Cost-Benefit Analysis versus Cost-Effectiveness Analysis from a Societal Perspective in Healthcare.

Cost-effectiveness analysis (CEA) is the main way that economic evaluations are carried out in the health care field. However, CEA has limited validity in deciding whether any health care evaluation is socially worthwhile and hence justifies funding. Cost-Benefit Analysis (CBA) is the economic evaluation method that should be used to help decide what to invest in when the objective is to record the impact on everyone in society. Cost-utility analysis (CUA), which has its roots in CEA, can be converted into CBA under certain circumstances that are not general. In this article, the strengths and weaknesses of CEA relative to CBA are analyzed in stages, starting in its most classical form and then proceeding via CUA to end up as CBA. The analysis takes place mainly in the context of five actual dementia interventions that have already been found to pass a CBA test. The CBA data is recast into CEA and CUA terms in tabular form in order that the contrast been CEA and CBA is most transparent. We find that how much of the fixed budget that is used up to fund other alternatives determines how much is left over to fund the particular intervention one is evaluating.

A Novel Approach to Developing Thresholds for Total Dissolved Solids Using Standardized and Experimental Toxicity Test Methods.

The increasing salinization of freshwater streams from anthropogenic land uses and activities is a growing global environmental problem. Increases in individual ions (such as sodium or chloride) and combined measures such as total dissolved solids (TDS) threaten drinking water supplies, agricultural and economic interests, and the ecological health of freshwater streams. Because the toxicity of high ionic strength waters depends on the specific ion composition, few water quality standards exist to protect freshwater streams from salinization. In the present study, we used a novel approach to develop site-specific and ecologically relevant TDS thresholds for the protection of aquatic life. The first step of the approach was to characterize the ion composition of the waterbody or region of interest and prepare artificial samples to match that composition. Using a combination of standardized toxicity test species and more ecologically relevant field-collected species, toxicity tests were then conducted on these artificial samples prepared at a range of TDS concentrations. The advantage of this approach is that water quality criteria can be developed for easy-to-measure generalized parameters such as TDS while ensuring that the criteria are protective of instream aquatic life and account for the complex interactions of the various ions contributing to salinization. We tested this approach in Sand Branch, Loudoun County, Virginia, USA, where salinization from hard rock mining and urban runoff has impaired aquatic life. Acute and chronic TDS thresholds of 938 and 463 mg/L, respectively, were developed in this stream and used for total maximum daily load development in the watershed. The approach provides a potential model for establishing protective thresholds for other waterbodies impacted by salinization. Environ Toxicol Chem 2022;41:2782-2796. © 2022 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Direct and Delayed Mortality of Ceriodaphnia dubia and Rainbow Trout Following Time-Varying Acute Exposures to Zinc.

The potential for delayed mortality following short-term episodic pollution events was evaluated by exposing cladocerans (Ceriodaphnia dubia) and rainbow trout (Oncorhynchus mykiss) to zinc (Zn) in various 1- to 48-h and 1- to 96-h exposures, respectively, followed by transferring the exposed organisms to clean water for up to 47 h for C. dubia and up to 95 h for trout for additional observation. For C. dubia, 1-h exposures of up to 3790 µg Zn/L never resulted in mortality during the actual Zn exposures, but by 48 h, a 1-h exposure to 114 µg/L, a concentration similar to the present US national water quality acute criterion for the test water conditions, ultimately killed 70% of C. dubia. With C. dubia, the speed of action of Zn toxicity was faster for intermediate concentrations than for the highest concentrations tested. For rainbow trout, pronounced delayed mortalities by 96 h only occurred following ≥8-h exposures. For both species, ultimate mortalities from Zn exposures ≤8 h mostly presented as delayed mortalities, whereas for exposures ≥24 h, almost all ultimate mortalities presented during the actual exposure periods. With Zn, risks of delayed mortality following exposures to all concentrations tested were much greater for the more sensitive, small-bodied invertebrate (C. dubia) than for the less sensitive, larger-bodied fish (rainbow trout). These results, along with previous studies, show that delayed mortality is an important consideration in evaluating risks to aquatic organisms from brief, episodic exposures to some substances. Environ Toxicol Chem 2021;40:2484-2498. © 2021 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

Behavioral versus Biological Definitions of Dementia Symptoms: Recognizing that Worthwhile Interventions already Exist.

BACKGROUND: The 2018 Alzheimer's Disease Facts and Figures special report includes two new guidelines for measuring dementia symptoms. The first requires that a biomarker (biological factor) be added to a doctor's clinical judgment of the cause of symptoms when determining whether dementia is present. The second involves identifying four stages of dementia: normal cognition, preclinical, MCI and dementia. Now only those with defining brain pathologies and significant symptoms will be judged to be persons with stage 4 dementia. This article examines the implications of adopting these two new guidelines. The implications are in terms of whether worthwhile dementia interventions can be said to exist, and the extent to which symptoms have to change for an intervention to be judged to have reduced the prevalence of dementia. METHODS: A cost-benefit framework is used to examine the implications of the new guidelines. To undertake a cost-benefit analysis (CBA) a measure of dementia symptoms change is required for any intervention to be judged effective. A behavioral measure of dementia symptoms is thought more useful than a biological one. The instrument that is recommended and explained is the clinical dementia rating (CDR) scale, which is measured on a 0-to-18 interval. Using this instrument, three CBAs can be shown to exist, and from a contracted version of the CDR, estimates of the prevalence rates for the four stages of dementia are derived. The implications for future dementia research of using the full CDR instrument is presented in the discussion section. RESULTS: The three CBAs that are reported and explained are years of education, Medicare eligibility and hearing aids. For each intervention, the analysis is in terms of demonstrating that it is effective, beneficial and socially worthwhile. CONCLUSIONS: By using a behavioral rather than a biological definition of dementia symptoms, we can show that worthwhile interventions already exist.

A Cost-Benefit Analysis of Hearing Aids, Including the Benefits of Reducing the Symptoms of Dementia.

We carried out a CBA of hearing aids (HAs) in which we estimated the direct utility benefits, and included the indirect utility benefits working through a reduction in dementia symptoms. The benefits methodology involved using QALYs as the outcome measure and then applying the price of a QALY to convert the outcome measure into monetary terms. The price of a QALY was derived from an age specific VSL estimate. The effects of HAs on utility were estimated from a fixed effects regression on a large national panel data set provided by NACC where we used a negative proxy for the QoL. We also used a fixed effects regression for the estimate of the indirect benefits involving HAs reducing dementia symptoms. We found that the total benefits, mainly coming from the direct benefits, were extremely large relative to the costs, with benefit-cost ratios over 30.

Estimating the monetary benefits of medicare eligibility for reducing the symptoms of dementia.

We adopt a three-component method based on the idea of cost-saving for estimating the monetary benefits of Medicare eligibility for reducing dementia symptoms. The method involves Medicare eligibility lowering dementia symptoms, which reduces the need for dependent living, which in turn lowers caregiving costs. We use the Regression Discontinuity approach to establish a causal link between Medicare eligibility and dementia. The novel aspect of the study comes from using a quality-of-life proxy measure for the utility function to derive the marginal rate of substitution between dementia symptoms reduction and dependent living arrangements.

Midwife-assisted planned home birth: an essential component of improving the safety of childbirth in Sub-Saharan Africa.

Hospital births, when compared to out-of-hospital births, have generally led to not only a significantly reduced maternal and perinatal mortality and morbidity but also an increase in certain interventions. A trend seems to be emerging, especially in the US where some women are requesting home births, which creates ethical challenges for obstetricians and the health care organizations and policy makers. In the developing world, a completely different reality exists. Home births constitute the majority of deliveries in the developing world. There are severe limitations in terms of facilities, health personnel and deeply entrenched cultural and socio-economic conditions militating against hospital births. As a consequence, maternal and perinatal mortality and morbidity remain the highest, especially in Sub-Saharan Africa (SSA). Midwife-assisted planned home birth therefore has a major role to play in increasing the safety of childbirth in SSA. The objective of this paper is to propose a model that can be used to improve the safety of childbirth in low resource countries and to outline why midwife assisted planned home birth with coordination of hospitals is the preferred alternative to unassisted or inadequately assisted planned home birth in SSA.

The value of a year's general education for reducing the symptoms of dementia.

We present a method for estimating the benefits of years of education for reducing dementia symptoms based on the cost savings that would accrue from continuing independent living rather than relying on formal or informal carers. Our method for estimating the benefits of education involves three steps: first taking a year of education and seeing how much this lowers dementia, second using this dementia reduction and estimating how much independent living is affected and third applying the change in caregiving costs associated with the independent living change. We apply our method for estimating education benefits to a National Alzheimer's Coordinating Center sample of 17,239 participants at 32 US Alzheimer's disease centres over the period September 2005 and May 2015.

Neonatal Mortality of Planned Home Birth in the United States in Relation to Professional Certification of Birth Attendants.

INTRODUCTION: Over the last decade, planned home births in the United States (US) have increased, and have been associated with increased neonatal mortality and other morbidities. In a previous study we reported that neonatal mortality is increased in planned home births but we did not perform an analysis for the presence of professional certification status. PURPOSE: The objective of this study therefore was to undertake an analysis to determine whether the professional certification status of midwives or the home birth setting are more closely associated with the increased neonatal mortality of planned midwife-attended home births in the United States. MATERIALS AND METHODS: This study is a secondary analysis of our prior study. The 2006-2009 period linked birth/infant deaths data set was analyzed to examine total neonatal deaths (deaths less than 28 days of life) in term singleton births (37+ weeks and newborn weight ≥ 2,500 grams) without documented congenital malformations by certification status of the midwife: certified nurse midwives (CNM), nurse midwives certified by the American Midwifery Certification Board, and "other" or uncertified midwives who are not certified by the American Midwifery Certification Board. RESULTS: Neonatal mortality rates in hospital births attended by certified midwives were significantly lower (3.2/10,000, RR 0.33 95% CI 0.21-0.53) than home births attended by certified midwives (NNM: 10.0/10,000; RR 1) and uncertified midwives (13.7/10,000; RR 1.41 [95% CI, 0.83-2.38]). The difference in neonatal mortality between certified and uncertified midwives at home births did not reach statistical levels (10.0/10,000 births versus 13.7/10,000 births p = 0.2). CONCLUSIONS: This study confirms that when compared to midwife-attended hospital births, neonatal mortality rates at home births are significantly increased. While NNM was increased in planned homebirths attended by uncertified midwives when compared to certified midwives, this difference was not statistically significant. Neonatal mortality rates at home births were not significantly different in relationship to professional certification status of the birth attendant, whether the delivery was by a certified or an uncertified birth attendant.

The value of reducing HIV stigma.

HIV-stigma is a major reason why HIV continues to be a global epidemic. Interventions targeting HIV-stigma are therefore necessary. To find an intervention that is worthwhile, a Cost-Benefit Analysis is needed which compares costs and benefits. There are many documented costs of HIV-stigma. What is missing is a valuation of the benefits of reducing HIV-stigma. The purpose of this paper is to present a general method that can be used to value the benefits of stigma reduction programs. The method involves estimating the marginal rate of substitution (MRS) between stigma and income in the utility function of older people with HIV. To illustrate how our framework can be used, we applied it to a sample of just over 900 people coming from the 2005-06 ROAH study (Research on Older Adults with HIV) in New York City.

Ethics and professional responsibility: Essential dimensions of planned home birth.

Planned home birth is a paradigmatic case study of the importance of ethics and professionalism in contemporary perinatology. In this article we provide a summary of recent analyses of the Centers for Disease Control database on attendants and birth outcomes in the United States. This summary documents the increased risks of neonatal mortality and morbidity of planned home birth as well as bias in Apgar scoring. We then describe the professional responsibility model of obstetric ethics, which is based on the professional medical ethics of two major figures in the history of medical ethics, Drs. John Gregory of Scotland and Thomas Percival of England. This model emphasizes the identification and careful balancing of the perinatologist's ethical obligations to pregnant, fetal, and neonatal patients. This model stands in sharp contrast to one-dimensional maternal-rights-based reductionist model of obstetric ethics, which is based solely on the pregnant woman's rights. We then identify the implications of the professional responsibility model for the perinatologist's role in directive counseling of women who express an interest in or ask about planned home birth. Perinatologists should explain the evidence of the increased, preventable perinatal risks of planned home birth, recommend against it, and recommend planned hospital birth. Perinatologists have the professional responsibility to create and sustain a strong culture of safety committed to a home-birth-like experience in the hospital. By routinely fulfilling these professional responsibilities perinatologists can help to prevent the documented, increased risks planned home birth.

Protection of the gametes embryo/fetus from prenatal radiation exposure.

There is no convincing evidence of germline mutation manifest as heritable disease in the offspring of humans attributable to ionizing radiation, yet radiation clearly induces mutations in microbes and somatic cells of rodents and humans. Doses to the embryo estimated to be in the range of 0.15-0.2 Gy during the pre-implantation and pre-somite stages may increase the risk of embryonic loss. However, an increased risk of congenital malformations or growth retardation has not been observed in the surviving embryos. These results are primarily derived from mammalian animal studies and are referred to as the "all-or-none phenomenon." The tissue reaction effects of ionizing radiation (previously referred to as deterministic effects) are congenital malformations, mental retardation, decreased intelligence quotient, microcephaly, neurobehavioral effects, convulsive disorders, growth retardation (height and weight), and embryonic and fetal death (miscarriage, stillbirth). All these effects are consistent with having a threshold dose below which there is no increased risk. The risk of cancer in offspring that have been exposed to diagnostic x-ray procedures while in utero has been debated for 55 y. High doses to the embryo or fetus (e.g., >0.5 Gy) increase the risk of cancer. Most pregnant women exposed to x-ray procedures and other forms of ionizing radiation today received doses to the embryo or fetus <0.1 Gy. The risk of cancer in offspring exposed in utero at exposures <0.1 Gy is controversial and has not been fully resolved. Diagnostic imaging procedures using ionizing radiation that are clinically indicated for the pregnant patient and her fetus should be performed because the clinical benefits outweigh the potential oncogenic risks.

Perinatal risks of planned home births in the United States.

OBJECTIVE: We analyzed the perinatal risks of midwife-attended planned home births in the United States from 2010 through 2012 and compared them with recommendations from the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) for planned home births. STUDY DESIGN: Data from the US Centers for Disease Control and Prevention's National Center for Health Statistics birth certificate data files from 2010 through 2012 were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP. RESULTS: Midwife-attended planned home births in the United States had the following risk factors: breech presentation, 0.74% (odds ratio [OR], 3.19; 95% confidence interval [CI], 2.87-3.56); prior cesarean delivery, 4.4% (OR, 2.08; 95% CI, 2.0-2.17); twins, 0.64% (OR, 2.06; 95% CI, 1.84-2.31); and gestational age 41 weeks or longer, 28.19% (OR, 1.71; 95% CI, 1.68-1.74). All 4 perinatal risk factors were significantly higher among midwife-attended planned home births when compared with certified nurse midwives-attended hospital births, and 3 of 4 perinatal risk factors were significantly higher in planned home births attended by non-American Midwifery Certification Board (AMCB)-certified midwives (other midwives) when compared with home births attended by certified nurse midwives. Among midwife-attended planned home births, 65.7% of midwives did not meet the ACOG and AAP recommendations for certification by the American Midwifery Certification Board. CONCLUSION: At least 30% of midwife-attended planned home births are not low risk and not within clinical criteria set by ACOG and AAP, and 65.7% of planned home births in the United States are attended by non-AMCB certified midwives, even though both AAP and ACOG state that only AMCB-certified midwives should attend home births.

Justified skepticism about Apgar scoring in out-of-hospital birth settings.

BACKGROUND: The Apgar score is used worldwide to assess the newborn infant shortly after birth. Apgar scores, including mean scores and those with high cut-off scores, have been used to support claims that planned home birth is as safe as hospital birth. The purpose of this study was to determine the distribution of 5 min Apgar scores among different birth settings and providers in the USA. METHODS: We obtained data from the National Center for Health Statistics of the US Centers for Disease Control birth certificate data for 2007-2010 for all singleton, term births of infants weighing ≥2500 g (n=13,830,531). Patients were then grouped into six categories by birth setting and birth attendant: hospital-based physician, hospital-based midwife, freestanding birth center with either certified nurse midwife and/or other midwife, and home-based delivery with either certified nurse midwife or other midwife. The distribution of each Apgar score from 0 to 10 was assessed for each group. RESULTS: Newborns delivered by other midwives or certified nurse midwives (CNMs) in a birthing center or at home had a significantly higher likelihood of a 5 min maximum Apgar score of 10 than those delivered in a hospital [52.63% in birthing centers, odds ratio (OR) 29.19, 95% confidence interval (CI): 28.29-30.06, and 52.44% at home, OR 28.95, 95% CI: 28.40-29.50; CNMs: 16.43% in birthing centers, OR 5.16, 95% CI: 4.99-5.34, and 36.9% at home births, OR 15.29, 95% CI: 14.85-15.73]. CONCLUSIONS: Our study shows an inexplicable bias of high 5 min Apgar scores of 10 in home or birthing center deliveries. Midwives delivering at home or in birthing centers assigned a significantly higher proportion of Apgar scores of 10 when compared to midwives or physicians delivering in the hospital. Studies that have claimed the safety of out-of-hospital deliveries by using higher mean or high cut-off 5 min Apgar scores and reviews based on these studies should be treated with skepticism by obstetricians and midwives, by pregnant women, and by policy makers. The continued use of studies using higher mean or high cut-off 5 min Apgar scores, and a bias of high Apgar score, to advocate the safety of home births is inappropriate.

Early and total neonatal mortality in relation to birth setting in the United States, 2006-2009.

OBJECTIVE: We examined neonatal mortality in relation to birth settings and birth attendants in the United States from 2006 through 2009. STUDY DESIGN: Data from the Centers for Disease Control and Prevention-linked birth and infant death dataset in the United States from 2006 through 2009 were used to assess early and total neonatal mortality for singleton, vertex, and term births without congenital malformations delivered by midwives and physicians in the hospital and midwives and others out of the hospital. Deliveries by hospital midwives served as the reference. RESULTS: Midwife home births had a significantly higher total neonatal mortality risk than deliveries by hospital midwives (1.26 per 1000 births; relative risk [RR], 3.87 vs 0.32 per 1000; P < .001). Midwife home births of 41 weeks or longer (1.84 per 1000; RR, 6.76 vs 0.27 per 1000; P < .001) and midwife home births of women with a first birth (2.19 per 1000; RR, 6.74 vs 0.33 per 1000; P < .001) had significantly higher risks of total neonatal mortality than deliveries by hospital midwives. In midwife home births, neonatal mortality for first births was twice that of subsequent births (2.19 vs 0.96 per 1000; P < .001). Similar results were observed for early neonatal mortality. The excess total neonatal mortality for midwife home births compared with midwife hospital births was 9.32 per 10,000 births, and the excess early neonatal mortality was 7.89 per 10,000 births. CONCLUSION: Our study shows a significantly increased total and early neonatal mortality for home births and even higher risks for women of 41 weeks or longer and women having a first birth. These significantly increased risks of neonatal mortality in home births must be disclosed by all obstetric practitioners to all pregnant women who express an interest in such births.