This study examines discourses in Chinese online discussions of gene editing by multiple social actors on Weibo before and after a significant scientific crisis, the 2018 scandal of Chinese gene-edited human babies. A content analysis of 2074 posts was done to identify frames, emotions, and metaphors. Findings reveal that Chinese social media have opened up new spaces for multiple social actors to generate multiple discourses. This has resulted in a more participatory public engagement with science and technology on Chinese social media, potentially influencing the online agenda and policy decisions on science and technology. Finally, findings indicate that a scientific crisis can serve as a trigger for significant changes in public attitudes and opinions regarding gene editing.
BACKGROUND:Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. This is an update of a Cochrane review first published in 2000.OBJECTIVES:To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for stage I, II or III breast cancer.SEARCH METHODS:For this 2014 review update, we searched the Cochrane Breast Cancer Group's Specialised Register (4 July 2014), MEDLINE (4 July 2014), Embase (4 July 2014), CENTRAL (2014, Issue 3), the World Health Organization (WHO) International Clinical Trials Registry Platform (4 July 2014) and ClinicalTrials.gov (4 July 2014). References from retrieved articles were also checked.SELECTION CRITERIA:All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion.DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trials for eligibility for inclusion in the review and risk of bias. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses were conducted by age, tumour size and lymph node status.MAIN RESULTS:Since 2000, one new trial has been published; the updated review now includes five RCTs involving 4023 women with breast cancer (clinical stage I, II or III).Two trials involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.84 to 1.15, two studies, 2563 participants, high-quality evidence), or disease-free survival (HR 0.84, 95% CI 0.71 to 1.00, two studies, 2563 participants, low-quality evidence) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. In 1999, 10-year follow-up data became available for one trial of these trials, and no significant differences in overall survival were found. No difference was noted in quality of life measures (one study, 639 participants, high-quality evidence).The new included trial, together with a previously included trial involving 1264 women compared follow-up performed by a hospital-based specialist versus follow-up performed by general practitioners. No significant differences were noted in overall survival (HR 1.07, 95% CI 0.64 to 1.78, one study, 968 participants, moderate-quality evidence), time to detection of recurrence (HR 1.06, 95% CI 0.76 to 1.47, two studies, 1264 participants, moderate-quality evidence), and quality of life (one study, 356 participants, high-quality evidence). Patient satisfaction was greater among patients treated by general practitioners. One RCT involving 196 women compared regularly scheduled follow-up visits versus less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of general practitioners's consultations.AUTHORS' CONCLUSIONS:This updated review of RCTs conducted almost 20 years ago suggests that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life.In two RCTs, follow-up care performed by trained and not trained general practitioners working in an organised practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of overall survival, recurrence detection, and quality of life.
Las revisiones sistemáticas deben establecerse sobre la base de un protocolo que describa la justificación, la hipótesis y los métodos planificados de la revisión, antes de su realización o publicación; sin embargo pocas revisiones publicadas informan sobre la existencia previa de un protocolo. Disponer de un protocolo detallado y bien escrito puede facilitar la comprensión y valoración de la metodología de la revisión, así como la detección de modificaciones en la metodología o la publicación selectiva en revisiones completadas. El presente trabajo describe el desarrollo de unas directrices de presentación de la información, Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols 2015 (PRISMA-P 2015). Las directrices PRISMA-P se componen de una lista de verificación de 17 elementos que pretenden facilitar la preparación y presentación de un protocolo sólido para la revisión sistemática. Las instituciones financiadoras y quienes encargan las revisiones podrían considerar la posibilidad de exigir la lista de verificación, a fin de facilitar la presentación de la información relevante del protocolo, para solicitar financiación. De forma similar, los revisores por pares y editores pueden utilizar las directrices para determinar la integridad y transparencia de un protocolo de revisión sistemática presentado a una revista u otro medio para su publicación. Traducción con permiso de los/las autores/as. Los autores originales no han revisado ni verificado la traducción del manuscrito al español, y no necesariamente están de acuerdo con su contenido.
Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
Artículo original: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6:e1000097. The original authors have not revised and verified the Spanish translation, and not necessary endorse it. Los autores originales no han revisado ni verificado la traducción del manuscrito al español, y no necesariamente están de acuerdo con su contenido. Publicación del artículo original: 21 Julio 2009 Derechos: © 2009 Moher et al. Este es un artículo de acceso abierto distribuido bajo las condiciones de The Creative Commons Attribution License, que permite el uso ilimitado, su distribución y reproducción en cualquier medio, siempre y cuando se acredite el autor y su fuente original. Procedencia: No comisionado; revisión científica externa. Para promover la publicación de la Declaración PRISMA, el artículo se ha publicado como acceso abierto y se puede encontrar en la página web de PLoS Medicine (http://medicine.plosjournals.org/) y también se ha publicado en Annals of Internal Medicine, BMJ, Journal of Clinical Epidemiology, y Open Medicine. Los autores tienen unánimemente los derechos de este artículo. Para más detalles de su uso ver la página web de PRISMA (http://www.prisma-statement.org/). Traducción y adaptación al español: Mercedes Sotos-Prieto, Johana Prieto, Maria Manera, Eduard Baladia, Rodrigo Martínez-Rodríguez y Julio Basulto. Autor de correspondencia de la traducción: Mercedes Sotos-Prieto (merchesotosprieto@gmail.com)
OBJECTIVES:In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. STUDY DESIGN AND SETTINGS:We focus on challenges with rating the confidence in effect estimates (quality of evidence) and incorporating resource use into evidence profiles and Summary of Findings (SoF) tables. RESULTS:GRADE recommends that important differences in resource use between alternative management strategies should be included along with other important outcomes in the evidence profile and SoF table. Key steps in considering resources in making recommendations with GRADE are the identification of items of resource use that may differ between alternative management strategies and that are potentially important to decision makers, finding evidence for the differences in resource use, making judgments regarding confidence in effect estimates using the same criteria used for health outcomes, and valuing the resource use in terms of costs for the specific setting for which recommendations are being made. CONCLUSIONS:With our framework, decision makers will have access to concise summaries of recommendations, including ratings of the quality of economic evidence, and better understand the implications for clinical decision making.
BACKGROUND:Healthcare decision makers face challenges when using guidelines, including understanding the quality of the evidence or the values and preferences upon which recommendations are made, which are often not clear. METHODS:GRADE is a systematic approach towards assessing the quality of evidence and the strength of recommendations in healthcare. GRADE also gives advice on how to go from evidence to decisions. It has been developed to address the weaknesses of other grading systems and is now widely used internationally. The Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence (DECIDE) consortium (http://www.decide-collaboration.eu/), which includes members of the GRADE Working Group and other partners, will explore methods to ensure effective communication of evidence-based recommendations targeted at key stakeholders: healthcare professionals, policymakers, and managers, as well as patients and the general public. Surveys and interviews with guideline producers and other stakeholders will explore how presentation of the evidence could be improved to better meet their information needs. We will collect further stakeholder input from advisory groups, via consultations and user testing; this will be done across a wide range of healthcare systems in Europe, North America, and other countries. Targeted communication strategies will be developed, evaluated in randomized trials, refined, and assessed during the development of real guidelines. DISCUSSION:Results of the DECIDE project will improve the communication of evidence-based healthcare recommendations. Building on the work of the GRADE Working Group, DECIDE will develop and evaluate methods that address communication needs of guideline users. The project will produce strategies for communicating recommendations that have been rigorously evaluated in diverse settings, and it will support the transfer of research into practice in healthcare systems globally.
Different strategies have been developed across countries to foster citizens’ and patients’ involvement, from health policies to patients’ active participation in decisions regarding their health. The spectrum varies from systems where patients lead the reform of health care services, to others where a paternalistic approach still limits patients’ autonomy in decision-making. This paper describes: (1) different interventions for involving patients; (2) experiences to promote consumer evidence-based advocacy; and (3) barriers to consumer involvement in health system reforms, including vested interests in patients’ associations. Citizens’ involvement in health systems can vary substantially, but is gaining increasing weight.
Background: To assess the relationship between surgical delay and mortality in elderly patients with hip fracture. Systematic review and meta-analysis of retrospective and prospective studies published from 1948 to 2011. Medline (from 1948), Embase (from 1974) and CINAHL (from 1982), and the Cochrane Library. Odds ratios (OR) and 95% confidence intervals for each study were extracted and pooled with a random effects model. Heterogeneity, publication bias, Bayesian analysis, and meta-regression analyses were done. Criteria for inclusion were retro-and prospective elderly population studies, patients with operated hip fractures, indication of timing of surgery and survival status.Methodology/Principal Findings: There were 35 independent studies, with 191,873 participants and 34,448 deaths. The majority considered a cut-off between 24 and 48 hours. Early hip surgery was associated with a lower risk of death (pooled odds ratio (OR) 0.74, 95% confidence interval (CI) 0.67 to 0.81; P<0.000) and pressure sores (0.48, 95% CI 0.38 to 0.60; P< 0.000). Meta-analysis of the adjusted prospective studies gave similar results. The Bayesian probability predicted that about 20% of future studies might find that early surgery is not beneficial for decreasing mortality. None of the confounders (e.g. age, sex, data source, baseline risk, cut-off points, study location, quality and year) explained the differences between studies.Conclusions/Significance: Surgical delay is associated with a significant increase in the risk of death and pressure sores. Conservative timing strategies should be avoided. Orthopaedic surgery services should ensure the majority of patients are operated within one or two days.
Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with a disabling progressive course. Chronic cerebrospinal venous insufficiency (CCSVI) has recently been described as a vascular condition characterized by restricted venous outflow from the brain, mainly due to blockages of the internal jugular and azygos veins. Despite a wide variability among studies, it has been found to be associated with MS. Data from a few small case series suggest possible improvement of the clinical course and quality of life by performing percutaneous balloon angioplasty (PTA) of the stenotic veins.Study design and methods: This is a multicenter, randomized, parallel group, blinded, sham-controlled trial to assess the efficacy and safety of PTA. Participants with relapsing remitting MS or secondary progressive MS and a sonographic diagnosis of CCSVI will be enrolled after providing their informed consent. Each participant will be centrally randomized to receive catheter venography and PTA or catheter venography and sham PTA. Two primary end points with respect to efficacy at 12 months are (1) a combined end point obtained through the integration of five functional indicators, walking, balance, manual dexterity, bladder control, and visual acuity, objectively measured by instruments; and (2) number of new brain lesions measured by T2-weighted MRI sequences. Secondary end points include annual relapse rate, change in Expanded Disability Status Scale score, proportion of patients with zero, one or two, or more than two relapses; fatigue; anxiety and depression; general cognitive state; memory/attention/calculus; impact of bladder incontinence; and adverse events. Six hundred seventy-nine patients will be recruited. The follow-up is scheduled at 12 months. Patients, treating neurologists, trained outcome assessors, and the statistician in charge of data analysis will be masked to the assigned treatment.Discussion: The study will provide an answer regarding the efficacy of PTA on patients' functional disability in balance, motor, sensory, visual and bladder function, cognitive status, and emotional status, which are meaningful clinical outcomes, beyond investigating the effects on inflammation. In fact, an important part of patients' expectations, sustained and amplified by anecdotal data, has to do precisely with these functional aspects. Trial registration: Clinicaltrials.gov NCT01371760
Background The process of systematically reviewing research evidence is useful for collecting, assessing and summarizing results from multiple studies planned to answer the same clinical question. The term “systematic” implies that the process, besides being organized and complete, is transparent and fully reported to allow other independent researchers to replicate the results, and therefore come to the same conclusions. Hundreds of new systematic reviews are indexed every year. The growing number increases the likelihood of finding multiple and discordant results. Objectives To clarify the impact of multiple and discordant systematic reviews, we designed a program aimed at finding out: (a) how often different systematic reviews are done on the same subject; (b) how often different systematic reviews on the same topic give different results or conclusions; (c) which methods or interpretation characteristics can explain the differences in results or conclusions. Methods This paper outlines the method used to explore the frequency and the causes of discordance among multiple systematic reviews on the same topic. These methods were then applied to a few medical fields as case studies. Conclusion This aim is particularly relevant for both clinicians and policy makers. Judgments about evidence and recommendation in health care are complex, and often rely on discordant results, especially when there are no empirical results to help serve as a guideline.