Statin use and sepsis events [corrected] in patients with chronic kidney disease

Context  Patients with chronic kidney disease are at high risk for sepsis and sepsis-related mortality. Objective  To assess whether statin use is associated with a reduction in hospitalizations for sepsis in dialysis patients. Design, Setting, and Patients  National prospective cohort study that enrolled 1041 incident dialysis patients at 81 US not-for-profit outpatient dialysis clinics from October 1995 to June 1998, with follow-up to January 2005. Statin use was determined by medical record review. Rates of hospitalization for sepsis between statin users and control patients were compared using multivariate regression models, with adjustment for potential confounders in the overall cohort and in a subcohort in which control patients were matched to statin users according to their likelihood (propensity) to have been prescribed a statin. Main Outcome Measure  Hospitalizations for sepsis were determined through hospital records from the United States Renal Data System (mean follow-up, 3.4 years). Results  There were 303 hospitalizations for sepsis. Rates of sepsis-related hospitalizations were significantly lower in patients receiving statins (crude incidence rate, 41/1000 patient-years) than in those not receiving statins (crude incidence rate, 110/1000 patient-years) (P<.001). With adjustment for demographics and dialysis modality, statin users were substantially less likely to be subsequently hospitalized for sepsis (incidence rate ratio, 0.41; 95% confidence interval [CI], 0.25-0.68). Further adjustment for comorbidities and laboratory values continued to show this protective association (incidence rate ratio, 0.38; 95% CI, 0.21-0.67). In the propensity-matched subcohort, statin use was even more protective (incidence rate ratio, 0.24; 95% CI, 0.11-0.49). Conclusions  Use of statins was strongly and independently associated with a reduction in the risk of hospitalization for sepsis in patients who had chronic kidney disease and were receiving dialysis. Randomized trials of statins in patients with chronic kidney disease should examine the prevention of sepsis as a potentially important benefit.      

Effectiveness of pharmacist care for patients with reactive airways disease: a randomized controlled trial

Context  It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions. Objective  To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease (COPD). Design, Setting, and Participants  Randomized controlled trial conducted at 36 community drugstores in Indianapolis, Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999. Outcomes were assessed in 947 (85.1%) participants at 6 months and 898 (80.7%) at 12 months. Interventions  The pharmaceutical care program (n = 447) provided pharmacists with recent patient-specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention. Main Outcome Measures  Peak expiratory flow rates, breathing-related ED or hospital visits, health-related quality of life (HRQOL), medication compliance, and patient satisfaction. Results  At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P = .02) but not than PEFR monitoring controls (P = .28). There were no significant between-group differences in medication compliance or HRQOL. Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group (odds ratio, 2.16; 95% confidence interval, 1.76-2.63; P<.001). Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group (P = .03) and the PEFR monitoring group (P = .001) and were more satisfied with their health care than the usual care group at 6 months only (P = .01). Despite ample opportunities to implement the program, pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed. Conclusions  This pharmaceutical care program increased patients' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone. Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought.      

Deceased-donor characteristics and the survival benefit of kidney transplantation

Context  Transplantation using kidneys from deceased donors who meet the expanded criteria donor (ECD) definition (age 60 years or 50 to 59 years with at least 2 of the following: history of hypertension, serum creatinine level >1.5 mg/dL [132.6 µmol/L], and cerebrovascular cause of death) is associated with 70% higher risk of graft failure compared with non-ECD transplants. However, if ECD transplants offer improved overall patient survival, inferior graft outcome may represent an acceptable trade-off. Objective  To compare mortality after ECD kidney transplantation vs that in a combined standard-therapy group of non-ECD recipients and those still receiving dialysis. Design, Setting, and Patients  Retrospective cohort study using data from a US national registry of mortality and graft outcomes among kidney transplant candidates and recipients. The cohort included 109 127 patients receiving dialysis and added to the kidney waiting list between January 1, 1995, and December 31, 2002, and followed up through July 31, 2004. Main Outcome Measure  Long-term (3-year) relative risk of mortality for ECD kidney recipients vs those receiving standard therapy, estimated using time-dependent Cox regression models. Results  By end of follow-up, 7790 ECD kidney transplants were performed. Because of excess ECD recipient mortality in the perioperative period, cumulative survival did not equal that of standard-therapy patients until 3.5 years posttransplantation. Long-term relative mortality risk was 17% lower for ECD recipients (relative risk, 0.83; 95% confidence interval, 0.77-0.90; P<.001). Subgroups with significant ECD survival benefit included patients older than 40 years, both sexes, non-Hispanics, all races, unsensitized patients, and those with diabetes or hypertension. In organ procurement organizations (OPOs) with long median waiting times (>1350 days), ECD recipients had a 27% lower risk of death (relative risk, 0.73; 95% confidence interval, 0.64-0.83; P<.001). In areas with shorter waiting times, only recipients with diabetes demonstrated an ECD survival benefit. Conclusions  ECD kidney transplants should be offered principally to candidates older than 40 years in OPOs with long waiting times. In OPOs with shorter waiting times, in which non-ECD kidney transplant availability is higher, candidates should be counseled that ECD survival benefit is observed only for patients with diabetes.      

Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial

Context  The scarcity of data addressing the health effects of popular diets is an important public health concern, especially since patients and physicians are interested in using popular diets as individualized eating strategies for disease prevention. Objective  To assess adherence rates and the effectiveness of 4 popular diets (Atkins, Zone, Weight Watchers, and Ornish) for weight loss and cardiac risk factor reduction. Design, Setting, and Participants  A single-center randomized trial at an academic medical center in Boston, Mass, of overweight or obese (body mass index: mean, 35; range, 27-42) adults aged 22 to 72 years with known hypertension, dyslipidemia, or fasting hyperglycemia. Participants were enrolled starting July 18, 2000, and randomized to 4 popular diet groups until January 24, 2002. Intervention  A total of 160 participants were randomly assigned to either Atkins (carbohydrate restriction, n=40), Zone (macronutrient balance, n=40), Weight Watchers (calorie restriction, n=40), or Ornish (fat restriction, n=40) diet groups. After 2 months of maximum effort, participants selected their own levels of dietary adherence. Main Outcome Measures  One-year changes in baseline weight and cardiac risk factors, and self-selected dietary adherence rates per self-report. Results  Assuming no change from baseline for participants who discontinued the study, mean (SD) weight loss at 1 year was 2.1 (4.8) kg for Atkins (21 [53%] of 40 participants completed, P = .009), 3.2 (6.0) kg for Zone (26 [65%] of 40 completed, P = .002), 3.0 (4.9) kg for Weight Watchers (26 [65%] of 40 completed, P < .001), and 3.3 (7.3) kg for Ornish (20 [50%] of 40 completed, P = .007). Greater effects were observed in study completers. Each diet significantly reduced the low-density lipoprotein/high-density lipoprotein (HDL) cholesterol ratio by approximately 10% (all P<.05), with no significant effects on blood pressure or glucose at 1 year. Amount of weight loss was associated with self-reported dietary adherence level (r = 0.60; P<.001) but not with diet type (r = 0.07; P = .40). For each diet, decreasing levels of total/HDL cholesterol, C-reactive protein, and insulin were significantly associated with weight loss (mean r = 0.36, 0.37, and 0.39, respectively) with no significant difference between diets (P = .48, P = .57, P = .31, respectively). Conclusions  Each popular diet modestly reduced body weight and several cardiac risk factors at 1 year. Overall dietary adherence rates were low, although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group.      

Mental health and health-related quality of life among adult Latino primary care patients living in the United States with previous exposure to political violence

Context  Although political violence continues in parts of Central America, South America, and Mexico, little is known about its relationship to the health of Latino immigrants living in the United States. Objective  To determine (1) rates of exposure to political violence among Latino adult primary care patients who have immigrated to the United States from Central America, South America, and Mexico and its impact on mental health and health-related quality of life and (2) frequency of disclosure of political violence to primary care clinicians. Design, Setting, and Participants  Two-stage cluster design survey of a systematic sample of Latino immigrant adults in 3 community-based primary care clinics in Los Angeles, conducted from July 2001 to February 2002. Main Outcome Measures  Reports of exposure to political violence in home country before immigrating to the United States and communication with clinicians about political violence; self-reported measures of health-related quality of life using the Medical Outcomes Study Short Form 36 (MOS SF-36); symptoms of depression, anxiety, and alcohol disorders using the Primary Care Evaluation of Mental Disorders (PRIME-MD); and symptoms of posttraumatic stress disorder (PTSD) using the PTSD Checklist–Civilian Version (PCL-C). Results  A total of 638 (69%) of 919 eligible patients participated. The nonresponse rates did not differ by age, sex, recruitment sites, or clinic sessions. In weighted analyses, 54% of participants reported political violence experiences in their home countries, including 8% who reported torture. Of those exposed to political violence, 36% had symptoms of depression and 18% had symptoms of PTSD vs 20% and 8%, respectively, among those not exposed to political violence. Controlling for age, sex, country, years lived in the United States, acculturation, income, health insurance status, and recruitment site in a subsample of 512 participants (56%), those who reported political violence exposure were more likely to meet symptom criteria for PTSD (adjusted odds ratio [AOR], 3.4; 95% confidence interval [CI], 1.4-8.4) and to have symptoms of depression (AOR, 2.8; 95% CI, 1.4-5.4) and symptoms of panic disorder (AOR, 4.8; 95% CI, 1.6-14.4) than participants not reporting political violence. Those exposed to political violence reported more chronic pain and role limitations due to physical problems, as well as worse physical functioning and lower perceptions of general health than those who were not exposed to political violence. Only 3% of the 267 patients who had experienced political violence reported ever telling a clinician about it after immigrating; none reported their current physician asking about political violence. Conclusion  Latino immigrants in primary care in Los Angeles have a high prevalence of exposure to political violence before immigrating to the United States and associated impairments in mental health and health-related quality of life.      

Predisplacement and postdisplacement factors associated with mental health of refugees and internally displaced persons: a meta-analysis

Context  The global refugee crisis requires that researchers, policymakers, and clinicians comprehend the magnitude of the psychological consequences of forced displacement and the factors that moderate them. To date, no empirical synthesis of research on these issues has been undertaken. Objective  To meta-analytically establish the extent of compromised mental health among refugees (including internally displaced persons, asylum seekers, and stateless persons) using a worldwide study sample. Potential moderators of mental health outcomes were examined, including enduring contextual variables (eg, postdisplacement accommodation and economic opportunity) and refugee characteristics. Data Sources  Published studies (1959-2002) were obtained using broad searches of computerized databases (PsycINFO and PILOTS), manual searches of reference lists, and interviews with prominent authors. Study Selection  Studies were selected if they investigated a refugee group and at least 1 nonrefugee comparison group and reported 1 or more quantitative group comparison on measures of psychopathology. Fifty-six reports met inclusion criteria (4.4% of identified reports), yielding 59 independent comparisons and including 67 294 participants (22 221 refugees and 45 073 nonrefugees). Data Extraction  Data on study and report characteristics, study participant characteristics, and statistical outcomes were extracted using a coding manual and subjected to blind recoding, which indicated high reliability. Methodological quality information was coded to assess potential sources of bias. Data Synthesis  Effect size estimates for the refugee-nonrefugee comparisons were averaged across psychopathology measures within studies and weighted by sample size. The weighted mean effect size was 0.41 (SD, 0.02; range, –1.36 to 2.91 [SE, 0.01]), indicating that refugees had moderately poorer outcomes. Postdisplacement conditions moderated mental health outcomes. Worse outcomes were observed for refugees living in institutional accommodation, experiencing restricted economic opportunity, displaced internally within their own country, repatriated to a country they had previously fled, or whose initiating conflict was unresolved. Refugees who were older, more educated, and female and who had higher predisplacement socioeconomic status and rural residence also had worse outcomes. Methodological differences between studies affected effect sizes. Conclusions  The sociopolitical context of the refugee experience is associated with refugee mental health. Humanitarian efforts that improve these conditions are likely to have positive impacts.      

Health status of adult long-term survivors of childhood cancer: a report from the Childhood Cancer Survivor Study

Context  Adult survivors of childhood cancer are at risk for medical and psychosocial sequelae that may adversely affect their health status. Objectives  To compare the health status of adult survivors of childhood cancer and siblings and to identify factors associated with adverse outcomes. Design, Setting, and Participants  Health status was assessed in 9535 adult participants of the Childhood Cancer Survivor Study, a cohort of long-term survivors of childhood cancer who were diagnosed between 1970 and 1986. A randomly selected cohort of the survivors' siblings (n = 2916) served as a comparison group. Main Outcome Measures  Six health status domains were assessed: general health, mental health, functional status, activity limitations, cancer-related pain, and cancer-related anxiety/fears. The first 4 domains were assessed in the control group. Results  Survivors were significantly more likely to report adverse general health (odds ratio [OR], 2.5; 95% confidence interval [CI], 2.1-3.0; P<.001), mental health (OR, 1.8; 95% CI, 1.6-2.1; P<.001), activity limitations (OR, 2.7; 95% CI, 2.3-3.3; P<.001), and functional impairment (OR, 5.2; 95% CI, 4.1-6.6; P<.001), compared with siblings. Forty-four percent of survivors reported at least 1 adversely affected health status domain. Sociodemographic factors associated with reporting at least 1 adverse health status domain included being female (OR, 1.4; 95% CI, 1.3-1.6; P<.001), lower level of educational attainment (OR, 2.0; 95% CI, 1.8-2.2; P<.001), and annual income less than $20 000 (OR, 1.8; 95% CI, 1.6-2.1; P<.001). Relative to those survivors with childhood leukemia, an increased risk was observed for at least 1 adverse health status domain among those with bone tumors (OR, 2.1; 95% CI, 1.8-2.5; P<.001), central nervous system tumors (OR, 1.7; 95% CI, 1.5-2.0; P<.001), and sarcomas (OR, 1.2; 95% CI, 1.1-1.5; P = .01). Conclusion  Clinicians caring for adult survivors of childhood cancer should be aware of the substantial risk for adverse health status, especially among females, those with low educational attainment, and those with low household incomes.      

The burden of out-of-pocket payments for health care in Tbilisi, Republic of Georgia

Jacek Skarbinski, MD; H. Kenneth Walker, MD; Laurence C. Baker, PhD; Archil Kobaladze, MD,PhD; Zviad Kirtava, MD,PhD; Thomas A. Raffin, MD

JAMA. 2002;287:1043-1049.

Context  In the 1990s, the Republic of Georgia instituted health care reforms to convert the centralized, state-operated health care system inherited from the Soviet Union to a decentralized, market-driven system of health care delivery. Under the new system, 87% of health care expenditures are financed through out-of-pocket payments at the point of service.

Objective  To describe the effects of health care reforms on access to care and health care financing among ill residents of Tbilisi, Georgia.

Design, Setting, and Participants  A probability-proportionate-to-size cluster survey conducted in 1999 of 248 households containing 306 household members who had been ill in the past 6 months in Tbilisi, Georgia.

Main Outcome Measures  Reported health care utilization, out-of-pocket expenditures, and financing practices.

Results  Of sick household members, 51% used official health care services at hospitals and clinics; 49% did not use official services and sought advice from relatives or friends, used traditional medicines, or did nothing. Those with serious illness were more likely to seek care through official services (82%) than those with nonserious illness (27%). Ninety-three percent of respondents said costs were the major deterrent to obtaining health care. Ten percent of ill household members reported that they were unable to obtain health care because of high costs; 16% reported being unable to afford all the medications necessary to treat their illness. Sixty-one percent of ill household members used savings to pay for health care expenditures and 19% of those able to obtain care had to use strategies such as borrowing money or selling personal items to pay for health care. Total out-of-pocket health care expenditures (53%) were paid for by borrowing money or selling personal items. A significant portion of households with ill members (87%) reported an interest in purchasing health care insurance.

Conclusions  Economic disruption and health care reforms have led to access problems and out-of-pocket financing strategies that include reliance on personal savings, selling personal items, and borrowing money. Future reforms should consider an appropriate system for health care insurance risk pooling for the population of Tbilisi, Georgia.

     

Preparedness for clinical practice: reports of graduating residents at academic health centers

Context  Medical educators are seeking improved measures to assess the clinical competency of residents as they complete their graduate medical education. Objective  To assess residents' perceptions of their preparedness to provide common clinical services during their last year of graduate medical education. Design, Setting, and Participants  A 1998 national survey of residents completing their training in 8 specialties (internal medicine, pediatrics, family practice, obstetrics/gynecology, general surgery, orthopedic surgery, psychiatry, and anesthesiology) at academic health centers in the United States. A total of 2626 residents responded (response rate, 65%). Main Outcome Measures  Residents' reports of their preparedness to perform clinical and nonclinical tasks relevant to their specialties. Results  Residents in all specialties rated themselves as prepared to manage most of the common conditions they would encounter in their clinical career. However, more than 10% of residents in each specialty reported that they felt unprepared to undertake 1 or more tasks relevant to their disciplines, such as caring for patients with human immunodeficiency virus/acquired immunodeficiency syndrome or substance abuse (family practice) or nursing home patients (internal medicine); performance of spinal surgery (orthopedic surgery) or abdominal aortic aneurysm repair (general surgery); and management of chronic pain (anesthesiology). Conclusions  Overall, residents in their last year of training at academic health centers rate their clinical preparedness as high. However, opportunities for improvement exist in preparing residents for clinical practice.      

Kidney paired donation and optimizing the use of live donor organs

Context  Blood type and crossmatch incompatibility will exclude at least one third of patients in need from receiving a live donor kidney transplant. Kidney paired donation (KPD) offers incompatible donor/recipient pairs the opportunity to match for compatible transplants. Despite its increasing popularity, very few transplants have resulted from KPD. Objective  To determine the potential impact of improved matching schemes on the number and quality of transplants achievable with KPD. Design, Setting, and Population  We developed a model that simulates pools of incompatible donor/recipient pairs. We designed a mathematically verifiable optimized matching algorithm and compared it with the scheme currently used in some centers and regions. Simulated patients from the general community with characteristics drawn from distributions describing end-stage renal disease patients eligible for renal transplantation and their willing and eligible live donors. Main Outcome Measures  Number of kidneys matched, HLA mismatch of matched kidneys, and number of grafts surviving 5 years after transplantation. Results  A national optimized matching algorithm would result in more transplants (47.7% vs 42.0%, P<.001), better HLA concordance (3.0 vs 4.5 mismatched antigens; P<.001), more grafts surviving at 5 years (34.9% vs 28.7%; P<.001), and a reduction in the number of pairs required to travel (2.9% vs 18.4%; P<.001) when compared with an extension of the currently used first-accept scheme to a national level. Furthermore, highly sensitized patients would benefit 6-fold from a national optimized scheme (2.3% vs 14.1% successfully matched; P<.001). Even if only 7% of patients awaiting kidney transplantation participated in an optimized national KPD program, the health care system could save as much as $750 million. Conclusions  The combination of a national KPD program and a mathematically optimized matching algorithm yields more matches with lower HLA disparity. Optimized matching affords patients the flexibility of customizing their matching priorities and the security of knowing that the greatest number of high-quality matches will be found and distributed equitably.      

Use of health care services by lower-income and higher-income uninsured adults

Context  More than 45 million individuals in the United States lack health insurance, potentially limiting their access to and use of appropriate health care services. Although the uninsured comprise a range of income levels, little attention has been directed at higher-income uninsured adults and their patterns of care. Objective  To examine whether having higher income attenuates the association between being uninsured and using fewer recommended health care services. Design, Setting, and Participants  Cross-sectional analysis of data from the 2002 Behavioral Risk Factor Surveillance System, drawn from a nationally representative sample of households. Participants were community-dwelling adults (n = 194 943; 50% women) aged 18 to 64 years in 2002. Main Outcome Measures  Self-reported use of screening for cervical, breast, and colorectal cancer; serum cholesterol screening and measurement, aspirin use, and tobacco cessation and weight loss counseling for cardiovascular risk reduction; and serum cholesterol and glycosylated hemoglobin measurement, eye and foot examination, and influenza and pneumococcal vaccination for diabetes management. Results  Among eligible adults, use of cancer prevention services ranged from 51% for colorectal cancer screening to 88% for cervical cancer screening, while use of cardiovascular risk reduction services ranged from 38% for weight loss counseling to 81% for aspirin use, and use of services for diabetes management ranged from 33% for pneumococcal vaccination to 88% for serum glycosylated hemoglobin measurement. In bivariate analyses, health insurance and annual household income were both strongly associated with use of nearly all examined health care services (P values <.01). Using multivariable analysis, increased annual household income did not significantly increase the likelihood of uninsured compared with insured adults receiving recommended health care services for cancer prevention, cardiovascular risk reduction, or diabetes management (P values >.05). Conclusions  Even among higher-income adults, lack of health care insurance was associated with significantly decreased use of recommended health care services; increased income did not attenuate the difference in use between uninsured and insured adults. Efforts to improve the use of recommended health care services among the uninsured should focus on patient education and expanding insurance eligibility for both lower-income and higher-income adults.      

Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial

Context  Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. Objective  To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women. Design, Setting, and Participants  The Women’s Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48 835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States. Interventions  Participants were randomly assigned to the dietary modification intervention (n = 19 541; 40%) or the comparison group (n = 29 294; 60%).The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern. Main Outcome Measure  Invasive colorectal cancer incidence. Results  A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention. Conclusion  In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up. Clinical Trials Registration  ClinicalTrials.gov Identifier: NCT00000611      

Childhood cancer survivors' knowledge about their past diagnosis and treatment: Childhood Cancer Survivor Study

Context  Adult survivors of childhood cancer are at risk for adverse effects later in life but may have limited access to information about their diagnosis and treatment. This knowledge is necessary to motivate them to seek medical follow-up and to report essential history to health care professionals. Objective  To assess knowledge of adult survivors of childhood cancer about their primary cancer diagnosis and associated therapies. Design, Setting, and Participants  Cross-sectional survey of 635 consecutive survivors (approximately 5%) drawn from 12 156 participants 18 years or older participating in the Childhood Cancer Survivor Study (a multiinstitutional cohort of individuals diagnosed between January 1, 1970, and December 31,1986, at an age <21 years, who had survived 5 years from diagnosis).The survey assessed knowledge of their cancer diagnosis and associated therapies in a 3- to 5-minute telephone questionnaire. Main Outcome Measures  Responses were compared with medical record data for accuracy, sensitivity, specificity, and positive and negative predictive value. Results  Overall, 72% accurately reported their diagnosis with precision and 19% were accurate but not precise. Individuals with central nervous system (CNS) cancer (odds ratio, 5.1; 95% confidence interval, 2.6-9.9) and neuroblastoma (OR, 4.2; 95% CI, 1.8-9.6) were more likely not to know their cancer diagnosis. Participants' accuracy rates for reporting their treatment history was 94% for chemotherapy, 89% for radiation, and 93% for splenectomy. Among those who received anthracyclines, only 30% recalled receiving daunorubicin therapy and 52% recalled receiving doxorubicin therapy, even after prompting with the drugs' names. Among those who received radiotherapy, 70% recalled the site of radiotherapy. History of receiving a written medical summary, attending a long-term follow-up clinic, and anxiety about late effects were not associated with greater knowledge. Conclusions  Important knowledge deficits exist among adult survivors of childhood cancer regarding basic aspects of their diagnosis and treatment. Such deficits could impair survivors' ability to seek and receive appropriate long-term follow-up care.      

Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial

Context  There has been increasing interest in the use of health-related quality-of-life (HRQL) assessments in daily clinical practice, yet few empirical studies have been conducted to evaluate the usefulness of such assessments. Objective  To evaluate the efficacy of standardized HRQL assessments in facilitating patient-physician communication and increasing physicians' awareness of their patients' HRQL-related problems. Design  Prospective, randomized crossover trial. Setting  Outpatient clinic of a cancer hospital in the Netherlands. Participants  Ten physicians and 214 patients (76% women; mean age, 57 years) undergoing palliative chemotherapy who were invited to participate between June 1996 and June 1998. Intervention  At 3 successive outpatient visits, patients completed an HRQL questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). The responses were computer scored and transformed into a graphic summary. Physicians and patients received a copy of the summary before the consultation. Main Outcome Measures  Audiotapes of the consultations were content analyzed to evaluate patient-physician communication. Physicians' awareness of their patients' health problems was assessed by comparing physicians' and patients' ratings on the Dartmouth Primary Care Cooperative Information Functional Health Assessment (COOP) and the World Organisation Project of National Colleges and Academics (WONCA) charts. Results  The HRQL-related issues were discussed significantly more frequently in the intervention than in the control group (mean [SD] communication composite scores: 4.5 [2.3] vs 3.7 [1.9], respectively (P = .01). Physicians in the intervention group identified a greater percentage of patients with moderate-to-severe health problems in several HRQL domains than did those in the control group. All physicians and 87% of the patients believed that the intervention facilitated communication and expressed interest in its continued use. Conclusion  Incorporating standardized HRQL assessments in daily clinical oncology practice facilitates the discussion of HRQL issues and can heighten physicians' awareness of their patients' HRQL.      

Improving child survival through environmental and nutritional interventions: the importance of targeting interventions toward the poor

Context  The United Nations Millennium Development Goals (MDGs) set targets related to important global poverty, health, and sustainability issues. A critical but underinvestigated question for planning and allocating resources toward the MDGs is how interventions related to one MDG might affect progress toward other goals. Objectives  To estimate the reduction in child mortality as a result of interventions related to the environmental and nutritional MDGs (improving child nutrition and providing clean water, sanitation, and fuels) and to estimate how the magnitude and distribution of the effects of interventions vary based on the economic status of intervention recipients. Design, Setting, and Population  Population-level comparative risk assessment modeling the mortality effects of interventions on child nutrition and environmental risk factors, stratified by economic status. Data on economic status, child underweight, water and sanitation, and household fuels were from the nationally representative Demographic and Health Surveys for 42 countries in Latin America and the Caribbean, South Asia, and sub-Saharan Africa. Data on disease-specific child mortality were from the World Health Organization. Data on the hazardous effects of each MDG-related risk factor were from systematic reviews and meta-analyses of epidemiological studies. Main Outcome Measure  Child mortality, stratified by comparable international quintiles of economic status. Results  Implementing interventions that improve child nutrition and provide clean water and sanitation and clean household fuels to all children younger than 5 years would result in an estimated annual reduction in child deaths of 49 700 (14%) in Latin America and the Caribbean, 0.80 million (24%) in South Asia, and 1.47 million (31%) in sub-Saharan Africa. These benefits are equivalent to 30% to 48% of the current regional gaps toward the MDG target on reducing child mortality. Fifty percent coverage of the same environmental and nutritional interventions, as envisioned by the MDGs, would reduce child mortality by 26 900, 0.51 million, and 1.02 million in the 3 regions, respectively, if the interventions are implemented among the poor first. These reductions are 30% to 75% larger than those expected if the same 50% coverage first reached the wealthier households, who nonetheless are in need of similar interventions. Conclusions  Interventions related to nutritional and environmental MDGs can also provide substantial gains toward the MDG of reducing child mortality. To maximize the reduction in childhood mortality, such integrated management of interventions should prioritize the poor.      

Communication of randomization in childhood leukemia trials

Context  Most children diagnosed as having leukemia become research subjects in randomized clinical trials (RCTs), but little is known about how randomization is explained to or understood by parents. Objective  To investigate physicians' explanation and parental understanding of randomization in childhood leukemia RCTs. Design and Setting  A multisite study of the informed consent communication process for RCTs of childhood leukemia. Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US children's hospitals associated with major academic medical centers from July 1, 1999, until December 31, 2001. The informed consent conferences were observed and audiotaped, and the information obtained was coded and analyzed. Parents were interviewed shortly after the conference to ascertain their understanding. Participants  Parents and members of the health care team who participated in 137 informed consent conferences for children with newly diagnosed acute leukemia. Main Outcome Measures  Observed explanations of randomization and parental understanding of randomization after the consent conference. Results  Randomization was explained by physicians in 83% of cases and a consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (P<.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial. Conclusions  Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.      

Cardiovascular mortality risk in chronic kidney disease: comparison of traditional and novel risk factors

Context  Elderly persons with chronic kidney disease have substantial risk for cardiovascular mortality, but the relative importance of traditional and novel risk factors is unknown. Objective  To compare traditional and novel risk factors as predictors of cardiovascular mortality. Design, Setting, and Patients  A total of 5808 community-dwelling persons aged 65 years or older living in 4 communities in the United States participated in the Cardiovascular Health Study cohort. Participants were initially recruited from 1989 to June 1990; an additional 687 black participants were recruited in 1992-1993. The average length of follow-up in this longitudinal study was 8.6 years. Main Outcome Measures  Cardiovascular mortality among those with and without chronic kidney disease. Chronic kidney disease was defined as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m². Results  Among the participants, 1249 (22%) had chronic kidney disease at baseline. The cardiovascular mortality risk rate was 32 deaths/1000 person-years among those with chronic kidney disease vs 16/1000 person-years among those without it. In multivariate analyses, diabetes, systolic hypertension, smoking, low physical activity, nonuse of alcohol, and left ventricular hypertrophy were predictors of cardiovascular mortality in persons with chronic kidney disease (all P values <.05). Among the novel risk factors, only log C-reactive protein (P = .05) and log interleukin 6 (P<.001) were associated with the outcome as linear predictors. Traditional risk factors were associated with the largest absolute increases in risks for cardiovascular deaths among persons with chronic kidney disease: for left ventricular hypertrophy, there were 25 deaths per 1000 person-years; current smoking, 20 per 1000 person-years; physical inactivity, 15 per 1000 person-years; systolic hypertension, 14 per 1000 person-years; diabetes, 14 per 1000 person-years; and nonuse of alcohol, 11 per 1000 person-years vs 5 deaths per 1000 person-years for those with increased C-reactive protein and 5 per 1000 person-years for those with increased interleukin 6 levels. A receiver operating characteristic analysis found that traditional risk factors had an area under the curve of 0.73 (95% confidence interval, 0.70-0.77) among those with chronic kidney disease. Adding novel risk factors only increased the area under the curve to 0.74 (95% confidence interval, 0.71-0.78; P for difference = .15). Conclusions  Traditional cardiovascular risk factors had larger associations with cardiovascular mortality than novel risk factors in elderly persons with chronic kidney disease. Future research should investigate whether aggressive lifestyle intervention in patients with chronic kidney disease can reduce their substantial cardiovascular risk.      

Predictive model to identify positive tuberculosis skin test results during contact investigations

Context  Budgetary constraints in tuberculosis (TB) control programs require streamlining contact investigations without sacrificing disease control. Objective  To develop more efficient methods of TB contact investigation by creating a model of TB transmission using variables that best predict a positive tuberculin skin test among contacts of an active TB case. Design, Setting, and Subjects  After standardizing the interview and documentation process, data were collected on 292 consecutive TB cases and their 2941 contacts identified by the Alabama Department of Public Health between January and October 1998. Generalized estimating equations were used to create a model for predicting positive skin test results in contacts of active TB cases. The model was then validated using data from a prospective cohort of 366 new TB cases and their 3162 contacts identified between October 1998 and April 2000. Main Outcome Measure  Tuberculin skin test result. Results  Using generalized estimating equations to build a predictive model, 7 variables were found to significantly predict a positive tuberculin skin test result among contacts of an active TB case. Further testing showed this model to have a sensitivity, specificity, and positive predictive value of approximately 89%, 36%, and 26%, respectively. The false-negative rate was less than 10%, and about 40% of the contact workload could be eliminated using this model. Conclusions  Certain characteristics can be used to predict contacts most likely to have a positive tuberculin skin test result. Use of such models can significantly reduce the number of contacts that public health officials need to investigate while still maintaining excellent disease control.      

Response to smallpox vaccine in persons immunized in the distant past

Context  There is renewed interest in use of smallpox vaccine due to the potential for a bioterrorist attack. This would involve vaccinating health care workers who were previously vaccinated. Objective  To evaluate the use of diluted vaccinia virus in vaccination of previously vaccinated (non-naive) participants. Design, Setting, and Participants  Eighty non-naive participants, aged 32 to 60 years, were randomized in a single-blinded study to receive either undiluted or diluted (1:3.2, 1:10, or 1:32) doses of smallpox vaccine. A comparison group, aged 18 to 31 years, of 10 vaccinia-naive participants received undiluted vaccine. Participants were enrolled between April 1 and May 15, 2002, at the National Institute of Allergy and Infectious Diseases Vaccine and Treatment Evaluation Unit at Saint Louis University, St Louis, Mo. Intervention  Smallpox vaccine was administered by scarification using 15 skin punctures in the deltoid region of the arm. Main Outcome Measures  Presence of a major reaction, defined as a vesicular or pustular lesion or area of palpable induration surrounding a central lesion following vaccination, and measures of viral shedding and antibody titers. Results  Initial vaccination resulted in a major reaction in 64 of 80 non-naive participants. Ninety-five percent of non-naive participants had major reactions in the undiluted group, 90% in the 1:3.2 dilution group, 81% in the 1:10 dilution group, and 52.6% in the 1:32 dilution group. All (n = 10) of the vaccinia-naive participants had major reactions. Compared with vaccinia-naive participants, non-naive participants had significantly smaller skin lesions (P = .04) and significantly less incidence of fever (P = .02). Preexisting antibody was present in 76 of 80 non-naive participants. Antibody responses were significantly higher and occurred more rapidly in the non-naive participants compared with the vaccinia-naive participants (P = .002 for day 28 and P = .003 for 6 months). Vaccinia-naive participants shed virus from the vaccination site 2 to 6 days longer and had significantly higher peak mean viral titers when compared with the non-naive participants (P = .002). Conclusions  Previously vaccinated persons can be successfully revaccinated with diluted (≤1:10) smallpox vaccine. Fewer adverse reactions were observed in this study of non-naive participants when compared with events in vaccinia-naive participants, which may be due to immunologic memory.      

Depressive symptoms and health-related quality of life: the Heart and Soul Study

Context  Little is known regarding the extent to which patient-reported health status, including symptom burden, physical limitation, and quality of life, is determined by psychosocial vs physiological factors among patients with chronic disease. Objective  To compare the contributions of depressive symptoms and measures of cardiac function to the health status of patients with coronary artery disease. Design, Setting, and Participants  Cross-sectional study of 1024 adults with stable coronary artery disease recruited from outpatient clinics in the San Francisco Bay Area between September 2000 and December 2002. Main Measures  Measurement of depressive symptoms using the Patient Health Questionnaire (PHQ); assessment of cardiac function by measuring left ventricular ejection fraction on echocardiography, exercise capacity on treadmill testing, and ischemia on stress echocardiography; and measurement of a range of health status outcomes, including symptom burden, physical limitation, and quality of life, using the Seattle Angina Questionnaire. Participants were also asked to rate their overall health as excellent, very good, good, fair, or poor. Results  Of the 1024 participants, 201 (20%) had depressive symptoms (PHQ score =" BORDER="0">10). Participants with depressive symptoms were more likely than those without depressive symptoms to report at least mild symptom burden (60% vs 33%; P<.001), mild physical limitation (73% vs 40%; P<.001), mildly diminished quality of life (67% vs 31%; P<.001), and fair or poor overall health (66% vs 30%; P<.001). In multivariate analyses adjusting for measures of cardiac function and other patient characteristics, depressive symptoms were strongly associated with greater symptom burden (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.3-2.7; P = .002), greater physical limitation (OR, 3.1; 95% CI, 2.1-4.6; P<.001), worse quality of life (OR, 3.1; 95% CI, 2.2-4.6; P<.001), and worse overall health (OR, 2.0; 95% CI, 1.3-2.9; P<.001). Although decreased exercise capacity was associated with worse health status, left ventricular ejection fraction and ischemia were not. Conclusions  Among patients with coronary disease, depressive symptoms are strongly associated with patient-reported health status, including symptom burden, physical limitation, quality of life, and overall health. Conversely, 2 traditional measures of cardiac function—ejection fraction and ischemia—are not. Efforts to improve health status should include assessment and treatment of depressive symptoms.