bluuebunny/crossref_metadata_2025 huggingface dataset:
The role of left atrial strain in patients with functional tricuspid regurgitation before and after annuloplasty: a long-term follow-up study
Authors: Meng Qing-long , Meng Hong , Tao Jia , Yang Shu , Wang Hao
Published: October 2021

Background

Functional tricuspid regurgitation (TR) is common among patients with left heart disease and may recur during the follow-up period after selective tricuspid valve annuloplasty (TVA). This study aims to analyse the relationship between left atrial (LA) strain and the degree of preoperative functional TR and to explore the role of LA strain in predicting TR recurrence.

Methods

This study included 63 patients with rheumatic mitral stenosis who underwent mitral valve replacement and concomitant TVA. Additionally, 20 healthy controls were enrolled. Preoperative conventional LA echocardiographic parameters and LA strain were measured. The association between LA strain and preoperative functional TR severity was analysed by Pearson correlation. Predictors of recurrent TR were determined by multivariate logistic regression analyses.

Results

Compared with the control group, the mitral stenosis group developed a significant impairment in terms of LA strain. The degree of preoperative functional TR exhibited moderate correlations with LA reservoir strain (r = − 0.57) and LA conduit strain (r = 0.48). During a median follow-up period of 66.4 ± 36.4 months, TR recurred in 18 patients. Preoperative LA reservoir strain and the mean transmitral gradient were predictors of postoperative TR recurrence. When the two indexes were combined to establish a prediction, the sensitivity and specificity of prediction increased. The area under the receiver operating characteristic curve of the combined indicator was higher than those of the single indicators (0.90 vs. 0.70 and 0.72).

Conclusions

LA strain correlates with preoperative functional TR severity in patients with rheumatic mitral stenosis. The LA reservoir strain and preoperative mean transmitral gradient are independent predictive factors for recurrent TR after TVA.
Prognostic value of immune-related lncRNA pairs in patients with bladder cancer
Authors: Gao Zhenzhen , Wu Dongjuan , Zheng Wenwen , Zhu Taohong , Sun Ting , Yuan Lianhong , Fei Faming , Fu Peng
Published: October 2021

Background

The characteristics of immune-related long non-coding ribonucleic acids (ir-lncRNAs), regardless of their specific levels, have important implications for the prognosis of patients with bladder cancer.

Methods

Based on The Cancer Genome Atlas database, original transcript data were analyzed. The ir-lncRNAs were obtained using a coexpression method, and their differentially expressed pairs (DE-ir-lncRNAs) were identified by univariate analysis. The lncRNA pairs were verified using a Lasso regression test. Thereafter, receiver operating characteristic curves were generated, and an optimal risk model was established. The clinical value of the model was verified through the analysis of patient survival rates, clinicopathological characteristics, presence of tumor-infiltrating immune cells, and chemotherapy efficacy evaluation.

Results

In total, 49 pairs of DE-ir-lncRNAs were identified, of which 21 were included in the Cox regression model. A risk regression model was established on the premise of not involving the specific expression value of the transcripts.

Conclusions

The method and model used in this study have important clinical predictive value for bladder cancer and other malignant tumors.
Plasma Prokineticin 1, a prognostic biomarker in colorectal cancer patients with curative resection: a retrospective cohort study
Authors: Tagai Noriyuki , Goi Takanori , Shimada Michiaki , Kurebayashi Hidetaka
Published: October 2021

Background

Prokineticin 1 (PROK1) was reported as an angiogenic factor, which is associated with tumor progression, cell invasion, and metastasis in colorectal cancer. Although the association between PROK1 expression in primary cancer lesion and patient prognosis was reported, it is unclear whether plasma PROK1 concentration may be a predictive factor in colorectal cancer patients. This study investigated the association between PROK1 concentration in plasma and prognosis in colorectal cancer patients.

Methods

We measured preoperative PROK1 plasma levels using ELISA method, while PROK1 expression in primary cancer lesion was evaluated using immunohistochemistry (IHC). The association between plasma PROK1 levels and cancer-related survival rate (CRS) was evaluated. Additionally, we examined whether simultaneous PROK1 expression in both primary cancer lesions and plasma was correlated with CRS. The cancer-related survival rate was calculated using the Kaplan-Meier method, and survival estimates were compared using the log-rank test.

Results

We have gathered eligible 130 CRC patients retrospectively. Out of 130 patients, 61 (46.9%) were positive on IHC in primary cancer, and 69 (53.1%) were negative, while 43 (33.1%) had high-value PROK1 in plasma. Out of these 43, 30 (25.4%) also had concomitant higher IHC expression in primary cancer. The plasma PROK1 levels tended to increase with advancing stages. The plasma PROK1-positive group had a lower 5-year CRS than the negative group (63.6% vs. 88.2%; P = 0.006). Additionally, simultaneous PROK1 expression was associated with a more significant decrease of 5-year CRS than both negative groups in all stages (76.2% vs. 92.5%; P = 0.003) and stage III (59.3% vs. 84.5%; P = 0.047). Multivariate analysis showed simultaneous PROK1 expression was independently associated with worse CRS (HR, 1.97; 95% CI 1.20‑3.24, P < 0.01).

Conclusion

PROK1 expression in preoperative plasma reflects poor prognosis in patients undergoing curative resection for colorectal cancer. The plasma PROK1 level may be a potential predictive marker, especially in stage III colorectal cancer patients.
Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States
Authors: Dubé Karine , Kanazawa John , Dee Lynda , Taylor Jeff , Sauceda John A. , Gianella Sara , Smith Davey , Deeks Steven G. , Peluso Michael J.
Published: October 2021

Background

An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.

Methods

We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.

Results

We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.

Conclusion

The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.
Modulation of host cell signaling during cytomegalovirus latency and reactivation
Authors: Smith Nicholas A. , Chan Gary C. , O’Connor Christine M.
Published: October 2021

Background

Human cytomegalovirus (HCMV) resides latently in cells of the myeloid compartment, including CD34+hematopoietic progenitor cells and circulating monocytes. Healthy hosts maintain the virus latently, and this infection is, for the most part, asymptomatic. However, given the proper external cues, HCMV reactivates from latency, at which point the virus disseminates, causing disease. The viral and cellular factors dictating the balance between these phases of infection are incompletely understood, though a large body of literature support a role for viral-mediated manipulation of host cell signaling.

Main body

To establish and maintain latency, HCMV has evolved various means by which it usurps host cell factors to alter the cellular environment to its own advantage, including altering host cell signaling cascades. As early as virus entry into myeloid cells, HCMV usurps cellular signaling to change the cellular milieu, and this regulation includes upregulation, as well as downregulation, of different signaling cascades. Indeed, given proper reactivation cues, this signaling is again altered to allow for transactivation of viral lytic genes.

Conclusions

HCMV modulation of host cell signaling is not binary, and many of the cellular pathways altered are finely regulated, wherein the slightest modification imparts profound changes to the cellular milieu. It is also evident that viral-mediated cell signaling differs not only between these phases of infection, but also is myeloid cell type specific. Nonetheless, understanding the exact pathways and the means by which HCMV mediates them will undoubtedly provide novel targets for therapeutic intervention.
Porcine reproductive and respiratory syndrome virus genetic variability a management and diagnostic dilemma
Authors: Risser Jessica , Ackerman Matthew , Evelsizer Robert , Wu Stephen , Kwon Byungjoon , Hammer James Mark
Published: October 2021

As genetic analysis becomes less expensive, more comprehensive diagnostics such as whole genome sequencing (WGS) will become available to the veterinary practitioner. The WGS elucidates more about porcine reproductive and respiratory syndrome virus (PRRSV) beyond the traditional analysis of open reading frame (ORF) 5 Sanger sequencing. The veterinary practitioner will require a more complete understanding of the mechanics and consequences of PRRSV genetic variability to interpret the WGS results. More recently, PRRSV recombination events have been described in the literature. The objective of this review is to provide a comprehensive outlook for swine practitioners that PRRSV mutates and recombines naturally causing genetic variability, review the diagnostic cadence when suspecting recombination has occurred, and present theory on how, why, and where industry accepted management practices may influence recombination. As practitioners, it is imperative to remember that PRRS viral recombination is occurring continuously in swine populations. Finding a recombinant by diagnostic analysis does not ultimately declare its significance. The error prone replication, mutation, and recombination of PRRSV means exact clones may exist; but a quasispecies swarm of variable strains also exist adding to the genetic diversity. PRRSV nonstructural proteins (nsps) are translated from ORF1a and ORF1b. The arterivirus nsps modulate the hosts’ immune response and are involved in viral pathogenesis. The strains that contribute the PRRSV replicase and transcription complex is driving replication and possibly recombination in the quasispecies swarm. Furthermore, mutations favoring the virus to evade the immune system may result in the emergence of a more fit virus. More fit viruses tend to become the dominant strains in the quasispecies swarm. In theory, the swine management practices that may exacerbate or mitigate recombination include immunization strategies, swine movements, regional swine density, and topography. Controlling PRRSV equates to managing the quasispecies swarm and its interaction with the host. Further research is warranted on the frequency of recombination and the genome characteristics impacting the recombination rate. With a well-defined understanding of these characteristics, the clinical implications from recombination can be detected and potentially reduced; thus, minimizing recombination and perhaps the emergence of epidemic strains.
The legacy of traditional rice cultivation by descendants of Indian contract laborers in Suriname
Authors: Ramdayal Melissa , Maat Harro , van Andel Tinde
Published: October 2021

Background

Some 35,000 indentured laborers from India were recruited to work on plantations in Suriname between 1868 and 1916. It is likely that most were familiar with farming before they were shipped to this former Dutch colony in the Caribbean. Around 1900, those who did not return received a piece of land where most of them started growing rice as a staple crop. Agronomists characterized their traditional landraces as inferior and infested with weedy rice and started to ‘purify’ these landraces. No research has been done on whether these ancient rice varieties still exist. We aimed to document the rice varieties (both landraces and more modern cultivars) grown currently or in the recent past by (descendants of) Hindustani smallholders in Suriname, their origin, morphological and agronomic characters, local uses and cultural and spiritual relevance. Given the rapid decline in small-scale rice cultivation in the past 40 years, we wanted to know why people continued or abandoned rice farming and what aspects of traditional practices still survived.

Methods

We interviewed 26 (former) small-scale Hindustani farmers and asked about the varieties they cultivated and traditional agricultural practices. We collected seed samples, local names and associated information, and compared these to information from agricultural reports from the colonial period. We also interviewed 11 Maroons, one Javanese farmer, and three persons of mixed ethnicity, who were somehow involved in the cultivation of East Indian rice varieties.

Results and discussion

Hindustani smallholders in Suriname largely lost their traditional rice landraces. Most of the interviewed farmers grew modern cultivars, developed after 2000. Some cultivars from the 1950s were still planted for fodder, but these were heavily mixed with weedy rice and other weeds. Maroon farmers in the interior, however, still actively cultivated varieties with names like ‘coolie rice’, which probably descend from landraces introduced by the Indian contract laborers, although this needs to be confirmed by molecular research. Although traditional cultivation practices seem to have been lost, smallholders still retain pleasant memories of the manual planting, harvesting, and processing of rice, as well as the gender-based practices and beliefs associated with the cultivation of the crop. The oral history of former rice farmers and traditional rice varieties (possibly obtained from Maroon fields) could play a role in museum settings as living vehicles for memories of the descendants of Asian contract labourers in Suriname and Guyana.
Exploring women’s perceptions of pain when breastfeeding using online forums
Authors: Caes Line , Abbott Katie , Currie Sinéad
Published: October 2021

Background

Despite numerous benefits, many mothers stop breastfeeding soon after birth. A common reason for this is the experience of pain or discomfort. One resource which women use to share their breastfeeding challenges and seek support are online forums. This study aimed to collect data from online forums to explore 1) usage of forums as social support for breastfeeding-related pain; 2) experiences of breastfeeding-related pain; 3) perceptions and strategies to deal with breastfeeding-related pain; and 4) the impact of pain on breastfeeding duration.

Methods

Data was gathered through searches of online forums based in the UK and USA: Netmums, What to Expect and Mumsnet using key terms: ‘painful breastfeeding’ and ‘sore breastfeeding’. Data extraction took place in July 2018 and included posts made between 2012 and 2018. Data included 123 posts and 193 replies, analysed using thematic analysis.

Results

The first theme identified was ‘variation in types of pain’, highlighting the variety of painful experiences and their descriptions. In particular, this theme reveals the large variety of different types of pain women experience at different stages throughout their breastfeeding journey, as well as the different pain characteristic they focus on in the description of their experience (i.e., location, sensory or physical aspects). Secondly, the theme ‘perceived causes and explanations for pain’ revealed how women interpret pain experiences either due to a recognised condition or behavioural cause. The third theme ‘cessation of breastfeeding related to pain’ identified. How women experience both physical and psychological struggles (e.g., guilt) related to breastfeeding cessation, with pain being a main factor in considering cessation of breastfeeding. Finally, the theme ‘shared experiences and support’ identified women’s strong need for both practical and emotional support to deal with pain. Many women look for this support through the knowledge exchange offered on the online forums.

Conclusions

Pain was a key reason for breastfeeding cessation, commonly associated with strong feelings of guilt. The online forums provide a unique form of social support for breastfeeding women to find ways to cope with the pain, while highlighting the urgent need for more appropriate antenatal education on realistic expectation surrounding breastfeeding.
Examining prevalence and correlates of smoking opioids in British Columbia: opioids are more often smoked than injected
Authors: Parent Stephanie , Papamihali Kristi , Graham Brittany , Buxton Jane A.
Published: October 2021

Background

British Columbia (BC) is in the midst of an opioid overdose crisis. Since 2017, smoking illicit drugs has been the leading mode of drug administration causing overdose death. Yet, little is known about people who smoke opioids, and factors underlying choice of mode of administration. The study objectives are to identify the prevalence and correlates associated with smoking opioids.

Methods

The Harm Reduction Client Survey is a monitoring tool used by the BC Centre for Disease Control since 2012. This survey is disseminated to harm reduction sites across BC to understand drug use trends and drug-related harms. We examined data from the survey administered October–December 2019 and performed descriptive, univariate, and multivariate analyses to better understand factors associated with smoking opioids.

Results

A total of 369 people who used opioids in the past 3 days were included, of whom 251 (68.0%) reported smoking opioids. A total of 109 (29.5%) respondents experienced an overdose in the past 6 months; of these 79 (72.5%) smoked opioids. Factors significantly associated with smoking opioids were: living in a small community (AOR =2.41, CI =1.27–4.58), being a woman (AOR = 1.84, CI = 1.03–3.30), age under 30 (AOR = 5.41, CI = 2.19–13.40) or 30–39 (AOR = 2.77, CI = 1.33–5.78) compared to age ≥ 50, using drugs alone (AOR = 2.98, CI = 1.30–6.83), and owning a take-home naloxone kit (AOR = 2.01, CI = 1.08–3.72). Reported use of methamphetamines within the past 3 days was strongly associated with smoking opioids (AOR = 6.48, CI = 3.51–11.96).

Conclusions

Our findings highlight important correlates associated with smoking opioids, particularly the recent use of methamphetamines. These findings identify actions to better respond to the overdose crisis, such as targeted harm reduction approaches, educating on safer smoking, advocating for consumption sites where people can smoke drugs, and providing a regulated supply of opioids that can be smoked.
Serum RANKL levels in Chinese patients with ankylosing spondylitis: a meta-analysis
Authors: Ni Feifei , Zhang Yanchao , Peng Yi , Peng Xiaoxiao , Li Jianjun
Published: October 2021

Objective

We aimed to determine the association between serum receptor activator of nuclear factor-kappa B ligand (sRANKL) levels and ankylosing spondylitis (AS) in Chinese patients.

Methods

The PubMed, Cochrane Library, Embase, Chinese Biomedical Database, Web of Science, China National Knowledge Infrastructure, VIP, and Wan Fang databases were searched for studies conducted before October 1, 2020, without language restrictions. STATA version 12.0 and Revman version 5.3 were used to analyze the data. The standard mean differences (SMDs) and corresponding 95% confidence intervals (95% CIs) were calculated.

Results

Twelve clinical case–control studies, including 585 patients with AS and 423 healthy controls, were included. The combined SMD for sRANKL suggested that the sRANKL level was significantly higher in Chinese patients with AS than in healthy controls (SMD: 3.27, 95% CI 2.11–4.43, P < 0.00001). Serum RANKL-related factor osteoprotegerin (OPG) levels (SMD: 0.86, 95% CI 0.09–1.64, P < 0.03) were lower in the Chinese patients with AS than in healthy controls, and the RANKL/OPG ratio (SMD = 1.05, 95% CI 0.64–1.46, P < 0.00001) in Chinese patients with AS was approximately the same as that of healthy controls. Subgroup analysis indicated that patients from North and South China had higher sRANKL levels than controls; the sRANKL levels of patients from South China were higher in the subgroup with a Bath Ankylosing Spondylitis Functional Index (BASFI) of > 4 than those of patients in other subgroups. In terms of duration, patients with AS for > 8 years had higher sRANKL levels than health controls. Other subgroup analyses were conducted by region, language, source of control, age, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). In these subgroups, the sRANKL levels were significantly higher in the patients with AS than in healthy controls. The BASFI and BASDAI were sources of heterogeneity.

Conclusions

The sRANKL levels are higher in Chinese patients with AS, especially among those from South China. sRANKL levels may be positively correlated with the pathogenesis of AS among Chinese patients.
Clinical value of MRI in evaluating and diagnosing of humeral lateral condyle fracture in children
Authors: Qi Yang , Guo Lin , Sun Man , Wang Zhi
Published: October 2021

Background

Humeral lateral condyle fractures (HLCFs) are common paediatric fractures. Radiographs are hard to accurately evaluate and diagnose the damage of articular epiphyseal cartilage in HLCFs.

Methods

60 children who should be suspected to be HLCFs in clinical practice from Dec 2015 to Nov 2017 were continuously included as the first part patients. Subsequently, 35 HLCFs patients with complete follow-up information who had no obvious displacement on radiograph were the second part patients. The sensitivity and specificity of radiograph and MRI in diagnosing of HLCFs and their stability were calculated respectively. Calculated the sensitivity and specificity of each scan sequence of MRI in diagnosing of HLCFs osteochondral fractures. The degree of fracture displacement was measured respectively. Compared the ratio of surgical treatment, secondary fracture displacement and complications between the stable fracture group and the unstable fracture group on MRI in part 2 patients.

Results

Sensitivity of diagnosing HLCFs by MRI was significantly higher than radiograph (100.00% vs. 89.09%, P = 0.03). Sensitivity of diagnosing integrity of trochlear cartilage chain by MRI was 96.30%, which was significantly higher than that by radiograph (62.96%, P < 0.01). The sensitivity of cartilage sensitive sequence (3D-FS-FSPGR/3D-FSPGR) was different with FS-PDWI and FS-T2WI (P = 0.01 and P = 0.02, respectively). The degree of HLCFs displacement by MRI was higher than radiograph (P < 0.05). In the unstable fracture group, 5 cases (45.45%) had a fracture displacement of more than 2 mm on MRI, which was significantly higher than that in stable fracture group (0.00%, P < 0.01).

Conclusions

MRI is superior to the radiograph of elbow joint in evaluating and diagnosing children HLCFs and their stability. The coronal 3D-FS-FSPGR/3D-FSPGR sequence is a significant sequence for diagnosing osteochondral fractures in HLCFs. MRI can provide important clinical value for treatment decisions of HLCFs without significant displacement.
The therapeutic promises of Lianhuaqingke in the mice model of coronavirus pneumonia (HCoV-229E and SARS-CoV-2)
Authors: Wang Mingye , Li Wenyan , Cui Wenwen , Hao Yuanyuan , Mi Yao , Wang Hongtao , Hou Yunlong , Jia Zhenhua
Published: October 2021

Background

Lianhuaqingke (LHQK) has been approved for the treatment of acute tracheobronchitis and exerts a broad-spectrum antiviral effect in our previous study.

Methods

Acute pneumonia caused by HCoV-229E was modeled in BALB/c mice. The anti-viral effect of LHQK was assessed by measuring the lung index and virus titer of lung tissues. The expression levels of pro-inflammatory cytokines in lung tissues and peripheral blood were measured by ELISA. The morphological changes of lung tissues were observed by H&E staining. The subsets of Th cells were assayed by the flow cytometry, including Th0, Th1, Th2, Treg, and Th17. The expression level of MUC5AC in 16HBE cells treated with TNFα was measured by ELISA. Immunofluorescence staining for β-IV tubulin was used to identify the airway epithelial ciliary in the condition-cultured RTE cells treated with TNFα. The direct antiviral effect of LHQK was assessed in vitro in Vero E6 infected by SARS-CoV-2, validated in vivo in the COVID-19 model of hACE2 transgenic mouse by detecting the lung index, the SARS-CoV-2 virus load, and the morphological changes of lung tissues.

Results

LHQK reduced the weight loss and the lung index by inhibiting the HCoV-229E replication and reducing the expression of pro-inflammatory cytokines in lung tissues. An assay for the Th cell subsets in peripheral blood revealed that LHQK could reduce the ratio of Th1/Th2 and increase the Treg/Th17 ratio in a dose-dependent way, which indicated that LHQK could coordinate the Th-mediated immune responses against the virus. In in vitro injury by TNFα, LHQK inhibited MUC5AC expression in 16HBE cells and increased the number of β-IV tubulin positive staining cells in the condition-cultured RTE cells. In the SARS-CoV-2-infected mice, LHQK could reduce weight loss, inhibit viral replication, and alleviate lung tissue damage.

Conclusions

Our results demonstrate that LHQK exerts therapeutic effects on pneumonia caused by HCoVs (HCoV-229E and SARS-CoV-2) in mice, and that the anti-HCoV effects might depend on its immunomodulatory capacities. All these results suggest that LHQK serves as a potential adjuvant for anti-HCoV therapies.
Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study
Authors: Padilla Brad , Shields Alan L. , Taylor Fiona , Li Xiaoran , Mcdonald Jeffrey , Green Tanya , Boral Anthony L. , Lin Hui-Min , Akin Cem , Siebenhaar Frank , Mar Brenton
Published: October 2021

Background

Indolent systemic mastocytosis (ISM) is a rare, clonal mast cell neoplasm characterized by severe, unpredictable symptoms. The Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) items compose a Total Symptom Score (TSS), Gastrointestinal Symptom Score (GSS), and Skin Symptom Score (SSS) to assess symptom severity. This study evaluated the psychometric performance of ISM-SAF among ISM patients.

Methods

In PIONEER, a Phase 2 trial evaluating safety and efficacy of selective kinase inhibitor avapritinib in patients with ISM, the 12-item ISM-SAF was administered daily. Psychometric evaluation of score reliability, validity, and clinical interpretation was conducted using the trial data.

Results

Thirty-eight patients contributed to analyses (78.9% female; mean age = 49). Baseline internal consistency reliability (α) for bi-weekly TSS, GSS, and SSS was 0.86, 0.83, and 0.82, respectively. Test–retest reliability among patients exhibiting no change in Patient Global Impression of Symptom Severity (PGIS) between Baseline and Day 15 exceeded 0.74 universally. Construct validity and known-groups analysis showed moderate to strong ISM-SAF score correlation (r = 0.382–0.881) to supportive patient-reported questionnaires (e.g., PGIS and Mastocytosis Quality of Life Questionnaire) symptom and skin scores, and ability to distinguish among clinically unique groups. Correlations of ISM-SAF and other assessment change scores reflect evidence of score sensitivity. Clinically important difference and response estimates were 7–10 and 19, respectively.

Discussion

ISM-SAF produced reliable, construct-valid, sensitive scores when administered in PIONEER to patients in the target population. Results of this study support the use of the ISM-SAF as a reliable and valid measure to evaluate disease symptomology in ISM patients.

Trial registration ClinicalTrials.gov, NCT03731260. Registered 10 October 2018, https://clinicaltrials.gov/ct2/show/study/NCT03731260.
Being a caregiver of a Behçet’s syndrome patient: challenges and perspectives during a complex journey
Authors: Talarico Rosaria , Marinello Diana , Manzo Arianna , Cannizzo Sara , Palla Ilaria , Ticciati Simone , Gaglioti Andrea , Trieste Leopoldo , Pisa Lorenzo , Badalamenti Luciano , Randisi Girolamo , Del Bianco Alessandra , Lorenzoni Valentina , Turchetti Giuseppe , Mosca Marta
Published: October 2021

Background

As often seen in many chronic diseases, the disease impact on patients also induces a significant impact on the quality of life (QoL) of caregivers. Caregivers are the ones who are really willing to offer care in the general approach of many aspects of the disease, including the awareness of the diseases itself, the daily management of therapy, and all the potential challenges that living with a chronic disease can include. The main objectives of the study were to explore the perspectives and views of caregivers of Behçet’s syndrome (BS) patients, to study their level of awareness on the disease and the impact that BS may have on their lives by means of a survey co-designed with caregivers and patients with this purpose. A survey was entirely co-designed with a panel of caregivers of patients living with BS patients.

Results

Results show that BS caregivers organise their life according to the needs of the patient, that they (79%) considered themselves as helpful for the patient and 53% of them replied that they can freely express their emotions. Notably, 70% and 68% of the respondents reported they renounced with a variable frequency to sexual relationships due to concerns regarding the health of the partner or to the partner’s illness, respectively. The majority (79%) of respondents indicated that they are familiar with the treatment taken by the patients and that 68% deal with the administration of some medicines. In terms of awareness, a good percentage (64%) of respondents reported to understand the illness and, in terms of education, 68% of participants are willing to take part in training programmes dedicated to BS.

Conclusions

The results of this survey contribute to provide new information on BS caregivers and on their important role, and to identify areas in which new initiatives could provide BS caregivers (and therefore patients) with tools and knowledge that can empower them in reducing the burden of the disease on their lives, on families, and on the patient.
Types of stigma experienced by patients with mental illness and mental health nurses in Indonesia: a qualitative content analysis
Authors: Subu Muhammad Arsyad , Wati Del Fatma , Netrida Netrida , Priscilla Vetty , Dias Jacqueline Maria , Abraham Mini Sarah , Slewa-Younan Shameran , Al-Yateem Nabeel
Published: October 2021

Background

Stigma refers to the discrediting, devaluing, and shaming of a person because of characteristics or attributes that they possess. Generally, stigma leads to negative social experiences such as isolation, rejection, marginalization, and discrimination. If related to a health condition such as mental illness, stigma may affect a person’s illness and treatment course, including access to appropriate and professional medical treatment. Stigma has also been reported to affect patients’ families or relatives, along with professionals who work in mental healthcare settings. Stigma is strongly influenced by cultural and contextual value systems that differ over time and across contexts. However, limited information is available on how types of stigma are experienced by patients with mental illness and mental health nurses in Indonesia.

Method

We explored the stigma-related experiences of 15 nurses and 15 patients in Indonesia. The study design and analysis of interview data were guided by deductive (directed) content analysis.

Results

Five themes emerged. Four themes were patient-related: personal/patients’ stigma, public/social stigma, family stigma, and employment stigma. The fifth theme related to stigma toward healthcare professionals working with patients with mental illnesses, which we categorized as professional stigma.

Conclusions

This study has achieved a deep understanding of the concept of stigma in the Indonesian context. This understanding is a prerequisite for developing appropriate interventions that address this phenomenon and thereby for the development of mental health services in Indonesia. This study may also be transferable to other countries that share similar cultural backgrounds and adhere to traditional and religious value systems.
Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial
Authors: Zheng Qin , Xu Haitao , Song Luxi , Yan Zeying , Sun Manqin , Peng Xia , Jiang Yiling , Shi Ling , Zhang Aiping , Wu Zhihao , Lu Jiahui , Luo Meihong
Published: October 2021

Background

Erythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions.

Methods

A prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors.

Discussion

This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS.

Trial registration

Chinese Clinical Trials Registry (http://www.chictr.org.cn/)ChiCTR1900026774.  Registered on October 21, 2019.
Scapular stabilization exercise based on the type of scapular dyskinesis versus traditional rehabilitation training in the treatment of periarthritis of the shoulder: study protocol for a randomized controlled trial
Authors: Tang Lan , Chen Kang , Ma Yuhui , Huang Lihua , Liang Juan , Ma Yanhong
Published: October 2021

Background

Periarthritis of the shoulder is a common disease leading to dysfunction of the shoulder joint and have a significant impact on patients’ daily life. Evidence shows that there is a close relationship between scapular dyskinesis (SD) and shoulder diseases. Scapular stabilization exercise has been proved to be efficacious in relieving pain and improving function. However, there is no targeted exercise based on the type of scapular dyskinesis. This study will investigate the potential of scapular stabilization exercise based on the type of scapular dyskinesis in treating periarthritis of the shoulder.

Methods

This study is a prospective, randomized controlled, parallel-group trial, intending to recruit 90 patients diagnosed with periarthritis of the shoulder. Patients will receive scapular stabilization exercise training based on the type of scapular dyskinesis or receive traditional rehabilitation training conducted for 30 min, once a day, for 6 weeks. The primary outcome is Constant-Murley score (CMS), and other outcomes include pain degree, range of motion (ROM), type of scapular dyskinesis, scapula position, and patients’ satisfaction with shoulder function. Assessments will be performed at baseline, 2-, 4- and 6-week treatment, and at the 6-week follow-up after the end of treatment.

Discussion

This study will be the first study to investigate the clinical efficacy of scapular stabilization exercise based on the type of scapular dyskinesis in patients with periarthritis of the shoulder. The results may provide evidence of the effect of targeted scapular stabilization exercise in improving shoulder function and correcting scapular dyskinesis, and provide valuable information for future research.

Trial registration

This study had been registered in the Chinese Clinical Trials Registry. Registration number: ChiCTR2100044332 at March 14, 2021.
Optimization of sepsis therapy based on patient-specific digital precision diagnostics using next generation sequencing (DigiSep-Trial)—study protocol for a randomized, controlled, interventional, open-label, multicenter trial
Authors: Brenner Thorsten , Skarabis Annabell , Stevens Philip , Axnick Jennifer , Haug Peter , Grumaz Silke , Bruckner Thomas , Luntz Steffen , Witzke Oliver , Pletz Mathias W. , Ruprecht Thomas M. , Marschall Ursula , Altin Sibel , Greiner Wolfgang , Berger Marc Moritz ,   for the TIFOnet Critical Care Trials Group
Published: October 2021

Background

Sepsis is triggered by an infection and represents one of the greatest challenges of modern intensive care medicine. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures represent a promising alternative. In particular, the plasmatic detection of circulating, cell-free DNA by next-generation sequencing (NGS) has shown to be suitable for identifying disease-causing pathogens in patients with bloodstream infections.

Methods

The DigiSep-Trial is a randomized, controlled, interventional, open-label, multicenter trial characterizing the effect of the combination of NGS-based digital precision diagnostics with standard-of-care microbiological analyses compared to solely standard-of-care microbiological analyses in the clinical picture of sepsis/septic shock. Additional anti-infective expert consultations are provided for both study groups. In 410 patients (n = 205 per arm) with sepsis/septic shock, the study examines whether the so-called DOOR-RADAR (Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) score (representing a combined endpoint including the criteria (1) intensive/intermediate care unit length of stay, (2) consumption of antibiotics, (3) mortality, and (4) acute kidney injury (AKI)) can be improved by an additional NGS-based diagnostic concept. We also aim to investigate the cost-effectiveness of this new diagnostic procedure. It is postulated that intensive/intermediate care unit length of stay, mortality rate, incidence of AKI, the duration of antimicrobial therapy as well as the costs caused by complications and outpatient aftercare can be reduced. Moreover, a significant improvement in patient’s quality of life is expected.

Discussion

The authors´ previous work suggests that NGS-based diagnostics have a higher specificity and sensitivity compared to standard-of-care microbiological analyses for detecting bloodstream infections. In combination with the here presented DigiSep-Trial, this work provides the optimal basis to establish a new NGS-driven concept as part of the national standard based on the best possible evidence.

Trial registrations

DRKS-ID DRKS00022782. Registered on August 25, 2020

ClinicalTrials.govNCT04571801. Registered October 1, 2020
The effect of a multidisciplinary lifestyle program for patients with rheumatoid arthritis, an increased risk for rheumatoid arthritis or with metabolic syndrome-associated osteoarthritis: the “Plants for Joints” randomized controlled trial protocol
Authors: Walrabenstein Wendy , van der Leeden Marike , Weijs Peter , van Middendorp Henriët , Wagenaar Carlijn , van Dongen Johanna Maria , Nieuwdorp Max , de Jonge Catharina Sophia , van Boheemen Laurette , van Schaardenburg Dirkjan
Published: October 2021

Low-grade inflammation and metabolic syndrome are seen in many chronic diseases, including rheumatoid arthritis (RA) and osteoarthritis (OA). Lifestyle interventions which combine different non-pharmacological therapies have shown synergizing effects in improving outcomes in patients with other chronic diseases or increased risk thereof, especially cardiovascular disease. For RA and metabolic syndrome-associated OA (MSOA), whole food plant-based diets (WFPDs) have shown promising results. A WFPD, however, had not yet been combined with other lifestyle interventions for RA and OA patients. In this protocol paper, we therefore present Plants for Joints, a multidisciplinary lifestyle program, based on a WFPD, exercise, and stress management. The objective is to study the effect of this program on disease activity in patients with RA (randomized controlled trial [RCT] 1), on a risk score for developing RA in patients with anti-citrullinated protein antibody (ACPA) positive arthralgia (RCT 2) and on pain, stiffness, and function in patients with MSOA (RCT 3), all in comparison with usual care.

We designed three 16-week observer-blind RCTs with a waiting-list control group for patients with RA with low to moderate disease activity (2.6 ≤ Disease Activity Score [DAS28] ≤ 5.1, RCT 1, n = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, n = 16) and for patients with metabolic syndrome and OA in the knee and/or hip (RCT 3, n = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6–12 other patients to receive theoretical and practical training on a WFPD, exercise, and stress management, while medication remains unchanged. The waiting-list control group receives usual care, while entering the program after the RCT. Primary outcomes are: difference in mean change between intervention and control groups within 16 weeks for the DAS28 in RA patients (RCT 1), the RA-risk score for ACPA positive arthralgia patients (RCT 2), and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score for MSOA patients (RCT 3). Continued adherence to the lifestyle program is measured in a two-year observational extension study.
Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial
Authors: Yang Maopeng , Liu Xinyan , Yang Daqiang , Bai Yahu , Qin Bingxin , Tian Shoucheng , Dong Ranran , Song Xuan
Published: October 2021

Background

Delirium is an acute cognitive disorder that presents with fluctuation in cognition, apathy, and non-organized thinking, resulting in increased morbidity, mortality, intensive care unit (ICU) stay, and total healthcare costs. In patients undergoing cardiac surgery, delirium also increases the risk of postoperative complications, such as respiratory insufficiency, sternum instability, and need for re-operation of the sternum. This study aims to understand the incidence of delirium in patients after cardiac surgery in patients sedated with remimazolam besylate versus propofol.

Methods

In this prospective, double-blind, randomized controlled clinical trial, we aim to recruit 200 patients undergoing cardiac surgery between January 1, 2021, and December 31, 2021, who will be randomized to receive either remimazolam besylate or propofol infusions postoperatively, until they are extubated. The primary outcome is the incidence of delirium within 5 days after surgery. Secondary outcomes include the time of delirium onset, duration of delirium, ICU length of stay, hospital length of stay, and mechanical ventilation time.

Discussion

The key objective of this study is to assess whether remimazolam besylate reduces the incidence of delirium in patients after cardiac surgery compared to propofol sedation. In this preliminary randomized controlled clinical trial, we will test the hypothesis that the use of remimazolam besylate lowers the incidence of delirium when compared to propofol in patients undergoing cardiac surgery.

Trial registration

chictr.org.cn ChiCTR2000038976. Registered on October 11, 2020
A desmoplastic fibroblastoma that developed in the anterior mediastinum: a case report
Authors: Hato Tai , Kashimada Hiroaki , Yamaguchi Masatoshi , Sugiyama Ato , Inoue Yoshiaki , Aoki Kohei , Fukuda Hiroki , Gika Masatoshi , Kikuchi Jun , Fujino Takashi , Yamaguchi Takehiko , Tamaru Jun-ichi , Kohno Mitsutomo , Nakayama Mitsuo
Published: October 2021

Background

Desmoplastic fibroblastoma (also known as collagenous fibroma) is a benign, slowly growing soft-tissue tumor. Most desmoplastic fibroblastomas develop in the limbs, neck, or trunk. A mediastinal origin is quite rare.

Case presentation

A 32-year-old Asian female was referred to us for the diagnosis and treatment of an anterior mediastinal tumor. The tumor was 80 mm in the largest diameter and was located on the pericardium. No invasion was evident. She underwent resection of the tumor via video-assisted thoracoscopic resection. The tumor was totally encapsulated, and its pedicle was on the pericardium. The resected specimen was very rigid, making it difficult to remove from the intercostal space. Histologically, the tumor was composed of a paucicellular dense collagenous tissue. Mitosis was rarely observed, and cellular atypia was not evident, suggesting that the tumor was benign. We diagnosed the tumor as a desmoplastic fibroblastoma by morphology and immunohistochemistry.

Conclusions

Desmoplastic fibroblastoma of the mediastinum is an extremely rare disease. Preoperative diagnosis is difficult. Early surgical resection is suitable for diagnosis and treatment planning.