Binary Outcome Measures Research Articles

Lymphedema Rates Following Axillary Lymph Node Dissection With and Without Immediate Lymphatic Reconstruction: A Prospective Trial.

Immediate lymphatic reconstruction (ILR) has been proposed to decrease lymphedema rates. The primary aim of our study was to determine whether ILR decreased the incidence of lymphedema in patients undergoing axillary lymph node dissection (ALND). We conducted a two-site pragmatic study of ALND with or without ILR, employing surgeon-level cohort assignment, based on breast surgeons' preferred standard practice. Lymphedema was assessed by limb volume measurements, patient self-reporting, provider documentation, and International Classification of Diseases, Tenth Revision (ICD-10) codes. Overall, 230 patients with breast cancer were enrolled; on an intention-to-treat basis, 99 underwent ALND and 131 underwent ALND with ILR. Of the 131 patients preoperatively planned for ILR, 115 (87.8%) underwent ILR; 72 (62.6%) were performed by one breast surgical oncologist and 43 (37.4%) by fellowship-trained microvascular plastic surgeons. ILR was associated with an increased risk of lymphedema when defined as ≥10% limb volume change on univariable analysis, but not on multivariable analysis, after propensity score adjustment. We did not find a statistically significant difference in limb volume measurements between the two cohorts when including subclinical lymphedema (≥5% inter-limb volume change), nor did we see a difference in grade between the two cohorts on an intent-to-treat or treatment received basis. For all patients, considering ascertainment strategies of patient self-reporting, provider documentation, and ICD-10 codes, as a single binary outcome measure, there was no significant difference in lymphedema rates between those undergoing ILR or not. We found no significant difference in lymphedema rates between patients undergoing ALND with or without ILR.

Assessing the predictive value of the Risk Analysis Index for short-term outcomes in acute spinal cord injury surgery.

Acute traumatic spinal cord injury (tSCI) requires rapid surgical intervention to maximize neurological function. Older patients comprise an increasingly larger proportion of SCI patients annually, necessitating accurate preoperative risk stratification tools. This study utilized a frailty-based preoperative risk stratification score to predict adverse events following non-elective neurosurgical intervention for acute tSCI patients. The National Inpatient Sample (NIS) was queried for acute tSCI patients aged ≥18 who underwent spine surgery in 2019-2020. The Risk Analysis Index (RAI) was implemented with crosstabulation, to analyze frailty scores with the following binary outcome measures: overall complications, non-home discharge (NHD), extended length of stay (eLOS) (>75th percentile), and mortality. Area Under the Receiver Operating Characteristic (AUROC) analysis assessed the discriminative threshold of RAI compared to the modified 5-item Frailty Index (mFI-5) for NHD and 30-day mortality. A total of 9995 SCI patients underwent non-elective spine surgery. There were 1525 perioperative complications (15.3%) and 510 (5.1%) mortalities. An increasing RAI score was significantly associated with increasing postoperative mortality rates: RAI 0-20 (1.5%, N.=45), RAI 21-30 (3.4%, N.=110), RAI 31-40 (6.8%, N.=115), and RAI>41 (11.8%, N.=240) (P<0.001). RAI demonstrated superior discrimination compared to the mFI-5 for mortality and NHD with a C-statistic >0.72. Increasing frailty, as measured by RAI, was a reliable predictor of non-home discharge and 30-day mortality for SCI patients who underwent non-elective spinal surgery and RAI demonstrated superior discrimination compared to the mFI-5 for NHD and mortality.

A guide to interpreting systematic reviews and meta-analyses in neurosurgery and surgery.

Systematic reviews (SRs) and meta-analyses (MAs) are methods of data analysis used to synthesize information presented in multiple publications on the same topic. A thorough understanding of the steps involved in conducting this type of research and approaches to data analysis is critical for appropriate understanding, interpretation, and application of the findings of these reviews. We reviewed reference texts in clinical neuroepidemiology, neurostatistics and research methods and other previously related articles on meta-analyses (MAs) in surgery. Based on existing theories and models and our cumulative years of expertise in conducting MAs, we have synthesized and presented a detailed pragmatic approach to interpreting MAs in Neurosurgery. Herein we have briefly defined SRs sand MAs and related terminologies, succinctly outlined the essential steps to conduct and critically appraise SRs and MAs. A practical approach to interpreting MAs for neurosurgeons is described in details. Based on summary outcome measures, we have used hypothetical examples to illustrate the Interpretation of the three commonest types of MAs in neurosurgery: MAs of Binary Outcome Measures (Pairwise MAs), MAs of proportions and MAs of Continuous Variables. Furthermore, we have elucidated on the concepts of heterogeneity, modeling, certainty, and bias essential for the robust and transparent interpretation of MAs. The basics for the Interpretation of Forest plots, the preferred graphical display of data in MAs are summarized. Additionally, a condensation of the assessment of the overall quality of methodology and reporting of MA and the applicability of evidence to patient care is presented. There is a paucity of pragmatic guides to appraise MAs for surgeons who are non-statisticians. This article serves as a detailed guide for the interpretation of systematic reviews and meta-analyses with examples of applications for clinical neurosurgeons.

Risk Analysis Index as a preoperative frailty tool for elective ventriculoperitoneal shunt surgery for idiopathic normal pressure hydrocephalus.

Idiopathic normal pressure hydrocephalus (iNPH) predominantly occurs in older patients, and ventriculoperitoneal shunt (VPS) placement is the definitive surgical treatment. VPS surgery carries significant postoperative complication rates, which may tip the risk/benefit balance of this treatment option for frail, or higher-risk, patients. In this study, the authors investigated the use of frailty scoring for preoperative risk stratification for adverse event prediction in iNPH patients who underwent elective VPS placement. The Nationwide Readmissions Database (NRD) was queried from 2018 to 2019 for iNPH patients aged ≥ 60 years who underwent VPS surgery. Risk Analysis Index (RAI) and modified 5-item Frailty Index (mFI-5) scores were calculated and RAI cross-tabulation was used to analyze trends in frailty scores by the following binary outcome measures: overall complications, nonhome discharge (NHD), extended length of stay (eLOS) (> 75th percentile), and mortality. Area under the receiver operating characteristic curve analysis was performed to assess the discriminatory accuracy of RAI and mFI-5 for primary outcomes. A total of 9319 iNPH patients underwent VPS surgery, and there were 685 readmissions (7.4%), 593 perioperative complications (6.4%), and 94 deaths (1.0%). Increasing RAI score was significantly associated with increasing rates of postoperative complications: RAI scores 11-15, 5.4% (n = 80); 16-20, 5.6% (n = 291); 21-25, 7.6% (n = 166); and ≥ 26, 11.6% (n = 56). The discriminatory accuracy of RAI was statistically superior (DeLong test, p < 0.05) to mFI-5 for the primary endpoints of mortality, NHD, and eLOS. All RAI C-statistics were > 0.60 for mortality within 30 days (C-statistic = 0.69, 95% CI 0.68-0.70). In a nationwide database analysis, increasing frailty, as measured by RAI, was associated with NHD, 30-day mortality, unplanned readmission, eLOS, and postoperative complications. Although the RAI outperformed the mFI-5, it is essential to account for the potentially reversible clinical issues related to the underlying disease process, as these factors may inflate frailty scores, assign undue risk, and diminish their utility. This knowledge may enhance provider understanding of the impact of frailty on postoperative outcomes for patients with iNPH, while highlighting the potential constraints associated with frailty assessment tools.

Desirability of Outcome Ranking for Status Epilepticus: A Benefit-Risk Approach to Design and Analyses of Clinical SE Trials.

Most clinical trials of treatment efficacy evaluate benefits and harms separately. Investigators generally rate the primary outcome of a trial with a binary outcome measure and consider harms separately as adverse events. This approach fails to recognize finer gradations of patient response, correlations between benefits and harms, and the overall effects on individual patients. For example, in status epilepticus trials, efficacy is often defined as the absence of clinically apparent seizures with recovery of consciousness. Such an efficacy outcome fails to recognize that some causes of status epilepticus, such as subarachnoid hemorrhage or stroke, may not be accompanied by return of consciousness, and the need to intubate a patient may be classified as treatment failure even if status was successfully terminated. The Desirability of Outcome Ranking (DOOR) method uses a different approach. The DOOR method involves comparing the experiences of trial participants in different treatment arms by the desirability of the overall patient outcome. Using status epilepticus treatment as an example, a patient who experiences successful termination of status epilepticus but with major side effects would have a less desirable outcome than a patient with treatment success and minor side effects, who in turn would have a less desirable outcome than a patient with treatment success but no side effects. This is a patient-centered approach because it considers treatment efficacy in the context of the costs borne by the patient, for example, toxicity in achieving efficacy. Thus, DOOR considers both the benefits and harms to individual patients in assessing the outcome of a clinical trial. In this article, we present the rationale for the use of DOOR, the issues involved in the development of and statistical analyses of an ordinal outcome, and an example of the potential application of the DOOR method to a clinical trial of convulsive status epilepticus.

Certification of qubits in the prepare-and-measure scenario with large input alphabet and connections with the Grothendieck constant

We address the problem of testing the quantumness of two-dimensional systems in the prepare-and-measure (PM) scenario, using a large number of preparations and a large number of measurement settings, with binary outcome measurements. In this scenario, we introduce constants, which we relate to the Grothendieck constant of order 3. We associate them with the white noise resistance of the prepared qubits and to the critical detection efficiency of the measurements performed. Large-scale numerical tools are used to bound the constants. This allows us to obtain new bounds on the minimum detection efficiency that a setup with 70 preparations and 70 measurement settings can tolerate.

Breaking the limits of purification: postselection enhances heat-bath algorithmic cooling

Quantum technologies require pure states, which are often generated by extreme refrigeration. Heat-bath algorithmic cooling is the theoretically optimal refrigeration technique: it shuttles entropy from a multiparticle system to a thermal bath, thereby generating a quantum state with a high degree of purity. Here, we show how to surpass this hitherto-optimal technique by taking advantage of a single binary-outcome measurement. Our protocols can create arbitrary numbers of pure quantum states without any residual mixedness by using a recently discovered device known as a quantum switch to put two operations in superposition, with postselection certifying the complete purification.

What is Nonclassical about Uncertainty Relations?

Uncertainty relations express limits on the extent to which the outcomes of distinct measurements on a single state can be made jointly predictable. The existence of nontrivial uncertainty relations in quantum theory is generally considered to be a way in which it entails a departure from the classical worldview. However, this perspective is undermined by the fact that there exist operational theories which exhibit nontrivial uncertainty relations but which are consistent with the classical worldview insofar as they admit of a generalized-noncontextual ontological model. This prompts the question of what aspects of uncertainty relations, if any, cannot be realized in this way and so constitute evidence of genuine nonclassicality. We here consider uncertainty relations describing the tradeoff between the predictability of a pair of binary-outcome measurements (e.g., measurements of Pauli X and Pauli Z observables in quantum theory). We show that, for a class of theories satisfying a particular symmetry property, the functional form of this predictability tradeoff is constrained by noncontextuality to be below a linear curve. Because qubit quantum theory has the relevant symmetry property, the fact that its predictability tradeoff describes a section of a circle is a violation of this noncontextual bound, and therefore constitutes an example of how the functional form of an uncertainty relation can witness contextuality. We also deduce the implications for a selected group of operational foils to quantum theory and consider the generalization to three measurements.

Double-port homodyne detection in a squeezed-state interferometry with a binary-outcome data processing

Performing homodyne detection at a single output port of a squeezed-state light interferometer and then separating the measurement quadrature into two intervals can realize super-resolving and super-sensitive phase measurements, which is equivalent to a binary-outcome measurement. Obviously, the single-port homodyne detection may lose almost part of the phase information, reducing the estimation precision. Here, we propose a data-processing technique over the double-port homodyne detection, where the two-dimensional measurement quadrature (p 1, p 2) has been divided into two regions. With such a binary-outcome measurement, we estimate the phase shift accumulated in the interferometer by inverting the output signal. By analyzing the full width at half maximum of the signal and the phase sensitivity, we show that both the resolution and the achievable sensitivity are better than that of the previous binary-outcome scheme.

Quantum phase estimation with a general binary-outcome measurement

As the simplest phase estimation protocol, the inversion estimator has been widely adopted in the quantum metrology, since its performance can be simply quantified by the error-propagation formula. For a general binary-outcome measurement, we show that both the inversion estimator and the maximum likelihood estimator are the same and can asymptotically saturate the Cramér-Rao lower bound. These observations are applied to the parity detection and the zero-nonzero photon counting that have achieved super-resolved phase measurement near the shot-noise phase sensitivity in a coherent-state light Mach–Zehnder interferometer. We numerically show that the phase uncertainty almost follows the theoretical prediction of the lower bound. At the optimal working point, the best sensitivities also reach their associated analytic results for the two binary-outcome measurement schemes.

Robustness of meta-analysis results in Cochrane systematic reviews: A case for acupuncture trials

BackgroundFragility index (FI) refers to the smallest value that change statistical significance of study results. Meta-analyses of Cochrane systematic reviews are considered as the best evidence for stake holders because they enable effect size estimation that cannot be derived by individual studies, particularly in the field of complementary and integrative medicine (CIM). Thus, this study aimed to evaluate robustness of meta-analysis in Cochrane systematic reviews of acupuncture, one of the most used CIM treatment, using FI of meta-analysis. MethodsMeta-analyses of acupuncture Cochrane systematic reviews with binary benefit outcome measures were searched in PubMed, Embase, and CENTRAL and subject to analysis. Randomized clinical trials (RCTs) or quasi RCTs adopted penetrating needles as treatment and compared with controls such as sham acupuncture, usual care, and active control were included. FI of meta-analyses was calculated in web (https://clinicalepidemio.fr/fragility_ma/); and fragility quotient (FQ) was calculated by dividing FI by total sample size of meta-analysis. ResultsOf 248 retrieved studies, 12 Cochrane systematic reviews with 48 meta-analyses were analyzed. The median FI for statistically significant and non-significant meta-analyses was 7 [interquartile range: 3 - 12] and 6 [interquartile range: 3 - 10]. FQ was similar irrespective of statistical significance. Among controls, meta-analyses adopting sham acupuncture displayed the widest range of FI and FQ. ConclusionRobustness of meta-analyses in Cochrane systematic reviews for acupuncture was similar irrespective of statistical significance. Impact of control intervention cannot be determined in this study. As FI enables intuitive interpretation, applications for CIM field can be useful.

A Bayesian model for combining standardized mean differences and odds ratios in the same meta-analysis

ABSTRACT In meta-analysis practice, researchers frequently face studies that report the same outcome differently, such as a continuous variable (e.g., scores for rating depression) or a binary variable (e.g., counts of patients with depression dichotomized by certain latent and unreported depression scores). For combining these two types of studies in the same analysis, a simple conversion method has been widely used to handle standardized mean differences (SMDs) and odds ratios (ORs). This conventional method uses a linear function connecting the SMD and log OR; it assumes logistic distributions for (latent) continuous measures. However, the normality assumption is more commonly used for continuous measures, and the conventional method may be inaccurate when effect sizes are large or cutoff values for dichotomizing binary events are extreme (leading to rare events). This article proposes a Bayesian hierarchical model to synthesize SMDs and ORs without using the conventional conversion method. This model assumes exact likelihoods for continuous and binary outcome measures, which account for full uncertainties in the synthesized results. We performed simulation studies to compare the performance of the conventional and Bayesian methods in various settings. The Bayesian method generally produced less biased results with smaller mean squared errors and higher coverage probabilities than the conventional method in most cases. Nevertheless, this superior performance depended on the normality assumption for continuous measures; the Bayesian method could lead to nonignorable biases for non-normal data. In addition, we used two case studies to illustrate the proposed Bayesian method in real-world settings.

Surgical Approaches in Primary Total Hip Arthroplasty: Systematic Review of Randomized Controlled Trials

AbstractThe aim of this study was to provide an overview of randomized controlled trials (RCTs) of surgical approaches in primary total hip arthroplasty (THA), summarizing the available high-quality evidence. Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, we performed the electronic searches in January 2021. We searched the Cochrane Central Register of Controlled Trials (2021, Issue 1), Ovid MEDLINE (including e-pub ahead of print, in-process, and other non-indexed citations, Ovid MEDLINE Daily, Ovid MEDLINE and Versions) (1946–January 20, 2021), and Embase (1980–January 20, 2021). We limited our search to English language literature. We excluded nonrandomized trials, trials on neck of femur fractures or revision surgery, systematic reviews, and meta-analyses. Trials that met our inclusion criteria were assessed using a binary outcome measure of whether they reported statistically significant findings. These were then classified according to the intervention groups. A total of 72 RCTs met the inclusion criteria. The total number of patients in those trials was 6,728. Only five RCTs (5.9%) reported significant differences between the intervention and the control groups. The largest subgroup of trials was minimally invasive versus standard techniques (18 RCTs) with no significant differences. Standard (lateral, posterior) approaches were compared in 23 RCTs with only 1 RCT reporting significant differences. Thirteen RCTs evaluated mini-incisions, with only 1 RCT reporting significant differences, and the remaining 18 RCTs evaluated variations of surgical approaches and interventions, with 3 RCTs reporting significant differences. The evidence reviewed indicates that for the vast majority of patients, a standard THA approach familiar to the surgeon leads to comparable outcomes. Level of evidence is II.

The role of alcohol packaging as a health communications tool: An online cross-sectional survey and experiment with young adult drinkers in the United Kingdom.

Alcohol packaging is a potentially valuable means of communicating product and health-related information, with growing academic and political interest in its role as a health communications vehicle. An online cross-sectional survey and experiment were conducted with a non-probability sample of 18-35-year-old drinkers in the United Kingdom (n=1360). The survey assessed exposure to, and engagement with, current messaging on packs, and support for displaying product and health-related information. For the randomised experiment, participants were shown, and asked questions about, a vodka bottle with either no warnings (control), small text warnings, large text warnings or pictorial (image-and-text) warnings; the main binary outcome measures were negative product appeal and social acceptability, and positive cognitive and behavioural impact. Two-fifths of the sample rarely or never saw on-pack health-related information, with almost three-quarters rarely or never reading or looking closely at this. There was strong support for displaying a range of product and health-related information (e.g. units, ingredients) on packs. Relative to the control, products with warnings were more likely to be perceived as unappealing and socially unacceptable, and to positively impact alcohol-related cognitions and behaviours. For example, pictorial warnings were 10 times as likely to positively influence cognitions and behaviours (AOR=10.01, 95% CI: 8.09, 17.46). Alcohol packaging could have an important role in delivering health messaging. Large pictorial or text warnings may help counteract the appeal and social acceptability of alcohol products and increase awareness of risks, potentially supporting a reduction in consumption and related harms.

Development and application of an offense severity index in the evaluation of treatment of individuals convicted of sexual crimes

ABSTRACT Dichotomous recidivism criteria are the main measure of success in forensic treatment studies. However, there is wide agreement that binary outcome measures are too undifferentiated, particularly when official reoffending rates are rather low. Considering previous research on offense severity and the Cambridge Crime Harm Index, we addressed this issue by developing a severity index based on sentencing provisions in the German law. Based on a large dataset of males convicted of sexual crimes who had been released from Bavarian prisons between 2004 and 2008, we analyzed the subgroup of n = 48 individuals who recidivated with a sexual offense. About half of the sample had received treatment during imprisonment. Whereas prior analyses did not reveal a significant treatment effect on dichotomous sexual reoffending, the present harm analyses showed a stronger decrease of sex offense severity for treated compared to untreated participants. Despite some limitations of our study, the results indicate that prison-based treatment might decrease the severity of sexual reoffending in males convicted of sexual offenses. From a harm reduction perspective, our findings support the use of severity measures complementary to dichotomous outcome criteria. The applicability of our severity index and implications for future research on prison-based treatment are discussed.

Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial

IntroductionPatients undergoing heart valve surgery are predominantly transferred postoperatively to the intensive care unit (ICU) under continuous sedation. Volatile anaesthetics are an increasingly used treatment alternative to intravenous substances in...

Geriatric patient outcomes in a multidisciplinary central nervous system community hospital clinic for radiation oncology and neurosurgery (RADIANS)

IntroductionManagement of older adult patients with central nervous system (CNS) cancers requires a patient-centric, multidisciplinary approach. Assessment of neurosurgical and radiation treatment outcomes can assist in establishing guidelines for this patient population. We previously reported on the RADIANS clinic, a novel community hospital-based multidisciplinary clinic (MDC) for CNS cancer care, providing simultaneous radiation oncology and neurosurgery evaluation in a same-day, single-setting clinic. We now provide a focused analysis of our older adult patient population and recommendations for triage and standardization of care. MethodsConsecutive older adult patients (age ≥ 65) evaluated at the RADIANS clinic for CNS disease were identified and retrospectively reviewed. Observed 30-day neurosurgical outcomes were compared to predicted outcomes determined by the American College of Physicians NSQIP Surgical Risk Calculator. One-sample binomial exact tests were used to evaluate binary outcome measures. A two-sample t-test was used to evaluate the length of hospital stay. Brier Scores were calculated to assess the deviation between predicted probabilities and observed outcomes for binary outcome measures. Overall survival at 90 days was reported. ResultsFifty-six older adult patients with malignant (42/56) and benign (14/56) CNS disease were evaluated. Mean distance traveled for multidisciplinary evaluation at the RADIANS clinic was 43.4 miles. There was no incidence of radiation-induced toxicity. Mean length of hospital stay for RADIANS patients was significantly shorter by about 1.5 to 3.5 days (95% CI). There was no statistically significant difference for other outcome measures, however, Brier Scores demonstrated that NSQIP was not a good predictive tool for any or serious complications, UTI, venous thromboembolism, return to OR, readmission, or death in our cohort. Local tumor control rate and progression-free survival at 90 days were 97.4% and 76.9%, respectively. ConclusionsThis is the first report of CNS disease outcomes in older adult patients evaluated by radiation oncology and neurosurgery at a community hospital-based MDC. We observed minimal adverse radiation outcomes and high tumor control in our cohort. Findings show significantly shorter postoperative hospital stay for patients evaluated and managed at the RADIANS clinic.

Generalized n -locality inequalities in a star-network configuration and their optimal quantum violations

Standard multiparty Bell experiments involve a single source shared by a set of observers. In contrast, network Bell experiments feature multiple independent sources, and each of them may distribute physical systems to a set of observers who perform randomly chosen measurements. The $n$-locality scenario in star-network configuration involves $n$ number of edge observers (Alices), a central observer (Bob), and $n$ number of independent sources having no prior correlation. Each Alice shares an independent state with the central observer Bob. Usually, in network Bell experiments, one considers that each party measures only two observables. In this work, we propose a non-trivial generalization of $n$-locality scenario in star-network configuration, where each Alice performs some integer $m$ number of binary-outcome measurements, and the central party Bob performs $2^{m-1}$ binary-outcome measurements. We derive a family of generalized $n$-locality inequalities for any arbitrary $m$. Using {blue}{an elegant} sum-of-squares approach, we derive the optimal quantum violation of the aforementioned inequalities can be attained when each and every Alice measures $m$ number of mutually anticommuting observables. For $m=2$ and $3$, one obtains the optimal quantum value {blue}{for qubit system local to each Alice, and it is sufficient to consider the sharing of} a two-qubit entangled state between each Alice and Bob. We further demonstrate that the optimal quantum violation of $n$-locality inequality for any arbitrary $m$ can be obtained when every Alice shares $\lfloor m/2\rfloor$ copies of two-qubit maximally entangled state with the central party Bob. We also argue that for $m>3$, a single copy of a two-qubit entangled state may not be enough to exhibit the violation of $n$-locality inequality but multiple copies of it can activate the quantum violation.

A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis.

IntroductionDespite of higher disease burden, lower efficacy to biologics has been reported in female compared to male patients with ankylosing spondylitis (AS). The aim of this study was to evaluate the efficacy and safety of secukinumab by sex in patients with active AS from five phase 3 studies (MEASURE 1–5) through 52 weeks.MethodsBaseline demographics, disease characteristics and efficacy outcomes at Weeks 16 and 52 were summarized for males versus females. Baseline predictor analysis used multivariable logistic regression for binary outcome measures or generalized linear model for continuous outcome measures to assess the impact of sex as one of the independent variables on selected efficacy outcomes at Week 52.ResultsOverall, 1031 males and 396 females were included in this analysis. Smoking status, hs-CRP, prior exposure to TNF inhibitors, BASMI occiput-to-wall and tragus-to-wall distance (cm) were higher in males, whereas MASES was higher in females. Efficacy outcomes i.e., ASAS40 responses and BASDAI change from baseline at Weeks 16 and 52 were generally comparable between males and females. Response rates were found to be significantly higher in male patients when compared with female patients only for ASDAS-CRP inactive disease (ID) at Week 52.ConclusionComparable efficacy and safety outcomes were observed between male and female patients with active AS treated with secukinumab over 52 weeks. Further, sex was not an independent predictor of treatment response to secukinumab as assessed by ASAS40 responder rates and BASDAI change from baseline; association of ASDAS-CRP ID responder rates with sex warrants further exploration.Trial registrationClinicalTrials.gov; NCT01358175, NCT01649375, NCT02008916, NCT02159053, and NCT02896127.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00380-2.

Impact of a diabetes remote monitoring program on medication adherence.

BACKGROUND: Medication nonadherence in diabetes is well documented to be associated with inadequate glycemic control. Through remote blood glucose (BG) monitoring, unlimited test strip and lancet supplies, personal coaching, and online access to clinical information and educational resources, diabetes remote monitoring (DRM) programs may provide a solution. OBJECTIVE: To examine the relationship between patient participation in a DRM solution and adherence to oral antidiabetic drugs (OAD). METHODS: A retrospective, propensity score-matched cohort study was conducted using deidentified administrative claims data from a large pharmacy benefit manager. Commercially insured patients aged 18 years or older and having 2 or more 30-day adjusted OAD claims comprised the target sample. Patients enrolled in insurance plans that implemented DRM, who had at least 1 BG check (ever engaged) between April 1, 2015, and March 31, 2018 (exposure) were matched to patients enrolled in insurance plans that did not implement DRM (nonexposure). After a 1:2 matching on baseline demographics, disease burden proxy, total pharmacy out-of-pocket costs, previous adherence and insulin use, nonexposure group participants were assigned the same first BG check date as their matched DRM participants. Medication adherence measured as proportion of days covered (PDC) in the 365 days following first BG check was examined as a continuous and binary outcome measure (PDC > 80% or adherent vs < 80% or nonadherent). Multivariable linear and logistic regression were conducted to examine differential magnitude in adherence and likelihood of being adherent, respectively. RESULTS: The final sample consisted of 6,002 exposure and 12,004 nonexposure group patients. DRM participants who were ever engaged had a 4.5% higher adherence rate (P < 0.001) and 42% higher odds of being adherent (P < 0.001) in the period after engagement compared with non-DRM participants. Sensitivity analyses showed that patients engaged continuously (> 1 BG check per week) for 3, 6, and 12 months had 5.1%, 5.2%, and 6.4% higher adherence rates, respectively (P < 0.001), and 52%, 64%, and 98% higher odds of being adherent, respectively (P < 0.001), compared with non-DRM participants. CONCLUSIONS: The study findings offer evidence that DRM engagement is associated with higher odds of medication adherence. DRM solutions that provide access to glucose test results, personalized coaching, educational resources, and lower testing supply cost can also influence adherence. Our findings have important implications for payers and patients related to improved health outcomes due to higher medication adherence. DISCLOSURES: Funding for this study was provided by Express Scripts. Munshi, Amelung, Carter, and Henderson are employed by Express Scripts. James and Shah are employed by Livongo, which provided the DRM solution.