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Article ; Online: Strengthening evidence-based medicine with real-world evidence.

Dreyer, Nancy A

The Lancet. Healthy longevity

2022 Volume 3, Issue 10, Page(s) e641–e642

MeSH term(s)	Evidence-Based Medicine
Language	English
Publishing date	2022-09-20
Publishing country	England
Document type	Journal Article
ISSN	2666-7568
ISSN (online)	2666-7568
DOI	10.1016/S2666-7568(22)00214-8
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Article: Tactical Considerations for Designing Real-World Studies: Fit-for-Purpose Designs That Bridge Research and Practice.

Dreyer, Nancy A / Mack, Christina D

Pragmatic and observational research

2023 Volume 14, Page(s) 101–110

Abstract: Real-world evidence (RWE) is being used to provide information on diverse groups of patients who may be highly impacted by disease but are not typically studied in traditional randomized clinical trials (RCT) and to obtain insights from everyday care ... ...

Abstract	Real-world evidence (RWE) is being used to provide information on diverse groups of patients who may be highly impacted by disease but are not typically studied in traditional randomized clinical trials (RCT) and to obtain insights from everyday care settings and real-world adherence to inform clinical practice. RWE is derived from so-called real-world data (RWD), ie, information generated by clinicians in the course of everyday patient care, and is sometimes coupled with systematic input from patients in the form of patient-reported outcomes or from wearable biosensors. Studies using RWD are conducted to evaluate how well medical interventions, services, and diagnostics perform under conditions of real-world use, and may include long-term follow-up. Here, we describe the main types of studies used to generate RWE and offer pointers for clinicians interested in study design and execution. Our tactical guidance addresses (1) opportunistic study designs, (2) considerations about representativeness of study participants, (3) expectations for transparency about data provenance, handling and quality assessments, and (4) considerations for strengthening studies using record linkage and/or randomization in pragmatic clinical trials. We also discuss likely sources of bias and suggest mitigation strategies. We see a future where clinical records - patient-generated data and other RWD - are brought together and harnessed by robust study design with efficient data capture and strong data curation. Traditional RCT will remain the mainstay of drug development, but RWE will play a growing role in clinical, regulatory, and payer decision-making. The most meaningful RWE will come from collaboration with astute clinicians with deep practice experience and questioning minds working closely with patients and researchers experienced in the development of RWE.
Language	English
Publishing date	2023-09-25
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2586661-8
ISSN	1179-7266
ISSN	1179-7266
DOI	10.2147/POR.S396024
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Article ; Online: Power to the People: Why person-generated health data is important for pharmacoepidemiology.

Dreyer, Nancy A / Blackburn, Stella C F

American journal of epidemiology

2024

Abstract: Person-generated health data (PGHD) are valuable to study outcomes relevant to everyday living, to obtain information not otherwise available, for long-term follow-up and in situations where decisions cannot wait for traditional clinical research to be ... ...

Abstract	Person-generated health data (PGHD) are valuable to study outcomes relevant to everyday living, to obtain information not otherwise available, for long-term follow-up and in situations where decisions cannot wait for traditional clinical research to be completed. While there is no dispute that these data are subject to bias, insights gained may be better than an information void, provided the biases are understood and acknowledged. People will share information known uniquely to them about exposures that may affect drug tolerance, safety and effectiveness, e.g., using non-prescription and complementary medications, alcohol, tobacco, illicit drugs, exercise, etc. Patients may be the best source of safety information when long-term follow-up is needed, e.g., the 5-15-year follow-up required for some gene therapies. Validation studies must be performed to evaluate what people can accurately report and when supplementary confirmation information is needed. But PGHD has already proven valuable in quantifying and contrasting COVID-19 vaccine benefits and risks, and for evaluating disease transmission and the accuracy of COVID-19 testing. Going forward, PGHD will be used for patient-measured and patient-relevant outcomes, including regulatory purposes, and will be linked to broader health data networks using tokenization, becoming a mainstay for signals about risks and benefits for diverse populations.
Language	English
Publishing date	2024-04-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwae035
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Article ; Online: Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable.

Dreyer, Nancy A

Therapeutic innovation & regulatory science

2018 Volume 52, Issue 3, Page(s) 362–368

Abstract: There is growing interest in regulatory use of randomized pragmatic trials and noninterventional real-world (RW) studies of effectiveness and safety, but there is no agreed-on framework for assessing when this type of evidence is sufficiently reliable. ... ...

Abstract	There is growing interest in regulatory use of randomized pragmatic trials and noninterventional real-world (RW) studies of effectiveness and safety, but there is no agreed-on framework for assessing when this type of evidence is sufficiently reliable. Rather than impose a clinical trial-like paradigm on RW evidence, like blinded treatments or complete, source-verified data, the framework for assessing the utility of RW evidence should be grounded in the context of specific study objectives, clinical events that are likely to be detected in routine care, and the extent to which systematic error (bias) is likely to impact effect estimation. Whether treatment is blinded should depend on how well the outcome can be measured objectively. Qualification of a data source should be based on (1) numbers of patients of interest available for study; (2) if "must-have" data are likely to be recorded, and if so, how and where; (3) the accessibility of systematic follow-up data for the time period of interest; and (4) the potential for systematic errors (bias) in data collection and the likely magnitude of any such bias. Accessible data may not be representative of an entire population, but still may provide reliable evidence about the experience of typical patients treated under conditions of conventional care. Similarly, RW data that falls short of optimal length of follow-up or study size may still be useful in terms of its ability to provide evidence for regulators for subgroups of special interest. Developing a framework to qualify RW evidence in the context of a particular study purpose and data asset will enable broader regulatory use of RW data for approval of new molecular entities and label changes. Reliable information about diverse populations and settings should also help us move closer to more affordable, effective health care.
MeSH term(s)	Data Collection/legislation & jurisprudence ; Evidence-Based Medicine ; Humans ; Pragmatic Clinical Trials as Topic/legislation & jurisprudence ; Research Design/legislation & jurisprudence ; Sample Size
Language	English
Publishing date	2018-03-19
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1177/2168479018763591
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Article ; Online: COVID-19 Vaccination Reactions and Risk of Breakthrough Infections Among People With Diabetes: Cohort Study Derived From Community Reporters.

Dreyer, Nancy A / Knuth, Kendall B / Xie, Yiqiong / Reynolds, Matthew W / Mack, Christina D

JMIR diabetes

2024 Volume 9, Page(s) e45536

Abstract: Background: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes.: Objective: The study uses ... ...

Abstract	Background: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes. Objective: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes. Methods: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes. Results: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes. Conclusions: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection. Trial registration: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.
Language	English
Publishing date	2024-02-27
Publishing country	Canada
Document type	Journal Article
ISSN	2371-4379
ISSN (online)	2371-4379
DOI	10.2196/45536
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Article ; Online: Modernizing Regulatory Evidence with Trials and Real-World Studies.

Dreyer, Nancy A / Hall, Marni / Christian, Jennifer B

Therapeutic innovation & regulatory science

2020 Volume 54, Issue 5, Page(s) 1112–1115

Language	English
Publishing date	2020-02-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-020-00131-5
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Article ; Online: Considerations when evaluating real-world data quality in the context of fitness for purpose.

Reynolds, Matthew W / Bourke, Alison / Dreyer, Nancy A

Pharmacoepidemiology and drug safety

2020 Volume 29, Issue 10, Page(s) 1316–1318

Language	English
Publishing date	2020-05-06
Publishing country	England
Document type	Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5010
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Article ; Online: Using observational studies for comparative effectiveness: finding quality with GRACE.

Dreyer, Nancy A

Journal of comparative effectiveness research

2013 Volume 2, Issue 5, Page(s) 413–418

MeSH term(s)	Africa ; Asia ; Benchmarking ; Comparative Effectiveness Research/methods ; Cooperative Behavior ; Europe ; Evidence-Based Medicine/methods ; Humans ; North America ; Observational Studies as Topic ; Patient-Centered Care/methods ; Research Design ; South America
Language	English
Publishing date	2013-09
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2042-6313
ISSN (online)	2042-6313
DOI	10.2217/cer.13.59
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Article ; Online: Daily COVID-19 symptom assessment over 28 days - findings from a daily direct-to-patient registry of COVID-19 positive patients.

Brinkley, Emma / Knuth, Kendall / Kwon, Tom / Mack, Christina / Leister-Tebbe, Heidi / Bao, Weihand / Reynolds, Matthew W / Dreyer, Nancy

Journal of patient-reported outcomes

2023 Volume 7, Issue 1, Page(s) 128

Abstract: In January 2021, 999 COVID-19 positive adults in the US enrolled in an online, direct-to-patient registry to describe daily symptom severity and progression over 28 days. The most commonly reported and persistent symptoms were fatigue, headache, ... ...

Abstract	In January 2021, 999 COVID-19 positive adults in the US enrolled in an online, direct-to-patient registry to describe daily symptom severity and progression over 28 days. The most commonly reported and persistent symptoms were fatigue, headache, decreased sense of taste, decreased sense of smell, and cough. Fast resolving symptoms included gastrointestinal symptoms (nausea, vomiting, diarrhea) and those related to fever and chills. While more than half (56%) of patients reported overall symptom improvement during the 28-day study period, 60% of patients were still reporting at least 1 COVID-19 symptom at the end of 28 days. Risk factors for experiencing symptoms for longer duration included at least one of the following: older age (> 60 years), higher BMI, lung disease, and receiving medication for hypertension. The study demonstrates the value of patient-reported data to provide important and timely insights to COVID-19 disease and symptom progression and the potential of using real-world data to inform clinical trial design and endpoints.
MeSH term(s)	Adult ; Humans ; COVID-19 ; SARS-CoV-2 ; Symptom Assessment ; Gastrointestinal Diseases ; Registries
Language	English
Publishing date	2023-12-07
Publishing country	Germany
Document type	Journal Article
ISSN	2509-8020
ISSN (online)	2509-8020
DOI	10.1186/s41687-023-00668-7
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Article ; Online: Cognitive and other neuropsychiatric symptoms in COVID-19: analysis of person-generated longitudinal health data from a community-based registry.

Largent, Joan / Xie, Yiqiong / Knuth, Kendall B / Toovey, Stephen / Reynolds, Matthew W / Brinkley, Emma / Mack, Christina D / Dreyer, Nancy A

BMJ open

2023 Volume 13, Issue 6, Page(s) e069118

Abstract: Objective: To describe cognitive symptoms in people not hospitalised at study enrolment for SARS-CoV-2 infection and associated demographics, medical history, other neuropsychiatric symptoms and SARS-CoV-2 vaccination.: Design: Longitudinal ... ...

Abstract	Objective: To describe cognitive symptoms in people not hospitalised at study enrolment for SARS-CoV-2 infection and associated demographics, medical history, other neuropsychiatric symptoms and SARS-CoV-2 vaccination. Design: Longitudinal observational study. Setting: Direct-to-participant registry with community-based recruitment via email and social media including Google, Facebook and Reddit, targeting adult US residents. Demographics, medical history, COVID-19-like symptoms, tests and vaccinations were collected through enrolment and follow-up surveys. Participants: Participants who reported positive COVID-19 test results between 15 December 2020 and 13 December 2021. Those with cognitive symptoms were compared with those not reporting such symptoms. Main outcome measure: Self-reported cognitive symptoms (defined as 'feeling disoriented or having trouble thinking' from listed options or related written-in symptoms) RESULTS: Of 3908 participants with a positive COVID-19 test result, 1014 (25.9%) reported cognitive symptoms at any time point during enrolment or follow-up, with approximately half reporting moderate/severe symptoms. Cognitive symptoms were associated with other neuropsychiatric symptoms, including dysgeusia, anosmia, trouble waking up, insomnia, headache, anxiety and depression. In multivariate analyses, female sex (OR, 95% CI): 1.7 (1.3 to 2.2), age (40-49 years (OR: 1.5 (1.2-1.9) compared with 18-29 years), history of autoimmune disease (OR: 1.5 (1.2-2.1)), lung disease (OR: 1.7 (1.3-2.2)) and depression (OR: 1.4 (1.1-1.7)) were associated with cognitive symptoms. Conversely, black race (OR: 0.6 (0.5-0.9)) and COVID-19 vaccination before infection (OR: 0.6 (0.4-0.7)) were associated with reduced occurrence of cognitive symptoms. Conclusions: In this study, cognitive symptoms among COVID-19-positive participants were associated with female gender, age, autoimmune disorders, lung disease and depression. Vaccination and black race were associated with lower occurrence of cognitive symptoms. A constellation of neuropsychiatric and psychological symptoms occurred with cognitive symptoms. Our findings suggest COVID-19's full health and economic burden may be underestimated. Trial registration number: NCT04368065.
MeSH term(s)	Adult ; Humans ; Female ; Middle Aged ; COVID-19/diagnosis ; COVID-19/epidemiology ; COVID-19 Vaccines ; SARS-CoV-2 ; Anxiety/epidemiology ; Cognition
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2023-06-19
Publishing country	England
Document type	Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-069118
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