bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective multicentre cohort trial on acute appendicitis and microbiota, aetiology and effects of antimicrobial treatment: study protocol for the MAPPAC (Microbiology APPendicitis ACuta) trial
Authors: Vanhatalo Sanja , Munukka Eveliina , Sippola Suvi , Jalkanen Sirpa , Grönroos Juha , Marttila Harri , Eerola Erkki , Hurme Saija , Hakanen Antti J , Salminen Paulina 
Published: September 2019

IntroductionBased on the epidemiological and clinical data, acute appendicitis can present either as uncomplicated or complicated. The aetiology of these different appendicitis forms remains unknown. Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis. Despite appendicitis being one of the most common surgical emergencies, there are very few reports on appendicitis aetiology and pathophysiology focusing on the differences between uncomplicated and complicated appendicitis. Microbiology APPendicitis ACuta (MAPPAC) trial aims to evaluate these microbiological and immunological aspects including immune response in the aetiology of these different forms also assessing both antibiotics non-responders and appendicitis recurrence. In addition, MAPPAC aims to determine antibiotic and placebo effects on gut microbiota composition and antimicrobial resistance.Methods and analysisMAPPAC is a prospective clinical trial with both single-centre and multicentre arm conducted in close synergy with concurrent trials APPendicitis ACuta II (APPAC II) (per oral (p.o.) vs intravenous+p.o. antibiotics,NCT03236961) and APPAC III (double-blind trial placebo vs antibiotics,NCT03234296) randomised clinical trials. Based on the enrolment for these trials, patients with CT-confirmed uncomplicated acute appendicitis are recruited also to the MAPPAC study. In addition to these conservatively treated randomised patients with uncomplicated acute appendicitis, MAPPAC will recruit patients with uncomplicated and complicated appendicitis undergoing appendectomy. Rectal and appendiceal swabs, appendicolith, faecal and serum samples, appendiceal biopsies and clinical data are collected during the hospital stay for microbiological and immunological analyses in both study arms with the longitudinal study arm collecting faecal samples also during follow-up up to 12 months after appendicitis treatment.Ethics and disseminationThis study has been approved by the Ethics Committee of the Hospital District of Southwest Finland (Turku University Hospital, approval number ATMK:142/1800/2016) and the Finnish Medicines Agency. Results of the trial will be published in peer-reviewed journals.Trial registration numberNCT03257423
Association of diabetic retinopathy and diabetic macular oedema with renal function in southern Chinese patients with type 2 diabetes mellitus: a single-centre observational study
Authors: Zhuang Xuenan , Cao Dan , Yang Dawei , Zeng Yunkao , Yu Honghua , Wang Jun , Kuang Jian , Xie Jianteng , Zhang Shuting , Zhang Liang 
Published: September 2019

Background and objectivesThe association of diabetic retinopathy (DR) and diabetic macular oedema (DME) with renal function in southern Chinese patients with diabetes is poorly understood. So we aimed to study the correlation between stage of DR and DME with stage of estimated glomerular filtration rate (eGFR) and stage of urine albumin-to-creatinine ratio (UACR), and to explore the systemic risk factors for DR and DME.Design and settingThis single-centre retrospective observational study was conducted from December 2017 to November 2018.Participants413 southern Chinese patients with type 2 diabetes mellitus.Outcome measuresThe correlations between stage of DR and DME with stage of eGFR/UACR were assessed by Spearman’s or χ² analyses and represented with histograms. Risk factors associated with the occurrence of DR and DME were performed by logistic regression and represented with nomograms.ResultsStage of DR had a positive correlation with stage of eGFR (r=0.264, p<0.001) and stage of UACR (r=0.542, p<0.001). With the stage of eGFR/UACR being more severe, the prevalence of DME became higher as well (both p<0.001). The risk factors for DR were DM duration (OR 1.072; 95% CI 1.032 to 1.114; p<0.001), stage of UACR (OR 2.001; 95% CI 1.567 to 2.555; p<0.001) and low-density lipoprotein (LDL) (OR 1.301; 95% CI 1.139 to 1.485; p<0.001), while risk factors for DME were stage of UACR (OR 2.308; 95% CI 1.815 to 2.934; p<0.001) and LDL (OR 1.460; 95% CI 1.123 to 1.875; p=0.008).ConclusionsAmong southern Chinese patients, stage of DR and DME were positively correlated with renal function, while stage of UACR performed a better relevance than stage of eGFR.
Using the CONSORT statement to evaluate the completeness of reporting of addiction randomised trials: a cross-sectional review
Authors: Vassar Matthew , Jellison Sam , Wendelbo Hannah , Wayant Cole , Gray Harrison , Bibens Michael 
Published: September 2019

ObjectivesEvaluate the completeness of reporting of addiction randomised controlled trials (RCTs) using the Consolidated Standards of Reporting Trials (CONSORT) statement.SettingNot applicable.ParticipantsRCTs identified using a PubMed search of 15 addiction journals and a 5-year cross-section.Outcome measuresCompleteness of reporting.ResultsOur analysis of 394 addiction RCTs found that the mean number of CONSORT items reported was 19.2 (SD 5.2), out of a possible 31. Twelve items were reported in <50% of RCTs; similarly, 12 items were reported in >75% of RCTs. Journal endorsement of CONSORT was found to improve the number of CONSORT items reported.ConclusionsPoor reporting quality may prohibit readers from critically appraising the methodological quality of addiction trials. We recommend journal endorsement of CONSORT since our study and those previous have shown that CONSORT endorsement improves the quality of reporting.
Systemic biomarkers of inflammation, oxidative stress and tissue injury and repair among waterpipe, cigarette and dual tobacco smokers
Authors: Khan Naushad Ahmad , Lawyer Gina , McDonough Samantha , Wang Qixin , Kassem Noura O , Kas-Petrus Flora , Ye Dongxia , Singh Kameshwar P , Kassem Nada OF , Rahman Irfan 
Published: September 2019

BackgroundWaterpipe tobacco (WPT) smoking is associated with deleterious effects on cardio-pulmonary systems which may have adverse repercussions in pathophysiology and progression of chronic lung and cardiovascular diseases. We compared the biomarkers of systemic inflammation, lipid mediators, injury/repair and oxidative stress between groups of non-smokers (NS), exclusive WPT smokers (WPS), exclusive cigarette smokers (CS) and dual WPS and CS (DS).MethodsTwo cohorts were recruited. Cohort I consisted of WPS (n=12), CS (n=26), DS (n=10) and NS (n=25). Cohort II consisted of WPS (n=33) and NS (n=24). Plasma and urine samples were collected and analysed for various systemic biomarkers.ResultsCompared with NS, plasma levels of inflammatory mediators (interleukin (IL)-6, IL-8, IL1β and tumor necrosis factor-α) were significantly higher in WPS and CS, and were further augmented in DS. Endothelial biomarkers (intracellular adhesion molecule-1, prostaglandin E-2 and metalloproteinase-9) were significantly higher in CS. Most notably, pro-resolving lipid mediator (resolvin E1) and biomarkers of immunity, tissue injury, and repair were significantly lower in WPS and CS. Urinary levels of 8-isoprostane were significantly higher in all smoking groups in cohort I, while 8-isoprostane, myeloperoxidase, receptor for advanced glycation end products (RAGE), En-RAGE and matrix metalloproteinase-9 were significantly higher in all smoking groups in cohort II.ConclusionsBiomarkers of inflammation, oxidative stress, immunity, tissue injury and repair were elevated in WPS and CS groups. Furthermore, concurrent use of WPT and cigarettes is more harmful than cigarette or WPT smoking alone. These data may help inform the public and policy-makers about the dangers of WPT smoking and dual use of tobacco products.
The Association between Polymorphisms of Vitamin D Metabolic-Related Genes and Vitamin D3 Supplementation in Type 2 Diabetic Patients
Authors: Hu Zhiyong , Tao ShaSha , Liu Huaqing , Pan Guotao , Li Bingyan , Zhang Zengli 
Published: September 2019

Objective. To investigate the effect of single nucleotide polymorphisms (SNPs) of the key genes in vitamin D metabolic pathway on the serum 25(OH)D level after long-term vitamin D3 supplementation and provide a theoretical basis for rational vitamin D3 supplementation in diabetic patients with different genetic backgrounds. Methods. Patients with type 2 diabetes (T2DM) who met the inclusive criteria were given 800 IU of vitamin D3 daily for 30 consecutive months. Serum 25(OH)D levels was measured at enrollment and every 6 months after enrollment. The average value of four-time measurements represented individual serum 25(OH)D level during vitamin D3 supplementation. Multiplex TaqMan genotyping was used to determine the distribution of eight candidate SNPs in genes of DHCR7, CYP2R1, CYP27B1, CYP24A1, and VDR, which are key genes in the vitamin D metabolic pathway, in diabetic patients. Results. At baseline, the average serum 25(OH)D level was 22.71±6.87 ng/mL, and 17.9% of patients had a ≥30 ng/mL level. During supplementation, the level of 25(OH)D increased significantly at each time point, and the average 25(OH)D level increased to 30.61±5.04 ng/mL; however, there were 44.6% of patients whose serum 25(OH)D levels were still below 30 ng/mL. In the patients with CYP27B1 (rs10877012) G/T genotype, 71.79% achieved sufficient level of 25(OH)D, which was significantly higher than the other two genotypes (P<0.05). Compared with those with T/T genotype, the RR of the patients with rs10877012 for <30 ng/mL level was 0.544 (95% CI: 0.291-0.917), and the RR after adjusting age and outdoor activity was 0.560 (95% CI: 0.292-0.970). Conclusion. The serum 25(OH)D level in patients with diabetes mellitus after long-term vitamin D3 supplementation is associated with CYP27B1 polymorphism. Patients with rs10877012 G/T allele have a better response to vitamin D3 supplementation. Trial Registration. This trial is registered with ChiCTR-IPC-17012657.
Noninvasive Mapping of the Electrophysiological Substrate in Cardiac Amyloidosis and Its Relationship to Structural Abnormalities
Authors: Orini Michele , Graham Adam J. , Martinez‐Naharro Ana , Andrews Christopher M. , de Marvao Antonio , Statton Ben , Cook Stuart A. , O'Regan Declan P. , Hawkins Philip N. , Rudy Yoram , Fontana Marianna , Lambiase Pier D. 
Published: September 2019

Background

The relationship between structural pathology and electrophysiological substrate in cardiac amyloidosis is unclear. Differences between light‐chain (
AL
) and transthyretin (
ATTR
) cardiac amyloidosis may have prognostic implications.

Methods and Results

ECG
imaging and cardiac magnetic resonance studies were conducted in 21 cardiac amyloidosis patients (11
AL
and 10
ATTR
). Healthy volunteers were included as controls. With respect to
ATTR
,
AL
patients had lower amyloid volume (51.0/37.7 versus 73.7/16.4 mL,
P
=0.04), lower myocardial cell volume (42.6/19.1 versus 58.5/17.2 mL,
P
=0.021), and higher T1 (1172/64 versus 1109/80 ms,
P
=0.022) and T2 (53.4/2.9 versus 50.0/3.1 ms,
P
=0.003).
ECG
imaging revealed differences between cardiac amyloidosis and control patients in virtually all conduction‐repolarization parameters. With respect to
ATTR
,
AL
patients had lower epicardial signal amplitude (1.07/0.46 versus 1.83/1.26 mV,
P
=0.026), greater epicardial signal fractionation (
P
=0.019), and slightly higher dispersion of repolarization (187.6/65 versus 158.3/40 ms,
P
=0.062). No significant difference between
AL
and
ATTR
patients was found using the standard 12‐lead
ECG
. T1 correlated with epicardial signal amplitude (cc=−0.78), and extracellular volume with epicardial signal fractionation (cc=0.48) and repolarization time (cc=0.43). Univariate models based on single features from both cardiac magnetic resonance and
ECG
imaging classified
AL
and
ATTR
patients with an accuracy of 70% to 80%.

Conclusions

In this exploratory study cardiac amyloidosis was associated with ventricular conduction and repolarization abnormalities, which were more pronounced in
AL
than in
ATTR
. Combined
ECG
imaging–cardiac magnetic resonance analysis supports the hypothesis that additional mechanisms beyond infiltration may contribute to myocardial damage in
AL
amyloidosis. Further studies are needed to assess the clinical impact of this approach.
Design, validation and performance of aspartate aminotransferase- and lactate dehydrogenase-reporting algorithms for haemolysed specimens including correction within quality specifications
Authors: Colak Selcuk , Tasdemir Onur , van der Schaaf Marianne , Opdam Frans , van den Noort Vincent , van den Broek Daan , van Rossum Huub H 
Published: September 2019

Background In vitro haemolysis is a major operational challenge for medical laboratories. A new experimental design was used to investigate under what conditions algorithms could be designed to report either quantitative or qualitative aspartate aminotransferase and lactate dehydrogenase results outside the manufacturer’s haemolysis specifications. Quantitative corrections were required to meet prespecified quality specifications. Methods Twenty-five patient samples were used to design reporting algorithms and another 41 patient samples were used to validate the algorithms. Aspartate aminotransferase, lactate dehydrogenase and haemolysis index were determined using a Cobas 6000 analyser (Roche diagnostics, Mannheim, Germany). Correction factors were determined, and the accuracy of the correction was investigated. Reporting algorithms were designed based on (i) the manufacturer’s cut-off for the haemolysis index, (ii) corrections within the total allowable error specification and (iii) qualitative reporting based on obtained results. The impact of the reporting algorithms was retrospectively determined by recalculating six months of aspartate aminotransferase and lactate dehydrogenase results. Results No correction for aspartate aminotransferase/lactate dehydrogenase was possible for results below the upper reference interval limit, while results equal to or greater than the upper reference interval limit could, up to mild haemolysis, be corrected within the total error criterion. All samples generated from the validated patient cohort fulfilled the set criteria. The algorithms allowed reporting 88.5% and 85.9% of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results, respectively. Conclusions An approach is presented that allows to generate and validate reporting algorithms for aspartate aminotransferase and lactate dehydrogenase compatible with prespecified quality specifications. The designed algorithms resulted in a significant reduction of otherwise unreported aspartate aminotransferase and lactate dehydrogenase results.
Combatting occupational deprivation and advancing occupational justice in institutional settings: Using a practice-based enquiry approach for service transformation
Authors: Whiteford Gail , Jones Katherine , Weekes Gemma , Ndlovu Nomagugu , Long Cassandra , Perkes Danielle , Brindle Sophie 
Published: September 2019

Introduction Occupational deprivation is a risk for residents of institutions. This is problematic at several levels: it can cause diminution of individual capacities; such environments pose philosophical and practical challenges for occupational therapists and the erosion of human rights can be an issue. Occupational therapists in an Australian forensic mental health setting ‘reclaimed’ occupation-centred practice, committed to occupational justice and tackled the experience of occupational deprivation of patients through utilising a practice-based enquiry approach. Method A community of practice scholars used a practice-based enquiry approach – a type of action methods research – involving iterative cycles of data collection, analysis, critique and implementation of practice innovations. Findings Through the practice-based enquiry process, participants’ practice became more occupation-centred, based and focused, resulting in: the creation of more opportunities for patients, which combatted occupational deprivation and increased potential for community reintegration; enhanced professional satisfaction and identity; and increased institutional ‘valuing’ of the occupational therapy service. Conclusion Ameliorating occupational deprivation can be achieved through becoming occupation-centred and embracing a stated commitment to occupational justice in the challenging practice setting of a forensic hospital. The use of the deeply reflective process of practice-based enquiry was pivotal to this shift in focus for the group of occupational therapists who participated in this study and also contributed to enhanced practitioner satisfaction, identity, autonomy and confidence.
Metformin's effectiveness in preventing prednisone-induced hyperglycemia in hematological cancers
Authors: Ochola Lucy A , Nyamu David G , Guantai Eric M , Weru Irene W 
Published: September 2019

Background Research has established the development of steroid-induced hyperglycemia as a glucometabolic side effect of high-dose prednisone therapy. Few studies, however, have demonstrated preventative measures that could effectively curtail this side effect in susceptible patients undergoing high-dose prednisone treatment. Objective To assess metformin's prophylactic effectiveness of prednisone-induced hyperglycemia among hematological cancer patients. Setting Prospective randomized controlled trial conducted at the Kenyatta National Hospital Oncology Clinic and Wards, Nairobi, Kenya. Method Non-hyperglycemic hematological cancer patients on current or newly initiated high-dose prednisone-based chemotherapy were randomized to receive metformin 850 mg once then 850 mg twice daily for two successive weeks each or to the control group receiving the standard care. Patients were subjected to once weekly fasting and 2-h postprandial glucose measurements for four weeks. Main outcome measure The primary outcome of measure was the development of hyperglycemia defined by fasting capillary blood glucose values >5.6 mmol/L or 2-h postprandial capillary blood glucose values >7.8 mmol/L. Results Eighteen of 24 randomized patients completed the study (11 control and 7 treatment). The proportion of the control subjects that developed prediabetes was 72.7% (95% confidence interval 45.5–90.9%) using fasting glucose and 54.5% (95% confidence interval 27.3–81.8%) using 2-h postprandial glucose. One treatment group participant developed prediabetes using fasting glucose, representing 14.3% (95% confidence interval 0–42.9%). No prediabetes was detected using the 2-h postprandial glucose. Analysis of mean fasting glucose between the two arms found no significant difference. However, significant differences in mean 2-h postprandial glucose were noted in week 2 ( p = 0.0144), week 3 ( p = 0.0095), and week 4 ( p = 0.0074) of the study. Double dose (1700 mg) metformin was more effective in lowering blood glucose than single dose (850 mg) ( p = 1.0000 (fasting), p = 0.4531(2-h postprandial). Conclusion Metformin's prophylactic effectiveness was demonstrated in this randomized study on new and previously exposed non-diabetic cancer patients on high-dose prednisone-based chemotherapy.
Excellence in elective hip and knee surgery: what does it look like? A positive deviance approach
Authors: Hughes Lesley , Sheard Laura , Pinkney Lisa , Lawton Rebecca L 
Published: September 2019

Objectives Positive deviance is a way of examining variation across health care settings to understand how and why high-performing clinical teams or organizations achieve their results despite facing the same constraints as others. This study explores how exceptional performance is delivered within enhanced hip and knee elective surgery in England. We were particularly interested in non-clinical factors that may influence patient outcomes. Methods We used 28-day emergency readmissions and patient-reported outcomes to identify two hospitals providing enhanced elective hip and knee replacement surgery and who presented different levels of performance. We used ethnographic observations, in-depth interviews, focus groups and documentary analysis, conducted over eight months. The study involved 54 health care professionals from multiple professional backgrounds. Results Five key themes were identified, which may underpin the high performance in the site identified as a positive deviant: (i) leadership and engagement that adopts a distributed approach to sustain progress and engage team members; (ii) autonomy, in particular the ability for all clinical staff to make decisions about patient care; (iii) relationships and communication, which promote clear lines of communication and a climate of shared decision making within and across teams; (iv) patient empowerment, which supports patients in managing their behaviour before and after surgery; and (v) resilience, which enables the workforce to respond to threats to maintain high performance such as those that could reduce capacity and flow, or interfere with provision and coordination. Conclusions Our study demonstrates that it is possible to build an excellent service that meets the needs of the local population and the wider organization agenda despite constraints and rising demands. The findings can inform orthopaedic and other surgical departments on ways in which they can achieve high performance within existing resources.
Online patient feedback: a scoping review and stakeholder consultation to guide health policy
Authors: Boylan Anne-Marie , Williams Veronika , Powell John 
Published: September 2019

Objective To provide a synthesis of the current evidence base of online patient feedback using a scoping review and a consultation of stakeholders in England, UK. Methods We searched MEDLINE, EMBASE, PsycINFO, CINAHL and the Social Science Citation Index and conducted hand searches up to January 2018. We included primary studies of internet-based reviews and other online feedback (e.g. social media and blogs) from patients, carers or the public about health care providers (individuals, services or organizations). Key findings were extracted and tabulated for further synthesis guided by the themes arising from a stakeholder consultation. Results The review found that awareness and usage of online feedback is increasing. Most feedback is about physicians, and is typically positive. Online reviews and ratings are used by some service users to inform choice of provider or treatment while providers tend to be concerned about the validity and representativeness of feedback. Reviewed studies found that those who post feedback are generally not representative of the general population, tending to be younger and more educated, but online feedback does broadly correlate with some other measures of health care quality. Conclusions In an increasingly digital society, where citizens provide and use feedback for a range of goods and services, online patient feedback can offer a convenient, low cost and widely accessible mechanism to capture experiences of health care, while being mindful to avoid issues of digital exclusion. This review provides important insights to inform policy development seeking to harness the opportunities offered by online feedback.