JSTOR

Methods

This study was performed at 2 hospitals in the University of Pennsylvania Health System: the Hospital of the University of Pennsylvania (HUP), an academic tertiary care medical center with 625 patient beds; and Penn Presbyterian Medical Center (PPMC), a 344‐bed urban community hospital. The primary service area of these 2 hospitals encompasses approximately 25% of the population of Philadelphia, including all of West Philadelphia, Southwest Philadelphia, and portions of South Philadelphia. It is an ethnically and racially diverse community; 68% of the population is African American, 27% white, 3.4% Asian, and 1.5% Latino. The percentage of women in this population was approximately 53%. All inpatients at these hospitals were eligible to be enrolled in this study. This study was reviewed and approved by the University of Pennsylvania's Committee on Studies Involving Human Beings.

In April and May 2004, we conducted a cross‐sectional survey, enrolling 3 groups of inpatients: (1) patients who had previously participated in a cohort study of fluoroquinolone‐resistant Escherichia coli, which involved collection of perirectal swab samples⁵ (group 1); (2) patients who had previously refused to participate in the fluoroquinolone‐resistant E. coli study (group 2); and (3) patients who were never asked to participate in the fluoroquinolone‐resistant E. coli study (group 3). Patients in each group were selected at random from among all eligible patients hospitalized during the study period. The current study was conducted during the final 2 months of the larger cohort study of fluoroquinolone‐resistant E. coli mentioned above.

A questionnaire was developed that examined patients’ attitudes regarding participation in studies of antimicrobial resistance, particularly those studies that involve perirectal swab sampling. In addition to questions about general demographic information, the survey included 17 items that covered 3 domains (Table 1). The first domain focused on general attitudes with respect to participation in medical research during hospitalization. The second domain specifically addressed views about perirectal swab sampling. The third domain dealt with attitudes about accepting monetary compensation for the time and effort involved in participating in a research project. The questionnaire was initially pilot tested on hospitalized patients and revised as necessary. To ensure consistency, all surveys were administered by the same interviewer. After providing informed consent, patients were asked to respond verbally to each survey statement, and responses were recorded by the interviewer. Response options were recorded on a 5‐point Likert scale.

Table 1.  Responses to Survey Statements About Medical Research and Perirectal Swab Sampling From 90 Patients

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The Fisher exact test was used to compare dichotomized responses across study groups. All statistical calculations were performed using Stata statistical software, version 9.0 (Stata).

Results

During the 2‐month study period, a total of 90 patients were surveyed. Overall, the median age was 61 years (range, 20‐94 years), and 40 patients (44%) were male. Fifty‐one patients (57%) were white, 36 (40%) were African American, and 3 (3%) were other races. Of the 90 study participants, 55 (61%) were hospitalized at the HUP and 35 (39%) were hospitalized at the PPMC.

Of the 90 patients surveyed, 38 (42%) had participated in past research studies, 14 (16%) said they knew of family or friends who had participated in past research studies, and 35 (39%) said they had been approached for another research study during the current hospitalization (including the previously mentioned cohort study of fluoroquinolone‐resistant E. coli). Responses to all other survey statements are given in Table 1.

Most of the patients surveyed recognized the importance of participation in research (Table 1). For example, 85 respondents (95%) agreed with the statement “If I take part in research studies, researchers may learn things that will help other patients in the future.” However, 34 patients (38%) also reported being “too sick” to take part in research at the present time, and 45 (50%) reported that they were “too tired” to participate. Finally, 31 patients (35%) believed that researchers might run additional tests on samples without informing the patient, and 25 (27%) believed that persons other than the research team or the primary care physician might gain access to study results. Responses did not differ significantly depending on the facility at which the patient was hospitalized (ie, HUP vs PPMC).

Of 90 patients, 29 (32%) had previously participated in a cohort study of fluoroquinolone‐resistant E. coli, which involved the collection of perirectal swab samples (group 1); 29 (32%) had previously refused to participate in the fluoroquinolone‐resistant E. coli study (group 2); and 32 (36%) had never been approached for the fluoroquinolone‐resistant E. coli study (group 3). The median age in group 1 was 66 years; in group 2, it was 61 years; and in group 3, it was 60 years. The number of males in group 2 (7 [24%]) was somewhat lower than the number in group 1 (14 [48%]) and group 3 (15 [47%]) ( ). The number of patients who reported being a race other than white was also somewhat lower in group 2 (13 [45%]), compared with group 1 (19 [66%]) and group 3 (20 [63%]) ( ).

There were numerous survey statements for which the percentage of patients who agreed (ie, those who reported that they “strongly agree” or “agree” with the statement) differed significantly across the 3 study groups (Table 2). Patients who had previously refused to participate in the fluoroquinolone‐resistant E. coli study were significantly less likely to agree with the statement “Taking part in a research study will not affect my care in the hospital.” More specifically, patients who had previously refused to participate in the fluoroquinolone‐resistant E. coli study were significantly less likely to agree with the statements “I would not get sicker as a result of someone taking a swab from the skin around my rectum” ( ) and “It would not be painful to have a swab taken from the skin around my rectum” ( ). Finally, patients who had previously refused to participate in the study were somewhat more likely to agree with the statement “I would take part in the study only if I were offered money to participate” ( ). However, even in this group, only 4 respondents (14%) agreed with this statement.

Table 2.  Agreement With Survey Statements, According to Study Group

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Discussion

In this study, we examined patients' beliefs and attitudes with respect to participation in studies of antimicrobial resistance, particularly those studies that involve perirectal swab sampling. Although most patients surveyed recognized the importance of participation in such studies, many of their attitudes (eg, fear or mistrust) suggested possible reasons for not participating in these studies. Indeed, for numerous survey statements, responses differed depending on whether the respondent had participated in similar studies in the past.

Patients often reported their belief that participation in a study might have a negative impact on their health. This belief was particularly common among patients who had previously refused to participate in the fluoroquinolone‐resistant E. coli study. These patients were significantly less likely to agree with statements such as “Taking part in a research study will not affect my care in the hospital,” “I would not get sicker as a result of someone taking a swab from the skin around my rectum,” and “It would not be painful to have a swab taken from the skin around my rectum.” Indeed, when patients were asked about their reasons for declining to participate in research, prior studies found that only a few potential study participants feared the research, particularly procedures perceived as invasive.^6,7 Given the well‐accepted safety of perirectal swab sampling, our findings suggest that openly acknowledging and addressing these concerns with patients may help increase the likelihood that they will participate in such studies. Studies that evaluate the impact of such interventions would be desirable.

We also found that up to one‐third of respondents were concerned that the results from their study samples might be shared with persons outside the research team and that additional tests might be run on samples without the patient's knowledge. Although these concerns were not significantly more common among people who had previously refused to participate in a study, they highlight issues that should be addressed during the process of obtaining consent. Indeed, mistrust of researchers has previously been identified as a barrier to participation in medical research, particularly among minority patients.^6‐8 Addressing these issues more directly during the initial invitation to participate in such studies would not only explicitly acknowledge these often unstated patient concerns but also, it is hoped, allay the concerns of potential study participants.

Our study showed that 83 (92%) of 90 patients surveyed disagreed with the statement “I would take part in the study only if I were offered money to participate,” although this percentage was somewhat lower among patients who had previously refused to participate. We did not assess patients' income level, but it has been previously noted that payment for research has a stronger influence on willingness to participate among wealthy people.⁹

This study had several potential limitations. It included only 90 patients, thus limiting our ability to demonstrate small differences across study groups. Given the nature of the statements included in the survey, it was not possible to blind the interviewer to the study group status of the respondent. Although this raises the possibility of interviewer bias, the survey was administered in a highly structured fashion, minimizing the interviewer's ability to modify the administration of the survey on the basis of the respondent’s group status. Standardization of survey administration was also facilitated by use of the same interviewer for all respondents. Also, this study was conducted in 2004; if knowledge of antibiotic resistance has changed among patients since that time, their attitudes and beliefs may also have evolved. Finally, our study was conducted in a large tertiary care medical center and a smaller urban community hospital, and the results may not be generalizable to other institutions.

This study highlights important beliefs and attitudes among hospitalized patients with respect to participation in studies of antimicrobial resistance. More importantly, these beliefs may be associated with the patients' likelihood of participating in such studies. Explicitly addressing these concerns with eligible study participants is critical to optimize successful participation in future studies.