The impact of hemoglobin A1c on outcomes after lower extremity bypass.

OBJECTIVE: Diabetes has been shown to be associated with increased risk of postoperative complications after lower extremity bypass (LEB), although it is unclear whether medium-term glucose control affects outcomes. This study aimed to assess the association of perioperative hemoglobin A1c (HbA1c) level on perioperative outcomes after LEB. METHODS: We examined consecutive infrainguinal LEBs for chronic limb-threatening ischemia (CLTI) using the Vascular Quality Initiative database (2007-2018). Perioperative HbA1c levels were stratified into <5.7%, 5.7% to 6.5%, and >6.5%. Propensity score matching on demographics, medical history, and procedural characteristics was used to select comparable patients across HbA1c groups. The primary outcome was postoperative wound infection. Multivariable analyses were performed for matched and unmatched groups using Cox proportional hazards models for survival outcomes and logistic regression for binary outcomes with association expressed by adjusted hazard ratio (aHR) or adjusted odds ratio (aOR) and corresponding 95% confidence intervals (CIs). RESULTS: The CLTI cohort included 8171 infrainguinal LEBs: 631 (7.7%) had HbA1c <5.7%; 1691 (20.6%), 5.7% to 6.5%; and 5849 (71.6%), >6.5%. There was no difference in rates of wound infection in the CLTI cohort (HbA1c ≤5.7%, 3.8%; HbA1c 5.7%-6.5%, 3.7%; HbA1c >6.5%, 3.2%; P = .53) or matched cohort (4.3%, 4.5%, 3.4%; P = .62). There were no differences in perioperative mortality in the CLTI cohort (2.5%, 1.7%, 1.5%; P = .16) or the matched cohort (2.7%, 2.3%, 2.2%; P = .84). In multivariable analysis, there was no significant association between HbA1c and wound infection in the CLTI cohort (HbA1c 5.7%-6.5% vs <5.7%: aOR, 0.91 [95% CI, 0.56-1.50; P = .72]; HbA1c >6.5% vs <5.7%: aOR, 0.81 [95% CI, 0.52-1.26; P = .35]). There was, however, a significant association between decreased HbA1c and mortality (HbA1c 5.7%-6.5% vs <5.7%: aHR, 0.77 [95% CI, 0.61-0.97; P = .03]; HbA1c >6.5% vs <5.7%: aHR, 0.75 [95% CI, 0.61-0.93; P = .01]). CONCLUSIONS: Our study suggests no significant association of increased HbA1c level and perioperative complications. Additional investigation is required to further evaluate the impact of short-term glycemic control and long-term outcomes of patients undergoing LEB.

Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury.

BACKGROUND: Individuals with acute-onset central nervous system (CNS) injury, including stroke, motor incomplete spinal cord injury, or traumatic brain injury, often experience lasting locomotor deficits, as quantified by decreases in gait speed and distance walked over a specific duration (timed distance). The goal of the present clinical practice guideline was to delineate the relative efficacy of various interventions to improve walking speed and timed distance in ambulatory individuals greater than 6 months following these specific diagnoses. METHODS: A systematic review of the literature published between 1995 and 2016 was performed in 4 databases for randomized controlled clinical trials focused on these specific patient populations, at least 6 months postinjury and with specific outcomes of walking speed and timed distance. For all studies, specific parameters of training interventions including frequency, intensity, time, and type were detailed as possible. Recommendations were determined on the basis of the strength of the evidence and the potential harm, risks, or costs of providing a specific training paradigm, particularly when another intervention may be available and can provide greater benefit. RESULTS: Strong evidence indicates that clinicians should offer walking training at moderate to high intensities or virtual reality-based training to ambulatory individuals greater than 6 months following acute-onset CNS injury to improve walking speed or distance. In contrast, weak evidence suggests that strength training, circuit (ie, combined) training or cycling training at moderate to high intensities, and virtual reality-based balance training may improve walking speed and distance in these patient groups. Finally, strong evidence suggests that body weight-supported treadmill training, robotic-assisted training, or sitting/standing balance training without virtual reality should not be performed to improve walking speed or distance in ambulatory individuals greater than 6 months following acute-onset CNS injury to improve walking speed or distance. DISCUSSION: The collective findings suggest that large amounts of task-specific (ie, locomotor) practice may be critical for improvements in walking function, although only at higher cardiovascular intensities or with augmented feedback to increase patient's engagement. Lower-intensity walking interventions or impairment-based training strategies demonstrated equivocal or limited efficacy. LIMITATIONS: As walking speed and distance were primary outcomes, the research participants included in the studies walked without substantial physical assistance. This guideline may not apply to patients with limited ambulatory function, where provision of walking training may require substantial physical assistance. SUMMARY: The guideline suggests that task-specific walking training should be performed to improve walking speed and distance in those with acute-onset CNS injury although only at higher intensities or with augmented feedback. Future studies should clarify the potential utility of specific training parameters that lead to improved walking speed and distance in these populations in both chronic and subacute stages following injury. DISCLAIMER: These recommendations are intended as a guide for clinicians to optimize rehabilitation outcomes for persons with chronic stroke, incomplete spinal cord injury, and traumatic brain injury to improve walking speed and distance.

Flexible NO2 -Functionalized N-Heterocyclic Carbene Monolayers on Au (111) Surface.

The formation of flexible self-assembled monolayers (SAMs) in which an external trigger modifies the geometry of surface-anchored molecules is essential for the development of functional materials with tunable properties. In this work, it is demonstrated that NO2 -functionalized N-heterocyclic carbene molecules (NHCs), which were anchored on Au (111) surface, change their orientation from tilted into flat-lying position following trigger-induced reduction of their nitro groups. DFT calculations identified that the energetic driving force for reorientation was the lower steric hindrance and stronger interactions between the chemically reduced NHCs and the Au surface. The trigger-induced changes in the NHCs' anchoring geometry and chemical functionality modified the work function and the hydrophobicity of the NHC-decorated Au surface, demonstrating the impact of a chemically tunable NHC-based SAM on the properties of the metal surface.

Flexible NO2 -Functionalized N-Heterocyclic Carbene Monolayers on Au(111) Surface.

Invited for the cover of this issue are Elad Gross, F. Dean Toste, and co-workers at The Hebrew University and UC Berkeley. The image depicts the flexible anchoring geometry of addressable carbene molecules on Au surface, which upon exposure to reducing conditions changed their orientation from a standing into a flat-lying position. Read the full text of the article at 10.1002/chem.201903434.

The role of immune cells in metabolism-related liver inflammation and development of non-alcoholic steatohepatitis (NASH).

The low grade inflammatory state present in obesity promotes the progression of Non-Alcoholic Fatty Liver Disease (NAFLD). In Non-Alcoholic Steatohepatitis (NASH), augmented hepatic steatosis is accompanied by aberrant intrahepatic inflammation and exacerbated hepatocellular injury. NASH is an important disorder and can lead to fibrosis, cirrhosis and even neoplasia. The pathology of NASH involves a complex network of mechanisms, including increased infiltration of different subsets of immune cells, such as monocytes, T-lymphocytes and neutrophils, to the liver, as well as activation and in situ expansion of liver resident cells such as Kupffer cells or stellate cells. In this review, we summarize recent advances regarding understanding the role of the various cells of the innate and adaptive immunity in NASH development and progression, and discuss possible future therapeutic options and tools to interfere with disease progression.

A case series of upper extremity reconstructions utilizing partial ECRB and ECRL tendon autografts.

Sources of autografts such as palmaris longus or plantaris are often limited or absent. We present our experience using a low donor-site morbidity method of harvesting strips of extensor carpi radialis brevis and longus (ECRB and ECRL) as free tendon autografts in upper extremity soft tissue reconstructions. Retrospective chart review identified five patients who received reconstructive upper extremity surgeries using ECRB and ECRL partial tendon autografts from January 2014 to October 2021 with at least a 12-month follow-up period. Mayo wrist scores were calculated to demonstrate clinical outcomes. All five patients (mean follow-up: 21 months) were able to return to regular activities while demonstrating improvements in 6- and 12-month postoperative Mayo wrist scores. There was minimal donor site morbidity and no ruptures of parent tendons following harvest. This study provides additional support for utilizing partial strips of ECRB and ECRL in repairing upper extremity tendon gap and ligament deformities.

Gender Diversity in Orthopaedic Surgery Residencies Does Not Translate to Accreditation Council for Graduate Medical Education-Accredited Fellowships.

Introduction: Gender representation among orthopaedic surgery applicants and residents has increased over the past two decades. The aims of this study were to evaluate trends of female fellows in ACGME-accredited orthopaedic subspecialties between 2007 and 2021, and to compare the fellowship trends of female representation to those of ACGME-accredited orthopaedic residencies. Methods: We conducted a retrospective review of publicly available ACGME-accredited fellowship demographic data from 2007 to 2021. The distribution of genders (male vs. female) across subspecialties and orthopaedic surgery residency programs was compared. Chi-square, Spearman correlation, and logistic regression tests were performed to analyze the relationships between year, gender, and fellowship. Results: Chi-square analysis demonstrated a significant relationship between gender and year for orthopaedic residency (p < 0.001), but not for any fellowship. There was a significant negative Spearman correlation between the two variables for hand (r(1844) = -0.06, p = 0.02) and sports medicine (r(2804) = -0.05, p = 0.01) fellowships. The negative Spearman correlation for pediatrics (r(499) = -0.09, p = 0.054) approached but did not reach statistical significance. Logistic regression analysis revealed that, holding year constant and comparing to orthopaedic residency, the odds of male participation increased by 173% (95% CI, 1.8-4.1) in spine, increased by 138% (95% CI, 1.7-3.3) in adult reconstruction, increased by 51% (95% CI, 1.3-1.7) in sports medicine, decreased by 41% (95% CI, 0.5-0.7) in hand, decreased by 36% (95% CI, 0.5-0.9) in foot and ankle, decreased by 48% (95% CI, 0.4-0.7) in musculoskeletal oncology, and decreased by 68% (95% CI, 0.3-0.4) in pediatrics. Conclusion: Although the percentage of female orthopaedic residents in ACGME-accredited programs increased significantly from 2007 to 2021, this has not translated to ACGME-accredited fellowship positions. Future research optimizing methods to improve the representation of females in orthopaedic surgery should be considered. Level of Evidence: III.

Reverse and Anatomic Shoulder Arthroplasty Regional Usage and Open Payment Analysis Using the Centers for Medicare and Medicaid Services Database.

Background: This retrospective review aimed to assess if open payments made by industry arthroplasty companies to physicians and hospital systems were significantly affected by implant type and geographic variation. Methods: Data was obtained from the Centers for Medicare and Medicaid Services (CMS) publicly available open payment datasets (2016-2019). Geographic locations were identified using regions as defined by the US Census Bureau. A linear regression was calculated to predict the open payment made based on the created variable region, the most used implant type (reverse vs anatomic, n > 30 to be included), and their hypothesized interaction. Results: A significant regression equation was found for the hypothesized interaction between implant and region, F(13,11 186) = 3.446, P < .0001, with an R2 of 0.005. Within the regression, the implant type alone was not significantly related to the open payment (P = .070) but only became significant when paired with the region in the South (US$5807; P < .0001) and West (US$5638; P = .0012) compared to the Northeast. Discussion: Our multivariate linear regression model revealed that reverse total shoulder implants were associated with higher open payments, but only within the South and West regions. This indicates that the contributions made by industry arthroplasty companies are a function of both implant and region.

Correction: Assessing social needs among patients with cardiovascular and psychiatric comorbidities in free community health clinics.

[This corrects the article DOI: 10.1371/journal.pone.0291682.].

Hemodynamics in Distally Based Sural Flaps for Lower Leg Reconstruction: A Literature Review.

Coverage of posttraumatic and chronic wounds at the distal leg is a difficult problem due to limited soft tissue available for local flaps. The sural flap is a versatile and effective method for reconstruction in this area since it does not need a significant amount of time or assistance to complete. Improving the survival of these flaps is critically dependent on understanding the basics of flap circulation and why recent modifications were introduced. This review will serve as a much-needed comprehensive analysis of these topics for surgeons looking to increase the reliability of their sural flaps.

Developing an automated skeletal phenotyping pipeline to leverage biobank-level medical imaging databases.

OBJECTIVES: Collecting skeletal measurements from medical imaging databases remains a tedious task, limiting the research utility of biobank-level data. Here we present an automated phenotyping pipeline for obtaining skeletal measurements from DXA scans and compare its performance to manually collected measurements. MATERIALS AND METHODS: A pipeline that extends the Advanced Normalization Tools (ANTs) framework was developed on 341 whole-body DXA scans of UK Biobank South Asian participants. A set of 10 measurements throughout the skeleton was automatically obtained via this process, and the performance of the method was tested on 20 additional DXA images by calculating percent error and concordance correlation coefficients (CCC) for manual and automated measurements. Stature was then regressed on the automated femoral and tibia lengths and compared to published stature regressions to further assess the reliability of the automated measurements. RESULTS: Based on percent error and CCC, the performance of the automated measurements falls into three categories: poor (sacral and acetabular breadths), variable (trunk length, upper thoracic breadth, and innominate height), and high (maximum pelvic aperture breadth, bi-iliac breadth, femoral maximum length, and tibia length). Stature regression plots indicate that the automated measurements reflect realistic body proportions and appear consistent with published data reflecting these relationships in South Asian populations. DISCUSSION: Based on the performance of this pipeline, a subset of measurements can be reliably extracted from DXA scans, greatly expanding the utility of biobank-level data for biological anthropologists and medical researchers.

Orthopedic surgery residents reported increased shoulder procedure volumes during the COVID-19 pandemic.

Background: The purpose of this study is to evaluate the impact of the COVID-19 pandemic on shoulder procedure volumes reported to the Accreditation Council for Graduate Medical Education by orthopedic surgery residents. Methods: We performed a retrospective review of Accreditation Council for Graduate Medical Education case logs reporting data from graduating orthopedic surgery residents during the academic years of 2006-2022. Data were queried for all patients for the following shoulder Current Procedural Terminology codes: incision, excision, intro or removal, repair/revision/reconstruction, fracture and/or dislocation, manipulation, arthroscopy, trauma, and total procedures performed. Individual t-tests were used to compare case log trends of graduating academic years before (classes of 2018 and 2019) and during (classes of 2020, 2021, and 2022) the COVID-19 pandemic. Statistical significance was established to be P <.05 for total procedure types, but at P <.005 during category comparisons to protect against alpha errors. Results: Reported mean total shoulder procedures per resident steadily increased each year from 2017 to 2022, but the only significant increase was seen when comparing the graduating classes of 2020 to 2021 (157.9 vs. 165.7, P =.02). Stratification of these procedures by subgroup revealed a significant increase in manipulation procedures from 2021 to 2022 (7.3 vs. 8.8, P =.001). Discussion/Conclusion: COVID-19 did not have a negative impact on logged shoulder procedure volume. Orthopedic surgery residents graduating during the COVID-19 pandemic reported more shoulder procedures than those graduating prepandemic. However, shoulder procedure log trends should be longitudinally investigated, as preceding years of procedural opportunities may underestimate the pandemic's impact.

Assessing social needs among patients with cardiovascular and psychiatric comorbidities in free community health clinics.

BACKGROUND: Community-related health assessments have been shown to improve several outcomes in socioeconomically disadvantaged populations with comorbid chronic health conditions. However, while it is recognized that modifiable social determinant of health (SDH) factors might be responsible for up to 60% of preventable deaths, it is not yet standard of care to routinely screen and address these at preventive health appointments. The objective of this study was to identify the social needs of socioeconomically disadvantaged patients. METHODS: We performed a retrospective review of the socioeconomic screening questionnaires distributed to under- and uninsured patients seen at a medical student-run free primary care-based community clinic. This study included participants of all ages (0 and up), genders, languages, and ethnicities who filled out the social screening questionnaire. Socioeconomic screening questionnaires assessed the need for critical resources such as food, housing, utilities, finances, transportation, childcare, employment, education, legal support, companionship, health literacy, and community assistance. The primary study outcome was to identify unmet social needs of our medical student-run free clinic patients. We secondarily sought to identify associations between these needs and chronic health conditions. We hypothesized that patients with multiple chronic health problems and financial stressors would have the highest requests for resources. RESULTS: Our retrospective review identified 264 uninsured participants who were evaluated for social needs using a screening questionnaire. Participants who reported unmet social needs had significantly more cardiovascular risk factors than those who did not. Cardiovascular comorbidities and a history of psychiatric illness were the two most common medical problems significantly associated with several unmet social needs. CONCLUSION: This study provides support for the preemptive identification and appropriate management of physical, mental, and social care to improve disproportionate disparities in long-term health outcomes.

Making sense of mobile health data: an open architecture to improve individual- and population-level health.

Mobile phones and devices, with their constant presence, data connectivity, and multiple intrinsic sensors, can support around-the-clock chronic disease prevention and management that is integrated with daily life. These mobile health (mHealth) devices can produce tremendous amounts of location-rich, real-time, high-frequency data. Unfortunately, these data are often full of bias, noise, variability, and gaps. Robust tools and techniques have not yet been developed to make mHealth data more meaningful to patients and clinicians. To be most useful, health data should be sharable across multiple mHealth applications and connected to electronic health records. The lack of data sharing and dearth of tools and techniques for making sense of health data are critical bottlenecks limiting the impact of mHealth to improve health outcomes. We describe Open mHealth, a nonprofit organization that is building an open software architecture to address these data sharing and "sense-making" bottlenecks. Our architecture consists of open source software modules with well-defined interfaces using a minimal set of common metadata. An initial set of modules, called InfoVis, has been developed for data analysis and visualization. A second set of modules, our Personal Evidence Architecture, will support scientific inferences from mHealth data. These Personal Evidence Architecture modules will include standardized, validated clinical measures to support novel evaluation methods, such as n-of-1 studies. All of Open mHealth's modules are designed to be reusable across multiple applications, disease conditions, and user populations to maximize impact and flexibility. We are also building an open community of developers and health innovators, modeled after the open approach taken in the initial growth of the Internet, to foster meaningful cross-disciplinary collaboration around new tools and techniques. An open mHealth community and architecture will catalyze increased mHealth efficiency, effectiveness, and innovation.

Tapered and non-tapered prosthetic grafts in upper extremity dialysis access: A systematic review and meta-analysis.

OBJECTIVE: It is unclear whether tapered arteriovenous grafts (AVGs) are superior to non-tapered AVGs when it comes to preventing upper extremity ischemic steal syndrome. We aimed to evaluate the outcomes of tapered and non-tapered AVGs using systematic review and meta-analysis. METHODS: A literature search was systemically performed to identify all English publications from 1999 to 2019 that directly compared the outcomes of upper extremity tapered and non-tapered AVGs. Outcomes evaluated were the primary patency at 1-year (number of studies (n) = 4), secondary patency at 1-year (n = 3), and risk of ischemic steal (n = 5) and infection (n = 4). Effect sizes of individual studies were pooled using random-effects model, and between-study variability was assessed using the I2 statistic. RESULTS: Of 5808 studies screened, five studies involving 4397 patients have met the inclusion criteria and included in the analysis. Meta-analyses revealed no significant difference for the risk of ischemic steal syndrome (pooled odds ratio (OR) 0.92, 95% Confidence Incidence (CI) 0.29-2.91, p = 0.89, I2 = 48%) between the tapered and non-tapered upper extremity AVG. The primary patency (OR 1.33, 95% CI 0.93-1.90, p = 0.12, I2 = 10%) and secondary patency at 1-year (OR 1.49, 95% CI 0.84-2.63, p = 0.17, I2 = 13%), and rate of infection (OR 0.62, 95% CI 0.30-1.27, p = 0.19, I2 = 29%) were also similar between the tapered and non-tapered AVG. CONCLUSIONS: The risk of ischemic steal syndrome and patency rate are comparable for upper extremity tapered and non-tapered AVGs. This meta-analysis does not support the routine use of tapered graft over non-tapered graft to prevent ischemic steal syndrome in upper extremity dialysis access. However, due to small number of studies and sample sizes as well as limited stratification of outcomes based on risk factors, future studies should take such limitations into account while designing more robust protocols to elucidate this issue.

Comparing Outcomes of Upper Extremity Brachiobasilic Arteriovenous Fistulas and Arteriovenous Grafts: A Systematic Review and Meta-Analysis.

OBJECTIVE: It is unclear what the optimal upper extremity hemodialysis access is for patients without a suitable cephalic vein for arteriovenous fistulas (AVFs). The objective of this systematic review and meta-analysis was to compare the outcomes for upper extremity transposed brachiobasilic AVFs (BBAVFs) and prosthetic arteriovenous grafts (AVGs). METHODS: A systematic review was performed to identify all English publications and abstracts comparing the patency outcomes of upper extremity BBAVFs and AVGs (January 1st, 1994 to April 1st, 2020). The outcomes assessed were 1-year and 2-year primary and secondary patency rates. Pooled odds ratios (OR) were calculated using the random-effects model, and I2 statistic was used to assess between-study variability. RESULTS: Twenty-three studies examining 2799 patients were identified and included in the study. The 1-year primary patency rates (OR = 1.68, 95% CI 1.24-2.28, p = 0.001, I2 = 69.40%) and 2-year primary patency rates (OR = 2.33, 95% CI 1.59-3.43, p < 0.001, I2 = 68.26%) were significantly better for BBAVFs than AVGs. Compared to AVGs, the 1-year secondary patency rates (OR = 1.45, 95% CI 1.05-1.98, p = 0.022, I2 = 56.64%) and 2-year secondary patency rates (OR = 1.93, 95% CI 1.39-2.68, p < 0.001, I2 = 57.61%) were also significantly higher for BBAVFs. CONCLUSION: The outcomes for upper extremity BBAVFs appear to be consistently superior to prosthetic hemodialysis access. This analysis supports the preferential placement of BBAVFs over AVGs in patients with a suitable upper extremity basilic vein.

Identifying site-dependent reactivity in oxidation reactions on single Pt particles.

Catalytic nanoparticles are heterogeneous in their nature and even within the simplest particle various surface sites exist and influence the catalytic reactivity. Thus, detailed chemical information at the nanoscale is essential for understanding how surface properties and reaction conditions direct the reactivity of different surface sites of catalytic nanoparticles. In this work, hydroxyl-functionalized N-heterocyclic carbene molecules (NHCs) were anchored to the surface of Pt particles and utilized as chemical markers to detect reactivity variations between different surface sites under liquid and gas phase oxidizing conditions. Differences in the chemical reactivity of surface-anchored NHCs were identified using synchrotron-radiation-based infrared nanospectroscopy with a spatial resolution of 20 nanometers. By conducting IR nanospectroscopy measurements, along with complementary spatially averaged IR and X-ray spectroscopy measurements, we identified that enhanced reactivity occurred on the particles' periphery under both gas and liquid phase oxidizing conditions. Under gas phase reaction conditions the NHCs' hydroxyl functional groups underwent preferential oxidization to the acid along the perimeter of the particle. Exposure of the sample to harsher, liquid phase oxidizing conditions induced modification of the NHCs, which was mostly identified at the particle's periphery. Analysis of X-ray absorption spectroscopy measurements revealed that exposure of the sample to oxidizing conditions induced aromatization of the NHCs, presumably due to oxidative dehydrogenation reaction, along with reorientation of the NHCs from perpendicular to parallel to the Pt surface. These results, based on single particle measurements, demonstrate the high reactivity of surface sites that are located at the nanoparticle's periphery and the influence of reaction conditions on site-dependent reactivity.

Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial.

Importance: Individually designed single-patient multi-crossover (n-of-1) trials can facilitate tailoring of treatments directed at various conditions, including chronic musculoskeletal pain (CMSP) but are potentially burdensome, which may limit uptake in research and practice. Objectives: To determine whether patients randomized to participate in an n-of-1 trial supported by a mobile health (mHealth) app would experience less pain and improved global health, adherence, satisfaction, and shared decision making compared with patients assigned to usual care. Design, Setting, and Participants: This randomized clinical trial compared participation in an individualized, mHealth-supported n-of-1 trial vs usual care. The participating 215 patients had CMSP for at least 6 weeks, had a smartphone or tablet with a data plan, were enrolled in northern California from July 2014 through July 2016, and were followed for up to 1 year by 48 clinicians in academic, community, Veterans Affairs, and military settings. Interventions: Intervention patients met with their clinicians and used a desktop interface to select treatments and trial parameters for an n-of-1 trial comparing 2 pain-management regimens. The mHealth app provided reminders to take designated treatments on assigned days and to upload responses to daily questions on pain and treatment-associated adverse effects. Control patients received care as usual. Main Outcomes and Measures: The primary outcome was change in the PROMIS (Patient-Reported Outcomes Measurement Information System) pain-related interference 8-item short-form scale (full scale range, 41-78) from baseline to 6 months. Secondary outcomes included patient-reported pain intensity, overall health, analgesic adherence, trust in clinician, satisfaction with care, medication-related shared decision making, and, for the n-of-1 group only, participant engagement and experience. Results: Among 215 patients (108 randomized to the n-of-1 intervention and 107 to control), 102 (47%) were women, and the mean (SD) age was 55.5 (11.1) years. At the 6-month follow-up, pain interference was reduced in both groups, though there was no difference between the intervention and control groups (-1.36 points; 95% CI, -2.91 to 0.19 points; P = .09). There were no advantages in secondary outcomes for intervention patients vs control patients except for higher medication-related shared decision making at 6 months (between-group difference, 11.9 points; 95% CI, 2.6-21.2 points; P = .01). Among patients assigned to the n-of-1 group, 88% (n = 86) affirmed that the mHealth app could help people like them manage their pain. Conclusions and Relevance: In this population of patients with CMSP, mHealth-supported n-of-1 trials were feasible and associated with a satisfactory user experience, but n-of-1 trial participation did not significantly improve pain interference at 6 months vs usual care. Trial Registration: ClinicalTrials.gov identifier: NCT02116621.

Does prior instillation of a topical anaesthetic alter the pupillary mydriasis produced by tropicamide (0.5%)?

PURPOSE: It is common clinical practice to instill a topical anaesthetic prior to the instillation of a mydriatic agent into the eye. The main rationale for using the anaesthetic is to increase corneal permeability, so that more of the mydriatic agent reaches the receptor sites within the anterior chamber. It addition, as mydriatics generally cause stinging, prior use of an anaesthetic should reduce the degree of discomfort. The aim of the present study was to determine whether the efficacy of mydriasis produced by an antimuscarinic agent is enhanced by prior instillation of a topical anaesthetic. METHOD: The study was performed using a double-masked protocol on 20 healthy young subjects. One drop of either proparacaine (proxymetacaine) (0.5%) or isotonic saline was instilled into the eye, followed by one drop of tropicamide (0.5%). Pupil diameter was measured using a customized photographic device at 0, 10, 20, 30 and 60 min following drug instillation. Additionally, subjects were asked to rate the degree of discomfort following the instillation of each drop on a scale from 0 (no discomfort) to 10 (agony). RESULTS: There was no significant difference in either the rate of onset of mydriasis, or the maximum pupil diameter achieved between the two conditions. The mean change in pupil diameter produced by tropicamide after the instillation of saline or proparacaine was 2.31 and 2.28 mm, respectively. The mean discomfort scores following instillation of saline and proparacaine were 1.15 and 1.65, respectively, while mean discomfort scores following the instillation of tropicamide after saline or proparacaine were 4.00 and 0.85, respectively. CONCLUSIONS: Instillation of a topical anaesthetic does significantly reduce the degree of discomfort produced by the instillation of tropicamide. However, it does not produce any significant increase in either the magnitude or rate of onset of mydriasis.