OBJECTIVE: Hypertension affects more than 50 million people in the United States alone. Despite clear evidence regarding the beneficial effects of quality treatment for high blood pressure, many millions of diagnosed and undiagnosed hypertensives are not receiving the optimal standard of care. The difference in patient outcomes achieved with present hypertension treatment methods and those thought to be possible using best practice treatment methods is known as a quality gap, and such gaps are at least partly responsible for the loss of thousands of lives each year. This review was organized to bring a systematic assessment of different quality improvement (QI) strategies and their effects to the process of identifying and managing hypertension. SEARCH STRATEGY AND
INCLUSION CRITERIA: Investigators searched the MEDLINE® database, the Cochrane Collaboration's Effective Practice and Organisation of Care (EPOC) registry, article bibliographies, and relevant journals for experimental evaluations of QI interventions aimed at improving hypertension screening and management of non-pregnant adults with primary hypertension. The reviewers included randomized or quasi-randomized controlled trials, controlled before-after studies, and interrupted time series in which at least one reported outcome measure included changes in blood pressure, or provider or patient adherence to a recommended process of care.
DATA COLLECTION AND ANALYSIS: Relevant data were abstracted independently by two reviewers. Each QI intervention was classified into one or more of the following components: provider education, provider reminders, facilitated relay of clinical information, patient education, promotion of self-management, patient reminders, audit and feedback, organizational change, or financial incentives. Certain categories were further subdivided into major subtypes (e.g., professional meetings for provider education and disease management for organizational change). The researchers also evaluated the impact of clinical information systems as a mediator for interventions of all types. They compared the different QI strategies in terms of the median effects achieved for blood pressure control and for a generalized measure of provider or patient adherence.
MAIN RESULTS: Sixty-three articles reporting a total of 82 comparisons met the inclusion criteria. Studies of hypertension identification were found to be too heterogeneous for quantitative analysis. The majority of screening studies were clinic-based (with a few offered at work sites), and the most common strategies involved patient and/or provider reminders. These generally showed positive results; several studies found that patients were more likely to know their blood pressure or attend clinic visits after receiving reminders. Across all studies with a variety of strategies, the median reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 4.5 mmHg (interquartile range: 1.5, 11.0) and 2.1 mmHg (interquartile range: -0.2, 5.0), respectively. The median increase in the proportion of patients in the target SBP range and target DBP range was 16.2 percent (interquartile range: 10.3, 32.2), and 6.0 percent (interquartile range: 1.5, 17.5), respectively. Studies that focused on improving provider adherence showed a range of median reduction of 1.3 percent to a median improvement of 3.3 percent across all QI strategies. Overall, patient adherence showed a median improvement of 2.8 percent (interquartile range: 1.9, 3.0).
CONCLUSION: The findings of this review suggest that QI strategies appear, in general, to be associated with the improved identification and control of hypertension. It is not possible to discern with complete confidence which specific QI strategies have the greatest effects, since most of the studies included more than one QI strategy. All of the assessed strategies may be beneficial under some circumstances, and in varying combinations. There may be other useful strategies that have not been studied in trials meeting the inclusion criteria for evidence-based review; it is not possible to draw conclusions about these strategies.

In 1999, the Blue Cross and Blue Shield Federal Employee Program (FEP) implemented a pilot disease management program to manage congestive heart failure (CHF) among members. The purpose of this project was to estimate the financial return on investment in the pilot CHF program, prior to a full program rollout. A cohort of 457 participants from the state of Maryland was matched to a cohort of 803 nonparticipants from a neighboring state where the CHF program was not offered. Each cohort was followed for 12 months before the program began and 12 months afterward. The outcome measures of primary interest were the differences over time in medical care expenditures paid by FEP and by all payers. Independent variables included indicators of program participation, type of heart disease, comorbidity measures, and demographics. From the perspective of the funding organization (FEP), the estimated return on investment for the pilot CHF disease management program was a savings of $1.08 in medical expenditure for every dollar spent on the program. Adding savings to other payers as well, the return on investment was a savings of $1.15 in medical expenditures per dollar spent on the program. The amount of savings depended upon CHF risk levels. The value of a pilot initiative and evaluation is that lessons for larger-scale efforts can be learned prior to full-scale rollout.

Setting: Santa Clara County, Northern California.

Objective: To characterize agreement of tuberculin skin test (TST) and QuantiFERON-TB (QFT) with repeated testing.

Design: Fifty-two subjects participating in an ongoing prospective study of infectious disease transmission were tested by TST and QFT at two home visits 3 months apart. Boosting was defined as reclassification of TST from negative to positive. Agreement and reproducibility of TST and QFT were assessed using kappa and McNemar statistics.

Results: Of 48 individuals completing all tests, 75% were foreign-born (92% Latin America) and 58% were BCG-vaccinated. Initial TST and QFT were positive in 13 (27%) and 21 (44%), respectively, with an overall agreement of 67% (K = 0.29). Ten (29%) of 35 initial TST-negative reactions boosted, nine of whom were BCG-vaccinated subjects. Boosting occurred in eight (67%) of 12 subjects who were initially QFT-positive/TST-negative. Compared to the second TST, initial QFT had a relative post-test probability of 76% (95% CI 0.58-0.95); boosting accounted for 8/16 (50%) of initial testing discordances.

Conclusion: Positive QFT in the setting of negative TST frequently anticipates a TST boost. This finding helps explain discordance between the two tests and may provide an alternative to serial TST testing.

Past research has identified social and environmental causes and correlates of behaviors thought to be associated with obesity and weight gain among children and adolescents. Much less research has documented the efficacy of interventions designed to manipulate those presumed causes and correlates. These latter efforts have been inhibited by the predominant biomedical and social science problem-oriented research paradigm, emphasizing reductionist approaches to understanding etiologic mechanisms of diseases and risk factors. The implications of this problem-oriented approach are responsible for leaving many of the most important applied research questions unanswered, and for slowing efforts to prevent obesity and improve individual and population health. An alternative, and complementary, solution-oriented research paradigm is proposed, emphasizing experimental research to identify the causes of improved health. This subtle conceptual shift has significant implications for phrasing research questions, generating hypotheses, designing research studies, and making research results more relevant to policy and practice. The solution-oriented research paradigm encourages research with more immediate relevance to human health and a shortened cycle of discovery from the laboratory to the patient and population. Finally, a "litmus test" for evaluating research studies is proposed, to maximize the efficiency of the research enterprise and contributions to the promotion of health and the prevention and treatment of disease. A research study should only be performed if (1) you know what you will conclude from each possible result (whether positive, negative, or null); and (2) the result may change how you would intervene to address a clinical, policy, or public health problem.

The pharmaceutical industry is facing substantial criticism from many directions, including financial barriers to access to drugs in both developed and developing countries, high profits, spending on advertising and marketing, and other issues. Underlying these criticisms are fundamental questions about the value of the current patent-based drug development system. Six major problems with the patent system are (1) recovery of research costs by patent monopoly reduces access to drugs; (2) market demand rather than health needs determines research priorities; (3) resources between research and marketing are misallocated; (4) the market for drugs has inherent market failures; (5) overall investment in drug research and development is too low, compared with profits; and (6) the existing system discriminates against US patients.

Potential solutions fall into 3 categories: change in drug pricing through either price controls or tiered pricing; change in drug industry structure through a "buy-out" pricing system or with the public sector acting as exclusive research funder; and change in development incentives through a disease burden incentive system, orphan drug approaches, or requiring new drugs to demonstrate improvement over existing products prior to US Food and Drug Administration approval. We recommend 4 complementary reforms: (1) having no requirement to test new drug products against existing products prior to approval but requiring rigorous comparative postapproval testing; (2) international tiered pricing and systematic safeguards to prevent flow-back; (3) increased government-funded research and buy-out for select conditions; and (4) targeted experiments using other approaches for health conditions in which there has been little progress and innovation over the last few decades.

Hereditary hemochromatosis is a genetic disorder of iron metabolism. Diagnosis of hereditary hemochromatosis is usually based on a combination of various genetic or phenotypic criteria. Decisions regarding screening are difficult because of the variable penetrance of mutations of the HFE gene and the absence of any definitive trials addressing the benefits and risks of therapeutic phlebotomy in asymptomatic patients or those with only laboratory abnormalities. The purpose of this guideline is to increase physician awareness of hereditary hemochromatosis, particularly the variable penetrance of genetic mutations; aid in case finding; and explain the role of genetic testing. This guideline provides recommendations based on a review of evidence in the accompanying background paper by Schmitt and colleagues. The target audience for this guideline is internists and other primary care physicians. The target patient population is all persons who have a probability or susceptibility of developing hereditary hemochromatosis, including the relatives of individuals who already have the disease.