Generated Narrative: ValueSet 181524 version: 25; Last updated: 2025-12-08 21:53:13+0000 Include these codes as defined in https://fevir.net/sevco version ?2.0 Code Display Definition (core metadata concept) Synonym (core metadata concept) SEVCO:00002 selection bias A bias resulting from methods used to select subjects or data, factors that influence initial study participation, or differences between the study sample and the population of interest SEVCO:00016 confounding covariate bias A situation in which the effect or association between an exposure and outcome is distorted by another variable. For confounding covariate bias to occur the distorting variable must be (1) associated with the exposure and the outcome, (2) not in the causal pathway between exposure and outcome, and (3) unequally distributed between the groups being compared. SEVCO:00017 performance bias A bias resulting from differences between the received exposure and the intended exposure. Performance Adherence Bias SEVCO:00019 attrition bias A bias due to absence of expected participation or data collection after selection for study inclusion. Missing data bias SEVCO:00020 detection bias A bias due to distortions in any process involved in the determination of the recorded values for a variable. SEVCO:00021 analysis bias A bias related to the analytic process applied to the data. SEVCO:00023 reporting bias A bias due to distortions in the selection of or representation of information in study results or research findings. SEVCO:00026 synthesis bias A bias in the conduct of a systematic review resulting from methods used to select, manipulate or interpret data for evidence synthesis. SEVCO:00028 qualitative research bias A bias specific to the design, conduct, analysis or reporting of qualitative research. SEVCO:00029 mixed methods research bias A bias specific to the coordination of design, conduct, analysis or reporting of qualitative research and quantitative research. SEVCO:00030 bias in validation assessment A bias in the design, conduct or reporting of studies or analyses intended to evaluate the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose. validation bias SEVCO:00370 early study termination bias A bias due to the decision to end the study earlier than planned. Bias due to early study termination SEVCO:00001 bias A systematic distortion in research results (estimation of effect, association, or inference). Distortions in research results means differences between the reported results (findings, conclusions, effect estimates) and the actuality (the truth, the estimand [the quantity targeted for estimation]) SEVCO:00003 participant selection bias A selection bias resulting from methods used to select participating subjects, factors that influence initial study participation, or differences between the study participants and the population of interest SEVCO:00004 inappropriate selection criteria A selection bias resulting from inclusion and exclusion criteria used to select participating subjects that could result in differences between the study participants and the population of interest. Selection bias due to inappropriate selection criteria SEVCO:00005 inappropriate sampling strategy A selection bias resulting from the sampling frame, sampling procedure, or methods used to recruit participating subjects that could result in differences between the study participants and the population of interest. Selection bias due to inappropriate sampling strategy SEVCO:00014 inappropriate data source for participant selection Participant selection bias due to inappropriate data source for sampling frame. Participant selection bias due to inappropriate data source for sampling frame SEVCO:00006 non-representative sample A selection bias due to differences between the included participants and the population of interest that distorts the research results (estimation of effect, association, or inference), limiting external validity or applicability. Nonrepresentative sample SEVCO:00008 inadequate enrollment of eligible subjects A selection bias in which insufficient enrollment of eligible subjects results in differences (recognized or unrecognized) between the included participants and the population of interest that distorts the research results. Non-representative sample due to inadequate enrollment SEVCO:00012 non-representative sample due to timing or duration of exposure A selection bias in which the timing or duration of exposure influences the outcome, and the timing or duration of exposure in the sample does not represent that of the population of interest. This selection bias may occur when the selection for study participation is not coincident with the initiation of the exposure or intervention under investigation. Mismatch in start of intervention and start of follow-up SEVCO:00013 depletion of susceptibles A non-representative sample due to exclusion of susceptible participants who have already had an outcome due to prior exposure. For example, the inclusion of prevalent users of a medication misrepresents the initial adverse effects rate by excluding persons who do not tolerate the medication. Non-representative sample due to depletion of susceptibles SEVCO:00009 post-baseline factors influence enrollment selection A selection bias in which factors observed after study entry, baseline, or start of follow-up influence enrollment Participant selection bias due to post-baseline factors SEVCO:00212 participant selection bias due to early study termination A selection bias due to premature closure of study enrollment. Early termination bias affecting enrollment SEVCO:00010 factor associated with exposure influences enrollment selection A selection bias in which a factor associated with the exposure under investigation influences study enrollment Participant selection bias due to factor associated wiith exposure SEVCO:00011 factor associated with outcome influences enrollment selection A selection bias in which a factor associated with the outcome under investigation influences study enrollment Participant selection bias due to factor associated wiith outcome SEVCO:00015 study selection bias A selection bias resulting from factors that influence study selection, from methods used to include or exclude studies for evidence synthesis, or from differences between the study sample and the population of interest SEVCO:00262 bias in study eligibility criteria SEVCO:00273 study eligibility criteria not prespecified SEVCO:00274 study eligibility criteria not appropriate for review question SEVCO:00275 study eligibility criteria ambiguous SEVCO:00276 study eligibility criteria limits for study characteristics not appropriate SEVCO:00277 study eligibility criteria limits for study report characteristics not appropriate SEVCO:00263 database search sources inadequate SEVCO:00264 non-database search sources inadequate SEVCO:00265 search strategy not sensitive SEVCO:00266 search strategy limits for study report characteristics not appropriate SEVCO:00267 misapplication of study eligibility criteria SEVCO:00268 bias in study selection process SEVCO:00269 language bias SEVCO:00270 geography bias SEVCO:00271 one-sided reference bias SEVCO:00272 publication bias SEVCO:00032 allocation bias A confounding covariate bias resulting from methods for assignment of the independent variable by the investigator to evaluate a response or outcome. SEVCO:00031 inadequate allocation concealment An allocation bias resulting from awareness of the assigned intervention before study enrolment and intervention assignment SEVCO:00278 bias due to non-randomized allocation An allocation bias resulting from a process of assigning participants or subjects to different groups or conditions which is not random. Bias due to non-random allocation SEVCO:00033 comparator selection bias A confounding covariate bias resulting from methods used to select participating subjects, or factors that influence study participation, for the comparator group. Comparison Selection Bias SEVCO:00034 confounding difference A confounding covariate bias in which the unequal distribution of a potentially distorting variable is recognized. Recognized confounding difference SEVCO:00280 confounding by time of observation A confounding covariate bias in which the distorting variable is the time at which the outcome is measured or observed. Confounding by follow-up time SEVCO:00281 lead time bias A confounding covariate bias in which the distorting variable is the length of time that the participant has had the condition of interest at study enrollment. Starting time bias SEVCO:00282 confounding influencing adherence to intervention A confounding covariate bias in which the distorting variable is associated with deviations from the intended intervention. SEVCO:00284 confounding by indication A confounding covariate bias in which the distorting variable is the reason for receiving an exposure. SEVCO:00388 confounding by contraindication A confounding covariate bias in which the distorting variable is the reason for not receiving an exposure. SEVCO:00390 time-varying confounding affected by past exposure A confounding covariate bias in which the distorting variable is itself influenced by the exposure. SEVCO:00035 inadequate blinding of participants A performance bias due to awareness of the allocated intervention by participants Lack of blinding of participants SEVCO:00036 inadequate blinding of intervention deliverers A performance bias due to awareness of the allocated intervention by individuals providing or delivering the intervention Lack of blinding of intervention deliverers SEVCO:00037 deviation from study intervention protocol A performance bias in which the intervention received differs from the intervention specified in the study protocol SEVCO:00038 deviation from standard of care A performance bias in which the intervention or exposure received differs from the from the usual practice or expected care SEVCO:00039 nonadherence of implementation A performance bias in which the intervention deliverers do not completely adhere to the expected intervention Nonadherence of interventionalist SEVCO:00040 nonadherence of participants A performance bias in which the participants do not completely adhere to the expected intervention or exposure SEVCO:00041 imbalance in deviations from intended intervention A performance bias in which the degree of performance bias is unequally distributed between groups being compared Asymmetry in adherence between groups SEVCO:00286 attrition bias due to participant attrition A bias due to absence of expected participation due to participant dropout, withdrawal or non-participation after selection for study inclusion. SEVCO:00287 attrition bias due to missing data A bias due to data loss or absence of data collection from participants after selection for study inclusion. SEVCO:00386 attrition bias due to missing outcome data An attrition bias due to missing data specific to the dependent variable. SEVCO:00288 attrition bias due to missing exposure data An attrition bias due to missing data specific to the independent variable(s) of primary interest, such as exposure or intervention. Attrition bias due to missing intervention data SEVCO:00289 attrition bias due to missing modifier data An attrition bias due to missing data specific to a confounder or effect modifier SEVCO:00387 attrition bias due to missing data about attrition An attrition bias due to missing data specific to the extent of or reasons for missing data. SEVCO:00290 imbalance in missing data An attrition bias in which the degree of missing data is unequally distributed between groups being compared. SEVCO:00291 inadequate response rate An attrition bias in which the reason for absence of data collection is a low response rate to data collection surveys. SEVCO:00042 outcome detection bias A detection bias due to distortions in how an outcome is determined. SEVCO:00047 cognitive interpretive bias for outcome determination An outcome detection bias due to the subjective nature of human interpretation. Subjectivity bias for outcome determination SEVCO:00048 bias due to lack of masking for outcome determination A cognitive interpretive bias for outcome determination due to awareness of the participant's status with respect to the exposure of interest. Awareness bias for outcome determination SEVCO:00049 observer bias for outcome determination A cognitive interpretive bias for outcome determination due to subjective interpretations in the process of observing and recording information. SEVCO:00052 confirmation bias for outcome determination An observer bias for outcome determination due to previous opinions or knowledge of a subject’s prior exposures or assessments. Previous opinion bias for outcome determination SEVCO:00050 recall bias for outcome determination A cognitive interpretive bias for outcome determination due to differences in accuracy or completeness of recall of past events or experiences. SEVCO:00051 apprehension bias for outcome determination A cognitive interpretive bias for outcome determination due to a study participant's responding or behaving differently when aware of being observed. Hawthorne effect for outcome determination SEVCO:00053 hypothetical assessment bias for outcome determination A cognitive interpretive bias for outcome determination due to a difference between an individual’s report of an imagined or hypothetical response from their actual response. The response may be a behavior or valuation. Subjunctivity bias for outcome determination SEVCO:00054 mimicry bias for outcome determination A cognitive interpretive bias for outcome determination due to a misinterpretation of observations that resemble the outcome. SEVCO:00057 unacceptability bias for outcome determination A cognitive interpretive bias for outcome determination due to distortions in response, response values, or recording of responses resulting from perception of the social unacceptability of an outcome. Unacceptable disease bias for outcome determination SEVCO:00058 outcome ascertainment bias An outcome detection bias due to distortions in how the data are collected. Ascertainment Bias for outcome determination SEVCO:00097 nonrepresentative observation period for outcome of interest An outcome ascertainment bias due to differences in the period used for observation of the outcome and the period for the outcome of interest. Misaligned follow up period for outcome of interest SEVCO:00098 nonrepresentative context for outcome ascertainment An outcome ascertainment bias due to differences in the context in which the outcome is observed and the intended context for the outcome of interest. SEVCO:00099 inconsistency in outcome ascertainment An outcome ascertainment bias due to differences within or between groups in how the data are collected. Imbalance in outcome ascertainment SEVCO:00059 outcome measurement bias An outcome detection bias due to distortions in how the observed outcomes are measured. Measurement Bias for outcome determination SEVCO:00100 inappropriate method for outcome measurement An outcome measurement bias due to use of an incorrect method or protocol. Inappropriate outcome measurement method SEVCO:00101 insensitive measure bias for outcome determination An outcome measurement bias due to use of a method that does not reliably detect the outcome when the outcome is present. Inadequate sensitivity for outcome measure SEVCO:00211 nonspecific measure bias for outcome determination An outcome measurement bias due to use of a method that falsely detects the outcome when the outcome is absent. Inadequate specificity for outcome measure SEVCO:00103 inappropriate application of method for outcome measurement An outcome measurement bias due to inappropriate application of the method or protocol. SEVCO:00104 inconsistency in outcome measurement An outcome measurement bias due to differences within groups in how the observed outcomes are measured. SEVCO:00243 inconsistency in instruments used for outcome measurement An outcome measurement bias due to differences within groups in the instruments used for measurement. SEVCO:00244 inconsistency in processes used for outcome measurement An outcome measurement bias due to differences within groups in the processes by which the instruments are used for measurement. SEVCO:00240 imbalance in outcome measurement An outcome measurement bias due to differences between groups in how the observed outcomes are measured. SEVCO:00245 imbalance in instruments used for outcome measurement An outcome measurement bias due to differences between groups in the instruments used for measurement. SEVCO:00246 imbalance in processes used for outcome measurement An outcome measurement bias due to differences between groups in the processes by which the instruments are used for measurement. SEVCO:00060 outcome classification bias An outcome detection bias due to distortions in how the observed outcomes are classified. Outcome Misclassification Bias SEVCO:00061 outcome classification system bias An outcome classification bias resulting from the definition or threshold used for outcome classification. Outcome definition bias SEVCO:00105 nonrepresentative definition for outcome classification An outcome classification system bias due to a mismatch between the outcome of interest and the definition or threshold used for outcome measurement. SEVCO:00108 surrogate marker bias for outcome classification An outcome classification system bias due to use of a definition that is proxy for the outcome rather than direct observation of the outcome. Substitution bias for outcome classification SEVCO:00106 post-hoc definition of outcome An outcome classification system bias due to defining the outcome after interacting with the study data. No prespecified definition for outcome classification SEVCO:00062 outcome classification process bias An outcome classification bias resulting from the application of the method used for outcome classification. Classification Process Bias for outcome determination SEVCO:00063 incorporation bias for outcome determination An outcome classification bias due to the inclusion of the exposure under investigation in the method or process used for outcome classification. SEVCO:00043 exposure detection bias A detection bias due to distortions in how an exposure of interest is determined. SEVCO:00055 cognitive interpretive bias for exposure determination An exposure detection bias due to the subjective nature of human interpretation. Subjectivity bias for exposure determination SEVCO:00056 bias due to lack of masking for exposure determination A cognitive interpretive bias for exposure determination due to awareness of the participant's status with respect to the outcome of interest or other relevant exposures. Awareness bias for exposure determination SEVCO:00238 observer bias for exposure determination A cognitive interpretive bias for exposure determination due to subjective interpretations in the process of observing and recording information. SEVCO:00239 confirmation bias for exposure determination An observer bias for exposure determination due to previous opinions or knowledge of a subject’s prior exposures or assessments. Previous opinion bias for exposure determination SEVCO:00214 recall bias for exposure determination A cognitive interpretive bias for exposure determination due to differences in accuracy or completeness of recall of past events or experiences. SEVCO:00215 apprehension bias for exposure determination A cognitive interpretive bias for exposure determination due to a study participant's responding or behaving differently when aware of being observed. Hawthorne effect for exposure determination SEVCO:00216 hypothetical assessment bias for exposure determination A cognitive interpretive bias for exposure determination due to a difference between an individual’s report of an imagined or hypothetical response from their actual response. Subjunctivity bias for exposure determination SEVCO:00217 mimicry bias for exposure determination A cognitive interpretive bias for exposure determination due to a misinterpretation of observations that resemble the exposure. SEVCO:00218 unacceptability bias for exposure determination A cognitive interpretive bias for exposure determination due to distortions in response, response values, or recording of responses resulting from perception of the social unacceptability of an exposure. Unacceptable disease bias for exposure determination SEVCO:00219 exposure ascertainment bias An exposure detection bias due to distortions in how the data are collected. Data collection bias for exposure determination SEVCO:00220 nonrepresentative observation period for exposure of interest An exposure ascertainment bias due to differences in the time period used for observation of the exposure and the intended time period for the exposure of interest. Misaligned follow up period for exposure of interest SEVCO:00221 nonrepresentative context for exposure ascertainment An exposure ascertainment bias due to differences in the context in which the exposure is observed and the intended context for the exposure of interest. SEVCO:00222 inconsistency in exposure ascertainment An exposure ascertainment bias due to differences within or between groups in how the data are collected. Imbalance in exposure ascertainment SEVCO:00223 exposure measurement bias An exposure detection bias due to distortions in how the observed exposures are measured. Measurement Bias for exposure determination SEVCO:00224 inappropriate method for exposure measurement An exposure measurement bias due to use of an incorrect method or protocol. Inappropriate exposure measurement method SEVCO:00225 insensitive measure bias for exposure determination An exposure measurement bias due to use of a method that does not reliably detect the exposure when the exposure is present. Inadequate sensitivity for exposure determination SEVCO:00226 nonspecific measure bias for exposure determination An exposure measurement bias due to use of a method that falsely detects the exposure when the exposure is absent. Inadequate specificity for exposure measure SEVCO:00228 inappropriate application of method for exposure measurement An exposure measurement bias due to inappropriate application of the method or protocol. Inappropriate exposure measurement conduct SEVCO:00229 inconsistency in exposure measurement An exposure measurement bias due to differences within groups in how the observed exposures are measured. SEVCO:00247 inconsistency in instruments used for exposure measurement An exposure measurement bias due to differences within groups in the instruments for measurement. SEVCO:00248 inconsistency in processes used for exposure measurement An exposure measurement bias due to differences within groups in the processes by which the instruments are used for measurement. SEVCO:00241 imbalance in exposure measurement An exposure measurement bias due to differences between groups in how the observed exposures are measured. SEVCO:00249 imbalance in instruments used for exposure measurement An exposure measurement bias due to differences between groups in the instruments used for measurement. SEVCO:00250 imbalance in processes used for exposure measurement An exposure measurement bias due to differences between groups in the processes by which the instruments are used for measurement. SEVCO:00230 exposure classification bias An exposure detection bias due to distortions in how the observed exposures are classified. Exposure Misclassification Bias SEVCO:00231 exposure definition bias An exposure classification bias resulting from the definition or threshold used for exposure classification. Threshold Bias for exposure determination SEVCO:00232 nonrepresentative definition for exposure classification An exposure definition bias due to a mismatch between the exposure of interest and the definition or threshold used for exposure measurement. SEVCO:00233 surrogate marker bias for exposure classification An exposure definition bias due to use of a definition that is proxy for the exposure rather than direct observation of the exposure. Proxy bias for exposure classification SEVCO:00234 post-hoc definition of exposure An exposure definition bias due to definition of the exposure after interacting with the study data. No prespecified definition for exposure classification SEVCO:00236 classification process bias for exposure determination An exposure classification bias resulting from the application of the method used for exposure classification. SEVCO:00237 incorporation bias for exposure determination An exposure classification bias due to the inclusion of the outcome or other relevant exposures under investigation in the method or process used for exposure classification. SEVCO:00044 confounder detection bias A detection bias due to distortions in how the data for a potential confounder are determined. SEVCO:00045 detection bias related to the reference standard A detection bias due to distortions in how the reference standard result is determined. Bias for reference standard result determination SEVCO:00046 detection bias related to the index test A detection bias due to distortions in how the index test result is determined. Bias for index test result determination SEVCO:00383 data entry bias A detection bias due to differences between measured values and recorded values. Data Recording Bias SEVCO:00389 inappropriate time interval between predictor assessment and outcome determination A detection bias involving the time interval between the observation of the predictor and outcome, where the interval used by the study differs from the interval assumed by the predictive model. SEVCO:00022 bias related to selection of the analysis An analysis bias due to inappropriate choice of analysis methods before the analysis is applied. Analysis Selection Bias SEVCO:00376 bias related to selection of the data for analysis An analysis bias due to inappropriate choice of data included in the analysis before the analysis is applied. SEVCO:00213 bias due to post-baseline factors influencing selection of the data for analysis A bias related to selection of the data analysis based on participant characteristics observed after study enrollment. SEVCO:00312 missing or inadequate intention-to-treat analysis A bias related to selection of the data analysis in which data are not completely analyzed according to the original assignment to comparison groups in an interventional study. Inadequate as-randomized analysis SEVCO:00313 missing or inadequate per-protocol analysis A bias related to selection of the data analysis in which data are not completely analyzed according to the study protocol. SEVCO:00381 missing or inadequate as-treated analysis A bias related to selection of the data analysis in which data are not completely analyzed according to the interventions actually received. SEVCO:00377 bias related to selection of the variables for analysis An analysis bias due to inappropriate choice of variables included in the analysis before the analysis is applied. SEVCO:00292 bias related to selection of the variables for adjustment for confounding An analysis bias due to inappropriate choice of the variables for adjustment for confounding before the analysis is applied. SEVCO:00299 bias controlling for time-varying confounding A bias related to selection of the variables for adjustment for confounding in which the confounding is time-dependent. SEVCO:00301 inadequate adherence effect analysis A bias related to selection of the variables for adjustment for confounding by adherence. Bias controlling for confounding by adherence SEVCO:00302 predictors included in outcome definition An analysis bias due to inappropriate choice of the variables for estimation of association in which one variable is incorporated in the definition of the other variable. SEVCO:00319 bias related to selection of predictors based on univariable analysis An analysis bias due to inappropriate choice of the predictor variables for estimation of association in which predictors are selected based on statistically significant univariable associations (without adjustment for other predictors). SEVCO:00378 bias related to selection of the analytic framework An analysis bias due to inappropriate choice of the analytic framework before the analysis is applied. Bias related to selection of the statistical framework SEVCO:00297 inappropriate statistical model A bias related to selection of the analytic framework in which the analytic model does not match the dataset characteristics or does not match the intention of the analysis. Inappropriate analytic model SEVCO:00375 inappropriate modeling of censoring An inappropriate statistical model due to inappropriate accounting for ranges of potential observation in which data observation is not possible. SEVCO:00316 bias due to selection of the statistical significance threshold An analysis bias resulting from selection of an inappropriate threshold for statistical significance. Bias related to selection of the threshold for statistical significance SEVCO:00317 bias related to multiple comparison adjustment An analysis bias resulting from selection of a threshold for statistical significance which does not appropriately account for the effect of multiple comparisons on the statistical probability related to the result. SEVCO:00382 mismatch of significance threshold and purpose An analysis bias resulting from selection of a threshold for statistical significance which is inappropriate due to a mismatch between (1) how the statistical probability related to the result is determined and (2) the purpose for categorizing the result as statistically significant. SEVCO:00304 immortal time bias A bias related to selection of the analytic framework in which an outcome variable includes an observation period during which the outcome could not have occurred. SEVCO:00293 inadequate sample size A bias related to selection of the analytic framework in which the sample size invalidates the assumptions of the analytic framework. Inadequate numbers for analysis SEVCO:00294 bias related to execution of the analysis An analysis bias due to inappropriate decisions pertaining to preparation of data for analysis and/or conduct of the analysis. Bias in processing of data SEVCO:00305 incomplete analysis An analysis bias due to absence of a component of the analytic process. Incomplete analysis process SEVCO:00306 inappropriate handling of uninterpretable data An analysis bias due to omission of uninterpretable values, or their replacement with inappropriate values. SEVCO:00307 inappropriate handling of missing data An analysis bias due to use of non-representative values in place of missing data. SEVCO:00308 inappropriate handling of variables An analysis bias due to processing a variable in an incorrect role or with an incorrect datatype. SEVCO:00300 bias in adjustment for selection bias An analysis bias due to inappropriate application of adjustment techniques for correction of bias in the selection of participants for analysis. SEVCO:00309 data transition bias An analysis bias due to differences between recorded data and data used for analysis. SEVCO:00311 inappropriate handling of missing confounder data An analysis bias due to use of non-representative values in place of missing data for variables in the role of confounder. SEVCO:00298 computational implementation bias An analysis bias due to miscalculations in the processing of the data. Programming Error SEVCO:00324 reported analysis not following pre-specified analysis plan An analysis bias in which the reported analysis does not match the pre-specified analysis plan. SEVCO:00303 collider bias An analysis bias in which an estimation of association between two variables is distorted by controlling for a third variable affected by both variables of interest (or factors causing the variables of interest). SEVCO:00314 preliminary analysis bias An analysis bias related to analysis of data before the complete dataset is available. Interim analysis bias SEVCO:00295 data-dredging bias An analysis bias involving use of data analyses that are not pre-specified and fully disclosed, to select analyses with desirable results. Fishing expedition bias SEVCO:00322 final model not corresponding to multivariable analysis An analysis bias in which the predictors and coefficients in the final model do not match the predictors and coefficients reported in the multivariable analysis. SEVCO:00310 cognitive interpretive bias affecting analysis A bias related to the analytic process due to the subjective nature of human interpretation. SEVCO:00379 cognitive interpretive bias affecting analysis selection A bias related to selection of the analysis due to the subjective nature of human interpretation. SEVCO:00315 availability bias affecting analysis selection A Cognitive Interpretive Bias due to the use of information which is most readily available, rather than information which is most representative, affecting analysis selection. SEVCO:00380 cognitive interpretive bias affecting execution of the analysis A bias in processing of data due to the subjective nature of human interpretation. SEVCO:00296 lack of blinding of data analysts A cognitive interpretive bias affecting execution of the analysis due to the analyst's awareness of the participants' status with respect to the variables defining the comparison groups. Lack of masking of data analysts SEVCO:00392 inappropriate weighting bias An analysis bias in which the weights used in model construction do not align with the target of estimation or estimand. SEVCO:00320 inappropriate evaluation of predictive model performance measures An analysis bias in which the method for analysis of a performance measure (such as calibration or discrimination) is not adequate or suitable for the predictive model. SEVCO:00393 inappropriate evaluation of calibration of predictive model An analysis bias in which the method for analysis of calibration is not adequate or suitable for the predictive model. SEVCO:00394 inappropriate evaluation of discrimination of predictive model An analysis bias in which the method for analysis of discrimination is not adequate or suitable for the predictive model. SEVCO:00321 model overfitting An analysis bias, specific to predictive model development studies, in which strategies to mitigate overfitting are not adequately applied. SEVCO:00024 selective reporting bias A reporting bias due to inappropriate selection of the results or research findings that are reported. SEVCO:00330 selective outcome reporting A selective reporting bias due to inappropriate selection of which outcomes are reported within results or research findings. Outcome reporting bias SEVCO:00336 selective outcome measure reporting A selective reporting bias due to inappropriate selection of which outcome measures are reported for an outcome. Selective outcome measure reporting within outcome domain SEVCO:00331 selective subgroup reporting A selective reporting bias due to inappropriate selection of subsets of groups of participants for which results or research findings are reported. Selective subgroup analysis reporting SEVCO:00331a selective comparison reporting A selective reporting bias due to inappropriate selection of comparison groups for which results or research findings are reported. SEVCO:00333 selective analysis reporting from repeated analyses at multiple times A selective reporting bias due to inappropriate selection of which analyses are reported for an outcome that was analyzed at multiple points in time in a longitudinal study. SEVCO:00334 selective analysis reporting from multiple analytic models A selective reporting bias due to inappropriate selection of which analyses are reported for an outcome that was analyzed in multiple ways. SEVCO:00335 selective threshold reporting bias A selective reporting bias due to inappropriate selection of which thresholds (used for definitions of the variables) are reported. Selective cutoff reporting bias SEVCO:00025 cognitive interpretive bias in reporting A distortion in the representation of study results or research findings due to the subjective nature of human interpretation. Cognitive interpretive reporting bias SEVCO:00338 interpretation of results not addressing potential for bias A cognitive interpretive bias in reporting whereby the reported interpretation of results does not adequately address potential for bias. Interpretation of results not addressing risk of bias SEVCO:00328 results emphasized based on statistical significance A cognitive interpretive bias in reporting whereby results with statistical significance are given exaggerated attention. SEVCO:00340 confirmation bias in reporting A cognitive interpretive bias in reporting due to the influence of an individual’s ideas, beliefs or hypotheses. SEVCO:00329 external validity bias A cognitive interpretive bias in reporting due to a mismatch between what the observed data represent and the results that were reported. SEVCO:00327 early dissemination bias A reporting bias due to publication or reporting of results or research findings that change in subsequent reports. Premature dissemination bias SEVCO:00384 fabrication bias A reporting bias resulting from intentional misrepresentation of any part of the study. Fraud SEVCO:00325 inadequate reporting of methods A reporting bias due to insufficient reporting of methods to determine the validity of the results. Inadequate methods reporting bias SEVCO:00326 inadequate explanation of participant withdrawals A reporting bias due to insufficient reporting of reasons for withdrawals of participants after study enrollment. Inadequate explanation of participant attrition SEVCO:00345 bias related to selection of the studies for synthesis SEVCO:00346 bias related to selection of the analytic framework for synthesis SEVCO:00347 inadequate accounting for heterogeneity SEVCO:00348 inadequate sensitivity analysis SEVCO:00349 inadequate accounting for bias in constituent studies SEVCO:00351 inadequate study characteristics available for results interpretation SEVCO:00352 bias related to selection of the data for synthesis SEVCO:00353 inadequate criteria for methodologic quality assessment SEVCO:00354 inadequate process for methodologic quality assessment SEVCO:00369 inadequate process for data extraction SEVCO:00356 bias in qualitative research design SEVCO:00357 bias in qualitative data collection methods SEVCO:00358 bias in qualitative analysis SEVCO:00359 unsubstantiated interpretation of results SEVCO:00360 incoherence among qualitative data, analysis, and interpretation SEVCO:00361 inadequate rationale for mixed methods design SEVCO:00362 ineffective integration of qualitative and quantitative study components SEVCO:00363 inappropriate interpretation of integration of qualitative and quantitative findings SEVCO:00364 inadequate handling of inconsistency between qualitative and quantitative findings SEVCO:00368 bias in external validation assessment A bias in validation assessment using a sample source that differs from those used in the derivation of the procedure. inadequate external validation assessment SEVCO:00367 bias in internal validation assessment A bias in validation assessment specific to a validation assessment that uses the same sample source that was used in the derivation of the procedure. inadequate internal validation assessment SEVCO:00371 early study termination bias due to competing interests An early study termination bias due to the decision to end the study being influenced by financial, commercial, legal, political, social, professional, or intellectual interests. SEVCO:00372 early study termination bias due to unplanned use of interim analysis An early study termination bias due to awareness of study results without following a preplanned protocol for how interim results will influence the decision to terminate the study. SEVCO:00373 early study termination bias due to inappropriate statistical stopping rule An early study termination bias due to use of an inappropriate model or threshold in the analysis used for determination to end the study. SEVCO:00374 early study termination bias due to external factors An early study termination bias due to a decision to end the study based on factors other than the results of interim analysis.
Risk Of Bias Type Value Set [Database Entry: FHIR ValueSet Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 181524. Revised 2025-12-08. Available at: https://fevir.net/resources/ValueSet/181524. Computable resource at: https://fevir.net/resources/ValueSet/181524#json.
HL7 International / Clinical Decision Support
Types of bias for use with risk of bias assessment. This is a snapshot version from a code system in development (original source at https://fevir.net/resources/CodeSystem/27270) and is provided for example support in the EBMonFHIR Implementation Guide.
Risk Of Bias Type Value Set [ValueSet]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 181524. Revised 2023-12-08. Available at: https://fevir.net/resources/ValueSet/181524. Computable resource at: https://fevir.net/resources/ValueSet/181524.
A bias resulting from methods used to select subjects or data, factors that influence initial study participation, or differences between the study sample and the population of interest
A situation in which the effect or association between an exposure and outcome is distorted by another variable. For confounding covariate bias to occur the distorting variable must be (1) associated with the exposure and the outcome, (2) not in the causal pathway between exposure and outcome, and (3) unequally distributed between the groups being compared.
A bias resulting from differences between the received exposure and the intended exposure.
A bias due to absence of expected participation or data collection after selection for study inclusion.
A bias due to distortions in any process involved in the determination of the recorded values for a variable.
A bias related to the analytic process applied to the data.
A bias due to distortions in the selection of or representation of information in study results or research findings.
A bias in the conduct of a systematic review resulting from methods used to select, manipulate or interpret data for evidence synthesis.
A bias specific to the design, conduct, analysis or reporting of qualitative research.
A bias specific to the coordination of design, conduct, analysis or reporting of qualitative research and quantitative research.
A bias in the design, conduct or reporting of studies or analyses intended to evaluate the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose.
A bias due to the decision to end the study earlier than planned.
A systematic distortion in research results (estimation of effect, association, or inference). Distortions in research results means differences between the reported results (findings, conclusions, effect estimates) and the actuality (the truth, the estimand [the quantity targeted for estimation])
A selection bias resulting from methods used to select participating subjects, factors that influence initial study participation, or differences between the study participants and the population of interest
A selection bias resulting from inclusion and exclusion criteria used to select participating subjects that could result in differences between the study participants and the population of interest.
Selection bias due to inappropriate selection criteria
A selection bias resulting from the sampling frame, sampling procedure, or methods used to recruit participating subjects that could result in differences between the study participants and the population of interest.
Selection bias due to inappropriate sampling strategy
inappropriate data source for participant selection
Participant selection bias due to inappropriate data source for sampling frame.
Participant selection bias due to inappropriate data source for sampling frame
A selection bias due to differences between the included participants and the population of interest that distorts the research results (estimation of effect, association, or inference), limiting external validity or applicability.
Selection bias due to non-representative sample
inadequate enrollment of eligible subjects
A selection bias in which insufficient enrollment of eligible subjects results in differences (recognized or unrecognized) between the included participants and the population of interest that distorts the research results.
Selection bias due to inadequate enrollment
Non-representative sample due to inadequate enrollment
non-representative sample due to timing or duration of exposure
A selection bias in which the timing or duration of exposure influences the outcome, and the timing or duration of exposure in the sample does not represent that of the population of interest. This selection bias may occur when the selection for study participation is not coincident with the initiation of the exposure or intervention under investigation.
Mismatch in start of intervention and start of follow-up
A non-representative sample due to exclusion of susceptible participants who have already had an outcome due to prior exposure. For example, the inclusion of prevalent users of a medication misrepresents the initial adverse effects rate by excluding persons who do not tolerate the medication.
Non-representative sample due to depletion of susceptibles
post-baseline factors influence enrollment selection
A selection bias in which factors observed after study entry, baseline, or start of follow-up influence enrollment
Participant selection bias due to post-baseline factors
participant selection bias due to early study termination
A selection bias due to premature closure of study enrollment.
Early termination bias affecting enrollment
factor associated with exposure influences enrollment selection
A selection bias in which a factor associated with the exposure under investigation influences study enrollment
Participant selection bias due to factor associated wiith exposure
factor associated with outcome influences enrollment selection
A selection bias in which a factor associated with the outcome under investigation influences study enrollment
Participant selection bias due to factor associated wiith outcome
A selection bias resulting from factors that influence study selection, from methods used to include or exclude studies for evidence synthesis, or from differences between the study sample and the population of interest
study eligibility criteria not prespecified
study eligibility criteria not appropriate for review question
study eligibility criteria limits for study characteristics not appropriate
study eligibility criteria limits for study report characteristics not appropriate
search strategy limits for study report characteristics not appropriate
misapplication of study eligibility criteria
A confounding covariate bias resulting from methods for assignment of the independent variable by the investigator to evaluate a response or outcome.
An allocation bias resulting from awareness of the assigned intervention before study enrolment and intervention assignment
An allocation bias resulting from a process of assigning participants or subjects to different groups or conditions which is not random.
A confounding covariate bias resulting from methods used to select participating subjects, or factors that influence study participation, for the comparator group.
A confounding covariate bias in which the unequal distribution of a potentially distorting variable is recognized.
Recognized Difference with Potential for Confounding
A confounding covariate bias in which the distorting variable is the time at which the outcome is measured or observed.
A confounding covariate bias in which the distorting variable is the length of time that the participant has had the condition of interest at study enrollment.
confounding influencing adherence to intervention
A confounding covariate bias in which the distorting variable is associated with deviations from the intended intervention.
A confounding covariate bias in which the distorting variable is the reason for receiving an exposure.
A confounding covariate bias in which the distorting variable is the reason for not receiving an exposure.
time-varying confounding affected by past exposure
A confounding covariate bias in which the distorting variable is itself influenced by the exposure.
A performance bias due to awareness of the allocated intervention by participants
inadequate blinding of intervention deliverers
A performance bias due to awareness of the allocated intervention by individuals providing or delivering the intervention
Inadequate masking of intervention deliverers
Lack of blinding of intervention deliverers
deviation from study intervention protocol
A performance bias in which the intervention received differs from the intervention specified in the study protocol
A performance bias in which the intervention or exposure received differs from the from the usual practice or expected care
A performance bias in which the intervention deliverers do not completely adhere to the expected intervention
A performance bias in which the participants do not completely adhere to the expected intervention or exposure
imbalance in deviations from intended intervention
A performance bias in which the degree of performance bias is unequally distributed between groups being compared
attrition bias due to participant attrition
A bias due to absence of expected participation due to participant dropout, withdrawal or non-participation after selection for study inclusion.
A bias due to data loss or absence of data collection from participants after selection for study inclusion.
attrition bias due to missing outcome data
An attrition bias due to missing data specific to the dependent variable.
attrition bias due to missing exposure data
An attrition bias due to missing data specific to the independent variable(s) of primary interest, such as exposure or intervention.
Attrition bias due to missing intervention data
attrition bias due to missing modifier data
An attrition bias due to missing data specific to a confounder or effect modifier
attrition bias due to missing data about attrition
An attrition bias due to missing data specific to the extent of or reasons for missing data.
An attrition bias in which the degree of missing data is unequally distributed between groups being compared.
An attrition bias in which the reason for absence of data collection is a low response rate to data collection surveys.
A detection bias due to distortions in how an outcome is determined.
cognitive interpretive bias for outcome determination
An outcome detection bias due to the subjective nature of human interpretation.
Perception bias for outcome determination
Subjective interpretive bias for outcome determination
Subjectivity bias for outcome determination
bias due to lack of masking for outcome determination
A cognitive interpretive bias for outcome determination due to awareness of the participant's status with respect to the exposure of interest.
Bias due to lack of blinding during outcome assessment
Bias due to lack of masking during outcome assessment
Awareness bias for outcome determination
A cognitive interpretive bias for outcome determination due to subjective interpretations in the process of observing and recording information.
confirmation bias for outcome determination
An observer bias for outcome determination due to previous opinions or knowledge of a subject’s prior exposures or assessments.
Diagnostic suspicion bias for outcome determination
Previous opinion bias for outcome determination
A cognitive interpretive bias for outcome determination due to differences in accuracy or completeness of recall of past events or experiences.
apprehension bias for outcome determination
A cognitive interpretive bias for outcome determination due to a study participant's responding or behaving differently when aware of being observed.
Hawthorne effect for outcome determination
hypothetical assessment bias for outcome determination
A cognitive interpretive bias for outcome determination due to a difference between an individual’s report of an imagined or hypothetical response from their actual response. The response may be a behavior or valuation.
Subjunctivity bias for outcome determination
A cognitive interpretive bias for outcome determination due to a misinterpretation of observations that resemble the outcome.
unacceptability bias for outcome determination
A cognitive interpretive bias for outcome determination due to distortions in response, response values, or recording of responses resulting from perception of the social unacceptability of an outcome.
Unacceptable disease bias for outcome determination
An outcome detection bias due to distortions in how the data are collected.
Ascertainment Bias for outcome determination
nonrepresentative observation period for outcome of interest
An outcome ascertainment bias due to differences in the period used for observation of the outcome and the period for the outcome of interest.
Misaligned follow up period for outcome of interest
nonrepresentative context for outcome ascertainment
An outcome ascertainment bias due to differences in the context in which the outcome is observed and the intended context for the outcome of interest.
An outcome ascertainment bias due to differences within or between groups in how the data are collected.
An outcome detection bias due to distortions in how the observed outcomes are measured.
Measurement Bias for outcome determination
inappropriate method for outcome measurement
An outcome measurement bias due to use of an incorrect method or protocol.
Inappropriate outcome measurement method
insensitive measure bias for outcome determination
An outcome measurement bias due to use of a method that does not reliably detect the outcome when the outcome is present.
Inadequate sensitivity for outcome measure
nonspecific measure bias for outcome determination
An outcome measurement bias due to use of a method that falsely detects the outcome when the outcome is absent.
Inadequate specificity for outcome measure
inappropriate application of method for outcome measurement
An outcome measurement bias due to inappropriate application of the method or protocol.
An outcome measurement bias due to differences within groups in how the observed outcomes are measured.
inconsistency in instruments used for outcome measurement
An outcome measurement bias due to differences within groups in the instruments used for measurement.
inconsistency in processes used for outcome measurement
An outcome measurement bias due to differences within groups in the processes by which the instruments are used for measurement.
An outcome measurement bias due to differences between groups in how the observed outcomes are measured.
imbalance in instruments used for outcome measurement
An outcome measurement bias due to differences between groups in the instruments used for measurement.
imbalance in processes used for outcome measurement
An outcome measurement bias due to differences between groups in the processes by which the instruments are used for measurement.
An outcome detection bias due to distortions in how the observed outcomes are classified.
Misclassification Bias for outcome determination
An outcome classification bias resulting from the definition or threshold used for outcome classification.
Definition Bias for outcome determination
nonrepresentative definition for outcome classification
An outcome classification system bias due to a mismatch between the outcome of interest and the definition or threshold used for outcome measurement.
surrogate marker bias for outcome classification
An outcome classification system bias due to use of a definition that is proxy for the outcome rather than direct observation of the outcome.
Substitution bias for outcome classification
An outcome classification system bias due to defining the outcome after interacting with the study data.
Definition for outcome classification not prespecified
No prespecified definition for outcome classification
An outcome classification bias resulting from the application of the method used for outcome classification.
Classification Process Bias for outcome determination
incorporation bias for outcome determination
An outcome classification bias due to the inclusion of the exposure under investigation in the method or process used for outcome classification.
A detection bias due to distortions in how an exposure of interest is determined.
cognitive interpretive bias for exposure determination
An exposure detection bias due to the subjective nature of human interpretation.
Perception bias for exposure determination
Subjective interpretive bias for exposure determination
Subjectivity bias for exposure determination
bias due to lack of masking for exposure determination
A cognitive interpretive bias for exposure determination due to awareness of the participant's status with respect to the outcome of interest or other relevant exposures.
Bias due to lack of blinding during exposure assessment
Bias due to lack of masking during exposure assessment
Awareness bias for exposure determination
observer bias for exposure determination
A cognitive interpretive bias for exposure determination due to subjective interpretations in the process of observing and recording information.
confirmation bias for exposure determination
An observer bias for exposure determination due to previous opinions or knowledge of a subject’s prior exposures or assessments.
Diagnostic suspicion bias for exposure determination
Previous opinion bias for exposure determination
A cognitive interpretive bias for exposure determination due to differences in accuracy or completeness of recall of past events or experiences.
apprehension bias for exposure determination
A cognitive interpretive bias for exposure determination due to a study participant's responding or behaving differently when aware of being observed.
Hawthorne effect for exposure determination
hypothetical assessment bias for exposure determination
A cognitive interpretive bias for exposure determination due to a difference between an individual’s report of an imagined or hypothetical response from their actual response.
Subjunctivity bias for exposure determination
A cognitive interpretive bias for exposure determination due to a misinterpretation of observations that resemble the exposure.
unacceptability bias for exposure determination
A cognitive interpretive bias for exposure determination due to distortions in response, response values, or recording of responses resulting from perception of the social unacceptability of an exposure.
Unacceptable disease bias for exposure determination
An exposure detection bias due to distortions in how the data are collected.
Ascertainment Bias for exposure determination
Data collection bias for exposure determination
nonrepresentative observation period for exposure of interest
An exposure ascertainment bias due to differences in the time period used for observation of the exposure and the intended time period for the exposure of interest.
Misaligned follow up period for exposure of interest
nonrepresentative context for exposure ascertainment
An exposure ascertainment bias due to differences in the context in which the exposure is observed and the intended context for the exposure of interest.
An exposure ascertainment bias due to differences within or between groups in how the data are collected.
An exposure detection bias due to distortions in how the observed exposures are measured.
Measurement Bias for exposure determination
inappropriate method for exposure measurement
An exposure measurement bias due to use of an incorrect method or protocol.
Inappropriate exposure measurement method
insensitive measure bias for exposure determination
An exposure measurement bias due to use of a method that does not reliably detect the exposure when the exposure is present.
Inadequate sensitivity for exposure measure
Inadequate sensitivity for exposure determination
nonspecific measure bias for exposure determination
An exposure measurement bias due to use of a method that falsely detects the exposure when the exposure is absent.
Inadequate specificity for exposure measure
inappropriate application of method for exposure measurement
An exposure measurement bias due to inappropriate application of the method or protocol.
Inappropriate exposure measurement conduct
An exposure measurement bias due to differences within groups in how the observed exposures are measured.
inconsistency in instruments used for exposure measurement
An exposure measurement bias due to differences within groups in the instruments for measurement.
inconsistency in processes used for exposure measurement
An exposure measurement bias due to differences within groups in the processes by which the instruments are used for measurement.
An exposure measurement bias due to differences between groups in how the observed exposures are measured.
imbalance in instruments used for exposure measurement
An exposure measurement bias due to differences between groups in the instruments used for measurement.
imbalance in processes used for exposure measurement
An exposure measurement bias due to differences between groups in the processes by which the instruments are used for measurement.
An exposure detection bias due to distortions in how the observed exposures are classified.
Misclassification Bias for exposure determination
An exposure classification bias resulting from the definition or threshold used for exposure classification.
Definition Bias for exposure determination
Threshold Bias for exposure determination
nonrepresentative definition for exposure classification
An exposure definition bias due to a mismatch between the exposure of interest and the definition or threshold used for exposure measurement.
surrogate marker bias for exposure classification
An exposure definition bias due to use of a definition that is proxy for the exposure rather than direct observation of the exposure.
Substitution bias for exposure classification
An exposure definition bias due to definition of the exposure after interacting with the study data.
Definition for exposure classification not prespecified
No prespecified definition for exposure classification
classification process bias for exposure determination
An exposure classification bias resulting from the application of the method used for exposure classification.
incorporation bias for exposure determination
An exposure classification bias due to the inclusion of the outcome or other relevant exposures under investigation in the method or process used for exposure classification.
A detection bias due to distortions in how the data for a potential confounder are determined.
detection bias related to the reference standard
A detection bias due to distortions in how the reference standard result is determined.
Bias for reference standard result determination
detection bias related to the index test
A detection bias due to distortions in how the index test result is determined.
Bias for index test result determination
A detection bias due to differences between measured values and recorded values.
inappropriate time interval between predictor assessment and outcome determination
A detection bias involving the time interval between the observation of the predictor and outcome, where the interval used by the study differs from the interval assumed by the predictive model.
bias related to selection of the analysis
An analysis bias due to inappropriate choice of analysis methods before the analysis is applied.
bias related to selection of the data for analysis
An analysis bias due to inappropriate choice of data included in the analysis before the analysis is applied.
bias due to post-baseline factors influencing selection of the data for analysis
A bias related to selection of the data analysis based on participant characteristics observed after study enrollment.
missing or inadequate intention-to-treat analysis
A bias related to selection of the data analysis in which data are not completely analyzed according to the original assignment to comparison groups in an interventional study.
missing or inadequate per-protocol analysis
A bias related to selection of the data analysis in which data are not completely analyzed according to the study protocol.
missing or inadequate as-treated analysis
A bias related to selection of the data analysis in which data are not completely analyzed according to the interventions actually received.
bias related to selection of the variables for analysis
An analysis bias due to inappropriate choice of variables included in the analysis before the analysis is applied.
bias related to selection of the variables for adjustment for confounding
An analysis bias due to inappropriate choice of the variables for adjustment for confounding before the analysis is applied.
bias controlling for time-varying confounding
A bias related to selection of the variables for adjustment for confounding in which the confounding is time-dependent.
A bias related to selection of the variables for adjustment for confounding by adherence.
Bias controlling for confounding by adherence
predictors included in outcome definition
An analysis bias due to inappropriate choice of the variables for estimation of association in which one variable is incorporated in the definition of the other variable.
bias related to selection of predictors based on univariable analysis
An analysis bias due to inappropriate choice of the predictor variables for estimation of association in which predictors are selected based on statistically significant univariable associations (without adjustment for other predictors).
bias related to selection of the analytic framework
An analysis bias due to inappropriate choice of the analytic framework before the analysis is applied.
Bias related to selection of the statistical framework
A bias related to selection of the analytic framework in which the analytic model does not match the dataset characteristics or does not match the intention of the analysis.
An inappropriate statistical model due to inappropriate accounting for ranges of potential observation in which data observation is not possible.
bias due to selection of the statistical significance threshold
An analysis bias resulting from selection of an inappropriate threshold for statistical significance.
Statistical significance threshold selection bias
Bias related to selection of the threshold for statistical significance
bias related to multiple comparison adjustment
An analysis bias resulting from selection of a threshold for statistical significance which does not appropriately account for the effect of multiple comparisons on the statistical probability related to the result.
mismatch of significance threshold and purpose
An analysis bias resulting from selection of a threshold for statistical significance which is inappropriate due to a mismatch between (1) how the statistical probability related to the result is determined and (2) the purpose for categorizing the result as statistically significant.
A bias related to selection of the analytic framework in which an outcome variable includes an observation period during which the outcome could not have occurred.
A bias related to selection of the analytic framework in which the sample size invalidates the assumptions of the analytic framework.
bias related to execution of the analysis
An analysis bias due to inappropriate decisions pertaining to preparation of data for analysis and/or conduct of the analysis.
An analysis bias due to absence of a component of the analytic process.
inappropriate handling of uninterpretable data
An analysis bias due to omission of uninterpretable values, or their replacement with inappropriate values.
An analysis bias due to use of non-representative values in place of missing data.
An analysis bias due to processing a variable in an incorrect role or with an incorrect datatype.
An analysis bias due to inappropriate application of adjustment techniques for correction of bias in the selection of participants for analysis.
An analysis bias due to differences between recorded data and data used for analysis.
inappropriate handling of missing confounder data
An analysis bias due to use of non-representative values in place of missing data for variables in the role of confounder.
An analysis bias due to miscalculations in the processing of the data.
reported analysis not following pre-specified analysis plan
An analysis bias in which the reported analysis does not match the pre-specified analysis plan.
An analysis bias in which an estimation of association between two variables is distorted by controlling for a third variable affected by both variables of interest (or factors causing the variables of interest).
An analysis bias related to analysis of data before the complete dataset is available.
An analysis bias involving use of data analyses that are not pre-specified and fully disclosed, to select analyses with desirable results.
final model not corresponding to multivariable analysis
An analysis bias in which the predictors and coefficients in the final model do not match the predictors and coefficients reported in the multivariable analysis.
cognitive interpretive bias affecting analysis
A bias related to the analytic process due to the subjective nature of human interpretation.
cognitive interpretive bias affecting analysis selection
A bias related to selection of the analysis due to the subjective nature of human interpretation.
availability bias affecting analysis selection
A Cognitive Interpretive Bias due to the use of information which is most readily available, rather than information which is most representative, affecting analysis selection.
cognitive interpretive bias affecting execution of the analysis
A bias in processing of data due to the subjective nature of human interpretation.
A cognitive interpretive bias affecting execution of the analysis due to the analyst's awareness of the participants' status with respect to the variables defining the comparison groups.
An analysis bias in which the weights used in model construction do not align with the target of estimation or estimand.
inappropriate evaluation of predictive model performance measures
An analysis bias in which the method for analysis of a performance measure (such as calibration or discrimination) is not adequate or suitable for the predictive model.
inappropriate evaluation of calibration of predictive model
An analysis bias in which the method for analysis of calibration is not adequate or suitable for the predictive model.
inappropriate evaluation of discrimination of predictive model
An analysis bias in which the method for analysis of discrimination is not adequate or suitable for the predictive model.
An analysis bias, specific to predictive model development studies, in which strategies to mitigate overfitting are not adequately applied.
A reporting bias due to inappropriate selection of the results or research findings that are reported.
A selective reporting bias due to inappropriate selection of which outcomes are reported within results or research findings.
A selective reporting bias due to inappropriate selection of which outcome measures are reported for an outcome.
Selective outcome measure reporting within outcome domain
A selective reporting bias due to inappropriate selection of subsets of groups of participants for which results or research findings are reported.
A selective reporting bias due to inappropriate selection of comparison groups for which results or research findings are reported.
selective analysis reporting from repeated analyses at multiple times
A selective reporting bias due to inappropriate selection of which analyses are reported for an outcome that was analyzed at multiple points in time in a longitudinal study.
selective analysis reporting from multiple analytic models
A selective reporting bias due to inappropriate selection of which analyses are reported for an outcome that was analyzed in multiple ways.
A selective reporting bias due to inappropriate selection of which thresholds (used for definitions of the variables) are reported.
cognitive interpretive bias in reporting
A distortion in the representation of study results or research findings due to the subjective nature of human interpretation.
Cognitive interpretive bias for reporting
interpretation of results not addressing potential for bias
A cognitive interpretive bias in reporting whereby the reported interpretation of results does not adequately address potential for bias.
Interpretation of results not addressing risk of bias
results emphasized based on statistical significance
A cognitive interpretive bias in reporting whereby results with statistical significance are given exaggerated attention.
A cognitive interpretive bias in reporting due to the influence of an individual’s ideas, beliefs or hypotheses.
A cognitive interpretive bias in reporting due to a mismatch between what the observed data represent and the results that were reported.
A reporting bias due to publication or reporting of results or research findings that change in subsequent reports.
A reporting bias resulting from intentional misrepresentation of any part of the study.
A reporting bias due to insufficient reporting of methods to determine the validity of the results.
Inadequate reporting to assess analytic strategy
inadequate explanation of participant withdrawals
A reporting bias due to insufficient reporting of reasons for withdrawals of participants after study enrollment.
Inadequate explanation of participant attrition
bias related to selection of the studies for synthesis
bias related to selection of the analytic framework for synthesis
inadequate accounting for bias in constituent studies
inadequate study characteristics available for results interpretation
bias related to selection of the data for synthesis
inadequate criteria for methodologic quality assessment
inadequate process for methodologic quality assessment
bias in qualitative data collection methods
unsubstantiated interpretation of results
incoherence among qualitative data, analysis, and interpretation
inadequate rationale for mixed methods design
ineffective integration of qualitative and quantitative study components
inappropriate interpretation of integration of qualitative and quantitative findings
inadequate handling of inconsistency between qualitative and quantitative findings
A bias in validation assessment using a sample source that differs from those used in the derivation of the procedure.
inadequate external validation assessment
A bias in validation assessment specific to a validation assessment that uses the same sample source that was used in the derivation of the procedure.
inadequate internal validation assessment
early study termination bias due to competing interests
An early study termination bias due to the decision to end the study being influenced by financial, commercial, legal, political, social, professional, or intellectual interests.
early study termination bias due to unplanned use of interim analysis
An early study termination bias due to awareness of study results without following a preplanned protocol for how interim results will influence the decision to terminate the study.
early study termination bias due to inappropriate statistical stopping rule
An early study termination bias due to use of an inappropriate model or threshold in the analysis used for determination to end the study.
early study termination bias due to external factors
An early study termination bias due to a decision to end the study based on factors other than the results of interim analysis.