Addressing missing participant outcome data in dental clinical trials

Spineli, Loukia M.; Fleming, Padhraig S.; Pandis, Nikolaos

doi:10.1016/j.jdent.2015.03.007

Cited by 14 publications

(8 citation statements)

References 50 publications

(154 reference statements)

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“…Some studies lost almost 50% of the originally randomized patients. Therefore, incomplete outcome data in these studies might be an important source of attrition bias that can possibly interfere with treatment estimates (Yao et al, ) and their precision given the lower than planned sample size (Spineli, Fleming, & Pandis, ). Again, it is important to emphasize that incomplete data may not lead to baseline imbalances in the evaluated primary outcome as this depends on the missingness mechanism (Hewitt, Kumaravel, Dumville, & Torgerson, ).…”

Section: Discussionmentioning

confidence: 99%

“…As pointed out earlier, assumptions on the relationship between incomplete data due to dropouts and influence on the treatment effects based on the quantity and the pattern of dropouts may be misleading (Bell, Kenward, Fairclough, & Horton, ). The keys for evaluating attrition bias are the reasons for dropouts and the approach used to deal with missing data (Bell et al, ; Rubin, ; Spineli et al, ). When data are MCAR (Little et al, ; Spineli et al, ): missing data are completely unrelated to the study variables.…”

Section: Discussionmentioning

confidence: 99%

“…The keys for evaluating attrition bias are the reasons for dropouts and the approach used to deal with missing data (Bell et al, ; Rubin, ; Spineli et al, ). When data are MCAR (Little et al, ; Spineli et al, ): missing data are completely unrelated to the study variables. In this scenario patients leaving the study constitute a random sample of the study participants with similar event probability of having the outcome with those remaining in the study (Bell et al, ).…”

Section: Discussionmentioning

confidence: 99%

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Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials

Lieber

Pandis

Faggion

2019

J Clinic Periodontology

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Aim To assess the reporting and handling of incomplete outcome data in randomized clinical trials (RCTs) published in implant dentistry. Materials and methods We included RCTs on interventions related to the treatment with dental implants and presented any form of missing data. PubMed, SCOPUS and Cochrane databases were searched for studies published between May 2015 and May 2018. Reporting and handling of missing data at the study level were evaluated using a series of relevant questions. Descriptive data were reported, and univariable analyses were performed to evaluate the association of study variables with quality of reporting and data handling. Results One‐hundred and thirty‐seven RCT reports were included from the 7,116 initially retrieved publications. The reporting of incomplete outcome data varied greatly among the trials and for the different questions. The range of adequately reported questions was between 3.64% (question: comparison of baseline characteristics of all randomised participants) and 100% (question: explicit reporting of missing data). The complete case analysis was the most used (45.3%) approach for incomplete outcome data handling. Conclusions Randomized studies in implant dentistry have room for improvement in both the reporting and the handling of incomplete outcome data.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials

Lieber

Pandis

Faggion

2019

J Clinic Periodontology

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“…An association of attrition bias and exaggerated treatment effects was recorded in the present study. Losses to follow up or incomplete accounting for dropouts may risk inflated effect sizes to either direction and erroneous study conclusions due to between-group discrepancies (25). This is of particular importance in the clinical context of orthodontics or other medical fields where treatment effectiveness is largely dependent on the cooperation/compliance of trial participants to the allocated intervention (19).…”

Section: Discussionmentioning

confidence: 99%

Risk of bias and magnitude of effect in orthodontic randomized controlled trials: a meta-epidemiological review

Koletsi¹,

Spineli²,

Lempesi³

et al. 2015

EORTHO

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SummaryAim: To assess the risk of bias (RoB) in a subset of randomized controlled trials (RCTs) published in orthodontic journals using the Cochrane RoB tool and to identify associations between domain RoB assessment and treatment effect estimates. Materials and methods: Fifty consecutive issues of four major orthodontic journals were electronically searched to identify RCTs. The quality of the included studies was assessed using the Cochrane RoB tool, which involves seven domains rated as 'low', 'unclear' or 'high': random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective outcome reporting, and other threats to internal validity. Estimates and confidence intervals (CIs) were recorded or calculated where possible for binary and continuous outcome measures. Meta-regression models were employed to assess the impact of RoB per domain on the magnitude of treatment effect. Results: One hundred and one eligible studies involving 128 pair-wise comparisons were retrieved. Blinding of outcome assessors and incomplete outcome data were frequently judged as 'high' for RoB both for studies with binary and continuous outcome (42.9 and 48.8 per cent, respectively). For binary outcomes, high RoB regarding random sequence generation [odds ratio (OR): 5.97, 95% CI: 2.03, 17.63, P-value: 0.002] and incomplete outcome data (OR: 4.07, 95% CI: 1.03, 16.15, P-value: 0.05) were more likely to provide exaggerated effect estimates. Conclusions: There is a need for improved clinical trial methodology and reporting, in order to avoid inflated associations and erroneous conclusions.

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“…A modification of this tool was utilized for the included in-vitro/pre-clinical studies, as no pre-determined guidelines to assess the risk of bias exist and in order to incorporate specific important elements that would help identify the presence of potential bias. These include selection bias [17,18], performance bias [19], attrition bias [20] and reporting issues [21,22].…”

Section: Risk Of Bias Assessment Within Individual Studiesmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

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Use of thermoplastic material in orthodontics, either as aligner or as retainer appliances, is common practice and is likely to increase in the years to come. However, no systematic assessment on safety considerations of these adjuncts has been implemented up to date. The aim of this systematic review was to collectively appraise the existing evidence from both clinical and laboratory studies, on whether these appliances are associated with any estrogenic/cytotoxic effects or bisphenol-A (BPA) and monomer leaching. Eight electronic databases were searched with no limits in December 22, 2019, for published and unpublished research. Eligibility criteria comprised of studies of any design, describing use of any type of thermoplastic aligner. Study selection, data extraction and risk of bias (RoB) assessment was done independently, either in duplicate or confirmed by a second reviewer. Random effects meta-analyses of weighted mean differences (WMD) with associated 95% Confidence Intervals (CIs) were planned. Quality of the evidence was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 58 articles were initially identified, while 5 were included in qualitative synthesis and 2 of those contributed to the quantitative syntheses. Four studies were in-vitro, while one was a randomized controlled trial; all assessed some type of orthodontic aligner or retainer, either as-received or retrieved. Risk of bias recordings ranged between unclear and high for all studies. Proliferation induction capacity of thermoplastic appliances’ eluents on MCF-7 cells failed to be confirmed compared to beta-estradiol (2 studies: 5% v/v, WMD: −182.08; 95% CI: −198.83, −165.33; p-value < 0.001; and 20% v/v, WMD: −184.53; 95% CI: −206.17, −162.88; p-value < 0.001). No cytotoxic activity was detected as well. In addition, although evidence from in-vitro studies was indicative of no traceable detection of BPA or other monomers, the findings from a single clinical trial were allied to increased levels of BPA in whole stimulated saliva, after up to 30 days of thermoplastic retainer usage, compared to standard Hawley retainer. The quality of the evidence overall was low to medium. Current data from in-vitro research are indicative of an absence of an estrogenic or cytotoxic effect of thermoplastic aligners or retainers. Regarding BPA or monomer release, evidence from clinical and laboratory studies appear inconsistent.

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Addressing missing participant outcome data in dental clinical trials

Cited by 14 publications

References 50 publications

Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials

Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials

Risk of bias and magnitude of effect in orthodontic randomized controlled trials: a meta-epidemiological review

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

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