Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.
Background Members of the practice-based research network Practitioners Engaged in Applied Research and Learning (PEARL) Network investigated the dentin caries activity in early occlusal lesions and its relationship to patient age, preoperative tooth sensitivity and radio-graphic appearance, as well as its influence on preparation depth and volume. Methods PEARL Network practitioner-investigators (P-Is) (n = 45), general dentists who were trained but whose methods were not calibrated, conducted a study regarding postoperative hypersensitivity in resin-based composite restorations. The P-Is enrolled as study participants 613 patients with occlusal carious lesions that, in the P-Is’ clinical judgment, required restoration. The P-Is used baseline radiographs to assess the depth and extent of the lesions. Data for 671 restorations included baseline sensitivity; ranking of dentin caries activity on the opening of the enamel; radiographic visibility (n = 652); and measurements of preparation depth, width and length. Results P-Is found rapidly progressing dentin caries in 38.5 percent (258 of 671) of lesions and slowly progressing (and potentially inactive dentin) caries in the remainder of the lesions. Rapidly progressing caries was not related to the participant’s age or participant-reported preoperative hypersensitivity but was related to the lesion depth as seen radiographically (P < .001) and depth (P < .001) and volume (P < .001) of the preparation. Molars had slightly higher but not statistically significant levels of caries activity. Conclusion Rapidly progressing dentin caries, while present in only 38.5 percent of lesions, was related to the lesion’s radiographic appearance but not to the participant’s age or the study tooth’s pre-operative sensitivity. Clinical Implications On the basis of the low level of rapidly progressing dentin caries in this study population and the fact that slowly progressing caries can be inactive or remineralizing, the authors advise sealing versus operative treatment of early or shallow occlusal lesions.
Background: The randomized case presentation (RCP) study is designed to assess the degree of diagnostic accuracy for described periodontal cases. This is to lay the basis for practitioner calibration in the Practitioners Engaged in Applied Research and Learning (PEARL) Network for future clinical studies.Methods: The RCP consisted of 10 case scenarios ranging from periodontal health to gingivitis and mild, moderate, and severe periodontitis. Respondents were asked to diagnose the described cases. Survey diagnoses were compared to two existing classifications of periodontal disease status. The RCP was administered via a proprietary electronic data capture system maintained by the PEARL Data Coordinating Center. Standard analytic techniques, including frequency counts and cross‐tabulations, were used for categorical data with mean and standard deviation and median values reported for continuous data elements.Results: Demonstrable variations in periodontal assessment for health, gingivitis, and mild, moderate, and severe periodontitis were found among the 130 PEARL general practitioners who participated in the RCP survey. The highest agreement for diagnosis among dentists was for severe periodontitis (88%) and the lowest for gingivitis (55%). The highest percentage of variation was found in cases with health and gingivitis.Conclusions: There was variation among PEARL practitioners in periodontal diagnosis that may affect treatment outcomes. Our findings add clinical support to recent publications suggesting a need for standardization of terminology in periodontitis diagnosis.
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