UMIN-CTR Clinical Trial

Basic information
Public title	Associated conflicts of interest among systematic review authors of long acting reversible contraceptives and the nature of the results and conclusions of these reviews
Acronym	FCOI LARC
Scientific Title	Associated conflicts of interest among systematic review authors of long acting reversible contraceptives and the nature of the results and conclusions of these reviews
Scientific Title:Acronym	Associated conflicts of interest among systematic review authors of long acting reversible contraceptives and the nature of the results and conclusions of these reviews
Region	North America

Condition
Condition	FCOI IN LARC
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Thus, the purpose of this study is to evaluate potential conflicts of interest of reviewers in systematic reviews focused on long acting reversible contraceptives.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Thus, the purpose of this study is to evaluate potential conflicts of interest of reviewers in systematic reviews focused on long acting reversible contraceptives.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Female
Key inclusion criteria	Furthermore, studies will be included which compare 1) LARCs to each other, 2) LARCs to oral contraceptives or 3) LARCs to nonpharmacologic therapy or placebo. Studies must have outcomes for one or more of the following 1) efficacy, 2) side effects including pain, nausea, weight gain, obesity, or preeclampsia etc 4) adverse events including complications, expulsion, perforation, infection, anemia, and/or bleeding, 5) application/insertion, or 6) promotion of use. Furthermore, to qualify for inclusion, systematic reviews must have been published from September of 2016 through January of 2020. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included. Published poster presentations and conference abstracts will be excluded.
Key exclusion criteria	Furthermore, studies will be included which compare 1) LARCs to each other, 2) LARCs to oral contraceptives or 3) LARCs to nonpharmacologic therapy or placebo. Studies must have outcomes for one or more of the following 1) efficacy, 2) side effects including pain, nausea, weight gain, obesity, or preeclampsia etc 4) adverse events including complications, expulsion, perforation, infection, anemia, and/or bleeding, 5) application/insertion, or 6) promotion of use. Furthermore, to qualify for inclusion, systematic reviews must have been published from September of 2016 through January of 2020. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included. Published poster presentations and conference abstracts will be excluded.
Target sample size

Research contact person
Name of lead principal investigator	1st name Micah Middle name Last name Hartwell
Organization	Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma. 1111 W 17th St. Tulsa, OK 74107
Division name	CHS
Zip code	74107
Address	1111 West 17th Street
TEL	9185948426
Email	micah.hartwell@okstate.edu

Public contact
Name of contact person	1st name micah Middle name Last name hartwell
Organization	Oklahoma State University
Division name	CHS
Zip code	74107
Address	1111 West 17th Street
TEL	9185948426
Homepage URL
Email	matt.vassar@okstate.edu

Sponsor
Institute	Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma. 1111 W 17th St. Tulsa, OK 74107
Institute
Department

Funding Source
Organization	Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma. 1111 W 17th St. Tulsa, OK 74107
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	OSU
Address	111 W 174th st
Tel	9185948426
Email	matt.vassar@okstate.edu

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 03 Month 02 Day
Date of IRB	2020 Year 01 Month 01 Day
Anticipated trial start date	2020 Year 03 Month 03 Day
Last follow-up date	2021 Year 04 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

To evaluate the risk of funding bias in the systematic reviews, we applied the Cochrane Collaborations criteria for assessment5, which includes 5 items from Mandrioli et al5 (i) whether explicit and ell defined criteria that could be replicated by others were used to select studies for inclusion or exclusion in the review (ii) whether there was an adequate study inclusion method, with two or more assessors selecting studies (iii) whether the search for studies was comprehensive and (iv) whether methodological differences and other characteristics that could introduce bias were controlled. Each item will be given a designation of yes, no, or unclear. The overall risk of bias will be considered low if 3 or more of these criteria had been met and high otherwise. Risk of bias will be evaluated at the study level. Results from risk of bias evaluations will be used to evaluate the relationship between systematic reviews at risk of bias, the COI of systematic review authors, and the systematic review sponsor.

Management information
Registered date	2020 Year 03 Month 03 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045261