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after which the inner edges of the packets were cultured. Sutures in group two were selected from a box that had been open for some time, opened in the standard man- ner, and then cultured. Suture packets in group three were taken from a freshly opened box, opened in the standard manner, and then cultured as with the previous two groups. To evaluate the suture packets in group four, the OR staff member washed her hands for two minutes in an aseptic manner and then removed suture from a freshly opened box and opened the suture packet, which was then cultured.

By using this design, the researcher established two inde- pendent variables (ie, dropping suture, taking suture from a box that had been open for an unspeci- fied period of time). The researcher also established two controls (ie, taking suture from a freshly opened box, washing the opener’s hands before taking suture from a freshly opened box) to help differentiate sources of contamination. Although the study was conducted while actual cases were in progress, no sutures opened for the study were used on patients. Manufacturers’ guide- lines were followed for opening suture packets, package integrity was confiied, and cultures were taken from the opening edges of the inner suture packets.

Cultures. Before data collec- tion began, the researcher cultured an area of each OR floor. Bacterial growth from these cultures ranged from five to 4 1 colony forming units (CFUs). The researcher also obtained six random cultures from the fingertips of a staff member who opened suture packets to assess the probability of the open- er’s hands being a separate source of contamination. These cultures

were taken before the staff mem- ber washed her hands. More than 100 CFUs were identified on each culture plate. Cultures taken after the staff member washed her hands grew 41 to 58 CFUs. Thus, the staff member’s hands were a greater source of potential conta- mination than the OR floors.

21 OR staff members whether they would use suture packets dropped on the floor; all 21 staff members stated the dropped suture was not safe to use. These same 21 staff members, however, stated that suture taken from an open box on the shelf was safe to use, even though these suture packets may have been handled and returned to the box by multi- ple staff members.

The findings of this study sup- port manufacturers’ guarantees that the packaging protects the sterile suture from contamination by dust particles or moisture pene- tration. The inner suture packets remained sterile with normal han- dling and also when their outer packets were dropped on OR floors. The study results also sug- gest that staff members’ hands rep- resent a greater source of potential contamination than OR floors. When the outer suture packets were opened according to manu- facturer’s directions, bacteria from the opener’s hands were not trans- ferred to the inner suture packets.

Perioperative nursing Impllca- tiOnS. The intent of this review is not to suggest that OR personnel can freely, and in good surgical conscience, open all suture pack- ets (or other sterile supplies) that are dropped on the floor. The intent is to evaluate a standard of practice that prevails 25 years after this study was reported. Wrapping techniques and types

Opinions. The researcher asked

of wrapping materials have improved greatly since 1969. As health care reform continues to focus on cost containment and patient outcomes, each periopera- tive nurse is challenged to evalu- ate sacred practices and deter- mine their overall cost and contri- bution to patient care. Perhaps it is time to put the practice of dis- carding dropped suture packets out to pasture. Only further research will provide the answer.

DONNA S. WATSON RN, MSN, CNOR

NURSINQ RESEARCH COMMIITEE

EXCLUSiON OF CERTAIN GROUPS FROM CLINICAL RESEARCH E. Larson IMAGE: Journal of Nursing Scholarship Vol26 (Fall 1994) 185-190

ecently reported large, clinical research projects that have been limited to male subjects

have underscored the need to include potentially underrepresent- ed groups in biomedical research. If subgroups such as women and racial minorities are not included in studies as subjects, investigators may draw inappropriate or inaccu- rate inferences from study results. Responses to diseases and interven- tions may differ according to gen- der, race, age, or socioeconomic status; therefore, some population subgroups may be harmed if inter- ventions are based on data extrapo- lated exclusively from middle-age Caucasian males.

Research subject selection is monitored in research projects sponsored by the federal govern- ment, but little data exist regarding inclusion of potentially underrepre- sented groups in privately funded studies. The purpose of this

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descriptive, retrospective review of research protocols was to identify the extent of explicit subject exclu- sion from research protocols at one academic health center and to describe the relationship between funding sources, investigator status (ie, nurse, nonnurse), and the iden- tified group exclusion criteria.

Group exclusion criteria. The investigator included all research protocols that underwent full insti- tutional review board (IRB) critique during a two-year period. The investigator developed a 56-item data collection instrument to review 754 protocols for 10 types of group exclusion criteria, which were rn age, rn gender, I medical condition, rn race,

socioeconomic status, 8 insurance status, 8 language, rn geography,

mental status, and other (eg, statements such as, “Individual who would not be likely to comply with protocol”). If an exclusion criterion was

identified, the data collectors noted whether there was a written ratio- nale for the exclusion. They also collected data regarding potential benefits (eg, free treatment, med- ication, payment) to research sub- jects for participating in the proto- cols. The investigator performed a chi-square analysis to compare the exclusion criteria used by nurse and nonnurse investigators and to com- pare proportions of subjects, according to funding source and type of study, who were compen- sated for their participation.

ity (55.9%) of the protocols had been submitted to the IRB by investigators from the departments of medicine or surgery; only 4.1%

PfotocOls reviewed. The major-

of the protocols were submitted by nurse investigators. Most of the studies (70.6%) had been funded by external agencies (eg, federal government, industry, founda- tions, professional organizations). Funding source was significantly associated with subject compensa- tion (p <. 0001); no monetary or therapeutic compensation was offered to 44% of subjects in non- funded studies.

Most of the protocols (8 1.4%) included both male and female subjects, and 56.6% included sub- jects over the age of 65 years. Sev- enty-six percent of the protocols defined exclusion criteria, which were related most often to medical conditions, age, and gender. Most of these protocols, however, failed to justify exclusion for age (55.1%), socioeconomic status (57.1%), and race (61.9%). Nurse investigators were significantly less likely than nonnurse investi- gators to define explicit exclusion criteria (p = .02).

Results. Contrary to claims in the literature that women are under- represented in biomedical research, this study found that women were not exchded from research proto- cols at this particular academic health center. Exclusions for age, however, occurred in approximately half of the protocols, and no justifi- cation was provided for 44.9% of these age-related exclusions. Nurse researchers excluded elderly sub- jects in less than 25% of protocols but failed to explain 74% of these age-related exclusions. Few propos- als included exclusions for race or socioeconomic status, but the exclu- sions that did occur for these factors frequently were unexplained.

Perloperative nursing impllca- tlons. In this study, age, race, and socioeconomic status were more likely than gender to serve as unjus-

tified exclusion criteria in research protocols. Based on these results and a review of the current litera- ture, it appears that elderly people, ethnic minority groups, and the poor may be underrepresented in research protocols. These disparities must be corrected if they are shown to result in harm to these population groups. A policy that requires recruitment and participation of all population subgroups, however, is inappropriate. Decisions about inclusion and exclusion of subjects and groups are made at several stages in studies, and the require- ments for rigorous study designs must be balanced with practical considerations, such as availability of subjects. Perioperative nurse researchers should consider careful- ly the inclusion and exclusion crite- ria necessary to recruit appropriate research subjects and document rationales for any group exclusions. Lack of group representation in study samples may affect the gener- alizability of perioperative nursing research findings.

KATHLEEN 8. GABERSON RN, PHD

NURSINQ RESEARCH COMMIITEE

BOOK REVIEWS

MANAGING THE MOSAIC: ADDRESSING WORKFORCE DIVER- SITY AND MANAGING INSTITU- TIONAL CHANGE IN HEALTH CARE By Trisha A. Svehla, Glen C. Crosier

$38 American Hospital Associa- tion members, $47.50 nonmem- bers paperback

1994,222 pp

iversity can be described as a mix of the characteristics that I makes us unique. Many in the

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