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BACKGROUND: Observing trends in research publications helps to identify the quantity and quality of research produced, as well as reveal evidence gaps. No comprehensive review of the quality and quantity of physical activity intervention trials has been conducted. OBJECTIVE: We aimed to investigate i) the volume and quality (and changes in these over time) of randomized controlled trials evaluating physical activity interventions, and ii) the association between journal ranking and trial quality. METHODS: We searched the Physiotherapy Evidence Database (PEDro) for trials investigating physical activity interventions (no restrictions for population, comparison, or language). Descriptive statistics were used to describe the volume and quality of trials. The association between journal ranking (Journal Impact Factor) and trial quality (PEDro Scale) was examined using Spearman's rho correlation. RESULTS: We identified 1779 trials, of which 40% (n = 710) were published between 2016 and 2020. The mean (SD) total PEDro score was 5.3 (1.5) points out of 10, increasing over time from 2.5 (0.7) points in 1975-1980 to 5.6 (1.4) points in 2016-2020. Quality criteria that were least reported included blinding of intervention deliverers (therapists) (n = 3, 0.2%), participants (n = 21, 1.2%), or assessors (n = 541, 31%); concealed allocation to groups (n = 526, 30%); and intention to treat analysis (n = 764, 43%). There was a small correlation between trial quality and Journal Impact Factor (0.21, p < 0.001). CONCLUSION: A large volume of trials has investigated physical activity interventions. The quality of these trial reports is suboptimal but improving over time. Journal ranking should not be used for selecting high quality trials.

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Meta-analyses have found that working memory (WM) can be improved with cognitive training; however, some authors have suggested that these improvements are mostly driven by biases in the measurement of WM, especially the use of similar tasks for assessment and training. In the present meta-analysis, we investigated whether WM, fluid intelligence, executive functions, and short-term memory can be improved by cognitive training and evaluated the impact of possible sources of bias. We performed a risk of bias assessment of the included studies and took special care in controlling for practice effects. Data from 52 independent comparisons were analyzed, including cognitive training aimed at different cognitive functions. Our results show small improvements in WM after training (SMD = 0.18). Much larger effects were observed when the analysis was restricted to assessment tasks similar to those used for training (SMD = 1.15). Fluid intelligence was not found to improve as a result of training, and improvements in WM were not related to changes in fluid intelligence. Our analyses did however indicate that cognitive training can improve specific executive functions. Contrary to expectations, a set of meta-regressions indicated that characteristics of the training programme, such as dosage and type of training, do not have an impact on the effectiveness of training. The risk of bias assessment revealed some concerns in the randomization process and possible selective reporting among studies. Overall, our results identified various potential sources of bias, with the most significant being the choice of assessment tasks.

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Objectives: To assess the risk of bias (RoB) of randomized controlled trials (RCTs) published in dental journals in the Spanish language. Methods: A systematic retrospective survey was conducted of all RCTs published from 1980 to 2019 in dentistry Spanish and Latin American journals. We extracted data and performed RoB assessments using the Cochrane Risk of Bias tool. Results: 292 RCTs published in 51 journals were included. The best-rated domains were incomplete outcome data, selective reporting, and other biases. The domains assessed with higher proportions of an unclear or high risk of bias were sequence generation, allocation concealment, and blinding of outcome assessment. There is a low proportion of RCTs published in Spanish language journals. However, the number has been increasing over the years, and the low risk of bias assessment rates across domains show an increasing trend. Conclusions: A low percentage of Spanish-language dental journals issue RCTs. Our assessment of these RCTs' RoB suggests higher difficulties in the design and conduction phase than in the posterior reporting stage.

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OBJECTIVES: This study aimed to investigate the adherence of randomized controlled trials of nutrition interventions to transparency practices informing assessments of selective reporting biases, including the availability of a trial registration entry, protocol and statistical analysis plan (SAP). STUDY DESIGN AND SETTING: Retrospective observational study with cross-sectional design. We systematically searched for trials published from 1 July 2019, to 30 June 2020, and included a randomly selected sample of 400 studies. We searched for registry entries, protocols, and SAPs for all included studies. We extracted data to characterize the disclosure of sufficient information in the available materials to inform assessments of selective reporting biases, considering the definition of outcome domain, measure, metric, method of aggregation, time point, analysis population, methods to handle missing data and method of adjustment. RESULTS: Most trials (69%) were registered, but these often lacked sufficient specification of outcomes and intended treatment effects. Protocols and SAPs provided more details but were less often available (14% and 3%, respectively), and even then, almost all studies presented limited information to inform the assessments of risk of bias due to the selection of the reported result. CONCLUSION: Lack of full specification of outcomes and intended treatment effects hinder a full adherence of randomized controlled trials of nutrition interventions to transparency practices and may affect their credibility.

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BACKGROUND: Systematic reviews (SRs) and meta-analyses are essential resources for the clinicians. They allow to evaluate the strengths and the weaknesses of the evidence to support clinical decision-making if they are adequately reported. Little is known in the rehabilitation field about the completeness of reporting of SRs and its relationship with the risk of bias (ROB). OBJECTIVES: Primary: 1) To evaluate the completeness of reporting of systematic reviews (SRs) published in rehabilitation journals by evaluating their adherence to the PRISMA 2009 checklist, 2) To investigate the relationship between ROB and completeness of reporting. Secondary: To study the association between completeness of reporting and journals and study characteristics. METHODS: A random sample of 200 SRs published between 2011 and 2020 in 68 rehabilitation journals was indexed under the "rehabilitation" category in the InCites database. Two independent reviewers evaluated adherence to the PRISMA checklist and assessed ROB using the ROBIS tool. Overall adherence and adherence to each PRISMA item and section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (impact factor, publication options, publication year, and study protocol registration). RESULTS: The mean overall PRISMA adherence across the 200 studies considered was 61.4%. Regression analyses show that having a high overall ROB is a significant predictor of lower adherence (B=-7.1%; 95%CI -12.1, -2.0). Studies published in fourth quartile journals displayed a lower overall adherence (B= -7.2%; 95%CI -13.2, -1.3) than those published in first quartile journals; the overall adherence increased (B= 11.9%; 95%CI 5.9, 18.0) if the SR protocol was registered. No association between adherence, publication options, and publication year was found. CONCLUSION: Reporting completeness in rehabilitation SRs is suboptimal and is associated with ROB, impact factor, and study registration. Authors of SRs should improve adherence to the PRISMA guideline, and journal editors should implement strategies to optimize the completeness of reporting.

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BACKGROUND: There is heterogeneity in the design of clinical trials (CT) for the treatment of keloid scars that compromises the validity of their results. OBJECTIVE: To assess the methodological quality of the CT published on keloid scars, mainly the outcomes used in them. METHOD: Articles of CT for keloid scars were analyzed, their methodological quality was evaluated following the CONSORT guidelines and the risk of bias based on the Cochrane tool. All the clinical outcomes measured in CT were identified. RESULTS: Fifty-two full-text articles were evaluated, of which, only 3.84% of the CT mentioned important changes in the methodology after starting patient recruitment. Fifty-nine percent of the CT were assessed as high risk of performance bias due to mistakes in blinding participants and personnel. The most frequent outcome was the height or thickness of the keloids. CONCLUSIONS: We recommend that participants with hypertrophic scars should be excluded from keloids' clinical trials, and that the main outcome must be the scar height and flattening. The pain and quality of life of patients should also be measured.

ANTECEDENTES: Existe heterogeneidad en el diseño de los ensayos clínicos (EC) para el tratamiento de cicatrices queloides que compromete la validez de sus resultados. OBJETIVO: Evaluar la calidad metodológica de los EC publicados sobre cicatrices queloides, principalmente las medidas de eficacia utilizadas. MÉTODO: Se analizaron los EC publicados sobre tratamientos para cicatrices queloides y se evaluó su calidad metodológica siguiendo los lineamientos CONSORT y el riesgo de sesgo según la herramienta de Cochrane. Se identificaron todas las medidas de eficacia utilizadas en los EC. RESULTADOS: Se incluyeron 52 artículos, de los cuales solo en el 3.84% se mencionan los cambios importantes en la metodología después de iniciar el reclutamiento de los pacientes. El 59.6% de los EC fueron evaluados con alto riesgo de sesgo de realización por errores en el cegamiento del equipo de investigación. La variable de respuesta más frecuente fue la altura o grosor de las cicatrices. CONCLUSIONES: Se recomienda que en los EC de cicatrices queloides se excluya a los participantes con cicatrices hipertróficas, y que la variable de resultado principal sea la altura de la cicatriz. También deben medirse el dolor y la calidad de vida de los pacientes.

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The maintenance of the excitability of neurons and circuits is a fundamental process for healthy brain functions. One of the main homeostatic mechanisms responsible for such regulation is synaptic scaling. While this type of plasticity is well-characterized through a robust body of literature, there are no systematic evaluations of the methodological and reporting features from these studies. Our review yielded 168 articles directly investigating synaptic scaling mechanisms, which display relatively high impact, with a median impact factor of 7.76 for the publishing journals. Our methodological analysis identified that 86% of the articles made use of inhibitory interventions to induce synaptic scaling, while only 41% of those studies contain excitatory manipulations. To verify the effects of synaptic scaling, the most assessed outcome was miniature excitatory postsynaptic current (mEPSC) recordings, performed in 71% of the articles. We could also observe that the field is mostly focused on mechanistic studies of the synaptic scaling pathways (70%), rather than the interaction with other types of plasticity, such as Hebbian processes (4%). We found that more than half of the articles failed to describe simple features, such as regulatory compliance statements, ethics committee approval, or statements of conflict of interests. In light of these results, we discuss the strengths and pitfalls existing in synaptic scaling literature.

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ABSTRACT BACKGROUND: The authors of randomized controlled trials will usually claim that they have met the randomization process criterion. However, sequence generation schemes differ and some schemes that are claimed to be randomized are not genuinely randomized. Even less well understood, and often more difficult to ascertain, is whether the allocation was really concealed. OBJECTIVE: To detect the extent of control over selection bias, in a comparison between two Cochrane groups: oral health and otorhinolaryngology; and to describe the methods used to control for this bias. DESIGN AND SETTING: Cross-sectional study conducted in a public university in São Paulo, Brazil. METHODS: The risk of selection bias in 1,714 records indexed in Medline database up to 2018 was assessed, independent of language and access. Two dimensions implicated in the allocation were considered: generation of the allocation sequence; and allocation concealment. RESULTS: We included 420 randomized controlled trials and all of them were evaluated to detect selection bias. In the sample studied, only 28 properly controlled the selection bias. Lack of control over selection bias was present in 80% of the studies evaluated in both groups. CONCLUSION: The two groups were similar regarding control over selection bias. They are also similar to the methods used. The dimension of allocation concealment appears to be a limiting factor with regard to production of randomized controlled trials with low risk of selection bias. The quality of reporting in studies on oral health and otorhinolaryngology is suboptimal and needs to be improved, in line with other fields of healthcare.

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Background The Cochrane collaboration risk of bias assessment (RoB) tool is used in several fields to evaluate the methodological quality of studies. Its strengths and challenges are discussed. Objective To assess the sensitivity of the RoB tool in studies of pharmacist interventions. Setting DEPICT database was used to pool randomized controlled trials (RCTs) of complex interventions. Method A Guide for RoB Judgment in Pharmacy Services was created to help in the interpretation and judgment of bias criteria. The evaluation of bias (low, unclear, high risk) was performed by RCT. Sensitivity analyses were performed to assess the influence of different interpretations of eight elements of judgment in the RoB tool. Paired analysis and estimations of the effect size (95% confidence interval) of the criteria modifications compared to the original analyses were calculated. Main outcome measure Changes in the interpretations of judgment in the RoB tool. Results Overall, 8.3, 45.4, and 46.3% of the studies were determined to have low, unclear, and high risk of bias, respectively. High risk of bias was caused by attrition and detection domains. The number of studies classified with high risk of bias significantly increased for five of the eight interpretations, while unclear risk of bias increased for three interpretations (with a negligible effect size in all of them). Lack of blinding, loss of participants, and the use of subjective and self-reported outcomes were the main elements resulting in high risk of bias. Conclusion The RoB tool is useful for evaluating RCTs of pharmacist interventions if adapted criteria for judgment are used. Ignoring these adjustments produces a floor-effect with studies classified with high risk of bias.

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Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación. Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

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Resumen Introducción: El ensayo clínico es la manera más rigurosa de conducir los experimentos en seres humanos. Desde su introducción en investigación biomédica se han implementado cambios en el modo de establecer las bases para el diagnóstico, pronóstico y la terapéutica en la práctica clínica. Se han realizado estudios para identificar los ensayos clínicos publicados en diferentes áreas médicas, pero hasta el momento ninguno había identificado los ensayos clínicos publicados en el Boletín Médico del Hospital Infantil de México (BMHIM). El objetivo de este trabajo fue identificar y describir los ensayos clínicos controlados (ECC) publicados en el BMHIM. Métodos: Se realizó búsqueda manual y sistemática en cada uno de los números y volúmenes del BMHIM de 1968 a 2016. Se registraron los ECC para obtener sus principales características. Adicionalmente, se evaluó su calidad metodológica mediante la herramienta de riesgo de sesgo. Los resultados se presentan de forma descriptiva, gráfica y temporal. Resultados: Se revisaron 73 números con 363 volúmenes, analizando 4925 artículos. La proporción de ECC identificados en el BMHIM fue del 1% (67/4925). En general, los ensayos clínicos se realizaron en el contexto nacional, en el tercer nivel de atención, con un tamaño de muestra reducido, y las intervenciones farmacológicas fueron las más utilizadas. La calidad metodológica de los estudios fue baja, con alto riesgo de sesgo. Conclusiones: Los ensayos clínicos representan el 1% de todos los artículos de investigación originales publicados en el BMHIM. Aún existen áreas de investigación pediátrica, las cuales requieren del desarrollo de ECC para mejorar la práctica clínica, así como para elevar la calidad de la investigación.

Abstract Background: Controlled clinical trials (CCT) are the study design with the highest accuracy and evidence level. From its introduction in biomedical research, changes have been implemented in the way of establishing the basis for diagnosis, prognosis and treatment in clinical practice. Studies to identify published CCTs regarding different medical fields have been carried out. To date, none of them has identified the clinical trials that have been published in the Boletín Médico del Hospital Infantil de México (BMHIM). The aim of this study was to identify and describe the controlled clinical trials published in the BMHIM. Methods: A manual and systematic search was performed in each of the volumes of the BMHIM from 1968 to 2016. CCTs were recorded to obtain their main characteristics. Additionally, their methodological quality was assessed through the "risk of bias" tool. Results are presented in a descriptive, graphic and time-based manner. Results: In total, 73 issues with 363 volumes were reviewed, and 4925 articles were analyzed. The proportion of CCTs identified in the BMHIM was 1% (67/4925). In general, clinical trials were performed in the national context and in the third-level of medical care. CCTs also presented reduced sample sizes; pharmacological interventions were the most frequent. The methodological quality of the studies was low with a high risk of bias. Conclusions: Clinical trials represented 1% of all the original research articles published in the BMHIM. There are still pediatric research fields that require CCTs to be developed in order to improve clinical practice, as well as to increase the quality of the research.

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PURPOSE: In the context of Cochrane systematic reviews/meta-analyses of randomized clinical trials, risk of bias (RoB) is assessed using categorical indicators (low, unclear, or high RoB). This study sought to evaluate the indicators of the Cochrane RoB tool available for construct validity as applied to randomized clinical trials of psychological treatments for bulimia nervosa and binge eating. METHODS: Bayesian confirmatory factor analysis was used to test the construct validity of the measurement model underlying the set of five categorical items, and the reliability of these indicators to measure RoB. RESULTS: In 48 primary randomized clinical trials, the model showed good fit indices and factor loadings higher than 0.4. CONCLUSIONS: The results support the construct validity of the Cochrane RoB tool and the reliability of three of five items in this health intervention context.

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To test how reliable the tool recommend by Cochrane Collaboration for assessing risk of bias systematic reviews of randomized clinical trials is in the context of methylphenidate for children and adolescents with attention deficit hyperactivity disorder. Confirmatory factor analysis was used to evaluate a unidimensional model for the 7 indicators, applied to 184 Randomized Clinical Trial (RCTs) within a 2015 Cochrane systematic review titled "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder." A unidimensional model resulted in excellent adequacy indices, but only 2 indicators had very high factor loadings and low measurement errors. In terms of content, the 7 indicators showed poor reliability (ω = 0.642); however, the set of indicators was precise in evaluating studies with a high amount of bias risk. The Cochrane model of risk of bias as it is, exhibited good fit indices but the majority of the items were not reliable to adequately capture risk of bias in the context of clinical trials of methylphenidate for ADHD.

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AIM: To determine construct validity and reliability indicators of the Cochrane risk of bias (RoB) tool in the context of randomized clinical trials (RCTs) for autism spectrum disorder (ASD). METHODS: Confirmatory factor analysis was used to evaluate a unidimensional model consisting of 9 RoB categorical indicators evaluated across 94 RCTs addressing interventions for ASD. RESULTS: Only five of the nine original RoB items returned good fit indices and so were retained in the analysis. Only one of this five had very high factor loadings. The remaining four indicators had more measurement error than common variance with the RoB latent factor. Together, the five indicators showed poor reliability (ω = 0.687; 95% CI: 0.613-0.761). CONCLUSION: Although the Cochrane model of RoB for ASD exhibited good fit indices, the majorities of the items have more residual variance than common variance and, therefore, did not adequately capture the RoB in ASD intervention trials.