Cost-Effectiveness Analysis of a Pharmacist-Led Medication Therapy Management Program: Hypertension Management

ObjectivesUncontrolled hypertension is a common cause of cardiovascular disease, which is the deadliest and costliest chronic disease in the United States. Pharmacists are an accessible community healthcare resource and are equipped with clinical skills to improve the management of hypertension through medication therapy management (MTM). Nevertheless, current reimbursement models do not incentivize pharmacists to provide clinical services. We aim to investigate the cost-effectiveness of a pharmacist-led comprehensive MTM clinic compared with no clinic for 10-year primary prevention of stroke and cardiovascular disease events in patients with hypertension.MethodsWe built a semi-Markov model to evaluate the clinical and economic consequences of an MTM clinic compared with no MTM clinic, from the payer perspective. The model was populated with data from a recently published controlled observational study investigating the effectiveness of an MTM clinic. Methodology was guided using recommendations from the Second Panel on Cost-Effectiveness in Health and Medicine, including appropriate sensitivity analyses.ResultsCompared with no MTM clinic, the MTM clinic was cost-effective with an incremental cost-effectiveness ratio of $38 798 per quality-adjusted life year (QALY) gained. The incremental net monetary benefit was $993 294 considering a willingness-to-pay threshold of $100 000 per QALY. Health-benefit benchmarks at $100 000 per QALY and $150 000 per QALY translate to a 95% and 170% increase from current reimbursement rates for MTM services.ConclusionsOur model shows current reimbursement rates for pharmacist-led MTM services may undervalue the benefit realized by US payers. New reimbursement models are needed to allow pharmacists to offer cost-effective clinical services.     

Evaluation of a community dental clinic providing care to people experiencing homelessness: A mixed methods approach

BackgroundPeople who experience homelessness have higher dental treatment needs compared to the general population. However, their utilization of dental services and levels of treatment completion are low. Peninsula Dental Social Enterprise, a not‐for‐profit organization in the United Kingdom, established a community dental clinic to improve access to dental care for this population.ObjectivesTo evaluate the impact and acceptability of the community dental service for patients and examine the barriers and enablers to using and providing the service.MethodsThe evaluation included a retrospective assessment of anonymous patient data and thematic analysis of semi‐structured interviews with patients, support staff and service providers. The interviews were thematically analysed. A cost analysis of the dental service was also conducted.ResultsBy 18 February 2020, 89 patients had attended the clinic. These included 62 males (70%) and 27 females (30%), aged 38.43 years on average (SD ± 11.07). Of these, 42 (47%) patients have completed their treatment, 23 (26%) are in active treatment and 24 (27%) left treatment. In total, 684 appointments (541.5 hours clinical time) were given. Of these, 82% (562) of appointments were attended (452.5 hours clinical time). The 22 interviews that were conducted identified flexibility, close collaboration with support services and health‐care team attitudes as key factors influencing service utilization and continuity of care.ConclusionsThis study provides details of a highly acceptable and accessible dental care model for people experiencing homelessness, with recommendations at research, practice and commissioning levels.     

Validation analysis of a composite real‐world mortality endpoint for patients with cancer in the United States

ObjectiveWe expanded the previous assessment of a mortality variable suited for real‐world evidence‐focused oncology research.Data sourceWe used a nationwide electronic health record (EHR)‐derived de‐identified database.Data collectionWe included patients with at least 1 of 18 cancer types between January 1, 2011 and December 31, 2017. Patient‐level structured data (EHRs, obituaries, and Social Security Death Index) and unstructured EHR data (abstracted) were linked to generate a composite mortality variable.Study designWe benchmarked sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ±15‐day agreement against the National Death Index (NDI). Real‐world overall survival (rwOS) was estimated using the Kaplan‐Meier method. We performed sensitivity analyses using a smaller patient cohort that underwent next‐generation sequencing testing.Principal findingsCompared with the NDI across 18 cancer types (overall N = 160 436): sensitivity, 83.9%‐91.5% (17/18 cancer types had sensitivity ≥85.0%); specificity, 93.5%‐99.7%; PPV, 96.3%‐98.3%; NPV, 75.0%‐98.7%; ±15‐day agreement, 95.6%‐97.6%; and median rwOS estimates ranging from 2.8% to 12.7% greater. Sensitivity analysis results (n = 17 540) were consistent with the main analysis.ConclusionsAcross all cancer types analyzed, this composite mortality variable showed high sensitivity, specificity, PPV, NPV, and ±15‐day agreement, and yielded median rwOS values modestly overestimated when compared to NDI‐based results.     

Implementation of tuberculosis preventive treatment among people living with HIV,South Sudan

ObjectiveTo describe an intervention to scale up tuberculosis preventive treatment for people living with human immunodeficiency virus (HIV) in South Sudan, 2017–2020.MethodsStaff of the health ministry and United States President’s Emergency Plan for AIDS Relief designed an intervention targeting the estimated 30 400 people living with HIV on antiretroviral therapy across South Sudan. The intervention comprised: (i) developing sensitization and operational guidance for clinicians to put tuberculosis preventive treatment delivery into clinical practice; (ii) disseminating monitoring and evaluation tools to document scale-up; (iii) implementing a programmatic pilot of tuberculosis preventive treatment; and (iv) identifying a mechanism for procurement and delivery of isoniazid to facilities dispensing tuberculosis preventive treatment. Staff aggregated routine programme data from facility registers on the numbers of people living with HIV who started on tuberculosis preventive treatment across all clinical sites providing this treatment during July 2019–March 2020.FindingsTuberculosis preventive treatment was implemented in 13 HIV treatment sites during July–October 2019, then in 26 sites during November 2019–March 2020. During July 2019–March 2020, 6503 people living with HIV started tuberculosis preventive treatment.ConclusionLessons for other low-resource settings may include supplementing national guidelines with health ministry directives, clinician guidance and training, and an implementation pilot. A cadre of field supervisors can rapidly disseminate a standardized approach to implementation and monitoring of tuberculosis preventive treatment, and this approach can be used to strengthen other tuberculosis–HIV services. Procuring a reliable and steady supply of tuberculosis preventive treatment medication is crucial.     

Implementing a Transition Program from Paediatric to Adult Services in Phenylketonuria: Results after Two Years of Follow-Up with an Adult Team

We aimed to report the implementation of a phenylketonuria (PKU) transition program and study the effects of follow-up with an adult team on metabolic control, adherence, and loss of follow-up. Fifty-five PKU patients were analysed in the study periods (SP): 2 years before (SP1) and after the beginning of adult care (SP2). Retrospective data on metabolic control and number of clinic appointments were collected for each SP, and protein intakes were analysed. In SP2, three patients (6%) were lost to follow-up. There was a small but statistically significant increase in median number of annual blood spots from SP1 to SP2: 11 (7–15) vs. 14 (7–20); p = 0.002. Mean ± SD of median blood Phe remained stable (525 ± 248 µmol/L vs. 552 ± 225 µmol/L; p = 0.100); median % of blood Phe < 480 µmol/L decreased (51 (4–96)% vs. 37 (5–85)%; p = 0.041) and median number of clinic appointments increased from SP1 to SP2: (5 (4–6) vs. 11 (8–13); p < 0.001). No significant differences were found regarding any parameter of protein intake. Our results suggest that the implementation of an adult service was successful as impact on metabolic control was limited and attendance remained high. Continuous dietetic care likely contributed to these results by keeping patients in follow-up and committed to treatment.     

Longitudinal Adherence With Fecal Occult Blood Test Screening in Community Practice

PURPOSE Although screening with fecal occult blood testing (FOBT) reduces colorectal cancer (CRC) mortality, its effectiveness may diminish if patients do not adhere with repeated screenings. Among patients who had previously engaged in FOBT screening, we assessed subsequent adherence with FOBT screening.METHODS We assessed longitudinal adherence with biennial FOBT screening (every other year) within a cohort of patients enrolled in an integrated Washington State health plan. Among 11,110 patients who participated in FOBT screening during a 2-year baseline period (2000–2001), we ascertained CRC screening use during a subsequent 2-year observation period (2002–2003). We used multinomial logistic regression to identify patient characteristics associated with higher incidence of repeat CRC screening (with or without FOBT) relative to patients who received no CRC screening.RESULTS Despite prior participation in FOBT screening, less than one-half of patients (44.4%; 95% CI, 42.9%–45.8%) completed FOBT screening during the 2-year observation period. Although 8.8% of patients (95% CI, 8.0%–9.7%) received other CRC tests without FOBT during the observation period, nearly one-half, 46.8% (95% CI, 45.3%–48.4%), received no CRC screening. After adjustment for other patient characteristics, receipt of a preventive health examination was strongly associated with FOBT adherence relative to no CRC screening (adjusted relative rate ratio = 11.16; 95% CI, 9.61–12.96).CONCLUSIONS Longitudinal adherence with FOBT screening was low in this insured population, potentially compromising its effectiveness in population CRC mortality reduction. Interventions to promote adherence may be necessary to achieve high effectiveness in population-based FOBT screening programs.     

Real-World Impact of Transferring the Dispensing of Hospital-Only Medicines to Community Pharmacies During the COVID-19 Pandemic

ObjectivesIn Portugal, the dispensing of most outpatient specialty medicines is performed exclusively through hospital pharmacies and totally financed by the National Health Service. During the COVID-19 first wave, the government allowed the transfer of the dispensing of hospital-only medicines (HOMs) to community pharmacies (CPs). This study aimed to measure the value generated by the intervention of CP in the dispensing of HOM.MethodsA single-arm, before-and-after study with 3-month follow-up was conducted enrolling a randomly selected sample of patients or caregivers with at least 1 dispensation of HOM through CP. Data were collected by telephone interview. Main outcomes were patients’ self-reported adherence (Measure Treatment Adherence), health-related quality of life (EQ-5D 3-Level), satisfaction with the service, and costs related to HOM access.ResultsOverall 603 subjects were recruited to participate in the study (males 50.6%) with mean 55 years old (SD = 16). The already high mean adherence score to therapy improved significantly (P < .0001), and no statistically significant change (P > .5757) was found in the mean EQ-5D score between baseline (0.7 ± 0.3) and 3-month follow-up (0.8 ± 0.3). Annual savings account for €262.1/person, arising from travel expenses and absenteeism reduction. Participants reported a significant increase in satisfaction levels in all evaluated domains—pharmacist’s availability, opening hours, waiting time, privacy conditions, and overall experience.ConclusionsChanging the dispense setting to CP may promote better access and satisfaction. Moreover, it ensures the persistence of treatments, promotes savings for citizens, and reduces the burden of healthcare services, representing a crucial public health measure.     

The implementation cost of a safety‐net hospital program addressing social needs in Atlanta

ObjectiveTo describe the cost of integrating social needs activities into a health care program that works toward health equity by addressing socioeconomic barriers.Data Sources/Study SettingCosts for a heart failure health care program based in a safety‐net hospital were reported by program staff for the program year May 2018–April 2019. Additional data sources included hospital records, invoices, and staff survey.Study DesignWe conducted a retrospective, cross‐sectional, case study of a program that includes health education, outpatient care, financial counseling and free medication; transportation and home services for those most in need; and connections to other social services. Program costs were summarized overall and for mutually exclusive categories: health care program (fixed and variable) and social needs activities.Data CollectionProgram cost data were collected using a activity‐based, micro‐costing approach. In addition, we conducted a survey that was completed by key staff to understand time allocation.Principal FindingsProgram costs were approximately $1.33 million, and the annual per patient cost was $1455. Thirty percent of the program costs was for social needs activities: 18% for 30‐day supply of medications and addressing socioeconomic barriers to medication adherence, 18% for mobile health services (outpatient home visits), 53% for navigating services through a financial counselor and community health worker, and 12% for transportation to visits and addressing transportation barriers. Most of the program costs were for personnel: 92% of the health care program fixed, 95% of the health care program variable, and 78% of social needs activities.DiscussionHistorically, social and health care services are funded by different systems and have not been integrated. We estimate the cost of implementing social needs activities into a health care program. This work can inform implementation for hospitals attempting to address social determinants of health and social needs in their patient population.     

A tuberculosis nationwide prevalence survey in Gambia, 2012

ObjectiveTo estimate the population prevalence of active pulmonary tuberculosis in Gambia.MethodsBetween December 2011 and January 2013, people aged ≥ 15 years participating in a nationwide, multistage cluster survey were screened for active pulmonary tuberculosis with chest radiography and for tuberculosis symptoms. For diagnostic confirmation, sputum samples were collected from those whose screening were positive and subjected to fluorescence microscopy and liquid tuberculosis cultures. Multiple imputation and inverse probability weighting were used to estimate tuberculosis prevalence.FindingsOf 100 678 people enumerated, 55 832 were eligible to participate and 43 100 (77.2%) of those participated. A majority of participants (42 942; 99.6%) were successfully screened for symptoms and by chest X-ray. Only 5948 (13.8%) were eligible for sputum examination, yielding 43 bacteriologically confirmed, 28 definite smear-positive and six probable smear-positive tuberculosis cases. Chest X-ray identified more tuberculosis cases (58/69) than did symptoms alone (43/71). The estimated prevalence of smear-positive and bacteriologically confirmed pulmonary tuberculosis were 90 (95% confidence interval, CI: 53–127) and 212 (95% CI: 152–272) per 100 000 population, respectively. Tuberculosis prevalence was higher in males (333; 95% CI: 233–433) and in the 35–54 year age group (355; 95% CI: 219–490).ConclusionThe burden of tuberculosis remains high in Gambia but lower than earlier estimates of 490 per 100 000 population in 2010. Less than half of all cases would have been identified based on smear microscopy results alone. Successful control efforts will require interventions targeting men, increased access to radiography and more accurate, rapid diagnostic tests.     

Cotrimoxazole prophylaxis and antiretroviral therapy: an observational cohort study in China

Objective

To assess if cotrimoxazole prophylaxis administered early during antiretroviral therapy (ART) reduces mortality in Chinese adults who are infected with human immunodeficiency virus (HIV).

Methods

We did a retrospective observational cohort study using data from the Chinese national free antiretroviral database. Patients older than 14 years who started ART between 1 January 2010 and 31 December 2012 and had baseline CD4+ T-lymphocyte (CD4+ cell) count less than 200 cells/µL were followed until death, loss to follow-up or 31 December 2013. Hazard ratios (HRs) for several variables were calculated using multivariate analyses.

Findings

The analysis involved 23 816 HIV-infected patients, 2706 of whom died during the follow-up. Mortality in patients who did and did not start cotrimoxazole during the first 6 months of ART was 5.3 and 7.0 per 100 person–years, respectively. Cotrimoxazole was associated with a 37% reduction in mortality (hazard ratio, HR: 0.63; 95% confidence interval, CI: 0.56–0.70). Cotrimoxazole in addition to ART reduced mortality significantly over follow-up lasting 6 months (HR: 0.65; 95% CI: 0.59–0.73), 12 months (HR: 0.58; 95% CI: 0.49–0.70), 18 months (HR: 0.49; 95% CI: 0.38–0.63) and 24 months (HR: 0.66; 95% CI: 0.48–0.90). The mortality reduction was evident in patients with baseline CD4+ cell counts less than 50 cells/µL (HR: 0.60; 95% CI: 0.54–0.67), 50–99 cells/µL (HR: 0.66; 95% CI: 0.56–0.78) and 100–199 cells/µL (HR: 0.78; 95% CI: 0.62–0.98).

Conclusion

Cotrimoxazole prophylaxis started early during ART reduced mortality and should be offered to HIV-infected patients in low- and middle-income countries.     

Awareness of and intention to use an online sexually transmitted and blood-borne infection testing service among gay and bisexual men in British Columbia,two years after implementation

ObjectivesThis study assessed gay, bisexual, and other men who have sex with men’s (GBMSM) awareness of and intention to use GetCheckedOnline, an online sexually transmitted and blood-borne infection (STBBI) testing service.MethodsA cross-sectional study was conducted two years after launch among GBMSM > 18 years of age in British Columbia, Canada. Participants were recruited through community venues, clinics, websites, and apps.ResultsOf 1272 participants, 32% were aware of GetCheckedOnline. Gay identity, regularly testing at an STBBI clinic, being out to one’s healthcare provider, attending GBMSM community venues, and frequent social media use were associated with awareness. Among participants who were aware but had not used GetCheckedOnline, knowing GetCheckedOnline users, using social media, not knowing where else to test, and not wanting to see a doctor were associated with intention to use GetCheckedOnline.ConclusionEarly promotion of GetCheckedOnline resulted in greater awareness among those connected to GBMSM.     

Urgent need to improve programmatic management of patients with HIV failing first-line antiretroviral therapy

Introduction:Delayed identification and response to virologic failure in case of first-line antiretroviral therapy (ART) in resource-limited settings is a threat to the health of HIV-infected patients. There is a need for the implementation of an effective, standardized response pathway in the public sector.Discussion:We evaluated published cohorts describing virologic failure on first-line ART. We focused on gaps in the detection and management of treatment failure, and posited ways to close these gaps, keeping in mind scalability and standardization. Specific shortcomings repeatedly recorded included early loss to follow-up (>20%) after recognized first-line ART virologic failure; frequent delays in confirmatory viral load testing; and excessive time between the confirmation of first-line ART failure and initiation of second-line ART, which exceeded 1 year in some cases. Strategies emphasizing patient tracing, resistance testing, drug concentration monitoring, adherence interventions, and streamlined response pathways for those failing therapy are further discussed.Conclusion:Comprehensive, evidence-based, clinical operational plans must be devised based on findings from existing research and further tested through implementation science research. Until this standard of evidence is available and implemented, high rates of losses from delays in appropriate switch to second-line ART will remain unacceptably common and a threat to the success of global HIV treatment programs.     

Prevalence of Sexual Dysfunctions: Results from a Decade of Research

Ten years of research that has provided data regarding the prevalence of sexual dysfunctions is reviewed. A thorough review of the literature identified 52 studies published in the 10 years since an earlier review by Spector and Carey (Arch. Sex. Behav. 19(4): 389–408, 1990). Community samples indicate a current prevalence of 0%–3% for male orgasmic disorder, 0%–5% for erectile disorder, and 0%–3% for male hypoactive sexual desire disorder. Pooling current and 1-year figures provides community prevalence estimates of 7%–10% for female orgasmic disorder and 4%–5% for premature ejaculation. Stable community estimates of the current prevalence of other sexual dysfunctions remain unavailable. Prevalence estimates obtained from primary care and sexuality clinic samples are characteristically higher. Although a relatively large number of studies has been conducted since the earlier review, the lack of methodological rigor of many studies limits the confidence that can be placed in these findings.     

Adherence to Repeat Fecal Occult Blood Testing in an Urban Community Health Center Network

Annual fecal occult blood testing (FOBT) has the potential to reduce colorectal cancer mortality, but in practice it is challenging to complete FOBT every year. Repeat FOBT adherence may be especially low in community health center (CHC) settings, where many patients face barriers to annual FOBT completion. We conducted a retrospective cohort analysis to investigate adherence to annual FOBT in an urban CHC network that serves a predominantly Spanish-speaking, uninsured adult patient population. This study used data from the two-year period between January 2010 and December 2011, and included adults aged 50–74 who completed a screening FOBT with a negative result during the first 6 months of 2010. We examined whether each patient completed a second FOBT between 9 and 18 months after the initial negative FOBT, and tested whether repeat FOBT adherence was associated with patient characteristics or the number of clinic visits after the initial negative FOBT. Only 69 of 281 included patients completed repeat FOBT (24.6 % adherence), and none of 62 patients (0 %) with 0 clinic visits completed repeat FOBT. We detected no significant differences in adherence by age, sex, preferred language, insurance status, or number of chronic conditions. In multivariable regression, the adjusted relative risk of repeat FOBT was 1.66 (95 % CI 1.09–2.54; p = 0.02) among patients with 3 or more clinic visits (referent: patients with 1–2 visits). The observed low rate of adherence greatly diminishes the effectiveness of FOBT in reducing CRC mortality. Findings demonstrate the need for systems-based interventions that increase adherence without requiring face-to-face encounters.     

Comparative effectiveness of external vs blended facilitation on collaborative care model implementation in slow-implementer community practices

ObjectiveTo evaluate the comparative effectiveness of external facilitation (EF) vs external + internal facilitation (EF/IF), on uptake of a collaborative chronic care model (CCM) in community practices that were slower to implement under low‐level implementation support.Study SettingPrimary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12 months following randomization.Study DesignSites that failed to meet a pre‐established implementation benchmark after six months of low‐level implementation support were randomized to add either EF or EF/IF support for up to 12 months. Key outcomes were change in number of patients receiving the CCM and number of patients receiving a clinically significant dose of the CCM. Moderators’ analyses further examined whether comparative effectiveness was dependent on prerandomization adoption, number of providers trained or practice size. Facilitation log data were used for exploratory follow‐up analyses.Data CollectionSites reported monthly on number of patients that had received the CCM. Facilitation logs were completed by study EF and site IFs and shared with the study team.Principal FindingsN = 21 sites were randomized to EF and 22 to EF/IF. Overall, EF/IF practices saw more uptake than EF sites after 12 months (Δ_EF/IF‐EF = 4.4 patients, 95% CI = 1.87‐6.87). Moderators'' analyses, however, revealed that it was only sites with no prerandomization uptake of the CCM (nonadopter sites) that saw significantly more benefit from EF/IF (Δ_EF/IF‐EF = 9.2 patients, 95% CI: 5.72, 12.63). For sites with prerandomization uptake (adopter sites), EF/IF offered no additional benefit (Δ_EF/IF‐EF = −0.9; 95% CI: −4.40, 2.60). Number of providers trained and practice size were not significant moderators.ConclusionsAlthough stepping up to the more intensive EF/IF did outperform EF overall, its benefit was limited to sites that failed to deliver any CCM under the low‐level strategy. Once one or more providers were delivering the CCM, additional on‐site personnel did not appear to add value to the implementation effort.