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1.
J Contemp Dent Pract ; 25(5): 459-462, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-39364845

RESUMEN

AIM: This study aimed to evaluate the reporting quality of systematic review (SR) abstracts in leading orthodontic journals using the PRISMA abstract criteria. Additionally, the study examined characteristics associated with improved abstract reporting quality. MATERIALS AND METHODS: A retrospective observational study design was employed. Systematic reviews published between January 2018 and December 2022 in four prominent orthodontic journals were identified through electronic and manual searches. Inclusion criteria focused on articles with "SR" or "meta-analysis" keywords in the title or abstract. Narrative and historical reviews, scoping reviews, and case reports with extensive literature reviews were not considered as part of the exclusion criteria. The screening was carried out in duplicate and independently by the two authors. RESULTS: The European Journal of Orthodontics had the highest number of included articles, while the Journal of Orthodontics had the lowest. The majority of SRs had authors affiliated with academic institutions. Compliance scores varied across journals and regions, with Asia scoring the highest. Certain checklist items, such as identifying the report as an SR, stating objectives, describing included studies, providing interpretation, and registration, were adequately reported in over 93% of the reviews. However, the reporting of risk of bias and synthesis of results showed room for improvement. CONCLUSION: The study revealed a significant improvement in the overall Preferred Reporting Items for SRs and Meta-Analyses for Abstracts (PRISMA-A) score of included SRs, primarily due to enhanced reporting of specific checklist items. However, there remains considerable scope for further improvement in abstract reporting, highlighting the importance of striving to meet higher standards in SR abstracts. CLINICAL SIGNIFICANCE: The study showed a notable increase in the PRISMA-A score. However, there is still a need for continued efforts to meet higher reporting standards in SR abstracts. How to cite this article: Alharbi F, Alghabban RO. Reporting Quality of Abstracts in Systematic Reviews in Orthodontics: An Observational Study. J Contemp Dent Pract 2024;25(5):459-462.


Asunto(s)
Indización y Redacción de Resúmenes , Ortodoncia , Revisiones Sistemáticas como Asunto , Indización y Redacción de Resúmenes/normas , Estudios Retrospectivos , Humanos , Publicaciones Periódicas como Asunto/normas , Lista de Verificación
2.
J Eval Clin Pract ; 2024 Sep 19.
Artículo en Inglés | MEDLINE | ID: mdl-39297397

RESUMEN

OBJECTIVE: To evaluate the methodological and reporting quality of systematic reviews (SR) of randomized controlled trials on esthetics and reconstructive breast surgery. METHODS: Meta-research study with a broad search strategy was developed to retrieve all relevant systematic reviews. We evaluated the methodological and reporting guidance adopted by these reviews and assessed their adequacy to items from AMSTAR-2 (methodological quality) and PRISMA 2020 (reporting quality). The protocol of this study was prospectively published in: https://osf.io/preprints/osf/ucpgd. RESULTS: After the selection process, 15 SR were included; eight (60%) referred the use of a methodological guide and five (33.3%) invertedly referred PRISMA as the methodological guide. Reporting guidelines were referred by none of the included systematic review. The median adequacy to PRISMA-2020 items was 42.9% (Q1 - 38.1%/Q3 - 95.2%) and to AMSTAR-2 items was 33.3% (Q1 - 23.3%/Q3 - 93.3%) which reflects overall low reporting and methodological quality of included SR. The overall confidence in the results using AMSTAR-2 framework was critically low in 73.3% of included SR. Although a small number of SR were included, a high correlation between the methodological and reporting quality was observed (Spearmean rho = 0.96, 95% bias-corrected confidence interval = 0.84 to 0.99). CONCLUSION: Methodological and reposting quality of SR of randomized clinical trials on esthetic or reconstructive breast surgery is poor. Half of the authors referred to the use of valid guidance to plan and conduct their reviews and none of them referred the use of a guidance for reporting their results.

3.
Syst Rev ; 13(1): 230, 2024 Sep 07.
Artículo en Inglés | MEDLINE | ID: mdl-39244603

RESUMEN

While undisputedly important, and part of any systematic review (SR) by definition, evaluation of the risk of bias within the included studies is one of the most time-consuming parts of performing an SR. In this paper, we describe a case study comprising an extensive analysis of risk of bias (RoB) and reporting quality (RQ) assessment from a previously published review (CRD42021236047). It included both animal and human studies, and the included studies compared baseline diseased subjects with controls, assessed the effects of investigational treatments, or both. We compared RoB and RQ between the different types of included primary studies. We also assessed the "informative value" of each of the separate elements for meta-researchers, based on the notion that variation in reporting may be more interesting for the meta-researcher than consistently high/low or reported/non-reported scores. In general, reporting of experimental details was low. This resulted in frequent unclear risk-of-bias scores. We observed this both for animal and for human studies and both for disease-control comparisons and investigations of experimental treatments. Plots and explorative chi-square tests showed that reporting was slightly better for human studies of investigational treatments than for the other study types. With the evidence reported as is, risk-of-bias assessments for systematic reviews have low informative value other than repeatedly showing that reporting of experimental details needs to improve in all kinds of in vivo research. Particularly for reviews that do not directly inform treatment decisions, it could be efficient to perform a thorough but partial assessment of the quality of the included studies, either of a random subset of the included publications or of a subset of relatively informative elements, comprising, e.g. ethics evaluation, conflicts of interest statements, study limitations, baseline characteristics, and the unit of analysis. This publication suggests several potential procedures.


Asunto(s)
Sesgo , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Humanos , Animales
4.
Int Endod J ; 2024 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-39253946

RESUMEN

OBJECTIVES: To evaluate the reporting quality of Scoping Reviews (ScRs) in endodontics according to the PRISMA Extension Checklist for Scoping Reviews (PRISMA-ScR) and to analyse their association with a range of publication and methodological/reporting characteristics. METHODS: Pubmed, Scopus, and Web of Science databases were searched up to 31 January 2024 to identify scoping reviews in the field of endodontics. An additional search was performed in three leading endodontic journals. Study selection and appraising the quality of the studies was carried out independently by two reviewers. Each of the 20 PRISMA-ScR items were allocated a score of either 0, 0.5 or 1 to reflect the completeness of the reporting. An item-specific and overall percentage reporting quality score was calculated and reported through descriptive statistics across a range of publication, as well as methodological/reporting characteristics. A univariable and multivariable quantile regression was performed to identify the effect of publication and methodological/reporting characteristics (year of publication, journal, inclusion of an appropriate reporting guideline, and study registration) on the overall percentage reporting quality score. Association of reporting quality score with publication characteristics was then investigated. RESULTS: A total of 40 ScRs were identified and included for appraisal. Most of the studies were published from 2021 onwards. The overall median reporting quality score was 86%. The most frequent items not included in the studies were: a priori protocol registration (22/40 compliant; 55%), and reporting of funding (16/40 compliant; 40%). Other key elements that were inadequately reported were the abstract (7/40 compliant; 18%), the rationale and justification of the ScR (21/40 compliant; 52%) and the objectives of the study (18/40 compliant; 45%). Studies that adhered to appropriate reporting guidelines were associated with greater reporting quality scores (ß-coefficient: 10; 95%CI: 1.1, 18.9; p = .03). ScRs with protocols registered a priori had significantly greater reporting quality scores (ß-coefficient: 12.5; 95%CI: 6.1, 18.9; p < .001), compared with non-registered reviews. CONCLUSIONS: The reporting quality of the ScRs in endodontics varied and was greater when the ScR protocols were registered a priori and when the authors adhered to reporting guidelines.

5.
J Clin Epidemiol ; : 111544, 2024 Sep 24.
Artículo en Inglés | MEDLINE | ID: mdl-39326471

RESUMEN

OBJECTIVE: Visual abstracts (VAs) lack study-specific reporting guidelines and are increasingly used as stand-alone sources in medical research dissemination although not designed for this purpose. Therefore, our objectives were to describe 1) completeness of reporting in VAs and corresponding written abstracts (WAs) of randomised controlled trials (RCTs), and 2) the extent and type of spin (i.e., any reporting pattern that could distort result interpretation and mislead readers) in VAs and WAs of RCTs with a statistically nonsignificant primary outcome. STUDY DESIGN AND SETTING: We conducted a cross-sectional study evaluating VAs and WAs of RCTs published between 01/01/2021 and 03/31/2023. We searched MEDLINE via PubMed for reports of RCTs published in the 15 highest impact factor journals from six medical fields (among which 34 journals producing VAs of RCTs were identified). One reviewer identified primary reports of RCTs published with a VA and randomly selected a maximum of 10 reports from each journal to avoid overrepresentation. Completeness of reporting assessment was based on the CONSORT extension for Abstracts. Spin was explored using a standardized spin classification for RCTs with statistically nonsignificant primary outcome results. Both assessments were conducted in duplicate, with discussion until consensus in case of discrepancy. RESULTS: A random sample of 253 reports from 34 journals was identified. The information provided in VAs was frequently incomplete: primary outcome identification, primary outcome results, and harms were respectively described or displayed in only 47% (n=116/247), 30% (n=75/247), and 35% (n=88/253). Reporting was slightly better for some items in WAs, although still unsatisfactory. Among trials with nonsignificant primary outcome results (n=101), 57% (n=58) of VAs and 55% (n=56) of WAs exhibited at least one type of spin. Post-hoc analyses showed VAs produced by journal editors of high impact general medical journals were more complete and more accurate than those produced by specialty journals or authors. CONCLUSIONS: The information conveyed in VAs was frequently incomplete and inaccurate, highlighting the urgent need to refer to appropriate specific reporting guidelines to avoid misinterpretation by readers.

6.
Syst Rev ; 13(1): 244, 2024 Sep 28.
Artículo en Inglés | MEDLINE | ID: mdl-39342302

RESUMEN

BACKGROUND: Meta-epidemiological research plays a vital role in providing empirical evidence needed to develop methodological manuals and tools, but the reporting quality has not been comprehensively assessed, and the influence of reporting guidelines remains unclear. The current study aims to evaluate the reporting quality of meta-epidemiological studies, assess the impact of reporting guidelines, and identify factors influencing reporting quality. METHODS: We searched PubMed and Embase for meta-epidemiological studies. The reporting quality of these studies was assessed for adherence to established reporting guidelines. Two researchers independently screened the studies and assessed the quality of the included studies. Time-series segmented linear regression was used to evaluate changes in reporting quality over time, while beta-regression analysis was performed to identify factors significantly associated with reporting quality. RESULTS: We initially identified 1720 articles, of which 125 meta-epidemiological studies met the inclusion criteria. Of these, 65 (52%) had low reporting quality, 60 (48%) had moderate quality, and none achieved high quality. Of the 24 items derived from established reporting guidelines, 4 had poor adherence, 13 had moderate adherence, and 7 had high adherences. High journal impact factor (≥ 10) (OR = 1.42, 95% CI: 1.13, 1.80; P = 0.003) and protocol registration (OR = 1.70, 95% CI: 1.30, 2.22; P < 0.001) were significantly associated with better reporting quality. The publication of the reporting guideline did not significantly increase the mean reporting quality score (- 0.53, 95% CI: - 3.37, 2.31; P = 0.67) or the trend (- 0.38, 95% CI: - 1.02, 0.26; P = 0.20). CONCLUSIONS: Our analysis showed suboptimal reporting quality in meta-epidemiological studies, with no improvement post-2017 guidelines. This potential shortcoming could hinder stakeholders' ability to draw reliable conclusions from these studies. While preregistration could reduce reporting bias, its adoption remains low. Registration platforms could consider creating tailored types for meta-epidemiological research, and journals need to adopt more proactive measures to enforce reporting standards.


Asunto(s)
Estudios Epidemiológicos , Humanos , Metaanálisis como Asunto , Proyectos de Investigación/normas , Adhesión a Directriz , Informe de Investigación/normas , Factor de Impacto de la Revista , Guías como Asunto
7.
Data Brief ; 57: 110868, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-39290420

RESUMEN

This paper presents a dataset from a survey of the perception and experiences of owner-managers and accountants of SMEs concerning the ethical culture and financial reporting quality in their organisation. The dataset was collected from November 2022 to February 2023 using the convenience sampling method. A total of 181 valid responses from 218 responses were obtained during the data collection process. During instrument development, extensive pretesting was used to validate suitable questions for the respondents. The instrument was developed by adapting from prior studies and the inferences made from the qualitative survey prior to this study process. The survey was designed to elicit data from the owner-managers and accountants of SMEs concerning the relationship between the elements of ethical culture (i.e., formal systems, informal systems, leadership, and religiosity) and the financial reporting quality in SMEs. The dataset serves as an insightful reference for researchers, SME players, and policymakers to better understand the impending benefits of implementing ethical culture for improving the financial reporting quality among SMEs. In summary, the dataset, which was stored in a publicly available repository, can be conveniently used to quantify, and understand the organisational ethical culture in the context of SMEs.

8.
Complement Med Res ; : 1-11, 2024 Aug 08.
Artículo en Inglés | MEDLINE | ID: mdl-39116842

RESUMEN

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.

9.
J Oral Rehabil ; 2024 Aug 02.
Artículo en Inglés | MEDLINE | ID: mdl-39095959

RESUMEN

BACKGROUND: Poor reporting quality and spin in randomized controlled trial (RCT) abstracts can lead to misinterpretation and distorted interpretation of results. OBJECTIVES: This methodological study aimed to assess the reporting quality and spin among RCT abstracts on splint therapy for temporomandibular disorders (TMD) and explore the association between spin and potentially related factors. METHODS: The authors searched PubMed for RCTs on splint therapy for TMD. The reporting quality of each abstract was assessed using the original 16-item CONSORT for abstracts checklist. The authors evaluated the presence and characteristics of spin only in abstracts with nonsignificant primary outcomes according to pre-determined spin strategies. Logistic regression analyses were performed to identify factors associated with the presence of spin. RESULTS: A total of 148 abstracts were included in the reporting quality evaluation. The mean overall CONSORT score (OCS) was 5.86 (score range: 0-16). Only interventions, objectives and conclusions were adequately reported. Of the 61 RCT abstracts included for spin analysis, spin was identified in 38 abstracts (62.3%), among which 32 abstracts (52.3%) had spin in the Results section and 21 (34.4%) had spin in the Conclusions section. A significantly lower presence of spin was found in studies with exact p-value reporting (OR: 0.170; 95% CI: 0.032-0.887; p = .036) and a two-arm comparison design (OR: 11.777; 95% CI: 2.171-63.877; p = .004). CONCLUSIONS: The reporting quality of RCT abstracts on splint therapy for TMD is suboptimal and the prevalence of spin is high. More awareness and joint efforts are needed to improve reporting quality and minimize spin.

10.
Syst Rev ; 13(1): 211, 2024 Aug 06.
Artículo en Inglés | MEDLINE | ID: mdl-39107813

RESUMEN

OBJECTIVE: It is crucial to conduct systematic reviews (SRs) and meta-analyses (MAs) to make causal references, in order to inform the clinical guidelines and decision-making. The high reporting quality of reviews through compliance with the guidelines Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Assessing the Methodological Quality of Systematic Reviews-2 (AMSTAR-2) could promote the consistency and reproducibility across the published articles. The purpose of this meta-epidemiological study is to evaluate the reporting methodological quality of SRs on the association between sleep duration and hypertension. METHODS: An electronic search in an online database was performed to retrieve systematic reviews and meta-analyses published up to 31st December 2022. Data screening and extraction were conducted by two investigators. The reporting quality of each included article was measured with reference to the 27-item 2020 PRISMA checklist, and methodological quality was evaluated using the AMSTAR-2. PRISMA evaluation was determined by total scores of individual SR and items scores and AMSTAR-2 assessment was also conducted using four categories. RESULTS: Of 2269 articles captured in the initial search, 15 SRs were included in the final analyses. All SRs had more than one incomplete PRISMA item. The mean of total scores was 20.5 (range 14-25), and the results of the AMSTAR-2 assessment were critically low to low. The reporting quality of "rationale," "objectives," "selection process," "study selection," "discussion," and 'support' was fully reported. SRs that reported registration information and protocol had a higher PRISMA score than articles that reported certain deficiencies. From the results of the AMSTAR-2 assessment, the methodological quality of these SRs and MAs was critically low to low. None of the included literature provided a list of excluded articles, and the report of the search strategy was incomplete; half of the SRs did not use appropriate tools to assess the risk of bias in each included study. CONCLUSIONS: Both the reporting and methodological quality of overall studies are less than ideal, with several key items being consistently under-reported. The quality measured by AMSTAR-2 is mainly consistent with the quality of reporting. Authors, reviewers, and journal editors should raise awareness and move forward to encourage completeness of SR reporting based on the results, which can aid in enhancing the quality of evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023459901.


Asunto(s)
Hipertensión , Metaanálisis como Asunto , Duración del Sueño , Revisiones Sistemáticas como Asunto , Humanos , Proyectos de Investigación
11.
Zhongguo Zhen Jiu ; 44(8): 966-74, 2024 Aug 12.
Artículo en Chino | MEDLINE | ID: mdl-39111798

RESUMEN

OBJECTIVE: To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for depression. METHODS: 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. RESULTS: 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. CONCLUSION: 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.


Asunto(s)
Terapia por Acupuntura , Depresión , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia por Acupuntura/normas , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Depresión/terapia , Lista de Verificación/normas , Proyectos de Investigación/normas
12.
J Evid Based Med ; 17(2): 399-408, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38943604

RESUMEN

OBJECTIVE: As a large and populous country, China releases a high number of diagnostic criteria. However, the published diagnostic criteria have not yet been systematically analyzed. Therefore, the aim of this study is to investigate the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria published in China. METHODS: We searched five databases for diagnostic criteria from their inception until July 31, 2023. All diagnostic criteria were screened through abstract and full-text reading, and included if satisfying the prespecified criteria. Two researchers independently extracted data on the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria. RESULTS: A total of 143 diagnostic criteria were included. In terms of development methods, the proportions of diagnostic criteria that involved a systematic literature search (n = 2; 1.4%; 95% confidence interval (CI), 0.4% to 5.0%), adoption of formal consensus methods (n = 4; 2.8%; 95% CI, 1.1% to 7.0%), and criteria validation (n = 9; 6.3%; 95% CI, 3.3% to 11.5%) were relatively low. Regarding reporting quality, the average compliance with the ACCORD checklist was 5.1%; none of the diagnostic criteria reported on registration, expert inclusion criteria, expert recruitment process, or consensus results. A majority (58.7%; 95% CI, 50.6% to 66.5%) of criteria did not cite any research, and only one (0.7%; 95% CI, 0.1% to 3.9%) criterion was derived from a systematic review. Moreover, only 16.1% (95% CI, 11.0% to 23.0%) of diagnostic criteria used evidence from the Chinese population. CONCLUSION: The diagnostic criteria developed in China exhibit serious flaws, particularly in evidence retrieval, formation of expert panels, consensus methods, and validation. Additionally, only few diagnostic criteria used a systematic synthesis of the evidence or evidence from the China. There is an urgent need to enhance the methodology for developing diagnostic criteria.


Asunto(s)
Medicina Basada en la Evidencia , China , Estudios Transversales , Humanos , Medicina Basada en la Evidencia/normas
13.
BMC Med Res Methodol ; 24(1): 130, 2024 Jun 05.
Artículo en Inglés | MEDLINE | ID: mdl-38840047

RESUMEN

BACKGROUND: Faced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive designs to speed up the development of new drugs. However, the application of adaptive design to drug randomized controlled trials (RCTs) and whether the reporting is adequate are unclear. Thus, this study aimed to summarize the epidemiological characteristics of the relevant trials and assess their reporting quality by the Adaptive designs CONSORT Extension (ACE) checklist. METHODS: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to January 2020. We included drug RCTs that explicitly claimed to be adaptive trials or used any type of adaptative design. We extracted the epidemiological characteristics of included studies to summarize their adaptive design application. We assessed the reporting quality of the trials by Adaptive designs CONSORT Extension (ACE) checklist. Univariable and multivariable linear regression models were used to the association of four prespecified factors with the quality of reporting. RESULTS: Our survey included 108 adaptive trials. We found that adaptive design has been increasingly applied over the years, and was commonly used in phase II trials (n = 45, 41.7%). The primary reasons for using adaptive design were to speed the trial and facilitate decision-making (n = 24, 22.2%), maximize the benefit of participants (n = 21, 19.4%), and reduce the total sample size (n = 15, 13.9%). Group sequential design (n = 63, 58.3%) was the most frequently applied method, followed by adaptive randomization design (n = 26, 24.1%), and adaptive dose-finding design (n = 24, 22.2%). The proportion of adherence to the ACE checklist of 26 topics ranged from 7.4 to 99.1%, with eight topics being adequately reported (i.e., level of adherence ≥ 80%), and eight others being poorly reported (i.e., level of adherence ≤ 30%). In addition, among the seven items specific for adaptive trials, three were poorly reported: accessibility to statistical analysis plan (n = 8, 7.4%), measures for confidentiality (n = 14, 13.0%), and assessments of similarity between interim stages (n = 25, 23.1%). The mean score of the ACE checklist was 13.9 (standard deviation [SD], 3.5) out of 26. According to our multivariable regression analysis, later published trials (estimated ß = 0.14, p < 0.01) and the multicenter trials (estimated ß = 2.22, p < 0.01) were associated with better reporting. CONCLUSION: Adaptive design has shown an increasing use over the years, and was primarily applied to early phase drug trials. However, the reporting quality of adaptive trials is suboptimal, and substantial efforts are needed to improve the reporting.


Asunto(s)
Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Humanos , Proyectos de Investigación/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Lista de Verificación/métodos , Lista de Verificación/normas , Ensayos Clínicos Fase II como Asunto/métodos , Ensayos Clínicos Fase II como Asunto/estadística & datos numéricos , Ensayos Clínicos Fase II como Asunto/normas
14.
Front Pharmacol ; 15: 1389808, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38910893

RESUMEN

Objectives: The impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review aimed to assess the reporting characteristics and quality of RCT protocols involving interventions such as Chinese herbal medicine formulas (CHMF), acupuncture, and moxibustion published in the last 3 years. Methods: We conducted an extensive search among multiple databases, including All EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid MEDLINE(R), PubMed, Web of Science, Google Scholar, and ClinicalTrials.gov for publications in English from 1 January 2020 to 10 August 2023. Two reviewers independently assessed the eligibility of the publications, extracted predetermined information, and evaluated the reporting based on the SPIRIT-TCM Extension 2018 checklist. Results: Of the 420 eligible protocols (comprising 163 studies on CHMF, 239 on acupuncture, and 18 on moxibustion), the average reporting compliance rate was only 35.4%. Approximately half of the assessed items fell into the category of poorly reported, demonstrating a compliance rate below 65%. Notably, reporting compliance in acupuncture and moxibustion interventional studies exhibited higher scores than compliance in CHMF studies. Conclusion: Continued, concerted, and coordinated efforts are required by journals, editors, reviewers, and investigators to improve the application and promotion of the SPIRIT-TCM Extension 2018 reporting guideline.

15.
Res Integr Peer Rev ; 9(1): 6, 2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-38816752

RESUMEN

BACKGROUND: Despite the improvements in the completeness of reporting of randomized trial protocols after the publication of the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines, many items remain poorly reported. This study aimed to assess the effectiveness of using SPIRIT-tailored templates for trial protocols to improve the completeness of reporting of the protocols that master's students write as part of their master's theses. METHODS: Before and after experimental study performed at the University Master's Degree in Orthopaedic Manual Physiotherapy of the Universitat Internacional de Catalunya (Barcelona, Spain). While students in the post-intervention period were instructed to use a trial protocol template that was tailored to SPIRIT, students in the pre-intervention period did not use the template. PRIMARY OUTCOME: Difference between the pre- and post-intervention periods in the mean number of adequately reported items (0-10 scale). The outcomes were evaluated independently and in duplicate by two blinded assessors. Students and their supervisors were not aware that they were part of a research project. For the statistical analysis, we used a generalized linear regression model (dependent variable: number of adequately reported items in the protocol; independent variables: intervention period, call, language). RESULTS: Thirty-four trial protocols were included (17, pre-intervention; 17, post-intervention). Protocols produced during the post-intervention period (mean: 8.24; SD: 1.52) were more completely reported than those produced during the pre-intervention period (mean: 6.35; SD: 1.80); adjusted difference: 1.79 (95% CI: 0.58 to 3.00). CONCLUSIONS: SPIRIT-based templates could be used to improve the completeness of reporting of randomized trial protocols.

16.
BMC Med Res Methodol ; 24(1): 117, 2024 May 20.
Artículo en Inglés | MEDLINE | ID: mdl-38769533

RESUMEN

BACKGROUND: Although randomized trials and systematic reviews provide the best evidence to guide medical practice, many permanent neonatal diabetes mellitus (PNDM) studies have been published as case reports. However, the quality of these studies has not been assessed. The purpose of this study was to assess the extent to which the current case reports for PNDM comply with the Case Report (CARE) guidelines and to explore variables associated with the reporting. METHOD: Six English and four Chinese databases were searched from their inception to December 2022 for PNDM case reports. The 23 items CARE checklist was used to measure reporting quality. Primary outcome was the adherence rate of each CARE item and second outcome was total reporting score for each included PNDM case report. Linear and logistic regression analyses were used to examine the connection between five pre-specified predictor variables and the reporting quality. The predictor variables were impact factor of the published journal (<3.4 vs. ≥3.4, categorized according to the median), funding (yes vs. no), language (English vs. other language), published journal type (general vs. special) and year of publication (>2013 vs. ≤ 2013). RESULT: In total, 105 PNDM case reports were included in this study. None of the 105 PNDM case reports fulfilled all 23 items of the CARE checklist. The response rate of 11 items were under 50%, including prognostic characteristics presentation (0%), patient perspective interpretation (0%), diagnostic challenges statement (2.9%), clinical course summary (21.0%), diagnostic reasoning statement (22.9%), title identification (24.8%), case presentation (33.3%), disease history description (34.3%), strengths and limitations explanation (41.0%), informed consent statement (45.7%), and lesson elucidation (47.6%). This study identified that the PNDM case reports published in higher impact factor journals were statistically associated with a higher reporting quality. CONCLUSION: The reporting of case reports for PNDM is generally poor. As a result, this information may be misleading to providers, and the clinical applications may be detrimental to patient care. To improve reporting quality, journals should encourage strict adherence to the CARE guidelines.


Asunto(s)
Diabetes Mellitus , Humanos , Estudios Transversales , Diabetes Mellitus/diagnóstico , Recién Nacido , Lista de Verificación , Informe de Investigación/normas , Femenino , Adhesión a Directriz/estadística & datos numéricos , Masculino , Proyectos de Investigación/normas , Factor de Impacto de la Revista
17.
Braz J Phys Ther ; 28(2): 101062, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38640642

RESUMEN

BACKGROUND: For evidence-based practice, clinicians and researchers can rely on well-conducted randomized clinical trials that exhibit good methodological quality, provide adequate intervention descriptions, and implementation fidelity. OBJECTIVE: To assess the description and implementation fidelity of exercise-based interventions in clinical trials for individuals with rotator cuff tears. METHODS: A systematic search was conducted in PubMed, Embase, CINAHL, LILACS, Cochrane Library, Web of Science, SCOPUS and SciELO. Randomized clinical trials that assessed individuals with rotator cuff tears confirmed by imaging exam were included. All individuals must have received an exercise-based treatment. The methodological quality was scored with the Physiotherapy Evidence Database (PEDro) scale. The Template for Intervention Description and Replication (TIDieR) checklist and the National Institutes of Health Behaviour Change Consortium (NIHBCC) were used to assess intervention description and implementation fidelity, respectively. RESULTS: A total of 13 studies were included. Despite their adequate methodological quality, the description of the intervention was poor with TIDieR scores ranging from 6 to 15 out of 24 total points. The TIDieR highest-scoring item was item 1 (brief name) that was reported in all studies. Considering fidelity, only one of the five domains of NIHBCC (i.e., treatment design) reached just over 50%. CONCLUSION: Exercise-based interventions used in studies for individuals with rotator cuff tears are poorly reported. The description and fidelity of the intervention need to be better reported to assist clinical decision-making and support evidence-based practice.


Asunto(s)
Terapia por Ejercicio , Lesiones del Manguito de los Rotadores , Humanos , Lesiones del Manguito de los Rotadores/terapia , Terapia por Ejercicio/métodos , Manguito de los Rotadores/fisiopatología , Ensayos Clínicos como Asunto
18.
Complement Ther Med ; 82: 103034, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38521419

RESUMEN

OBJECTIVE: Acupuncture overviews are increasing rapidly; however, their reporting quality is yet unclear. We aimed to investigate the reporting quality of relevant overviews according to the preferred reporting items for overviews of reviews (PRIOR) statement. METHODS: We systematically searched PubMed from inception to August 16, 2022 for overviews on acupuncture therapies. Reporting quality of included overviews was evaluated using the PRIOR statement, and the results were cross-checked. Multiple linear regression analysis was used to assess the predictors of the reporting completeness. GraphPad 9.4 was utilized to generate an evidence map, Excel 2019 was used to extract and manage data, and R 4.2.3 was used for data analysis. RESULTS: A total of 49 overviews published from 2006 to 2022 were included, of which China ranked first with 38 overviews. The most frequently searched database was PubMed/ Medline (n = 48, 98%), and commonly used methodological quality assessment tool was AMSTAR-2 (n = 14, 29%). The overarching themes centered on acupuncture for obstetrics, gynecology, reproductive diseases, as well as depression, anxiety, and insomnia. Reporting quality needs to be improved involving the definition of systematic reviews (SRs), overlap of primary studies and SRs, methods for managing discrepant data across SRs, risk of bias in primary studies, heterogeneity, and sensitivity analysis of synthesized results, reporting bias assessment, and registration and protocol. Moreover, publication in recent years and receiving funding support were significantly associated with higher overall reporting quality score (P < 0.05). CONCLUSION: Based on the PRIOR statement, this methodological study indicates that the reporting quality of the included acupuncture overviews is poor. In the future, authors of overviews are encouraged to use the PRIOR statement for standardized reporting. Furthermore, it is recommended that journal editors mandate the inclusion of this statement in authors' reports and require a complete PRIOR checklist.


Asunto(s)
Terapia por Acupuntura , Humanos , Proyectos de Investigación/normas , Revisiones Sistemáticas como Asunto
19.
J Biomed Inform ; 152: 104628, 2024 04.
Artículo en Inglés | MEDLINE | ID: mdl-38548008

RESUMEN

OBJECTIVE: Acknowledging study limitations in a scientific publication is a crucial element in scientific transparency and progress. However, limitation reporting is often inadequate. Natural language processing (NLP) methods could support automated reporting checks, improving research transparency. In this study, our objective was to develop a dataset and NLP methods to detect and categorize self-acknowledged limitations (e.g., sample size, blinding) reported in randomized controlled trial (RCT) publications. METHODS: We created a data model of limitation types in RCT studies and annotated a corpus of 200 full-text RCT publications using this data model. We fine-tuned BERT-based sentence classification models to recognize the limitation sentences and their types. To address the small size of the annotated corpus, we experimented with data augmentation approaches, including Easy Data Augmentation (EDA) and Prompt-Based Data Augmentation (PromDA). We applied the best-performing model to a set of about 12K RCT publications to characterize self-acknowledged limitations at larger scale. RESULTS: Our data model consists of 15 categories and 24 sub-categories (e.g., Population and its sub-category DiagnosticCriteria). We annotated 1090 instances of limitation types in 952 sentences (4.8 limitation sentences and 5.5 limitation types per article). A fine-tuned PubMedBERT model for limitation sentence classification improved upon our earlier model by about 1.5 absolute percentage points in F1 score (0.821 vs. 0.8) with statistical significance (p<.001). Our best-performing limitation type classification model, PubMedBERT fine-tuning with PromDA (Output View), achieved an F1 score of 0.7, improving upon the vanilla PubMedBERT model by 2.7 percentage points, with statistical significance (p<.001). CONCLUSION: The model could support automated screening tools which can be used by journals to draw the authors' attention to reporting issues. Automatic extraction of limitations from RCT publications could benefit peer review and evidence synthesis, and support advanced methods to search and aggregate the evidence from the clinical trial literature.


Asunto(s)
Procesamiento de Lenguaje Natural , Publicaciones , Tamaño de la Muestra , Lenguaje
20.
Can Assoc Radiol J ; 75(3): 549-557, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38420881

RESUMEN

Objective: To assess the reporting quality of radiomics studies on ischemic stroke, intracranial and carotid atherosclerotic disease using the Image Biomarker Standardization Initiative (IBSI) reporting guidelines with the aim of finding avenues of improvement for future publications. Method: PubMed database was searched to identify relevant radiomics studies. Of 560 articles, 41 original research articles were included in this analysis. Based on IBSI radiomics reporting guidelines, checklists for CT-based and MRI-based studies were created to allow a structured and comprehensive evaluation of each study's adherence to these guidelines. Results: The main topics covered included radiomics studies were ischemic stroke, intracranial artery disease, and carotid atherosclerotic disease. The reporting checklist median score was 17/40 for the 20 CT-based radiomics studies and 22.5/50 for the 20 MRI-based studies. Basic items like imaging modality, region of interest, and image biomarker set utilized were included in all studies. However, details regarding image acquisition and reconstruction, post-acquisition image processing, and image biomarkers computation were inconsistently detailed across studies. Conclusion: The overall reporting quality of the included radiomics studies was suboptimal. These findings underscore a pressing need for improved reporting practices in radiomics research, to ensure validation and reproducibility of results. Our study provides insights into current reporting standards and highlights specific areas where adherence to IBSI guidelines could be significantly improved.


Asunto(s)
Enfermedades de las Arterias Carótidas , Accidente Cerebrovascular Isquémico , Imagen por Resonancia Magnética , Radiómica , Tomografía Computarizada por Rayos X , Humanos , Enfermedades de las Arterias Carótidas/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Tomografía Computarizada por Rayos X/métodos
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