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1.
J Orthop Surg Res ; 17(1): 174, 2022 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-35313901

RESUMO

BACKGROUND: For biomechanical investigations on bone or bone implants, bone quality represents an important potential bias. Several techniques for assessing bone quality have been described in the literature. This study aims to systematically summarize the methods currently available for assessing bone quality in human bone tissue, and to discuss the advantages and limitations of these techniques. METHODS: A systematic review of the literature was carried out by searching the PubMed and Web of Science databases from January 2000 to April 2021. References will be screened and evaluated for eligibility by two independent reviewers as per PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Studies must apply to bone quality assessment with imaging techniques, mechanical testing modalities, and compositional characterization. The terms used for the systematic search were: "(bone quality". Ti,ab.) AND "(human bone specimens)". RESULTS: The systematic review identified 502 relevant articles in total. Sixty-eight articles met the inclusion criteria. Among them, forty-seven articles investigated several imaging modalities, including radiography, dual-energy X-ray absorptiometry (DEXA), CT-based techniques, and MRI-based methods. Nineteen articles dealt with mechanical testing approaches, including traditional testing modalities and novel indentation techniques. Nine articles reported the correlation between bone quality and compositional characterization, such as degree of bone mineralization (DBM) and organic composition. A total of 2898 human cadaveric bone specimens were included. CONCLUSIONS: Advanced techniques are playing an increasingly important role due to their multiple advantages, focusing on the assessment of bone morphology and microarchitecture. Non-invasive imaging modalities and mechanical testing techniques, as well as the assessment of bone composition, need to complement each other to provide comprehensive and ideal information on the bone quality of human bone specimens.


Assuntos
Absorciometria de Fóton , Osso e Ossos/diagnóstico por imagem , Imageamento por Ressonância Magnética , Tomografia Computadorizada por Raios X , Humanos , Projetos de Pesquisa/normas
3.
Psychol Aging ; 37(1): 43-50, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35113613

RESUMO

Clinical trials are governed by principles of good clinical practice (GCP), which can strengthen the achievement of rigor, reproducibility, and transparency in scientific research. Rigor, reproducibility, and transparency are key for producing findings with greater certainty. Clinical trials are closely supervised, often by a clinical trial coordinating center, data safety and monitoring board, and a funding agency, with policies that are a manifestation of GCP and support rigor, reproducibility, and transparency. The multisite Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study is an example clinical trial of relevance to a psychology and aging audience that utilized many protocols that can be applied to single-laboratory designs, including a manualized protocol with accompanying scientific rationale, predefined analysis plans, standardization of procedures across field sites, assurance of competence of study staff in study procedures, transparent coding/entry/transmittal of data, regular quality assurance, and open publication of data. Despite substantial resource discrepancies between the two, single-laboratory studies can model the GCP principles utilized in large clinical trials to provide an excellent foundation for rigor, reproducibility, and transparency. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Assuntos
Projetos de Pesquisa , Idoso , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas
6.
PLoS Biol ; 20(2): e3001562, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35180228

RESUMO

The power of language to modify the reader's perception of interpreting biomedical results cannot be underestimated. Misreporting and misinterpretation are pressing problems in randomized controlled trials (RCT) output. This may be partially related to the statistical significance paradigm used in clinical trials centered around a P value below 0.05 cutoff. Strict use of this P value may lead to strategies of clinical researchers to describe their clinical results with P values approaching but not reaching the threshold to be "almost significant." The question is how phrases expressing nonsignificant results have been reported in RCTs over the past 30 years. To this end, we conducted a quantitative analysis of English full texts containing 567,758 RCTs recorded in PubMed between 1990 and 2020 (81.5% of all published RCTs in PubMed). We determined the exact presence of 505 predefined phrases denoting results that approach but do not cross the line of formal statistical significance (P < 0.05). We modeled temporal trends in phrase data with Bayesian linear regression. Evidence for temporal change was obtained through Bayes factor (BF) analysis. In a randomly sampled subset, the associated P values were manually extracted. We identified 61,741 phrases in 49,134 RCTs indicating almost significant results (8.65%; 95% confidence interval (CI): 8.58% to 8.73%). The overall prevalence of these phrases remained stable over time, with the most prevalent phrases being "marginally significant" (in 7,735 RCTs), "all but significant" (7,015), "a nonsignificant trend" (3,442), "failed to reach statistical significance" (2,578), and "a strong trend" (1,700). The strongest evidence for an increased temporal prevalence was found for "a numerical trend," "a positive trend," "an increasing trend," and "nominally significant." In contrast, the phrases "all but significant," "approaches statistical significance," "did not quite reach statistical significance," "difference was apparent," "failed to reach statistical significance," and "not quite significant" decreased over time. In a random sampled subset of 29,000 phrases, the manually identified and corresponding 11,926 P values, 68,1% ranged between 0.05 and 0.15 (CI: 67. to 69.0; median 0.06). Our results show that RCT reports regularly contain specific phrases describing marginally nonsignificant results to report P values close to but above the dominant 0.05 cutoff. The fact that the prevalence of the phrases remained stable over time indicates that this practice of broadly interpreting P values close to a predefined threshold remains prevalent. To enhance responsible and transparent interpretation of RCT results, researchers, clinicians, reviewers, and editors may reduce the focus on formal statistical significance thresholds and stimulate reporting of P values with corresponding effect sizes and CIs and focus on the clinical relevance of the statistical difference found in RCTs.


Assuntos
PubMed/normas , Publicações/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Relatório de Pesquisa/normas , Teorema de Bayes , Viés , Humanos , Modelos Lineares , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , PubMed/estatística & dados numéricos , Publicações/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Reprodutibilidade dos Testes
7.
PLoS One ; 17(2): e0263695, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35134099

RESUMO

BACKGROUND: Bronchiectasis is a chronic respiratory disease characterised by airways widening and recurrent infections, resulting in episodes of chronic cough, sputum expectoration, and dyspnoea. This leads to deterioration in daily function, repeated hospital admissions and poor quality of life. The prevalence and mortality related to bronchiectasis is increasing worldwide with growing economic burden on healthcare systems. Physiotherapy for bronchiectasis aims to decrease accumulation of sputum, dyspnoea, and improve exercise capacity and daily function. A robust evidence base to support physiotherapy in bronchiectasis is currently lacking. This is partly because of inconsistency and poor reporting of outcomes in available studies. A core outcome set is the minimum acceptable group of outcomes that should be used in clinical trials for a specific condition. This decreases research waste by improving consistency and reporting of key outcomes and facilitates the synthesis of study outcomes in systematic reviews and guidelines. The aim of the study is therefore to develop a core outcome set and outcome measurement set for physiotherapy research in adults with bronchiectasis. This will ensure outcomes important to key stakeholders are consistently used and reported in future research. METHODS AND ANALYSIS: This project will use the COMET Initiative and COSMIN guidelines of core outcome set development and will include three phases. In the first phase, a comprehensive list of outcomes will be developed using systematic review of reported outcomes and qualitative interviews with patients and physiotherapists. Then consensus on key outcomes will be established in phase two using a Delphi survey and a consensus meeting. Finally, in phase three, we will identify appropriate instruments to measure the core outcomes by evaluating the psychometric properties of available instruments and a stakeholders' meeting to establish consensus. ETHICS: The study was reviewed and has received ethical approval from the health-related Research Ethics Committee- Edge Hill University (ETH2021-0217). REGISTRATION: This study is registered with the COMET database. https://www.comet-initiative.org/Studies/Details/1931. The full systematic review protocol is registered in PROSPERO under the number CRD42021266247.


Assuntos
Bronquiectasia/terapia , Avaliação de Resultados em Cuidados de Saúde/métodos , Modalidades de Fisioterapia/normas , Ensaios Clínicos como Assunto , Consenso , Coleta de Dados , Técnica Delfos , Determinação de Ponto Final , Humanos , Projetos de Pesquisa/normas , Revisões Sistemáticas como Assunto , Resultado do Tratamento
10.
PLoS One ; 17(2): e0263023, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35171921

RESUMO

Prevalence of research misconduct, questionable research practices (QRPs) and their associations with a range of explanatory factors has not been studied sufficiently among academic researchers. The National Survey on Research Integrity targeted all disciplinary fields and academic ranks in the Netherlands. It included questions about engagement in fabrication, falsification and 11 QRPs over the previous three years, and 12 explanatory factor scales. We ensured strict identity protection and used the randomized response method for questions on research misconduct. 6,813 respondents completed the survey. Prevalence of fabrication was 4.3% (95% CI: 2.9, 5.7) and of falsification 4.2% (95% CI: 2.8, 5.6). Prevalence of QRPs ranged from 0.6% (95% CI: 0.5, 0.9) to 17.5% (95% CI: 16.4, 18.7) with 51.3% (95% CI: 50.1, 52.5) of respondents engaging frequently in at least one QRP. Being a PhD candidate or junior researcher increased the odds of frequently engaging in at least one QRP, as did being male. Scientific norm subscription (odds ratio (OR) 0.79; 95% CI: 0.63, 1.00) and perceived likelihood of detection by reviewers (OR 0.62, 95% CI: 0.44, 0.88) were associated with engaging in less research misconduct. Publication pressure was associated with more often engaging in one or more QRPs frequently (OR 1.22, 95% CI: 1.14, 1.30). We found higher prevalence of misconduct than earlier surveys. Our results suggest that greater emphasis on scientific norm subscription, strengthening reviewers in their role as gatekeepers of research quality and curbing the "publish or perish" incentive system promotes research integrity.


Assuntos
Pesquisa Biomédica/ética , Ética em Pesquisa , Projetos de Pesquisa/normas , Pesquisadores/ética , Má Conduta Científica/ética , Má Conduta Científica/estatística & dados numéricos , Estudos Transversais , Feminino , Humanos , Masculino , Prevalência , Inquéritos e Questionários
11.
Am J Physiol Heart Circ Physiol ; 322(3): H350-H354, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-35030071

RESUMO

The recent move to require sex as a biological variable (SABV), which includes gender, into the reporting of research published by the American Journal of Physiology-Heart and Circulatory Physiology follows a growing, and much-needed, trend by journals. Understandably, there is concern over how to do this without adding considerable work, especially if one's primary research focus is not on elucidating sex/gender differences. The purpose of this article is to provide additional guidance and examples on how to incorporate SABV into the conduct and reporting of basic and clinical research. Using examples from our research, which includes both studies focused and not focused on sex/gender differences, we offer suggestions for how to incorporate SABV into basic and clinical research studies.


Assuntos
Pesquisa Biomédica/normas , Ensaios Clínicos como Assunto/normas , Projetos de Pesquisa/normas , Sexo , Animais , Pesquisa Biomédica/métodos , Ensaios Clínicos como Assunto/métodos , Humanos , Caracteres Sexuais
13.
Asian Pac J Cancer Prev ; 22(12): 3735-3740, 2022 01 02.
Artigo em Inglês | MEDLINE | ID: mdl-34973682

RESUMO

The journal of APJCP (Asian Pacific Journal of Cancer Prevention) focuses to gather relevant and up-to-date novel information's related to cancer sciences. The research methodologies and approaches adopted by the researcher are prone to variation which may be desirable in the context of novel scientific findings however, the reproducibility for these studies needs to be unified and assured. The reproducibility issues are highly concerned when preclinical studies are reported in cancer, for natural products in particular. The natural products and medicinal plants are prone to a wide variation in terms of phytochemistry and phyto-pharmacology, ultimately affecting the end results for cancer studies. Hence the need for specific guidelines to adopt a best-practice in cancer research are utmost essential. The current AIMRDA guidelines aims to develop a consensus-based tool in order to enhance the quality and assure the reproducibility of studies reporting natural products in cancer prevention. A core working committee of the experts developed an initial draft for the guidelines where more focus was kept for the inclusion of specific items not covered in previous published tools. The initial draft was peer-reviewed, experts-views provided, and improved by a scientific committee comprising of field research experts, editorial experts of different journals, and academics working in different organization worldwide. The feedback from continuous online meetings, mail communications, and webinars resulted a final draft in the shape of a checklist tool, covering the best practices related to the field of natural products research in cancer prevention and treatment. It is mandatory for the authors to read and follow the AIMRDA tool, and be aware of the good-practices to be followed in cancer research prior to any submission to APJCP. Though the tool is developed based on experts in the field, it needs to be further updated and validated in practice via implementation in the field.


Assuntos
Antineoplásicos , Produtos Biológicos , Políticas Editoriais , Revisão por Pares/normas , Projetos de Pesquisa/normas , Consenso , Humanos , Reprodutibilidade dos Testes
14.
Am J Physiol Heart Circ Physiol ; 322(3): H355-H358, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-34995165

RESUMO

The number of research studies investigating whether similar or different cardiovascular responses or adaptations exist between males and females is increasing. Traditionally, difference-based statistical methods, e.g., t test, ANOVA, etc., have been implemented to compare cardiovascular function between males and females, with a P value of >0.05 used to denote similarity between sexes. However, an absence of evidence, i.e., large P value, is not evidence of absence, i.e., no sex differences. Equivalence testing determines whether two measures or groups provide statistically equivalent outcomes, in that they differ by less than an "ideally prespecified" smallest effect size of interest. Our perspective discusses the applicability and utility of integrating equivalence testing when conducting sex comparisons in cardiovascular research. An emphasis is placed on how cardiovascular researchers may conduct equivalence testing across multiple study designs, e.g., cross-sectional comparisons, repeated-measures intervention, etc. The strengths and weaknesses of this statistical tool are discussed. Equivalence analyses are relatively simple to conduct, may be used in conjunction with traditional hypothesis testing to interpret findings, and permit the determination of statistically equivalent responses between sexes. We recommend that cardiovascular researchers consider implementing equivalence testing to better our understanding of similar and different cardiovascular processes between sexes.


Assuntos
Fenômenos Fisiológicos Cardiovasculares , Projetos de Pesquisa/normas , Caracteres Sexuais , Animais , Humanos , Sexo
16.
Value Health ; 25(1): 3-9, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35031096

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Lista de Checagem , Economia Médica/normas , Análise Custo-Benefício/normas , Humanos , Editoração , Projetos de Pesquisa/normas
17.
Fertil Steril ; 117(3): 548-559, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35058041

RESUMO

OBJECTIVE: To measure the consequences of nonadherence with the 2013 American Society for Reproductive Medicine elective single embryo transfer (eSET) guidelines for favorable-prognosis patients. DESIGN: Retrospective cohort. SETTING: In vitro fertilization clinics. PATIENT(S): A total of 28,311 fresh autologous, 2,500 frozen-thawed autologous, and 3,534 fresh oocyte-donor in vitro fertilization cycles in 2014-2016 at Society for Assisted Reproductive Technology-reporting centers. INTERVENTION(S): Patients aged <35 years or using donors aged <35 years underwent first blastocyst transfer. MAIN OUTCOME MEASURE(S): Singleton birth rate, gestational age at delivery, and birth weight were compared between the eSET and non-eSET groups using the chi-square or Fisher's exact test or t-tests. RESULT(S): Among fresh transfers, 15,643 (55%) underwent eSET. Live births after non-eSETs were less likely singletons (38.0% vs. 96.5%; adjusted relative risk [aRR], 0.56) and more likely complicated by preterm delivery (55.0% vs. 20.1%; aRR, 2.39) and low birth weight (<2,500 g) (40.1% vs. 10.6%; aRR, 3.4) compared with those after eSET. Among frozen-thawed transfers, 1,439 (58%) underwent eSET. Live births after non-eSETs were less likely singletons (41.9% vs. 95.2%; aRR, 0.69; 95% confidence interval, 0.66-0.73) and more likely complicated by preterm delivery (56.4% vs. 19.5%; aRR, 2.6; 95% confidence interval, 2.2-3.1) and low birth weight (38.0% vs. 8.9%; aRR, 3.9) compared with those after eSET. Among fresh donor oocyte transfers, 1,946 (55%) underwent eSET. Live births after non-eSETs were less likely singletons (31.3% vs. 97.3%; aRR, 0.48) and more likely complicated by preterm delivery (61.1% vs. 25.7%; aRR, 2.09) and low birth weight (44.3% vs. 11.7%; aRR, 3.39) compared with those after eSET. CONCLUSION(S): Nonadherence with transfer guidelines was associated with dramatically increased multiple pregnancies, preterm births, and low birth weights.


Assuntos
Transferência Embrionária/normas , Fidelidade a Diretrizes/normas , Nascido Vivo/epidemiologia , Oócitos/fisiologia , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , Adulto , Estudos de Coortes , Transferência Embrionária/métodos , Feminino , Humanos , Recém-Nascido , Doadores Vivos , Masculino , Gravidez , Prognóstico , Sistema de Registros , Técnicas de Reprodução Assistida/normas , Projetos de Pesquisa/normas , Estudos Retrospectivos , Transplante Autólogo/normas , Estados Unidos/epidemiologia , Adulto Jovem
18.
BJOG ; 129(3): 336-344, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-35014160

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.


Assuntos
Análise Custo-Benefício/normas , Economia Médica/normas , Projetos de Pesquisa/normas , Lista de Checagem , Guias como Assunto , Humanos
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