ABSTRACT
AIDS clinical trials (ACTs) are critical to the development of new treatments for HIV infection. However, people of color living with HIV/AIDS are involved in ACTs at disproportionally low rates, with African-Americans experiencing the greatest under-representation. In this article, we describe the core elements and key characteristics of a highly efficacious multi-component peer-driven intervention (PDI) designed to increase rates of screening for and enrollment into ACTs among African-American and Latino/Hispanic individuals, by addressing the main complex, multi-level barriers they experience to ACTs. We discuss the process of developing the intervention, the theoretical models guiding its delivery format and content, and provide an overview of the intervention's components. We then use brief case studies to illustrate a number of key issues that may arise during intervention implementation. Finally, we describe lessons learned and provide recommendations for the PDI's uptake in clinical and clinical trials settings.
Subject(s)
Acquired Immunodeficiency Syndrome/drug therapy , Black or African American/psychology , Clinical Trials as Topic/psychology , Health Knowledge, Attitudes, Practice/ethnology , Hispanic or Latino/psychology , Patient Selection , Acquired Immunodeficiency Syndrome/diagnosis , Acquired Immunodeficiency Syndrome/ethnology , Black or African American/education , Black or African American/statistics & numerical data , Attitude of Health Personnel , Clinical Trials as Topic/standards , Clinical Trials as Topic/statistics & numerical data , Fear/psychology , Female , Hispanic or Latino/education , Hispanic or Latino/statistics & numerical data , Humans , Male , Mass Screening/psychology , Patient Education as Topic/methods , Patient Navigation/methods , Patient Navigation/organization & administration , Peer Group , Selection Bias , Trust/psychologyABSTRACT
BACKGROUND: Quality of life measurement in cholangiocarcinoma and gallbladder cancer involves the assessment of patient-reported issues related to the symptoms, disease and treatment of these tumours. This study describes the development of the disease-specific quality of life (QoL) questionnaire for patients with cholangiocarcinoma and gallbladder cancer to supplement the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30 core cancer questionnaire. METHODS: Phases 1-3 of the guidelines for module development published by the EORTC were followed, with adaptations for incorporation of questions from existing modules. RESULTS: A total of 47 QoL issues (questions) were identified; 44 questions from the two related validated questionnaires, the EORTC QLQ-PAN26 (pancreatic module) and the EORTC QLQ-LMC21 (liver metastases module), two from the Functional Assessment of Cancer Therapy hepatobiliary module questionnaire in the literature search and one from healthcare professional interviews. Following phase 1 and 2 interviews with patients (n=101) and health care professionals (n=6), a 23-question provisional questionnaire was formulated. There were five questions from PAN26, 15 from LMC21 and three extra questions. In phase 3, the provisional item list was pre-tested in 52 patients in four languages and this resulted in a 21-item module. CONCLUSION: This is the only disease-specific QoL questionnaire for patients with cholangiocarcinoma and gallbladder cancer, and initial assessments show it to be accurate and acceptable to patients in reflecting QoL in these diseases.
Subject(s)
Bile Duct Neoplasms/psychology , Bile Ducts, Intrahepatic , Cholangiocarcinoma/psychology , Gallbladder Neoplasms/psychology , Quality of Life , Surveys and Questionnaires , Adult , Aged , Aged, 80 and over , Bile Duct Neoplasms/epidemiology , Bile Duct Neoplasms/pathology , Bile Duct Neoplasms/therapy , Bile Ducts, Intrahepatic/pathology , Cholangiocarcinoma/epidemiology , Cholangiocarcinoma/pathology , Cholangiocarcinoma/therapy , Europe/epidemiology , Female , Gallbladder Neoplasms/epidemiology , Gallbladder Neoplasms/pathology , Gallbladder Neoplasms/therapy , Humans , Liver Neoplasms/epidemiology , Liver Neoplasms/psychology , Liver Neoplasms/secondary , Liver Neoplasms/therapy , Male , Middle Aged , Quality of Life/psychology , Research Design , Surveys and Questionnaires/standards , Validation Studies as TopicABSTRACT
This article gives an overview of neuroendocrine tumours of the gut, liver and pancreas and will make the case for a multidisciplinary approach to management.
Subject(s)
Gastrointestinal Neoplasms/therapy , Liver Neoplasms/therapy , Neuroendocrine Tumors/therapy , Pancreatic Neoplasms/therapy , Gastrointestinal Neoplasms/classification , Gastrointestinal Neoplasms/diagnosis , Humans , Liver Neoplasms/classification , Liver Neoplasms/diagnosis , Neuroendocrine Tumors/classification , Neuroendocrine Tumors/diagnosis , Pancreatic Neoplasms/classification , Pancreatic Neoplasms/diagnosis , Patient Care Team/organization & administrationABSTRACT
BACKGROUND: The goal of this study was to assess the prognostic value of ambulatory versus clinic blood pressure measurement and to relate cardiovascular risk to ambulatory systolic and diastolic blood pressure levels. METHODS AND RESULTS: The study population consisted of 688 patients 51+/-11 years of age who had undergone pretreatment 24-hour intra-arterial ambulatory blood pressure monitoring on the basis of elevated clinic blood pressure. A total of 157 first events were recorded during a 9.2+/-4.1-year follow-up period. The predictive value of a regression model containing age, sex, race, body mass index, smoking, diabetes mellitus, fasting cholesterol level, and previous history of cardiovascular disease was significantly improved by the addition of any ambulatory systolic or diastolic blood pressure parameter (whether 24-hour, daytime, or nighttime mean) or pulse pressure, whereas inclusion of baseline clinic blood pressure variables did not enhance the prediction of events. The most predictive models contained the ambulatory systolic blood pressure parameters. In the model containing 24-hour mean ambulatory systolic blood pressure (P=0.001), age (P<0.001), male sex (P<0.001), South Asian origin (P=0.008), diabetes mellitus (P=0. 05), and previous cardiovascular disease (P<0.001) were additional independent predictors of events. Whereas 24-hour ambulatory systolic blood pressure was linearly related to the incidence of both coronary and cerebrovascular events, 24-hour ambulatory diastolic blood pressure exhibited a positive linear relationship with cerebrovascular events but a curvilinear relationship with coronary events. CONCLUSIONS: Ambulatory blood pressure is superior to clinic measurement for the assessment of cardiovascular risk; there is no reduction in coronary risk at lower levels of ambulatory diastolic blood pressure.
