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Elizabeth Y Chiao - One of the best experts on this subject based on the ideXlab platform.

  • the utility of digital anal rectal examinations in a Public Health Screening program for anal cancer
    Journal of Lower Genital Tract Disease, 2020
    Co-Authors: Alan G Nyitray, Gypsyamber Dʼsouza, Elizabeth A Stier, Gary M Clifford, Elizabeth Y Chiao
    Abstract:

    Objectives There are no uniform Screening recommendations for anal cancer. Medical practice guidelines are now available on the use of Digital Anal Rectal Examinations (DARE) for the detection of anal cancer; however, because Screening can result in more harm than benefit, our objective was to assess the evidence for use of DARE as a Public Health Screening tool. Materials and methods We conducted a current critical appraisal of anal cancer literature using World Health Organization criteria for assessing the potential utility of a Public Health Screening program. Results Digital Anal Rectal Examination satisfies most, but not all, World Health Organization criteria for a Public Health program that seeks to detect early invasive anal cancer in populations at high risk for anal cancer, most notably HIV-positive men who have sex with men; however, DARE is not appropriate when facilities for treatment are nonexistent. In addition, there are insufficient data on DARE sensitivity and specificity. Conclusions The mildly invasive nature of DARE, limited likelihood of adverse procedure-related events, cost-effectiveness and patient acceptability, as well as wide availability of DARE support consideration of its integration into Screening for populations at high risk of anal cancer, especially HIV-positive men who have sex with men.

A Arslanow - One of the best experts on this subject based on the ideXlab platform.

  • transient elastography for Screening of liver fibrosis cost effectiveness analysis from six prospective cohorts in europe and asia
    Journal of Hepatology, 2019
    Co-Authors: Miquel Serraburriel, Isabel Graupera, Pere Toran, Maja Thiele, Dominique Roulot, Vincent Waisun Wong, I N Guha, Nuria Fabrellas, A Arslanow
    Abstract:

    Background & Aims Non-alcoholic fatty liver disease and alcohol-related liver disease pose an important challenge to current clinical Healthcare pathways because of the large number of at-risk patients. Therefore, we aimed to explore the cost-effectiveness of transient elastography (TE) as a Screening method to detect liver fibrosis in a primary care pathway. Methods Cost-effectiveness analysis was performed using real-life individual patient data from 6 independent prospective cohorts (5 from Europe and 1 from Asia). A diagnostic algorithm with conditional inference trees was developed to explore the relationships between liver stiffness, socio-demographics, comorbidities, and hepatic fibrosis, the latter assessed by fibrosis scores (FIB-4, NFS) and liver biopsies in a subset of 352 patients. We compared the incremental cost-effectiveness of a Screening strategy against standard of care alongside the numbers needed to screen to diagnose a patient with fibrosis stage ≥F2. Results The data set encompassed 6,295 participants (mean age 55 ± 12 years, BMI 27 ± 5 kg/m2, liver stiffness 5.6 ± 5.0 kPa). A 9.1 kPa TE cut-off provided the best accuracy for the diagnosis of significant fibrosis (≥F2) in general population settings, whereas a threshold of 9.5 kPa was optimal for populations at-risk of alcohol-related liver disease. TE with the proposed cut-offs outperformed fibrosis scores in terms of accuracy. Screening with TE was cost-effective with mean incremental cost-effectiveness ratios ranging from 2,570 €/QALY (95% CI 2,456–2,683) for a population at-risk of alcohol-related liver disease (age ≥45 years) to 6,217 €/QALY (95% CI 5,832–6,601) in the general population. Overall, there was a 12% chance of TE Screening being cost saving across countries and populations. Conclusions Screening for liver fibrosis with TE in primary care is a cost-effective intervention for European and Asian populations and may even be cost saving. Lay summary The lack of optimized Public Health Screening strategies for the detection of liver fibrosis in adults without known liver disease presents a major Healthcare challenge. Analyses from 6 independent international cohorts, with transient elastography measurements, show that a community-based risk-stratification strategy for alcohol-related and non-alcoholic fatty liver diseases is cost-effective and potentially cost saving for our Healthcare systems, as it leads to earlier identification of patients.

Sandy Oliver - One of the best experts on this subject based on the ideXlab platform.

  • informed choice and Public Health Screening for children the case of blood spot Screening
    Health Expectations, 2005
    Co-Authors: Katrina Hargreaves, Ruth Stewart, Sandy Oliver
    Abstract:

    Objective: To examine parents' and Health professionals' views on informed choice in newborn blood spot Screening, and assess information and communication needs. Design and participants: A qualitative study involving semi-structured telephone interviews and focus groups with 47 parents of children who were either found to be affected or unaffected by the screened conditions, and 35 Health professionals with differing roles in newborn blood spot Screening programmes across the UK. Results and conclusions: Parents and Health professionals recognize a tension between informed choice in newborn blood spot Screening and Public Health Screening for children. Some propose resolving this tension with more information and better communication, and some with rigorous dissent procedures. This paper argues that neither extensive parent information, nor a signed dissent model adequately address this tension. Instead, clear, brief and accurate parent information and effective communication between Health professionals and parents, which take into account parents' information needs, are required, if informed choice and Public Health Screening for children are to coexist successfully.

Beth A Tarini - One of the best experts on this subject based on the ideXlab platform.

  • storage and use of residual newborn Screening blood spots a Public policy emergency
    Genetics in Medicine, 2011
    Co-Authors: Beth A Tarini
    Abstract:

    The Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) is a federally appointed committee whose responsibility is “to advise the Secretary regarding the most appropriate application of universal newborn Screening tests, technologies, policies, guidelines and standards for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders.”[1] In this issue of Genetics in Medicine, SACHDNC has set forth recommendations that provide national guidance on state policies regarding the storage and use of residual dried blood spots (DBS) after newborn Screening (NBS).[2] They have based their recommendations on over a year of investigation and deliberation (started in February 2009) involving international and national experts in NBS, Public Health and law, and members of the lay Public. Although they should be commended for their efforts in bringing this contentious discussion onto the national stage, it comes too late for some states. Those not familiar with the issue of residual NBS blood spots might ask—Why does SACHDNC feel compelled to set forth recommendations now? In some states, DBS have been stored and used for decades[3] for quality improvement purposes (e.g., calibration of equipment) and for epidemiologic and environmental studies unrelated to NBS.[4-6] In addition, a federally funded consortium of regional genetic services networks previously published guidelines on the use and storage of these residual blood spots in 1996.[7] Two factors loom large in these recommendations: genetic technology and lawsuits filed against states in 2009. With the completion of the human genome project and the popularity of genome-wide association studies, the research value of residual DBS has skyrocketed. In fact, this year, researchers successfully amplified DNA and conducted genome-wide gene expression profiles using DBS.[8] Researchers have also successfully extracted and amplified RNA from stored unfrozen samples almost a decade old.[9] Although SACHDNC hints gently at the lawsuits with their reference to “heightened Public awareness” and “concerns in some consumer communities regarding both the potential uses of residual specimens and patient (newborn and family) privacy,” this language does not do full justice to the acrimonious nature of the disputes. The first lawsuit came from families in Minnesota who alleged that storage and use of DBS violated the state’s Genetic Privacy Act.[9] The court dismissed the case, ruling that the state’s Genetic Privacy Act was not applicable to the NBS program. In a subsequent appeal, the Minnesota Court of Appeals affirmed the original court’s ruling,[11] and the case is going to the Minnesota Supreme Court. The second lawsuit was filed against the Texas State Department of Health by families who claimed storage and use of NBS for undisclosed research purposes violated their constitutional protection from unlawful search and seizure.[12] This case was settled. However, the terms of the settlement required the state to destroy more than 5 million residual DBS—a move that stunned many in the NBS community.[13,14] It is neither surprising nor unreasonable that members of the Public have voiced concerns about appropriate privacy safeguards and DBS. What is surprising is the bitter and contentious atmosphere surrounding these lawsuits, much of it stemming from antigovernment rhetoric that brands storage and use of DBS as “Big Brother in one of its worst incarnations”[15] and accuses the government of building a DNA biobank for eugenic purposes.[16] Unfortunately, the rhetoric has only escalated amid the recent national debate about Healthcare reform with claims that the government will ultimately use DBS to ration Healthcare.[16] These claims are unfounded and, in some cases, represent a coopting of these issues for broader political agendas. It has not helped that the state of Texas is currently embroiled in a lawsuit over failure to disclose that it provided 800 anonymous DBS specimens to the US Armed Forces Laboratory to assist creation of a forensics database.[17] The reality is that these specimens were used to determine population-level variation in DNA among different ethnic groups. Unfortunately, perception often trumps reality, and this incident has fueled Public mistrust of NBS and DBS beyond the boundaries of the state of Texas. Clearly, much of the Publicized backlash is not simply about protection of privacy but rather protection of privacy from perceived government intrusion. This is hardly surprising given that polls last year revealed Public trust in government was at its lowest in 45 years, while anger and frustration at the government was at its highest in the past decade.[18] So although SACHDNC is correct that with the storage and use of DBS the “privacy and confidentiality (of individuals) should be ensured,” the challenge for state Public Health departments that run NBS programs is that they must do so in a politically charged antigovernment climate. This is not to say that scientific policy should be ruled by the politics of the day or bend at the will of a few, loud voices. Research suggests that most parents support research with these newborn Screening samples.[19,20] The goal should not be to persuade the minority that opposes such research: It is unlikely that even the best of efforts by Public Health officials will change the opinion of those who strongly oppose the storage and use of DBS. Rather, the goal should be to address their concerns in a respectful and meaningful way, so as to prevent the spread of fear and misinformation to the majority. In pediatrics, we have witnessed a similar phenomenon with vaccine refusal that provides valuable lessons.[21] In short, the challenge for state NBS programs is not just to develop explicit and transparent policies regarding the storage and use of NBS DBS—although that is a necessary first step. The real challenge lies in getting the Public to believe in these processes and the value of the DBS. SACHDNC does acknowledge the problem of “an unclear message to the Public about the purpose of storage and use of residual NBS blood specimens.”[2] Although they highlight the value of the DBS throughout the recommendations—describing them as “valuable resources for the Public good” and asking policymakers to “consider the value of the specimens as a promising resource for research”—specific examples in which DBS specimens have generated important Public Health and medical insights[4] are not provided. Although the value of the DBS specimens may be a foregone conclusion to those of us who work in Public Health and scientific research, that is unlikely to be the case for the general Public. Given that the collections of DBS are a Public resource provided by the Public, it is our responsibility to showcase existing studies to explicitly demonstrate research using DBS is valuable and provides an important Public good. To some extent, this controversy is emblematic of a larger problem of Public awareness about NBS, which SACHDNC also acknowledges in its report. Much of the Public has little understanding or awareness of the NBS program, which identifies individual newborns with inherited conditions, so that they may receive early, effective treatment.[22] SACHDNC recognizes the danger that the Public may conflate the clinical NBS program with the storage and use of residual NBS blood spots for research—“minimal Public awareness of NBS … has engendered Public concern about the storage of residual NBS specimens even for standard NBS program uses.” In fact, it has already happened. Privacy advocates have gone on record referring to NBS as “The New Eugenics”[23]—a preposterous claim that may encourage some parents to refuse this potentially lifesaving testing for their newborns. It is critical that all educational efforts ensure that the NBS program and storage and use of residual DBS for research of DBS are distinct in the Public’s mind. The response to these threats to NBS and DBS should not be to “tighten the screw” on Public engagement about the use and storage of residual DBS. On the contrary, states should allow parents a choice in whether their child’s blood spot is used for research that is not directly related to quality improvements of the existing tests with NBS programs. Research suggests that denying parents an opportunity to provide their permission—whether through opt-in or opt-out mechanisms, written or verbal—is likely to damage Public support[20] causing programs to lose both the battle and the war. Michigan provides an example of a state that has successfully embarked on a consent program for storage of both past and future DBS.[24] Discussions about the storage and use of DBS have focused heavily on legal (e.g., who owns the DBS) and ethical research issues. For example, SACHDNC explicitly notes that “there are no documented cases of harm resulting from the use of residual NBS specimens.” However, this misses the point. The real challenge with the storage and use of residual NBS is neither an ethical nor a legal one—it is a Public policy one. These samples were taken as part of a mandatory Public Health Screening program. Failure to allow parents a voice in whether those samples are used for other purposes fuels the antigovernment ire. Some worry that establishing consent/dissent processes for storage and use of DBS will hamper enrollment. Paradoxically, it is likely that allowing parents the opportunity to say “no” may actually get them to say “yes.” Those not convinced should ask Andrea Beleno, one of the plaintiffs, in the Texas lawsuit, who said “And if they’d asked me if I would consent for this blood to be used for specific medical research … I would have probably said yes.”[15]

Douglas R. Bish - One of the best experts on this subject based on the ideXlab platform.