Association and correlation of patient symptom perception and asthma control - a rapid literature review.

BACKGROUND: Several studies suggest that patients often under-estimate their asthma symptoms and over-estimate their level of asthma control, potentially putting them at risk of undertreatment with inhaled corticosteroids. OBJECTIVE: To determine the association and correlation between patient symptom perception and asthma control. METHODS: A rapid literature review comprising searches in MEDLINE, Embase and Cochrane Library identified English language articles published between 2011-2021 that included a statistical measure of the association or correlation between perceptions of symptoms and asthma control in patients with asthma (adults and/or children). [PROSPERO CRD42021230152]. The Joanna Briggs Institute (JBI) instrument was used for study quality appraisal. RESULTS: Of 22 identified studies, nine presented association data and 13 reported correlation analyses. Eight of nine association studies showed a discordance between patients perceived symptoms and level of asthma control or lung function; among these, patients more frequently overestimated their asthma control than they underestimated their asthma control. Of 10 studies reporting correlation coefficients, all reported a statistically significant correlation between increased symptoms and worse asthma control; however, the strength of the correlation was shown to be only weak or moderate in most studies (coefficients numerically ranged from 0.12 to 0.74). CONCLUSION: Many patients with asthma tend to overestimate their level of asthma control. Although more frequent or worse symptoms were shown to be statistically significantly correlated with worsening asthma control, there was wide variation in correlation strengths, most showing weak or moderate correlations. Research to further understand the reasons for patient symptom misperceptions are warranted.

Health Care Provider Decisions to Initiate Oral HIV Preexposure Prophylaxis in New York City Public Sexual Health Clinics.

BACKGROUND: Oral HIV preexposure prophylaxis (PrEP) is safe and effective but underutilized. Health care providers' beliefs about PrEP and attitudes toward people who could benefit may affect PrEP access. METHODS: This mixed-methods study (2016-2018) was conducted in 8 New York City public sexual health clinics that implemented a PrEP program. Data included 32 in-depth qualitative interviews with clinicians, quantitatively coded to reflect their PrEP beliefs; a provider questionnaire; and 6 months of medical record visit data for these providers. Among patients with a PrEP indication, we examined the odds of a patient being initiated on PrEP associated with providers' PrEP beliefs and demographic characteristics, and patient characteristics. RESULTS: Providers reported strong support for offering PrEP to eligible patients. The majority denied concerns about possible development of drug-resistant viral strains, giving PrEP to people who might not benefit, and PrEP toxicity. Nevertheless, about one-third agreed with each of these concerns, and 55% thought PrEP use might limit condom use. Of 2176 patients with a PrEP indication, 20% were initiated. Providers with more restrictive PrEP beliefs did not have lower odds of initiating patients on PrEP. Women as well as Black and Latinx patients were less likely to be initiated on PrEP. CONCLUSIONS: Contrary to our hypotheses, providers' negative PrEP beliefs did not seem to reduce initiation of PrEP for eligible patients. This may be attributable to clear clinical protocols, strong staff support, and training on implementing PrEP in this setting. Racial and gender disparities in PrEP uptake urgently require attention.

Cholestatic Pruritus Treatments in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: A Systematic Literature Review.

BACKGROUND AND AIMS: We conducted a systematic literature review to understand the evidence supporting treatment decisions for cholestatic pruritus associated with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). METHODS: Studies that enrolled ≥ 75% participants with PBC or PSC and reported ≥ 1 endpoint(s) related to efficacy, safety, health-related quality of life (HRQoL) or other patient-reported outcomes were included. Bias was assessed using the Cochrane risk of bias tool for randomised controlled trials (RCTs) and the Quality of Cohort studies tool for non-RCTs. RESULTS: Thirty-nine publications were identified, covering 42 studies and six treatment classes (including investigational and approved products): anion-exchange resins, antibiotics (rifampicin/derivatives), opiates, selective serotonin reuptake inhibitors, fibrates, ileal bile acid transporter inhibitors and other agents not categorised in these six classes. Across studies, median sample size was small (n = 18), 20 studies were over 20 years old, 25 followed patients for ≤ 6 weeks, only 25 were RCTs. Pruritus was assessed using several different tools, with inconsistencies in their application. Cholestyramine, considered first-line therapy for moderate-severe cholestatic pruritus, was assessed in six studies (two RCTs) including 56 patients with PBC and 2 with PSC, with evidence of efficacy demonstrated in only three studies, among which, two RCTs were assessed as having a high risk of bias. Findings were similar for other drug classes. CONCLUSIONS: There is a lack of consistent and reproducible evidence available on efficacy, impact on HRQoL, and safety of cholestatic pruritus treatments, leaving physicians to rely on clinical experience rather than evidence-based medicine for treatment selection.

Motivations and Barriers to Routine HIV Testing Among Men Who Have Sex with Men in New York City.

In-depth qualitative interviews explored the experiences and understandings of men 18-39 years old who have sex with men that could facilitate or prevent HIV testing and routine HIV testing. For many men who tested frequently, testing and routine testing were motivated by awareness of the benefit of prompt treatment; public health and provider encouragement to test periodically; responsibility towards sexual partners; and wanting to share a recent HIV-negative test result when seeking sex online. For some men, any testing was impeded by anxiety around possible HIV diagnosis that made testing a stressful occasion that required time and energy to prepare for. This anxiety was often compounded by stigma related to sex between men, having condomless sex, or having HIV. Routine testing could be further stigmatized as some men felt judged by testing providers or partners if they asked for a test or said they tested frequently. We describe efforts to promote testing and routine testing by countering fear and stigma associated with HIV and testing.

PrEP Use and Correlates of Use Among a Large, Urban Sample of Men and Transgender Persons Who Have Sex with Men.

We examined recent pre-exposure prophylaxis (PrEP) use (past 6 months) and its correlates among a large sample of men who have sex with men and transgender and gender non-conforming persons participating in a home HIV self-testing program conducted by the New York City Health Department between 11/2016 and 1/2017. Correlates examined included demographic characteristics and HIV-related behaviors in the past 6 months. Associations with recent PrEP use were assessed using log-binomial regression. 400 (22.5%) of 1776 participants reported recent PrEP use. In adjusted models, recent PrEP use was associated with Manhattan residence [adjusted prevalence ratio (aPR) 1.26; 95% confidence interval (CI) (1.04, 1.53)], higher income [aPR 1.29; 95% CI (1.03, 1.62)], and having insurance [aPR 1.89; 95% CI (1.33, 2.69)]. All HIV-related behaviors, except for injection drug use, were individually associated with PrEP use. More research is needed to better understand barriers to PrEP use among patients who are low income and/or uninsured as this may help improve current public health efforts to increase PrEP uptake among disproportionately impacted populations.

#Testathome: Implementing 2 Phases of a HIV Self-Testing Program Through Community-Based Organization Partnerships in New York City.

BACKGROUND: Access to human immnodeficiency virus (HIV) testing in New York City (NYC) has increased, but disparities in testing rates still exist among most communities impacted by HIV. HIV self-tests (HIVSTs) present an opportunity to address testing barriers, but HIV-affected communities experience difficulties accessing HIVSTs, including lack of awareness and cost. To support increased access to HIVSTs, the NYC Health Department launched a partnership with select organizations to pilot distribution of free HIVSTs in 2 phases among priority populations across NYC. METHODS: Organizations that were diverse in their missions, experiences, capacities and populations served were recruited through a formal application process. The program initially launched with 10 organization partners (phase 1); as the pilot continued, partners identified necessary revisions to the program and launched a second phase in year 2. Both phases included outreach to NYC priority populations, HIVST distribution/redemption, and a follow-up survey. RESULTS: From March 2017 to August 2019, organizations distributed 75 HIVSTs during phase 1 and 252 during phase 2. All intended priority populations were reached, notably, those who had never tested before: 35% in phase 1 and 12% in phase 2. Over half of the follow-up survey respondents reported testing sooner. Respondents reported liking the HIVST because it did not require a visit to a clinic (84%) and preferred an HIVST to testing in a clinic (92%). CONCLUSIONS: Through 2 phases of implementation, this innovative partnership was able to reach and offer HIVSTs to priority populations across NYC. This program supports the feasibility of distributing HIVSTs through close partnerships with diverse organizations.

Five Waves of an Online HIV Self-Test Giveaway in New York City, 2015 to 2018.

BACKGROUND: HIV self-tests increase HIV status awareness by providing convenience and privacy, although cost and access may limit use. Since 2015, the New York City (NYC) Health Department has conducted 5 waves of an online Home Test Giveaway. METHODS: We recruited adult cisgender men who have sex with men (MSM) and transgender and gender-nonconforming (TGNC) individuals who had sex with men, who were living in NYC, not previously HIV diagnosed, and using paid digital advertisements (4-8 weeks per wave). Eligible respondents were e-mailed a code to redeem on the manufacturer's website for a free HIV self-test and an online follow-up survey ~2 months later. For key process and outcome measures, we present means across 5 waves. RESULTS: Across the 5 waves of Home Test Giveaway, there were 28,921 responses to the eligibility questionnaire: 17,383 were eligible, 12,182 redeemed a code for a free HIV self-test, and 7935 responded to the follow-up survey (46% of eligible responses). Among eligible responses, approximately half were Latino/a (mean, 32%) or non-Latino/a, black (mean, 17%). Mean report of never testing before was 16%. Among 5903 follow-up survey responses who reported test use, 32 reported reactive results with no known previous diagnosis (0.54%), of whom 78% reported receiving confirmatory testing. Report of likelihood of recommending the Home Test Giveaway to friends was high (mean, 96%). CONCLUSIONS: We recruited diverse NYC MSM and TGNC and distributed a large number of HIV self-tests to them. Among respondents who reported newly reactive tests, the majority reported confirmatory testing. This seems to be one acceptable way to reach MSM and TGNC for HIV testing, including those who have never tested before.

Public Health Detailing for Human Immunodeficiency Virus Pre-exposure Prophylaxis.

Despite the promise of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), PrEP remains underutilized, often due to clinician factors. Academic or public health detailing is a process by which university and/or government groups employ the marketing practices of pharmaceutical companies to improve clinical practice. We describe the novel application of detailing to increase PrEP prescribing and related care in New York City and New England. Detailing can play a crucial role in PrEP implementation.

Preexposure Prophylaxis Monitoring in New York City: A Public Health Approach.

The scale-up of preexposure prophylaxis (PrEP) represents a paradigm shift in HIV prevention that poses unique challenges for public health programs. Monitoring of PrEP implementation at the population level is a national priority, with particular significance in New York City (NYC) given the substantial HIV burden and the prominence of PrEP in state and local Ending the Epidemic program plans. We highlight the importance of local monitoring and evaluation of PrEP implementation outcomes and describe the experience at the NYC Health Department, which includes engaging communities, triangulating a variety of data sources regarding PrEP implementation, and leveraging those data to help guide programming. In NYC, we used data from national surveillance systems and incorporated PrEP-related indicators into existing local data collection systems to help illustrate gaps in PrEP awareness and use. Ultimately, ensuring that PrEP achieves the desired impact at the population level depends on identifying disparities through appropriate and accurate measurement, and addressing them through evidence-based programs.

Availability, Accessibility, and Price of Rapid HIV Self-Tests, New York City Pharmacies, Summer 2013.

We conducted an in-person survey of New York City (NYC) pharmacies to assess the availability, accessibility, and price of the over-the-counter, rapid HIV self-test kit. NYC pharmacies were stratified into high, moderate and low morbidity neighborhoods by the HIV diagnosis rate of the neighborhood in which the pharmacy was located. A random sample of 500 pharmacies was taken [250 from high morbidity neighborhoods (HighMN) and 250 from low morbidity neighborhoods (LowMN)]. Pharmacies were excluded if: closed during survey, non-retail, or >10 min walk from subway. Project staff visited pharmacies to determine kit availability (in pharmacy on day of survey), accessibility (not locked/behind counter), and price (marked on shelf/product). Of 361 pharmacies (161 LowMN; 200 HighMN), kits were available in 27 % and accessible in 10 %; there was no difference by neighborhood. Kits were most often kept behind the pharmacy counter; this was more common in HighMN than in LowMN. Kits were kept solely behind the pharmacy counter in 52 %. Median price was US $42.99 without variability across neighborhoods. The rapid HIV self-test had limited availability and access in retail pharmacies. The high median price measured suggests that cost remained a barrier.

Increase in CD4+ T-Cell Count at the Time of HIV Diagnosis and Antiretroviral Treatment Initiation Among Persons With HIV in New York City.

BACKGROUND: Trends in CD4+ T-cell count at human immunodeficiency virus (HIV) infection diagnosis and antiretroviral therapy (ART) initiation can be characterized using laboratory tests from surveillance. METHODS: We used CD4+ T-cell counts and viral loads from New York City for persons who received a diagnosis of HIV infection during 2006-2012. RESULTS: From 2006 to 2012, the median CD4+ T-cell count increased from 325 to 379 cells/µL at diagnosis and from 178 to 360 cells/µL at ART initiation. CD4+ T-cell counts were consistently lower in women, blacks, Hispanics, persons who inject drugs, and heterosexuals. DISCUSSION: Increases in CD4+ T-cell count at diagnosis and ART initiation suggest that the time from HIV infection to ART initiation has been reduced substantially in New York City.

Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program.

BACKGROUND: Substantial evidence gaps remain regarding human immunodeficiency virus (HIV) intervention strategies that improve engagement in care (EiC) and viral load suppression (VLS). We assessed EiC and VLS before and after enrollment in a comprehensive intervention for persons at risk of poor HIV care outcomes. METHODS: New York City's Ryan White Part A HIV Care Coordination Program (CCP), launched at 28 agencies in 2009, applies multiple strategies to promote optimal utilization of medical and social services. Using laboratory test records from an HIV surveillance registry, we examined pre-post outcomes among 3641 CCP clients enrolled before April 2011. For the year before and after enrollment, we assessed EiC (defined as ≥2 tests, ≥90 days apart, with ≥1 in each half-year) and VLS (defined as viral load [VL] ≤200 copies/mL on latest VL test in the second half of the year). We estimated relative risks (RRs), comparing pre- and postenrollment proportions achieving EiC and VLS. RESULTS: Among newly diagnosed clients, 90.5% (95% confidence interval [CI], 87.9%-93.2%) and 66.2% (95% CI, 61.9%-70.6%) achieved EiC and VLS, respectively. Among previously diagnosed clients, EiC increased from 73.7% to 91.3% (RR = 1.24; 95% CI, 1.21-1.27) and VLS increased from 32.3% to 50.9% (RR = 1.58; 95% CI, 1.50-1.66). Clients without evidence of HIV care during the 6 months preenrollment contributed most to overall improvements. Pre-post improvements were robust, retaining statistical significance within most sociodemographic and clinical subgroups, and in 89% (EiC) and 75% (VLS) of CCP agencies. CONCLUSIONS: Clients in comprehensive HIV care coordination for persons with evident barriers to care showed substantial and consistent improvement in short-term outcomes.

Acceptability of home self-tests for HIV in New York City, 2006.

Data from a 2006 telephone survey representative of New York City adults showed that more than half (56.2%) of those aged 18 to 64 years responded favorably to a question about acceptability of a rapid home HIV test. More than two thirds of certain subpopulations at high risk for HIV reported that they would use a rapid home HIV test, but approximately half who expressed interest had indications of financial hardship. The match of acceptability and HIV risk bodes well for self-testing utility, but cost might impede uptake.

The efficacy of duloxetine, non-steroidal anti-inflammatory drugs, and opioids in osteoarthritis: a systematic literature review and meta-analysis.

BACKGROUND: This meta-analysis assessed the efficacy of duloxetine versus other oral treatments used after failure of acetaminophen for management of patients with osteoarthritis. METHODS: A systematic literature review of English language articles was performed in PUBMED, EMBASE, MedLine In-Process, Cochrane Library, and ClinicalTrials.gov between January 1985 and March 2013. Randomized controlled trials of duloxetine and all oral non-steroidal anti-inflammatory drugs and opioids were included if treatment was ≥12 weeks and the Western Ontario and McMaster Universities Index (WOMAC) total score was available. Studies were assessed for quality using the assessment tool from the National Institute for Health and Clinical Excellence guidelines for single technology appraisal submissions.WOMAC baseline and change from baseline total scores were extracted and standardized. A frequentist meta-analysis, meta-regression, and indirect comparison were performed using the DerSimonian-Laird and Bucher methods. Bayesian analyses with and without adjustment for study-level covariates were performed using noninformative priors. RESULTS: Thirty-two publications reported 34 trials (2 publications each reported 2 trials) that met inclusion criteria. The analyses found all treatments except oxycodone (frequentist) and hydromorphone (frequentist and Bayesian) to be more effective than placebo. Indirect comparisons to duloxetine found no significant differences for most of the compounds. Some analyses showed evidence of a difference with duloxetine for etoricoxib (better), tramadol and oxycodone (worse), but without consistent results between analyses. Forest plots revealed positive trends in overall efficacy improvement with baseline scores. Adjusting for baseline, the probability duloxetine is superior to other treatments ranges between 15% to 100%.Limitations of this study include the low number of studies included in the analyses, the inclusion of only English language publications, and possible ecological fallacy associated with patient level characteristics. CONCLUSIONS: This analysis suggests no difference between duloxetine and other post-first line oral treatments for osteoarthritis (OA) in total WOMAC score after approximately 12 weeks of treatment. Significant results for 3 compounds (1 better and 2 worse) were not consistent across performed analyses.

Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET-altered solid tumors in the US.

OBJECTIVE: To estimate the potential budget impact on US third party payers (commercial or Medicare) associated with addition of selpercatinib as a tumor-agnostic treatment for patients with Rearranged during Transfection (RET)-altered solid tumors. METHODS: An integrated budget impact model (iBIM) with 3-year (Y) time horizon was developed for 19 RET-altered tumors. It is referred to as an integrated model because it is a single model that integrated results across multiple tumor types (as opposed to tumor-specific models developed traditionally). The model estimated eligible patient populations and included tumor-specific comparator treatments for each tumor type. Estimated annual total costs (2022USD, $) included costs of drug, administration, supportive care, and toxicity. For a one-million-member plan, the number of patients with RET-altered tumors eligible for treatment, incremental total costs, and incremental per-member per-month (PMPM) costs associated with introduction of selpercatinib treatment were estimated. Uncertainty associated with model parameters was assessed using various sensitivity analyses. RESULTS: Commercial perspective estimated 11.68 patients/million with RET-altered tumors as treatment-eligible annually, of which 7.59 (Y1), 8.17 (Y2), and 8.76 (Y3) patients would be selpercatinib-treated (based on forecasted market share). The associated incremental total and PMPM costs (commercial) were estimated to be: $873,099 and $0.073 (Y1), $2,160,525 and $0.180 (Y2), and $2,561,281 and $0.213 (Y3), respectively. The Medicare perspective estimated 55.82 patients/million with RET-altered tumors as treatment-eligible annually, of which 36.29 (Y1), 39.08 (Y2), and 41.87 (Y3) patients would be selpercatinib-treated. The associated incremental total and PMPM costs (Medicare) were estimated to be: $4,447,832 and $0.371 (Y1), $11,076,422 and $0.923 (Y2), and $12,637,458 and $1.053 (Y3), respectively. One-way sensitivity analyses across both perspectives identified drug costs, selpercatinib market share, incidence of RET, and treatment duration as significant drivers of incremental costs. CONCLUSIONS: Three-year incremental PMPM cost estimates suggest a modest impact on payer-budgets associated with introduction of tumor-agnostic selpercatinib treatment.

A pill for HIV prevention: déjà vu all over again?

Recent FDA approval of tenofovir-emtricitabine for prevention of human immunodeficiency virus (HIV) as a form of pre-exposure prophylaxis (PrEP) has led to concern about implementation of this strategy. Fifty years ago, a very similar national and international debate occurred when the oral contraceptive pill ("the Pill" or "OCP") was approved. Contentious issues included OCP safety, cost, and the potential impact on sexual behavior--many of the same concerns being voiced currently about PrEP. In this article, we review the social and medical history of OCP, drawing parallels with the current PrEP debate. We also explore the key areas where PrEP differs from its forbear: lower efficacy, presence of drug resistance, and a more circumscribed (and marginalized) target population. A thoughtful approach to PrEP implementation, bearing in mind the historical insights gained from the 1960s, might serve as well as we begin this new chapter in the control of the HIV epidemic.

Knowledge and use of pre-exposure prophylaxis among an online sample of young men who have sex with men in New York City.

Understanding prior knowledge and experience with pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) is critical to its implementation. In fall 2011, NYC MSM were recruited via banner advertisements on six popular dating websites and asked questions about their knowledge and use of PrEP (n = 329). Overall, 123 (38%) respondents reported knowledge of PrEP, of whom two (1.5%) reported PrEP use in the past 6 months. Knowledge of PrEP was associated with high educational attainment, gay identity and recent HIV testing, suggesting an uneven dissemination of information about PrEP and missed opportunities for education. To avoid disparities in use during scale-up, MSM should be provided with additional information about PrEP.

Healthcare-related correlates of recent HIV testing in New York City.

OBJECTIVE: To examine healthcare-related correlates of recent HIV testing among New York City (NYC) residents, controlling for socio-demographic and HIV-related risk factors. METHODS: Using the NYC 2007 Community Health Survey (population-based telephone survey, n=8911), recent HIV testing was examined for its association with healthcare-related variables, including medical screening for other conditions, controlling for other HIV testing correlates using multiple logistic regression. RESULTS: Factors associated with a recent HIV test included: provider recommendation for an HIV test (adjusted odds ratio [AOR]: 10.1, 95% confidence interval [CI]:7.6-13.5), Medicaid versus private insurance (AOR: 1.6, 95% CI: 1.2-2.1), and having a personal doctor (AOR: 1.6, 95% CI: 1.3-2.1). The proportion of HIV tests attributed to each factor (attributable-fraction [AF]) was 49% for provider recommendation, 33% for having a personal doctor, and 8.3% for Medicaid insurance. Among subgroups eligible for other medical screening, factors associated with recent HIV testing included recent receipt of blood lipid testing (AOR: 2.2, 95% CI: 1.6-3.0; AF: 45%), and Pap smear (AOR: 2.7, 95% CI: 2.1-3.5; AF: 52%). Recent receipt of mammography and colonoscopy was not associated with recent HIV testing. CONCLUSIONS: A substantial proportion of recent HIV testing coverage among New Yorkers may be attributable to healthcare-related factors. Joint medical screening may provide opportunities to increase population HIV testing coverage.