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in an experimental study, refers to whether patients, clinicians providing an intervention, people assessing outcomes, and/or data analysts were aware or unaware of the group to which patients were assigned. In the design section of Evidence-Based Nursing abstracts of treatment studies, the study is identified as blinded, with specification of who was blinded; unblinded, if all parties were aware of patients' group assignments; or blinded (unclear) if the authors did not report or provide us with an indication of who was aware or unaware of patients' group assignments.
Concealment of randomisation:
concealment of randomisation is specified in the design section of Evidence-Based Nursing abstracts of treatment studies as follows: allocation concealed (deemed to have taken adequate measures to conceal allocation to study group assignments from those responsible for assessing patients for entry in the trial [ie, central randomisation; sequentially numbered, opaque, sealed envelopes; sealed envelopes from a closed bag; numbered or coded bottles or containers; drugs prepared by the pharmacy; or other descriptions that contain elements convincing of concealment]); allocation not concealed (deemed to have not taken adequate measures to conceal allocation to study group assignments from those responsible for assessing patients for entry in the trial [ie, no concealment procedure was undertaken, sealed envelopes that were not opaque or were not sequentially numbered, or other descriptions that contained elements not convincing of concealment]); unclear allocation concealment (the authors did not report or provide a description of an allocation concealment approach that allowed for the classification as concealed or not concealed).
Confidence interval (CI):
quantifies the uncertainty in measurement; usually reported as 95% CI, which is the range of values within which we can be 95% sure that the true value for the whole population lies.
a procedure used in qualitative research wherein newly collected data are compared in an ongoing fashion with data obtained earlier, to refine theoretically relevant categories.
Fixed effects model:2
gives a summary estimate of the magnitude of effect in meta-analysis. It takes into account within-study variation but not between-study variation and hence is usually not used if there is significant heterogeneity.
an approach to collecting and analysing qualitative data with the aim of developing theories grounded in real world observations.
a defined, representative sample of patients is assembled for a study at a common (ideally early) point in their disease or condition and followed up over time.
Intention to treat analysis (ITT):
all patients are analysed in the groups to which they were randomised, even if they failed to complete the intervention or received the wrong intervention.
Number needed to harm (NNH):3
number of patients who, if they received the experimental treatment, would lead to 1 additional person being harmed compared with patients who receive the control treatment; this is calculated as 1/absolute risk increase (rounded to the next whole number), accompanied by the 95% confidence interval.
Number needed to treat (NNT):
number of patients who need to be treated to prevent 1 additional negative event (or to promote 1 additional positive event); this is calculated as 1/absolute risk reduction (rounded to the next whole number), accompanied by the 95% confidence interval.
an approach to inquiry that emphasises the complexity of human experience and the need to understand that experience holistically as it is actually lived.
participants are not randomly allocated to groups, but some other form of allocation is used (eg, day of the week, month of birth).
Relative benefit increase (RBI):
the proportional increase in the rates of good events between experimental and control participants; it is reported as a percentage (%).
Relative risk (RR) (risk ratio):
proportion of patients experiencing an outcome in the treated (or exposed) group divided by the proportion experiencing the outcome in the control (or unexposed) group.
Relative risk increase (RRI):
the proportional increase in bad outcomes between experimental and control participants; it is reported as a percentage (%).
Relative risk reduction (RRR):
the proportional reduction in bad outcomes between experimental and control participants; it is reported as a percentage (%).
Standardised mean difference:2
in a systematic review, a way of combining the results of studies that may have measured the outcome (eg, pain) in different ways, using different scales; effects are expressed as a standard value, with no units (difference between 2 means / estimate of within group standard deviation).
a qualitative research method that focuses on the way in which people make sense of social interactions and the meanings they attach to social symbols such as language.
in qualitative studies, selection of study participants based on emerging findings to ensure adequate representation of important themes.
statistical analysis accounts for differences in certain important variables.
Weighted mean difference:2
in a meta-analysis, used to combine outcomes measured on continuous scales (eg, height), assuming that all trials measured the outcome on the same scale; the mean, standard deviation and sample size of each group are known, and weight given to each trial is determined by the precision of its estimate of effect.
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