BACKGROUND: Chemistry safety assessments are interpreted by using chemistry reference ranges (CRRs). Verification of CRRs is time consuming and often requires a statistical background. OBJECTIVES: We report on an easy and cost-saving method to verify CRRs. METHODS: Using a former method introduced by Sigma Diagnostics, three study sites in sub-Saharan Africa, Bondo, Kenya, and Pretoria and Bloemfontein, South Africa, verified the CRRs for hepatic and renal biochemistry assays performed during a clinical trial of HIV antiretroviral pre-exposure prophylaxis. The aspartate aminotransferase/alanine aminotransferase, creatinine and phosphorus results from 10 clinically-healthy participants at the screening visit were used. In the event the CRRs did not pass the verification, new CRRs had to be calculated based on 40 clinically-healthy participants. RESULTS: Within a few weeks, the study sites accomplished verification of the CRRs without additional costs. The aspartate aminotransferase reference ranges for the Bondo, Kenya site and the alanine aminotransferase reference ranges for the Pretoria, South Africa site required adjustment. The phosphorus CRR passed verification and the creatinine CRR required adjustment at every site. The newly-established CRR intervals were narrower than the CRRs used previously at these study sites due to decreases in the upper limits of the reference ranges. As a result, more toxicities were detected. CONCLUSION: To ensure the safety of clinical trial participants, verification of CRRs should be standard practice in clinical trials conducted in settings where the CRR has not been validated for the local population. This verification method is simple, inexpensive, and can be performed by any medical laboratory.

In Latin America, one of the most common barriers to family planning access is denial of services to women who present at clinics in the absence of menses. Where pregnancy tests are unavailable, many providers fear that nonmenstruating women may be pregnant and, worrying about possible harm to the fetus, require the woman to await the onset of menses before initiating a contraceptive method. In 2005, during a randomized trial of oral contraceptive users in Nicaragua, we assessed a job aid endorsed by the World Health Organization to help providers exclude pregnancy among family planning clients. Among 263 new, nonmenstruating clients, the job aid ruled out pregnancy for 60% of the women. Only 1% of the women were pregnant, and no woman identified by the job aid as "not pregnant" was pregnant. Provider fears that nonmenstruating clients are pregnant are usually misplaced, while fears that hormonal methods can harm fetuses are exaggerated.

En América Latina, uno de los obstáculos más frecuentes para acceder a los servicios de planificación familiar es la negativa a atender a las mujeres que se presentan en las clínicas sin menstruación. Cuando no hay pruebas de embarazo disponibles, muchos profesionales piensan que las mujeres sin menstruación visible pueden estar embarazadas y por temor a ocasionar algún daño al feto les exigen esperar hasta el inicio de la menstruación para comenzar con algún método anticonceptivo. En 2005, durante un ensayo aleatorizado con usuarias de anticonceptivos orales en Nicaragua, se evaluó una lista de verificación avalada por la Organización Mundial de la Salud para ayudar a los profesionales sanitarios a descartar el embarazo en las mujeres que solicitan servicios de planificación familiar. Este procedimiento permitió descartar el embarazo en 60% de las 263 mujeres sin menstruación que solicitaban por primera vez ese servicio. Solamente 1% de las mujeres estaban embarazadas y ninguna de las identificadas por este procedimiento como "no embarazada" lo estaba. El temor de los profesionales de la salud de que las mujeres sin menstruación estén embarazadas es frecuentemente infundado y los temores de que los métodos hormonales puedan dañar al feto son exagerados.