Methamphetamine use and illicit opioid use during buprenorphine treatment.

Introduction: Although methamphetamine use is rising in the United States, its impacts on patient outcomes among persons undergoing treatment for opioid use disorder (OUD) remain unclear. This study aims to assess the association between baseline methamphetamine/amphetamine (MA/A) use and subsequent illicit opioid use among patients with OUD initiating buprenorphine in an office-based setting. Methods: We conducted a secondary analysis of a pilot randomized controlled trial of a behavioral mobile health intervention for buprenorphine adherence conducted over a 12-week study period at two clinic sites. The study defined baseline MA/A use by a positive urine drug test (UDT) and/or self-report of use within the past 30-days. Separate Poisson regression models with robust standard errors evaluated associations between MA/A and: i) illicit opioid use measured by weekly UDT (primary) and ii) self-reported past 30-day use at end of study (secondary). Other secondary outcomes included buprenorphine positive UDTs throughout the study and retention in OUD treatment at both weeks 12 and 24 post-randomization. Results: At baseline, 28 (36%) of the 78 participants had MA/A use and use was associated with a statistically significant increase in risk of testing positive for illicit opioids on UDT during the study follow-up period (adjusted relative risk (aRR)=1.54; 95% CI=1.09-2.17; p=0.015), as well as an increased risk for reported past 30-day illicit opioid use at week 12 (aRR=3.86; 95% CI=1.47-10.18; P=0.006). The study found no significant associations between MA/A use and buprenorphine positive UDT or retention in OUD treatment. Conclusions: In this sample of patients initiating buprenorphine, methamphetamine/amphetamine use at baseline was associated with illicit opioid use over a 12-week period. These findings demonstrate how co-use of methamphetamine can impede attainment of ideal OUD treatment outcomes.

Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting.

OBJECTIVES: Video directly observed therapy (video DOT) is a tool for confirming buprenorphine adherence that could complement the use of urine toxicology; research is needed to characterize the patients who are receptive and able to use this technology. We aimed to describe video DOT utilization and assess participant characteristics associated with use. METHODS: We performed a secondary analysis of data from a pilot randomized controlled trial of adults who recently initiated sublingual buprenorphine in office-based programs, restricting to intervention arm participants, which consisted of 12 weeks of video DOT via a mobile health technology platform. Participants were instructed to record at least 1 daily video of buprenorphine self-administration. Poisson regression models with robust standard errors were used to measure associations between participant characteristics and frequency of submitted videos. RESULTS: The sample included 39 participants. Of 3276 possible videos, 1002 (31%) were submitted. Age ≥40 years (relative risk [RR], 2.54 [95% confidence interval {CI}, 1.31-4.91]) and once-daily buprenorphine dosing (RR, 3.10 [95% CI, 1.76-5.48]) were positively associated with video submissions. Non-White race (RR, 0.43 [95% CI, 0.19-0.97]), less than high school education (RR, 0.27 [95% CI, 0.10-0.74]), history of previous buprenorphine treatment (RR, 0.50 [95% CI, 0.25-0.97]), and ≥3 previous treatment attempts (RR, 0.16 [95% CI, 0.07-0.37]) were negatively associated. CONCLUSIONS: Video DOT utilization resulted in about a third of expected videos, although there were differences in use according to age, race, buprenorphine treatment factors, and educational status. Such differences underscore that mobile-health interventions such as video DOT may not be equally used by all patients.Trial Registration : ClinicalTrails.gov , NCT03779997 , registered on December 19, 2018.

Buprenorphine adherence and illicit opioid use among patients in treatment for opioid use disorder.

Background: Buprenorphine is a partial mu opioid agonist medication that has been shown to decrease non-prescribed opioid use, cravings, and opioid related morbidity and mortality. There is an assumption that full adherence is needed to achieve ideal treatment outcomes, and that non-adherence is associated with ongoing opioid use. However, literature documenting the strength of that assertion is lacking.Objectives: Evaluate the association between daily buprenorphine adherence and illicit opioid use.Methods: Secondary analysis of a 12-week randomized controlled trial of adults with opioid use disorder who recently initiated buprenorphine. Weekly study visits included self-report of daily buprenorphine adherence over the past 7 days (Timeline Follow Back method) and urine drug tests (UDT). A log-linear regression model accounting for clustering by participant was used to assess the association between buprenorphine adherence and illicit opioid use. Buprenorphine adherence was measured as a continuous variable (0-7 days).Results: Among 78 participants (56 men, 20 women, 2 nonbinary) with 737 visits, full 7-day adherence was reported at 70% of visits. The predominant form of non-adherence was missed doses (92% of cases). Each additional day of adherence was associated with an 8% higher rate of negative UDT for illicit opioids (RR = 1.08; 95% CI:1.03-1.13, p = .0002).Conclusion: In this sample of participants starting buprenorphine, missed doses were not uncommon. Fewer missed days was significantly associated with a lower risk of illicit opioid use. These findings suggest that efforts to minimize the number of missed days of buprenorphine are beneficial for treatment outcomes.

Timing of hepatitis C treatment initiation and retention in office-based opioid treatment with buprenorphine: a retrospective cohort study.

BACKGROUND: This study examined associations between receipt of hepatitis C (HCV) treatment and retention in office-based opioid treatment (OBOT) care. METHODS: We conducted a retrospective cohort study of HCV-infected patients who initiated OBOT treatment between December 2015 and March 2021 to characterize HCV treatment and assess associations with OBOT retention. HCV treatment was characterized as no treatment, early treatment (< 100 days since OBOT initiation) or late treatment (≥ 100 days). We evaluated associations between HCV treatment and cumulative days in OBOT. A secondary analysis using Cox Proportional Hazards regression was done to determine the rate of discharge over time when comparing those who did versus did not receive HCV treatment as a time-varying covariate. We also analyzed a subset of patients retained at least 100 days in OBOT care and evaluated whether HCV treatment during that period was associated with OBOT retention beyond 100 days. RESULTS: Of 191 HCV-infected OBOT patients, 30% initiated HCV treatment, of whom 31% received early treatment and 69% received late treatment. Median cumulative duration in OBOT was greater among those who received HCV treatment (any: 398 days, early: 284 days and late: 430 days) when compared to those who did not receive treatment (90 days). Compared to no HCV treatment, there were 83% (95% CI: 33-152%, P < 0.001), 95% (95% CI: 28%-197%, p = 0.002 and 77% (95% CI: 25-153%, p = 0.002) more cumulative days in OBOT for any, early and late HCV treatment, respectively. HCV treatment was associated with a lower relative hazard for discharge/drop-out, although results did not meet statistical significance (aHR = 0.59;95% CI: 0.34-1.00; p = 0.052). Among the subset of 84 patients retained in OBOT at least 100 days, 18 received HCV treatment during that period. Compared to those who did not receive treatment within the first 100 days, those who received treatment had 57% (95% CI: -3%-152%, p = 0.065) more subsequent days in OBOT. CONCLUSIONS: A minority of HCV-infected patients received HCV treatment after initiating OBOT treatment, but those who did had better retention. Further efforts are needed to facilitate rapid HCV treatment and evaluate whether early HCV treatment improves OBOT engagement.

Implementing the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis: Long-term effect of a simple educational intervention.

Background: A standardized pathology management tool for melanocytic skin lesions may improve patient care by simplifying interpretation and categorization of the diverse terminology currently extant. Objective: To assess an online educational intervention that teaches dermatopathologists to use the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx), a schema collapsing multiple diagnostic terms into 5 classes ranging from benign to invasive melanoma. Methods: Practicing dermatopathologists (N = 149) from 40 US states participated in a 2-year educational intervention study (71% response rate). The intervention involved a brief tutorial followed by practice on 28 melanocytic lesions, with the goal of teaching pathologists how to correctly use the MPATH-Dx schema; competence using the MPATH-Dx tool 12-24 months postintervention was assessed. Participants' self-reported confidence using the MPATH-Dx tool was assessed preintervention and postintervention. Results: At preintervention, confidence using the MPATH-Dx tool was already high, despite 68% lacking prior familiarity with it, and confidence increased postintervention (P = .0003). During the intervention, participants used the MPATH-Dx tool correctly for 90% of their interpretations; postintervention, participants used the MPATH-Dx tool correctly for 88% of their interpretations. Limitations: Future research should examine implementing a standardized pathology assessment schema in actual clinical practice. Conclusion: Dermatopathologists can be taught to confidently and competently use the MPATH-Dx schema with a simple educational tutorial followed by practice.

Effect of Prior Diagnoses on Dermatopathologists' Interpretations of Melanocytic Lesions: A Randomized Controlled Trial.

Importance: Medical second opinions are common, although little is known about the best processes for obtaining them. This study assesses whether knowledge of a prior physician's diagnosis influences consulting physicians' diagnoses. Objective: To measure the extent to which dermatopathologists' diagnoses are influenced by prior diagnostic information from another dermatopathologist. Design, Setting, and Participants: Dermatopathologists were randomly assigned to interpret 1 slide set of 18 melanocytic skin biopsy specimens in 2 phases (5 slide sets totaling 90 cases). Phase 1 interpretations were conducted without prior diagnostic information. After a washout period of 12 or more months, dermatopathologists' phase 2 interpretations were conducted with their identical slide set; for a random subset of cases in phase 2, participants were shown prior diagnoses by other dermatopathologists that were either more or less severe than their own phase 1 diagnosis of the case. Using the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis tool, cases ranged from class I (benign) to class V (≥pT1b invasive melanoma). Data collection took place from August 2018 to March 2021, and data analysis was performed from March to December 2021. Intervention: Prior diagnoses were actual diagnoses from board-certified and/or fellowship-trained dermatopathologists. A prior diagnosis was always in a more severe or less severe diagnostic class than the participant's phase 1 interpretation; more or less severe was determined by the randomization scheme. In the control condition of no prior diagnostic information, the participants were told that a prior diagnosis was not available. Main Outcomes and Measures: When exposure was to a prior diagnosis in a higher diagnostic class, the primary study outcome was whether a participant's diagnosis in phase 2 was in a higher diagnostic class than the participant's diagnosis in phase 1. When exposure was to a prior diagnosis in a lower diagnostic class, the primary study outcome was whether a participant's diagnosis in phase 2 was in a lower diagnostic class than the participant's diagnosis in phase 1. The effect of prior diagnostic information was measured using the relative risk (RR) of each outcome relative to the control condition of no prior diagnostic information, adjusted for the diagnostic class of the phase 1 diagnosis. Prior to data collection, it was hypothesized that participants would be swayed in the direction of prior diagnostic information. Results: A total of 149 dermatopathologists (median [range] age, 47 years [34-76] years; 101 [68%] were male) provided 5322 interpretations of study cases. Participants were more likely to increase the severity of their diagnosis when the prior diagnosis was of greater severity compared with when no prior diagnosis was provided (RR, 1.52; 95% CI, 1.34-1.73); likewise, participants gave less severe diagnoses when prior diagnoses were of lesser severity (RR, 1.38; 95% CI, 1.19-1.59). Trends were similar among dermatopathologists who had previously stated they were "not at all influenced" by prior diagnoses. Prior diagnoses also swayed dermatopathologists away from correct diagnoses. Conclusions and Relevance: In this randomized controlled trial, despite the preference of most dermatopathologists to receive prior diagnoses when providing second opinions, this information swayed them away from a correct diagnosis to an incorrect diagnosis.

Histopathological diagnosis of cutaneous melanocytic lesions: blinded and nonblinded second opinions offer similar improvement in diagnostic accuracy.

BACKGROUND: Previous studies of second opinions in the diagnosis of melanocytic skin lesions have examined blinded second opinions, which do not reflect usual clinical practice. The current study, conducted in the USA, investigated both blinded and nonblinded second opinions for their impact on diagnostic accuracy. METHODS: In total, 100 melanocytic skin biopsy cases, ranging from benign to invasive melanoma, were interpreted by 74 dermatopathologists. Subsequently, 151 dermatopathologists performed nonblinded second and third reviews. We compared the accuracy of single reviewers, second opinions obtained from independent, blinded reviewers and second opinions obtained from sequential, nonblinded reviewers. Accuracy was defined with respect to a consensus reference diagnosis. RESULTS: The mean case-level diagnostic accuracy of single reviewers was 65.3% (95% CI 63.4-67.2%). Second opinions arising from sequential, nonblinded reviewers significantly improved accuracy to 69.9% (95% CI 68.0-71.7%; P < 0.001). Similarly, second opinions arising from blinded reviewers improved upon the accuracy of single reviewers (69.2%; 95% CI 68.0-71.7%). Nonblinded reviewers were more likely than blinded reviewers to give diagnoses in the same diagnostic classes as the first diagnosis. Nonblinded reviewers tended to be more confident when they agreed with previous reviewers, even with inaccurate diagnoses. CONCLUSION: We found that both blinded and nonblinded second reviewers offered a similar modest improvement in diagnostic accuracy compared with single reviewers. Obtaining second opinions with knowledge of previous reviews tends to generate agreement among reviews, and may generate unwarranted confidence in an inaccurate diagnosis. Combining aspects of both blinded and nonblinded review in practice may leverage the advantages while mitigating the disadvantages of each approach. Specifically, a second pathologist could give an initial diagnosis blinded to the results of the first pathologist, with subsequent nonblinded discussion between the two pathologists if their diagnoses differ.

Dermatopathologist Perceptions of Overdiagnosis of Melanocytic Skin Lesions and Association With Diagnostic Behaviors.

Importance: Despite evidence of overdiagnosis of in situ and invasive melanoma, neither the perceptions of practicing dermatopathologists about overdiagnosis nor possible associations between perceptions of overdiagnosis and diagnostic practices have been studied. Objective: To examine practicing US dermatopathologists' perceptions of melanoma overdiagnosis as a public health issue, and to associate diagnostic behaviors of dermatopathologists with perceptions of melanoma overdiagnosis. Design, Setting, and Participants: This survey study included 115 board-certified and/or fellowship-trained dermatopathologists and their diagnostic interpretations on a set of 18 skin biopsy cases (5 slide sets comprising 90 melanocytic skin lesions). Participants interpreted cases remotely using their own microscopes. Survey invitations occurred during 2018 to 2019, with data collection completed 2021. Data analysis was performed from June to September 2021. Main Outcomes and Measures: Agreement vs disagreement that overdiagnosis is a public health issue for atypical nevi, melanoma in situ, and invasive melanoma. Associations between perceptions regarding overdiagnosis and interpretive behavior on study cases. Results: Of 115 dermatopathologists, 68% (95% CI, 59%-76%) agreed that overdiagnosis is a public health issue for atypical nevi; 47% (95% CI, 38%-56%) for melanoma in situ; and 35% (95% CI, 26%-43%) for invasive melanoma. Dermatopathologists with more years in practice were significantly less likely to perceive that atypical nevi are overdiagnosed, eg, 46% of dermatopathologists with 20 or more years of experience agreed that atypical nevi are overdiagnosed compared with 93% of dermatopathologists with 1 to 4 years of experience. Compared with other dermatopathologists, those who agreed that all 3 conditions are overdiagnosed were slightly more likely to diagnose study cases as mild to moderately dysplastic nevi (odds ratio, 1.26; 95% CI, 0.97-1.64; P = .08), but the difference was not statistically significant. Dermatopathologists who agreed that invasive melanoma is overdiagnosed did not significantly differ in diagnosing invasive melanoma for study cases compared with those who disagreed (odds ratio, 1.10; 95% CI, 0.86-1.41; P = .44). Conclusions and Relevance: In this survey study, about two-thirds of dermatopathologists thought that atypical nevi are overdiagnosed, half thought that melanoma in situ is overdiagnosed, and one-third thought that invasive melanoma is overdiagnosed. No statistically significant associations were found between perceptions about overdiagnosis and interpretive behavior when diagnosing skin biopsy cases.

Care partners reading patients' visit notes via patient portals: Characteristics and perceptions.

BACKGROUND: Care partners are key members of patients' health care teams, yet little is known about their experiences accessing patient information via electronic portals. OBJECTIVE: To better understand the characteristics and perceptions of care partners who read patients' electronic visit notes. PATIENT INVOLVEMENT: Focus groups with diverse patients from a community health center provided input into survey development. METHODS: We contacted patient portal users at 3 geographically distinct sites in the US via email in 2017 for an online survey including open ended questions which we qualitatively analyzed. RESULTS: Respondents chose whether to answer as care partners (N = 874) or patients (N = 28,782). Among care partner respondents, 44% were spouses, 43% children/other family members, and 14% friends/neighbors/other. Both care partners and patients reported that access to electronic notes was very important for promoting positive health behaviors, but care partners' perceptions of importance were consistently more positive than patients' perceptions of engagement behaviors. Open-ended comments included positive benefits such as: help with remembering the plan for care, coordinating care with other doctors, decreasing stress of care giving, improving efficiency of visits, and supporting patients from a geographical distance. They also offered suggestions for improving electronic portal and note experience for care partners such as having a separate log on for care partners; having doctors avoid judgmental language in their notes; and the ability to prompt needed medical care for patients. DISCUSSION: Care partners value electronic access to patients' health information even more than patients. The majority of care partners were family members, whose feedback is important for improving portal design that effectively engages these care team members. PRACTICAL VALUE: Patient care in the time of COVID-19 increasingly requires social distancing which may place additional burden on care partners supporting vulnerable patients. Access to patient notes may promote quality of care by keeping care partners informed, and care partner's input should be used to optimize portal design and electronic access to patient information.

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial.

BACKGROUND: We conducted a pilot study to assess feasibility of using video directly-observed therapy (DOT) for patients initiating buprenorphine to evaluate whether it is associated with better opioid use disorder (OUD) outcomes when compared to treatment-as-usual (TAU). METHODS: Pilot randomized controlled trial of adult patients with OUD initiating buprenorphine treatment (n = 78) at two sites (Seattle, WA and Boston, MA) from January 2019 to May 2020. Intervention was video DOT using a HIPAA-compliant smartphone application to record taking daily buprenorphine. Study smartphones, text reminders to upload a video, and calendar summaries of video DOT adherence were provided. Main outcomes were 1) percentage of 12 weekly urine drug tests (UDT) negative for illicit opioids and 2) engagement in treatment at week 12 (i.e., having an active prescription for buprenorphine within the last 7 days). RESULTS: Of 78 enrolled, 20 (26 %) were female; 29 (37 %) non-white; and 31 (40 %) homeless. The mean (standard deviation) percentage of doses confirmed by video was 31 % (34 %). In intention-to-treat analysis, the average percentage of weekly opioid negative UDT was 50 % (95 % CI: 40-63 %) in the intervention arm versus 64 % (95 % CI: 55-74 %) among controls; RR = 0.78 (95 % CI: 0.60-1.02, p = 0.07). Engagement at week 12 was 69 % (95 % CI: 56-86 %) v. 82 % (95 % CI: 71-95 %) in the intervention vs. TAU arms, respectively; RR = 0.84 (95 % CI: 0.65-1.10, p = 0.20). CONCLUSIONS: The video DOT intervention did not result in improvements in illicit opioid use and treatment engagement compared to TAU. The study was limited by low rates of intervention use. TRIAL REGISTRATION: ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Histopathologic synoptic reporting of invasive melanoma: How reliable are the data?

BACKGROUND: Synoptic reporting is recommended by many guideline committees to encourage the thorough histologic documentation necessary for optimal management of patients with melanoma. METHODS: One hundred fifty-one pathologists from 40 US states interpreted 41 invasive melanoma cases. For each synoptic reporting factor, the authors identified cases with "complete agreement" (all participants recorded the same value) versus any disagreement. Pairwise agreement was calculated for each case as the proportion of pairs of responses that agreed, where paired responses were generated by the comparison of each reviewer's response with all others. RESULTS: There was complete agreement among all reviewers for 22 of the 41 cases (54%) on Breslow thickness dichotomized at 0.8 mm, with pairwise agreement ranging from 49% to 100% across the 41 cases. There was complete agreement for "no ulceration" in 24 of the 41 cases (59%), with pairwise agreement ranging from 42% to 100%. Tumor transected at base had complete agreement for 26 of the 41 cases (63%), with pairwise agreement ranging from 31% to 100%. Mitotic rate, categorized as 0/mm2 , 1/mm2 , or 2/mm2 , had complete agreement for 17 of the 41 cases (41%), with pairwise agreement ranging from 36% to 100%. Regression saw complete agreement for 14 of 41 cases (34%), with pairwise agreement ranging from 40% to 100%. Lymphovascular invasion, perineural invasion, and microscopic satellites were rarely reported as present. Respectively, these prognostic factors had complete agreement for 32 (78%), 37 (90%), and 18 (44%) of the 41 cases, and the ranges of pairwise agreement were 47% to 100%, 70% to 100%, and 53% to 100%, respectively. CONCLUSIONS: These findings alert pathologists and clinicians to the problem of interobserver variability in recording critical prognostic factors. LAY SUMMARY: This study addresses variability in the assessment and reporting of critical characteristics of invasive melanomas that are used by clinicians to guide patient care. The authors characterize the diagnostic variability among pathologists and their reporting methods in light of recently updated national guidelines. Results demonstrate considerable variability in the diagnostic reporting of melanoma with regard to the following: Breslow thickness, mitotic rate, ulceration, regression, and microscopic satellites. This work serves to alert pathologists and clinicians to the existence of variability in reporting these prognostic factors.

Terminology for melanocytic skin lesions and the MPATH-Dx classification schema: A survey of dermatopathologists.

BACKGROUND: Diagnostic terms used in histopathology reports of cutaneous melanocytic lesions are not standardized. We describe dermatopathologists' views regarding diverse diagnostic terminology and the utility of the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx) for categorizing melanocytic lesions. METHODS: July 2018-2019 survey of board-certified and/or fellowship-trained dermatopathologists with experience interpreting melanocytic lesions. RESULTS: Among 160 participants, 99% reported witnessing different terminology being used for the same melanocytic lesion. Most viewed diverse terminology as confusing to primary care physicians (98%), frustrating to pathologists (83%), requiring more of their time as a consultant (64%), and providing necessary clinical information (52%). Most perceived that adoption of the MPATH-Dx would: improve communication with other pathologists and treating physicians (87%), generally be a change for the better (80%), improve patient care (79%), be acceptable to clinical colleagues (68%), save time in pathology report documentation (53%), and protect from malpractice (51%). CONCLUSIONS: Most dermatopathologists view diverse terminology as contributing to miscommunication with clinicians and patients, adversely impacting patient care. They view the MPATH-Dx as a promising tool to standardize terminology and improve communication. The MPATH-Dx may be a useful supplement to conventional pathology reports. Further revision and refinement are necessary for widespread clinical use.

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial.

BACKGROUND: Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. METHODS: Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. DISCUSSION: Video DOT delivered through mHealth technology platform offers possibility of improving patients' buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Malpractice and Patient Safety Concerns.

OBJECTIVES: "Assurance behaviors," a type of defensive medicine, involve physicians' utilization of additional patient services to avoid adverse legal outcomes. We aim to compare the use of clinical behaviors (such as ordering additional tests, services, and consultations) due to malpractice concerns with the same behaviors due to patient safety concerns. METHODS: A national sample of dermatopathologists (n = 160) completed an online survey. RESULTS: Participants reported using one or more of five clinical behaviors due to concerns about medical malpractice (95%) and patient safety (99%). Self-reported use of clinical behaviors due to malpractice concerns and patient safety concerns was compared, including ordering additional immunohistochemistry/molecular tests (71% vs 90%, respectively, P < .0001), recommending additional surgical sampling (78% vs 91%, P < .0001), requesting additional slides (81% vs 95%, P < .0001), obtaining second reviews (78% vs 91%, P < .0001), and adding caveats into reports regarding lesion difficulty (85% vs 89%, P > .05). CONCLUSIONS: Dermatopathologists use many clinical behaviors both as assurance behaviors and due to patient safety concerns, with a higher proportion reporting patient safety concerns as a motivation for specific behaviors.

Dermatopathologists' Experience With and Perceptions of Patient Online Access to Pathologic Test Result Reports.

Importance: Many patients presently have access to their pathologic test result reports via online patient portals, yet little is known about pathologists' perspective on this topic. Objective: To examine dermatopathologists' experience and perceptions of patient online access to pathology reports. Design, Setting, and Participants: A survey of 160 dermatopathologists currently practicing in the United States who are board certified and/or fellowship trained in dermatopathology was conducted between July 15, 2018, and September 23, 2019. Those who reported interpreting skin biopsies of melanocytic lesions within the previous year and expected to continue interpreting them for the next 2 years were included. Main Outcomes and Measures: Dermatopathologists' demographic and clinical characteristics, experiences with patient online access to pathologic test result reports, potential behaviors and reactions to patient online access to those reports, and effects on patients who read their pathologic test result reports online. Results: Of the 160 participating dermatopathologists from the 226 eligible for participation (71% response rate), 107 were men (67%); mean (SD) age was 49 (9.7) years (range, 34-77 years). Ninety-one participants (57%) reported that patients have contacted them directly about pathologic test reports they had written. Some participants noted that they would decrease their use of abbreviations and/or specialized terminology (57 [36%]), change the way they describe lesions suspicious for cancer (29 [18%]), and need specialized training in communicating with patients (39 [24%]) if patients were reading their reports. Most respondents perceived that patient understanding would increase (97 [61%]) and the quality of patient-physician communication would increase (98 [61%]) owing to the availability of online reports. Slightly higher proportions perceived increased patient worry (114 [71%]) and confusion (116 [73%]). However, on balance, most participants (114 [71%]) agreed that making pathologic test result reports available to patients online is a good idea. Conclusions and Relevance: Dermatopathologists in this survey study perceived both positive and negative consequences of patient online access to pathologic test result reports written by the respondents. Most participants believe that making pathologic test result reports available to patients online is a good idea; however, they also report concerns about patient worry and confusion increasing as a result. Further research regarding best practices and the effect on both patients and clinicians is warranted.

Pathologists' agreement on treatment suggestions for melanocytic skin lesions.

BACKGROUND: Although treatment guidelines exist for melanoma in situ and invasive melanoma, guidelines for other melanocytic skin lesions do not exist. OBJECTIVE: To examine pathologists' treatment suggestions for a broad spectrum of melanocytic skin lesions and compare them with existing guidelines. METHODS: Pathologists (N = 187) completed a survey and then provided diagnoses and treatment suggestions for 240 melanocytic skin lesions. Physician characteristics associated with treatment suggestions were evaluated with multivariable modeling. RESULTS: Treatment suggestions were concordant with National Comprehensive Cancer Network guidelines for the majority of cases interpreted as melanoma in situ (73%) and invasive melanoma (86%). Greater variability of treatment suggestions was seen for other lesion types without existing treatment guidelines. Characteristics associated with provision of treatment suggestions discordant with National Comprehensive Cancer Network guidelines were low caseloads (invasive melanoma), lack of fellowship training or board certification (melanoma in situ), and more than 10 years of experience (invasive melanoma and melanoma in situ). LIMITATIONS: Pathologists could not perform immunohistochemical staining or other diagnostic tests; only 1 glass side was provided per biopsy case. CONCLUSIONS: Pathologists' treatment suggestions vary significantly for melanocytic lesions, with lower variability for lesion types with national guidelines. Results suggest the need for standardization of treatment guidelines for all melanocytic lesion types.

Concordance and Reproducibility of Melanoma Staging According to the 7th vs 8th Edition of the AJCC Cancer Staging Manual.

IMPORTANCE: The recently updated American Joint Committee on Cancer (AJCC) classification of cancer staging, the AJCC Cancer Staging Manual, 8th edition (AJCC 8), includes revisions to definitions of T1a vs T1b or greater. The Melanoma Pathology Study database affords a comparison,of pathologists' concordance and reproducibility in the microstaging of melanoma according to both the existing 7th edition (AJCC 7) and the new AJCC 8. OBJECTIVE: To compare AJCC 7 and AJCC 8 to examine whether changes to the definitions of T1a and T1b or greater are associated with changes in concordance and reproducibility. DESIGN SETTING AND PARTICIPANTS: In this diagnostic study conducted as part of the national Melanoma Pathology Study across US states, 187 pathologists interpreting melanocytic skin lesions in practice completed 4342 independent case interpretations of 116 invasive melanoma cases. A consensus reference diagnosis and participating pathologists' interpretations were classified into the Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis class IV (T1a) or class V ( T1b) using both the AJCC 7 and AJCC 8 criteria. MAIN OUTCOMES AND MEASURES: Concordance with consensus reference diagnosis, interobserver reproducibility, and intraobserver reproducibility. RESULTS: For T1a diagnoses, participating pathologists' concordance with the consensus reference diagnosis increased from 44% (95% CI, 41%-48%) to 54% (95% CI, 51%-57%) using AJCC 7 and AJCC 8 criteria, respectively. The concordance for cases of T1b or greater increased from 72% (95% CI, 69%-75%) to 78% (95% CI, 75%-80%). Intraobserver reproducibility of diagnoses also improved, increasing from 59% (95% CI, 56%-63%) to 64% (95% CI, 62%-67%) for T1a invasive melanoma, and from 74% (95% CI, 71%-76%) to 77% (95% CI, 74%-79%) for T1b or greater invasive melanoma cases. CONCLUSIONS AND RELEVANCE: Melanoma staging in AJCC 8 shows greater reproducibility and higher concordance with a reference standard. Improved classification of invasive melanoma can be expected after implementation of AJCC 8, suggesting a positive impact on patients. However, despite improvement, concordance and reproducibility remain low.

Accuracy of Digital Pathologic Analysis vs Traditional Microscopy in the Interpretation of Melanocytic Lesions.

Importance: Use of digital whole-slide imaging (WSI) for dermatopathology in general has been noted to be similar to traditional microscopy (TM); however, concern has been noted that WSI is inferior for interpretation of melanocytic lesions. Since approximately 1 of every 4 skin biopsies is of a melanocytic lesion, the use of WSI requires verification before use in clinical practice. Objective: To compare pathologists' accuracy and reproducibility in diagnosing melanocytic lesions using Melanocytic Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx) categories when analyzing by TM vs WSI. Design, Setting, and Participants: A total of 87 pathologists in community-based and academic settings from 10 US states were randomized with stratification based on clinical experience to interpret in TM format 180 skin biopsy cases of melanocytic lesions, including 90 invasive melanoma, divided into 5 sets of 36 cases (phase 1). The pathologists were then randomized via stratified permuted block randomization with block size 2 to interpret cases in either TM (n = 46) or WSI format (n = 41), with each pathologist interpreting the same 36 cases on 2 separate occasions (phase 2). Diagnoses were categorized as MPATH-Dx categories I through V, with I indicating the least severe and V the most severe. Main Outcomes and Measures: Accuracy with respect to a consensus reference diagnosis and the reproducibility of repeated interpretations of the same cases. Results: Of the 87 pathologists in the study, 46% (40) were women and the mean (SD) age was 50.7 (10.2) years. Except for class III melanocytic lesions, the diagnostic categories showed no significant differences in diagnostic accuracy between TM and WSI interpretation. Discordance was lower among class III lesions for the TM interpretation arm (51%; 95% CI, 46%-57%) than for the WSI arm (61%; 95% CI, 53%-69%) (P = .05). This difference is likely to have clinical significance, because 6% of TM vs 11% of WSI class III lesions were interpreted as invasive melanoma. Reproducibility was similar between the traditional and digital formats overall (66.4%; 95% CI, 63.3%-69.3%; and 62.7%; 95% CI, 59.5%-65.7%, respectively), and for all classes, although class III showed a nonsignificant lower intraobserver agreement for digital. Significantly more mitotic figures were detected with TM compared with WSI: mean (SD) TM, 6.72 (2.89); WSI, 5.84 (2.56); P = .002. Conclusions and Relevance: Interpretive accuracy for melanocytic lesions was similar for WSI and TM slides except for class III lesions. We found no clinically meaningful differences in reproducibility for any of the diagnostic classes.

Characteristics and diagnostic performance of pathologists who enjoy interpreting melanocytic lesions.

Diagnostic discrepancy among pathologists interpreting melanocytic skin lesions (MSL) is an ongoing concern for patient care. Given that job satisfaction could impact patient care, this study aimed to characterize which pathologists enjoy interpreting MSL and estimate the association between enjoyment and diagnostic accuracy. Pathologists' demographics, training, and experience were obtained by a cross-sectional survey. Associations between these characteristics and self-reported enjoyment when interpreting MSL were estimated by Pearson's Chi-square tests. Diagnostic accuracy was determined by comparing pathologists' MSL interpretations with reference standard diagnoses. Associations between enjoyment and diagnostic accuracy were evaluated by generalized estimating equations (GEE) models. One hundred and eighty-seven (90%) pathologists completed the study. Seventy percent agreed that interpreting MSL is enjoyable. Pathologists who enjoyed interpreting MSL were more likely to be board certified and/or fellowship trained in dermatopathology (P=0.008), have ?10 years of experience (P=0.010) and have an MSL caseload of ?60 per month (P=<0.001). After adjustment, there was no association between enjoyment and diagnostic accuracy. Our data suggest that job dissatisfaction does not adversely affect diagnostic accuracy in the interpretation of melanocytic lesions, which is of importance given the progressive increase in annual biopsy rates and the attendant work demands imposed on pathologists.

Use of Digital Whole Slide Imaging in Dermatopathology.

Digital whole slide imaging (WSI) is an emerging technology for pathology interpretation, with specific challenges for dermatopathology, yet little is known about pathologists' practice patterns or perceptions regarding WSI for interpretation of melanocytic lesions. A national sample of pathologists (N = 207) was recruited from 864 invited pathologists from ten US states (CA, CT, HI, IA, KY, LA, NJ, NM, UT, and WA). Pathologists who had interpreted melanocytic lesions in the past year were surveyed in this cross-sectional study. The survey included questions on pathologists' experience, WSI practice patterns and perceptions using a 6-point Likert scale. Agreement was summarized with descriptive statistics to characterize pathologists' use and perceptions of WSI. The majority of participating pathologists were between 40 and 59 years of age (62%) and not affiliated with an academic medical center (71%). Use of WSI was seen more often among dermatopathologists and participants affiliated with an academic medical center. Experience with WSI was reported by 41%, with the most common type of use being for education and testing (CME, board exams, and teaching in general, 71%), and clinical use at tumor boards and conferences (44%). Most respondents (77%) agreed that accurate diagnoses can be made with this technology, and 59% agreed that benefits of WSI outweigh concerns. However, 78% of pathologists reported that digital slides are too slow for routine clinical interpretation. The respondents were equally split as to whether they would like to adopt WSI (49%) or not (51%). The majority of pathologists who interpret melanocytic lesions do not use WSI, but among pathologists who do, use is largely for CME, licensure/board exams, and teaching. Positive perceptions regarding WSI slightly outweigh negative perceptions. Understanding practice patterns with WSI as dissemination advances may facilitate concordance of perceptions with adoption of the technology.