Reports Of Randomized Controlled Trials Research Articles

Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement

To evaluate the quality of randomized controlled trials(RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement， and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included， with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones： using validated tools to report adverse effects， standards for coding of the adverse reactions， describing how and when to collect data on adverse reactions in Method， describing how adverse reactions are attributed to T. wilfordii， clearly stating who has reported the adverse reactions， describing the analysis method of adverse reactions， describing the method of collecting recurrent adverse reaction data， describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement， and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions， dose， taking time， combined medication and the dialectical typology of research objects.

Randomized controlled trials: significant results—fragile, though

In their systematic review, Shochet etal. question the robustness of the statistical significance of the results of randomized controlled trials (RCTs) in nephrology reported in high-impact journals (2005-2014). They hypothesized that a high proportion of RCTs in nephrology would be fragile. They calculated a Fragility Index that is a tool for testing robustness of RCTs, based on 107 RCT reports. The observation of an alarming median Fragility Index equal to 3 suggests that in half of the trials, the sole additional occurrence of 3events would compromise the significance of nominally significant results.

Systematic review on the reporting quality of randomized controlled trials in patients with hepatitis B or C in China

BackgroundThe numbers of articles reporting randomized controlled trials (RCTs) on viral hepatitis in China have been increasing, but there have been few systematic studies evaluating the reporting quality of RCTs in this field. This study was performed to assess the reporting quality of RCTs on the treatment of hepatitis B and C in China from 1991 to 2015. MethodsArticles published between January 1991 and December 2015 were identified via the PubMed, MEDLINE, and Embase databases using the key words “randomized clinical trials”, “treatment”, “therapy”, “hepatitis B”, “HBV”, “hepatitis C”, “HCV”, “China”, and “Chinese”. The reporting quality was assessed against the Consolidated Standards of Reporting Trials (CONSORT) checklist. ResultsIn total, 211 RCTs on the treatment of hepatitis B or C were included. The number of articles focusing on these RCTs increased rapidly over time, while the reporting quality improved steadily over time. Overall, compliance with the key components of the CONSORT checklist was low, with only 8.5%, 3.8%, and 11.4% of the articles fulfilling the reporting requirements of randomization, allocation concealment, and blinding, respectively. ConclusionsBoth the number and the quality of RCT articles were found to have increased steadily over the last two decades. However, compliance with the key components of the CONSORT checklist still needs improvement. It is hoped that the results of this study will lead to improvements in the reporting quality of clinical trials on hepatitis B and C in China.

Pharmacotherapy for social anxiety disorder (SAnD).

Recognition is growing that social anxiety disorder (SAnD) is a chronic and disabling disorder, and data from early trials demonstrate that medication may be effective in its treatment. This systematic review is an update of an earlier review of pharmacotherapy of SAnD. To assess the effects of pharmacotherapy for social anxiety disorder in adults and identify which factors (methodological or clinical) predict response to treatment. We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR-Studies and CCMDCTR-References) to 17 August 2015. The CCMDCTR contains reports of relevant RCTs from MEDLINE (1950-), Embase (1974-), PsycINFO (1967-) and CENTRAL (all years). We scanned the reference lists of articles for additional studies. We updated the search in August 2017 and placed additional studies in Awaiting Classification, these will be incorporated in the next version of the review, as appropriate. We restricted studies to randomised controlled trials (RCTs) of pharmacotherapy versus placebo in the treatment of SAnD in adults. Two authors (TW and JI) assessed trials for eligibility and inclusion for this review update. We extracted descriptive, methodological and outcome information from each trial, contacting investigators for missing information where necessary. We calculated summary statistics for continuous and dichotomous variables (if provided) and undertook subgroup and sensitivity analyses. We included 66 RCTs in the review (> 24 weeks; 11,597 participants; age range 18 to 70 years) and 63 in the meta-analysis. For the primary outcome of treatment response, we found very low-quality evidence of treatment response for selective serotonin reuptake inhibitors (SSRIs) compared with placebo (number of studies (k) = 24, risk ratio (RR) 1.65; 95% confidence interval (CI) 1.48 to 1.85, N = 4984). On this outcome there was also evidence of benefit for monoamine oxidase inhibitors (MAOIs) (k = 4, RR 2.36; 95% CI 1.48 to 3.75, N = 235), reversible inhibitors of monoamine oxidase A (RIMAs) (k = 8, RR 1.83; 95% CI 1.32 to 2.55, N = 1270), and the benzodiazepines (k = 2, RR 4.03; 95% CI 2.45 to 6.65, N = 132), although the evidence was low quality. We also found clinical response for the anticonvulsants with gamma-amino butyric acid (GABA) analogues (k = 3, RR 1.60; 95% CI 1.16 to 2.20, N = 532; moderate-quality evidence). The SSRIs were the only medication proving effective in reducing relapse based on moderate-quality evidence. We assessed tolerability of SSRIs and the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine on the basis of treatment withdrawal; this was higher for medication than placebo (SSRIs: k = 24, RR 2.59; 95% CI 1.97 to 3.39, N = 5131, low-quality evidence; venlafaxine: k = 4, RR 3.23; 95% CI 2.15 to 4.86, N = 1213, moderate-quality evidence), but there were low absolute rates of withdrawal for both these medications classes compared to placebo. We did not find evidence of a benefit for the rest of the medications compared to placebo.For the secondary outcome of SAnD symptom severity, there was benefit for the SSRIs, the SNRI venlafaxine, MAOIs, RIMAs, benzodiazepines, the antipsychotic olanzapine, and the noradrenergic and specific serotonergic antidepressant (NaSSA) atomoxetine in the reduction of SAnD symptoms, but most of the evidence was of very low quality. Treatment with SSRIs and RIMAs was also associated with a reduction in depression symptoms. The SSRIs were the only medication class that demonstrated evidence of reduction in disability across a number of domains.We observed a response to long-term treatment with medication for the SSRIs (low-quality evidence), for the MAOIs (very low-quality evidence) and for the RIMAs (moderate-quality evidence). We found evidence of treatment efficacy for the SSRIs, but it is based on very low- to moderate-quality evidence. Tolerability of SSRIs was lower than placebo, but absolute withdrawal rates were low.While a small number of trials did report treatment efficacy for benzodiazepines, anticonvulsants, MAOIs, and RIMAs, readers should consider this finding in the context of potential for abuse or unfavourable side effects.

Quality Assessment of Published Randomized, Controlled Trials in Trauma Monthly Journal

Context: Randomized controlled trials (RCTs) have a major role in making the evidence-based decisions on healthcare. Therefore, the assessment of the quality of RCTs is important to properly apply the evidence-based healthcare. The current study aimed at assessing the quality of RCT reports published in Trauma Monthly Journal. Evidence Acquisition: The quality assessment of each report was performed using a checklist based on the CONSORT (consolidated standards of reporting trials) Statement and Jadad criteria. Results: Fifteen RCTs were published from 2011 to 2015 in Trauma Monthly journal out of which 5 (33.3%) reported the pain outcomes, 7 (46.6%) reports included surgical interventions, and 3 (33.3%) reports included patients with different types of fractures. According to the CONSORT checklist, the best report belonged to the definition of interventions for each group with sufficient details. The mean score of Jadad was 2.27 (45.4% of maximum possible total score). According to both scales, there was an increase in the periods of time in the quality of reporting. Conclusions: The results showed a moderate quality score in RCTs and an improvement over the years. Training courses for researchers, managing reporting standard tools presented by editors (CONSORT checklist) and employing methodologists and statistical experts can improve the quality of published RCTs.

A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

IntroductionSystematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to...

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality.

Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. MEDLINE® , Embase® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly.

Play seriously: Effectiveness of serious games and their features in motor rehabilitation. A meta-analysis.

Evidence for the effectiveness of serious games (SGs) and their various features is inconsistent in the motor rehabilitation field, which makes evidence based development of SGs a rare practice. To investigate the effectiveness of SGs in motor rehabilitation for upper limb and movement/balance and to test the potential moderating role of SGs features like feedback, activities, characters and background. We ran a meta-analysis including 61 studies reporting randomized controlled trials (RCTs), controlled trials (CTs) or case series designs in which at least one intervention for motor rehabilitation included the use of SGs as standalone or in combination. There was an overall moderate effect of SGs on motor indices, d = 0.59, [95% CI, 0.48, 0.71], p < 0.001. Regarding the game features, only two out of 17 moderators were statistically different in terms of effect sizes: type of activity (combination of group with individual activities had the highest effects), and realism of the scenario (fantasy scenarios had the highest effects). While we showed that SGs are more effective in improving motor upper limb and movement/balance functions compared to conventional rehabilitation, there were no consistent differences between various game features in their contribution to effects. Further research should systematically investigate SGs features that might have added value in improving effectiveness.

Ventral Hernia Repair: A Meta-Analysis of Randomized Controlled Trials.

From the patient's perspective, a ventral hernia (VH) can cause pain, adversely affect function, increase size, cosmetically distort the abdomen, and incarcerate/strangulate abdominal contents. The only known "cure" for a VH is surgical repair. The aim of this study was to review systematically the published randomized controlled trials (RCTs) of the surgical care of VH. A search of the Ovid, MEDLINE, EMBASE, and Cochrane databases was performed to obtain reports of RCTs on the use of mesh reinforcement in abdominal wall hernia repair. The outcomes assessed were hernia recurrence and surgical site infection (SSI). The overall quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). When feasible, based on assessment of heterogeneity, data were pooled and analyzed in a meta-analysis. Of the 10,349 titles screened, 25 articles (23 studies) met the search criteria. Evidence indicates that mesh reinforcement in clean cases can decrease hernia recurrence (number needed to treat = 7.9) but increase risk of SSI (number needed to harm = 27.8). Placing mesh in the sublay position (as opposed to the onlay or underlay position) may decrease the risk of hernia recurrence and SSI. Mesh reinforcement is recommended for all VH repairs in a clean case (high grade of evidence). Sublay mesh location may result in fewer recurrences and SSIs than onlay or inlay placement, but further study is needed to confirm this hypothesis (moderate grade of evidence).

Digital Support Interventions for the Self-Management of Low Back Pain: A Systematic Review.

BackgroundLow back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health.ObjectiveThe study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP. The following specific questions were examined: (1) What are the key components of digital self-management interventions for LBP, including theoretical underpinnings? (2) What outcome measures have been used in randomized trials of digital self-management interventions in LBP and what effect, if any, did the intervention have on these? and (3) What specific characteristics or components, if any, of interventions appear to be associated with beneficial outcomes?MethodsBibliographic databases searched from 2000 to March 2016 included Medline, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER and TRoPHI, Social Science Citation Index, and Science Citation Index. Reference and citation searching was also undertaken. Search strategy combined the following concepts: (1) back pain, (2) digital intervention, and (3) self-management. Only randomized controlled trial (RCT) protocols or completed RCTs involving adults with LBP published in peer-reviewed journals were included. Two reviewers independently screened titles and abstracts, full-text articles, extracted data, and assessed risk of bias using Cochrane risk of bias tool. An independent third reviewer adjudicated on disagreements. Data were synthesized narratively.ResultsOf the total 7014 references identified, 11 were included, describing 9 studies: 6 completed RCTs and 3 protocols for future RCTs. The completed RCTs included a total of 2706 participants (range of 114-1343 participants per study) and varied considerably in the nature and delivery of the interventions, the duration/definition of LBP, the outcomes measured, and the effectiveness of the interventions. Participants were generally white, middle aged, and in 5 of 6 RCT reports, the majority were female and most reported educational level as time at college or higher. Only one study reported between-group differences in favor of the digital intervention. There was considerable variation in the extent of reporting the characteristics, components, and theories underpinning each intervention. None of the studies showed evidence of harm.ConclusionsThe literature is extremely heterogeneous, making it difficult to understand what might work best, for whom, and in what circumstances. Participants were predominantly female, white, well educated, and middle aged, and thus the wider applicability of digital self-management interventions remains uncertain. No information on cost-effectiveness was reported. The evidence base for interactive digital interventions to support patient self-management of LBP remains weak.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

Global cardiovascular risk assessment in the primary prevention of cardiovascular disease in adults: systematic review of systematic reviews

ObjectiveTo identify, critically appraise and summarise existing systematic reviews on the impact of global cardiovascular risk assessment in the primary prevention of cardiovascular disease (CVD) in adults.DesignSystematic review of systematic...

Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry

ObjectivesThe aim of this study was to assess if journal endorsement of the CONSORT Statement is associated with improved completeness of reporting of randomized controlled trials (RCTs) in restorative dentistry. Materials and methodsRCTs in restorative dentistry published in two journals that have (Journal of Dentistry and Clinical Oral Investigations) and have not (Operative Dentistry and Journal of Prosthetic Dentistry) endorsed the CONSORT Statement were selected. We compared the completeness of reporting between comparison groups (endorsers versus non-endorsers, before versus after endorsement) using a risk ratio (RR) with a 99% confidence interval for each outcome of CONSORT 2010. Also, the risk of bias of each study was evaluated. ResultsThe electronic search retrieved a total of 3701 records. After the title and abstract evaluation, 169 full texts were screened and 79 RCTs identified. Considering CONSORT-endorsing journals before and after CONSORT endorsement, six items had effect estimates indicating a relatively higher proportion of completely reported RCTs published after CONSORT endorsement. Considering CONSORT-endorsing journals compared to non-endorsing journals, twelve items indicated a relatively higher proportion of completely reported RCTs published in CONSORT-endorsing journals. In both analyses the overall evidence did not present statistical significance. ConclusionAlthough CONSORT endorsement has been linked with some improvement in the completeness of RCTs reports in the biomedical literature, this was not reflected in the present analysis confined to restorative dentistry. More innovative and involved approaches to enhancing reported may therefore be required.Clinical significance: Inadequate reporting of randomized controlled trials can produce important consequences for all stakeholders including waste of resources and implication on healthcare decisions. A broad understandment of the use of reporting guidelines is necessary to lead to better results.

Ultrasonography for neuraxial blocks: a review of the evidence.

This narrative review summarizes the evidence derived from randomized controlled trials (RCTs) pertaining to the use of adjunctive ultrasonography (US) for neuraxial blocks. The literature search was conducted using the MEDLINE, EMBASE and PUBMED databases. For the MEDLINE and EMBASE searches, the MESH terms "ultrasonography" and key word "ultrasound" were queried; using the operator "and", they were combined with the MESH terms "neuraxial block," "epidural anesthesia," "epidural analgesia," "spinal anesthesia," "spinal analgesia," "intrathecal anesthesia," "intrathecal analgesia," "caudal anesthesia," and "caudal analgesia." For the PUBMED search, the search terms "ultrasound neuraxial," "ultrasound intrathecal," "ultrasound epidural" (limited to clinical trials), "ultrasound spinal" (limited to clinical trials), and "ultrasound caudal" (limited to clinical trials) were queried. Seventeen RCTs were retained for analysis. Compared to conventional palpation of landmarks, US assistance (i.e., preprocedural scanning) results in fewer needle passes/insertions and skin punctures for neuraxial blocks in obstetrical and surgical patients. These benefits seem most pronounced when expert operators carry out the sonographic exams and for patients displaying difficult spinal anatomy. Preliminary findings also suggest that US provides similar pain relief and functional improvement to fluoroscopy for epidural/caudal steroid injection in patients afflicted with chronic spinal pain. Although one trial demonstrated shorter needling time with US guidance (i.e., real-time scanning of needle advancement) compared to US assistance, these findings require further validation. Published reports of RCTs provide evidence to formulate limited recommendations regarding the use of adjunctive US for neuraxial blocks. Further well-designed RCTs are warranted.

Framing of research question using the PICOT format in randomised controlled trials of venous ulcer disease: a protocol for a systematic survey of the literature

IntroductionAlthough venous ulcers have a great social and economic impact, there is a lack of evidence from randomised controlled trials (RCTs) to support appropriate management for this disease. Framing the...

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record

Has the quality of reporting in periodontology changed in 14years? A systematic review.

Quality of reporting randomized controlled trials (RCTs) in periodontology has been poor. Consolidated Standards of Reporting Trials guidelines and an extension for non-pharmacologic trials (CONSORT-NPE), were introduced to aid in improving this. The aim of this study was to assess the quality of reporting in periodontology, changes over the last 14years, and adherence to CONSORT-NPE. Randomized controlled trials in humans, published in three periodontal journals, from 2013 to 2015 were included. Search was conducted through Medline, Embase and hand searching. One hundred and seventy-three full-text articles included. Two reviewers screened for reporting quality (κ=0.69, 95% CI 0.60-0.76). 84% of studies (n=145) described randomization methods, 74% (n=128) highlighted examiner blinding and 87% (n=151) accounted for patients at study conclusion. Patient and caregiver blinding was addressed in 50% (n=70) and 50% (n=27) of studies respectively. 64% (n=110) described adequate allocation concealment. Compared with Montenegro etal. (2002, Journal of Dental Research, 81, 866), improvements seen in describing randomization (2002, 16.5%; 2016, 84%), allocation concealment (2002, 6.5%; 2016, 64%), caregiver masking (2002, 17%; 2016, 50%). CONSORT-NPE; 62% (n=107) had detailed explanations of all treatments, 88% (n=152) lacked protocols for adherence of caregivers' to an intervention. Only 17% (n=29) described caregivers' expertise and case volume. Substantial improvements have occurred. Attention is required for statistical analysis of patient losses and masking. CONSORT-NPE aspects were poorly reported.

Choice of primary outcomes evaluating treatment for heavy menstrual bleeding.

Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta-analysis (IPDMA). To give insight into the primary endpoints and outcome measures chosen in randomised controlled trials (RCTs) and systematic reviews regarding the treatment of HMB. Published systematic reviews and RCTs. Full reports of RCTs or systematic reviews. For RCTs, we used the primary outcomes, as they were used for the sample size calculation. For systematic reviews, all outcomes listed as primary were included. Four authors selected the studies. Twelve different primary outcomes were reported by 66 RCTs, most blood loss- related (44/66 studies). Amenorrhoea was the most common blood loss primary outcome (16/44 studies) and the Pictorial Blood Loss Assessment Chart (PBAC) was the most used measurement tool (27/44 studies). Satisfaction was the second most prevalent primary outcome measure (13/66 studies). In all, 14/26 (54%) systematic reviews prespecified a single primary outcome, whereas all other reviews used composite primary outcomes. Blood loss was the most studied outcome (12/26 reviews). The most used primary outcomes in HMB studies relate to blood loss but there is no consistency regarding the endpoints chosen or measurement tools used to describe blood loss. Standardising outcomes will aid valid comparison and interpretation of data pertaining to the treatment of HMB. A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed.

The risk of bias of animal experiments in implant dentistry: a methodological study.

To evaluate the risk of bias (ROB) in reports of randomised controlled trials (RCTs) of animal experiments published in implant dentistry, and to explore the association between animal experiment characteristics and ROB. We searched the MEDLINE (via PubMed), SCOPUS and SciELO databases from 2010 to March 2015 for reports of RCTs of animal experiments published in implant dentistry. We evaluated independently and in duplicate the ROB of these experiments by the use of a tool specifically developed to evaluate ROB in animal studies, the SYRCLE's tool. ROB was judged as low, high or unclear (when there was not enough information to judge ROB). We used univariate and multivariate logistic regression analyses to evaluate the association of specific study characteristics and extent of ROB. We initially selected 850 publications and 161 reports of animal experiments were included. For a total of 1449 entries (records), 486 (34%) were rated as low ROB. High ROB was attributed to 80 (6%) of entries, and 883 (60%) entries were rated as unclear ROB. The characteristics "impact factor" (IF), reporting of standard error (SE) and reporting of confidence interval (CI) were significantly associated with low ROB in some SYRCLE domains. A substantial number of items with unclear ROB were observed in this sample of animal experiments in implant dentistry. Furthermore, the present findings suggest that implant dentistry animal experiments published in journals with higher IF and better report of measures of precision; that is, CI and SE may have lower ROB than those not having these characteristics.

Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates.

Assessment of events by adjudication committees (ACs) is recommended in multicentre randomised controlled trials (RCTs). However, its usefulness has been questioned. The aim of this systematic review was to compare 1) treatment effect estimates of subjective clinical events assessed by onsite assessors versus by AC, and 2) treatment effect estimates according to the blinding status of the onsite assessor as well as the process used to select events to adjudicate. We searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, PsycINFO, CINAHL and Google Scholar (25 August 2015 as the last updated search date), using a combination of terms to retrieve RCTs with commonly used terms to describe ACs. We included all reports of RCTs and the published RCTs included in reviews and meta-analyses that reported the same subjective outcome event assessed by both an onsite assessor and an AC. We extracted the odds ratio (OR) from onsite assessment and the corresponding OR from AC assessment and calculated the ratio of the odds ratios (ROR). A ratio of odds ratios < 1 indicated that onsite assessors generated larger effect estimates in favour of the experimental treatment than ACs. Data from 47 RCTs (275,078 patients) were used in the meta-analysis. We excluded 11 RCTs because of incomplete outcome data to calculate the OR for onsite and AC assessments. On average, there was no difference in treatment effect estimates from onsite assessors and AC (combined ROR: 1.00, 95% confidence interval (CI) 0.97 to 1.04; I(2) = 0%, 47 RCTs). The combined ROR was 1.00 (95% CI 0.96 to 1.04; I(2) = 0%, 35 RCTs) when onsite assessors were blinded; 0.76 (95% CI 0.48 to 1.12, I(2) = 0%, two RCTs) when AC assessed events identified independently from unblinded onsite assessors; and 1.11 (95% CI 0.96 to 1.27, I(2) = 0%, 10 RCTs) when AC assessed events identified by unblinded onsite assessors. However, there was a statistically significant interaction between these subgroups (P = 0.03) AUTHORS' CONCLUSIONS: On average, treatment effect estimates for subjective outcome events assessed by onsite assessors did not differ from those assessed by ACs. Results of subgroup analysis showed an interaction according to the blinded status of onsite assessors and the process used to submit data to AC. These results suggest that the use of ACs might be most important when onsite assessors are not blinded and the risk of misclassification is high. Furthermore, research is needed to explore the impact of the different procedures used to select events to adjudicate.