Clinical Research Puerto Rico

Although American Psychological Association (APA) guidelines encourage clinical supervisors to integrate diversity into all aspects of practice and supervision, dominant models perpetuate hegemonic systems such as white Eurocentric imperialism and individualism, that foster a one-size-fits-all approach. Therefore, reimagining an anti-hegemonic approach to supervision that is focused on shifting power to the unique social locations of the supervisory triad is imperative. The present paper aims to offer readers an application of liberation praxis to supervisory relationships. Liberation psychology offers a guide to developing a supervision praxis through cultivating one’s critical consciousness of oppressive systems. In this paper, the authors propose a framework that (a) humanizes the wholeness of interlocking experiences of clients, supervisees, and supervisors; (b) invites collaboration through interrogation of power dynamics; and (c) engages in problematization (i.e., oppositional consciousness, deideologizing, and denaturalization) designed to recover historical memory, and revise dominant ideologies to match the lived experiences of minoritized groups, including the Global Majority. The authors aim to challenge existing supervisory models that perpetuate colonialism, and thereby advance practices that disrupt the traditional methods of psychotherapy training.

ABSTRACT This article examines birth seasonality in Puerto Rico and explores whether patterns shift during periods of economic transformation. We compiled monthly birth counts for approximately 5.64 million births occurring from 1935 to 2024. Data sources include reports to U.S. agencies (1935–1966), a prior publication (1967–1971), and the Puerto Rico Vital Statistics System (1972–2024). To assess the temporal concentration, we calculated a seasonal index of births and modeled 5-year patterns with LOESS curves. We identified four distinct seasonal patterns. From 1943 to 1949, births peaked in April – May. Between 1950 and 1954, this peak declined as a new one emerged from August to October. Beginning in 1955, a third pattern appeared, with fewer births early in the year and a peak in the second half. This pattern remained stable until about 2010. After 2010, we observe (1) a narrowing of early-year minimums, (2) increased within-period variability, and (3) a decline in December, though (4) the August to November peak persists. These changes align with economic transitions that occurred under US occupation, bringing forth the need to reexamine the hypothesis of cultural or media influence in future studies. Given observed patterns, future research should explore the role that economic shifts may have in shaping birth seasonality in Puerto Rico.

In environmental economics studies US Hispanics are frequently depicted as one large homogeneous group, despite diversity in their countries’ cultural traditions, genetic background and socioeconomic status (SES). This study aimed to compare Florida’s very diverse Hispanic population of Caribbean, Mexican, Central, and South American ancestry.Twelve independent variables were selected from environmental pollution, geospatial challenges, and SES categories. Dependent variables included the relative prevalence of three major chronic diseases: asthma, diabetes, and heart disease. Analysis of pairs correlations was supplemented by multi-variable linear regression. Majority-Hispanic areas have higher than average pollution, diabetes, proximity to disadvantaged neighborhoods, and lower SES. Despite lower pollution than in urban areas, Florida’s inland rural areas had higher rates of all major diseases and lower life expectancies. Cuban and Puerto Rican populations of Miami and Orlando metro areas, respectively, have less favorable SES outcomes and higher diabetes. Columbian and Venezuelan communities have significantly higher education levels than other Hispanic cohorts, and they have the best relative outcome among US Hispanics in SES and health, although still lagging US averages. African-American community in Miami-Dade County was by far the most disadvantaged, with significantly lower SES and health outcomes than any other group in the study, including the nearby Cuban-majority community. Our results confirmed the view that Hispanics are environmentally disadvantaged in Florida, with worse outcomes than the US and Florida average in health and economic factors. Furthermore, the study highlighted significant differentiation of SES and health outcomes among various regional Hispanic cohorts.

Consuming foods away from home (FAFH) is prevalent in the United States and contributes to high food spending and daily energy intake. We recently showed that adults in Puerto Rico (PR) who frequently consume FAFH had lower diet quality and adherence to dietary recommendations. It remains unknown if these associations translate into poor cardiometabolic health. We aimed to determine the association between the consumption of FAFH and cardiometabolic risk factors among adults in PR. Data were obtained from 1,246 adults (30-75 years) in the Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends (PROSPECT). Participants self-reported the frequency of consuming FAFH for any meal as "rarely" (<2 times/week), "sometimes" (2-4 times/week), or "frequently" (>4 times/week) at various commercial or noncommercial venues. A food frequency questionnaire assessed usual diet, and the Alternate Healthy Eating Index (AHEI) was calculated to capture diet quality. Clinical and laboratory markers from fasting blood samples were measured using standardized protocols. Generalized linear regression models were used to obtain means (SE) of cardiometabolic markers by FAFH category adjusted for sociodemographic and lifestyle behavioral factors. A second model was adjusted for AHEI. Frequently consuming commercial FAFH (cFAFH) was reported by 15.8% (192 of 1,218) and noncommercial FAFH (ncFAFH) by 4.4% (54 of 1,217), while cFAFH sometimes was reported by 31.8% (387 of 1,218) and ncFAFH by 19.0% (231 of 1,217). Participants who reported consuming cFAFH frequently (vs. rarely) had significantly higher waist circumference (107 (1.6) vs. 103 (1.3) cm; P= 0.003), BMI (31.5 (0.82) vs. 29.9 (0.64) kg/m 2 ; P= 0.032), and insulin (geometric mean 9.4 (2.1) vs. 7.8 (2.0) μIU/mL; p<0.001), and lower HDL-C (geometric mean 42.9 (1.0) vs. 45.6 (1.0) mg/dL; P= 0.012). Participants who reported consuming cFAFH sometimes (vs. rarely) had significantly higher plasma triglycerides (geometric mean 126.1 (1.5) vs. 102.1 (1.4) mg/dL; P= 0.012). Plasma glucose ( P= 0.004) and insulin ( P= 0.041) were higher in individuals frequently reporting (vs. rarely) consuming ncFAFH. Adjusting for AHEI did not appreciably change the models, except to nullify the association with BMI. Consuming FAFH, especially >4 times/week, was associated with adverse adiposity, lipids, and glucose markers and generally independent of overall diet quality. Future studies should identify the directionality of these associations and the potential mechanisms connecting them to cardiometabolic markers. Policymakers and food producers should enhance the quality of FAFH for commercial and at-home consumption for better cardiometabolic health.

In this paper, we consider randomized controlled clinical trials comparing two treatments in efficacy assessment using a time to event outcome. We assume a relatively small number of candidate biomarkers available in the beginning of the trial, which may help define an efficacy subgroup which shows differential treatment effect. The efficacy subgroup is to be defined by one or two biomarkers and cut-offs that are unknown to the investigator and must be learned from the data. We propose a two-stage adaptive design with a pre-planned interim analysis and a final analysis. At the interim, several subgroup-finding algorithms are evaluated to search for a subgroup with enhanced survival for treated versus placebo. Conditional powers computed based on the subgroup and the overall population are used to make decision at the interim to terminate the study for futility, continue the study as planned, or conduct sample size recalculation for the subgroup or the overall population. At the final analysis, combination tests together with closed testing procedures are used to determine efficacy in the subgroup or the overall population. We conducted simulation studies to compare our proposed procedures with several subgroup-identification methods in terms of a novel utility function and several other measures. This research demonstrated the benefit of incorporating data-driven subgroup selection into adaptive clinical trial designs.

Assuming the Dirac wavefunction describes the state of a single particle. We propose that the relation derived by Schrödinger, which contains the Zitterbewegung term, is a position equation for an amplitude modulated wave. Namely, the elementary constituents are amplitude modulated waves. Indeed, we surmise that a second wave is associated with the particle, which corresponds to a signal. At the same time, we interpret that Broglie’s wave corresponds to a carrier. Furthermore, the quantum object is a recording medium and, like in a hologram, information encoded on its surface. We suggest a description and the cause of the Zitterbewegung heretofore never considered regarding the previous assertions. Hereunder, we shall also apply the quantum amplitude modulation interpretation to the single-photon wave function by Bialynicki-Birula. The predictions are testable, thence providing evidence for the proposed hypothesis.

Chikungunya virus (CHIKV) is a mosquito-borne Alphavirus prevalent worldwide. There are currently no licensed vaccines or therapies. To evaluate the safety and tolerability of an investigational CHIKV virus-like particle (VLP) vaccine in endemic regions. This was a randomized, placebo-controlled, double-blind, phase 2 clinical trial to assess the vaccine VRC-CHKVLP059-00-VP (CHIKV VLP). The trial was conducted at 6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico. A total of 400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria. The first study enrollment occurred on November 18, 2015; the final study visit, March 6, 2018. Participants were randomized 1:1 to receive 2 intramuscular injections 28 days apart (20 µg, n = 201) or placebo (n = 199) and were followed up for 72 weeks. The primary outcome was the safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity) of the vaccine, and the secondary outcome was immune response by neutralization assay 4 weeks after second vaccination. Of the 400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis. All injections were well tolerated. Of the 16 serious adverse events unrelated to the study drugs, 4 (25%) occurred among 4 patients in the vaccine group and 12 (75%) occurred among 11 patients in the placebo group. Of the 16 mild to moderate unsolicited adverse events that were potentially related to the drug, 12 (75%) occurred among 8 patients in the vaccine group and 4 (25%) occurred among 3 patients in the placebo group. All potentially related adverse events resolved without clinical sequelae. At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57). Eight weeks following the first administration, the EC50 GMT in the vaccine group was 2005 (95% CI, 1680-2392) vs 43 (95% CI, 32-58; P < .001) in the placebo group. Durability of the immune response was demonstrated through 72 weeks after vaccination. Among healthy adults in a chikungunya endemic population, a virus-like particle vaccine compared with placebo demonstrated safety and tolerability. Phase 3 trials are needed to assess clinical efficacy. ClinicalTrials.gov Identifier: NCT02562482.