12/25/2023 0 Comments 2245 stone fish drWas exposure to intervention assessed using a valid method? Other: Valid method of exposure assessment Not applicable: Article reports on post-hoc analysis of data from a study initially published elsewhere.ġ0. It is likely that the majority of studies will fall into this category. Unclear risk: Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. subscales) that were not pre-specified one or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect) one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis the study report fails to include results for a key outcome that would be expected to have been reported for such a study. High risk: Any one of the following: not all of the study’s pre-specified primary outcomes have been reported one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. Low risk: Any of the following: the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon). This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement – for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealedįor studies that purport to be reporting the prespecified study outcomes, do the outcomes reported match those listed in the Methods section under “Outcomes,” or does the article state that some of the prespecified outcomes will be reported in subsequent articles? if envelopes were unsealed or non¬opaque or not sequentially numbered) alternation or rotation date of birth case record number any other explicitly unconcealed procedure. a list of random numbers) assignment envelopes were used without appropriate safeguards (e.g. High risk: Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization) sequentially numbered drug containers of identical appearance sequentially numbered, opaque, sealed envelopes. Low risk: Use of a third party and opaque envelopes of their equivalent are low risk. Was the group allocation concealed (such that assignments could not be predicted) Unclear risk: Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’ They usually involve judgement or some method of non-random categorization of participants, for example: allocation by judgement of the clinician allocation by preference of the participant allocation based on the results of a laboratory test or a series of tests allocation by availability of the intervention. Other non-random approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious. Usually, the description would involve some systematic, non-random approach, for example: sequence generated by odd or even date of birth sequence generated by some rule based on date (or day) of admission sequence generated by some rule based on hospital or clinic record number. High risk: The investigators describe a non-random component in the sequence generation process. Low risk: The investigators describe a random component in the sequence generation process such as: referring to a random number table using a computer random number generator coin tossing shuffling cards or envelopes throwing dice drawing of lots minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). Random sequence generation (selection bias)įor RCTs, is the sequence generation (recruitment) described as being random?įor CCTs, is the allocation described in such a way that it appears to be free of obvious (intentional) bias?įor crossover trials, was the order of receiving treatments randomized adequately?
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