Study design appropriate to objective? |
Objective |
If they agreed (0) was assigned. |
Study sample representative? |
Source of sample |
[0] when well described |
[+] partial information |
[++] when not informed |
Sampling method |
[0] probabilistic |
[+] not probabilistic |
[++] not reported |
Sample size |
For studies without the sample calculation, 145 teeth were considered as an ideal sample size according to Moccelini et al.22
|
[0] did sample calculation |
[+] with sample >145 |
[++] with sample <145 |
Entry criteria/ exclusions |
[0] inclusion and exclusion criteria |
[+] only one of the criteria |
[++] criteria not reported |
Non-respondents |
[0] completed clinical records/sheets |
[+] incomplete/partially clinical records |
[++] does not report the data of the patient’s clinical records/how many patients did not participate in the follow-up |
Control group acceptable? |
Definition of controls |
[0] the comparison group was adequate |
[+] the comparison group showed small failures (e.g. just clinical evaluation) |
[++] the comparison group was not adequate, which could cause distortions (when the evaluation used to collect information regarding pulp necrosis was different for the comparison group) |
Source of controls |
[0] all participants from the same source and the source is representative |
[+] the characteristics for both groups showed small distortions (e.g. root development) |
[++] the source of the comparison was not adequate for the purpose of the study (different source of sample and/or the distribution of the sample characteristics was distinct between the groups) |
Comparable characteristics |
[0] equivalent degree of eruption of the sample |
[+] small range of degree of eruption |
[++] not reported or the degree of eruption was not adequate for the purpose of the study |
Quality of measurements and outcomes? |
Validity |
[0] with complete data about criteria for evaluation and diagnosis |
[+] only partial data |
[++] the studies did not provide the adequate criteria for evaluation of sequelae |
Reproducibility |
[0] reported kappa value and in the case of only one examiner performing the intra-rate evaluation |
[+] for a study with more than one examiner, if only the inter-rater evaluation was performed |
[++] for studies in which the reliability of the Cohen’s kappa and intra-class correlations (ICCs) measurements was not performed, inter-rater (if more than one examiner) and/or intra-rate (if only one or more than one examiner) |
Quality control |
[0] for studies that presented measures for data quality control in which they described the statistical methods, and that standardized procedures and training were adopted to ensure the quality of information obtained through patient records |
[+] study performed without only one/or two the factors |
[++] for studies that did not present measures for data quality control (monitoring), and who did not describe statistical methods in which standardization and training procedures were not adopted and reported to ensure the quality of information obtained through patient records, since they may have deficiencies in completeness |
Completeness? |
Compliance |
[0] for studies that performed standardization of the electric pulp testing and radiographic examination |
[+] for studies that did not perform standardization of the electric pulp testing (if performed) or radiographic examination |
[++] for studies that did not perform standardization of the radiographic examination and electric pulp testing (if both were performed) |
Missing data |
[0] all required data provided (frequency, number, p value) |
[+] incomplete data not affecting completion |
[++] incomplete results, and exclusion of important data that compromise completion |
Confounding factors |
[0] (dental caries) if used as an exclusion factor and in the confounding of statistical analysis or article discussion |
[+] when used only in the discussion |
[++] if the research did not mention the considered factor (dental caries) |
Distortion reduced by analysis |
[0] used multiple regression and when the confounding factor was excluded |
[+] did not perform multiple regression, however, when the confounding factor was excluded |
[++] did not perform multiple regression to reduce influences and did not use confounding factors |
Summary |
Bias - Are the results erroneously biased in a certain direction? |
“YES” or “NO” answers were assigned to each question. If the answers to the three questions were “NO”, the article could be judged as solid (low risk of bias). |
Questions |
Confounding - Are there any serious confounding or other distorting influences? |
Chance - Is it likely that the results occurred by chance? |