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.

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.

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.

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.

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.

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns.

BACKGROUND: Pre-exposure prophylaxis (PrEP) for HIV prevention requires engagement throughout the PrEP care continuum. Using data from a PrEP navigation program, we examine reasons for PrEP discontinuation. SETTING: Participants were recruited from New York City Health Department Sexual Health Clinics with PrEP navigation programs. METHODS: Participants completed a survey and up to 3 interviews about PrEP navigation and use. This analysis includes 94 PrEP initiators that were PrEP-naive before their clinic visit, started PrEP during the study, and completed at least 2 interviews. Interview transcripts were reviewed to assess reasons for PrEP discontinuation. RESULTS: Approximately half of PrEP initiators discontinued PrEP during the study period (n = 44; 47%). Most participants (71%) noted systemic issues (insurance or financial problems, clinic or pharmacy logistics, and scheduling barriers) as reasons for discontinuation. One-third cited medication concerns (side effects, potential long-term side effects, and medication beliefs; 32%) and behavioral factors (low relevance of PrEP because of sexual behavior change; 34%) as contributing reasons. Over half (53.5%) highlighted systemic issues alone, while an additional 19% attributed discontinuation to systemic issues in combination with other factors. Of those who discontinued, approximately one-third (30%) restarted PrEP during the follow-up period, citing resolution of systemic issues or behavior change that increased PrEP relevance. CONCLUSIONS: PrEP continuation is dependent on interacting factors and often presents complex hurdles for patients to navigate. To promote sustained engagement in PrEP care, financial, clinic, and pharmacy barriers must be addressed and counseling and navigation should acknowledge factors beyond sexual risk that influence PrEP use.

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.

Public Health Detailing to Promote HIV Pre- and Postexposure Prophylaxis Among Women's Healthcare Providers in New York City.

INTRODUCTION: Equitable access to HIV pre- and postexposure prophylaxis for women is essential to ending the HIV epidemic. Providers' lack of knowledge and comfort in discussing and prescribing pre-exposure prophylaxis to women persist as barriers. METHODS: From May to November 2019, the New York City Health Department conducted its first public health detailing campaigns among women's healthcare providers to promote pre- and postexposure prophylaxis and the associated best practices. Over 2 campaigns (10 weeks each), trained Health Department representatives visited providers for 1-on-1 visits at select practices to promote key messages. Representatives distributed an Action Kit that addressed knowledge gaps and practice needs on providing pre-exposure prophylaxis and postexposure prophylaxis to cisgender and transgender women. Providers completed an assessment at the beginning of initial and follow-up visits, used to compare responses across visits. Statistically significant changes were evaluated by generalized linear models of bivariate outcomes, adjusted for nonindependence of providers at the same practice. RESULTS: Representatives visited 1,348 providers specializing in primary care (47%), women's health (30%), adolescent health (7%), infectious disease (4%), and other (12%) at 860 sites; 1,097 providers received initial and follow-up visits. Provider report of ever prescribing pre-exposure prophylaxis increased by 12% (n=119 providers); increases were reported in measures of taking sexual history, asking about partners' HIV status, providing postexposure prophylaxis, recognizing pre-exposure prophylaxis's effectiveness, and discussing and referring for pre-exposure prophylaxis. CONCLUSIONS: After public health detailing, women's healthcare providers report increased adoption of recommended practices that promote pre- and postexposure prophylaxis uptake and sexual wellness among women. Detailing may be adaptable to other regions and contexts to reach providers.

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.

#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.

Next-Wave HIV Pre-Exposure Prophylaxis Implementation for Gay and Bisexual Men.

Data indicate that diffusion of pre-exposure prophylaxis (PrEP) programs for HIV prevention is increasing in the United States; however, persistent disparities in PrEP access remain. Earlier waves of PrEP implementation focused on development (2012-2015) and diffusion (2016-2018). To reduce disparities, the next wave of PrEP implementation should focus on integration; that is, the assimilation of PrEP service as an integral part of HIV prevention, sexual health, and primary care. This review analyzes PrEP implementation literature in the context of three "next-wave" challenges: increasing patient demand, enhancing provider investment and competency, and improving health systems capacity. Our review revealed five activities we consider critical to successful next-wave PrEP implementation efforts: (1) redefining PrEP eligibility assessment, (2) de-emphasizing risk perception as a strategy to increase demand, (3) rejecting risk compensation arguments, (4) altering guidelines to make PrEP follow-up less onerous, and (5) focusing directly on strategies to reduce the cost of PrEP medication. This article ends with a case study of a research-practice partnership designed to instantiate new approaches to integrative implementation efforts.

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.

Short-term effectiveness of HIV care coordination among persons with recent HIV diagnosis or history of poor HIV outcomes.

The New York City HIV Care Coordination Program (CCP) combines multiple evidence-based strategies to support persons living with HIV (PLWH) at risk for, or with a recent history of, poor HIV outcomes. We assessed the comparative effectiveness of the CCP by merging programmatic data on CCP clients with population-based surveillance data on all New York City PLWH. A non-CCP comparison group of similar PLWH who met CCP eligibility criteria was identified using surveillance data. The CCP and non-CCP groups were matched on propensity for CCP enrollment within four baseline treatment status groups (newly diagnosed or previously diagnosed and either consistently unsuppressed, inconsistently suppressed or consistently suppressed). We compared CCP to non-CCP proportions with viral load suppression at 12-month follow-up. Among the 13,624 persons included, 15∙3% were newly diagnosed; among the 84∙7% previously diagnosed, 14∙2% were consistently suppressed, 28∙9% were inconsistently suppressed, and 41∙6% were consistently unsuppressed in the year prior to baseline. At 12-month follow-up, 59∙9% of CCP and 53∙9% of non-CCP participants had viral load suppression (Relative Risk = 1.11, 95%CI:1.08-1.14). Among those newly diagnosed and those consistently unsuppressed at baseline, the relative risk of viral load suppression in the CCP versus non-CCP participants was 1.15 (95%CI:1.09-1.23) and 1.32 (95%CI:1.23-1.42), respectively. CCP exposure shows benefits over no CCP exposure for persons newly diagnosed or consistently unsuppressed, but not for persons suppressed in the year prior to baseline. We recommend more targeted case finding for CCP enrollment and increased attention to viral load suppression maintenance.

Redefining Prevention and Care: A Status-Neutral Approach to HIV.

Recent biomedical advances inspire hope that an end to the epidemic of HIV is in sight. Adopting new approaches and paradigms for treatment and prevention in terms of both messaging and programming is a priority to accelerate progress. Defining the key sequential steps that comprise engagement in HIV care has provided a useful framework for clinical programs and motivated quality improvement initiatives. Recently, the same approach has been applied to use of pre-exposure prophylaxis for HIV prevention. Building on the various prevention and care continua previously proposed, we present a novel schematic that incorporates both people living with HIV and people at risk, making it effectively "status-neutral" in that it proposes the same approach for engagement, regardless of one's HIV status. This multidirectional continuum begins with an HIV test and offers 2 divergent paths depending on the results; these paths end at a common final state. To illustrate how this continuum can be utilized for program planning as well as for monitoring, we provide an example using data for New York City men who have sex with men, a population with high HIV incidence and prevalence.

Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA Steps 4 or 5 treatment.

OBJECTIVE: This study sought to characterize the epidemiologic, clinical, humanistic, and economic burden of patients with asthma uncontrolled by GINA Steps 4 or 5 treatment (severe, uncontrolled asthma [SUA]). METHODS: A systematic literature review adhering to PRISMA guidelines was performed. Relevant publications were searched for in MEDLINE and EMBASE from January 2004 to September 2016 and in a conference proceedings database from January 2012 to October 2016. Studies were screened using the Population, Intervention, Comparator, Outcomes, Study Design, and Time (PICOS-T) framework. Studies of SUA with observational (prospective and retrospective), randomized, or nonrandomized study designs; adult patient populations; sample sizes ≥20 patients; epidemiologic or clinical outcomes, patient-reported outcomes (PROs), or economic outcomes were included. For our analysis, SUA was defined as inadequate control of asthma, despite the use of medium- to high-dosage inhaled corticosteroids and at least one additional treatment. RESULTS: A total of 195 articles reporting unique study populations were included. Prevalence of SUA was as great as 87.4% for patients with severe asthma, although values varied depending on the criteria used to define asthma control. Compared with patients with severe asthma who were controlled, patients with SUA experienced more symptoms, night-time awakenings, rescue medication use, and worse PROs. SUA-associated costs were 3-times greater than costs for patients with severe, controlled disease. CONCLUSION: Despite the availability of approved asthma treatments, this literature analysis confirms that SUA poses a substantial epidemiologic, clinical, humanistic, and economic burden. Published data are limited for certain aspects of SUA, highlighting a need for further research.