Edmund M. Ricci

Public Attitudes Regarding Willingness to Participate in Medical Research Studies

Abstract The recruitment of adequate numbers of people to participate in medical research studies is an ongoing problem for biomedical researchers. Although the general public has come to expect and demand that the biomedical community develop new, safe and effective approaches to the prevention and treatment of diseases, that same public is not aware of the important role that public participation plays in the development of medical advances. Much is known about willingness to participate in research studies from the perspectives of patients, survivors, and those at-risk for getting a particular disease. However, little is known about the attitudes and willingness of the general public to participate in medical research. Yet, it is this population that comprises the potential pool of participants for future treatment and prevention studies. In order to examine public attitudes toward and support for medical research, a random digit dial telephone survey was conducted with 489 persons in southwestern Pennsylvania. The survey measured the respondents stated willingness to take part in a medical research study and the factors associated with willingness to participate. These included the respondents health status, demographic characteristics, attitudes and beliefs about participation and their knowledge about the conduct of medical research. The results of the study indicate that 46% of those surveyed said that they would be willing to take part in a medical research study focusing on a new treatment for a specific disease that was of concern to them, 25% stated that they would not be willing and 29% stated that they were undecided regarding participation. However, under certain circumstances, such as having cancer, over half of those who were undecided said they would be willing to participate. The characteristics of those willing to participate in a medical research study differ from those not willing. Determinants of willingness include: having a relative or friend who has an illness, being middle aged (between 35-64 years old), prior experience with participation in a medical research study, having a favorable attitude toward the use of human subjects in medical research and beliefs that diverse types of persons participate in clinical trials. Those respondents who were undecided about joining a clinical trial, also have different characteristics than those who are not willing. The determinants of being undecided in contrast to not willing include: having at least a college degree, having a favorable or neutral attitude toward the use of humans in medical research and, believing that the well-being of participants is the primary concern of researchers. The findings of this study have both public policy and practice implications. From a policy perspective, medical research designed to develop new treatments for disease requires an evidenced-based approach for decision making. Such an approach can only succeed if adequate numbers of individuals are willing to participate in these studies. From a practice perspective, the current study suggests that opportunities exist to increase participation by targeting recruitment efforts not only toward the willing but also toward those who are undecided about participation in medical research studies. This would involve tailoring the content of communications to meet the specific characteristics and concerns of each of these two groups of individuals.

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.

Informed Decision-Making and Colorectal Cancer Screening : Is it Occurring in Primary Care?

Background:Current recommendations advise patients to participate in the decision-making for selecting a colorectal cancer (CRC) screening option. The degree to which providers communicate the information necessary to prepare patients for participation in this process is not known. Objective:To assess the level of informed decision-making occurring during actual patient-provider communications on CRC screening and test for the association between informed decision-making and screening behavior. Research Design:Observational study of audiotaped clinic visits between patients and their providers in the primary care clinic at a Veterans Administration Medical Center. Subjects:Male patients, age 50–74 years, presenting to a primary care visit at the study site. Measures:The Informed Decision-Making (IDM) Model was used to code the audiotapes for 9 elements of communication that should occur to prepare patients for participation in decision-making. The primary outcome is completion of CRC screening during the study period. Results:The analytic cohort consisted of 91 patients due for CRC screening who had a test ordered at the visit. Six of the 9 IDM elements occurred in ≤20% of the visits with none addressed in ≥50%. CRC screening occurred less frequently for those discussing “pros and cons” (12% vs. 46%, P = 0.01) and “patient preferences” (6% vs. 47%, P = 0.001) compared with those who did not. Conclusions:We found that a lack of informed decision-making occurred during CRC screening discussions and that particular elements of the process were negatively associated with screening. Further research is needed to better understand the effects of informed decision-making on screening behavior.

An analysis of prehospital mortality in an earthquake. Disaster Reanimatology Study Group.

INTRODUCTION Anecdotal observations about prehospital emergency medical care in major natural and human-made disasters, such as earthquakes, have suggested that some injured victims survive the initial impact, but eventually die because of a delay in the application of life-saving medical therapy. METHODS A multidisciplinary, retrospective structured interview methodology to investigate injury risk factors, and causes and circumstances of prehospital death after major disasters was developed. In this study, a team of United States researchers and Costa Rican health officials conducted a survey of lay survivors and health care professionals who participated in the emergency medical response to the earthquake in Costa Rica on 22 April 1991. RESULTS Fifty-four deaths occurred prior to hospitalization (crude death rate = 0.4/1,000 population). Seventeen percent of these deaths (9/54) were of casualties who survived the initial impact but died at the scene or during transport. Twenty-two percent (2/9) were judged preventable if earlier emergency medical care had been available. Most injuries and deaths occurred in victims who were inside wooden buildings (p < .01) as opposed to other building types or were pinned by rubble from building collapse. Autopsies performed on a sample of victims showed crush injury to be the predominant cause of death. CONCLUSIONS A substantial proportion of earthquake mortality in Costa Rica was protracted. Crush injury was the principal mechanism of injury and cause of death. The rapid institution of enhanced prehospital emergency medical services may be associated with a significant life-saving potential in these events.

Strategies for Increasing the Rigor of Qualitative Methods in Evaluation of Health Care Programs

The traditional quantitative emphasis of health services research obscures the fact that qualitative techniques are the best means of investigating the evaluation of certain health services research problems. Two evaluation studies employing qualitative methods are described to illustrate the appropriateness of such methods for addressing certain research questions. A brief discussion of current opinion concerning reliability and validity issues associated with these methods is provided A detailed description of the techniques that can be used to improve the rigor and credibility of qualitative methods in evaluation research concludes this article.

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 childrens 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). χ2tests 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 childrens 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.

Disaster reanimatology potentials : A structured interview study in Armenia : I. Methodology and preliminary results

In general, preparations for disasters which result in mass casualties do not incorporate a modern resuscitation approach. We explored the life-saving potential of, and time limits for life-supporting first aid (LSFA), advanced trauma life support (ATLS), resuscitative surgery, and prolonged life support (PLS: intensive care) following the earthquake in Armenia on 7 December 1988. We used a structured, retrospective interview method applied previously to evaluation of emergency medical services (EMS) in the United States. A total of 120 survivors of, and participants in the earthquake in Armenia were interviewed on site (49 lay eyewitnesses, 20 search-rescue personnel, 39 medical personnel and records, and 12 administrators). Answers were verified by crosschecks. Preliminary results permit the following generalizations: 1) a significant number of victims died slowly as the result of injuries such as external hemorrhage, head injury with coma, shock, or crush syndrome; 2) early search and rescue was performed primarily by uninjured covictims using hand tools; 3) many lives potentially could have been saved by the use of LSFA and ATLS started during extrication of crushed victims. 4) medical teams from neighboring EMS systems started to arrive at the site at 2-3 hours and therefore, A TLS could have been provided in time to save lives and limbs; 5) some amputations had to be performed in the field to enable extrication; 6) the usefulness of other resuscitative surgery in the field needs to be clarified; 7) evacuations were rapid; 8) air evacuation proved essential; 9) hospital intensive care was well organized; and 10) international medical aid, which arrived after 48 hours, was too late to impact on resuscitation. Definitive analysis of data in the near future will lead to recommendations for local, regional, and National Disaster Medical Systems (NDMS).

Disaster Reanimatology Potentials: A Structured Interview Study in Armenia. III. Results, Conclusions, and Recommendations

National medical responses to catastrophic disasters have failed to incorporate a resuscitation component. Purpose: This study sought to determine the lifesaving potentials of modern resuscitation medicine as applied to a catastrophic disaster situation. Previous articles reported the preliminary results (I), and methodology (II) of a structured, retrospective interview study of the 1988 earthquake in Armenia. The present article (III) reports and discusses the definitive findings, formulates conclusions, and puts forth recommendations for future responses to catastrophic disasters anywhere in the world. Results: Observations include: 1) The lack of adequate construction materials and procedures in the Armenian region contributed significantly to injury and loss of life; 2) The uninjured, lay population together with medical teams including physicians in Armenia were capable of rapid response (within two hours); 3) Due to a lack of Advanced Trauma Life Support (ATLS) training for medical teams and of basic first-aid training of the lay public, and scarcity of supplies and equipment for extrication of casualties, they were unable to do much at the scene. As a result, an undetermined number of severely injured earthquake victims in Armenia died slowly without the benefit of appropriate and feasible resuscitation attempts. Recommendations: 1) Widespread adoption of seismic-resistant building codes for regions of high seismic risk; 2) The lay public living in these regions should be trained in life-supporting first-aid (LSFA) and basic rescue techniques; 3) Community-wide emergency medical services (EMS) systems should be developed world-wide (tai-lored to the emergency needs of each region) with ATLS capability for field resuscitation; 4) Such systems be prepared to extend coverage to mass casualties; 5) National disaster medical system (NDMS) plans should provide integration of existing trauma-EMS systems into regional systems linked with advanced (heavy) rescue (public works, fire, police); and 6) New techniques and devices for victim extrication should be developed to enable rapid extrication of earthquake casualties within 24 hours.

Maintenance of Mobility in Residents of an Alzheimer Special Care Facility

The cognitive and functional decline of demented residents in a specialized Alzheimers facility was compared to that of demented residents living in a traditional nursing home. All residents met DSM-III-R criteria for dementia. The evaluation consisted of a clinical interview with patients and collateral assessments of cognition, general health, problem behaviors, depression, and a broad range of activities of daily living (ADLs) including mobility. Residents were evaluated at baseline and 6-month intervals over 18 months. Similar rates of decline were found in cognition and overall ADLs in both groups. However, the most striking finding was preserved mobility in residents of the Alzheimers facility. This finding suggests that specialized facilities do not halt or slow the overall progression of cognitive and functional decline seen in Alzheimers disease; however, residents of such facilities may show slower decline in mobility.

Local Health Departments' Mission to the Uninsured

It is often maintained that local health departments (LHDs) should not directly provide personal health services. However, our nationally representative sample revealed that most LHD directors (87%) believed LHDs must directly provide these services, primarily because they perceived a high level of unmet need among the uninsured. While only a minority believed LHDs should focus exclusively on the core functions, this proportion rose dramatically when we asked directors to assume that there were no uninsured people. Directors who perceived a high level of unmet need among the uninsured in their jurisdictions were much less likely to believe that LHDs should exclusively focus on the core functions. In theory, LHDs have a unique responsibility for assuring that the uninsured and vulnerable have access to personal health services. However, a majority of directors (67%) acknowledged that they have no enforceable means of assuring access to services the health department did not directly provide.