bluuebunny/crossref_metadata_2025_split huggingface dataset:
A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice
Authors: Byrne Ben E. , Rooshenas Leila , Lambert Helen S. , Blazeby Jane M. 
Published: May 2020

AbstractBackgroundWhile randomised controlled trials (RCTs) provide high-quality evidence to guide practice, much routine care is not based upon available RCTs. This disconnect between evidence and practice is not sufficiently well understood. This case study explores this relationship using a novel approach. Better understanding may improve trial design, conduct, reporting and implementation, helping patients benefit from the best available evidence.MethodsWe employed a case-study approach, comprising mixed methods to examine the case of interest: the primary outcome paper of a surgical RCT (the TIME trial). Letters and editorials citing the TIME trial’s primary report underwent qualitative thematic analysis, and the RCT was critically appraised using validated tools. These analyses were compared to provide insight into how the TIME trial findings were interpreted and appraised by the clinical community.Results23 letters and editorials were studied. Most authorship included at least one academic (20/23) and one surgeon (21/23). Authors identified wide-ranging issues including confounding variables or outcome selection. Clear descriptions of bias or generalisability were lacking. Structured appraisal identified risks of bias. Non-RCT evidence was less critically appraised. Authors reached varying conclusions about the trial without consistent justification. Authors discussed aspects of internal and external validity covered by appraisal tools but did not use these methodological terms in their articles.ConclusionsThis novel method for examining interpretation of an RCT in the clinical community showed that published responses identified limited issues with trial design. Responses did not provide coherent rationales for accepting (or not) trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Multiple case studies with cross-case analysis of other trials are needed.
Peer education for HIV prevention among high-risk groups: a systematic review and meta-analysis
Authors: He Jiayu , Wang Ying , Du Zhicheng , Liao Jing , He Na , Hao Yuantao 
Published: May 2020

Abstract
Background
Peer education has become a strategy for health promotion among high-risk groups for HIV infection worldwide. However, the extent to which peer education could have an impact on HIV prevention or the long-term effect of this impact is still unknown. This study thus quantifies the impact of peer education over time among high-risk HIV groups globally.

Method
Following the PRISMA guidelines, a systematic review and meta-analysis was used to assess the effects and duration of peer education. A thorough literature search of PubMed, Web of Science, Embase and Cochrane Library was performed, and studies about peer education on high-risk HIV groups were reviewed. Pooled effects were calculated and the sources of heterogeneity were explored using meta-regression and subgroup analysis.

Results
A total of 60 articles with 96,484 subjects were identified, and peer education was associated with 36% decreased rates of HIV infection among overall high risk groups (OR: 0.64; 95%CI: 0.47–0.87). Peer education can promote HIV testing (OR = 3.19; 95%CI:2.13,4.79) and condom use (OR = 2.66, 95% CI: 2.11–3.36) while reduce equipment sharing (OR = 0.50; 95%CI:0.33,0.75) and unprotected sex (OR = 0.82; 95%CI: 0.72–0.94). Time trend analysis revealed that peer education had a consistent effect on behavior change for over 24 months and the different follow-up times were a source of heterogeneity.

Conclusion
Our study shows that peer education is an effective tool with long-term impact for behavior change among high-risk HIV groups worldwide. Low and middle-income countries are encouraged to conduct large-scale peer education.
An unusual case of dengue shock syndrome complicated by ilio-femoral deep vein thrombosis; a case report
Authors: Ranasinghe K. M. I. U. , Dissanayaka D. , Thirumavalavan K. , Seneviratne M. 
Published: May 2020

Abstract
Background
Dengue fever is a hemorrhagic fever caused by flaviviruses. Hemorrhagic manifestations are well known to be associated with dengue fever, though the thrombotic events are only seldom reported. Underlying pathophysiology of thrombotic events is multifactorial and the management is challenging due to associated thrombocytopenia and bleeding tendency. We report a case of dengue shock syndrome with severe thrombocytopenia complicated by ilio-femoral deep vein thrombosis.

Case presentation
A 16 year old boy presented with dengue fever. He had dengue shock syndrome after entering the critical phase on the fifth day of the illness. With the recovery from the critical phase he developed deep vein thrombosis involving right external iliac, common femoral and superficial femoral veins. There were no provocative factors other than dengue fever itself. His platelet count was 12,000/μl at the time of diagnosis with deep vein thrombosis. Anticoagulation was started with intravenous unfractionated heparin 500 IU/hour while closely being observed for bleeding complications. 1000 IU/hour dose was commenced with the recovery of the platelet count above 50,000/μl. Thrombophilia screening was negative and he was discharged on warfarin. Venous duplex done after 6 weeks showed normal lower limb venous flow and warfarin was omitted after three months.

Conclusions
With dengue fever, complications like deep vein thrombosis can be easily missed given its rarity and that the major concern is on hemorrhagic complications. Management is challenging due to associated thrombocytopenia and hemorrhagic complications.
Promoting positive maternal, newborn, and child health behaviors through a group-based health education and microfinance program: a prospective matched cohort study in western Kenya
Authors: Maldonado Lauren Y. , Songok Julia J. , Snelgrove John W. , Ochieng Christian B. , Chelagat Sheilah , Ikemeri Justus E. , Okwanyi Monica A. , Cole Donald C. , Ruhl Laura J. , Christoffersen-Deb Astrid 
Published: May 2020

Abstract
Background
Chamas for Change (Chamas) is a group-based health education and microfinance program for pregnant and postpartum women that aims to address inequities contributing to high rates of maternal and infant mortality in rural western Kenya. In this prospective matched cohort study, we evaluated the association between Chamas participation and facility-based delivery. We additionally explored the effect of participation on promoting other positive maternal, newborn and child health (MNCH) behaviors.

Methods
We prospectively compared outcomes between a cohort of Chamas participants and controls matched for age, parity, and prenatal care location. Between October–December 2012, government-sponsored community health volunteers (CHV) recruited pregnant women attending their first antenatal care (ANC) visits at rural health facilities in Busia County to participate in Chamas. Women enrolled in Chamas agreed to attend group-based health education and microfinance sessions for one year; controls received the standard of care. We used descriptive analyses, multivariable logistic regression models, and random effect models to compare outcomes across cohorts 12 months following enrollment, with α set to 0.05.

Results
Compared to controls (n = 115), a significantly higher proportion of Chamas participants (n = 211) delivered in a health facility (84.4% vs. 50.4%, p < 0.001), attended at least four ANC visits (64.0% vs. 37.4%, p < 0·001), exclusively breastfed to six months (82.0% vs. 47.0%, p < 0·001), and received a CHV home visit within 48 h postpartum (75.8% vs. 38.3%, p < 0·001). In multivariable models, Chamas participants were over five times as likely as controls to deliver in a health facility (OR 5.49, 95% CI 3.12–9.64, p < 0.001). Though not significant, Chamas participants experienced a lower proportion of stillbirths (0.9% vs. 5.2%), miscarriages (5.2% vs. 7.8%), infant deaths (2.8% vs. 3.4%), and maternal deaths (0.9% vs. 1.7%) compared to controls.

Conclusions
Chamas participation was associated with increased odds of facility-based delivery compared to the standard of care in rural western Kenya. Larger proportions of program participants also practiced other positive MNCH behaviors. Our findings demonstrate Chamas’ potential to achieve population-level MNCH benefits; however, a larger study is needed to validate this observed effect.

Trial registration
ClinicalTrials.gov, NCT03188250 (retrospectively registered 31 May 2017).
Cardiovascular disease events within 5 years after a diagnosis of breast cancer
Authors: Mery Benoîte , Fouilloux Antoine , Rowinski Elise , Catella-Chatron Judith , Guichard Jean-Baptiste , Da Costa Antoine , Tinquaut Fabien , Magné N. , Bertoletti Laurent 
Published: May 2020

Abstract
Background
Concern for cardiovascular disease (particularly atrial fibrillation-AF) among women with breast cancer is becoming a major issue. We aimed at determining the incidence of cardiovascular disease events (AF, arterial and cardiac events, venous-thromboembolism-VTE) in patients diagnosed with breast cancer, and assessing potential risk factors.

Methods
We reviewed medical records of all patients diagnosed with breast cancer from 2010 to 2011 in our cancer center. Baseline characteristics of patients and tumors were collected. The main outcome was the occurrence of cardiovascular disease events (AF, VTE, arterial and cardiac events) during the 5-years follow-up.

Results
Among the 682 breast cancer patients, 22 (3.2%) patients had a history of atrial fibrillation. Thirty-four patients (5%) presented at least one cardiovascular disease event, leading to a cumulative incidence of 5.8% events at 5-years ([3.8–7.7] CI 95%), with most of them occurring in the first 2 years. AF cumulative incidence was 1.1% ([0.1–2.1] CI 95%). Factors associated with the occurrence of cardiovascular disease events (including AF) were an overexpression of HER-2 (HR 2.6 [1.21–5.56] p < 0.011), UICC-stage III tumors or more (HR 5.47 [2.78–10.76] p < 0.001) and pre-existing cardiovascular risk factors (HR 2.91 [1.36–6.23] p < 0.004).

Conclusion
The incidence of cardiovascular disease events was 5.8% ([3.8–7.7] CI 95%), with HER-2 over-expression, UICC-stage III tumors or more and pre-existing cardiovascular diseases being associated with them. These findings call for the development of preventive strategies in patients diagnosed with breast cancer.
PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial
Authors: De Bruycker A. , Spiessens A. , Dirix P. , Koutsouvelis N. , Semac I. , Liefhooghe N. , Gomez-Iturriaga A. , Everaerts W. , Otte F. , Papachristofilou A. , Scorsetti M. , Shelan M. , Siva S. , Ameye F. , Guckenberger M. , Heikkilä R. , Putora P. M. , Zapatero A. , Conde-Moreno A. , Couñago F. , Vanhoutte F. , Goetghebeur E. , Reynders D. , Zilli T. , Ost P. 
Published: May 2020

Abstract
Background
Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12–18 months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence.

Methods & design
Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6 months of ADT, or arm B: WPRT added to MDT and 6 months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023.

Discussion
This is the first prospective multicentre randomized phase II trial assessing the potential of combined WPRT and MDT as compared to MDT alone on MFS for patients with nodal oligorecurrent PCa.

Trial registration
ClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ;
Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.
The impact of parental psychopathology and sociodemographic factors in selective mutism - a nationwide population-based study
Authors: Koskela Miina , Chudal Roshan , Luntamo Terhi , Suominen Auli , Steinhausen Hans-Christoph , Sourander Andre 
Published: May 2020

Abstract
Background
Selective mutism (SM) is nowadays considered a relatively rare anxiety disorder characterized by children failing to speak in certain situations. Research on risk factors for SM are limited in comparison to other psychiatric disorders. The aim of this study was to examine several potential risk factors for SM in a large nationwide cohort, namely parental psychopathology, parental age, maternal SES, urbanicity, maternal marital status and parental immigration status.

Methods
This nested case-control study comprised 860 cases with SM, identified from the Finnish Hospital Discharge Register and 3250 controls matched for sex and age from the Finnish Central Population Register. Conditional logistic regression was used to examine the association between the risk factors and SM.

Results
If both parents had any psychiatric disorder, this almost tripled their odds of having a child with SM (OR 2.8, 95% CI 2.0–4.0). There were increased rates of all types of psychiatric disorders in the parents of the children with SM, with a wider range of diagnoses among the mothers than fathers. Fathers over 35 years (OR 1.4, 95% CI 1.1–1.8) were significantly more likely to have children with SM. Offspring of a single mother had a 2-fold (OR = 2.0, 95% CI 1.4–3.0) increased odds of SM than mothers who were married or in a relationship.

Conclusions
Several parental psychiatric disorders were associated with offspring SM. This points towards a shared aetiology of psychiatric disorders. Findings on paternal age and single motherhood help to improve our understanding of risk factors for SM.
Social interactions, experiences with adverse life events and depressive symptoms in individuals with visual impairment: a cross-sectional study
Authors: Brunes Audun , Heir Trond 
Published: May 2020

Abstract
Background
Knowledge about the high rates of depression in people with visual impairment (VI) remains unclear. The study aimed to examine whether depressive symptoms in people with VI were associated with social isolation, perceived social support and lifetime exposure to bullying, physical abuse or sexual abuse.

Methods
An anonymous telephone survey was conducted from January to May 2017 in an age-stratified sample of adults with VI who were members of the Norwegian Association of the Blind and Partially Sighted. Participants were asked questions about social isolation, perceived social support, and past experiences with bullying and abuse. Depressive symptoms were measured by the nine-item Patient Health Questionnaire (PHQ-9). We calculated unadjusted and full-adjusted exponentiated beta-values (Exp(β)) and corresponding 95% confidence intervals (CIs) using generalized linear models.

Results
Overall, 736 (61%) adults participated in the study. The mean depression scores were 5.24 (SD: 5.3, range: 0–27), 4.61 for men and 5.77 for women. Results from the full-adjusted model showed higher levels of depressive symptoms among participants who reported social isolation (Exp(β): 1.89, 95% CI: 1.63–2.20), lower levels of perceived social support (Exp(β): 1.55, 95% CI: 1.31–1.83), and past experiences of abuse (Exp(β): 1.41, 95% CI: 1.17–1.70). The strength of the associations between past exposure to bullying or abuse and depressive symptoms was similar for those with low and high levels of support.

Conclusion
Social isolation, perceived support and experiences of adverse events appear to be independently associated with depressive symptoms. Thus, social integration may be appropriate for the promotion of mental health among people with VI.
Khat use and intimate partner violence in a refugee population: a qualitative study in Dollo Ado, Ethiopia
Authors: Sharma Vandana , Papaefstathiou Stephanos , Tewolde Samuel , Amobi Adaugo , Deyessa Negussie , Relyea Bridget , Scott Jennifer 
Published: May 2020

Abstract
Background
Intimate partner violence (IPV) is the most common form of gender-based violence affecting women and girls worldwide and is exacerbated in humanitarian crises. There is evidence that substance use is associated with male perpetration of IPV. Consumption of khat —a plant containing amphetamines traditionally chewed in the horn of Africa and legal in some countries including Ethiopia—may increase risk of IPV toward women. This analysis aimed to assess perceptions on khat use among Somali refugees in Dollo Ado, Ethiopia and its association with IPV to inform an IPV and HIV prevention intervention.

Methods
A descriptive qualitative study comprising individual interviews (n = 30) and focus group discussions (n = 10) was conducted in Bokolmayo refugee camp in Dollo Ado, Ethiopia in October 2016. A purposive sample of male and female Somali refugees, religious and community leaders, and service providers (n = 110 individuals; 44 women and 66 men) was included. Trained interviewers from the camp conducted the interviews and discussion, which were audio recorded, transcribed and translated. A content analysis was conducted on coded excerpts from the transcripts to identify factors contributing to IPV toward women, including khat use.

Results
Participants reported that displacement has resulted in limited employment opportunities for men and increased idle time, which has led to increased khat use among men as a coping mechanism. Male khat use was perceived to be associated with perpetration of physical and sexual IPV through several mechanisms including increased anger and aggression and enhanced sexual desire. Khat use also contributes to intra-marital conflict as money allocated for a household is spent on purchasing khat.

Conclusion
Khat use should be addressed as part of IPV prevention programming in this context. Livelihood interventions and other strategies to improve economic conditions, should be explored in collaboration with refugee camp authorities and community leaders as a potential avenue to mitigate the impact of khat use on women and families.
The Brazilian Portuguese version of the Exercise Adherence Rating Scale (EARS-Br) showed acceptable reliability, validity and responsiveness in chronic low back pain
Authors: de Lira Mariana Romano , de Oliveira Anamaria Siriani , França Roberta Aniceto , Pereira Ana Claudia , Godfrey Emma L. , Chaves Thais Cristina 
Published: May 2020

Abstract
Background
This study aimed to adapt the Exercise Adherence Rating Scale (EARS) into Brazilian Portuguese and evaluate its measurement properties, given as reliability, validity, and responsiveness in patients with non-specific Chronic Low Back Pain (CLBP).

Methods
A total of 108 patients with a mean age of 46.62 years (SD = 9.98) and CLBP participated in this longitudinal study. Participants were oriented on undertaking the prescribed exercises in the first session, and adherence behavior was assessed after 1 week, and finally reassessed after 2 weeks (test-retest reliability). Three weeks after the first assessment, they were invited again to full fill the EARS (responsiveness). The intraclass correlation coefficient (ICC2,1) and Cronbach’s α were used to assess test-retest reliability and internal consistency, respectively. Spearman’s correlation and confirmatory factor analysis (CFA) were used to assess construct validity, and the Receiver operating characteristic curve and area under the curve (AUC) were used to analyze responsiveness.

Results
The one-factor EARS-Br (adherence behavior) structure with 6 items showed acceptable fit indexes (comparative fit index and goodness of fit index> 0.90 and root-mean-square error of approximation< 0.08). The EARS-Br scale showed acceptable internal consistency (α = 0.88) and excellent reliability (ICC = 0.91 [95% CI 0.86–0.94]). Mild to moderate correlations were observed between EARS-Br total score vs. disability, pain catastrophizing, depression/anxiety, fear-avoidance and pain intensity. A Minimally Important Change (MIC) of 5.5 in the EARS-Br total score was considered as a meaningful change in the adherence behavior (AUC = 0.82). Moderate accuracy (AUC = 0.89) was obtained for a 17/24 total EARS cutoff score after home exercise was prescribed. The sensitivity and specificity were also acceptable (greater than 80%).

Conclusion
Our results demonstrated acceptable EARS-Br reliability, validity, and responsiveness for patients with CLBP. A final score of 17/24 on EARS after the prescription of home-exercise could be used as a cut-off for an acceptable adherence behavior associated with improvement in patient outcomes.