bluuebunny/crossref_metadata_2025_split huggingface dataset:
Health policy experts’ perspectives on implementing mental health specialist video consultations in routine primary care – a qualitative interview study
Authors: Tönnies Justus , Oeljeklaus Lydia , Wensing Michel , Hartmann Mechthild , Friederich Hans-Christoph , Haun Markus W. 
Published: July 2021

Abstract
Background
Many patients with mental disorders are treated by their general practitioner (GP). Innovative technology-based integrated care models (e.g., mental health specialist video consultations) have been proposed to facilitate access to specialist services in primary care settings. While perspectives of patients and providers have been examined, there is little insight into the perspectives of health policy experts on such models. The purpose of this study was to examine the perspectives of health policy experts on (1) current challenges for continuity of care, (2) anticipated benefits and barriers for implementation of mental health specialist video consultations along with (3) practical and regulative preconditions for sustained implementation in primary care.

Methods
In a cross-sectional qualitative study, we conducted 15 semi-structured interviews with health policy experts representing various stakeholders in the German health care system: health insurances, governmental bodies, clinicians’ professional associations, and patient representatives. Following a critical realism approach, we applied a qualitative inductive content analysis to derive key themes from the material.

Results
Health policy experts saw long waiting times for patients and a lack of collaboration between in- and outpatient mental health services as well as mental health specialists and GPs as main barriers for current continuity of care. Health policy experts also felt that video consultations bear great potential to foster coordinated care between GPs and specialists and ensure timely referral for severely burdened patients. Increased workload for the general practice staff to facilitate video consultations and difficulties in establishing reliable therapeutic alliances between patients and specialists via remote treatment were considered as major barriers. Health policy experts varied significantly in their level of knowledge concerning legal frameworks and regulations pertaining to video consultations. However, the implementation of appropriate reimbursement schemes and sufficient data protection were regarded as the major regulative challenges.

Conclusions
Health policy experts mostly consider mental health specialist video consultations as a promising way to overcome current challenges for the management of patients with mental disorders at the interface between primary and specialist care. To ensure sustained implementation, a multi-stakeholder approach accounting for the perspective of health policy experts, patients, and providers should be followed.

Trial registration
German Clinical Trials Register DRKS00012487
Randomized controlled study of the impact of a participatory patient care plan among primary care patients with common chronic diseases: a one-year follow-up study
Authors: Tusa Nina , Kautiainen Hannu , Elfving Pia , Sinikallio Sanna , Mäntyselkä Pekka 
Published: July 2021

Abstract
Backround
Chronic diseases and multimorbidity are common in the ageing population and affect the health related quality of life. Health care resources are limited and the continuity of care has to be assured. Therefore it is essential to find demonstrable tools for best treatment practices for patients with chronic diseases.
Our aim was to study the influence of a participatory patient care plan on the health-related quality of life and disease specific outcomes related to diabetes, ischemic heart disease and hypertension.

Methods
The data of the present study were based on the Participatory Patient Care Planning in Primary Care. A total of 605 patients were recruited in the Siilinjärvi Health Center in the years 2017–2018 from those patients who were followed up due to the treatment of hypertension, ischemic heart disease or diabetes. Patients were randomized into usual care and intervention groups. The intervention consisted of a participatory patient care plan, which was formulated in collaboration with the patient and the nurse and the physician during the first health care visit.
Health-related quality of life with the 15D instrument and the disease-specific outcomes of body mass index (BMI), low density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1C) and blood pressure were assessed at the baseline and after a one-year follow-up.

Results
A total of 587 patients with a mean age of 69 years were followed for 12 months. In the intervention group there were 289 patients (54% women) and in the usual care group there were 298 patients (50% women). During the follow-up there were no significant changes between the groups in health-related quality and disease-specific outcomes.

Conclusions
During the 12-month follow-up, no significant differences between the intervention and the usual care groups were detected, as the intervention and the usual care groups were already in good therapeutic equilibrium at the baseline.

Trial registration
ClinicalTrials.gov Identifier: NCT02992431. Registered 14/12/2016
Impaired cerebrospinal fluid transport due to idiopathic subdural hematoma in pig: an unusual case
Authors: Shanbhag Nagesh C. , Bèchet Nicholas Burdon , Kritsilis Marios , Lundgaard Iben 
Published: July 2021

Abstract
Background
We report the effects of the presentation of an idiopathic subdural hematoma (SDH) in an adult domestic pig on the glymphatic system, a brain-wide solute clearance system. This accidental finding is based on our recently published study that described this system for the first time in large mammals. Our current results define the need to investigate cerebrovascular pathologies that could compromise glymphatic function in gyrencephalic animal models as a tool to bridge rodent and human glymphatic studies.

Case presentation
The pig underwent intracisternal infusion of a fluorescent tracer under general anesthesia to delineate cerebrospinal fluid (CSF) pathways, and was euthanized at the end of 3 h of tracer circulation. During brain isolation, a hematoma measuring approximately 15 × 35 mm in size beneath the dura was evident overlying fronto-parietal brain surface. Interestingly, CSF tracer distribution was markedly reduced on dorsal, lateral and ventral surfaces of the brain when compared with a control pig that was infused with the same tracer. Furthermore, regional distribution of tracer along the interhemispheric fissure, lateral fissure and hippocampus was 4–5-fold reduced in comparison with a control pig. Microscopically, glial-fibrillary acidic protein and aquaporin-4 water channel immunoreactivities were altered in the SDH pig brain.

Conclusions
This is the first case of impaired glymphatic pathway due to an idiopathic SDH in a pig. Potential etiology could involve an acceleration-deceleration injury inflicted prior to arrival at our housing facility (e.g., during animal transportation) leading to disruption of bridging veins along the superior sagittal sinus and impairing CSF pathways in the whole brain. This accidental finding of globally impaired glymphatic function sheds light on a novel consequence of SDH, which may play a role in the enhanced cognitive decline seen in elderly presenting with chronic SDH.
Molecular profiling of basal cell carcinomas in young patients
Authors: Abi Karam Marc , Kourie Hampig Raphael , Jalkh Nadine , Mehawej Cybel , Kesrouani Carole , Haddad Fady Gh , Feghaly Iman , Chouery Eliane , Tomb Roland 
Published: July 2021

Abstract
Background
Basal cell carcinoma (BCC) represents by far the most common non-melanoma skin cancer (NMSC) in the world with an increasing incidence of 3% to 10% per year, especially in patients under the age of 40. While variants in the sonic Hedgehog and cell cycle regulation pathways account for the majority of BCC cases in adults, the molecular etiology of BCC in young patients is unelucidated yet. This study aims to investigate the molecular profile of BCC in the young population.

Methods
28 tumors belonging to 25 Lebanese patients under the age of 40, presenting different stages of BCC and diagnosed at Hôtel Dieu de France—Saint Joseph University Medical Center were included in this study. A selected panel of 150 genes involved in cancer was analyzed by Next Generation Sequencing (NGS) in the 28 included tumors.

Results
Genetic variants detected in more than 5% of the reads, with a sequencing depth ≥ 50x, were selected. Two hundred and two genetic variants in 48 different genes were detected, with an overall average sequencing depth of 1069x. Among the 28 studied tumors, 18 (64.3%) show variations in the PTCH1 gene, 6 (21.4%) in TP53 and 3 (10.7%) in SMO.

Conclusions
This is the first study reporting NGS-based analysis of BCC in a cohort of young patients. Our results highlight the involvement of the hedgehog and cell cycle regulation pathways in the genesis of BCC in the general population. The inclusion of a larger cohort of young patients is needed to confirm our findings.
Fibrinogen/albumin ratio index is an independent predictor of recurrence-free survival in patients with intrahepatic cholangiocarcinoma following surgical resection
Authors: Liu Hu , Qiu Guoteng , Hu Fengjuan , Wu Hong 
Published: July 2021

Abstract
Background
Systemic inflammation and nutritional status are associated with tumor development and progression. This study investigated the prognostic value of fibrinogen/albumin ratio index (FARI) in predicting recurrence-free survival (RFS) in patients with intrahepatic cholangiocarcinoma (ICC) undergoing hepatectomy.

Methods
A retrospective cohort was conducted including patients who received curative hepatectomy for ICC at our hospital between May 2010 and December 2016. We collected the preoperative hematologic parameters and clinical data of all patients. Time-dependent receiver operating characteristic curve was used to identify the optimal cutoff value of FARI. The association between FARI-high and FARI-low group was investigated by using the Kaplan–Meier method. A nomogram based on the results of univariate and multivariate analysis was established.

Results
A total of 394 patients with ICC who underwent hepatectomy at our hospital were enrolled. K-M analysis revealed that increased FARI was related to reduced RFS (P < 0.001). The multivariate analysis indicated that tumor number, tumor–node–metastasis stage, lymph node metastasis, cirrhosis, serum carbohydrate antigen 19-9, and FARI were independent predictors of RFS, and the ROC curve analysis showed that the optimal cutoff value for FARI was 0.084 based on the Youden index. The nomogram for FARI showed satisfactory accuracy in predicting RFS for ICC patients undergoing hepatectomy (C index = 0.663; AIC = 3081.07).

Conclusion
Preoperative FARI is an independent predictor of RFS in patients undergoing hepatectomy for ICC, and the nomogram can be useful for clinical decision-making in the postoperative management of these patients.
Comparing options for females seeking permanent contraception in high resource countries: a systematic review
Authors: Gormley Rebecca , Vickers Brian , Cheng Brooke , Norman Wendy V. 
Published: July 2021

AbstractBackgroundMultiple options for permanent or long-acting contraception are available, each with adverse effects and benefits. People seeking to end their fertility, and their healthcare providers, need a comprehensive comparison of methods to support their decision-making. Permanent contraceptive methods should be compared with long-acting methods that have similar effectiveness and lower anticipated adverse effects, such as the levonorgestrel-releasing intrauterine contraception (LNG-IUC). We aimed to understand the comparability of options for people seeking to end their fertility, using high-quality studies. We sought studies comparing laparoscopic tubal ligation, hysteroscopic tubal occlusion, bilateral salpingectomy, and insertion of the LNG-IUC, for effectiveness, adverse events, tolerability, patient recovery, non-contraceptive benefits, and healthcare system costs among females in high resource countries seeking to permanently avoid conception.MethodsWe followed PRISMA guidelines, searched EMBASE, Pubmed (Medline), Web of Science, and screened retrieved articles to identify additional studies. We extracted data on population, interventions, outcomes, follow-up, health system costs, and study funding source. We used the Newcastle–Ottawa Scale to assess risk of bias and excluded studies with medium–high risk of bias (NOS < 7). Due to considerable heterogeneity, we performed a narrative synthesis.ResultsOur search identified 6,612 articles. RG, BV, BC independently reviewed titles and abstracts for relevance. We reviewed the full text of 154 studies, yielding 34 studies which met inclusion criteria. We excluded 10 studies with medium–high risk of bias, retaining 24 in our synthesis. Most studies compared hysteroscopic tubal occlusion and/or laparoscopic tubal ligation. Most comparisons reported on effectiveness and adverse events; fewer reported tolerability, patient recovery, non-contraceptive benefits, and/or healthcare system costs. No comparisons reported accessibility, eligibility, or follow-up required. We found inconclusive evidence comparing the effectiveness of hysteroscopic tubal occlusion to laparoscopic tubal ligation. All studies reported adverse events. All forms of tubal interruption reported a protective effect against cancers. Tolerability appeared greater among tubal ligation patients compared to hysteroscopic tubal occlusion patients. No high-quality studies included the LNG-IUC.ConclusionsStudies are needed to directly compare surgical forms of permanent contraception, such as tubal ligation or removal, with alternative options, such as intrauterine contraception to support decision-making.Systematic review registrationPROSPERO [CRD42016038254].
Clinical significance and mechanisms associated with segmental UPD
Authors: Papenhausen Peter R. , Kelly Carla A. , Harris Samuel , Caldwell Samantha , Schwartz Stuart , Penton Andrea 
Published: July 2021

AbstractWhole chromosome uniparental disomy (UPD) has been well documented with mechanisms largely understood. However, the etiology of segmental limited UPD (segUPD) is not as clear. In a 10-year period of confirming (> 300) cases of whole chromosome UPD, we identified 86 segmental cases in both prenatal and postnatal samples. Thirty-two of these cases showed mosaic segmental UPD at 11p due to somatic selection associated with Beckwith–Wiedemann syndrome. This study focuses on apparent mechanisms associated with the remaining cases, many of which appear to represent corrections of genomic imbalance such as deletions and derivative chromosomes. In some cases, segmental UPD was associated with the generation of additional genomic imbalance while in others it apparently resulted in restoration of euploidy. Multiple tests utilizing noninvasive prenatal testing (NIPT), chorionic villus sampling (CVS) and amniotic fluid samples from the same pregnancy revealed temporal evidence of correction and a “hotspot” at 1p. Although in many cases the genomic imbalance was dosage “repaired” in the analyzed tissue, clinical effects could be sustained due to early developmental effects of the original imbalance or due to its continued existence in other tissues. In addition, if correction did not occur in the gametes there would be recurrence risks for the offspring of those individuals. Familial microarray allele patterns are presented that differentiate lack of gamete correction from somatic derived gonadal mosaicism. These results suggest that the incidence of segUPD mediated correction is underestimated and may explain the etiology of some clinical phenotypes which are undetected by routine microarray analysis and many exome sequencing studies.
Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial
Authors: Ooms Alexander , Dutton Susan J. , Parsons Scott , Fordham Beth , Hing Caroline , Lamb Sarah , Smith Toby 
Published: July 2021

Abstract
Background
Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, remains the same pre- to post-operatively, and in some instances declines. The PEP-TALK trial evaluates the effects of a group-based, behaviour change intervention on physical activity following a THR or TKR.

Methods
PEP-TALK is an open, phase III, pragmatic, multi-centre, parallel, two-arm, two-way superiority randomised controlled trial investigating the effectiveness of usual care plus a behaviour change therapy compared with usual care alone following primary THR or TKR. The primary outcome is the UCLA Activity Score at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes measured at 6 months and 12 months after randomisation include the UCLA Activity Score, Lower Extremity Functional Scale, Oxford Hip/Knee Score, Numerical Rating Scale for Pain, Generalised Self-Efficacy Scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale, EuroQoL EQ-5D-5L index and EQ-VAS and complications or adverse events. Full details of the planned analysis approaches for the primary and secondary outcomes, as well as the planned sensitivity analyses to be undertaken due to the COVID-19 pandemic, are described here. The PEP-TALK study protocol has been published previously.

Discussion
This paper provides details of the planned statistical analyses for the PEP-TALK trial. This is aimed to reduce the risk of outcome reporting bias and enhance transparency in reporting.

Trial registration
International Standard Randomised Controlled Trials database, ISRCTN Number: 29770908. Registered on October 2018.
Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial
Authors: Skullerud Kristin Helene , Gjersvik Petter , Pripp Are Hugo , Qvigstad Erik , Helgesen Anne Lise Ording 
Published: July 2021

Abstract
Background
Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial.

Methods
We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1–6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted.

Discussion
The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis.

Trial registration
ClinicalTrials.govNCT0365666. Registered on 4 September 2018.
Characteristics and outcomes of family-practice patients with coronavirus disease 2019: a case series
Authors: Dzieciolowska Stefania , Ravi Oumeet , Grad Roland 
Published: July 2021

Abstract
Background
The clinical history and outcomes of coronavirus disease 2019 among people not hospitalized is not yet well characterized. To better inform clinical evaluation, we set out to characterize the natural history of coronavirus disease 2019 in primary health care.

Methods
Case series of all patients rostered to physicians at a university-affiliated Family Medicine clinic. Cases met the Centers for Disease Control and Prevention definition of coronavirus disease 2019 from March 1 to May 21 2020.

Results
In total, 89 patients meeting Centers for Disease Control and Prevention criteria for coronavirus disease 2019 were documented. Their average age was 55.6 years (range 6–95 years), and all but one was symptomatic. Fifty-seven cases (64%) had a polymerase chain reaction test for coronavirus disease 2019, of whom 77.2% tested positive. Thirty cases (33.7%) reported contact with a confirmed or probable case of coronavirus disease 2019. Based on the Charlson Comorbidity Index, 28 cases (31.5%) had no comorbid conditions. The median number of days from symptom onset to first polymerase chain reaction test was 6 days (interquartile range 2.3–11 days). The median duration of fever was 3.5 days (interquartile range 1–7 days). Twenty-four cases (27%) visited the Emergency Department, and 10 were admitted to hospital. The median number of days between symptom onset and first Emergency Department visit was 8 days (interquartile range 3.5–27 days).

Conclusions
At the start of this pandemic, the implementation of basic measures such as diagnostic testing was delayed. If we are to improve our control over the spread of coronavirus disease 2019, we will need to substantially reduce the time from symptom onset to diagnostic testing, and subsequent contact tracing. To minimize unnecessary Emergency Department visits, we propose a testable strategy for Family Medicine to engage with coronavirus disease 2019 patients in the acute phase of their illness.