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Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.

Dmitry GryaznovAyodele OdutayoBelinda von NiederhäusernBenjamin SpeichBenjamin KasendaElena Ojeda-RuizAnette BlümleStefan SchandelmaierDominik MertzYuki TomonagaAlain AmstutzChristiane Pauli-MagnusViktoria GloyKarin BischoffKatharina WollmannLaura RehnerSzimonetta LohnerJoerg J MeerpohlAlain NordmannKatharina KlatteNilabh GhoshAla Taji HeraviJacqueline WongNgai ChowPatrick Jiho HongKimberly Mc CordSirintip SricharoenchaiJason W BusseArnav AgarwalRamon SaccilottoMatthias SchwenkglenksGiusi MoffaLars G HemkensSally HopewellErik von ElmMatthias Briel
Published in: Trials (2020)
The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.
Keyphrases
  • cross sectional
  • study protocol
  • clinical trial
  • phase iii
  • insulin resistance
  • risk assessment
  • human health
  • weight loss