Respiratory syncytial virus knowledge, attitudes, and perceptions among adults in the United States.

Respiratory syncytial virus (RSV) is associated with considerable morbidity and mortality among older adults (aged ≥60 years) and adults with certain chronic conditions in the United States (US). Despite this burden, no previous studies have assessed the knowledge, attitudes, and perceptions (KAP) of RSV among these populations. This study evaluates RSV-related KAP among US adults at increased risk of severe RSV infection. A cross-sectional, web-based survey was administered from May to June 2022 to better understand respiratory infection- and RSV-related KAP among US adults who are at risk of severe RSV infection. The survey included ≥200 adults in each of 4 subgroups: adults aged 60-89 years, and adults aged 18-59 years with ≥1 chronic cardiovascular condition, chronic pulmonary condition, or diabetes mellitus. Survey responses were analyzed descriptively overall and by subgroup, with exploratory logistic regression modeling used to evaluate characteristics associated with RSV awareness and concern. Among the 827 survey respondents, only 43.3% had ever heard of RSV (n = 358/827). The study identified key knowledge gaps (e.g. bacterial vs. viral nature of respiratory infections, RSV seasonality, common RSV symptoms, extent to which RSV causes respiratory infections in specific patient populations). Although 33.7% of RSV-aware adults (n = 120/356) reported being worried/very worried about RSV, 67.3% (n = 241/358) rarely consider RSV as a potential cause of their cold/flu-like symptoms. Results from this study highlight important knowledge gaps related to RSV, perceived risk, and severity of RSV. Findings can be used to support the development of tailored education efforts to support RSV prevention.

What is the context? Respiratory syncytial virus (RSV) is a common cause of illness among older adults (60 years and older) and adults with certain chronic conditions in the United States (US), with some adults experiencing severe RSV outcomes such as hospitalization or death.Despite this considerable burden, the awareness of RSV among these at-risk populations has never been studied until now.What is new? We assessed RSV-related knowledge, attitudes, and perceptions among US adults at increased risk of severe RSV infection (adults aged 60­89 years and adults aged 18­59 years with ≥1 chronic cardiovascular condition, chronic pulmonary condition, or diabetes).Among older and at-risk adults, 43.3% had ever heard of RSV, with a lower awareness in the older adult subgroup.Among adults at increased risk of severe RSV who are aware of RSV, less than 35% consider themselves to be knowledgeable about RSV and 16­19% were unable to assess their perceived risk of contracting RSV or potential severity of RSV should they contract it.Knowledge gaps specific to RSV include the viral nature of RSV, its seasonality, symptoms, extent to which it causes respiratory infections in specific patient populations, the difficulty distinguishing RSV from other respiratory infections based on symptoms alone, and the limited testing for RSV in routine clinical practice.What is the impact? Two RSV vaccines were recently approved in the US and are recommended for the prevention of RSV among adults aged 60 years and older with shared clinical decision making.Results from this study reveal limited awareness of RSV among adults in the US at increased risk of severe RSV and knowledge gaps among those aware of RSV.These findings can be used by healthcare providers initiating shared clinical decision-making conversations with their patients aged 60 years and older who are eligible for RSV vaccination, as well as to tailor RSV disease awareness educational interventions to healthcare providers and patients.

Tolvaptan and Kidney Function Decline in Older Individuals With Autosomal Dominant Polycystic Kidney Disease: A Pooled Analysis of Randomized Clinical Trials and Observational Studies.

Rationale & Objective: Tolvaptan is indicated for treatment of patients with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Participants aged 56-65 years constituted a small proportion of the Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD (REPRISE) trial population. We assessed effects of tolvaptan on estimated glomerular filtration rate (eGFR) decline in participants aged >55 years. Study Design: This was a pooled data analysis from 8 studies of tolvaptan or non-tolvaptan standard of care (SOC). Setting & Participants: Participants aged >55 years with ADPKD were included. Data on participants in >1 study were linked longitudinally for maximum follow-up duration, with matching for age, sex, eGFR, and chronic kidney disease (CKD) stage to minimize confounding. Interventions: Tolvaptan or non-tolvaptan SOC. Outcomes: Treatment effects on annualized eGFR decline were compared using mixed models with fixed effects for treatment, time, treatment-by-time interaction, and baseline eGFR. Results: In the pooled studies, 230 tolvaptan-treated and 907 SOC participants were aged >55 years at baseline. Ninety-five participant pairs from each treatment group were matched, all in CKD G3 or G4, ranging from 56.0 to 65.0 years (tolvaptan) or from 55.1 to 67.0 years (SOC). The eGFR annual decline rate was significantly reduced by 1.66 mL/min/1.73 m2 (95% CI, 0.43-2.90; P = 0.009) in the tolvaptan group compared with SOC (-2.33 versus -3.99 mL/min/1.73 m2) over 3 years. Limitations: Limitations include potential bias because of study population differences (bias risk was reduced through matching and multiple regression adjustment); vascular disease history data was not uniformly collected, and therefore not adjusted; and natural history of ADPKD precludes evaluating certain clinical endpoints within the study time frame. Conclusions: In individuals aged 56-65 years with CKD G3 or G4, compared to a SOC group with mean GFR rate of decline ≥3 mL/min/1.73 m2/year, tolvaptan was associated with efficacy similar to that observed in the overall indication. Funding: Otsuka Pharmaceutical Development & Commercialization, Inc (Rockville, MD). Trial Registration: TEMPO 2:4 (NCT00413777); phase 1 tolvaptan trial (no NCT number; trial number 156-06-260); phase 2 tolvaptan trial (NCT01336972); TEMPO 4:4 (NCT01214421); REPRISE (NCT02160145); long-term tolvaptan safety extension trial (NCT02251275); OVERTURE (NCT01430494); HALT Progression of Polycystic Kidney Disease (HALT-PKD) study B (NCT01885559).

Health-related quality-of-life analyses from a multicenter, randomized, double-blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day.

BACKGROUND: In the phase 2 double-blind Study 211, a starting dose of lenvatinib 18 mg/day was compared with the approved starting dose of 24 mg/day in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Predefined criteria for noninferiority for efficacy in the 18 mg arm were not met; safety was similar in both arms. Impact of lenvatinib treatment on health-related quality-of-life (HRQoL) was a secondary endpoint of Study 211. METHODS: Patients with RR-DTC were randomly assigned to a blinded starting dose of lenvatinib 18 mg/day or 24 mg/day. HRQoL was assessed at baseline, every 8 weeks until Week 24, then every 16 weeks, and at the off-treatment visit, using the EQ-5D-3L and FACT-G instruments. Completion and compliance rates, mean change from baseline, and times to first and definitive deterioration were evaluated. RESULTS: Baseline EQ-5D and FACT-G scores, and overall changes from baseline, were comparable between patients in the lenvatinib 18 mg/day (n = 77) and 24 mg/day arms (n = 75). For the 18 mg versus 24 mg arms, least squares mean differences were -0.42 (95% CI -4.88, 4.03) for EQ-5D-VAS and 0.47 (95% CI -3.45, 4.39) for FACT-G total. Time to first deterioration did not significantly favor either arm; EQ-5D-VAS HR [18 mg/24 mg] 0.93 (95% CI 0.61-1.40), EQ-5D-HUI HR [18 mg/24 mg] 0.68 (95% CI 0.44-1.05), FACT-G total HR [18 mg/24 mg] 0.73 (95% CI 0.48-1.12). Time to definitive deterioration did not significantly favor either arm, though EQ-5D-VAS showed a trend in favor of the 24 mg arm (HR [18 mg/24 mg] 1.72; 95% CI 0.99-3.01); EQ-5D-HUI HR [18 mg/24 mg] was 0.96 (95% CI 0.57-1.63), FACT-G total HR [18 mg/24 mg] was 0.72 (95% CI 0.43-1.21). CONCLUSIONS: In Study 211, HRQoL for patients in the lenvatinib 18 mg/day arm was not statistically different from that of patients in the 24 mg/day arm. These data further support the use of the approved lenvatinib starting dose of 24 mg/day in patients with RR-DTC. GOV NUMBER: NCT02702388.

Real-World Clinical and Patient-Reported Outcomes from the Longitudinal Telotristat Ethyl Treatment Registry of Patients with Neuroendocrine Tumors.

Background: Telotristat ethyl (TE) is an oral tryptophan hydroxylase inhibitor approved for the treatment of carcinoid syndrome diarrhea (CSD) in combination with somatostatin analogs (SSAs). Methods: This prospective, observational, single-arm study evaluated long-term patient-reported outcomes for adults initiating TE in US clinical practice from 2017 through January 2022. The primary objective was satisfaction with overall CS symptom control 6 months after initiating TE. Secondary objectives evaluated satisfaction with control of CSD, flushing, and CS symptoms, as well as work productivity/activity impairment, SSA use, and weight. All analyses were descriptive in nature. Results: A total of 223 patients completed the baseline survey; 56% also completed the 6-month follow-up survey. Mean age was 61 years and 61% were women. After 6 months of TE treatment, the majority of patients (76%, n=95/125) reported being satisfied with control of their CS symptoms which was markedly improved from baseline (41%, n=91). Similarly, the majority of patients (78%, n=97/125) were satisfied with control of their CSD after 6 months of TE, markedly improved from baseline (36%). Conclusion: This longitudinal observational study showed improvements in real-world clinical and humanistic outcomes for patients with CS and at least 6 months of TE treatment.

Pooled Data Analysis of the Long-Term Treatment Effects of Tolvaptan in ADPKD.

Introduction: In 1- and 3-year randomized trials, tolvaptan slowed kidney function decline in subjects with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. The 3-year trial also evaluated effects on total kidney volume (TKV); slowing of TKV growth was demonstrated. Subjects were followed in open-label extension trials. To characterize longer-term effects of treatment, an analysis was conducted comparing tolvaptan-treated subjects with subjects from standard of care (SOC) ADPKD studies without tolvaptan. Methods: This was a pooled, longitudinal analysis of data from 8 tolvaptan clinical trials and 5 studies without tolvaptan (natural history or SOC) in ADPKD. Data from subjects who participated in multiple studies were linked for longer follow-up. Outcomes were rates of change in estimated glomerular filtration rate (eGFR) and TKV over 5.5 years. To control for heterogeneity in disease characteristics between tolvaptan and SOC treatment groups, analysis populations matched for baseline demographic and disease characteristics were constructed. Results: Matched analysis (n = 1186 in each treatment group) indicated that tolvaptan slowed annualized eGFR decline by 1.01 ml/min per 1.73 m2 (P < 0.001) versus SOC over 5.5 years. An analysis conducted on the full, unmatched data set (tolvaptan: n = 2928; SOC: n = 4189) confirmed significant reduction in annual eGFR decline. Among subjects with TKV data, TKV was significantly reduced at years 1, 3, and 5 for tolvaptan versus SOC in both matched and full data sets. Conclusion: Comparison of a pooled tolvaptan cohort to a pooled control cohort with ADPKD supports longer-term treatment effects of tolvaptan.

National and State-Level Composite Completion of Recommended Vaccines Among Adolescents in the United States, 2015-2018.

BACKGROUND: Routine adolescent vaccination recommendations in the United States include tetanus, diphtheria, and acellular pertussis, quadrivalent meningococcal conjugate vaccine, and human papillomavirus vaccines. Although coverage for these individual vaccines is known, limited data are available on composite completion for all three vaccines. METHODS: This cross-sectional analysis of pooled 2015-2018 National Immunization Survey-Teen data used logistic regression to estimate model-adjusted composite vaccination completion nationally and by state among United States adolescents aged 17 years. National Immunization Survey-Teen data were combined with state-level data to estimate a multilevel model identifying factors associated with composite vaccination completion. RESULTS: The pooled model-adjusted composite vaccination completion was 30.6% (95% confidence interval [CI], 30.13%-31.04%) nationally, varying from 11.3% in Idaho (6.91%-17.95%) to 56.4% (49.81%-62.82%) in Rhode Island. Individual-level factors with the greatest impact on composite completion were having a provider's recommendation for human papillomavirus vaccination (odds ratio, 3.24; 95% CI, 2.76-3.80) and a check-up visit at age 16-17 years (odds ratio, 2.35; 95% CI, 1.80-3.07), with other individual-level factors associated with completion including being Medicaid insured, female, Hispanic, or non-Hispanic black. State-level quadrivalent meningococcal conjugate vaccination mandates were also associated with an increased likelihood of composite vaccination completion (odds ratio, 1.64; 95% CI, 1.16-2.33). CONCLUSIONS: Fewer than one-third of 17-year-old individuals have completed all three recommended vaccines, with rates varying by state. Although this study identified implementable strategies to improve composite completion, additional research is needed to further understand factors associated with adolescent vaccination completion.

Patients' satisfaction with long-acting injectable somatostatin analog therapy for neuroendocrine tumors.

BACKGROUND: Long-acting somatostatin analogs (LA SSAs) are approved and recommended for the treatment of patients with advanced neuroendocrine tumors (NETs). Given the long duration of therapy and differences in administration routes, it is important to understand patients' experiences with receiving LA SSA injections. METHODS: We conducted a serial survey, informed by qualitative interviews with eight patients treated with LA SSAs and two nurses who administer LA SSA injections, among patients undergoing LA SSA treatment over a 28-day period (administered at baseline and 14 days and 28 days after injection). Eligible patients, recruited by the Carcinoid Cancer Foundation, self-reported having received an LA SSA injection for physician-diagnosed NET within the 5 days before the survey. RESULTS: 202 patients completed the survey at baseline (82 receiving lanreotide and 120 receiving octreotide), 148 at day 14, and 124 at day 28. Patients reported consistently high satisfaction levels with their most recent LA SSA injection (91.1% at baseline, 85.1% at day 14, and 85.5% at day 28); 68.8% reported that their injection experience differed based on the nursing staff administering the injection. CONCLUSIONS: Satisfaction with LA SSA injections is high among patients in this population, and specific experiences with LA SSA injections varied based on the nursing staff administering the injection. Evaluations of patients' experiences and satisfaction with treatment are increasingly important as patients take more active roles in decision-making for their treatment pathways.

State-Level Variations and Factors Associated with Adult Vaccination Coverage: A Multilevel Modeling Approach.

BACKGROUND: Adult vaccination rates in the USA are generally low and fall short of public health goals. OBJECTIVES: Our aim was to evaluate the effect of state-level characteristics on adult vaccination coverage in the USA. METHODS: This study was a cross-sectional, retrospective analysis of 2015-2017 Behavioral Risk Factor Surveillance System data, conducted from March to October 2019 and including seasonal influenza; pneumococcal; tetanus, diphtheria, and acellular pertussis (Tdap); and herpes zoster (HZ) vaccines. Multilevel logistic regression models examined interstate vaccination coverage variability and assessed the impact of state-level characteristics, with model-adjusted coverage estimated. RESULTS: Model-adjusted vaccination coverage varied by state, with 35.1-48.1% coverage for influenza (2017), 68.2-80.8% for pneumococcal (2017), 21.9-46.5% for Tdap (2016), and 30.5-50.9% for HZ (2017). Characteristics associated with vaccination included state-level insurance coverage, pharmacists' vaccination authority, vaccination exemptions, and adult immunization information systems participation, as well as individual-level measures of income and education. After adjusting for these factors, substantial interstate heterogeneity remained. CONCLUSIONS: Model-adjusted coverage was generally low and varied by state. A small number of state-level characteristics partially explained interstate coverage variability. This and future research assessing additional state characteristics may help determine policies most likely to increase adult vaccination.

Adult vaccination rates in the USA are generally low and fall short of public health goals. Previous studies have indicated that adult vaccination rates vary between states and that individual characteristics affect vaccination coverage. We used modeling to evaluate the effects of both individual- and state-level factors on adult vaccination coverage. Health insurance coverage, the authority of pharmacists to vaccinate, existence of vaccination exemptions, and immunization information systems adult participation rates had a positive impact on vaccination coverage, although the impact varied by vaccine. These results provide policy decision makers at both state and federal levels with information to consider when expanding vaccination programs or preventive care efforts. However, additional data are needed to further explain the variations between states.

Meningococcal B vaccination coverage among older adolescents in the United States.

BACKGROUND: Serogroup B meningococcal (MenB) vaccination recommendations for adolescents in the United States (US) include routine vaccination for all individuals at increased risk and vaccination for individuals not at increased risk aged 16-23 years (preferred age 16-18 years) based on shared clinical decision-making. The two licensed MenB vaccines require administration of ≥2 doses. METHODS: This cross-sectional study analyzed 2017-2018 National Immunization Survey-Teen (NIS-Teen) data to evaluate ≥1 dose and ≥2 dose MenB vaccination coverage among adolescents aged 17 years. Multivariable logistic regression was used to further evaluate determinants of MenB vaccination. RESULTS: Nationally, MenB vaccination coverage among 17-year-olds increased from 14.5% in 2017 to 17.2% in 2018 for ≥1 dose and from 6.3% to 8.4% for ≥2 doses. MenB vaccination coverage (2017-2018) was the lowest in the South (≥1 dose: 14.6%; ≥2 doses: 6.3%) and highest in the Northeast region (18.3% and 9.3%), with variation observed by census division. Adolescents were more likely to have received ≥1 dose of MenB vaccine if they had any Medicaid insurance (odds ratio [OR], 1.77; 95% confidence interval [CI], 1.32-2.39) or had received human papillomavirus (OR, 1.94; 95% CI, 1.41-2.67) or meningococcal A, C, W, and Y (OR, 4.03; 95% CI, 2.92-5.56) vaccinations. CONCLUSIONS: MenB first-dose coverage in the US is low, and even lower for a second dose, with regional variation. Being up to date with other routinely administered vaccines increased the likelihood of receiving MenB vaccination.