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Publication selection bias undermines the systematic accumulation of evidence. To assess the extent of this problem, we survey over 68,000 meta-analyses containing over 700,000 effect size estimates from medicine (67,386/597,699), environmental sciences (199/12,707), psychology (605/23,563), and economics (327/91,421). Our results indicate that meta-analyses in economics are the most severely contaminated by publication selection bias, closely followed by meta-analyses in environmental sciences and psychology, whereas meta-analyses in medicine are contaminated the least. After adjusting for publication selection bias, the median probability of the presence of an effect decreased from 99.9% to 29.7% in economics, from 98.9% to 55.7% in psychology, from 99.8% to 70.7% in environmental sciences, and from 38.0% to 29.7% in medicine. The median absolute effect sizes (in terms of standardized mean differences) decreased from d = 0.20 to d = 0.07 in economics, from d = 0.37 to d = 0.26 in psychology, from d = 0.62 to d = 0.43 in environmental sciences, and from d = 0.24 to d = 0.13 in medicine.
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Economía , Metaanálisis como Asunto , Psicología , Sesgo de Publicación , Humanos , Ecología , Proyectos de Investigación , Sesgo de Selección , Probabilidad , MedicinaRESUMEN
The incorporation of publications that have been retracted is a risk in reliable evidence synthesis. Retraction is an important mechanism for correcting the literature and protecting its integrity. Within the medical literature, the continued citation of retracted publications occurs for a variety of reasons. Recent evidence suggests that systematic reviews and meta-analyses often unwittingly cite retracted publications which, at least in some cases, may significantly impact quantitative effect estimates in meta-analyses. There is strong evidence that authors of systematic reviews and meta-analyses may be unaware of the retracted status of publications and treat them as if they are not retracted. These problems are difficult to address for several reasons: identifying retracted publications is important but logistically challenging; publications may be retracted while a review is in preparation or in press and problems with a publication may also be discovered after the evidence synthesis is published. We propose a set of concrete actions that stakeholders (eg, scientists, peer-reviewers, journal editors) might take in the near-term, and that research funders, citation management systems, and databases and search engines might take in the longer term to limit the impact of retracted primary studies on evidence syntheses.
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Mala Conducta Científica , Humanos , Revisiones Sistemáticas como Asunto , Metaanálisis como Asunto , Bases de Datos BibliográficasRESUMEN
OBJECTIVES: This descriptive study of registered trials aimed to identify large clinical trials on antidepressants for mental disorders: (1) to assess what proportion could be labelled as 'seeding trials' (trials for marketing purposes) and (2) to describe their methodological characteristics and outcomes. DESIGN: A search was conducted across all trials registered on ClinicalTrials.gov by drug name in March 2017. SETTING: All trials registered in the database of ClinicalTrials.gov were screened. Large registered studies were received and studies focusing prospectively on the effects of antidepressants in mental health disorders. Specific data items were extracted automatically, and subsequently inspected, corrected and completed by hand. PARTICIPANTS: Prospective studies were selected focusing on the effects of antidepressants in any mental health disorder with 800 participants or more planned for inclusion. MAIN OUTCOME MEASURES: Three members from the study team independently assessed the following 'seeding trial' characteristics in each registered study: a high level of involvement of the product manufacturer in the study design, in the data analysis and reporting of the study, an abnormally low ratio of patient numbers to study site, spin and/or omissions of clinically relevant findings in the abstracts, and conclusions that focused on secondary endpoints and surrogate markers. Secondary outcomes were the exploration of a functional outcome and suicidality. RESULTS: 31 trials were identified from clinical trials database. 18/31 were published (58%). 8 of these 18 (44%) studies were identified as possible seeding trials. 13/31 (42%) large trials planned to explore functioning and 5/31 (16%) suicidality. CONCLUSIONS: Large trials are rare in the field of antidepressant research. Some could be 'seeding trials'. Few explored suicidality. Identifying seeding trials from incomplete data entries in registries, especially when almost half of the studies were still unpublished, posed considerable challenges. The delay between our research and publication limits the strength of our conclusions. PROSPERO REGISTRATION NUMBER: CRD42017065591.
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Trastorno Depresivo Mayor , Trastornos Mentales , Humanos , Estudios Prospectivos , Antidepresivos/uso terapéutico , Trastornos Mentales/tratamiento farmacológico , Trastorno Depresivo Mayor/tratamiento farmacológico , Ideación SuicidaRESUMEN
Pressures to publish, perverse incentives, financial interest and gender are amongst the most commonly discussed risk factors for scientific misconduct. However, evidence of their association with actual data fabrication and falsification is inconclusive. A recent case-controlled analysis of articles containing problematic image duplications suggested that country of affiliation of first and last authors is a significant predictor of scientific misconduct. The same analysis found null or negative associations with individual proxies of publication rate, impact and gender. The latter findings, in line with previous evidence, failed to support common hypotheses about the prevalence and causes of misconduct, but country-level effects may have confounded these results. Here we extend and complete previous results by comparing, via matched-controls analysis, articles from authors in the same country. We found that evidence for individual-level risk factors may be significant in some countries, and null or opposite in others. In particular, in countries where publications are rewarded with cash incentives, and especially China, the risk of problematic image duplication was higher for more productive, more frequently cited, earlier-career researchers working in lower-ranking institutions, in accordance with a "misaligned incentives" explanation for scientific misconduct. However, a null or opposite pattern was observed in all other countries, and especially the USA, UK and Canada, countries where concerns for misaligned incentives are commonly expressed. In line with previous results, we failed to observe a statistically significant association with industry funding and with gender. This is the first direct evidence of a link between publication performance and risk of misconduct and between university ranking and risk of misconduct. Commonly hypothesised individual risk factors for scientific misconduct, including career status and productivity, might be relevant in countries where cash-reward policies generate perverse incentives. In most scientifically active countries, however, where other incentives systems are in place, these patterns are not observed, and other risk factors might be more relevant. Policies to prevent and correct scientific misconduct may need to be tailored to a countries' or institutions' specific context.
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Mala Conducta CientíficaRESUMEN
The double-incision technique with bone-tunnel fixation provides anatomical reattachment of a distal biceps tendon rupture to the radial tuberosity1. This technique has been described by Boyd and Anderson2 and was later modified by Morrey et al.3. The aim of the procedure is to achieve good return of elbow strength and motion with a low rate of neurological complications. Description: A longitudinal antecubital incision of 3 to 4 cm allows dissection to identify and isolate the lateral antebrachial cutaneous nerve (LABCN). Supination of the forearm protects the posterior interosseus nerve, which often cannot be visualized. The distal portion of the distal biceps should be carefully identified and exposed. A high-resistance nonresorbable suture is sewn with use of a Krackow technique to whipstitch the distal 4 cm of the tendon. Alternatively, 2 sutures (4 strands) can be utilized. A curved forceps is placed in the interosseous space to identify the location for the second 4-cm incision, on the dorsal proximal forearm over the tip of the forceps with the forearm pronated. The radial tuberosity is exposed by bluntly separating the common extensor tendons, followed by transection of the supinator fibers. Two drill holes are made 5 mm apart from one another for suture passage. The tendon is passed across a loop of wire, from the anterior to the posterior incision. With the elbow at 90° of flexion and full pronation, the tendon is docked into the trough and the sutures are tied. Alternatives: Alternatively, the surgical repair of the distal biceps tendon rupture can be performed through a single anterior approach4. The exposure starts with a curved longitudinal antecubital incision, exploiting the interval between the brachioradialis and pronator teres with radial (lateral) retraction of the brachioradialis and medial retraction of the pronator teres. A single anterior incision allows repair through the use of various types of fixation devices, such as suture anchors, cortical buttons, and interference screws, but seems to carry an increased risk of neurological complications, especially in terms of paresthesias in the distribution of the LABCN. Nonoperative treatment might be acceptable for elderly patients with poor functional demands. Rationale: The double-incision technique with bone-tunnel fixation provides good fixation strength with an expected low rate of neurological complications1. This approach offers a useful treatment option for young and active patients with physically demanding lifestyles. Expected Outcomes: The double-incision technique is an effective and safe procedure to restore elbow functionality in patients with distal biceps tendon rupture. A meta-analysis1,4-16 revealed no significant differences in postoperative functional scores following procedures performed via the single-incision compared with double-incision approach. Although the differences were smaller than the minimal clinically important difference17, the single-incision technique yielded significantly greater flexion (mean ± standard deviation, 136° ± 13°) and pronation range of motion (79° ± 10°) compared with the double-incision technique (133° ± 13° and 75° ± 14°, respectively) at 2 years postoperatively. No differences in extension and supination were observed. Rates of heterotopic ossification ranged from 0.5% to 11% for the single-incision approach and from 1% to 21.4% for the double-incision approach, with significant differences favoring the single-incision technique, although in the majority of cases the heterotopic ossification was an incidental finding. Neurological complications were found in 24.5% and 13.4% cases for the single- and double-incision techniques, respectively, with a significant difference favoring the double-incision technique. When damage to specific nerves was evaluated, the double-incision technique was associated with significantly less risk of LABCN damage. Important Tips: One or 2 high-resistance nonresorbable sutures are sewn with use of a Krackow technique to whipstitch the distal 4 cm of the biceps tendon.A curved forceps is placed in the interosseous space to identify the location for the second incision, on the dorsal proximal forearm over the tip of the forceps.Pronation of the forearm protects the posterior interosseus nerve, which often cannot be visualized during volar dissection and bone fixation.Positioning the tendon more posteriorly on the radial tuberosity allows for optimal biomechanical function. Acronyms and Abbreviations: ROM = range of motionCR = conventional radiologyMRI = magnetic resonance imagingUS = ultrasoundLABC = lateral antebrachial cutaneousPIN = posterior interosseous nerveHO = heterotopic ossificationCI = confidence intervalSI = single incisionDI = double incision.
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INTRODUCTION: Tibial shaft fractures are common occurrence in children and surgical treatment is sometimes required, particularly in unstable or open fractures, and in polytrauma. The aim of this study was to investigate the available evidence on the efficacy and safety of flexible intramedullary nailing (FIN) for both open and closed tibia fractures in children, exploring the main surgical outcomes and rate of complications. MATERIALS AND METHODS: Pubmed/Medline, Scopus and Cochrane Central databases were searched following the PRISMA guideline. Studies reporting on the outcomes of FIN for paediatric tibia shaft fractures were included. Weighted means were evaluated for surgical outcomes. Meta-analysis of proportion and odd ratios were used to analyse total complication rates and differences between open and closed fractures. RESULTS: Twenty-eight studies (835 patients) were included; the mean age was 11.0 ± 3.0 years. The mean follow-up was 22.5 ± 13.5 months; the mean time to full weight-bearing was 7.5 ± 3.7 weeks. The total complication rate was 28.1% (minor = 20.7%, major = 6.3%); this was greater in open fractures (13.6% vs 5.1%, p = 0.007). The rate of union was 97.5%, with a mean time to union of 11.9 ± 7.2 weeks. Malunion was found in 8.5% cases, delayed union in 3.8%, non-union in 1.4%, symptomatic hardware in 5.1%, leg-length discrepancy in 5.0%, superficial infections in 2.3%, deep infections in 1.0%, compartment syndromes in 1.4%, and refracture in 0.2%. Almost all patients returned to unrestricted physical activity. CONCLUSIONS: FIN offers excellent outcomes for the treatment of paediatric tibia shaft fractures. Patients presenting with an open fracture have a higher but acceptable complication rate. Comparative studies are needed to clarify if other treatments have superior outcomes.
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Fijación Intramedular de Fracturas , Fracturas Abiertas , Fracturas de la Tibia , Adolescente , Clavos Ortopédicos , Niño , Fijación Intramedular de Fracturas/efectos adversos , Curación de Fractura , Fracturas Abiertas/cirugía , Humanos , Estudios Retrospectivos , Fracturas de la Tibia/cirugía , Resultado del TratamientoRESUMEN
The extent to which a retraction might require revising previous scientific estimates and beliefs - which we define as the epistemic cost - is unknown. We collected a sample of 229 meta-analyses published between 2013 and 2016 that had cited a retracted study, assessed whether this study was included in the meta-analytic estimate and, if so, re-calculated the summary effect size without it. The majority (68% of N = 229) of retractions had occurred at least one year prior to the publication of the citing meta-analysis. In 53% of these avoidable citations, the retracted study was cited as a candidate for inclusion, and only in 34% of these meta-analyses (13% of total) the study was explicitly excluded because it had been retracted. Meta-analyses that included retracted studies were published in journals with significantly lower impact factor. Summary estimates without the retracted study were lower than the original if the retraction was due to issues with data or results and higher otherwise, but the effect was small. We conclude that meta-analyses have a problematically high probability of citing retracted articles and of including them in their pooled summaries, but the overall epistemic cost is contained.
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Cronin and Gerow first introduced silicone breast implants in 1962; they now serve as first-line for breast augmentation. Breast augmentation is effective in restoring both physical and psychological well-being in women post-mastectomy. Many studies in the literature on complications of silicone breast implant rupture focus on lymphomas and capsular contractures. Only a few studies discuss the hepatobiliary complications. By reviewing the literature over the past 30 years, the authors aim to analyse the clinical presentation, diagnostic findings, as well as management outcomes amongst women with ruptured silicone implant-related hepatobiliary complications. To the best of our knowledge, this is the first comprehensive review on this topic.
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Implantes de Mama , Neoplasias de la Mama , Mamoplastia , Implantes de Mama/efectos adversos , Femenino , Humanos , Mastectomía , Siliconas/efectos adversosRESUMEN
PURPOSE: Ankle arthrodesis (AA) has traditionally been the surgical standard for patients with an end-stage ankle osteoarthritis, with total ankle arthroplasty (TAA) recently becoming an alternative. The aim of this study was to update evidence in terms of functional outcomes, complications, and quality of life between AA and TAA by analyzing comparative studies. METHODS: PubMed, MEDLINE, Scopus, and Cochrane Central databases were used to search keywords. A total of 21 studies entered our qualitative and quantitative analysis. Demographics, functional outcomes, and complications were extracted. Random and fixed-effect models were used for the meta-analysis of standardized mean differences (SMDs) and odds ratios (ORs). RESULTS: A total of 18,448 patients were identified, with a mean age of 57.3 ± 11.3 years. TAA showed significantly greater post-operative range of motion (SMD - 0.883, 95% CI - 1.175 to - 0.590; I2 < 0.001) and Ankle Osteoarthritis Scale scores (SMD - 1.648, 95% CI - 3.177 to - 0.118; I2 = 97.67), but no differences in other patient-reported outcome scores were found. Patients undergoing TAA showed higher post-operative SF-36 (SMD - 0.960, 95% CI - 1.584 to - 0.336; I2 = 68.77). The total complication rate was similar between the two procedures (OR 0.936, 95% CI 0.826 to 1.060; I2 = 87.44), including the incidence of re-operations (OR 1.720, 95% CI 0.892 to 3.316; I2 = 77.65). CONCLUSION: While TAA and AA showed no differences in most post-operative functional outcomes, our review demonstrates that patients undergoing TAA show better health-related quality of life than AA. We found no evidence to suggest that TAA carries a higher risk of complications and re-operations compared to AA.
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Artroplastia de Reemplazo de Tobillo , Osteoartritis , Anciano , Tobillo , Articulación del Tobillo/cirugía , Artrodesis/efectos adversos , Artroplastia de Reemplazo de Tobillo/efectos adversos , Humanos , Persona de Mediana Edad , Osteoartritis/epidemiología , Osteoartritis/cirugía , Calidad de Vida , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
This systematic review investigates factors associated with outcomes after meniscal allograft transplantation (MAT). The PubMed, Scopus, and Cochrane Central Register databases were used to search relevant articles in April 2018. Studies that evaluated at least one association between a factor and outcomes were extracted. Of 3,381 titles, 52 studies were finally analyzed. Data about predictors, patient-reported outcome scores (PROMs), and failure rates were extracted for quantitative and qualitative analysis. A total of 3,382 patients and 3,460 transplants were identified. Thirty different predictors were reported in the current MAT literature, 18 of which by at least two studies. Subgroup analysis showed that lateral MAT had higher postoperative values than medial MAT in Lysholm's (p = 0.0102) and International Knee Documentation Committee (IKDC; p = 0.0056) scores. Soft tissue fixation showed higher postoperative IKDC scores than bone fixation (p = 0.0008). Fresh frozen allografts had higher Lysholm's scores (p < 0.0001) and showed significantly lower failure rates (p < 0.0001) than cryopreserved allografts. Age (p < 0.015, ß = 0.80), sex (p < 0.034, ß = - 8.52), and body mass index (BMI; p < 0.014, ß = -4.87) demonstrated an association with PROMs in the regression model. Qualitative analysis found moderate evidence that a higher number of previous procedures in the same knee are an independent predictor of transplant failure. Conflicting evidence was found with regard to chondral damage, time from meniscectomy, smoke, sport level, worker's compensation status, and preoperative Lysholm's score as predictors of outcomes. Our review suggests that the ideal candidate to undergo MAT may be a young male of normal weight with no previous knee surgeries, treated with a lateral isolated procedure. However, MAT is associated with good outcomes in the majority of patients with many of the PROMs requiring further study to determine their direct effects on long-term outcomes. This study is a systematic review and reflects level of evidence IV.
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Artropatías/cirugía , Articulación de la Rodilla/cirugía , Meniscos Tibiales/trasplante , Aloinjertos , Humanos , Meniscectomía , Meniscos Tibiales/cirugía , Medición de Resultados Informados por el Paciente , Pronóstico , Procedimientos de Cirugía Plástica , Trasplante Homólogo , Resultado del TratamientoRESUMEN
AIMS: The aim of this systematic review and meta-analysis is to evaluate differences in functional outcomes and complications between single- (SI) and double-incision (DI) techniques for the treatment of distal biceps tendon rupture. METHODS: A comprehensive search on PubMed, MEDLINE, Scopus, and Cochrane Central databases was conducted to identify studies reporting comparative results of the SI versus the DI approach. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used for search strategy. Of 606 titles, 13 studies met the inclusion criteria; methodological quality was assessed with the Newcastle-Ottawa scale. Random- and fixed-effects models were used to find differences in outcomes between the two surgical approaches. The range of motion (ROM) and the Disabilities of the Arm, Shoulder and Hand (DASH) scores, as well as neurological and non-neurological complications, were assessed. RESULTS: A total of 2,622 patients were identified. No significant differences in DASH score were detected between the techniques. The SI approach showed significantly greater ROM in flexion (standardized mean difference (SMD) -0.508; 95% confidence interval (CI) -0.904 to -0.112) and pronation (SMD -0.325, 95% CI -0.637 to -0.012). The DI technique was associated with significantly less risk of lateral antebrachial cutaneous nerve damage (odds ratio (OR) 4.239, 95% CI 2.171 to 8.278), but no differences were found for other nerves evaluated. The SI group showed significantly fewer events of heterotopic ossification (OR 0.430, 95% CI 0.226 to 0.816) and a lower reoperation rate (OR 0.503, 95% CI 0.317 to 0.798). CONCLUSION: No significant differences in functional scores can be expected between the SI and DI approaches after distal biceps tendon repair. The SI approach showed greater flexion and pronation ROM and a lower risk of heterotopic ossification and reoperation. The DI approach was favourable in terms of lower risk of neurological complications. Cite this article: Bone Joint J 2020;102-B(12):1608-1617.
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Traumatismos del Brazo/cirugía , Traumatismos de los Tendones/cirugía , Tendones/cirugía , Humanos , Músculo Esquelético/lesiones , Músculo Esquelético/cirugía , Procedimientos Ortopédicos/métodos , Herida QuirúrgicaRESUMEN
May-Thurner syndrome (MTS) is an unusual cause of deep venous thrombosis; even rarer is the spontaneous rupture of collaterals around the thrombosed common iliac vein due to MTS. We present a case of MTS which presented with left leg swelling and abdominal mass due to retroperitoneal haemorrhage.
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BACKGROUND: Controversies remain regarding the predictors for outcomes and recurrence after scarf osteotomy for hallux valgus deformity. METHODS: Sixty-two patients (70 feet) underwent scarf osteotomy for hallux valgus deformity. The radiological angles, tibial sesamoid position, articular congruence, demographics, comorbidities, AOFAS, VAS and SF-12 scores, and the postoperative compliance were tested as predictors for outcomes and recurrence. RESULTS: After a mean 38±15.4 months follow-up, all of the radiological angles, the total AOFAS, PCS-12 and VAS scores significantly improved (all P<0.001). Preoperative MCS-12 was directly related to the total postoperative AOFAS score (P=0.003). A higher number of cardiovascular risk factors negatively affected the postoperative total AOFAS score, VAS and PCS-12 (ß=-3.42, P=0.030; ß=0.262, P=0.022; ß=-0.181, P=0.025, respectively). The BMI influenced postoperative PCS-12 (ß=-0.244, P=0.002). Preoperative HVA was directly related to postoperative DMAA (P=0.002) and tibial sesamoid position (P=0.005). Preoperative joint incongruence and postoperative noncompliance were associated with recurrence (P=0.043 and P=0.035, respectively). CONCLUSIONS: Satisfactory results can be expected after scarf osteotomy. Higher BMI and number of cardiovascular risk factors, and low mental status should be carefully considered when counselling patients for this procedure. Adherence to postoperative care instructions influences deformity recurrence.
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Hallux Valgus/cirugía , Hallux/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Hallux/diagnóstico por imagen , Hallux Valgus/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Osteotomía/métodos , Radiografía , Recurrencia , Resultado del Tratamiento , Adulto JovenRESUMEN
This article proposes quantitative answers to meta-scientific questions including 'how much knowledge is attained by a research field?', 'how rapidly is a field making progress?', 'what is the expected reproducibility of a result?', 'how much knowledge is lost from scientific bias and misconduct?', 'what do we mean by soft science?', and 'what demarcates a pseudoscience?'. Knowledge is suggested to be a system-specific property measured by K, a quantity determined by how much of the information contained in an explanandum is compressed by an explanans, which is composed of an information 'input' and a 'theory/methodology' conditioning factor. This approach is justified on three grounds: (i) K is derived from postulating that information is finite and knowledge is information compression; (ii) K is compatible and convertible to ordinary measures of effect size and algorithmic complexity; (iii) K is physically interpretable as a measure of entropic efficiency. Moreover, the K function has useful properties that support its potential as a measure of knowledge. Examples given to illustrate the possible uses of K include: the knowledge value of proving Fermat's last theorem; the accuracy of measurements of the mass of the electron; the half life of predictions of solar eclipses; the usefulness of evolutionary models of reproductive skew; the significance of gender differences in personality; the sources of irreproducibility in psychology; the impact of scientific misconduct and questionable research practices; the knowledge value of astrology. Furthermore, measures derived from K may complement ordinary meta-analysis and may give rise to a universal classification of sciences and pseudosciences. Simple and memorable mathematical formulae that summarize the theory's key results may find practical uses in meta-research, philosophy and research policy.
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It is commonly hypothesized that scientists are more likely to engage in data falsification and fabrication when they are subject to pressures to publish, when they are not restrained by forms of social control, when they work in countries lacking policies to tackle scientific misconduct, and when they are male. Evidence to test these hypotheses, however, is inconclusive due to the difficulties of obtaining unbiased data. Here we report a pre-registered test of these four hypotheses, conducted on papers that were identified in a previous study as containing problematic image duplications through a systematic screening of the journal PLoS ONE. Image duplications were classified into three categories based on their complexity, with category 1 being most likely to reflect unintentional error and category 3 being most likely to reflect intentional fabrication. We tested multiple parameters connected to the hypotheses above with a matched-control paradigm, by collecting two controls for each paper containing duplications. Category 1 duplications were mostly not associated with any of the parameters tested, as was predicted based on the assumption that these duplications were mostly not due to misconduct. Categories 2 and 3, however, exhibited numerous statistically significant associations. Results of univariable and multivariable analyses support the hypotheses that academic culture, peer control, cash-based publication incentives and national misconduct policies might affect scientific integrity. No clear support was found for the "pressures to publish" hypothesis. Female authors were found to be equally likely to publish duplicated images compared to males. Country-level parameters generally exhibited stronger effects than individual-level parameters, because developing countries were significantly more likely to produce problematic image duplications. This suggests that promoting good research practices in all countries should be a priority for the international research integrity agenda.
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Intención , Edición , Mala Conducta Científica/ética , Mala Conducta Científica/psicología , Mala Conducta Científica/estadística & datos numéricos , Países Desarrollados , Países en Desarrollo , Femenino , Humanos , Masculino , Análisis por Apareamiento , Publicaciones Periódicas como Asunto , Prevalencia , Riesgo , Mala Conducta Científica/legislación & jurisprudencia , Factores Sexuales , Control Social FormalRESUMEN
Efforts to improve the reproducibility and integrity of science are typically justified by a narrative of crisis, according to which most published results are unreliable due to growing problems with research and publication practices. This article provides an overview of recent evidence suggesting that this narrative is mistaken, and argues that a narrative of epochal changes and empowerment of scientists would be more accurate, inspiring, and compelling.
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OBJECTIVES: To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes. DESIGN: Survey of published RCTs. SETTING: PubMed/Medline. ELIGIBILITY CRITERIA: RCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals. MAIN OUTCOME MEASURE: The primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described. RESULTS: 37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups. CONCLUSIONS: Data availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data. TRIAL REGISTRATION: Open Science Framework osf.io/c4zke.
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Difusión de la Información , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Exactitud de los Datos , HumanosRESUMEN
Retractions solicited by authors following the discovery of an unintentional error-what we henceforth call a "self-retraction"-are a new phenomenon of growing importance, about which very little is known. Here we present results of a small qualitative study aimed at gaining preliminary insights about circumstances, motivations and beliefs that accompanied the experience of a self-retraction. We identified retraction notes that unambiguously reported an honest error and that had been published between the years 2010 and 2015. We limited our sample to retractions with at least one co-author based in the Netherlands, Belgium, United Kingdom, Germany or a Scandinavian country, and we invited these authors to a semi-structured interview. Fourteen authors accepted our invitation. Contrary to our initial assumptions, most of our interviewees had not originally intended to retract their paper. They had contacted the journal to request a correction and the decision to retract had been made by journal editors. All interviewees reported that having to retract their own publication made them concerned for their scientific reputation and career, often causing considerable stress and anxiety. Interviewees also encountered difficulties in communicating with the journal and recalled other procedural issues that had unnecessarily slowed down the process of self-retraction. Intriguingly, however, all interviewees reported how, contrary to their own expectations, the self-retraction had brought no damage to their reputation and in some cases had actually improved it. We also examined the ethical motivations that interviewees ascribed, retrospectively, to their actions and found that such motivations included a combination of moral and prudential (i.e. pragmatic) considerations. These preliminary results suggest that scientists would welcome innovations to facilitate the process of self-retraction.