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New challenges facing interinstitutional social science and educational program evaluation research at academic health centers: a case study from the ELAM program.

Since the mid-1990s, the protection of human subjects through institutional review boards (IRBs) has progressively broadened in scope. In this case study, the authors describe their challenges in effectively handling IRB processes to conduct educational and social sciences research within academic health centers, particularly (1) complications in conducting longitudinal interinstitutional research that involves multiple IRBs, each with different procedures that changed over ten years; and (2) factors affecting consent form and survey response rates when applying the biomedical IRB process to obtain the consent of human subjects for participation in social and educational research. The authors had a unique opportunity to follow the effect of changes in consent forms (from no form to a one-page form to a three-page form requiring signature of a witness), ways of administration (in person or by mail), and time of administration (at the time of the program or years later) on consent form and survey response rates among medical and dental school faculty members. The authors explore the extended timelines required for data collection and increased costs in dealing with these issues, as well as the effects on response rates of consent form language and administration procedures. The authors recommend strategies to lessen adverse effects of dealing with multiple IRBs at different institutions for social science and educational research, and discuss policy implications for funders, institutions and investigators.

Academic Medical Centers↗

The Strong African American Families Program: translating research into prevention programming.

A randomized prevention trial contrasted families who took part in the Strong African American Families Program (SAAF), a preventive intervention for rural African American mothers and their 11-year-olds, with control families. SAAF is based on a contextual model positing that regulated, communicative parenting causes changes in factors protecting youths from early alcohol use and sexual activity. Parenting variables included involvement-vigilance, racial socialization, communication about sex, and clear expectations for alcohol use. Youth protective factors included negative attitudes about early alcohol use and sexual activity, negative images of drinking youths, resistance efficacy, a goal-directed future orientation, and acceptance of parental influence. Intervention-induced changes in parenting mediated the effect of intervention group influences on changes in protective factors over a 7-month period.

Adult↗

Clinical significance of programmed death-1 ligand-1 and programmed death-1 ligand-2 expression in human esophageal cancer.

PURPOSE: The negative regulatory programmed death-1/programmed death-1 ligand (PD-1/PD-L) pathway in T-cell activation has been suggested to play an important role in tumor evasion from host immunity. In this study, we investigated the expression of PD-L1 and PD-L2 in human esophageal cancer to define their clinical significance in patients' prognosis after surgery. EXPERIMENTAL DESIGN: PD-L1 and PD-L2 gene expression was evaluated in 41 esophagectomy patients by real-time quantitative PCR. The protein expression was also evaluated with newly generated monoclonal antibodies that recognize human PD-L1 (MIH1) and PD-L2 (MIH18). RESULTS: The protein and the mRNA levels of determination by immunohistochemistry and real-time quantitative PCR were closely correlated. PD-L-positive patients had a significantly poorer prognosis than the negative patients. This was more pronounced in the advanced stage of tumor than in the early stage. Furthermore, multivariate analysis indicated that PD-L status was an independent prognostic factor. Although there was no significant correlation between PD-L1 expression and tumor-infiltrating T lymphocytes, PD-L2 expression was inversely correlated with tumor-infiltrating CD8(+) T cells. CONCLUSIONS: These data suggest that PD-L1 and PD-L2 status may be a new predictor of prognosis for patients with esophageal cancer and provide the rationale for developing novel immunotherapy of targeting PD-1/PD-L pathway.

Aged↗

The role of parents and older peers in school-based cardiovascular prevention programs: implications for program development.

This article describes a set of studies which compare the effectiveness of innovative interventions led by older peers and which included a parent component with teacher-led interventions for nutrition, blood pressure, and smoking prevention. Information about the agreement between parents' and children's (grades six through eight) perception of the children's health behavior and family interaction was also found, by surveying parents and children in 1051 households. Both teacher-led and older peer-led interventions were successful in increasing behavioral capabilities for nutrition and blood pressure, measured one year after the interventions. Results of the parent-child survey showed reasonable agreement between parents and children for reports of the child's exercise, dieting, and fast food consumption, but poorer agreement for smoking and perceptions of family interaction. Results are discussed in relation to the planning of future programs designed to address the importance of peer and parental role models.

Adolescent↗

Differential role of programmed death-ligand 1 [corrected] and programmed death-ligand 2 [corrected] in regulating the susceptibility and chronic progression of experimental autoimmune encephalomyelitis.

Programmed death-1 (PD-1) is a negative costimulatory molecule, and blocking the interaction of PD-1 with its ligands, PD-L1 (B7-H1) and PD-L2 (B7-DC), enhances autoimmune disease in several animal models. We have studied the role of PD-1 ligands in disease susceptibility and chronic progression in experimental autoimmune encephalomyelitis (EAE). In BALB/c mice immunized with myelin oligodendrocyte glycoprotein (MOG) peptide 35-55, PD-L1 but not PD-L2 blockade significantly increased EAE incidence. In B10.S mice immunized with myelin proteolipid protein (PLP) peptide 139-151, both PD-L1 and PD-L2 blockade markedly enhanced EAE severity. In prediabetic NOD mice immunized with PLP48-70, PD-L2 blockade worsened EAE but did not induce diabetes, whereas PD-L1 blockade precipitated diabetes but did not worsen EAE, suggesting different regulatory roles of these two ligands in EAE and diabetes. B6 mice immunized with MOG35-55 developed chronic persistent EAE, and PD-L2 blockade in the chronic phase exacerbated EAE, whereas PD-L1 blockade did not. In contrast, SJL/J mice immunized with PLP139-151 developed chronic relapsing-remitting EAE, and only PD-L1 blockade during remission precipitated EAE relapse. The strain-specific effects of PD-1 ligand blockade did not correlate with the expression of PD-L1 and PD-L2 on dendritic cells and macrophages in lymphoid tissue, or on inflammatory cells in the CNS. However, EAE enhancement is correlated with less prominent Th2 cytokine induction after specific PD-1 ligand blockade. In conclusion, PD-L1 and PD-L2 differentially regulate the susceptibility and chronic progression of EAE in a strain-specific manner.

Animals↗

Medicaid program; rescission of the guidelines for documenting Medicaid recipient access to immunizations under the Vaccines for Children (VFC) Program--HCFA. Notice.

This notice rescinds the guidelines that we published in the Federal Register on October 3, 1994, that required States to document equal access to immunizations for Medicaid children if States elected to use lower vaccine administration fees than the maximum charges that were published and applicable under the Vaccines for Children program. These guidelines are rescinded in response to public comments on the October 3, 1994 notice. States indicated that there were numerous problems regarding the collection of useable data.

Centers for Medicare and Medicaid Services, U.S.↗

Using clinical data in program design: a family support program for families with preterm infants.

HMOs can use clinical data culled from computerized medical records and provider and patient interviews to examine the impact of premature infant births on the family. The results can help guide health plans in developing a clinical intervention program to address the physical and emotional consequences of low birthweight babies. The Harvard Pilgrim Health Care experience describes the data collection process administrators are taking to design such a clinical intervention.

Case Management↗

Program activity in the second year of the Rural Telemedicine Grant Program Part 2.

Part 1, in our last issue, detailed the activity levels, number and types of consults, and transmission costs of the 13 telemedicine networks funded in 1994 by the Office of Rural Health Policy's Rural Telemedicine Grant Program. This concluding section presents the authors' conclusions drawn from the objective data in Part 1.

California↗

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE program; nonavailability statement requirements--DoD. Final rule.

This final rule revises certain requirements and procedures for the TRICARE Program, the purpose of which is to implement a comprehensive managed health care delivery system composed of military medical treatment facilities and CHAMPUS. Issues addressed in this rule include priority for access to care in military treatment facilities and requirements for payment of enrollment fees. This rule also includes provisions revising the requirement that certain beneficiaries obtain a non-availability statement from a military treatment facility commander prior to receiving certain health care services from civilian providers.

Government Agencies↗

Medicare program; End Stage Renal Disease Program; responsibilities of network organizations--HCFA. Final rule.

This final rule revises final regulations published on August 26, 1986 (51 FR 30356) pertaining to the End Stage Renal DIsease (ESRD) networks and organizations to reflect certain provisions of the ESRD program amendments contained in sections 9335 (d) through (h) of the Omnibus Budget Reconciliation Act of 1986. These regulations revise the responsibilities of network organizations.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule.

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.

Centers for Medicare and Medicaid Services, U.S.↗

National Vaccine Injury Compensation Program: addition of vaccines against rotavirus to the program. Department of Health and Human Services (HHS), Public Health Service (PHS), Health Resources and Services Administration (HRSA). Final rule.

This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.

Humans↗

A mobile mammography program in the workplace. Successful program.

United States companies recognize health care costs are rising and the prevention, early detection, and treatment of disease can help with cost control. Onsite mobile mammography can provide a convenient, effective, and time saving service for employees. Establishing a mobile mammography program requires some planning, but is relatively easy to administer and maintain.

Adult↗

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); TRICARE Reserve Select for certain members of the selected reserve; Transitional Assistance Management Program; early eligibility for TRICARE for certain reserve component members. Interim final rule with comment period.

This interim final rule establishes requirements and procedures for implementation of TRICARE Reserve Select. It also revises requirements and procedures for the Transitional Assistance Management Program. In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.

Eligibility Determination↗

Government intervention programs in HIV/tuberculous infection. Outline of guidelines for national tuberculosis control programs in view of the HIV epidemic.

Tuberculosis is one of the most widespread infections known in the world. WHO estimates that in 1990, 1.7 billion people, or one third of the world population, are or have been infected with the tubercle bacillus. Fortunately, few of those infected develop active forms of the disease but it is estimated that in 1990, there will be 8 million new cases and 2.9 million deaths from tuberculosis in the world. This already alarming situation of the tuberculosis problem is getting worse, mainly due to the AIDS epidemic. A basic understanding of tuberculosis/HIV epidemiology is necessary and priority actions are to be strongly recommended for application in government intervention programs. They are specified in the present article.

Adolescent↗

Five-year findings of the Hypertension Detection and Follow-up Program: mortality by race-sex and blood pressure level. A further analysis. Hypertension Detection and Follow-up Program Cooperative Group.

The Hypertension Detection and Follow-up Program (HDFP) data are reported by diastolic blood pressure (DBP) stratum for four race-sex subgroups. For Stratum I (entry DBP 90-104 mm Hg) in each of the race-sex subgroups (black male, black female, white male, and white female). Stepped Care (SC) participants experienced a reduced mortality as compared to Referred Care (RC). For black males and females in all three entry DBP strata, mortality was lower in the SC than RC. Only in three subgroups did the SC mortality exceed RC: Stratum II (entry DBP 105-114 mm Hg) white females and Stratum III (entry DBP 115 + mm Hg) white males and females. Possible explanations for these deviant findings are discussed. The HDFP was designed to determine the difference in total 5-year mortality between SC and RC; subgroup analyses may be subject to large chance variation and must be interpreted with great caution. The value of vigorous treatment of "mild" hypertension (Stratum I) in males and females, black and white, and the value of treatment for all blood pressure strata in blacks are confirmed by this analysis.

Adult↗

[Global program of smallpox eradication. 1. Smallpox in the world before acceptance of the program of its eradication by the World Health Organization].

Despite a considerable success in control smallpox in a number of countries reached as a result of vaccination the problem of eradication of this infection could not be solved without uniting the efforts of all the countries in the world. Guided by humanity principles the delegation of the USSR suggested in 1958 a program of smallpox eradication in the whole world. World smallpox morbidity is analyzed in this work.

Africa↗