UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039680 |
|---|---|
| Receipt number | R000045261 |
| 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 |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2020/03/03 23:04:41 |
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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
| Obstetrics 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
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
matt.vassar@okstate.edu
Sponsor or person
Institute
Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma. 1111 W 17th St. Tulsa, OK 74107
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045261
