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level: Level 7

Questions and Answers List

level questions: Level 7

Question	Answer
researchers use this or other framework to portray the relative quality of various study designs for the purpose of evaluating a single study as well as a body of evidence comprising multiple studies	Evidence Hierarchies
integrative method or secondary data method. it gets data or result from a multiple single studies	Systematic reviews and meta-analyses of RCTs
does not comprise evidence tho it may reflect the judgment of 1 or more people drawing on their perception of scientific evidence, personal experience, and other subjected input	Expert opinion
one depend internal validity they do not generally reflect the external validity of the evidence of more diverse patients and care settings	1 dimensional evidence hierarchy
Alternative and Emerging Study Designs relevant to HTA	1 Comparative Effectiveness Research 2 Large sample trials (LSTs) 3 Pragmatic clinical Trials (PCTs) 4 Cluster randomized trials 5 Adaptive clinical trials 6 Bayesian clinical trials 7 Enrichment 8 Clinical registry trials 9 N-of-1 trials 10 Patient preference trials
Emphasize evidence from direct (“head-to-head”) comparisons, effectiveness in real-world health care settings, health care outcomes (as opposed to surrogate or other intermediate endpoints), and ability to identify different treatment effects in patient subgroups -reflects the demand for a real world evidence to support practical decisions -used because of increasing cause of conducting clinical trial --can draw on variety of complementary study designs and also analytical methods -useful in gradual increase in use of electronic health records and more powerful in computing and related health information technology	Comparative Effectiveness Research
o retain the methodological strengths of prospective, randomized design, but use large numbers of patients, more flexible patient entry criteria and multiple study sites to generate effectiveness data and improve external validity fewer types of data may be collected for each patient easing the participation patients and also clinicians	Large simple trials (LSTs)
o related group of trial designs whose main attributes include: comparison of clinically relevant alternative interventions, a diverse population of study participants, participants recruited from heterogeneous practice settings, and data collection on a broad range of health outcomes	Pragmatic clinical Trials (PCTs)
• usually conducted in a sets of clinic, hospitals, nursing homes, schools, communities, or geographic regions that are randomized to receive interventions or comparators o involve randomized assignment of interventions at the level of natural groups or organizations rather than at the level of patients or other individuals used when it is not visible to randomized individuals or when an intervention is designed to be delivered at a group or socio level such as workplace	Cluster randomized trials
o accumulating data to determine how to modify the design of ongoing trials according to a prespecified plan • intended to increase quality, speed, and efficiency of trials • typically involve interim analysis, changes to sample size, changes to in randomization to treatment arms and control groups and changes in dosage or regimen of drug or other technology	Adaptive clinical trials
o allows for assessment of results during the course of the trial and modifying its design to arrive at results more efficiently enable more efficient allocation of patients to treatment arms, with the potential for smaller trials and for patients to receive better treatment	Bayesian clinical trials
o techniques of identifying patients for enrollment in clinical trials based on prospective use of patient attributes that are intended to increase the likelihood of detecting a treatment effect (if one truly exists) compared to an unselected population such technique can decrease the number of patients needed to enroll in a trial investigators seek to discern predictive markers during the course of the trial and apply this to enrich subsequent patient enrollment in the trial	Enrichment
o type of multicenter trial design using existing online registries as an efficient platform to conduct patient assignment to treatment and control groups, maintain case records, and conduct follow-up.	Clinical registry trials
o clinical trials in which a single patient is the total population for the trial and in which a sequence of experimental and control interventions is allocated to the patient random allocation is used to determine the sequence of interventions given to a patient in this o used to determine treatment effects in individuals and also set of this individuals can be used to estimate the heterogeneity of treatment effects across a treatment population	N-of-1 trials
o intended to account for patient preferences in the design of RCTs, including their ability to discern the impact of patient preference on health outcomes enables patient to express their preferred treatment prior to enrolling in RCT enables patient with strong preferences to receive their preferred treatment provide insight about the relative impact on outcomes on receiving ones preferred treatment subjected to selection bias (systematic differences)	Patient preference trials