Biomedical subjects

Roberto Rivera

Publications and source records attributed to Roberto Rivera.

7 recordsLinked to original sources

PubMed2006

Informed consent: an international researchers' perspective.

We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

Africa↗

PubMed2006

Establishment of ethical oversight of human research in El Salvador: lessons learned.

Human research is necessary for establishing the best approaches to health care, and should be overseen by a functional research ethics committee. However, in most low-income countries these committees are inadequate in providing the guidelines needed to ensure that ethics remain a prominent feature of human research. We developed a model of interaction with key institutions in low-income countries that had an interest in improving the infrastructure of human participant research. As a result, a research ethics committee was established at three hospitals in El Salvador. The skills gained from developing these committees and the interest shown by the Salvadoran government in rigorous ethical oversight of research involving human participants has allowed the creation of a national ethics committee, which serves as an entity to establish norms and guidelines for further development of research ethics committees in El Salvador. This model of interaction can also be used by institutions in high-income countries to create and strengthen the capacity for ethics in human research in low-income countries.

El Salvador↗

PubMed2005

Comparative acceptability of combined and progestin-only injectable contraceptives in Kenya.

OBJECTIVE: We compared 12-month continuation rates, menstrual bleeding patterns and other aspects of acceptability between users of Cyclofem and users of Depo-Provera. METHODS: The life-table method was used to calculate quarterly continuation rates. In all, 360 Kenyan women were randomly assigned to one of the two contraceptives. User-satisfaction questionnaires were administered at 6 and 12 months or at discontinuation, whichever occurred first. RESULTS: The 1-year continuation rate was 75.4% for Depo-Provera users versus 56.5% for Cyclofem users (p<.001). Main reasons for discontinuation included difficulty making clinic visits (45.1% for Cyclofem vs. 40% for Depo-Provera), menstrual changes (14.1% vs. 12.5%) and nonmenstrual problems (15.5% vs. 12.5%). None of the Depo-Provera users and 8.5% of the Cyclofem users claimed frequency of visits as the main reason for discontinuation. In all, 70.6% of the Depo-Provera users were amenorrheic after 12 months, as were 20.8% of the Cyclofem users. CONCLUSIONS: The 1-year continuation rate was higher for Depo-Provera than for Cyclofem. There was no important difference in discontinuation rates because of menstrual problems; the difference mainly reflected the frequency of visits required.

Adult↗

PubMed2005

Effect of a levonorgestrel intrauterine system on women with type 1 diabetes: a randomized trial.

OBJECTIVE: Women with diabetes need safe, effective contraception. Although intrauterine devices provide superior contraception, concerns remain that progestin absorbed systemically from the levonorgestrel-releasing device may impair carbohydrate metabolism. To examine the effect of the levonorgestrel-releasing intrauterine system on glucose metabolism in diabetic women. METHODS: We randomly assigned 62 women with uncomplicated insulin-dependent diabetes mellitus to either a levonorgestrel-releasing or a copper T 380A intrauterine device. The primary outcome to assess glucose metabolism was glycosylated hemoglobin; fasting serum-glucose levels and daily insulin dose requirements over 12 months of observation were examined as well. RESULTS: Outcome data were available for 29 women using the levonorgestrel-releasing and 30 using the copper device. At 12 months, mean glycosylated levels were similar for women of the 2 groups (6.3%, standard deviation [SD] +/- 1.5 compared with 6.3%, SD +/- 1.3, respectively). The same was true for mean fasting-serum glucose levels (7.4 mM, SD +/- 4.2 compared with 7.5 mM, SD +/- 4.2) and daily insulin doses (35.1 units, SD +/- 12.8 compared with 36.4 units, SD +/- 9.0). No important differences were noted at either 6 weeks or 6 months. CONCLUSION: The levonorgestrel-releasing device had no adverse effect on glucose metabolism, even at the 6-week observation when systemic levels of levonorgestrel would have been higher than at later observations. Concern about a potential adverse effect of this contraceptive on glucose control is unwarranted, and its use in women with diabetes should be liberalized. LEVEL OF EVIDENCE: I.

Adult↗

PubMed2005

Many worlds, one ethic: design and development of a global research ethics training curriculum.

The demand for basic research ethics training has grown considerably in the past few years. Research and education organizations face the challenge of providing this training with limited resources and training tools available. To meet this need, Family Health International (FHI), a U.S.-based international research organization, recently developed a Research Ethics Training Curriculum (RETC). It was designed as a practical, user-friendly tool that provides basic, up-to-date, standardized training on the ethics of human research. The curriculum can easily be adapted to different audiences and training requirements. The RETC was reviewed by a group of international experts and field tested in five countries. It is available in English, French, and Spanish as a three-ring binder and CD-ROM, as well as on the Web. It may be used as either an interactive self-study program or for group training.

Clinical Trials as Topic↗

PubMed2003

Characteristics of menstrual problems associated with Norplant discontinuation: results of a multinational study.

This paper presents a secondary analysis of 3419 Norplant users from 11 countries throughout Asia, Africa and Latin America. The main objective was to identify the menstrual problems associated with a high risk of early discontinuation of Norplant use. Eligible participants were divided into two groups: those who continued use (n = 2667) for the first 3 years and those who discontinued use because of bleeding or pain (n = 752) during the first 3 years of use. Menstrual characteristics of the women were compared between groups using a logistic regression model with generalized estimating equations. Flow duration of more than 7 days, excessive amount of flow, dysmenorrhea and intermenstrual bleeding for more than 7 days were associated with a significant risk of discontinuation. The highest risk was observed in association with flow duration of more than 7 days (adjusted odds ratios of 1.85, 2.01 and 2.20 at 1, 2 and 3 years, respectively). The appropriate management of prolonged or excessive bleeding, namely by continuous counseling, is essential for successful Norplant use.

Adult↗

PubMed2002

Current opinion: consensus statement on intrauterine contraception.

Forty-five experts from around the world attended a 1-day seminar in September 2001 in Chapel Hill, North Carolina, USA, to identify ways that they might collaborate to overcome unnecessary barriers to the use of intrauterine devices (IUDs). Seminar participants formed working groups that produced at least three specific recommendations relating to: training/performance improvement; service delivery improvement; general public information; and clinical and programmatic research. Key recommendations included: integrating reproductive health knowledge and skills into curricula for all healthcare professionals; reviewing and reinforcing with providers evidence-based guidelines for IUD use; encouraging evidence-based review of the IUD label and package insert; and conducting further research about IUD client eligibility, potential health benefits, acceptability among clients and providers, and use by HIV-infected women. At the meeting's conclusion, a number of participants, representing the fields of research, policy, communications, donors, women's advocacy, and medicine, expressed an interest in refining and acting upon the recommendations. Hosted by Family Health International, the meeting was supported by the Mellon Foundation.

Contraception↗