Prevalence of Genital Herpes and Antiviral Treatment.

BACKGROUND: Genital herpes is a common sexually transmitted infection caused by the herpes simplex virus. Contemporary US population-based epidemiologic data on genital herpes are limited. This study aimed to provide nationally representative estimates of genital herpes prevalence and treatment using a large US health insurance claims database. METHODS: This observational cohort study used administrative claims data from HealthVerity. Crude and age- and sex-standardized prevalence rates of genital herpes and recurrent genital herpes were calculated for the years 2019 to 2021. The distribution of patients with prevalent genital herpes who received episodic or suppressive antiviral therapy was also estimated. RESULTS: From 2019 to 2021, the standardized prevalence of genital herpes and recurrent genital herpes ranged from 236 to 280 cases per 100,000 person-years and 81 to 98 cases per 100,000 person-years, respectively. The prevalence of genital herpes was highest among those aged 25 to 29 years (prevalence range, 497-582 years), female patients (prevalence range, 348-404 years), and those with a history of HIV infection (prevalence range, 1608-2080 years). The prevalence of recurrent genital herpes was also highest in these groups. From 2019 to 2021, two-thirds of patients (65%-68%) with prevalent genital herpes received antiviral medications; the majority received episodic therapy (80%) rather than suppressive therapy (20%). CONCLUSIONS: The burden of genital herpes and recurrent genital herpes in the United States is substantial, with the highest rates observed in young adults, women, and immunocompromised individuals. About two-thirds receive antiviral treatment each year.

Temporal effect of imatinib adherence on time to remission in chronic myeloid leukemia patients.

INTRODUCTION: Adherence to imatinib in chronic myeloid leukemia (CML) patients is estimated to be as low as 70% despite its clinical benefit, and our understanding of the impact of nonadherence in this population is limited. This study presents a novel application of the Alternating Conditional Estimation (ACE) algorithm in newly diagnosed CML patients to map the full dose-response curve (DRC) and determine how the strength of this curve varies over time. METHODS: We applied the ACE algorithm alongside a backward elimination procedure to detect the presence of time dependence and nonlinearity in the relationship between imatinib adherence and time-to-remission. An extended Cox model allowing for the flexible modeling of identified effects via unpenalized B-splines was subsequently fit and assessed. RESULTS: The substantial improvement in model fit associated with the extended Cox approach suggests that traditional Cox proportional hazards model assumptions do not hold in this setting. Results indicate that the DRC for imatinib is non-linearly increasing, with an attenuated effect above a 74% adherence rate. The strength of this effect on remission varied over time and was strongest in the initial months of treatment, reaching a peak around 90 days post-initiation (log hazard ratio: 2.12, 95% confidence interval: 1.47 to 2.66). CONCLUSION: Most patients that achieved remission did so by 4 months (120 days) with consistently high adherence, suggesting that this could be a critical time and duration for realizing treatment benefit and patient monitoring. Findings regarding the relationship between adherence and remission can additionally help guide the design of future studies.

Community pharmacist intervention to close statin gaps in diabetes care: The GuIDE-S study.

BACKGROUND: Statin therapy is recommended for people with type 2 diabetes (T2D) to lower cardiovascular risk; however, evidence suggests that significant gaps in statin therapy exist. OBJECTIVE: To evaluate (1) the impact of a community pharmacist-led model for initiating statin therapy in people with type 2 diabetes (T2D) on statin initiation and (2) pharmacists' self-reported perceptions of the intervention feasibility and fidelity to the intervention. METHODS: This was a type 1 hybrid effectiveness-implementation study of 9 intervention and 18 control pharmacies within a community pharmacy chain. Pharmacy staff proactively identified patients with T2D not taking a statin and prescribed a statin via a collaborative practice agreement or facilitated acquisition of a prescription from the patient's preferred prescriber. The eligible population included patients aged 18-84 years with T2D, who had filled ≥60 days' supply of one, noninsulin, diabetes medication in a rolling 6-month period, and who had not filled a statin during the same period. A Cox proportional hazards model was used to compare time to statin initiation. Pharmacists at intervention pharmacies completed a survey at 6 and 12 months after implementation (March and August 2019, respectively) to assess intervention feasibility and fidelity. RESULTS: For the statin initiation analysis, 1670 intervention patients were matched to 3358 control patients. Overall, 26.3% (n=442) of intervention patients and 25.4% (n=854) of control patients initiated a statin within 12 months of their index date. There was no difference in statin initiation likelihood between intervention and control patients (hazard ratio: 1.00; 95% CI: 0.83, 1.21). Fifteen pharmacists completed the 6-month survey (33% response rate), and 12 completed the 12-month survey (26%). The intervention's feasibility score was 4.0 at 6 months and 4.2 at 12 months, indicating an increase in perceived feasibility. Fidelity decreased from 6 to 12 months. CONCLUSION: The community pharmacist-led intervention resulted in more patients initiating statin therapy as compared to usual care; however, the differences were not statistically significant. Pharmacists perceived the intervention to be feasible; however, fidelity decreased over time.

Community pharmacist intervention to optimize statin adherence in diabetes care: The GuIDE-S study.

BACKGROUND: Statin use in people with type 2 diabetes (T2D) reduces cardiovascular events, yet adherence remains suboptimal. OBJECTIVE: This study evaluated the impact of a community pharmacist intervention on statin adherence in new users with T2D. METHODS: As part of a quasi-experimental study, community pharmacy staff proactively identified adult patients with T2D who were not prescribed a statin. When appropriate, the pharmacist prescribed a statin via a collaborative practice agreement or facilitated acquisition of a prescription from another prescriber. Patients received individualized education and follow-up and monitoring for 1 year. Adherence was defined as the proportion of days covered (PDC) by a statin over 12 months. Linear and logistic regression were used to compare the effect of the intervention on continuous and a binary adherence threshold, defined as PDC ≥ 80%, respectively. RESULTS: Overall, 185 patients started statin therapy and were matched to 370 control patients for analysis. Adjusted average PDC was 3.1% higher in the intervention group (95% CI -0.037 to 0.098). Patients in the intervention group were 21.2% more likely to have PDC ≥ 80% (95% CI 0.828-1.774). CONCLUSION: The intervention resulted in higher statin adherence than usual care; however, the differences were not statistically significant.

Prescribing Alzheimer's Disease treatments by provider type and geographic region: a comparison among physicians, nurse practitioners, and physician assistants.

BACKGROUND: The estimated increase in Alzheimer's Disease (AD) caseload may present a logistical challenge to the US healthcare system. While nurse practitioners (NPs) and physician assistants (PAs) are increasingly delivering primary care to patients with chronic diseases, the nature of their prescribing of AD medications is largely unknown. The primary objective of this study was to compare the prescribing of AD medications across provider types (physician, NP, and PA) and geographic regions. METHODS: We conducted a retrospective cohort study using IBM MarketScan® commercial and Medicare supplemental claims to examine unique AD prescriptions prescribed between January 1, 2016, and December 31, 2019. Parallel analysis of prescriptions for another geriatric condition, osteoporosis (OP), was also conducted for comparison. RESULTS: A total of 103,067 AD prescriptions and 131,773 OP prescriptions were included in analyses. Physicians prescribed most AD prescriptions (95.65%), followed by NPs (3.37%) and PAs (0.98%). Small differences were identified among individual AD medications prescribed by physicians compared to NP/PAs. NPs/PAs prescribed a significantly higher proportion of AD prescriptions in rural as compared to urban areas (z = 0.023, 95%CI [0.018, 0.028]). CONCLUSION: Minimal variation exists in AD prescribing among physicians, NPs, and PAs, but NPs/PAs prescribe more AD prescriptions in rural areas. NPs/PAs, especially in rural areas, may play critical roles in alleviating projected workforce constraints. Further research assessing AD care, health outcomes, and costs by provider type and region is necessary to better guide healthcare workforce planning for AD care.

Association between having a family member with dementia and perceptions of dementia preventability.

BACKGROUND: One's experience with dementia may affect their perceptions about dementia preventability, which in turn could influence preventive health behaviors. We aimed to examine how having a family history of dementia and caregiving experience are associated with perceptions about and self-efficacy for dementia preventability. METHODS: Cross-sectional, self-administered survey. Participants reported whether they have had a family member with dementia and, among those who reported having a family member with dementia, whether they served as a caregiver. Outcomes were perceptions about the likelihood of dementia preventability, self-efficacy for dementia prevention, and benefits of specific dementia prevention strategies. Associations were assessed via partial proportional odds model for ordinal outcome variables and logistic regression for binary outcome variables. RESULTS: Of 1,575 respondents, 71% had a family member with dementia, of which 42% served as a caregiver. People with a family member with dementia were less likely to believe that dementia is preventable (aOR = 0.75, 95% CI: 0.58, 0.96) and had lower self-efficacy for dementia prevention (aOR = 0.71, 95% CI: 0.56, 0.90). The subgroup analysis among those with caregiving experience was consistent with the primary findings, showing less belief in the likelihood of dementia preventability (aOR = 0.69, 95% CI: 0.46, 1.03) and self-efficacy (aOR = 0.75, 95% CI: 0.56, 1.00). CONCLUSION: Having a family member with dementia is associated with unfavorable perceptions about dementia preventability. Incorporating family history of dementia into communication efforts about dementia risk reduction may help address potential barriers to preventive health behaviors.

Challenges and Successes of Global Deprescribing Networks: A Qualitative Key Informant Study.

The landscape of deprescribing has been rapidly evolving and expanding globally with the formation of regional and national deprescribing networks. The work of these networks is primarily focused on older adults and high-risk medications. The purpose of the current qualitative study is to describe successes and challenges of deprescribing from thought-leaders across the world. Fourteen key informant interviews were conducted from various disciplines, levels of experiences, and regions around the globe. From the interviews, six major themes across two domains were identified: (a) network structure, (b) public perception, (c) policy implications, (d) implementation, (e) challenges, and (f) recommendations. These domains, themes, and insight provided by deprescribing leaders contribute to the advancement of deprescribing networks as global efforts continue to focus on optimizing medication management. Collaboration among interprofessional team members will be critical to the expansion as well as sustainability of this important work. [Journal of Gerontological Nursing, 48(1), 7-14.].

Difficulty with Taking Medications Is Associated with Future Diagnosis of Alzheimer's Disease and Related Dementias.

BACKGROUND: Medication management requires complex cognitive functioning, and therefore, difficulty taking medications might be an early sign of cognitive impairment and could be a risk factor for Alzheimer's disease and related dementias (ADRD). Accordingly, people with difficulty taking medications may benefit from more detailed cognitive screening, potentially aiding in the diagnosis of ADRD, which is underdiagnosed. We are unaware of evidence on medication management difficulties that precede a real-world ADRD diagnosis in the USA. OBJECTIVE: Examine the association between difficulty taking medications and subsequent real-world ADRD diagnoses. DESIGN: Case-control study, using Health and Retirement Study (HRS) survey data linked to Medicare claims. PARTICIPANTS: A total of 1461 HRS respondents with an ADRD diagnosis observed from 1993 to 2012 (cases), matched by year of birth, wave of HRS entry, and sex to 3771 controls with no ADRD diagnosis. MAIN MEASURES: We examined the association between diagnosis of ADRD and self-reported difficulty taking medications in the preceding years (1-2 and 3-4 years prior to case definition). Control individuals were assigned the index date from their matched case. Conditional logistic regressions adjusted for age, sex, race, education, and comorbidities. KEY RESULTS: Compared with matched controls, cases had higher prevalence of difficulty taking medications 1-2 years prior to diagnosis (11.0% versus 2.3%), and 3-4 years prior to diagnosis (5.8% versus 2.3%). Adjusted analyses showed that compared with individuals without ADRD, those with an ADRD diagnosis had more than four times higher odds of difficulty taking medications 1-2 years prior (OR = 4.56 (CI 3.30-6.31)), and more than two times higher odds of difficulty taking medications 3-4 years prior (OR = 2.41 (CI 1.61-3.59)). CONCLUSIONS: Odds of medication difficulty 1-2 years prior were more than four times greater for individuals with ADRD diagnoses compared with those without ADRD. Medication management difficulties may prompt further cognitive screening, potentially aiding in earlier recognition of ADRD.

Effects of Including Epidemiologic Data in Lumbar Spine Imaging Reports on Prescribing Non-Opioid Medications for Pain.

BACKGROUND: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing. OBJECTIVE: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). SECONDARY OUTCOMES: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97-1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99-1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455.

Antiseizure medication adherence trajectories in Medicare beneficiaries with newly treated epilepsy.

OBJECTIVE: This study was undertaken to characterize trajectories of antiseizure medication (ASM) adherence in adults with newly treated epilepsy and to determine predictors of trajectories. METHODS: This was a retrospective cohort study using Medicare. We included beneficiaries with newly treated epilepsy (one or more ASM and none in the preceding 2 years, plus International Classification of Diseases codes) in 2010-2013. We calculated the proportion of days covered (proportion of total days with any ASM pill supply) for 8 quarters or until death. Group-based trajectory models characterized and determined predictors of trajectories. RESULTS: We included 24 923 beneficiaries. Models identified four groups: early adherent (60%), early nonadherent (18%), late adherent (11%), and late nonadherent (11%). Numerous predictors were associated with being in the early nonadherent versus early adherent group: non-White race (e.g., Black, odds ratio [OR] = 1.7, 95% confidence interval [CI] = 1.5-1.8), region (e.g., South vs. Northeast: OR = 1.2, 95% CI = 1.1-1.4), and once daily initial medication (OR = 1.1, 95% CI = 1.0-1.3). Predictors associated with decreased odds of being in the early nonadherent group included older age (OR = .9 per decade, 95% CI = .9-.9), female sex (OR = .9, 95% CI = .8-1.0), full Medicaid eligibility (OR = .6, 95% CI = .4-.8), neurologist visit (OR = .6, 95% CI = .6-.7), and initial older generation ASM (OR = .6, 95% CI = .6-.7). SIGNIFICANCE: We identified four ASM adherence trajectories in individuals with newly treated epilepsy. Whereas risk factors for early nonadherence such as race or geographic region are nonmodifiable, our work highlighted a modifiable risk factor for early nonadherence: lacking a neurologist. These data may guide future interventions aimed at improving ASM adherence, in terms of both timing and target populations.

The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology.

Narrative electronic prescribing instructions (NEPIs) are text that convey information on the administration or co-administration of a drug as directed by a prescriber. For researchers, NEPIs have the potential to advance our understanding of the risks and benefits of medications in populations; however, due to their unstructured nature, they are not often utilized. The goal of this scoping review was to evaluate how NEPIs are currently employed in research, identify opportunities and challenges for their broader application, and provide recommendations on their future use. The scoping review comprised a comprehensive literature review and a survey of key stakeholders. From the literature review, we identified 33 primary articles that described the use of NEPIs. The majority of articles (n = 19) identified issues with the quality of information in NEPIs compared with structured prescribing information; nine articles described the development of novel algorithms that performed well in extracting information from NEPIs, and five described the used of manual or simpler algorithms to extract prescribing information from NEPIs. A survey of 19 stakeholders indicated concerns for the quality of information in NEPIs and called for standardization of NEPIs to reduce data variability/errors. Nevertheless, stakeholders believed NEPIs present an opportunity to identify prescriber's intent for the prescription and to study temporal treatment patterns. In summary, NEPIs hold much promise for advancing the field of pharmacoepidemiology. Researchers should take advantage of addressing important questions that can be uniquely answered with NEPIs, but exercise caution when using this information and carefully consider the quality of the data.

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

Persistent polypharmacy and fall injury risk: the Health, Aging and Body Composition Study.

BACKGROUND: Older adults receive treatment for fall injuries in both inpatient and outpatient settings. The effect of persistent polypharmacy (i.e. using multiple medications over a long period) on fall injuries is understudied, particularly for outpatient injuries. We examined the association between persistent polypharmacy and treated fall injury risk from inpatient and outpatient settings in community-dwelling older adults. METHODS: The Health, Aging and Body Composition Study included 1764 community-dwelling adults (age 73.6 ± 2.9 years; 52% women; 38% black) with Medicare Fee-For-Service (FFS) claims at or within 6 months after 1998/99 clinic visit. Incident fall injuries (N = 545 in 4.6 ± 2.9 years) were defined as the initial claim with an ICD-9 fall E-code and non-fracture injury, or fracture code with/without a fall code from 1998/99 clinic visit to 12/31/08. Those without fall injury (N = 1219) were followed for 8.1 ± 2.6 years. Stepwise Cox models of fall injury risk with a time-varying variable for persistent polypharmacy (defined as ≥6 prescription medications at the two most recent consecutive clinic visits) were adjusted for demographics, lifestyle characteristics, chronic conditions, and functional ability. Sensitivity analyses explored if persistent polypharmacy both with and without fall risk increasing drugs (FRID) use were similarly associated with fall injury risk. RESULTS: Among 1764 participants, 636 (36%) had persistent polypharmacy over the follow-up period, and 1128 (64%) did not. Fall injury incidence was 38 per 1000 person-years. Persistent polypharmacy increased fall injury risk (hazard ratio [HR]: 1.31 [1.06, 1.63]) after adjusting for covariates. Persistent polypharmacy with FRID use was associated with a 48% increase in fall injury risk (95%CI: 1.10, 2.00) vs. those who had non-persistent polypharmacy without FRID use. Risks for persistent polypharmacy without FRID use (HR: 1.22 [0.93, 1.60]) and non-persistent polypharmacy with FRID use (HR: 1.08 [0.77, 1.51]) did not significantly increase compared to non-persistent polypharmacy without FRID use. CONCLUSIONS: Persistent polypharmacy, particularly combined with FRID use, was associated with increased risk for treated fall injuries from inpatient and outpatient settings. Clinicians may need to consider medication management for FRID and other fall prevention strategies in community-dwelling older adults with persistent polypharmacy to reduce fall injury risk.

Predictors of tyrosine kinase inhibitor adherence trajectories in patients with newly diagnosed chronic myeloid leukemia.

INTRODUCTION: Although consistent use of tyrosine kinase inhibitors (TKIs) confers significant improvements in long-term survival for individuals with chronic myeloid leukemia (CML), only 70% of CML patients are adherent to TKIs. Understanding the factors that contribute to non-adherence and establishing dynamic adherence patterns in this population are essential aspects of targeted drug monitoring and intervention strategies. METHODS: Newly diagnosed CML patients were identified in the MarketScan database and relevant covariate values extracted. Proportion of days covered (PDC) per 30-day interval was used to calculate adherence over a 12-month follow-up period. We conducted a latent profile analysis (LPA) on these PDC estimates to identify distinct, dynamic patterns of TKI adherence. Identified trajectories were grouped into four clinically relevant categories and predictors of membership in these categories were determined via multinomial logistic regression. RESULTS: Four broad adherence categories were identified from the LPA: never adherent, initially non-adherent becoming adherent, initially adherent becoming non-adherent, and stable adherent. Results from the subsequent multinomial logistic regression indicated that younger age, female sex, greater monthly financial burden, fewer comorbidities, fewer concomitant medications, year of diagnosis, higher starting dose, TKI type, and a longer duration from diagnosis to treatment were significantly associated with membership in at least one of the three non-stable adherent groups. CONCLUSION: Select sociodemographic and clinical characteristics were found to predict membership in clinically meaningful groups of longitudinal TKI adherence. These findings could have major implications for informing personalized monitoring and intervention strategies for individuals who are likely to be non-adherent.

Toward a broader concept of societal value: family spillovers in Alzheimer's disease.

Recognizing that the "healthcare sector perspective" can be too limited in some situations, the National Institute of Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), and the U.S. Second Panel on Cost-Effectiveness in Health and Medicine all recommend a "societal" perspective in "reference case" cost-effectiveness analyses (CEAs). Although costs of informal caregiving are sometimes included in the CEAs of Alzheimer's Disease (AD) drugs, the benefits and disutility to family members, referred to as "family spillovers" by the U.S. Second Panel, are usually omitted. We estimate that the aggregate cost of family spillovers could be substantial in the USA-on the order of USD 57 billion or over 10 percent of the total economic burden of AD in 2020. Incorporation of family spillovers in AD value frameworks and HTAs is important for comprehensively defining, rewarding, and providing high-value care in AD.

Feasibility and Acceptability of mHealth Interventions for Managing Hyperphosphatemia in Patients Undergoing Hemodialysis.

OBJECTIVE: The objective of the study was to evaluate the feasibility and acceptability of mobile health (mHealth) phosphorus management programs in hemodialysis (HD) patients. METHODS: Patients receiving thrice-weekly HD who had 3-month average serum phosphorus of >5.5 mg/dL were randomized to one of the three self-directed phosphorus management programs delivered using tablet PCs: (1) educational videos and handouts (Education), (2) education intervention plus mobile self-monitoring with email feedback (Monitoring), or (3) education and monitoring interventions plus social cognitive theory-based behavioral videos (Combined). Feasibility and acceptability were assessed based on enrollment and retention and training needs (feasibility) and adherence to self-monitoring and reported satisfaction (acceptability). RESULTS: Of 312 patients, 56 expressed interest, and 40 were enrolled. The majority of participants (80%) completed the 6-month study; none withdrew for intervention-related reasons. The Monitoring and Combined groups received 44 ± 15 minutes of technology training, which was considered adequate by most (75%). Self-monitoring rates were initially high, with 78% and 71% of the participants recording at least one meal and phosphate binder in week 1, respectively, but decreased over time to 15% and 9% in the final week. Most participants reported that self-monitoring helped them stay motivated (64%), track nutrients (80%), and understand how to change diet (76%), and nearly two-thirds of participants (64%) stated that they would like to continue using the tablet PC to manage their health. However, few participants (16%) indicated that self-monitoring was worth the effort. The Monitoring and Combined groups did not differ from the Education group in study outcomes. CONCLUSION: Although the mHealth programs were generally well received, self-monitoring rates decreased substantially over time and were unaffected by social cognitive theory-based videos. Self-directed mHealth programs may be a useful adjunct to standard care but should be compared to more resource intensive programs (e.g., involving more "live" contact with a dietitian) to determine overall cost-effectiveness and role in HD care.

Alzheimer's disease and related dementias risk: Comparing users of non-selective and M3-selective bladder antimuscarinic drugs.

PURPOSE: Bladder antimuscarinic (BAM) drug use is associated with increased risk of Alzheimer's disease and related dementias (ADRD). It is hypothesized that BAMs with non-selective receptor binding may increase ADRD risk more than M3-selective BAMs. This study compared ADRD risk for users of non-selective and M3-selective BAMs and examines ADRD risk associated with overall BAM use. METHODS: Retrospective cohort study of Medicare claims for 71 688 individuals who used BAM drugs during 2007-2009 without an ADRD diagnosis. We compared ADRD incidence (2011-2016) between non-selective BAM users (fesoterodine, flavoxate, oxybutynin, tolterodine, trospium) and M3-selective BAM users (darifenacin, solifenacin). Logistic regressions compared individuals using target drugs in the same category of total standardized daily doses (TSDD) as a standardized measure of drug exposure, and adjusted for age, sex, race/ethnicity, healthcare utilization, other medication use, socioeconomic status, and comorbidities. Secondary analyses compared ADRD risk associated with different doses of BAMs overall. RESULTS: Non-selective BAM use (compared to M3-selective) was not significantly associated with ADRD incidence. Odds ratios for non-selective use were 0.97 (CI: 0.89-1.04) for 1-364 TSDD, 0.94 (CI: 0.83-1.06) for 365-729, 1.00 (CI: 0.87-1.16) for 730-1094, and 1.03 (CI: 0.88-1.20) for >1094. Higher TSDD of BAMs overall (combining both non-selective and M3-selective BAMs), when compared to 1-364 TSDD, were associated with increased ADRD incidence (OR = 1.05 (CI: 0.99-1.10) for 365-729, OR = 1.11 (CI: 1.05-1.17) for 730-1094, and OR = 1.10 (CI: 1.04-1.15) for >1094). CONCLUSIONS: Non-selective and M3-selective BAM users had similar odds of ADRD incidence, and BAM use overall was significantly associated with ADRD incidence.

Medication persistence of targeted immunomodulators for plaque psoriasis: A retrospective analysis using a U.S. claims database.

PURPOSE: Studies of medication persistence in plaque psoriasis have shown inconsistent results, likely due to differing definitions of nonpersistence and of the permissible gap between refills. Also, medication persistence information for two recently approved drugs, apremilast and ixekizumab, is limited. METHODS: We use the Truven Health MarketScan claims database to assess persistence for six drugs: adalimumab, apremilast, etanercept, ixekizumab, secukinumab, and ustekinumab. We define the permissible gap in three ways: 150 days for ustekinumab and 90 days for all other drugs (150/90 model); 120 days for all drugs (120 model); and twice the days' supply for all drugs (days' supply model). To estimate unadjusted persistence, we use Kaplan-Meier curves, and a proportional hazards model to estimate the adjusted risk of non-persistence. RESULTS: Ustekinumab is most sensitive to changes in the definition of permissible gap, likely because of its longer maintenance dosing interval. Among targeted drug-experienced patients using ustekinumab, median persistence is 358 days (95% confidence interval: 343-371) in the 150/90 model and 189 days (179-199) in the days' supply model. Among targeted drug-experienced patients, median persistence in the days' supply model is longest for ixekizumab and secukinumab at 252 (217-301) and 222 (210-244) days, respectively. We also find that adjusted risk of nonpersistence increases by approximately 1% per year at treatment start. CONCLUSION: The definition of permissible gap meaningfully changes both absolute and ordinal estimates of medication persistence. Each definition has unique limitations, which should be considered when interpreting persistence data.

Statin Dosing Instructions, Medication Adherence, and Low-Density Lipoprotein Cholesterol: a Cohort Study of Incident Statin Users.

BACKGROUND: Robust evidence is lacking on optimal timing of statin administration and its impact on patient outcomes. OBJECTIVE: This study aims to evaluate among incident statin users the relationship between those prescribed evening vs. daily dosing instructions, medication adherence, and changes in low-density lipoprotein cholesterol (LDL-c). DESIGN: This is an observational cohort study at Sutter Health, a community-based healthcare system, 2010-2016. PARTICIPANTS: Patients were ≥ 35 years of age as of the first statin prescription (baseline), with 12 to 36 months of electronic health record activity before and after baseline. Incident use was defined as no statin prescription in 12 months prior to baseline. MAIN MEASURES: Differences in medication adherence (proportion of days covered ≥ 0.80) over 12 months from baseline and mean change in LDL-c between 12 and 24 months from baseline were measured using regression modeling, adjusting for baseline demographics and clinical, prescriber, and statin characteristics. KEY RESULTS: Among 31,252 patients with valid statin prescriptions between 2010 and 2016, 5099 eligible incident statin users (mean age, 63 years) were identified, of whom 53% were prescribed evening and 47% daily dosing instructions. No difference in likelihood of statin adherence over 12 months was observed for evening vs. daily dosing (adjusted odds ratio [OR] 0.90; 95% CI 0.75, 1.08). No differences were observed in mean change in LDL-c (adjusted mean difference 1.42 mg/dL; 95% CI - 1.02, 3.89) or likelihood of attaining LDL-c < 70 mg/dL (adjusted OR 0.83; 95% CI 0.67, 1.04) for evening vs. daily dosing over a mean of 19 months follow-up. CONCLUSIONS: Among incident statin users from a real-world clinical setting, those with daily and evening dosing instructions had similar adherence rates and mean changes in LDL-c. Given potential clinical equipoise for evening and daily dosing, clinicians should consider patient-tailored statin dosing instructions to reduce potentially unnecessary regimen complexity.

Patterns of antihypertensive and statin adherence prior to dementia: findings from the adult changes in thought study.

BACKGROUND: Detecting patients with undiagnosed dementia is an important clinical challenge. Changes in medication adherence might represent an early sign of cognitive impairment. We sought to examine antihypertensive and statin adherence trajectories in community-dwelling older adults, comparing people who went on to develop dementia to those who did not. METHODS: We analyzed data from Adult Changes in Thought (ACT), a population-based cohort study embedded within an integrated healthcare delivery system. Analyses included 4368 participants aged ≥65 years who had at least one follow-up visit. Research-quality dementia diagnoses were used to identify cases. We selected non-dementia control visits matched on age, sex, and study cohort that occurred at similar ACT follow-up time as the case's dementia onset; we treated this as the index date. Participants were included if they were prevalent users of either a statin or antihypertensive medication on the first day of follow up - 3 years prior to the index date. Using prescription fill dates and days supply, we calculated daily binary medication availability measures for each participant ('days covered') over 3 years leading up to the index date. We used group-based trajectory models to identify patterns of antihypertensive and statin adherence, and used conditional logistic regression to examine associations between adherence trajectories and dementia. RESULTS: Four trajectories were identified for antihypertensive users (292 cases, 3890 control visits), including near perfect (n = 1877, 36.6% cases, 45.5% controls), high (n = 1840, 43.2% cases, 44.1% controls), moderate (n = 365, 18.5% cases, 8.0% controls) and early poor adherence (n = 100, 1.7% cases, 2.4% controls). Odds of dementia was 3 times greater for those with moderate antihypertensive adherence compared to those with near perfect adherence (adjusted OR 3.0, 95% CI 2.0, 4.3). Four trajectories were identified for statin users (148 cases, 1131 control visits), including high (n = 1004, 75.0% cases, 79.0% controls), moderate (n = 192, 19.6% cases, 14.4% controls), early poor (n = 43, 2.0% cases, 3.5% controls), and delayed poor adherence (n = 40, 3.4% cases, 3.1% controls). No association was detected between statin adherence trajectories and dementia. CONCLUSIONS: Patterns of medication adherence may be useful to identify a subset of people at higher likelihood of developing dementia.