Bias relates to: | INTERNAL VALIDITY RATING FORM | YES | NO |
Participants | - Sample selection: did investigators clearly specify inclusion/exclusion criteria to minimize sample heterogeneity? In studies with a control group, this bias should affect both groups equally.
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Participants | - Attrition (participant drop out): is participant drop out less than 20% in total sample and balanced between groups? If drop out is greater than 20% and unbalanced between groups, attrition may be a concern. Consider reasons for attrition if reported by researchers.
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Participants | - Attentional bias (Hawthorne effect):was participant behavior unaltered by experimenter expectations or attention? This bias should affect both groups equally assuming the control or placebo group gets equal attention.
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Participants | - Baseline equality: Were groups equal on important participant characteristics (e.g. age, gender, severity of disability) and outcome measures (dependent variables) at study outset? If not, were differences dealt with appropriately in data analysis?
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Participants | - Maturation or spontaneous recovery:there is no evidence that patients got better because of maturing (children) or natural healing (adults in acute phase of recovery) between pre and post testing? Not a significant concern in studies where data collection is completed in a short time (single session) or if there is a control group.
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Outcome Measures | - Psychometrics of dependent variables: Were the outcome measures valid and reliable for measuring the outcomes of interest? In studies with a control group, this bias should affect both groups equally.
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Outcome Measures | - Instrumentation bias: were the investigators careful to record information accurately and with calibrated instruments? In studies with a control group, this bias should affect both groups equally.
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Outcome Measures | - Blinding: Evaluator bias: was the outcome assessor unaware of group assignment (treatment or control)? Investigator bias: If possible,was the person providing the intervention blinded to group assignment?
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Outcome Measures | - Testing effects: the outcomes of interest were measured such that learning or fatigue were not likely to account for changes? Did investigators take care to measure at the same time of day at pre and post-testing? For studies where all participants experience multiple conditions, was the order of the conditions randomized (counterbalanced)? If order effects are not relevant based on the research design, ok to say "yes". In studies with a control group, this bias should affect both groups equally.
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Research Methods | - Data Analysis:Was the correct statistical analysis used for the data?
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Research Methods | - Was there adherence to the intervention? Did investigators keep track of and report compliance to treatment?In studies with a control group, this bias should affect both groups equally.
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Research Methods | - Co-intervention: participants did not begin or stop an activity/treatment in addition to their assigned intervention. Participants assigned to control group did not begin treatment of interest (contamination). In studies with a control group, this bias should affect both groups equally.
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