Design & Statistics

Substantial risks associated with few clusters in cluster randomized and stepped wedge designs

Posted on by Beth C

Substantial risks associated with few clusters in cluster randomized and stepped wedge designs

March 3, 2016

This paper addresses the implications and risks involved in the use of novel cluster randomized trial designs that aim to maximize the informational value from relatively few clusters, including increased probability of chance imbalances and type I and type II error, limited perceived or actual generalizability, and fewer options for statistical analysis. Read the full article at this link.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

Posted on by Beth C

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

November 9, 2018

This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The statement was developed to allow for the unique characteristics of this increasingly used study design, and the guideline was developed using a Delphi survey and consensus meeting and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. Read the full article at this link.

IMPACT Members provide resources to a new topic within Pepper Center’s GRASP statistical analysis resource

Posted on by Sonya Sutton

Members of the IMPACT Collaboratory Design and Statistics Core recently contributed to a curated list of statistical analysis programs for biostatisticians engaged in studies of human aging.

Heather Allore, PhD, and Joan Monin, PhD, MS and colleagues authored the Analyzing Dyad Data with Additional Clustering resource in GRASP, an online resource developed by the Claude D. Pepper Older Americans Independence Centers at Yale University, Duke University and Wake Forest University. The program provides a brief introduction and overview of approaches to dyadic analysis with references as well as two approaches to performing dyadic analysis when dyads are nested in a higher level of clustering, such as dyads participating in cluster-randomized clinical trials.

See the full list at this link.

Allore joins JAMAevidence podcast to discuss latent class analysis to identify hidden clinical phenotypes

Posted on by Sonya Sutton

Heather Allore, PhD, Core Leader for the IMPACT Design and Statistics Core, recently appeared on the JAMAevidence podcast to discuss latent class analysis to identify hidden clinical phenotypes. A latent variable is an unobserved variable that investigators don’t have a construct or measure for, but believe it exists and could impact outcomes. Dr. Allore uses frailty as an example of latent variables in the discussion.

The podcast was hosted by JAMA Statistical Editor Roger Lewis, MD, PHD and is a supplement to the JAMA Guide to Statistics and Methods.

Listen to the podcast at this link.

Apply Now for the 3rd Annual Virtual ePCT Training Workshop | January 25-26, 2023

Posted on by Erin Luers

Building Skills to Conduct Embedded Pragmatic Clinical Trials for People Living with Dementia and their Care Partners

Wednesday, January 25th, 2023  |  11:00am - 3:30pm ET
Thursday, January 26th, 2023  |  11:00am - 5:00pm ET

Apply here!

This year’s modules will focus on:

  • Using real-world data to identify PLWD and ascertain outcomes in ePCTs
  • Designing the implementation evaluation for an ePCT
  • Defining a pilot: What is a pilot study for an ePCT?

The IMPACT Collaboratory will hold our third annual Training Workshop on January 25-26, 2023 entitled Building Skills to Conduct Embedded Pragmatic Clinical Trials (ePCTs) among People Living with Dementia (PLWD) and their Care Partners. This 1.5-day virtual workshop features all new material to build a foundation in practical aspects of designing and conducting ePCTs in Alzheimer’s disease (AD) and AD-related dementias (ADRD). The workshop will include a combination of activities including: panel discussions, small group sessions, and networking opportunities with experts in the field.

We are inviting applications from early to mid-stage researchers who seek to develop competence in designing and conducting ePCTs of non-pharmacological interventions embedded in health care systems for PLWD and care partners.

Upon completion of the workshop, participants will be able to:

  • Transmit knowledge about designing and conducting ePCTs among PLWD and care partners in health care systems that integrates considerations related to identifying PLWD and ascertaining pragmatic outcomes
  • Problem-solve common challenges in designing and conducting ePCTs for PLWD and care partners
  • Apply the acquired knowledge to move their current and future research in ePCTs forward, including applying for competitive funding

Successful applicants will be expected to complete selected readings and online training prior to the workshop. All participants are expected to attend and participate in the entire 1.5-day event.

HOW TO APPLY

Please submit your online application using the following link:
IMPACT Training Workshop Application

Deadline: October 21, 2022

Eligibility Criteria:

  • Applicants should have an MD, PhD, or equivalent research degree
  • Hold a full-time position at an academic or research organization in the United States
  • Early-stage investigators pursuing careers conducting ePCTs in AD/ADRD
  • Mid-career investigators seeking to pursue research on ePCTs in AD/ADRD

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply.

Selection Criteria: Applicants will be selected based on their demonstrated commitment to improving care of PLWD and/or their care partners through the conduct of ePCTs in HCS and the potential impact of the workshop on promoting the applicant’s career in this area.

Find the working agenda and more information about the workshop on our website at impactcollaboratory.org/training-workshop. Email IMPACTcollaboratory@hsl.harvard.edu with questions regarding this opportunity.