Assessment of Opioid Prescribing Patterns in a Large Network of US Community Health Centers, 2009 to 2018.

Importance: Understanding opioid prescribing patterns in community health centers (CHCs) that disproportionately serve low-income patients may help to guide strategies to reduce opioid-related harms. Objective: To assess opioid prescribing patterns between January 1, 2009, and December 31, 2018, in a network of safety-net clinics serving high-risk patients. Design, Setting, and Participants: Cross-sectional study of 3 227 459 opioid prescriptions abstracted from the electronic health records of 2 129 097 unique primary care patients treated from 2009 through 2018 at a network of CHCs that included 449 clinic sites in 17 states. All age groups were included in the analysis. Main Outcomes and Measures: The following measures were described at the population level for each study year: (1) percentage of patients with at least 1 prescription for an opioid by age and sex, (2) number of opioid prescriptions per 100 patients, (3) number of long-acting opioid prescriptions per 100 patients, (4) mean annual morphine milligram equivalents (MMEs) per patient, (5) mean MME per prescription, (6) number of chronic opioid users, and (7) mean of high-dose opioid users. Results: The study population included 2 129 097 patients (1 158 413 women [54.4%]) with a mean (SD) age of 32.2 (21.1) years and a total of 3 227 459 opioid prescriptions. The percentage of patients receiving at least 1 opioid prescription in a calendar year declined 67.4% from 15.9% in 2009 to 5.2% in 2018. Over the 10-year study period, a greater percentage of women received a prescription (13.1%) compared with men (10.9%), and a greater percentage of non-Hispanic White patients (18.1%) received an opioid prescription compared with non-Hispanic Black patients (9.5%), non-Hispanic patients who self-identified as other races (8.0%), and Hispanic patients (6.9%). The number of opioid prescriptions for every 100 patients decreased 73.7% from 110.8 in 2009 to 29.1 in 2018. The number of long-acting opioids for every 100 patients decreased 85.5% during the same period, from 22.0 to 3.2. The MMEs per patient decreased from 1682.7 in 2009 to 243.1 in 2018, a decline of 85.6%. Conclusions and Relevance: In this cross-sectional study, the opioid prescribing rate in 2009 in the CHC network was higher than national population estimates but began to decline earlier and more precipitously. This finding likely reflects harm mitigation policies and efforts at federal, state, and clinic levels and strong clinical quality improvement strategies within the CHCs.

Psychometric Properties of the Reduced Version of the Glaucoma Treatment Compliance Assessment Tool (GTCAT).

PURPOSE: To measure the psychometric properties of a reduced, 27-statement version of the Glaucoma Treatment Compliance Assessment Tool (GTCAT). METHODS: We administered the GTCAT to 183 participants who were using a single bottle of an ocular hypotensive agent, and objectively measured adherence with Medication Event Monitoring System devices over 60 days. Adherence was the number of days with correctly timed bottle openings divided by the total number of study days. Using the 47-statement GTCAT, we created a reduced GTCAT by removing statements that: (1) did not load using Principal Components Analysis (PCA); (2) did not have a univariable association with adherence; or (3) were highly correlated (.75 or higher) with another statement. We assessed the construct validity of the remaining statements using PCA and assessed the predictive validity using multiple logistic regression analysis. RESULTS: We removed 20 statements because they did not appear in the PCA analysis; were not predictive of adherence; and/or had high correlation. PCA of the reduced GTCAT (27 statements) extracted 5 components of the Health Belief Model (knowledge, susceptibility, cues-to-action, self-efficacy, and barriers). Multiple regression showed that the 27 statements predicted adherence (Rsq = .11, p = .03). CONCLUSIONS: The reduced version of the GTCAT is associated with adherence, which suggests that after external validation, future glaucoma medication adherence studies could use the reduced version to efficiently measure health behaviors and determine the benefit of the GTCAT to develop personalized interventions in glaucoma adherence.

Psychometric Properties of the Glaucoma Treatment Compliance Assessment Tool (GTCAT) in a Brazilian Population.

PURPOSE: To determine the psychometric properties of a reduced version of the Glaucoma Treatment Compliance Assessment Tool (GTCAT), which was translated to Brazilian Portuguese. PATIENTS AND METHODS: We translated into Portuguese the GTCAT using validated techniques and administered it to a group of glaucoma patients using at least 1 ocular hypotensive eye drop medication. We used principal components analysis to determine construct validity, Rasch analysis, and Cronbach α for internal consistency reliability, frequency analysis for floor and ceiling effects, and Spearman ρ for test-retest reliability. RESULTS: We included 76 glaucoma patients. Principal component analysis loaded 14 questions into 7 components that were consistent with the Health Belief Model. The components were related to "barriers due to lack of drops," "self-efficacy," "experience of negative effects of the disease," "well-being," "general glaucoma knowledge," "glaucoma symptoms," and "cues-to-action." No statements had floor or ceiling effects, and all statements had acceptable test-retest reliability. Components had internal consistency Cronbach α reliability between 0.125 and 0.794. and average Spearman ρ reliability was 0.73, ranging from 0.44 to 1.00. According to Rasch analysis, the mean (±SD) of the person measures was 0.24±0.15 logits, person separation index was 0.58, and person reliability 0.25. CONCLUSIONS: The Portuguese-translated version of the GTCAT showed acceptable psychometric properties. With further refinement, clinicians and researchers could use it to better investigate glaucoma adherence issues in the Brazilian population.

Concentration Accuracy of Compounded Mitomycin C for Ophthalmic Surgery.

IMPORTANCE: Ophthalmologists rely on accurate concentrations of mitomycin C (MMC) to prevent scarring with trabeculectomy surgery. To our knowledge, the concentration accuracy and variability of compounded MMC are unknown. OBJECTIVE: To determine whether the measured concentration differs from the expected concentration of 0.4 mg/mL of MMC used in ophthalmic surgery. DESIGN, SETTING, AND PARTICIPANTS: Laboratory experimental investigation conducted in July 2013. We acquired 60 samples of 0.4 mg/mL of MMC from a spectrum of common compounding and storage techniques (refrigeration, freezing, and immediately compounded dry powder) and a variety of pharmacies (an academic hospital, a community hospital, and an independent Pharmacy Compounding Accreditation Board-accredited pharmacy). We used C18 reversed-phase high-performance liquid chromatography to measure the MMC concentration of all samples. We used pure MMC (Medisca Inc) to generate calibration curves and sulfanilamide as an internal standard. MAIN OUTCOMES AND MEASURES: We calculated MMC concentration using a calibration curve (range, 0.3-0.5 mg/mL) generated by dividing MMC peak area by internal standard peak area and plotting the area ratio against the calibrant concentrations. We compared the measured concentration against the expected 0.4 mg/mL concentration for all samples. RESULTS: Measurement of MMC using the high-performance liquid chromatography method demonstrated acceptable accuracy (92%-100%), precision (2%-6% coefficient of variation), and linearity (mean correlation coefficient of r2 = 0.99). The measured MMC concentration determined using the high-performance liquid chromatography method for all samples was 12.5% lower than the expected 0.4 mg/mL value (mean [SD], 0.35 [0.04] mg/mL; 95% CI, 0.34-0.36; P < .001) with a wide concentration range between 0.26 and 0.46 mg/mL. CONCLUSIONS AND RELEVANCE: Common compounding and storage techniques for MMC resulted in a lower accuracy and wider range of concentration than expected. These differences in concentration may result from compounding techniques and/or MMC degradation. Variability in MMC concentration could cause inconsistency in glaucoma surgical results, but the clinical relevance of such findings on glaucoma surgery outcomes remains unknown.

The Degradation of Mitomycin C Under Various Storage Methods.

PURPOSE: To compare the effects of common pharmacy preparation and storage conditions on the stability of mitomycin C (MMC) in solution. METHODS: We used C18 reversed-phase high-performance liquid chromatography to determine the stability of 0.4 mg/mL MMC solutions, and liquid chromatography-electrospray ionization-mass spectrometry to identify degradation products. Conditions compared were: compounding and storage by refrigeration (1 and 2 wk), freezing (23 d), shipment "on-ice" (1 mo frozen followed by 1-wk refrigeration), and immediately compounding dry powder (Mitosol; Mobius Therapeutics LLC). We tested 3 samples for each storage method when samples reached room temperature (time 0), and then 1, 4, and 24 hours later. We used MMC peak area as a percentage of total (MMC plus degradants) area detected with high-performance liquid chromatography as a measure of stability. RESULTS: We assessed MMC stability for 5 preparation and storage methods at 4 timepoints (with n=3 per timepoint). At time 0, we found similar stabilities for MMC (F=0.72, P=0.599) between all 5 storage methods: 1-week refrigerated (97.9±0.2%), dry powder (97.5±0.3%), 2-week refrigerated (96.9±0.2%), 23-day frozen (96.7±3.1%), and shipment on-ice (96.0±1.2%). However, MMC demonstrated significant degradation over a 24-hour period with 2-week refrigeration (95.7±0.3%, ß=-0.1%/h, P<0.001) and shipment on-ice (93.1±1.8%, ß=-0.1%/h, P=0.013). We identified small amounts (<3.2%) of 2 degradants, cis-hydroxymitosene and trans-hydroxymitosene, across all samples. CONCLUSIONS: The different preparation and storage methods of MMC showed similar stability when used immediately upon reaching room temperature. However, degradation of MMC occurred with further storage at room temperature. The clinical implication of small amounts of MMC degradants is unclear.

Psychometric properties of the Glaucoma Treatment Compliance Assessment Tool in a multicenter trial.

PURPOSE: To assess the psychometric properties of a new version of the Glaucoma Treatment Compliance Assessment Tool, a survey evaluating health behavior and glaucoma adherence using constructs from the Health Belief Model. DESIGN: Psychometric analysis. METHODS: We administered the 47-statement Glaucoma Treatment Compliance Assessment Tool to 201 participants who were using a single bottle of an ocular hypotensive agent, and objectively measured adherence with medication event monitoring system devices over 60 days. Adherence was the percentage of days with correctly timed bottle openings. We used principal components analysis to determine construct validity, Cronbach's alpha for internal consistency reliability, frequency analysis for floor and ceiling effects, and Spearman rho for test-retest reliability. We determined predictive validity using univariate and multiple regression. RESULTS: The mean (±SD, range) adherence percentage was 79.9% (±18.5%, 20.3%-100.0%). Principal component analysis loaded 24 questions into 6 components that were consistent with the Health Belief Model. All 6 components had Cronbach's alpha reliability between 0.601 and 0.797. No statements had floor or ceiling effects, and all statements had acceptable test-retest reliability. Multiple regression analysis showed 4 Health Belief Model statements, white race, older age, and married marital status to be associated with higher adherence (adjusted R(2) = 0.27, P < .001). CONCLUSIONS: The newest version of the Glaucoma Treatment Compliance Assessment Tool showed acceptable psychometric properties. With further refinement, clinicians and researchers could use it to examine factors related to adherence and measure improvement in adherence with a change in health behavior attitudes.

Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial.

IMPORTANCE: Minimal information exists regarding the long-term comparative effectiveness of telemedicine to provide diabetic retinopathy screening examinations. OBJECTIVE: To compare telemedicine to traditional eye examinations in their ability to provide diabetic retinopathy screening examinations. DESIGN, SETTING, AND PARTICIPANTS: From August 1, 2006, through September 31, 2009, 567 participants with diabetes were randomized and followed up to 5 years of follow-up (last date of patient follow-up occurred on August 6, 2012) as part of a multicenter randomized clinical trial with an intent to treat analysis. We assigned participants to telemedicine with a nonmydriatic camera in a primary care medical clinic (n = 296) or traditional surveillance with an eye care professional (n = 271). Two years after enrollment, we offered telemedicine to all participants. MAIN OUTCOMES AND MEASURES: Percentage of participants receiving annual diabetic retinopathy screening examinations, percentage of eyes with worsening diabetic retinopathy during the follow-up period using a validated scale from stage 0 (none) to stage 4 (proliferative diabetic retinopathy), and percentage of telemedicine participants who would require referral to an eye care professional for follow-up care using a cutoff of moderate diabetic retinopathy or worse, the presence of macular edema, or an unable-to-determine result for retinopathy or macular edema. RESULTS: The telemedicine group was more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group during the 6-month or less (94.6% [280/296] vs 43.9% [119/271]; 95% CI, 46.6%-54.8%; P < .001) and greater than 6-month through 18-month (53.0% [157/296] vs 33.2% [90/271]; 95% CI, 16.5%-23.1%; P < .001) time bins. After we offered telemedicine to both groups, we could not identify a difference between the groups in the percentage of diabetic retinopathy screening examinations. Diabetic retinopathy worsened by 2 stages or more in 35 (8.6%) of 409 participants (95% CI, 5.8%-11.2%) and improved by 2 stages or more in 5 (1.2%) of 409 participants (95% CI, 0.1%-2.3%) during the 4-year period. The percent of telemedicine participants requiring referral ranged from 19.2% (52/271) to 27.9% (58/208). CONCLUSIONS AND RELEVANCE: Telemedicine increased the percentage of diabetic retinopathy screening examinations, most participants did not require referral to an eye care professional, and diabetic retinopathy levels were generally stable during the study period. This finding suggests that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for disease worsening over a long period. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01364129.