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Report of the Cancer Therapy Evaluation Program monitoring plan for secondary acute myeloid leukemia following treatment with epipodophyllotoxins.

BACKGROUND: Recent reports have documented the occurrence of treatment-related acute myeloid leukemia (AML) following therapy with epipodophyllotoxins. These reports have led to growing concern among oncologists, which could lead to premature abandonment of these agents at a time when the relationship between cumulative dose of epipodophyllotoxin and risk of treatment-related AML has not been determined. PURPOSE: Because of the increasingly important role of epipodophyllotoxins in the treatment of several types of adult and pediatric tumors, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) has developed a monitoring plan to obtain reliable estimates of the risk of treatment-related AML following epipodophyllotoxin treatment. METHODS: We identified 12 NCI-supported Cooperative Group clinical trials in which patients with solid tumors are being treated with epipodophyllotoxins at different cumulative doses. One trial is using a moderate dose of teniposide (900 mg/m2), and 11 trials are using etoposide at a low dose (< 1500 mg/m2), a moderate dose (1500-3999 mg/m2), or a high dose (> or = 4000 mg/m2). Cases of treatment-related AML and treatment-related myelodysplastic syndrome (MDS) (hereafter referred to as treatment-related AML/MDS) occurring in these trials are reported to CTEP, with initial analysis for each cumulative dose group triggered by the reporting of four cases of treatment-related AML/MDS in that group. For each analysis, total patient follow-up for the group is determined and cumulative 6-year incidence rate is calculated. RESULTS: Three cases of treatment-related AML and one case of treatment-related MDS (with documented monosomy 7) were reported in a group of 207 patients who received etoposide at a low cumulative dose. The calculated 6-year rate of development of treatment-related AML/MDS was 3.2% (95% upper confidence interval bounded by 7.2%). CONCLUSIONS: The 6-year cumulative rate of treatment-related AML/MDS (3.2%) is within the range previously reported for alkylator-based regimens that did not include epipodophyllotoxins. IMPLICATIONS: Previous reports have suggested that higher cumulative doses of alkylators are associated with increased risk of treatment-related AML, and a critical goal of the monitoring plan is to determine whether a similar relationship exists for the epipodophyllotoxins. Estimates will be developed for leukemogenic risk for the moderate- and high-cumulative-dose groups when four cases of treatment-related AML/MDS have been identified within each group.

Acute Disease↗

Cervical cancer prevention in remote rural Nicaragua: a program evaluation.

BACKGROUND: Nicaragua has some of the highest rates of cervical cancer in Latin America and the world. In 2003, the Nicaraguan Ministry of Health, the Central American Institute of Health and the Maria Luisa Ortiz Clinic combined efforts to create an effective remote rural service network, with centralized quality-controlled cytology, and coordinated treatment. METHODS AND MATERIALS: Data was taken from the clinic Pap log, tracking records, patient charts, and pathology reports. Patients were stratified by age (25 and older, and under 25). Standard indicators addressing key components in the entire continuum of an effective screening program were adapted from suggestions by a work group of the Pan American Health Organization. RESULTS: A total of 2132 women received Pap screening. 68% (N = 1448) were 25 and older and 32% (N = 684) were under 25. The proportion of high-grade abnormal screens was 3.7% for women over 25 and 0.4% for women under 25. The proportion of women with high-grade abnormal results who received diagnostic work-up and needed treatment was 94% for women over 25 and 100% for women under 25. The proportion of high-grade squamous cell Pap tests resulting in histologically confirmed disease was 68%. The ratio of pre-invasive disease to invasive disease was 1.9. The invasive cancer detection rate was 0.62%. CONCLUSION: This program evaluation demonstrates that outreach to high-risk women, quality cytology screening and high rates of diagnostic follow-up and treatment can be conducted in remote, low-resource settings when coordinated efforts are made to remove barriers and ensure quality.

Adult↗

Identification of persons at high risk for kidney disease via targeted screening: the NKF Kidney Early Evaluation Program.

BACKGROUND: More than 340,000 individuals were receiving renal replacement therapy in the United States at the end of 1999; this number is projected to double by the year 2010. Almost half had a primary diagnosis of diabetes mellitus particularly type 2, and more than one quarter a primary diagnosis of hypertension. Studies have demonstrated effective maneuvers to prevent or delay the rate of progression of kidney disease, and decrease morbidity and mortality. The objective of early diagnosis is early detection of asymptomatic disease at a time when intervention has a reasonable potential to have a positive impact on outcome. METHODS: In 1997, the National Kidney Foundation launched KEEP trade mark (Kidney Early Evaluation Program), a free community-based screening that targets first order relatives of persons with hypertension, diabetes or kidney disease, and those with a personal history of diabetes or hypertension. RESULTS: Of the 889 individuals screened in the pilot study, 71.4% had at least one abnormality. The program includes an educational component and referral to a physician for follow-up of abnormal values. CONCLUSIONS: Targeted screenings are an effective means of identifying persons at risk for kidney disease, and can identify individuals at risk early enough in the course of their disease to allow for effective intervention.

Early Diagnosis↗

Vaccination practices, policies, and management factors associated with high vaccination coverage levels in Georgia public clinics. Georgia Immunization Program Evaluation Team.

BACKGROUND: Controlling vaccine-preventable diseases by achieving high childhood vaccination coverage levels is a national priority. However, there are few, if any, comprehensive evaluations of state immunization programs in the United States, and little attention has been given to the importance of vaccination clinic management style and staff motivation. OBJECTIVE: To evaluate the factors associated with the increase in childhood vaccination coverage levels from 53% in 1988 to 89% in 1994 in Georgia's public health clinics. DESIGN: A 1994 mail survey obtaining information on clinic vaccination policies and practices and management practices. SETTING: All 227 public health clinics in Georgia. PARTICIPANTS: Clinic nurses responsible for vaccination services. OUTCOME MEASURE: The 1994 clinic-specific coverage level for 21- to 23-month-old children for 4 doses of diphtheria and tetanus toxoids and pertussis vaccine, 3 doses of polio vaccine, and 1 dose of a measles-containing vaccine as determined by an independent state assessment of clinic coverage levels. RESULTS: Univariate analysis showed that higher coverage levels were significantly (P<.05) associated with smaller clinic size, higher proportions of clientele enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), being a nonurban clinic, and numerous vaccination practices and policies. Multivariable analysis showed that only 8 of greater than 150 factors remained associated with higher coverage levels, including having no waiting time to be seen, having telephone reminder systems, conducting home visits for defaulters, and restricting WIC vouchers when a child was undervaccinated. Motivational factors related to higher coverage included clinic lead nurses receiving an incentive to raise coverage and lead nurses participating in assessments of clinic coverage levels by state immunization staff. CONCLUSIONS: No single factor is responsible for raising vaccination coverage levels. Efforts to improve coverage should include local assessment to provide feedback on performance and identify appropriate local solutions. Coordinating with WIC, conducting recall and reminder activities, motivating clinic staff, and having staff participate in decisions are important in raising vaccination levels.

Ambulatory Care Facilities↗

Validity of self-reported needle exchange attendance among injection drug users: implications for program evaluation.

Some studies have indicated that needle exchange programs (NEPs) can be effective in reducing drug-related risks for human immunodeficiency virus (HIV) seroconversion; however, others have reported higher HIV incidence rates among NEP attendees. Since many studies rely on self-reports of NEP attendance, the authors investigated the extent to which differential misreporting of NEP attendance could bias risk estimates. Over a 3-year period from 1994 to 1997, self-reports of NEP attendance from participants in a prospective study in Baltimore, Maryland, were compared with NEP records. Of 1,315 participants, 459 (35%) had registered with the Baltimore NEP. There was 86.7% concordance between self-reported and actual NEP use; 11.0% reported NEP attendance but did not attend (overreported), and 2.2% reported not attending NEP but did attend (underreported). In multivariate analyses using generalized estimating equations, persons who overreported NEP attendance were more likely to have injected frequently (adjusted odds ratio (AOR) = 1.29, 95% confidence interval (CI): 1.04, 1.61), denied needle sharing (AOR = 0.69; 95% CI: 0.52, 0.89), and been an HIV seroconverter (AOR = 1.83, 95% CI: 1.11, 3.01). With Poisson regression to model predictors of HIV seroconversion, models that included measures of NEP attendance based on self-reports compared with actual program data underestimated a protective association by 18%. These findings have important implications for evaluations of NEPs.

Adult↗

The Southern California Kaiser-Permanente Chemical Dependency Recovery Program evaluation: results of a treatment outcome study in an HMO setting.

This report presents the methodology and outcomes of an evaluation of the Chemical Dependency Recovery Program (CDRP) of Southern California Kaiser-Permanente, a large group model HMO. CDRP treatment includes specialized detoxification inpatient facilities, day treatment and outpatient services. Substance use outcomes in a population of 1,986 patients consecutively entering treatment were obtained via telephone at six and twelve months post intake. For patients who consumed only alcohol at baseline (N = 621), significantly higher six month point prevalence abstinence rates were found among those who remained in treatment for a minimum of three months (89%), compared to those patients who failed to return for treatment after their intake (31%). For polydrug users (N = 1365), as contrasted with patients who utilized services only on their intake date, significantly higher six month point prevalence rates were restricted to those who remained in treatment for a minimum of six months (74% versus 21%). The evaluation documented the need for CDRP services, validated program effectiveness and highlighted areas for systematic improvement.

Adult↗

Performance evaluation programs for determining HIV-1 viral loads, testing for HIV p24 antigen, and identifying Mycobacterium tuberculosis using nucleic acid amplification tests.

CDC's Division of Laboratory Systems, Public Health Practice Program Office, is implementing three new laboratory performance evaluation (PE) programs. The first assesses the performance of laboratories that perform tests to determine the viral RNA copy number (viral load) in the blood of persons infected with human immunodeficiency virus type 1 (HIV-1); the second assesses the performance of laboratories that perform HIV p24 antigen (Ag) testing; and the third assesses the performance of laboratories that perform nucleic acid amplification (NAA) tests for Mycobacterium tuberculosis.

Clinical Laboratory Techniques↗

Annual recertification program for audit standards used in the EPA PM2.5 Performance Evaluation Program.

This paper describes procedures used to perform 152 annual recertifications of temperature, pressure, and flow rate audit standards. It discusses the metrology laboratories and the uncertainty of their recertifications. It describes the data base for the standards that tracks their recertifications and shipments. Finally, it presents some illustrative recertification results and describes what these results reveal about the audit standards and the recertifications.

Air Pollution, Indoor↗

Cardiac rehabilitation with nurse care management and telephonic interactions at a community hospital: program evaluation of participation and lipid outcomes.

Cardiac rehabilitation (CR) can help patients with heart disease control some risk factors, limit new coronary artery lesions, and decrease death rates. However, participation rates in CR are low. Using a descriptive design, we evaluated a modified CR program in which nurse care managers used telephonic communication with patients in their homes by comparing it to a traditional CR program in a hospital setting. Using multivariate analysis we compared the patient cohorts eligible for each of the programs, and program participants to the nonparticipants for each program. Compared to traditional CR, the modified CR program with nurse care management was associated with significantly improved participation rates (11% vs. 22%) and the apparent overcoming of several well-described barriers to CR participation (distance from the hospital and domestic isolation). Risk factor management, including testing of serum lipids and achieving goals for lipid reduction, for participants in both CR programs was superior to risk factor management for nonparticipants.

Aged↗

Preceptor program evaluation demonstrates improved orientation.

Although the preceptor method of orientation is generally accepted as an effective mechanism for orienting newly employed nurses, very few evaluation studies of preceptor programs have been reported in the literature. This article describes a study designed prior to implementing a preceptor program at the University of Wisconsin Hospital and Clinics in order to measure the outcomes of the program. Data were collected on the satisfaction of orientees, preceptors, other staff nurses, and nurse managers. The preceptor role and preceptor's level of comfort and skill were studied. To quantify the economic impact, both length of orientation and nursing turnover were considered.

Education, Nursing, Continuing↗

[Outpatient insulin therapy in type II diabetes: program evaluation and calculation of cost saving].

BACKGROUND: Evaluation of the results of a program of outpatient insulinization in type II diabetes and the resulting saving in cost. METHODS: Data from 39 patients with that disease (mean age 62 years) were evaluated four months after the beginning of insulin therapy and diabetic education. The economic cost of the outpatient program was calculated and compared with the cost if patients had been admitted. RESULTS: A good metabolic control was achieved with a significant reduction (p less than 0.001) of the glycemic levels from 281 +/- 43 mg/dl (15.6 +/- 2.4 mmol/l) to 156 +/- 22 mg/dl (8.6 +/- 1.5 mmol/l). Fructose levels were reduced from 4.7 +/- 0.54 mmol/l to 3.29 +/- 0.51 mmol/l. Seventeen patients had some episode of mild hypoglycemia. The insulin dose was increased from 0.27 +/- 0.06 U per kg and day to 0.42 +/- 0.1 (11 patients required two insulin doses). At onset, no patient controlled the glycemia at home, while at the end of the program 46% did so. The evaluation of each educational end-point showed a mean of 4.8 +/- 0.3 (from 0 to 5); the end-point with the best score were the technical aspects. The economic cost of the program was 230.39 ptas per patient and day, versus 1351.75 ptas per patient and day if the patients had been admitted. CONCLUSIONS: Outpatient insulinization in type II diabetes has very good results and is economically effective provided the adequate equipment and facilities are available.

Adult↗

Vocational rehabilitation services in workers' compensation programs: evaluating research model effectiveness.

Vocational rehabilitation programs are a strategy used by many, employers to manage workers' compensation costs and the consequence of injuries for their workers. Soaring costs for employers and public entities associated with workers' compensation programs and vocational rehabilitation services indicate that additional research is needed--a need further demonstrated by the serious financial, social and psychological costs that workplace disability exacts from workers.

Accidents, Occupational↗

[Evaluation program for cancer patients].

The medical evaluation and requisite radiologic examinations for the cancer patient are presented. Adequate clinical staging is essential for determining prognosis, optimal therapeutic plan, and evaluation of therapy results. Newer radiologic methods allow more detailed evaluation and determination of disease stage.

Bronchial Neoplasms↗

Employee assistance program evaluation. Employee perceptions, awareness, and utilization.

Periodic evaluation is necessary to maintain a quality employee assistance program. This survey was undertaken to determine employee awareness of the existing EAP and their satisfaction with the program. Likewise, the survey allowed for employee input on areas of the program they had concerns with that may have caused hesitancy in further use of the program. The survey not only documents to management that the program is of value to employees and identifies areas where changes may be focused in the future to meet employee needs, but actually serves as a communication tool in itself as a reminder of the availability of the Employee Assistance Program.

Adult↗

[Dietary assessment program evaluation (third-year secondary school students)].

ANTECEDENTS: The appropriate contribution of nutrients determines the phenotypic expression of the genotype. OBJECTIVE: The Dietary Assessment Program consists on the transmission of necessary information to carry out a balanced diet. AMBIT: The program embraces twenty-three schools in the Basque Country, on a total of 2,400 girls and boys, studying 3rd year of ESO. SUBJECTS: The evaluation was carried out on 130 girls and boys at Liceo Santo Tomás in Donostia. The DAP consists of an educational program with the students (theoretical and practical workshop), educational program for parents and educators and evaluation program of the Dietary Intervention. RESULTS: The students' response was positive. The parents and educators maintained the same constructive attitude, in all the projects. EVALUATION: 61% of the teenagers said that their diet stays equally (28% previous balanced diet), 2% worse and 36% find an improvement (3% great improvement). In 94% of those interviewed there is a theoretical-subjective agreement in the answer. 85% of the teenagers are able to identify the Mediterranean balanced diet correctly. CONCLUSIONS: 36% of the youths said that the quality of their diet has improved. 85% knows the balanced dietary pattern. These results encourage us to continue working in the DAP, perfecting and modernizing it. A good diet facilitates a good genetic expression and, therefore an appropriate nutrition determines the quantity and quality of life. Teenagers don't take a balanced diet. A better nutritional education would improve the health of future generations.

Child↗