Evidence map›Paper›PMID 35251579›Full record

ArticleJournal of healthcare engineering2022

A Clinical Data Management System for Diabetes Clinical Trials.

Aynaz Nourani, Haleh Ayatollahi, Masoud Solaymani-Dodaran

Abstract read
In one paragraph

Article in Journal of healthcare engineering, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Aynaz NouraniDepartment of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran.ORCID 0000-0001-5010-9774
Haleh AyatollahiHealth Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran.ORCID 0000-0003-3974-3648
Masoud Solaymani-DodaranDepartment of Epidemiology, Iran University of Medical Sciences, Tehran, Iran.ORCID 0000-0002-1817-5664

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of novel medications and methods to prevent, diagnose, treat, and manage diabetes requires confirmation of safety and efficacy in a well-designed study prior to widespread adoption. Diabetes clinical trials are the studies that examine these issues. The aim of the present study was to develop a web-based system for data management in diabetes clinical trials.

methodsThe present research was a mixed-methods study conducted in 2019. To identify the required data elements and functions to develop the system, 60 researchers completed a questionnaire. The designed system was evaluated using two methods. The usability of the system was initially evaluated by a group of researchers (

resultsThe main data elements which were required to develop a case report form included "study data," "participant's personal data," and "clinical data." The functional requirements of the system were "managing the study," "creating case report forms," "data management," "data quality control," and "data security and confidentiality." After using the system, researchers rated the system functions at a "good" level (6.3 ± 0.73) on a seven-point Likert scale.

conclusionGiven the complexity of the data management processes in diabetes clinical trials and the widespread use of information technologies in research, the use of clinical data management systems in diabetes clinical trials seems inevitable. The system developed in the current study can facilitate and improve the process of creating and managing case report forms as well as collecting data in diabetes clinical trials.

Indexed as

Data ManagementDiabetes MellitusClinical Trials as TopicHumansResearch DesignSurveys and Questionnaires

Identifiers

PMID35251579
PMCPMC8894039

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.