Journal of Evidence‐Based Medicine最新文献

A scientific journal may reject a submitted manuscript for several reasons. For example, desk rejection occurs when a topic is addressed that does not fit a journal's aims. Or the submitted manuscript has insufficient methodological quality. Therefore, authors need to manage manuscript rejection as a normal part of the publication process. Because methodological quality is not the only reason for rejection, authors will typically submit a rejected manuscript to another journal. This allows research authors to maintain efficiency and avoid wasted effort.¹ Actually, not attempting to publish research material due to one journal's rejection can be considered a form of publication bias.²

The fate of rejected manuscripts has already been researched in different biomedical disciplines. However, the quality and characteristics of the studies assessing rejected manuscripts have not been performed. The aim of the present survey was to examine the characteristics of studies assessing the fate of rejected manuscript submissions in various biomedical disciplines and to provide manuscript rejection rates.

Studies assessing the fate of rejected manuscripts in different biomedical disciplines were included. Similar studies focused on other scientific disciplines were excluded. Only articles written in English were included. The PubMed, Scopus, and Web of Science Core Collection databases were searched on 12 May 2024, and articles published from the database's inception to the date of search were considered for inclusion. The following keywords and Boolean operators were applied in a search of the database: “rejected manuscript” OR “rejected manuscripts” OR “rejected articles” OR “rejected papers.” Additionally, the reference lists of the articles included were scrutinized for further potential studies to include (Section S1). We selected articles based on the eligibility criteria. Those not meeting these criteria were excluded, first in a title/abstract assessment and then in a full-text assessment (Sections S2–S4, Figure S1).

The reasons for exclusion were individually determined. When data on rejection rates were not reported, we calculated them by dividing the number of manuscripts submitted by the number of manuscripts rejected. The data were extracted into an Excel datasheet, and the included information is reported in Table 1. Study selection and data extraction were performed in duplicate for 10 studies. After good agreement (more than 80%), the remaining process was performed by one author (M.C.M.).³ Data were presented as frequencies and percentages and, when applicable, as means and medians.

A total of 36 studies meeting the eligibility criteria were found (Section S5). The most prevalent affiliation of the first author of the studies was the USA (n = 17, 47%), followed by Italy and Switzerland (each n = 3, 9%). The discipline of radiology

Two clinical trials (MITRA-FR and COAPT), which were set out to evaluate the effectiveness of adding percutaneous repair (PR) for patients with severe secondary mitral regurgitation (SMR), came to very different conclusions. The MITRA-FR showed no benefit of PR,¹ while the COAPT trial reported a dramatic improvement of clinical outcomes.² We reviewed the assessment of and response to the MITRA-FR and COAPT trials by key stakeholders, whether regulators and Health Technology Assessment (HTA) bodies, or authors of publications in medical journals.

Briefly, a systematic literature search was conducted to identify documents that met the following criteria: (1) licensing/reimbursement decisions, clinical guidelines, and academic papers from top medical journals; (2) published between September 2018 and December 2023; (3) dealing with the conflicting evidence from the two trials. A total of 53 studies meeting our inclusion criteria over the period among our selected sources (details methods and details could be accessed by contacting the authors), reflecting the major controversy resulting from the publication of the two trials. The majority were authored by clinicians (46 out of 53) while five (9%) were elaborated by health services managers/HTA bodies, and two (4%) by regulatory agencies.

The main factors highlighted as potential reasons for the conflicting results were differences in terms of patients’ echocardiographic characteristics (n = 52), the concurrent control therapy (64%), and the rate of interventional procedure success (43%). Less frequently, document authors explained the divergence in findings by focusing on the definition and measurement of outcomes (n = 9), or considering differences in the learning curve and/or the experience of operators (n = 8). Only one document (2%) mentioned the difference between industrial and academic support as a potential explanation for the discrepancy.

In 51% of cases (n = 27) (Table 1), authors were deemed to be in favor of the findings of COAPT when drawing conclusions while in 34% (n = 18) of the documents, conclusions were equivocal with authors accepting the unexplained heterogeneity in the findings. Less frequently, the conclusions were that effectiveness depended on contextual factors (n = 5), or were not clearly drawn (n = 3). None of the selected documents seemed to favor the findings of the MITRA-FR trial. All six official documents, either originating from policymakers, managers of health services, or regulators, supported the findings of COAPT.

Irrespective of their main conclusions, 26% (n = 14) of authors suggested further research to be conducted, either mentioning the ongoing RESHAPE-2 RCT as an additional source of evidence or advocating for an individual-patient data meta-analysis based on the two trials (n = 4). In 34 cases (64%), analyses were carri

Subclinical hypothyroidism (SCH) is characterized by an elevated thyroid-stimulating hormone (TSH) with normal thyroxine (T4) levels. The 2017 American Thyroid Association (ATA) recommends that an upper reference limit of 4.0 mIU/L should be used in the absence of pregnancy-specific TSH ranges.¹ It is well known that overt hypothyroidism exerts a profound effect on pregnancy outcomes; conflicting data have been reported regarding the association between SCH and the incidence of adverse pregnancy outcomes. To date, various observational studies have shown that SCH is associated with adverse pregnancy outcomes, including preterm delivery,² gestational diabetes,³ gestational hypertension, eclampsia,⁴ low birth weight, low Apgar score, and lower childhood IQ.^{5, 6} Additional studies have not demonstrated the association of adverse outcomes with SCH,^{7, 8} although the status of antithyroid peroxidase antibodies (TPOAbs) was not differentiated in these studies. Previous studies have shown higher impairment of positive TPOAbs (TPOAb⁺) on neurocognitive outcomes in offspring.⁹ The adverse impact of negative TPOAbs in gestational SCH (SCH-TPOAb⁻) on offspring development has not yet been identified.

No consensus has been demonstrated on the treatment of pregnant women with SCH-TPOAb⁻. The Endocrine Society recommends therapy in all pregnant women with SCH, irrespective of their TPOAb status.¹⁰ The 2017 ATA supports treatment for a specific subgroup of women with SCH who are TPOAb⁺ (SCH-TPOAb⁺) or TPOAb⁻ and possess TSH levels greater than 10 mU/L.¹ The application of levothyroxine (L-T4) treatment for SCH-TPOAb⁻ is somewhat ambiguous (TSH cutoff 4.0–10.0 mIU/L). Moreover, a limited number of studies have investigated the influence of the time frame on the treatment effect in SCH during pregnancy. Previously, it was reported from our group that standardized treatment should be used for SCH-TPOAb⁻ pregnant women prior to 8 gestational weeks; their TSH levels ranged from 4.0 to 10.0 mIU/L, which might significantly improve the intellectual development of the 2-year-old offspring.¹¹ It was hypothesized that the later treatment of patients with negative TPOAb and TSH levels between 4.0 and 10.0 mlU/L (4.0 mIU/L < TSH ≤ 10.0) would have greater adverse effects on the neurobehavioral development of their offspring.

To assess this hypothesis, electronic health records and abstracted clinical data from patients who were reviewed at the Second Affiliated Hospital of Wenzhou Medical University were retrieved from June 2016 to June 2019. Pregnant women were routinely screened at their first antenatal visit for thyroid function, s