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ObjectivesTo assess the association between the Human Development Index (HDI) and covariates on the mortality-to-incidence ratio (MIR) of lips and oral cavity cancer (LOCC) in Mexico.DesignEcological study.SettingData from 32 Mexican states for year 2019.ParticipantsData set of male and female populations from Mexico.ExposuresSocioeconomic conditions based on HDI and covariates related to healthcare system capacity (total health spending per capita, school dropout and ratio of medical personnel in direct contact with patients).Primary and secondary outcome measuresMIR of LOCC by state and sex was calculated from the Global Burden of Disease Study website for year 2019. Data for calculating HDI 2019 by state and covariates were obtained from the National Institute of Statistics and Geography. A multiple regression model was constructed to measure the effects of HDI and covariates on LOCC-MIR.ResultsAmong the states with the highest HDI (>0.780), Colima had the highest aged-standardised rates per 100.000 in men for incidence (5.026) and mortality (3.118). The greatest burden of the disease was found on men, with the highest Men:Women MIR in Colima (3.10) and Baja California Sur (2.73). The highest MIR (>0.65) was found among the states with the lowest HDI (Oaxaca and Chiapas). For each unit of increase of the HDI there was a decrease in the LOCC- MIR of −0.778, controlling for the covariates. The most suitable regression model explained the 57% (F (p): 0.000) of the variance.ConclusionsMen were most affected by LOCC in Mexican states. The highest MIRs of LOCC were found in the states with the highest HDI. But a worse prognosis of the disease, expressed as a higher MIR, is expected in contexts with lower HDI in the country, even with lower MIRs.

IntroductionFrom 2012 to 2017, the Cervical Cancer Prevention in El Salvador (CAPE) piloted and scaled up a human papillomavirus (HPV) screen-and-treat intervention. Findings resulted in El Salvador’s adoption of the strategy as part of the national programme, but long-term clinical outcomes are unknown. Here, we compare the detection of high-grade cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and HPV infection after recommended screening intervals between two groups: women who participated in CAPE and a comparable group screened via cytology.MethodsCAPE participants who had undergone screening at least 5 years previously (screen-and-treat group) and women in the same age range with conventional cytology screening 2 to 3 years previously (cytology group) were recruited for repeat screening with primary HPV testing. Women with positive HPV results were referred for colposcopy and cervical biopsy to determine further management. Women with negative HPV results received recommendations for routine future screening according to national guidelines.ResultsA total of 6631 women were enrolled (screen-and-treat = 4087; cytology=2544). Significantly less CIN2+ was detected in the screen-and-treat group at 0.7% (29/4087) than in the cytology group at 2.1% (54/2544) (p<0.001) with a risk ratio of 0.41 (95% CI 0.26 to 0.61). HPV positivity was also lower in the screen-and-treat group at 9.5% (388/4077) compared with the cytology group at 11.5% (293/2445) (p=0.008).ConclusionAt the first round of repeat screening after the implementation of CAPE, women who underwent HPV testing in a screen-and-treat strategy had significantly less CIN2+ and HPV positivity compared with those who underwent cytology. These outcomes occurred despite a longer screening interval for HPV testing than cytology. Findings provide reassurance for women and health systems that primary HPV screen-and-treat programmes with extended screening intervals, like the one in El Salvador, are achievable and effective in low- and middle-income settings.

Background Cervical cancer remains a leading cause of cancer death for women worldwide. Screen-and-treat programs are a key strategy to reduce disease burden in low and middle-income countries (LMICs). Thermal ablation (TA) has emerged as a portable alternative to cryotherapy, the treatment typically used in screen-and-treat initiatives. Interest in TA is growing, but there is limited research on its implementation in public health settings. Here we present results from a preliminary evaluation of the barriers and facilitators of TA in El Salvador, one of the first countries to adopt a national HPV screen-and-treat program. Methods This mixed-methods study took place between August 2022 to February 2023 across five clinics. The Practical, Robust Implementation and Sustainability Model (PRISM) was utilized to map findings to contextual factors that impact implementation and sustainability. Participants were frontline providers and women who presented for treatment after a positive HPV test. Providers took part in semi-structured interviews while women completed questionnaires. Additional data were collected from clinic records. Quantitative data were analyzed using inferential statistics and a rapid qualitative analysis approach was used for interviews. Results Providers perceived TA as easier to use and more comfortable for patients, but cryotherapy was utilized 20% more frequently during the study period (cryotherapy treatments = 133 vs. TA treatments = 100). Although the two treatments have the same contraindications, a greater proportion of women were deemed eligible for treatment with TA vs. cryotherapy (95% vs. 79%, p  < .001). There were discrepancies in provider and women’s perceptions of pain and side-effects. While > 80% of women received counseling during the screen-and-treat process, misconceptions regarding screenings results and treatment remained. Conclusions The new treatment (TA) was highly acceptable to participants. However, there may be a need for additional provider training to support TA adoption and fidelity to program guidelines, while patients would benefit from more effective counseling. As LMICs strive to meet cervical cancer elimination targets set by the World Health Organization, it is expected that innovations will be quickly introduced to clinical practice. Thus, it is critical to understand the factors that impact their implementation and sustainability in these settings.

Pregnancy loss is the most common complication of human reproduction, occurring in up to 20% of all recognized pregnancies. Aspirin, a widely available anti-inflammatory drug is hypothesized to improve pregnancy outcomes in women with a previous pregnancy loss if administered early in gestation. Under this premise, the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial was devised to evaluate the benefits of assigning preconception lowdose aspirin on live birth. While the study findings suggest a moderate increase in live birth rate of 5.1% (95% CI -0.84 to 11.2), this is currently of limited use due to (1) potential effect modification of the aspirin effect among heterogenous subgroups in the EAGeR population; (2) low generalizability ensuing after demographic differences between the trial sample and the U.S. population; and (3) measurement error associated with time-varying treatments. Presently, there is a critical need to develop epidemiologic methods to overcome these limitations.This dissertation will focus on evaluating and developing epidemiologic methods to address these limitations. In section 2, we will conduct a simulation study to evaluate the performance of nonparametric doubly robust estimators (i.e., Augmented Inverse Probability Weighting and Targeted Minimum Loss-Based Estimation) against correctly specified Generalized Linear Models to quantify effect modification. Then, we will apply these methods in 1,228 women enrolled in the EAGeR trial to quantify the extent to which the effect of low-dose aspirin on live birth is modified by pre-pregnancy body mass index. In Section 3, we address generalizability concerns in EAGeR that result from its highly selective recruitment process. Specifically, we will adapt the parametric g-formula to generalize the intention-to-treat (ITT) and per-protocol (PP) effects of aspirin to a more representative U.S. sample of childbearing age women with a previous pregnancy loss (National Survey of Family Growth). Finally, in Section 4, we will develop an approach based on the parametric g-formula to correct for measurement error of time-varying exposures in complex longitudinal settings. The results from this work will improve our understanding on preconception aspirin role in pregnancy loss. Furthermore, our methods will help to overcome major limitations present in modern epidemiological studies.

Gas-based cryotherapy is the conventional ablative treatment for cervical pre-cancer in low-income settings, but the use of gas poses significant challenges. We compared the depth of necrosis induced by gas-based cryotherapy with two gas-free alternatives: cryotherapy using CryoPen,and thermoablation. We conducted a five-arm randomized non-inferiority trial: double-freeze carbon dioxide (CO2) cryotherapy (referent), single-freeze CO2 cryotherapy, double-freeze CryoPen, single-freeze CryoPen, and thermoablation. Subjects were 130 women scheduled for hysterectomy for indications other than cervical pathology, and thus with healthy cervical tissue available for histological evaluation of depth of necrosis post-surgery. The null hypothesis was rejected (ie, conclude non-inferiority) if the upper bound of the 90% confidence interval (90% CI) for the difference in mean depth of necrosis (referent minus each experimental method) was <1.14 mm. Patient pain during treatment was reported on a scale of 0 (no pain) to 10 (worst pain). A total of 133 patients were enrolled in the study. The slides from three women were deemed unreadable. One patient was excluded because her hysterectomy was postponed for reasons unrelated to the study, and two patients were excluded because treatment application did not follow the established protocol. For the remaining 127 women, mean depth of necrosis for double-freeze CO2 (referent) was 6.0±1.6 mm. Differences between this and other methods were: single-freeze CO2 = 0.4mm (90% CI −0.4 to 1.2 mm), double-freeze CryoPen= 0.7mm (90% CI 0.04 to 1.4 mm), single-freeze CryoPen= 0.5mm (90% CI −0.2 to 1.2 mm), and thermoablation = 2.6mm (90% CI 2.0 to 3.1 mm). Mean pain levels were 2.2±1.0 (double-freeze CO2 cryotherapy), 1.8±0.8 (single-freeze CO2 cryotherapy), 2.5±1.4 (double-freeze CryoPen), 2.6±1.4 (single-freeze CryoPen), and 4.1±2.3 (thermoablation). Compared with the referent, non-inferiority could not be concluded for other methods. Mean pain scores were low for all treatments. Depth of necrosis is a surrogate for treatment efficacy, but a randomized clinical trial is necessary to establish true cure rates.