Assignment Task
Study Design Valid for a Randomised Control Trial
Consider: Did the study address a clearly focussed research question or hypothesis, was PICO used to define the question, was the assignment of participants randomised, were all participants that entered the study accounted for at its conclusion?
Methodologically sound
Consider: did ‘blinding’ occur, were the study groups similar at the start of the study, could any differences affect the outcome, apart from the intervention did each study group receive the same standard of care, was there a clear study protocol, were follow up intervals the same for each group, is the sample and setting appropriate?
Data collection, instruments, and analysis
Consider: What instruments were used to collect data, were they appropriate for the study, and how was the data analysed?
Results
Were the effects of the intervention reported comprehensively?
Summary
Consider: What is your conclusion about the strength of the evidence? Would you use it to change your practice or to recommend changes to care? Strengths and limitations?
The problem the study was designed to solve
Consider: Is there a clear statement of the aim, why was it thought important to conduct this study?
Qualitative methodology appropriateness
Consider: what type of study design was used, was it appropriate to answer the research question, did the authors justify the research design?
Recruitment and sample
Consider: how were participants selected, were the sample’s characteristics appropriate based on the design and setting of the study?
Data collection
Consider: Was the setting for collection justified, is it clear how it was collected, were tools or instruments used, were they appropriate based on study design, is the form of the data clear (e.g., recordings, video, etc)?
Data analysis rigor
Consider: is an in-depth description of the analysis process given; is sufficient data presented to support findings; are contradictory data considered; has the researcher examined their own role, potential bias, and influence during the analysis and collection of data?