Thanks @SCYou ! I agree this sounds like a great opportunity to help resolve an active controversy. Given your important role with JACC, do you think a publication of a proper RWE study that provides explicit comparative effectiveness and safety prasugrel vs. itcagrelor could inform the next iteration of the ACC/AHA and ESC guidelines?
Thanks for your interest! Yes, I believe a well-conducted observational study comparing the effectiveness and safety of prasugrel versus ticagrelor could significantly inform future guideline updates. This is particularly important given the current interesting global heterogeneity in clinical practice.
The current situation is quite unique in cardiology - thereās a clear geographic divide in P2Y12 inhibitor preferences. Prasugrel is favored in European countries and Japan, while ticagrelor is predominantly used in the United States and South Korea. What makes this especially notable is that some recent RCT evidence comparing these agents hasnāt yet been incorporated into ACC guidelines.
Given this context, a high-quality observational study providing comparative effectiveness and safety data could be particularly impactful for the next iterations of both ACC/AHA and ESC guidelines. It would complement existing RCT evidence and help address this noteworthy practice variation across different healthcare systems.
The due date of abstract submission for ESC is March 1st. We can determine the impact of the study by the result of the abstract acceptance.
JoaoSilva
(JoĆ£o dos Santos Soares Oliveira e Silva)
43
Thank you for your thoughtful response and for raising this question.
I am planning to investigate this issue more thoroughly, but currently, the key points I have identified for consideration are:
The use of diuretics, specifically comparing low vs. high doses, and the role of agents like thiazides, metolazone, or acetazolamide.
Indications for the use of inotropes and vasopressors.
The role of vasodilators in acute heart failure management.
The utility of opioids in this context.
A comparison between norepinephrine and dopamine, as well as the combination of norepinephrine with inotropes.
The potential applications of mechanical circulatory support.
I believe addressing these areas with new phenotypes could provide actionable insights to inform the 2021 ESC Guidelines and improve decision-making in clinical practice.
I would be happy to hear your thoughts and any suggestions the community might have!
Limited data on pregnancy-related outcomes for several ASMs, including acetazolamide, eslicarbazepine, ethosuximide, lacosamide, nitrazepam, perampanel, piracetam, pregabalin, rufinamide, stiripentol, tiagabine, and vigabatrin.
Neurodevelopmental outcomes of children exposed in utero ā the long-term impact of ASMs on fetal brain development is still poorly understood. The guideline notes that many ASMs lack sufficient data on their effects during both early and late pregnancy, making treatment decisions even more challenging.
Folic acid supplementation ā while itās widely recommended, the evidence is conflicting in women with epilepsy, with concerns about asthma risk, B12 deficiency masking, and potential effects on new or preexisting neoplasia.
I know that itās gonna be difficult to evaluate pregnancy outcomes, but Iād love to hear thoughts on how we can approach this.
Hello everyone.
Thanks @Patrick_Ryan for bringing it up.
I was thinking about good oncology cases and decide to look at AE management field, not on active anticancer treatment. I do believe that weāll be lucky to find most of data elements required to run such studies in many actively used OMOP CDMs.
Iāve looked at NCCN and ISTH guidelines and found an obvious gap in a niche of cytopenia (particularly thrombopenia) management: role and AE profile of TPO-RAs in solid oncology is still unclear or debatable.
So generally, questions for study may be:
How often are TPO-RA group drugs prescribed/administered to patients with solid tumors?
What is the frequency of venous embolic complications in patients with CIT (chemotherapy-induced thrombocytopenia) receiving drugs from TPO-RA class regardless of anticancer treatment intent (curative/perioperative, palliative).
Assess the frequency of platelet transfusions in patients receiving TPO-RA before and after the drugās exposure.
Determine the frequency of MDS (Myelodysplastic Syndrome) development in patients who survive 5, 10 years after TPO-RAs therapy.
I am excited to delve deeper into this topic with others who share a similar interest. I would appreciate the help from Phenotype-WG (@Gowtham_Rao@Azza_Shoaibi ) as well as from Oncology-WG (@Christian_Reich@agolozar@Dymshyts ) and of course anyone whoās interested in.
Sincerely yours,
Vlad The guy whoās talking about cytopenia.
Iād like to bring a piece of neurology to the wide diversity of your ideas
Post-herpetic neuralgia is a common complication of herpes zoster, primarily affecting elderly individuals and significantly diminishing their quality of life.
Current first-line treatments for PHN, as outlined in clinical guidelines (AAFP, 2017, UpToDate), include tricyclic antidepressants (TCAs) like amitriptyline. However, TCAs are often poorly tolerated or contraindicated in elderly patients due to their adverse effects such as cardiotoxicity, sedation, cognitive impairment, and orthostatic hypotension.
An alternative treatment recommendation exists for serotonin-norepinephrine reuptake inhibitors (SNRIs), particularly duloxetine and venlafaxine. This recommendation is based on their proven efficacy in patients with neuropathic pain of other origins (chemotherapy-induced, painful diabetic neuropathy).
Despite their comparable effectiveness and more favorable safety profile AE profile, SNRIs are not included in the first-line therapy of postherpetic neuralgia.
To address this gap, I propose a comparative study evaluating the effectiveness and safety of TCAs (e.g., amitriptyline) versus SNRIs (e.g., duloxetine) in patients with PHN. This study aims to determine whether SNRIs could be a viable first-line alternative for PHN, particularly in elderly populations.
Thanks @Tetiana_Orlova , indeed pregnancy-related outcomes are often critically understudied in RCT and offer a good opportunity for RWE to fill a clear gap for a vulnerable population, both for the mother and the child. For questions involving only the mother, we need to be able to define pregnancy episodes so that we can infer timing of exposure, I know our Perinatal and Reproductive Health workgroup (@acallahan@sleonard@louisahsmith ) have been working toward that. For questions involving the baby, we need mother-child linkage and there has been work within some databases in our community showing that is possible. Whether there is sufficient statistical power once we restrict to epilepsy and look for rare adverse outcomes is another issue.
Thanks @Vlad_Korsik , Iām glad weāve someone talking about cytopenias In seriousness, its a great idea in the oncology space to not only think about the oncology treatments and their effectiveness, but also put approrpriate focus on the frequent adverse events associated with cancer therapy and evaluate the management of those events.
Youāve outlined 4 different characterization questions, which indeed seem like they would shed some light on current practice. Iām curious how you see this evidence impacting the current guidelines? Is there something you think we can learn that would promote or discourage TPO-RA use in patients with solid tumors?
@m-khitrun , this is a great suggestion! I was not aware of this guideline recommendation, or the potential for their to be a preferred alternative. And given that these drugs are mature and this represents a secondary use, its quite unlikely we would see a head-to-head RCT to challenge the current guideline and move SNRIs into the recommendation. But a good observational study that could show real world effectiveness and safety could be compelling. For post-herpetic neuralgia, what are some outcomes that you think we could observe to demonstrate these are comparable classes? I imagine for the safety profile, we have quite a few phenotypes in place that could support this evaluation (and one of our first large-scale studies before LEGEND-HTN was looking at comparative safety of antidepressants)
I would propose using common pain rating scales, such as the Visual Analog Pain Scale or Numeric Pain Rating Scale, as primary outcomes to assess pain severity and its decline in patients that received amitriptyline and duloxetine, respectively. These tools are widely used, and likely to be present in the data.
Additionally, if sufficient patient data on quality of life is available, secondary outcomes may include changes in QoL using, e.g. SF-36 questionnaire.
I was a former Evidence Based Medicine Specialist (using both CPGs, Professional Org Statements, and local practice) to create electronic order sets and protocols. I primarily did this for womenās health, pharmacy, anesthesia and some facets of mental health. I thought I would share the VA/DOD CPG for Management of First Episode Psychosis and Schizophrenia @aostropolets, @chistophe_lambert and @TatianaSkugarevskaya. Warning: It is very dense; however, they have nice summaries as well. This page also has links to other CPGs. [VA_DOD CPG Management of First-Episode Psychosis & SCZ 2023] (Management of First-Episode Psychosis and Schizophrenia (SCZ) (2023) - VA/DOD Clinical Practice Guidelines). If there is need to assist in finding EBM, particularly in clinical areas mentioned above, I may be able to help.
Diabetic retinopathy is the leading cause of vision loss among working-age adults in the U.S. and is expected to affect upwards of 16.0 million patients by 2050.[1] Both the American Diabetes Association and Academic of Ophthalmology recommend diabetic retinopathy screening at the time of receiving a type 2 diabetes diagnosis.[2,3] However, adherence to guidelines in the real-world are low, ranging from 15% to 77%.[4ā7] Appropriate screening and timely treatment can reduce the risk of blindness by over 90%.[8]
Over the years, there have been major advances in methods available to perform diabetic retinopathy screening.[3] Traditional diabetic retinopathy screening involves in-office examinations with a board-certified optometrist or ophthalmologist. More recently, remote screening can be performed with telemedicine.[9] Typically, a staff member takes a fundus photo of the retina, and a certified physician (typically ophthalmologist) reads the images remotely. Even more recently, the FDA has approved artificial intelligence (AI) algorithms to independently diagnose diabetic retinopathy without physician oversight.[10] Both telemedicine and AI DR screening offer the potential to dramatically improve screening rates by reducing the barriers to screening.[11] However, it is unclear if these newer methods of screening are reaching the populations that need them the most, for example rural or minority populations.
The purpose of this study is to characterize the current landscape of diabetic retinopathy screening and to compare the populations that undergo the 3 types of DR screening (in-office, telemedicine, AI). We will focus on the study period 2021 and beyond since the AI screening with its own dedicated current procedural terminology (CPT) code was not available until then. Results from this OHDSI study can inform current usage of DR screening and opportunities for future growth of these vision saving technologies.
Aim 1: Characterize the current landscape of initial diabetic retinopathy screening (in-office, telemedicine, AI) among patients newly diagnosed with type 2 diabetes
Aim 2: Characterize the sequence of diabetic retinopathy screening (in-office, telemedicine, AI) in the 3 years after type 2 diabetes diagnosis. This will, for example, assess the number of patients who started with AI screening that was followed-up with in-office screening.
Aim 3: Compare the baseline characteristics of patients newly diagnosed with type 2 diabetes who is initially screened with the 3 modalities (in-office, telemedicine, AI)
Aim 4: Compare the time to initial diabetic retinopathy screening among patients with newly diagnosed type 2 diabetes between the 3 modalities (in-office, telemedicine, AI)
Cohorts:
Indication cohort: patients with newly diagnosed type 2 diabetes (1-year prior observation without diabetes) 2021 or beyond
Outcome cohorts:
In-office diabetic retinopathy screening: can be identified based on CPT codes
Telemedicine screening: can be identified based on CPT codes
AI screening: can be identified based on CPT codes
References:
Saaddine JB, Honeycutt AA, Narayan KMV, Zhang X, Klein R, Boyle JP. Projection of Diabetic Retinopathy and Other Major Eye Diseases Among People With Diabetes Mellitus: United States, 2005-2050. Arch Ophthalmol. 2008;126(12):1740-1747. doi:10.1001/archopht.126.12.1740
ElSayed NA, Aleppo G, Aroda VR, et al. 12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetesā2023. Diabetes Care. 2022;46(Supplement_1):S203-S215. doi:10.2337/dc23-s012
Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice PatternĀ®. Ophthalmology. 2020;127(1):P66-P145. doi:10.1016/j.ophtha.2019.09.025
Sloan FA, Yashkin AP, Chen Y. Gaps in Receipt of Regular Eye Examinations among Medicare Beneficiaries Diagnosed with Diabetes or Chronic Eye Diseases. Ophthalmology. 2014;121(12):2452-2460. doi:10.1016/j.ophtha.2014.07.020
Lee PP, Feldman ZW, Ostermann J, Brown DS, Sloan FA. Longitudinal Prevalence of Major Eye Diseases. Arch Ophthalmol-chic. 2003;121(9):1303-1310. doi:10.1001/archopht.121.9.1303
Benoit SR, Swenor B, Geiss LS, Gregg EW, Saaddine JB. Eye Care Utilization Among Insured People With Diabetes in the U.S., 2010-2014. Diabetes care. 2019;42(3):427-433. doi:10.2337/dc18-0828
Hatef E, Vanderver BG, Fagan P, Albert M, Alexander M. Annual diabetic eye examinations in a managed care Medicaid population. Am J Managed Care. 2015;21(5):e297-302.
Ferris FL. Results of 20 Years of Research on the Treatment of Diabetic Retinopathy. Prev Med. 1994;23(5):740-742. doi:10.1006/pmed.1994.1127
Chen JS, Lin MC, Yiu G, et al. Barriers to Implementation of Teleretinal Diabetic Retinopathy Screening Programs Across the University of California. Telemed e-Heal. 2023;29(12):1810-1818. doi:10.1089/tmj.2022.0489
Shah SA, Sokol JT, Wai KM, et al. Use of Artificial IntelligenceāBased Detection of Diabetic Retinopathy in the US. JAMA Ophthalmol. 2024;142(12):1171-1173. doi:10.1001/jamaophthalmol.2024.4493
Huang JJ, Channa R, Wolf RM, et al. Autonomous artificial intelligence for diabetic eye disease increases access and health equity in underserved populations. npj Digit Med. 2024;7(1):196. doi:10.1038/s41746-024-01197-3
Here is another anesthesia-related project currently in development.
The idea, proposed by Dr Lee Goeddel (Johns Hopkins), is to study the incidence and severity of postoperative acute kidney injury in major non-cardiac and cardiac surgery. For this project, we joined forces with the Surgery and Perioperative Medicine WG, led by @Evan_Minty.
The results are of significant interest to the clinical community (eg. EPIS-AKI study) and would serve both as a valuable addition to current guidelines and as the basis for prospective studies and clinical trials. Postop-AKI can be studied in OHDSI using the HowOften pipeline with adjustments to phenotypes.
Scientific background: postoperative acute kidney injury (Postop-AKI) represents a significant perioperative complication with substantial clinical implications, affecting 1-30% of surgical patients. Despite its recognized importance, the precise incidence and risk factors remain incompletely characterized across different surgical procedures. Current literature suggests substantial variability in Postop-AKI rates, with potential differences influenced by surgical type, patient demographics, and underlying health conditions. Accurate epidemiologic data is critical for developing targeted prevention and management strategies to mitigate the morbidity and mortality associated with this devastating complication.
Thanks @cindyxcai for your clear post, it sounds like understanding current practice is the necessary first step to evaluating screening performance. Iām curious: has the 3 modalities of screening shown different rates of case identification?
I guess looking at the humanistic outcomes will be great idea @m-khitrun , however, I am not sure how this would be done using the secondary data unless these data are recorded in the database, or we could take a sample and do these scales on sample of target population.
Pediatric Vision Screening Guidelines Good vision is critical for a childās development and learning. Refractive errors (myopia, hyperopia, and astigmatism), amblyopia, and strabismus are typically detected through vision screenings at primary care physician offices and schools. Regular vision screenings are recommended throughout childhood to identify vision problems so they can be addressed, but guidelines vary as to when screening should start and the recommended intervals between screenings. Vision screening methods can be broadly classified into two categories: (1) instrument-based, involving the use of photoscreeners or autorefractors to determine significant refractive errors, and (2) monocular distance visual acuity testing which involves checking vision in each eye using letter or symbol charts. In general, instrument-based vision screening has been recommended in children as young as 6 months of age, at annual well-child visits, or at least once between 1-3 years of age. The American Academy of Ophthalmology recommends monocular distance visual acuity testing in children 3 years and older with screenings recommended yearly between 3-5 years of age and every 1-2 years after age 5. In 2017, the United States Preventive Services Task Force (USPSTF) analyzed the evidence for the efficacy of vision screening methods and benefits and harms of pediatric vision screening. The report found moderate benefit in detection of amblyopia or its risk factors in children between 3-5 years of age and recommended vision screening at least once between 3-5 years of age while the evidence for screening was insufficient in children ā¤ 3 years. The USPSTF stated:
The USPSTF identified several gaps in the evidence. Well-designed trials are needed to better understand the effects of screening vs no screening, the optimal age for initiation of screening, and appropriate screening intervals. Additional studies are needed to determine the best screening approach and most favorable combinations of screening tests in primary care. There is also a need for studies that examine the benefits and harms of vision screening and treatment in children younger than 3 years and the long-term benefits and harms of preschool vision screening on health outcomes, such as quality of life, school performance, developmental trajectory, and functioning.
There are several potential OHDSI studies, including those that would need additions to the OMOP CDM:
Characterization of current screening practices by age, region, etc. using procedure codes. There are 3 codes used for screening in the pediatric primary care setting: CPT 99173/OMOP Concept 2414379 (visual acuity test using optotypes or charts), CPT 99174/ OMOP Concept 2414380 (instrument-based screening with offsite analysis) and CPT 99177/ OMOP Concept 42628000 (instrument-based screening with on-site analysis). This study can be done now with the existing OMOP CDM.
Characterization of current screening practices by age, region, etc. using vision screening methods and results recorded in the EHR. Billing codes alone do not provide the full picture of screening practices since not all children have insurance and some insurance plans will not cover screening, particularly for children under the age of 3. Screening data recorded in the EHR provides a more thorough record of pediatric vision screening. Concepts related to vision screening would need to be added to the OMOP CDM to do this study.
Studies of the benefit of vision screening, particularly in children under the age of 3. This will need details of the screening results, referrals, vision diagnoses, and visual outcomes over time. The current OMOP CDM would need several additional concepts to study this:
Vision screening results (date, pass/fail, type of screening, any suspected diagnosis)
Referral information (date, diagnosis, referral status)
Thanks @hribarm , Iāve never looked at pediatric vision screening rates in our data, but now Iām quite curious to see if its recorded and how the type of screening plays out. Iām also curious to know whether practice has changed over time.
Primary Open-Angle Glaucoma Suspect Preferred Practice Pattern
Primary Open-Angle Glaucoma (POAG) is a disease afecting the optic nerve and a major cause of vision loss in the US and around the world. The latest estimates find that approximately 4 million people have the disease in teh US alone. 1 The disease is diagnosed based on changes in the anatomy of the optic nerve and retinal nerve fiber layer (RNFL), and abnormalities in the peripheral and central visual field.2 These measeures of optic nerve damage are evaluated via in-office testing which is expected to be performed at the time of diagnosis and then periodically to assess worsening of the disease. The American Academy of Ophthalmology Preferred Practice Pattern guideline recommends examination with gonioscopy and objective testing: automated visual fields and Retinal Nerve Fiber Layer Optical Coherence Tomography (RNFL OCT) for the identification and monitoring of POAG.3 Assessment of anterior chamber angle with gonioscopy rules out angle closure or secondary causes of elevated IOP. Optic nerve imaging examinations are critical for identifying structural changes linked to glaucoma, which often precede detectable functional impairment. Visual field testing is done to identify areas of vision loss. This approach is useful in detecting early (peripheral) to late (central) visual field damage and monitoring response to treatment. Information from these tests help providers track disease progression and functional impact on patients. 4,5The expected management of patients with POAG are monitoring IOP, and assessing structural and functional changes in optic nerve through in-office testing. Patients at risk of POAG should be monitored every 12 to 24 months but more frequent monitoring is required if they have multiple risk factors or are being treated until IOP control is achieved.6
The aim of the study is to evaluate whether patients with POAG undergo the recommended gonioscopy examination, and annual RNFL OCT or HVF testing as outlined by the preferred practice guidelines.
Cohorts:
Indication cohort: patients with Primary Open Angle Glaucoma
Outcome cohort:
Gonioscopy examination within 15 months of diagnosis (can be identified via Current Procedural Terminology (CPT) codes)
HVF and RNFL testing within 15 months of diagnosis (can be identified via CPT codes), and then annually thereafter
References:
Ehrlich JR, Burke-Conte Z, Wittenborn JS, et al. Prevalence of glaucoma among US adults in 2022. JAMA Ophthalmol. 2024;142(11):1046-1053.
Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol. 2002;86(2):238-242.
Feder RS, Olsen TW, Prum BE, et al. Comprehensive adult medical eye evaluation Preferred Practice PatternĀ® guidelines. Ophthalmology. 2016;123(1):P209-P236.
De Moraes CG, Hood DC, Thenappan A, et al. 24-2 visual fields miss central defects shown on 10-2 tests in glaucoma suspects, ocular hypertensives, and early glaucoma. Ophthalmology. 2017;124(10):1449-1456.
Keltner JL, Johnson CA, Quigg JM, Cello KE, Kass MA, Gordon MO. Confirmation of visual field abnormalities in the Ocular Hypertension Treatment Study. Ocular Hypertension Treatment Study Group. Arch Ophthalmol. 2000;118(9):1187-1194.
Gedde SJ, Lind JT, Wright MM, et al. Primary open-angle glaucoma suspect preferred practice patternĀ®. Ophthalmology. 2021;128(1):P151-P192.
Thanks @Patrick_Ryan. It would be interesting to study rates of screening now, but also to use this guideline for additions to the CDM so we can study it more thoroughly.
Limited data on pregnancy-related outcomes for several ASMs, including acetazolamide, eslicarbazepine, ethosuximide, lacosamide, nitrazepam, perampanel, piracetam, pregabalin, rufinamide, stiripentol, tiagabine, and vigabatrin.