2023
Juneau, Carl-Etienne; Briand, Anne-Sara; Collazzo, Pablo; Siebert, Uwe; Pueyo, Tomas
Effective contact tracing for COVID-19: A systematic review Journal Article
In: Glob Epidemiol, vol. 5, pp. 100103, 2023, ISSN: 2590-1133.
@article{pmid36959868,
title = {Effective contact tracing for COVID-19: A systematic review},
author = {Carl-Etienne Juneau and Anne-Sara Briand and Pablo Collazzo and Uwe Siebert and Tomas Pueyo},
doi = {10.1016/j.gloepi.2023.100103},
issn = {2590-1133},
year = {2023},
date = {2023-12-01},
journal = {Glob Epidemiol},
volume = {5},
pages = {100103},
abstract = {Contact tracing is commonly recommended to control outbreaks of COVID-19, but its effectiveness is unclear. Following PRISMA guidelines, we searched four databases using a range of terms related to contact tracing effectiveness for COVID-19. We found 343 papers; 32 were included. All were observational or modelling studies. Observational studies ( = 14) provided consistent, very-low certainty evidence that contact tracing (alone or in combination with other interventions) was associated with better control of COVID-19 (e.g. in Hong Kong, only 1084 cases and four deaths were recorded in the first 4.5 months of the pandemic). Modelling studies ( = 18) provided consistent, high-certainty evidence that under assumptions of prompt and thorough tracing with effective quarantines, contact tracing could stop the spread of COVID-19 (e.g. by reducing the reproduction number from 2.2 to 0.57). A cautious interpretation indicates that to stop the spread of COVID-19, public health practitioners have 2-3 days from the time a new case develops symptoms to isolate the case and quarantine at least 80% of its contacts.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Chhatwal, Jagpreet; Samur, Sumeyye; Yang, Ju Dong; Roberts, Lewis R; Nguyen, Mindie H; Ozbay, A Burak; Ayer, Turgay; Parikh, Neehar D; Singal, Amit G
Effectiveness of HCC surveillance programs using multitarget blood test: A modeling study Journal Article
In: Hepatol Commun, vol. 7, no. 6, 2023, ISSN: 2471-254X.
@article{pmid37204402,
title = {Effectiveness of HCC surveillance programs using multitarget blood test: A modeling study},
author = {Jagpreet Chhatwal and Sumeyye Samur and Ju Dong Yang and Lewis R Roberts and Mindie H Nguyen and A Burak Ozbay and Turgay Ayer and Neehar D Parikh and Amit G Singal},
doi = {10.1097/HC9.0000000000000146},
issn = {2471-254X},
year = {2023},
date = {2023-06-01},
journal = {Hepatol Commun},
volume = {7},
number = {6},
abstract = {BACKGROUND: The effectiveness of ultrasound-based surveillance for HCC in patients with cirrhosis is limited by suboptimal sensitivity for early tumor detection and poor adherence. Emerging blood-based biomarkers have been proposed as an alternative surveillance strategy. We aimed to evaluate the comparative effectiveness of a multitarget HCC blood test (mt-HBT)-with and without improved adherence-against ultrasound-based HCC surveillance.nnMETHODS: We developed a Markov-based mathematical model that simulated a virtual trial in patients with compensated cirrhosis comparing potential surveillance strategies: biannual surveillance using ultrasound, ultrasound plus AFP, and mt-HBT with or without improved adherence (+10% increase). We used published data to inform underlying liver disease progression rates, HCC tumor growth patterns, performance characteristics of surveillance modalities, and efficacy of treatments. Primary outcomes of interest were the number of early-stage HCCs detected and life years gained.nnRESULTS: Per 100,000 patients with cirrhosis, mt-HBT detected 1680 more early-stage HCCs than ultrasound alone and 350 more early-stage HCCs than ultrasound + AFP, yielding an additional 5720 and 1000 life years, respectively. mt-HBT with improved adherence detected 2200 more early-stage HCCs than ultrasound and 880 more early-stage HCCs than ultrasound + AFP, yielding an additional 8140 and 3420 life years, respectively. The number of screening tests needed to detect one HCC case was 139 with ultrasound, 122 with ultrasound + AFP, 119 with mt-HBT, and 124 with mt-HBT with improved adherence.nnCONCLUSIONS: mt-HBT is a promising alternative to ultrasound-based HCC surveillance, particularly given anticipated improved adherence with blood-based biomarkers could increase HCC surveillance effectiveness.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Gartlehner, Gerald; Schernhammer, Eva; Lax, Sigurd F; Preusser, Matthias; Bachler, Herbert; Tietzer, Harald; Kletecka-Pulker, Maria; Turnher, Helga; Siebert, Uwe
Screening for colorectal cancer : A recommendation statement of the Austrian National Committee for Cancer Screening Journal Article
In: Wien Klin Wochenschr, 2023, ISSN: 1613-7671.
@article{pmid37256423,
title = {Screening for colorectal cancer : A recommendation statement of the Austrian National Committee for Cancer Screening},
author = {Gerald Gartlehner and Eva Schernhammer and Sigurd F Lax and Matthias Preusser and Herbert Bachler and Harald Tietzer and Maria Kletecka-Pulker and Helga Turnher and Uwe Siebert},
doi = {10.1007/s00508-023-02209-0},
issn = {1613-7671},
year = {2023},
date = {2023-05-01},
journal = {Wien Klin Wochenschr},
abstract = {BACKGROUND: Colorectal cancer is the fourth most common cancer in Austria. To date, colorectal cancer screening in Austria remains opportunistic and includes colonoscopy or stool-based blood tests. The Austrian National Committee for Cancer Screening developed evidence-based recommendations for a nationwide organized colorectal cancer screening program.nnMETHODS: The methodological framework followed the approach of the United States Preventive Services Task Force. The evidence base underlying the newly developed recommendations comprised a review of the existing published evidence and a decision analytic model tailored to the Austrian context. Using a structured process, committee members considered 1) the magnitude of the net benefit of each screening strategy, 2) the certainty of evidence, and 3) the level of acceptance of the interventions among the target population.nnRECOMMENDATIONS: The Austrian National Committee for Cancer Screening recommends the implementation of a nationwide organized colorectal cancer screening program for all adults aged 45-75 years. For persons 65 years or older, screening decisions should occur on an individual basis in accordance with a person's overall health, prior screening history, and preferences. Specifically, the committee recommends either a 10-year screening colonoscopy or biennial fecal immunochemical tests with colonoscopy following a positive result, with both screening strategies considered equivalent. Each citizen should be able to make an informed decision about their preferred screening method. Switching between the two screening strategies should be possible. Following an unremarkable colonoscopy, screening by fecal immunochemical test (FIT) is only required after 10 years. Screening recommendations apply only to asymptomatic persons at average risk for colorectal cancer. The screening program must be pilot tested, and accompanied by a public information campaign, formative evaluation, quality assurance, and data collection.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Claypool, Anneke L; DiGennaro, Catherine; Russell, W Alton; Yildirim, Melike F; Zhang, Alan F; Reid, Zuri; Stringfellow, Erin J; Bearnot, Benjamin; Schackman, Bruce R; Humphreys, Keith; Jalali, Mohammad S
Cost-effectiveness of Increasing Buprenorphine Treatment Initiation, Duration, and Capacity Among Individuals Who Use Opioids Journal Article
In: JAMA Health Forum, vol. 4, no. 5, pp. e231080, 2023, ISSN: 2689-0186.
@article{pmid37204803,
title = {Cost-effectiveness of Increasing Buprenorphine Treatment Initiation, Duration, and Capacity Among Individuals Who Use Opioids},
author = {Anneke L Claypool and Catherine DiGennaro and W Alton Russell and Melike F Yildirim and Alan F Zhang and Zuri Reid and Erin J Stringfellow and Benjamin Bearnot and Bruce R Schackman and Keith Humphreys and Mohammad S Jalali},
doi = {10.1001/jamahealthforum.2023.1080},
issn = {2689-0186},
year = {2023},
date = {2023-05-01},
journal = {JAMA Health Forum},
volume = {4},
number = {5},
pages = {e231080},
abstract = {IMPORTANCE: Buprenorphine is an effective and cost-effective medication to treat opioid use disorder (OUD), but is not readily available to many people with OUD in the US. The current cost-effectiveness literature does not consider interventions that concurrently increase buprenorphine initiation, duration, and capacity.nnOBJECTIVE: To conduct a cost-effectiveness analysis and compare interventions associated with increased buprenorphine treatment initiation, duration, and capacity.nnDESIGN AND SETTING: This study modeled the effects of 5 interventions individually and in combination using SOURCE, a recent system dynamics model of prescription opioid and illicit opioid use, treatment, and remission, calibrated to US data from 1999 to 2020. The analysis was run during a 12-year time horizon from 2021 to 2032, with lifetime follow-up. A probabilistic sensitivity analysis on intervention effectiveness and costs was conducted. Analyses were performed from April 2021 through March 2023. Modeled participants included people with opioid misuse and OUD in the US.nnINTERVENTIONS: Interventions included emergency department buprenorphine initiation, contingency management, psychotherapy, telehealth, and expansion of hub-and-spoke narcotic treatment programs, individually and in combination.nnMAIN OUTCOMES AND MEASURES: Total national opioid overdose deaths, quality-adjusted life years (QALYs) gained, and costs from the societal and health care perspective.nnRESULTS: Projections showed that contingency management expansion would avert 3530 opioid overdose deaths over 12 years, more than any other single-intervention strategy. Interventions that increased buprenorphine treatment duration initially were associated with an increased number of opioid overdose deaths in the absence of expanded treatment capacity. With an incremental cost- effectiveness ratio of $19 381 per QALY gained (2021 USD), the strategy that expanded contingency management, hub-and-spoke training, emergency department initiation, and telehealth was the preferred strategy for any willingness-to-pay threshold from $20 000 to $200 000/QALY gained, as it was associated with increased treatment duration and capacity simultaneously.nnCONCLUSION AND RELEVANCE: This modeling analysis simulated the effects of implementing several intervention strategies across the buprenorphine cascade of care and found that strategies that were concurrently associated with increased buprenorphine treatment initiation, duration, and capacity were cost-effective.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Yildirim, Melike; Webb, Karen A; Ciaranello, Andrea L; Amick, Alyssa K; Mushavi, Angela; Chimwaza, Anesu; Claypool, Anneke; Murape, Tendayi; McCann, Nicole C; Flanagan, Clare F; Jalali, Mohammad S
In: Int J Infect Dis, 2023, ISSN: 1878-3511.
@article{pmid37196759,
title = {Increasing the initiation of antiretroviral therapy through optimal placement of diagnostic technologies for pediatric HIV in Zimbabwe: a modeling analysis},
author = {Melike Yildirim and Karen A Webb and Andrea L Ciaranello and Alyssa K Amick and Angela Mushavi and Anesu Chimwaza and Anneke Claypool and Tendayi Murape and Nicole C McCann and Clare F Flanagan and Mohammad S Jalali},
doi = {10.1016/j.ijid.2023.05.013},
issn = {1878-3511},
year = {2023},
date = {2023-05-01},
journal = {Int J Infect Dis},
abstract = {OBJECTIVES: Point-of-care (POC) devices for infant HIV testing provide timely result-return and increase ART initiation. We aimed to optimally locate POC devices to increase 30-day ART initiation in Matabeleland South, Zimbabwe.nnMETHODS: We developed an optimization model to identify locations for limited POC devices at health facilities, maximizing the number of infants who receive HIV test results and initiate ART within 30 days of testing. We compared location-optimization model results to non-model-based decision heuristics, which are more practical and less data intensive. Heuristics assign POC devices based on demand, test positivity, laboratory result-return probability, and POC machine functionality.nnRESULTS: With current placement of 11 existing POC machines, 37% of all tested infants with HIV were projected to receive results, 35% to initiate ART within 30 days of testing. With optimal placement of existing machines, 46% were projected to receive results and 44% to initiate ART within 30 days, retaining 3 machines in current locations, moving 8 to new facilities. Relocation based on the highest POC device functionality would be the best-performing heuristic decision (44% receiving results and 42% initiating ART withing 30 days), although it still would not perform as well as the optimization-based approach.nnCONCLUSION: Optimal and ad-hoc heuristic relocation of limited POC machines would increase timely result-return and ART initiation, without further, often costly, interventions. Location-optimization can enhance decision-making regarding placement of medical technologies for HIV care.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Collins, Reagan A; Sheriff, Salma A; Yoon, Christopher; Cobb, Adrianne N; Kothari, Anai N; Newman, Lisa A; Dossett, Lesly A; Willis, Alliric I; Wong, Sandra L; Clarke, Callisia N
In: Ann Surg Oncol, 2023, ISSN: 1534-4681.
@article{pmid37191861,
title = {ASO Visual Abstract: Assessing the Complex General Surgical Oncology Pipeline-Trends in Race and Ethnicity Among US Medical Students, General Surgery Residents, and Complex General Surgical Oncology Trainees},
author = {Reagan A Collins and Salma A Sheriff and Christopher Yoon and Adrianne N Cobb and Anai N Kothari and Lisa A Newman and Lesly A Dossett and Alliric I Willis and Sandra L Wong and Callisia N Clarke},
doi = {10.1245/s10434-023-13609-x},
issn = {1534-4681},
year = {2023},
date = {2023-05-01},
journal = {Ann Surg Oncol},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Kocak, Burak; Baessler, Bettina; Bakas, Spyridon; Cuocolo, Renato; Fedorov, Andrey; Maier-Hein, Lena; Mercaldo, Nathaniel; Müller, Henning; Orlhac, Fanny; Santos, Daniel Pinto Dos; Stanzione, Arnaldo; Ugga, Lorenzo; Zwanenburg, Alex
CheckList for EvaluAtion of Radiomics research (CLEAR): a step-by-step reporting guideline for authors and reviewers endorsed by ESR and EuSoMII Journal Article
In: Insights Imaging, vol. 14, no. 1, pp. 75, 2023, ISSN: 1869-4101.
@article{pmid37142815,
title = {CheckList for EvaluAtion of Radiomics research (CLEAR): a step-by-step reporting guideline for authors and reviewers endorsed by ESR and EuSoMII},
author = {Burak Kocak and Bettina Baessler and Spyridon Bakas and Renato Cuocolo and Andrey Fedorov and Lena Maier-Hein and Nathaniel Mercaldo and Henning M\"{u}ller and Fanny Orlhac and Daniel Pinto Dos Santos and Arnaldo Stanzione and Lorenzo Ugga and Alex Zwanenburg},
doi = {10.1186/s13244-023-01415-8},
issn = {1869-4101},
year = {2023},
date = {2023-05-01},
journal = {Insights Imaging},
volume = {14},
number = {1},
pages = {75},
abstract = {Even though radiomics can hold great potential for supporting clinical decision-making, its current use is mostly limited to academic research, without applications in routine clinical practice. The workflow of radiomics is complex due to several methodological steps and nuances, which often leads to inadequate reporting and evaluation, and poor reproducibility. Available reporting guidelines and checklists for artificial intelligence and predictive modeling include relevant good practices, but they are not tailored to radiomic research. There is a clear need for a complete radiomics checklist for study planning, manuscript writing, and evaluation during the review process to facilitate the repeatability and reproducibility of studies. We here present a documentation standard for radiomic research that can guide authors and reviewers. Our motivation is to improve the quality and reliability and, in turn, the reproducibility of radiomic research. We name the checklist CLEAR (CheckList for EvaluAtion of Radiomics research), to convey the idea of being more transparent. With its 58 items, the CLEAR checklist should be considered a standardization tool providing the minimum requirements for presenting clinical radiomics research. In addition to a dynamic online version of the checklist, a public repository has also been set up to allow the radiomics community to comment on the checklist items and adapt the checklist for future versions. Prepared and revised by an international group of experts using a modified Delphi method, we hope the CLEAR checklist will serve well as a single and complete scientific documentation tool for authors and reviewers to improve the radiomics literature.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Veličković, Vladica M; Carradice, Daniel; Boyle, Jonathan R; Hamady, Mohamad; Cleveland, Trevor; Neequaye, Simon; Ignjatović, Aleksandra; Bogdanović, Dragana; Savovic, Jelena; Siebert, Uwe
In: Expert Rev Cardiovasc Ther, vol. 21, no. 5, pp. 347–356, 2023, ISSN: 1744-8344.
@article{pmid37128666,
title = {Umbrella review and meta-analysis of reconstructed individual patient data of mortality following conventional endovascular and open surgical repair of infrarenal abdominal aortic aneurysm},
author = {Vladica M Veli\v{c}kovi\'{c} and Daniel Carradice and Jonathan R Boyle and Mohamad Hamady and Trevor Cleveland and Simon Neequaye and Aleksandra Ignjatovi\'{c} and Dragana Bogdanovi\'{c} and Jelena Savovic and Uwe Siebert},
doi = {10.1080/14779072.2023.2207009},
issn = {1744-8344},
year = {2023},
date = {2023-05-01},
journal = {Expert Rev Cardiovasc Ther},
volume = {21},
number = {5},
pages = {347--356},
abstract = {OBJECTIVES: This umbrella review aims to quality assess published meta-analyses, conduct a de-novo meta-analysis of the available randomized control trials (RCTs), and test the hypothesis that there is a long-term difference in mortality between OSR and EVAR.nnMETHODS: A systematic search was conducted in MEDLINE and EMBASE's bibliographic databases (June 2022). Data were extracted using standardized extraction forms. The methodological quality of publications was assessed using the ROBIS tool. Data were analyzed with 'one-stage' and 'two-stage' approaches.nnRESULTS: According to two-stage analysis, EVAR has significantly favorable mortality for up to four years (increasing evidence). Subsequently, until the longest available time period, there is no difference between EVAR and OSR; all the results are statistically non-significant.In one stage analysis, the Cox model demonstrated a non-significant (weak evidence) hazard ratio of 1.03 (95% confidence interval [CI]: 0.94-1.12) in favor of OSR. The best-fitting parametric model (generalized gamma), leads to an hazard ratio of 0.97 (95% CI: 0.93-1.01) in favor of EVAR, with the results approaching significance (weak evidence).nnCONCLUSION: The results of this umbrella systematic review and meta-analysis failed to demonstrate any difference in long-term mortality following planned EVAR, compared with OSR of infrarenal AAA.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Alzumaili, Bayan A; Krumeich, Lauren N; Collins, Reagan; Kravchenko, Timothy; Ababneh, Emad I; Fisch, Adam S; Faquin, William C; Nosé, Vania; Martinez-Lage, Maria; Randolph, Gregory W; Gartland, Rajshri M; Lubitz, Carrie C; Sadow, Peter M
A Comprehensive Study on the Diagnosis and Management of Noninvasive Follicular Thyroid Neoplasm with Papillary-Like Nuclear Features Journal Article
In: Thyroid, vol. 33, no. 5, pp. 566–577, 2023, ISSN: 1557-9077.
@article{pmid36960710,
title = {A Comprehensive Study on the Diagnosis and Management of Noninvasive Follicular Thyroid Neoplasm with Papillary-Like Nuclear Features},
author = {Bayan A Alzumaili and Lauren N Krumeich and Reagan Collins and Timothy Kravchenko and Emad I Ababneh and Adam S Fisch and William C Faquin and Vania Nos\'{e} and Maria Martinez-Lage and Gregory W Randolph and Rajshri M Gartland and Carrie C Lubitz and Peter M Sadow},
doi = {10.1089/thy.2023.0035},
issn = {1557-9077},
year = {2023},
date = {2023-05-01},
journal = {Thyroid},
volume = {33},
number = {5},
pages = {566--577},
abstract = { Since the noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTPs) was introduced in 2016, most retrospective studies have included cases diagnosed as encapsulated follicular variant of papillary thyroid carcinoma. We investigate a cohort diagnosed with NIFTP at resection. Retrospective institutional cohort of NIFTP from 2016 to 2022, including clinical, cytological, and molecular data for 319 cases (6.6% of thyroid surgeries, 183 cases as NIFTP-only). The patient cohort had unifocal or multifocal thyroid nodules. Female:male ratio was 2.7:1, mean age was 52 years and median NIFTP size was 2.1 cm. NIFTP was associated with multiple nodules in 23% patients ( = 73) and 12% of NIFTP were multifocal ( = 39). Fine needle aspiration (FNA) of NIFTP ( = 255) were designated as nondiagnostic = 5%, benign = 13%, atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS) = 49%, follicular neoplasm/suspicious for follicular neoplasm (FN/SFN) = 17%, suspicious for malignancy = 12%, or malignant = 4%. Molecular alterations were identified in 93% ( = 114), or -like. Thyroid Imaging Reporting and Data System (TI-RADS) score 4 was recorded in 50% of NIFTP, followed by scores 3 and 5 (26% and 20%, respectively). We also investigated the factors associated with extent of surgery. In our NIFTP-only group ( = 183), 66% were identified after hemithyroidectomy (HT) and 34% after total thyroidectomy (TT). On univariate analysis, TT patients demonstrated higher Bethesda category by FNA, more often had aberrant preoperative thyroid function, and/or underwent an FNA of additional nodule(s). With multivariable regression, Bethesda V NIFTP, in the presence of other nodules being evaluated by FNA and aberrant preoperative thyroid function, independently predicts TT. Bethesda II NIFTP correlated significantly with HT. Fifty-two patients (28%) with NIFTP-only had at least one postoperative surveillance ultrasound. In the NIFTP-only cohort, no HT patients had completion thyroidectomy or received postoperative radioactive iodine. No recurrence or metastases were recorded with median follow-up of 35 months (6-76 months; = 120). Given this large cohort of NIFTP, including a large subset of isolated NIFTP-only, some with >6 years of follow-up and no tumor recurrences, consensus practical guidelines are needed for adequate postoperative management. Given the American Thyroid Association (ATA) provides guidelines for management of low-risk malignancies, guidance regarding that for borderline/biologically uncertain tumors, including NIFTP, is a reasonable next step.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Vinke, Petra C; Combalia, Marc; de Bock, Geertruida H; Leyrat, Clémence; Spanjaart, Anne Mea; Dalle, Stephane; da Silva, Maria Gomes; Essongue, Aurore Fouda; Rabier, Aurélie; Pannard, Myriam; Jalali, Mohammad S; Elgammal, Amal; Papazoglou, Mike; Hacid, Mohand-Said; Rioufol, Catherine; Kersten, Marie-José; van Oijen, Martijn Gh; Suazo-Zepeda, Erick; Malhotra, Ananya; Coquery, Emmanuel; Anota, Amélie; Preau, Marie; Fauvernier, Mathieu; Coz, Elsa; Puig, Susana; Maucort-Boulch, Delphine
In: BMJ Open, vol. 13, no. 4, pp. e069090, 2023, ISSN: 2044-6055.
@article{pmid37105689,
title = {Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study},
author = {Petra C Vinke and Marc Combalia and Geertruida H de Bock and Cl\'{e}mence Leyrat and Anne Mea Spanjaart and Stephane Dalle and Maria Gomes da Silva and Aurore Fouda Essongue and Aur\'{e}lie Rabier and Myriam Pannard and Mohammad S Jalali and Amal Elgammal and Mike Papazoglou and Mohand-Said Hacid and Catherine Rioufol and Marie-Jos\'{e} Kersten and Martijn Gh van Oijen and Erick Suazo-Zepeda and Ananya Malhotra and Emmanuel Coquery and Am\'{e}lie Anota and Marie Preau and Mathieu Fauvernier and Elsa Coz and Susana Puig and Delphine Maucort-Boulch},
doi = {10.1136/bmjopen-2022-069090},
issn = {2044-6055},
year = {2023},
date = {2023-04-01},
journal = {BMJ Open},
volume = {13},
number = {4},
pages = {e069090},
abstract = {INTRODUCTION: Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy.nnMETHODS AND ANALYSIS: This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL.nnETHICS AND DISSEMINATION: All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine.nnTRIAL REGISTRATION NUMBER: NCT05626764.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Kulkarni, Neeti S; Wadhwa, Divneet K; Kanwal, Fasiha; Chhatwal, Jagpreet
Alcohol-Associated Liver Disease Mortality Rates by Race Before and During the COVID-19 Pandemic in the US Miscellaneous
2023, ISSN: 2689-0186.
@misc{pmid37083825,
title = {Alcohol-Associated Liver Disease Mortality Rates by Race Before and During the COVID-19 Pandemic in the US},
author = {Neeti S Kulkarni and Divneet K Wadhwa and Fasiha Kanwal and Jagpreet Chhatwal},
doi = {10.1001/jamahealthforum.2023.0527},
issn = {2689-0186},
year = {2023},
date = {2023-04-01},
journal = {JAMA Health Forum},
volume = {4},
number = {4},
pages = {e230527},
keywords = {},
pubstate = {published},
tppubtype = {misc}
}
Spencer, Kristen; Pappas, Leontios; Baiev, Islam; Maurer, Jordan; Bocobo, Andrea Grace; Zhang, Karen; Jain, Apurva; Armas, Anaemy Danner De; Reyes, Stephanie; Le, Tri Minh; Rahma, Osama E; Stanton, Jennifer; DeLeon, Thomas T; Roth, Marc; Peters, Mary Linton B; Zhu, Andrew X; Lennerz, Jochen K; Iafrate, A John; Boyhen, Kylie; VanCott, Christine; Roberts, Lewis R; Lindsey, Stacie; Horick, Nora; Goff, Laura Williams; Mody, Kabir; Borad, Mitesh J; Shroff, Rachna T; Kelley, R Katie; Javle, Milind M; Goyal, Lipika
Molecular Profiling and Treatment Pattern Differences between Intrahepatic and Extrahepatic Cholangiocarcinoma Journal Article
In: J Natl Cancer Inst, 2023, ISSN: 1460-2105.
@article{pmid37040087,
title = {Molecular Profiling and Treatment Pattern Differences between Intrahepatic and Extrahepatic Cholangiocarcinoma},
author = {Kristen Spencer and Leontios Pappas and Islam Baiev and Jordan Maurer and Andrea Grace Bocobo and Karen Zhang and Apurva Jain and Anaemy Danner De Armas and Stephanie Reyes and Tri Minh Le and Osama E Rahma and Jennifer Stanton and Thomas T DeLeon and Marc Roth and Mary Linton B Peters and Andrew X Zhu and Jochen K Lennerz and A John Iafrate and Kylie Boyhen and Christine VanCott and Lewis R Roberts and Stacie Lindsey and Nora Horick and Laura Williams Goff and Kabir Mody and Mitesh J Borad and Rachna T Shroff and R Katie Kelley and Milind M Javle and Lipika Goyal},
doi = {10.1093/jnci/djad046},
issn = {1460-2105},
year = {2023},
date = {2023-04-01},
journal = {J Natl Cancer Inst},
abstract = {BACKGROUND: Treatment patterns for intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) differ, but limited studies exist comparing them. This study examines differences in molecular profiling rates and treatment patterns in these populations, focusing on use of adjuvant, liver-directed, targeted, and investigational therapies.nnMETHODS: This multi-center collaboration included patients with ICC or ECC treated at one of eight participating institutions. Retrospective data were collected on risk factors, pathology, treatments, and survival. Comparative statistical tests were two-sided.nnRESULTS: Among 1,039 patients screened, 847 patients met eligibility (ICC = 611, ECC = 236). Patients with ECC were more likely than those with ICC to present with early-stage disease (53.8% vs 28.0%), undergo surgical resection (55.1% vs 29.8%), and receive adjuvant chemoradiation (36.5% vs 4.2%), (all p < 0.00001). However, they were less likely to undergo molecular profiling (50.3% vs 64.3%) or receive liver directed therapy (17.9% vs 35.7%), targeted therapy (4.7% vs 18.9%), and clinical trial therapy (10.6% vs 24.8%), (all p < 0.001). In patients with recurrent ECC after surgery, the molecular profiling rate was 64.5%. Patients with advanced ECC had a shorter median overall survival than those with advanced ICC (11.8 vs 15.1 months, p < 0.001).nnCONCLUSIONS: Patients with advanced ECC have low rates of molecular profiling, possibly in part due to insufficient tissue. They also have low rates of targeted therapy use and clinical trial enrollment. While these rates are higher in advanced ICC, the prognosis for both subtypes of cholangiocarcinoma remains poor, and a pressing need exists for new effective targeted therapies and broader access to clinical trials.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Collins, Reagan A; Wang, Tracy S; Dream, Sophie; Solórzano, Carmen C; Kiernan, Colleen M
Adoption of Robotic Adrenalectomy: A Two-Institution Study of Surgeon Learning Curve Journal Article
In: Ann Surg Oncol, 2023, ISSN: 1534-4681.
@article{pmid37040047,
title = {Adoption of Robotic Adrenalectomy: A Two-Institution Study of Surgeon Learning Curve},
author = {Reagan A Collins and Tracy S Wang and Sophie Dream and Carmen C Sol\'{o}rzano and Colleen M Kiernan},
doi = {10.1245/s10434-023-13406-6},
issn = {1534-4681},
year = {2023},
date = {2023-04-01},
journal = {Ann Surg Oncol},
abstract = {BACKGROUND: Robotic adrenalectomy is feasible and safe, yet concerns over increased operative times and the learning curve (LC) for proficiency have limited its adoption. This study aimed to assess the LC for robotic adrenalectomy.nnMETHODS: This is a two-institution retrospective review of consecutive unilateral minimally invasive adrenalectomies performed by four high-volume adrenal surgeons between 2007 and 2022. Two surgeons transitioned from laparoscopic to robotic adrenalectomy, and two surgeons adopted the approach, with proctoring, after completion of fellowship training without robotic experience. Operative time and complications were analyzed. Multivariable regression was used to identify factors associated with operative time. The number of cases required to overcome the LC was determined using the LC-cumulative-sum (LC-CUSUM) analysis.nnRESULTS: Of 457 adrenalectomies, 182 (40%) were laparoscopic and 275 (60%) robotic. The robotic approach was associated with shorter median operative time (106 vs 119 min; p = 0.002), fewer complications (6% vs 13%; p = 0.018), and fewer conversions to open adrenalectomy (1% vs 4%; p = 0.030), with no difference between the senior and junior surgeons. On adjusted analysis, factors associated with increased operative time were male sex (p < 0.001), BMI > 30 kg/m (p < 0.001), and higher gland weight (p < 0.001). The LC-CUSUM analysis showed proficiency after 8-29 procedures. Compared with the first 10 cases, there was a mean reduction in operative time of 14 min after 10-20 cases, 28 min after 20-30 cases, and 29 min after > 30 cases, regardless of surgeon experience.nnDISCUSSION: With dedicated teams and proctoring, robotic adrenalectomy can be safely adopted at high-volume centers with a minimal LC.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Collins, Reagan A; Wang, Tracy S; Dream, Sophie; Solórzano, Carmen C; Kiernan, Colleen M
ASO Visual Abstract: Adoption of Robotic Adrenalectomy: A Two-Institution Study of Surgeon Learning Curve Journal Article
In: Ann Surg Oncol, 2023, ISSN: 1534-4681.
@article{pmid37040051,
title = {ASO Visual Abstract: Adoption of Robotic Adrenalectomy: A Two-Institution Study of Surgeon Learning Curve},
author = {Reagan A Collins and Tracy S Wang and Sophie Dream and Carmen C Sol\'{o}rzano and Colleen M Kiernan},
doi = {10.1245/s10434-023-13492-6},
issn = {1534-4681},
year = {2023},
date = {2023-04-01},
journal = {Ann Surg Oncol},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Stringfellow, Erin J; Lim, Tse Yang; DiGennaro, Catherine; Hasgul, Zeynep; Jalali, Mohammad S
Enumerating contributions of fentanyls and other factors to the unprecedented 2020 rise in opioid overdose deaths: model-based analysis Journal Article
In: PNAS Nexus, vol. 2, no. 4, pp. pgad064, 2023, ISSN: 2752-6542.
@article{pmid37020497,
title = {Enumerating contributions of fentanyls and other factors to the unprecedented 2020 rise in opioid overdose deaths: model-based analysis},
author = {Erin J Stringfellow and Tse Yang Lim and Catherine DiGennaro and Zeynep Hasgul and Mohammad S Jalali},
doi = {10.1093/pnasnexus/pgad064},
issn = {2752-6542},
year = {2023},
date = {2023-04-01},
journal = {PNAS Nexus},
volume = {2},
number = {4},
pages = {pgad064},
abstract = {In 2020, the ongoing US opioid overdose crisis collided with the emerging COVID-19 pandemic. Opioid overdose deaths (OODs) rose an unprecedented 38%, due to a combination of COVID-19 disrupting services essential to people who use drugs, continued increases in fentanyls in the illicit drug supply, and other factors. How much did these factors contribute to increased OODs? We used a validated simulation model of the opioid overdose crisis, SOURCE, to estimate excess OODs in 2020 and the distribution of that excess attributable to various factors. Factors affecting OODs that could have been disrupted by COVID-19, and for which data were available, included opioid prescribing, naloxone distribution, and receipt of medications for opioid use disorder. We also accounted for fentanyls' presence in the heroin supply. We estimated a total of 18,276 potential excess OODs, including 1,792 lives saved due to increases in buprenorphine receipt and naloxone distribution and decreases in opioid prescribing. Critically, growth in fentanyls drove 43% (7,879) of the excess OODs. A further 8% is attributable to first-ever declines in methadone maintenance treatment and extended-released injectable naltrexone treatment, most likely due to COVID-19-related disruptions. In all, 49% of potential excess OODs remain unexplained, at least some of which are likely due to additional COVID-19-related disruptions. While the confluence of various COVID-19-related factors could have been responsible for more than half of excess OODs, fentanyls continued to play a singular role in excess OODs, highlighting the urgency of mitigating their effects on overdoses.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Winograd, Rachel P; Coffey, Bridget; Woolfolk, Candice; Wood, Claire A; Ilavarasan, Vinith; Liss, David; Jain, Subodh; Stringfellow, Erin
To Prescribe or Not to Prescribe?: Barriers and Motivators for Progressing Along Each Stage of the Buprenorphine Training and Prescribing Path Journal Article
In: J Behav Health Serv Res, vol. 50, no. 2, pp. 165–180, 2023, ISSN: 1556-3308.
@article{pmid35060002,
title = {To Prescribe or Not to Prescribe?: Barriers and Motivators for Progressing Along Each Stage of the Buprenorphine Training and Prescribing Path},
author = {Rachel P Winograd and Bridget Coffey and Candice Woolfolk and Claire A Wood and Vinith Ilavarasan and David Liss and Subodh Jain and Erin Stringfellow},
doi = {10.1007/s11414-021-09783-z},
issn = {1556-3308},
year = {2023},
date = {2023-04-01},
journal = {J Behav Health Serv Res},
volume = {50},
number = {2},
pages = {165--180},
abstract = {This study aimed to identify the strongest barriers and motivators associated with each step toward buprenorphine prescribing (1. obtaining a waiver, 2. beginning to prescribe, and 3. prescribing to more people) among a sample of Missouri-based medical professionals (N = 130). Item weights (number of endorsements times mean rank of the item's importance) were calculated based on their responses. Across groups, lack of access to psychosocial support services, need for higher levels of care, and clinical complexity were strong barriers. Among non-prescribers (n = 57, 46.3%), administrative burden, potential of becoming an addiction clinic, and concern about misuse and diversion were most heavily weighted. Among prescribers (n = 66, 53.7%), patients' inability to afford medications was a barrier across phases. Prominent motivators among all groups were the effectiveness of buprenorphine, improvement in other health outcomes, and a personal interest in treating addiction. Only prescribers reported the presence of institutional support and mentors as significant motivators.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Chaves, Natalia; Broekhuis, Jordan M; Fligor, Scott C; Collins, Reagan A; Modest, Anna M; Kaul, Sumedh; James, Benjamin C
Delay in Surgery and Papillary Thyroid Cancer Survival in the United States: a SEER-Medicare Analysis Journal Article
In: J Clin Endocrinol Metab, 2023, ISSN: 1945-7197.
@article{pmid36987566,
title = {Delay in Surgery and Papillary Thyroid Cancer Survival in the United States: a SEER-Medicare Analysis},
author = {Natalia Chaves and Jordan M Broekhuis and Scott C Fligor and Reagan A Collins and Anna M Modest and Sumedh Kaul and Benjamin C James},
doi = {10.1210/clinem/dgad163},
issn = {1945-7197},
year = {2023},
date = {2023-03-01},
journal = {J Clin Endocrinol Metab},
abstract = {INTRODUCTION: Delays in surgery and their impact on survival in papillary thyroid cancer (PTC) is unclear. We sought to investigate the association between time to surgery and survival in patients with PTC.nnMETHODS: A total of 8,170 Medicare beneficiaries with PTC who underwent thyroidectomy were identified within the SEER-Medicare linked data files between 1999-2018. Disease-specific survival (DSS) and overall survival (OS) were estimated using Kaplan-Meir analysis, and Cox proportional hazards models were specified to estimate the association between time to surgery and survival.nnRESULTS: Among 8,170 patients with PTC, mean age 69.3 (SD+/- 11.4), 89.8% had surgery within the first 90 days, 7.8% had surgery 91-180 days from diagnosis, and 2.4% had surgery after 180 days. Increasing time to surgery was associated with increased mortality for OS in the >180-day group (aHR 1.24, 95% CI 1.01-1.53). Moreover, on stratification by summary stage, those with localized disease in the 91-180-day group increased risk by 25% (aHR 1.25 95%CI 1.05-1.51) and delaying over 180 days increased risk by 61% (aHR 1.61 95%CI 1.19-2.18) in OS. Those with localized disease in the >180-day group had almost four times the estimated rate of DSS mortality (aHR3.51 95%CI 1.68-7.32). When stratified by T stage, those with T2 disease in the >180 days group had double the estimated rate of all-cause mortality (aHR 2.0, 95% CI 1.1-3.3) and almost triple the estimated rate of disease-specific mortality (aHR 2.7, 95% CI 1.05-6.8).nnCONCLUSIONS: Delays in surgery for PTC may impact OS and DSS in localized disease, prior to nodal metastasis.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Zauber, Ann G; Winawer, Sidney J; O'Brien, Michael J; Mills, Glenn M; Allen, John I; Feld, Andrew D; Jordan, Paul A; Fleisher, Martin; Orlow, Irene; Meester, Reinier G S; Lansdorp-Vogelaar, Iris; Rutter, Carolyn M; Knudsen, Amy B; Mandelson, Margaret; Shaukat, Aasma; Mendelsohn, Robin B; Hahn, Anne I; Lobaugh, Stephanie M; Palmer, Brittany Soto; Serrano, Victoria; Kumar, Julie R; Fischer, Sara E; Chen, Jennifer C; Bayuga-Miller, Sharon; Kuk, Deborah; O'Connell, Kelli; Church, Timothy R
Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test Journal Article
In: Gastroenterology, 2023, ISSN: 1528-0012.
@article{pmid36948424,
title = {Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test},
author = {Ann G Zauber and Sidney J Winawer and Michael J O'Brien and Glenn M Mills and John I Allen and Andrew D Feld and Paul A Jordan and Martin Fleisher and Irene Orlow and Reinier G S Meester and Iris Lansdorp-Vogelaar and Carolyn M Rutter and Amy B Knudsen and Margaret Mandelson and Aasma Shaukat and Robin B Mendelsohn and Anne I Hahn and Stephanie M Lobaugh and Brittany Soto Palmer and Victoria Serrano and Julie R Kumar and Sara E Fischer and Jennifer C Chen and Sharon Bayuga-Miller and Deborah Kuk and Kelli O'Connell and Timothy R Church},
doi = {10.1053/j.gastro.2023.03.206},
issn = {1528-0012},
year = {2023},
date = {2023-03-01},
journal = {Gastroenterology},
abstract = {BACKGROUND \& AIMS: Colorectal cancer (CRC) screening guidelines include screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT), with expectation of similar effectiveness based on the assumption of similar high adherence. However, adherence to screening colonoscopy compared with sequential HSgFOBT has not been reported. In this randomized clinical trial, we assessed adherence and pathology findings for a single screening colonoscopy vs sequential and nonsequential HSgFOBTs.nnMETHODS: Participants aged 40-69 years were enrolled at 3 centers representing different clinical settings. Participants were randomized into a single screening colonoscopy arm vs sequential HSgFOBT arm composed of 4-7 rounds. Initial adherence to screening colonoscopy and sequential adherence to HSgFOBT, follow-up colonoscopy for positive HSgFOBT tests, crossover to colonoscopy, and detection of advanced neoplasia or large serrated lesions (ADN-SERs) were measured.nnRESULTS: There were 3523 participants included in the trial; 1761 and 1762 participants were randomized to the screening colonoscopy and HSgFOBT arms, respectively. Adherence was 1473 (83.6%) for the screening colonoscopy arm vs 1288 (73.1%) for the HSgFOBT arm after 1 round (relative risk [RR], 1.14; 95% CI, 1.10-1.19; P ≤ .001), but only 674 (38.3%) over 4 sequential HSgFOBT rounds (RR, 2.19; 95% CI, 2.05-2.33). Overall adherence to any screening increased to 1558 (88.5%) in the screening colonoscopy arm during the entire study period and 1493 (84.7%) in the HSgFOBT arm (RR, 1.04; 95% CI, 1.02-1.07). Four hundred thirty-six participants (24.7%) crossed over to screening colonoscopy during the first 4 rounds. ADN-SERs were detected in 121 of the 1473 participants (8.2%) in the colonoscopy arm who were adherent to protocol in the first 12 months of the study, whereas detection of ADN-SERs among those who were not sequentially adherent (n = 709) to HSgFOBT was subpar (0.6%) (RR, 14.72; 95% CI, 5.46-39.67) compared with those who were sequentially adherent (3.3%) (n = 647) (RR, 2.52; 95% CI, 1.61-3.98) to HSgFOBT in the first 4 rounds. When including colonoscopies from HSgFOBT patients who were never positive yet crossed over (n = 1483), 5.5% of ADN-SERs were detected (RR, 1.50; 95% CI, 1.15-1.96) in the first 4 rounds.nnCONCLUSIONS: Observed adherence to sequential rounds of HSgFOBT was suboptimal compared with a single screening colonoscopy. Detection of ADN-SERs was inferior when nonsequential HSgFOBT adherence was compared with sequential adherence. However, the greatest number of ADN-SERs was detected among those who crossed over to colonoscopy and opted to receive a colonoscopy. The effectiveness of an HSgFOBT screening program may be enhanced if crossover to screening colonoscopy is permitted.nnCLINICALTRIALS: gov, Number: NCT00102011.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Coleman, D C; Deasy, E C; Swan, J S; O'Donnell, M J; Scott, T A
2023.
@{pmid36906179,
title = {Direct evidence for effective cleaning and decontamination of the internal air and water channels, heads and head-gears of multiple contra-angle dental handpieces using an enzymatic detergent and automated washer-disinfection in a dental hospital setting},
author = {D C Coleman and E C Deasy and J S Swan and M J O'Donnell and T A Scott},
doi = {10.1016/j.jhin.2023.03.001},
issn = {1532-2939},
year = {2023},
date = {2023-03-01},
journal = {J Hosp Infect},
keywords = {},
pubstate = {published},
tppubtype = {}
}
Stringfellow, Erin J; Lim, Tse Yang; DiGennaro, Catherine; Zhang, Ziyuan; Paramasivam, Pritika; Bearnot, Benjamin; Humphreys, Keith; Jalali, Mohammad S
Long-Term Effects of Increasing Buprenorphine Treatment Seeking, Duration, and Capacity on Opioid Overdose Fatalities: A Model-Based Analysis Journal Article
In: J Addict Med, 2023, ISSN: 1935-3227.
@article{pmid36799870,
title = {Long-Term Effects of Increasing Buprenorphine Treatment Seeking, Duration, and Capacity on Opioid Overdose Fatalities: A Model-Based Analysis},
author = {Erin J Stringfellow and Tse Yang Lim and Catherine DiGennaro and Ziyuan Zhang and Pritika Paramasivam and Benjamin Bearnot and Keith Humphreys and Mohammad S Jalali},
doi = {10.1097/ADM.0000000000001153},
issn = {1935-3227},
year = {2023},
date = {2023-02-01},
journal = {J Addict Med},
abstract = {OBJECTIVES: Because buprenorphine treatment of opioid use disorder reduces opioid overdose deaths (OODs), expanding access to care is an important policy and clinical care goal. Policymakers must choose within capacity limitations whether to expand the number of people with opioid use disorder who are treated or extend duration for existing patients. This inherent tradeoff could be made less acute with expanded buprenorphine treatment capacity.
METHODS: To inform such decisions, we used a validated simulation model to project the effects of increasing buprenorphine treatment-seeking, average episode duration, and capacity (patients per provider) on OODs in the United States from 2023 to 2033, varying the start time to assess the effects of implementation delays.
RESULTS: Results show that increasing treatment duration alone could cost lives in the short term by reducing capacity for new admissions yet save more lives in the long term than accomplished by only increasing treatment seeking. Increasing provider capacity had negligible effects. The most effective 2-policy combination was increasing capacity and duration simultaneously, which would reduce OODs up to 18.6% over a decade. By 2033, the greatest reduction in OODs (≥20%) was achieved when capacity was doubled and average duration reached 2 years, but only if the policy changes started in 2023. Delaying even a year diminishes the benefits. Treatment-seeking increases were equally beneficial whether they began in 2023 or 2025 but of only marginal benefit beyond what capacity and duration achieved.
CONCLUSIONS: If policymakers only target 2 policies to reduce OODs, they should be to increase capacity and duration, enacted quickly and aggressively.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: To inform such decisions, we used a validated simulation model to project the effects of increasing buprenorphine treatment-seeking, average episode duration, and capacity (patients per provider) on OODs in the United States from 2023 to 2033, varying the start time to assess the effects of implementation delays.
RESULTS: Results show that increasing treatment duration alone could cost lives in the short term by reducing capacity for new admissions yet save more lives in the long term than accomplished by only increasing treatment seeking. Increasing provider capacity had negligible effects. The most effective 2-policy combination was increasing capacity and duration simultaneously, which would reduce OODs up to 18.6% over a decade. By 2033, the greatest reduction in OODs (≥20%) was achieved when capacity was doubled and average duration reached 2 years, but only if the policy changes started in 2023. Delaying even a year diminishes the benefits. Treatment-seeking increases were equally beneficial whether they began in 2023 or 2025 but of only marginal benefit beyond what capacity and duration achieved.
CONCLUSIONS: If policymakers only target 2 policies to reduce OODs, they should be to increase capacity and duration, enacted quickly and aggressively.
Toumazis, Iakovos; Cao, Pianpian; de Nijs, Koen; Bastani, Mehrad; Munshi, Vidit; Hemmati, Mehdi; Haaf, Kevin Ten; Jeon, Jihyoun; Tammemägi, Martin; Gazelle, G Scott; Feuer, Eric J; Kong, Chung Yin; Meza, Rafael; de Koning, Harry J; Plevritis, Sylvia K; Han, Summer S
Risk Model-Based Lung Cancer Screening : A Cost-Effectiveness Analysis Journal Article
In: Ann Intern Med, 2023, ISSN: 1539-3704.
@article{pmid36745885,
title = {Risk Model-Based Lung Cancer Screening : A Cost-Effectiveness Analysis},
author = {Iakovos Toumazis and Pianpian Cao and Koen de Nijs and Mehrad Bastani and Vidit Munshi and Mehdi Hemmati and Kevin Ten Haaf and Jihyoun Jeon and Martin Tammem\"{a}gi and G Scott Gazelle and Eric J Feuer and Chung Yin Kong and Rafael Meza and Harry J de Koning and Sylvia K Plevritis and Summer S Han},
doi = {10.7326/M22-2216},
issn = {1539-3704},
year = {2023},
date = {2023-02-01},
journal = {Ann Intern Med},
abstract = {BACKGROUND: In their 2021 lung cancer screening recommendation update, the U.S. Preventive Services Task Force (USPSTF) evaluated strategies that select people based on their personal lung cancer risk (risk model-based strategies), highlighting the need for further research on the benefits and harms of risk model-based screening.
OBJECTIVE: To evaluate and compare the cost-effectiveness of risk model-based lung cancer screening strategies versus the USPSTF recommendation and to explore optimal risk thresholds.
DESIGN: Comparative modeling analysis.
DATA SOURCES: National Lung Screening Trial; Surveillance, Epidemiology, and End Results program; U.S. Smoking History Generator.
TARGET POPULATION: 1960 U.S. birth cohort.
TIME HORIZON: 45 years.
PERSPECTIVE: U.S. health care sector.
INTERVENTION: Annual low-dose computed tomography in risk model-based strategies that start screening at age 50 or 55 years, stop screening at age 80 years, with 6-year risk thresholds between 0.5% and 2.2% using the PLCOm2012 model.
OUTCOME MEASURES: Incremental cost-effectiveness ratio (ICER) and cost-effectiveness efficiency frontier connecting strategies with the highest health benefit at a given cost.
RESULTS OF BASE-CASE ANALYSIS: Risk model-based screening strategies were more cost-effective than the USPSTF recommendation and exclusively comprised the cost-effectiveness efficiency frontier. Among the strategies on the efficiency frontier, those with a 6-year risk threshold of 1.2% or greater were cost-effective with an ICER less than $100 000 per quality-adjusted life-year (QALY). Specifically, the strategy with a 1.2% risk threshold had an ICER of $94 659 (model range, $72 639 to $156 774), yielding more QALYs for less cost than the USPSTF recommendation, while having a similar level of screening coverage (person ever-screened 21.7% vs. USPSTF's 22.6%).
RESULTS OF SENSITIVITY ANALYSES: Risk model-based strategies were robustly more cost-effective than the 2021 USPSTF recommendation under varying modeling assumptions.
LIMITATION: Risk models were restricted to age, sex, and smoking-related risk predictors.
CONCLUSION: Risk model-based screening is more cost-effective than the USPSTF recommendation, thus warranting further consideration.
PRIMARY FUNDING SOURCE: National Cancer Institute (NCI).},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
OBJECTIVE: To evaluate and compare the cost-effectiveness of risk model-based lung cancer screening strategies versus the USPSTF recommendation and to explore optimal risk thresholds.
DESIGN: Comparative modeling analysis.
DATA SOURCES: National Lung Screening Trial; Surveillance, Epidemiology, and End Results program; U.S. Smoking History Generator.
TARGET POPULATION: 1960 U.S. birth cohort.
TIME HORIZON: 45 years.
PERSPECTIVE: U.S. health care sector.
INTERVENTION: Annual low-dose computed tomography in risk model-based strategies that start screening at age 50 or 55 years, stop screening at age 80 years, with 6-year risk thresholds between 0.5% and 2.2% using the PLCOm2012 model.
OUTCOME MEASURES: Incremental cost-effectiveness ratio (ICER) and cost-effectiveness efficiency frontier connecting strategies with the highest health benefit at a given cost.
RESULTS OF BASE-CASE ANALYSIS: Risk model-based screening strategies were more cost-effective than the USPSTF recommendation and exclusively comprised the cost-effectiveness efficiency frontier. Among the strategies on the efficiency frontier, those with a 6-year risk threshold of 1.2% or greater were cost-effective with an ICER less than $100 000 per quality-adjusted life-year (QALY). Specifically, the strategy with a 1.2% risk threshold had an ICER of $94 659 (model range, $72 639 to $156 774), yielding more QALYs for less cost than the USPSTF recommendation, while having a similar level of screening coverage (person ever-screened 21.7% vs. USPSTF's 22.6%).
RESULTS OF SENSITIVITY ANALYSES: Risk model-based strategies were robustly more cost-effective than the 2021 USPSTF recommendation under varying modeling assumptions.
LIMITATION: Risk models were restricted to age, sex, and smoking-related risk predictors.
CONCLUSION: Risk model-based screening is more cost-effective than the USPSTF recommendation, thus warranting further consideration.
PRIMARY FUNDING SOURCE: National Cancer Institute (NCI).
de la Fuente, Rodrigo Paredes; Doolin, James W; Peters, Mary Linton
In: BMJ Case Rep, vol. 16, no. 2, 2023, ISSN: 1757-790X.
@article{pmid36746516,
title = {Partial response in non-resectable adenosquamous carcinoma of the pancreas with high tumour mutation burden treated with gemcitabine, nab-paclitaxel and pembrolizumab},
author = {Rodrigo Paredes de la Fuente and James W Doolin and Mary Linton Peters},
doi = {10.1136/bcr-2022-251936},
issn = {1757-790X},
year = {2023},
date = {2023-02-01},
journal = {BMJ Case Rep},
volume = {16},
number = {2},
abstract = {A previously healthy man in his 60s was diagnosed with a rare histological subtype of pancreatic cancer, adenosquamous carcinoma. After somatic mutation profiling, it was found that the tumour had microsatellite instability status high and a high tumour mutational burden. The patient was started on combination therapy with gemcitabine, nab-paclitaxel and pembrolizumab. Tumour size and biomarkers showed a dramatic response eventually leading to the patient being transitioned to maintenance therapy with pembrolizumab. The patient has demonstrated continued response since the start of the treatment. This is the first report in the literature showing a sustained response in this type of neoplasm that was treated with a checkpoint inhibitor, and thus adds to the evidence supporting universal somatic testing in all pancreatic cancers for a tailored approach to therapy.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Castellano, Tara; Moore, Kathleen; Ting, Jie; Washington, Christina; Yildiz, Yasin; Surinach, Andy; Sonawane, Kalyani; Chhatwal, Jagpreet; Ayer, Turgay
In: Gynecol Oncol, vol. 169, pp. 113–117, 2023, ISSN: 1095-6859.
@article{pmid36549175,
title = {Cervical cancer geographical burden analyzer: An interactive, open-access tool for understanding geographical disease burden in patients with recurrent or metastatic cervical cancer},
author = {Tara Castellano and Kathleen Moore and Jie Ting and Christina Washington and Yasin Yildiz and Andy Surinach and Kalyani Sonawane and Jagpreet Chhatwal and Turgay Ayer},
doi = {10.1016/j.ygyno.2022.12.004},
issn = {1095-6859},
year = {2023},
date = {2023-02-01},
urldate = {2022-12-01},
journal = {Gynecol Oncol},
volume = {169},
pages = {113--117},
abstract = {OBJECTIVE: Cervical cancer (CC) disproportionately affects women based on socioeconomic status and racial/ethnic background. There is limited research in quantifying and visualizing whether substantial geographical disparities in the US exist with respect to CC burden, and especially with respect to recurrent or metastatic CC (r/mCC) disease burden. Identifying regions with higher r/mCC burden may help inform effective healthcare resource allocation and navigating patients to appropriate care.
METHODS: We conducted a retrospective analysis of the 2015-2020 MarketScan® Commercial and Supplemental Medicare claims data; r/mCC burden was estimated as the number of patients initiating r/mCC systemic therapy over CC-diagnosed patients for each of the 410 metropolitan statistical areas (MSAs) considered. We developed a public, web-based tool, the Cervical Cancer Geographical Disease Burden Analyzer (Cervical Cancer Geo-Analyzer, http://www.geo-analyzer.org), that allows users to visualize r/mCC burden across MSAs over multiple years.
RESULTS: There was considerable variation in r/mCC burden across MSAs, with a range of 0-83.3%. Burden increased in Boston-Cambridge-Newton, MA (r/mCC to CC ratio: 41% in 2018 to 50% in 2020), and Sacramento-Roseville-Arden-Arcade, CA (33% in 2018 to 50% in 2020). On the other hand, while r/mCC burden remained high, it decreased in Grand Rapids, MI (55% in 2018 to 31% in 2020) and San Francisco-Oakland-Hayward, CA (40% in 2018 to 26% in 2020). There were regions with sparse or no data, suggesting a need for more representative data capture.
CONCLUSION: The Cervical Geo-Analyzer is a tool to visualize areas with high need for CC interventions. It also builds the foundation for further work to understand local risk factors of disease burden, identify populations of interest, characterize health disparities of CC or r/mCC and inform targeted interventions.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We conducted a retrospective analysis of the 2015-2020 MarketScan® Commercial and Supplemental Medicare claims data; r/mCC burden was estimated as the number of patients initiating r/mCC systemic therapy over CC-diagnosed patients for each of the 410 metropolitan statistical areas (MSAs) considered. We developed a public, web-based tool, the Cervical Cancer Geographical Disease Burden Analyzer (Cervical Cancer Geo-Analyzer, http://www.geo-analyzer.org), that allows users to visualize r/mCC burden across MSAs over multiple years.
RESULTS: There was considerable variation in r/mCC burden across MSAs, with a range of 0-83.3%. Burden increased in Boston-Cambridge-Newton, MA (r/mCC to CC ratio: 41% in 2018 to 50% in 2020), and Sacramento-Roseville-Arden-Arcade, CA (33% in 2018 to 50% in 2020). On the other hand, while r/mCC burden remained high, it decreased in Grand Rapids, MI (55% in 2018 to 31% in 2020) and San Francisco-Oakland-Hayward, CA (40% in 2018 to 26% in 2020). There were regions with sparse or no data, suggesting a need for more representative data capture.
CONCLUSION: The Cervical Geo-Analyzer is a tool to visualize areas with high need for CC interventions. It also builds the foundation for further work to understand local risk factors of disease burden, identify populations of interest, characterize health disparities of CC or r/mCC and inform targeted interventions.
Schnell-Inderst, Petra; Conrads-Frank, Annette; Stojkov, Igor; Krenn, Cornelia; Kofler, Lisa-Maria; Siebert, Uwe
Occupational therapy for persons with cognitive impairments Journal Article
In: Ger Med Sci, vol. 21, pp. Doc02, 2023, ISSN: 1612-3174.
@article{pmid37260919,
title = {Occupational therapy for persons with cognitive impairments},
author = {Petra Schnell-Inderst and Annette Conrads-Frank and Igor Stojkov and Cornelia Krenn and Lisa-Maria Kofler and Uwe Siebert},
doi = {10.3205/000316},
issn = {1612-3174},
year = {2023},
date = {2023-01-01},
journal = {Ger Med Sci},
volume = {21},
pages = {Doc02},
abstract = {BACKGROUND: Damage to the central nervous system can occur in adulthood, for example, due to stroke, trauma, tumours, or chronic diseases. After damage to the central nervous system, cognitive impairments occur in addition to physical limitations. Occupational therapy is most often prescribed for neurological diagnoses, including stroke and traumatic brain injury.nnMETHODS: The health technology assessment (HTA) report this HTA article is based on investigates the clinical effectiveness, cost-effectiveness, and patient-related, social and ethical aspects of occupational therapy for patients with cognitive impairments compared to no occupational therapy. In addition, the effects of different occupational therapy interventions with and without cognitive components were compared in an explorative overview. Patients with moderate or severe dementia are excluded from the assessment. Systematic overviews, that is, systematic reviews of systematic reviews, were conducted.nnRESULTS: For the evaluation of clinical effectiveness, a total of nine systematic reviews were included. No systematic review was identified for the assessment of costs or cost-effectiveness. Five systematic reviews were included for the assessment of patient and social aspects. For the assessment of clinical effectiveness compared with no occupational therapy, five systematic reviews comprising 20 randomised controlled trials with a total of 1,316 subjects reported small positive effects for the outcomes "global cognitive function" and "activities of daily living" as well as a non-quantified positive effect on the outcomes "health-related quality of life" and "behavioural control". No effect was found for individual components of cognition and measures of perception. The quality of the evidence for all outcomes is low due to a high risk of bias. In the supplementary presentations, no positive effects could be demonstrated on the basis of the available evidence. The quality of this evidence was not assessed. For the assessment of patient and social aspects, five systematic reviews on patients with a stroke or a traumatic brain injury - without specification regarding cognitive deficits or studies with their relatives - were included. It was reported that patients and family caregivers go through different phases of rehabilitation in which the discharge home is a decisive turning point. The discharge home represents a crucial breaking point. Regaining an active, self-determining role is a process that requires therapists to find the right level of support for patients and relatives. For the assessment of ethical aspects, nine documents were included. We identified ethical problem-solving models for occupational therapy and 16 ethical aspects in occupational therapy for cognitive deficits. The central theme of the analysis is the limited autonomy due to the consequences of the disease as well as the resulting tensions with those treating the patient.nnCONCLUSIONS: Based on this systematic overview, it can neither be proven nor excluded with certainty that occupational therapy for cognitive impairment is an effective therapy for adult patients with central nervous system injuries compared to no occupational therapy. There is a lack of randomised trials with sufficient sample size, well-defined interventions, and comparable concomitant therapies in the control groups, but there is also a lack of well-designed observational studies in routine care and health economic studies. The identified systematic reviews on patient and social aspects provide information on the needs of patients after stroke or traumatic brain injury and their relatives, but there is a lack of studies on this aspect in German-speaking countries. For the ethical assessment, in addition to the identified theoretical models for solving ethical conflicts in occupational therapy, more empirical studies on ethical aspects with patients with cognitive deficits and their relatives as well as occupational therapists are needed.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Frates, Beth; Cron, David; Lubitz, Carrie Cunningham; Boland, Genevieve; Srivastava, Sunita; Hodin, Richard A; Stephen, Antonia E; Carney, Kelsey; Phitayakorn, Roy
In: Am J Lifestyle Med, vol. 17, no. 2, pp. 213–215, 2023, ISSN: 1559-8284.
@article{pmid36896035,
title = {Incorporating Well-Being into Mentorship Meetings: A Case Demonstration at Massachusetts General Hospital Department of Surgery a Harvard Medical School Affiliate},
author = {Beth Frates and David Cron and Carrie Cunningham Lubitz and Genevieve Boland and Sunita Srivastava and Richard A Hodin and Antonia E Stephen and Kelsey Carney and Roy Phitayakorn},
doi = {10.1177/15598276221105830},
issn = {1559-8284},
year = {2023},
date = {2023-01-01},
urldate = {2023-01-01},
journal = {Am J Lifestyle Med},
volume = {17},
number = {2},
pages = {213--215},
abstract = {Surgeons have been under great pressure during the COVID pandemic. Their careers are filled with fast paced decisions, life and death situations, and long hours at work. The COVID pandemic created more tasks and even new responsibilities at times, but when the operating rooms were closed down, there was less work. The COVID experience invited the opportunity to rethink mentoring in the surgery department at the Massachusetts General Hospital. The leadership experimented with a new style of mentoring which involved a team approach. In addition, they tried something else that was new: adding a lifestyle medicine expert and wellness coach to the mentoring team. The program was tested on 13 early stage surgeons who found the experience to be beneficial, and they commented that they wished they had it even earlier in their careers. Including a non-surgeon who was a lifestyle medicine physician and wellness coach added an element of whole person health that was acceptable to the surgeons and even embraced as the majority of them elected to follow up with one on one coaching after the mentoring meeting. This team mentoring program with senior surgeons and a lifestyle medicine expert is one that can be explored by other departments and other hospitals given its success at the department of surgery at Massachusetts General Hospital.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Yoon, Byung C; Pomerantz, Stuart R; Mercaldo, Nathaniel D; Goyal, Swati; L'Italien, Eric M; Lev, Michael H; Buch, Karen A; Buchbinder, Bradley R; Chen, John W; Conklin, John; Gupta, Rajiv; Hunter, George J; Kamalian, Shahmir C; Kelly, Hillary R; Rapalino, Otto; Rincon, Sandra P; Romero, Javier M; He, Julian; Schaefer, Pamela W; Do, Synho; González, Ramon Gilberto
Incorporating algorithmic uncertainty into a clinical machine deep learning algorithm for urgent head CTs Journal Article
In: PLoS One, vol. 18, no. 3, pp. e0281900, 2023, ISSN: 1932-6203.
@article{pmid36913348,
title = {Incorporating algorithmic uncertainty into a clinical machine deep learning algorithm for urgent head CTs},
author = {Byung C Yoon and Stuart R Pomerantz and Nathaniel D Mercaldo and Swati Goyal and Eric M L'Italien and Michael H Lev and Karen A Buch and Bradley R Buchbinder and John W Chen and John Conklin and Rajiv Gupta and George J Hunter and Shahmir C Kamalian and Hillary R Kelly and Otto Rapalino and Sandra P Rincon and Javier M Romero and Julian He and Pamela W Schaefer and Synho Do and Ramon Gilberto Gonz\'{a}lez},
doi = {10.1371/journal.pone.0281900},
issn = {1932-6203},
year = {2023},
date = {2023-01-01},
journal = {PLoS One},
volume = {18},
number = {3},
pages = {e0281900},
abstract = {Machine learning (ML) algorithms to detect critical findings on head CTs may expedite patient management. Most ML algorithms for diagnostic imaging analysis utilize dichotomous classifications to determine whether a specific abnormality is present. However, imaging findings may be indeterminate, and algorithmic inferences may have substantial uncertainty. We incorporated awareness of uncertainty into an ML algorithm that detects intracranial hemorrhage or other urgent intracranial abnormalities and evaluated prospectively identified, 1000 consecutive noncontrast head CTs assigned to Emergency Department Neuroradiology for interpretation. The algorithm classified the scans into high (IC+) and low (IC-) probabilities for intracranial hemorrhage or other urgent abnormalities. All other cases were designated as No Prediction (NP) by the algorithm. The positive predictive value for IC+ cases (N = 103) was 0.91 (CI: 0.84-0.96), and the negative predictive value for IC- cases (N = 729) was 0.94 (0.91-0.96). Admission, neurosurgical intervention, and 30-day mortality rates for IC+ was 75% (63-84), 35% (24-47), and 10% (4-20), compared to 43% (40-47), 4% (3-6), and 3% (2-5) for IC-. There were 168 NP cases, of which 32% had intracranial hemorrhage or other urgent abnormalities, 31% had artifacts and postoperative changes, and 29% had no abnormalities. An ML algorithm incorporating uncertainty classified most head CTs into clinically relevant groups with high predictive values and may help accelerate the management of patients with intracranial hemorrhage or other urgent intracranial abnormalities.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Dong, Huiru; Stringfellow, Erin J; Russell, W Alton; Jalali, Mohammad S
Racial and Ethnic Disparities in Buprenorphine Treatment Duration in the US Journal Article
In: JAMA Psychiatry, vol. 80, iss. 1, pp. 93-95, 2023, ISSN: 2168-6238.
@article{pmid36350592,
title = {Racial and Ethnic Disparities in Buprenorphine Treatment Duration in the US},
author = {Huiru Dong and Erin J Stringfellow and W Alton Russell and Mohammad S Jalali},
doi = {10.1001/jamapsychiatry.2022.3673},
issn = {2168-6238},
year = {2023},
date = {2023-01-01},
urldate = {2023-01-01},
journal = {JAMA Psychiatry},
volume = {80},
issue = {1},
pages = {93-95},
abstract = {Buprenorphine is used to treat opioid use disorder (OUD) and reduce overdose risk.1 Duration of buprenorphine treatment is a measure of quality of care; longer retention is associated with superior clinical outcomes. Racial and ethnic minority patients are more likely to discontinue buprenorphine treatment earlier than White patients. To our knowledge, no nationally representative studies have examined buprenorphine treatment duration over time across racial and ethnic groups. This information is needed to close the racial and ethnic gap in treatment retention for OUD.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
Collins, Reagan A; DiGennaro, Catherine; Beninato, Toni; Gartland, Rajshri M; Chaves, Natalia; Broekhuis, Jordan M; Reddy, Lekha; Lee, Jenna; Deimiller, Angelina; Alterio, Maeve M; Campbell, Michael J; Lee, Yeon Joo; Khilnani, Tyler K; Stewart, Latoya A; O'Brien, Mollie A; Alvarado, Miguel Valdivia Y; Zheng, Feibi; McAneny, David; Liou, Rachel; McManus, Catherine; Dream, Sophie Y; Wang, Tracy S; Yen, Tina W; Alhefdhi, Amal; Finnerty, Brendan M; Fahey, Thomas J; Graves, Claire E; Laird, Amanda M; Nehs, Matthew A; Drake, Frederick Thurston; Lee, James A; McHenry, Christopher R; James, Benjamin C; Pasieka, Janice L; Kuo, Jennifer H; Lubitz, Carrie Cunningham
Limited disease progression in endocrine surgery patients with treatment delays due to COVID-19 Journal Article
In: Surgery, vol. 173, no. 1, pp. 93–100, 2023, ISSN: 1532-7361.
@article{pmid36210185,
title = {Limited disease progression in endocrine surgery patients with treatment delays due to COVID-19},
author = {Reagan A Collins and Catherine DiGennaro and Toni Beninato and Rajshri M Gartland and Natalia Chaves and Jordan M Broekhuis and Lekha Reddy and Jenna Lee and Angelina Deimiller and Maeve M Alterio and Michael J Campbell and Yeon Joo Lee and Tyler K Khilnani and Latoya A Stewart and Mollie A O'Brien and Miguel Valdivia Y Alvarado and Feibi Zheng and David McAneny and Rachel Liou and Catherine McManus and Sophie Y Dream and Tracy S Wang and Tina W Yen and Amal Alhefdhi and Brendan M Finnerty and Thomas J Fahey and Claire E Graves and Amanda M Laird and Matthew A Nehs and Frederick Thurston Drake and James A Lee and Christopher R McHenry and Benjamin C James and Janice L Pasieka and Jennifer H Kuo and Carrie Cunningham Lubitz},
doi = {10.1016/j.surg.2022.06.043},
issn = {1532-7361},
year = {2023},
date = {2023-01-01},
journal = {Surgery},
volume = {173},
number = {1},
pages = {93--100},
abstract = {BACKGROUND: The COVID-19 pandemic profoundly impacted the delivery of care and timing of elective surgical procedures. Most endocrine-related operations were considered elective and safe to postpone, providing a unique opportunity to assess clinical outcomes under protracted treatment plans.
METHODS: American Association of Endocrine Surgeon members were surveyed for participation. A Research Electronic Data Capture survey was developed and distributed to 27 institutions to assess the impact of COVID-19-related delays. The information collected included patient demographics, primary diagnosis, resumption of care, and assessment of disease progression by the surgeon.
RESULTS: Twelve out of 27 institutions completed the survey (44.4%). Of 850 patients, 74.8% (636) were female; median age was 56 (interquartile range, 44-66) years. Forty percent (34) of patients had not been seen since their original surgical appointment was delayed; 86.2% (733) of patients had a delay in care with women more likely to have a delay (87.6% vs 82.2% of men, χ = 3.84, P = .05). Median duration of delay was 70 (interquartile range, 42-118) days. Among patients with a delay in care, primary disease site included thyroid (54.2%), parathyroid (37.2%), adrenal (6.5%), and pancreatic/gastrointestinal neuroendocrine tumors (1.3%). In addition, 4.0% (26) of patients experienced disease progression and 4.1% (24) had a change from the initial operative plan. The duration of delay was not associated with disease progression (P = .96) or a change in operative plan (P = .66).
CONCLUSION: Although some patients experienced disease progression during COVID-19 delays to endocrine disease-related care, most patients with follow-up did not. Our analysis indicated that temporary delay may be an acceptable course of action in extreme circumstances for most endocrine-related surgical disease.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: American Association of Endocrine Surgeon members were surveyed for participation. A Research Electronic Data Capture survey was developed and distributed to 27 institutions to assess the impact of COVID-19-related delays. The information collected included patient demographics, primary diagnosis, resumption of care, and assessment of disease progression by the surgeon.
RESULTS: Twelve out of 27 institutions completed the survey (44.4%). Of 850 patients, 74.8% (636) were female; median age was 56 (interquartile range, 44-66) years. Forty percent (34) of patients had not been seen since their original surgical appointment was delayed; 86.2% (733) of patients had a delay in care with women more likely to have a delay (87.6% vs 82.2% of men, χ = 3.84, P = .05). Median duration of delay was 70 (interquartile range, 42-118) days. Among patients with a delay in care, primary disease site included thyroid (54.2%), parathyroid (37.2%), adrenal (6.5%), and pancreatic/gastrointestinal neuroendocrine tumors (1.3%). In addition, 4.0% (26) of patients experienced disease progression and 4.1% (24) had a change from the initial operative plan. The duration of delay was not associated with disease progression (P = .96) or a change in operative plan (P = .66).
CONCLUSION: Although some patients experienced disease progression during COVID-19 delays to endocrine disease-related care, most patients with follow-up did not. Our analysis indicated that temporary delay may be an acceptable course of action in extreme circumstances for most endocrine-related surgical disease.
McCandlish, John Austin; Ayer, Turgay; Chhatwal, Jagpreet
Cost-Effectiveness and Value-of-Information Analysis Using Machine Learning-Based Metamodeling: A Case of Hepatitis C Treatment Journal Article
In: Med Decis Making, vol. 43, no. 1, pp. 68–77, 2023, ISSN: 1552-681X.
@article{pmid36113098,
title = {Cost-Effectiveness and Value-of-Information Analysis Using Machine Learning-Based Metamodeling: A Case of Hepatitis C Treatment},
author = {John Austin McCandlish and Turgay Ayer and Jagpreet Chhatwal},
doi = {10.1177/0272989X221125418},
issn = {1552-681X},
year = {2023},
date = {2023-01-01},
journal = {Med Decis Making},
volume = {43},
number = {1},
pages = {68--77},
abstract = {BACKGROUND: Metamodels can address some of the limitations of complex simulation models by formulating a mathematical relationship between input parameters and simulation model outcomes. Our objective was to develop and compare the performance of a machine learning (ML)-based metamodel against a conventional metamodeling approach in replicating the findings of a complex simulation model.
METHODS: We constructed 3 ML-based metamodels using random forest, support vector regression, and artificial neural networks and a linear regression-based metamodel from a previously validated microsimulation model of the natural history hepatitis C virus (HCV) consisting of 40 input parameters. Outcomes of interest included societal costs and quality-adjusted life-years (QALYs), the incremental cost-effectiveness (ICER) of HCV treatment versus no treatment, cost-effectiveness analysis curve (CEAC), and expected value of perfect information (EVPI). We evaluated metamodel performance using root mean squared error (RMSE) and Pearson's on the normalized data.
RESULTS: The values for the linear regression metamodel for QALYs without treatment, QALYs with treatment, societal cost without treatment, societal cost with treatment, and ICER were 0.92, 0.98, 0.85, 0.92, and 0.60, respectively. The corresponding values for our ML-based metamodels were 0.96, 0.97, 0.90, 0.95, and 0.49 for support vector regression; 0.99, 0.83, 0.99, 0.99, and 0.82 for artificial neural network; and 0.99, 0.99, 0.99, 0.99, and 0.98 for random forest. Similar trends were observed for RMSE. The CEAC and EVPI curves produced by the random forest metamodel matched the results of the simulation output more closely than the linear regression metamodel.
CONCLUSIONS: ML-based metamodels generally outperformed traditional linear regression metamodels at replicating results from complex simulation models, with random forest metamodels performing best.
HIGHLIGHTS: Decision-analytic models are frequently used by policy makers and other stakeholders to assess the impact of new medical technologies and interventions. However, complex models can impose limitations on conducting probabilistic sensitivity analysis and value-of-information analysis, and may not be suitable for developing online decision-support tools.Metamodels, which accurately formulate a mathematical relationship between input parameters and model outcomes, can replicate complex simulation models and address the above limitation.The machine learning-based random forest model can outperform linear regression in replicating the findings of a complex simulation model. Such a metamodel can be used for conducting cost-effectiveness and value-of-information analyses or developing online decision support tools.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We constructed 3 ML-based metamodels using random forest, support vector regression, and artificial neural networks and a linear regression-based metamodel from a previously validated microsimulation model of the natural history hepatitis C virus (HCV) consisting of 40 input parameters. Outcomes of interest included societal costs and quality-adjusted life-years (QALYs), the incremental cost-effectiveness (ICER) of HCV treatment versus no treatment, cost-effectiveness analysis curve (CEAC), and expected value of perfect information (EVPI). We evaluated metamodel performance using root mean squared error (RMSE) and Pearson's on the normalized data.
RESULTS: The values for the linear regression metamodel for QALYs without treatment, QALYs with treatment, societal cost without treatment, societal cost with treatment, and ICER were 0.92, 0.98, 0.85, 0.92, and 0.60, respectively. The corresponding values for our ML-based metamodels were 0.96, 0.97, 0.90, 0.95, and 0.49 for support vector regression; 0.99, 0.83, 0.99, 0.99, and 0.82 for artificial neural network; and 0.99, 0.99, 0.99, 0.99, and 0.98 for random forest. Similar trends were observed for RMSE. The CEAC and EVPI curves produced by the random forest metamodel matched the results of the simulation output more closely than the linear regression metamodel.
CONCLUSIONS: ML-based metamodels generally outperformed traditional linear regression metamodels at replicating results from complex simulation models, with random forest metamodels performing best.
HIGHLIGHTS: Decision-analytic models are frequently used by policy makers and other stakeholders to assess the impact of new medical technologies and interventions. However, complex models can impose limitations on conducting probabilistic sensitivity analysis and value-of-information analysis, and may not be suitable for developing online decision-support tools.Metamodels, which accurately formulate a mathematical relationship between input parameters and model outcomes, can replicate complex simulation models and address the above limitation.The machine learning-based random forest model can outperform linear regression in replicating the findings of a complex simulation model. Such a metamodel can be used for conducting cost-effectiveness and value-of-information analyses or developing online decision support tools.
2022
Haslwanter, Veronika; Rochau, Ursula; Siebert, Uwe; Schönherr, Hans-Robert; Oberaigner, Willi
A population-based cohort of adult patients with diabetes mellitus in a Western District of Austria: The Diabetes Landeck cohort Journal Article
In: Endocrinol Diabetes Metab, pp. e395, 2022, ISSN: 2398-9238.
@article{pmid36527244,
title = {A population-based cohort of adult patients with diabetes mellitus in a Western District of Austria: The Diabetes Landeck cohort},
author = {Veronika Haslwanter and Ursula Rochau and Uwe Siebert and Hans-Robert Sch\"{o}nherr and Willi Oberaigner},
doi = {10.1002/edm2.395},
issn = {2398-9238},
year = {2022},
date = {2022-12-16},
urldate = {2022-12-01},
journal = {Endocrinol Diabetes Metab},
pages = {e395},
abstract = {INTRODUCTION: Diabetes mellitus (DM) has become an important and exacerbating health epidemic, with severe consequences for both patients and health systems. The National Diabetes Strategy of Austria addresses the lack of high-quality data on DM in Austria and the need for developing a national data network. The aims of our study are to establish a cohort including all adult diabetes patients in a district in western Austria, describe the demographic and clinical characteristics of this cohort, and provide an estimation of diabetes prevalence.
METHODS: We recruited a population-based cohort of adult patients with a diagnosis of DM in cooperation with a network of all caregivers. Data collection was based on a case report form, including patient characteristics, clinical parameters and long-term complications.
RESULTS: In total, 1845 patients with DM were recruited and analysed. We observed an overall prevalence of 5.3% [95% CI: 5.0%-5.5%]. For the subsequent main analysis, we included 1755 patients with DM after excluding 90 patients with gestational DM. There were significant differences between genders in the distribution of specific clinical parameters, patient characteristics, and the long-term complications diabetic foot, amputation and cardiovascular disease.
CONCLUSION: To the best of our knowledge, we established the first diabetes cohort study in Austria. Prevalence and the proportion of specific long-term complications were lower when compared to the international context. We assume that the Diabetes Landeck Cohort has reached a high degree of completeness; however, we were not able to identify independent data sources for a valid check of completeness.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We recruited a population-based cohort of adult patients with a diagnosis of DM in cooperation with a network of all caregivers. Data collection was based on a case report form, including patient characteristics, clinical parameters and long-term complications.
RESULTS: In total, 1845 patients with DM were recruited and analysed. We observed an overall prevalence of 5.3% [95% CI: 5.0%-5.5%]. For the subsequent main analysis, we included 1755 patients with DM after excluding 90 patients with gestational DM. There were significant differences between genders in the distribution of specific clinical parameters, patient characteristics, and the long-term complications diabetic foot, amputation and cardiovascular disease.
CONCLUSION: To the best of our knowledge, we established the first diabetes cohort study in Austria. Prevalence and the proportion of specific long-term complications were lower when compared to the international context. We assume that the Diabetes Landeck Cohort has reached a high degree of completeness; however, we were not able to identify independent data sources for a valid check of completeness.
Efficace, Fabio; Koinig, Karin; Cottone, Francesco; Bowen, David; Mittelman, Moshe; Sommer, Kathrin; Langemeijer, Saskia; Culligan, Dominic; Filanovsky, Kalman; Storck, Michael; Smith, Alexandra; van Marrewijk, Corine; Dugas, Martin; Stojkov, Igor; Siebert, Uwe; de Witte, Theo; Stauder, Reinhard
In: Cancer Med, 2022, ISSN: 2045-7634.
@article{pmid36533415,
title = {Raising the standards of patient-centered outcomes research in myelodysplastic syndromes: Clinical utility and validation of the subscales of the QUALMS from the MDS-RIGHT project},
author = {Fabio Efficace and Karin Koinig and Francesco Cottone and David Bowen and Moshe Mittelman and Kathrin Sommer and Saskia Langemeijer and Dominic Culligan and Kalman Filanovsky and Michael Storck and Alexandra Smith and Corine van Marrewijk and Martin Dugas and Igor Stojkov and Uwe Siebert and Theo de Witte and Reinhard Stauder},
doi = {10.1002/cam4.5487},
issn = {2045-7634},
year = {2022},
date = {2022-12-01},
journal = {Cancer Med},
abstract = {BACKGROUND: Clinical decision-making for patients with myelodysplastic syndromes (MDS) is challenging, and both disease and treatment effects heavily impact health-related quality of life (HRQoL) of these patients. Therefore, disease-specific HRQoL measures can be critical to harness the patient voice in MDS research.
METHODS: We report a prospective international validation study of the Quality of Life in Myelodysplasia Scale (QUALMS) with a main focus on providing information on the psychometric characteristics of its three subscales: physical burden (QUALMS-P), emotional burden (QUALMS-E), and benefit finding (QUALMS-BF). The analysis is based on patients enrolled from three European countries and Israel, participating to the MDS-RIGHT Project. The scale structure and psychometric properties of the QUALMS were assessed.
RESULTS: Overall, 270 patients with a median age of 74 years were analyzed and the majority of them (60.3%) had a low MDS-Comorbidity Index score. Results of the confirmatory factor analysis supported the underlying scale structure of the QUALMS, which, in addition to a total score, includes three subscales: QUALMS-P, QUALMS-E, and the QUALMS-BF. The QUALMS-P exhibited the highest Cronbach's alpha coefficients. Discriminant validity analysis indicated good results with the QUALMS-P and QUALMS-E distinguishing between patients with different performance status, comorbidity, anemia, and transfusion dependency status. No floor and ceiling effects were observed. Responsiveness to change analysis supported the validity of the measure. Patients with a hemoglobin (Hb) level of <11 g/dL at study entry, who subsequently showed an improvement in their Hb levels, also reported a mean score change of 9 and 8 points (scales ranging between 0 and 100) in the expected direction of the QUALMS-E and QUALMS-P, respectively.
CONCLUSIONS: Our study provides additional validation data on the QUALMS from the international MDS-RIGHT Project. The use of this disease-specific HRQoL measure may contribute to raise quality standards of patient-centered outcomes research in MDS.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We report a prospective international validation study of the Quality of Life in Myelodysplasia Scale (QUALMS) with a main focus on providing information on the psychometric characteristics of its three subscales: physical burden (QUALMS-P), emotional burden (QUALMS-E), and benefit finding (QUALMS-BF). The analysis is based on patients enrolled from three European countries and Israel, participating to the MDS-RIGHT Project. The scale structure and psychometric properties of the QUALMS were assessed.
RESULTS: Overall, 270 patients with a median age of 74 years were analyzed and the majority of them (60.3%) had a low MDS-Comorbidity Index score. Results of the confirmatory factor analysis supported the underlying scale structure of the QUALMS, which, in addition to a total score, includes three subscales: QUALMS-P, QUALMS-E, and the QUALMS-BF. The QUALMS-P exhibited the highest Cronbach's alpha coefficients. Discriminant validity analysis indicated good results with the QUALMS-P and QUALMS-E distinguishing between patients with different performance status, comorbidity, anemia, and transfusion dependency status. No floor and ceiling effects were observed. Responsiveness to change analysis supported the validity of the measure. Patients with a hemoglobin (Hb) level of <11 g/dL at study entry, who subsequently showed an improvement in their Hb levels, also reported a mean score change of 9 and 8 points (scales ranging between 0 and 100) in the expected direction of the QUALMS-E and QUALMS-P, respectively.
CONCLUSIONS: Our study provides additional validation data on the QUALMS from the international MDS-RIGHT Project. The use of this disease-specific HRQoL measure may contribute to raise quality standards of patient-centered outcomes research in MDS.
Sonawane, Kalyani; Castellano, Tara; Washington, Christina; Ting, Jie; Surinach, Andy; Kirshner, Carol; Chhatwal, Jagpreet; Ayer, Turgay; Moore, Kathleen
In: Gynecol Oncol Rep, vol. 44, no. Suppl 1, pp. 101101, 2022, ISSN: 2352-5789.
@article{pmid36506039,
title = {Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis},
author = {Kalyani Sonawane and Tara Castellano and Christina Washington and Jie Ting and Andy Surinach and Carol Kirshner and Jagpreet Chhatwal and Turgay Ayer and Kathleen Moore},
doi = {10.1016/j.gore.2022.101101},
issn = {2352-5789},
year = {2022},
date = {2022-12-01},
journal = {Gynecol Oncol Rep},
volume = {44},
number = {Suppl 1},
pages = {101101},
abstract = {PURPOSE: Contemporary, real-world data on eligible patients receiving treatment following progression on first-line (1L) recurrent or metastatic cervical cancer (r/mCC) therapy are needed to inform treatment algorithms and identify potential gaps in the r/mCC care continuum.
METHODS: This study estimated the prevalence and predictors of second-line (2L) r/mCC therapy among 1L-treated patients using the 2015-2020 IBM MarketScan® commercial claims database. Women ≥ 18 years diagnosed with cervical cancer and treated with first-line systemic therapies were identified and followed for 12 months from their 1L therapy end date. Women with claims for a new therapy after 60 days but no later than 365 days from the end of 1L treatment were identified as those who progressed and received 2L therapy for r/mCC. Descriptive statistics examined baseline cohort characteristics and multivariable logistic regression model examined the factors associated with receiving 2L treatment.
RESULTS: We identified 384 1L-treated patients with r/mCC with ≥ 12 months of follow-up post-1L treatment. During follow-up, over half (51.0 %) of the 1L-treated r/mCC patients received 2L treatment. Patients from the South and Midwest had a lower likelihood of receiving 2L treatment compared with those living in the Northeast (adjusted odds ratio [aOR] = 0.43; 0.23-0.84) and (aOR = 0.52; 0.28-0.95, respectively). Patients not treated with bevacizumab in 1L were also less likely to receive 2L therapy (aOR = 0.65; 0.43-0.99).
CONCLUSION: Additional research and targeted outreach efforts are needed to understand geography-, population-, or practice-specific barriers impacting access to 2L therapy among patients with r/mCC.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: This study estimated the prevalence and predictors of second-line (2L) r/mCC therapy among 1L-treated patients using the 2015-2020 IBM MarketScan® commercial claims database. Women ≥ 18 years diagnosed with cervical cancer and treated with first-line systemic therapies were identified and followed for 12 months from their 1L therapy end date. Women with claims for a new therapy after 60 days but no later than 365 days from the end of 1L treatment were identified as those who progressed and received 2L therapy for r/mCC. Descriptive statistics examined baseline cohort characteristics and multivariable logistic regression model examined the factors associated with receiving 2L treatment.
RESULTS: We identified 384 1L-treated patients with r/mCC with ≥ 12 months of follow-up post-1L treatment. During follow-up, over half (51.0 %) of the 1L-treated r/mCC patients received 2L treatment. Patients from the South and Midwest had a lower likelihood of receiving 2L treatment compared with those living in the Northeast (adjusted odds ratio [aOR] = 0.43; 0.23-0.84) and (aOR = 0.52; 0.28-0.95, respectively). Patients not treated with bevacizumab in 1L were also less likely to receive 2L therapy (aOR = 0.65; 0.43-0.99).
CONCLUSION: Additional research and targeted outreach efforts are needed to understand geography-, population-, or practice-specific barriers impacting access to 2L therapy among patients with r/mCC.
Steigenberger, Caroline; Flatscher-Thoeni, Magdalena; Siebert, Uwe; Leiter, Andrea M
Determinants of willingness to pay for health services: a systematic review of contingent valuation studies Journal Article
In: Eur J Health Econ, vol. 23, no. 9, pp. 1455–1482, 2022, ISSN: 1618-7601.
@article{pmid35166973,
title = {Determinants of willingness to pay for health services: a systematic review of contingent valuation studies},
author = {Caroline Steigenberger and Magdalena Flatscher-Thoeni and Uwe Siebert and Andrea M Leiter},
doi = {10.1007/s10198-022-01437-x},
issn = {1618-7601},
year = {2022},
date = {2022-12-01},
journal = {Eur J Health Econ},
volume = {23},
number = {9},
pages = {1455--1482},
abstract = {INTRODUCTION: Stated preference studies are a valuable tool to elicit respondents' willingness to pay (WTP) for goods or services, especially in situations where no market valuation exists. Contingent valuation (CV) is a widely used approach among stated-preference techniques for eliciting WTP if prices do not exist or do not reflect actual costs, for example, when services are covered by insurance. This review aimed to provide an overview of relevant factors determining WTP for health services to support variable selection.
METHODS: A comprehensive systematic literature search and review of CV studies assessing determinants of WTP for health services was conducted, including 11 electronic databases. Two of the authors made independent decisions on the eligibility of studies. We extracted all determinants used and related p values for the effect sizes (e.g. reported in regression models with WTP for a health service as outcome variable). Determinants were summarised in systematic evidence tables and structured by thematic domains.
RESULTS: We identified 2082 publications, of which 202 full texts were checked for eligibility. We included 62 publications on 61 studies in the review. Across all studies, we identified 22 WTP determinants and other factors from 5 thematic domains: sociodemographic characteristics, perceived threat, perceived benefit, perceived barriers, and other information.
CONCLUSION: Our review provides evidence on 22 relevant determinants of WTP for health services, which may be used for variable selection and as guidance for planning CV surveys. Endogeneity should be carefully considered before interpreting these determinants as causal factors and potential intervention targets.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: A comprehensive systematic literature search and review of CV studies assessing determinants of WTP for health services was conducted, including 11 electronic databases. Two of the authors made independent decisions on the eligibility of studies. We extracted all determinants used and related p values for the effect sizes (e.g. reported in regression models with WTP for a health service as outcome variable). Determinants were summarised in systematic evidence tables and structured by thematic domains.
RESULTS: We identified 2082 publications, of which 202 full texts were checked for eligibility. We included 62 publications on 61 studies in the review. Across all studies, we identified 22 WTP determinants and other factors from 5 thematic domains: sociodemographic characteristics, perceived threat, perceived benefit, perceived barriers, and other information.
CONCLUSION: Our review provides evidence on 22 relevant determinants of WTP for health services, which may be used for variable selection and as guidance for planning CV surveys. Endogeneity should be carefully considered before interpreting these determinants as causal factors and potential intervention targets.
Kuehne, Felicitas; Arvandi, Marjan; Hess, Lisa M; Faries, Douglas E; Gothe, Raffaella Matteucci; Gothe, Holger; Beyrer, Julie; Zeimet, Alain Gustave; Stojkov, Igor; Mühlberger, Nikolai; Oberaigner, Willi; Marth, Christian; Siebert, Uwe
In: J Clin Epidemiol, vol. 152, pp. 269-280, 2022, ISSN: 1878-5921.
@article{pmid36252741,
title = {Causal analyses with target trial emulation for real-world evidence removed large self-inflicted biases: Systematic bias assessment of ovarian cancer treatment effectiveness},
author = {Felicitas Kuehne and Marjan Arvandi and Lisa M Hess and Douglas E Faries and Raffaella Matteucci Gothe and Holger Gothe and Julie Beyrer and Alain Gustave Zeimet and Igor Stojkov and Nikolai M\"{u}hlberger and Willi Oberaigner and Christian Marth and Uwe Siebert},
doi = {10.1016/j.jclinepi.2022.10.005},
issn = {1878-5921},
year = {2022},
date = {2022-12-01},
urldate = {2022-10-01},
journal = {J Clin Epidemiol},
volume = {152},
pages = {269-280},
abstract = {BACKGROUND: Drawing causal conclusions from real-world data (RWD) poses methodological challenges and risk of bias. We aimed to systematically assess the type and impact of potential biases that may occur when analyzing RWD using the case of progressive ovarian cancer.
METHODS: We retrospectively compared overall survival with and without second-line chemotherapy using electronic medical records. Potential biases were determined using directed acyclic graphs. We followed a stepwise analytic approach ranging from crude analysis and multivariable-adjusted Cox model up to a full causal analysis using a marginal-structural-Cox-model (MSCM) with replicates emulating a reference randomized controlled trial. To assess biases, we compared effect estimates (hazard ratios [HRs]) of each approach to the HR of the reference trial.
RESULTS: The reference trial showed a HR for second-line versus delayed-therapy of 1.01 (95% confidence interval [95%CI]: 0.82-1.25). The corresponding HRs from the RWD analysis ranged from 0.51 for simple baseline adjustments to 1.41 (95%CI 1.22-1.64) accounting for immortal time bias with time-varying covariates. Causal trial emulation yielded a HR of 1.12 (95%CI: 0.96-1.28).
CONCLUSIONS: Our study, using ovarian cancer as an example, shows the importance of a thorough causal design and analysis if one is expecting RWD to emulate clinical trial results.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We retrospectively compared overall survival with and without second-line chemotherapy using electronic medical records. Potential biases were determined using directed acyclic graphs. We followed a stepwise analytic approach ranging from crude analysis and multivariable-adjusted Cox model up to a full causal analysis using a marginal-structural-Cox-model (MSCM) with replicates emulating a reference randomized controlled trial. To assess biases, we compared effect estimates (hazard ratios [HRs]) of each approach to the HR of the reference trial.
RESULTS: The reference trial showed a HR for second-line versus delayed-therapy of 1.01 (95% confidence interval [95%CI]: 0.82-1.25). The corresponding HRs from the RWD analysis ranged from 0.51 for simple baseline adjustments to 1.41 (95%CI 1.22-1.64) accounting for immortal time bias with time-varying covariates. Causal trial emulation yielded a HR of 1.12 (95%CI: 0.96-1.28).
CONCLUSIONS: Our study, using ovarian cancer as an example, shows the importance of a thorough causal design and analysis if one is expecting RWD to emulate clinical trial results.
Rainer, Lukas; Bachner, Florian; Eglau, Karin; Ostermann, Herwig; Siebert, Uwe; Zuba, Martin
Comorbidities and COVID-19 hospitalization, ICU admission and hospital mortality in Austria : A retrospective cohort study Journal Article
In: Wien Klin Wochenschr, vol. 134, no. 23-24, pp. 856–867, 2022, ISSN: 1613-7671.
@article{pmid35608673,
title = {Comorbidities and COVID-19 hospitalization, ICU admission and hospital mortality in Austria : A retrospective cohort study},
author = {Lukas Rainer and Florian Bachner and Karin Eglau and Herwig Ostermann and Uwe Siebert and Martin Zuba},
doi = {10.1007/s00508-022-02036-9},
issn = {1613-7671},
year = {2022},
date = {2022-12-01},
journal = {Wien Klin Wochenschr},
volume = {134},
number = {23-24},
pages = {856--867},
abstract = {BACKGROUND: The protection of vulnerable populations is a central task in managing the Coronavirus disease 2019 (COVID-19) pandemic to avoid severe courses of COVID-19 and the risk of healthcare system capacity being exceeded. To identify factors of vulnerability in Austria, we assessed the impact of comorbidities on COVID-19 hospitalization, intensive care unit (ICU) admission, and hospital mortality.
METHODS: A retrospective cohort study was performed including all patients with COVID-19 in the period February 2020 to December 2021 who had a previous inpatient stay in the period 2015-2019 in Austria. All patients with COVID-19 were matched to population controls on age, sex, and healthcare region. Multiple logistic regression was used to estimate adjusted odds ratios (OR) of included factors with 95% confidence intervals (CI).
RESULTS: Hemiplegia or paraplegia constitutes the highest risk factor for hospitalization (OR 1.61, 95% CI 1.44-1.79), followed by COPD (OR 1.48, 95% CI 1.43-1.53) and diabetes without complications (OR 1.41, 95% CI 1.37-1.46). The highest risk factors for ICU admission are renal diseases (OR 1.76, 95% CI 1.61-1.92), diabetes without complications (OR 1.57, 95% CI 1.46-1.69) and COPD (OR 1.53, 95% CI 1.41-1.66). Hemiplegia or paraplegia, renal disease and COPD constitute the highest risk factors for hospital mortality, with ORs of 1.5. Diabetes without complications constitutes a significantly higher risk factor for women with respect to all three endpoints.
CONCLUSION: We contribute to the literature by identifying sex-specific risk factors. In general, our results are consistent with the literature, particularly regarding diabetes as a risk factor for severe courses of COVID-19. Due to the observational nature of our data, caution is warranted regarding causal interpretation. Our results contribute to the protection of vulnerable populations and may be used for targeting further pharmaceutical interventions.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: A retrospective cohort study was performed including all patients with COVID-19 in the period February 2020 to December 2021 who had a previous inpatient stay in the period 2015-2019 in Austria. All patients with COVID-19 were matched to population controls on age, sex, and healthcare region. Multiple logistic regression was used to estimate adjusted odds ratios (OR) of included factors with 95% confidence intervals (CI).
RESULTS: Hemiplegia or paraplegia constitutes the highest risk factor for hospitalization (OR 1.61, 95% CI 1.44-1.79), followed by COPD (OR 1.48, 95% CI 1.43-1.53) and diabetes without complications (OR 1.41, 95% CI 1.37-1.46). The highest risk factors for ICU admission are renal diseases (OR 1.76, 95% CI 1.61-1.92), diabetes without complications (OR 1.57, 95% CI 1.46-1.69) and COPD (OR 1.53, 95% CI 1.41-1.66). Hemiplegia or paraplegia, renal disease and COPD constitute the highest risk factors for hospital mortality, with ORs of 1.5. Diabetes without complications constitutes a significantly higher risk factor for women with respect to all three endpoints.
CONCLUSION: We contribute to the literature by identifying sex-specific risk factors. In general, our results are consistent with the literature, particularly regarding diabetes as a risk factor for severe courses of COVID-19. Due to the observational nature of our data, caution is warranted regarding causal interpretation. Our results contribute to the protection of vulnerable populations and may be used for targeting further pharmaceutical interventions.
Garcia, Gian-Gabriel P; Stringfellow, Erin J; DiGennaro, Catherine; Poellinger, Nicole; Wood, Jaden; Wakeman, Sarah; Jalali, Mohammad S
Opioid overdose decedent characteristics during COVID-19 Journal Article
In: Ann Med, vol. 54, no. 1, pp. 1081–1088, 2022, ISSN: 1365-2060.
@article{pmid35467475,
title = {Opioid overdose decedent characteristics during COVID-19},
author = {Gian-Gabriel P Garcia and Erin J Stringfellow and Catherine DiGennaro and Nicole Poellinger and Jaden Wood and Sarah Wakeman and Mohammad S Jalali},
doi = {10.1080/07853890.2022.2067350},
issn = {1365-2060},
year = {2022},
date = {2022-12-01},
journal = {Ann Med},
volume = {54},
number = {1},
pages = {1081--1088},
abstract = {INTRODUCTION: Alongside the emergence of COVID-19 in the United States, several reports highlighted increasing rates of opioid overdose from preliminary data. Yet, little is known about how state-level opioid overdose death trends and decedent characteristics have evolved using official death records.
METHODS: We requested vital statistics data from 2018-2020 from all 50 states and the District of Columbia, receiving data from 14 states. Accounting for COVID-19, we excluded states without data past March 2020, leaving 11 states for analysis. We defined state-specific analysis periods from March 13 until the latest reliable date in each state's data, then conducted retrospective year-over-year analyses comparing opioid-related overdose death rates, the presence of specific opioids and other psychoactive substances, and decedents' sex, race, and age from 2020 to 2019 and 2019 to 2018 within each state's analysis period. We assessed whether significant changes in 2020 vs. 2019 in opioid overdose deaths were new or continuing trends using joinpoint regression.
RESULTS: We found significant increases in opioid-related overdose death rates in Alaska (55.3%), Colorado (80.2%), Indiana (40.1%), Nevada (50.0%), North Carolina (30.5%), Rhode Island (29.6%), and Virginia (66.4%) - all continuing previous trends. Increases in synthetic opioid-involved overdose deaths were new in Alaska (136.5%), Indiana (27.6%), and Virginia (16.5%), whilst continuing in Colorado (44.4%), Connecticut (3.6%), Nevada (75.0%), and North Carolina (14.6%). We found new increases in male decedents in Indiana (12.0%), and continuing increases in Colorado (15.2%). We also found continuing increases in Black non-Hispanic decedents in Massachusetts (43.9%) and Virginia (33.7%).
CONCLUSION: This research analyzes vital statistics data from 11 states, highlighting new trends in opioid overdose deaths and decedent characteristics across 10 of these states. These findings can inform state-specific public health interventions and highlight the need for timely and comprehensive fatal opioid overdose data, especially amidst concurrent crises such as COVID-19. Key messages:Our results highlight shifts in opioid overdose trends during the COVID-19 pandemic that cannot otherwise be extracted from aggregated or provisional opioid overdose death data such as those published by the Centres for Disease Control and Prevention.Fentanyl and other synthetic opioids continue to drive increases in fatal overdoses, making it difficult to separate these trends from any possible COVID-19-related factors.Black non-Hispanic people are making up an increasing proportion of opioid overdose deaths in some states.State-specific limitations and variations in data-reporting for vital statistics make it challenging to acquire and analyse up-to-date data on opioid-related overdose deaths. More timely and comprehensive data are needed to generate broader insights on the nature of the intersecting opioid and COVID-19 crises.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We requested vital statistics data from 2018-2020 from all 50 states and the District of Columbia, receiving data from 14 states. Accounting for COVID-19, we excluded states without data past March 2020, leaving 11 states for analysis. We defined state-specific analysis periods from March 13 until the latest reliable date in each state's data, then conducted retrospective year-over-year analyses comparing opioid-related overdose death rates, the presence of specific opioids and other psychoactive substances, and decedents' sex, race, and age from 2020 to 2019 and 2019 to 2018 within each state's analysis period. We assessed whether significant changes in 2020 vs. 2019 in opioid overdose deaths were new or continuing trends using joinpoint regression.
RESULTS: We found significant increases in opioid-related overdose death rates in Alaska (55.3%), Colorado (80.2%), Indiana (40.1%), Nevada (50.0%), North Carolina (30.5%), Rhode Island (29.6%), and Virginia (66.4%) - all continuing previous trends. Increases in synthetic opioid-involved overdose deaths were new in Alaska (136.5%), Indiana (27.6%), and Virginia (16.5%), whilst continuing in Colorado (44.4%), Connecticut (3.6%), Nevada (75.0%), and North Carolina (14.6%). We found new increases in male decedents in Indiana (12.0%), and continuing increases in Colorado (15.2%). We also found continuing increases in Black non-Hispanic decedents in Massachusetts (43.9%) and Virginia (33.7%).
CONCLUSION: This research analyzes vital statistics data from 11 states, highlighting new trends in opioid overdose deaths and decedent characteristics across 10 of these states. These findings can inform state-specific public health interventions and highlight the need for timely and comprehensive fatal opioid overdose data, especially amidst concurrent crises such as COVID-19. Key messages:Our results highlight shifts in opioid overdose trends during the COVID-19 pandemic that cannot otherwise be extracted from aggregated or provisional opioid overdose death data such as those published by the Centres for Disease Control and Prevention.Fentanyl and other synthetic opioids continue to drive increases in fatal overdoses, making it difficult to separate these trends from any possible COVID-19-related factors.Black non-Hispanic people are making up an increasing proportion of opioid overdose deaths in some states.State-specific limitations and variations in data-reporting for vital statistics make it challenging to acquire and analyse up-to-date data on opioid-related overdose deaths. More timely and comprehensive data are needed to generate broader insights on the nature of the intersecting opioid and COVID-19 crises.
Chen, Qiushi; Griffin, Paul M; Kawasaki, Sarah S
Disability-Adjusted Life Years for Drug Overdose Crisis and COVID-19 Are Comparable During the Two Years of Pandemic in the United States Journal Article
In: Value Health, 2022, ISSN: 1524-4733.
@article{pmid36436793,
title = {Disability-Adjusted Life Years for Drug Overdose Crisis and COVID-19 Are Comparable During the Two Years of Pandemic in the United States},
author = {Qiushi Chen and Paul M Griffin and Sarah S Kawasaki},
doi = {10.1016/j.jval.2022.11.010},
issn = {1524-4733},
year = {2022},
date = {2022-11-01},
journal = {Value Health},
abstract = {OBJECTIVES: The drug overdose crisis with shifting patterns from primarily opioid to polysubstance uses and COVID-19 infections are two concurrent public health crises in the United States, affecting the population of sizes in different magnitudes (approximately <10 million for substance use disorder (SUD) and drug overdoses vs. 80 million for COVID-19 within two years of the pandemic). Our objective is to compare the relative scale of disease burden for the two crises within a common framework, which could help inform policymakers with resource allocation and prioritization strategies.
METHODS: We calculated disability-adjusted life years (DALYs) for SUD (including opioids and stimulants) and COVID-19 infections, respectively. We collected estimates for SUD prevalence, overdose deaths, COVID-19 cases and deaths, disability weights, and life expectancy from multiple publicly available sources. We then compared age distributions of estimated DALYs.
RESULTS: We estimated a total burden of 13.83 million DALYs for SUD and drug overdoses and 15.03 million DALYs for COVID-19 in two years since March 2020. COVID-19 burden was dominated by the fatal burden (>95% of total DALYs), whereas SUD burden was attributed to both fatal (53%) and non-fatal burdens (47%). The highest disease burden was among individuals aged 30-39 for SUD (27%) and 50-64 for COVID-19 (31%).
CONCLUSIONS: Despite the smaller size of the affected population, SUD and drug overdoses resulted in comparable disease burden to the COVID-19 pandemic. Additional resources supporting evidence-based interventions in prevention and treatment may be warranted to ameliorate SUD and drug overdoses during both the pandemic and post-pandemic recovery.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We calculated disability-adjusted life years (DALYs) for SUD (including opioids and stimulants) and COVID-19 infections, respectively. We collected estimates for SUD prevalence, overdose deaths, COVID-19 cases and deaths, disability weights, and life expectancy from multiple publicly available sources. We then compared age distributions of estimated DALYs.
RESULTS: We estimated a total burden of 13.83 million DALYs for SUD and drug overdoses and 15.03 million DALYs for COVID-19 in two years since March 2020. COVID-19 burden was dominated by the fatal burden (>95% of total DALYs), whereas SUD burden was attributed to both fatal (53%) and non-fatal burdens (47%). The highest disease burden was among individuals aged 30-39 for SUD (27%) and 50-64 for COVID-19 (31%).
CONCLUSIONS: Despite the smaller size of the affected population, SUD and drug overdoses resulted in comparable disease burden to the COVID-19 pandemic. Additional resources supporting evidence-based interventions in prevention and treatment may be warranted to ameliorate SUD and drug overdoses during both the pandemic and post-pandemic recovery.
Herzog, Chiara; Sundström, Karin; Jones, Allison; Evans, Iona; Barrett, James E; Wang, Jiangrong; Redl, Elisa; Schreiberhuber, Lena; Costas, Laura; Paytubi, Sonia; Dostalek, Lukas; Zikan, Michal; Cibula, David; Sroczynski, Gaby; Siebert, Uwe; Dillner, Joakim; Widschwendter, Martin
In: Clin Epigenetics, vol. 14, no. 1, pp. 150, 2022, ISSN: 1868-7083.
@article{pmid36414968,
title = {DNA methylation-based detection and prediction of cervical intraepithelial neoplasia grade 3 and invasive cervical cancer with the WID™-qCIN test},
author = {Chiara Herzog and Karin Sundstr\"{o}m and Allison Jones and Iona Evans and James E Barrett and Jiangrong Wang and Elisa Redl and Lena Schreiberhuber and Laura Costas and Sonia Paytubi and Lukas Dostalek and Michal Zikan and David Cibula and Gaby Sroczynski and Uwe Siebert and Joakim Dillner and Martin Widschwendter},
doi = {10.1186/s13148-022-01353-0},
issn = {1868-7083},
year = {2022},
date = {2022-11-01},
journal = {Clin Epigenetics},
volume = {14},
number = {1},
pages = {150},
abstract = {BACKGROUND: Cervical screening using primary human papilloma virus (HPV) testing and cytology is being implemented in several countries. Cytology as triage for colposcopy referral suffers from several shortcomings. HPV testing overcomes some of these but lacks specificity in women under 30. Here, we aimed to develop and validate an automatable triage test that is highly sensitive and specific independently of age and sample heterogeneity, and predicts progression to CIN3+ in HPV+ patients.
RESULTS: The WID™-qCIN, assessing three regions in human genes DPP6, RALYL, and GSX1, was validated in both a diagnostic (case-control) and predictive setting (nested case-control), in a total of 761 samples. Using a predefined threshold, the sensitivity of the WID™-qCIN test was 100% and 78% to detect invasive cancer and CIN3, respectively. Sensitivity to detect CIN3+ was 65% and 83% for women < and ≥ 30 years of age. The specificity was 90%. Importantly, the WID™-qCIN test identified 52% of ≥ 30-year-old women with a cytology negative (cyt-) index sample who were diagnosed with CIN3 1-4 years after sample donation.
CONCLUSION: We identified suitable DNAme regions in an epigenome-wide discovery using HPV+ controls and CIN3+ cases and established the WID™-qCIN, a PCR-based DNAme test. The WID™-qCIN test has a high sensitivity and specificity that may outperform conventional cervical triage tests and can in an objective, cheap, and scalable fashion identify most women with and at risk of (pre-)invasive cervical cancer. However, evaluation was limited to case-control settings and future studies will assess performance and generalisability in a randomised controlled trial.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
RESULTS: The WID™-qCIN, assessing three regions in human genes DPP6, RALYL, and GSX1, was validated in both a diagnostic (case-control) and predictive setting (nested case-control), in a total of 761 samples. Using a predefined threshold, the sensitivity of the WID™-qCIN test was 100% and 78% to detect invasive cancer and CIN3, respectively. Sensitivity to detect CIN3+ was 65% and 83% for women < and ≥ 30 years of age. The specificity was 90%. Importantly, the WID™-qCIN test identified 52% of ≥ 30-year-old women with a cytology negative (cyt-) index sample who were diagnosed with CIN3 1-4 years after sample donation.
CONCLUSION: We identified suitable DNAme regions in an epigenome-wide discovery using HPV+ controls and CIN3+ cases and established the WID™-qCIN, a PCR-based DNAme test. The WID™-qCIN test has a high sensitivity and specificity that may outperform conventional cervical triage tests and can in an objective, cheap, and scalable fashion identify most women with and at risk of (pre-)invasive cervical cancer. However, evaluation was limited to case-control settings and future studies will assess performance and generalisability in a randomised controlled trial.
Kramer, Jennifer R; Cao, Yumei; Li, Liang; Smith, Donna; Chhatwal, Jagpreet; El-Serag, Hashem B; Kanwal, Fasiha
Longitudinal Associations of Risk Factors and Hepatocellular Carcinoma in Patients With Cured Hepatitis C Virus Infection Journal Article
In: Am J Gastroenterol, vol. 117, no. 11, pp. 1834–1844, 2022, ISSN: 1572-0241.
@article{pmid36327437,
title = {Longitudinal Associations of Risk Factors and Hepatocellular Carcinoma in Patients With Cured Hepatitis C Virus Infection},
author = {Jennifer R Kramer and Yumei Cao and Liang Li and Donna Smith and Jagpreet Chhatwal and Hashem B El-Serag and Fasiha Kanwal},
doi = {10.14309/ajg.0000000000001968},
issn = {1572-0241},
year = {2022},
date = {2022-11-01},
journal = {Am J Gastroenterol},
volume = {117},
number = {11},
pages = {1834--1844},
abstract = {INTRODUCTION: There are limited data on the effect and evolution of risk factors for hepatocellular carcinoma (HCC) in patients with virologically cured hepatitis C virus (HCV) infection.
METHODS: We conducted a retrospective cohort study of patients with HCV who achieved sustained virological response with direct-acting antivirals from 130 Veterans Administration hospitals during 2014-2018, followed through 2021. Cox proportional hazards models were constructed at 3 landmark times (baseline and 12 and 24 months after sustained virological response) to examine associations between demographic, clinical, and behavioral factors and HCC risk, stratified by cirrhosis status.
RESULTS: Among 92,567 patients (32% cirrhosis), 3,247 cases of HCC were diagnosed during a mean follow-up of 2.5 years. In patients with cirrhosis, male sex (hazard ratios [HR]: 1.89, 1.93, and 1.99), cirrhosis duration ≥5 years (HR: 1.71, 1.79, and 1.34), varices (HR: 1.73, 1.60, and 1.56), baseline albumin (HR: 0.48, 0.47, and 0.49), and change in albumin (HR: 0.82 and 0.90) predicted HCC risk at each landmark time. HCV genotype 3, previous treatment, bilirubin, smoking, and race influenced HCC risk at baseline, but their effects attenuated over time. In patients without cirrhosis, diabetes (HR: 1.54, 1.42, and 1.47) and hypertension (HR: 1.59, 1.65, and 1.74) were associated with HCC risk at all landmark times. Changes in fibrosis-4 scores over time were associated with HCC risk both in patients with and without cirrhosis.
DISCUSSION: Risk factors for HCC were different in patients with and without cirrhosis and some also evolved during follow-up. These factors can help with risk stratification and HCC surveillance decisions in patients with cured HCV.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}
METHODS: We conducted a retrospective cohort study of patients with HCV who achieved sustained virological response with direct-acting antivirals from 130 Veterans Administration hospitals during 2014-2018, followed through 2021. Cox proportional hazards models were constructed at 3 landmark times (baseline and 12 and 24 months after sustained virological response) to examine associations between demographic, clinical, and behavioral factors and HCC risk, stratified by cirrhosis status.
RESULTS: Among 92,567 patients (32% cirrhosis), 3,247 cases of HCC were diagnosed during a mean follow-up of 2.5 years. In patients with cirrhosis, male sex (hazard ratios [HR]: 1.89, 1.93, and 1.99), cirrhosis duration ≥5 years (HR: 1.71, 1.79, and 1.34), varices (HR: 1.73, 1.60, and 1.56), baseline albumin (HR: 0.48, 0.47, and 0.49), and change in albumin (HR: 0.82 and 0.90) predicted HCC risk at each landmark time. HCV genotype 3, previous treatment, bilirubin, smoking, and race influenced HCC risk at baseline, but their effects attenuated over time. In patients without cirrhosis, diabetes (HR: 1.54, 1.42, and 1.47) and hypertension (HR: 1.59, 1.65, and 1.74) were associated with HCC risk at all landmark times. Changes in fibrosis-4 scores over time were associated with HCC risk both in patients with and without cirrhosis.
DISCUSSION: Risk factors for HCC were different in patients with and without cirrhosis and some also evolved during follow-up. These factors can help with risk stratification and HCC surveillance decisions in patients with cured HCV.
Javed, Sumreen; Soukhtehzari, Sepideh; Fernandes, Nazarine; Williams, Karla C
Longitudinal bioluminescence imaging to monitor breast tumor growth and treatment response using the chick chorioallantoic membrane model Journal Article
In: Sci Rep, vol. 12, no. 1, pp. 17192, 2022, ISSN: 2045-2322.
@article{pmid36229503,
title = {Longitudinal bioluminescence imaging to monitor breast tumor growth and treatment response using the chick chorioallantoic membrane model},
author = {Sumreen Javed and Sepideh Soukhtehzari and Nazarine Fernandes and Karla C Williams},
doi = {10.1038/s41598-022-20854-9},
issn = {2045-2322},
year = {2022},
date = {2022-10-01},
journal = {Sci Rep},
volume = {12},
number = {1},
pages = {17192},
abstract = {The development of successful treatment regimens for breast cancer requires strong pre-clinical data generated in physiologically relevant pre-clinical models. Here we report the development of the chick embryo chorioallantoic membrane (CAM) model to study tumor growth and angiogenesis using breast cancer cell lines. MDA-MB-231 and MCF7 tumor cell lines were engrafted onto the chick embryo CAM to study tumor growth and treatment response. Tumor growth was evaluated through bioluminescence imaging and a significant increase in tumor size and vascularization was found over a 9-day period. We then evaluated the impact of anti-angiogenic drugs, axitinib and bevacizumab, on tumor growth and angiogenesis. Drug treatment significantly reduced tumor vascularization and size. Overall, our findings demonstrate that the chick embryo CAM is a clinically relevant model to monitor therapeutic response in breast cancer and can be used as a platform for drug screening to evaluate not only gross changes in tumor burden but physiological processes such as angiogenesis.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}