A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways.

Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory tools for the timely provision of effective, safe, quality medicines for people worldwide; however, little research has been conducted on the best way to measure the public health impact of using reliance-based pathways. The current mixed methods study was designed to explore which characteristics or "metrics" could be used to measure the impact of reliance-based pathways. A quantitative survey (n = 70) and in-depth interviews (IDIs) (n = 10) were employed to query various stakeholders (e.g., industry, regulatory authorities, NGOs) about the metrics they believed would be important to include in a framework designed to measure the impact of reliance-based regulatory pathways on advancing public health. Based on survey results, (1) ability to meet targeted product assessment timeline, (2) increased access to expertise, which is limited or not available in the agency, (3) shortened median number of days (annually) to market for medical products, (4) lower morbidity and mortality rates due to greater access to medical products, and (5) movement toward technical standards harmonization were the Top Five most important metrics to be included in a framework. IDI results suggest that, while important, the relevance of the Top Five metrics may vary by region or regulatory authority. Interviewed stakeholders intuitively believe reliance-based regulatory pathways are a worthwhile endeavor; however, there must be "harmonization" within the reliance ecosystem that creates a strong understanding of the factors necessary for reliance-based pathways to be utilized in a successful manner.

Talking about cancer: Explaining differences in social support among Chinese American and European American breast cancer survivors.

Cultural models of emotional disclosure and its impact on seeking support are understudied in the context of cancer diagnosis. We argue that two different cultural norms must be considered: (1) the importance of emotional disclosure and (2) attitudes toward seeking support from loved ones. Our interviews with 37 foreign-born Chinese American and 23 European American breast cancer survivors revealed differences in disclosure of cancer diagnosis and perception of social support. Both Chinese American and European American survivors receive and provide emotional and social support with loved ones, but their manifestations of disclosure and help-seeking behaviors are culturally specific.

Perceived barriers to achieving a healthy weight: a qualitative study using focus groups at public and private schools in Guatemala City.

BACKGROUND: Overweight prevalence among Guatemalan girls is higher in public than in private schools. Little is known about adolescent girls' perceptions of the right ways to achieve a healthy weight. This study examines public and private school adolescent girls' perceptions of a "healthy weight," and barriers and facilitators to achieving it. METHODS: We conducted 4 focus groups in public and private schools in Guatemala City with girls from 13 to 15 years old. The discussion guide included open-ended questions and activities aimed at examining perceptions of "healthy weight" and barriers and motivators to achieving it within the school environment. Focus groups were audio-recorded and transcribed. Data analyses followed established methods of content analysis. RESULTS: Twenty-eight girls (private school, n = 12; public school, n = 16) of ages ranging from 13.1 to 15.9 years (median, 14, IQR, 13.6-14.9) participated in the study. Girls identified images of thin and fit women as healthy. They cited healthy eating and physical activity as ways to achieve a healthy weight. Within the school environment, barriers to maintaining a healthy weight included a lack of healthy food options and the prioritization of sports for boys over girls. In public schools, facilities were less than optimal; in private schools, girls' access to facilities was limited. Public school girls stated that their uniforms were inappropriate for exercising. CONCLUSION: Our findings support the need to provide more healthy food options in Guatemalan schools. In addition, physical activity for girls should be promoted and facilities made available for their use.

Delivering on the Promise of Smoke-Free Public Housing.

On November 30, 2016, the US Department of Housing and Urban Development (HUD) published a final rule mandating that public housing authorities it supports prohibit all smoking on their residential premises, including within residents' apartments. The primary rationale for this action was to protect nonsmoking residents from the harms of tobacco smoke exposure. Although the harms of secondhand smoke are clear and the potential for reducing nonsmoking residents' exposure is real, it will be no simple matter to successfully implement the policy requirements set down by HUD. Some challenges to policy implementation will apply to all public housing authorities, and others will be unique to specific settings. By being aware of the benefits of smoke-free public housing as well as the challenges inherent in complying with HUD's rule, public housing authorities stand the best chance of fulfilling the potential of this major policy initiative to significantly improve public health in a vulnerable population.

What Black Women Know and Want to Know About Counseling and Testing for BRCA1/2.

Black women are just as likely to have hereditary breast cancer mutations as White women, yet their participation in genetic counseling and testing is substantially lower. This study sought to describe Black women's awareness and perceptions of BRCA1/2 testing and to identify barriers and motivators to seeking BRCA1/2 services. Fifty intercept interviews were conducted with Black women in public places (a professional women's basketball game, a grocery store, a faith-based community event, and the waiting area at a breast care clinic) in Washington, DC. More than half of the women (54%) were aware that genetic tests to determine risk for certain breast and ovarian cancers exist, but the majority (88%) had never heard of BRCA1/2, specifically. After hearing a description of BRCA1/2 genetic markers, 82% stated that they would agree to BRCA1/2 testing if it was offered to them. Perceived advantages of testing included cancer prevention and the ability to share information with family members. Perceived disadvantages included emotional distress associated with identification of the mutation and the potential misuse of results to deny healthcare or employment. Physician recommendation, self-care, and known family history were among the motivators for testing. Women listed possible media and venues for intervention. In spite of low rates of BRCA1/2 testing in the Black community, women in this sample were open to the idea. Interventions that address barriers and include cultural tailoring are necessary.

Perceptions, expectations, and attitudes about communication with physicians among Chinese American and non-Hispanic white women with early stage breast cancer.

PURPOSE: Asian Americans have consistently reported poorer communication with physicians compared with non-Hispanic Whites (NHW). This qualitative study sought to elucidate the similarities and differences in communication with physicians between Chinese and NHW breast cancer survivors. METHODS: Forty-four Chinese and 28 NHW women with early stage breast cancer (stage 0-IIa) from the Greater Bay Area Cancer Registry participated in focus group discussions or individual interviews. We oversampled Chinese women because little is known about their cancer care experiences. In both interview formats, questions explored patients' experiences and feelings when communicating with physicians about their diagnosis, treatment, and follow-up care. RESULTS: Physician empathy at the time of diagnosis was important to both ethnic groups; however, during treatment and follow-up care, physicians' ability to treat cancer and alleviate physical symptoms was a higher priority. NHW and US-born Chinese survivors were more likely to assert their needs, whereas Chinese immigrants accepted physician advice even when it did not alleviate physical problems (e.g., pain). Patients viewed all physicians as the primary source for information about cancer care. Many Chinese immigrants sought additional information from primary care physicians and stressed optimal communication over language concordance. CONCLUSIONS: Physician empathy and precise information were important for cancer patients. Cultural differences such as the Western emphasis on individual autonomy vs. Chinese emphasis on respect and hierarchy can be the basis for the varied approaches to physician communication we observed. Interventions based on cultural understanding can foster more effective communication between immigrant patients and physicians ultimately improving patient outcomes.

A mixed method exploration of survivorship among Chinese American and non-Hispanic White breast cancer survivors: the role of socioeconomic well-being.

PURPOSE: Cancer-related stress is heavily influenced by culture. This study explored similarities and differences in survivorship care concerns among Chinese American and non-Hispanic White (NHW) breast cancer survivors. METHODS: A sequential, mixed-method design (inductive/qualitative research-phase I and deductive/quantitative research-phase II) was employed. Eligible women identified from the Greater Bay Area Cancer Registry were age ≥21, diagnosed with stage 0-IIa breast cancer between 2006 and 2011, and had no recurrence or other cancers. In phase I, we conducted 4 Chinese (n = 19) and 4 NHW (n = 22) focus groups, and 31 individual telephone interviews (18 Chinese immigrants, 7 Chinese US-born, and 6 NHW). Content analysis was conducted to examine qualitative data. In phase II, another 296 survivors (148 NHW age-matched to 148 Chinese cases) completed a cross-sectional survey. Descriptive statistics and linear regression analysis were conducted to examine quantitative data. RESULTS: Qualitative data revealed "socioeconomic well-being" (SWB) as a dominant survivorship concern, which was operationalized as a cancer survivor's perceived economic and social resources available to access care. Quantitative data showed that low-acculturated Chinese immigrants reported the poorest SWB, controlling for covariates. Highly acculturated Chinese immigrants and the US-born Chinese/NHW group reported similar SWB. Women who had low-income levels or chemotherapy had poorer SWB. CONCLUSIONS: SWB emerged as an important aspect of breast cancer survivorship. Immigration stress, cancer care costs, and cultural values all contributed to immigrants' socioeconomic distress. Immigrant and US-born breast cancer survivors experienced different socioeconomic circumstances and well-being following treatment. Our findings warrant further investigation of socioeconomic distress and survivorship outcomes.

Results of a randomized controlled trial testing the efficacy of a culturally targeted and a generic video on mammography screening among chinese-american immigrants.

BACKGROUND: Research comparing the effects of culturally targeted and generic but linguistically appropriate intervention programs is limited. We conducted a randomized controlled trial comparing the efficacy of a culturally targeted video, a generic video, and a fact sheet (control) in promoting mammography screening among Chinese-American immigrants. METHODS: We randomized 664 Chinese-American women from the Washington, DC, and New York City areas who were older than 40 years and nonadherent to annual mammography screening guidelines to three study arms (each with ∼221 women). The outcome was self-reported mammography screening 6 months post intervention. Measures of knowledge, Eastern cultural views, and health beliefs were administered before and after the intervention. RESULTS: The culturally targeted video, the generic video, and the fact sheet increased mammography use by 40.3%, 38.5%, and 31.1% from baseline, respectively. A significant intervention effect was observed only in one subgroup: The culturally targeted video significantly increased mammography screening among low-acculturated women over the fact sheet [OR, 1.70; 95% confidence interval (CI), 1.04-2.78]. Overall, women who obtained a mammogram during the follow-up period reported significantly fewer barriers to screening after intervention than those who had not obtained screening. Both of the video groups reported fewer barriers after intervention than the control group. CONCLUSIONS: Both theoretically guided videos increased the likelihood of mammography use to a similar extent. Cultural targeting was only effective for low-acculturated women. Both videos reduced perceived barriers to screening and consequently increased screening behavior. IMPACT: The results of this study provide empirical evidence on the efficacy of cultural targeting for minority immigrants.

Physical distress and cancer care experiences among Chinese-American and non-Hispanic White breast cancer survivors.

OBJECTIVE: The number of Chinese-American breast cancer survivors (BCS) is increasing as a result of increasing incidence rates. There has been little research on Chinese BCS' follow-up cancer care. This qualitative study aims to understand how Chinese-American BCS experience and cope with physical distress relative to non-Hispanic White (NHW) survivors. METHODS: Seventy-one BCS (37 Chinese immigrant, 7 US-born Chinese, 27 NHW) were recruited from the Greater Bay Area Cancer Registry to participate in focus group discussions or one-on-one interviews about their survivorship experiences. All BCS were diagnosed with breast cancer at stage 0-IIA between 2006 and 2009, and had survived for 1-4 years without recurrence. Interviews were conducted in Cantonese, Mandarin, or English. Data analyses followed established qualitative methods of content analysis. RESULTS: BCS experienced pain and side effects from radiation, surgery, and hormonal therapy. Physical distress subsequently caused emotional concerns about recurrence or metastasis. Most BCS consulted physicians about their physical distress. Chinese immigrant BCS were less likely to have their issues resolved compared to NHW and US-born Chinese who were more likely to question physicians, ask for referrals, and make repeat attempts if their problems were not resolved. Some Chinese immigrant BCS turned to Traditional Chinese Medicine for relief or accepted the idea that physical distress was part of survivorship. CONCLUSION: Chinese immigrant BCS may be at risk for greater distress compared with US-born Chinese and NHW BCS because of cultural norms that make them less inclined to express their needs to physicians or challenge physicians when their needs are not met. Furthermore, they may express symptoms in culturally unique ways (e.g., hot-cold imbalances). Further research is needed to determine how to best improve survivorship care experiences in this understudied population, with the goal of decreasing BCS' physical distress and improving quality of life.

The role of patient-provider communication for black women making decisions about breast cancer treatment.

OBJECTIVE: Recent reports suggest that Black breast cancer patients receive adjuvant therapies less often than their White counterparts; however, few studies have examined the self-reported experiences of Black breast cancer patients making treatment decisions. This study examined cultural beliefs and healthcare factors that impacted Black women's treatment decisions. METHODS: In-depth interviews were conducted with 49 Black women with early stage breast cancer (stages 0-III). Participants resided in Washington, DC (n = 13), and Philadelphia, Pennsylvania (n = 36). Women's ages ranged from 26 to 85 (m = 53.9). All interviews were transcribed verbatim and then entered into a qualitative software program. Three coders independently read and coded transcripts using this software. RESULTS: The data did not reveal common cultural themes that influenced women's treatment decisions. Spiritual beliefs were important to all participants and did seem to help them cope with and reframe their illness experiences. The patient-provider relationship was the most notable factor that influenced treatment decisions. While most women reported that they were satisfied with their provider relationships, their narratives revealed that many lacked knowledge about their diagnoses and treatment regimens. Those patients who demonstrated a better understanding of their disease and treatments also seemed to adhere to recommendations for adjuvant therapy. CONCLUSIONS: Poor communication may impact treatment decision-making and, ultimately, outcomes. Important next steps will include quantifying Black women's patient-provider interactions and examining how these factors influence adherence behaviors. Ensuring that patients understand their diagnosis and treatment options will also be important for clinical practice.

Caregiving at the end of life: Perceptions of health care quality and quality of life among patients and caregivers.

This study explored the association between perceptions of health care quality and quality of life in patients with advanced metastatic cancer and their informal caregivers (n=39). Patients' and caregivers' perceptions of health care quality, mental health, health-related quality of life, symptoms, and burden were measured. The key findings included the following: 1) patients' mental health and depression scores correlated with those of caregivers, suggesting that the mental health of patients and their caregivers are associated; 2) patients and caregivers shared similar perceptions regarding health care quality; 3) the presence of depression in caregivers correlated with caregivers being less satisfied with the health care being given to their patients (this correlation did not exist for patients, a finding that may be due in part to the protective buffering effect that caregivers provide their patients as illness progresses); and 4) a modified Primary Care Assessment Survey, originally designed for primary care patients, was a useful measure of health care assessment for both patients and caregivers. These data suggest that patients with advanced disease and their caregivers share similar perceptions and evolve as a "unit of care," and caregivers, as unique and important members of the patient's health care team, are also in need of care. When depressed, caregivers may unilaterally lose trust by becoming less satisfied with the quality of health care being provided to their patients.

Adolescents' knowledge, beliefs, and behaviors regarding hepatitis B: Insights and implications for programs targeting vaccine-preventable diseases.

PURPOSE: To gain a better understanding of adolescents' knowledge, beliefs, and behaviors regarding hepatitis B. METHOD: Three types of data were collected as part of this investigation: (a) 45 in-depth individual interviews with staff from 20 adolescent health, sexually transmitted disease (STD), and family planning clinics; (b) 96 individual interviews with adolescents and young adults; and (c) questionnaires completed by 17,063 adolescents and young adults. All instruments focused on one or more of the following five topics: (a) knowledge about vaccines; (b) knowledge about hepatitis B; (c) barriers to vaccine acceptance, and ways to overcome these barriers; (d) benefits of the vaccine acceptance, and ways to enhance these benefits; and (e) eight hepatitis B risk factors. Interview data was analyzed using qualitative thematic note-based analyses. Survey data was analyzed using descriptive statistics and Chi-square tests. RESULTS: Adolescents and young adults seen in these clinics know very little about vaccinations in general, or hepatitis B, in particular. Adolescents exhibit low levels of perceived susceptibility, severity, response efficacy, and self-efficacy toward hepatitis B and the hepatitis B vaccine. On average, these adolescents engage in 2.36 high-risk behaviors (the most frequent of which include sexual activity, body piercing, and tattooing). Those who were sexually active, had a tattoo, had a STD, or worked with blood were significantly more likely to begin the vaccination series. CONCLUSIONS: There is a clear need for additional educational efforts regarding both vaccinations in general, and hepatitis B in particular. Though adolescents are engaging in a variety of high-risk behaviors, most perceive their risk to be low, and therefore many are not taking the necessary precautions to protect themselves.

Success and failure: a case study of two rural telemedicine projects.

We studied two rural telemedicine projects in the state of Michigan: one that enjoyed success and steady growth in activity, and one that experienced frustration and a lack of clinical utilization. Multiple data collection strategies were employed during study periods, which lasted approximately one year. Both projects enjoyed a grassroots approach and had dedicated project coordinators. However, the more successful project benefited from resources and expertise not available to the less successful project. In addition, the more successful project possessed a more formalized organizational structure for the telemedicine application. A comparison of the two projects leads to a simple conclusion. Telemedicine programmes are positioned within larger health organizations and do not operate in a vacuum. It is crucial that the organization in which it is intended to launch telemedicine is examined carefully first. Each organization operates within a larger environment, which is often constrained by fiscal, geographical and personnel factors. All these will affect the introduction of telemedicine.

A success model: Marquette General Health System.

The Marquette General Health System (MGHS) initiated its telehealth program in 1995 with eight network sites in Michigan's Upper Peninsula. There are currently almost 30 active sites in this network that provide clinical, educational, and administrative services. In this article, MGHS is assessed against four criteria, namely, integration, evaluation, expansion, and acceptance. Several assessment data collection strategies were employed among patients, providers, administrators, and rural community members. This paper delineates the extent to which the MGHS program meets the definition of success as defined by this four-level model. Data and anecdotal evidence are presented that illustrate that the MGHS program has been successful in its attempt to increase access to medical services for the rural population of the Michigan Upper Peninsula, as well as facilitate medical and health education, and home care services.