scholarly journals Impact of peer review on discussion of study limitations and strength of claims in randomized trial reports: a before and after study

Author(s):  
Kerem Keserlioglu ◽  
Halil Kilicoglu ◽  
Gerben ter Riet

Abstract Background In their research reports, scientists are expected to discuss limitations that their studies have. Previous research showed that often, such discussion is absent. Also, many journals emphasize the importance of avoiding overstatement of claims. We wanted to see to what extent editorial handling and peer review affects self-acknowledgment of limitations and hedging of claims. Methods Using software that automatically detects limitation-acknowledging sentences and calculates the level of hedging in sentences, we compared the submitted manuscripts and their ultimate publications of all randomized trials published in 2015 in 27 BioMed Central (BMC) journals and BMJ Open. We used mixed linear and logistic regression models, accounting for clustering of manuscript-publication pairs within journals, to quantify before-after changes in the mean numbers of limitation-acknowledging sentences, in the probability that a manuscript with zero self-acknowledged limitations ended up as a publication with at least one and in hedging scores. Results Four hundred forty-six manuscript-publication pairs were analyzed. The median number of manuscripts per journal was 10.5 (interquartile range 6–18). The average number of distinct limitation sentences increased by 1.39 (95% CI 1.09–1.76), from 2.48 in manuscripts to 3.87 in publications. Two hundred two manuscripts (45.3%) did not mention any limitations. Sixty-three (31%, 95% CI 25–38) of these mentioned at least one after peer review. Changes in mean hedging scores were negligible. Conclusions Our findings support the idea that editorial handling and peer review lead to more self-acknowledgment of study limitations, but not to changes in linguistic nuance.

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Roberto Pecoits-Filho ◽  
Daniel Muenz ◽  
K P McCullough ◽  
Johannes Duttlinger ◽  
Viviane Calice-Siva ◽  
...  

Abstract Background and Aims Hyperkalemia (HK) (serum K>5.0 mEq/L) is a chronic condition in patients with chronic kidney disease (CKD) associated with high morbidity and mortality, and it is a frequent reasons for renin angiotensin aldosterone inhibition (RAASi) discontinuation. Patiromer is a non-absorbed, sodium-free, K+ binder that has been shown to reduce serum K+ in patients with HK, and thereby enable RAASi therapy, which is supported by randomized trial evidence. The description of patiromer utilization in patients with moderate to advanced CKD in the real-world setting in Europe is lacking. The objective of this analysis was to describe predictors of patiromer initiation and time to discontinuation among CKD patients using contemporary (April 2018-October 2020) data from German participants in CKD Outcomes and Practice Patterns Study (CKDopps). Method We identified 136 patiromer users (116 with matching K measurement) during the observation period. Patients with eGFR <60ml/min/1.73m2 and a serum potassium ≥4mEq/L who never initiated patiromer during the follow up were used as a comparison. We used the most recent lab and drug use information available within the 6-month period prior to baseline, which was defined as either first use of patiromer, April 1, 2018, or entry into the PDOPPS study. The median time between the most recent K+ measurement and baseline was 45 days for non-patiromer users and 4 days for patiromer users. Logistic regression models were used to test associations between patient factors and whether the patient was in the patiromer initiation group or the comparison group. Time on patiromer was estimated using a Kaplan-Meier curve, censoring for death, dialysis, transplantation, or loss of follow-up. Results Patiromer was prescribed to ≥2 patients in 11 clinics, one patient in 19 clinics, and zero patients in 57 clinics. Patients prescribed patiromer had lower eGFR (23.2 [15.8, 28.6] vs 36.9 [27.7, 46.3]ml/min) and higher serum K levels (5.6 [5.4, 6.1] vs 4.6 [4.3, 5.0]ml/min). There were no major differences according to patiromer use in other demographic, clinical, and biochemical characteristics. Despite the differences in serum K, use of RAAS inhibitors was similar in patiromer users (83%) versus non-users (80%). Thirty three percent of patiromer users were prescribed polystyrene sulfonate (SPS) before patiromer initiation. In a multiple logistic regression models (including serum K, CKD stage, gender, age, prescription of RAASi, diabetes, coronary artery disease, heart failure), patiromer use was strongly associated more advanced CKD stage (independently of high serum K), with odds ratios of initiation >3 for CKD stage 4 or 5 versus CKD stage 3. Among new users, 90% of patients had active prescription at 30 days and about one-half had active prescription at one year (Figure). Conclusion The main predictors of Patiromer initiation were advanced CKD stage and hyperkalemia. Treatment decisions did not appear to be based on other patient or clinical characteristics. Patiromer was often prescribed to patients already receiving alternative HK treatment (SPS), suggesting use for chronic hyperkalemia rather than response to acute event. Further analysis with a larger population and measurements of K+ before and after patiromer initiation may improve the understanding of its pharmacoutilization in moderate to advanced CKD.


2020 ◽  
Vol 93 (1111) ◽  
pp. 20190827 ◽  
Author(s):  
Han Na Lee ◽  
Jung Im Kim ◽  
So Youn Shin ◽  
Dae Hyun Kim ◽  
Chanwoo Kim ◽  
...  

Objective: To assess the accuracy of a combination of CT texture analysis (CTTA) and nodal axial ratio to detect metastatic lymph nodes (LNs) in esophageal squamous cell carcinoma (ESCC). Methods: The contrast-enhanced chest CT images of 78 LNs (40 metastasis, 38 benign) from 38 patients with ESCC were retrospectively analyzed. Nodal axial ratios (short-axis/long-axis diameter) were calculated. CCTA parameters (kurtosis, entropy, skewness) were extracted using commercial software (TexRAD) with fine, medium, and coarse spatial filters. Combinations of significant texture features and nodal axial ratios were entered as predictors in logistic regression models to differentiate metastatic from benign LNs, and the performance of the logistic regression models was analyzed using the area under the receiver operating characteristic curve (AUROC). Results: The mean axial ratio of metastatic LNs was significantly higher than that of benign LNs (0.81 ± 0.2 vs 0.71 ± 0.1, p = 0.005; sensitivity 82.5%, specificity 47.4%); namely, significantly more round than benign. The mean values of the entropy (all filters) and kurtosis (fine and medium) of metastatic LNs were significantly higher than those of benign LNs (all, p < 0.05). Medium entropy showed the best performance in the AUROC analysis with 0.802 (p < 0.001; sensitivity 85.0%, specificity 63.2%). A binary logistic regression analysis combining the nodal axial ratio, fine entropy, and fine kurtosis identified metastatic LNs with 87.5% sensitivity and 65.8% specificity (AUROC = 0.855, p < 0.001). Conclusion: The combination of CTTA features and the axial ratio of LNs has the potential to differentiate metastatic from benign LNs and improves the sensitivity for detection of LN metastases in ESCC. Advances in knowledge: The combination of CTTA and nodal axial ratio has improved CT sensitivity (up to 87.5%) for the diagnosis of metastatic LNs in esophageal cancer.


Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1614 ◽  
Author(s):  
Yingying Wang ◽  
Yonggen Jiang ◽  
Na Wang ◽  
Meiying Zhu ◽  
Xing Liu ◽  
...  

Objective: Obesity and homocysteine (Hcy) are two important risk factors for cardiovascular disease (CVD). However, evidence on the association between obesity and Hcy concentration was conflicting. The aim of our study is to explore the associations of general and central obesity with hyperhomocysteinemia (HHcy) in middle-aged women. Methods: The current analysis was based on data from 11,007 women aged 40–60 years. Height, weight, and waist circumference (WC) were measured and serum homocysteine was determined. Multiple logistic regression models were used to assess the associations of the risk of hyperhomocysteinemia (HHcy, Hcy > 15 μmol/L) with BMI and WC. Results: 13.71% women had HHcy. The prevalences of BMI-based general obesity and WC-based central obesity were 11.17% and 22.88%, respectively. Compared with non-obese women, the mean serum Hcy concentration was significantly higher in WC-based central obese women (p = 0.002), but not in BMI-based general obese women (p > 0.05). In the multiple logistic regression models, central obesity was positively related to the risk of HHcy (OR = 1.30, 95% CI = 1.10 to 1.52), while general obesity was inversely related to the risk of HHcy (OR = 0.82, 95% CI = 0.72 to 0.93 and OR = 0.71, 95% CI = 0.57 to 0.89). Conclusions: Central obesity was positively related to the risk of HHcy, while general obesity was negatively related. Menopause showed no effect modification on these associations.


2018 ◽  
Vol 31 (1) ◽  
pp. 41-51 ◽  
Author(s):  
Yen-Han Lee ◽  
Timothy Chiang ◽  
Ching-Ti Liu

Purpose China launched a comprehensive health reform in 2009 to improve healthcare quality. Because preventive care utilization in China has not been frequently discussed, the purpose of this paper is to focus on the association between education level and preventive care before and after the initiation of the reform. Education has been referred to as the best health outcome indicator and China’s educational reform has been progressive, such as the health reform. Design/methodology/approach The authors analyzed data from four China Health and Nutrition Surveys (CHNS): 2004 (n=9,617); 2006 (n=9,527); 2009 (n=9,873); and 2011 (n=9,430). Variables were selected based on Andersen’s healthcare utilization model (predisposing, enabling and need factors). Multivariable logistic regression models, odds ratios (ORs) and 95 percent confidence intervals (95 percent CI) were conducted and reported. Findings In the adjusted multivariable logistic regression models, the authors found that general education was associated (p<0.05) with access to preventive care in 2004, 2009 and 2011, but not in 2006. Individuals with higher education had higher ORs for utilizing preventive care, compared with lower education (primary school education or none). Practical implications Policy implications include providing educational protocols regarding preventive care’s significance to residents educated at lower level schools, especially younger individuals. Originality/value To the authors’ knowledge, this is the first comparative assessment on education level and preventive care utilization before and after the implementation of the Chinese health reform.


Objective: While the use of intraoperative laser angiography (SPY) is increasing in mastectomy patients, its impact in the operating room to change the type of reconstruction performed has not been well described. The purpose of this study is to investigate whether SPY angiography influences post-mastectomy reconstruction decisions and outcomes. Methods and materials: A retrospective analysis of mastectomy patients with reconstruction at a single institution was performed from 2015-2017.All patients underwent intraoperative SPY after mastectomy but prior to reconstruction. SPY results were defined as ‘good’, ‘questionable’, ‘bad’, or ‘had skin excised’. Complications within 60 days of surgery were compared between those whose SPY results did not change the type of reconstruction done versus those who did. Preoperative and intraoperative variables were entered into multivariable logistic regression models if significant at the univariate level. A p-value <0.05 was considered significant. Results: 267 mastectomies were identified, 42 underwent a change in the type of planned reconstruction due to intraoperative SPY results. Of the 42 breasts that underwent a change in reconstruction, 6 had a ‘good’ SPY result, 10 ‘questionable’, 25 ‘bad’, and 2 ‘had areas excised’ (p<0.01). After multivariable analysis, predictors of skin necrosis included patients with ‘questionable’ SPY results (p<0.01, OR: 8.1, 95%CI: 2.06 – 32.2) and smokers (p<0.01, OR:5.7, 95%CI: 1.5 – 21.2). Predictors of any complication included a change in reconstruction (p<0.05, OR:4.5, 95%CI: 1.4-14.9) and ‘questionable’ SPY result (p<0.01, OR: 4.4, 95%CI: 1.6-14.9). Conclusion: SPY angiography results strongly influence intraoperative surgical decisions regarding the type of reconstruction performed. Patients most at risk for flap necrosis and complication post-mastectomy are those with questionable SPY results.


Author(s):  
Mike Wenzel ◽  
Felix Preisser ◽  
Matthias Mueller ◽  
Lena H. Theissen ◽  
Maria N. Welte ◽  
...  

Abstract Purpose To test the effect of anatomic variants of the prostatic apex overlapping the membranous urethra (Lee type classification), as well as median urethral sphincter length (USL) in preoperative multiparametric magnetic resonance imaging (mpMRI) on the very early continence in open (ORP) and robotic-assisted radical prostatectomy (RARP) patients. Methods In 128 consecutive patients (01/2018–12/2019), USL and the prostatic apex classified according to Lee types A–D in mpMRI prior to ORP or RARP were retrospectively analyzed. Uni- and multivariable logistic regression models were used to identify anatomic characteristics for very early continence rates, defined as urine loss of ≤ 1 g in the PAD-test. Results Of 128 patients with mpMRI prior to surgery, 76 (59.4%) underwent RARP vs. 52 (40.6%) ORP. In total, median USL was 15, 15 and 10 mm in the sagittal, coronal and axial dimensions. After stratification according to very early continence in the PAD-test (≤ 1 g vs. > 1 g), continent patients had significantly more frequently Lee type D (71.4 vs. 54.4%) and C (14.3 vs. 7.6%, p = 0.03). In multivariable logistic regression models, the sagittal median USL (odds ratio [OR] 1.03) and Lee type C (OR: 7.0) and D (OR: 4.9) were independent predictors for achieving very early continence in the PAD-test. Conclusion Patients’ individual anatomical characteristics in mpMRI prior to radical prostatectomy can be used to predict very early continence. Lee type C and D suggest being the most favorable anatomical characteristics. Moreover, longer sagittal median USL in mpMRI seems to improve very early continence rates.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A305-A306
Author(s):  
Jesse Moore ◽  
Ellita Williams ◽  
Collin Popp ◽  
Anthony Briggs ◽  
Judite Blanc ◽  
...  

Abstract Introduction Literature shows that exercise moderates the relationship between sleep and emotional distress (ED.) However, it is unclear whether different types of exercise, such as aerobic and strengthening, affect this relationship differently. We investigated the moderating role of two types of exercise (aerobic and strengthening) regarding the relationship between ED and sleep. Methods Our analysis was based on data from 2018 National Health Interview Survey (NHIS), a nationally representative study in which 2,814 participants provided all data. Participants were asked 1) “how many days they woke up feeling rested over the past week”, 2) the Kessler 6 scale to determine ED (a score &gt;13 indicates ED), and 3) the average frequency of strengthening or aerobic exercise per week. Logistic regression analyses were performed to determine if the reported days of waking up rested predicted level of ED. We then investigated whether strengthening or aerobic exercise differentially moderated this relationship. Covariates such as age and sex were adjusted in the logistic regression models. Logistic regression analyses were performed to determine if subjective reporting of restful sleep predicted level of ED. We investigated whether strengthening exercise or aerobic exercise differentially moderated this relationship. Covariates such as age and sex were adjusted in the logistic regression models. Results On average, participants reported 4.41 restful nights of sleep (SD =2.41), 3.43 strengthening activities (SD = 3.19,) and 8.47 aerobic activities a week (SD=5.91.) We found a significant association between days over the past week reporting waking up feeling rested and ED outcome according to K6, Χ2(1) = -741, p= &lt;.001. The odds ratio signified a decrease of 52% in ED scores for each unit of restful sleep (OR = .48, (95% CI = .33, .65) p=&lt;.001.) In the logistic regression model with moderation, aerobic exercise had a significant moderation effect, Χ2(1) = .03, p=.04, but strengthening exercise did not. Conclusion We found that restful sleep predicted reduction in ED scores. Aerobic exercise moderated this relationship, while strengthening exercise did not. Further research should investigate the longitudinal effects of exercise type on the relationship between restful sleep and ED. Support (if any) NIH (K07AG052685, R01MD007716, K01HL135452, R01HL152453)


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