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PHARMCARE 5
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HTA Methods
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Level 4
level: Level 4
Questions and Answers List
level questions: Level 4
Question
Answer
usually occurs when any factor that is associated with an intervention has an impact on an outcome that is independent of the impact of the intervention. MASK TRUE IMPACT OF INTERVENTION. can arise due to differences between the intervention and controlled groups such as there is differences in the baseline risk factors at the start of a trial or there are different exposure during the trial that could also affect outcomes
Confounding
Control groups for confounding factors (to address confounding factors) Controlled studies:
Controlled studies: 1 Contemporaneous control with intervention groups 2 Historical control groups 3 Crossover design study 4 Randominization (pseudorandominization)
(planned and implemented by investigators using real time data collection) subjected to confounding; more biased than retrospective more suited to investigating health problems that are prevalent and yield health outcomes or other events that occur relatively frequently and within short follow up periods
Prospective design
collect samples of data from past interventions and outcomes involving one or more patient groups more subject to selection biased than prospective; dependence on existing data; designed to extract data from longer time spans and they can also offer the advantage of being able to canvas large volumes of data over extended time periods
Retrospective design
can be designed to reduce biased such as selection biased and detection biased which is advantage over most retrospective studies
patient enrollment and data collection
any systematic deviation in an observation from the true nature of the event
bias
Types of Bias
1 Selection bias 2 Performance bias 3 Detection bias 4 Attrition bias 5 Reporting bias
o systematic differences between baseline characteristics of the groups that are compared o Random sequence generation and allocation concealment
Selection bias
o systematic differences between comparison groups in the care that is provided, or in exposure to factors other than the interventions of interest.
Detection bias
o systematic differences between comparison groups in withdrawals (drop-outs) from a study, loss to follow-up, or other exclusion of patients/participants and how these losses are analyzed
Attrition bias
o systematic differences between reported and unreported findings
Reporting bias
systematic error or distortion that occurs in the assessment of outcomes due to differences in the care provided to study participants. It occurs when there are variations in the management, administration, or delivery of interventions between the groups being compared in a study. This bias can significantly impact the validity and reliability of research findings in pharmacy practice. For example, if one group of patients in a clinical trial receives medication counseling from highly trained pharmacists while the other group receives minimal guidance, any observed differences in outcomes could be influenced by this disparity in care rather than the effectiveness of the medication itself.
Performance Bias