bluuebunny/crossref_metadata_2025_split huggingface dataset:
The effects of promoting oral intake using the Kuchi-kara Taberu index, a comprehensive feeding assistant tool, in older pneumonia patients: a cluster randomized controlled trial
Authors: Shamoto Hiroshi , Koyama Tamami , Momosaki Ryo , Maeda Keisuke , Wakabayashi Hidetaka 
Published: January 2020

Abstract
Background
The multidisciplinary comprehensive care (MDCC) program promotes the improvement of oral intake for older patients. The Kuchi-kara Taberu (ingesting orally in Japanese, KT) index was developed to objectively assess patient conditions in the MDCC program. This trial examined the effects of the index in promoting oral intake in older patients with pneumonia.

Methods
A cluster randomized controlled trial was conducted in 10 local hospitals targeting older patients with pneumonia (≥65 years). Ten hospitals were allocated randomly to either the intervention or the control group. Both groups (each with five hospitals) received the MDCC program for oral feeding, which consisted of professional assessment, care, and treatment. The KT index was used by the intervention group, focusing on improving low score items. The primary outcome was determined using the Functional Oral Intake Scale (FOIS) at discharge or 1 month after admission.

Results
One hundred and twelve patients (46 women and 66 men) who participated from 10 hospitals, with a median age of 88 years (interquartile range [IQR], 80–91), were examined. The median FOIS level and the number of patients with oral intake (FOIS ≥ level 4) at discharge were 4 (IQR, 4–6) and 89 (79.5%), respectively. The duration of nil per os was 2 (IQR, 1–5) days. Clusters were not matched in the presence of Kuchi-kara Taberu Shiawase-wo Mamoru-kai-certified medical staff promoting oral intake in patients with dysphagia in each hospital. The median FOIS levels of 53 patients in the intervention group and 59 patients in the control group were 5 (IQR, 4–6) and 4 (IQR, 4–5), respectively, showing no statistically significant difference (P = 0.76). According to a multivariate analysis, the KT index had no positive effect on FOIS levels.

Conclusions
This trial was not able to demonstrate the usefulness of the KT index due to random assignment failure. However, both the intervention and control groups showed a high prevalence of oral intake (FOIS ≥ level 4) at discharge.

Trial registration
UMIN-Clinical Trial Registry, UMIN000025172, December 17, 2016.
Identification of subclinical tuberculosis in household contacts using exposure scores and contact investigations
Authors: Bekken Gry Klouman , Ritz Christian , Selvam Sumithra , Jesuraj Nelson , Hesseling Anneke C. , Doherty T. Mark , Grewal Harleen M. S. , Vaz Mario , Jenum Synne 
Published: January 2020

Abstract
Background
The goal of tuberculosis elimination put forward in the End TB Strategy prioritizes diagnosis and treatment of incipient and subclinical TB, recently defined by key stakeholders as “asymptomatic, early pre-clinical disease during which pathology evolves”. Regarded as indicative of a high risk of TB progression, considerable efforts have been made to identify these cases through exploration of biomarkers. The present study aimed to evaluate simple scoring systems for TB exposure as screening tools for subclinical TB, the only identifiable of the incipient and subclinical disease states, in a contact investigation (CI) setting of low HIV-prevalence.

Methods
Nested within a large prospective study in household contacts (HHCs) of smear positive pulmonary TB cases in South-India conducted 2010–2012, we assessed 1) the association between the Tuberculosis Contact Score (TCS) and the Infectivity Score, with established tools for Mycobacterium tuberculosis (Mtb) infection, corrected for established TB risk factors, and 2) the capability of the TB exposure scores to identify subclinical TB defined by Mtb-culture positivity in sputum or gastric aspirate (subjects < 5 years) specimen.

Results
Of 525 HHCs, 29 were Mtb-culture positive and 96.6% of these asymptomatic. The TCS and the Infectivity Score associated with positive Tuberculin Skin Test and QuantiFeron TB-Gold In-tube assay (QFT) results in multivariate analyses (TCS: ORTST 1.16, 95% CI: 1.01, 1.33; ORQFT 1.33 95% CI: 1.16, 1.51. Infectivity Score: ORTST 1.39, 95% CI: 1.10, 1.76; ORQFT 1.41 95% CI: 1.16, 1.71). The Infectivity Score showed a moderate capability to identify subclinical TB (AUC of 0.61, 95% CI: 0.52, 0.70).

Conclusions
Although our results did not identify an easily applicable screening tool for subclinical TB, the present study indicates that focusing on TB-related symptoms in CI settings may be of limited value for early identification of HHCs with high risk for TB progression.
Ambulatory screening and decontamination to prevent Staphylococcus aureus complications in patients undergoing elective surgery (STAUfrei): study protocol for a controlled intervention study
Authors: Bauer Antonia , Grünewald Martin , Eberhardt Hans , Schulz Rieke , Martus Peter , Brüggenjürgen Bernd , Joos Stefanie , Sturm Heidrun 
Published: January 2020

Abstract
Background
Surgical site infections (SSI) are the most common health care associated infections in German acute hospitals and can result in prolonged hospital stays, increased use of antibiotics and utilisation of care. Staphylococcus aureus bacteria (methicillin-resistant S Aureus (MRSA) and methicillin-susceptible S Aureus (MSSA)) are amongst the most prominent causes of SSI. While up to 90% of documented S Aureus colonization is already detectable prior to hospital admission, the majority of hygiene measures in Germany is focused on the hospital setting. It is hypothesized that early detection and decontamination of S Aureus colonization in primary care can prevent health care associated infections and reduce the number of S Aureus isolates in the hospital setting.

Methods
This study is a controlled interventional study (N = 13,260) with a pre-post comparison. The intersectoral intervention (over 2 years) will encompass the following elements: ambulatory detection and decontamination of MRSA and MSSA prior to elective surgery combined with a structured follow-up care. Patients from the control group will be screened in the hospital setting, in accordance with the standard operating procedure (SOP) in routine care. The primary endpoint is the reduction of MRSA and MSSA colonization upon hospital admission. Secondary endpoints are complication rate (SSI), length of stay, recolonization of patients (3 and 6 months after release), patient and provider satisfaction, patient compliance and cost development.

Discussion
In case of positive results, the chance of a widespread uptake and implementation in routine care are considered high. The active involvement of primary care providers in the implementation of screening and decontamination as well as follow-up care is a unique feature of this study. The positive resonance of primary care providers during the recruitment phase highlights the relevance of the topic to the participating actors. These efforts are coupled with patient education and specifically trained medical staff, promising a sustained impact. The STAUfrei care pathway can homogenize current practices in routine care and provide a template for further intersectoral cooperation.

Trial registration
German Clinical Trials Register (DRKS), DRKS00016615. Registered on April 1st, 2019.
Methyl-CpG-binding protein 2 (MECP2) mutation type is associated with bone disease severity in Rett syndrome
Authors: Caffarelli Carla , Gonnelli Stefano , Pitinca Maria Dea Tomai , Camarri Silvia , Al Refaie Antonella , Hayek Joussef , Nuti Ranuccio 
Published: January 2020

Abstract
Background
More than 95% of individuals with RTT have mutations in methyl-CpG-binding protein 2 (MECP2), whose protein product modulates gene transcription. The disorder is caused by mutations in a single gene and the disease severity in affected individuals can be quite variable. Specific MECP2 mutations may lead phenotypic variability and different degrees of disease severity. It is known that low bone mass is a frequent and early complication of subjects with Rett syndrome. As a consequence of the low bone mass Rett girls are at an increased risk of fragility fractures. This study aimed to investigate if specific MECP2 mutations may affects the degree of involvement of the bone status in Rett subjects.

Methods
In 232 women with Rett syndrome (mean age 13.8 ± 8.3 yrs) we measured bone mineral density at whole body and at femur (BMD-FN and BMD-TH) by using a DXA machine (Hologic QDR 4500). QUS parameters were assessed at phalanxes by Bone Profiler-IGEA (amplitude dependent speed of sound: AD-SoS and bone transmission time: BTT). Moreover, ambulation capacity (independent or assisted), fracture history and presence of scoliosis were assessed. We divided the subjects with the most common point mutations in two group based on genotype-phenotype severity; in particular, there has been consensus in recognising that the mutations R106T, R168X, R255X, R270X are considered more severe.

Results
As aspect, BMD-WB, BMD-FN and BMD-TH were lower in subjects with Rett syndrome that present the most severe mutations with respect to subjects with Rett syndrome with less severe mutations, but the difference was statistically significant only for BMD-FN and BMD-TH (p < 0.05). Also both AD-SoS and BTT values were lower in subjects that present the most severe mutations with respect to less severe mutations but the difference was not statistically significant. Moreover, subjects with Rett syndrome with more severe mutations present a higher prevalence of scoliosis (p < 0.05) and of inability to walk (p < 0.05).

Conclusion
This study confirms that MECP2 mutation type is a strong predictor of disease severity in subjects with Rett syndrome. In particular, the subjects with more severe mutation present a greater deterioration of bone status, and a higher prevalence of scoliosis and inability to walk.
Association of reduced inner retinal thicknesses with chronic kidney disease
Authors: Paterson Euan N. , Ravindran Meera L. , Griffiths Kayleigh , Le Velly Claire A. , Cardwell Chris C. , McCarter Rachel V. , Nicol Patrick , Chhablani Jay K. , Rasheed Mohammed Abdul , Vupparaboina Kiran Kumar , MacGillivray Thomas J. , Harbinson Mark , Maxwell Alexander P. , Hogg Ruth E. , McKay Gareth J. 
Published: January 2020

Abstract
Background
Tissue derived biomarkers may offer utility as indicators of accumulated damage. Reduced thickness of retinal neuronal tissue and the vascular choroid have previously been associated with vascular damage and diabetes. We evaluated associations between retinal thickness, retinal microvascular and choroidal measures, and renal function in a population with a high burden of comorbidity.

Methods
Participants were recruited from nuclear cardiology or renal medicine clinics. Retinal and choroidal thickness were measured from spectral-domain optical coherence tomograms. Retinal microvascular parameters were assessed from digital fundus photographs using a semi-automated software package. Main Outcome Measure: Chronic kidney disease (CKD) categorised as: CKD stages 1–2, eGFR ≥60 ml/min/1.73m2; CKD stage 3, eGFR 30–59 ml/min/1.73m2, and CKD stages 4–5, eGFR ≤29 ml/min/1.73m2.

Results
Participants (n = 241) had a mean age of 65 years and a mean eGFR of 66.9 ml/min/1.73m2. Thirty–nine % of the cohort had diabetes and 27% were using diuretics. Thinning of the inner retina and changes to its microvascular blood supply were associated with lower eGFR and CKD stages 4 and 5, while no associations were found between the outer retinal layers or their choroidal blood supply and CKD of any stage. These associations remained following adjustment for age, mean arterial blood pressure, diabetes status, low-density lipoprotein, body mass index, and sex.

Conclusions
Inner retinal thinning and retinal microvascular variation is associated with advanced CKD (stages 4 & 5) independent of important confounding factors, but not with earlier stage CKD (stage 3) and, therefore, its utility as a biomarker for early CKD is not supported in this study.
Urgent start peritoneal dialysis: are we there yet?
Authors: Greenberg Keiko I. , Jaar Bernard G. 
Published: January 2020

AbstractThe use of peritoneal dialysis (PD) has increased substantially in the United States (US) in the past decade. This was likely spurred in large part by the implementation of the expanded prospective payment system for the Medicare End Stage Renal Disease (ESRD) program in 2011. Over the same period, there has also been growing interest in urgent start PD, which is commonly defined as initiation of PD within 14 days of catheter insertion. Ye and colleagues recently reported their experience with urgent start PD in 2059 Chinese ESRD patients over a 9-year period. Rates of complications, including peri-catheter leaks and peritonitis, were very low despite initiation of PD immediately after open catheter placement via open laparotomy in nearly all patients. Long term technique survival was good, with only 75 patients developing catheter failure. This study provides further evidence to suggest that urgent start PD is feasible and effective, although the generalizability of these results to Western populations is unclear. Recent proposed changes to the payment models in the Medicare ESRD program, designed to incentivize use of kidney transplantation and home dialysis, are likely to further propel growth of PD and urgent start PD in the US. Further studies are needed to optimize use of urgent PD and patient outcomes.
Protocol of a randomized open label multicentre trial comparing continuous intrajejunal levodopa infusion with deep brain stimulation in Parkinson’s disease - the INfusion VErsus STimulation (INVEST) study
Authors: van Poppelen D. , Sisodia V. , de Haan R. J. , Dijkgraaf M. G. W. , Schuurman P. R. , Geurtsen G. J. , Berk A. E. M. , de Bie R. M. A. , Dijk J. M. 
Published: January 2020

Abstract
Background
Both Deep Brain Stimulation (DBS) and Continuous intrajejunal Levodopa Infusion (CLI) are effective therapies for the treatment of Parkinson’s disease (PD). To our knowledge, no direct head-to-head comparison of DBS and CLI has been performed, whilst the costs probably differ significantly. In the INfusion VErsus STimulation (INVEST) study, costs and effectiveness of DBS and CLI are compared in a randomized controlled trial (RCT) in patients with PD, to study whether higher costs of one of the therapies are justified by superiority of that treatment.

Methods
A prospective open label multicentre RCT is being performed, with ancillary patient preference observational arms. Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, bradykinesia, dyskinesias, or painful dystonia are eligible for inclusion. A total of 66 patients will be randomized. There is no minimal inclusion in the patient preference arms. The primary health economic outcomes are costs per unit on the Parkinson’s Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months. The main clinical outcome is patient-reported quality of life measured with the PDQ-39 at 12 months. Patients will additionally be followed during 36 months after initiation of the study treatment.

Discussion
The INVEST trial directly compares the costs and effectiveness of the advanced therapies DBS and CLI.

Trial registration
Dutch Trial Register identifier 4753, registered November 3rd, 2014; EudraCT number 2014–001501-32, Clinicaltrials.gov: NCT02480803.
TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial – a study protocol
Authors:   On behalf of the TRAAP2 Study Group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG), Sentilhes Loïc , Daniel Valérie , Deneux-Tharaux Catherine 
Published: January 2020

Abstract
Background
An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries.

Methods/design
This study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%.

Discussion
As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.

Trial registration
ClinicalTrials.gov NCT03431805 (February 12, 2018).
Caesarean section rates from Malaysian tertiary hospitals using Robson’s 10-group classification
Authors: Karalasingam Shamala Devi , Jeganathan Ravichandran , Jegasothy Ravindran , Reidpath Daniel D. 
Published: January 2020

Abstract
Background
Rising caesarean section rates is a concern worldwide. This study aimed to use Robson’s ten group classification to identify which groups of women were contributing most to the rising caesarean section rates in Malaysian tertiary hospitals and to compare between hospitals, using a common standard set of variables.

Methods
A 5-year (2011–2015) cross-sectional study was conducted using data from the Malaysian National Obstetrics Registry (NOR). A total of 608,747 deliveries were recorded from 11 tertiary state hospitals and 1 tertiary hospital from the Federal territory.

Results
During the study period, there were 141,257 Caesarean sections (23.2%). Caesarean sections in Group 1 (nulliparous term pregnancy in spontaneous labour) and Group 3 (multiparous term pregnancy in spontaneous labour) had an increasing trend from 2011 to 2015. The group that contributed most to the overall caesarean section rates was Group 5 (multiparous, singleton, cephalic≥37 weeks with previous caesarean section) and the rates remained high during the 5-year study period. Groups 6, 7 and 9 had the highest caesarean section rates but they made the smallest contribution to the overall rates.

Conclusions
Like many countries, the rate of caesarean section has risen over time, and the rise is driven by caesarean section in low-risk groups. There was an important hospital to hospital variation. The rise in caesarean section rates reflects a globally disturbing trend, and changes in policy and training that creates a uniform standard across hospitals should be considered.
Gestational diabetes and the human salivary microbiota: a longitudinal study during pregnancy and postpartum
Authors: Crusell Mie K. W. , Brink Lærke R. , Nielsen Trine , Allin Kristine H. , Hansen Torben , Damm Peter , Lauenborg Jeannet , Hansen Tue H. , Pedersen Oluf 
Published: January 2020

Abstract
Background
An aberrant composition of the salivary microbiota has been found in individuals with type 2 diabetes, and in pregnant women salivary microbiota composition has been associated with preeclampsia and pre-term birth. Pregnant women, who develop gestational diabetes (GDM), have a high risk of developing type 2 diabetes after pregnancy. In the present study we assessed whether GDM is linked to variation in the oral microbial community by examining the diversity and composition of the salivary microbiota.

Method
In this observational study the salivary microbiota of pregnant women with GDM (n = 50) and normal glucose regulation (n = 160) in third trimester and 9 months postpartum was assessed by 16S rRNA gene amplicon sequencing of the V1-V3 region. GDM was diagnosed in accordance with the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria. Cross-sectional difference in alpha diversity was assessed using Student’s t-test and longitudinal changes were assessed by mixed linear regression. Cross-sectional and longitudinal difference in beta diversity was assessed by permutational multivariate analyses of variance. Differentially abundant genera and OTUs were identified by negative binomial regression.

Results
In the third trimester, two species-level operational taxonomic units (OTUs), while eight OTUs postpartum were differentially abundant in women with GDM compared with normoglycaemic women. OTU richness, Shannon diversity and Pielou evenness decreased from late pregnancy to 9 months after delivery regardless of glycaemic status.

Conclusion
GDM is associated with a minor aberration of the salivary microbiota during late pregnancy and postpartum. For unknown reasons richness of the salivary microbiota decreased from late pregnancy to postpartum, which might be explained by the physiological changes of the immune system during human pregnancy.
Transverse versus vertical skin incision for planned cesarean hysterectomy: does it matter?
Authors: Szlachta-McGinn Alec , Mei Jenny , Tabsh Khalil , Afshar Yalda 
Published: January 2020

Abstract
Background
To investigate differences in perioperative outcomes by type of skin incision, transverse versus vertical, for planned cesarean hysterectomy for placenta accreta spectrum (PAS).

Methods
A retrospective cohort study of all women who underwent a planned cesarean hysterectomy for abnormal placentation at a single academic medical center over 5 years. The Student’s t-test was used for continuous variables and Fisher’s exact test compared categorical variables. Continuous data were presented as median and compared using the Wilcoxon-rank sum test.

Results
Forty-two planned cesarean hysterectomies were identified. A transverse skin incision was made in 43% (n = 18); a vertical skin incision was made in 57% (n = 24). Skin incision was independent of BMI (30.3 vs 30.8 kg/m2, p = 0.37), placental location (p = 0.82), and PAS-subtype (p = 0.26). Mean estimated blood loss (EBL) was 2.73 l (L) (range 0.5–20) and was not significantly different between transverse and vertical skin incision (2.6 L vs 2.8 L, p = 0.8). There was significantly shorter operative time with transverse skin incision (180 vs 238 min, p = 0.03), with no difference in intraoperative complications, including cystotomy (p = 0.22) and ureteral injury (p = 0.73). Postoperatively, there was no difference in maternal length of stay (4.8 vs 4.4 days, p = 0.74) or post-operative opioid use (117 vs 180 morphine equivalents, p = 0.31).

Conclusion
Transverse skin incision is associated with shorter operative time for patients undergoing planned cesarean hysterectomy. There was no difference in EBL, intraoperative complications, postoperative length of stay, or opioid use. Given an increasing rate of cesarean hysterectomy, we should consider variables that optimize maternal outcomes and resource utilization.