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 effects of pyruvate supplementation on body composition in overweight individuals.

A 6-wk, double-blinded, placebo-controlled study was done to ascertain the effects of pyruvate supplementation (6 g/d) on body weight, body composition, and vigor and fatigue levels in healthy overweight Caucasian men and women. Twenty-six individuals were randomly assigned to a placebo group (seven men, seven women) and a pyruvate-supplemented group (three men, nine women). In addition, all subjects participated in a 3 d/wk exercise program, which consisted of a 45-60 min aerobic/anaerobic routine. After 6 wk of treatment, there was a statistically significant decrease in body weight (-1.2 kg, P<0.001), body fat (-2.5 kg, P<0.001), and percent body fat (23.0% pre versus 20.3% 6 wk post) in the pyruvate group. Furthermore, Profile of Mood States fatigue and vigor scores improved significantly for the pyruvate group (P<0.05) at 6 wk (vigor) and 4 and 6 wk (fatigue). There was no significant change in total lean body mass in the pyruvate group. The placebo group demonstrated a significant increase (P<0.05) for POMS vigor at 2 and 4 wk with no changes occurring in any of the remaining parameters measured. Thus, the ingestion of 6 g of pyruvate for 6 wk, in conjunction with mild physical activity, resulted in a significant decrease in body weight and fat mass.

Abnormalities of serum amylase and lipase in HIV-positive patients.

OBJECTIVE: We sought to study asymptomatic pancreatic enzyme abnormalities in patients with human immunodeficiency virus (HIV) infection. METHODS: Serial serum amylase and lipase determinations were performed in ambulatory HIV-seropositive patients in whom pancreatitis was not suspected. RESULTS: Eighty-six patients were enrolled in the study. Fifty-two patients (60%) were found to have abnormal amylase or lipase values on at least one determination. Only 12 (14% of all patients) had a more than twofold elevation of pancreatic enzymes. Seven patients had transient elevations of lipase within 3 months after the initiation of antiretroviral therapy. Independent factors associated with abnormal pancreatic enzymes were: positive serology for chronic hepatitis B or C, history of intravenous cotrimoxazole administration for the treatment of Pneumocystis carinii pneumonia, stage B of HIV disease, and HIV risk factors other than male homosexuality (mainly intravenous drug use). None of the patients developed clinical pancreatitis. CONCLUSIONS: Asymptomatic mild to moderate elevations of amylase or lipase are common in HIV-positive patients, and are usually associated with positive serology for chronic hepatitis B or C, and medications, especially antiretrovirals and intravenous cotrimoxazole.

Linking women in jail to community services: factors associated with rearrest and retention of drug-using women following release from jail.

Women in jail experience high rates of many health and social problems. This study examined the effects of preexisting social and health characteristics and the type of services received on retention in community aftercare for 193 drug-using women released from the New York City jail to two low-income communities. Rearrest rates for program participants were compared to a group of women not eligible for services because of their residence outside the target communities. Women who enrolled in residential programs with on-site drug treatment and other social services after release were compared to women who enrolled in less comprehensive services. The residential treatment group participated in the program significantly longer (276 v 180 days, p = .02) than women in other types of services. Women in residential programs were significantly more likely to have used crack or cocaine in the 30 days prior to arrest than women in other types of programs (84% v 59%, p = .001), but few other prior differences among the different treatment groups were noted. Therefore, differences in outcome are unlikely to be attributed to preexisting differences in risk profile. Women who participated in postrelease services were significantly less likely to be rearrested in the year after release than a comparable group of women who participated in jail services, but were not eligible for postrelease services (38% v 59%, p = .02).

Recovery time and safe discharge of endoscopy patients after conscious sedation.

The aim of this study was to identify the best method for determining when to safely discharge the endoscopy patient; specifically, it was designed to determine whether the patient's risk factors, intraoperative occurrences, and/or medications used during endoscopy should be used to determine the minimum length of stay postconscious sedation or whether a general policy can be used, as is currently practiced at many institutions. Preoperative, intraoperative, and postoperative data were collected on a convenience sample of 405 adult ambulatory outpatients undergoing upper endoscopy and/or colonoscopy. Subjects were also interviewed by phone within 48 hours of discharge to assess postdischarge complications and their duration. Age predicted length of time in recovery, but only 2% of the variation in recovery time was predicted by the study variables. Intraprocedure occurrences predicted postprocedure occurrence. The implications of these and other findings are discussed in relation to nursing practice and future research.

Psychiatric comorbidity among hospitalized AIDS patients vs. non-AIDS patients referred for psychiatric consultation.

Data were collected on 3,420 psychiatric consultations from July 1, 1989, to January 1, 1994, of which 675 were for patients identified as infected with the human immunodeficiency virus (HIV). Comparisons of psychiatric comorbidity among persons with AIDS (PWAs), HIV+ asymptomatic patients, and non-HIV patients were made. Dementia was a significantly frequent comorbid diagnosis among the referred PWAs compared with the general consultation population and was related to older age. Psychiatric comorbidity among the referred HIV+ asymptomatic patients more closely resembled the general consultation population. Major depression was relatively rare among the PWAs. The authors believe that the large sample size of this study allows for an accurate representation of the psychiatric disorders found among medically ill HIV patients in an urban hospital who are referred for psychiatric consultation.

Tolerance of initial diphtheria-tetanus-pertussis immunization in preterm infants.

With the use of neurologic examinations, cranial sonograms, electroencephalograms, an cry analyses, we assessed neurologic function before and after an initial diphtheria-tetanus-pertussis immunization in 22 very low birth weight infants. Mean birth weight was 1036 +/- 137 gm; mean gestational age was 28.0 +/- 1.3 weeks. All 22 infants had recovered from respiratory distress syndrome, 10 infants had been treated for invasive bacterial or fungal infection, and 9 infants had had previous intraventricular hemorrhages. Initial immunization was administered at a mean age of 71 +/- 15 days (range 57 to 120 days) and a mean weight of 1895 +/- 245 gm (1370 to 2280 gm). Clinical reactions were mild and transient. No postimmunization changes in neurologic examinations or objective studies were noted compared with results of preimmunization studies. These findings support the safety of administering an initial diphtheria-tetanus-pertussis immunization to very low birth weight infants at the recommended age of 8 weeks.

Impact of endocrine and diabetes team consultation on hospital length of stay for patients with diabetes.

PURPOSE: To determine whether consultation by an individual endocrinologist or by a multidisciplinary diabetes team (endocrinologist, diabetes nurse educator, and registered dietitian) can impact length of hospital stay of patients with diabetes. PATIENTS AND METHODS: Hospital stays of consecutive patients with a principal diagnosis of diabetes were compared. Forty-three patients were seen by an individual endocrine consultant and 27 were managed by the internist alone. Thirty-four patients were seen in consultation by the diabetes team. All consultations were performed at the request of the primary physician. There were no statistically significant differences among groups with respect to age, duration of diabetes, admitting diagnosis, glucose levels, or concomitant acute or chronic illness. RESULTS: Average length of stay of diabetes-team patients was 3.6 +/- 1.7 days, 56% shorter than the value, 8.2 +/- 6.2 days, of patients in the no-consultation group (P < 0.0001), and 35% shorter than the value, 5.5 +/- 3.4 days, of patients who received a traditional individual endocrine consultation (P < 0.05). The length of stay correlated with time from admission to consultation (regression equation: y = 3.92 + [1.09 x time to consultation]; r = .55; P < 0.0001). The slope (1.09) indicates that each 1-day delay in consultation resulted in a 1-day increase in length of stay. CONCLUSIONS: Length of stay was lowest in patients who received diabetes-team consultation. Three million Americans are hospitalized annually with diabetes at a cost of $65 billion. A team approach to their inpatient care may reduce their hospital stays, resulting in considerable health and economic benefits.

Patient knowledge about electroconvulsive therapy: effect of an informational video.

We wished to ascertain whether the addition of an informational video to the informed consent procedure for electroconvulsive therapy (ECT) results in improved patient knowledge about ECT. Eighteen ECT patients were randomized to consent using the usual written document or using the written document and an informational video. The two groups were similar when compared on demographic variables and scores on the Brief Psychiatric Rating Scale (BPRS) and Mini-Mental State Examination (MMSE). Each subject, just after signing the informed consent document, was administered an 8-question ECT knowledge questionnaire. The addition of an informational video to the consent process for ECT did not result in improved knowledge about ECT. Poor knowledge about ECT might be accounted for by unsuccessful communication from the doctors or cognitive impairment and apathy on the part of the patients. One benefit of the video was increased interest from family members in ECT and the consent process.

Drug-resistant tuberculosis: factors associated with rise in resistance in an HIV-infected urban population.

Our objective was to characterize the population with tuberculosis (TB) and to identify factors predictive of resistance to anti-TB agents in an area of high prevalence of human immunodeficiency virus infection. We reviewed microbiology and clinical records from 1988 to 1991 at Beth Israel Medical Center, New York City, for patients with culture-proved TB and analyzed the frequency of resistance to anti-TB agents with respect to demographic and clinical variables. Of 360 patients with TB, 17.5% had drug-resistant isolates. Of the 333 patients on whom the information was available, 72% reported HIV risk factors, 54% injectable drug use, and nearly one-third homelessness. The majority (56%) had documented HIV infection. Between 1988 and 1991, acquired resistance to isoniazid (INH) alone rose from 5% to 21% and initial resistance to INH alone rose from 0% to 19%. Drug resistance was more likely in previously treated patients; 61% of the previously treated patients admitted noncompliance with therapy. Cavitary lung disease was the strongest predictor of acquired drug resistance. Initial drug resistance was more likely in patients with HIV infection. Among persons with HIV infection, none of the analyzed factors was found to be predictive of drug resistance. Noncompliance with therapy and the HIV epidemic played a major role in the rise of drug resistance in our population. HIV infection confounds the epidemiologic factors that might otherwise allow clinical prediction of resistance.

Treatment outcome after varicocelectomy. A critical analysis.

After extensively reviewing the literature that addresses the efficacy of varicocelectomy, it is apparent that the extent data are flawed because of inappropriate study design and reporting. These difficulties are compounded by an inadequate understanding of the pathophysiology of the varicocele and the complexities intrinsic to the study of reproduction. Varicocelectomy does, indeed, appear to have a beneficial effect on sperm density. This effect seems more pronounced when initial semen densities are greater than 10 million/mL. Conversely, a "ceiling effect" or less of a response may occur when preoperative sperm densities are greater than 40 million/mL. Although anecdotal reports suggest that varicocelectomy may be of benefit even to the azoospermic individual, we do not ascribe to this approach. Motility and morphology may improve significantly after varicocelectomy when an associated rise in density has occurred. Isolated improvements in either of these parameters have also been observed. Simultaneous improvements in density and morphology, however, have not been reported unless a concurrent significant improvement in semen density occurs. In spite of the occasional study which indicates that varicocelectomy does not improve fertility, the preponderance of the literature does in fact support a favorable effect. After carefully analyzing the design and outcome of the studies reviewed, it is clear that a definitive statement concerning the efficacy of varicocelectomy cannot be made. This therapeutic dilemma can be resolved only by a well-designed prospective, randomized, controlled study that examines the impact of varicocelectomy on seminal parameters, sperm function tests, and the pregnancy rates in couples evaluated by stringent protocols. Patients should be stratified according to seminal parameters and age. We conclude as we began: Varicocelectomy remains an important treatment of male factor infertility.

Psychiatric histories of drug using mothers: treatment implications.

One hundred forty six crack/cocaine using mothers in New York City were interviewed in a cross sectional study about life histories and drug related behaviors. Forty one (28%) reported histories of previous psychiatric medication or hospitalization. These women were significantly more likely than the rest of the sample to currently be in drug treatment; to have sexual abuse histories; and to be currently involved with men who urged them to use crack during pregnancy. Within this group, two subgroups were distinguishable: one, who had been sexually abused and initiated drug use early, and the other whose psychiatric and drug use histories were not associated with sexual abuse. The implications of these findings for screening, treatment planning, and future research are discussed.

Endogenous interferon and triglyceride concentrations to assess response to zidovudine in AIDS and advanced AIDS-related complex.

To improve evaluation of new antiretroviral drugs in the acquired immunodeficiency syndrome (AIDS), sensitive biological markers that accurately predict response to treatment are needed. Two possible markers are endogenous interferon (E-IFN), which is a cytokine involved in the pathophysiology of AIDS, and serum triglycerides (TG), which are raised in patients with AIDS, possibly reflecting enhanced cytokine activity. E-IFN, TG, body-mass index, CD4 count, and HIV p24 were measured in 19 patients (15 with AIDS, 4 with AIDS-related complex), who were part of the phase II licensing trial of zidovudine (ZDV). 10 received ZDV and 9 received placebo. Rapid, significant, and sustained declines from initial values in E-IFN and TG concentrations were observed in ZDV patients but not in placebo patients. Baseline values of E-IFN and TG concentrations after 4 months on ZDV treatment were both important contributors to long-term survival. The findings suggest that these indicators of abnormal cytokine expression may be useful measures of not only disease severity but also efficacy of antiretroviral therapy in AIDS.

Neonatal opiate abstinence syndrome in term and preterm infants.

Data on 178 term and 34 preterm infants born to methadone-maintained mothers were analyzed to assess the effects of neonatal opiate abstinence in infants of varying gestational ages. More mothers in the term group (79%) than in the preterm group (53%) had abused other drugs during pregnancy (p less than 0.001). Mean (+/- SD) gestational age was 39.5 weeks +/- 1.4 for term infants and 34.3 weeks +/- 2.6 for preterm infants. On the basis of a semiobjective symptom scoring scale, term infants had more severe abstinence symptoms and more prominent central nervous system manifestations than preterm infants. The severity of abstinence symptoms correlated with maternal methadone dosage in both term and preterm infants. Maternal multiple drug abuse (e.g., heroin, cocaine) did not influence severity of abstinence symptoms in either group. More term infants (145/178) than preterm infants (20/34) required treatment for these symptoms (p less than 0.005). In 13 of 178 term infants, compared with 1 of 34 preterm infants, abstinence-related seizures developed. Peak severity occurred 1 to 2 days earlier in term than in preterm infants. A less severe abstinence syndrome in preterm infants may be due to (1) developmental immaturity of either dendritic ramifications, specific opiate receptors, or neurotransmitter function, or (2) reduced total drug exposure during the intrauterine period.