BIOM 3210 Lecture Notes - Lecture 21: Sulfasalazine

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18 Feb 2021

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Since it does not consider those who were lost, this is considered a pre-protocol (pp) analysis. Within the clinical efficiency section, researchers stated that an intention-to-treat (itt) mixed-model analysis was being used. However, since they are using only those who completed the study, they did not perform an itt. Right after this was stated, they mentioned that acr responses (primary outcome) were shown to be as high as 65% and 33% in patients who received. By stating in patients who received x treatment , the researchers are inadvertently saying that a pp analysis was used and not an itt. If an itt analysis were used, all participants who were enrolled in each group would be accounted for. In the twhf group, 37/60 individuals completed the study as mentioned. Therefore, if the treatment was 100% effective, then an itt result could only show that 37/60 patients had acr responses.

Related Questions

This module discussed the importance of selecting a suitablestudy design and methods for data analysis based on a researchquestion. For each of the following research questions. state thetype of study described by each of the following paragraphs. Alsoexplain your reasoning for why you chose the study type.

To investigate the relationship between egg consumptionand heart disease, a group of patients admitted to a hospital withmyocardial infarction were questioned about their egg consumption.Another group of patients admitted to a fracture clinic and matchedon age and sex with the first group were also questioned abouttheir egg consumption using an identical protocol.
To investigate the relationship between certainsolvents and cancer, all employees at a factory were questionedabout their exposure to an industrial solvent, and the amount andlength of exposure measured. These subjects were regularlymonitored, and after 10 years a copy of the death certificate forall those who died was obtained.
A survey was conducted of all nurses employed at aparticular hospital. Among other questions, the questionnaire askedabout the grade of the nurse and whether or not she was satisfiedwith her career prospects.
To evaluate a new school (i.e., approach) for treatingback pain, patients with lower back pain were randomly allocated toeither the new school or to conventional occupational therapy.After 3 months, they were questioned about their back pain, andobserved lifting a weight by independent monitors.

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IDE Case Study

A IDE was submitted by Hyman Parts, (HP) for knee and hip replacement devices. HP informed the FDA that they had implanted a significant number of devices prior to the approval of the IDE in the hip study. These subjects did not receive informed consent nor were they aware that they had received an investigational device. HP stated that they sold these investigational devices by physicianâs prescription. Based on this information the FDA decided to conduct âfor causeâ inspections of HP as well as the Clinical Investigators. The inspections revealed the following:

â¢ Failure to ensure control of the investigational device.

â¢ Failure to document and report adverse events.

â¢ Failure to ensure the clinical investigators obtain informed consent from subjects prior to the use of the device.

â¢ Failure to utilize IRB approved informed consent forms.

â¢ Failure to adhere to study protocol.

Based on the inspections, the FDA took the following action:

â¢ Issued a Warning Letter to HP.

â¢ Issued Notices of Initiation and Disqualification Proceed in HP and Opportunity to Explain

â¢ Letters (NIDPOE) to the Clinical Investigators

The FDA requested that no additional patients be enrolled in the study and that the HP send a patient notification letter to those who had received the device without informed consent. HP also needed to prepare a Corrective Action Plan and audit all the data from the hip study.

HP submitted a draft Audit/Corrective Action Operating Plan, however, this CAP was inadequate due to its lack of specificity in terms of actions to be taken and documentation for corrective action already made.

HP then notified the FDA that one of their hip devices that was approved in Japan not the U.S. was imported into the U.S. and implanted in 245 patients in Boston, Massachusetts and these sales were made pursuant to the physiciansâ âprescriptionsâ as custom devices.

HP then notified the FDA that they had found similar problems as the ones documented in their hip study in their knee study

. Answer the following questions:

What are the problems that you see in this case?

What action would you take if you were representing the FDA?

What action would you take if you were representing HP?

The Scientific Method

For any controlled scientific study, a scientist starts with an observation, does some research to develop a hypothesis, and then designs an experiment that compares some baseline group with a test group. Data are then collected to confirm or refute the hypothesis.

As you review the following study, consider whether the researchers correctly followed the scientific method.

In the late 1990s, gastroenterologist Andrew Wakefield, along with a research team, set out to determine if bowel disease caused by vaccines led to autism.

He compiled a group of 12 children who had loss of acquired skills, developmental delays in language, diarrhea, and abdominal pain-essentially, those with both bowel disease and autism. He questioned each parent about the behavior and personality of the child before the child was vaccinated with the Measles, Mumps, and Rubella (MMR) vaccine. He then ran tests on the children to determine the health of the gastrointestinal tract, brain, and nervous system.

His reported data (tabulated below) included that children experienced either gastrointestinal or autism-like symptoms, sometimes within a short period after being vaccinated. From these data, the researchers concluded that there was no link between autism and the MMR vaccine. Wakefield though, contradicted this conclusion and stated that the vaccine caused changes in the gastrointestinal tract of the children, which then led to autism (Wakefield, et al., 1998). Currently, he still contends that the MMR vaccine contributes to autism (Ziv, 2015).

Many researchers tried to duplicate this study and could not replicate Wakefield's results. In fact, they found no link between the vaccines, bowel disease, and autism. In the United Kingdom, the MMR vaccine was not introduced until 1988. If Wakefield's conclusions were correct, one would then expect a jump in autism cases after 1988, but this was not observed, even when hundreds of children were studied (Taylor et al., 1999). In these additional studies, children who had not been vaccinated were included as a control group, and no difference in the rates of autism was observed.

In 2011, Brian Deer reviewed Wakefield's study and all available records from the National Health Service (NHS) in the United Kingdom for these 12 children. He found that at most, two children showed symptoms days after vaccinations. At least five children showed developmental delays before being vaccinated. Six out of the 12 children may have had autism symptoms. None of the 12 children tested had all three-regressive autism, colitis, and symptoms days after vaccination.

Symptom	Wakefield	Wakefield NHS Records (Deer)
Symptoms days after vaccination	8	2?
Non-specific colitis	12	3
Regressive autism	9	6?
Intestinal/autism/symptoms after vaccine	12	0

(Wakefield, et al., 1998; Deer, 2011)

Wakefield's statements led to a worldwide panic about the safety of vaccines, but after Deer's report, Wakefield's study was retracted and his medical license was revoked for falsifying data. Click on the following links to review materials to enhance your knowledge of the scientific method and to support your analysis of Wakefield's experiment:

Steps of the Scientific Method: A simplified explanation of how the scientific method works, the steps taken to investigate phenomenon with diagrams

Do Vaccines Cause Autism?: A review of research demonstrating that vaccines and their components are not the cause of autism

Fifteen years after a vaccine scare, a measles epidemic: An analysis of vaccination trends and an increase in measles cases seen the UK

Answer the following 4 questions:

What was wrong with Wakefield's study? Discuss at least 1 variable or approach that should have been controlled or assessed.

Consider the source of some of his data (parental memory, for example), the small sample size, and whether he considered other variables (genetics, diet, and so on) that could have resulted in symptoms in these children.

Discuss the importance of a control group when using the scientific method.

Did Wakefield deserve to be barred from medical practice?

What were the consequences of his inflated conclusions?

BIOM 3210 Lecture Notes - Lecture 21: Sulfasalazine

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