Evidence map›Paper›PMID 36877564›Full record

ArticleJMIR research protocols2023

Investigating the Secondary Use of Clinical Research Data: Protocol for a Mixed Methods Study.

Naomi Waithira, Evelyne Kestelyn, Keitcheya Chotthanawathit, Anne Osterrieder, Mavuto Mukaka, Trudie Lang, Phaik Yeong Cheah

Full text read
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
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

7 authors.

Naomi WaithiraCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-2267-9347
Evelyne KestelynCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-5728-0918
Keitcheya ChotthanawathitMahidol-Oxford Tropical Medicine Research Unit, Bangkok, Thailand.ORCID https://orcid.org/0000-0002-5346-5288
Anne OsterriederCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0003-3378-4211
Mavuto MukakaCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0002-5036-6583
Trudie LangCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0003-2273-5975
Phaik Yeong CheahCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID https://orcid.org/0000-0001-6327-3266

Funding

Medical Research Council MC_PC_19073Medical Research Council MR/S014357/1Wellcome Trust
6 · The paper itself

Abstract

backgroundThe increasing emphasis to share patient data from clinical research has resulted in substantial investments in data repositories and infrastructure. However, it is unclear how shared data are used and whether anticipated benefits are being realized.

objectiveThe purpose of our study is to examine the current utilization of shared clinical research data sets and assess the effects on both scientific research and public health outcomes. Additionally, the study seeks to identify the factors that hinder or facilitate the ethical and efficient use of existing data based on the perspectives of data users.

methodsThe study will utilize a mixed methods design, incorporating a cross-sectional survey and in-depth interviews. The survey will involve at least 400 clinical researchers, while the in-depth interviews will include 20 to 40 participants who have utilized data from repositories or institutional data access committees. The survey will target a global sample, while the in-depth interviews will focus on individuals who have used data collected from low- and middle-income countries. Quantitative data will be summarized by using descriptive statistics, while multivariable analyses will be used to assess the relationships between variables. Qualitative data will be analyzed through thematic analysis, and the findings will be reported in accordance with the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The study received ethical approval from the Oxford Tropical Research Ethics Committee in 2020 (reference number: 568-20).

resultsThe results of the analysis, including both quantitative data and qualitative data, will be available in 2023.

conclusionsThe outcomes of our study will offer crucial understanding into the current status of data reuse in clinical research, serving as a basis for guiding future endeavors to enhance the utilization of shared data for the betterment of public health outcomes and for scientific progress.

trial registrationThai Clinical Trials Registry TCTR20210301006; https://tinyurl.com/2p9atzhr. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44875.

Indexed as

artificial intelligencebarriersclinical researchclinical trials datadata reusedata sharingindividual patient datalow- and middle-income countrymachine learningmixed methodsonline surveysecondary data use

Identifiers

PMID36877564
PMCPMC10028503

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read5
Read underepoch 390

Registered trials

None linked

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.