Evidence mapPaperPMID 33389690Full record

SynthesisDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2021

Withdrawal reasons of randomized controlled trials on type 2 diabetes: a systematic review.

Shahrzad Mohseni, Ozra Tabatabaei-Malazy, Maryam Peimani, Hanieh-Sadat Ejtahed, Mehrnoosh Khodaeian, Elahe Nazeri, Zahra Nouhi, Kajal Khodamoradi, Maryam Aboeerad, Bagher Larijani

Open access · greenAbstract readSystematic Review
In one paragraph

Synthesis in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 20% of its field
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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Trial
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

10 authors at 3 institutions in 2 countries.

Shahrzad MohseniDiabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0003-3641-0805
Ozra Tabatabaei-MalazyNon-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. tabatabaeiml@sina.tums.ac.ir.ORCID http://orcid.org/0000-0003-0188-9721
Maryam PeimaniDiabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0002-8675-510X
Hanieh-Sadat EjtahedEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0002-6395-4915
Mehrnoosh KhodaeianEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0001-6064-018X
Elahe NazeriGenetics Department, Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran.ORCID https://orcid.org/0000-0003-0956-8375
Zahra NouhiEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0003-4445-2423
Kajal KhodamoradiDepartment of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA.ORCID https://orcid.org/0000-0003-2951-4382
Maryam AboeeradEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0003-0896-6398
Bagher LarijaniEndocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.ORCID https://orcid.org/0000-0001-5386-7597
Tehran University of Medical Sciences · IRAcademic Center for Education, Culture and Research · IRUniversity of Miami · US

Funding

Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences 1396-02-97-2161
6 · The paper itself

Abstract

purposeType 2 diabetes mellitus (T2DM) is the subject of numerous randomized controlled trials (RCTs). The validity of RCTs may be threatened by attrition bias due to the discontinuation of the study. The aim of this systematic review is to evaluate the reasons of patient's withdrawal from these RCTs.

methodsA systematic literature search on PubMed, Cochrane Library, Web of Science, and Scopus databases was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. The aim was to obtain all relevant blinded RCTs published before January 2017 in which the effectiveness of synthetic drugs, vitamins/minerals were compared to that of placebo or active control in T2DM. The quality of RCTs was assessed using the Jadad score. The frequency of withdrawal reasons was presented based on treatments with placebo/active control, national/international level of the studies, and publication year. Meta-analysis was not performed due to the heterogeneity.

resultsOverall, 1368 articles comprising of 640,780 subjects were included. In the majority of the RCTs (75.0%), the intervention and the placebo arms were compared. Most of the included studies (96%) were classified in the high-quality category (Jadad score≥3). The highest proportion of reported withdrawal cases was found in international studies, national RCTs conducted in Japan, and RCTs published in 2011. The withdrawal reasons were reported for 91,669 (63.75%) of the total 143,794 participants who had withdrawn from these studies. The main reported reasons were "adverse effects" (24.04%), "withdraw consent" (16.10%), and "missing data" (11.08%). Variations in the reported withdrawal reasons were based on the country or published year. RCTs with triple blinded design as well as those in which anti-hyperlipidemia and anti-obesity medications were applied, showed significantly higher probability of reported the withdrawal.

conclusionHigh proportion of reported discontinuation in blinded RCTs on patients with T2DM was related to drug adverse effects. Overall, the total number and reason of drop out were unsatisfactory.

Indexed as

Diabetes Mellitus, Type 2HumansPatient DropoutsRandomized Controlled Trials as TopicBiasDiabetes mellitusDiscontinuingRandomized controlled trialsReasonsSystematic reviewWithdrawal

Identifiers

PMID33389690
PMCPMC8149490
OpenAlexW3120597148

What Socratic holds

Textmetadata
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 Socratic graph.