Epidemiology Issues The Past and Present Situation

Epidemiology Issues - Past & Present

Problem #1: The Public Health Service Syphilis Study (1932-1971)

The U.S. Public Health Service Syphilis Study at Tuskegee, popularly and hereafter referred to as the Tuskegee Syphilis study, is infamous clinical research in Macon County, Alabama, USA, from 1932 to 1972. The target population was black men suffering from syphilis. The sample was made up of uneducated black men, approximately six hundred, of which about four hundred were suffering from syphilis. The uninfected group, about two hundred, served as the control group. The study aimed to determine whether the reaction to syphilis among blacks was similar to whites and determine how long a human being could live with untreated syphilis (Reverby, 2012). In this discussion, the Tuskegee Syphilis Study will be evaluated to establish ethical violations from a Biomedical research perspective.

Based on reflections on the dictates of ethical biomedical research that has human beings as participants, it is clear that the Tuskegee Syphilis Study violated several ethical requirements;

i. Lack of informed consent – there is no evidence of the study participants being informed correctly, on the study’s purpose and their part, consenting willingly to participate in the study. Moreover, the study included uneducated black men – which would indicate a purposive sampling method, despite there being educated black elites in the Tuskegee local at the time.

ii. Deception and none beneficence – although there was no known cure for syphilis at the time, the study was designed initially to make treatment available for African-American men. This clarifies that the researchers intended to carry out therapeutic measures such as providing a cure for or control of syphilis among the study participants. The study participants were also deliberately misinformed on why some of the procedures were carried out; for example, spinal taps were disguised as necessary and special “free treatment” for “bad blood.”

iii. Withholding of vital information – at some point, funding to avail drugs for the study participants was cut, a point from which the study turned to be a natural history study. Hundreds of the study participants infected with syphilis were kept in the dark about developments in the industry and the research progress.

iv. A clear violation of non-maleficence is evident that the researchers didn’t institute any measures to avoid harming the study participants. There were measures taken to “ensure harm” to the study participants;

· Even after penicillin was determined to be a safe and effective treatment for syphilis in the 1940s, the study participants infected with syphilis were denied antibiotics

· The researchers colluded with the military and local area healthcare professionals to prevent treatments of the study participants

· The study continued up to and until 1972

· The results of the study were the death of 28 men, 100 disability cases, and 19 congenital syphilis cases (newborns with syphilis)

v. Racism and clear inclusion of vulnerable groups of people – even though the study targeted population was black men, racisms come in when they include only uneducated black men, which in this case is a vulnerable group of people, given race relations in the U.S. at the time, and the history of slavery. Also, the vulnerable group used for the study would not benefit from their participation in the study.

vi. Endangering men and their families – at the time of the Tuskegee Syphilis Study, there was no known treatment for syphilis. Moreover, it is ethically required that the dangers of any new medication must be first investigated using animals. Therefore, it is obvious that the study participants were guinea pigs, and the lack of treatment resulted in some women contracting the disease from men who were participating in the study. (Note: no woman was included in the study).

vii. Annulation of freedom to opt-out at any time – for research involving human beings, there is always the freedom to leave the study for so long as one wishes to. In this study, the participants were closely monitored, including using the military, to ensure that none leaves the study. Even worse, none could seek medical intervention from the nearby medical facilities.

viii. Abuse of the study participants – the Tuskegee Syphilis Study was no different from the Nazi-era experiments. It violated all the principles set out in both the Helsinki declaration and Nuremberg Code. The study harmed the human participants by maximizing risks and minimizing benefits. Human dignity in the study was not respected, the privacy of the participants was violated, and their autonomy was withdrawn.

At the time of this study, there was not, among others, a set ethics code for biomedical research. Also, there was no requirement for research to be approved by an institutional review board, which would have detected the ethical issues and barred its implementation in the Tuskegee Study case. This notwithstanding, when the Judiciary Council of the American Medical Association issues a report in 1946, December 10th, on the ethics required for experiments that involve human participants, the researchers of the Tuskegee Syphilis Study took no steps as to revise or terminate the research (Ogungbure, 2011). In case, it continued until 1972 and only terminated after public outcry.

Problem #2: Review of “Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force” by Fortmann et al. (2013)

1. Following the PICO frame-work we have discussed: describe the Population succinctly for this systematic review.

The target population for this study is research articles on vitamins and minerals supplements. The study sought studies of the subsequent minerals and vitamins; vitamins A, B1, B2, B6, B12, C, D, and E; calcium; zinc; iron; niacin; magnesium; ?-carotene; folic acid; and selenium.

1. Following the PICO frame-work, we have discussed the Interventions and Comparisons succinctly for this systematic review.

The Intervention for this systematic review was taking multivitamins or single and paired nutrients supplements. The studies included in this review had conducted a research where the study participants took multivitamin supplements or single and paired nutrients. The comparison was made with community-dwelling nutrient-sufficient adults who were NOT taking multivitamin supplements or single and paired nutrients.

1. Following the PICO frame-work we have discussed: describe the Outcomes succinctly for this systematic review.

This systematic review’s outcomes were the occurrence of cardiovascular disease, cancer, or all-cause mortality in the adult population without CVD or cancer. The review examined the health outcomes of community-dwelling nutrient-sufficient adults taking multivitamins or single and paired nutrients compared to those who did not take these supplements.

1. What type of study design did this systematic review include for assessing “the effectiveness or safety of supplements in the primary prevention of CVD, cancer, or all-cause mortality”?

The inclusion criteria for this systematic review outlined only studies that utilized a field experimental research design. The studies included persons in their natural community settings, but the consumption of supplements was the control, thus experimental design. Thus, it is concluded that this was a field experimental research design.

1. How many individuals performed the title and abstract screening for each citation that was found in the search?

Two investigators independently reviewed each potential article’s title and abstract and determined whether it meets the inclusion criteria set out for the review.

1. How many individuals assessed the risk of bias (or quality) for each included study?

Two investigators were used to independently access the quality of each study and ranked it “good,” “fair,” or “poor” through the use of predetermined quality criteria that were based on USPSTF methods.

1. What is the rationale of having two or more individuals complete the systematic review-related tasks of title and abstract screening, data abstraction, and risk of bias assessment? Please write in your own words and limit your answer to 100 words.

The purpose of using two or more reviewers to screen articles for inclusion in a systematic review is to; 1) improve reliability, validity, and the quality of the systematic review, 2) to minimize the risk of errors, 3) to minimize the risk of selection bias, information bias, opinions, and bias in the analysis, and 4) minimize meta-bias. Moreover, under the current requirements laid out by PRISMA (Preferred reporting items for systematic reviews and meta-analyses), more than one reviewer must be used in the data extraction processes.

Problem #3: Rayman MP, Blundell-Pound G, Pastor-Barriuso R, Guallar E, Steinbrenner H, Stranges S. A randomized trial of selenium supplementation and risk of type-2 diabetes, as assessed by plasma adiponectin. PLoS One. 2012;7(9):e45269. DOI: 10.1371/journal.pone.0045269. Epub 2012 September 19th.

1. Sequence generation

Risk of bias: Low. “Computer-generated random permuted blocks, stratified by study center, gender and age group were used to generate the randomization list at the Clinical Trials and Statistics Unit, Institute of Cancer Research, Sutton Surrey, UK.”

1. Allocation concealment

Risk of bias: low. The allocation to one of the four groups was done randomly as stated: “501 volunteers were randomly assigned (allocation ratio 1?1:1?1) to one of four treatment regimens: placebo, 100, 200 or 300 µg of Se per day for a minimum of six months.”

1. Blinding or masking of participants. Identify criteria for the study population.

Risk of bias: high. The study targeted adults aged between age 60 and 74; however, participants in the study were “volunteers recruited from four general practices (study centers) in different parts of the country.” Participation by volunteering exposes the study to the risk of bias as participants could participate with diverse ulterior motives.

1. Blinding or masking of outcome assessors for the outcome “mean plasma selenium concentration.”

Risk of bias: unclear. The article reports that “Participants, research nurses, other study center personnel, investigators and those who analyzed the data were blinded to treatment” however, it is also reported that the “mean (S.D.) plasma selenium concentration had been 88.5 ng/g (19.1) at baseline and heightened considerably in the selenium-treatment groups.” While it is not clear, it is also a possibility that the persons assessing the mean plasma selenium, by the knowledge of the mean and its purpose in the research, could have used it to identify those participating in the study. The mean plasma selenium could have been an identifying element, this compromising the blinding efforts, thus not clear.

1. Blinding or masking of outcome assessors for the outcome “adverse events.” Identify primary and other (if applicable) outcomes.

Risk of bias: unclear. Just is the above case, while it is stated that “Participants, research nurses, other study center personnel, investigators and those who analyzed the data were blinded to treatment,” it is obvious that there was a certain outcome that was expected. Thus, it is not explicitly stated whether the assessor was unaware of this outcome. Assuming they were aware of the expected outcome, it is possible that, once the outcome was achieved, then it could affect the subsequence data (advance events) from a participant. However, this information is only assumed; thus, the risk of bias is unclear.

1. Blinding or masking of health care providers

Risk of bias: low. The article states that the experiment was “double-blind” and that “…research nurses… were blinded to treatment.” This is a significant control measure that almost eliminates the risk of bias as the nurses administer or care for the study participants. It eliminates any risks of possible preferential treatment for the study participants; thus, the risk of bias is low.

Problem #5: Review of fresh red cell transfusions on intraventricular hemorrhage in premature infants: A Systematic Review.

1. Review article and Formulate PICO format question

P – premature infants

I – fresh red cell transfusion

C – Standard Red cells transfusion

O – intraventricular hemorrhage

PICO Question – What is the effect of fresh red cells transfusion on standard red cell transfusion on intraventricular hemorrhage in premature infants?

2. Describe search strategy

A search was conducted in one scholarly database, PubMed, through the U.S. National Library of Medicine National Center for Biotechnology Information (https://pubmed.ncbi.nlm.nih.gov). Four search phrases were used to search relevant articles in the two databases. These search phrases were intentionally similar, with the only difference being the intentional use of Boolean operatives “and,” “or,” and “not” (Dinet, Favart & Passerault, 2004). The four search phrases used were, therefore; “Effect of fresh red cells transfusion on intraventricular hemorrhage in premature infants,” “(Effect of fresh red cells transfusion on intraventricular hemorrhage in premature infants) AND (standard red cells transfusion),” “(Effect of fresh red cells transfusion on intraventricular hemorrhage in premature infants) OR (standard red cells transfusion),” and “(Effect of fresh red cells transfusion on intraventricular hemorrhage in premature infants) NOT (standard red cells transfusion).” The first search place was the basic search, and the other three were advanced searched. The first keyword was the basic search, after which the advanced search was done to include the Boolean operatives.