A multicentre evaluation of an opioid patient-provider agreement.

The role of the patient-provider agreement (PPA) is to set forth respective roles and responsibilities for opioid therapy with the goal of improving outcomes, reducing risks, and improving patient education. The Food and Drug Administration (FDA) Safe Use Initiative Opioid PPA Working Group convened to develop a PPA and test it for acceptability as an educational and shared decision-making tool in opioid therapy. This multicentre study evaluated the utility of the PPA, how readily patients understood it, its ability to educate patients in an unbiased way about opioid treatment and the feasibility of incorporating a PPA in clinical practice. A total of 117 patients and 14 providers at urban centres were included (mean patient age: 56 years) with 85% of patients treated for pain for >3 months. Most patients reported the PPA to be 'somewhat helpful' or 'very helpful' in deciding a course of treatment (96%) and 'easy to understand' (97%). Both patients and prescribers (89% and 92%, respectively) found the PPA was neutral in terms of presenting opioid therapy. Most centres found the PPA could be administered in ≤10 min and 72% of prescribers said this PPA could be readily incorporated into their practice. This PPA was perceived by both patients and prescribers as helpful in deciding a course of treatment and unbiased in terms of presentation of the risks and benefits of opioid therapy.

A pilot study of dentists' assessment of caries detection and staging systems applied to early caries: PEARL Network findings.

The International Caries Detection and Assessment System (ICDAS II) and the Caries Classification System (CCS) are caries stage description systems proposed for adoption into clinical practice. This pilot study investigated clinicians' training in and use of these systems for detection of early caries and recommendations for individual tooth treatment. Patient participants (N = 8) with a range of noncavitated lesions (CCS ranks 2 and 4 and ICDAS II ranks 2-4) identified by a team of calibrated examiners were recruited from the New York University College of Dentistry clinic. Eighteen dentists-8 from the Practitioners Engaged in Applied Research and Learning (PEARL) Network and 10 recruited from the Academy of General Dentistry-were randomly assigned to 1 of 3 groups: 5 dentists used only visual-tactile (VT) examination, 7 were trained in the ICDAS II, and 6 were trained in the CCS. Lesion stage for each tooth was determined by the ICDAS II and CCS groups, and recommended treatment was decided by all groups. Teeth were assessed both with and without radiographs. Caries was detected in 92.7% (95% CI, 88%-96%) of the teeth by dentists with CCS training, 88.8% (95% CI, 84%-92%) of the teeth by those with ICDAS II training, and 62.3% (95% CI, 55%-69%) of teeth by the VT group. Web-based training was acceptable to all dentists in the CCS group (6 of 6) but fewer of the dentists in the ICDAS II group (5 of 7). The modified CCS translated clinically to more accurate caries detection, particularly compared to detection by untrained dentists (VT group). Moreover, the CCS was more accepted than was the ICDAS II, but dentists in both groups were open to the application of these systems. Agreement on caries staging requires additional training prior to a larger validation study.

The Trajectory of Pharmacology Education in Dentistry: Is a Course Correction Needed?

In effort to stem the opioid epidemic, the authors of this editorial urge reforms for dental training by returning to the basics. This near abandonment of foundational sciences by stakeholders is at a high price: compromised patient safety and health.

Opioid, NSAID, and OTC Analgesic Medications for Dental Procedures: PEARL Network Findings.

OBJECTIVE: Dental treatment is often categorized as a moderately or severely painful experience; however, no clinical data reported by the patient and dentist currently exists to support this degree of pain. This has contributed possibly to the overprescribing of analgesics, in particular the opioid class of medications. The primary objective of the study was to document the dentists' postprocedural prescriptions and recommendations for analgesic medications and their effectiveness for a 5-day period. Medications prescribed or recommended in the patient-reported outcomes included: opioid, nonsteroidal anti-inflammatory drugs (NSAIDs), and over-the-counter (OTC) analgesics. Met hods : This study used both dentist and patient responses to evaluate the use of opioid, NSAID, and OTC recommended or prescribed analgesics following one of seven classes of dental procedures encompassing over 22 specific coded procedures thought to elicit pain. The patient-centered study included a 5-day postprocedural patient follow-up assessment of the medication's effectiveness in relieving pain. RESULTS: Baseline questionnaires were completed by 2765 (99.9%) of 2767 eligible patients, and 2381 (86%) patients responded to the Day 5 follow-up questionnaires. CONCLUSION: The data suggest NSAIDs, both OTC and prescribed dosages, may be a sufficient analgesic to treat most postoperative dental pain. Clinical judgment as to the use of an opioid should include the physiological principles related to the pharmacology of pain and inflammation and may include a central effect. ClinicalTrials.gov Identifier: NCT02929602.

Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network.

A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. The model represents robust clinical data from persons of record allowing for improved interpretation of drug/device side-effects and for regulatory reviewers to expedite the approval process.

Clinical implications of patient-provider agreements in opioid prescribing.

In June, 2012 the United States Food and Drug Administration (FDA) developed a "blueprint" for prescriber education as a means of directing Certified Medical Education (CME) activities that included content which would meet the regulatory requirements of the class-wide, longacting/ extended-release (LA-ER) opioid Risk Evaluation Mitigation Strategies (REMS). Within the blueprint is the suggested adoption of Patient-Provider Agreements (PPAs) to be used in association with opioid prescribing, but, to our knowledge, there have been no reported evaluations of the role played by opioid-agent PPAs in clinical practice, or of the perceptions of this regulatory mandate by clinicians. Therefore, we conducted a survey regarding PPA perceptions by opioid prescribers that was posted for five weeks on a well-trafficked online CME service provider (Medscape). Of the 1,232 respondents (reflecting a 99.5% completion rate), 52.4% treat acute or chronic pain with opioids. The survey identified an improvement of opioid safe-use education (21% of respondents) as the most frequently selected beneficial element of PPAs. Conversely, the challenges to adoption included time constraints (21% of physicians) as well as lack of evidence that PPAs will reduce drug misuse, and the lack of a uniform, patient-friendly PPA. Based on our survey, clinicians consider the PPA of potential value, but data regarding the utility of such an instrument are lacking.

Case Presentations Demonstrating Periodontal Treatment Variation: PEARL Network.

BACKGROUND: Variation in periodontal terminology can affect the diagnosis and treatment plan as assessed by practicing general dentists in the Practitioners Engaged in Applied Research and Learning (PEARL) Network. General dentists participating in the PEARL Network are highly screened, credentialed, and qualified and may not be representative of the general population of dentists. METHODS: Ten randomized case presentations ranging from periodontal health to gingivitis, to mild, moderate, and severe periodontitis were randomly presented to respondents. Descriptive comparisons were made between these diagnosis groups in terms of the treatment recommendations following diagnosis. RESULTS: PEARL practitioners assessing periodontal clinical scenarios were found to either over- or under-diagnose the case presentations, which affected treatment planning, while the remaining responses concurred with respect to the diagnosis. The predominant diagnosis was compared with that assigned by two practicing periodontists. There was variation in treatment based on the diagnosis for gingivitis and the lesser forms of periodontitis. CONCLUSION: Data suggests that a lack of clarity of periodontal terminology affects both diagnosis and treatment planning, and terminology may be improved by having diagnosis codes, which could be used to assess treatment outcomes. CLINICAL IMPLICATIONS: This article provides data to support best practice for the use of diagnosis coding and integration of dentistry with medicine using ICD-10 terminology.

Person-centric clinical trials: Ethical challenges in recruitment and data transparency for improved outcomes.

Practitioners participating in clinical studies are faced with a number of ethical issues related to recruitment, informed consent, handling and transparency of data. Practitioners educated in Good Clinical Practice, applying the philosophy of person-centricity within a network utilizing risk-based monitoring and remote data entry can provide the requisite infrastructure and oversight to support person-centric clinical studies. While "patient-centered" clinical studies allow for a broader clinical outcome perspective beyond the investigator, the person-centric approach, accounts for the comprehensiveness and complexity of how we make health and healthcare decisions. Augmenting person centricity with comparative effectiveness studies allow for the inclusion of individual data significantly contributing to the aggregation of multiple data sets about individuals and populations. This enables more powerful and personal analytics and care and everyone is afforded the opportunity and privilege to contribute to improve clinical outcomes and in controlling and containing costs. Policy and institutional investment in infrastructure are prerequisite to accommodate these opportunities, to minimize abuses, and provide pathways for analyzing alternative healthcare patterns. Data provided will be comprehensive and robust, representative of use, with safety data more easily discernible from persons with a known past medical and health history.

Prevalence of persistent pain 3 to 5 years post primary root canal therapy and its impact on oral health-related quality of life: PEARL Network findings.

INTRODUCTION: The frequency of persistent pain 3-5 years after primary root canal therapy and its impact on the patient's perceived oral health-related quality of life was determined in a practice-based research network. METHODS: All patients presenting to participating network practices who received primary root canal therapy and restoration for a permanent tooth 3-5 years previously were invited to enroll. Persistent pain was defined as pain occurring spontaneously or elicited by percussion, palpation, or biting. The patient also completed an oral health-related quality of life questionnaire (Oral Health Impact Profile-14). RESULTS: Sixty-four network practices enrolled 1323 patients; 13 were ineligible, 12 did not receive a final restoration, and 41 were extracted, leaving 1257 for analysis. The average time to follow-up was 3.9 ± 0.6 years. Five percent (63/1257) of the patients reported persistent pain, whereas 24 of 63 (38%) exhibited periapical pathosis and/or root fracture (odontogenic pain). No obvious odontogenic cause for persistent pain was found for 39 of 63 (62%). Teeth treated by specialists had a greater frequency of persistent pain than teeth treated by generalists (9.3% vs 3.0%, respectively; P < .0001). Sex, age, tooth type, type of dentist, and arch were not found to be associated with nonodontogenic persistent pain; however, ethnicity and a preoperative diagnosis of pulpitis without periapical pathosis were. Patients reporting pain with percussion tended to experience pain with other stimuli that negatively impacted quality of life including oral function and psychological discomfort and disability. CONCLUSIONS: These results suggest that a small percentage (3.1%) of patients experience persistent pain not attributable to odontogenic causes 3-5 years after primary root canal therapy that may adversely impact their quality of life.

Outcomes of implants and restorations placed in general dental practices: a retrospective study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

OBJECTIVES: The authors conducted a study to determine the types, outcomes, risk factors and esthetic assessment of implants and their restorations placed in the general practices of a practice-based research network. METHODS: All patients who visited network practices three to five years previously and underwent placement of an implant and restoration within the practice were invited to enroll. Practitioner-investigators (P-Is) recorded the status of the implant and restoration, characteristics of the implant site and restoration, presence of peri-implant pathology and an esthetic assessment by the P-I and patient. The P-Is classified implants as failures if the original implant was missing or had been replaced, the implant was mobile or elicited pain on percussion, there was overt clinical or radiographic evidence of pathology or excessive bone loss (> 0.2 millimeter per year after an initial bone loss of 2 mm). They classified restorations as failures if they had been replaced or if there was abutment or restoration fracture. RESULTS: The authors enrolled 922 implants and patients from 87 practices, with a mean (standard deviation) follow-up of 4.2 (0.6) years. Of the 920 implants for which complete data records were available, 64 (7.0 percent) were classified as failures when excessive bone loss was excluded from the analysis. When excessive bone loss was included, 172 implants (18.7 percent) were classified as failures. According to the results of univariate analysis, a history of severe periodontitis, sites with preexisting inflammation or type IV bone, cases of immediate implant placement and placement in the incisor or canine region were associated with implant failure. According to the results of multivariate analysis, sites with preexisting inflammation (odds ratio [OR] = 2.17; 95 percent confidence interval [CI], 1.41-3.34]) or type IV bone (OR = 1.99; 95 percent CI, 1.12-3.55) were associated with a greater risk of implant failure. Of the 908 surviving implants, 20 (2.2 percent) had restorations replaced or judged as needing to be replaced. The majority of P-Is and patients were satisfied with the esthetic outcomes for both the implant and restoration. CONCLUSIONS: These results suggest that implant survival and success rates in general dental practices may be lower than those reported in studies conducted in academic or specialty settings. PRACTICAL IMPLICATIONS: The results of this study, generated in the private general practice setting, add to the evidence base to facilitate implant treatment planning.

Medical Histories: A Case Report of Pharmacovigilance in Supporting Dentists and Participation in a Drug-Safety Program.

INTRODUCTION: Antibiotics are a class of medications widely used by dentists. The class of agents has a number of listed side effects. This case report details an unusual adverse effect of tetracycline-induced psychosis recognized due to the diligence of a practitioner. To our knowledge, this is the first reported case by a dentist. CASE PRESENTATION: A 44-year-old patient was started on tetracycline therapy for prophylaxis before a periodontal procedure. The patient began having paranoid and psychotic experiences. The patient sought psychiatric medical care and was diagnosed with tetracycline-induced psychosis. He was treated with an antipsychotic drug, which resolved his symptoms. CONCLUSION: Dental medical histories are a resource that is underused and can often be of value in the continual assessment of drug safety and pharmacovigilance.

Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research.

The Patient-Centered Outcomes Research Institute (PCORI), created and funded by the Affordable Care Act, is charged with bringing the patient perspective to clinical research design and the outcomes that are studied. However, there is no consensus definition of "patient-centeredness" or "patient-centricity." This paper distinguishes between the terms and describes an infrastructure for supporting the concept of patient-centricity. The patient's role needs to be described in a way that makes it feasible to implement health care delivery and support parameters to conduct clinical research over a sustained period of time. The authors propose the use of a structured Practice-Based Clinical Research Network to perform patient-centered outcomes research consistent with the requirements of the pharmaceutical sector in a safe, ethical, and effective manner and congruent with the principles of Good Clinical Practice (GCP).

Practice based research networks impacting periodontal care: PEARL Initiative.

In 2005, the National Institute of Dental and Craniofacial Research /National Institutes of Health funded the largest initiative to date to affect change in the delivery of oral care. This commentary provides the background for the first study related to periodontics in a Practice Based Research Network (PBRN). It was conducted in the Practitioners Engaged in Applied Research & Learning (PEARL) Network. The PEARL Network is headquartered at New York University College of Dentistry. The basic tenet of the PBRN initiative is to engage clinicians to participate in clinical studies, where they will be more likely to accept the results and to incorporate the findings into their practices. This process may reduce the translational gap that exists between new findings and the time it takes for them to be incorporated into clinical practice. The cornerstone of the PBRN studies is to conduct comparative effectiveness research studies to disseminate findings to the profession and improve care. This is particularly important because the majority of dentists practice independently. Having practitioners generate clinical data allows them to contribute in the process of knowledge development and incorporate the results in their practice to assist in closing the translational gap. With the advent of electronic health systems on the horizon, dentistry may be brought into the mainstream health care paradigm and the PBRN concept can serve as the skeletal framework for advancing the profession provided there is consensus on the terminology used.

Person-centric clinical trials: an opportunity for the good clinical practice (GCP)-practice-based research network.

Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug-drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

Periodontal diagnosis affected by variation in terminology.

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.