Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial.

BACKGROUND: Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation. METHODS: The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation. CONCLUSIONS: The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection. TRIAL REGISTRATION: ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. PROTOCOL VERSION: April 27, 2020, v2.

Longitude-based time zone partitions and rates of suicide.

BACKGROUND: Increasing evidence suggests that conditions with decreased morning and increased evening light exposure, including shift work, daylight-saving time, and eveningness, are associated with elevated mortality and suicide risk. Given that the alignment between the astronomical, biological, and social time varies across a time zone, with later-shifted daylight exposure in the western partition, we hypothesized that western time zone partitions would have higher suicide rates than eastern partitions. METHODS: United States (U.S.) county-level suicide and demographic data, from 2010 to 2018, were obtained from a Centers for Disease Control database. Using longitude and latitude, counties were sorted into the western, middle, or eastern partition of their respective time zones, as well as the northern and southern halves of the U.S. Linear regressions were used to estimate the associations between suicide rates and time zone partitions, adjusting for gender, race, ethnicity, age group, and unemployment rates. RESULTS: Data were available for 2872 counties. Across the U.S., western partitions had statistically significantly higher rates of suicide compared to eastern partitions and averaged up to two additional yearly deaths per 100,000 people (p < .001). LIMITATIONS: Ecological design and limited adjustment for socioeconomic factors. CONCLUSIONS: To our knowledge, this is the first study of the relationship between longitude-based time zone partitions and suicide. The results were consistent with the hypothesized elevated suicide rates in the western partitions, and concordant with previous reports on cancer mortality and transportation fatalities. The next step is to retest the hypothesis with individual-level data, accounting for latitude, photoperiodic changes, daylight-saving time, geoclimatic variables, physical and mental health indicators, as well as socioeconomic adversity and protection.

Premature Infant Gut Microbiome relationships with childhood behavioral scales: preliminary insights.

Introduction: Very Low Birth Weight (VLBW) infants, born weighing less than 1,500 grams, are at risk for both gut dysbiosis and later neuropsychological developmental deficits. Behavioral effects, while related to neurodevelopment, are often more subtle and difficult to measure. The extent of later neurobehavioral consequences associated with such microbial dysbiosis has yet to be determined. We explored associations between the infants' gut microbiome and early childhood behavior at 4 years of age and identified the bacterial taxa through a multivariate analysis by linear models. Methods: Parents completed the Child Behavior Checklist (CBCL) focused on different DSM diagnostic categories: affective, anxiety, pervasive developmental, attention deficit/hyperactivity, and oppositional defiant. All the CBCL scores were corrected for gender, delivery method, gestational age, infant birth weight, occurrence of sepsis, and days on antibiotics prior statistical analyses. Canonical correlation analysis (CCA) was performed to determine the relationship between early life gut microbiome and the adjusted CBCL scores. The association of bacterial Amplicon sequence Variants (ASVs) to the CBCL scores were tested with multivariate analysis by linear models (MaAsLin). Results: Nineteen children who were previously born with very low birth weight and studied while hospitalized in the Neonatal Intensive Care Unit (NICU) were included in this study. Statistically significant associations were observed between early life gut bacteria such as Veillonella dispar, Enterococcus, Escherichia coli, and Rumincococcus to later behavior at 4 years. No significant association could be observed with early-life gut microbiome alpha diversity and behavioral measures at 4 years. Discussion: These preliminary observational data provide insight into the relationships between VLBW gut microbiome dysbiosis and childhood behavior. This study contributes to the literature on gut microbiome analysis by examining various behavioral domains using a standardized tool linked to the Diagnostic and Statistical Manual of Mental Disorders (DSM).

Bach Flower Remedies as Complementary Therapies in Health Care: A Scope Review.

The objective of this article was to map the use of Bach flower remedies in adult health care. The studies reported that the following flower essences were used: Impatiens, Cherry Plum, White Chestnut, and Beech. When applied in 4 diluted drops, they helped reducing anxiety, depression, fear, and pain.

Caracterización del cáncer de mama en mujeres de Panamá

Objetivo: Caracterizar la edad y el perfil étnico/racial y el número de casos de cáncer de mama, las características del tumor y el tiempo de supervivencia entre las mujeres 2012-2016. Métodos: Este análisis secundario descriptivo aprovechó la información del Registro Nacional de Cáncer de Panamá. Resultados: Hubo 4134 casos de cáncer de mama con una edad media de 58años. La mayoría de las mujeres eran blancas (n=2514; 60,8%). Las regiones con más casos fueron Panamá (53,7%), Chiriquí (10,6%), Panamá Oeste (9,5%), Colón (6,6%) y Coclé (5,5%). Pocos (n=337) casos incluyeron datos desde el diagnóstico hasta la muerte para un tiempo de supervivencia que varió de 7.08 (Colón) a 17.08 (Panamá Oeste) meses. No se observaron diferencias estadísticamente significativas en los tiempos de supervivencia entre provincias. Pocos (n=1787) casos tenían datos de estadificación; El 15,1% estaba en estadio I, el 39,1% en estadio II, el 33,6% en estadio III y el 11,2% en estadio IV. La mayoría de los casos se clasificaron como T2 (7,1%) o T3 (7,1%). Conclusiones: La edad media y la raza del cáncer de mama es similar a la del hemisferio occidental. Las mujeres en Panamá tenían más probabilidades de ser diagnosticadas en una etapa más avanzada de la enfermedad, con solo el 15% diagnosticado con enfermedad en etapa I, con un tiempo de supervivencia que oscilaba entre 7,1 y 17,8 meses. Si bien la mayoría de los casos de cáncer de mama se encuentran en la provincia metropolitana de Panamá, la razón exacta de esto sigue sin estar clara. (provisto por Infomedic International)

Objective: To characterize the age and ethnic/racial profile and the number of breast cancer cases, tumor characteristics, and survival time among women 2012-2016. Methods: This descriptive, secondary analysis leveraged information from the Panama's National Cancer Registry. Results: There were 4134 cases of breast cancer with a mean age of 58. Most women were white (n=2514; 60.8%). The regions with the most cases were Panama (53.7%), Chiriquí (10.6%), Panama Oeste (9.5%), Colon (6.6%), and Coclé (5.5%). Few (n=337) cases included data from time from diagnosis to death for a survival time ranging from 7.08 (Colón) to 17.08 (Panamá Oeste) months. No statistically significant differences were observed in survival times between provinces. Few (n=1787) cases had staging data; 15.1% were StageI, 39.1% were StageII, 33.6% were StageIII, and 11.2% were StageIV. Most cases were classified as T2 (7.1%) or T3 (7.1%). Conclusions: The mean age and race of breast cancer is similar to that of the Western hemisphere. Women in Panama were more likely to be diagnosed at a more advanced disease stage, with only 15% diagnosed with StageI disease, with a survival time ranging between 7.1 and 17.8months. While most breast cancer cases are reportedly in the metropolitan province of Panamá, the exact reason for this remains unclear. (provided by Infomedic International)