bluuebunny/crossref_metadata_2025 huggingface dataset:
Features and associated factors of bacterial skin infections in hospitalized patients with pemphigus: a single-center retrospective study
Authors: Li Furong , Wu Yejun , Bian Wenjie , Huang Lei , Zhu Xuejun , Chen Xixue , Wang Mingyue
Published: October 2020

Background

Infections were the primary cause of death (34.3–55.5%) in patients with pemphigus. Skin was usually the origin of infections. The study aimed to explore features and associated factors of bacterial skin infections (BSIs) in inpatients with pemphigus.

Methods

One hundred and seventy-seven inpatients with pemphigus hospitalizing from November 2014 to April 2019 were continuously
recruited through Peking University First Hospital’s inpatient records inpatients with pemphigus hospitalizing from November 2014 to April 2019 were continuously recruited through Peking University First Hospital’s inpatient records. Then, we retrieved the clinical and laboratory data to explore the characteristics and associated factors of BSIs.

Results

Of patients enrolled, pemphigus vulgaris (PV, n = 142) and pemphigus foliaceus (PF, n = 9) were most common, followed by pemphigus erythematosus (PE, n = 25) and pemphigus vegetans (Pveg, n = 1). Eighty-seven of 177 (49.2%) inpatients developed BSIs, and they had a longer length of stay compared with inpatients without BSIs (median: 18.9 vs. 14.1 days, p = 0.008). Staphylococcus aureus was the most common bacteria (71.3%, 62/87) and highly resistant to penicillin (91.9%, 57/62). Higher levels of anti-Dsg1 autoantibodies (> 124.2 U/mL) (p < 0.001, odds ratio [OR] = 3.564, 95% confidence interval [CI]: 1.784–7.123) and anti-Dsg3 autoantibodies (> 169.5 U/mL) (p = 0.03, OR = 2.074, 95% CI: 1.084–3.969) were underlying risk factors of BSIs when analyzed by binary regression analysis. As for Gram’s stain of bacteria, females had a lower rate of Gram-positive infections (p = 0.03). Patients using oral antibiotics (p = 0.05) had a higher rate of Gram-negative infections. Inpatients who were hospitalized in other hospitals within 2 weeks before the current admission had a higher rate of Gram-negative and co-infections (p = 0.03).

Conclusions

Inpatients with pemphigus had a high incidence of BSIs. Some factors were associated with the susceptibility of BSIs and bacterial species.
Identification of a distinct luminal subgroup diagnosing and stratifying early stage prostate cancer by tissue-based single-cell RNA sequencing
Authors: Ma Xiaoshi , Guo Jinan , Liu Kaisheng , Chen Lipeng , Liu Dale , Dong Shaowei , Xia Jinquan , Long Qiaoyun , Yue Yongjian , Zhao Pan , Hu Fengyan , Xiao Zhangang , Pan Xinghua , Xiao Kefeng , Cheng Zhiqiang , Ke Zunfu , Chen Zhe-Sheng , Zou Chang
Published: October 2020

Background

The highly intra-tumoral heterogeneity and complex cell origination of prostate cancer greatly limits the utility of traditional bulk RNA sequencing in finding better biomarker for disease diagnosis and stratification. Tissue specimens based single-cell RNA sequencing holds great promise for identification of novel biomarkers. However, this technique has yet been used in the study of prostate cancer heterogeneity.

Methods

Cell types and the corresponding marker genes were identified by single-cell RNA sequencing. Malignant states of different clusters were evaluated by copy number variation analysis and differentially expressed genes of pseudo-bulks sequencing. Diagnosis and stratification of prostate cancer was estimated by receiver operating characteristic curves of marker genes. Expression characteristics of marker genes were verified by immunostaining.

Results

Fifteen cell groups including three luminal clusters with different expression profiles were identified in prostate cancer tissues. The luminal cluster with the highest copy number variation level and marker genes enriched in prostate cancer-related metabolic processes was considered the malignant cluster. This cluster contained a distinct subgroup with high expression level of prostate cancer biomarkers and a strong distinguishing ability of normal and cancerous prostates across different pathology grading. In addition, we identified another marker gene, Hepsin (HPN), with a 0.930 area under the curve score distinguishing normal tissue from prostate cancer lesion. This finding was further validated by immunostaining of HPN in prostate cancer tissue array.

Conclusion

Our findings provide a valuable resource for interpreting tumor heterogeneity in prostate cancer, and a novel candidate marker for prostate cancer management.
Measuring the prevalence of 60 health conditions in older Australians in residential aged care with electronic health records: a retrospective dynamic cohort study
Authors: Lind Kimberly E. , Raban Magdalena Z. , Brett Lindsey , Jorgensen Mikaela L. , Georgiou Andrew , Westbrook Johanna I.
Published: October 2020

Background

The number of older Australians using aged care services is increasing, yet there is an absence of reliable data on their health. Multimorbidity in this population has not been well described. A clear picture of the health status of people using aged care is essential for informing health practice and policy to support evidence-based, equitable, high-quality care. Our objective was to describe the health status of older Australians living in residential aged care facilities (RACFs) and develop a model for monitoring health conditions using data from electronic health record systems.

Methods

Using a dynamic retrospective cohort of 9436 RACF residents living in 68 RACFs in New South Wales and the Australian Capital Territory from 2014 to 2017, we developed an algorithm to identify residents’ conditions using aged care funding assessments, medications administered, and clinical notes from their facility electronic health record (EHR). We generated age- and sex-specific prevalence estimates for 60 health conditions. Agreement between conditions recorded in aged care funding assessments and those documented in residents’ EHRs was evaluated using Cohen’s kappa. Cluster analysis was used to describe combinations of health conditions (multimorbidity) occurring among residents.

Results

Using all data sources, 93% of residents had some form of circulatory disease, with hypertension the most common (62%). Most residents (93%) had a mental or behavioural disorder, including dementia (58%) or depression (54%). For most conditions, EHR data identified approximately twice the number of people with the condition compared to aged care funding assessments. Agreement between data sources was highest for multiple sclerosis, Huntington’s disease, and dementia. The cluster analysis identified seven groups with distinct combinations of health conditions and demographic characteristics and found that the most complex cluster represented a group of residents that had on average the longest lengths of stay in residential care.

Conclusions

The prevalence of many health conditions among RACF residents in Australia is underestimated in previous reports. Aged care EHR data have the potential to be used to better understand the complex health needs of this vulnerable population and can help fill the information gaps needed for population health surveillance and quality monitoring.
Gene correlation network analysis to identify regulatory factors in sepsis
Authors: Zhang Zhongheng , Chen Lin , Xu Ping , Xing Lifeng , Hong Yucai , Chen Pengpeng
Published: October 2020

Background and objectives

Sepsis is a leading cause of mortality and morbidity in the intensive care unit. Regulatory mechanisms underlying the disease progression and prognosis are largely unknown. The study aimed to identify master regulators of mortality-related modules, providing potential therapeutic target for further translational experiments.

Methods

The dataset GSE65682 from the Gene Expression Omnibus (GEO) database was utilized for bioinformatic analysis. Consensus weighted gene co-expression netwoek analysis (WGCNA) was performed to identify modules of sepsis. The module most significantly associated with mortality were further analyzed for the identification of master regulators of transcription factors and miRNA.

Results

A total number of 682 subjects with various causes of sepsis were included for consensus WGCNA analysis, which identified 27 modules. The network was well preserved among different causes of sepsis. Two modules designated as black and light yellow module were found to be associated with mortality outcome. Key regulators of the black and light yellow modules were the transcription factor CEBPB (normalized enrichment score = 5.53) and ETV6 (NES = 6), respectively. The top 5 miRNA regulated the most number of genes were hsa-miR-335-5p (n = 59), hsa-miR-26b-5p (n = 57), hsa-miR-16-5p (n = 44), hsa-miR-17-5p (n = 42), and hsa-miR-124-3p (n = 38). Clustering analysis in 2-dimension space derived from manifold learning identified two subclasses of sepsis, which showed significant association with survival in Cox proportional hazard model (p = 0.018).

Conclusions

The present study showed that the black and light-yellow modules were significantly associated with mortality outcome. Master regulators of the module included transcription factor CEBPB and ETV6. miRNA-target interactions identified significantly enriched miRNA.
Decreased expression of miR-29 family associated with autoimmune myasthenia gravis
Authors: Cron Mélanie A. , Payet Cloé A. , Fayet Odessa-Maud , Maillard Solène , Truffault Frédérique , Fadel Elie , Guihaire Julien , Berrih-Aknin Sonia , Liston Adrian , Le Panse Rozen
Published: October 2020

Background

Myasthenia gravis (MG) is a rare autoimmune disease mainly mediated by autoantibodies against the acetylcholine receptor (AChR) at the neuromuscular junction. The thymus is the effector organ, and its removal alleviates the symptoms of the disease. In the early-onset form of MG, the thymus displays functional and morphological abnormalities such as B cell infiltration leading to follicular hyperplasia, and the production of AChR antibodies. Type-I interferon (IFN-I), especially IFN-β, is the orchestrator of thymic changes observed in MG. As Dicer and miR-29 subtypes play a role in modulating the IFN-I signalization in mouse thymus, we investigated their expression in MG thymus.

Methods

The expression of DICER and miR-29 subtypes were thoroughly investigated by RT-PCR in human control and MG thymuses, and in thymic epithelial cells (TECs). Using miR-29a/b-1-deficient mice, with lower miR-29a/b-1 expression, we investigated their susceptibility to experimental autoimmune MG (EAMG) as compared to wild-type mice.

Results

DICER mRNA and all miR-29 subtypes were down-regulated in the thymus of MG patients and DICER expression was correlated with the lower expression of miR-29a-3p. A decreased expression of miR-29 subtypes was similarly observed in MG TECs; a decrease also induced in TECs upon IFN-β treatment. We demonstrated that miR-29a/b-1-deficient mice were more susceptible to EAMG without higher levels of anti-AChR IgG subtypes. In the thymus, if no B cell infiltration was observed, an increased expression of Ifn-β associated with Baff expression and the differentiation of Th17 cells associated with increased expression of Il-6, Il-17a and Il-21 and decreased Tgf-β1 mRNA were demonstrated in miR-29a/b-1-deficient EAMG mice.

Conclusions

It is not clear if the decreased expression of miR-29 subtypes in human MG is a consequence or a causative factor of thymic inflammation. However, our results from the EAMG mouse model indicated that a reduction in miR-29a/b1 may contribute to the pathophysiological process involved in MG by favoring the increased expression of IFN-β and the emergence of pro-inflammatory Th17 cells.
Prevalence and perceived importance of racial matching in the psychotherapeutic dyad: a national survey of addictions treatment clinical practices
Authors: Steinfeldt Jesse A. , Clay Shondra L. , Priester Paul E.
Published: October 2020

Background

Despite conflicting results in the literature concerning its efficacy in practice, racial matching has been identified as a component of culturally sensitive treatment.

Methods

This study examined the perceived importance and prevalence of racial matching by surveying a national sample of substance use disorder (SUD) centers from the Substance Abuse and Mental Health Services Administration (SAMHSA).

Results

Using univariate statistical analysis, results for the prevalence of racial matching revealed that in 58% of the clinics, there was the potential to match a counselor with a racially similar client, while in 39% of the clinics, there was no potential to provide such a match. Among the agencies that displayed a potential for racial matching, 26% of the respondents indicated that they never racially matched clients and therapists, 71% reported that they sometimes practice racial matching, 15% indicated that they usually racially match, and only 7% purported to always racially match clients and therapists. Results for the perceived importance of racial matching revealed that in both situations where treatment centers had the potential for racial matching and did not have the potential for racial matching, supervisors reported that it was relatively important to provide culturally sensitive treatment but that it was not as important to match clients in SUD centers with racially/ethnically similar counselors.

Conclusion

The topic of racial matching can be very complex and has shown variation amongst SUD centers; however, this study emphasizes the importance of providing culturally sensitive treatment and an appreciation of differences among members within each racial group.
Treatment of secondary hip arthritis from shell fragment and gunshot injury in the Syrian civil war
Authors: Özden Raif , Davut Serkan , Doğramacı Yunus , Kalacı Aydıner , Duman İbrahim Gökhan , Uruç Vedat
Published: October 2020

Background

In gunshot and shell fragment injuries to the hip joint, orthopedic intervention includes wound assessment and care, osteosynthesis of fractures, and avoiding of infection and osteoarthritis. Individuals injured in the Syrian civil war were frequently transferred to the authors’ institution in neighboring city. Orthopedic trauma exposures were determined in approximately 30% of these patients. The aim of this study was to evaluate the outcomes of the patients with secondary hip arthritis due to prior gunshot and shell fragment (shrapnel) injuries who underwent primary total hip arthroplasty.

Methods

This retrospective study reviewed 26 patients (24 males, 2 females) who underwent hip arthroplasty due to prior gunshot and shell fragment injuries from November 2013 to January 2019. For all patients, the Harris Hip Score (HHS) was evaluated preoperatively and after surgery.

Results

Mean age was 31.5 (range, 19–48) years. The mean preoperative HHS was 52.95 points, and the mean postoperative HHS was 79.92 points at the final follow-up after surgery. Patients with shell fragment injuries to the hip joint had higher infection rates, but it is not statistically significant.

Conclusions

An anatomic reduction of the fracture may not be possible in these cases as a result of significant bone and/or cartilage loss. Total hip arthroplasty can be done after gunshot- and shell fragment-related posttraumatic arthritis. It is an effective treatment choice to reduce pain and improve function, but the surgeon must be very careful because of high rate of infection.
Abdominal fat pad biopsies exhibit good diagnostic accuracy in patients with suspected transthyretin amyloidosis
Authors: Paulsson Rokke Hedvig , Sadat Gousheh Nima , Westermark Per , Suhr Ole B. , Anan Intissar , Ihse Elisabet , Pilebro Björn , Wixner Jonas
Published: October 2020

Background

The diagnostic accuracy of histopathological detection of transthyretin amyloid (ATTR) by Congo red staining of abdominal fat samples has been questioned since low sensitivity has been reported, especially for patients with ATTR cardiomyopathy. However, the outcome of surgically obtained fat pad biopsies has not yet been evaluated. The aim was to evaluate the diagnostic accuracy of skin punch biopsies from abdominal fat in patients with suspected ATTR amyloidosis.

Material and methods

Data were evaluated from patients who had undergone abdominal fat pad biopsies using a skin punch due to suspected amyloidosis from 2006 to 2015. The biopsies had been analysed using Congo red staining to determine the presence of amyloid, and immunohistochemistry or Western blot to determine the type of amyloidosis. The final diagnosis was based on the clinical picture, biopsy results and DNA sequencing. Minimum follow-up after the initial biopsy was 3 years.

Results

Two hundred seventy-four patients (61% males) were identified, and in 132 (48%), a final diagnosis of amyloidosis had been settled. The majority (93%) had been diagnosed with hereditary transthyretin (ATTRv) amyloidosis, and therefore subsequent analyses were focused on these patients. Overall, our data showed a test specificity of 99% and a sensitivity of 91%. Ninety-eight (94%) of the patients had neuropathic symptoms at diagnosis, whereas 57 (55%) had signs of amyloid cardiomyopathy. Subgroup analyses showed that patients with merely neuropathic symptoms displayed the highest test sensitivity of 91%, whereas patients with pure cardiomyopathy displayed the lowest sensitivity of 83%. However, no significant differences in sensitivity were found between patients with or without cardiomyopathy or between the sexes.

Conclusions

Abdominal fat pad biopsies exhibit good diagnostic accuracy in patients with suspect ATTRv amyloidosis, including patients presenting with cardiomyopathy. In addition, the method enables typing not only of the precursor protein but also of the amyloid fibril type, which is related to the phenotype and to the outcome of the disease.
Endosomal dysfunction in iPSC-derived neural cells from Parkinson’s disease patients with VPS35 D620N
Authors: Bono Keiko , Hara-Miyauchi Chikako , Sumi Shunsuke , Oka Hisayoshi , Iguchi Yasuyuki , Okano Hirotaka James
Published: October 2020

Mutations in the Vacuolar protein sorting 35 (VPS35) gene have been linked to familial Parkinson’s disease (PD), PARK17. VPS35 is a key component of the retromer complex, which plays a central role in endosomal trafficking. However, whether and how VPS35 deficiency or mutation contributes to PD pathogenesis remain unclear. Here, we analyzed human induced pluripotent stem cell (iPSC)-derived neurons from PD patients with the VPS35 D620N mutation and addressed relevant disease mechanisms. In the disease group, dopaminergic (DA) neurons underwent extensive apoptotic cell death. The movement of Rab5a- or Rab7a-positive endosomes was slower, and the endosome fission and fusion frequencies were lower in the PD group than in the healthy control group. Interestingly, vesicles positive for cation-independent mannose 6-phosphate receptor transported by retromers were abnormally localized in glial cells derived from patient iPSCs. Furthermore, we found α-synuclein accumulation in TH positive DA neurons. Our results demonstrate the induction of cell death, endosomal dysfunction and α -synuclein accumulation in neural cells of the PD group. PARK17 patient-derived iPSCs provide an excellent experimental tool for understanding the pathophysiology underlying PD.
Outcomes with sequential FLT3-inhibitor-based therapies in patients with AML
Authors: Yilmaz Musa , Alfayez Mansour , DiNardo Courtney D. , Borthakur Gautam , Kadia Tapan M. , Konopleva Marina Y. , Loghavi Sanam , Kanagal-Shamanna Rashmi , Patel Keyur P. , Jabbour Elias J. , Garcia-Manero Guillermo , Pemmaraju Naveen , Pierce Sherry A. , Ghayas Issa , Short Nicholas J. , Montalban-Bravo Guillermo , Takahashi Koichi , Assi Rita , Alotaibi Ahmad S. , Ohanian Maro , Andreeff Michael , Cortes Jorge E. , Kantarjian Hagop M. , Ravandi Farhad , Daver Naval G.
Published: October 2020

Background

Second-generation FLT3-inhibitors (FLT3i) demonstrated single-agent composite CR rates (CRc) of 45–55% in patients with relapsed/refractory (R/R) FLT3-mutated AML in phase II/III trials. However, > 85% of patients treated were prior FLT3i naïve. The response rates to sequential FLT3i exposure remain poorly defined.

Methods

We retrospectively reviewed patients with FLT3-mutated AML between November 2006 and December 2019.

Results

In frontline patients treated with a FLT3i (cohort 1), the CRc rates and median overall survival (OS) with the first (n = 56), second (n = 32), and third FLT3i-based (n = 8) therapy were 77%, 31%, and 25%, and 16.7 months, 6.0 months, and 1.4 months, respectively. In patients receiving a FLT3i-based therapy for the first time in a R/R AML setting (cohort 2), the CRc rates and median OS were 45%, 21%, and 10%, and 7.9 months, 4.0 months, and 4.1 months with the first (n = 183), second (n = 89), and third/fourth (n = 29) FLT3i-based therapy, respectively.

In cohort 1, CRc rates with single-agent FLT3i (n = 21) versus FLT3i-based combinations (n = 19) in second/third sequential FLT3i exposures were 19% versus 42%, respectively. In cohort 2, the CRc rates with single-agent FLT3i (n = 82) versus FLT3i-based combinations (n = 101) in first FLT3i exposure were 34% versus 53%, respectively, and those with single-agent FLT3i (n = 63) versus FLT3i-based combinations (n = 55) in second/third/fourth sequential FLT3i exposures were 13% versus 25%, respectively.

Conclusion

CRc rates drop progressively with sequential exposure to FLT3i’s in FLT3-mutated AML. In all settings, CRc rates were higher with FLT3i-based combinations compared with single-agent FLT3i therapy in similar FLT3i exposure settings.
Synergistic antitumor interaction of valproic acid and simvastatin sensitizes prostate cancer to docetaxel by targeting CSCs compartment via YAP inhibition
Authors: Iannelli Federica , Roca Maria Serena , Lombardi Rita , Ciardiello Chiara , Grumetti Laura , De Rienzo Simona , Moccia Tania , Vitagliano Carlo , Sorice Angela , Costantini Susan , Milone Maria Rita , Pucci Biagio , Leone Alessandra , Di Gennaro Elena , Mancini Rita , Ciliberto Gennaro , Bruzzese Francesca , Budillon Alfredo
Published: October 2020

Background

Despite the introduction of several novel therapeutic approaches that improved survival, metastatic castration-resistant prostate cancer (mCRPC) remains an incurable disease. Herein we report the synergistic antitumor interaction between two well-known drugs used for years in clinical practice, the antiepileptic agent with histone deacetylase inhibitory activity valproic acid and the cholesterol lowering agent simvastatin, in mCRPC models.

Methods

Synergistic anti-tumor effect was assessed on PC3, 22Rv1, DU145, DU145R80, LNCaP prostate cancer cell lines and EPN normal prostate epithelial cells, by calculating combination index (CI), caspase 3/7 activation and colony formation assays as well as on tumor spheroids and microtissues scored with luminescence 3D-cell viability assay. Cancer stem cells (CSC) compartment was studied evaluating specific markers by RT-PCR, western blotting and flow cytometry as well as by limiting dilution assay. Cholesterol content was evaluated by 1H-NMR. Overexpression of wild-type YAP and constitutively active YAP5SA were obtained by lipofectamine-based transfection and evaluated by immunofluorescence, western blotting and RT-PCR. 22Rv1 R_39 docetaxel resistant cells were selected by stepwise exposure to increasing drug concentrations. In vivo experiments were performed on xenograft models of DU145R80, 22Rv1 parental and docetaxel resistant cells, in athymic mice.

Results

We demonstrated the capacity of the combined approach to target CSC compartment by a novel molecular mechanism based on the inhibition of YAP oncogene via concurrent modulation of mevalonate pathway and AMPK. Because both CSCs and YAP activation have been associated with chemo-resistance, we tested if the combined approach can potentiate docetaxel, a standard of care in mCRCP treatment. Indeed, we demonstrated, both in vitro and in vivo models, the ability of valproic acid/simvastatin combination to sensitize mCRPC cells to docetaxel and to revert docetaxel-resistance, by mevalonate pathway/YAP axis modulation.

Conclusion

Overall, mCRPC progression and therapeutic resistance driven by CSCs via YAP, can be tackled by the combined repurposing of two generic and safe drugs, an approach that warrants further clinical development in this disease.
Recommendations from the Italian Society of Pediatric Orthopaedics and Traumatology for the management of pediatric orthopaedic patients during the COVID19 pandemic and post-pandemic period in Italy
Authors: Trisolino Giovanni , Origo Carlo Enrico , De Sanctis Nando , Dibello Daniela , Farsetti Pasquale , Gigante Cosimo , Guida Pasquale , Marengo Lorenza , Panuccio Elena , Toniolo Renato Maria , Verdoni Fabio , Memeo Antonio
Published: October 2020

The rapid spread of the COVID-19 outbreak in Italy has dramatically impacted the National Healthcare System, causing the sudden congestion of hospitals, especially in Northern Italy, thus imposing drastic restriction of almost all routine medical care. This exceptional adaptation of the Italian National Healthcare System has also been felt by non-frontline settings such as Pediatric Orthopaedic Units, where the limitation or temporary suspension of most routine care activities met with a need to maintain continuity of care and avoid secondary issues due to the delay or suspension of the routine clinical practice. The Italian Society of Pediatric Orthopaedics and Traumatology formulated general and specific recommendations to face the COVID-19 outbreak, aiming to provide essential care for children needing orthopaedic treatments during the pandemic and early post-peak period, ensure safety of children, caregivers and healthcare providers and limit the spread of contagion.
Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial
Authors: Wester Michael , Koll Franziska , Zeman Florian , Dempfle Astrid , Koller Michael , Frey Norbert , Maier Lars S. , Sossalla Samuel
Published: October 2020

Background

Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS.

Design and methods

The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI.

Discussion

The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory.

Trial registration

German Clinical Trials Register DRKS00017524. Registered on 5 July 2019
The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Authors: Bugge Carol , Kearney Rohna , Dembinsky Melanie , Khunda Aethele , Graham Margaret , Agur Wael , Breeman Suzanne , Dwyer Lucy , Elders Andrew , Forrest Mark , Goodman Kirsteen , Guerrero Karen , Hemming Christine , Mason Helen , McClurg Doreen , Melone Lynn , Norrie John , Thakar Ranee , Hagen Suzanne
Published: October 2020

Background

Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women’s condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants’ and healthcare professionals’ experiences.

Methods

The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12–18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan.

Discussion

The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs.

Trial registration

ISRCTN62510577. Registered on 6 October 2017.
Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial
Authors: Hagen Suzanne , Kearney Rohna , Goodman Kirsteen , Melone Lynn , Elders Andrew , Manoukian Sarkis , Agur Wael , Best Catherine , Breeman Suzanne , Dembinsky Melanie , Dwyer Lucy , Forrest Mark , Graham Margaret , Guerrero Karen , Hemming Christine , Khunda Aethele , Mason Helen , McClurg Doreen , Norrie John , Karachalia-Sandri Anastasia , Thakar Ranee , Bugge Carol
Published: October 2020

Background

Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care.

Methods

This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months’ post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months’ post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper.

Discussion

The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women’s quality of life, and of its cost-effectiveness.

Trial registration

ISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.
Associations between pre-pregnancy body mass index and gestational weight gain with pregnancy outcomes in women with polycystic ovary syndrome
Authors: Zhang Lirui , Zheng Wei , Liu Cheng , Liang Xin , Zhang Li , Tian Zhihong , Li Guanghui
Published: October 2020

Background

The influence of pre-pregnancy body mass index (BMI) and gestational weight gain (GWG) on perinatal outcomes of women with polycystic ovary syndrome (PCOS) remains unclear. Therefore, we explored how the above indicators influence pregnancy outcomes in women with PCOS.

Methods

A retrospective study was conducted involving the baseline characteristics, laboratory data, and pregnancy outcomes of 722 pregnant women with PCOS. Subjects were grouped in a way to find out risks in their pregnancy outcomes. Multivariable logistic regression analysis was performed to investigate how BMI and GWG were associated with perinatal outcomes.

Results

Among women with PCOS, underweight increased the risk of small for gestational age (SGA) (OR 12.35, 95% CI 3.56–42.82), but reduced the risk of large for gestational age (LGA). Overweight but not obese women were more susceptible to developing preeclampsia (PE) than women with normal weight. In PCOS women with BMI < 25 kg/m2 before pregnancy, inadequate GWG was a protective factor for gestational hypertension (GH) and postpartum hemorrhage (PPH), excessive GWG exhibited a positive correlation with LGA. But in PCOS women with BMI ≥ 25 kg/m2, excessive GWG increased the probability of undergoing a cesarean section. Inadequate GWG did not reduce the likelihood of LGA in women with BMI ≥ 25 kg/m2, and excessive GWG did not reduce the probability of SGA in women with BMI < 25 kg/m2.

Conclusion

The impacts of pre-pregnancy BMI, GWG on maternal and infant outcomes among PCOS women are similar to reported results in general pregnant women. However, some unique trends were also observed in PCOS women. While the underweight factor significantly increased the risk of SGA birth, overweight but not obesity was correlated with the risk of PE. Inadequate GWG was a protective factor for GH and PPH only in women with pregestational BMI < 25 kg/m2. Inadequate GWG did not reduce the probability of LGA in women with BMI ≥ 25 kg/m2, and similarly, excessive GWG did not reduce the probability of SGA in women with BMI < 25 kg/m2. Overall, these findings indicate that women with PCOS should begin weight management before pregnancy.
Laparoscopic liver resection after laparoscopic pancreatoduodenectomy for liver metastases of ampulla of Vater adenocarcinoma
Authors: Kiriyama Muneyasu , Kaneoka Yuji , Maeda Atsuyuki , Takayama Yuichi , Takahashi Takamasa , Seita Kazuaki
Published: October 2020

Background

Repeat laparoscopic surgery has become increasingly common. However, reports of liver resection after pancreatoduodenectomy are scarce, and we report the first successful case of a patient who underwent laparoscopic liver resection after laparoscopic pancreatoduodenectomy.

Case presentation

A 65-year-old man underwent laparoscopic pancreatoduodenectomy for ampulla of Vater adenocarcinoma. According to the American Joint Committee on Cancer (8th edition) staging guidelines, the tumour was labelled as stage IIIB (fT2N2M0). Twelve months later, a computed tomography (CT) scan revealed liver masses (in segments 3 and 5) and swollen para-aortic lymph nodes. After six chemotherapy courses of gemcitabine with cisplatin, the CT scan showed the disappearance of the para-aortic lymph nodes and progression of liver metastases. Nineteen months after the initial surgery, the patient underwent laparoscopic partial liver resection of segment 5 and left lateral sectionectomy. First, we performed the operation in the left half lateral decubitus position. In this position, the portal vein was isolated safely without hindering the hepato-jejunal anastomosis, although the adhesions around the hepato-jejunal anastomosis were dense. Therefore, we were able to perform liver transection safely with vascular inflow control. The operation duration was 235 min, and the volume of blood loss was 100 g. Macroscopically, the resected margins were negative. The patient was uneventfully discharged 12 days after the second operation. Afterwards, drainage was needed because of an intra-abdominal abscess. Currently, he has been alive for 8 months postoperatively, receives chemotherapy to suppress para-aortic lymph node metastases, and has not had another recurrence.

Conclusions

Liver resection after pancreatoduodenectomy can be performed safely with an innovative body position to isolate the portal vein, which is a key point of the surgery. A laparoscopic approach for liver resection after pancreatoduodenectomy is a feasible option.
Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder
Authors: Revicki Dennis A. , Althof Stanley E. , Derogatis Leonard R. , Kingsberg Sheryl A. , Wilson Hilary , Sadiq Amama , Krop Julie , Jordan Robert , Lucas Johna
Published: October 2020

Background

The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials.

Methods

Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit.

Results

At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001).

Conclusions

The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire.

Trial registration

NCT02338960 and NCT02333071 (RECONNECT studies).
Trans-Radial Approach: technical and clinical outcomes in neurovascular procedures
Authors: Romano D. G. , Frauenfelder G. , Tartaglione S. , Diana F. , Saponiero R.
Published: October 2020

Background

To evaluate efficacy and safety of Trans-Radial Approach (TRA) in cerebral angiography for diagnostic and therapeutic purpose.

Methods

We retrospectively included consecutive patients eligible for TRA cerebral angiography at our Institution between September 2019 and January 2020. Cerebral DSA was classified in diagnostic (one-vessel imaging) or therapeutic (emergency/elective). Technical and clinical outcome were recorded for each group.

Results

A total of 61 TRA angiographies were evaluated. Right-sided TRA was obtained in 85,2% of all cases. Interventional procedures included 11 strokes, 2 ruptured aneurysms, 2 unrupted aneurysms, 1 DAVF and 3 symptomatic atheromatous intracranial stenosis. Successful TRA angiographies were obtained in 97,6% and 94,7% for diagnostic and therapeutic group, respectively. No major radial artery complications were recorded. Mean puncture-to-final angiogram was 11 and 62 min for diagnostic and therapeutic groups, respectively. Mean radial compression maintenance was 4 h, allowing patients discharge within 6 h in all cases undergone diagnostic angiography.

Conclusions

TRA could be a valid technique in terms of efficacy and safety both for diagnostic and therapeutic cerebral angiographies, with low complication rate.
Do early trends in oak barrens fire treatment predict later outcomes? Insights from three decades of vegetation monitoring
Authors: Taft John B.
Published: October 2020

Background

Vegetation structure, species diversity, and composition have been monitored at a fire-treatment and a fire-free control unit of a dry oak barrens and woodland complex in southern Illinois, USA, over a 29-year period and five burns. The restoration hypothesis is that fire management would result in different trends for vegetation parameters of conservation interest between fire treatment and control units, that before–after differences would be greater with fire management, and that early trends provide a reliable predictor for later outcomes. This study examines effectiveness of management in achieving restoration goals and uses response to the first two burns and monitoring results over the first seven years as an estimation period to test whether early trends with fire treatment are a reliable predictor for outcomes following three additional burns over the following 22 years.

Results

Trends differed between fire-treatment and control units for all parameters measured, and before–after differences were greater at the fire treatment unit. However, trends at the fire-treatment unit during the estimation period were a poor predictor of later outcomes. Tree density and basal area declined more than expected while ground-layer species density, richness, diversity, and percent cover did not keep pace with expectations of increase. Trends at the control unit were more predictable; however, tree basal area declined more than expected, possibly due to an outbreak of rapid white oak mortality disease, and decline of ground-layer species density was less than predicted from the early estimation period.

Conclusions

Results suggested that fire alone can be effective at restoring woodland and barrens natural areas and that a fire return interval of about every four years would be optimal for maintaining composition and diversity in this specific oak barrens habitat. However, burns followed immediately by severe drought possibly can have negative interactions, resulting in declines of ground-layer species diversity.
COL1A1 polymorphism and neurological complications in pediatric acute lymphoblastic leukemia patients and their associations with altered bone mineral density
Authors: Omran Alaa A. , Nageeb Rania S. , Nageeb Ghada S. , Yosif Manal A. , Mohammad Yassir A. , Ali Alshimaa A. , Atfy Mervat , Azmy Taghreed M. , Elsaid Hanaa H.
Published: October 2020

Background

Osteoporosis and neurological complications are consequences of acute lymphoblastic leukemia (ALL). Collagen type I alpha 1 gene (COL1A1) polymorphism is associated with osteoporosis. This study aimed to detect the COL1A1 polymorphism and the neurological complications in ALL patients and their association with decreased lumbar spine bone mineral density (BMDLS). This study included 100 pediatric ALL patients and 100 controls. All participants were subjected to laboratory assessment and assessment of BMDLS at the start of the study and 3 years later. COLIA1 genotyping was done once for all participants.

Results

At the start of the study, there was a significant decrease in osteocalcin (OC), alkaline phosphatase (ALP), and BMDLS levels in the patients. G/T variants and “T” alleles were significantly more detected in the patients (34% and 35% respectively); also, significant differences were detected between patients with polymorphism (G/T and T/T) and those without polymorphism (G/G) regarding OC, ALP, and BMDLS. After 3 years, significant decrement in BMDLS, OC, and ALP was detected in the patients. Twenty-four patients had neurological complications and seven patients had bone fractures. Those patients had significant decrement in BMDLS, OC, and ALP levels. As regards COL1A1 gene polymorphism, the GT and TT variants were significantly detected in fractured patients, while there was no significant difference regarding GT and TT variants in the patients with neurological complications. T allele, neurological complications, high-risk stratification, and age were significantly associated with decreased BMDLS. T allele was the most significant risk factor.

Conclusion

COLIA1 gene polymorphism, decreased BMDLS, and neurological complications were significantly detected in pediatric ALL patients. COLIA1 gene polymorphism is a significant risk factor for decreased BMDLS in pediatric ALL patients. There is no significant relation between COLIA1 gene polymorphism and the development of neurologic complications.