A paradigm for understanding trust and mistrust in medical research: The Community VOICES study.

BACKGROUND: To promote justice in research practice and rectify health disparities, greater diversity in research participation is needed. Lack of trust in medical research is one of the most significant obstacles to research participation. Multiple variables have been identified as factors associated with research participant trust/mistrust. A conceptual model that provides meaningful insight into the interplay of factors impacting trust may promote more ethical research practice and provide an enhanced, actionable understanding of participant mistrust. METHODS: A structured survey was developed to capture attitudes toward research conducted in emergency situations; this article focuses on items designed to assess respondents' level of trust or mistrust in medical research in general. Community-based interviews were conducted in English or Spanish with 355 New York City residents (white 42%, African American 29%, Latino 22%). RESULTS: Generally favorable attitudes toward research were expressed by a majority (85.3%), but many respondents expressed mistrust. Factor analysis yielded four specific domains of trust/mistrust, each of which was associated with different demographic variables: general trustworthiness (older age, not disabled); perceptions of discrimination (African American, Latino, Spanish language preference); perceptions of deception (prior research experience, African American); and perceptions of exploitation (less education). CONCLUSIONS: The four domains identified in the analysis provide a framework for understanding specific areas of research trust/mistrust among disparate study populations. This model offers a conceptual basis for the design of tailored interventions that target specific groups to promote trust of individual researchers and research institutions as well as to facilitate broader research participation.

The impact of a Children's health insurance program by age.

OBJECTIVES: 1) To examine age variation in unmet need/delayed care, access, utilization, and restricted activities attributable to lack of health insurance in children before they receive health insurance; and 2) to examine the effect of health insurance on these indicators within each age group of children (in years). METHODS: We use cohort data on children before and after receiving health insurance. The study population consists of 750 children, 0 through 19 years of age, newly enrolling in two children's health programs. The families of the newly enrolled children were interviewed at the time of their enrollment (baseline), and again at 6 months and 1 year after enrollment. The dependent variables measured included access to regular provider, utilization, unmet need or delayed health care, and restrictions on activities attributable to health insurance status. All these indicator variables were examined by age groups (0-5, 6-10, 11-14, and 15-19 years of age). chi(2) tests were performed to determine whether these dependent variables varied by age at baseline. Using logistic regression, odds ratios were calculated for baseline indicators by age group of child, adjusting for variables commonly found to be associated with health insurance status and utilization. Changes in indicator variables from before to after receiving health insurance within each age group were documented and tested using the McNemar test. A comparison group of families of children enrolling newly 12 months later were interviewed to identify any potential effects of trend. RESULTS: All ages of children saw statistically significant improvements in access, reduced unmet/delayed care, dental utilization, and childhood activities. Before obtaining health insurance, older children, compared with younger children, were more likely to have had unmet/delayed care, to have not received health care, to have low access, and to have had activities limited by their parents. This pattern held for all types of care except dental care. Age effects were strong and independent of covariates. After being covered by health insurance, the majority of the delayed care, low utilization, low access, and limited activities in the older age groups (11-14 and 15-19 years) was eliminated. Thus, as levels of unmet need, delayed care, and limitations in activities approached zero in all age groups by 1 year after receipt of health insurance, age variation in these variables was eliminated. By contrast, age variation in utilization remained detectable yet greatly reduced. CONCLUSION: Health insurance will reduce unmet need, delayed care, and restricted childhood activities in all age groups. Health care professionals and policy makers also should be aware of the especially high health care delay, unmet need, and restricted activities experienced by uninsured older children. The new state children's health insurance programs offer the potential to eliminate these problems. Realization of this potential requires that enrollment criteria, outreach strategies, and delivery systems be effectively fashioned so that all ages of children are enrolled in health insurance.

Processes and outcomes of care for patients with community-acquired pneumonia: results from the Pneumonia Patient Outcomes Research Team (PORT) cohort study.

BACKGROUND: Although understanding the processes of care and medical outcomes for patients with community-acquired pneumonia is instrumental to improving the quality and cost-effectiveness of care for this illness, limited information is available on how physicians manage patients with this illness or on medical outcomes other than short-term mortality. OBJECTIVES: To describe the processes of care and to assess a broad range of medical outcomes for ambulatory and hospitalized patients with community-acquired pneumonia. METHODS: This prospective, observational study was conducted at 4 hospitals and 1 health maintenance organization in Pittsburgh, Pa, Boston, Mass, and Halifax, Nova Scotia. Data were collected via patient interviews and reviews of medical records for 944 outpatients and 1343 inpatients with clinical and radiographic evidence of community-acquired pneumonia. Processes of care and medical outcomes were assessed 30 days after presentation. RESULTS: Only 29.7% of outpatients had 1 or more microbiologic tests performed, and only 5.7% had an assigned microbiologic cause. Although 95.7% of inpatients had 1 or more microbiologic tests performed, a cause was established in only 29.6%. Six outpatients (0.6%) died, and 3 of these deaths were pneumonia related. Of surviving outpatients, 8.0% had 1 or more medical complications. At 30 days, 88.9% (nonemployed) to 95.6% (employed) of the surviving outpatients had returned to usual activities, yet 76.0% of outpatients had 1 or more persisting pneumonia-related symptoms. Overall, 107 inpatients (8.0%) died, and 81 of these deaths were pneumonia related. Most surviving inpatients (69.0%) had 1 or more medical complications. At 30 days, 57.3% (non-employed) to 82.0% (employed) of surviving inpatients had returned to usual activities, and 86.1% had 1 or more persisting pneumonia-related symptoms. CONCLUSIONS: In this study, conducted primarily at hospital sites with affiliated medical education training programs, virtually all outpatients and most inpatients had pneumonia of unknown cause. Although outpatients had an excellent prognosis, pneumonia-related symptoms often persisted at 30 days. Inpatients had substantial mortality, morbidity, and pneumonia-related symptoms at 30 days.

Impact of a children's health insurance program on newly enrolled children.

CONTEXT: Although there is considerable interest in decreasing the number of US children who do not have health insurance, there is little information on the effect that health insurance has on children and their families. OBJECTIVE: To determine the impact of children's health insurance programs on access to health care and on other aspects of the lives of the children and their families. DESIGN: A before-after design with a control group. The families of newly enrolled children were interviewed by telephone using an identical survey instrument at baseline, at 6 months, and at 12 months after enrollment into the program. A second group of families of newly enrolled children were interviewed 12 months after the initial interviews to form a comparison sample. SETTING: The 29 counties of western Pennsylvania, an area with a population of 4.1 million people. SUBJECTS: A total of 887 families of newly enrolled children were randomly selected to be interviewed; 88.3% agreed to participate. Of these, 659 (84%) responded to all 3 interviews. The study population consists of 1031 newly enrolled children. The children were further classified into those who were continuously enrolled in the programs. The 330 comparison families had 460 newly enrolled children. MAIN OUTCOME MEASURES: The following access measures were examined: whether the child had a usual source of medical or dental care; the number of physician visits, emergency department visits, and dentist visits; and whether the child had experienced unmet need, delayed care, or both for 6 types of care. Other indicators were restrictions on the child's usual activities and the impact of being insured or uninsured on the families. RESULTS: Access to health care services after enrollment in the program improved: at 12 months after enrollment, 99% of the children had a regular source of medical care, and 85% had a regular dentist, up from 89% and 60%, respectively, at baseline. The proportion of children reporting any unmet need or delayed care in the past 6 months decreased from 57% at baseline to 16% at 12 months. The proportion of children seeing a physician increased from 59% to 64%, while the proportion visiting an emergency department decreased from 22% to 17%. Since the comparison children were similar to the newly enrolled children at enrollment into the insurance programs, these findings can be attributed to the program. Restrictions on childhood activities because of lack of health insurance were eliminated. Parents reported that having health insurance reduced the amount of family stress, enabled children to get the care they needed, and eased family burdens. CONCLUSIONS: Extending health insurance to uninsured children had a major positive impact on children and their families. In western Pennsylvania, health insurance did not lead to excessive utilization but to more appropriate utilization.

The impact of lack of health insurance on children.

This paper examines the impact that the lack of health insurance has on children and their families. A random sample of families of children who were newly enrolled in a children's health insurance program were interviewed by telephone and asked about the children's health status, the amount of unmet need and delayed care for a number of services, consequences of unmet need and delayed care, usual activities, and the effect on the lack of health insurance. Data were analyzed by using both quantitative and qualitative methods. We found that uninsured children had experienced considerable unmet need and delayed care that increased as the time without insurance increased. The parents reported some adverse consequences. The children were also found to be limited in the extent to which they could participate in various activities specifically because they lacked health insurance. Finally, the parents reported considerable stress and worry associated with their children's lack of coverage. We conclude that being without health insurance has broad consequences for America's children.

Impact of free vaccine and insurance status on physician referral of children to public vaccine clinics.

CONTEXT: Concerns about financial barriers to vaccination led to the development of the Vaccines for Children (VFC) program, which provides free vaccines to states for children who are uninsured, Medicaid eligible, or Native American or Native Alaskan. OBJECTIVE: To understand the effect of economic factors on physician likelihood of referring children to public vaccine clinics for immunizations and to evaluate the VFC program. DESIGN: A standardized survey was conducted in 1995 by trained personnel using computer-assisted telephone interviewing. SETTING AND PARTICIPANTS: A stratified random sample of family physicians, pediatricians, and general practitioners younger than 65 years who were in office-based practices across the United States. MAIN OUTCOME MEASURES: Likelihood of referral of a child to a health department for vaccination by child's insurance status and by the physician's receipt of free vaccines. RESULTS: Of the 1769 physicians with whom an interviewer spoke, 1236 participated. Most respondents (66%) were likely to refer an uninsured child to the health department for vaccination, whereas only 8% were likely to refer a child who had insurance that covers vaccination. The majority (58%) of physicians reported differential referral based on insurance status. Among physicians who received free vaccine supplies from the VFC program or elsewhere, 44% were likely to refer an uninsured child whereas 90% of those not receiving free vaccine were likely to refer the same child (P<.001). In regression analysis, the receipt of free vaccine supplies accounted for 24% of the variance in the likelihood to refer an uninsured child for vaccination. CONCLUSIONS: Physicians receiving free vaccine supplies report being less likely to refer children to public clinics for vaccinations.

The hospital admission decision for patients with community-acquired pneumonia. Results from the pneumonia Patient Outcomes Research Team cohort study.

BACKGROUND: The hospital admission decision directly influences the magnitude of resource use in patients with community-acquired pneumonia, yet little information exists on how medical practitioners make this decision. OBJECTIVES: To determine which factors medical practitioners consider in making the hospital admission decision and which health care services they believe would allow ambulatory treatment of low-risk hospitalized patients with community-acquired pneumonia. METHODS: Medical practitioners responsible for the hospital admission decision for low-risk patients with community-acquired pneumonia were asked to describe patient characteristics at initial examination that influenced the hospitalization decision, and to identify the health care services that would have allowed initial outpatient treatment of hospitalized patients. RESULTS: A total of 292 medical practitioners completed questionnaires for 472 (76%) of the 624 low-risk patients eligible for this study. Although all patients had a predicted probability of death of less than 4%, practitioners estimated that 5% of outpatients and 41% of inpatients had an expected 30-day risk of death of more than 5%. Univariate analyses identified 3 practitioner-rated factors that were nearly universally associated with hospitalization: hypoxemia (odds ratio, 173.3; 95% confidence interval, 23.8-1265.0), inability to maintain oral intake (odds ratio, 53.3; 95% confidence interval, 12.8-222.5), and lack of patient home care support (odds ratio, 54.4; 95% confidence interval, 7.3-402.6). In patients without these 3 factors, logistic regression analysis demonstrated that practitioner-estimated risk of death of more than 5% had a strong independent association with hospitalization (odds ratio, 18.4; 95% confidence interval, 6.1-55.7). Practitioners identified home intravenous antibiotic therapy and home nursing observation as services that would have allowed outpatient treatment of more than half (68% and 59%, respectively) of the patients initially hospitalized for treatment. CONCLUSIONS: Practitioners' survey responses suggest that the availability of outpatient intravenous antimicrobial therapy and home nursing care would allow outpatient care for a large proportion of low-risk patients who are hospitalized for community-acquired pneumonia. These data also suggest that methods to improve practitioners' identification of low-risk patients with community-acquired pneumonia could decrease the hospitalization of such patients. Future studies are required to help physicians identify which low-risk patients could safely be treated in the outpatient setting on the basis of clinical information readily available at presentation.

The hospital discharge decision for patients with community-acquired pneumonia. Results from the Pneumonia Patient Outcomes Research Team cohort study.

BACKGROUND: The hospital discharge decision directly influences the length of stay in patients with community-acquired pneumonia, yet no information exists on how physicians make this decision. OBJECTIVES: To identify the factors physicians considered the factors responsible for extending length of hospital stay in clinically stable patients, and the outpatient medical services that would allow earlier hospital discharge for patients with community-acquired pneumonia. METHODS: Physicians responsible for the hospital discharge decision of patients with community-acquired pneumonia were asked to identify the factors responsible for extending stay in patients hospitalized beyond stability, and the medical services that could have allowed earlier hospital discharge to occur. RESULTS: For the 418 eligible patients with community-acquired pneumonia identified during the study, 332 questionnaires (79%) were completed by 168 physicians. Physicians believed 71 patients (22%) were discharged from the hospital 1 day or more (median, 2.5 days) after reaching clinical stability. The most common factors rated as being "very important" in delaying discharge were diagnostic evaluation or treatment of comorbid illness (56%), completion of a "standard course" of antimicrobials (15%), and delays with arrangements for long-term care (14%). Among the 302 patients with available information on both length of hospital stay and stability at discharge, median length of stay was 7.0 days for the 29 low-risk patients hospitalized beyond reaching clinical stability and 5.0 days for the remaining 128 low-risk patients (P < .005); median length of stay was 12.5 days for the 42 medium- and high-risk patients hospitalized beyond reaching clinical stability and 8.0 days in the remaining 113 medium- and high-risk patients (P < .001). Frequently cited medical services that "probably" or "definitely" would have allowed earlier discharge to occur included availability of home intravenous antimicrobial infusion (26%) and home visits by nurses (20%). CONCLUSIONS: Physicians believed that diagnostic evaluation or treatment of comorbid illness, completion of a standard course of antimicrobial therapy, and delays with arrangements for long-term care delayed hospital discharge in clinically stable patients. Addressing the efficiency of these aspects of inpatient medical care, as well as providing home treatment programs, could decrease the length of hospital stay in patients with community-acquired pneumonia.

Funding resuscitation research.

The present trend in managed care has meant downsizing expectations concerning the availability of support for resuscitation research. This trend applies to funding possibilities from industry, governmental agencies, and nongovernmental agencies (Table 1). There will be increasing barriers to making innovations. Truth, science, and good patient care alone will not make potential donors give grants. Investigators must also understand the potential donors' expectations and be persuasive. "Delight your donor". Industries' concerns include intellectual property rights and publications. The National Institutes of Health, recently favoring molecular biology over lifesaving therapies or integrated physiologic research, is an anomaly. The current peer review system propagates itself without having advocates for resuscitation research. This system has become a self-fulfilling prophecy. The American Heart Association is only recently, after 30 yrs of educational activities concerning cardiopulmonary resuscitation, considering putting some basic research money into resuscitation research. In university hospitals, where clinical departments have made significant contributions to innovative, clinically relevant life-support research, funded with incomes from patient care, the sky is beginning to fall. Resuscitation researchers need persuasive advocates with clout and hard data to convince funding agencies to give support to multilevel research and development in areas of pathophysiology and reversibility of terminal states and clinical death--to give these topics a higher priority than is currently available.

Evaluation of outpatient geriatric assessment: a randomized multi-site trial.

OBJECTIVE: To evaluate the process and outcome of outpatient consultative geriatric assessment compared with traditional community care. DESIGN: Randomized, controlled clinical trial, with 12-month follow-up. SETTING: Four hospital-based ambulatory geriatric assessment clinics and community physicians' offices. PARTICIPANTS: 442 recruited older adults with a health problem or recent change in health status. INTERVENTION: Outpatient consultative geriatric assessment or usual physician assessment. MAIN OUTCOME MEASURES: Identification of health problems, mortality, nursing home admissions, health status, health services utilization, satisfaction with care, and caregiver well-being. RESULTS: Geriatric assessment, in comparison with usual community care, resulted in the identification of a significantly greater number of patients with cognitive impairment (P < .0001), depression (P = .0004) and incontinence (P < .0001). The group receiving a geriatric assessment had greater improvement in anxiety levels at 1 year (P = .036). Caregivers of participants in the geriatric assessment group had less caregiver stress at 1 year (P = .002). No outcome differences in mortality, nursing home admissions, cognitive health, functional health, or health services utilization were observed. Some evidence of greater patient satisfaction with respect to qualities of the physician was found for the geriatric assessment group. CONCLUSIONS: Consultative outpatient geriatric assessment led to significantly improved diagnosis of the common health problems of cognitive impairment, depression, and incontinence, to psychological and emotional benefits for patients, and to reduced levels of caregiver stress. Even with limited follow-up care and control of treatment, outpatient geriatric assessment has potential for significant positive effects.

Deliberations on the dissemination of PORT products: translating research findings into improved patient outcomes.

This report outlines the activities undertaken by the Inter-PORT Dissemination work group during its first 2 years of operation. The work group's initial purpose was to assist the individual PORTs in developing their plans for both disseminating research findings and evaluating the effectiveness of these strategies. However, it became quickly apparent that in a discipline little more than a decade old, a commonly understood vocabulary had yet to be adopted. Even the term "dissemination" held different meaning for different constituencies. Consequently, the work group has tried to encourage the development of both a definitional framework and a set of common data elements of importance to all dissemination programs. The work group has analogously attempted to agree on minimum standards of methodologic rigor as a starting point for coordination of evaluations across PORTs. To help determine the potential for further coordination, a matrix of each individual PORT's target audiences, intervention strategies, and evaluation designs has been constructed. Much remains to be learned before we can know with any certainty how best to translate research findings into useful behavior change and improved patient outcomes. Our goal is that the efforts of the work group will serve to catalyze this process.

Contacts with pharmacists before and after "free" medical care--the Quebec experience.

This study reports the effects which the introduction of a national health insurance plan had upon established patterns of seeking health advice from pharmacists. Data were obtained from a household survey conducted in Montreal, Canada before and after the introduction of the government sponsored compulsory health insurance program. The report documents the extent to which the citizens of Montreal sought advice about health matters from pharmacists and describes the dramatic alteration in the pattern of advice seeking which occurred when the economic barriers to medical care were removed.