scholarly journals Quality of reporting of outcomes in trials of therapeutic interventions for pressure ulcers in adults: a protocol for a systematic survey

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024633
Author(s):  
Jessica Steffany Miranda ◽  
Luciana Patricia Fernandes Abbade ◽  
Arthur Pollo Deonizio ◽  
Joelcio Francisco Abbade ◽  
Lawrence Mbuagbaw ◽  
...  

Pressure ulcers (PUs) have a high incidence, especially in hospital units. Randomised clinical trials (RCTs) of therapeutic interventions for PU should include a clear description of the outcomes and results to enhance transparency and replicability.ObjectivesThe primary objective of this study is to assess the completeness of the descriptions of the outcomes of therapeutic interventions in RCTs in adult patients with PU. The secondary objectives are to evaluate the types of reported primary outcomes, measurement methods or tools used to evaluate the outcomes and the results of reported outcomes.MethodsWe will conduct a systematic survey of RCTs published from January 2006 to April 2018. The selection process of the studies will be done in two stages of screening: title and abstract, and full text revision, always by two researchers independently. The completeness of the outcome will be assessed according to five criteria: domain (outcome title), specific measurement or technique/instrument used, specific metric or format of the outcome data that will be used for analysis, method of aggregation (how data from each group will be summarised) and time-points that will be used for analysis. The quality of the results of the outcome will be classified as either complete, incomplete or unreported. We will conduct a descriptive analysis of the number, type and degrees of outcome specification in the included RCTs. The frequency of categories in each domain of the outcomes will also be reported. The median and IQR will be estimated for each element of the specified outcome (out of five).Ethics and disseminationThis will be the first systematic assessment of the outcomes of therapeutic interventions used for pressure ulcers. After completion, this review will be submitted to a peer-reviewed journals.

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036148
Author(s):  
Vivienne C Bachelet ◽  
Víctor A Carrasco ◽  
Fabiana Bravo-Córdova ◽  
Ruben A Díaz ◽  
Francisca J Lizana ◽  
...  

IntroductionQuality of reporting refers to how published articles communicate how the research was done and what was found. Gaps and imprecisions of reporting hamper the assessment of the methodological quality and internal and external validity. The CONsolidated Standards of Reporting Trials (CONSORT) are a set of evidence-based recommendations of the minimum elements to be included in the reporting of randomised controlled trials (RCTs) to ensure a complete and transparent account of what was done, how it was done and what was found. Few studies have been conducted on the impact of CONSORT on RCTs published in Latin American and Spanish journals. We aim to assess the reporting quality of RCTs of three clinical specialities published in Spanish and Latin American journals, as well as to assess changes over time and associations of quality with journal and country indicators.Methods and analysisWe will conduct a systematic survey of all RCTs published in Spanish-language journals in three clinical fields (dentistry, neurology and geriatrics) from 1990 to 2018. We will include RCTs from previous work that has identified all RCTs on these medical fields published in Spain and Latin America. We will update this work via handsearching of relevant journals. Assessment of quality of reporting will be conducted independently and in duplicate using the CONSORT 2010 Statement. We will also extract journal and country indicators. We will conduct descriptive statistics and secondary analyses considering the year, country, and journal of publication, among others.Ethics and disseminationThe Universidad de Santiago de Chile’s ethics committee approved the protocol. We will disseminate the results of this work in peer-reviewed scientific journals and conference proceedings. We expect to raise awareness among researchers, journal editors and funders on the importance of training in reporting guidelines and using them from the inception of RCT protocols.


Author(s):  
Jéssica Steffany Miranda ◽  
Arthur Pollo Deonizio ◽  
Joelcio Francisco Abbade ◽  
Hélio Amante Miot ◽  
Lawrence Mbuagbaw ◽  
...  

Dermatology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Vanessa Lin ◽  
Raahi Patel ◽  
Alexis Wirtz ◽  
Deepika Mannem ◽  
Ryan Ottwell ◽  
...  

<b><i>Background:</i></b> Spin – the misrepresentation of a study’s results – has been identified in abstracts of studies focused on a variety of disorders from multiple fields of medicine. <b><i>Objectives:</i></b> This study’s primary objective was to evaluate the abstracts of systematic reviews and meta-analyses focused on the treatment of atopic dermatitis for the nine most severe forms of spin. <b><i>Methods:</i></b> We systematically searched Embase and MEDLINE for systematic reviews of atopic dermatitis therapies. Screening and data extraction occurred in a masked, duplicate fashion. Each included study was evaluated for the nine most severe types of spin and other study characteristics. <b><i>Results:</i></b> Our searches retrieved 2,456 studies, of which 113 were included for data extraction. Spin was found in 74.3% of our included studies (84/113). Spin type 6 occurred most frequently (68/113, 60.2%). Spin types 1, 2, and 9 were not identified. All industry-funded systematic reviews contained spin in their abstract. The presence of spin was not associated with any specific study characteristics, including the methodological quality of the study. <b><i>Conclusions:</i></b> Severe forms of spin were found in the majority of abstracts for systematic reviews of atopic dermatitis treatments. Steps should be taken to prevent spin to improve the quality of reporting in abstracts.


Vaccines ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1322
Author(s):  
Shirin Heidari ◽  
Alice Palmer-Ross ◽  
Tracey Goodman

Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.


2016 ◽  
Vol 27 (04) ◽  
pp. 352-360 ◽  
Author(s):  
Meriem Zahed ◽  
Floriane Guimond ◽  
Karine Baumstarck ◽  
Alice Faure ◽  
Fabrice Michel ◽  
...  

Introduction Quantify quality of life (QoL) outcomes in gastroschisis children is little assessed. The primary objective was to describe the long-term outcome of newborns with gastroschisis treated in three tertiary care hospitals of France in terms of neurodevelopment and QoL. Materials and Methods The study reported was a cross-sectional, descriptive multicentric retrospective study assessing the outcome of newborns with gastroschisis, born between January 1, 2009, and December 31, 2014, treated at two large and French level III neonatal intensive care units. Long-term outcome data were assessed by questionnaires sent to the infants' parents. Questionnaires explored global health, neurological development, and quality of life (overall assessment including socio-economic and medical), Age & Stages Questionnaire, infants' quality of life (KIDSCREEN), and quality of parents' life (General Questionnaire Short Form-36). Results In this study, 50% of the survivor's families answered the assessment form (n = 33). The average follow-up age was 40 months, ranging from 8 months to 6 years. Cases of simple gastroschisis more often had a normal score for “communication” (p = 0.033), while patients who received morphine for a longer duration had significantly lower scores for the items “communication” and “problem resolving” (p = 0.024 and p = 0.011, respectively). Children's QoL was significantly lower for patients with gestational age younger than 36 weeks (p = 0.023) and for patients born following “fetal cause delivery” (p = 0.022). Parents had a significantly higher physical composite score if their child underwent primary closure (p = 0.012). Conclusion Our analyses confirm the idea that cases of complex gastroschisis and preterm delivery may lead to poorer outcome. Such hindsight (40 months in mean) allowed for an interesting assessment of development long after the patient's initial hospitalization and to confirm these results, a standardized neuropsychological evaluation of patients should be done when at least 6 years old. An accurate assessment of the social environment and its impact on the development and QoL of children will be fundamental to avoid selection bias.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Vivienne C. Bachelet ◽  
María S. Navarrete ◽  
Constanza Barrera-Riquelme ◽  
Víctor A. Carrasco ◽  
Matías Dallaserra ◽  
...  

Abstract Background The Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Database of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of reporting of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time. Methods We did a systematic survey with time trend analysis of RCTs for dentistry, geriatrics, and neurology. These fields were chosen for pragmatic reasons as they had not yet been completed in BADERI. After screening RCTs from 1990 to 2018 for randomised or quasi-randomised clinical trials, we extracted data for 23 CONSORT items. The primary outcome was the total score of the 23 predefined CONSORT 2010 items for each RCT (score range from 0 to 34). The secondary outcome measure was the score for each one of these 23 items. Results A total of 392 articles from 1990 to 2018 were included as follows: dentistry (282), neurology (80), and geriatrics (30). We found that the overall compliance score for the CONSORT items included in this study for all 392 RCTs analysed was 12.6 on a scale with a maximum score of 34. With time, the quality of reporting improved slightly for all RCTs. None of the articles achieved the complete individual CONSORT item compliance score. The lowest overall compliance percentage was for item 10 (Randomisation implementation) and item 24 (Protocol registration), with a dismal 1% compliance across all included RCTs, regardless of country. Conclusions CONSORT compliance is very poor in the 392 analysed RCTs. The impact of the CONSORT statement on improving the completeness of RCT reporting in Latin America and Spain is not clear. Iberoamerican journals should become more involved in endorsing and enforcing adherence to the CONSORT guidelines.


BMJ Open ◽  
2017 ◽  
Vol 7 (4) ◽  
pp. e014981 ◽  
Author(s):  
Federico Germini ◽  
Maura Marcucci ◽  
Marta Fedele ◽  
Maria Giulia Galli ◽  
Lawrence Mbuagbaw ◽  
...  

2020 ◽  
Vol 48 (2) ◽  
pp. 85-91
Author(s):  
Vijay Pal Singh ◽  
Ayushi Jain ◽  
Shubhra Gupta ◽  
Manudharshy Vijayakumar ◽  
Kunal Pratap ◽  
...  

The quality of animal experiments in terms of appropriate reporting is a concern, particularly with regard to their validity and the recording of the measures taken to reduce various types of bias. A systematic survey of 1371 and 236 publications from India and Sri Lanka, respectively, which were published between 1905 and 2017 and indexed in NCBI-PubMed, Cinhal, MEDLINE and Scopus, was carried out. The level of detail in the descriptions of animals used and the measures taken to reduce bias were analysed in each article. Selected parameters from the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines, such as age, weight, sex, sample size calculation, blinding and randomisation were considered. The findings revealed poor reporting standards in animal experiments carried out in India and Sri Lanka, confirming the limited impact of the ARRIVE guidelines. These findings emphasise the urgent need for improvements in the peer review process, both prior to a study being set up and in the post-study reporting phase, and for more stringent adherence to the ARRIVE guidelines in the reporting of animal experiments.


2021 ◽  
Vol 07 (03) ◽  
pp. 1-9
Author(s):  
Surya Bali ◽  

Despite existing frameworks for the improvement of adolescent reproductive health, there is a lack in provision of the Adolescent Friendly Health Services (AFHS). The primary objective of this study was to assess the quality and proficiency of service providers to deliver Adolescent Friendly Health Services (AFHS) in central India. Data was gathered by visiting 30 secondary and tertiary level health facilities to assess their infrastructure and preparedness for providing AFHS using a pre-designed questionnaire based on WHO guidelines for assessing quality. Descriptive analysis was done using SPSS v21 and Microsoft Excel. Quality of AFHS services was found to be poor in non- RKSK facilities. However the knowledge level, training status and counseling skills of the service provider was found to be highly substandard in both RKSK and Non-RKSK facilities. The RKSK program has not been properly implemented and has failed to make an impact where it was required.


Author(s):  
Andrew Atia ◽  
Hannah C. Langdell ◽  
Andrew Hollins ◽  
Ronnie L. Shammas ◽  
Adam Glener ◽  
...  

Abstract Background Microsurgery fellowship applicants make decisions for future training based on information obtained from colleagues, mentors, and microsurgery fellowship program Websites (MFWs). In this study, we sought to evaluate the accessibility and quality of available information by microsurgery programs by analyzing the most commonly used web resources and social media outlets for applicants. Methods The San Francisco (SF) Match and American Society of Reconstructive Microsurgery Websites were queried in April 2020 for microsurgery fellowship programs (MFPs) participating in the SF Match. Twenty-two independent variables of information were assessed on MFWs based on previously published data. Social media presence was also assessed by querying Facebook, Instagram, and Twitter for official hospital, plastic surgery residency, and microsurgery fellowship accounts. Results All 24 MFWs participating in the SF Match had a webpage. Program description, faculty listing, operative volume, and eligibility requirements were listed for all programs (100%). The majority of MFWs listed affiliated hospitals (75%), provided a link to the fellowship application (66.7%), listed interview dates (66.7%), and highlighted research interests (50%). A minority of MFWs provided information on conference schedule (37.5%), current fellow listing (25%), previous fellow listing (16.67%), and positions held by previous fellows (8.33%). No MFWs (0%) presented information on selection process, or rotation schedule.All hospitals with an MFP had a Facebook page and nearly all had Instagram (83.3%) and Twitter accounts (95.8%). Plastic surgery residency programs at the same institution of an MFP had social media presence on Facebook (38.9%), Twitter (38.9%), and Instagram (66.7%). Only three MFPs had Facebook accounts (12.5%) and none had Instagram or Twitter accounts. Conclusion As the field of microsurgery continues to grow, the need for effective recruitment and training of microsurgeons continues to be essential. Overall, we conclude that both the accessibility and quality of information available to applicants are limited, which is a missed opportunity for recruitment.


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