Design and Rationale of Penn Medicine Healthy Heart, a Randomized Trial of Effectiveness of a Centrally Organized Approach to Blood Pressure and Cholesterol Improvement Among Patients at Elevated Risk of Atherosclerotic Cardiovascular Disease.

RATIONALES: Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Suboptimal control of hypertension and hyperlipidemia are common factors contributing to ASCVD risk. The Penn Medicine Healthy Heart (PMHH) Study is a randomized clinical trial testing the effectiveness of a system designed to offload work from primary care clinicians and improve patient follow-through with risk reduction strategies by using a centralized team of non-clinical navigators and advanced practice providers, remote monitoring, and bi-directional text messaging, augmented by behavioral science engagement strategies. The intervention builds on prior non-randomized evaluations of these design elements that demonstrated significant improvement in patients' systolic blood pressure and LDL Cholesterol (LDL-C). PRIMARY HYPOTHESIS: Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention. DESIGN: Randomized clinical trial of Penn Medicine Healthy Heart in patients aged 35-80 years at elevated risk of ASCVD whose systolic blood pressure and LDL-C are not well controlled. The intervention consists of four modules that address blood pressure management, lipid management, nutrition, and smoking cessation, offered in a phased approach to give the participant time to learn about each topic, adopt any recommendations, and build a relationship with the care team. SITES: University of Pennsylvania Health System at primary care practices located in inner-city urban and rural/semi-rural areas PRIMARY OUTCOMES: Improvement in systolic blood pressure and LDL-C SECONDARY OUTCOMES: Cost-effectiveness analyses are planned to evaluate the health care costs and health outcomes of the intervention approach. An implementation evaluation is planned to understand factors influencing success of the intervention. ESTIMATED ENROLLMENT: 2,420 active patients of Penn Medicine primary care practices who have clinical ASCVD, or who are at elevated risk for ASCVD, and who are (a) not on statins or have LDL-C > 100 despite being on statins and (b) had systolic blood pressure>140 at two recent ambulatory visits. ENROLLMENT DATES: March 2024-March 2025. The intervention will last 6 months with a 12-month follow-up to determine whether its effects persist. CURRENT STATUS: Enrolling (1,240 enrolled as of August 15, 2024) CLINICAL TRIAL REGISTRATION: NCT06062394.

The content of social media's shared images about Ebola: a retrospective study.

OBJECTIVE: Social media have strongly influenced awareness and perceptions of public health emergencies, but a considerable amount of social media content is now carried through images, rather than just text. This study's objective is to explore how image-sharing platforms are used for information dissemination in public health emergencies. STUDY DESIGN: Retrospective review of images posted on two popular image-sharing platforms to characterize public discourse about Ebola. METHODS: Using the keyword '#ebola' we identified a 1% sample of images posted on Instagram and Flickr across two sequential weeks in November 2014. Images from both platforms were independently coded by two reviewers and characterized by themes. We reviewed 1217 images posted on Instagram and Flickr and identified themes. RESULTS: Nine distinct themes were identified. These included: images of health care workers and professionals [308 (25%)], West Africa [75 (6%)], the Ebola virus [59 (5%)], and artistic renderings of Ebola [64 (5%)]. Also identified were images with accompanying embedded text related to Ebola and associated: facts [68 (6%)], fears [40 (3%)], politics [46 (4%)], and jokes [284 (23%)]. Several [273 (22%)] images were unrelated to Ebola or its sequelae. Instagram images were primarily coded as jokes [255 (42%)] or unrelated [219 (36%)], while Flickr images primarily depicted health care workers and other professionals [281 (46%)] providing care or other services for prevention or treatment. CONCLUSION: Image sharing platforms are being used for information exchange about public health crises, like Ebola. Use differs by platform and discerning these differences can help inform future uses for health care professionals and researchers seeking to assess public fears and misinformation or provide targeted education/awareness interventions.

Transplantation of kidneys from donors at increased risk for blood-borne viral infection: recipient outcomes and patterns of organ use.

Kidney transplantation from deceased donors classified as increased risk for viral infection by the Centers for Disease Control (CDC) is controversial. Analyses of Organ Procurement and Transplantation Network (OPTN) data from 7/1/2004 to 7/1/2006 were performed. The primary cohort included 48 054 adults added to the kidney transplant wait list. Compared to receiving a standard criteria donor (SCD) kidney or remaining wait-listed, CDC recipients (HR 0.80, p = 0.18) had no significant difference in mortality. In a secondary cohort of 19 872 kidney recipients at 180 centers, SCD (reference) and CDC (HR 0.91, p = 0.16) recipients had no difference in the combined endpoint of allograft failure or death. Among centers performing >10 kidney transplants during the study period, the median proportion of CDC transplants/total transplants was 7.2% (range 1.1-35.6%). Higher volume transplant centers were more likely to use CDC kidneys compared to low and intermediate volume centers (p < 0.01). An analysis of procured kidneys revealed that 6.8% of SCD versus 7.8% of CDC (p = 0.13) kidneys were discarded. In summary, center use of CDC kidneys varied widely, and recipients had good short-term outcomes. OPTN should collect detailed data about long-term outcomes and recipient viral testing so the potential risks of CDC kidneys can be fully evaluated.

Substantial variation in the acceptance of medically complex live kidney donors across US renal transplant centers.

Concern exists about accepting live kidney donation from 'medically complex donors'--those with risk factors for future kidney disease. This study's aim was to examine variation in complex kidney donor use across US transplant centers. We conducted a retrospective cohort study of live kidney donors using organ procurement and transplantation network data. Donors with hypertension, obesity or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m(2) were considered medically complex. Among 9319 donors, 2254 (24.2%) were complex: 1194 (12.8%) were obese, 956 (10.3%) hypertensive and 392 (4.2%) had low eGFR. The mean proportion of medically complex donors at a center was 24% (range 0-65%). In multivariate analysis, donor characteristics associated with medical complexity included spousal relationship to the recipient (OR 1.29, CI 1.06-1.56, p < 0.01), low education (OR 1.19, CI 1.04-1.37, p = 0.01), older age (OR 1.01 per year, CI 1.01-1.02, p < 0.01) and non-US citizenship (OR 0.70, CI 0.51-0.97, p = 0.03). Renal transplant centers with the highest transplant volume (OR 1.26, CI 1.02-1.57, p = 0.03), and with a higher proportion of (living donation)/(all kidney transplants) (OR 1.97, CI 1.23-3.16, p < 0.01) were more likely to use medically complex donors. Though controversial, the use of medically complex donors is widespread and varies widely across centers.

Cost-effectiveness of pharmacogenetic testing to tailor smoking-cessation treatment.

We evaluated the cost-effectiveness of a range of smoking cessation drug treatments, including varenicline, transdermal nicotine (TN), bupropion and the use of a genetic test to choose between TN and bupropion. We performed Monte Carlo simulation with sensitivity analysis, informing analyses with published estimates of model parameters and current prices for genetic testing and smoking-cessation therapy. The primary outcomes were discounted life-years (LY) and lifetime tobacco-cessation treatment costs. In the base case, varenicline treatment was optimal with an ICER, compared to bupropion, of $2985/LY saved. In sensitivity analyses, varenicline was in all cases (and bupropion in most cases) admissible; only under favorable assumptions was the genetically tailored approach competitive. Our data suggest that an untailored approach of treatment with either bupropion or varenicline is a cost-effective form of tobacco dependence treatment, but a tailored approach for selecting between TN and bupropion can be cost-effective under plausible assumptions.

Make the healthy choice the easy choice: using behavioral economics to advance a culture of health.

Despite great advances in the science and technology of health care, a large gap separates theoretically achievable advances in health from what individuals and populations actually achieve. Human behavior sits on the final common pathway to so many of our health and health care goals, including the prevention and management of illness and the fostering of wellness. Behavioral economics is a relatively new field offering approaches to supplement many of the conventional approaches to improving health behaviors that rely on education or standard economic theory. While those conventional approaches presume that an educated public will naturally make decisions that optimize personal welfare, approaches derived from behavioral economics harness existing and predictable patterns of behavior that often lead people to make choices against their best interests. By keeping these predictable patterns of behavior in mind when designing health insurance, health care programs or the health-related aspects of everyday life, behavioral economists aim to meet people half-way: no longer asking them to reshape their behavior to something more health promoting, but helping the behavioral patterns they already follow lead them to better health.

Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes.

OBJECTIVES: We compared the effectiveness of diabetes-focused messaging strategies at increasing enrolment in a healthy food programme among adults with diabetes. METHODS: Vitality is a multifaceted wellness benefit available to members of Discovery Health, a South Africa-based health insurer. One of the largest Vitality programmes is HealthyFood (HF), an incentive-based programme designed to encourage healthier diets by providing up to 25% cashback on healthy food purchases. We randomised adults with type 2 diabetes to 1 of 5 arms: (1) control, (2) a diabetes-specific message, (3) a message with a recommendation of HF written from the perspective of a HF member with diabetes, (4) a message containing a physician's recommendation of HF, or (5) the diabetes-specific message from arm 2 paired with an 'enhanced active choice'(EAC). In an EAC, readers are asked to make an immediate choice (in this case, to enrol or not enrol); the pros and cons associated with the preferred and non-preferred options are highlighted. HF enrolment was assessed 1 month following the first emailed message. RESULTS: We randomised 3906 members. After excluding those who enrolled in HF or departed from the Vitality programme before the first intervention email, 3665 (94%) were included in a modified intent-to-treat analysis. All 4 experimental arms had significantly higher HF enrolment rates compared with control (p<0.0001 for all comparisons). When comparing experimental arms, the diabetes-specific message with the EAC had a significantly higher enrolment rate (12.6%) than the diabetes-specific message alone (7.6%, p=0.0016). CONCLUSIONS: Messages focused on diabetes were effective at increasing enrolment in a healthy food programme. The addition of a framed active choice to a message significantly raised enrolment rates in this population. These findings suggest that simple, low-cost interventions can enhance enrolment in health promoting programmes and also be pragmatically tested within those programmes. TRIAL REGISTRATION NUMBER: NCT02462057.

Are supplementary services provided during methadone maintenance really cost-effective?

OBJECTIVE: Previous research has suggested that support services supplementing methadone maintenance programs vary in their cost-effectiveness. This study examined the cost-effectiveness of varying levels of supplementary support services to determine whether the relative cost-effectiveness of alternative levels of support is sustained over time. METHOD: A group of 100 methadone-maintained opiate users were randomly assigned to three treatment groups receiving different levels of support services during a 24-week clinical trial. One group received methadone treatment with a minimum of counseling, the second received methadone plus more intensive counseling, and the third received methadone plus enhanced counseling, medical, and psychosocial services. The results at the end of the trial period have been published elsewhere. This article reports the results of an analysis at a 6-month follow-up. RESULTS: The follow-up analysis reaffirmed the preliminary findings that the methadone plus counseling level provided the most cost-effective implementation of the treatment program. At 12 months, the annual cost per abstinent client was $16,485, $9,804, and $11,818 for the low, intermediate, and high levels of support, respectively. Abstinence rates were highest, but modestly so, for the group receiving the high-intensity, high-cost methadone with enhanced services intervention. CONCLUSIONS: This study suggests that large amounts of support to methadone-maintained clients are not cost-effective, but it also demonstrates that moderate amounts of support are better than minimal amounts. As funding for these programs is reduced, these findings suggest a floor below which supplementary support should not fall.

Do persons with dementia vote?

To examine whether patients with dementia voted in the 2000 US Presidential Election, the authors surveyed 75 caregivers of patients with dementia. A substantial portion of patients with mild to moderate dementia voted on their own at a voting booth. Patients cared for by spouses were more likely to vote than patients cared for by adult children. Further research is needed to understand how persons with dementia and their caregivers decide what activities the person can and cannot continue and how well these decisions correspond to measures of competency.

Caregivers' preferences for the treatment of patients with Alzheimer's disease.

OBJECTIVES: To learn caregivers' preferences for the treatment of AD with a disease-slowing therapy, and to identify relationships between these preferences and the characteristics of caregivers and patients. METHODS: A structured interview with 40 caregivers of patients with AD. Preferences were measured for an AD-slowing medicine with the benefits of a gain in survival and a delay to nursing home placement (NHP), and risks of three degrees of severity of GI bleeding. RESULTS: Using a six-point scale ranging from "not at all important" to "extremely important," the median rating of the importance of survival as a treatment benefit was "very important" and of a delay to NHP was "extremely important." Fifty-five percent of the caregivers identified a benefit more important than these two benefits. Qualitative data showed that caregivers' reasons for these preferences featured the importance of patient quality of life, and the preservation of patient cognition and function. Bivariate analyses showed that increasing importance of the benefit of survival was related to higher assessments of the patient's health and quality of life, and lower ratings of the caregiver's experience of burden. In order to slow disease progression by 1 year, 25/38 (66%) of caregivers would accept some risk of death from gastrointestinal bleeding. Regression models showed that risk tolerance was higher among caregivers who were working, adult children caring for early stage patients or from families with an history of dementia. CONCLUSIONS: Caregivers generally are willing to tolerate notable amounts of risk to slow AD progression. Factors that describe the caregiver's experience and perception of the patient and the patient-caregiver relationship influence how they want to treat the disease. This information may be useful for decisions about how to study and prescribe AD treatments.

Obtaining informed consent for clinical pain research: patients' concerns and information needs.

Investigators who conduct clinical pain research are required to obtain voluntary informed consent from patients. However, little is known about what information patients expect when they decide whether to enroll in such studies. It is important that investigators understand these information needs so they can effectively and clearly describe the research risks and potential benefits that matter to potential subjects. By understanding these needs for information, investigators may also be better able to anticipate patients' concerns and to recruit subjects more efficiently. This study was designed to define information needs that patients have when they decide whether to participate in clinical pain research. This paper describes these information needs, and identifies clinical and demographic variables associated with specific needs.

The sequence of withdrawing life-sustaining treatment from patients.

PURPOSE: To describe the observed sequence of withdrawal of eight different forms of life-sustaining treatment and to determine whether aspects of those treatments determine the order of withdrawal. SUBJECTS AND METHODS: We observed 211 consecutive patients dying in four midwestern US hospitals from whom at least one of eight specific life-sustaining treatments was or could have been withdrawn. We used a parametric statistical technique to explain the order of withdrawal based on selected characteristics of the forms of life support, including cost, scarcity, and discomfort. RESULTS: The eight forms of life support were withdrawn in a distinct sequence. From earliest to latest, the order was blood products, hemodialysis, vasopressors, mechanical ventilation, total parenteral nutrition, antibiotics, intravenous fluids, and tube feedings (P <0.0001). The sequence was almost identical to that observed in a previous study based on hypothetical scenarios. Forms of life support that were perceived as more artificial, scarce, or expensive were withdrawn earlier. CONCLUSION: The preference for withdrawing some forms of life-sustaining treatments more than others is associated with intrinsic characteristics of these treatments. Once the decision has been made to forgo life-sustaining treatment, the process remains complex and appears to target many different goals simultaneously.

Timing payments to subjects of mail surveys: cost-effectiveness and bias.

Although mailed surveys are an important component of epidemiological research, results from mailed surveys are often suspect because of poor response rates and the potential for nonresponse bias. Previous work has demonstrated that paying subjects to complete questionnaires increases response rates, but this work has not well addressed the impact of the timing of incentives on total cost, cost effectiveness, and response bias. We surveyed 400 university employees about health benefits. By random allocation, half received a check for $5 along with the mailed survey, and the other half received the promise of $5 on return of a completed survey. The response rates for both groups were about the same (64 and 59%, respectively), but prepayment was less expensive in aggregate and less expensive per response. In addition, we found that subjects with lower salaries were more likely to respond when paid in advance. We conclude that prepayment may actually be less expensive and more cost effective than payment on completion, but that the timing of payment may influence the profile of respondents.

Response rates to mail surveys published in medical journals.

OBJECTIVE: The purpose of this study was to characterize response rates for mail surveys published in medical journals; to determine how the response rate among subjects who are typical targets of mail surveys varies; and to evaluate the contribution of several techniques used by investigators to enhance response rates. METHODS: One hundred seventy-eight manuscripts published in 1991, representing 321 distinct mail surveys, were abstracted to determine response rates and survey techniques. In a follow-up mail survey, 113 authors of these manuscripts provided supplementary information. RESULTS: The mean response rate among mail surveys published in medical journals is approximately 60%. However, response rates vary according to subject studied and techniques used. Published surveys of physicians have a mean response rate of only 54%, and those of non-physicians have a mean response rate of 68%. In addition, multivariable models suggest that written reminders provided with a copy of the instrument and telephone reminders are each associated with response rates about 13% higher than surveys that do not use these techniques. Other techniques, such as anonymity and financial incentives, are not associated with higher response rates. CONCLUSIONS: Although several mail survey techniques are associated with higher response rates, response rates to published mail surveys tend to be moderate. However, a survey's response rate is at best an indirect indication of the extent of non-respondent bias. Investigators, journal editors, and readers should devote more attention to assessments of bias, and less to specific response rate thresholds.

Cognitive processes and the decisions of some parents to forego pertussis vaccination for their children.

Public health analyses suggest that, in spite of the possibility that pertussis vaccine may cause rare cases of neurological injury, catastrophic risks to individual children are lower if they are vaccinated. A number of parents, however, choose not to vaccinate their children. The purpose of this study was to investigate the decision processes of some parents who choose to vaccinate and some parents who choose not to do so. Surveys were mailed to 500 randomly selected subscribers of Mothering magazine. Two hundred and ninety-four completed questionnaires were returned (59%). In addition to well-recognized factors in vaccination decisions, perceived dangers of the vaccine, and of the disease and susceptibility to the disease, several cognitive processes not previously considered in vaccination decision studies were found to be important predictors in this population of parents: perceived ability to control children's susceptibility to the disease and the outcome of the disease; ambiguity or doubts about the reliability of vaccine information; a preference for errors of omission over errors of commission; and recognition that if many other children are vaccinated, the risk to unvaccinated children may be lowered. Although perhaps most cases of undervaccination for pertussis reflect more general problems of health care access, some parents choose to forego vaccination for their children for other reasons. Traditional risk-benefit arguments alone will be unlikely to persuade these parents to reassess their decisions. Efforts to increase childhood vaccination must incorporate an understanding of the cognitive processes that help drive these decisions.

Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions.

OBJECTIVE: To determine clinical and patient-centered factors predicting non-elective hospital readmissions. DESIGN: Secondary analysis from a randomized clinical trial. CLINICAL SETTING: Nine VA medical centers. PARTICIPANTS: Patients discharged from the medical service with diabetes mellitus, congestive heart failure, and/or chronic obstructive pulmonary disease (COPD). MAIN OUTCOME MEASUREMENT: Non-elective readmission within 90 days. RESULTS: Of 1378 patients discharged, 23.3% were readmitted. After controlling for hospital and intervention status, risk of readmission was increased if the patient had more hospitalizations and emergency room visits in the prior 6 months, higher blood urea nitrogen, lower mental health function, a diagnosis of COPD, and increased satisfaction with access to emergency care assessed on the index hospitalization. CONCLUSIONS: Both clinical and patient-centered factors identifiable at discharge are related to non-elective readmission. These factors identify high-risk patients and provide guidance for future interventions. The relationship of patient satisfaction measures to readmission deserves further study.

Prenatal screening for toxoplasmosis.

OBJECTIVE: To evaluate the merits of screening for toxoplasmosis in all pregnant women. METHODS: We used decision analysis to compare three strategies for the antepartum management of congenital toxoplasmosis: 1) no testing for congenital toxoplasmosis; 2) current practice, which is to perform targeted screening in cases of incidental abnormalities noted on ultrasound; and 3) universal serologic screening of pregnant women followed by amniocentesis to diagnose fetal infection in cases of maternal seroconversion. For each of the three strategies, we considered the two available treatment options: intrauterine antiparasitic treatment or pregnancy termination. RESULTS: Universal screening reduced the total number of cases of congenital toxoplasmosis compared with no testing or targeted screening. However, compared with no testing, universal screening with medical treatment resulted in 18.5 additional pregnancy losses for each case of toxoplasmosis avoided. If infected pregnancies underwent termination, universal screening resulted in 12.1 additional pregnancy losses for each case avoided. CONCLUSION: Maternal screening reduces the number of cases of disease, but at a substantial clinical cost. The rarity of the disease and limitations in diagnosis and therapy limit the effectiveness of screening strategies. The risks associated with amniocentesis are particularly important. Universal maternal screening for congenital toxoplasmosis should not be performed.

Measuring community benefits provided by for-profit and nonprofit hospitals.

Nonprofit hospitals are expected to provide benefits to their community in return for being exempt from most taxes. In this paper we develop a new method of identifying activities that should qualify as community benefits and of determining a benchmark for the amount of community benefits a nonprofit hospital should be expected to provide. We then compare estimates of nonprofits' current level of community benefits with our benchmark and show that actual provision appears to fall short. Either nonprofit hospitals as a group ought to provide more community benefits, or they are performing activities that cannot be measured. In either case, better measurement and accounting of community benefits would improve public policy.

The limits of suffering: critical care nurses' views of hospital care at the end of life.

This study explores critical care nurses' beliefs, motivations, and experiences regarding end of life care. We performed a content analysis of the text comments provided by 468 U.S. critical care nurses in response to an anonymous mail survey about euthanasia. These comments reveal that these U.S. critical care nurses' feelings about issues surrounding the end of life are extremely complex. Eight themes emerged from 37 coded concepts, and the median number of themes volunteered per nurse was three. Among the most prevalent themes were patient concerns (53%), family concerns (33%), clinical circumstances (42%), the nurses' personal concerns (38%), and external or structural issues (68%). A profound sense of compassion and often conflicting forces were noted within and across themes. The nurses' comments offer a unique perspective on the care of critically ill patients and reveal much about that care that should be improved. In particular, (1) some nurses are frustrated about their limited role in the management of patients at the end of life, given their special understanding of these patients' experiences and wishes; (2) considerable confusion remains about the most appropriate way to care for these patients; and (3) the environment of some critical care setting may be unable to foster the compassion that many patients need.

Is the defensive use of diagnostic tests good for patients, or bad?

Physicians sometimes order diagnostic tests to reduce the risk of malpractice liability. The authors develop an expected-utility model that links a rational physician's concerns about malpractice liability to increases in the use of diagnostic tests and use this model to assess the effects of defensive testing on patients' interests. To do so, they adapt the threshold approach to clinical decision making to incorporate the physician's interests, focusing on 1) the effect of the physician's expected liability risks and 2) the effect of any expected liability reduction due to diagnostic testing. Surprisingly, the mere existence of liability risks is often sufficient to widen the range of disease probabilities for which diagnostic testing is the preferred clinical strategy. If testing reduces the physician's expected liability risks, the testing range is widened further. For some disease probabilities, testing is preferred by the physician even though it is not in the patient's best interests. When tests are performed in such instances, utility is transferred from the patient to the physician and the physician's insurer. Although the defensive use of diagnostic tests improves clinical outcomes for some patients, it worsens clinical outcomes for others. Moreover, defensive testing worsens the expected outcomes of all patients whose clinical strategies are changed. Physicians should realize that defensive testing necessarily reduces the overall quality of patient care.