Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review

Abstract Background Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials...

Full description

Bibliographic Details
Main Authors: Colin Levey, Nicola Innes, Falk Schwendicke, Thomas Lamont, Gerd Göstemeyer
Format: Article
Language:English
Published: BMC 2017-11-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-2256-1
id doaj-e6e2c434fa274ec0b747ea9333712f29
record_format Article
spelling doaj-e6e2c434fa274ec0b747ea9333712f292020-11-24T23:06:47ZengBMCTrials1745-62152017-11-0118111110.1186/s13063-017-2256-1Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic reviewColin Levey0Nicola Innes1Falk Schwendicke2Thomas Lamont3Gerd Göstemeyer4School of Dentistry, University of DundeeSchool of Dentistry, University of DundeeDepartment of Operative and Preventive Dentistry, Charité-UniversitätsmedizinSchool of Dentistry, University of DundeeDepartment of Operative and Preventive Dentistry, Charité-UniversitätsmedizinAbstract Background Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations. Methods PubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). Inclusion criteria: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly. Results Of 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968–1980 and 2001–2010, reporting of outcome ‘caries experience’ reduced from 39% to 18%; ‘clinical performance of the restoration’ reporting increased from 33% to 42% although there was a reduction to 22% in 2011–2015. Emerging outcome domains include ‘lesion activity’ and ‘pulp health-related outcomes’, accounting for 1% and 0%, respectively, during 1968–1980 and 10% and 4% for 2011–2015. Reporting ‘resource efficiency’ and ‘quality of life measures’ have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports. Conclusions Over the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future. Trial registration PROSPERO, CRD42015025310 . Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017).http://link.springer.com/article/10.1186/s13063-017-2256-1Systematic reviewCariesCore outcome setOutcomesRestorationsCaries prevention
collection DOAJ
language English
format Article
sources DOAJ
author Colin Levey
Nicola Innes
Falk Schwendicke
Thomas Lamont
Gerd Göstemeyer
spellingShingle Colin Levey
Nicola Innes
Falk Schwendicke
Thomas Lamont
Gerd Göstemeyer
Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
Trials
Systematic review
Caries
Core outcome set
Outcomes
Restorations
Caries prevention
author_facet Colin Levey
Nicola Innes
Falk Schwendicke
Thomas Lamont
Gerd Göstemeyer
author_sort Colin Levey
title Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
title_short Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
title_full Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
title_fullStr Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
title_full_unstemmed Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
title_sort outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review
publisher BMC
series Trials
issn 1745-6215
publishDate 2017-11-01
description Abstract Background Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations. Methods PubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). Inclusion criteria: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly. Results Of 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968–1980 and 2001–2010, reporting of outcome ‘caries experience’ reduced from 39% to 18%; ‘clinical performance of the restoration’ reporting increased from 33% to 42% although there was a reduction to 22% in 2011–2015. Emerging outcome domains include ‘lesion activity’ and ‘pulp health-related outcomes’, accounting for 1% and 0%, respectively, during 1968–1980 and 10% and 4% for 2011–2015. Reporting ‘resource efficiency’ and ‘quality of life measures’ have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports. Conclusions Over the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future. Trial registration PROSPERO, CRD42015025310 . Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017).
topic Systematic review
Caries
Core outcome set
Outcomes
Restorations
Caries prevention
url http://link.springer.com/article/10.1186/s13063-017-2256-1
work_keys_str_mv AT colinlevey outcomesinrandomisedcontrolledtrialsinpreventionandmanagementofcariouslesionsasystematicreview
AT nicolainnes outcomesinrandomisedcontrolledtrialsinpreventionandmanagementofcariouslesionsasystematicreview
AT falkschwendicke outcomesinrandomisedcontrolledtrialsinpreventionandmanagementofcariouslesionsasystematicreview
AT thomaslamont outcomesinrandomisedcontrolledtrialsinpreventionandmanagementofcariouslesionsasystematicreview
AT gerdgostemeyer outcomesinrandomisedcontrolledtrialsinpreventionandmanagementofcariouslesionsasystematicreview
_version_ 1725621112981684224