The effectiveness of the confidential unit exclusion option

BACKGROUND: The confidential unit exclusion (CUE) option is intended to reduce human immunodeficiency virus (HIV) transmission by excluding donors newly infected with HIV who have not yet developed HIV antibody (window-period donors); however, its efficacy in excluding window- period donors has not been evaluated. STUDY DESIGN AND METHODS: The use of the CUE option was studied among the donors of 3.7 million units at 18 American Red Cross blood services regions during 1991 and 1992 and among 322 previously HIV-1-seronegative donors who subsequently donated a seropositive unit between 1987 and 1990 at 40 United States blood centers. These seroconverting donors had previously been shown to be highly likely to donate during their window period. RESULTS: On the basis of data from these two populations, it was estimated that only 3 to 5 percent of units donated by window-period donors were not transfused because of the CUE option, that 0.4 percent of all donations were from donors who confidentially excluded their blood from transfusion, and that donors who confidentially excluded their blood were 21 times more likely to be HIV antibody-positive than donors who did not use the CUE option. It is estimated that, if all US blood centers used the CUE option, a total of 2 to 17 otherwise acceptable units donated by window-period donors would not be transfused annually. CONCLUSION: Although donors who confidentially exclude their blood from transfusion are 21 times more likely to have HIV antibody, the rarity of window-period donors and the infrequency of confidential exclusion by window-period donors cause the CUE option to have minimal impact on transfusion safety.     

Demographic characteristics and prevalence of serologic markers among blood donors who use confidential unit exclusion (CUE) in São Paulo,Brazil: implications for modification of CUE polices in Brazil

BACKGROUND: This study evaluated demographic profiles and prevalence of serologic markers among donors who used confidential unit exclusion (CUE) to assess the effectiveness of CUE and guide public policies regarding the use of CUE for enhancing safety versus jeopardizing the blood supply by dropping CUE. STUDY DESIGN AND METHODS: We conducted a cross‐sectional analysis of whole blood donations at a large public blood center in São Paulo from July 2007 through June 2009, compared demographic data, and confirmed serologic results among donors who used and who have never used CUE (CUE never). RESULTS: There were 265,550 whole blood units collected from 181,418 donors from July 2007 through June 2009. A total of 9658 (3.6%) units were discarded, 2973 (1.1%) because CUE was used at the current donation (CUE now) and 6685 (2.5%) because CUE was used in the past (CUE past). The CUE rate was highest among donors with less than 8 years of education (odds ratio [OR], 2.78; 95% confidence interval [CI], 2.51‐3.08). CUE now donations were associated with higher positive infectious disease marker rates than CUE never donations (OR, 1.41; CI, 1.13‐1.77), whereas CUE past donations were not (OR, 1.04; CI, 0.75‐1.45). CONCLUSION: The CUE process results in a high rate of unit discard. CUE use on an individual donation appears predictive of a high‐risk marker‐positive donation and, thus, appears to contribute modestly to blood safety. The policy of discarding units from donors who have previously CUE‐positive donations does not improve safety and should be discontinued.     

Demographic characteristics and prevalence of serologic markers among donors who use the confidential unit exclusion process: the Retrovirus Epidemiology Donor Study

BACKGROUND: Most blood centers utilize a confidential unit exclusion (CUE) process, intended to reduce the risk of transfusion-associated infectious diseases by allowing high-risk donors confidentially to exclude their blood from use for transfusion. The effectiveness of this method remains controversial. STUDY DESIGN AND METHODS: Confirmatory or supplemental test results for antibodies to human immunodeficiency virus, human T-lymphotropic virus type I, and hepatitis C virus, as well as hepatitis B surface antigen and syphilis and screening test results for antibodies to hepatitis B core (antigen) and alanine aminotransferase levels were obtained for approximately 1.8 million units donated during 1991 and 1992 at five blood centers within the United States. The prevalences of these infectious disease markers in units that the donors confidentially excluded (CUE+) and units that the donors did not exclude (CUE-) were calculated and examined within demographic subgroups. RESULTS: Units that were CUE+ were 8 to 41 times more likely to be seropositive for antibodies to human immunodeficiency virus and hepatitis C virus, hepatitis B surface antigen, and syphilis and three to four times more likely to react for antibody to hepatitis B core (antigen) or to have elevated alanine aminotransferase levels than units that were CUE- (p < 0.001). The positive predictive value of CUE (the percentage of CUE+ units that were confirmed seropositive for any marker) was 3.5 percent, and the sensitivity of CUE (the percentage of confirmed-seropositive units that were CUE+) was 2.3 percent. CONCLUSION: The current CUE process has low sensitivity and apparently low positive predictive value, and in many cases, it appeared that donors misunderstood it. Yet, CUE was not a “random process,” as CUE+ units were more likely to be seropositive for any infectious disease marker than CUE- units. This suggests that efforts to improve the CUE system may be warranted. As risk factors for transfusion-transmitted infection become more difficult to identify by history-based screening, however, such efforts may have limited effect.     

Current impact of the confidential unit exclusion option

BACKGROUND: In 1986, the FDA recommended using a confidential unit exclusion (CUE) option in blood centers; this was rescinded in 1992. The American Red Cross (ARC) has continued using the option. This study assessed its current impact. STUDY DESIGN AND METHODS: Donor records from ARC for 1995 through 2001 were examined for CUE use in association with the prevalence and frequency of seroconversion of infectious disease markers. The likely yield of CUE was also estimated. RESULTS: Donations with CUE use had a higher prevalence of HIV, HBV, HCV, and syphilis markers than those without CUE use, although both the sensitivity and positive predictive value (PPV) of CUE were low. Seroconverters had a higher frequency of using the CUE option than nonseroconverters. Similarly, the sensitivity and PPV of CUE were low. Based on analysis of infectious disease residual risk, the CUE option was estimated to have prevented the collection of 0.2 to 1.3 window-period units annually within the entire ARC system. CONCLUSION: The CUE option had minimal effectiveness in further reducing the transmission of infectious diseases through window-period units. Further study of its current impact on reduction of units from risky but test-negative donors, as well as on loss of safe donors, may be warranted.     

Human immunodeficiency virus type 1-infected blood donors: behavioral characteristics and reasons for donation. The HIV Blood Donor Study Group

Between May 1988 and September 1989, 829 human immunodeficiency virus type 1 (HIV-1)-seropositive donors were identified from 3,919,000 units of blood donated at 20 United States (US) blood centers. Of the 829,512 (62%) were interviewed to assess behavioral characteristics of the largest subgroup, men reporting sex with men, use of the confidential unit exclusion (CUE) and reasons for donation among all donors. Among 216 men reporting sex with men, 97 percent had male and 72 percent had female sexual contact since 1978. The majority identified themselves as bisexual (29%) or heterosexual (26%). Although 61 percent of 512 donors were aware of their risk behavior at donation, including 57 percent of those infected through heterosexual transmission, only 5 percent used the CUE. Reasons for donation included failure to read carefully (46%) or comprehend (15%) the deferral materials, pressure to donate (27%), a desire to be tested for HIV-1 (15%), and a reliance on screening to identify infected blood (10%). Reasons given for a perception of being at low risk included no recent risk behaviors, infrequent risk behaviors, or modification of risk behaviors. To reach high-risk donors, centers should assess whether referral materials provide necessary medical information and are clearly written for persons with diverse cultural and language backgrounds. Staff should be encouraged to avoid the use of culturally stigmatized terms and behaviors that may be perceived as high pressure.     

The impact of simple donor education on donor behavioral deferral and infectious disease rates in São Paulo,Brazil

BACKGROUND: Studies have shown that human immunodeficiency virus (HIV) residual risk is higher in Brazilian than in US and European blood donors, probably due to failure to defer at‐risk individuals in Brazil. This study assessed the impact of an educational brochure in enhancing blood donors' knowledge about screening test window phase and reducing at‐risk individuals from donating. STUDY DESIGN AND METHODS: This trial compared an educational intervention with a blood center's usual practice. The brochure was distributed in alternating months to all donors. After donating, sampled participants completed two questions about their HIV window period knowledge. The impact on HIV risk deferral, leaving without donation, confidential unit exclusion (CUE) use, and test positivity was also analyzed. RESULTS: From August to November 2007 we evaluated 33,940 donations in the main collection center of Fundação Pró‐Sangue/Hemocentro de São Paulo in São Paulo, Brazil. A significant (p < 0.001) pamphlet effect was found on correct responses to both questions assessing HIV window phase knowledge (68.1% vs. 52.9%) and transfusion risk (91.1% vs. 87.2%). After adjusting for sex and age, the pamphlet effect was strongest for people with more than 8 years of education. There was no significant pamphlet effect on HIV risk deferral rate, leaving without donation, use of CUE, or infectious disease rates. CONCLUSION: While the educational pamphlet increased window period knowledge, contrary to expectations this information alone was not enough to make donors self‐defer or acknowledge their behavioral risk.     

Measures to decrease the risk of acquired immunodeficiency syndrome transmission by blood transfusion. Evidence of volunteer blood donor cooperation

We studied whether volunteers giving blood to the Greater New York Blood Program (GNYBP) cooperated with procedures implementing public health recommendations intended to decrease the risk of acquired immunodeficiency syndrome (AIDS) transmission by blood transfusion. Predonation medical screening was expanded to exclude donors who might be ill with AIDS. To exclude possible asymptomatic carriers of the disease, members of groups at increased risk of AIDS were asked either not to give blood or to give it for laboratory studies. A confidential questionnaire, administered to all donors after medical screening, provided the vehicle for donors to advise the GNYBP whether their donation was for laboratory studies or for patient transfusion. We found that the number of male donors decreased; AIDS-related questions in medical history led to a 2 percent increase in donor rejections; 97 percent of donors said their blood could be used for transfusions; 1.4 percent said their blood could be used for laboratory studies only; and 1.6 percent did not respond. Only units designated for transfusion were released to hospitals. People who indicated that their donation was for laboratory studies had a higher prevalence of markers for hepatitis B virus and of antibodies to cytomegalovirus. White cell counts and helper/suppressor T lymphocyte ratios were not significantly different in the two groups. We conclude that volunteer donors have cooperated with the established procedures. None of the laboratory assays identified blood units donated by individuals who, based on information about AIDS high-risk groups, designated their donation for laboratory studies.     

Efficacy of various methods of confidential unit exclusion in identifying potentially infectious blood donations

To determine the efficacy of various methods of confidential unit exclusion (CUE) among donors at increased risk of HIV exposure, we surveyed AABB institutional members on their experience with 3 CUE methods: ballot or barcode, completed at the time of donation, and call-back, performed by the donor after leaving the donor center. From June 1985 to December 1987, 5,049,883 donations at 48 donor centers were evaluable for analysis. The results of this survey suggest that ballot and barcode methods of CUE are important adjuncts to other donor screening procedures in identifying potentially infectious units, and that both of these methods are superior to the call-back system of unit exclusion.     

Hepatitis C (HCV)-positive blood donors in South-West England: a case control study

SUMMARY. The aim of this study was to compare the socio-demographic characteristics and risk factors in anti-HCV positive blood donors with those of matched controls. The participants were 50 hepatitis C antibody (HCV) positive blood donors and 50 matched blood donors with no evidence of HCV infection, who gave blood to the South Western Transfusion Centre between November 1991 and July 1992. A confidential structured interview was conducted to collect socio-demographic data and to elicit information on risk factors for HCV. Measurements were made of the prevalence of risk factors and socio-demographic characteristics in cases and controls.
The main results were that 45 of the 50 cases could have been exposed to HCV by previous intravenous drug abuse (IVDA), blood transfusion or medical employment. Cases were significantly more likely to have a history of IVDA, tattooing or of medical employment than matched controls. Cases with no history of IVDA were significantly more likely to have had a blood transfusion.
The key conclusions to emerge are that current policies are ineffective at excluding those with a history of IVDA from the donor pool. Consideration should be given to the introduction of a policy of direct confidential questioning about risk factors for all donors, or, at a minimum, the use of a questionnaire.     

Donor room personnel attitudes toward autologous donors

Patients with serious illnesses who donate their blood for autologous use create anxiety for many phlebotomists. Donor room staff were surveyed at three donor centers, using confidential questionnaires, to identify their concerns and to evaluate factors associated with reduced anxiety toward autologous donors. Among respondents (n = 93), 58 percent had patient care experience within the last 5 years, which correlated with diminished concern about phlebotomizing cardiac patients (r = .21; p = 0.04). Fifty-seven percent of respondents had drawn blood from greater than 50 autologous donors. Surprisingly, the experience of drawing blood from relatively large numbers of autologous donors did not correlate with increased confidence in phlebotomizing pediatric, cardiac, and elderly patients (r = -.04; p = 0.75). Those respondents who felt that they had adequate medical support agreed with more liberal donor criteria and were more confident about phlebotomizing pediatric, cardiac, and elderly patients (r = -.32; p = 0.001). Those respondents who believed most strongly in the benefits of autologous transfusion had the least anxiety toward donors who were medically more complex (r = .39; p = 0.0001). It is concluded that, contrary to what might be expected, phlebotomizing large numbers of autologous donors does not reduce the anxiety of staff members when they encounter donors with complex medical problems. Factors that do reduce anxiety include dependable physician and other medical support services, previous experience in direct patient care, and knowledge of the benefits of autologous transfusion.     

Autologous versus homologous donors. Evaluation of markers for infectious disease

Autologous blood donations may provide a new source of blood when components not used by the donors are deemed suitable for homologous use. However, the risk of transfusion-transmitted diseases form such donors has not been evaluated. We compared the prevalence of infectious markers and rate of abnormal responses to a confidential donor ballot in autologous donors from two blood collection programs, one blood center and one hospital-based, to corresponding homologous blood programs. The incidence of abnormal test results in autologous donors for HIV antibodies (either Western blot confirmed or repeatedly reactive, unconfirmed), HBsAg, ALT, and anti-HBc were not statistically different from homologous rates. The incidence of STS abnormalities in autologous donors was statistically significant, although all positive results were biologic false positives. The rate of abnormal responses to the confidential ballot was statistically significant only in autologous donors whose collections were already determined to be unsuitable for homologous use due to medical history problems. Although the data do not address infectious complications in transfusion recipients, this study offers no evidence that autologous blood components are less safe than their homologous equivalents.     

Donor self-exclusion patterns and human immunodeficiency virus antibody test results over a twelve-month period

Donor behavior in completing a pre-donation confidential self-exclusion form, which identified blood donors at high-risk of AIDS exposure, was evaluated. The form was completed by all donors during a 12 month period beginning in September, 1985. 188,824 units of blood were collected from 123,608 donors. On the first donation occasion 901 donors (0.73%) laboratory (LAB) designated, 224 (0.18%) did not complete the form correctly, and the remaining 122,483 transfusion (TRAN) designated. A greater proportion of LAB donors were men, under the age of 30 and had not donated in the previous two years than TRAN designated donors. Confirmed reactive anti-HIV, Western blot positive (WB+) results were greater in LAB than TRAN donors (1.664% vs 0.014%) on the first donation occasion. There were 43,982 donors who returned to donate on at least one other occasion. Of these, 43,778 designated TRAN initially, and only 217 (0.49%) changed their designation to LAB on any subsequent donation event. In contrast, of the 204 donors who designated LAB initially, 134 (65.6%) changed to TRAN on at least one other occasion. A variety of designation combinations from LAB to TRAN and back to LAB occurred. Thus, donors who initially LAB designated were more likely to change their designation on at least one other occasion than those who initially designated for TRAN. Of two donors who became anti-HIV WB positive on the second donation, one of these LAB designated on both occasions, was negative for anti-HIV by enzyme-linked immunoassay (EIA-) on the first donation but converted to EIA+, WB+ on the second.(ABSTRACT TRUNCATED AT 250 WORDS)     

Conflict management styles in the health professions.

The purpose of the study was to determine prevalent conflict management styles chosen by students in nursing and to contrast these styles with those chosen by students in allied health professions. The associations among the level of professional health care education and the style chosen were also determined. A convenience sample of 126 students in a comprehensive university completed the Thomas-Kilmann Conflict Mode Instrument (TKI), which requires respondents to choose behaviors most characteristic of their response to conflict and classifies these behaviors as one of five styles. There was no significant difference between the prevalent conflict management styles chosen by graduate and undergraduate nursing students and those in allied health. Some of the students were already licensed in their discipline; others had not yet taken a licensing exam. Licensure and educational level were not associated with choice of styles. Women and men had similar preferences. The prevalent style for nursing students was compromise, followed by avoidance. In contrast, avoidance, followed by compromise and accommodation, was the prevalent style for allied health students. When compared to the TKI norms, slightly more than one half of all participants chose two or more conflict management styles, commonly avoidance and accommodation at the 75th percentile or above. Only 9.8% of the participants chose collaboration at that level. Implications for nurse educators, researchers, and administrators are discussed.     

Evaluation of a confidential method of excluding blood donors exposed to human immunodeficiency virus: studies on hepatitis and cytomegalovirus markers

A confidential self-administered questionnaire was given to all blood donors prior to donation (n = 95,917). The questionnaire describes groups at increased risk of acquired immunodeficiency syndrome (AIDS) and requires the donor to designate his blood either for laboratory purposes or for transfusion. In a previous communication, we reported that donors in the former group had a much higher prevalence of antibody to human immunodeficiency virus (HIV) than age, sex and clinic matched controls or a group of "miscellaneous" donors who did not fill out the form properly. In this communication, we report results of tests for other viral markers performed on the three designation groups, namely laboratory-designated, miscellaneous and controls. We found that the former two groups had a higher prevalence of antibody to hepatitis B surface antigen (anti-HBs), hepatitis B core antigen (anti-HBc) and cytomegalovirus (anti-CMV) than controls, but there were no differences in alanine aminotransferase (ALT) levels among the groups. In addition, the laboratory-designated group had a higher prevalence of hepatitis B surface antigen (HBsAg) than the general donor population. These data indicate that a questionnaire designed to ascertain AIDS high-risk donors is valuable in excluding donors who may be carriers of other viruses as well.     

Vasovagal symptoms mediate the relationship between predonation anxiety and subsequent blood donation in female volunteers

BACKGROUND: Although not universal, a certain amount of predonation anxiety is common and not surprising among inexperienced blood donors. Variations in predonation anxiety, however, may influence the donor's experience in several respects and might be related to the likelihood of subsequent donation even among those who do not report particularly high levels of anxiety. STUDY DESIGN AND METHODS: A total of 671 inexperienced blood donors (zero or one prior donation) enrolled in a treatment study and completed questionnaires assessing anxiety before and after giving blood. Ratings of pain and blood donation-related symptoms were obtained after giving blood, as well as information from the nurses about the blood donation procedure. Follow-up information on number of additional visits to a blood collection clinic during the subsequent year was also obtained for most participants. RESULTS: Predonation anxiety was positively related to ratings of blood donation-related symptoms and chair reclining by the nurses and negatively related to the donor's rating, obtained at the end of the procedure, of the likelihood that he or she would give blood again. Women, but not men, with higher predonation anxiety were significantly less likely to return to a blood clinic in the following year. The results of mediation analyses suggest that this was due to the association between anxiety and donation-related symptoms. CONCLUSION: The results do not indicate whether or not it is feasible or useful to modify predonation anxiety, but highlight the relationships between the emotional state of inexperienced donors and several aspects of the donation experience, including subsequent donor return. Further study of the psychosocial aspects of blood donation and examination of related research (e.g., treatment of dental anxieties) may be worthwhile.     

Antibiotic prophylaxis of infective endocarditis during digestive endoscopy: over- and underuse in Switzerland despite professed adherence to guidelines

BACKGROUND AND STUDY AIMS: Guidelines for antibiotic prophylaxis of infective endocarditis associated with gastrointestinal endoscopy are not uniform. Though based on weak scientific evidence, they do represent an attempt to unify the management of antibiotic prophylaxis. We investigated whether physicians who profess to adhere to these guidelines actually do apply them correctly. MATERIALS AND METHODS: A questionnaire was sent to all 195 Swiss gastroenterologists asking whether they adhered to antibiotic prophylaxis guidelines and under what conditions did they apply antibiotic prophylaxis in gastrointestinal endoscopy. We analysed whether the Swiss gastroenterologists who claim to adhere to these guidelines actually do so in practice. RESULTS: The response rate to our questionnaire was 95%. Of the Swiss gastroenterologists, 60% correctly employ antibiotic prophylaxis guidelines in gastroscopy, as do 47% in colonoscopy. In therapeutic endoscopy, the percentage of correct antibiotic prophylaxis use depends upon the type of intervention and varies between 21 and 58%. Overuse of antibiotic prophylaxis is at least twice as frequent in colonoscopy and therapeutic endoscopy than in gastroscopy. CONCLUSIONS: Guidelines for antibiotic prophylaxis are not well applied and do not lead to uniform management despite a high degree of professed adherence to them. This phenomenon can be explained by "cognitive dissonance" and "reactance." We conclude that guidelines based on unconvincing data may even prove harmful.     

Using the Pelvic Floor Impact Questionnaire to Improve Urinary Incontinence Assessments for Female Veterans

ObjectiveTo evaluate quality of life (QoL) in female veterans by comparing responses of the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after a chosen treatment for urinary incontinence (UI), determine whether a QoL assessment was being completed for each woman seeking care for UI, and review the PFIQ-7 questionnaire scores to ensure the veterans were offered the appropriate levels of treatment.DesignQuality improvement project using the plan–do–study–act cycle for evaluating change.Setting/Local ProblemA Veterans Affairs Medical Center in the midwestern United States. No standardized education or QoL questionnaire was being used for female veterans diagnosed with UI before implementation of the project.ParticipantsTwenty female veterans diagnosed with stress or mixed UI who had completed Kegel exercises or pelvic floor rehabilitation (PFR) and a pre- and posttreatment PFIQ-7.Interventions/MeasurementsThe Veterans Affairs Medical Center incorporated the PFIQ-7 into routine practice for pre- and posttreatment assessment of UI. Data were collected through a retrospective chart review.ResultsThe mean initial PFIQ-7 score for participants (n = 4) who chose PFR was 71.77 (SD = 82.79). The mean final PFIQ-7 score for participants in the PFR group was 43.99 (SD = 63.34). The mean initial PFIQ-7 score for participants who chose Kegel exercises was 71.72 (SD = 34.92), and the final score was 60.71 (SD = 44.98). When comparing pre- and posttreatment scores, a lower score means there was a positive effect from the treatment and reflects an improved QoL.ConclusionThe addition of the QoL assessment tool assisted staff in developing an individualized plan of care for female veterans. Regardless of treatment option chosen, participants who did not show an overall improvement in the pre- and posttreatment QoL scores were referred to a more advanced level of care.     

Changes in intention to donate blood under a hypothetical condition of reduced confidentiality

Lawsuits related to transfusion-associated human immunodeficiency virus infections have increasingly resulted in requests for the release of confidential information about volunteer blood donors. Concern that loss of confidentiality might change blood donor behavior led to a survey of donors at collection sites within an American Red Cross Blood Services Region. Of the 361 respondents, 50.3 percent (181) indicated reduced intent to provide accurate medical and personal history information under conditions of reduced confidentiality. Ten percent (34) indicated that they were not sure whether they would or would not donate blood in the future under this condition. The results indicate that the possibility of release of donors' medical and personal information may have a negative effect on the safety and adequacy of the nation's volunteer blood supply.     

Evaluation of a confidential method of excluding blood donors exposed to human immunodeficiency virus

A confidential self-administered questionnaire was given to all donors prior to blood donation (n = 95,917). The questionnaire describes acquired immunodeficiency syndrome (AIDS) high-risk groups and requires the donor to designate his blood for either laboratory purposes or for transfusion. Six-hundred and twenty-seven people (0.65%; 78% men) designated their blood for laboratory purposes. In addition to routine enzyme-linked immunoassay (EIA) screening for human immunodeficiency virus (HIV) antibody, all units from the latter group of donors were tested by Western blot (WB) irrespective of the EIA result. An equal number of donor units was selected from those designating their blood for transfusion (age, sex and clinic matched) and these too were tested by WB irrespective of the EIA result. We found that donors designating their blood for laboratory purposes had a 10 times (vs transfusion-designated controls) to 100 times (vs general donor population) greater exposure to HIV. In the laboratory-designated group, an EIA negative donor was WB positive, yielding an estimated EIA false-negative rate of 16 per million. A confidential questionnaire, as described, is a valuable adjunct in ascertaining high-risk blood donors.