Table 6.
Examples of types of bias during different phases of study progression, descriptions of bias, examples of their effect on outcomes and preventive measures to be taken to minimize bias
| Phase | Type of bias | Description | Effect on outcome | Preventive measures |
|---|---|---|---|---|
| Planning | Selection bias | Errors during identification of study population or in any process of gathering sample | May undermine external validity and can lead to overestimation of e.g. accuracy | Choose prospective study design and enrol consecutively or randomly Perform a sample size calculation aligned with intended use of imaging method |
| Spectrum bias | Included sample does not represent intended spectrum of disease severity Subgroup differences e.g. screening population vs specialist population | May influence disease prevalence and thereby study outcomes e.g. accuracy may be overestimated | Ensure that included participants are representative of those that imaging method is intended for | |
| Referral bias | A type of spectrum bias Referral pattern distorts sample distribution | |||
| Implementation | Information bias | Selective revealing or suppression of information
|
May lead to status quo where multiple researchers discover and discard same outcomes May lead to overestimation of test performance | Provide detailed descriptions of information given prior to interpretation of index test, if possible ensure that intended use of test and/or normal clinical practices are followedStrive for blinding or double-blinding of subjects, researchers, technicians, data collector/analysts and evaluators or any persons involved, who may influence outcomes subjectively |
| Performance bias | Conduct and/or interpretation of index test is inadequately performed and/or insufficiently reported | May affect study outcomes and will not enable comparison or meta-analyses of studies of same imaging method | Provide detailed descriptions of methods and consider appropriate number of raters and think carefully about raters’ expertise | |
| Classification bias | Reference standard does not correctly classify target condition | May affect disease prevalence and thereby study outcomes | Ensure reference standard correctly reflects patients within target condition | |
| Verification bias | A set of participants does not undergo reference standard | Usually leads to overestimation of sensitivity | Ensure all participants undergo both index test and reference standard | |
| Incorporation bias | Reference standard is not independent of index test | May lead to overestimation of accuracy | Ensure reference standard and index test are independent | |
| Analysis Writing up | Verification bias | Attrition rate or reasons for withdrawals are not documented | Estimates may be inconclusive | Account for all participants who entered study Explain uninterruptable or intermediate test results |
| Citation bias | Citation or non-citation of research findings, depending on nature and direction | May threaten validity of future research as some results may incorrectly receive more and more emphasis | Cite and discuss supportive as well as unsupportive high-quality studies Analyse original data | |
| Publication bias Multiple (duplicate) publication bias | Publication or non-publication of research findings, depending on nature and direction of results Multiple publications overlap each other substantially or same publication is published several times | May lead to incorrect estimation of intervention effects May distort results of systematic reviews and meta-analyses | Strategy depends on whether aim is to tackle sets of missing studies, or whether selective/incomplete reporting of data is a primary problem In systematic reviews construct a funnel plot where estimates of efficacy are plotted against e.g. sample size Update systematic reviews regularly |