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Table 2 Development and operational phase differences

From: Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA))

 

DACHA (funded up to November 2023)

Virtual Trials Archive (December 2023 onward)

Name

DACHA Trials repository

Virtual International Care Homes Trials Archive (VICHTA)

Funding

HS&DR NIHR127234

Supported through data access fees

Analysis

• Internal to WP2 team only

• Analysis on University of Glasgow (UG) server (VPN access for LI)

• Focus on descriptive statistics

• Available to external researchers via for data request process

• All analysis performed on VTA Analysis Platform

• More advanced statistical analysis

Management

University of Hertfordshire (UH) and Virtual Trials Archive/Robertson Biostatistics Centre (UG)

Virtual Trials Archive/Robertson Biostatistics Centre (UG)

Inclusion criteria

• UK only

• RCTs only

• Older adult focus

• At least 100 participants

• Any intervention/condition

• Published since 2010

• Evidence of resident/consultee consent

• Add non-UK studies

Publication policy

All TSC members full authors for the main paper describing the development of repository.

For other publications arising:

• By-line ‘on behalf of VICHTA collaborators’

• Option to get involved in research and full authorship dependent on ICMJE guidelines.

By-line ‘on behalf of VICHTA collaborators’

Option to get involved in research and full authorship dependent on ICMJE guidelines.

Analyses

• Generalisability of RCT data

• Using the repository to inform Minimum Dataset

Open for external researchers

Independent Oversight

DACHA Steering Group

Robertson Biostatistics Centre, UG

PPIE

Led by Anne Killett and Priti Biswas at UEA

 

Ethics

University of Hertfordshire HSK/SF/UH/04185 approved 18 June 2020

Amendment for VTA ethics via UG

Trialist Steering Committee (TSC) membership

Co-chairs: Jenni Burton and Terry Quinn

Up to two representatives per trial—principle investigator; CTU delegate; statistician; ECR

Minimal face-to-face contact; Zoom conferencing

Chair/co-chair may rotate over years

Minimal face-to-face contact