The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

HIV care coverage among HIV-positive adolescent girls and young women in South Africa: Results from the HERStory Study.

BACKGROUND: Health service coverage cascades measure the proportion of a population in need of a service that experienced a positive health outcome from the service, and enable tracking of progress in achieving universal health coverage and inequities in care coverage. OBJECTIVES: To investigate HIV care coverage among HIV-positive adolescent girls and young women (AGYW) living in six South African districts, compare coverage by age and socioeconomic status (SES), and investigate other associated factors including participation in a combination HIV prevention intervention. METHODS: The HERStory Study was an evaluation of the combination intervention, comprising a representative household survey of AGYW aged 15 - 24 years living in six intervention districts. From September 2017 to November 2018, biological, sociodemographic and behavioural data were collected. HIV-positive status, initiation of antiretroviral therapy (ART) and viral suppression were determined through laboratory tests (enzyme-linked immunosorbent assay for HIV antibodies, antiretroviral (ARV) metabolites and viral load (VL) testing). Viral suppression was defined as a VL <1 000 copies/mL. Knowledge of HIV-positive status was self-reported, and participants testing positive for ARV metabolites were assumed to have known their HIV-positive status. Unconditional HIV care cascades were created, stratified by age and SES. We used Pearson's χ2 tests corrected for survey-based analysis to describe factors associated with knowledge of HIV status, and being on ART. RESULTS: Of the 4 399 participants, 568 were HIV-positive (12.4%), of whom 60.8% (95% confidence interval (CI) 57.1 - 64.5) knew their status, 50.6% (95% CI 46.6 - 54.0) were on ART, and 62.1% (95% CI 58.4 - 65.9) were virally suppressed. Most participants (84.9%) were in the lower SES group, and they had better coverage than the higher SES group: 61.9% (95% CI 58.3 - 65.4) knew their status, 52.1% (95% CI 48.4 - 55.9) were on ART, and 64.9% (95% CI 61.3 - 68.4) were virally suppressed, compared with 55.0% (95% CI 42.1 - 68.0), 40.0% (95% CI 29.2 - 50.8), and 46.6% (95% CI 34.5 - 58.7), respectively. Participants aged 15 - 19 years had slightly inferior coverage to the 20 - 24-year-old group: 57.5% knew their status, 46.1% were on ART and 59.5% were virally suppressed, compared with 62.3%, 52.2% and 63.3%. CONCLUSIONS: These findings emphasise the need to close the gaps in HIV care coverage among AGYW, of whom only 61% knew their HIV-positive status and only 62% were virally suppressed. There is pro-poor inequality in HIV care coverage, with those in lower socioeconomic groups more likely to be virally suppressed.

Utility of crime surveys for Sustainable Development Goals monitoring and violence prevention using a public health approach.

The Sustainable Development Goals (SDGs) have highlighted interpersonal violence and violence against women and girls as impediments to development globally. South Africa is adversely affected by violence and injury. The annual Victims of Crime Survey (VoCS) provides a potentially useful source of complementary data to bolster vital registration and police crime statistics, but it may not provide data that are sufficiently accurate and reliable to inform prevention efforts. We conducted a critical assessment of the VoCS's methodological robustness and strength as a data source for high-level analyses, adopting a public health and SDGs monitoring perspective that was based on expert opinion and comparison with other data sources. We concluded that either the survey methods should be improved to provide findings that are better aligned with the SDGs agenda and are robust enough to inform high-quality research and prevention, or the funds used to conduct the VoCS should be redirected to other more suitable instruments.

First social impact bond for the SAMRC: A novel financing strategy to address the health and social challenges facing adolescent girls and young women in South Africa.

A social impact bond (SIB) is an innovative financing mechanism to attract investors to social programmes traditionally funded by governments. In this article, in celebration of the 50th anniversary of the South African Medical Research Council (SAMRC), the authors describe the SAMRC's first foray into this new world of financing through a SIB to improve the health and quality of life of adolescent girls and young women (AGYW). The AGYW SIB is in its preparatory phase and is scheduled for implementation in 2020. The authors describe the mechanism, including financial flows and the process of customising the SIB to meet the needs of AGYW, focusing on HIV prevention and treatment and the prevention and management of unintended pregnancies in schoolgoing AGYW. The authors outline an approach to designing the package of interventions, the metrics associated with such a programme and the business model. It is hypothesised that the proposed approach will lead to an improvement in programmatic outcomes, monitoring and evaluation tools and cost-effectiveness, and will develop key learning data for the future use of SIBs in health service delivery.

Optical projection tomography permits efficient assessment of infarct volume in the murine heart postmyocardial infarction.

The extent of infarct injury is a key determinant of structural and functional remodeling following myocardial infarction (MI). Infarct volume in experimental models of MI can be determined accurately by in vivo magnetic resonance imaging (MRI), but this is costly and not widely available. Experimental studies therefore commonly assess injury by histological analysis of sections sampled from the infarcted heart, an approach that is labor intensive, can be subjective, and does not fully assess the extent of injury. The present study aimed to assess the suitability of optical projection tomography (OPT) for identification of injured myocardium and for accurate and efficient assessment of infarct volume. Intact, perfusion-fixed, optically cleared hearts, collected from mice 7 days after induction of MI by coronary artery occlusion, were scanned by a tomograph for autofluorescence emission after UV excitation, generating >400 transaxial sections for reconstruction. Differential autofluorescence permitted discrimination between viable and injured myocardium and highlighted the heterogeneity within the infarct zone. Two-dimensional infarct areas derived from OPT imaging and Masson's trichrome staining of slices from the same heart were highly correlated (r(2) = 0.99, P < 0.0001). Infarct volume derived from reconstructed OPT sections correlated with volume derived from in vivo late gadolinium enhancement MRI (r(2) = 0.7608, P < 0.005). Tissue processing for OPT did not compromise subsequent immunohistochemical detection of endothelial cell and inflammatory cell markers. OPT is thus a nondestructive, efficient, and accurate approach for routine in vitro assessment of murine myocardial infarct volume.

Phase I of The National Beef Quality Audit-2011: quantifying willingness-to-pay, best-worst scaling, and current status of quality characteristics in different beef industry marketing sectors.

The National Beef Quality Audit (NBQA)-2011 benchmarked the current status of and assessed progress being made toward quality and consistency of U.S. cattle, carcasses, and beef products after the completion of the first NBQA in 1991. Unlike previous NBQA, objectives of the 2011 Phase I study were to determine how each beef market sector defined 7 quality categories, estimate willingness-to-pay (WTP) for the same quality categories by market sector, and establish a best-worst (B/W) scaling for the quality categories. Structured face-to-face interviews were conducted and responses were recorded using dynamic routing software over an 11-mo period (February to December 2011) with decision makers in each of the following beef market sectors: Feeders (n = 59), Packers (n = 26), Food Service, Distribution, and Further Processors (n = 48), Retailers (n = 30), and Government and Allied Industries (n = 47). All respondents participated in a structured interview consisting of WTP and B/W questions that were tied to 7 quality categories and then were asked to "define" each of the 7 categories in terms of what the category meant to them, resulting in completely unbiased results. The 7 quality categories were a) how and where the cattle were raised, b) lean, fat, and bone, c) weight and size, d) cattle genetics, e) visual characteristics, f) food safety, and g) eating satisfaction. Overall, "food safety" and "eating satisfaction" were the categories of greatest and second most importance, respectively, to all beef market sectors except for Feeders. Feeders ranked "how and where the cattle were raised" and "weight and size" as the most important and second most important, respectively. Overall, "how and where the cattle were raised" had the greatest odds of being considered a nonnegotiable requirement before the raw material for each sector would be considered for purchase and was statistically more important (P < 0.05) as a requirement for purchase than all other categories except "food safety." When all market sectors were considered, "eating satisfaction" was shown to generate the greatest average WTP percentage premium (11.1%), but that WTP premium value only differed statistically (P < 0.05) from "weight and size" (8.8%). Most notably, when a sector said that "food safety" was a nonnegotiable requirement, no sector was willing to purchase the product at a discounted price if the "food safety" of the product could not be assured.

Key issues in the clinical development and implementation of TB vaccines in South Africa.

Significant progress has been made in advancing the development pipeline for a new and more effective TB vaccine with some candidate vaccines now in late stage clinical evaluation. However, progress has been hampered by an incomplete understanding of the components of a protective immune response and limited animal models, rendering the field unable to reliably predict vaccine efficacy earlier in preclinical development, including by evaluation in animal models, and limiting the predictive utility of comparing immunogenic effects across vaccine candidates in phase I/II studies. Consequently, new candidate vaccines have to be evaluated for efficacy in large-scale phase II/III trials using clinical endpoints. Apart from the technical challenges of characterising TB incidence in target populations at high risk of acquiring TB disease and standardising case definitions in order to improve both the sensitivity and more importantly the specificity of trial endpoints, there is an urgency in expanding and supporting the considerable trial infrastructure that will be required to evaluate and ultimately license a new TB vaccine. In the longer term, implementation strategies are dependent on what policy makers most value. Economic analyses will be essential to guide policy and implementation. This paper outlines the gaps and challenges and identifies solutions for effectively developing and efficiently introducing a new TB vaccine.

Mother-to-child transmission of HIV: developing integration of healthcare programmes with clinical, social and basic research studies. Report of the International Workshop held at Chobe Marina Lodge, Kasane, Botswana, 21-25 January 2003.

Considerable efforts are still needed in the public health sector, as well as in clinical, social and basic research, to improve programmes for HIV-1 MTCT (mother-to-child transmission) prevention and care. Advantage should be taken of the remarkable amount of expertise and resources that have accumulated over the past few years to accelerate the process of integration. Future initiatives should include integrating specialists and people with diverse backgrounds and targeting their scientific and programmatic ideas to address real-world problems in the area of MTCT of HIV-1.

Active surveillance of birth defects among U.S. Department of Defense beneficiaries: a feasibility study.

Since the Vietnam War, concern regarding the association of military exposures and birth defects has grown. The possibility of such associations remains a source of unease. To determine if such an association exists, birth defects surveillance among military families must be conducted. This project compared health record abstraction (active surveillance) with screening of Department of Defense electronic medical data (passive surveillance) to detect birth defects among San Diego County military families during the period January 1, 1997, through June 30, 1998. A total of 171 of 5,351 infants (3.2%) were identified as having a major defect, consistent with national civilian rates. There was approximately 80% concurrence between passive and active surveillance birth defect data, suggesting that a hybrid system of electronic data, supplemented with active surveillance in a specific region, represents a feasible and cost-effective surveillance program for the geographically dispersed military population.

Risk/risk trade-offs in pesticide regulation: an exploratory analysis of the public health effects of a ban on organophosphate and carbamate pesticides.

Efforts to reduce pesticide-related risks to consumers and farmworkers often neglect the possibility that measures to reduce the target risk may introduce or enhance countervailing risks. These may arise from substitute pesticides or pest-control practices, from increased levels of pests or pest-related hazards, from increased levels of toxic natural pesticides in plants, from increased costs and decreased consumption of health-enhancing fruits and vegetables, or from direct income effects on consumers and farmers. The effect of the countervailing risks may partially or completely offset the reduction in the target risk. A risk-trade-off analysis was conducted of a potential ban on the use of organophosphate and carbamate (OP/Carbamate) insecticides in U.S. agriculture. Although this scenario is extreme, it has the analytic virtue of dispensing with the infinite number of "next-best" OP/Carbamates that might be substituted for specific combinations of crops and pests should only selected uses be banned. The analysis relies on detailed descriptions of the alternative pesticides and pest-control measures that would be used for each of 14 major crops. The effects of pest-control cost changes on prices and consumption and effects on consumer and producer incomes are projected using a general-equilibrium economic model. Several countervailing risks that may be significant were found, including acute toxicity to farmworkers from substitute pesticides, cancer and noncancer risks from substitute pesticides, and mortality induced by changes in disposable income. Other countervailing risks are more difficult to estimate or weigh. Potential increases in natural plant pesticides following an OP/Carbamate ban are discussed but data are lacking to quantify the effects. Changes in diet following the ban have both positive and negative effects, and the ultimate change is difficult to estimate. Although a net risk cannot be estimated, several approaches were illustrated that would be useful in risk-trade-off analyses. Key factors complicating comprehensive analysis of risk/risk trade-offs for pesticides were also identified, including data gaps and shortcomings of current risk assessment methods.

Primary care and the de facto mental health care system: improving care where it counts.

Only 28% of individuals suffering from psychiatric disorders seek care from mental health specialists. In this paper, the authors describe how the de facto PCP mental health care system gained ground when it seemed the financing and organizational structure of managed care would have predicted the opposite result. They argue that the new realities of mental health practice require new approaches to improving behavioral health treatment. These approaches, they believe, will maximize the benefit of care delivered in and accessed through the primary care office.

Adult adenovirus infections: loss of orphaned vaccines precipitates military respiratory disease epidemics. For the Adenovirus Surveillance Group.

Adenovirus vaccines have greatly reduced military respiratory disease morbidity since the 1970s. However, in 1995, for economic reasons, the sole manufacturer of these vaccines ceased production. A population-based adenovirus surveillance was established among trainees with acute respiratory illness at 4 US military training centers as the last stores of vaccines were depleted. From October 1996 to June 1998, 1814 (53.1%) of 3413 throat cultures for symptomatic trainees (78% men) yielded adenovirus. Adenovirus types 4, 7, 3, and 21 accounted for 57%, 25%, 9%, and 7% of the isolates, respectively. Unvaccinated trainees were much more likely than vaccinated trainees to be positive for types 4 or 7 (odds ratio [OR] = 28.1; 95% CI, 20.2-39.2). Two training centers experienced epidemics of respiratory disease affecting thousands of trainees when vaccines were not available. Until a new manufacturer is identified, the loss of orphaned adenovirus vaccines will result in thousands of additional preventable adenovirus infections.

Family practice career attrition, 1969 to 1993: a comparison of 336 civilian and military graduates of one medical school.

Instability of specialty choice and career after initial residency entry will affect health personnel projections. Military physicians may differ from civilian physicians in their specialty choice behaviors during their careers. A cohort of 336 graduates who chose family medicine residency training was identified from the graduating classes of 1969 through 1993 at a large private medical school. Current specialty identification was determined, and attrition from family medicine was computed. As of 1997, 275 graduates (82%) were still in family medicine careers, defined by American Academy of Family Physicians membership or current American Board of Family Practice certification. Of graduates who entered military programs, 22 of 77 (28%) had left family medicine careers; 39 of 259 (15%) of the graduates who entered civilian programs had left. This difference was statistically significant (p = 0.007). Family medicine career retention is lower for males in military programs compared with males in civilian programs or females in military programs.

Appendicitis: why so complicated? Analysis of 5755 consecutive appendectomies.

A perceived high rate of complicated (gangrenous or perforated) appendicitis, despite advances in laboratory and radiographic diagnostic modalities, prompted a review of our experience with appendicitis followed by a prospective analysis that examined the time course from presentation to definitive treatment in 218 consecutive patients. In 5755 appendectomies, our overall rate of complicated appendicitis was 32 per cent; higher in males, in the young, and in the elderly; and relatively stable over each year reviewed. Prospectively, we determined that of the various time intervals, the time from the onset of symptoms to first seeking medical attention is the only significant predictor of complicated appendicitis (39.8 vs 16.5 hours for acute appendicitis). On the other hand, the time from surgical evaluation to operative intervention was significantly shorter for complicated appendicitis (3.8 vs 4.7 hours for acute appendicitis). The high rate of complicated appendicitis with its subsequent sequelae of increased morbidity and resource expenditure is primarily the direct result of patient delay in seeking medical attention and not the result of diagnostic dilemma or surgical delay. Public education, specifically targeting those groups at risk, may provide a substantial and significant solution to the complicated appendix.