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As an observational study, the study limitations include inability to control for unknown confounders and residual confounding effect of known confounders which are adjusted for.
Meta-analyses were limited to randomized controlled trials because they are the only way to control for unknown confounders as well as the fact that nonrandomized controlled trials tend to overestimate the effects of treatment in healthcare interventions [ 12, 13].
Further, because this was an observational study, we were unable to control for unknown confounders.
Proportion sales were used instead of counts to control for unknown confounders such as changes in store hours.
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Although a randomised controlled trial design is generally a robust design that controls for unknown confounders and can often provide a causal link, there are inherent biases that may be particularly relevant in behavioural intervention trials.
Despite the study reporting similar populations and treatment of patients between the control and intervention groups, the historical control study design introduces the potential for unknown confounders and historical factors that may have affected the results.
However, it is not possible to adjust for unknown confounders or confounders on which data were not collected.
One of these is the potential for unknown confounders that were not recorded in the database.
Nevertheless, lack of adjustment for unknown confounders cannot be ruled out in our small study population.
Although all confounders known for the individual women are documented in detail at baseline adjustment or stratification cannot be done for unknown confounders.
Randomised controlled trials are used widely for showing causal relations in health and social care because their study design is the only one that is able to control for unknown or unmeasured confounders.
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