David M. OʼSullivan

Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the usefulness of phenazopyridine for confirmation of ureteral patency during intraoperative cystoscopy. METHODS: We conducted a randomized controlled trial comparing use of phenazopyridine with no medications for evaluation of ureteral patency during intraoperative cystoscopy in women undergoing pelvic surgery. The primary study outcome was time to visualize ureteral urine efflux. To detect a 3-minute difference with &agr; of 0.05 using a two-sided, two-sample t test and &bgr; 0.80 required 98 patients equally divided into two groups. RESULTS: A total of 104 women were randomized from April to December 2015. Patients in the treatment group tended to be older (P=.02); otherwise, study groups were similar. Time to visualize ureteral urine efflux did not differ between study groups with a mean time of 2 minutes 40 seconds (±2 minutes 38 seconds) in the control group and 2 minutes 53 seconds (±4 minutes 35 seconds) in the treatment group (P=.77). Regarding the surgeon survey, surgeons felt less frustrated and impatient in visualization of ureteral urine efflux in the treatment group compared with the control group (mean response 1.5±0.8 in treatment compared with 2.0±1.0 in control, P=.007), and surgeons felt that the cystoscopy took too long more often in the control than in the treatment group (1.7±0.9 in treatment compared with 2.1±1.0 in control, P=.02). Trial of void result differed significantly between groups with fewer patients in the treatment group failing a void trial (P=.04). There were no adverse events related to phenazopyridine use. CONCLUSION: Preoperative phenazopyridine is a useful and cost-saving medication for use in planned cystoscopy for evaluation of ureteral patency. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02424149.

Text Message Appointment Reminders as a Tool to Improve PPV Show Rates in an Urban Resident Clinic

INTRODUCTION: The objective of this research is to determine if text messaging can improve access to postpartum care for an urban clinic population by decreasing no-show rates. Last years PPV rate at Womens Ambulatory Health Services at Hartford Hospital (71%) falls below the national average of 88.7% noted by the Centers for Disease Control and Prevention in 2004 with a 30% no-show rate. METHODS: Scheduled PPVs are randomized to a text message reminder 4 days in advance, one day in advance, or no reminder. Reminders are sent through a free SMS web site with a standardized message in English or Spanish including instructions to reschedule if needed. The electronic medical record is reviewed to determine if a PPV occurred. RESULTS: The study is powered to require 750 scheduled visits obtained by Spring 2014; at this interim analysis, we have reached 20% and note trends; the overall PPV show rate remains 71%. The current no-show rate is 19.7%. In the group randomized to no text message, 67% had PPVs, 22% no-showed, and five patients rescheduled. In the group receiving a text message 1 day before their appointment, 63% had PPVs, 22% no-showed, and 14% rescheduled. In the group receiving a text message 4 days in advance, 83% had PPVs, 13% no-showed, and two rescheduled. CONCLUSIONS: Preliminary results suggest that 4-day advance text message reminders improve PPV rates and decrease no-show rates. In a high-risk urban population for whom preventive and interconception services are particularly important, automated reminders may be a worthy investment.

Effects of Calcium, Vitamin D, and Hormone Therapy on Cardiovascular Disease Risk Factors in the Women's Health Initiative: A Randomized Controlled Trial.

OBJECTIVE To analyze the treatment effect of calcium+vitamin D supplementation, hormone therapy, both, and neither on cardiovascular disease risk factors. METHODS We conducted a prospective, randomized, double-blind, placebo-controlled trial among Womens Health Initiative (WHI) participants. The predefined primary outcome was low-density lipoprotein cholesterol (LDL-C). RESULTS Between September 1993 and October 1998, a total of 68,132 women aged 50-79 years were recruited and randomized to the WHI-Dietary Modification (n=48,835) and WHI-Hormone Therapy trials (n=27,347). Subsequently, 36,282 women from WHI-Hormone Therapy (16,089) and WHI-Dietary Modification (n=25,210) trials were randomized in the WHI-Calcium+Vitamin D trial to 1,000 mg elemental calcium carbonate plus 400 international units vitamin D3 daily or placebo. Our study group included 1,521 women who participated in both the hormone therapy and calcium+vitamin D trials and were in the 6% subsample of trial participants with blood sample collections at baseline and years 1, 3, and 6. The average treatment effect with 95% confidence interval, for LDL-C, compared with placebo, was -1.6, (95% confidence interval [CI] -5.5 to 2.2) mg/dL for calcium+vitamin D alone, -9.0 (95% CI -13.0 to -5.1) mg/dL for hormone therapy alone, and -13.8 (95% CI -17.8 to -9.8) mg/dL for the combination. There was no evidence of a synergistic effect of calcium+vitamin D+hormone therapy on LDL-C (P value for interaction=.26) except in those with low total intakes of vitamin D, for whom there was a significant synergistic effect on LDL (P value for interaction=.03). CONCLUSION Reductions in LDL-C were greater among women randomized to both calcium+vitamin D and hormone therapy than for those randomized to either intervention alone or to placebo. The treatment effect observed in the calcium+vitamin D+hormone therapy combination group may be additive rather than synergistic. For clinicians and patients deciding to begin calcium+vitamin D supplementation, current use of hormone therapy should not influence that decision. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov, NCT00000611.

Utilidad de la prueba del virus del papiloma humano en el manejo de las células glandulares atípicas en la citología

Objetivo. Determinar la utilidad de la prueba del virus del papiloma humano (VPH) para la enfermedad cervical asociada al VPH (EA‐VPH) y para el conjunto de la enfermedad (enfermedad cervical asociada a células glandulares atípicas [AGC]) en mujeres con AGC. Material y métodos. Se llevó a cabo una búsqueda bibliográfica correspondiente al periodo comprendido entre enero de 1993 y septiembre de 2007, utilizando diversos términos relacionados con las AGC, junto con términos de Medical Subject Heading (MeSH) “HPV” ampliado. Se utilizaron los resultados de 7 estudios para calcular las tasas de enfermedad según el estado del VPH. Resultados. La tasa de enfermedad cervical asociada a AGC para 661 casos de AGC con pruebas de VPH simultáneas fue del 23,3%. La tasa de EA‐VPH fue mayor en las mujeres con VPH positivos, en comparación con las que tenían un VPH negativo (53% frente a 3%, respectivamente). El estado de positividad para el virus del papiloma humano, en comparación con el de negatividad, predijo una mayor proporción de lesiones de neoplasia intraepitelial cervical 2/3 (odds ratio = 39,6, IC del 95% = 17,9‐87,4, p < 0,001). La tasa de cánceres no asociados a VPH fue significativamente superior en las pacientes negativas, en comparación con las positivas, para el VPH (4% frente a 0,4%; p = 0,016). La prueba del virus del papiloma humano tuvo una sensibilidad global del 90%, una especificidad del 79%, un valor predictivo positivo del 53% y un valor predictivo negativo del 97% para los casos de EA‐VPH. Las células glandulares atípicas con presencia simultánea de células escamosas atípicas (ASC) o de lesión intraepitelial escamosa (SIL) (ASC/SIL) presentaron tasas de enfermedad superiores a las de las AGC solas. El valor predictivo positivo de la prueba de VPH para las AGC con presencia simultánea de ASC/SIL fue superior al de las AGC solas. Conclusiones. En todas las mujeres con AGC debe realizarse un examen inicial detallado, sea cual sea el estado del VPH. La presencia de VPH identifica a un grupo de mujeres con mayor riesgo de enfermedad cervical que deben ser objeto de un seguimiento estricto. Las mujeres positivas para el virus del papiloma humano con AGC y presencia simultánea de ASC/SIL tienen un riesgo aún mayor. Si, tras un examen inicial completo, las mujeres con AGC sin otra especificación y con un VPH positivo no tienen ninguna causa identificable, puede considerarse una conización cervical. ▪