scholarly journals Implementation of serological and molecular tools to inform COVID-19 patient management: protocol for the GENCOV prospective cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e052842
Author(s):  
Jennifer Taher ◽  
Chloe Mighton ◽  
Sunakshi Chowdhary ◽  
Selina Casalino ◽  
Erika Frangione ◽  
...  
Keyword(s):  
Immune Response ◽  
Cohort Study ◽  
Antibody Response ◽  
Patient Outcomes ◽  
Patient Reported Outcomes ◽  
Sequence Information ◽  
Management Protocol ◽  
Patient Reported ◽  
The Impact ◽  
Viral Lineage

IntroductionThere is considerable variability in symptoms and severity of COVID-19 among patients infected by the SARS-CoV-2 virus. Linking host and virus genome sequence information to antibody response and biological information may identify patient or viral characteristics associated with poor and favourable outcomes. This study aims to (1) identify characteristics of the antibody response that result in maintained immune response and better outcomes, (2) determine the impact of genetic differences on infection severity and immune response, (3) determine the impact of viral lineage on antibody response and patient outcomes and (4) evaluate patient-reported outcomes of receiving host genome, antibody and viral lineage results.Methods and analysisA prospective, observational cohort study is being conducted among adult patients with COVID-19 in the Greater Toronto Area. Blood samples are collected at baseline (during infection) and 1, 6 and 12 months after diagnosis. Serial antibody titres, isotype, antigen target and viral neutralisation will be assessed. Clinical data will be collected from chart reviews and patient surveys. Host genomes and T-cell and B-cell receptors will be sequenced. Viral genomes will be sequenced to identify viral lineage. Regression models will be used to test associations between antibody response, physiological response, genetic markers and patient outcomes. Pathogenic genomic variants related to disease severity, or negative outcomes will be identified and genome wide association will be conducted. Immune repertoire diversity during infection will be correlated with severity of COVID-19 symptoms and human leucocyte antigen-type associated with SARS-CoV-2 infection. Participants can learn their genome sequencing, antibody and viral sequencing results; patient-reported outcomes of receiving this information will be assessed through surveys and qualitative interviews.Ethics and disseminationThis study was approved by Clinical Trials Ontario Streamlined Ethics Review System (CTO Project ID: 3302) and the research ethics boards at participating hospitals. Study findings will be disseminated through peer-reviewed publications, conference presentations and end-users.

scholarly journals The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study

2018 ◽  
Vol 7 (3) ◽  
pp. 373-385 ◽  
Author(s):  
Patricia A. M. Kracht ◽  
Faydra I. Lieveld ◽  
Linde M. Amelung ◽  
Carina J. R. Verstraete ◽  
Eveline P. Mauser-Bunschoten ◽  
...  
Keyword(s):  
Cohort Study ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Direct Acting Antivirals ◽  
Patient Reported ◽  
Direct Acting ◽  
The Impact

scholarly journals Tracking Patient Outcomes Following Foot and Ankle Surgery: The OFAR Experience 2018-2019

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0003
Author(s):  
Kenneth Hunt ◽  
Ross Benthien ◽  
Judith F. Baumhauer ◽  
Christopher DiGiovanni ◽  
Shanthan Challa ◽  
...  
Keyword(s):  
Data Collection ◽  
Patient Outcomes ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Healthy Population ◽  
Foot And Ankle ◽  
Aggregated Data ◽  
Postoperative Changes ◽  
Patient Reported ◽  
The Impact

Category: Patient Reported Outcomes Introduction/Purpose: Collection and reporting of Patient Reported Outcomes (PROs) has become an integral part of healthcare and healthcare research. In an effort to facilitate AOFAS member participation in secure and efficient patient outcomes data collection, the Orthopaedic Foot and Ankle Outcomes Research (OFAR) Network, a national collaborative surgical outcomes registry, was established in 2018 by and for AOFAS member surgeons and their patients. OFAR aims to collect, aggregate, and report PRO data using the measurement instruments developed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS). We hypothesize that multiple sites from a variety of health systems can successfully enroll patients into a secure, web-based registry, and that foot and ankle procedures will significantly improve patient reported function and pain. Methods: Since December 2018, seven OFAR pilot sites have been enrolling patients, including three private and four academic practices. Each enrolled patient completed a pre-operative assessment as well as post-operative assessments at 3 time points. Five PROMIS metrics were collected, including Physical Function CAT (PF), Pain Intensity Short Form (PInSF), Pain Interference CAT (PInCAT), Global Health Short Form, and Depression CAT. Pathways, a secure web platform accessible by both patients and providers, was utilized for data collection and storage. The platform also includes a provider dashboard that collects diagnosis, treatment, implant and complication data. The aggregated data was analyzed using Python (v3.6) along with Pandas (v0.23.4). Results: As of December 2018, 877 patients have been enrolled in OFAR. Patients were enrolled from both academic (57%) and private practice (43%) sites. The three most frequently encountered conditions were: ankle impingement, ankle fractures and ankle arthritis. The largest pre- to postoperative changes were seen in the PF and PInCAT scores which significantly improved at 6 months and 12 months for nearly all condition groups (Figure 1). Many of these improvements averaged 20 points on the PROMIS t-score scale, which represents two standard deviations in the PROMIS scoring system, and restored PInCAT and PF to 50 or better, the US healthy population average. There was a trend toward improvement in depression scores for most conditions, with substantial improvement following fracture treatment. Conclusion: We were able to successfully onboard multiple pilot sites, including community private practices without dedicated research resources, to enroll patients in the OFAR platform. Aggregated data demonstrate a significant improvement in PROMIS scores for all conditions treated. The library of information collected is automated, extensive and comprehensive. By aggregating outcomes following treatment by orthopaedic foot and ankle surgeons across practice settings, the OFAR database empowers an unprecedented scrutiny of ‘real world’ patient outcomes and related factors. This facilitates an increasingly granular assessment of the impact of conditions and treatments, enabling patients and providers alike to share in the decision-making process.

scholarly journals O58: THE IMPACT OF RADIOTHERAPY ON PATIENT-REPORTED OUTCOMES OF IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION: RESULTS OF A PROSPECTIVE MULTICENTRE COHORT STUDY

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
E Sewart ◽  
N Turner ◽  
EJ Conroy ◽  
R Cutress ◽  
J Skillman ◽  
...  
Keyword(s):  
Cohort Study ◽  
Breast Reconstruction ◽  
Patient Reported Outcomes ◽  
Random Effect ◽  
Well Being ◽  
Patient Reported Outcome ◽  
Complication Rates ◽  
Informed Decisions ◽  
Patient Reported ◽  
The Impact

Abstract Introduction Post-mastectomy radiotherapy (PMRT) is increasing given to improve breast cancer outcomes but can increase complication rates following implant-based breast reconstruction (IBBR). Little, however, is known about the impact of PMRT on patient-reported outcomes (PROs) of IBBR, especially in the context of mesh-assisted techniques. Method 2108 consecutive women undergoing IBBR at 81 UK centres were prospectively recruited between 2014 and 2016. Demographic, operative, oncological and 3-month complication data were collected, and patients who consented received post-operative questionnaires. An 18-month questionnaire assessed PROs using the validated BREAST-Q. The effect of IBBR on PROs was investigated using mixed-effects regression models adjusted for clinically relevant confounders and including a random effect to account for potential clustering by centre. Result 1693 iBRA participants underwent mastectomy for malignancy, of whom 1187 (70%) consented to receive the 18-month questionnaire and 732 (43%) completed it. Patients undergoing PMRT (n=214) reported significantly worse scores across 3 BREAST-Q domains: satisfaction with breasts (-6.27 points, p=0.008, 95% confidence interval (CI)[-10.91,-1.63]), satisfaction with outcome (-7.53 points, p=0.002, CI[-12.20,-2.85]) and physical well-being (-6.55 points, p<0.001, CI[-9.43,-3.67]). Overall satisfaction was worse in the PMRT group (OR 0.497, p=0.002, CI[0.32,0.77]). Use of biological mesh did not ameliorate the impact of PMRT on patient satisfaction (interaction term p-values [0.173 - 0.826]). Conclusion: PMRT adversely affects PROs of IBBR. This should be discussed with patients considering IBBR, especially if PMRT is anticipated or indications are borderline, to enable informed decisions regarding oncological and reconstructive options. Abbrev PMRT: post-mastectomy radiotherapy, PRO: patient-reported outcome Take-home message This multicentre, prospective cohort study of 732 patients undergoing implant-based breast reconstruction demonstrates worse 18-month patient-reported outcomes in women who received post-mastectomy radiotherapy than those who did not. These data should be discussed with patients to help them make informed decisions about reconstructive surgery.

Overview of the Patient Perspective at OMERACT 10 — Conceptualizing Methods for Developing Patient-Reported Outcomes

2011 ◽  
Vol 38 (8) ◽  
pp. 1699-1701 ◽  
Author(s):  
JOHN R. KIRWAN ◽  
PETER S. TUGWELL
Keyword(s):  
Clinical Trials ◽  
Experimental Work ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Methodological Issues ◽  
Instrument Selection ◽  
Patient Reported ◽  
The Impact ◽  
Choice Of Instruments ◽  
The Way

This overview draws out the main conclusions from the 4 workshops focused on incorporating the patient perspective into outcome assessment at the 10th Outcome Measures in Rheumatology (OMERACT 10) conference. They raised methodological issues about the choice of outcome domains to include in clinical trials, the development or choice of instruments to measure these domains, and the way these instruments might capture the impact of a disease and its treatment. The need to develop a more rigorous conceptual model of quantifying the way conditions affect health, and the need to ensure patients are directly involved in the decisions about domains and instruments, emerged clearly. The OMERACT participants voted to develop guidelines for domain and instrument selection, and conceptual and experimental work will be brought forward to revise and upgrade the OMERACT Filter.

The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis

2012 ◽  
Vol 21 (10) ◽  
pp. 1677-1684 ◽  
Author(s):  
Brian C. Healy ◽  
Irene R. Degano ◽  
Ana Schreck ◽  
David Rintell ◽  
Howard Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
The Impact
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