PHS Guidelines Research Articles

Utilization of PHS Increased Risk for Transmission of Infectious Disease Donor Organs in Lung Transplantation: One Center's 7-year Experience

Over the past several years 37 to 41% of all deceased donor organs in Region 1 were designated as Public Health Service increased risk for infectious disease transmission compared to 25-27% nationally. Limited by the number of standard donors our Center sought to develop guidelines for utilizing these donors and implement a system for follow-up testing for disease transmission. We reviewed our single-center 7-year experience utilizing PHS donor organs in our lung transplant program. Our Center developed a protocol based on the PHS Guidelines to guide the lung transplant program in the management of recipients. Transplant recipients of PHS donor organs had blood testing (serology and viral load) for HIV, HBV and HCV performed on the day of transplant; 1-3 months and 6-12 months after transplant. A QAPI project was implemented to ensure medical record documentation and follow-up testing was conducted. From 2013 to October 2019 there were 66 lung transplants performed from PHS donor organs. A retrospective analysis revealed one false positive HIV antibody test; and 15 recipients (23%) converted their HBV core antibody from negative to positive at the 1-3 month time frame after surgery. Of the 15, 11 converted back to HBV core antibody negative within a year after transplant; 2 patients did not have testing performed/expired; and 2 patients were still within the first year after surgery and remained HBV core antibody positive. Although the etiology of the conversion remains unclear it was attributed to the administration of cytomegalovirus immune globulin in the recipients. Of note, 8 of the 66 PHS organs (12%) were also HCV positive and were transplanted under an IRB protocol. The recipients of HCV NAT positive donor organs were started on direct acting anti-viral agents. All of these patients remained HCV viral load negative after transplant. In addition to these donors, there was one HCV antibody/NAT positive donor organ that did not meet PHS criteria that was tracked and the recipient was HCV viral load negative after transplant. Our Center experience suggests that there is limited risk to using PHS donor organs in lung transplantation. Special considerations may be warranted in tracking recipients of HCV positive donor organs that may not meet PHS donor organ criteria.

A pilot study to implement and sustain the US PHS clinical practice guidelines for treating tobacco use and dependence in free clinics, a safety net care setting for the uninsured

AbstractIntroductionUninsured patients are more likely than the general population to use tobacco and less likely to quit.AimsTo determine if the mode of delivering the PHS Guidelines influenced the effectiveness of smoking cessation among patients in a safety net setting.MethodsSix free clinics were randomly assigned to a training program delivered by an academic physician or community partner plus video support. A repeated cross-sectional survey of patients was conducted at three waves to assess effectiveness to promote quitting.ResultsTobacco use was triple the rate of the US population: 57.7% (Wave 1), 44.7% (Wave 2), and 48.9% (Wave 3). Patients were more likely to report receipt of at least one evidence-based strategy to promote quitting at Wave 2 (AOR = 2.33, 95% CI (1.18–4.58)). Patients treated in clinics trained by the community partner were significantly more likely to report receiving cessation assistance at Wave 2 (AOR 2.54, 95%CI 1.29–5.00) and the trend was similar, but not significant at Wave 3. Patients in the community partner-led arm were significantly less likely to report tobacco use at Wave 3 (AOR 0.59, 95% CI 0.35–0.99).ConclusionsImplementation of the PHS Guidelines in free clinics demonstrates preliminary efficacy, with delivery by community partners offering greater scalability.

Changing the US Public Health Service Guideline for Reducing Viral Transmission Through Organ Transplantation

In response to several inadvertent transmissions of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation, the US Public Health Services issued guidelines to prevent the transmission of HIV through transplantation of human tissue and organs in 1994. Despite significant changes in the epidemiology of HIV in the USA and advances in screening assays for detecting latent infection, the guidelines remained generally unchanged for nearly 20 years. Although the 1994 guidelines identified risk factors in donors that placed them at increased risk of HIV transmission, compliance with the recommendations was highly variable at US transplant centers. After the cotransmission of HIV and HCV from one donor to four transplant recipients, the OPTN policies were amended to incorporate the definitions of donors at increased risk for HIV and required transplant centers to obtain specific informed consent and follow-up when such donor organs were utilized. With renewed attention, it became obvious that the guidelines needed to be revised and expanded to include HBV and HCV. A revised US PHS Guideline was developed over a several year period, and final recommendations were published in 2013. Despite the revisions, definitions of donors at increased risk of disease transmission require further review and revision. This article will attempt to review the revision process of the US PHS Guideline and make suggestions for next steps in further refining the guideline.

Cerebral Perfusion Patterns in Transgenic Murine Models of Sickle Cell Disease As Seen By MRI Is Reflective of Their Anemia Profile and Parallels the Human Disease

Background: Sickle cell disease is an anemia disorder of the red blood cell in which hemoglobin S (HbS) undergoes polymerization and sickling under low-oxygenation conditions, leading to vaso-occlusive events. Major frequent neurological complications of SCD include ischemia and stroke leading to cognitive deficits and morbidity. Clinical observations have done little to identify the causes of stroke in SCD. Animal models of SCD, and in particular transgenic models have been useful in understanding the microvascular phenomena leading to vasculopathy. Polymerization and consequent sickling of red blood cells (RBC) under oxygen stress conditions likely result in sludging of blood and consequent vasoocclusion, at least in peripheral post-capillary tissues. Most animal studies suggest that the primary site for interaction of RBC's carrying HbSreside in the venous vasculature, yet large arterial stroke remains a significant occurrence in clinical SCD, where suggested risk factors include elevated carotid blood velocity and turbulence, cerebral blood flow asymmetry, loss of cerebrovascular reactivity and cerebral hyperemia. In particular, human cerebral hyperemia appears to be a frequent and significant finding, presumably a compensatory response to the SCD anemia.We sought to determine how closely Tg animal models of SCD mimic the cerebral findings associated with human SCD. Several models have been developed, including the NY1DD model which does not exhibit anemia, but in which sickling only occurs following a period of hypoxia, the S+S Antilles (SSAnt) model which suffers mild anemia and sickling under normal conditions, and the Berkley (BERK) which exhibits severe anemia, sickling and early mortality. We used MRI to evaluate these SCD models and compared the findings to those of WT animals.Methods: NY1DD (n=11, 2.6± 0.8 mo, HCT=0.47± 0.04), SSAnt (n=11, 3.3 ± 1.2 mo, HCT=0.43± 0.04), BERK (n=11 at 3 mo, n=5 at 10 mo, HCT=0.33± 0.03) and WT (C57bl, n=5 at 10 mo, n=4) were studied in accord with PHS and AALAC guidelines. Anesthetized (isoflurane) animals were studied with a 9.4 T MRI (Agilent, Inc., CA). MRI included assessment of perfusion (FAIR-ASL), fMRI (BOLD response to a period of hyperoxia), Diffusion Tensor Imaging (DTI), and structural imaging.Results: No differences were observed in CBF, BRHO or MD between young and old animals. Cerebral blood flow increased with severity of anemia-with BERK CBF higher than WT, NY1DD or SSAnt CBF (P < 0.0001). NY1DD and SSAnt CBF were not different, but both were higher than WT CBF (p < 0.001). Bold Response to hyperoxia indicated that BERK animals suffered the greatest oxygen debt, while NY1DD and SSAnt were not significantly worse than WT under normoxia conditions. Mean tissue diffusivity (obtained from DTI), a marker for edema and inflammation, was elevated only in BERK mice compared to WT mice (p < 0.05), while fractional anisotropy was not different between groups.Conclusion: As the degree of anemia worsens, CBF increases presumably to compensate for lower hemoglobin and reduced oxygen carrying capacity. In BERK mice, this increase in CBF is inadequate to compensate for reduced oxygen delivery, and this is indicated by an increase in the BOLD response to hyperoxia (BRHO measure). SSAnt and NY1DD animals both exhibited elevated CBF, but their BRHO was not significantly different from WT animals. This suggests that their increase in CBF was adequate to compensate for sickle induced vasoocclusion and/or mild anemia under normal oxygenation conditions. Our findings suggest that the BERK mouse may be the best model for evaluating therapeutics directed at treating the chronic anemia associated with human SCD, and for evaluating therapeutics aimed at remedying hypoxia induced oxygen radical damage. However, NY1DD or SSAnt may be better models for studying experimentally induced sickle crisis (extended durations of hypoxia), as BERK mice are to fragile to survive such perturbations. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Landscape of Deceased Donors Labeled Increased Risk for Disease Transmission Under New Guidelines.

Deceased donors are labeled increased risk for disease transmission (IRD) if they meet certain criteria. New PHS guidelines were recently implemented; the impact of these changes remains unknown. We aimed to quantify the impact of the new guidelines on the proportion of deceased donors labeled IRD, as well as demographic and clinical characteristics. We used Poisson regression with an interaction term for era (new vs. old guidelines) to quantify changes. Under the new guidelines, 19.5% donors were labeled IRD, compared to 10.4%, 12.2%, and 12.3% in the 3 most recent years under the old guidelines (IRR = 1.45, p < 0.001). Increases were consistent across OPOs: 44/59 had an increase in the percent of donors labeled IRD, and 14 OPOs labeled 25% of their donors IRD under the new guidelines (vs. 5 OPOs under the old). African-Americans were 52% more likely to be labeled IRD under the new guidelines (RR = 1.52, p = 0.01). There has been a substantial increase in donors labeled IRD under the new PHS guidelines; it is important to understand the mechanism and consequences to ensure an optimal balance of patient safety and organ utilization is achieved.

Excerpt From PHS Guideline for Reducing HIV, HBV and HCV Transmission Through Organ Transplantation

The intent of the PHS guideline is to improve organ transplant recipient outcomes by reducing the risk of unexpected HIV, HBV and HCV transmission, while preserving the availability of high-quality organs. An evidence-based approach was used to identify the most relevant studies and reports on which to formulate the recommendations. This excerpt from the guideline comprises (1) the executive summary; (2) 12 criteria for assessment of risk factors for recent HIV, HBV and HCV infection; (3) 34 recommendations on risk assessment (screening) of living and deceased donors; testing of living and deceased donors; informed consent discussion with transplant candidates; testing of recipients pre- and posttransplant; collection and/or storage of donor and recipient specimens; and tracking and reporting of HIV, HBV and HCV; and (4) 20 recommendations for further study. For the PHS guideline in its entirety, including the background, methodology and primary evidence underlying the recommendations, refer to the source document in Public Health Reports, accessible at http://www.publichealthreports.org/issuecontents.cfm?Volume=128&Issue=4. For more in-depth information on the evidence base, including tables of all study-level data, refer to Solid Organ Transplantation and the Probability of Transmitting HIV, HBV or HCV: A Systematic Review to Support an Evidence-Based Guideline, accessible at http://stacks.cdc.gov/view/cdc/12164/.

Adoption of Policies to Treat Tobacco Dependence in U.S. Medical Groups

There remains an ongoing need to reduce tobacco use in the U.S. Physician organizations, such as medical groups, can support healthcare providers to be more effective in their delivery of tobacco cessation by adopting practices recommended in the Public Health Service Clinical Practice Guideline for Treating Tobacco Use and Dependence (PHS Guideline). To document the extent to which activities to reduce tobacco use, as recommended in the PHS Guideline as system-level interventions, are provided within large medical groups in the U.S. During 2006-2007, data were collected on 339 medical groups operating in the U.S., with 20 or more physicians treating at least one of four chronic conditions. Organizations were surveyed regarding activities to reduce tobacco use as recommended in the PHS Guideline as system-level interventions (i.e., tobacco-use status documentation, policies to promote provider interventions, and staff dedicated to treating tobacco dependence). Between 2008 and 2009, bivariate associations and multivariate logistic regression models assessed the relationship of organizational characteristics and external incentives with adoption of systems strategies for treating tobacco dependence. Nearly 83% of medical groups with 20 or more physicians operating in the U.S. in 2006-2007 have adopted one or more strategies recommended as effective to support the treatment of tobacco dependence. However, only 5.6% of medical groups engage in all eight tobacco control activities examined in this study. The two factors that were associated most consistently with medical group policies to treat tobacco dependence were the patient-centeredness of the organization and participation in a quality demonstration program. There is much room for improvement in increasing medical group adoption of systems strategies to reduce tobacco use. The findings in this paper suggest recommendations to achieve these improvements.

Training Physicians to Do Office-based Smoking Cessation Increases Adherence to PHS Guidelines

Cigarette smoking is the leading cause of preventable mortality and morbidity in the United States. Healthcare providers can contribute significantly to the war against tobacco use; patients advised to quit smoking by their physicians are 1.6 times more likely to quit than patients not receiving physician advice. However, most smokers do not receive this advice when visiting their physicians. The Morehouse School of Medicine Tobacco Control Research Program was undertaken to develop best practices for implementing the "2000 Public Health Services Clinical Practice Guidelines on Treating Tobacco Use and Dependence" and the "Pathways to Freedom" tobacco cessation program among African American physicians in private practice and healthcare providers at community health centers. Ten focus groups were conducted; 82 healthcare professionals participated. Six major themes were identified as barriers to the provision of smoking cessation services. An intervention was developed based on these results and tested among Georgia community-based physicians. A total of 308 charts were abstracted both pre- and post-intervention. Charts were scored using a system awarding one point for each of the five "A's" recommended by the PHS guidelines (Ask, Advise, Assess, Assist, Arrange) employed during the patient visit. The mean pre-intervention five "A's" score was 1.29 compared to 1.90 post-intervention (P < 0.001). All charts had evidence of the first "A" ("asked") both pre- and post-intervention, and the other four "A's" all had statistically significant increases pre-to post-intervention. The results demonstrate that, with training of physicians, compliance with the PHS tobacco guidelines can be greatly improved.

Reliability of Vision Screening Tests for School Children

Estimate the reliability of the E-chart as used with Israeli school children. Cross-sectional, population-based study conducted among 751 Israeli students of the Northern District, aged 6- and 7-year-olds and 13- and 14-years-old in 30 schools in 2003. Each student was screened separately by two public health nurses using the illiterate E-chart. Collected data included the students' vision and demographic characteristics, the nurses' professional background, and whether they referred students for medical testing. The reliabilities of vision testing and of the recommendations were determined using total, positive, and negative percentages of agreement and Kappa coefficients. Total percentage of agreement on vision (combined findings for both eyes) was 78.2% (Kappa 0.47, 95%CI 0.41-0.53). Logistic regression models to predict agreement on vision abnormality showed a higher percentage of agreement among females and 13- and 14-year-old students than among males and 6- and 7-year old students. Total agreement of 85.8% was found in referral recommendations (Kappa 0.58, 95%CI 0.51-0.65). Significant relationships were noted with student age, ethnicity, subdistrict of residence, nurse seniority, and agreement on vision findings. Improvement in school vision-screening reliability is needed, especially among 6- and 7-year-old students. To this end, the determinants of fair reliability should be investigated and training programs planned. Reasons for differences in the reliability of nurses' recommendations detected among subdistricts must be further studied, together with careful supervision, to ensure better performance and adherence to PHS guidelines. Implications for nurses and nursing should be considered. Demographic characteristics were found to predict reliability, which can guide nurses in selecting students who need more careful attention or closer supervision during vision testing.

Availability of smoking prevention and cessation services for childhood cancer survivors

To characterize the smoking-related services available to childhood cancer survivors and describe organizational characteristics that were related to institutions' capacity to provide smoking services. Institutions affiliated with the Children's Oncology Group were surveyed from 2003 to 2004. Of the 132 responding institutions, 85% assessed the smoking status of their cancer survivors intermittingly, but only 3% assessed smoking status at every visit, as recommended by the PHS guidelines. A minority of sites offered either smoking prevention (39%) or cessation (25%) services; 58% of sites had a mechanism in place to refer survivors for cessation services. In multivariate analyses, the most parsimonious model predicting capacity for smoking service delivery included barriers, respondents' attitudes, complexity, and institutional stability. These data highlight an important need to improve the availability of smoking services for childhood cancer survivors. Additionally, these findings will inform the development of future interventions that are sensitive to barriers and facilitators to providing prevention services.

Treatment of tobacco use in preconception care.

Treatment of tobacco use in preconception care.

Zidovudine use during pregnancy among HIV-infected women on Medicaid.

This study estimates the rate of zidovudine (ZDV) use during pregnancy among HIV-infected women receiving Medicaid. The rates of ZDV use during pregnancy are compared before (preperiod) and after (postperiod) the 1994 publication of US Public Service Task Force guidelines, recommending use of ZDV during pregnancy. The authors also compare and contrast the correlates of ZDV use during pregnancy in each of the preguideline and postguideline periods. New Jersey AIDS/HIV surveillance data and paid Medicaid claims data between 1992 and 1996 were merged to examine ZDV use during pregnancy. Among ZDV users, the authors also examined persistence of ZDV use during the 3 months preceding delivery. In these analyses, the authors examined care received during pregnancy and differentiated routine medical care from pregnancy-specific care. Correlates of intrapregnancy ZDV use were examined using chi2 analysis and robust regression techniques that correct for correlation among repeated observations. Use of ZDV during pregnancy steadily increased from 13% in 1992 to 70% in 1996, with the upward trend beginning before the release of the guidelines. Averaged over the full preperiod (1992-1994), the rate was 29%, increasing to 57% during the full postperiod (1995-1996). Women with no health care during pregnancy did not receive any ZDV prophylaxis. Women who had some health care contacts, but did not receive pregnancy-specific care, had low rates of ZDV use that did not increase after the promulgation of the guidelines (21% in preperiod and 27% in postperiod). Women who received pregnancy-specific care, whether from obstetrician-gynecologists (OB-GYNs) or other providers, substantially increased their use of ZDV in the postguideline period (from 37% to 63% for those who saw OB-GYNS, and from 20% to 59% for those who received pregnancy-specific care from other providers). However, among users of ZDV, only a minority (24%) used ZDV persistently during the 3 months preceding delivery. African American women were less likely to be persistent ZDV users, even after controlling for other factors. The study highlights the underutilization of ZDV by women who did not receive pregnancy-related care, even after the publication of guidelines. Lack of pregnancy-specific medical care during pregnancy is an important barrier to ZDV prophylaxis. This study confirms that the receipt of prenatal care during pregnancy is a key intervening variable in the real world application of the PHS guidelines and underscores the importance of proactive efforts to provide prenatal care to pregnant women with HIV.

Agency Information Collection Activities; Submission for OMB Review; Comment Request; PHS Guideline on Infectious Disease Issues in Xenotransplantation

Agency Information Collection Activities; Submission for OMB Review; Comment Request; PHS Guideline on Infectious Disease Issues in Xenotransplantation

Draft: PHS Guideline on Infectious Disease Issues in Xenotransplantation (August 1996)

<i>Draft</i>: PHS Guideline on Infectious Disease Issues in Xenotransplantation (August 1996)

PHS Guideline on Infectious Disease Issues in Xenotransplantation

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