Humoral and cellular immune responses in persons with rheumatoid arthritis after a third dose of mRNA COVID-19 vaccine.

OBJECTIVE: Disease-modifying anti-rheumatic drugs (DMARDs) that treat rheumatoid arthritis (RA) may reduce immune responses to COVID-19 vaccination. We compared humoral and cell-mediated immunity before and after a 3rd dose of mRNA COVID vaccine in RA subjects. METHODS: RA patients that received 2 doses of mRNA vaccine enrolled in an observational study in 2021 before receiving a 3rd dose. Subjects self-reported holding or continuing DMARDs. Blood samples were collected pre- and 4 weeks after the 3rd dose. 50 healthy controls provided blood samples. Humoral response was measured with in-house ELISA assays for anti-Spike IgG (anti-S) and anti-receptor binding domain IgG (anti-RBD). T cell activation was measured after stimulation with SARS-CoV-2 peptide. Spearman's correlations assessed the relationship between anti-S, anti-RBD, and frequencies of activated T cells. RESULTS: Among 60 subjects, mean age was 63 years and 88% were female. 57% of subjects held at least 1 DMARD around the 3rd dose. 43% (anti-S) and 62% (anti-RBD) had a normal humoral response at week 4, defined as ELISA within 1 standard deviation of the healthy control mean. No differences in antibody levels were observed based on holding DMARDs. Median frequency of activated CD4 T cells was significantly greater post- vs. pre-3rd dose. Changes in antibody levels did not correlate with change in frequency of activated CD4 T cells. CONCLUSION: Virus-specific IgG levels significantly increased in RA subjects using DMARDs after completing the primary vaccine series, though fewer than two-thirds achieved a humoral response like healthy controls. Humoral and cellular changes were not correlated.

Examining Treatment Decision-Making Among Patients With Axial Spondyloarthritis: Insights From a Conjoint Analysis Survey.

OBJECTIVE: The number of therapies for axial spondyloarthritis (axSpA) is increasing. Thus, it has become more challenging for patients and physicians to navigate the risk-benefit profiles of the various treatment options. In this study, we used conjoint analysis-a form of trade-off analysis that elucidates how people make complex decisions by balancing competing factors-to examine patient decision-making surrounding medication options for axSpA. METHODS: We conducted an adaptive choice-based conjoint analysis survey for patients with axSpA to assess the relative importance of medication attributes (eg, chance of symptom improvement, risk of side effects, route of administration, etc) in their decision-making. We also performed logistic regression to explore whether patient demographics and disease characteristics predicted decision-making. RESULTS: Overall, 397 patients with axSpA completed the conjoint analysis survey. Patients prioritized medication efficacy (importance score 26.8%), cost (26.3%), and route of administration (13.9%) as most important in their decision-making. These were followed by risk of lymphoma (9.5%), dosing frequency (7.2%), risk of serious infection (6.0%), tolerability of side effects (5.3%), and clinic visit and laboratory test frequency (4.8%). In regression analyses, there were few significant associations between patients' treatment preferences and sociodemographic and axSpA characteristics. CONCLUSIONS: Treatment decision-making in axSpA is highly individualized, and demographics and baseline disease characteristics are poor predictors of individual preferences. This calls for the development of online shared decision-making tools for patients and providers, with the goal of selecting a treatment that is consistent with patients' preferences.

Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial.

OBJECTIVES: Therapeutic virtual reality (VR) has emerged as an effective, drug-free tool for pain management, but there is a lack of randomized, controlled data evaluating its effectiveness in hospitalized patients. We sought to measure the impact of on-demand VR versus "health and wellness" television programming for pain in hospitalized patients. METHODS: We performed a prospective, randomized, comparative effectiveness trial in hospitalized patients with an average pain score of ≥3 out of 10 points. Patients in the experimental group received a library of 21 VR experiences administered using the Samsung Gear Oculus headset; control patients viewed specialized television programming to promote health and wellness. Clinical staff followed usual care; study interventions were not protocolized. The primary outcome was patient-reported pain using a numeric rating scale, as recorded by nursing staff during usual care. Pre- and post-intervention pain scores were compared immediately after initial treatment and after 48- and 72-hours. RESULTS: There were 120 subjects (61 VR; 59 control). The mean within-subject difference in immediate pre- and post-intervention pain scores was larger in the VR group (-1.72 points; SD 3.56) than in the control group (-0.46 points; SD 3.01); this difference was significant in favor of VR (P < .04). When limited to the subgroup of patients with severe baseline pain (≥7 points), the effect of VR was more pronounced vs. control (-3.04, SD 3.75 vs. -0.93, SD 2.16 points; P = .02). In regression analyses adjusting for pre-intervention pain, time, age, gender, and type of pain, VR yielded a .59 (P = .03) and .56 (P = .04) point incremental reduction in pain versus control during the 48- and 72-hour post-intervention periods, respectively. CONCLUSIONS: VR significantly reduces pain versus an active control condition in hospitalized patients. VR is most effective for severe pain. Future trials should evaluate standardized order sets that interpose VR as an early non-drug option for analgesia.

Patient Concerns and Perceptions Regarding Biologic Therapies in Ankylosing Spondylitis: Insights From a Large-Scale Survey of Social Media Platforms.

OBJECTIVE: Few studies have examined ankylosing spondylitis (AS) patients' concerns about and perceptions of biologic therapies, apart from traditional surveys. In this study, we used social media data to examine the knowledge, attitudes, and beliefs of AS patients regarding biologic therapies. METHODS: We collected posts published on 601 social media sites between January 1, 2016 and April 26, 2017. In each post, both an AS keyword and a biologic were mentioned. To explore themes within the collection of posts in an unsupervised manner, a latent Dirichlet allocation topic model was fit to the data set. Each discovered topic was represented as a discrete distribution over the words in the collection, similar to a word cloud. The topics were manually reviewed to identify themes, which were confirmed using thematic data analysis. RESULTS: We examined 27,416 social media posts and identified 112 themes. The majority of themes (n = 67 [60%]) focused on discussions related to AS treatment. Other themes, including the psychological impact of AS, reporting of medical literature, and AS disease consequences, accounted for the remaining 40% (n = 45). In discussions regarding AS treatment, most topics involved biologics, and most subthemes involved side effects (e.g., fatigue, allergic reactions), biologic treatment attributes (e.g., dosing, frequency), and concerns about use of biologics (e.g., increased cancer risk). Additional implicit patient needs (e.g., support) were identified using qualitative analyses. CONCLUSION: Social media revealed a dynamic range of themes governing AS patients' experience with and choice of biologic agents. The complexity of selecting biologics from among many such agents and navigating their risk/benefit profiles suggests the merit of creating online tools tailored to support patients' decision-making with regard to biologic therapies for AS.

Differences in Online Consumer Ratings of Health Care Providers Across Medical, Surgical, and Allied Health Specialties: Observational Study of 212,933 Providers.

BACKGROUND: Health care consumers are increasingly using online ratings to select providers, but differences in the distribution of scores across specialties and skew of the data have the potential to mislead consumers about the interpretation of ratings. OBJECTIVE: The objective of our study was to determine whether distributions of consumer ratings differ across specialties and to provide specialty-specific data to assist consumers and clinicians in interpreting ratings. METHODS: We sampled 212,933 health care providers rated on the Healthgrades consumer ratings website, representing 29 medical specialties (n=128,678), 15 surgical specialties (n=72,531), and 6 allied health (nonmedical, nonnursing) professions (n=11,724) in the United States. We created boxplots depicting distributions and tested the normality of overall patient satisfaction scores. We then determined the specialty-specific percentile rank for scores across groupings of specialties and individual specialties. RESULTS: Allied health providers had higher median overall satisfaction scores (4.5, interquartile range [IQR] 4.0-5.0) than physicians in medical specialties (4.0, IQR 3.3-4.5) and surgical specialties (4.2, IQR 3.6-4.6, P<.001). Overall satisfaction scores were highly left skewed (normal between -0.5 and 0.5) for all specialties, but skewness was greatest among allied health providers (-1.23, 95% CI -1.280 to -1.181), followed by surgical (-0.77, 95% CI -0.787 to -0.755) and medical specialties (-0.64, 95% CI -0.648 to -0.628). As a result of the skewness, the percentages of overall satisfaction scores less than 4 were only 23% for allied health, 37% for surgical specialties, and 50% for medical specialties. Percentile ranks for overall satisfaction scores varied across specialties; percentile ranks for scores of 2 (0.7%, 2.9%, 0.8%), 3 (5.8%, 16.6%, 8.1%), 4 (23.0%, 50.3%, 37.3%), and 5 (63.9%, 89.5%, 86.8%) differed for allied health, medical specialties, and surgical specialties, respectively. CONCLUSIONS: Online consumer ratings of health care providers are highly left skewed, fall within narrow ranges, and differ by specialty, which precludes meaningful interpretation by health care consumers. Specialty-specific percentile ranks may help consumers to more meaningfully assess online physician ratings.

Cost Effectiveness of Biomarker Tests for Irritable Bowel Syndrome With Diarrhea: A Framework for Payers.

BACKGROUND & AIMS: Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) relies on the Rome IV symptom-based criteria, which are imperfect for separating functional vs organic disease. Biomarker tests for IBS-D might be added to symptom data to allow clinicians to make more accurate and precise diagnoses in a cost-effective manner. We tested the economic consequences of using a range of hypothetical IBS-D biomarkers, and explored at what cost and level of accuracy a biomarker becomes cost effective. We produced a framework for payers to evaluate the return on an investment of implementing IBS-D biomarkers of varying accuracy and cost. METHODS: We used decision analysis software to evaluate a hypothetical cohort of patients who met Rome IV criteria for IBS-D. We conducted cost-utility and budget impact analyses of 2 competing approaches: usual care or an IBS biomarker-based diagnostic approach. Patients in the usual care group received empiric IBS treatment; non-responders received additional diagnostic tests for organic disease. In the group evaluated with a biomarker test, those with a positive result received IBS treatment before additional diagnostic analyses, whereas patients with a negative result underwent upfront diagnostic testing. Outcomes were incremental cost per quality-adjusted life year gained (third-party payer perspective) and incremental per-member per-month cost. RESULTS: In the base-case analysis, using a willingness-to-pay threshold of $100,000/quality-adjusted life year, we found that biomarkers are not cost effective when the biomarker test costs more than $846, even if the test is 100% accurate in detecting IBS-D. In probabilistic analysis using 1,000 simulations, most trials (75% or more) show that the biomarker-based diagnostic approach is cost effective above the following accuracy thresholds: a $100 biomarker test with 51% accuracy, a $200 test with 57% accuracy, a $300 test with 63% accuracy, a $400 test with 69% accuracy, a $500 test with 76% accuracy, a $600 test with 82% accuracy, a $700 test with 89% accuracy, and a $800 test with 94% accuracy. CONCLUSIONS: In decision analysis of a hypothetical cohort of patients who met Rome IV criteria for IBS-D, we identified cost and accuracy thresholds that can guide investigators and payers as they develop, validate, price, and/or reimburse IBS-D biomarker tests for use in everyday clinical practice.

Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials.

Despite growing interest in remote patient monitoring, limited evidence exists to substantiate claims of its ability to improve outcomes. Our aim was to evaluate randomized controlled trials (RCTs) that assess the effects of using wearable biosensors (e.g. activity trackers) for remote patient monitoring on clinical outcomes. We expanded upon prior reviews by assessing effectiveness across indications and presenting quantitative summary data. We searched for articles from January 2000 to October 2016 in PubMed, reviewed 4,348 titles, selected 777 for abstract review, and 64 for full text review. A total of 27 RCTs from 13 different countries focused on a range of clinical outcomes and were retained for final analysis; of these, we identified 16 high-quality studies. We estimated a difference-in-differences random effects meta-analysis on select outcomes. We weighted the studies by sample size and used 95% confidence intervals (CI) around point estimates. Difference-in-difference point estimation revealed no statistically significant impact of remote patient monitoring on any of six reported clinical outcomes, including body mass index (-0.73; 95% CI: -1.84, 0.38), weight (-1.29; -3.06, 0.48), waist circumference (-2.41; -5.16, 0.34), body fat percentage (0.11; -1.56, 1.34), systolic blood pressure (-2.62; -5.31, 0.06), and diastolic blood pressure (-0.99; -2.73, 0.74). Studies were highly heterogeneous in their design, device type, and outcomes. Interventions based on health behavior models and personalized coaching were most successful. We found substantial gaps in the evidence base that should be considered before implementation of remote patient monitoring in the clinical setting.

Erratum: Author Correction: Impact of remote patient monitoring on clinical outcomes: an updated meta-analysis of randomized controlled trials.

[This corrects the article DOI: 10.1038/s41746-017-0002-4.].

An evaluation of touchscreen versus keyboard/mouse interaction for large screen process control displays.

The objectives of this study were to test the effect of interaction device on performance in a process control task (managing a tank farm). The study compared the following two conditions: a) 4K-resolution 55" screen with a 21" touchscreen versus b) 4K-resolution 55″ screen with keyboard/mouse. The touchscreen acted both as an interaction device for data entry and navigation and as an additional source of information. A within-subject experiment was conducted among 20 college engineering students. A primary task of preventing tanks from overfilling as well as a secondary task of manual logging with situation awareness questions were designed for the study. Primary Task performance (including tank level at discharge, number of tank discharged and performance score), Secondary Task Performance (including Tank log count, performance score), system interaction times, subjective workload, situation awareness questionnaire, user experience survey regarding usability and condition comparison were used as the measures. Parametric data resulted in two metrics statistically different means between the two conditions: The 4K-keyboard condition resulted in faster Detection + Navigation time compared to the 4K-touchscreen condition, by about 2 s, while participants within the 4K-touchscreen condition were about 2 s faster in data entry than in the 4K-keyboard condition. No significant results were found for: performance on the secondary task, situation awareness, and workload. Additionally, no clear significant differences were found in the non-parametric data analysis. However, participants showed a slight preference for the 4K-touchscreen condition compared to the 4K-keyboard condition in subjective responses in comparing the conditions. Introducing the touchscreen as an additional/alternative input device showed to have an effect in interaction times, which suggests that proper design considerations need to be made. While having values shown on the interaction device provides value, a potential issue of visual distraction exists when having an additional visual display. The allocation of visual attention between primary displays and the touchscreen should be further investigated.

Nasal tip deprojection with crural cartilage overlap: the M-arch model.

Vertical arch division is a mainstay of tip surgery, and its applications are expanding. It allows deprojection of the overprojected tip, and modifies rotation, length, and lobule definition. These parameters can be altered in a controlled, predictable fashion when the alar cartilage is preserved and overlapped, maintaining its strength. Cartilage overlay techniques aim to preserve normal anatomy and establish support for the nasal framework. We discuss the uses of vertical arch division when applied to the M-arch model, an expansion of the nasal tip tripod concept, which provides for a utilitarian approach to surgical techniques for the nasal tip.

Pediatric esthetic otoplasty.

Pediatric otoplasty is generally considered to be a "simple" procedure, but an astute surgeon recognizes the challenges of this operation and is mindful of the degree of detail involved in its planning and execution. The vast number of described otoplasty methods, which are ever evolving, is a testament to the complexity of this procedure. In this article, the authors' methodology with respect to preoperative analysis and planning, surgical technique, and postoperative care, including management of complications and potential pitfalls, are highlighted.