Dataset Information

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 (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).

SUBMITTER: Levey C

PROVIDER: S-EPMC5669005 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Levey Colin C Innes Nicola N Schwendicke Falk F Lamont Thomas T Göstemeyer Gerd G

Trials 20171102 1

<h4>Background</h4>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.<h4>Methods</h4>PubMed, Embase, Web of Knowledge and C ...[more]

PMID: 29096680

Similar Datasets

Project description:OBJECTIVE:Randomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients' preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined. DESIGN:Systematic review and meta-analyses. DATA SOURCES:MEDLINE, Embase, PsycINFO and the Cochrane Library. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:RPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included. DATA EXTRACTION AND SYNTHESIS:Two independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed. RESULTS:In total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%-100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%-99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI -0.178 to 0.364, p=0.502). CONCLUSIONS:Patients' preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs. PROSPERO REGISTRATION NUMBER:CRD42019094438.

Project description:IntroductionMidshaft clavicular fractures are common amongst young adults. Conservative or surgical treatment for definitive fracture management has been widely debate, both with their pros and cons. Previous meta-analyses compared the clinical outcomes between conservative and surgical treatment options of midshaft clavicular fractures but failed to elucidate any difference in functional improvement. We postulate that functional improvement after fracture union plateaus and the clinical outcome after treatment varies at different time points. This meta-analysis will focus on the synthesis comparison of outcomes at early, short-term results (3 months), intermediate-term (6 to 12 months) and long-term (>24 months) clinical outcomes.MethodsA systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) in June 2021. Search keywords were: midshaft clavicular fractures and clinical trials. Clinical trials fulfilling the inclusion criteria were selected for comparison and the clinical outcomes of midshaft clavicular fractures using surgical and non-surgical interventions in terms of improvement in the Disabilities of the Arm, Shoulder and Hand (DASH) score, Constant-Murley Score (CMS), time to union and risk ratio of treatment related complications were analysed in correlation with post-treatment timeframe.ResultsOf the 3094 patients of mean age 36.7 years in the 31 selected studies, surgical intervention was associated with improved DASH score (standard-mean difference SMD -0.22, 95% CI -0.36 to -0.07, p = 0.003; mean difference MD -1.72, 95% CI -2.93 to -0.51, p = 0.005), CMS (SMD 0.44, 95% CI 0.17-0.72, p = 0.001; MD 3.64, 95% CI 1.09 to 6.19, p = 0.005), time to union (non-adjusted SMD -2.83, 95% CI -4.59 to -1.07, p = 0.002; adjusted SMD -0.69, 95% CI -0.97 to -0.41, p<0.001) and risk ratio of bone-related complications including bone non-union, malunion and implant failure (0.21, 95% CI 0.1 to 0.42; p<0.001). Subgroup analysis based on time period after treatment showed that surgical intervention was far superior in terms of improved DASH score at the intermediate-term results (6-12 months later, SMD -0.16, 95% CI -0.30 to -0.02, p = 0.02; and long term results (>24 months SMD -4.24, 95% CI -7.03 to -1.45, p = 0.003) and CMS (>24 months, SMD 1.03, 95% CI 0.39 to 1.68, p = 0.002; MD 5.77, 95% CI 1.63 to 9.91, p = 0.006). Surgical outcome is independent of fixation with plates or intra-medullary nails.ConclusionSurgical intervention was associated with better clinical outcomes compared with non-surgical approach for midshaft clavicular fractures in terms of improvement in functional scores DASH, CMS, time to union and fracture related complications, although not to the minimal clinically significant difference. Benefits in the long-term functional improvements are more pronounced.

Project description:Background: Pain management is an important priority in the treatment of acute pancreatitis (AP). Current evidence and guideline recommendations are inconsistent on the most effective analgesic protocol. This systematic review and meta-analysis of randomised controlled trials (RCTs) aimed to compare the safety and efficacy of analgesics for pain relief in AP. Methods: A literature search was performed to identify all RCTs assessing analgesics in patients with AP. The primary outcome was the number of participants who needed rescue analgesia. Study quality was assessed using Jadad score. Pooled odds ratios (ORs) or weighted mean differences (WMDs) with 95% confidence intervals (CI) were analysed using a random-effects model. Results: Twelve studies comprising 699 patients with AP (83% mild AP) were analysed. The tested analgesics significantly decreased the need for rescue analgesia (3 studies, OR.36, 95% CI 0.21 to 0.60) vs. placebo or conventional treatment. The analgesics also improved the pain score [Visual Analogue Scale (Δ-VAS)] at 24 h (WMD 18.46, 0.84 to 36.07) and by the 3rd to 7th days (WMD 11.57, 0.87 to 22.28). Opioids vs. non-opioids were associated with a decrease in the need for rescue analgesia (6 studies, OR 0.25, 95% CI 0.07 to 0.86, p = 0.03) but without significance in pain score. In subgroup analyses, opioids were similar to non-steroidal anti-inflammatory drugs (NSAIDs) regarding the primary outcome (4 studies, OR 0.56, 95% CI 0.24 to 1.32, p = 0.18). There were no significant differences in other clinical outcomes and rate of adverse events. Other studies, comparing epidural anaesthesia vs. patient-controlled analgesia and opioid (buprenorphine) vs. opioid (pethidine) did not show significant difference in primary outcome. Study quality issues significantly contributed to overall study heterogeneity. Conclusions: NSAIDs and opioids are equally effective in decreasing the need for rescue analgesia in patients with mild AP. The relative paucity of trials and high-quality data in this setting is notable and the optimal analgesic strategy for patients with moderately severe and severe AP still requires to be determined.

Project description:ObjectiveTo evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital with acute and chronic conditions.DesignSystematic review of randomised and non-randomised controlled trials.Data sourcesMedline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature.Study selectionRandomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome.Data extraction and synthesisTwo investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials.Results24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P<0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P<0.05).ConclusionsThese findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care.Systematic review registrationPROSPERO CRD42018107099.

Project description:ObjectivesThe epidemiological transition from infectious to chronic diseases leads to novel challenges in African health systems. The prevalence of diabetes mellitus (DM) is increasing dramatically. Undiagnosed and undertreated DM leads to numerous complications including end-organ damage and death. Our objectives were to collect the best locally generated evidence on DM interventions, identify knowledge gaps and determine underexplored research areas.DesignA systematic review and meta-analysis of randomised controlled trials.Participants and settingAfrican patients in primary, secondary and tertiary prevention, diagnosis and treatment DM type 1 (DM1), type 2 (DM2) and gestational DM (GDM).OutcomeAll-cause mortality, glycaemic control, complications, quality of life, hospital admission, treatment adherence and costs.Data sourcesArticles published in MEDLINE Ovid, CENTRAL, CINAHL, African Journals Online and African Index Medicus and the International Clinical Trials Registry Platform in English language without time restrictions. The systematic search was last updated in October 2020.ResultsOut of 3736 identified publications, we included 60 eligible studies conducted in 15 countries, 75% were conducted in urban healthcare settings, including 10 112 participants. We included 8 studies on DM1, 6 on GDM, 2 on pre-DM, 37 on mainly DM2 including 7 on DM-related complications. The design of the studied intervention was heterogeneous with a focus on educational strategies. The other studies investigated the efficacy of nutritional strategies including food supplementations, pharmacological strategies and strategies to enhance physical activity. Seven studies included interventions on DM-related complications.ConclusionsResearch activities increased in recent years, but available evidence is still not representative for all African countries. There is a big lack of evidence in primary healthcare and rural settings, implementation research, pharmacological interventions, especially in poorer countries. Nevertheless, the identified studies offer a variety of effective interventions that can inform medical care and future research.Prospero registration numberCRD42019122785.

Project description:BackgroundChronic painful conditions have an important influence on the ability to work. Work-related outcomes, however, are not commonly reported in publications on trials investigating the treatment of chronic painful conditions. We aim to provide an overview of the reporting of work-related outcomes in such trials and investigate the relationship between work-related outcomes and pain outcomes.MethodsWe conducted a systematic literature search in PubMed with the aim of identifying randomised placebo-controlled clinical trials investigating treatments for chronic painful conditions or rheumatic diseases that also reported on work-related outcomes. Methodological study quality was assessed with the Oxford Quality Scale (OQS). Meta-analyses were conducted for the outcomes of interference with work and number of patients with at least 30% reduction in pain intensity (30% pain responders). The correlation between work-related and pain outcomes was investigated with regression analyses.ResultsWe included 31 publications reporting on 27 datasets from randomised placebo-controlled trials (with a total of 11,434 study participants) conducted in chronic painful or rheumatic diseases and reporting on work-related outcomes. These 31 publications make up only about 0.2% of all publications on randomised placebo-controlled trials in such conditions. The methodological quality of the included studies was high; only nine studies scored less than four (out of a maximum five) points on the OQS. Sixteen different work-related outcomes were reported on in the studies. Of 25 studies testing for the statistical significance of changes in work-related outcomes over the course of the trials, 14 (56%) reported a significant improvement; the others reported non-significant changes. Eight studies reported data on both interference with work and 30% pain responders: meta-analyses demonstrated similar, statistically significant improvements in both these outcomes with active therapy compared to placebo and regression analysis showed that these outcomes were correlated.ConclusionsDespite the importance of pain as a reason for decreased ability to work, work-related outcomes are reported in substantially less than 1% of publications on placebo-controlled trials in chronic painful and rheumatic diseases. Work-related outcomes and pain responder outcomes are closely related.

Dataset Information

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

Background

Methods

Inclusion criteria

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets