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1.
BJU Int ; 133 Suppl 3: 57-67, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37986556

ABSTRACT

OBJECTIVE: To evaluate the efficacy of sequential treatment with ipilimumab and nivolumab following progression on nivolumab monotherapy in individuals with advanced, non-clear-cell renal cell carcinoma (nccRCC). MATERIALS AND METHODS: UNISoN (ANZUP1602; NCT03177239) was an open-label, single-arm, phase 2 clinical trial that recruited adults with immunotherapy-naïve, advanced nccRCC. Participants received nivolumab 240 mg i.v. two-weekly for up to 12 months (Part 1), followed by sequential addition of ipilimumab 1 mg/kg three-weekly for four doses to nivolumab if disease progression occurred during treatment (Part 2). The primary endpoint was objective tumour response rate (OTRR) and secondary endpoints included duration of response (DOR), progression-free (PFS) and overall survival (OS), and toxicity (treatment-related adverse events). RESULTS: A total of 83 participants were eligible for Part 1, including people with papillary (37/83, 45%), chromophobe (15/83, 18%) and other nccRCC subtypes (31/83, 37%); 41 participants enrolled in Part 2. The median (range) follow-up was 22 (16-30) months. In Part 1, the OTRR was 16.9% (95% confidence interval [CI] 9.5-26.7), the median DOR was 20.7 months (95% CI 3.7-not reached) and the median PFS was 4.0 months (95% CI 3.6-7.4). Treatment-related adverse events were reported in 71% of participants; 19% were grade 3 or 4. For participants who enrolled in Part 2, the OTRR was 10%; the median DOR was 13.5 months (95% CI 4.8-19.7) and the median PFS 2.6 months (95% CI 2.2-3.8). Treatment-related adverse events occurred in 80% of these participants; 49% had grade 3, 4 or 5. The median OS was 24 months (95% CI 16-28) from time of enrolment in Part 1. CONCLUSIONS: Nivolumab monotherapy had a modest effect overall, with a few participants experiencing a long DOR. Sequential combination immunotherapy by addition of ipilimumab in the context of disease progression to nivolumab in nccRCC is not supported by this study, with only a minority of participants benefiting from this strategy.


Subject(s)
Carcinoma, Renal Cell , Nivolumab , Adult , Humans , Nivolumab/therapeutic use , Nivolumab/adverse effects , Ipilimumab/adverse effects , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/pathology , Disease Progression , Antineoplastic Combined Chemotherapy Protocols/adverse effects
2.
Asia Pac J Clin Oncol ; 19(6): 585-595, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37727139

ABSTRACT

The 5-year survival rate of metastatic urothelial carcinoma (mUC) is estimated to be as low as 5%. Currently, systemic platinum-based chemotherapy followed by avelumab maintenance therapy is the only first-line treatment for mUC that has an overall survival benefit. Cisplatin-based chemotherapy (usually in combination with gemcitabine) is the preferred treatment but carboplatin is substituted where contraindications to cisplatin exist. Treatment with immune checkpoint inhibitors, antibody-drug conjugates, and kinase inhibitors has not yet demonstrated superiority to chemotherapy as first-line therapy and remains investigational in this setting. A recent media release indicates that chemotherapy plus nivolumab gives an OS advantage as first-line treatment but results of this study have not yet been made public. Pembrolizumab remains an option in those having primary progression on first-line chemotherapy or within 12 months of neoadjuvant chemotherapy. The antibody-drug conjugate, enfortumab vedotin has TGA approval for patients whose cancer has progressed following chemotherapy and immunotherapy and has just received a positive Pharmaceutical Benefits Scheme recommendation. The use of molecular screens for somatic genetic mutations, gene amplifications, and protein expression is expanding as drugs that target such abnormalities show promise. However, despite these advances, a substantial proportion of patients with mUC have significant barriers to receiving any treatment, including advancing age, frailty, and comorbidities, and less toxic, effective therapies are needed.


Subject(s)
Carcinoma, Transitional Cell , Urinary Bladder Neoplasms , Humans , Carcinoma, Transitional Cell/drug therapy , Carcinoma, Transitional Cell/pathology , Cisplatin/therapeutic use , Urinary Bladder Neoplasms/pathology , Carboplatin , Nivolumab/therapeutic use
3.
BMC Health Serv Res ; 23(1): 1023, 2023 Sep 22.
Article in English | MEDLINE | ID: mdl-37740170

ABSTRACT

BACKGROUND: The majority of cancer patients and cancer care clinicians-CCCs (e.g., oncologists) believe that exercise is an important adjunct therapy that should be embedded in standard practice. Yet, CCCs do not routinely discuss exercise with their patients, nor do they regularly refer them to exercise professionals (e.g., exercise physiologists-EPs). This study evaluated the feasibility and acceptability of an evidence-based approach to improving exercise communication between CCCs and their patients, including an exercise referral pathway. METHODS: Implementation and testing of the Exercise Communication and Referral Pathway (ECRP) occurred in Sydney, Australia. The ECRP included a brief oncology-initiated communication exchange with patients, CCC exercise referral to an EP, followed by EP-initiated telephone consultation with patients concerning tailored exercise advice. Participant perceptions concerning the feasibility and applicability of the ECPR were evaluated. Semi-structured interviews were conducted with CCCs (n = 3), cancer patients (n = 21), and an EP (n = 1). Inductive thematic analysis was undertaken. RESULTS: Analysis generated three themes: (1) Navigating the role of CCCs in the ECRP, suggesting that oncology-initiated communication is a cue to action, however there was a lack of role clarity regarding exercise referral; (2) Implementing Patient-Orientated Care within a Standardised Pathway, highlighting the need for tailored information and advice for patients that reflects individual disease, socio-cultural, and environmental factors, and; (3) Taking Steps Towards Action, revealing the need for structural (e.g., EP initiated contact with patients) and policy changes (i.e., changes to Medicare, direct oncologist referral) to engage patients and better integrate exercise as part of standard care. CONCLUSIONS: Findings provide important insights into improving oncology-patient exercise communication and developing an exercise referral pathway to increase engagement and patient reach. However, individual (e.g., experience, knowledge) and contextual factors (e.g., time, resources) need consideration when implementing an ECRP. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical (#ACTRN12620000358943) on March 13, 2020.


Subject(s)
Neoplasms , Referral and Consultation , Humans , Aged , Feasibility Studies , Australia , Telephone , National Health Programs , Communication , Neoplasms/therapy
4.
Cancers (Basel) ; 14(6)2022 Mar 09.
Article in English | MEDLINE | ID: mdl-35326557

ABSTRACT

Angiogenesis inhibitors have been adopted into the standard armamentarium of therapies for advanced-stage renal cell carcinomas (RCC), but more recently, combination regimens with immune checkpoint inhibitors have demonstrated better outcomes. Despite this, the majority of affected patients still eventually experience progressive disease due to therapeutic resistance mechanisms, and there remains a need to develop novel therapeutic strategies. This article will review the synergistic mechanisms behind angiogenesis and immunomodulation in the tumor microenvironment and discuss the pre-clinical and clinical evidence for both clear-cell and non-clear-cell RCC, exploring opportunities for future growth in this exciting area of drug development.

5.
Immunotherapy ; 14(7): 511-520, 2022 05.
Article in English | MEDLINE | ID: mdl-35321560

ABSTRACT

Immune checkpoint inhibitors have been incorporated into the treatment of various malignancies. An increasing body of literature is reporting rare but potentially fatal adverse events associated with these agents. In this case series, the authors report the clinical features and outcomes of seven patients who received immune checkpoint inhibitors for different solid organ malignancies and developed a tetrad of immune-related myocarditis, myositis, myasthenia gravis and transaminitis. Herein the authors review the literature and describe the current diagnostic and management approach for this overlapping syndrome. The authors' series highlights the importance of a high index of clinical suspicion, prompt comprehensive investigations, early multidisciplinary team involvement and initiation of immunosuppressive therapy when immune-related adverse events are suspected.


Cancer immunotherapy is used in the treatment of different cancer types. Immunotherapy activates the immune system to detect and attack cancer cells, but side effects may arise from the immune system inadvertently attacking normal tissues and organs. The increased use of immunotherapy has led to an increase in the reporting of rare but potentially life-threatening treatment-related side effects. In this case series, the authors report the clinical features and outcomes of seven patients who developed inflammation of the heart, muscles, nerve and muscle junctions and liver following treatment with immunotherapy. The authors review the scientific literature and discuss the current understanding of and management approach to this rare syndrome. The authors' report highlights the importance of a high degree of clinical suspicion, prompt comprehensive testing to confirm diagnosis, early involvement of experts from different specialties and early initiation of treatment in the management of this unique syndrome.


Subject(s)
Myasthenia Gravis , Myocarditis , Myositis , Neoplasms , Humans , Immune Checkpoint Inhibitors/adverse effects , Myasthenia Gravis/chemically induced , Myocarditis/chemically induced , Myocarditis/diagnosis , Myocarditis/drug therapy , Myositis/chemically induced , Myositis/diagnosis , Neoplasms/drug therapy
6.
Asia Pac J Clin Oncol ; 18(6): 625-633, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35098655

ABSTRACT

AIMS: This study aimed to (1) explore the perceptions of people living with cancer about exercise in general and exercise as an adjunct form of cancer care, (2) explore their perceptions regarding exercise counselling needs and preferences, and (3) investigate how these perceptions of exercise as an adjunct form of cancer care shape survivors exercise levels postcancer diagnosis. METHODS: A cross-sectional design and online survey were used to recruit cancer survivors via cancer-related networks throughout Australia. Two factor analyses were conducted to examine the structure and reduce the number of variables pertaining to exercise during and after the cancer treatment. Extracted components were used in one-way analysis of variance to compare differences in physical activity levels postcancer diagnosis. RESULTS: Participants (N = 288) had very positive perceptions of exercise, yet only 50% of participants would prefer to receive exercise counselling. Those who were more active postcancer diagnosis had higher exercise beliefs than those who were similarly active (p = 0.04, r = 0.27) and less active (p = 0.03, r = 0.24) postdiagnosis. Those who were less active also had lower exercise knowledge than those who were similarly active (p = 0.01, r = 0.31) and more active (p = 0.03, r = 0.26). Safety beliefs did not significantly differ between cancer survivors' activity levels (p = 0.16) CONCLUSION: This survey highlights the potential benefits of a concentrated effort in connecting survivors to relevant services and resources, and utilizing cancer clinicians to communicate with survivors about the role of exercise in cancer care.


Subject(s)
Cancer Survivors , Neoplasms , Humans , Cross-Sectional Studies , Australia , Exercise , Survivors , Neoplasms/therapy
7.
Patient Educ Couns ; 105(7): 2489-2496, 2022 07.
Article in English | MEDLINE | ID: mdl-34823926

ABSTRACT

OBJECTIVE: This study aimed to 1) understand factors impacting the implementation of exercise communication and referral, and 2) explore integrated clinical approaches to exercise communication and referral in cancer care. METHODS: Seven focus groups (N = 53) were conducted with clinicians and exercise professionals throughout Sydney, Australia. A sub-sample of participants (n = 9) attended a half-day workshop to identifying best practice approaches for moving forward. Data were analysed using thematic content analysis. RESULTS: Two themes emerged: 1) Factors impacting the knowledge-to-action gap, inclusive of limited exercise specific knowledge and training opportunities, funding structure, and current referral process, and 2) Recommendations for a consistent and efficient way forward, detailing the need for oncologist-initiated communication, distribution of cancer-exercise resources, and access to exercise professionals with cancer expertise. CONCLUSIONS: This study identified factors (e.g., cancer-exercise specific training, integration of exercise physiologists) influencing exercise counselling and referral. A potential implementation-referral approach accounting for these factors and how to incorporate exercise into a standard model of cancer care, is described. Future testing is required to determine feasibility and practicality of these approaches. PRACTICAL IMPLICATIONS: A pragmatic model is provided to guide implementation-referral, inclusive of oncologist-initiated communication exchange, relevant resources, and access to exercise professionals with cancer expertise.


Subject(s)
Neoplasms , Referral and Consultation , Attitude of Health Personnel , Australia , Counseling , Exercise , Humans , Neoplasms/therapy , Qualitative Research
8.
Asia Pac J Clin Oncol ; 15 Suppl 10: 3-10, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31762165

ABSTRACT

Vascular endothelial growth factor receptor tyrosine kinase inhibitors have provided an effective standard of care for the treatment of metastatic clear cell renal cell carcinoma (mRCC). Survival is prolonged with emergence of modern immuno-oncology combination regimens. Prognostic risk assessment is essential for choosing between these therapies to determine the most appropriate first line treatment option, with selection based on International Metastatic RCC Database Consortium Risk Category. We review the current subsidized first line treatments for mRCC in Australia and consider the evidence for treatment selection and sequencing.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Renal Cell/drug therapy , Immunotherapy/methods , Kidney Neoplasms/drug therapy , Angiogenesis Inhibitors/therapeutic use , Australia , Humans , Prognosis , Protein Kinase Inhibitors/therapeutic use
9.
Prev Chronic Dis ; 16: E104, 2019 08 08.
Article in English | MEDLINE | ID: mdl-31400098

ABSTRACT

Obesity and lack of physical activity among children and adolescents are public health problems in the United States. This Presidential Youth Fitness Program (PYFP) evaluation measured program implementation in 13 middle schools and its effect on physical education practices, student fitness knowledge, and student physical activity and fitness levels. PYFP, a free program with the potential to positively affect student health and fitness outcomes, was designed to improve fitness education practices that are easily integrated into existing physical education programs. We used a 2-group (13 PYFP and 13 comparison schools) quasi-experimental design to collect FitnessGram assessments, accelerometry data, and surveys of students, physical education teachers, and administrators. Although the program was positively associated with student cardiovascular endurance and physical activity gains during the semester, schools underused professional development courses and fitness recognition resources.


Subject(s)
Educational Personnel/standards , Exercise , Health Promotion , Pediatric Obesity , Physical Education and Training , Adolescent , Child , Female , Health Promotion/methods , Health Promotion/organization & administration , Humans , Male , Pediatric Obesity/epidemiology , Pediatric Obesity/prevention & control , Physical Education and Training/methods , Physical Education and Training/standards , Physical Fitness , Program Evaluation , School Health Services , Students/statistics & numerical data
10.
Child Obes ; 14(S1): S12-S21, 2018 03.
Article in English | MEDLINE | ID: mdl-29565653

ABSTRACT

BACKGROUND: Although childhood obesity rates have been high in the last few decades, recent national reports indicate a stabilization of rates among some subpopulations of children. This study examines the implementation of initiatives, policies, and programs (referred to as strategies) in four communities that experienced declines in childhood obesity between 2003 and 2012. METHODS AND RESULTS: The Childhood Obesity Decline project verified obesity declines and identified strategies that may have influenced and supported the decline in obesity. The project used an adaptation of the Systematic Screening and Assessment method to identify key informants in each site. Four settings were highlighted related to childhood: (1) communities, (2) schools, (3) early care and education, and (4) healthcare. The findings indicate that programs and policies were implemented across local settings (primarily in schools and early childhood settings) and at the state level, during a timeframe of supportive federal policies and initiatives. CONCLUSIONS: Multilevel approaches were aimed to improve the nutrition and physical activity environments where children spend most of their time. We hypothesized that other, more distal strategies amplified and reinforced the impact of the efforts that more directly targeted children. The simultaneous public health messaging and multilayered initiatives, supported by cross-sector partnerships and active, high-level champions, were identified as likely important contributors to success in attaining declines in rates of childhood obesity.


Subject(s)
Community Health Services/organization & administration , Health Promotion/organization & administration , Pediatric Obesity/prevention & control , Adolescent , Child , Child, Preschool , Diet, Healthy , Exercise , Female , Humans , Male , Pediatric Obesity/epidemiology , Policy Making , Prevalence , Program Evaluation , United States/epidemiology
11.
Child Obes ; 14(S1): S32-S39, 2018 03.
Article in English | MEDLINE | ID: mdl-29565654

ABSTRACT

BACKGROUND: The social ecological model (SEM) is a framework for understanding the interactive effects of personal and environmental factors that determine behavior. The SEM has been used to examine childhood obesity interventions and identify factors at each level that impact behaviors. However, little is known about how those factors interact both within and across levels of the SEM. METHODS: The Childhood Obesity Declines (COBD) project was exploratory, attempting to capture retrospectively policies and programs that occurred in four communities that reported small declines in childhood obesity. It also examined contextual factors that may have influenced initiatives, programs, or policies. Data collection included policy and program assessments, key informant interviews, and document reviews. These data were aggregated by the COBD project team to form a site report for each community (available at www.nccor.org/projects/obesity-declines ). These reports were used to develop site summaries that illustrate how policies, programs, and activities worked to address childhood obesity in each study site. RESULTS/CONCLUSIONS: Site summaries for Anchorage, AK; Granville County, NC; Philadelphia, PA; and New York City, NY, describe those policies and programs implemented across the levels of the SEM to address childhood obesity and examine interactions both across and within levels of the model to better understand what factors appear important for implementation success.


Subject(s)
Community Health Services/organization & administration , Guideline Adherence/statistics & numerical data , Health Policy , Health Promotion/organization & administration , Pediatric Obesity/prevention & control , Adolescent , Child , Child, Preschool , Female , Humans , Male , Pediatric Obesity/epidemiology , Prevalence , Program Evaluation , Retrospective Studies , United States/epidemiology
12.
Child Obes ; 14(S1): S22-S31, 2018 03.
Article in English | MEDLINE | ID: mdl-29565655

ABSTRACT

BACKGROUND: State- and local-level policies can influence children's diet quality and physical activity (PA) behaviors. The goal of this article is to understand the enacted state and local policy landscape in four communities reporting declines in childhood obesity. METHODS AND RESULTS: State-level policies were searched within the CDC's online Chronic Disease State Policy Tracking System. Local level policies were captured during key informant interviews in each of the sites. Policies were coded by setting [i.e., early care and education (ECE) also known as child care, school, community], jurisdictional level (i.e., state or local) and policy type (i.e., legislation or regulation). The time period for each site was unique, capturing enacted policies 5 years before the reported declines in childhood obesity in each of the communities. A total of 39 policies were captured across the 4 sites. The majority originated at the state level. Two policies pertaining to ECE, documented during key informant interviews, were found to be adopted at the local level. CONCLUSION: Similarities were noted between the four communities in the types of polices enacted. All four communities had state- and/or local-level policies that aimed to improve the nutrition environment and increase opportunities for PA in both the ECE and K-12 school settings. This article is a step in the process of determining what may have contributed to obesity declines in the selected communities.


Subject(s)
Community Health Services/organization & administration , Guideline Adherence , Health Promotion/organization & administration , Pediatric Obesity/prevention & control , Adolescent , Child , Child Nutritional Physiological Phenomena , Child, Preschool , Exercise , Humans , Nutrition Policy , Pediatric Obesity/epidemiology , Social Environment , United States/epidemiology
13.
Child Obes ; 14(S1): S40-S44, 2018 03.
Article in English | MEDLINE | ID: mdl-29565656

ABSTRACT

BACKGROUND: Childhood obesity remains prevalent and is increasing in some disadvantaged populations. Numerous research, policy and community initiatives are undertaken to impact this pandemic. Understudied are natural experiments. The need to learn from these efforts is paramount. Resulting evidence may not be readily available to inform future research, community initiatives, and policy development/implementation. METHODS: We discuss the implications of using an adaptation of the Systematic Screening and Assessment (SSA) method to evaluate the Childhood Obesity Declines (COBD) project. The project examined successful initiatives, programs and policies in four diverse communities which were concurrent with significant declines in child obesity. In the context of other research designs and evaluation schemas, rationale for use of SSA is presented. Evidence generated by this method is highlighted and guidance suggested for evaluation of future studies of community-based childhood obesity prevention initiatives. Support for the role of stakeholder collaboratives, in particular the National Collaborative on Childhood Obesity Research, as a synergistic vehicle to accelerate research on childhood obesity is discussed. RESULTS/DISCUSSION: SSA mapped active processes and provided contextual understanding of multi-level/component simultaneous efforts to reduce rates of childhood obesity in community settings. Initiatives, programs and policies were not necessarily coordinated. And although direct attribution of intervention/initiative/policy components could not be made, the what, by who, how, to whom was temporally associated with statistically significant reductions in childhood obesity. CONCLUSIONS: SSA provides evidence for context and processes which are not often evaluated in other data analytic methods. SSA provides an additional tool to layer with other evaluation approaches.


Subject(s)
Community Health Services/organization & administration , Health Promotion/organization & administration , Pediatric Obesity/prevention & control , Adolescent , Child , Child, Preschool , Female , Humans , Male , Pediatric Obesity/epidemiology , Policy Making , Program Evaluation , Qualitative Research , United States/epidemiology
14.
Child Obes ; 14(S1): S5-S11, 2018 03.
Article in English | MEDLINE | ID: mdl-29565657

ABSTRACT

BACKGROUND: The evidence for and our understanding of community-level strategies such as policies, system, and environmental changes that support healthy eating and active living is growing. However, researchers and evaluation scientists alike are still not confident in what to recommend for preventing or sustaining declines in the prevalence of obesity. METHODS: The Systematic Screening and Assessment (SSA) methodology was adapted as a retrospective process to confirm obesity declines and to better understand what and how policies and programs or interventions may contribute as drivers. The Childhood Obesity Declines (COBD) project's adaptation of the SSA methodology consisted of the following components: (1) establishing and convening an external expert advisory panel; (2) identification and selection of sites reporting obesity declines; (3) confirmation and review of what strategies occurred and contextual factors were present during the period of the obesity decline; and (4) reporting the findings to sites and the field. RESULTS/DISCUSSION: The primary result of the COBD project is an in-depth examination of the question, "What happened and how did it happen in communities where the prevalence of obesity declined?" The primary aim of this article is to describe the project's methodology and present its limitations and strengths. CONCLUSIONS: Exploration of the natural experiments such that occurred in Anchorage, Granville County, New York City, and Philadelphia is the beginning of our understanding of the drivers and contextual factors that may affect childhood obesity. This retrospective examination allows us to: (1) describe targeted interventions; (2) examine the timeline and summarize intervention implementation; (3) document national, state, local, and institutional policies; and (4) examine the influence of the reach and potential multisector layering of interventions.


Subject(s)
Community Health Services/organization & administration , Health Promotion/organization & administration , Pediatric Obesity/prevention & control , Adolescent , Child , Child, Preschool , Female , Health Knowledge, Attitudes, Practice , Health Policy , Humans , Male , Pediatric Obesity/epidemiology , Prevalence , Program Development , Retrospective Studies , United States/epidemiology
15.
Child Obes ; 14(S1): S1-S4, 2018 03.
Article in English | MEDLINE | ID: mdl-29565658

ABSTRACT

BACKGROUND: Recent findings show that national childhood obesity prevalence overall is improving among some age groups, but that disparities continue to persist, particularly among populations that have historically been at higher risk of obesity and overweight. Over the past several years, many jurisdictions at the city or county level across the nation have also reported declines. Little evaluation has focused on understanding the factors that influence the implementation of efforts to reduce childhood obesity rates. This article summarizes the rationale, aims, and overall design of the Childhood Obesity Declines Project (COBD), which was the first of its kind to systematically study and document the what, how, when, and where of community-based obesity strategies in four distinct communities across the nation. METHODS: COBD was initiated by the National Collaborative on Childhood Obesity Research (NCCOR), was led by a subset of NCCOR advisors and a research team at ICF, and was guided by external advisors made up of researchers, decision makers, and other key stakeholders. The research team used an adapted version of the Systematic Screening and Assessment method to review and collect retrospective implementation data in four communities. RESULTS: COBD found that sites implemented strategies across the many levels and environments that impact children's well being (akin to the social-ecological framework), building a Culture of Health in their communities. CONCLUSIONS: COBD demonstrates how collaboratives of major funders with the support of other experts and key stakeholders, can help to accelerate progress in identifying and disseminating strategies that promote healthy eating and physical activity.


Subject(s)
Community Health Services/organization & administration , Health Promotion , Pediatric Obesity/prevention & control , Adolescent , Child , Child, Preschool , Diet, Healthy , Exercise , Female , Health Promotion/methods , Humans , Male , Pediatric Obesity/epidemiology , Prevalence , Qualitative Research , Retrospective Studies , Stakeholder Participation , United States/epidemiology
16.
Public Health Res Pract ; 27(5)2017 Dec 07.
Article in English | MEDLINE | ID: mdl-31044212

ABSTRACT

OBJECTIVES: Dispensing claims are used increasingly to investigate the real-world use and impact of prescribed medicines. Claims databases, established for payment purposes, lack clinical data and only capture prescriptions for which insurers pay a contribution. We compare Australia's Pharmaceutical Benefits Scheme (PBS) dispensing claims of HER2-positive early breast cancer patients with medicines prescribed and administered to determine the accuracy of dispensing data to identify treatment protocols, number of treatment cycles and durations of therapy. METHOD: Our cohort comprised 110 female HER2-positive early breast cancer patients who started treatment at four cancer centres in New South Wales, Australia, between 2008 and 2011. Patients consented to retrospective medical chart audit and linkage to PBS claims data. We constructed protocols from prescribing and dispensing records independently, based on the timing of trastuzumab and cytotoxic treatments; and estimated the median number of treatment cycles and duration of therapy by protocol. RESULTS: Patients' median age was 53 years (range 21-86). Two chemotherapy protocols accounted for 90% of chemotherapy protocols: doxorubicin and cyclophosphamide followed by a paclitaxel or docetaxel and trastuzumab (known as ACTH; 58.2%) and trastuzumab with docetaxel, carboplatin and trastuzumab (known as TCH; 31.2%). Seventy-six patients (69.1%) were assigned the same protocols based on prescribing and claims data. Twenty-six of the protocols that did not match were due to the absence of cyclophosphamide in PBS data because it falls below the patient copayment for general PBS beneficiaries. Compared with prescription data, the number of treatment cycles was underestimated in dispensing data (30 vs 44 for ACTH and 26.5 vs 29 for TCH); however, median durations of therapy were well matched (422 vs 442 days for ACTH and 368 vs 367 for TCH). CONCLUSIONS: PBS dispensing data provide an alternative option to prescription data for estimating cancer medicine use. Recent changes to PBS data capture that include all medicines costing less than the copayment will strengthen the capacity of PBS data to reflect prescribing practice in all patients, including treatment protocols and duration of therapy in patients with complete ascertainment of PBS dispensing history.


Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Drug Prescriptions/statistics & numerical data , Drug Utilization Review/statistics & numerical data , Insurance Claim Review/statistics & numerical data , Prescription Drugs/therapeutic use , Product Surveillance, Postmarketing/statistics & numerical data , Adult , Aged , Aged, 80 and over , Female , Genes, erbB-2 , Humans , Middle Aged , New South Wales , Retrospective Studies , Young Adult
17.
Prev Med ; 67 Suppl 1: S34-9, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24589440

ABSTRACT

We described the prevalence of overweight and obesity among low-income women in rural West Virginia (WV) and urban Los Angeles County (LA County). Both communities participated in the national Communities Putting Prevention to Work program during 2010-2012. In each community, we completed health assessments on adult women recruited from public-sector clinics serving low-income populations. All participants answered survey questions regarding socio-demographics and diets. In both jurisdictions, we assessed obesity using objectively measured height and weight (calculated BMI). As part of each community case study, we performed multivariable regression analyses to describe the relationships between overweight and obesity and selected covariates (e.g., dietary behaviors). Overweight and obesity were prevalent among low-income women from WV (73%, combined) and LA County (67%, combined). In both communities, race and ethnicity appeared to predict the two conditions; however, the associations were not robust. In LA County, for example, African American and Hispanic women were 1.4 times (95% CI=1.12, 1.81) more likely than white women to be overweight and obese. Collectively, these subpopulation health data served as an important guide for further planning of obesity prevention efforts in both communities. These efforts became a part of the subsequent Community Transformation Grants portfolio.


Subject(s)
Overweight/epidemiology , Adolescent , Adult , Black or African American/statistics & numerical data , Aged , Body Mass Index , Cross-Sectional Studies , Female , Health Promotion , Hispanic or Latino/statistics & numerical data , Humans , Los Angeles/epidemiology , Middle Aged , Nutrition Surveys , Obesity/epidemiology , Poverty , Prevalence , Rural Population/statistics & numerical data , Urban Population/statistics & numerical data , West Virginia/epidemiology , White People/statistics & numerical data , Women's Health , Young Adult
18.
W V Med J ; 109(4): 12-6, 2013.
Article in English | MEDLINE | ID: mdl-23930556

ABSTRACT

BACKGROUND: Physical education (PE) provides a natural opportunity for students to be physically active during the school day; however, the amount and intensity of this activity varies. The Centers for Disease Control and Prevention recommends that students engage in MVPA for at least 50% of their PE class period. The purpose of the present study was to quantify the amount of MVPA that occurs during elementary school PE. METHODS: Accelerometer data were collected from 203 students (100 2nd grade; 103 5th grade) in 10 West Virginia elementary schools. At each school, PE teachers identified three 2nd grade classes and three 5th grade classes in which to collect the physical activity data. For each selected class, the teachers identified the first 4 students on their alphabetic roll to wear the accelerometers. PE teachers recorded the date and time of the class and the gender of the students wearing the accelerometers. RESULTS: Using 5-second epochs and Puyau's cut-offs, results indicated that, on average, students engaged in MVPA for 27% of their PE class. No significant differences were observed in MVPA between 2nd and 5th grade students or between males and females. Male and female students spent equal amounts of PE class in MVPA. CONCLUSION: Findings support policy to increase the required minimum amount of MVPA during each PE class.


Subject(s)
Motor Activity , Physical Education and Training , Accelerometry , Child , Female , Humans , Male , Rural Population , Schools , West Virginia
19.
Res Social Adm Pharm ; 9(6): 851-62, 2013.
Article in English | MEDLINE | ID: mdl-23287815

ABSTRACT

BACKGROUND: Studies have shown a negative association between value of the future (preference for long-term vs. short-term rewards) and harmful addictive behaviors; however, research in the area of preventive behaviors is limited and has shown conflicting results. OBJECTIVES: The primary objectives were: (1) to examine the association among value of the future and diet and physical activity (PA) behaviors, and (2) to assess whether value of the future explained additional variance in behaviors after controlling for theory-based health beliefs related to coronary heart disease (CHD). METHODS: An online survey was conducted in adults (N = 172) with no prior history of CHD. A delay discounting task was administered to measure value of the future. Questionnaire items were based on the Health Belief Model (HBM) and included CHD knowledge, perceived risk, perceived severity, perceived benefits of and barriers to behavior change, self-efficacy, cues to action, diet and PA behaviors and demographic variables. RESULTS: High value of the future was associated with younger age, lower BMI, more healthful diet, and increased PA. After controlling for HBM components and demographics, value of the future did not explain any additional variance in diet or PA behaviors. Significant predictors of healthful diet included female gender (P = .013), increased age (P = .029), greater than high school education (P = .023), greater diet-related self-efficacy (P = .021), and not having received a healthcare provider recommendation to improve diet (P = .018). Significant predictors of PA level included income between $20,000 and $69,999 (P = .014), greater exercise-related self-efficacy (P < .001) and not having received a healthcare provider recommendation to increase levels of PA (P = .015). CONCLUSIONS: Behaviors to prevent CHD may be associated with a person's outlook on the future; however, self-efficacy was a stronger predictor of behavior. These findings support recommendations for enhancement of diet- and PA-related self-efficacy and problem-solving to address myopia in terms of long-term health benefits.


Subject(s)
Coronary Disease/prevention & control , Forecasting , Health Behavior , Adult , Aged , Culture , Diet , Female , Health Knowledge, Attitudes, Practice , Humans , Male , Middle Aged , Motor Activity , Surveys and Questionnaires , Young Adult
20.
Int J Paediatr Dent ; 23(6): 424-34, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23171413

ABSTRACT

BACKGROUND: Novelty sweets resemble or can be used as toys, are brightly coloured, with striking imagery, and sold at pocket money prices. They encourage regular consumption as packaging can be resealed, leading to prolonged exposure of these high-sugar and low pH products to the oral tissues, risk factors for dental caries and erosion, respectively. AIM: To determine how children conceptualise novelty sweets and their motivations for buying and consuming them. DESIGN: Focus groups conducted using a brief schedule of open-ended questions, supported by novelty sweets used as prompts in the latter stages. Participants were school children (aged 9-10) from purposively selected state primary schools in Cardiff, UK. RESULTS: Key findings related to the routine nature of sweet eating; familiarity with and availability of novelty sweets; parental awareness and control; lack of awareness of health consequences; and the overall appeal of novelty sweets. CONCLUSIONS: Parents reported vagueness regarding consumption habits and permissiveness about any limits they set may have diluted the concept of treats. Flexible permissiveness to sweet buying applied to sweets of all kinds. Parents' reported lack of familiarity with novelty sweets combined with their low cost, easy availability, high sugar content, and acidity give cause for concern.


Subject(s)
Food Preferences , Child , Focus Groups , Humans , United Kingdom
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