Proportion Of Randomized Controlled Trials Research Articles

Evaluation of quality and quantity of randomized controlled trials in hepatobiliary surgery: A scoping/mapping review.

To evaluate the quantity and quality of randomized controlled trials (RCTs) in hepatobiliary surgery and for identifying gaps in current evidences. A systematic search was conducted in MEDLINE (via PubMed), Web of Science, and Cochrane Controlled Register of Trials (CENTRAL) for RCTs of hepatobiliary surgery published from inception until the end of 2023. The quality of each study was assessed using the Cochrane risk-of-bias (RoB) tool. The associations between risk of bias and the region and publication date were also assessed. Evidence mapping was performed to identify research gaps in the field. The study included 1187 records. The number and proportion of published randomized controlled trials (RCTs) in hepatobiliary surgery increased over time, from 13 RCTs (.0005% of publications) in 1970-1979 to 201 RCTs (.003% of publications) in 2020-2023. There was a significant increase in the number of studies with a low risk of bias in RoB domains (p < .01). The proportion of RCTs with low risk of bias improved significantly after the introduction of CONSORT guidelines (p < .001). The evidence mapping revealed a significant research focus on major and minor hepatectomy and cholecystectomy. However, gaps were identified in liver cyst surgery and hepatobiliary vascular surgery. Additionally, there are gaps in the field of perioperative management and nutrition intervention. The quantity and quality of RCTs in hepatobiliary surgery have increased over time, but there is still room for improvement. We have identified gaps in current research that can be addressed in future studies.

Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act

Recent research misconduct, represented by the valsartan scandal, has raised questions about the quality of non-commercial trials not for regulatory approval in Japan. Unlike in the US and Europe, non-commercial clinical trials are not regulated by law in Japan, which was believed to be a reason why quality could not be guaranteed. However, until now, few studies have compared the quality of clinical studies among countries. In this study, the quality of Japanese non-commercial phase Ⅲ trials before the implementation of the Clinical Trials Act (CTA) in 2018 was compared with Western non-commercial trials registered in the database using study design as quality indicators. The study found a lower proportion of randomized, controlled trials (RCTs) (70％ in Japan, 89％ in the US, and 88％ in the UK) and fewer blinded designs (46％ in Japan, 59％ in the US, and 52％ in the UK) in non-commercial trials in Japan. Single-arm trials not for either cancer or rare diseases, which are usually considered low quality because of a lack of fair comparison, were more common in Japan (82％) than in the US (76％) and the UK (50％). In terms of endpoint setting, most non-commercial trials in Japan had surrogate endpoints, with only a few trials using true endpoints (5％) compared to the US (24％) and the UK (40％). A comparison of these quality indicators in Japanese non-commercial trials before and after the CTA implementation showed no increases in the proportion of RCT and blinded designs, but an increase in the proportion of trials using true endpoints and appropriate use of single-arm design. In conclusion, the lack of legal regulation in Japan may have indirectly affected the quality of non-commercial phase Ⅲ trials in Japan at the time. Implementation of the CTA has contributed to some quality improvements, but the effect is limited at present.

Trends and quality of randomized controlled trials on acupuncture conducted in Japan by decade from the 1960s to the 2010s: a systematic review

BackgroundMore new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs.MethodsThe literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team’s compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting.ResultsA total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that “sequence generation” improved in and after 1990 (73%–80% of RCTs were rated as “low”) and “blinding of outcome assessors” slightly improved in and after the 2000s (40%–50% judged as “low”). However, “high” or “unclear” remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or “placebo”) needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s.ConclusionsThe quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for “sequence generation.” While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved.

Globalization of oncology clinical trials: Which lower-middle and upper-middle income countries are participating?

e13512 Background: With globalization of cancer research, many randomized controlled trials (RCTs) led by high income countries (HICs) are now enrolling patients from lower- and upper-middle income countries (LMICs/UMICs). While enrolling diverse global populations promotes research collaborations, there are unanswered questions about which countries participate in RCTs and how this may contribute to global research capacity. Here we describe which UMICs/LMICs participate in RCTs led by HICs. Methods: The study cohort was identified from a database of all oncology RCTs (systemic/surgery/RT) published globally during 2014-2017. The study cohort was restricted to RCTs led by HICs which enrolled participants from LMIC/UMICs. We used a bibliometric approach to explore whether the participation of UMICs/LMICs in RCTs led by HICs was as expected based on other measures of cancer research activity. Country-level bibliometric output for 2007-2017 was identified in the Web of Science database. We compared RCT participation (i.e. % of RCTs in our cohort that each LMIC/UMIC participated in) with country-level cancer research bibliometric output (i.e. % of total cancer research bibliometric output from the same group of countries that came from a specific LMIC/UMIC). Results: The global cohort included 694 RCTs; 636 (92%) of which were led by HICs. Among the HIC-led trials, 187 (29%) enrolled patients in LMICs (n=84) and/or UMICs (n=182); this formed the study cohort. The most common participating LMICs were India (50% of trials, 42/84), Ukraine (46%, 39/84), Philippines (25%, 21/84), and Egypt (14%, 12/84). The most common participating UMICs were Russian Federation (63% of trials, 115/182), Brazil (50%, 91/182), Romania (34%, 61/182), China (31%, 56/182), Mexico (31%,56/182) and South Africa (30%, 54/182). Several LMICs are over-represented in our cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (25% RCTs, 1% output), Georgia (8% RCTs, 0.2% output). Several UMICs are also over-represented in the study cohort of RCTs including Russia (63% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output) and South Africa (30% RCTs, 1% output). The inverse relationship was seen for China (31% RCTs, 69% output). Conclusions: A substantial proportion of RCTs led by HICs enroll patients in LMICs/UMICs. The LMICs/UMICs which participate in these trials are not as one would expected based on overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity strengthening activities require further study.

Temporal trends in the inclusion of patient-reported outcomes in heart failure randomized trials published in high-impact medical journals: a systematic bibliometric review

Abstract Background Patient reported outcomes (PROs) are important measures of health, particularly in symptomatic conditions such as heart failure (HF), and regulatory agencies have encouraged their collection in randomized controlled trials (RCTs). Purpose To assess temporal trends in the inclusion of patient-reported outcomes (PROs) in heart failure (HF) randomized controlled trials (RCTs) published in high-impact medical journals, explore trial characteristics associated with inclusion of PROs, and describe the quality of PRO reporting in HF RCTs. Methods We searched MEDLINE, EMBASE and CINAHL for studies published between January 1, 2000 and July 17, 2020. We included RCTs published in journals with impact factor ≥10. We assessed temporal trends using the Jonckheere-Terpstra test and conducted multivariable logistic regression analysis to explore trial characteristics independently associated with inclusion of PROs. We assessed the quality of PRO reporting using the Consolidated Standards for Trial Reporting PRO extension statement. Results We identified 12,342 articles, of which 417 RCTs met inclusion criteria. PROs were included in 224 RCTs (53.7%, 95% confidence interval [CI]: 48.8%-58.6%), of which 44 (19.6%) reported PRO as primary or co-primary endpoint. The proportion of RCTs with PROs increased significantly between 2000–2003 (37.4%) and 2016–2020 (65.1%) (p&amp;lt;0.001). PROs had higher odds of inclusion in RCTs that were multicenter (odds ratio [OR]: 1.95; 95% CI: 1.05–3.64; p=0.036); medium-sized (n=51–250) (OR: 2.29; 95% CI: 1.24–4.23; p=0.008); coordinated in in Central and South America (OR: 6.79; 95% CI: 1.34–34.36; p=0.021); and assessed health services (OR: 4.21; 1.97–8.98; p&amp;lt;0.001), device / surgical (OR: 6.24; 95% CI 3.05–12.80; p&amp;lt;0.001), or exercise and rehabilitation interventions (OR: 3.98; 95% CI 1.59–9.97; p=0.003). A majority (54.9%) of the 224 RCTs reported four or less of the eleven CONSORT-PRO items. The median number of CONSORT-PRO items reported was 4 (interquartile range [IQR] 3–6 items per trial), with improved reporting in trials with PRO as primary or co-primary endpoint. Conclusions PROs are included in in just over half of HF RCTs, with an increased reporting of PROs between 2000 and 2020. Large, pharmacotherapy trials conducted in North America and Europe were less likely to include PROs. The quality of PRO reporting in HF RCTs was modest, with trials most often reporting four of eleven CONSORT-PRO items. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Canadian Institutes of Health Research

Incorporating single-arm studies in meta-analysis of randomised controlled trials: a simulation study

BackgroundUse of real world data (RWD) from non-randomised studies (e.g. single-arm studies) is increasingly being explored to overcome issues associated with data from randomised controlled trials (RCTs). We aimed to compare methods for pairwise meta-analysis of RCTs and single-arm studies using aggregate data, via a simulation study and application to an illustrative example.MethodsWe considered contrast-based methods proposed by Begg & Pilote (1991) and arm-based methods by Zhang et al (2019). We performed a simulation study with scenarios varying (i) the proportion of RCTs and single-arm studies in the synthesis (ii) the magnitude of bias, and (iii) between-study heterogeneity. We also applied methods to data from a published health technology assessment (HTA), including three RCTs and 11 single-arm studies.ResultsOur simulation study showed that the hierarchical power and commensurate prior methods by Zhang et al provided a consistent reduction in uncertainty, whilst maintaining over-coverage and small error in scenarios where there was limited RCT data, bias and differences in between-study heterogeneity between the two sets of data. The contrast-based methods provided a reduction in uncertainty, but performed worse in terms of coverage and error, unless there was no marked difference in heterogeneity between the two sets of data.ConclusionsThe hierarchical power and commensurate prior methods provide the most robust approach to synthesising aggregate data from RCTs and single-arm studies, balancing the need to account for bias and differences in between-study heterogeneity, whilst reducing uncertainty in estimates. This work was restricted to considering a pairwise meta-analysis using aggregate data.

Trends and predictors of biomedical research quality, 1990–2015: a meta-research study

ObjectiveTo measure the frequency of adequate methods, inadequate methods and poor reporting in published randomised controlled trials (RCTs) and test potential factors associated with adequacy of methods and reporting.DesignRetrospective analysis...

Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

ObjectivesTo identify the risk of bias of randomised controlled trials (RCTs) referenced in the 2015 American Heart Association (AHA) guidelines update for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC).DesignA...

Publication pattern, study design, authors and countries involved in orthodontic RCTs - a bibliometric MEDLINE survey over the past 50 years.

The objective of this study was to investigate the number and proportions, study design, journal publications, authors and countries involved in orthodontic randomised controlled trials (RCTs) over the past 50 years. A MEDLINE database search (Entrez PubMed, http://www.ncbi.nlm.nih.gov ) was performed in November 2018 for RCT publications from 1 January 1968 to 31 December 2017. All orthodontic publications, clinical trials (CTs) or RCTs were selected. For each year from 1968 to 2017, the total number of orthodontic publications and total number of CTs and RCTs were computed. Following this, study design, journal publications, authors and countries involved in orthodontic RCTs were noted. The RCTs accounted for 0.1% of all orthodontic publications in the 1970s and 1980s, and, following this, the proportion of RCTs was increased and amounted to 2.7% over the past decade (2008-2017). The majority of RCTs were of single centre design (93.4%) and in 88.3% a parallel-arm design was performed. The United States and United Kingdom endorsed 16.9% and 15.5% of the RCTs, followed by Turkey (11.1%), Brazil (7.0%), Sweden (6.6%), China (5.6%), Italy (5.4%), and Germany (4.1%). Of all RCTs, 74.2% were published in 20 orthodontic journals and 25.8% in 81 non-orthodontic journals. The American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics and Journal of Orthodontics contributed to 60.2% of all the RCTs. The considerable increase in orthodontic RCTs over the past 50 years implies an increased scientific impact of orthodontic literature.

Assessment of research waste part 2: wrong study populations- an exemplar of baseline vitamin D status of participants in trials of vitamin D supplementation

BackgroundResearch waste can occur when trials are conducted in the wrong populations. Vitamin D deficient populations are most likely to benefit from vitamin D supplementation. We investigated waste attributable to randomised controlled trials (RCTs) of supplementation in populations that were not vitamin D deficient.MethodsIn December 2015, we searched Pubmed, recent systematic reviews, and three trial registries for RCTs of vitamin D with clinical endpoints in adults, and 25-hydroxvitamin D (25OHD) survey data relevant to large (N ≥ 1000) RCTs. We investigated the proportion of RCTs that studied vitamin D deficient populations, temporal trends in baseline 25OHD, and whether investigators in large RCTs considered relevant 25OHD survey data or systematic reviews in their trial justifications.ResultsOf 137 RCTs of vitamin D with clinical endpoints, 118 (86%) reported baseline mean/median 25OHD, which was < 25, 25–49, 50–74, and ≥ 75 nmol/L in 12 (10%), 62 (53%), 36 (31%), and 8 (7%) RCTs, respectively. In 70% of RCTs, baseline 25OHD was > 40 nmol/L. Baseline 25OHD increased over time. Before 2006, 38%, 62%, 0% and 0% of RCTs had baseline 25OHD < 25, 25–49, 50–74, and ≥ 75 nmol/L respectively; in 2011–15, the respective proportions were 9%, 49%, 37%, and 6%. Of 12 RCTs with baseline 25OHD < 25 nmol/L, 8 had neutral findings. Of 25 large RCTs (18 completed, 7 ongoing), 1 was undertaken in a vitamin D deficient population, 3 in vitamin D insufficient populations, and 17 had, or probably will have, baseline 25OHD > 40 nmol/L. 44% (8/18) of large completed RCTs cited relevant prior population 25OHD data, and only 3/10 (30%) relevant prior systematic reviews.ConclusionsUp to 70% of RCTs of vitamin D with clinical endpoints, 71% of large completed RCTs, and 100% of ongoing large RCTs could be considered research waste because they studied cohorts that were not vitamin D deficient.

Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study

BackgroundWe are witnessing an exponential increase in the number of randomized controlled trials (RCTs) reported from mainland China. The increase is particularly notable in the field of new generation antidepressants and antipsychotics. Several previous studies have raised doubts regarding their quality. However, the quality of most recent RCTs published in China may have improved.MethodsWe searched RCTs that examined new generation antidepressants and antipsychotics published between 2013 and 2016 in the China National Knowledge Infrastructure (CNKI), the largest database of scientific publications in China. We interviewed the authors of a random subset of the identified references. We assessed the methodological rigor of each study based on the published reports and telephone interviews with the authors using six methodological domains adapted from the Cochrane’s risk of bias tool.ResultsThe final sample consisted of 138 studies, for which we interviewed 58 authors; the authors of 51 studies declined the interview, and the authors of 29 studies could not be contacted. The 51 studies with refused interviews were significantly less likely to be reported from university-affiliated hospitals and were less likely to be published in Chinese core journals. Based on the published reports, most of the 58 studies were assessed to be at unclear risk of bias in most methodological domains. After the interview, only 10 studies were assessed to be at low risk of bias for sequence generation and allocation concealment. Assuming that the studies for which the authors declined interviews had an unclear risk, the proportion of RCTs at low risk of bias in both sequence generation and allocation concealment was 9.2% (10/109, 95% confidence interval [CI]: 5.0 to 16.2). The interviews indicated that the studies were at high risk of bias for most of the other domains.ConclusionIn general, RCTs that evaluate new generation antidepressants or antipsychotics and are indexed in the CNKI continue to be of low quality. When conducting systematic reviews and meta-analyses in this field, it would be wise to include a specialist from China as a coresearcher to help assess the risk of bias in the identified studies.

A mapping of 115,000 randomized trials revealed a mismatch between research effort and health needs in non–high-income regions

BackgroundConcerns exist as to whether the allocation of resources in clinical research is aligned with public health needs. We evaluated the alignment between the effort of clinical research through the conduct of randomized controlled trials (RCTs) and health needs measured as the burden of diseases for all regions and a broad range of diseases. MethodsWe grouped countries into seven regions and diseases into 27 groups. We mapped all RCTs initiated between 2006 and 2015 that were registered at the WHO International Clinical Trials Registry Platform to regions and diseases. The burden of diseases in 2005 was mapped as disability-adjusted life years (DALYs), based on the 2010 Global Burden of Diseases study. Within regions, we defined a research gap when the proportion of RCTs concerning a disease in the region was less than half the relative burden of the disease. ResultsWe mapped 117,180 RCTs planning to enroll 42.6 million patients and 2,220 million DALYs. In high- versus non–high-income countries, 130.9 versus 6.9 RCTs per million DALYs were conducted. We did not identify any research gap in high-income countries. We identified research gaps for all other regions. In particular, for Sub-Saharan Africa, we identified research gaps for common infectious diseases (CID) and neonatal disorders (ND): 5.8% (95% uncertainty interval 4.7–6.9) and 2.0% (0.9–4.5) of RCTs in Sub-Saharan Africa concerned CID and ND, although these diseases represented 22.9% and 11.6% of the burden in the region, respectively. For South Asia, we identified research gaps for the same two groups of diseases. ConclusionsIn non–high-income regions, the conduct of RCTs was misaligned with the distribution of major causes of burden, in particular infectious diseases and neonatal disorders in Sub-Saharan Africa and South Asia.

Prevalence of randomised controlled trials in Japanese cardiovascular journals: a descriptive study

BackgroundLittle is known about the recent proportion and trends of randomised controlled trials (RCTs) published in Japanese cardiovascular journals.Methods and resultsThis study retrospectively reviewed all original research articles published between...

Predicting the failure of randomized clinical trials in radiation oncology: What can we learn?

e18241 Background: Although randomizedcontrolled trials (RCTs) are essential to evidence-based medicine, a significant proportion of cancer RCTs fail to complete. As RCT failure is not well understood in the field of radiation oncology, we sought to review radiotherapy RCTs to identify predictors of RCT failure. Methods: We undertook a review of the trial registry ClinicalTrials.gov to assess factors influencing the completion of RCTs involving radiotherapy. Eligible trials were registered in ClinicalTrials.gov between 09/27/2007 to 12/31/2010, included radiation (brachytherapy or external beam radiotherapy) in at least one study arm, and were closed due to either successful completion or failure to complete. Data was abstracted by two independent investigators, with discrepancies settled through consensus. Univariable and multivariable logistic regression analyses were performed to determine factors predictive of RCT failure. Results: The initial search yielded 460studies. After reviewing protocol details, 138 studies met inclusion criteria, of which 41 (30%) failed to complete. Most common reasons for RCT incompletion were: lack of accrual (59%), inadequate funding (15%), drug unavailability (7%) and interim data monitoring report recommendations (7%). The highest proportion of RCT failure was observed in the most recent era (p = 0.009), with rates increasing from 11% (1987-2006) to 39% (2009-2012). On univariable analysis, independent predictors of failure included RCTs with a surgical comparator (odds ratio [OR] of failure 6.45; p = 0.010), government sponsorship (OR 3.68; p = 0.024), inclusion of a safety endpoint (OR 3.03; p = 0.014) and study start year (OR 1.18; p = 0.030). On multivariate analysis, surgical RCTs were strongly predictive of failure (OR 7.90; p = 0.015), while behavioral RCTs were less likely to fail (OR 0.14; p = 0.047). Conclusions: Rates of RCT failure in radiation oncology are high. Trials with a surgical comparator are highly prone to failure, whereas behavioral trials are more likely to succeed. These factors can help to inform the design of future RCTs, and develop strategies to mitigate the risk of failure in future radiation RCTs that include a surgical comparator.

Methodological quality of antimalarial randomized controlled trials during pregnancy and its impact on the risk of low birth weight.

To describe biases in antimalarial randomized controlled trials (RCTs) during pregnancy and their influence on antimalarial drug efficacy to reduce the risk of low birth weight (LBW). RCT characteristics and results were retrieved from a previous systematic review on the efficacy of antimalarials. The Cochrane risk of bias assessment was used to investigate source of biases in each RCT. The quality of RCT reporting published after the introduction of the CONSORT statement in medical literature in 1996 were compared to those published before 1996. A meta-regression analysis was performed to examine the impact of bias on the efficacy of antimalarials to reduce LBW after controlling for the time period prior to 1996. Twenty out of 25 RCTs (80%) had a high risk of bias. The proportion of RCTs having a low risk of bias was higher in manuscripts published after the introduction of CONSORT compared to those published before 1996 for sequence generation (P=0.04) and allocation concealment (P=0.04). Heterogeneity between RCTs was associated with an overestimation of the efficacy of antimalarial drugs in reducing LBW in RCTs with inadequate methods for randomization, allocation concealment or not being free of other bias. Antimalarial RCTs during pregnancy are poorly reported but may be improved by using the CONSORT statement. After taking into account the time period before 1996, we found that biases had an impact on the efficacy of antimalarials to reduce the risk of LBW.

Misleading reporting and interpretation of results in major infertility journals

To evaluate the proportion of randomized controlled trials (RCTs) published in top infertility journals indexed on PubMed that reported their results with proper effect estimates and their precision estimation, while correctly interpreting both measures. Cross-sectional study evaluating all the RCTs published in top infertility journals during2014. Not applicable. Not applicable. Not applicable. Proportion of RCTs that reported both relative and absolute effect size measures and its precision. Among the 32 RCTs published in 2014 in the top infertility journals reviewed, 37.5% (95% confidence interval [CI], 21.1-56.3) did not mention in their abstracts whether the difference among the study arms was statistically or clinically significant, and only 6.3% (95% CI, 0.8-20.8) used a CI of the absolute difference. Similarly, in the results section, these elements were observed in 28.2% (95% CI, 13.7-46.7) and 15.6% (95% CI, 5.3-32.8), respectively. Only one study clearly expressed the minimal clinically important difference in their methods section, but we found related proxies in 53% (95% CI, 34.7-70.9). None of the studies used CIs to draw conclusions about the clinical or statistical significance. We found 13 studies where the interpretation of the findings could be misleading. Recommended reporting items are underused in top infertility journals, which could lead to misleading interpretations. Authors, reviewers, and editorial boards should emphasize their use to improve reporting quality.

CONSORT and the internal validity of randomized controlled trials in Female Pelvic Medicine.

To investigate authors' adherence to the CONSORT reporting guideline for randomized controlled trials (RCTs) in the sub-specialty Female Pelvic Medicine and to detect any changes in adherence between the years 2008 and 2013. Bibliometric study. We included Female Pelvic Medicine RCTs published in 2008 and 2012-2013 in 10 journals. Full-text versions of RCTs for the inclusion of the CONSORT checklist items Randomization, Allocation, Blinding, and Participants' flowchart were screened. Each CONSORT checklist item was categorized for each included RCT as either "complete reporting", "insufficient reporting", "no reporting," or "not applicable". We screened the "Instructions to authors" for the requirement to adhere to CONSORT. We included 94 Female Pelvic Medicine RCTs for analysis. Most RCTs in 2008, 2012, and 2013 were published by IUJ (n =n39), followed by NAU (n = 13), GREEN (n = 12), European Urology (n = 8), FMPRS (n = 6), AJOG (n = 4), Urology (n = 3), NEJM (n = 3), Lancet (n = 1), and BJOG (n = 1). Proportion of RCTs in the category "complete reporting" comparing 2008 and 2013 was (47 and 70%) for Randomization, (18 and 45%) for Allocation, and (29 and 52%) for Blinding; a flowchart was presented in (71 and 91%). The increase was not statistically significant in any of the investigated CONSORT items. Complete reporting of Female Pelvic Medicine RCTs has increased between 2008 and 2013. However, there are still a relevant number of published RCTs, which do not fulfill these criteria. Reporting according to the CONSORT guidelines should be further encouraged to improve internal validity of Female Pelvic Medicine RCTs. Neurourol. Urodynam. 35:826-830, 2016. © 2015 Wiley Periodicals, Inc.

Quality and Quantity of Published Studies Evaluating Lumbar Fusion during the Past 10 Years: A Systematic Review.

Study Design Systematic review. Clinical Questions (1) Has the proportion and number of randomized controlled trials (RCTs) as an indicator of quality of evidence regarding lumbar fusion increased over the past 10 years? (2) Is there a difference in the proportion of RCTs among the four primary fusion diagnoses (degenerative disk disease, spondylolisthesis, deformity, and adjacent segment disease) over the past 10 years? (3) Is there a difference in the type and quality of clinical outcomes measures reported among RCTs over time? (4) Is there a difference in the type and quality of adverse events measures reported among RCTs over time? (5) Are there changes in fusion surgical approach and techniques over time by diagnosis over the past 10 years? Methods Electronic databases and reference lists of key articles were searched from January 1, 2004, through December 31, 2013, to identify lumbar fusion RCTs. Fusion studies designed specifically to evaluate recombinant human bone morphogenetic protein-2 or other bone substitutes, revision surgery studies, nonrandomized comparison studies, case reports, case series, and cost-effectiveness studies were excluded. Results Forty-two RCTs between January 1, 2004, and December 31, 2013, met the inclusion criteria and form the basis for this report. There were 35 RCTs identified evaluating patients diagnosed with degenerative disk disease, 4 RCTs evaluating patients diagnosed with degenerative spondylolisthesis, and 3 RCTs evaluating patients with a combination of degenerative disk disease and degenerative spondylolisthesis. No RCTs were identified evaluating patients with deformity or adjacent segment disease. Conclusions This structured review demonstrates that there has been an increase in the available clinical database of RCTs using patient-reported outcomes evaluating the benefit of lumbar spinal fusion for the diagnoses of degenerative disk disease and degenerative spondylolisthesis. Gaps remain in the standardization of reportage of adverse events in such trials, as well as uniformity of surgical approaches used. Finally, continued efforts to develop higher-quality data for other surgical indications for lumbar fusion, most notably in the presence of adult spinal deformity and revision of prior surgical fusions, appear warranted.

Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature using the CONSORT statement and STRICTA guidelines

ObjectivesThis study aims to assess the completeness of reporting of randomised controlled trials (RCTs) of acupuncture in the Korean literature.DesignSystematic review.MethodsWe searched 12 Korean databases and 7 Korean journals to...

10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002–2011

BackgroundQuality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period.MethodsWe individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol.ResultsOf 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000).ConclusionsIn mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years.