Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage.

BACKGROUND: South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis. OBJECTIVES: To develop and test an Ethics Framework for use in the SA context for health priority-setting. METHODS: The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval. RESULTS: This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs. CONCLUSIONS: The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere.

Unintended changes in cognition, mood, and behavior arising from cell-based interventions for neurological conditions: ethical challenges.

The prospect of using cell-based interventions (CBIs) to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior-brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment.

How patients experience progressive loss of visual function: a model of adjustment using qualitative methods.

BACKGROUND: People with retinitis pigmentosa (RP) experience functional and psychological challenges as they adjust to progressive loss of visual function. The authors aimed to understand better the process of adjusting to RP in light of the emotional suffering associated with this process. METHODS: Adults with RP were recruited from the Foundation Fighting Blindness and the Wilmer Eye Institute in Baltimore. Focus groups and semistructured interviews addressed the process of adjusting to RP and were audiotaped and transcribed. The transcripts were analysed qualitatively in order to generate a model of adjustment. RESULTS: A total of 43 individuals participated. It was found that, on diagnosis, people with RP seek to understand its meaning in their lives. Mastering the progressive functional implications associated with RP is contingent upon shifting personal identity from a sighted to a visually impaired person. In this sample, six participants self identified as sighted, 10 self identified as in transition, and 27 self identified as visually impaired. This adjustment process can be understood in terms of a five stage model of behaviour change. CONCLUSIONS: The proposed model presents one way to understand the process of adjusting to RP and could assist ophthalmologists in meeting their moral obligation to lessen patients' suffering, which arises in the course of their adjustment to progressive loss of visual function.

Medical house officers' knowledge, attitudes, and confidence regarding medical ethics.

As part of a trial of ethics education in a university-based, categorical, internal medicine training program, we surveyed all medical house officers at our institution regarding their knowledge of medical ethics, their attitudes and beliefs about selected issues in medical ethics, and their confidence in dealing with ethical problems. In a multivariate linear regression model, house officer knowledge scores were negatively correlated with postgraduate year, and positively correlated with age and with reporting a Jewish religious identity. A multivariate linear regression model predicting house officer confidence in dealing with ethical issues revealed a positive correlation with self-reported quality of ethics training in medical school and with being in the experimental group of house officers receiving ethics education. Attitudes and beliefs were largely uncorrelated with training or demographic characteristics. These results have implications for ethics education of both medical students and residents.

Informed consent in medical practice. With particular reference to neurology.

Informed consent is a significant ethical as well as medicolegal issue. Both aspects are summarized in this article, which focuses on the major unresolved problems raised by legal and moral analyses of informed consent. The discussion stresses the effects of the doctrine of informed consent on medical practice, with particular reference to problems encountered in the neurological health field.

Effect of informed parental consent on mothers' knowledge of newborn screening.

To determine whether knowledge was improved as a result of obtaining informed consent from parents for newborn screening of their infants for phenylketonuria (PKU) and other hereditary metabolic disorders, new mothers in seven Maryland hospitals were interviewed either before receiving a standard disclosure (n = 210) or after giving consent (n = 418). The mean knowledge score of the women interviewed after giving consent was significantly higher (P less than .001). Receiving the disclosure was a more powerful predictor of knowledge score, accounting for 40% of the variance, than demographic factors, which accounted for 9%. Women whose consent was obtained just prior to discharge tended to have lower knowledge scores than women whose consent was obtained earlier (P = .03). Women with higher knowledge scores were somewhat less likely to favor consent than women with lower scores. Although consent may not be appropriate for some low-risk procedures, informing parents can be easily and inexpensively accomplished.

Maternal employment during the early postpartum period: effects on initiation and continuation of breast-feeding.

This study sought to determine whether and to what extent maternal employment in the early post-partum period is associated with the initiation and continuation of breast-feeding in a heterogeneous, urban population. A panel of women were interviewed twice during the first 3 months postpartum. In analyses adjusted for maternal demographic characteristics, there was no association between planning to be employed within the first 6 months postpartum and initiation of breast-feeding. However, actually being employed was significantly associated with cessation of breast-feeding as early as 2 or 3 months postpartum, even after adjustment for maternal demographic variables. Less than one half of mothers who were employed were still breast-feeding at the second postpartum interview, whereas two thirds of those who were not employed were still breast-feeding. Among employed mothers, working no more than 20 hours per week appeared to be protective for continued breast-feeding.

Attitudes of physicians and genetics professionals toward cystic fibrosis carrier screening.

With the identification of the cystic fibrosis (CF) gene and its major mutations in 1989, there has been considerable debate among health professionals as to whether population-based carrier testing should be instituted. This paper presents the results of a survey to determine the attitudes of physicians and genetics professionals toward CF carrier testing. Factors associated with differences in attitudes also were examined. A questionnaire was mailed to primary care physicians and psychiatrists in 10 states who graduated from medical school between 1950 and 1985. For comparison, medical geneticists and genetic counselors in the same states also received the questionnaire. A total of 1,140 primary care physicians and psychiatrists (64.8%) and 280 medical geneticists and genetic counselors (79.1%) responded. Although 92% of respondents believed that a couple should be tested after asking about a test that detected 80% of carriers, only 43.9% of respondents believed such a test should be offered routinely. Those specialists most likely to have been involved in genetic services were most opposed to routine screening. The most important reason reported for opposition to routine screening was the consequences of an 80% detection rate. When presented with a hypothetical "error-free" test, 75.9% of respondents favored routine testing. Our findings suggest that there was little support for routinely offering the CF carrier test available at the time of this study among the physicians and professionals most involved in the provision of genetic services.

Confirmation of self-report of HIV testing among a cohort of pregnant women.

Early identification of pregnant women infected with the human immunodeficiency virus (HIV) is becoming increasingly important in light of recent findings that interventions during and shortly after pregnancy can reduce the rates of vertical transmission. The ability of patients to accurately self-report previous HIV testing and test results is important in clinical settings. Over a one-year period, 283 women attending a hospital-affiliated obstetrical clinic reported previous HIV testing (44% of the total women approached), and 105 women (37% of the women reporting previous testing) reported being previously tested at that hospital. Self-reported data on previous HIV testing at the hospital were compared with information maintained in a centralized computerized database by the hospital laboratory. Only 41.9% of the women who reported previous HIV testing at the hospital had their reports confirmed. Women whose HIV testing reports were confirmed were found to be similar to those women whose reports were not confirmed with regard to age, educational level, gestational age, parity, reason(s) for seeking HIV testing, and knowledge of testing, transmission and acquired immunodeficiency syndrome (AIDS). These data suggest that, when HIV status is of concern, health care professionals should continue to encourage testing in the absence of laboratory documentation of recent HIV antibody testing.

Informed consent and medical ethics.

Informed consent is based on a shared decision between physician and patient, with the physician understanding the relevant values of the patient and the patient understanding the nature of the disease and intervention, including risks and benefits. Informed consent has developed rapidly since it was introduced in the 1950s, reflecting recent changes in the practice of medicine that respect the increase of patient autonomy. The purpose of the written consent form is to document that a process of informed consent has taken place. It is generally agreed that all surgical as well as research procedures require written consent. For certain nonsurgical procedures, the decision regarding obtaining written consent will consider both the risk involved for the patient and the general community standard. Informed consent serves as an important symbol of a physician-patient relationship that adheres to the valued principles of medical ethics.

The impact of pregnancy on women's prenatal and postpartum smoking behavior.

We report patterns of prenatal smoking cessation and postpartum relapse for a large urban population of pregnant women. We examined associations between sociodemographic factors and prepregnancy, pregnancy, and early postpartum smoking behavior. Forty-one percent of women smoking before pregnancy quit smoking during pregnancy. Sociodemographic factors important in predicting smoking cessation during pregnancy, as determined through logistic regression analyses, differed significantly for white and black women. Among white women, education, age, and parity were important predictors of cessation, whereas among black women, only intention to breastfeed was a significant predictor of smoking cessation during pregnancy. Early postpartum smoking relapse rates differed by ethnicity. Twenty-eight percent of white women and 46% of black women who had quit during pregnancy relapsed within 6-12 weeks postpartum. Using logistic regression, we found formula feeding to be the most important predictor of early postpartum smoking relapse for both white and black women.

Women intending to breastfeed: predictors of early infant feeding experiences.

We conducted interviews prenatally and postpartum with 187 women, all of whom intended to breastfeed their newborns. However, 18% of these women either never initiated breastfeeding or stopped within one week. Among women who initiated breastfeeding, we identified four variables as significant predictors of failure to breastfeed for more than seven days: lower confidence in ability to breastfeed, less certainty in the decision to breastfeed, delayed first breastfeeding experience, and lack of rooming in with the baby. Results of this study suggest that women at high risk for not implementing their prenatal breastfeeding intention can be identified for additional support; interventions should focus on prenatal confidence building, early and continuing contact with the newborn, anticipatory guidance prior to discharge, and early pediatric follow-up.

Physicians' knowledge of genetics and genetic tests.

PURPOSE: To assess primary care physicians' and psychiatrists' knowledge of genetics and genetic tests and the factors associated with differences in these physicians' knowledge. METHOD: Questionnaires were mailed in 1991 to 1,795 primary care physicians (family physicians, internists, pediatricians, obstetrician-gynecologists) and psychiatrists who had graduated from medical school between 1950 and 1985 (67.6% of the sample had graduated after 1970) and who were members of professional societies. The questions elicited demographic and practice characteristics as well as knowledge of genetics concepts and facts and awareness of the availability of genetic tests. To validate the questionnaire, 360 medical geneticists and genetic counselors received questionnaires. Statistical analysis involved arc-sine function transformation, t-tests, analyses of variance, F-tests, Tukey's HSD, and stepwise multiple regression. RESULTS: A total of 1,140 (64.8%) of the non-geneticist physicians responded. They correctly answered an average of 73.9%, SD, 13.9%, of the knowledge items, compared with 94.6%, SD, 4.2%, for the genetics professionals (p < .001). The most significant predictors of knowledge were recency of graduation from medical school and practicing in primary care specialties in which exposure to genetics problems is likely. Other significant predictors (from most to least important) were graduation from a U.S. medical school, willingness to adopt a new predictive test before it becomes standard practice, not using pharmaceutical companies as a source of information about new medical practices, and taking a required genetics course in medical school. CONCLUSIONS: The results suggest that knowledge of genetics and genetic tests is increasing among physicians, particularly among more recent graduates and physicians who are exposed to genetics problems in their practices, but deficiencies remain. Although a medical school course in genetics may improve knowledge, it is not sufficient. Greater emphasis is needed at all levels of medical education to reduce the chance of physician error as more genetic tests become available.

Tolerance for ambiguity among medical students: implications for their selection, training and practice.

The practice of medicine has always been characterized by uncertainty. Yet, attempts to study tolerance for uncertainty in medicine have been few, and limited to its influence on specialty preferences and test-ordering behavior. In particular, studies have not investigated how the process of socialization into the medical profession affects tolerance for uncertainty. Based on the assumption that uncertainty and ambiguity are related concepts, a modified version of a tolerance for ambiguity scale was used to study Johns Hopkins medical students' (N = 386) tolerance for ambiguity (TFA) through 4 yr of medical school. In addition, using alcoholism as an example of a clinically ambiguous condition, the association between students' tolerance for ambiguity and their perceived role in diagnosing and treating alcoholism was also investigated. Results indicate that tolerance for ambiguity (1) does not change throughout medical school, (2) is lower among men, whites and students who are younger when they begin medical school, (3) is higher among prospective psychiatrists than surgeons, and (4) is lower among students who do not feel responsible for diagnosing and treating alcoholism. These findings suggest that tolerance for ambiguity may, indeed, affect practitioners' career choices and performance and that selection of medical students may be more important than medical training per se in influencing students' tolerance for ambiguity. If medical schools admitted students who possess a high tolerance for ambiguity, quality of care for ambiguous conditions might improve, imbalances in physician supply and practice patterns might be reduced, and the increasing ambiguity in medical practice might be better acknowledge and accepted.

Quality of life among women living with HIV: the importance violence, social support, and self care behaviors.

This paper describes the relationship between psychosocial factors and health related quality of life among 287 HIV-positive women using items from the Medical Outcomes Study HIV Health Survey to measure physical functioning, mental health and overall quality of life. Multivariate models tested the relative importance of sociodemographic characteristics, HIV-related factors and psychosocial variables in explaining these quality of life outcomes. A history of child sexual abuse and adult abuse, social support and health promoting self-care behaviors were the psychosocial factors studied. Women in the sample were on average 33 years old and had known they were HIV-positive for 41 months; 39% had been hospitalized at least once due to their HIV; 83% had children; 19% had a main sex partner who was also HIV-positive. More than one-half of the women (55%) had a history of injection drug use and 63% reported having been physically or sexually assaulted at least once as an adult. A history of childhood sexual abuse. reported by 41% of the sample, was significantly related to mental health after controlling for sociodemographic and HIV-related characteristics. Women with larger social support networks reported better mental health and overall quality of life. Women who practiced more self-care behaviors (healthy diet and vitamins, adequate sleep and exercise, and stress management) reported better physical and mental health and overall quality of life. The high prevalence of physical abuse and child sexual abuse reported by this sample underscores the importance of screening for domestic violence when providing services to HIV-positive women. That such potentially modifiable factors as social support and self care behaviors are strongly associated with health-related quality of life suggests a new opportunity to improve the lives of women living with HIV.

Interpersonal conflict and physical violence during the childbearing year.

Reducing physical abuse directed at women by male partners is one of the nation's Year 2000 health objectives. An important target group for achieving this health objective is pregnant women. The present study examines the frequency, severity, perpetrators and psychosocial correlates of violence during the childbearing year. A panel of 275 women were interviewed 3 times during pregnancy and at 6 months postpartum. Moderate or severe violence was somewhat more common during the postpartum period than during the prenatal period--19% of women reported experiencing moderate or severe violence prenatally, compared to 25% in the postpartum period. For partner-perpetrated violence, being better educated was associated with increased risk of violence as was having had a sex partner who ever shot drugs; being older, having a confidant and having social support from friends were significant protective factors. For violence perpetrated by someone other than a male partner, having a confidant was a significant protective factor. Obstetric care providers who routinely come in contact with pregnant women, as well as emergency department staff, need to be systematically screening for violence against women. Efforts to enhance women's social support networks should be included in primary and secondary prevention programs.

Women's protective sexual behaviors: a test of the health belief model.

Heterosexual transmission of the human immunodeficiency virus (HIV) has become a significant health issue for women. The present study describes the extent to which a sample of women from an urban area report making efforts to protect themselves from becoming infected with HIV through several protective sexual behaviors. Secondly, we assess the extent to which adoption of these protective behaviors can be explained by health beliefs and previous HIV testing. Forty-nine percent of the sample reported having used a condom in the past year because of fear of AIDS and 48% reported having carried condoms. Women in this sample perceived themselves to be moderately susceptible to AIDS and they were well aware of the severity of the disease. Women tended to think that protecting themselves from AIDS would not be overly burdensome and that the recommended sexual protective behaviors were highly effective for preventing AIDS. Messages about the severity of AIDS and the effectiveness of protective sexual behaviors seem to be reaching women. Beliefs about personal susceptibility were consistently associated with the adoption of multiple protective behaviors, suggesting that messages emphasizing the ubiquity of risk, especially in demographically high-risk populations, may be particularly appropriate and effective.

PIP: The health belief structures that distinguish women who use condoms to protect themselves from themselves from the human immunodeficiency virus (HIV) and those who fail to take protective measures were investigated in a survey of 573 heterosexual women enrolled during their first prenatal visit to the Johns Hopkins Hospital Obstetrical Clinic. 90% of study subjects were African Americans, only 11% were currently married, and 65% were under 25 years of age. The proportions of respondents who had adopted any of the following 6 protective measures in the past year due to a fear of getting acquired immunodeficiency syndrome (AIDS) was the following: had fewer sexual partners (62%), had sex less often (48%), talked with a sex partner about AIDS (72%), decided to refuse sex because of concern a partner might be HIV-positive (47%), used condoms (49%), and carried condoms (48%). On the basis of the Health Belief Model of Janz and Becker, respondents were then questioned on their perceptions of susceptibility to AIDS, severity of the disease, barriers to condom use, and benefits of protected sex. Their mean scores on the preceding subscales, out of a maximum of 5.0, were 3.19, 4.08, 2.18, and 3.75, respectively. After adjusting for demographic factors and number of high-risk life-style practices, multiple regression analysis was used to determine the importance of these health beliefs to protective sexual behaviors. Beliefs about susceptibility and barriers emerged as the most significant correlates and were associated with having sex less often, deciding not to have sex, and carrying condoms. Condom use in the past year was correlated with beliefs about susceptibility, severity, and barriers. Overall, the findings suggest that women are motivated by feelings of personal susceptibility to try protective behaviors, but then conclude they are burdensome and discontinue.

Verbal abuse and physical violence among a cohort of low-income pregnant women.

We report on the occurrence of verbal abuse and physical violence during pregnancy for 358 low-income women. Overall, 65% of the women in our study experienced either verbal abuse or physical violence during their pregnancies. Twenty percent of the women in our sample experienced moderate or severe violence. Perpetrators, although primarily male partners, included family members and friends. These rates varied by age, with younger women experiencing significantly higher rates of verbal abuse and physical violence. There was no association between verbal abuse or physical violence and birth weight or gestational age. Prenatal care may be one of the only opportunities that women, and especially disadvantaged women, may have to get proper assistance with domestic violence. We conclude that enhanced screening, counseling, and referral by obstetricians and other health care providers are some of the immediate activities that could be implemented in prenatal care settings to address the compelling problems of violence during pregnancy.

PIP: This study examines the frequency, perpetrators, and impact of verbal abuse and physical violence among low-income pregnant women. A cohort of 358 low-income pregnant women attending the Johns Hopkins Hospital Adult Obstetric Clinic between December 1989 and September 1990 were included in the study. Information gathered through interview and descriptive analysis revealed that 65% of the women experienced verbal abuse and physical violence during pregnancy; 20% had been through moderate to severe violence. Violence was primarily inflicted by male partners and also by other family members and friends. Moreover, the occurrence of verbal abuse and physical violence were significantly higher among younger aged women, but no association was noted between violence and birth weight and gestational age. Due to the fact that prenatal care may be the only opportunity for low-income women to obtain medical assistance and referral services, prenatal care should include enhanced screening, counseling, and good referral by obstetricians and other health providers in order to address this problem.

Reproductive preferences of pregnant women under shifting probabilities of vertical HIV transmission.

PIP: Between December 1989 and September 1990 in Baltimore, Maryland, researchers interviewed 363 pregnant women attending the Johns Hopkins Hospital obstetric clinic concerning their perspectives on HIV infection and childbearing. All women who agreed to be tested for HIV infection (91%) tested negative for HIV infection. The women lived in a community with a high prevalence of HIV infection. 90% were African-American. As the stated probability of vertical transmission increased so did the women's stated willingness to undergo an abortion. Specifically, if the stated transmission rate was 30%, 28% said they would have an abortion. If the rate was 50%, 47% would have an abortion. At a 70% transmission rate, 68% would have an abortion. At a 100% transmission rate, 74% would have an abortion. 23% of the women would never have an abortion, even if the vertical transmission rate were 100%. 36% of the women had had at least 1 abortion. They were more likely than the non-abortion group to have an abortion at all stated transmission rates. 74% of the women stated that prayer was important during personal problems. 28% of women had a planned pregnancy. These 2 aforementioned groups were less likely than their counterparts to have an abortion at the 30% transmission rate. 48% reported that HIV infection is the only reason for an abortion. An increase in the stated probability of vertical transmission did not strongly influence the women's willingness to avoid pregnancy. 78% would avoid pregnancy at the 30% transmission rate. At the 50% transmission rate, 97% would avoid pregnancy. 99% would avoid pregnancy at the 70% transmission rate. Only 3 women would not avoid pregnancy at the 100% transmission rate. These findings suggest that HIV-positive pregnant women need access to health care providers who are as comfortable respecting and supporting decisions to continue their pregnancies as they are referring them to abortion facilities.^ieng

Pediatricians and breastfeeding promotion: attitudes, beliefs, and practices.

Abstract This study investigated both the degree to which pediatricians promote breastfeeding in their practices, and the attitudes and beliefs about breastfeeding which are associated with their breastfeeding promotion activities. We interviewed a sample of 59 pediatricians from a large urban area who had a variety of practice types and differing patient populations. Almost one half of the pediatricians in this study reported they did not routinely recommend breastfeeding to the mothers of their patients. In addition, few specific interventions to assist in breastfeeding continuation were reported. However, the overwhelming majority of pediatricians sampled reported very favorable attitudes toward breastfeeding promotion by pediatricians. Infrequent prenatal pediatric visits and the lack of formal training in breastfeeding and its management are discussed as potential barriers to more active participation of pediatricians in current efforts to achieve increased rates of breastfeeding.