CONSORT Statement Research Articles

Anaesthetic Efficacy of Adjunct Therapy with Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Randomised Controlled Study

Abstract Objective: The aim of this prospective, randomised controlled study was to evaluate the efficacy of pulpal anaesthesia in the management of pain in mandibular first molars with symptomatic irreversible pulpitis (SIP) in relation to alternative adjunct therapies with a conventional inferior alveolar nerve block (IANB) versus the conventional IANB technique. Methods: In accordance with the CONSORT statement, a prospective, randomised controlled parallel-design clinical trial was created. Group 1: Conventional IANB (Control group); Group 2: IANB plus local infiltration; Group 3: IANB plus long buccal nerve block; Group 4: IANB plus premedication with paracetamol; and Group 5: IANB plus cryotherapy was the five groups comprised 50 participants who met the inclusion and exclusion criteria. People were asked to use the Heft-Parker Visual Analogue Scale (HP-VAS) to score their level of discomfort at three separate intervals during the treatment process: before treatment, during access opening, and during pulp extirpation. Results: During access opening, Tukey’s post hoc multiple comparison tests showed statistically highly significant differences (P < 0.001) between Group 1 and Group 4 and a statistically significant difference (P < 0.05) between Group 1 and Group 3. During pulp extirpation statistically significant difference (P < 0.05) between Group 1 and Group 4 were reported. While the other group shows a statistically insignificant difference. Conclusion: IANB alone does not provide painless endodontic treatment in SIP patients. Hence, adjunct therapy of premedication with paracetamol or a supplementarily anaesthetising long buccal nerve block can significantly increase anaesthetic efficacy of IANB.

Family member and service provider experiences and perspectives of a digital surveillance and service navigation approach in multicultural context: a qualitative study in identifying the barriers and enablers to Watch Me Grow-Electronic (WMG-E) program with a culturally diverse community

BackgroundChildren and families from priority populations experienced significant psychosocial and mental health issues to the COVID-19 pandemic. Yet they also faced significant barriers to service access, particularly families from culturally and linguistically diverse (CALD) backgrounds. With most child and family health nurse clinics ceasing in-person consultations due to the pandemic, many children missed out on health and developmental checks. The aim of this study was to investigate the perspectives and experiences of family members and service providers from an urban, CALD community regarding the implementation of a digital, developmental surveillance, Watch Me Grow-Electronic (WMG-E) program.MethodsSemi-structured interviews were conducted with 17 family members, service navigators, and service providers in a multicultural community in South Western Sydney, Australia. This qualitative study is an implementation evaluation which formed as part of a larger, two-site, randomised controlled trial of the WMG-E program. A reflexive thematic analysis approach, using inductive coding, was adopted to analyse the data.ResultsParticipants highlighted the comprehensive and personalised support offered by existing child and family health services. The WMG-E was deemed beneficial because the weblink was easy and quick to use and it enabled access to a service navigator who support family access to relevant services. However, the WMG-E was problematic because of technology or language barriers, and it did not facilitate immediate clinician involvement when families completed the weblink.ConclusionsFamilies and service providers in this qualitative study found that using WMG-E empowered parents and caregivers to access developmental screening and learn more about their child’s development and engage with relevant services. This beds down a new and innovative solution to the current service delivery gap and create mechanisms that can engage families currently not accessing services, and increases knowledge around navigating the health and social care services. Notwithstanding the issues that were raised by families and service providers, which include accessibility challenges for CALD communities, absence of clinical oversight during screening, and narrow scope of engagement with available services being offered, it is worth noting that improvements regarding these implementation factors must be considered and addressed in order to have longevity and sustainability of the program.Trial registration.The study is part of a large randomised controlled trial (Protocol No. 1.0, Version 3.1) was registered with ANZCTR (registration number: ACTRN12621000766819) on July 21st, 2021 and reporting of the trial results will be according to recommendations in the CONSORT Statement.

Evaluation of the reporting quality of randomized controlled trials of acupuncture for depression based on CONSORT statement, STRICTA criteria and SHARE checklist

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. Systematic searches were performed in PubMed, the Cochrane Library, EMbase, CNKI, Wanfang, SinoMed and VIP Database for RCTs of acupuncture in treatment of depression. The search time was from the establishment of database to December 1, 2023, and the language restriction was Chinese and English. The reporting quality of RCTs of acupuncture for depression was evaluated using the CONSORT statement, the international standardization for trial reporting, STRICTA, the international standard for clinical trial interventions of acupuncture, and SHARE, the guideline and checklist for reporting sham acupuncture controls. According to the CONSORT statement items, the items with the reporting rate less than 50% was accounted for 54.05% of all of the items for Chinese articles, and there were 8 and 1 items with a reporting rate of 0% and 100%, respectively. For the English articles, the items with the reporting rate less than 50% was accounted for 35.14% of all of the items, and there were 3 and 7 items with a reporting rate of 0% and 100%, respectively. The reporting rate of 15 items in Chinese and English articles was greater than 50%, e.g. structured abstract, background and purpose. Based on STRICTA criteria, the reporting rate of either Chinese or English articles was relatively high. The items for Chinese articles with the reporting rate less than 50% was accounted for 23.53% of all of the items, and there were 1 and 4 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 11.76% of all of the items, and there was 1 item with a reporting rate of either 0% or 100%. In compliance with SHARE checklist, the reporting rate was low for either Chinese or English articles. The items with the reporting rate less than 50% was accounted for 57.89% of all of the items for Chinese articles, and there were 2 and 0 items with a reporting rate of 0% and 100%, respectively. For English articles, the items with the reporting rate less than 50% was accounted for 52.63% of all of the items, and there was 1 item with a reporting rate of 0% and 100%, respectively. The overall reporting quality of RCTs of acupuncture for depression is low currently. It is urgent to enhance the reporting of the details on sham acupuncture control especially. It is suggested that RCTs should be reported strictly in compliance with the CONSORT statement, STRICTA criteria, and SHARE checklist in the future.

Assessment of Quality of Reporting in Randomized Controlled Trials of Moxibustion for Chronic Diseases Using the Consolidated Standards of Reporting Trials and Standards for Reporting Interventions in Clinical Trials of Moxibustion Statements

Introduction: Moxibustion is clinically used for treating various chronic diseases; however, the reporting quality of current published RCTs of moxibustion is unclear. The objective of this study was to assess the reporting quality of RCTs focusing on moxibustion as a treatment for chronic diseases. Methods: Seven databases were searched to identify relevant RCTs. Criteria for evaluating the reporting quality of standard RCT elements and moxibustion intervention-related information were developed based on the CONSORT statement and its STRICTOM extension, respectively. Multivariate regression models were used to investigate factors impacting reporting quality. Results: A total of 310 RCTs were included, with 41 (7.6%) published in English journals and 269 (92.4%) in Chinese journals. The median CONSORT and STRICTOM scores of these RCTs, with a maximum score of 100, were 41.2 and 62.9, respectively. RCTs with a later publication year and protocol registration or ethical approval exhibited significantly higher CONSORT and STRICTOM scores. Higher CONSORT scores were also significantly associated with English language publication, funding support, and inclusion of a safety evaluation, while higher STRICTOM scores were additionally associated with an active control design. Conclusion: The reporting quality of RCTs focusing on moxibustion treatment for chronic diseases is subpar, with gradual but limited improvement over the last 25 years. To enhance the reporting quality of moxibustion RCTs, researchers should develop a comprehensive study protocol and standardize result reporting based on CONSORT and STRICTOM statements. Registration platforms, ethical approval organizations, funders, and journals can also contribute to this improvement by bolstering structured information reporting in the review process.

TABLET TOSCANA to Develop Innovative Organizational Models for Tele-Rehabilitation in Subjects with Congenital and Acquired Developmental Disabilities: A Wait-List Control Group Trial Protocol.

Background/Objectives: In recent years, the advent of new technologies has fostered their application in neuro-psychomotor and language rehabilitation, particularly since the COVID-19 pandemic. Tele-rehabilitation has emerged as an innovative and timely solution, enabling personalized interventions monitored by clinicians. TABLET TOSCANA project aims to develop innovative tele-rehabilitation organizational models in children, adolescents and young adults with congenital and acquired developmental disabilities, using the Virtual Reality Rehabilitation System (VRRS) Home Kit and the MedicoAmico APP. Methods: The trial is designed according to the CONSORT statement guidelines. The project encompasses three phases: adapting the technologies for pediatric use, validating them through a wait-list study, and analyzing feasibility and effectiveness data to define new organizational models. A randomized wait-list-control study with 100 subjects aged 6 to 30 years will compare tele-rehabilitation versus prosecution of standard care. Discussion: Although literature highlights tele-rehabilitation benefits such as improved access, cost savings, and enhanced treatment adherence, practical implementation remains limited (i.e., the definition of standardized procedures). TABLET TOSCANA project seeks to address these gaps by focusing on multi-domain treatments for neurodevelopmental disabilities and emphasizing the integration of tele-rehabilitation into local health services. Conclusion: The project aims to improve the continuity and intensity of care through innovative models that integrate tele-rehabilitation into local health services. The results could inform healthcare policies and promote the development of innovative and collaborative models of care, paving the way for more effective and widespread tele-rehabilitation solutions and fostering collaborative networks among professionals.

Investigating the effectiveness of commercially available mouthwash on SARS-CoV-2 in vivo using viable virus titre as the primary outcome. A randomised controlled trial.

This multi-arm, parallel group, single-blinded randomised controlled trial aimed to assess three commercially available mouthwashes effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This manuscript has been written in accordance with the CONSORT statement. Methods. Eligible participants were SARS-CoV-2 positive with a positive test in the last 72 h. All participants had mild to moderate symptoms and could provide five saliva samples over a 60 min period. Participants delivered a baseline saliva sample and then used a mouthwash as per manufacturer's instructions. They provided further saliva samples at minute 1, 10, 30 and 60. Participants were randomised to one of four groups; OraWize+, Total Care Listerine, Cool Mint Listerine and water (control). The lab-based research team were blind to the intervention. The research question was: can SARS-CoV-2 be rendered inactive in saliva by using a mouthwash and how long does this effect last? The primary outcome was the amount of viable infectious SARS-CoV-2 virus in the sample, compared to the baseline sample. The secondary outcome measure was the amount of genetic material from the SARS-CoV-2 virus in the sample, measured via PCR testing. Results. In total 100 participants were recruited (25 per group). Eight participants did not receive the allocated intervention and did not have saliva samples collected. There were no adverse events. In total 42 of the 92 participants had viable virus which could be cultured at baseline. Statistical analysis of the primary outcome was not advised due to the reduced level of viable virus at baseline and the positive skewness present in the distribution of log10(titre) data. Observational data of the primary outcome measure is presented. Analysis of the secondary outcome PCR measure showed that there was strong evidence for a decrease in SARS-CoV-2 RNA levels compared to water for all mouthwashes after 1 min, OraWize+ -0.49 (-0.92, -0.05), p-value 0.029, Cool Mint Listerine -0.81 (-1.25, -0.38), p-value<0.001, Total Care Listerine -1.05 (-1.48, -0.62), p-value<0.001. For the remaining timepoints there was generally no evidence of virus level reduction compared to water although there is weak evidence for a decrease at ten minutes using Total Care Listerine -0.44 (-0.88, 0.01), p-value 0.053. Conclusion. The three mouthwashes included in this trial observationally demonstrated a reduction in virus titre level 1 min after use, with virus levels normalising up to 60 min compared to the control. Although an interesting observation, this result could not be statistically analysed. Using the secondary outcome PCR measure all three included mouthwashes reduced virus levels compared to water at 1 min and these results were statistically significant. Clinically this result does not support the use of the included mouthwashes to reduce SARS-CoV-2 levels in saliva.

Systematic review of educator behaviours associated with physical activity of early years children.

Educators in early years settings influence children's physical activity (PA) levels through their pedagogical choices and behaviours. To date, minimal research has been conducted on the relationship between educator action and children's PA levels. The purpose of this systematic review was to understand which educator behaviours and actions in early years settings have been shown to engage children in PA. Five online databases (Academic Search Complete, ERIC, SPORTDiscus, CINAHL Complete and PubMed) were searched for articles that showed an association between educator behaviour and the PA level of children between the ages of zero and eight. Eleven studies met all inclusion criteria, yet showed great variability in design and data collection methods. The risk of bias was assessed using previously published criteria adapted to this study and inline with the CONSORT statement. A binomial test on the data revealed a statistically significant deviation from chance expectation (p < .001) in relation to educator action influencing child PA. Ten of the studies focussed on educator PA, four studies highlighted the use of prompting and encouragement, three studies analysed broad statements of adult interaction, two studies called for planning activity sessions and discussions and two studies encouraged role modelling. The low number of studies included in the review and the high risk of bias indicates that caution with these results is needed. While this review highlights the importance of educator PA (and other behaviours that had a positive association) on child PA level, it underscores the need for high-quality research to examine the relationship between educator actions and child PA. (PROSPERO registration: CRD42022338819).

CONSORT statement adherence and risk of bias in randomized controlled trials on deep caries management: a meta-research

BackgroundRecently, trials have supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of randomized controlled trials (RCTs) on deep caries management published in pediatric dental journals.MethodsWe searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%).ResultsWe analyzed 127 RCTs. The mean (standard deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for the "estimated effect size”. The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years.ConclusionAdherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias.Trial RegistrationThis study protocol was prospectively registered on the Open Science Framework - DOI (10.17605/OSF.IO/V6SYZ).

Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts, and trials: Adherence to the SPIRIT and CONSORT statements.

It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles. Published trial protocols and phase II/III trial result articles relating to pediatric brain tumors (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article. Nine trial protocols, 68 phase II trials, and 8 phase III trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials. The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.

The reporting quality and spin of randomized controlled trials of endometriosis pain: Methodological study based on CONSORT extension on abstracts.

To assess the reporting quality of published RCT abstracts regarding patients with endometriosis pelvic pain and investigate the prevalence and characteristics of spin in these abstracts. PubMed and Scopus were searched for RCT abstracts addressing endometriosis pelvic pain published from January 1st, 2010 to December 1st, 2023.The reporting quality of RCT abstracts was assessed using the CONSORT statement for abstracts. Additionally, spin was evaluated in the results and conclusions section of the abstracts, defined as the misleading reporting of study findings to emphasize the perceived benefits of an intervention or to confound readers from statistically non-significant results. Assessing factors affecting the reporting quality and spin existence, linear and logistic regression was used, respectively. A total of 47 RCT abstracts were included. Out of 16 checklist items, only three items including objective, intervention and conclusions were sufficiently reported in the most abstracts (more than 95%), and none of the abstracts presented precise data as required by the CONSORT-A guidelines. In the reporting quality of material and method section, trial design, type of randomization, the generation of random allocation sequences, the allocation concealment and blinding were most items identified that were suboptimal. The total score for the quality varied between 5 and 15 (mean: 9.59, SD: 3.03, median: 9, IQR: 5). Word count (beta = 0.015, p-value = 0.005) and publishing in open-accessed journals (beta = 2.023, p-value = 0.023) were the significant factors that affecting the reporting quality. Evaluating spin within each included paper, we found that 18 (51.43%) papers had statistically non-significant results. From these studies, 12 (66.66%) had spin in both results and conclusion sections. Furthermore, the spin intensity increased during 2010-2023 and 38.29% of abstracts had spin in both results and conclusion sections. Overall poor adherence to CONSORT-A was observed, with spin detected in several RCTs featuring non-significant primary endpoints in obstetrics and gynecology literature.

Reporting Quality and Risk of Bias Analysis of Published RCTs Assessing Anti-CGRP Monoclonal Antibodies in Migraine Prophylaxis: A Systematic Review.

Objective: Phase II/III randomized clinical trials (RCTs) are vulnerable to many types of bias beyond randomization. Insights into the reporting quality of RCTs involving migraine patients treated with monoclonal antibodies targeting the calcitonin gene-related peptide system (anti-CGRP MAbs) are currently lacking. Our aim was to analyze the reporting quality of phase II/III RCTs involving migraine patients treated with anti-CGRP MAbs. Methods: A systematic search was performed on the PubMed and EMBASE databases, according to PRISMA guidelines, for relevant RCTs in either episodic or chronic migraine prevention. Additionally, an adapted version of the 2010 CONSORT statement checklist was utilized. The ROBvis online tool was used to document the risk of bias. Results: From the initially identified 179 articles, we finally found 31 RCTs that were eligible for evaluation. The average CONSORT compliance was 88.7% (69.7-100%), while 93.5% (N = 29) of the articles had a compliance greater than 75%. Twenty-eight CONSORT items were reported in more than 75% of the articles. The average compliance of the analyzed RCTs was 93.9% for Galcanezumab, 91.3% for Fremanezumab, followed by 85.4% for Erenumab and Eptinezumab studies. Implementation of the ROB2 tool showed some concerning "missing information" arising from the inadequate reporting. Specifically, 50% of the studies (N = 16) were categorized as having inadequate information regarding the randomization process. Conclusions: Adequate reporting quality was disclosed in the evaluated RCTs with anti-CGRP MAbs in migraine prevention. However, some methodological issues need to be highlighted to be addressed in future studies assessing the efficacy of new molecules targeting CGRP or other candidate pathways implicated in migraine pathophysiology.

The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas.

Background: This study aimed to assess the overall reporting quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) formulas for patients with diabetes, and to identify factors associated with better reporting quality. Methods: Four databases including PubMed, Embase, Cochrane Library and Web of Science were systematically searched from their inception to December 2022. The reporting quality was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) statement and its CHM formula extension. The overall CONSORT and its CHM formula extension scores were calculated and expressed as proportions separately. We also analyzed the pre-specified study characteristics and performed exploratory regressions to determine their associations with the reporting quality. Results: Seventy-two RCTs were included. Overall reporting quality (mean adherence) were 53.56% and 45.71% on the CONSORT statement and its CHM formula extension, respectively. The strongest associations with reporting quality based on the CONSORT statement were multiple centers and larger author numbers. Compliance with the CHM formula extension, particularly regarding the disclosure of the targeted traditional Chinese medicine (TCM) pattern (s), was generally insufficient. Conclusion: The reporting quality of RCTs in CHM formulas for diabetes remains unsatisfactory, and the adherence to the CHM formula extension is even poorer. In order to ensure transparent and standardized reporting of RCTs, it is essential to advocate for or even mandate adherence of the CONSORT statement and its CHM formula extension when reporting trials in CHM formulas for diabetes by both authors and editors.

Efficacy of therapeutic intervention with NanoBEO to manage agitation and pain in patients suffering from severe dementia: a pilot clinical trial.

An estimated 57.4 million people live with dementia worldwide, with the social burden of the disease steadily growing. Despite the approval of lecanemab and ongoing trials, there is still a lack of effective and safe treatments for behavioral and psychological symptoms of dementia (BPSD), which affect 99% of patients. Agitation is one of the most disabling BPSD, with a cross-sectional prevalence of ≥50% in nursing homes, and refers to help-seeking behavior in response to various sources of discomfort, among which pain is a crucial component. This pilot phase of the BRAINAID (NCT04321889) trial aimed to assess the effectiveness of the patented nanotechnological device NanoBEO in older (≥65 years) people with severe dementia. This randomized placebo-controlled trial, with quadruple masking that involved all operators and participants, followed the SPIRIT and CONSORT statements. A total of 29 patients completed the trial. The patients were randomly allocated in a 1:1 ratio to the NanoBEO or placebo group, and the corresponding product was applied on both arms once daily for 4weeks, with a 4-week follow-up period. The primary endpoint was efficacy against agitation. The secondary endpoints were efficacy against agitation at follow-up and efficacy against pain. Any adverse events were reported, and biochemical analyses were performed. The NanoBEO intervention reduced the frequency (28%) and level of disruptiveness of agitated behaviors. The effect on frequency was statistically significant after 2weeks of treatment. The efficacy of NanoBEO on agitated behaviors lasted for the entire 4-week treatment period. No additional psychotropic drugs were prescribed throughout the study duration. The results after 1week of treatment demonstrated that NanoBEO had statistically significant analgesic efficacy (45.46% improvement in pain intensity). The treatment was well tolerated. This trial investigated the efficacy of NanoBEO therapy in managing agitation and pain in dementia. No need for rescue medications was recorded, strengthening the efficacy of NanoBEO in prolonged therapy for advanced-stage dementia and the usefulness of the intervention in the deprescription of potentially harmful drugs. This study provided a robust rationale for the application of NanoBEO in a subsequent large-scale pivotal trial to allow clinical translation of the product. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT04321889.

ANALYSIS OF REPORTING GUIDELINE AND TRIAL REGISTRATION POLICIES AMONG GERIATRIC JOURNALS: A CROSS-SECTIONAL STUDY

Abstract The use of reporting guidelines and clinical trial registration policies by academic journals reduces bias and improves transparency in clinical research. It is unknown whether geriatric and gerontology journals mention, recommend, or require their use for the studies they may potentially publish. The purpose of this study is to assess the submission guidelines of the top geriatric and gerontology journals for their editorial recommendation or requirement of predetermined reporting guidelines and clinical trial registration. We identified the top 100 journals in the “Geriatrics and Gerontology” subcategory using the 2021 Scopus CiteScore tool. We probed each journal’s “Instructions to Authors” for statements regarding reporting guidelines for popular study designs and extracted them as “Not Mentioned”, “Recommended”, “Does Not Require”, or “Required”. Further, we classified each journal’s reference to clinical trial registration in a similar manner. Of the 100 examined journals included in our analysis, the QUOROM statement was not mentioned by any journals, whereas the CONSORT statement (44/100, 44%) was mentioned and recommended/required the most often. PRISMA guidelines were not mentioned by 57 journals (57/100,57%). Furthermore, 45 journals (45/100,45%) did not mention study registration. Therefore, the recommendation or requirement of reporting guidelines and clinical trial registration in the top 100 geriatric and gerontology journals is inconsistent. Journal editors should strongly recommend that author’s follow validated reporting guidelines to reduce potential bias and improve transparency in the articles they publish.

Quality evaluation of the literature on randomized controlled clinical trials of traditional Chinese medicine for treatment of gastric precancerous lesions in last 20 years.

To evaluate the methodological quality of randomized controlled trials (RCTs) of traditional Chinese medicines for the treatment of gastric precancerous lesions in the past 20 years. The studies of RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the Chinese full-text journal database, Wanfang database, VIP database, PubMed, and Embase from January 2001 to December 2021. The retrieved articles were screened, extracted and evaluated based on the 2010 edition of CONSORT statement, Cochrane Risk of Bias Assessment Scale and additional indicators. A total of 840 papers were included. According to the Cochrane Risk of Bias Assessment Scale, the high risk of bias in the application of randomized methods was 5.95%; the concealed risk of uncertainty in the allocation scheme was 98.93%; the low risk of bias for blinding of patients or testers was 1.30%; the risk of bias for blinding of the outcome assessor was 100.00%; the risk of bias for completeness of the outcome data was 2.86%; and the risk of uncertainty for selective reporting was 98.44%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries of introduction, objectives and interventions; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature implemented a randomized program, 1.07% of the literature hid the randomized program and 1.31% of the literature was blinded; 36.67% of the literature reported adverse reactions; no literature reported sample size prediction methods; additional evaluation indicators showed that 17.02% of the studies had ethical approval; 43.81% of the literature specified Chinese medicine evidence; 16.55% of the studies excluded severe heterotrophic hyperplasia; 7.26% of the studies conducted follow-up; and 65.12% of the literature used composite efficacy indicators; 46.67% of the literature applied pathological histological evaluation; 2.62% of the literature applied quality of life evaluation, etc. The overall risk of bias in RCTs of traditional Chinese medicines for gastric precancerous lesions is high, and the quality of most of the study reports needs to be improved. In the future, it is necessary to strengthen the study design of RCTs and refer to appropriate traditional Chinese medicines evidence grading standards, select study protocols according to different purposes, provide objective and strong evidence of clinical studies on traditional Chinese medicines, and carry out clinical study design and result reporting suitable for traditional Chinese medicines according to the CONSORT principle.

Protocol Study: Resistance Training Program, Nutritional, Sleep, and Screen Use Recommendations in Schoolchildren from Educational Centers in the Extreme South of Chile.

Childhood obesity has tripled, reaching critical levels of malnutrition. This factor is directly associated with a poorer health-related quality of life of the child and adolescent population. This article presents the study protocol of the project "Strong schoolchildren with a healthy lifestyle" (EF-Salud), which seeks to analyze the effects of a multicomponent program based on muscle strength exercises, sleep nutritional recommendations, and the use of screens in Chilean educational centers with extremely cold weather. The study protocol of a randomized controlled trial with a pre- and post-test conducted according to the CONSORT statement is reported. The total sample (n = 144) will be schoolchildren from six different school years, four of which will perform an intervention and two control. Intervention group 1 (from two different school years) will receive a muscular strength exercise program in the classroom once a day from Monday to Friday for six months and nutritional, sleep, and use of screens recommendations once a week. Intervention group 2 (from two different school years) will receive a program of nutritional, sleep, and use of screens recommendations once per week for six months. The control group (from two different school years) will carry out their usual school day in relation to physical education classes. Before and after the intervention, the investigators will evaluate the cardiovascular risk, physical condition, and lifestyle related to sleep and use of screens. The schoolchildren in intervention group 1 will obtain significant results in increased strength, decreased cardiovascular risk, improved sleep habits, and fewer hours of screen use compared to the other two groups.

Quality of reporting of randomized controlled trials of top 10 herbs prescribed in Thailand

IntroductionGiven the questionable quality of reporting of randomized controlled trials (RCTs) of herbal interventions, especially in developing countries, this study aims to evaluate the quality of reporting of RCTs of the top 10 herbs prescribed in Thailand and published in Thai healthcare journals. MethodsA systematic search was conducted within five databases: PubMed, Cochrane Library, Thai Journal Online, Thai Index Medicus, and Online Public Access Catalog of Khon Kaen University for Thai and English herbal medicine intervention RCTs published in Thai healthcare journals. Reporting quality of RCTs was assessed by using adapted CONSORT Herbal Intervention and CONSORT 2010 comprised of 52 items. ResultsOf 1351 potential studies, 16 RCTs met the eligibility criteria. For the quality of reporting by each item of 16 included studies, 27 of 52 items were reported in at least 50 % of RCTs which data on participants, physical characteristics of the herbal product, similarity of interventions, baseline data, numbers analyzed, ancillary analyses, and generalizability were reported in all included RCTs when applicable. However, 20 items had less than 50 % reported in included RCTs. There were no included RCTs reported information on the participant flow diagram, registration, and protocol. Discussion/ConclusionsThe quality of reporting of Thai herbal invention RCTs published in Thai healthcare journals was suboptimal. Improvement in the reporting quality of Thai herbal RCTs was needed to provide a high level of evidence. Relevant Thai healthcare journals should encourage Thai herbal medicine RCT authors to follow the CONSORT statement and herbal medicine intervention extensions.

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlledtrial.

To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). A single-centre, parallel-group, pilot randomised control trial. Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. Study methods and results reported in adherence to the CONSORT Statement. No patient or public contribution.

Fibrin-based haemostatic agents for reducing blood loss in adult liver resection.

Liver resection is the optimal treatment for selected benign and malignant liver tumours, but it can be associated with significant blood loss. Numerous anaesthetic and surgical techniques have been developed to reduce blood loss and improve perioperative outcomes. One such technique is the application of topical fibrin-based haemostatic agents (FBHAs) to the resection surface. There is no standard practice for FBHA use, and a variety of commercial agents and devices are available, as well as non-FBHAs (e.g. collagen-based agents). The literature is inconclusive on the effectiveness of these methods and on the clinical benefits of their routine use. To evaluate the benefits and harms of fibrin-based haemostatic agents in reducing intraoperative blood loss in adults undergoing liver resection. We searched the Cochrane Hepato-Biliary Group (CHBG) Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science up to 20 January 2023. We also searched online trial registries, checked the reference lists of all primary studies, and contacted the authors of included trials for additional published or unpublished trials. We considered for inclusion all randomised clinical trials evaluating FBHAs versus no topical intervention or non-FBHAs, irrespective of publication type, publication status, language of publication, and outcomes reported. Eligible participants could have any liver pathology and be undergoing major or minor liver resections through open or laparoscopic surgery. Two review authors independently screened the results of the literature search and used data extraction forms to collate the results. We expressed dichotomous outcome results as risk ratios (RRs) and continuous outcome results as mean differences (MDs), each with their corresponding 95% confidence interval (CI). We used a random-effects model for the main analyses. Our primary outcomes were perioperative mortality, serious adverse events, haemostatic efficacy, and health-related quality of life. Our secondary outcomes were efficacy as sealant, adverse events considered non-serious, operating time, and length of hospital stay. We assessed the certainty of the evidence with GRADE and presented results in two summary of findings tables. We included 22 trials (2945 participants) evaluating FBHAs versus no intervention or non-FBHAs; 19 trials with 2642 participants provided data for the meta-analyses. Twelve trials reported commercial funding, one trial reported no financial support, and nine trials provided no information on funding. Below we present the most clinically relevant outcome results, also displayed in our summary of findings table. Fibrin-based haemostatic agents versus no intervention Six trials (1001 participants) compared FBHAs with no intervention. One trial was at low risk of bias in all five domains, and all other trials were at high or unclear risk of bias in at least one domain. Two trials were at high risk of bias related to blinding. It is unclear if FBHAs compared with no intervention have an effect on perioperative mortality (RR 2.58, 95% CI 0.89 to 7.44; 4 trials, 782 participants), serious adverse events (RR 0.96, 95% CI 0.88 to 1.05; 4 trials, 782 participants), postoperative transfusion (RR 1.04, 95% CI 0.77 to 1.40; 5 trials, 864 participants), reoperation (RR 2.92, 95% CI 0.58 to 14.61; 2 trials, 612 participants), or postoperative bile leak (RR 1.00, 95% CI 0.67 to 1.48; 4 trials, 782 participants), as the certainty of evidence was very low for all these outcomes. Fibrin-based haemostatic agents versus non-fibrin-based haemostatic agents Sixteen trials (1944 participants) compared FBHAs with non-FBHAs. All trials had at least one domain at high or unclear risk of bias. Twelve trials were at high risk of bias related to blinding. It is unclear if FBHAs compared with non-FBHAs have an effect on perioperative mortality (RR 1.03, 95% CI 0.62 to 1.72; 11 trials, 1436 participants), postoperative transfusion (RR 0.92, 95% CI 0.68 to 1.25; 7 trials, 599 participants), reoperation (RR 0.48, 95% CI 0.25 to 0.90; 3 trials, 358 participants), or postoperative bile leak (RR 1.15, 95% CI 0.60 to 2.21; 9 trials, 1115 participants), as the certainty of evidence was very low for all these outcomes. FBHAs compared with non-FBHAs may have little or no effect on the risk of serious adverse events (RR 0.99, 95% CI 0.95 to 1.03; 9 trials, 1176 participants; low-certainty evidence). The evidence for the outcomes in both comparisons (FBHAs versus no intervention and FBHAs versus non-FBHAs) was of very low certainty (or low certainty in one instance) and cannot justify the routine use of FBHAs to reduce blood loss in adult liver resection. While the meta-analysis showed a reduced risk of reoperation with FBHAs compared with non-FBHAs, the analysis was confounded by the small number of trials reporting the event and the risk of bias in all these trials. Future trials should focus on the use of FBHAs in people undergoing liver resection who are at particularly high risk of bleeding. Investigators should evaluate clinically meaningful and patient-important outcomes and follow the SPIRIT and CONSORT statements.

Cost Effectiveness of Screening &amp; Diagnostic Methods for Cervical Cancer in Women aged 30-65 Years Globally: A Systematic Review Protocol to Guide Policy Documents

Background: Cervical cancer is the fourth most common cancer in females, with high prevalence in developing countries, and the most common cause (99%) is the Human Papillomavirus (HPV). The global incidence of cervical cancer is increasing every year, with an incidence of 13.3 cases per 100,000 women and a mortality rate of 7.2 deaths per 100,000 women in 2020. There are various screening and diagnostic methods; however, the availability of any strong evidence on the most cost-effective method is limited. This review systematically analyzes the available screening and diagnostic methodologies for cervical cancer, sensitivity, specificity, and cost implications. Methods and Analysis: Electronic databases like PubMed, Cochrane, and Google Scholar will be systematically searched for relevant articles using medical subject headings (MeSH) terms. Eight reviewers (DL, SW, PP, AK, AR, MS, TK, NT) will independently assess titles and abstracts against the selection criteria during the first phase. Five reviewers will assess all full-text papers before the final decision is made. The studies will be selected based on the predefined inclusion and exclusion criteria. The selected systematic reviews will undergo a quality assessment using the PRISMA checklist and RCTs using CONSORT and CHEERS statements to examine economic evaluations. A narrative synthesis will be formulated from the studies based on two types of outcomes- Clinical and Economical. If sufficient data is available, a meta-analysis will be performed. Conclusion: The results from this study may aid in identifying factors influencing test performance and have evidence of the cost-effectiveness of the screening and diagnostic tests for cervical cancer. This review will generate a platform for more studies that will provide answers to crucial research concerns about cervical cancer screening.