Publications by authors named "Daniel Vail"

60 Publications

Availability of Cost-effectiveness Studies for Drugs With High Medicare Part D Expenditures.

JAMA Netw Open 2021 Jun 1;4(6):e2113969. Epub 2021 Jun 1.

Division of Cardiology, Department of Medicine, Stanford University School of Medicine, Stanford, California.

Importance: Prescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions.

Objective: To characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending.

Design, Setting, And Participants: In this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020.

Main Outcomes And Measures: The presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry.

Results: Medicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements.

Conclusions And Relevance: In this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.13969DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214163PMC
June 2021

Racial Differences in Anti-VEGF Intravitreal Injections Among Commercially Insured Beneficiaries.

Ophthalmic Surg Lasers Imaging Retina 2021 Apr 1;52(4):208-217. Epub 2021 Apr 1.

Background And Objective: This study assessed racial and ethnic differences in receiving anti-vascular endothelial growth factor (VEGF) intravitreal injections among commercially insured patients.

Patients And Methods: A retrospective cohort study of 104,430 patients diagnosed with wet age-related macular degeneration (AMD), diabetic retinopathy, central retinal vein occlusion (CRVO), and branch retinal vein occlusion (BRVO) in the Optum Research Database between 2011 and 2016. Main outcomes included receiving an intravitreal anti-VEGF treatment; the first type of treatment received, if any; and subsequent treatment with ranibizumab or aflibercept among patients who were first treated with bevacizumab.

Results: In a logistic regression model in all 104,430 patients, Asian patients were significantly less likely to receive an anti-VEGF treatment compared to white patients (odds ratio [OR] = 0.725; 95% confidence interval [CI], 0.667-0.789; < .001), but Black and Hispanic patients were not. Overall, 19.9% (n = 20,753) of all included patients received treatment with intravitreal injections of anti-VEGF or steroids. In multinomial logistic models of treatment type among all patients who received intravitreal injections, Hispanic patients were less likely than white patients to initially be treated with ranibizumab (relative risk ratio [RRR] = 0.776; 95% CI, 0.647-0.929; = .006) or aflibercept (RRR = 0.794; 95% CI, 0.654-0.964; = .020). Black and Asian patients were not significantly more or less likely to receive different types of first-line injections compared to white patients. Among 17,092 patients who received bevacizumab as first-line therapy, Hispanic patients were less likely to subsequently transition to aflibercept than their white counterparts (RRR = 0.756; 95% CI, 0.634-0.903; = .002).

Conclusions: The authors found minimal racial and ethnic differences in receiving anti-VEGF treatment among commercially insured patients with wet AMD, diabetic retinopathy, CRVO, and BRVO. These results are limited by the fact that all of the patients included were commercially insured, and there are limited data on the socioeconomic status of the patients in their sample. .
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http://dx.doi.org/10.3928/23258160-20210330-05DOI Listing
April 2021

Defining and describing treatment heterogeneity in new-onset idiopathic lower back and extremity pain through reconstruction of longitudinal care sequences.

Spine J 2021 May 23. Epub 2021 May 23.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA 94305, USA. Electronic address:

Background Context: Despite established guidelines, long-term management of surgically-treated low back pain (LBP) and lower extremity pain (LEP) remains heterogeneous. Understanding care heterogeneity could inform future approaches for standardization of practices.

Purpose: To describe treatment heterogeneity in surgically-managed LBP and LEP.

Study Design/setting: Retrospective study of a nationwide commercial database spanning inpatient and outpatient encounters for enrollees of eligible employer-supplied healthcare plans (2007-2016).

Patient Sample: A population-based sample of opioid-naïve adult patients with newly-diagnosed LBP or LEP were identified. Inclusion required at least 12-months of pre-diagnosis and post-diagnosis continuous follow-up.

Exposure: Included treatments/evaluations include conservative management (chiropractic manipulative therapy, physical therapy, epidural steroid injections), imaging (x-ray, MRI, CT), pharmaceuticals (opioids, benzodiazepines), and spine surgery (decompression, fusion).

Outcome Measures: Primary outcomes-of-interest were 12-month net healthcare expenditures (inpatient and outpatient) and 12-month opioid usage.

Methods: Analyses include interrogation of care sequence heterogeneity and temporal trends in sequence-initiating services. Comparisons were conducted in the framework of sequence-specific treatment sequences, which reflect the personalized order of healthcare services pursued by each patient. Outlier sequences characterized by high opioid use and costs were identified from frequently observed surgical treatment sequences using Mahalanobis distance.

Results: A total of 2,496,908 opioid-naïve adult patients with newly-diagnosed LBP or LEP were included (29,519 surgical). In the matched setting, increased care sequence heterogeneity was observed in surgical patients (0.51 vs. 0.12 previously-unused interventions/studies pursued per month). Early opioid and MRI use has decreased between 2008 and 2015 but is matched by increases in early benzodiazepine and x-ray use. Outlier sequences, characterized by increased opioid use and costs, were found in 5.8% of surgical patients. Use of imaging prior to conservative management was common in patients pursuing outlier sequences compared to non-outlier sequences (96.5% vs. 63.8%, p<.001). Non-outlier sequences were more frequently characterized by early conservative interventions (31.9% vs. 7.4%, p<.001).

Conclusions: Surgically-managed LBP and LEP care sequences demonstrate high heterogeneity despite established practice guidelines. Outlier sequences associated with high opioid usage and costs can be identified and are characterized by increased early imaging and decreased early conservative management. Elements that may portend suboptimal longitudinal management could provide opportunities for standardization of patient care.
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http://dx.doi.org/10.1016/j.spinee.2021.05.019DOI Listing
May 2021

Comparison between wide-field digital imaging system and the red reflex test for universal newborn eye screening in Brazil.

Acta Ophthalmol 2021 May 24. Epub 2021 May 24.

Stanford University, Byers Eye Institute, Palo Alto, CA, USA.

Purpose: To compare neonatal eye screening using the red reflex test (RRT) versus the wide-field digital imaging (WFDI) system.

Methods: Prospective cohort study. Newborns (n = 380, 760 eyes) in the Maternity Ward of Irmandade Santa Casa de Misericórdia de São Paulo hospital from May to July 2014 underwent RRT by a paediatrician and WFDI performed by the authors. Wide-field digital imaging (WFDI) images were analysed by the authors. Validity of the paediatrician's RRT was assessed by unweighted kappa [κ] statistic, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

Results: While WFDI showed abnormalities in 130 eyes (17.1%), RRT was only abnormal in 13 eyes (1.7%). Wide-field digital imaging (WFDI) detected treatable retina pathology that RRT missed including hyphema, CMV retinitis, FEVR and a vitreous haemorrhage. The sensitivity of the paediatrician's RRT to detect abnormalities was poor at 0.77% (95% confidence interval, CI, 0.02%-4.21%) with a PPV of only 7.69% (95% CI, 1.08%-38.85%). Overall, there was no agreement between screening modalities (κ = -0.02, 95% CI, -0.05 to 0.01). The number needed to screen to detect ocular abnormalities using WFDI was 5.9 newborns and to detect treatable abnormalities was 76 newborns.

Conclusion: While RRT detects gross abnormalities that preclude visualization of the retina (i.e. media opacities and very large tumours), only WFDI consistently detects subtle treatable retina and optic nerve pathology. With a higher sensitivity than the current gold standard, universal WFDI allows for early detection and management of potentially blinding ophthalmic disease missed by RRT.
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http://dx.doi.org/10.1111/aos.14759DOI Listing
May 2021

Visual acuity and progression of macular atrophy in patients receiving intravitreal anti-VEGF for age-related macular degeneration.

Eur J Ophthalmol 2021 Mar 29:11206721211001708. Epub 2021 Mar 29.

Byers Eye Institute, Horngren Family Vitreoretinal Center, Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, CA, USA.

Purpose: Whether intravitreal anti-vascular endothelial growth factors (VEGFs) cause retinal atrophy is still a subject of debate. We reported 13 eyes that received several injections of anti-VEGF for wet age-related macular degeneration (AMD) with good visual acuity despite geographic atrophy on imaging.

Methods: This is a case series study conducted at Byers Eye Institute at Stanford University. Patients of three retina specialists with wet AMD who received six or more intravitreal injection of anti-VEGFs with visual acuity of 20/60 or better and incomplete RPE and outer retina atrophy (iRORA) or complete RPE and outer retinal atrophy (cRORA) were enrolled in this case series. Different imaging modalities were reviewed by three retina specialists comparing the baseline with the most recent exam.

Results: About 13 eyes of 10 patients met the selection criteria. Eleven eyes were classified as iRORA and 2 as cRORA. Despite the development of macular atrophy on imaging after an average of 38.1 injections, eyes maintained stable visual acuity.

Conclusion: The discrepancy between structural and functional findings in this cohort suggests that patients treated by anti-VEGF drugs exhibit divergent clinical outcomes for currently unknown reasons. The authors propose anti-VEGF may affect melanosomes within RPE without disrupting RPE and photoreceptors function completely. This requires further investigation.
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http://dx.doi.org/10.1177/11206721211001708DOI Listing
March 2021

Key factors in a rigorous longitudinal image-based assessment of retinopathy of prematurity.

Sci Rep 2021 Mar 8;11(1):5369. Epub 2021 Mar 8.

Department of Ophthalmology, Byers Eye Institute, Stanford School of Medicine, 2452 Watson Court, Palo Alto, CA, 94303, USA.

To describe a database of longitudinally graded telemedicine retinal images to be used as a comparator for future studies assessing grader recall bias and ability to detect typical progression (e.g. International Classification of Retinopathy of Prematurity (ICROP) stages) as well as incremental changes in retinopathy of prematurity (ROP). Cohort comprised of retinal images from 84 eyes of 42 patients who were sequentially screened for ROP over 6 consecutive weeks in a telemedicine program and then followed to vascular maturation or treatment, and then disease stabilization. De-identified retinal images across the 6 weekly exams (2520 total images) were graded by an ROP expert based on whether ROP had improved, worsened, or stayed the same compared to the prior week's images, corresponding to an overall clinical "gestalt" score. Subsequently, we examined which parameters might have influenced the examiner's ability to detect longitudinal change; images were graded by the same ROP expert by image view (central, inferior, nasal, superior, temporal) and by retinal components (vascular tortuosity, vascular dilation, stage, hemorrhage, vessel growth), again determining if each particular retinal component or ROP in each image view had improved, worsened, or stayed the same compared to the prior week's images. Agreement between gestalt scores and view, component, and component by view scores was assessed using percent agreement, absolute agreement, and Cohen's weighted kappa statistic to determine if any of the hypothesized image features correlated with the ability to predict ROP disease trajectory in patients. The central view showed substantial agreement with gestalt scores (κ = 0.63), with moderate agreement in the remaining views. Of retinal components, vascular tortuosity showed the most overall agreement with gestalt (κ = 0.42-0.61), with only slight to fair agreement for all other components. This is a well-defined ROP database graded by one expert in a real-world setting in a masked fashion that correlated with the actual (remote in time) exams and known outcomes. This provides a foundation for subsequent study of telemedicine's ability to longitudinally assess ROP disease trajectory, as well as for potential artificial intelligence approaches to retinal image grading, in order to expand patient access to timely, accurate ROP screening.
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http://dx.doi.org/10.1038/s41598-021-84723-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7940603PMC
March 2021

Reply to Comment on: The Effect of Obstructive Sleep Apnea on Absolute Risk of Central Serous Chorioretinopathy.

Am J Ophthalmol 2021 Jun 7;226:270-275. Epub 2021 Feb 7.

Byers Eye Institute, Department of Ophthalmology, Stanford University.

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http://dx.doi.org/10.1016/j.ajo.2021.01.016DOI Listing
June 2021

Higher prevalence of fundus haemorrhages in early-screened (NEST Study) as compared to late-screened (SUNDROP Study) newborn populations.

Br J Ophthalmol 2021 Jan 29. Epub 2021 Jan 29.

Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California, USA

Background/aims: To determine whether timing of ophthalmic screening influences prevalence of neonatal fundus haemorrhages. We compared the prevalence of fundus haemorrhages in two populations: term newborns screened early (less than 72 hours) and preterm newborns screened late (4-11 weeks). Additionally, we reviewed the literature on timing and prevalence of newborn haemorrhages.

Methods: Retrospective observational cohort study. Infants who underwent wide-angle ophthalmic digital imaging over one overlapping year in the Newborn Eye Screen Testing (NEST) or Stanford University Network for Diagnosis of Retinopathy of Prematurity (SUNDROP) programme were included. The PubMed database was filtered to include English-language articles dating back to 1950. Nine articles were selected for review based on inclusion of the prevalence of newborn fundus haemorrhages at multiple time points.

Results: A total of 202 patients received early imaging in the NEST cohort and 73 patients received late imaging in the SUNDROP cohort. In the NEST cohort, 20.2% of newborns had haemorrhages. In contrast, we found haemorrhages in only one case or 1.4% of the SUNDROP cohort. Using prevalence data from nine additional studies, we developed a predicted probabilities model of newborn haemorrhages. Per this model, the probability of seeing a haemorrhage if you screen an infant at 1 hour is 18.8%, at 2 weeks is 2.9% and at 1 month is 0.28%.

Conclusion: We found a significant difference in the prevalence of fundus haemorrhages between the early-screened NEST cohort and the late-screened, preterm SUNDROP cohort. Likely, this difference is due to the transient nature of most newborn haemorrhages.
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http://dx.doi.org/10.1136/bjophthalmol-2020-317908DOI Listing
January 2021

Increasing Incidence and Prevalence of Common Retinal Diseases in Retina Practices Across the United States.

Ophthalmic Surg Lasers Imaging Retina 2021 01;52(1):29-36

Background And Objective: To provide an updated estimate of incidence and prevalence of the foremost retinal diseases in the U.S.

Patients And Methods: Retrospective study of the Vestrum Health Database evaluating eyes with diagnoses of wet or dry age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), branch or central retinal vein occlusion (BRVO; CRVO) from January 2014 to December 2019 across 58 retina practices.

Results: Of the 3,086,791 eyes examined, 490,881 (15.9%) had dry AMD, 294,041 (9.5%) wet AMD, 270,703 (8.8%) DME, 254,690 (8.3%) DR without DME, 73,617 (2.4%) BRVO, and 50,670 (1.6%) CRVO. Dry AMD had the highest incidence. These diseases comprised 61.0% of total prevalence and 54.3% of incidence among patients at the retina practices analyzed.

Conclusions: Based on a diverse database, these diseases comprised the majority of U.S. retina practice cases, with increasing annual incidences. AMD is the most common diagnosis, then diabetic eye disease. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:29-36.].
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http://dx.doi.org/10.3928/23258160-20201223-06DOI Listing
January 2021

Risk of Retinal Artery Occlusion in Patients with Migraine.

Am J Ophthalmol 2021 05 24;225:157-165. Epub 2020 Dec 24.

Department of Ophthalmology, Byers Eye Institute, Horngren Family Vitreoretinal Center, Stanford University School of Medicine, Palo Alto, California, USA. Electronic address:

Purpose: We sought to determine if migraine is associated with increased risk of retinal artery occlusion (RAO).

Design: Retrospective cohort study.

Methods: We reviewed a large insurance claims database for patients with migraine and matched control subjects without migraine between 2007 and 2016. Cox proportional hazard regression models were used to investigate the association between migraine and risk of all RAO, central RAO (CRAO), branch RAO (BRAO), and "other" RAO, which includes transient and partial RAO. Primary outcome measures included the incidence of all RAO, including CRAO, BRAO, and other RAO, after first migraine diagnosis.

Result: There were 418,965 patients with migraine who met the study criteria and were included in the analysis with the appropriate matched control subjects. Among the 418,965 patients with migraine, 1060 (0.25%) were subsequently diagnosed with RAO, whereas only 335 (0.08%) of the patients without migraine were diagnosed with RAO. The hazard ratio (HR) for incident all RAO in patients with migraine compared with those without migraine was 3.48 (95% confidence interval [CI] 3.07-3.94; P < .0001). This association was consistent across all types of RAO, including CRAO (HR 1.62 [95% CI 1.15-2.28]; P = .004), BRAO (HR 2.09 [95% CI 1.60-2.72]; P < .001), and other types of RAO (HR 4.61 [95% CI 3.94-5.38]; P < .001). Patients with migraine with aura had a higher risk for incident RAO compared with those with migraine without aura (HR 1.58 [95% CI 1.40-1.79]; P < .001). This association was consistent for BRAO (HR 1.43 [95% CI 1.04-1.97]; P < .03) and other types of RAO (HR 1.67 [95% CI 1.45-1.91]; P < .001) but was not statistically significant for CRAO (HR 1.18 [95% CI 0.75-1.87]; P = .475). Significant risk factors for this association included increased age, male sex, acute coronary syndrome, valvular disease, carotid disease, hyperlipidemia, hypertension, retinal vasculitis or inflammation, and systemic lupus erythematosus.

Conclusions: Migraine is associated with increased risk of all types of RAO and migraine with aura is associated with increased risk of RAO compared with migraine without aura.
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http://dx.doi.org/10.1016/j.ajo.2020.11.004DOI Listing
May 2021

Rates of Reoperation in 10 114 Patients with Epiretinal Membranes Treated by Vitrectomy with or without Inner Limiting Membrane Peeling.

Ophthalmol Retina 2021 Jul 27;5(7):664-669. Epub 2020 Oct 27.

Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address:

Purpose: To compare rates of reoperation in patients with idiopathic epiretinal membrane (ERM) who received pars plana vitrectomy (PPV) with or without inner limiting membrane (ILM) peeling and to assess trends in the overall use of ILM peeling over time.

Design: Retrospective cohort study.

Participants: Patients included in the IBM Marketscan database between January 1, 2008, and December 31, 2016, who underwent surgery for idiopathic ERM.

Methods: Procedure claims with laterality codes were used to determine patients with idiopathic ERM who received PPV with or without ILM peel between 2008 and 2016, and to identify cases of reoperation and subsequent retinal detachment within 1 year of index surgery.

Main Outcome Measures: The primary outcome was rate of reoperation for recurrent ERM according to whether or not patients receive an ILM peel during their index ERM surgery. We also assessed trends for index ERM surgery (ILM peel or no ILM peel) between 2008 and 2016, and the risk of developing retinal detachment within 1 year of the index ERM surgery.

Results: A total of 10 114 patients received ERM surgery and met inclusion criteria (5310 without ILM peel and 4804 with ILM peel). The reoperation rate was significantly lower among patients who received PPV with ILM peel (0.88%) compared with patients without ILM peel (1.48%; P = 0.007). In 2008, PPV without ILM peel represented 70% of ERM procedures, but PPV with ILM peeling accounted for 52% and 70% of ERM procedures in 2013 (P < 0.001) and 2016 (P < 0.001), respectively. The rates of retinal detachment were similar between patients who received an ILM peel (0.79%) and patients who did not receive an ILM peel (0.92%) during their primary ERM surgery (P = 0.474).

Conclusions: The increasing use of PPV with ILM peeling to address ERM removal is associated with significantly reduced reoperation rates within 1 year. Future studies are needed to determine the cost-effectiveness of performing an ILM peel for initial idiopathic ERM repairs and evaluate long-term visual and structural changes related to ILM peeling.
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http://dx.doi.org/10.1016/j.oret.2020.10.013DOI Listing
July 2021

Can antipoverty programmes save lives? Quasi-experimental evidence from the Earned Income Tax Credit in the USA.

BMJ Open 2020 08 20;10(8):e037051. Epub 2020 Aug 20.

U.S. Bureau of Census, Suitland, Maryland, USA.

Objective: To estimate the impact of state-level supplements of the Earned Income Tax Credit (EITC) on mortality in the USA. The EITC supplements the wages of lower-income workers by providing larger returns when taxes are filed.

Setting: Nationwide sample spanning 25 cohorts of people across every state in the USA.

Participants: 793 000 respondents within the National Longitudinal Mortality Survey (NLMS) between 1986 and 2011, a representative sample of the USA.

Intervention: State-level supplementation to the EITC programme. Some, but not all, states added EITC supplementation to varying degrees beginning in 1986 (Wisconsin) and most recently in 2015 (California). Participants who were eligible in states with supplementary programmes were compared with those who were not eligible for supplementation. Comparisons were made both before and after implementation of the supplementary programme (a difference-in-difference, intent-to-treat analysis). This quasi-experimental approach further controls for age, gender, marital status, race or ethnicity, educational attainment, income and employment status.

Primary And Secondary Outcome Measures: The primary outcome measure was survival at 10 years. Secondary outcome measures included survival at 5 years and survival to the end of the intervention period.

Results: We find an association between state supplemental EITC and survival, with a HR of 0.973 (95% CI=0.951-0.996) for each US$100 of EITC increase (p<0.05).

Conclusion: State-level supplemental EITC may be an effective means of increasing survival in the USA.
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http://dx.doi.org/10.1136/bmjopen-2020-037051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443298PMC
August 2020

Idiopathic bilateral inner retinal defects in a child.

Can J Ophthalmol 2020 12 6;55(6):e197-e199. Epub 2020 Jul 6.

Stanford University School of Medicine, Palo Alto, CA. Electronic address:

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http://dx.doi.org/10.1016/j.jcjo.2020.04.018DOI Listing
December 2020

Sex Differences in the Repair of Retinal Detachments in the United States.

Am J Ophthalmol 2020 11 5;219:284-294. Epub 2020 Jul 5.

Byers Eye Institute at the Stanford University School of Medicine, Palo Alto, California, USA.

Purpose: To investigate differences between women and men in the repair of rhegmatogenous retinal detachments (RRDs) in the United States.

Design: Retrospective cohort study.

Methods: Setting: A large insurance claims database.

Participants: Subjects with an incident RRD between 2007 and 2015.

Data: Demographic data, comorbid ocular conditions associated with RRD, systemic comorbidities, and surgical intervention (pneumatic retinopexy [PR], pars plana vitrectomy [PPV], laser barricade, or scleral buckle [SB]) were collected.

Main Outcome Measures: Odds of receipt of surgical intervention for incident RRD, time to repair, type of intervention, and the rate of reoperation by sex.

Results: The study period included 133 million eligible records with 61,071 cases of incident RRD among which 43% (n = 26,289) were women. The primary outcome model had 23,933 confirmed RRD cases with a 93% retinal detachment repair rate. Women had 34% reduced odds of receipt of surgical repair of an RRD (odds ratio [OR] 0.66, 95% confidence interval [CI] 0.59, 0.73; P < .001) after adjusting for confounders. This effect persisted in all sensitivity models. Among patients who received repair, women were more often delayed (0.17 days, P = .04). Women were more likely to undergo primary laser barricade (relative risk ratio [RRR] 1.68, P < .001), primary SB (RRR 1.15, P < .001), and PR (RRR 1.07, P < .04) than men. The odds of reoperation were lower in women (OR 0.91, 95% CI 0.85, 0.96; P = .002) after adjustment.

Conclusions: Insured women are less likely than insured men to receive surgical intervention for an RRD. Based on the results of this study, if the odds of repair were equal between women and men in the United States, then 781 more women would receive surgery each year, or 7,029 more during the study period. Women are more likely to have the repair performed with scleral buckle, laser barricade, and pneumatic retinopexy. The reason for these sex differences in RRD repair remains unknown and requires further investigation.
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http://dx.doi.org/10.1016/j.ajo.2020.06.039DOI Listing
November 2020

Timing and Reoperation Rate of Rhegmatogenous Retinal Detachments Occurring During Major Ophthalmology Meetings.

Ophthalmic Surg Lasers Imaging Retina 2020 06;51(6):328-337

Background And Objective: To investigate whether surgical management of newly diagnosed rhegmatogenous retinal detachment (RRD) varies if patients are diagnosed during a major national ophthalmology conference.

Patients And Methods: This retrospective cohort study included 34,759 patients with incident RRD, of whom, 1,246 (3.6%) were diagnosed during dates of three national ophthalmology conferences, and 1,170 (3.4%) underwent surgery during conference dates. The authors identified patients with primary repair with cryotherapy, laser, scleral buckle, pneumatic retinopexy, or pars plana vitrectomy. Multinomial logistic regression models were used to determine patients' likelihood of receiving each type of repair within 30 days of their diagnosis depending on whether they were diagnosed during a national ophthalmology conference. Linear regression models were used to determine the relationship between the date patients were diagnosed and how long they waited to receive a repair. Main outcome measures included days between diagnosis with RRD and RRD repair, receiving repair on the same day of diagnosis, and reoperation rate within 30 days of the primary repair.

Results: Mean time from diagnosis to repair was 1.5 days (standard deviation: ± 2.4 days), and 71% of patients underwent repair within a day of diagnosis. Repairs were followed by a second surgery within 30 days in 11.1% of patients. Patients diagnosed during conferences waited 0.23 days longer between diagnosis and repair compared with patients diagnosed outside of conference dates (P = .001). Patients diagnosed with RRD during conferences were less likely to receive surgical repair within a day of diagnosis compared to patients diagnosed during non-conference dates (P = .037). Patients who were diagnosed with RRD during a conference date and also received surgery during a conference date were more likely to undergo a second surgery within 30 days of the primary procedure (P = .006) CONCLUSIONS: Patients diagnosed with RRD during national ophthalmology conference dates waited slightly longer for surgery, were slightly less likely to receive surgery within a day, and were more likely to undergo a second surgery within 30 days of the primary procedure. The "national meeting effect" phenomenon is present in ophthalmology, albeit to a lesser degree that is likely not visually significant. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:328-337.].
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http://dx.doi.org/10.3928/23258160-20200603-03DOI Listing
June 2020

The Effect of Obstructive Sleep Apnea on Absolute Risk of Central Serous Chorioretinopathy.

Am J Ophthalmol 2020 10 20;218:148-155. Epub 2020 Jun 20.

Byers Eye Institute, Department of Ophthalmology, Stanford University, Palo Alto, California, USA. Electronic address:

Purpose: To determine the incidence of central serous chorioretinopathy (CSC) stratified by age, sex, and diagnosis with obstructive sleep apnea (OSA), and to determine whether some patients with newly diagnosed CSC may be candidates for OSA evaluation.

Design: Retrospective cohort study.

Methods: We used the IBM MarketScan database to select 59,016,145 commercially insured patients in the United States between 2007 and 2016. We identified patients' first diagnosis with CSC, and defined patients as having OSA if they had a diagnosis following a sleep study. We specified Cox proportional hazard models with interactions between age, sex, and OSA status to determine patients' risk of developing CSC. We estimated the positive predictive value (PPV) that a new diagnosis of CSC would have in predicting a subsequent diagnosis of OSA.

Results: Risk of CSC increased with age in years (hazard ratio [HR] = 1.030, P < .001) and OSA diagnosis (HR = 1.081, P < .033), and was lower in women (HR = 0.284, P < .001). We estimated the annual incidence of CSC was 9.6 and 23.4 per 100,000 women and men, respectively. Incidence was higher in women and men with OSA (17.2 and 40.8 per 100,000). The PPV of CSC diagnosis as a predictor of OSA was highest in the fifth decade of life.

Conclusion: The incidence of CSC in our patient sample is higher than previously reported. Risk of CSC is higher in men than in women, and OSA increases risk of CSC in both men and women. Some patients, particularly older male patients, may be good candidates for OSA evaluation following a CSC diagnosis.
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http://dx.doi.org/10.1016/j.ajo.2020.05.040DOI Listing
October 2020

Questions on Rhegmatogenous Retinal Detachment and the Day of the Week of Repair or Diagnosis-Reply.

JAMA Ophthalmol 2020 07;138(7):803

Byers Eye Institute, Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, California.

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http://dx.doi.org/10.1001/jamaophthalmol.2020.1867DOI Listing
July 2020

Telemedicine Follow-Up for Intravitreal Bevacizumab Injection in the Stanford University Network for Diagnosis of Retinopathy of Prematurity (SUNDROP) Cohort.

Clin Ophthalmol 2020 29;14:1161-1163. Epub 2020 Apr 29.

Byers Eye Institute, Horngren Family Vitreoretinal Center, Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, California.

Telemedicine has emerged as a potential solution to face the disproportion between infants that need to be screened for retinopathy of prematurity (ROP) and the lack of ophthalmologists. We evaluated its utility in the follow-up after off-label intravitreal injection of bevacizumab. None of the treated infants ended up with bad anatomic outcome. Telemedicine is an alternative safe method to monitor patients after treatment.
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http://dx.doi.org/10.2147/OPTH.S250361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7200391PMC
April 2020

Retinopathy of prematurity and neurodevelopmental outcomes in premature infants.

Eye (Lond) 2021 03 12;35(3):1014-1016. Epub 2020 May 12.

Department of Ophthalmology, Byers Eye Institute, Horngren Family Vitreoretinal Center, Stanford University School of Medicine, Palo Alto, CA, 94303, USA.

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http://dx.doi.org/10.1038/s41433-020-0941-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8027850PMC
March 2021

Reply.

Ophthalmology 2020 05;127(5):e36

Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address:

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http://dx.doi.org/10.1016/j.ophtha.2020.01.005DOI Listing
May 2020

Myeloid-Derived Suppressor Cell Subsets Drive Glioblastoma Growth in a Sex-Specific Manner.

Cancer Discov 2020 08 16;10(8):1210-1225. Epub 2020 Apr 16.

Cancer Impact Area and Department of Cardiovascular & Metabolic Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.

Myeloid-derived suppressor cells (MDSC) that block antitumor immunity are elevated in glioblastoma (GBM) patient blood and tumors. However, the distinct contributions of monocytic (mMDSC) versus granulocytic (gMDSC) subsets have yet to be determined. In mouse models of GBM, we observed that mMDSCs were enriched in the male tumors, whereas gMDSCs were elevated in the blood of females. Depletion of gMDSCs extended survival only in female mice. Using gene-expression signatures coupled with network medicine analysis, we demonstrated in preclinical models that mMDSCs could be targeted with antiproliferative agents in males, whereas gMDSC function could be inhibited by IL1β blockade in females. Analysis of patient data confirmed that proliferating mMDSCs were predominant in male tumors and that a high gMDSC/IL1β gene signature correlated with poor prognosis in female patients. These findings demonstrate that MDSC subsets differentially drive immune suppression in a sex-specific manner and can be leveraged for therapeutic intervention in GBM. SIGNIFICANCE: Sexual dimorphism at the level of MDSC subset prevalence, localization, and gene-expression profile constitutes a therapeutic opportunity. Our results indicate that chemotherapy can be used to target mMDSCs in males, whereas IL1 pathway inhibitors can provide benefit to females via inhibition of gMDSCs...
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http://dx.doi.org/10.1158/2159-8290.CD-19-1355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415660PMC
August 2020

Trends in Age of Cochlear Implant Recipients, and the Impact on Perioperative Complication Rates.

Otol Neurotol 2020 04;41(4):438-443

Department of Otolaryngology, Stanford University School of Medicine, Stanford California, USA.

Objective: The aim of the study is to examine trends in the age of patients receiving cochlear implants and to determine the effect of age on the rate of perioperative complications.

Study Design: Retrospective analysis of deidentified administrative claims data from a US commercial insurance database (Optum).

Patients: Individuals undergoing cochlear implantation between 2003 and 2016.

Setting: US hospital and outpatient facilities serving commercially insured patients.

Intervention: Cochlear implantation.

Main Outcome Measures: Age at implantation, incidence of perioperative complications within 30 days identified by ICD9/10 codes including device problems, myocardial infarction, stroke, venous thromboembolism, local infection, meningitis, stroke, cerebrospinal fluid leak, and facial weakness.

Results: Between 2003 and 2016, 3420 patients underwent a total of 4154 cochlear implants. The number of implants per year increased annually from 171 in 2003 to 531 in 2016, with the greatest growth demonstrated in those aged 60 and older.The age of patients undergoing implantation increased annually from an average of 26.6-57.2 years (p < 0.001). The implantation rates from 2003 to 2016, per 100,000 enrollees, increased from 1.64 to 6.82 for patients 60-79 years of age, and 0 to 11.57 for patients greater than 80 years of age (p < 0.001). No significant differences in 30-day complication rates were found between patients when grouped by age in decades, except for device related problems, which was significantly higher in younger patients (<18 years).

Conclusion: Over the past decade and a half, cochlear implantation is more frequently being performed, and in an increasingly aging population. This trend does not seem to alter the risk of perioperative complications.
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http://dx.doi.org/10.1097/MAO.0000000000002558DOI Listing
April 2020

Von Hippel-Lindau Syndrome Phenotype With Prominent Vitreoretinal Neovascularization Treated With Early PPV: A Case Series and Literature Review.

Ophthalmic Surg Lasers Imaging Retina 2020 02;51(2):109-115

Background And Objective: To describe a case series of three patients in one family with Von Hippel-Lindau (VHL) disease who presented with vitreoretinal neovascularization and resulting tractional retinal detachments (TRDs). This vitreoretinal phenotype of VHL may benefit from early surgical intervention.

Patients And Methods: Descriptive case series of three patients in one family with VHL disease. A review of the literature regarding surgical intervention for VHL was performed.

Results: All three patients developed prominent intravitreal neovascularization with fibrovascular growth within the vitreous secondary to a retinal capillary hemangioma. Two subjects with intravitreal neovascularization were treated with laser and cryotherapy but eventually developed a TRD. The final vision in these two patients was light perception and 20/300. The eye that was preemptively treated with vitrectomy to remove the vitreous sustaining the neovascularization had visual acuity of 20/50 after surgery.

Conclusion: Intravitreal neovascularization with fibrovascular proliferation may be an indication for vitrectomy prior to the development of retinal detachment. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:109-115.].
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http://dx.doi.org/10.3928/23258160-20200129-07DOI Listing
February 2020

Resolution of optic disc pit-associated macular retinoschisis after topical carbonic anhydrase inhibitor treatment: Report of a case.

Eur J Ophthalmol 2020 Feb 4:1120672120904664. Epub 2020 Feb 4.

Byers Eye Institute, Horngren Family Vitreoretinal Center, Department of Ophthalmology, Stanford University School of Medicine, Palo Alto, CA, USA.

Background: Optic disc pits frequently lead to visual deterioration due to macular retinoschisis or serous retinal detachment. Here, we report a case of optic disc pit-associated macular retinoschisis due to intraretinal fluid accumulation that resolved with improvement in visual acuity after treatment with topical dorzolamide.

Case Description: A 56-year-old otherwise healthy female with no ocular history presented with 2 weeks of slowly worsening blurry vision in her right eye. Visual acuity was 20/30 in the right eye. Posterior segment examination revealed posterior vitreous detachment, an optic disc pit at 9 o'clock, macular edema and foveoschisis with fluid extending from the optic nerve, and a normal peripheral retina. Optical coherence tomography imaging of the macula showed central subfield thickness of 526 µm. The patient preferred no surgical intervention, so topical dorzolamide 2% three times daily was initiated. Over the next 2 years, the central subfield thickness steadily declined from 526 to 262 µm, and her vision improved to 20/20 with improvement in the macular retinoschisis.

Conclusion: Our report presents a case of resolution of optic disc pit-associated macular retinoschisis due to intraretinal fluid accumulation with possible role for dorzolamide as a potential treatment option.
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http://dx.doi.org/10.1177/1120672120904664DOI Listing
February 2020

Pentosan Polysulfate Sodium Exposure and Drug-Induced Maculopathy in Commercially Insured Patients in the United States.

Ophthalmology 2020 04 5;127(4):535-543. Epub 2019 Nov 5.

Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address:

Purpose: To determine the association and cumulative dose-response pattern between pentosan polysulfate sodium (PPS) use for interstitial cystitis (IC) and maculopathy.

Design: Large, multicenter, retrospective cohort study of commercially insured patients in the MarketScan database (Truven Health Analytics, San Jose, CA).

Participants: Two hundred twenty-seven thousand three hundred twenty-five patients with IC who were enrolled continuously in the MarketScan database.

Methods: Cox proportional hazards models (controlling for patient gender, age at index diagnosis of IC, and diagnosis with diabetes mellitus) followed up patients from index diagnosis of IC for 5 years, or until patients discontinued insurance coverage, or until patients' first diagnosis with a maculopathy. As a sensitivity analysis, we re-estimate all models after excluding all patients with diabetes. To assess for dose response, we calculated the total days of PPS prescriptions filled and created a categorical variable indicating total exposure.

Main Outcome Measures: The primary outcome measure was association between binary PPS exposure and any maculopathy. Secondary outcome measures included exposure between binary and categorical, time-dependent, exposure to PPS and to drusen, nonexudative age-related macular degeneration (AMD), exudative AMD, hereditary maculopathy, and toxic maculopathy.

Results: The most common diagnoses of maculopathy in patients with IC were exudative AMD (1.5%), drusen (0.8%), nonexudative AMD (0.3%), toxic maculopathy (0.1%), and hereditary dystrophy (0.04%). In unadjusted analyses, the percentage of patients who filled a PPS prescription and were diagnosed later with a maculopathy (2.37%) was very similar to the percentage of patients who did not fill a prescription (2.77%). Survival models using a binary variable indicating PPS exposure showed no significant associations between PPS exposure and diagnosis of drusen, nonexudative AMD, exudative AMD, toxic maculopathy, hereditary dystrophy, or an aggregate variable of any maculopathy. Similarly, there was no dose-dependent relationship between PPS exposure and diagnosis of any maculopathy. These findings remained stable in sensitivity analysis models that excluded patients with diabetes mellitus.

Conclusions: In this large, commercial claims database analysis, no association was found between PPS exposure and subsequent diagnosis of maculopathy.
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http://dx.doi.org/10.1016/j.ophtha.2019.10.036DOI Listing
April 2020

Association of Rhegmatogenous Retinal Detachment and Outcomes With the Day of the Week That Patients Undergo a Repair or Receive a Diagnosis.

JAMA Ophthalmol 2020 02;138(2):156-163

Byers Eye Institute, Department of Ophthalmology, Stanford University, Stanford, California.

Importance: Because variation in care on weekends has been reported in many surgical fields, it is of interest if variations were noted for care patterns of rhegmatogenous retinal detachments (RRDs).

Objective: To assess the association between modality of RRD repair and day of the week that patients receive a diagnosis or undergo RRD repair.

Design, Setting, And Participants: A retrospective claims-based cohort analysis was performed of primary RRD surgery for 38 144 commercially insured patients in the United States who received a diagnosis of incident RRD between January 1, 2008, and December 31, 2016, and underwent repair within 14 days of diagnosis. Multinomial regression models were used to assess patients' likelihood of repair with different modalities, logistic regression models were used to assess patients' likelihood of reoperation, and linear regression models were used to assess time from diagnosis to repair. Data analysis was performed from March 9 to September 5, 2019.

Exposures: Day of the week that the patient received a diagnosis of RRD or underwent RRD repair.

Main Outcome And Measures: Modality of repair, time from diagnosis to repair, and 30-day reoperation rate.

Results: Among the 38 144 patients in the study (23 031 men [60.4%]; mean [SD] age at diagnosis, 56.8 [13.4] years), pneumatic retinopexy (PR) was more likely to occur when patients received a diagnosis of RRD on Friday (relative risk ratio [RRR], 1.37; 95% CI, 1.17-1.60), Saturday (RRR, 1.73; 95% CI, 1.36-2.20), or Sunday (RRR, 1.53; 95% CI, 1.08-2.17) compared with Wednesday. Pneumatic retinopexy was more likely to be used for surgical procedures on Friday (RRR, 1.55; 95% CI, 1.33-1.80), Saturday (RRR, 2.03; 95% CI, 1.61-2.56), Sunday (RRR, 2.28; 95% CI, 1.55-3.35), or Monday (RRR, 1.70; 95% CI, 1.46-1.98). Patients undergoing PR on Sundays were more likely to receive another procedure (PR, scleral buckle, or pars plana vitrectomy) within 30 days (odds ratio, 1.62; 95% CI, 1.07-2.45). An association between the need for reoperation for repairs performed via scleral buckle or pars plana vitrectomy and the day of the week of the initial repair was not identified. Patients who received a diagnosis on a Friday waited a mean of 0.28 days (95% CI, 0.20-0.36 days) longer for repair than patients who received a diagnosis on a Wednesday.

Conclusions And Relevance: These findings suggest that management of RRD varies according to the day of the week that diagnosis and repair occurs, with PR disproportionately likely to be used to repair RRDs during the weekend. Ophthalmologists should be aware that these results suggest that patients undergoing PR on Sundays may be more likely to require reoperation within 30 days.
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http://dx.doi.org/10.1001/jamaophthalmol.2019.5253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990708PMC
February 2020

Patterns of Opioid and Benzodiazepine Use in Opioid-Naïve Patients with Newly Diagnosed Low Back and Lower Extremity Pain.

J Gen Intern Med 2020 01 12;35(1):291-297. Epub 2019 Nov 12.

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA, USA.

Background: The morbidity and mortality associated with opioid and benzodiazepine co-prescription is a pressing national concern. Little is known about patterns of opioid and benzodiazepine use in patients with acute low back pain or lower extremity pain.

Objective: To characterize patterns of opioid and benzodiazepine prescribing among opioid-naïve, newly diagnosed low back pain (LBP) or lower extremity pain (LEP) patients and to investigate the relationship between benzodiazepine prescribing and long-term opioid use.

Design/setting: We performed a retrospective analysis of a commercial database containing claims for more than 75 million enrollees in the USA.

Participants: Participants were adult patients newly diagnosed with LBP or LEP between 2008 and 2015 who did not have a red flag diagnosis, had not received an opioid prescription in the 6 months prior to diagnosis, and had 12 months of continuous enrollment after diagnosis.

Main Outcomes And Measures: Among patients receiving at least one opioid prescription within 12 months of diagnosis, we defined discrete patterns of benzodiazepine prescribing-continued use, new use, stopped use, and never use. We tested the association of these prescription patterns with long-term opioid use, defined as six or more fills within 12 months.

Results: We identified 2,497,653 opioid-naïve patients with newly diagnosed LBP or LEP. Between 2008 and 2015, 31.9% and 11.5% of these patients received opioid and benzodiazepine prescriptions, respectively, within 12 months of diagnosis. Rates of opioid prescription decreased from 34.8% in 2008 to 27.0% in 2015 (P < 0.001); however, prescribing of benzodiazepines only decreased from 11.6% in 2008 to 10.8% in 2015. Patients with continued or new benzodiazepine use consistently used more opioids than patients who never used or stopped using benzodiazepines during the study period (one-way ANOVA, P < 0.001). For patients with continued and new benzodiazepine use, the odds ratio of long-term opioid use compared with those never prescribed a benzodiazepine was 2.99 (95% CI, 2.89-3.08) and 2.68 (95% CI, 2.62-2.75), respectively.

Limitations: This study used administrative claims analyses, which rely on accuracy and completeness of diagnostic, procedural, and prescription codes.

Conclusion: Overall opioid prescribing for low back pain or lower extremity pain decreased substantially during the study period, indicating a shift in management within the medical community. Rates of benzodiazepine prescribing, however, remained at approximately 11%. Concurrent prescriptions of benzodiazepines and opioids after LBP or LEP diagnosis were associated with increased risk of long-term opioid use.
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http://dx.doi.org/10.1007/s11606-019-05549-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6957597PMC
January 2020

Transcriptome dynamics of long noncoding RNAs and transcription factors demarcate human neonatal, adult, and human mesenchymal stem cell-derived engineered cartilage.

J Tissue Eng Regen Med 2020 01 18;14(1):29-44. Epub 2019 Dec 18.

Department of Genetics and Genome Sciences, Case Western Reserve University School of Medicine, Cleveland, OH.

The engineering of a native-like articular cartilage (AC) is a long-standing objective that could serve the clinical needs of millions of patients suffering from osteoarthritis and cartilage injury. An incomplete understanding of the developmental stages of AC has contributed to limited success in this endeavor. Using next generation RNA sequencing, we have transcriptionally characterized two critical stages of AC development in humans-that is, immature neonatal and mature adult, as well as tissue-engineered cartilage derived from culture expanded human mesenchymal stem cells. We identified key transcription factors (TFs) and long noncoding RNAs (lncRNAs) as candidate drivers of the distinct phenotypes of these tissues. AGTR2, SCGB3A1, TFCP2L1, RORC, and TBX4 stand out as key TFs, whose expression may be capable of reprogramming engineered cartilage into a more expandable and neonatal-like cartilage primed for maturation into biomechanically competent cartilage. We also identified that the transcriptional profiles of many annotated but poorly studied lncRNAs were dramatically different between these cartilages, indicating that lncRNAs may also be playing significant roles in cartilage biology. Key neonatal-specific lncRNAs identified include AC092818.1, AC099560.1, and KC877982. Collectively, our results suggest that tissue-engineered cartilage can be optimized for future clinical applications by the specific expression of TFs and lncRNAs.
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http://dx.doi.org/10.1002/term.2961DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6992527PMC
January 2020

TO THE EDITOR.

Spine (Phila Pa 1976) 2019 09;44(18):E1109-E1110

Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA.

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http://dx.doi.org/10.1097/BRS.0000000000003143DOI Listing
September 2019