Quantitative and Qualitative Pharmacy Research

Question 1

What are the three main types of primary research?

Answer 1

1. Basic research
2. Clinical research
3. Epidemiological research

Question 2

What are some examples of secondary research?

Answer 2

• Meta-analysis
• Review
• Systematic
• Simple (narrative)

Question 3

What are the FIVE steps to a research basis?

Answer 3

1. Question -> What do the researchers want to know?
2. Aim –> May be framed as specific objectives and/or hypotheses
3. Methods –> Should be appropriate to the research question
4. Results –> Attempt to answer research question
5. Discussion and Conclusion –> Main findings + Comparison with previous work Strengths and weaknesses (limitations) + Future directions

Question 4

For basic research (experimental research);

A) What does it determine the effect of?

B) what are examples of procedures and experimental design that are precisely specified + implemented?

C) What is done for confounding factors?

D) How is high internal validity achieved?

E) Why is external validity difficult to achieve?

Answer 4

A)

• Determines the effect of variable X on outcome Y

B)

• Animal/cell population, number of groups, case numbers, treatments, dosages of medication (mg/kg or mcg/kg)

C)

• They are controlled or reduced

D)

HIV: outcome that occurs is because of intervention

• Achieved by standardised experimental conditions

E)

• Lab conditions not directly transferable to clinical practice –> e.g. may not be same, dose, route or dosage regimen

Question 5

What are some considerations and obstacles to basic research?

Answer 5

Controlling conditions

• Temperature and humidity

Availability/purity of materials and equipment

• equipment breakdown

Animal research ethics

Need for excellent practical skills

• Precision and accuracy

Unforeseen issues

Cost

Question 6

What are the two types of clinical studies? Explain the differences.

Answer 6

Interventional

• Compare the outcomes of treatments, procedures, practices, etc
• Randomisation and blinding used to ensure observed differences are likely to be due to the intervention alone (.g. clinical trials)
• Intervention is the only thing different between the two groups

Observational/descriptive

• Patients treated individually based on clinical judgment and patient preference and outcomes monitored
• Include non-interventional therapeutic studies, prognostic studies, observational drug studies, secondary data analyses, case series, and single case analyses.

Question 7

For intervention clinical studies –> explain what the following terms mean

A) Randomised

B) Blinded

C) Double-blind

D) Controlled and placebo-controlled

Answer 7

A)

• Active drug vs placebo (subgroups are similar e.g. age)
• Randomly allocate to a treatment group

B)

• Easier for a drug

C)

• The patient and whoever is assessing the outcome doesn’t know if the patient had the active drug/placebo

D)

• Treatment A is being compared treatment B

Question 8

What is the negative of using a before-after design in pharmacy practice research?

Answer 8

Difficult to infer causation

Question 9

Why may randomisation may be difficult in pharmacy practice research?

Answer 9

Risk of contamination —> the pharmacist shares too much information to the patient –> the patient becomes contaminated

Question 10

What is an alternative to randomised designs? Briefly explain what it consists of.

Answer 10

Cluster randomised trials –> large numbers of patient required

• Break pharmacies down to group A and group B –> group A provides information to patients and group B gives no pharmacist-based intervention
• Usual care = control group; may be difficult to recruit

Question 11

What are some factors for the ‘PICO’ clinical studies that have to be considered?

Answer 11

• Patient recruitment, sample size
• Adherence to study protocol

> Intention to treat vs per protocol

intention to treat: analyse data according to which group the patient was randomized to

per protocol: doing analysis based on whether the patient received intervention exactly according to what the study protocol did

• Human research ethics

Question 12

What do epidemiological studies investigate?

Answer 12

Investigate the distribution and historical changes in the frequency of diseases and the causes

• Large patient groups

Question 13

Epidemiological subtypes can be interventional or observational –> what are some examples of observational subtypes?

Answer 13

• Cohort studies (longitudinal) —> compares the rate of disease among people exposed and not exposed to a hazard –> recruit a group of patients and follow them over time
• Case control (retrospective) –> compares rate of prior exposure to a hazard among people with and without a health condition
• Cross-sectional –> work at a simple time point –> split to those with and without disease –> look at exposure to factors among 2 groups
• Longitdinal –> follow people over time

Prospective (recruit patient group and follow into the future) vs retrospective (looking backwards, reliant on patient recall and documentation)

Question 14

What do prevalence and incidence mean in epidemiological studies?

Answer 14

Prevalence –> number of cases of disease present in a population

• represented as a proportion/percentage
• point prevalence –> at a particular point in time
• period prevalence –> over a specified time period

Incidence –> number of NEW cases of a disease/disease onset

• cumulative incidence = number of new cases over a time period/number of people at risk over that time period (proportion)
• incidence rate = number of new cases/total person-time

incidence rate: used if different follow-up time for different people e.g. 10.8 per 100 patient years

Question 15

What are some considerations for epidemiological studies?

Answer 15

1. Selection bias –> match cases and controls
2. Documentation/recall bias –> problem in case-control studies because it’s retrospective
3. Loss to follow-up –> problem in cohort study
4. Confounding –> less of a problem in cohort study as there is regular follow up –> can reliably ensure the gathering of information
5. Time required
6. Costs

5 and 6 = significant in a cohort study –> following over 10-20 years.

Question 16

Pharmacoepidemiology –> study of use and effects of drugs in large numbers of people. What does it investigate?

Answer 16

• Patterns of drug use
• Safety
• Effectiveness
• Economic evaluations

Increasing using large datasets (e.g. administrative claims data, registries, electronic medical records, adverse event reporting systems)

Question 17

What are some examples of quantitative research?

Answer 17

Studies in which the researcher aims to quantify phenomena

• Quantitative research produces numerical data

> Categorical (e.g. sex)

> Continuous (e.g. age)

Question 18

What are some examples of qualitative research? What do they investigate?

Answer 18

Qualitative researchers seek a deeper truth. They aim to study things in their natural setting, attempting to make sense of, or interpret, phenomena in terms of the meanings people bring to them

• Investigate how people see or interpret events or how they make sense of experiences
• Identify the meaning that people attach to particular situations or explain their priorities and concerns
• Exploring viewpoints of individuals in details –> small number of carefully selected samples
• Why people hold these views and how it affects their behaviour
• Not only what they say, but how they say it

Question 19

Compare quantitative vs qualitative research

Answer 19

Question 20

What are some methods for qualitative research?

Answer 20

Question 21

What does thematic analysis mean for qualitative data?

Answer 21

* Focus on themes emerging from data

• Transcripts read by 2+ researchers who identify broad/issues/themes/codes
• Choose exemplars (often verbatim quotes) that best represented the themes

Tools for data analysis

• NVivo
• Manual coding