Selection bias

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

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日曜日, 6月 2, 2024

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Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

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火曜日, 5月 28, 2024

Knowledge, Real-World Evidence, Selection bias, Commission, Sensitivity analysis, Metadata, Risk, European Medicines Agency, Scope, TTE, FDA, ICES, Vaccine, Answer, MWP, Reflection, Process, Probability, Health care, Community, Interval (mathematics), Hospital, HMA, Applicant (sketch), Data quality, Checklist, Target, Coronary thrombosis, Clutch (eggs), Name, Medicine, User experience, Methodology, CTS, Reproduction, RWD, Annex, Risk assessment, European, Clinical trial, Multi, Moyamoya disease, Data collection, Prognosis, Literature, Health, Trial of the century, Collection, Safety, Marketing, HTA, Research, Cancer, Draft, Incidence, Attention, Isabella Tree, Patient, RWE, ASA, Data, Bias, Guideline, Chapter Six, Prevalence, Diagnosis, Overalls, Big data, Registry, Person, Electronic health record, Good, Area studies, EMA, Drug, MAH, ICH, Classification, Benchmarking, Confounding, CHMP, PASS, Medical imaging

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Reflection paper on use of real-world data in noninterventional studies to generate real-world evidence

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Table of contents

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1.
References ............................................................................................ 15
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Reflection paper on use of real-world data in non-interventional studies to generate
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1.
Introduction
45

This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-

46

world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes.
These include absence of randomisation, uncontrolled conditions, non-
61

standardised treatments and uncertainties regarding data quality and completeness.
The
63

increasing ability to capture electronic healthcare data and data from registries is now providing new

64

opportunities to use RWD and generate RWE that reflects clinical practice.
Scope
89

The scope of this reflection paper is the design, conduct and analysis of NIS using RWD to generate

90

RWE for regulatory purposes.
data collected specifically for the study in
106

question, or secondary use of existing data sources.
In both cases, attention should be paid to the
107

possible selection mechanisms in the data collection, for example the inclusion of specific patients or

108

the collection of specific clinical data.
Reference to studies with causal objectives in this document does not
119

imply an expectation that specific analytical methods will be used.
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The legal obligations and regulatory requirements applicable to NIS should be followed.
138
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Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of

139
140

personal data and on the free movement of such data.
The specific aim of the study forms the basis for the
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selection of data source(s), study design, and analysis approach.
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4.2.
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Regional differences in clinical practice and healthcare systems management, e.g.
Misclassification can arise at many different
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steps of data collection and extraction: diagnosis, coding, recording, data transformation, data

297

aggregation, summarisation, and analysis.
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6.4.
For these studies, the study protocol should describe:
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?

The data elements used to link the data.
Heterogeneity
530

In multi-database studies, different estimates may be found even when the same protocol is applied

531

across all data sources (22).
(2023)
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15.
Draft guidance Real-World Data: Assessing Electronic Health Records and Medical Claims
Data To Support Regulatory Decision-Making for Drug and Biological Products (2021)
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572
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LV Distribution and NewVest Establish Strategic Partnership to Facilitate Better Access to Private Markets Investing

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火曜日, 3月 19, 2024

Partnership, Registered investment adviser, Index, RIAS, Risk management, ETF, Selection bias, Family, Financial services

NEW YORK, March 19, 2024 /PRNewswire/ -- LV Distribution, specializing in third-party asset management distribution, proudly announces a groundbreaking partnership with NewVest, the first-of-its-kind platform of index funds for the private markets.

Key Points:

NEW YORK, March 19, 2024 /PRNewswire/ -- LV Distribution, specializing in third-party asset management distribution, proudly announces a groundbreaking partnership with NewVest, the first-of-its-kind platform of index funds for the private markets.
This collaboration marks a transformative moment for LV Distribution as it ventures into the realm of private markets, bringing institutional-quality investment strategies to Registered Investment Advisors (RIAs) and Family Offices.
"We are thrilled to partner with NewVest, a pioneering investment manager that is seeking to redefine how investors can establish core, diversified exposure to private equity, private debt and other private markets strategies," said Edward Soltys, Head of LV Distribution.
The LV Distribution and NewVest partnership exemplifies a commitment to providing innovative, accessible solutions for navigating the complexities of private markets.

Mortgage borrowing limits and house prices: evidence from a policy change in Ireland

Retrieved on:

金曜日, 2月 16, 2024

Key Points:

Philadelphia hopes year-round schooling can catch kids up to grade level – will it make a difference?

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火曜日, 2月 13, 2024

Atmosphere, School, Child care, A Nation at Risk, Parent, Hope, Risk, Selection bias, Fatigue, Evaluation, Student, Tutoring

Upon becoming mayor of Philadelphia, Cherelle Parker announced that she will establish a working group on full-day and year-round schooling – an idea she had supported while campaigning.

Key Points:

Upon becoming mayor of Philadelphia, Cherelle Parker announced that she will establish a working group on full-day and year-round schooling – an idea she had supported while campaigning.
The group will develop a strategy to keep Philadelphia public schools open for longer hours during the week, from 7:30 a.m. to 6 p.m., as well as over the summer, and to provide “meaningful, instructive out-of-school programming and job opportunities for students.” Below, education expert Daniel H. Robinson answers five questions about year-round schooling in Philadelphia.

What do we know about the mayor’s plan?

It does not state how many days or hours will be added to the 180 days Philadelphia currently requires.
For example, students might have 45 school days followed by 15 days of break, or 60 school days followed by 20 days of break.
The report suggested that the school year should be increased to 200 to 220 days.

How prevalent is year-round schooling?

Japan and Australia have school for almost the entire year, while the U.S. has school for only about nine months.
But they still maintain traditional school hours during the school year.
This three-year initiative involves 40 schools that will add 300 hours to their existing school calendar by having either longer days, longer school years or both.

Can the mayor legally do this?

The Philadelphia mayor can certainly extend the school day and the school hours since she appoints the school board members, who in turn control who is hired or fired as superintendent.
A more important question is: Should the mayor do this?
Despite the hope that longer school days or years will lead to gains in student achievement, there’s little evidence that they will.
A better evaluation plan would be to first solicit applications for the pilot program from the more than 200 Philadelphia schools.

What are the potential gains?

It makes it easier for them to drop off and pick up kids on their way to and from work.
It also provides kids a safe and supportive environment for more hours.
Keeping kids at school longer during the day and for more days during the year can lower juvenile crime.

What hurdles might year-round schooling face in Philly?

Many Philly public schools do not have adequate air conditioning to be open throughout the hot summer months.
More Philadelphia teachers are quitting or retiring than those who are being newly trained, according to the report.

Daniel H. Robinson does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Demographics, labor market power and the spatial equilibrium

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火曜日, 2月 13, 2024

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Abstract

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Abstract
This paper studies how demographics affect aggregate labor market power, the urban wage
premium and the spatial concentration of population.
I develop a quantitative spatial model
in which labor market competitiveness depends on the demographic composition of the local
workforce.
If these factors differ across workers, labor market power has a role to
play in explaining wage inequality.
This paper contributes to the literature on differences in labor market power by analyzing a
new dimension of heterogeneity: demographics.
Since older workers are less mobile in terms of
switching workplaces, firms have more labor market power over older workers.
I start by estimating labor market power by measuring the sensitivity of worker turnover to
the wage paid.
I find a strong
role of demographics in determining the degree of labor market power enjoyed by firms.
Next, I provide evidence of the importance of differences in labor market power for spatial
wage inequality.
To explore the consequences of labor market sorting, I build a spatial general equilibrium
model in which labor market competitiveness depends on the demographic composition of the
ECB Working Paper Series No 2906

2

local workforce.
If these factors differ across workers, labor market power has a role to
play in explaining wage inequality.
In
the model, geographic sorting by age matters and leads to higher labor market power in rural
areas, which implies an urban wage premium that is 4% larger than with uniform labor supply
elasticities.
I follow Manning (2013) and estimate labor market power by measuring the sensitivity of worker
turnover to the wage paid.
Bachmann et al., 2021; Ahlfeldt et al., 2022a; Berger et al.,
2022) that nest a monopsonistic labor market in a spatial general equilibrium model (Redding
and Rossi-Hansberg, 2017).
As firms have more labor market power
over older workers, they face an upward-sloping labor supply curve that is less elastic in regions
with an older workforce.
Firms choose in which labor market to operate in the sense that there is free
entry at fixed costs into all locations.
How are differences in labor market competitiveness across space sustained in spatial equilibrium?
I use the model to quantify the importance of heterogeneity
in labor market power for the urban wage premium and the spatial concentration of population.
My work is complementary to but quite different
from this paper since I argue that population aging increases labor market power rather than
product market power.
By analyzing the effects of a changing age composition of the workforce in the context
of labor market power, I relate to literature on the labor market effects of population aging.
ECB Working Paper Series No 2906
7

after controlling for age, differences in labor market power between East and West Germany
vanish.
They conclude that higher
concentration is associated with higher labor market power (as in the model of Jarosch et al.,
forthcoming).
I offer an alternative explanation why labor market power differs across regions:
Since denser regions have a younger workforce, workers are more mobile in terms of switching
jobs which implies lower labor market power of firms.
In this case, I infer a
high labor supply elasticity and low labor market power of firms.
I contribute to this growing debate by
quantifying differences in labor market power across worker groups and their effects on regional
inequality.
While the model shows how demographics affect labor market power, the urban wage premium and agglomeration, one fundamental question remains open for future research: What
are the policy implications of (differences in) labor market power?

A forward-looking tracker of negotiated wages in the euro area

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土曜日, 2月 10, 2024

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Kahoot! earns Level III Certification for Alignment with ESSA, proving requirements for positive student learning outcomes

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金曜日, 1月 26, 2024

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OSLO, Norway, Jan. 26, 2024 /PRNewswire/ -- Kahoot!, the global learning and engagement platform company, today announced it has earned Level III certification for its alignment with standards outlined by the Every Student Succeeds Act (ESSA). This certification demonstrates "Promising Evidence" of Kahoot!'s efficacy in driving positive learning outcomes for students.

Key Points:

satisfies Every Student Succeeds Act (ESSA) Level III certification requirements.
OSLO, Norway, Jan. 26, 2024 /PRNewswire/ -- Kahoot!, the global learning and engagement platform company, today announced it has earned Level III certification for its alignment with standards outlined by the Every Student Succeeds Act (ESSA).
"With Level III certification in the ESSA evidence standards, educators and administrators can now be even more confident that using Kahoot!
is supported by a properly designed and implemented correlational study, statistically controlling for selection bias, and showing a statistically significant positive effect on student learning outcomes.

NeoGenomics and ConcertAI Announce Collaboration to Advance Population-Scale, Definitive Hematological Research & Generative AI Solutions at ASH 2023

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月曜日, 1月 8, 2024

Hematological malignancies require surveillance of patients over multiple time periods with numerous clinical and diagnostic measures to assess sustained response to treatment or relapse.

Key Points:

Hematological malignancies require surveillance of patients over multiple time periods with numerous clinical and diagnostic measures to assess sustained response to treatment or relapse.
Combining ConcertAI's longitudinal clinical data with NeoGenomics' comprehensive biomarkers derived from hundreds of hematological tests we are able to establishe a robust and definitive RWE hematology solution.
The collaboration advances molecular and genetic data solutions for the entire drug development lifecycle, from early clinical development to post-approval epidemiological studies.
"ConcertAI has spent the last three years with biopharma researchers, medical societies, patient advocacy groups, and academic teams to define requirements for truly definitive, insight-enabling research solutions for hematological malignancies," said Jeff Elton, PhD, CEO of ConcertAI.

Does picking your nose really increase your risk of COVID?

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木曜日, 8月 3, 2023

Picking your nose is linked to an increased risk of COVID, according to a study out today.

Key Points:

Picking your nose is linked to an increased risk of COVID, according to a study out today.
Read more:
When you pick your nose, you're jamming germs and contaminants up there too.

What did the study find?

They had regular antibody testing, which tells us if they had been exposed to SARS-CoV-2, the virus that causes COVID.
Just over 17% of health workers who reported picking their nose caught COVID versus about 6% of those who did not report nose picking.
At first glance, it might appear feasible that people who pick their noses would be at increased risk of contracting COVID.

Hang on a minute

For example, people who picked their noses only monthly had a higher chance of infection than daily nose pickers.
Logically, you would expect the daily nose pickers to have a higher risk of infection due to more transmission opportunities.
There were also several aspects of how the study was designed that may have influenced the results.
Just over half of the people approached to participate in the study actually did so, which may cause selection bias.
This is where people who choose to participate may differ in some key characteristic from those who don’t.

So, what now?

Overall, the risk of SARS-CoV-2 transmission via nose picking is probably comparatively low, particularly for the general public who are not working in high COVID environments.
But you can definitely decrease your risk through good hand hygiene (and using a tissue that you dispose of afterwards).