Decentralized clinical trials offer the promise of reduced patient burden, faster and more diverse recruitment, and have received regulatory support during the COVID-19 pandemic. However, lack of data...
In this article we evaluate the estimation and statistical inference for three scenarios: (1) all onsite measurements, (2) a mixture of onsite and decentralized measurements, and (3) all decentralized...
In the mixed modality setting, simulation studies showed that the estimation and inference for the key time points with onsite measurements have good properties and are not impacted by the additional ...
Mixed modality trials can help achieve the benefits of decentralized clinical trials by reducing the number of onsite visits with little impact on statistical inferences for various estimands, compare...
Standardised data collection processes allow for harmonisation and comparison of data across different studies and services. This project aimed to develop a 'core dataset' to serve as the default coll...
A working group was established, comprising clinicians, researchers, data managers and consumers from public sector and non-government organisation AOD services in the NSW Drug and Alcohol Clinical Re...
There were 20-40 attendees at each meeting. An initial consensus criterion of having received >70% of the vote was established. Given the difficulty in reaching consensus for most items, subsequently,...
This important process received considerable interest and buy-in across the NSW AOD sector. Ample opportunity for discussion and voting was provided for the three domains of interest, allowing partici...
As a national effort to better understand the current pandemic, three cohorts collect sociodemographic and clinical data from coronavirus disease 2019 (COVID-19) patients from different target populat...
The goal of this work is to assure high consistency of research data mapped to the GECCO data model. In particular, it aims at identifying contradictions within interdependent GECCO data items of the ...
All suitable data items from each of the three NAPKON cohorts are mapped to the GECCO items. A consistency assessment tool (dqGecco) is implemented, following the design of an existing quality assessm...
Our consistency assessment tool helped in correcting the mapping procedure and reveals remaining contradictory value combinations within COVID-19 symptoms, vital signs, and COVID-19 severity. Consiste...
An efficient and portable tool capable of discovering inconsistencies in the COVID-19 domain has been developed and applied to three different cohorts. As the GECCO dataset is employed in different pl...
By 2030, over 50% of individuals living with bipolar disorder (BD) are expected to be aged ≥50 years. However, older age bipolar disorder (OABD) remains understudied. There are limited large-scale pro...
We developed initial recommendations for the essential dimensions for OABD data collection, based on (1) a systematic review of measures used in OABD studies, (2) a Delphi consensus of international O...
We identified 15 key dimensions and variables within each that are relevant for the investigation of OABD: (1) demographics, (2) core symptoms of depression and (3) mania, (4) cognition screening and ...
The essential data dimensions we present should be of use to guide future international data collection in OABD and clinical practice. In the longer term, we aim to establish a prospective consortium ...
The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-m...
This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk-benefit c...
The finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Informati...
With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the s...
We assessed the feasibility and acceptability of using BACtrack Skyn wearable alcohol monitors for alcohol research in a college student population....
We enrolled n = 5 (Sample 1) and n = 84 (Sample 2) Indiana University undergraduate students to wear BACtrack Skyn devices continuously over a 5-day to 7-day study period. We assessed feasibility in b...
All participants were able to successfully use the alcohol monitors, producing a total of 11,504 h of TAC data. TAC data were produced on 567 days of the 602 total possible days of data collection. Th...
The high feasibility and acceptability we observed underscore the promise of using BACtrack Skyn wearable alcohol monitors to improve our understanding of alcohol consumption among college students, a...
To provide five methodological and pragmatic tips for conducting remote qualitative data collection during the context of the COVID-19 pandemic....
The tips presented in this article are drawn from insights of our own experiences as researchers conducting remote qualitative research and from the evidence from the literature on qualitative methods...
Five tips are provided: 1) Pay attention to ethical issues; 2) Identify and select potential participants; 3) Choose the type of remote interview; 4) Be prepared to conduct the remote interview; and 5...
Despite the challenges in conducting remote data collection, strengths are also acknowledged and our experience has shown that it is feasible to recruit and interview participants remotely. The discus...
This study evaluated the feasibility of measuring patient recovery after locoregional therapies (LRTs) using a wearable activity tracker (WAT). Twenty adult patients with cancer were provided with a W...
Patient-reported outcomes (PROs) are used in clinical trials to provide evidence of the benefits and risks of interventions from a patient perspective and to inform regulatory decisions and health pol...
A major challenge in the study of high-impact, low-frequency procedures in trauma is the lack of accurate data for time-sensitive processes of care. Trauma video review offers a possible solution, all...
We conducted a prospective cohort study of patients undergoing resuscitative thoracotomy at a single urban academic level 1 trauma center. Key data on the timing and completion of procedural milestone...
We included 51 subjects (88% Black, 82% male, 90% injured by gunshot wounds) over the study period. Missingness in resuscitative thoracotomy procedural milestone time measurements ranged from 34% to 6...
The data collected using video review have less missingness and bias than prospective collection data collected by trained research assistants. Audiovisual recording should be the gold standard for da...
