PiSCES dataset (manuscript under review). Here we present three PiSCES-derived definitions of acute painful episodes, and we analyze the impact of various definitions on pain outcome results potentially useful for research. Methods: PiSCES Patients (N=81) who completed at least 5 out of the expected 6 months of daily diaries and did not have gaps in their daily diary of 4 days or more were included. Patients self-reported their worst sickle cell pain intensity on a scale from 0 (none) to 9 (unbearable), and independently self-reported whether they were having a crisis that day, whether they went for an unscheduled physician visit, an Emergency Department visit, or whether they were hospitalized for sickle cell pain. Definitions of acute pain episodes compared here include self-reported crisis days, days with pain ≥ 5, and days with utilization of the ED or overnight hospitalization (other potential definitions not shown). To meet any definition, a crisis day (pain≥ 5, utilization) had to be reported for 2 or more consecutive days. Non-crisis intervals were 2 or more consecutive days without a self-reported crisis (pain ≥ 5, utilization). The average length of non-crisis intervals was considered to represent the time between crisis episodes. For Results: (Table) For each definition of an acute painful episode, a larger percentage of patients with chronic pain had acute episodes than patients without chronic pain. Similarly, chronic pain patients had statistically significantly more episodes and higher mean pain intensity on non-episode days. For 2 of 3 definitions (but not ED or hospitalization use), chronic pain patients had longer episodes and shorter time between episodes. Only for the self-reported crisis definition, patients had higher mean pain intensity during episodes. Raising the pain intensity threshold from 5 to 6 to define an acute episode slightly decreased the absolute percentage with acute episodes, the number of episodes, and the length of episodes, but did not affect the relationships between outcomes for patients with and without chronic pain (results not shown in table). Conclusions: A comparison of various definitions of acute painful episodes using the PiSCES dataset yields slightly different pain outcome results. However, these differences are intuitive. For example, chronic pain patients still have more intense and more frequent acute painful episodes regardless of the definition used. The finding of more frequent acute pain in SCD adults with chronic pain has important implications for treatment and the design of SCD clinical trials. Table. Table. Disclosures Field: Ironwood: Consultancy, Research Funding; Prolong: Research Funding; Incyte: Research Funding. Dampier:Pfizer: Research Funding.

Background: Patient reported outcomes (PROs) for people with Sickle Cell Disease (SCD) have been shown to be associated with the degree of sickle cell organ system involvement using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) medical health checklist [Keller et al]. But since SCD is characterized mainly by vaso-occlusive pain, we explored how and how much various PRO measures correlated with the frequency and severity of painful crises, particularly the annual number of painful crises, which has been related to long-term mortality. Methods: All included patients had non-missing values (N=200, 52.5% female), age 15 or older and were enrolled in the Start Healing in Patients with Hydroxyurea (SHIP-HU, R18HL112737) randomized controlled trial. Patients completed various ASCQ-Me (A) and Patient Reported Outcomes Measurement Information System (PROMIS, or P) forms to assess PROs in the psychosocial domain (emotional impact, social impact, global mental health and satisfaction with social roles), physical domain (sleep impact, stiffness, global physical health, physical functioning, fatigue and wake disturbance) and pain domain (behavior and impact). Pain attack (crisis) frequency and severity were measured via the ASCQ-Me SCD pain episode frequency and severity short form. The frequency subscale assessed the number of crises in the past year and the timing of the most recent crisis. The severity subscale assessed the pain intensity rating (0-10) during the most recent crisis and the length of that crisis in days. Crises were defined solely by self-report. We tested PRO correlations with crisis frequency and crisis severity, controlling for possible confounding by age, sex, genotype, and education. Analysis used baseline data only. Results: At baseline, 81.5% of SHIP-HU enrollees were on HU and 87% were SS genotype. The mean age was 29.5 years and 48% had at least some college; 44.2% had a low ASCQ-Me medical health checklist value, 27.9% had a medium value and 27.9% had a high value. See Table for correlations. PRO correlations with crisis frequency and crisis severity were almost always statistically significant, regardless of PRO domain (except for correlations of crisis severity with either global mental health or satisfaction with social roles). Correlations were always higher with crisis frequency than severity. The strongest correlations were -0.43 and -0.42, relating global physical health and social impact, respectively, to crisis frequency. Conclusions: In SHIP-HU, PROs in the psychosocial, physical and pain domains were statistically correlated with painful crisis frequency and severity, although none were higher than 0.43. More frequent crises and greater crisis severity were correlated with worse psychosocial, physical function and pain behavior and impact, though the correlation was always higher with crisis frequency than with crisis severity. Whether reported painful crisis frequency and severity using PROs are also associated with mortality is not known. Table. Table. Disclosures No relevant conflicts of interest to declare.

Treatment options for sickle cell disease (SCD) pain could be tailored to pain locations. But few epidemiologic descriptions of SCD pain location exist; these are based on few subjects over short time periods. We examined whether SCD pain locations vary by disease genotype, gender, age, frequency of pain, depression, pain crisis or healthcare utilization. We enrolled 308 adults with SCD in 2002-2004. Subjects kept daily pain diaries for up to 6months, including a body chart. Mixed model and generalized estimating equations were employed for analyses. Two hundred and sixty subjects completed at least one body chart. An average of 3.3/16 sites (25%) were painful. The number of pain sites varied by age, depression, frequent pain days, crisis and unplanned hospital/ED utilization. Lower back, knee/shin and hip, hurt on average more than a third of pain days, while jaw and pelvis hurt on fewer than 10% of days. Odds of a crisis were increased substantially when pain was in the arm, shoulder, upper back, sternum, clavicle, chest or pelvis (OR>1.5) while the odds of unplanned utilization were substantially increased for the sternum, clavicle and chest (OR>2.0). Pain in SCD varies considerably both within and between subjects, although it occurs most commonly in the lower back and lower extremities. The number and location of pain sites vary significantly by age, frequent pain, crisis and utilization. Identification and understanding of combinations of pain location and intensity may help to understand the etiology of SCD and improve SCD management.

Study objective Patients with sickle cell disease often receive a substantial amount of their health care in the emergency department (ED) and some come to the ED frequently, seeking treatment for pain. As a result, patients with sickle cell disease are often stigmatized as opioid-seeking ED overutilizers. We describe the proportion of sickle cell disease patients who are high utilizers of the ED and compare them with other sickle cell disease patients on demographics, pain characteristics, health data, psychosocial characteristics, and quality of life. Methods Two hundred thirty-two patients completed baseline data and at least 30 days of daily diary data. Baseline data included demographics, health data, and quality of life (Medical Outcome Study 36 Item Short Form). Daily diary data included ED utilization for sickle cell pain and descriptors of pain and distress. Results Eighty-two (35.5%) patients were found to be high ED utilizers. Clinically important and statistically significant differences were found between high ED utilizers and all other sickle cell disease patients: lower hematocrit level, more transfusions, more pain days, more pain crises, higher mean pain and distress, and worse quality of life on Medical Outcome Study 36 Item Short Form physical function summary scales. After controlling for severity and frequency of pain, high ED utilizers did not use opioids more frequently than other sickle cell disease patients. Conclusion A substantial minority of sickle cell disease patients are high ED utilizers. However, high ED utilizers with sickle cell disease are more severely ill as measured by laboratory variables, have more pain, more distress, and have a lower quality of life.

A randomized trial investigated the impact of risk-tailored messages on mammography in diverse women in the Virginia Commonwealth University Health System's gynecology clinics.From 2003 to 2005, 899 patientsor =40 years of age were randomized to receive risk-tailored information or general information about breast health. Multiple logistic regression analyses summarize their breast health practices at 18 months.At baseline, 576 (64%) women reported having a mammogram in the past year. At 18-month follow-up, mammography rates were 72.6% in the intervention group and 74.2% in the control group (N.S.). Women (n = 123) who reported worrying about breast cancer "often" or "all the time" had significantly higher mammography rates with the intervention (85.0%) vs. the controls (63.5%). No significant differences existed in clinical breast examination, self-examination, or mammography intentions between the two study arms. However, intervention women with lower education reported significantly fewer clinical breast examinations at follow-up.The brief intervention with a risk-tailored message did not have a significant effect overall on screening at 18 months. However, among those who worried, mammography rates in the intervention group were higher. Individual characteristics, such as worry about breast cancer and education status, may impact interventions to improve breast cancer prevention practices.

Context:Increased fruit and vegetable intake can reduce cancer risk. Information from this study contributes to research exploring health disparities in high-risk dietary behavior. Purpose: Changes in fruit and vegetable behavior were evaluated to assess the effects of a low-intensity, physician-endorsed dietary intervention in a rural population. Methods: The study was a randomized trial of 754 patients from 3 physician practices in rural Virginia. Low-literacy nutrition education materials and personalized dietary feedback were administered by mail and telephone. Mixed model analysis of variance was used to determine the effect of the intervention on fruit and vegetable intake behavior, knowledge, intentions, and self-efficacy at 1, 6, and 12 months. Findings: The intervention effect was moderated by age, race, sex, and education. Intake at 1 and 6 months was increased for older and younger participants and those with some college, and further maintained at 12 months by those who did not complete high school. African Americans in the intervention group displayed significantly greater intentions to increase fruit/vegetable intake than whites/others. Knowledge of fruit/vegetable recommendations significantly increased in the intervention group at 12 months, particularly for men. Conclusions: For the rural population, a low-intensity physician-endorsed self-help dietary intervention was successful in initiating fruit and vegetable dietary changes at 1 and 6 months post-intervention, and increasing intentions to change in African Americans. The relationship of the moderating effects of age, race, sex and education need to be further explored in relation to dietary intervention and dietary behavior change for the rural population.

OBJECTIVE Depression and anxiety are common in sickle cell disease (SCD) but relatively little is known about their impact on SCD adults. This study measured prevalence of depression and anxiety in SCD adults, and their effects on crisis and noncrisis pain, quality-of-life, opioid usage, and healthcare utilization. METHODS The Pain in Sickle Cell Epidemiology Study is a prospective cohort study in 308 SCD adults. Baseline variables included demographics, genotype, laboratory data, health-related quality-of-life, depression, and anxiety. Subjects completed daily diaries for up to 6 months, reporting sickle cell pain intensity, distress, interference, whether they were in a sickle cell crisis, as well as health care and opioid utilization. RESULTS Two hundred thirty-two subjects who completed at least 1 month of diaries were studied; 27.6% were depressed and 6.5% had any anxiety disorder. Depressed subjects had pain on significantly more days than nondepressed subjects (mean pain days 71.1% versus 49.6%, p < .001). When in pain on noncrisis days, depressed subjects had higher mean pain, distress from pain, and interference from pain. Both depressed and anxious subjects had poorer functioning on all eight SF-36 subscales, even after controlling for demographics, hemoglobin type, and pain. The anxious subjects had more pain, distress from pain, and interference from pain, both on noncrisis pain days and on crisis days, and used opioids more often. CONCLUSIONS Depression and anxiety predicted more daily pain and poorer physical and mental quality-of-life in adults with SCD, and accounted for more of the variance in all domains of quality-of-life than hemoglobin type.

OBJECTIVES To examine parent closeness and its effect in predicting youth smoking when 0, 1, or 2 parents smoked. METHODS Youth and parent smoking, closeness to parents, family structure, and gender and ethnicity among middle (n=17,468) and high school (n=5457) students were measured using a questionnaire. RESULTS Number of parents smoking incrementally moderated the protective effect of all 4 measures of parent closeness, in predicting youth smoking. CONCLUSIONS Addressing parent smoking and strengthening family relationships need significantly greater emphasis in interventions to further reduce youth smoking.

Alcohol abuse is common in patients with chronic painful medical disorders, but it has not been studied in sickle cell disease (SCD). In a prospective cohort study of SCD adults, 31.4% were identified as abusing alcohol. There were no significant differences between alcohol abusers and nonabusers on demographics, biological variables, depression, anxiety, measures of crisis and noncrisis pain, or opioid use, but abusers reported more pain relief from opioids than nonabusers did. Alcohol abusers had fewer unscheduled clinic visits, emergency room visits, hospital days, and any health care utilization for SCD, but this was only significant for emergency room visits. Quality of life was similar between both groups, except that alcohol abusers unexpectedly had better overall physical summary scores. Alcohol abusers were more likely to report coping by ignoring pain, diverting attention, and using particular self-statements.

Background There is a lack of research concerning health-related quality of life (HRQoL) in Saudi patients with sickle cell disease (SCD), particularly among adult populations. The aim of the current study was to describe the characteristics of SCD patients and their impact on their quality of life (QoL). Methods Six hundred twenty-nine adult SCD patients who attended King Fahad Hospital in Hofuf and King Fahad Central Hospital in Jazan were included in the analysis. Demographic/clinical data were collected and an Arabic version of the Medical Outcomes 36-Item Short-Form Health Survey (SF-36) questionnaire was used to assess QoL. Results SCD patients who hold a university degree reported positive impacts on the following domains of SF-36: physical role function, vitality, emotional well being, social function, pain reduction, and general health (P = .002, P = .001, P = .001, P = .003, P = .004, and P = .001, respectively). In general, patients with fever, skin redness, swelling, or history of blood transfusion tended to impair the health status of the SF-36. A multivariate analysis revealed that patients with a university degree tended to report high scores of physical role functions, emotional role function, and vitality. Patients with regular exercise tend to increase vitality, social function, general health, and reduce pain. Unemployment tends to lessen vitality and worsen pain. On average, pain, social function, and physical function scores tended to worsen in patients with swelling or history of blood transfusion. Conclusions This study highlighted that poor education, fever, skin redness, and swelling were negatively associated with specific components of SF-36. SCD patients with a history of blood transfusion found their QoL poorer, whereas regular exercise tended to improve QoL.

This study explored risk perceptions after breast cancer risk appraisal. The study involved a randomized trial of Women's Health clinic patients (≥ 40 years old). Primary outcome was perceived breast cancer risk at baseline, 1 month, 6 months, and 18 months. Perceived breast cancer risks were higher than actual calculated risks at baseline. At baseline, 45% reported moderate/strong risk and 43% reported lower-than-average risk; 53% said that their risk was lower than 15%. Mean perceived lifetime risk was 31 out of 100. Throughout follow-up, the treatment group reported lower risks by all measures, as compared to controls. However, for African American women, perceived risk “out of 100 women” did not change. A brief health risk appraisal tends to lower breast cancer risk perceptions for at least 18 months, but the impact may vary by race/ethnicity. These findings could affect health behaviors, such as annual mammograms, which are influenced by perceived risk.

Many studies have found gender differences in frequency and intensity of pain. Women often report lower pain thresholds, higher pain ratings, and lower tolerance for pain. People with sickle cell disease (SCD) experience both chronic and acute pain throughout life.To compare adult men and women with SCD in terms of reported pain, crises, healthcare utilization, and opioid usage.Two hundred twenty-six adults with SCD in Virginia were enrolled in a prospective cohort study of pain and completed daily diaries for 1-6 months. Subjects reported for the previous day their maximum SCD-related pain, distress, and interference (0-9 scale), whether they were in a sickle cell crisis, had unplanned utilization (clinic, emergency room, or hospitalization), or used opioids. Episodes of pain, crisis, or utilization were defined as consecutive days of such. Men and women were compared, using analysis of covariance (ANCOVA), controlling for age, SCD genotype, depression, and education.There were no significant differences between men and women in the percentage of days subjects experienced pain (men 58.6% vs. women 56.5%) or the number of pain episodes/6 months (7.7 vs. 9.6). Mean pain scores were comparable, when subjects were in crisis (5.5 vs. 5.6) or not (2.5 vs. 2.2). Distress and interference results were similar. Men with the SS genotype reported a higher percentage of days with crisis(18.5% vs. 11.6%) and utilization (5.1% vs. 2.7%) than women with the SS genotype.Contrary to many studies of pain, particularly chronic pain, men and women with SCD reported generally similar pain experiences.

Background Dietary behavior, specifically a low-fat, high-fiber diet, plays a role in the primary prevention of chronic diseases including cancer. Design A community-based randomized trial to assess the impact of a low-intensity, physician-endorsed, self-help dietary intervention that provided tailored dietary feedback, and was designed to promote improved fat and fiber behavior in a rural, low-education/low-literacy, partly minority population. The data were collected from 1999 to 2003. Setting/participants A total of 754 patients from three physician practices in rural Virginia completed a baseline telephone survey assessing dietary and psychosocial information, and were then randomly assigned to the intervention or control condition. Follow-up telephone evaluation was based on 522 participants at 1 month, 470 at 6 months, and 516 participants at 12 months. Intervention A series of tailored feedback, followed by brief telephone counseling and theory-based nutritional education booklets, provided by staggered delivery to the home. Main outcome measures Dietary fat and fiber behavior, dietary intentions to change, self-efficacy for dietary change, and fat and fiber knowledge. Results The intervention group demonstrated significant improvement in dietary fat and fiber behaviors and intentions to change fat and fiber intake ( p Conclusions The Rural Physician Cancer Prevention Project provides an effective model for achieving public health-level dietary health behavior changes among a rural, minority, and low-literacy/low-education population.

Cancer surveillance is essential for assessing patterns of cancer occurrence. State cancer registries do not capture all available cases potentially biasing results. Secondary data may be useful in identifying new cases and estimating the number of cases missed.We sought to create 2 distinct data sources from Medicare claims to use in combination with registry data as 3 sources for a capture-recapture analysis to estimate the capture rate and bias in capture of a statewide cancer registry.Data from the Virginia cancer registry (Registry) were merged with Medicare inpatient (Part A) as well as Medicare outpatient and physician claims (Part B) to provide 3 sources to estimate missing cases. A 3-source loglinear model was used to estimate the number of missing cancer cases for breast, lung, colorectal, and prostate cancer. Models included main effects and interactions. Additional analysis looked at the effect of demographic and comorbidity variables.Loglinear models demonstrated mostly positive dependence between the 3 sources, implying that 2-source models would underestimate missing cases and overestimate capture rates. Using capture-recapture estimates of total number of cancer cases as the denominator, capture rates for Registry ranged from 59% (colorectal) to 74% (lung). When the aggregate of cases found by either Medicare or Registry were used the capture rates ranged from 74% (prostate) to 89% (breast). Further analysis indicated that capture rates differed by demographic characteristics.We conclude that Medicare claims are useful to supplement a Registry, estimate the number of missing cases, and assess bias in capture.

Objective. To perform a systematic review of the effects of estrogen therapy on symptoms suggestive of overactive bladder (OAB) in postmenopausal women. Materials and methods. This analysis involved a literature review of Medline, Excerpta Medica, and the Science Citation Index and a manual search of popular urology, gynecology, gerontology, and primary care medicine journals from January 1969 to December 1999. Articles had to include estrogen and placebo treatment groups, published or original data presented at a scientific meeting and report symptoms suggestive of OAB. This search identified 11 randomized trials and included a total of 430 subjects. Thirty-six subjects who participated in two crossover studies received both estrogen and placebo and thus are counted twice, therefore 236 received estrogen therapy and 230 were placebo controls. Estrogen was administered systemically or locally as estriol, estradiol, conjugated estrogen, or estradiol and estriol. A meta-analysis of these studies was perform...

Rates of fluoroquinolone resistance among Pseudomonas aeruginosa in hospitals are increasing, but interhospital variability is great. We sought to determine whether this variability correlated to fluoroquinolone use in hospitals and in the surrounding community. Hospital quinolone use in 1999 (24 hospitals) through 2001 (35 hospitals) was determined from billing records. The number of fluoroquinolone prescriptions within a 10-mile (approximately 16-km) radius of each hospital was determined for 1999 and 2000. Hospital fluoroquinolone use increased from 1999 through 2001, from 137 to 163 defined daily doses (DDD)/1000 patient-days (P=.01). The rate of community fluoroquinolone use also increased, from 2.3 to 2.8 DDD/1000 inhabitant-days (P

Background: Cancer surveillance is essential for assessing patterns of cancer. State cancer registries do not capture all cases. We used a statewide hospital discharge file to estimate the capture rate and determine biases in capture by a state cancer registry. Methods: We merged the Virginia hospital discharge file and cancer registry for 1995, then used multivariate two- source capture-recapture techniques to control for heterogeneity and more accurately estimate the number and characteristics of missing breast, lung, colorectal and prostate cancer cases. Results: Results suggest heterogeneity of capture, with rates a function of demographics, surgery and being in a hospital with a cancer program certified by the American College of Surgeons(ACOS). Overall registry capture rates ranged from 66% (prostate)–79% (breast). Capture rates varied by subgroup, with differences larger according to surgery and ACOS certification status than for demographic subgroups. While the registry captured most cases who had surgery (85–89%), capture rates for those without surgery was much lower (37–71%). Conclusion: We conclude that hospital discharge data and multivariate capture-recapture techniques are useful to registries to estimate the number of missing cases and assess bias in capture. Epidemiologic research based on registry data alone would likely provide biased, misleading results.

Patients can benefit from accessible breast cancer risk information. The Gail model is a well-known means of providing risk information to patients and for guiding clinical decisions. Risk presentation often includes 5-year and life-time percent chances for a woman to develop breast cancer. How do women perceive their risks after Gail model risk assessment? This exploratory study used a randomized clinical trial design to address this question among women not previously selected for breast cancer risk. Results suggest a brief risk assessment intervention changes quantitative and comparative risk perceptions and improves accuracy. This study improves our understanding of risk perceptions by evaluating an intervention in a population not previously selected for high-risk status and measuring perceptions in a variety of formats.

Background and Objective: The purpose of this study was to use Medicare claims to develop models to assist cancer registries in identifying cancer patients with second primaries or recurrences (an "event"). Methods: Medicare inpatient and Part B data were merged with a cancer registry for patients first diagnosed in 1993–1994. Logistic regression was used to model the occurrence of an event at least 1 year after initial diagnosis, and to identify factors that could discriminate between recurrences and second primaries. Results: Predictors of an event included an inpatient cancer diagnosis, cancer diagnosis different from the initial diagnosis from any source, and radiation or surgery claims in Part B. The ROC curve area was 0.90 with all Medicare data; 0.84 when restricted to inpatient data. A cancer diagnosis different from the initial diagnosis or having surgery predicted a second primary; regional or distant stage disease, diagnosis of secondary malignancy, or an inpatient diagnosis of primary cancer in a position other than principal predicted recurrence. Conclusions: Although Medicare claims have not been evaluated as a stand-alone system to identify second primaries and recurrences, Medicare claims may be useful tools for Cancer Registries in case ascertainment and follow-up.