When numbers don’t satisfy science: multicenter studies and digital protocols

SummaryThe endovascular treatment of abdominal aortic aneurysms has generated a great deal of interest since the early 1990s, and many different devices are currently available. The procedure of endovascular repair has been evaluated in many institutions and the different devices are compared. The first results were encouraging, but complications like endoleak, dislocation or thrombosis of the graft occurred. By the available devices the stent application is only promising, if the known exclusion criteria are strictly respected. Therefore a careful preinterventional assessment of the patient by different imaging modalities is necessary. As the available results up to now are preliminary and the durability of the devices has to be controlled, multicenter studies are required to improve the devices and observe their long- term success in the exclusion of abdominal aortic aneurysms.

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The Management of Post-Tonsillectomy Morbidity in Patients With Sleep Apnoea

Revista de Chimie ◽

10.37358/rc.19.10.3738 ◽

2019 ◽

Vol 70 (10) ◽

pp. 3738-3740

Keyword(s):

Day Surgery ◽

Sleep Apnoea ◽

Integrative Approach ◽

Multicenter Studies ◽

Therapeutic Modalities ◽

Advantages And Disadvantages ◽

Obstructive Sleep ◽

Wide Range ◽

The Impact ◽

Surgery Center

The Tonsillectomy in children or adults is an intervention commonly encountered in the ENT (Ear Nose and Throat) and Head and Neck surgeon practice. The current tendency is to perform this type of surgery in major ambulatory surgery centers. Two objectives are thus pursued: first of all, the increase of the patient quality of life through the reintegration into the family as quickly as possible and secondly, the expenses associated with continuous hospitalization are reduced. Any tertiary (multidisciplinary) sleep center must ensure the complete diagnosis and treatment (including surgery) of sleep respiratory disorders. Under these conditions the selection of patients and especially the implementation of the specific protocols in order to control the postoperative complications it becomes essential. The present paper describes our experience of tonsillectomy as treatment for selected patients with chronic rhonchopathy (snoring) and mild to moderate obstructive sleep apnoea. It was presented the impact of antibiotics protocols in reducing the main morbid outcomes following tonsillectomy, in our day surgery center. The obtained results can also be a prerequisite for the integrative approach of the patients with sleep apnoea who were recommended surgical treatment. Considering the wide range of therapeutic modalities used in sleep apnoea, each with its specific advantages and disadvantages, more extensive and multicenter studies are needed. Keywords: post-tonsillectomy morbidity, day surgery center, sleep disorders

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Functional outcomes of patients with short-segment Hirschsprung disease after transanal endorectal pull-through

BMC Gastroenterology ◽

10.1186/s12876-021-01668-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Gunadi ◽

Gabriele Ivana ◽

Desyifa Annisa Mursalin ◽

Ririd Tri Pitaka ◽

Muhammad Wildan Zain ◽

...

Keyword(s):

Functional Outcomes ◽

Hirschsprung Disease ◽

Treatment Method ◽

Strongly Correlated ◽

Short Segment ◽

Multicenter Studies ◽

Operative Complications ◽

Pull Through ◽

Larger Sample ◽

Post Operative Complications

Abstract Background Transanal endorectal pull-through (TEPT) is considered the most preferable treatment method for Hirschsprung disease (HSCR) since it is less invasive and has fewer morbidities than transabdominal pull-through. Here, functional outcomes in short-segment HSCR patients after TEPT were assessed and associated with the prognostic factors. Methods Krickenbeck classification was used to assess the functional outcomes in patients with HSCR after TEPT surgery at our institution from 2012 to 2020. Results Fifty patients were involved in this study. Voluntary bowel movement (VBM) was achieved in 82% of subjects. Nine (18%) subjects had soiling grade 1, while two (4%) and two (4%) patients suffered constipation that was manageable with diet and laxative agents, respectively. Patients who underwent TEPT at ≥ 4 years old tended to have soiling more than patients who underwent TEPT at < 4 years old (OR = 16.47 [95% CI 0.9–301.61]; p = 0.06), whereas patients with post-operative complications had 10.5-fold higher risk for constipation than patients without post-operative complications (p = 0.037; 95% CI 1.15–95.92). Multivariate analysis showed male sex was significantly associated with VBM (OR = 9.25 [95% CI 1.34–63.77]; p = 0.024), while post-operative complications were strongly correlated with constipation (OR = 10 [95% CI 1.09–91.44]; p = 0.04). Conclusions The functional outcomes of HSCR patients after TEPT in our institution are considered relatively good. Moreover, the VBM, soiling, and constipation risk after TEPT might be affected by sex, age at TEPT performed, and post-operative complications, respectively, while the age at TEPT performed might not be associated with functional outcomes. Further multicenter studies with a larger sample size are necessary to clarify and confirm our findings.

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Patterns of infections and antimicrobial drugs’ prescribing among pregnant women in Saudi Arabia: a cross sectional study

Journal of Pharmaceutical Policy and Practice ◽

10.1186/s40545-020-00292-6 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Mohamed A. Baraka ◽

Lina Hussain AlLehaibi ◽

Hind Nasser AlSuwaidan ◽

Duaa Alsulaiman ◽

Md. Ashraful Islam ◽

...

Keyword(s):

Saudi Arabia ◽

Pregnant Women ◽

Antimicrobial Agents ◽

Cross Sectional Study ◽

Maternal Complications ◽

Multicenter Studies ◽

Antimicrobial Drugs ◽

Cross Sectional ◽

Categorization System ◽

Tract Infections

Abstract Background Antimicrobial agents are among the most commonly prescribed drugs in pregnancy due to the increased susceptibility to infections during pregnancy. Antimicrobials can contribute to different maternal complications. Therefore, it is important to study their patterns in prescription and utilization. The data regarding this issue is scarce in Saudi Arabia. Therefore, the aim of this study is to generate data on the antimicrobial agents that are most commonly prescribed during pregnancy as well as their indications and safety. Methods This is a retrospective study focusing on pregnant women with a known antimicrobial use at Johns Hopkins Aramco Healthcare (JHAH). The sample included 344 pregnant women with a total of 688 antimicrobial agents prescribed. Data was collected on the proportion of pregnant women who received antimicrobial agents and on the drug safety during pregnancy using the risk categorization system of the U.S. Food and Drug Administration (FDA). Results The results showed that urinary tract infections (UTIs) were the most reported (59%) infectious diseases. Around 48% of pregnant women received antimicrobial medications at some point during pregnancy. The top two antimicrobial agents based on prescription frequency were B-lactams (44.6%) and azole anti-fungals (30%). The prescribed drugs in the study were found to be from classes B, C and D under the FDA risk classification system. Conclusion The study revealed a high proportion of antimicrobials prescribed during pregnancy that might pose risks to mothers and their fetuses. Future multicenter studies are warranted to evaluate the rational prescription of antimicrobial medications during pregnancy.

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TIRADS, SRE and SWE in INDETERMINATE thyroid nodule characterization: Which has better diagnostic performance?

La radiologia medica ◽

10.1007/s11547-021-01349-5 ◽

2021 ◽

Author(s):

Ilaria Celletti ◽

Daniele Fresilli ◽

Corrado De Vito ◽

Marco Bononi ◽

Sara Cardaccio ◽

...

Keyword(s):

Thyroid Nodule ◽

Preoperative Staging ◽

Shear Wave Elastography ◽

Roc Curves ◽

Strain Ratio ◽

Multicenter Studies ◽

Increased Sensitivity ◽

Bonferroni Test ◽

Indeterminate Cytology ◽

Sensitivity Specificity

Abstract Purpose To assess Strain Ratio (SRE) and Shear Wave Elastography (SWE) accuracy alone and with TIRADS classification, for the risk stratification of indeterminate thyroid nodules. Materials and methods 128 Patients with 128 indeterminate nodules candidates for thyroidectomy underwent preoperative staging neck ultrasound and were classified according to K-TIRADS score. After TIRADS evaluation, semi-quantitative (SRE) and quantitative (SWE expressed in kPa) elastosonography were performed and relative diagnostic performances, alone and in combination, were compared through ROC curves analysis. In order to maximize the SRE and SWE sensitivity and specificity, their cut-off values were calculated using the Liu test. Bonferroni test was used to evaluate statistically significant differences with a p value < 0.05. Results Sensitivity, specificity, PPV and NPV were, respectively, 71.4%, 82.4%, 62.5%, 87.5% for K-TIRADS baseline US, 85.7%, 94.1%, 85.7%, 94.1% for SRE and 57.1%, 79.4%, 53.3%, 81.8% for SWE (kPa expressed). SRE evaluation showed the best diagnostic accuracy compared to the SWE (kPa expressed) (p < 0.05) and to the K-TIRADS (p > 0.05). The association of SRE with conventional ultrasound with K-TIRADS score increased sensitivity (92.9% vs 71.4%) but decreased the specificity than conventional US alone (76.5% vs 82.4%). Conclusion Strain Elastosonography can be associated with K-TIRADS US examination in the thyroid nodule characterization with indeterminate cytology; in fact, adding the SRE to K-TIRADS assessment significantly increases its sensitivity and negative predictive value. However, further multicenter studies on larger population are warranted.

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Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program

Pituitary ◽

10.1007/s11102-021-01138-3 ◽

2021 ◽

Author(s):

Beverly M. K. Biller ◽

Charlotte Höybye ◽

Paul Carroll ◽

Murray B. Gordon ◽

Anna Camilla Birkegård ◽

...

Keyword(s):

Growth Hormone ◽

Replacement Therapy ◽

Hormone Replacement ◽

Outcome Study ◽

Real World Data ◽

Multicenter Studies ◽

Clinical Trial Registration ◽

Normal Delivery ◽

Growth Hormone Replacement Therapy ◽

Gh Replacement

Abstract Purpose Data on the safety of growth hormone (GH) replacement therapy during pregnancy are limited. We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program. Methods Pregnancy data were pooled from NordiNet® IOS and the ANSWER Program. Data were collected during routine clinic visits by participating physicians using a web-based system. Patients exposed to GH replacement therapy during pregnancy were included in the analysis. Results The study population included 40 female patients with typical causes of adult GH deficiency (GHD). Overall, there were 54 pregnancies. Of these, 47 were exposed to GH between conception and delivery. In 48.9% of pregnancies exposed to GH, the dose was > 0.6 mg/day. GH was continued past conception and then stopped during the first, second, and third trimester, in 27.7%, 17.0%, and 2.1% of pregnancies, respectively. In 29.8%, GH was continued throughout pregnancy, with an unchanged dose in most cases. Of the 47 GH-exposed pregnancies, 37 (78.7%) progressed to normal delivery. There were three adverse events reported in two pregnancies. Conclusion These real-world data suggest that there were no new safety signals related to GH exposure in women with GHD during pregnancy. These results are consistent with findings from previous studies reporting data in pregnancies exposed to GH at conception or throughout pregnancy. This observational study in additional pregnancies provides further evidence that GH exposure does not adversely affect pregnancy outcome. Clinical trial registration: ClinicalTrials.gov NCT00960128 (date of registration: August 13, 2009) and NCT01009905 (date of registration: November 5, 2009).

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Safety of growth hormone (GH) treatment in GH deficient children and adults treated for cancer and non-malignant intracranial tumors—a review of research and clinical practice

Pituitary ◽

10.1007/s11102-021-01173-0 ◽

2021 ◽

Author(s):

Margaret C. S. Boguszewski ◽

Adriane A. Cardoso-Demartini ◽

Cesar Luiz Boguszewski ◽

Wassim Chemaitilly ◽

Claire E. Higham ◽

...

Keyword(s):

Growth Hormone ◽

Clinical Practice ◽

Brain Tumors ◽

Cancer Recurrence ◽

Childhood Cancer Survivors ◽

Multicenter Studies ◽

Gh Treatment ◽

Secondary Neoplasms ◽

Gh Replacement

AbstractIndividuals surviving cancer and brain tumors may experience growth hormone (GH) deficiency as a result of tumor growth, surgical resection and/or radiotherapy involving the hypothalamic-pituitary region. Given the pro-mitogenic and anti-apoptotic properties of GH and insulin-like growth factor-I, the safety of GH replacement in this population has raised hypothetical safety concerns that have been debated for decades. Data from multicenter studies with extended follow-up have generally not found significant associations between GH replacement and cancer recurrence or mortality from cancer among childhood cancer survivors. Potential associations with secondary neoplasms, especially solid tumors, have been reported, although this risk appears to decline with longer follow-up. Data from survivors of pediatric or adult cancers who are treated with GH during adulthood are scarce, and the risk versus benefit profile of GH replacement of this population remains unclear. Studies pertaining to the safety of GH replacement in individuals treated for nonmalignant brain tumors, including craniopharyngioma and non-functioning pituitary adenoma, have generally been reassuring with regards to the risk of tumor recurrence. The present review offers a summary of the most current medical literature regarding GH treatment of patients who have survived cancer and brain tumors, with the emphasis on areas where active research is required and where consensus on clinical practice is lacking.

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Predictive impact of PVL assessments on clinical outcomes in patients undergoing TAVR

European Heart Journal ◽

10.1093/ehjci/ehaa946.2581 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

K Matsushita ◽

B Marchandot ◽

M Kibler ◽

C Sato ◽

J Heger ◽

...

Keyword(s):

Clinical Outcomes ◽

Cox Regression ◽

Adenosine Diphosphate ◽

Rank Test ◽

Multicenter Studies ◽

Cox Regression Analysis ◽

Paravalvular Leakage ◽

Transcatheter Aortic Valve ◽

Log Rank Test ◽

Cerebrovascular Events

Abstract Introduction Paravalvular leakage (PVL) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality. In clinical practice, determining PVL severity after TAVR remains challenging and often requires multiparametric assessment. Purpose This study sought to evaluate the respective value of various modalities of PVL assessments, including transthoracic echocardiography (TTE), cine-angiography, aortic regurgitation index (ARI), and closure time with adenosine diphosphate (CT-ADP), in the prediction of adverse clinical outcomes. Methods We included 1044 patients from our prospective TAVR registry between February 2010 and May 2019. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause death, myocardial infarction, stroke, and heart failure hospitalization within 1-year. Established cutoff values of ARI (<25) and CT-ADP (>180 sec) were used to assess the presence of PVL after TAVR. Results Moderate to severe PVL occurred in 14.2% and 5.2% of patients as measured by TTE and angiography. The rate of patients with ARI <25 and CT-ADP >180 sec were 36.5% and 24.9%, respectively. Among the four modalities, PVL evaluated by angiography predicted poorer clinical outcomes (Log rank test; p=0.001), whereas TTE, ARI <25, and CT-ADP >180 sec were not associated with 1-year MACCE. By multivariate Cox regression analysis, moderate to severe PVL by angiography was an independent predictor of 1-year MACCE (hazard ratio: 1.96; 95% confidence interval: 1.22–3.00; p=0.007). Conclusions Paravalvular leakage measured by angiography was evidenced as the most meaningful modality in the prediction of adverse clinical outcomes. Future multicenter studies are warranted to ensure these findings in the current TAVR era. Figure 1 Funding Acknowledgement Type of funding source: None

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Multicenter Clinical and Molecular Epidemiological Analysis of Bacteremia Due to Carbapenem-Resistant Enterobacteriaceae (CRE) in the CRE Epicenter of the United States

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02349-16 ◽

2017 ◽

Vol 61 (4) ◽

Cited By ~ 98

Author(s):

Michael J. Satlin ◽

Liang Chen ◽

Gopi Patel ◽

Angela Gomez-Simmonds ◽

Gregory Weston ◽

...

Keyword(s):

New York ◽

Empirical Therapy ◽

Carbapenem Resistance ◽

The United States ◽

Resistance Mechanisms ◽

Rapid Diagnostics ◽

Multicenter Studies ◽

Content Type ◽

Medical Centers ◽

Carbapenem Resistant

ABSTRACT Although the New York/New Jersey (NY/NJ) area is an epicenter for carbapenem-resistant Enterobacteriaceae (CRE), there are few multicenter studies of CRE from this region. We characterized patients with CRE bacteremia in 2013 at eight NY/NJ medical centers and determined the prevalence of carbapenem resistance among Enterobacteriaceae bloodstream isolates and CRE resistance mechanisms, genetic backgrounds, capsular types (cps), and antimicrobial susceptibilities. Of 121 patients with CRE bacteremia, 50% had cancer or had undergone transplantation. The prevalences of carbapenem resistance among Klebsiella pneumoniae, Enterobacter spp., and Escherichia coli bacteremias were 9.7%, 2.2%, and 0.1%, respectively. Ninety percent of CRE were K. pneumoniae and 92% produced K. pneumoniae carbapenemase (KPC-3, 48%; KPC-2, 44%). Two CRE produced NDM-1 and OXA-48 carbapenemases. Sequence type 258 (ST258) predominated among KPC-producing K. pneumoniae (KPC-Kp). The wzi154 allele, corresponding to cps-2, was present in 93% of KPC-3-Kp, whereas KPC-2-Kp had greater cps diversity. Ninety-nine percent of CRE were ceftazidime-avibactam (CAZ-AVI)-susceptible, although 42% of KPC-3-Kp had an CAZ-AVI MIC of ≥4/4 μg/ml. There was a median of 47 h from bacteremia onset until active antimicrobial therapy, 38% of patients had septic shock, and 49% died within 30 days. KPC-3-Kp bacteremia (adjusted odds ratio [aOR], 2.58; P = 0.045), cancer (aOR, 3.61, P = 0.01), and bacteremia onset in the intensive care unit (aOR, 3.79; P = 0.03) were independently associated with mortality. Active empirical therapy and combination therapy were not associated with survival. Despite a decade of experience with CRE, patients with CRE bacteremia have protracted delays in appropriate therapies and high mortality rates, highlighting the need for rapid diagnostics and evaluation of new therapeutics.

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A consensus approach toward the standardization of spinal stiffness measurement using a loaded rolling wheel device: results of a Delphi study

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04313-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Maliheh Hadizadeh ◽

Greg Kawchuk ◽

Simon French

Keyword(s):

Delphi Study ◽

Best Practice ◽

Standard Protocol ◽

Research Experience ◽

Multicenter Studies ◽

Stiffness Measurement ◽

Delphi Approach ◽

Spinal Stiffness ◽

Human Participants ◽

Rolling Wheel

Abstract Background Spinal stiffness assessment has the potential to become an important clinical measure. Various spinal stiffness-testing devices are available to help researchers objectively evaluate the spine and patient complaints. One of these is VerteTrack, a device capable of measuring posteroanterior displacement values over an entire spinal region. This study aimed to develop a best-practice protocol for evaluating spinal stiffness in human participants using VerteTrack. Methods Twenty-five individuals with research experience in measuring spinal stiffness, or who were trained in spinal stiffness measurement using the VerteTrack device, were invited to participate in this 3-Round Delphi study. Answers to open-ended questions in Round 1 were thematically analyzed and translated into statements about VerteTrack operation for spinal stiffness measurements. Participants then rated their level of agreement with these statements using a 5-point Likert scale in Rounds 2 and 3. A descriptive statistical analysis was performed. Consensus was achieved when at least 70% of the participants either strongly agreed, agreed, (or strongly disagreed, disagreed) to include a statement in the final protocol. Results Twenty participants completed Round 1 (80%). All these participants completed Rounds 2 and 3. In total, the pre-defined consensus threshold was reached for 67.2% (123/183) of statements after three rounds of surveys. From this, a best-practice protocol was created. Conclusions Using a Delphi approach, a consensus-based protocol for measuring spinal stiffness using the VerteTrack was developed. This standard protocol will help to improve the accuracy, efficiency, and safety of spinal stiffness measurements, facilitate the training of new operators, increase consistency of these measurements in multicenter studies, and provide the synergy and potential for data comparison between spine studies internationally. Although specific to VerteTrack, the resulting standard protocol could be modified for use with other devices designed to collect spinal stiffness measures.

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