bluuebunny/crossref_metadata_2025 huggingface dataset:
COVID-19 related poor mental health and sleep disorders in rheumatic patients: a citizen science project
Authors: Ingegnoli Francesca , Buoli Massimiliano , Posio Cristina , Di Taranto Raffaele , Lo Muscio Alessandro , Cumbo Enrico , Ostuzzi Silvia , Caporali Roberto
Published: August 2021

Background

Patients with chronic rheumatic diseases (RDs) are more vulnerable and the containment measures related to the COVID-19 pandemic might have severe psychological consequences. We investigated the presence of and risk factors associated with poor mental health, sleep disorders among RDs during the pandemic.

Methods

This cross-sectional Italian citizen science project evaluated the psychological impact of the COVID-19 pandemic in patients with RDs. Between May and September 2020, eleven RD patients’ associations sent the survey by using their mailing list and the related webpage and social network. 507 RD patients completed an ad-hoc anonymous online survey including the Perceived Stress Scale (PSS) and Impact Event Scale-Revised (IES-R).

Results

The mean scores on the PSS-10 and the IES-R were 18.1 and 29.7, respectively. Higher PSS scores were associated with younger age (p <  0.01), female gender (p <  0.01), overweight/obesity (p = 0.01), psychiatric pharmacotherapy (p <  0.01), and anxiety for loss of income (p <  0.01). Higher IES-R scores were associated with female gender (p <  0.01), intestinal diseases (p = 0.03), anxiety (p <  0.01), and health concern (p <  0.01). Among 375 patients with inflammatory arthritis, 246 (65.6%) had trouble staying asleep, 238 (63.5%) falling asleep, and 112 (29.9%) had dreams about the pandemic. Older age (OR = 1.038, CI 1.002–1.076), psychiatric pharmacotherapy (OR = 25.819, CI 11.465–58.143), and COVID infection (OR = 2.783, CI 1.215–6.372) were predictive of insomnia during the pandemic.

Conclusions

A considerable COVID-19 related psychosocial burden has been detected in RDs. Different factors were predictive of poor mental health and sleep disorders in these patients. Focused supportive strategies should be implemented to improve the psychological well-being of fragile patients during pandemics.
Learning to mentalize: Exploring vulnerable parents’ experiences of change during video guidance in an infant mental health clinic
Authors: Simhan Indra , Vik Kari , Veseth Marius , Hjeltnes Aslak
Published: August 2021

Background

Interventions that promote infant mental health face challenges when applied for parents who struggle with psychosocial and psychological burdens. Video-based guidance using the Marte Meo method is used in specialized clinical settings with high-risk families to improve parent-child interaction, parental sensitivity and mentalizing. However, knowledge about the lifeworlds of these parents and their experiences of the therapeutic process during video guidance is limited.

Aim

This qualitative study explores how parents in an infant mental health outpatient clinic who had difficulties mentalizing and maintaining an emotional connection with their infants experienced the change process during Marte Meo video guidance.

Methods

We identified a strategic sample of parents with difficulties mentalizing and maintaining an emotional connection with their infants through the Parent Development Interview. Twelve parents received video guidance and were afterwards interviewed in-depth. The research interviews were qualitatively analysed via a team-based reflexive thematic analysis.

Result

We identified four themes: a) feeling inadequate or disconnected as a parent; b) discovering the infant as a relating and intentional person; c) becoming more agentic and interconnected; and d) still feeling challenged by personal mental health issues.

Conclusion

Parents described positive changes in their interactions, in mentalizing their infants, the relationship and themselves as parents, in their experiences of self-efficacy and on a representational level. They also described increased confidence and improved coping despite ongoing personal mental health challenges. The findings suggest that video guidance using the Marte Meo method can be a critical intervention for vulnerable parents but should be coordinated with parents’ primary treatments when complex parental mental health issues are involved.
Associations between non-suicidal self-injury and negative romantic relationship life events in male justice-involved adolescents
Authors: Drubina Boglárka , Kökönyei Gyöngyi , Reinhardt Melinda
Published: August 2021

Background

In the current study we investigated impulsivity and negative life events in relation to non-suicidal self-injury (NSSI) in correctional settings.

Methods

A total of 141 male justice-involved juveniles participated in our cross-sectional study, aged between 14 and 21 years old (M = 17.75; SD = 1.38). Data collection took place in correctional institutions in Hungary. A binary logistic regression was conducted to investigate possible associations between NSSI, impulsivity and negative life events.

Results

Lifetime prevalence of NSSI was 53.9% (N = 76). In a binary logistic regression model, only negative romantic relationship events were significantly associated with the risk of current NSSI (OR = 1.29; 95% CI = [1.06–1.56]). Other types of negative life events (family-related, friendship-related), impulsivity, age and conviction status did not have a significant role in the model.

Conclusions

The results suggest that juvenile offenders should receive additional support to manage stress that is associated with negative life events, especially problems in romantic relationships. It is essential to help young inmates to find an adaptive way of reducing stress caused by negative relationship life events.
Empowerment and use of modern contraceptive methods among married women in Burkina Faso: a multilevel analysis
Authors: Some Sylvain Y. M. , Pu Christy , Huang Song-Lih
Published: August 2021

Background

In Burkina Faso, gender inequality prevents women from meeting their reproductive needs, leading to high rates of unintended pregnancies, abortions and deaths. Evidence shows that empowering women may increase the proportion of demand for family planning satisfied using modern methods (mDFPS), but few studies have measured this process in multiple spheres of life. We investigated how empowerment influences the mDFPS among married women of reproductive age (MWRA) in Burkina Faso.

Methods

We analyzed data from the 2010 Burkina Faso Demographic and Health Survey (DHS) on 4714 MWRA with reproductive needs living in 573 communities. We used principal component analysis (PCA) and Cronbach’s alpha test to explore and assess specific and consistently relevant components of women’s agency in marital relationships. Aggregated measures at the cluster level were used to assess gender norms and relationships in communities. Descriptive statistics were performed and multilevel logistic regression models were carried out to concurrently gauge the effects of women’s agency and community-level of gender equality on mDFPS, controlling for socioeconomic factors.

Results

Overall, less than one-third (30.8%) of the demand for family planning among MWRA were satisfied with modern methods. Participation in household decision-making, freedom in accessing healthcare, and opposition to domestic violence were underlying components of women’s agency in marital relationships. In the full model adjusted for socioeconomic status, freedom in accessing healthcare was significantly (aOR 1.27, CI 1.06–1.51) associated with mDFPS. For community-level variables, women’s greater access to assets (aOR 1.72, 95% CI 1.13–2.61) and family planning messages (aOR 2.68, 95% CI 1.64–4.36) increased mDFPS, while higher fertility expectations (aOR 0.75, 95% CI 0.64–0.87) reduced it. Unexpectedly, women in communities with higher rates of female genital mutilation were more likely (aOR 2.46, 95% CI 1.52–3.99) to have mDFPS.

Conclusions

Empowering women has the potential to reduce gender inequality, raise women’s agency and increase mDFPS. This influence may occur through both balanced marital relationships and fair community gender norms and relationships. Progress toward universal access to reproductive services should integrate the promotion of women’s rights.

Trial registration

No clinical trial has been performed in this study.
Mental health consequences during alerting situations and recovering to a new normal of coronavirus epidemic in 2019: a cross-sectional study based on the affected population
Authors: Zhang Qian , Zheng Rujun , Fu Yan , Mu Qianqian , Li Junying
Published: August 2021

Background

As a major virus outbreak in the twenty-first century, the coronavirus disease 2019 (COVID-19) pandemic has caused unprecedented hazards to mental health globally.

Methods

We performed a cross-sectional study based on the results of an online survey. The survey was conducted 1 month after the outbreak (February 18–29, 2020) and repeated at the time of resuming activity (April 8–14, 2020). The 15-item Death Anxiety Scale (T-DAS) was used to assess the degree of death anxiety, and the Chinese version of PTSD checklist-civilian version (PCL-C), for PTSD symptom clusters. Through convenient sampling, a total of 7678 cases were collected.

Results

Our findings showed that even after the lockdown was lifted, the prevalence of the symptoms of post-traumatic stress disorder (PTSD) and death anxiety remained significantly high in the general population affected by the outbreak. Regression model analysis showed that PTSD was significantly associated with age > 50 years, contact history/living community, poor health status of participants, past traumatic experience (PTE), and medical occupation. Moreover, death anxiety mediated the relationship between life-threatening PTE and PTSD, indicating that reducing death anxiety could buffer the negative effects of PTE on PTSD.

Conclusions

Despite the lifting of the lockdown, long-term adverse psychological effects remain in the affected general population. The management of mental health after major public health events is important, and high-risk groups such as the elderly and healthcare workers should receive targeted interventions. In addition, the study suggests that methods for alleviating death anxiety must be included in plans to manage the psychological impact of public health emergencies.
Thromboelastography parameters in diagnosing periprosthetic joint infection and predicting reimplantation timing
Authors: Yuan Tao , Wang Yi , Sun Shui
Published: August 2021

Background

Coagulation-related biomarkers are drawing new attention in the diagnosis of periprosthetic joint infection (PJI). The thromboelastography (TEG) assay provides a comprehensive assessment of blood coagulation; therefore, it could be a promising test for PJI. This study aims to assess the value of TEG in diagnosing PJI and to determine the clinical significance of TEG in analysing reimplantation timing for second-stage revision.

Methods

From October 2017 to September 2020, 62 patients who underwent revision arthroplasty were prospectively included. PJI was defined by the 2011 Musculoskeletal Infection Society criteria, in which 23 patients were diagnosed with PJI (Group A), and the remaining 39 patients were included as having aseptic loosening (Group B). In group A, 17 patients completed a two-stage revision in our centre. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), D-dimer, and TEG parameters (clotting time, α-angle, MA [maximum amplitude], amplitude at 30 min, and thrombodynamic potential index) were measured preoperatively in all included patients. In addition, receiver operating characteristic curves were used to evaluate the diagnostic value of these biomarkers.

Results

ESR (area under curve [AUC], 0.953; sensitivity, 81.82; specificity, 94.87) performed best for PJI diagnosis, followed by MA (AUC, 0.895; sensitivity, 82.61; specificity, 97.44) and CRP (AUC, 0.893; sensitivity, 82.61; specificity, 94.74). When these biomarkers were combined in pairs, the diagnostic value improved compared with any individual biomarker. The overall success rate of the two-stage revision was 100%. Furthermore, ESR and MA were valuable in determining the time of reimplantation, and their values all decreased below the cut-off values before reimplantation.

Conclusion

TEG could be a promising test in assisting PJI diagnosis, and a useful tool in judging the proper timing of reimplantation.
Relationship between emotional intelligence and job well-being in Chinese clinical nurses: multiple mediating effects of empathy and communication satisfaction
Authors: Li Xue , Chang Hongjuan , Zhang Quanying , Yang Jianli , Liu Rui , Song Yajie
Published: August 2021

Background

Nursing work is associated with great pressure, and nurses are often overwhelmed. Therefore, correct emotional regulation is essential to improve nurses’ job well-being and promote better engagement in nursing work. The purpose of this study was to establish a structural model to estimate the impact of Chinese clinical nurses’ emotional intelligence on job well-being, using multiple intermediaries to explain the internal mechanisms underlying the relationship.

Methods

This was a cross-sectional study of 1475 registered nurses from a Chinese hospital who provided responses to emotional intelligence, empathy, communication satisfaction, and job well-being scales. Path analysis using a multiple mediation model was performed using AMOS 23.0.

Results

Among all clinical nurses who participated in the survey, 1475 (98.33 %) completed the questionnaire. The nurses’ job well-being score was 83.61 ± 12.63. There was a significant positive correlation between job well-being and communication satisfaction, emotional intelligence, and empathy ability (r = 0.346–0.570, P < 0.001). Empathy and communication satisfaction partially mediated the relationship between emotional intelligence and job well-being, with effect sizes of 0.047 and 0.227, respectively. The chain mediating effect of empathy and communication satisfaction had a value of 0.045.

Conclusions

It is recommended that hospital managers take actions to improve nurses’ emotional intelligence level, and conduct professional psychological training to improve nurses’ empathy and communication satisfaction, and ultimately improve their job well-being.
Self-managed occupational therapy and physiotherapy for adults receiving inpatient rehabilitation (‘My Therapy’): protocol for a mixed-methods process evaluation
Authors: Whittaker Sara L. , Taylor Nicholas F. , Hill Keith D. , Ekegren Christina L. , Brusco Natasha K.
Published: August 2021

Background

Process evaluations have been recommended alongside clinical and economic evaluations to enable an in-depth understanding of factors impacting results. My Therapy is a self-management program designed to augment usual care inpatient rehabilitation through the provision of additional occupational therapy and physiotherapy exercises and activities, for the patient to complete outside of supervised therapy. The aims of the process evaluation are to assess the implementation process by investigating fidelity, quality of implementation, acceptability, adoption, appropriateness, feasibility and adaptation of the My Therapy intervention; and identify contextual factors associated with variations in outcomes, including the perspectives and experiences of patients and therapists.

Methods

The process evaluation will be conducted alongside the clinical and economic evaluation of My Therapy, within eight rehabilitation wards across two public and two private Australian health networks. All participants of the stepped wedge cluster randomised trial (2,160 rehabilitation patients) will be included in the process evaluation (e.g., ward audit); with a subset of 120 participants undergoing more intensive evaluation (e.g., surveys and activity logs). In addition, 24 staff (occupational therapists and physiotherapists) from participating wards will participate in the process evaluation. The mixed-methods study design will adopt a range of quantitative and qualitative research approaches. Data will be collected via a service profile survey and audits of clinical practice across the participating wards (considering areas such as staffing profiles and prescription of self-management programs). The intensive patient participant data collection will involve structured therapy participation and self-management program audits, Exercise Self Efficacy Scale, patient activity logs, patient surveys, and patient-worn activity monitors. Staff data collection will include surveys and focus groups.

Discussion

The process evaluation will provide context to the clinical and economic outcomes associated with the My Therapy clinical trial. It considers how clinical and economic outcomes were achieved, and how to sustain the outcomes within the participating health networks. It will also provide context to inform future scaling of My Therapy to other health networks, and influence future models of rehabilitation and related policy.

Trial registration

This study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12621000313831; registered 22/03/2021,http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380828&isReview=true).
Association between care coordination tasks with non-VA community care and VA PCP burnout: an analysis of a national, cross-sectional survey
Authors: Apaydin Eric A. , Rose Danielle E. , McClean Michael R. , Yano Elizabeth M. , Shekelle Paul G. , Nelson Karin M. , Stockdale Susan E.
Published: August 2021

Background

The scope of care coordination in VA primary care increased with the launch of the Veterans Choice Act, which aimed to increase access through greater use of non-VA Community Care. These changes may have overburdened already busy providers with additional administrative tasks, contributing to provider burnout. Our objective was to understand the role of challenges with care coordination in burnout. We analyzed relationships between care coordination challenges with Community Care reported by VA primary care providers (PCPs) and VA PCP burnout.

Methods

Our cross-sectional survey contained five questions about challenges with care coordination. We assessed whether care coordination challenges were associated with two measures of provider burnout, adjusted for provider and facility characteristics. Models were also adjusted for survey nonresponse and clustered by facility. Trainee and executive respondents were excluded. 1,543 PCPs in 129 VA facilities nationwide responded to our survey (13 % response rate).

Results

51 % of our sample reported some level of burnout overall, and 46 % reported feeling burned out at least once a week. PCPs were more likely to be burned out overall if they reported more than average challenges with care coordination (odds ratio [OR] 2.04, 95 % confidence interval [CI] 1.58 to 2.63). These challenges include managing patients with outside prescriptions or obtaining outside tests or records.

Conclusions

VA primary care providers who reported greater than average care coordination challenges were more likely to be burned out. Interventions to improve care coordination could help improve VA provider experience.
Trajectories of middle-aged and elderly people’s chronic diseases Disability Adjusted Life Years (DALYs): cohort, socio-economic status and gender disparities
Authors: Zhang Gangming , Tang Fang , Liang Jing , Wang Peigang
Published: August 2021

Background

The accelerated aging trend brought great chronic diseases burdens. Disabled Adjusted Life Years (DALYs) is a novel way to measure the chronic diseases burden. This study aimed to explore the cohort, socioeconomic status (SES), and gender disparities of the DALYs trajectories.

Methods

A total of 15,062 participants (55,740 observations) comes from China Health and Retirement Longitudinal Study (CHARLS) from 2011 to 2018. Mixed growth curve model was adopted to predict the DALYS trajectories in 45–90 years old people influenced by different birth cohorts and SES.

Results

We find significant cohort, SES (resident place, education level and income) disparities differences in the chronic diseases DALYs. For individuals of earlier cohort, DALYs are developed in a late age but grow fast with age but reversed for most recent cohorts. Living in urban, having higher SES level will decrease the growth rate with age, but converges for most recent cohorts. Meanwhile, DALYs disparities of resident place and education level show gender differentials that those for female are narrowed across cohort but for male are not.

Conclusions

The cohort effects on chronic diseases DALYs are accumulated with China’s unique social, and political settings. There are large inequalities in early experiences, SES and DALYs. Efforts of reducing these inequalities must focus on the lower SES individuals and those living in rural areas, which greatly benefit individuals from recent cohorts.
Immune and stromal scoring system associated with tumor microenvironment and prognosis: a gene-based multi-cancer analysis
Authors: Zeng Zihang , Li Jiali , Zhang Jianguo , Li Yangyi , Liu Xingyu , Chen Jiarui , Huang Zhengrong , Wu Qiuji , Gong Yan , Xie Conghua
Published: August 2021

Background

Tumor microenvironment (TME) is associated with tumor progression and prognosis. Previous studies provided tools to estimate immune and stromal cell infiltration in TME. However, there is still a lack of single index to reflect both immune and stromal status associated with prognosis and immunotherapy responses.

Methods

A novel immune and stromal scoring system named ISTMEscore was developed. A total of 15 datasets were used to train and validate this system, containing 2965 samples from lung adenocarcinoma, skin cutaneous melanoma and head and neck squamous cell carcinoma.

Results

The patients with high immune and low stromal scores (HL) were associated with low ratio of T cell co-inhibitory/stimulatory molecules and low levels of angiogenesis markers, while the patients with low immune and high stromal scores (LH) had the opposite characteristics. The HL patients had immune-centered networks, while the patients with low immune and low stromal scores (LL) had desert-like networks. Moreover, copy number alteration burden was decreased in the HL patients. For the clinical characteristics, our TME classification was an independent prognostic factor. In the 5 cohorts with immunotherapy, the LH patients were linked to the lowest response rate.

Conclusions

ISTMEscore system could reflect the TME status and predict the prognosis. Compared to previous TME scores, our ISTMEscore was superior in the prediction of prognosis and immunotherapy response.
Anasarca as the presenting symptom of juvenile dermatomyositis: a case series
Authors: Schildt Emily E. , De Ranieri Deirdre
Published: August 2021

Background

Juvenile Dermatomyositis (JDM) is an autoimmune disease that typically presents with classic skin rashes and proximal muscle weakness. Anasarca is a rare manifestation of this disease and is associated with a more severe and refractory course, requiring increased immunosuppression. Early recognition of this atypical presentation of JDM may lead to earlier treatment and better outcomes.

Case presentation

We present two female patients, ages 11 years old and 4 years old, who presented to the ED with anasarca and were subsequently diagnosed with JDM. Both patients required ICU-level care and significant immunosuppression, including prolonged courses of IV methylprednisolone, IVIG, and Rituximab.

Conclusions

Anasarca is a rare presentation of Juvenile Dermatomyositis, but it is important for clinicians to recognize this manifestation of the disease. Early recognition and treatment will lead to better outcomes in these children and hopefully decrease the need for prolonged hospitalization and ICU level care.
Pharmacist dispensing of the abortion pill in Canada: Diffusion of Innovation meets integrated knowledge translation
Authors: Munro Sarah , Wahl Kate , Soon Judith A. , Guilbert Edith , Wilcox Elizabeth S. , Leduc-Robert Genevieve , Ansari Nadra , Devane Courtney , Norman Wendy V.
Published: August 2021

Background

Since Canadian drug regulatory approval of mifepristone for medical abortion in 2015 and its market availability in January 2017, the role of pharmacists in abortion provision has changed rapidly. We sought to identify the factors that influenced the initiation and provision of medical abortion from the perspectives of Canadian pharmacists, bridging two frameworks — Diffusion of Innovation in Health Service Organizations and integrated knowledge translation.

Methods

We conducted one-on-one semi-structured interviews with pharmacists residing in Canada who intended to stock and dispense mifepristone within the first year of availability. Our data collection, analysis, and interpretation were guided by reflexive thematic analysis and supported by an integrated knowledge translation partnership with pharmacy stakeholders.

Results

We completed interviews with 24 participants from across Canada: 33% had stocked and 21% had dispensed mifepristone. We found that pharmacists were willing and able to integrate medical abortion care into their practice and that those who had initiated practice were satisfied with their dispensing experience. Our analysis indicated that several key Diffusion of Innovation constructs impacted the uptake of mifepristone, including: innovation (relative advantage, complexity and compatibility, technical support), system readiness (innovation-system fit, dedicated time, resources), diffusion and dissemination (expert opinion, boundary spanners, champions, social networks, peer opinions), implementation (external collaboration), and linkage. Participants’ experiences suggest that integrated knowledge translation facilitated evidence-based changes to mifepristone dispensing restrictions, and communication of those changes to front line pharmacists.

Conclusions

We illustrate how Diffusion of Innovation and integrated knowledge translation may work together as complimentary frameworks for implementation science research. Unlike in the USA, UK, and other highly regulated settings globally, pharmacists in Canada are permitted to dispense mifepristone for medical abortion. We contribute to literature that shows that mifepristone dispensed outside of hospitals, clinics, and medical offices is safe and acceptable to both patients and prescribers. This finding is of particular importance to the current COVID-19 pandemic response and calls for continued and equitable access to abortion care in primary practice.
Clinical and radiological outcomes in three-dimensional printing assisted revision total hip and knee arthroplasty: a systematic review
Authors: Zhang Rui , Lin Jiajun , Chen Fenyong , Liu Wenge , Chen Min
Published: August 2021

Background

This study investigates whether three-dimensional (3D) printing-assisted revision total hip/knee arthroplasty could improve its clinical and radiological outcomes and assess the depth and breadth of research conducted on 3D printing-assisted revision total hip and knee arthroplasty.

Methods

A literature search was carried out on PubMed, Web of Science, EMBASE, and the Cochrane Library. Only studies that investigated 3D printing-assisted revision total hip and knee arthroplasty were included. The author, publication year, study design, number of patients, patients’ age, the time of follow-up, surgery category, Coleman score, clinical outcomes measured, clinical outcomes conclusion, radiological outcomes measured, and radiological outcomes conclusion were extracted and analyzed.

Results

Ten articles were included in our review. Three articles investigated the outcome of revision total knee arthroplasty, and seven investigated the outcome of revision total hip arthroplasty. Two papers compared a 3D printing group with a control group, and the other eight reported 3D printing treatment outcomes alone. Nine articles investigated the clinical outcomes of total hip/knee arthroplasty, and eight studied the radiological outcomes of total hip/knee arthroplasty.

Conclusion

3D printing is being introduced in revision total hip and knee arthroplasty. Current literature suggests satisfactory clinical and radiological outcomes could be obtained with the assistance of 3D printing. Further long-term follow-up studies are required, particularly focusing on cost-benefit analysis, resource availability, and, importantly, the durability and biomechanics of customized prostheses using 3D printing compared to traditional techniques.
Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial
Authors: Gramberg Meryl Cinzía Tila Tamara , Lagrand Rimke Sabine , Sabelis Louise Willy Elizabeth , den Heijer Martin , de Groot Vincent , Nieuwdorp Max , Kortmann Willemijn , Sieswerda Elske , Peters Edgar Josephus Gerardus
Published: August 2021

Background

Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on percutaneous bone biopsy culture, while in practice, therapy is frequently based on (less invasive) ulcer bed cultures. It is currently unknown if treatment outcomes of DFO differ depending on the chosen diagnostic strategy.

Methods

The BeBoP trial is a multicentre; randomised controlled; physician-, researcher- and subject-blinded; clinical trial comparing two diagnostic strategies in persons with DFO. Culture-directed antibacterial therapy will be based on either percutaneous bone biopsy culture results (intervention group) or ulcer bed biopsy culture results (comparison group). We will enrol 80 subjects with diabetes mellitus (≥ 18 years) and DFO, and we will use block randomisation stratified per centre to randomise them in a 1:1 allocation. The primary outcome is remission of DFO 12 months after enrolment. The secondary outcomes are the time to remission, signs of inflammation or ulceration at the primary location of infection at 6 and 12 months, microbiological and molecular profiles of culture outcomes, surgical interventions including amputation, total antibacterial therapy duration, infection-free survival days, adverse events, quality of life and survival. We will compare the outcomes by intention-to-treat and per-protocol analysis.

Discussion

We aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results.

Trial registration

Netherlands Trial RegisterNL 7582. Registered on 05 March 2019
Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial
Authors: Reynaud D. , Bouscaren N. , Lenclume V. , Boukerrou M.
Published: August 2021

Background

Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity, and popularity may be key elements for an optimal relaxation response to music.

This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).

Methods

The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 min of music 1 h before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).

Results

The mean age of the 171 evaluated patients was 41.5 years (SD = 10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M = 38.8, SD = 11.9) and the intervention group (M = 39.0, SD = 13.1). After the music session, this score had significantly decreased in both the control group (M = −7.2, SD = 9.0) and the intervention group (M = −5.5, SD = 6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.

Conclusion

Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.

Trial registration

The MUANX trial (MUsic therapy on ANXiety) is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017.https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1
Simplified binomial estimation of human malaria transmission exposure distributions based on hard classification of where and when mosquitoes are caught: statistical applications with off-the-shelf tools
Authors: Killeen Gerry F. , Monroe April , Govella Nicodem J.
Published: August 2021

The impacts and limitations of personal protection measures against exposure to vectors of malaria and other mosquito-borne pathogens depend on behavioural interactions between humans and mosquitoes. Therefore, understanding where and when they overlap in time and space is critical. Commonly used approaches for calculating behaviour-adjusted estimates of human exposure distribution deliberately use soft classification of where and when people spend their time, to yield nuanced and representative distributions of mean exposure to mosquito bites across entire human populations or population groups. However, these weighted averages rely on aggregating individual-level data to obtain mean human population distributions across the relevant behavioural classes for each time increment, so they cannot be used to test for variation between individuals. Also, these summary outcomes are quite complex functions of the disaggregated data, so they do not match the standard binomial or count distributions to which routine off-the-shelf statistical tools may be confidently applied. Fortunately, the proportions of exposure to mosquito bites that occur while indoors or asleep can also be estimated in a simple binomial fashion, based on hard classification of human location over a given time increment, as being either completely indoors or completely outdoors. This simplified binomial approach allows convenient analysis with standard off-the-shelf logistic regression tools, to statistically assess variations between individual humans, human population subsets or vector species. Such simplified binomial estimates of behavioural interactions between humans and mosquitoes should be more widely used for estimating confidence intervals around means of these indicators, comparing different vector populations and human population groups, and assessing the influence of individual behaviour on exposure patterns and infection risk. Also, standard sample size estimation techniques may be readily used to estimate necessary minimum experimental scales and data collection targets for field studies recording these indicators as key outcomes. Sample size calculations for field studies should allow for natural geographic variation and seasonality, taking advantage of rolling cross-sectional designs to survey and re-survey large numbers of separate study locations in a logistically feasible manner.
First exposure to rituximab is associated to high rate of anti-drug antibodies in systemic lupus erythematosus but not in ANCA-associated vasculitis
Authors: Faustini Francesca , Dunn Nicky , Kharlamova Nastya , Ryner Malin , Bruchfeld Annette , Malmström Vivianne , Fogdell-Hahn Anna , Gunnarsson Iva
Published: August 2021

Background

Anti-drug antibodies (ADAs) can impact on the efficacy and safety of biologicals, today used to treat several chronic inflammatory conditions. Specific patient groups may be more prone to develop ADAs. Rituximab is routinely used for ANCA-associated vasculitis (AAV) and as off-label therapy for systemic lupus erythematosus (SLE), but data on occurrence and predisposing factors to ADAs in these diseases is limited.

Objectives

To elucidate the rate of occurrence, and risk factors for ADAs against rituximab in SLE and AAV.

Methods

ADAs were detected using a bridging electrochemiluminescent (ECL) immunoassay in sera from rituximab-naïve (AAV; n = 41 and SLE; n = 62) and rituximab-treated (AAV; n = 22 and SLE; n = 66) patients. Clinical data was retrieved from medical records. Disease activity was estimated by the SLE Disease Activity Index-2000 (SLEDAI-2 K) and the Birmingham Vasculitis Activity Score (BVAS).

Results

After first rituximab cycle, no AAV patients were ADA-positive compared to 37.8% of the SLE patients. Samples were obtained at a median (IQR) time of 5.5 (3.7–7.0) months (AAV), and 6.0 (5.0–7.0) months (SLE). ADA-positive SLE individuals were younger (34.0 (25.9–40.8) vs 44.3 (32.7–56.3) years, p = 0.002) and with more active disease (SLEDAI-2 K 14.0 (10.0–18.5) vs. 8.0 (6.0–14), p = 0.0017) and shorter disease duration (4.14 (1.18–10.08) vs 9.19 (5.71–16.93), p = 0.0097) compared to ADA-negative SLE. ADAs primarily occurred in nephritis patients, were associated with anti-dsDNA positivity but were not influenced by concomitant use of corticosteroids, cyclophosphamide or previous treatments.

Despite overall reduction of SLEDAI-2 K (12.0 (7.0–16) to 4.0 (2.0–6.7), p < 0.0001), ADA-positive individuals still had higher SLEDAI-2 K (6.0 (4.0–9.0) vs 4.0 (2.0–6.0), p = 0.004) and their B cell count at 6 months follow-up was higher (CD19 + % 4.0 (0.5–10.0) vs 0.5 (0.4–1.0), p = 0.002). At retreatment, two ADA-positive SLE patients developed serum sickness (16.7%), and three had infusion reactions (25%) in contrast with one (5.2%) serum sickness in the ADA-negative group.

Conclusions

In contrast to AAV, ADAs were highly prevalent among rituximab-treated SLE patients already after the first course of treatment and were found to effect on both clinical and immunological responses. The high frequency in SLE may warrant implementations of ADA screening before retreatment and survey of immediate and late-onset infusion reactions.
EHMT2 promotes the pathogenesis of hepatocellular carcinoma by epigenetically silencing APC expression
Authors: Guo Yuan , Zhao Yan-Rong , Liu Huan , Xin Yang , Yu Jian-Zhi , Zang Yun-Jin , Xu Qing-guo
Published: August 2021

Background

Hepatocellular carcinoma (HCC), the second leading cause of cancer death worldwide, alone accounts for over half (466,100) of new cancer cases and 422,100 deaths based on the average year incidence rates of 2009 to 2011 in China. Due to unclear and complex underlying mechanisms for HCC development, effective therapy for HCC is still unavailable. The Wnt–β-catenin pathway is a critical contributor of HCC pathogenesis: 40–70% of HCCs from patients harbor the nuclear accumulation of β-catenin protein. However, the mechanisms for β-catenin activation are not fully understood.

Methods

The deletion of EHMT2 in Hep3B and Huh1 cells was achieved by transiently transfecting cells with pX459 plasmids, which carry EHMT2 specific small guide RNA (sgRNA) sequences for Cas9 protein. All experiments were performed in triplicate and repeated more than three times.

Results

In the present study, we observed thatEHMT2(but notEHMT1) mRNA and protein levels were significantly elevated in HCC compared with normal controls. Next, the results of Ki67 staining, as well as MTT, soft-agar and xenograft assays, in wild-type andEHMT2−/−Hep3B and Huh1 cancer stem cells collectively revealed that the elevation of EHMT2 expression is required for the tumorigenesis of HCC. Meanwhile, we found that elevated EHMT2 expression contributes to the activation of Wnt–β-catenin signaling: deletion ofEHMT2in Hep3B or Huh1 cells promoted the cytoplasmic localization of β-catenin and restrained the expression of Wnt–β-catenin signaling targets such asMyc,CCND1,MMP-7, etc. We demonstrated that EMHT2 directly mediates the H3K9me2 methylation of theAPCpromoter to epigenetically silence its expression. More intriguingly, our findings also showed that UNC0642, a specific inhibitor of EHMT2, exhibits anti-tumorigenesis effects in HCC both in vitro and in vivo, which were largely abolished by deletion ofEHMT2or overexpression ofAPCin Hep3B and Huh1 cells.

Conclusion

Altogether, our observations emphasize that the EHMT2–APC axis is a critical contributor to Wnt–β-catenin pathway activation in HCC, and UNC0642 may be a potential candidate for target drug treatment of HCC.
Parental stress around ophthalmological health conditions: a systematic review of literature protocol
Authors: Souza-Silva Julio Cesar , Martins Cleusa Alves , Garciazapata Marco Túlio Antônio , Barbosa Maria Alves
Published: August 2021

Background

Parents can be psychologically impacted when their children are diagnosed with eye diseases, such as blindness, strabismus, and eye cancer. Stress can reduce the quality of parental care and may be linked to the deterioration of parents’ and children’s mental and physical health and family dynamics. No systematic literature review on parental stress in ophthalmology has been found to provide evidence synthesis capable of stimulating and defining new studies and thereby promoting research in this field. To address this important gap, the present review aims to synthesize evidence about approaches, methods, instruments, and results from research regarding ophthalmology-related parental stress.

Methods

Primary epidemiological observational studies should be original in addressing parental stress caused by ophthalmological health conditions in children. They should present the characteristics of the study population and the clinical and ophthalmic characterizations of children.

MEDLINE (via Ovid), EMBASE, PsycINFO, Google Scholar, and gray literature (PsycEXTRA, NTIS, and OpenSINGLE) will be searched. Controlled vocabulary, Boolean operators, and defined search strategies will be used. There will be no restrictions on the studies’ publication language, which will be selected in two screening stages. Two reviewers will independently retrieve full-text studies, assess methodological quality, and extract data. Data available through December 2021 will be considered for inclusion.

Discussion

The socioeconomic characterization of the participants, the identification of which ophthalmological diseases have been studied in relation to parental stress, and the knowledge of each instrument and methodology peculiarities potentially contribute to this study. The results may promote the development or enhancement of public policies focused on this specific theme, thereby providing the means for potential improvement of the physical and mental health of parents and children with eye diseases.

Systematic review registration

PROSPEROCRD42018094972
Roles of physical exercise in neurodegeneration: reversal of epigenetic clock
Authors: Xu Miao , Zhu JiaYi , Liu Xian-Dong , Luo Ming-Ying , Xu Nan-Jie
Published: August 2021

The epigenetic clock is defined by the DNA methylation (DNAm) level and has been extensively applied to distinguish biological age from chronological age. Aging-related neurodegeneration is associated with epigenetic alteration, which determines the status of diseases. In recent years, extensive research has shown that physical exercise (PE) can affect the DNAm level, implying a reversal of the epigenetic clock in neurodegeneration. PE also regulates brain plasticity, neuroinflammation, and molecular signaling cascades associated with epigenetics. This review summarizes the effects of PE on neurodegenerative diseases via both general and disease-specific DNAm mechanisms, and discusses epigenetic modifications that alleviate the pathological symptoms of these diseases. This may lead to probing of the underpinnings of neurodegenerative disorders and provide valuable therapeutic references for cognitive and motor dysfunction.
The role of personality, social economic and prevention strategy effects on health-related quality of life among people living with HIV/AIDS
Authors: Wang Xiaowen , Luo Hongbing , Yao Enlong , Tang Renhai , Dong Wenbin , Liu Fuyong , Liang Jun , Li Huilan , Xiao Minyang , Zhang Zuyang , Niu Jin , Song Lijun , Fu Liru , Li Xuehua , Qian Shicong , Guo Qing , Song Zhizhong
Published: August 2021

Background

HIV/AIDS has transformed into a chronic controllable but not yet curable infectious disease as other chronic diseases to some extent. The additional of so called fourth 90% that included the improved health-related quality of life (HRQoL) for people living with HIV (PLWHIV) required solutions beyond antiretroviral therapy and viral load suppression. This study will explore the role of personality, social economic and prevention strategy effection on HRQoL among people living with HIV/AIDS.

Methods

A cross-sectional study was conducted among PLWHIV aged more than 16 years old in the 10 municipalities in Yunnan Province, China from October 2019 to May 2020, enrolling total 1997 participants. Individual-level HRQoL data were measured by 12-item Short Form Health Survey (SF-12) and EuroQol Five Dimensions Questionnaire (EQ-5D-5L). We assembled municipal-level data about social economic from Yunnan Statistical Yearbook in 2020 and strategy practice information from the self-evaluation system. We used the principal component analysis to build the social economic and strategy effect on each area respectively and one-way ANOVA was used to perform univariate analysis to identify the predictors with significant differences. Finally we used multi-level model (MLM) to explore the personality, social economic and strategy effects in health-related quality of life among PLWHIV.

Results

The global score for quality of life measured using EQ-5D-5L had an estimated mean score (standard deviation, SD) of 0.901 ± 0.146. The HRQoL score measured using PCS-12 had an estimated mean score (SD) of 46.62 ± 8.55. The mean MCS-12 score (SD) was estimated to be 47.80 ± 9.71. The area-level predictors explained a proportion of 13.6–17.2% for the between-area variation of the HRQoL scores, regardless of the total HRQoL, physical component and mental component. The impacts of stigma (P < 0.01), social support (P < 0.001), anxiety (P < 0.001), depression (P < 0.05) and social economic status (P < 0.05) on HRQoL at the individual-level were significantly different. The plots visualized the impact of individual-level factors on a respondent’s HRQoL was modified by the area-level characteristics.

Conclusions

The study identified the possible strategy determinant of individual HRQoL of PLWHIV and also the area effect on HRQoL. Stigma, social support, anxiety, depression and social economic status were the individual-level determinants on HRQoL. These could be a valuable resource for evaluating the overall health of the areas and help improve local decision making.

Graphic abstract