PICO Research question
PICO is a focused clinical question that involves three or four concepts, and it facilitates the identification and search process for the best evidence. Therefore, below is the PICO format for the research question under study.
Type of study
The type of study used to answer the research question is a Prospective Observational study design. In this type of study, there is clinical research in which people who have or are being treated for a specific ailment are monitored over time. The study may not be suitable enough for the research question under investigation since it might involve some form of biasness. The ideal design that can be used in the research is the case-control study. This type of study starts with the results and does not follow the participants over time. Researchers select persons with a specific outcome (the cases) and interview or examine their records to learn about their diverse experiences (Khalaf, 2021). They evaluate the chances of having an affair with a positive outcome to the possibility of not having an experience at all. The case-control study design will aid in preventing conducting a clinical study for an extended period hence the faster intervention of a particular incidence.
Source population and study participants
The source population is the group of individuals from which the study subjects are drawn, while study participants consist of a sample. In the above pancreatic cancer disease research, all individuals aged 18 years and above from the thirty general hospitals in Connecticut state were used as the study participants. The source population was the patients from the 30 public hospitals where the specific group of pancreatic cancer disease individuals aged eighteen years and over were drawn.
Issues of concern about selection bias in the study
Several selection bias issues include excluding pancreatic cancer disease studies in individuals less than 18 years as a focus group. Selection bias is a type of inaccuracy that arises when an individual selects the people who will be investigated. It is usually connected with studies when the participants are not randomly chosen (i.e., with observational studies such as case-control, cohort, and cross-sectional studies). For example, one wishes to investigate the impact of working nights on the occurrence of a specific health concern. They gather health data on a group of 9-to-5 employees and employees who do the same type of work but at night (Khalaf, 2021). The rates at which individuals of both groups reported the health condition are then compared. You might conclude that night work is linked to an increase in that issue. In the pancreatic cancer case study, 18 years and above individuals were selected for the analysis. However, the results, including the mortality rate, were for all aged individuals at the end of the study.
Main Study factors
The primary study factor is Aspirin which reduces the risk of pancreatic and other epidemiologic cancers. They measured the duration of Aspirin use, years past the Aspirin use began, and the period of Aspirin use regarding low dose vs. regular dose-response. The problem with the measurement error in this is that it takes Aspirin within two years, which is associated with the risk of pancreatic cancer. The term ‘measurement error’ is often used to describe when a continuous variable (such as HbA1c or BMI) is not precisely quantified (Khalaf, 2021). Misclassification is the measurement mistake of categorical variables, such as when a Cushing patient is incorrectly categorized as a non-Cushing patient.
Outcome factors
Outcomes (also known as events or endpoints) are variables that are tracked during research to record the effect of a certain intervention or exposure on the health of a specific population. Cure, clinical deterioration, and fatality are all examples of outcomes (Khalaf, 2021). The outcome factors in this study are that regular-dose and low-dose Aspirin were observed to decrease the risk of pancreatic cancer. The measurement is taken by interviewing an individual and reporting use via Aspirin questioning. The main problem is the data of how much they have taken Aspirin daily and what dose estimation.
Potential confounding in the study
Confounding, unlike selection or information bias, is a type of bias that can be addressed using statistical models after data collection. Investigators should quantify the confounders in the trial to control for bias in the analysis. In this research study, the researchers have dealt with potential confounding by using multivariate models whereby they handle large numbers of covariates simultaneously. For example, in the study, the researchers aimed to measure the relationship between Aspirin intake and the risk of pancreatic cancer among different individuals. In addition, they were able to control other covariates such as sex, age, smoking, and ethnicity hence preventing confusion during the study.
Problems with confounding
There are problems with confounding, such as having an appropriate response to the Aspirin in regards to regular and low doses, like the exact amount intake of Aspirin daily. This can occur when the distribution of a known prognostic factor differs between groups in a clinical trial. Confounding factors may obscure an accurate correlation or, more typically, incorrectly reveal an apparent relationship between treatment and result when there is none (Khalaf, 2021). Because of confounding variables in studies, it is difficult to establish a causal link between medicine and results unless adequate procedures to correct the confounders’ effect are utilized.
Result summary
The results show that individuals who regularly used Aspirin were at less risk of pancreatic cancer than those who never used any low-dose aspirin. In addition, the number of years an individual has used Aspirin is significant for pancreatic cancer. People who have regularly used Aspirin for less or equal to six years are at less risk of pancreatic cancer than those who have used any low dose. Although, people who have used low-dose Aspirin for greater than ten years are at less pancreatic cancer risk than those on regular Aspirin use.
Assessment of the external and internal validity of the study findings
Validity can be divided into two sorts when testing cause-and-effect relationships: internal and external validity. Internal validity is the degree of certainty that the causal link under investigation is reliable and unaffected by other factors or variables. External validity is the amount to which a study’s findings may be extended (generalized) to different contexts, groups, or events. The experimental design has a significant role in determining the study’s validity. One must also consider measurement validity when ensuring the validity of the instruments or tests they utilize. Therefore, the only formal approach to determine external validity in this research is to repeat the study in the specified target group, which is impractical given the vast number of RCTs and the much more significant number of prospective target populations.
Reference
Khalaf, N., El-Serag, H. B., Abrams, H. R., & Thrift, A. P. (2021). Burden of pancreatic cancer: From epidemiology to practice.Clinical Gastroenterology and Hepatology, 19(5), 876-884.