Phase I clinical trials in 56 patients with thyroid cancer: the M. D. Anderson Cancer Center experience.

INTRODUCTION: Thyroid cancer is the most common endocrine malignancy. The outcomes of patients with relapsed thyroid cancer treated on early-phase clinical trials have not been systematically analyzed. PATIENTS AND METHODS: We reviewed the records of consecutive patients with metastatic thyroid cancer referred to the Phase I Clinical Trials Program from March 2006 to April 2008. Best response was assessed by Response Evaluation Criteria in Solid Tumors. RESULTS: Fifty-six patients were identified. The median age was 55 yr (range 35-79 yr). Of 49 patients evaluable for response, nine (18.4%) had a partial response, and 16 (32.7%) had stable disease for 6 months or longer. The median progression-free survival was 1.12 yr. With a median follow-up of 15.6 months, the 1-yr survival rate was 81%. In univariate analysis, factors predicting shorter survival were anaplastic histology (P = 0.0002) and albumin levels less than 3.5 g/dl (P = 0.05). Among 26 patients with tumor decreases, none died (median follow-up 1.3 yr), whereas 52% of patients with any tumor increase died by 1 yr (P = 0.0001). The median time to failure in our phase I clinical trials was 11.5 months vs. 4.1 months for the previous treatment (P = 0.04). CONCLUSION: Patients with advanced thyroid cancer treated on phase I clinical trials had high rates of partial response and prolonged stable disease. Time to failure was significantly longer on the first phase I trial compared with the prior conventional treatment. Patients with any tumor decrease had significantly longer survival than those with any tumor increase.

A practice-based culminating experience with Texas Children's Hospital: A hospital's journey to baby-friendly status

Breastfeeding and the use of human milk are widely accepted as the most complete form of nutrition for infants. Breastfeeding is shown to be associated with many positive health outcomes for both infants and mothers. Healthy People 2000 goals to increase breastfeeding rates in the early postpartum period to 75% fell short, with only 64% of mothers meeting this objective. Lack of support from healthcare providers, and unsupportive hospital policies and practices are noted as barriers to the initiation and duration of breastfeeding. The purpose of this study was to evaluate implementation of the BFHI Ten Steps to Successful Breastfeeding at Texas Children's Hospital. ^ The Baby-Friendly Hospital Initiative (BFHI) was developed in 1991 by the World Health Organization and the United Nations Children's Fund (UNICEF) to ensure that healthcare facilities offering maternity services adhere to the Ten Steps of Successful Breastfeeding and the International Code of Marketing of Breast-Milk Substitutes, and create legislation to protect the rights of breastfeeding women. The instrument used in this study was the BFHI 100 Assessment Tool created by Dr. Laura Haiek, Director of Public Health in Monteregie, Quebec, and her staff at Health and Social Services Agency of Quebec. The BFHI 100 tool utilizes 100 different indicators of compliance with BFHI through questionnaires administered to staff and administrators, pregnant and postpartum mothers, and an observer. ^ The study concluded that although there is much room for improvement in educating breastfeeding mothers, overall, the mothers interviewed were satisfied with their level of care in regards to breastfeeding support. Areas of improvement include staff training, as some nursing staff admitted to relying on the lactation consultants to provide most of the breastfeeding education for mothers. Only a small percentage of mothers interviewed reported that their baby “roomed-in” on average of 22 hours per day during their hospital stay. Staff encouragement of the rooming-in practice will help to increase the proportion of mothers who allow their babies to room-in. The current breastfeeding policy will also need to be revised and strengthened to be compliant with the Ten Steps. Ideally, Baby-Friendly practices will become the norm after staff are trained and policy revisions are made. Staff training and acceptance of breastfeeding as optimal nutrition for infants are the most critical factors that will ultimately drive change for the organization. ^

Health significance of chlorination byproducts in drinking water: The Houston experience: A continuation study

Background. Houston, Texas, once obtained all its drinking water from underground sources. However, in 1853, the city began supplementing its water from the surface source Lake Houston. This created differences in the exposure to disinfection byproducts (DBPs) in different parts of Houston. Trihalomethanes (THMs) are the most common DBP and are useful indicators of DBPs in treated drinking water. This study examines the relationship between THMs in chlorinated drinking water and the incidence of bladder cancer in Houston. ^ Methods. Individual bladder cancer deaths, from 1975 to 2004, were assigned to four surface water exposure areas in Houston utilizing census tracts—area A used groundwater the longest, area B used treated lake water the longest, area C used treated lake water the second longest, and area D used a combination of groundwater and treated lake water. Within each surface water exposure area mortality rates were calculated in 5 year intervals by four race-gender categories. Linear regression models were fitted to the bladder cancer mortality rates over the entire period of available data (1990–2004). ^ Results. A decrease in bladder cancer mortality was observed amongst white males in area B (p = 0.030), white females in area A (p = 0.008), non-white males in area D (p = 0.003), and non-white females in areas A and B (p = 0.002 & 0.001). Bladder cancer mortality differed by race-gender and time (p ≤ 0.001 & p ≤ 0.001), but not by surface water exposure area (p = 0.876). ^ Conclusion. The relationship between bladder cancer mortality and the four surface water exposure areas (signifying THM exposure) was insignificant. This result could be attributable to Houston controlling for THMs starting in the early 1980’s by using chloramine as a secondary disinfectant in the drinking water purification process.^

Workers and respirators: What factors influence medical clearance? Experience in the petrochemical industry 2004--2008

This retrospective cohort study analyzed data from more than 2200 OSHA-mandated respirator medical evaluations performed between 2004 and 2008, with information initially obtained using an online questionnaire, to determine what factors influence medical clearance and the ability to safely wear respiratory protection in a large petrochemical company.^ The employees were mostly white males with a high school education, ranging in age from 25 to 60 years of age, who had been employed with the company an average of eight years. Their work was typically performed outdoors in a rural or offshore setting. Respirators were typically required for emergency response – escape or rescue only – and/or limited to less than four hours per month.^ Approximately 90% of the population achieved medical clearance by utilizing the online questionnaire. Of the remaining 10%, 66% were cleared after additional "hands-on" medical examination exam; 28% of the individuals' jobs were modified by their supervisor in order to not use a respirator, and 6% of the individuals (n=13) were excluded from wearing a respirator on the basis of the medical examination. The primary causes for exclusion from respirator use were cardiovascular (37.5%) and respiratory (31.3%) issues, followed by psychological (18.8%) and musculoskeletal (12.5%) concerns. Ultimately, over 99% of workers evaluated under this system were found capable of using respiratory protection safely. This questionnaire has proven to be an excellent health screening tool capable of initiating early detection and further investigation of potentially serious medical conditions within a large and diverse population in multiple locations. ^

Quality of life, symptom experience, and use of complementary and alternative medicine among women with ovarian cancer

The objectives of this dissertation were to determine the quality of life in women with ovarian cancer and the association of their physical and emotional well-being with the number of symptoms, duration of symptoms, and the scores of common symptoms of ovarian cancer; to study the prevalence of complementary and alternative medicine techniques for symptom relief and its association with the number of symptoms, age, education, insurance, comorbidity, and satisfaction with medical care they received, and their pre-diagnostic experience of symptoms.^ This study was based on a secondary data analysis of a study of early detection of ovarian cancer. A sample of 139 women with ovarian cancer was recruited and was administered a questionnaire comprised of questions on their quality of life, their symptoms and what they did about the symptoms, whether they used any complementary and alternative medicine techniques, and other medical conditions they had. Out of this sample, 53 patients underwent in-depth interviews relating to their symptoms before the diagnosis and their experiences with the health care system leading to the ovarian cancer diagnosis. ^ In article #1, ovarian cancer patients were observed to have significantly poorer quality of life on all subscales and summary scores except pain, compared to that of the general population of US women. Physical well-being scores were negatively associated with the number of symptoms before diagnosis and a significant negative association of comorbidity index was observed with physical well-being. Higher education and increase in time since diagnosis was found to have better physical scores. Emotional well-being scores showed marginally significant associations with number of symptoms and bloating. ^ In article #2, a thematic content analysis of the ovarian cancer patients’ interviews revealed that on recognition of their symptoms women first assumed their symptoms to be a normal transient occurrence due to a pre-existing disease condition, or due to some other disease. A series of misattributions of their symptoms on their and their doctors’ part impacted their health care seeking.In article #3, a significantly greater likelihood of CAM use with an increase in the number of symptoms was observed.^ Based on the foregoing results, it is important to educate women on possible signs of ovarian cancer and also to educate doctors about the results of current research regarding ovarian cancer diagnosis. This will help to avoid a delay in getting a diagnosis and improve women’s quality of life. It emphasizes the diagnosis of ovarian cancer in earlier stages by more sensitive screening techniques. This study emphasizes the importance of consideration of comorbidity in any quality of life research. Additionally, educating women in the safe use of CAM techniques carries immense significance because the efficacy and safety of many of the currently advertized CAM products has not been scientifically validated. Further research is needed to confirm the findings of this study. ^

Process evaluation of intervention program for prevention of early sexual activity and alcohol use among Hispanic teenagers

Hispanic teens are a high-risk population for initiation of early sexual activity and alcohol use which in turn has numerous social and health consequences. One strategy to address prevention of these behaviors is to implement a capacity building intervention that promotes parent child communication, encompasses their cultural values and community participation. This study describes the process evaluation of a pilot intervention program amongst Hispanic teens and their families living along the Texas-Mexico border. “Girls Lets Talk” is a small group intervention with 10-14 year old teens and their female adult family members that involves education regarding effects of alcohol use and sexual activity as well as activities for monitoring and refusal skills to prevent risky behaviors. Two waves of the program each consisting of at least seven mother daughter dyads were conducted. During the designing process, community advisory board meetings and focus groups were held to review course materials and ensure they were appropriate to the Mexican American culture. Parent and adolescent surveys were administered at the beginning and end of the intervention to assess for psychosocial outcome variables. All sessions received high mean satisfactory scores (mean of 4.00 or better on a five point scale) for both adult and adolescent participants. Qualitative feedback was obtained via debriefing sessions to evaluate experience as well as alter recruitment strategies. A Wilcoxon Sign Rank analysis of the pre and post intervention surveys was done that showed significant changes in some outcome variables such as intentions and confidence for monitoring behaviors for adults and beliefs regarding sexual activity. “Girls Lets Talk” is a promising example of how a process evaluation plan can help develop a theory based health promotion program using the community based participatory research approach. The intervention may also be effective in altering intentions and enhancing self-efficacy among parents and teens in order to decrease risky behaviors such as early sexual activity and alcohol use.^

Is family medicine meeting the HIV/AIDS challenge? A national survey of family physicians' beliefs, clinical competence, and experience regarding HIV disease

A national sample of family physicians was surveyed to (1) assess family physicians' beliefs about the human immunodeficiency virus (HIV) and individuals at risk for infection, their clinical competence regarding HIV-related issues, and their experiences with HIV disease; (2) present conclusions to the American Academy of Family Physicians (AAFP) to effect the development of an early clinical care protocol and a continuing medical education curriculum; and (3) collect base-line data for use in the evaluation of an early clinical care protocol and a continuing medical education curriculum, in the case that such programs are developed and disseminated. After considering retired or deceased respondents, of the 2,660 physicians surveyed, 1,678 (63.7%) responded. The resulting sample was representative of the active members of the AAFP. About 77% of the respondents were unable to accurately identify the universal precautions for blood and body fluids to prevent occupational transmission of HIV or hepatitis B virus (HBV). Residency trained and board certified physicians expressed fewer "external constraints," such as fear of losing patients, obviating them from providing treatment to individuals with HIV disease (p =.004 and p $<$.001, respectively). These physicians also manifested fewer "internal constraints" to the provision of HIV treatment, such as fear of becoming infected (p $<$.001 and p =.012, respectively). Residency trained physicians also expressed a greater comfort with discussing sexually-related topics with their patients than did non-residency trained physicians (p $<$.001). There were 67.1% of the physicians surveyed who reported never providing treatment to an individual with HIV disease. Residency trained and board certified physicians expressed a greater likelihood to provide treatment to HIV-infected patients (p $<$.001) than non-residency trained and non-board certified physicians.^ Among the various primary care specialties, family medicine is especially vulnerable to the current challenges of HIV/AIDS. These challenges are augmented by the epidemiologic pattern that characterizes AIDS. For the past several years, we have seen AIDS in this country assume a similar pattern to that seen in most other countries; HIV is becoming increasingly prevalent in the heterosexual population as well as in locations removed from metropolitan centers. This current phase of the epidemic generates greater pressures upon primary care physicians, particularly family physicians, to become better acquainted with the means to provide early care to HIV/AIDS patients and to prevent HIV/AIDS among their patients. Family medicine is especially appropriate for providing care to HIV patients because family medicine involves treatment to all age groups and conditions; other primary care specialties focus on limited patient populations or specific conditions. Family physicians should be armed with the expertise to confront HIV/AIDS. However, family physicians' clinical competence and experience with HIV is not known. The data collected in this survey describes their competencies, attitudes, and experiences. ^

Computerizing Social-Emotional Assessment for School Readiness: First Steps toward an Assessment Battery for Early Childhood Settings

The transition into formal schooling is a crucial foundation that can set children on a cycle of success or failure in both academic and social domains. A child’s abilities to express healthy emotions, understand emotions of self and others, regulate emotion, attention, and behavior, make good decisions regarding social problems, and engage in a range of prosocial behaviors, all work together to promote a successful school experience. However, many children have deficits in these skills by school entry, and educators lack the requisite tools to identify, track and assess skills these children need to learn. Thus, because social-emotional learning (SEL) is so crucial, assessment tools to pinpoint children’s skills and progress are vitally necessary. Previous work by the authors and other researchers has led to the development of strong assessment tools; however, these tools are often developed solely for research use, not practitioner application. In the following, using our assessment battery as an example, we will discuss the steps necessary to adapt SEL assessment for computer-based administration and optimal utility in early childhood education programs.

Exploring parental factors and their influence on early adolescent sexual health

Black and Hispanic youth experience the largest burden of sexually transmitted infections, teen pregnancy, and childbirth (Hamilton, Martin, & Ventura, 2011). Minority youth are disporportionately more likely to sexually debut at every age and debut before the age of 13 compared to whites (Centers for Disease Control and Prevention, 2011). However, there is little known about pre-coital sexual activity or protective parental factors in early adolscent minority youth. Parental factors such as parent-child communication and parental monitoring influence adolescent sexual behaviors and pre-coital sexual behaviors in early adolescence. Three distinct methods were used in this dissertation. Study one used qualitative methods, semi-structured, in-depth, individual interviews, to explore parent-child communication in African American mother-early adolescent son dyads. Study two used quantitative methods, secondary data analysis of a cross sectional study, to conduct a moderation analysis. For study three, I conducted a systematic review of parent-based adolescent sexual health interventions. Study one found that mothers feel comfortable talking about sex with adolescents, provide a two-prong sexual health message, and want their sons to tell their when they are thinking of having sex. Study found that parental monitoring moderates the relation between parent-child communication and pre-coital sexual behaviors. Study three found that interventions use a variety of theory, methods, and strategies and that no parent-based programs target faith-based organizations, mother-son or father-daughter dyads, or parents of LGBTQ youth. Adolescent sexual health interventions should consider addressing youth-to-parent disclosure of sexual activity or intentions to debut, addressing both parent-child sexual health communication and parental monitoring, and using a theoretical framework.^