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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2
Quality Indicator Notes
Was the spectrum of patients representative of the spectrum of patients who will receive the test in practice? 'Yes' if the inclusion criteria clearly stipulated people attending an ambulatory healthcare setting with symptoms of malaria, and the sampling method was consecutive or random.
'No' if the sample was unrepresentative of people with uncomplicated malaria in general (for example, if the majority of participants also had some other presenting health problem, such as pneumonia). Where a proportion of potential participants were excluded due to recent antimalarial use, well defined co‐morbidities or pregnancy, the sample could be classed as representative, because these groups may also be excluded from testing as normal clinical practice, depending on local policy and practice.
'Unclear' if the source or characteristics of participants was not adequately described; or if the sampling method was not described.
Is the reference standard likely to correctly identify the target condition? 'Yes' if microscopy was undertaken by experienced microscopists with adequate laboratory facilities. Laboratory facilities were assumed to be adequate unless the study report indicated otherwise. Slides were viewed by at least two independent observers, either for all slides or for those where there were discordant results between the index and the reference test. At least 100 microscopic fields were viewed before declaring a slide negative.
'Yes' if reference standard was PCR.
'No' if microscopy was undertaken by insufficiently trained individuals, by one individual only, or in a situation with inadequate equipment, or if they viewed less than 100 microscopic fields before declaring negative.
'Unclear' if insufficient information was provided.
Is partial verification avoided? 'Yes' if all participants who received the index test also received the reference test.
'No' if not all the participants who received the index test also received the reference test.
'Unclear' if insufficient information was provided to assess this.
If not all participants received the reference test, we reported how many did not.
Is differential verification avoided? 'Yes' if the same reference test was used regardless of the index test results.
'No' if different reference tests were used depending on the results of the index test.
'Unclear' if insufficient information was provided.
If any participants received a different reference test, we reported the reasons stated for this, and how many participants were involved.
Is incorporation avoided? (the index test does not form part of the reference standard) Should be ‘Yes’ for all studies, as the reference standard is defined in the inclusion criteria as microscopy or PCR.
Are the reference standard test results blinded? 'Yes' if the person undertaking the reference test did not know the results of the index tests, if the two tests were carried out in different places, or it was clear that the reference test was undertaken and the results recorded before the index test.
'No' if the same person performed both tests, or if the results of the index tests were known to the person undertaking the reference tests.
'Unclear' if insufficient information was provided.
Are the index test results blinded? 'Yes' if the person undertaking the index test did not know the results of the reference tests, or if the two tests were carried out in different places, or it was clear that the index test was undertaken and the results recorded before the reference test.
'No' if the same person performed both tests, or if the results of the index tests were known to the person undertaking the reference tests.
'Unclear' if insufficient information was provided.
Were uninterpretable results reported? 'Yes' if the paper stated whether there were any uninterpretable or invalid results, and how those were handled; for example whether they were repeated until a valid result was obtained, or excluded from the analysis.
'No' if the number of participants presented in the analysis did not match the number of participants originally enrolled in the study, and insufficient explanation was provided for any discrepancy.
'Unclear' if uninterpretable or invalid test results were not mentioned, but the number of participants presented in the analysis corresponded to the number of participants reported to be originally recruited into the study, or if insufficient information was given to permit this judgement; for example if the original number of participants recruited into the study was unclear.
We reported how many results were uninterpretable (of the total), and how these were handled in the analysis.
Were any withdrawals explained? 'Yes' if it was clear that no participants were excluded from the analysis (the number of participants originally enrolled was clearly stated, and corresponded to the number presented in the analysis) or if exclusions were adequately described.
'No' if there were participants missing or excluded from the analysis and there was no explanation given; usually where the number of participants reported to have been enrolled and the number presented in the analysis did not correspond.
'Unclear' if not enough information was given to assess whether any participants were excluded from the analysis; for example if the original number of participants recruited into the study was unclear.
We reported how many participants were excluded from the analysis.