bluuebunny/crossref_metadata_2025_split huggingface dataset:
Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study
Authors: Bruhn Simon Majormoen , Ingelsrud Lina Holm , Bandholm Thomas , Skou Søren Thorgaard , Schroder Henrik M , Reventlow Susanne , Møller Anne , Kjellberg Jakob , Kallemose Thomas , Troelsen Anders 
Published: November 2022

IntroductionKnee osteoarthritis (OA) is associated with chronic knee pain and functional disability that negatively affect the ability to carry out normal daily activities. Patients are offered a large variety of non-surgical treatments, often not in accordance with clinical guidelines. This observational study will provide a comprehensive overview of treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon, including timing and order of treatment modalities, predictors of treatment outcomes, cost-effectiveness of treatment pathways and patients’ views on different treatment pathways.Methods and analysisPatients with primary referrals to an orthopaedic surgeon due to knee OA are consecutively invited to participate and fill out a questionnaire prior to their consultation with an orthopaedic surgeon. Follow-up questionnaires will be obtained at 6 and 24 months after inclusion. Based on a prospective cohort study design, including questionnaires and register data, we will (1) describe treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon; (2) describe the characteristics of patients choosing different treatment pathways; (3) develop predictive models for patient-self-determined classifications of good and poor treatment outcomes; (4) evaluate the cost-effectiveness of treatment pathways that live up to clinical guidelines versus pathways that do not; based on a qualitative study design using semistructured individual interviews, we will (5) describe the patients’ perspectives on treatment pathways for knee OA.Ethics and disseminationThe study is approved by the Danish regional ethical committee (journal number H-17017295) and the Danish Data Protection Agency (journal number AHH-2017–072). Data will be anonymised and handled in line with the General Data Protection Regulation and the Danish Data Protection Act. The study results will be submitted to international open-access peer-reviewed journals and disseminated at conferences.Trial registration numberNCT03746184, pre-results.
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS):
protocol of a prospective, randomised, adaptive, multicentre clinical
trial
Authors: Kanjo Anna , Molnar Zsolt , Zádori Noémi , Gede Noémi , Erőss Bálint , Szakó Lajos , Kiss Tamás , Márton Zsolt , Malbrain Manu L N G , Szuldrzynski Konstanty , Szrama Jakub , Kusza Krzysztof , Kogelmann Klaus , Hegyi Péter 
Published: November 2022

Introduction
Sepsis and septic shock have mortality rates between 20% and 50%. In
sepsis, the immune response becomes dysregulated, which leads to an
imbalance between proinflammatory and anti-inflammatory mediators. When
standard therapeutic measures fail to improve patients’ condition,
additional therapeutic alternatives are applied to reduce morbidity and
mortality. One of the most recent alternatives is extracorporeal
cytokine adsorption with a device called CytoSorb. This study aims to
compare the efficacy of standard medical therapy and continuous
extracorporeal cytokine removal with CytoSorb therapy in patients with
early refractory septic shock. Furthermore, we compare the dosing of
CytoSorb adsorber device changed every 12 or 24 hours.

Methods and analysis
It is a prospective, randomised, controlled, open-label,
international, multicentre, phase III study. Patients fulfilling the
inclusion criteria will be randomly assigned to receive standard medical
therapy (group A) or—in addition to standard treatment—CytoSorb therapy.
CytoSorb treatment will be continuous and last for at least 24 hours,
CytoSorb adsorber device will be changed every 12 (group B) or 24 hours
(group C). Our primary outcome is shock reversal (no further need or a
reduced (≤10% of the maximum dose) vasopressor requirement for 3 hours)
and time to shock reversal (number of hours elapsed from the start of
the treatment to shock reversal).
Based on sample size calculation, 135 patients (1:1:1) will need to
be enrolled in the study. A predefined interim analysis will be
performed after reaching 50% of the planned sample size, therefore, the
corrected level of significance (p value) will be 0.0294.

Ethics and dissemination
Ethics approval was obtained from the Scientific and Research Ethics
Committee of the Hungarian Medical Research Council (OGYÉI/65049/2020).
Results will be submitted for publication in a peer-reviewed
journal.

Trial registration number
NCT04742764; Pre-results.
SHAPER-PND trial: clinical effectiveness protocol of a community singing
intervention for postnatal depression
Authors: Estevao Carolina , Bind Rebecca , Fancourt Daisy , Sawyer Kristi , Dazzan Paola , Sevdalis Nick , Woods Anthony , Crane Nikki , Rebecchini Lavinia , Hazelgrove Katie , Manoharan Manonmani , Burton Alexandra , Dye Hannah , Osborn Tim , Greenwood Lorna , Davis Rachel E , Soukup Tayana , Arias de la Torre Jorge , Bakolis Ioannis , Healey Andy , Perkins Rosie , Pariante Carmine 
Published: November 2022

Introduction
Postnatal depression (PND) affects approximately 13% of new mothers.
Community-based activities are sought after by many mothers, especially
mothers that prefer not to access pharmacological or psychological
interventions. Singing has shown positive effects in maternal mood and
mother–child bonding. The Scaling-Up Health-Arts Programmes:
Implementation and Effectiveness Research-Postnatal Depression study
will analyse the clinical and implementation effectiveness of 10-week
singing sessions for PND in new mothers. This protocol paper will focus
on the clinical effectiveness of this trial.

Methods and analysis
A total of 400 mothers with PND (with a score of at least 10 on the
Edinburgh Postnatal Depression Scale) and their babies will be recruited
for this hybrid type II randomised controlled trial. The intervention
group will attend 10 weekly singing sessions held at community venues or
online, facilitated by the arts organisation, Breathe Arts Health
Research (Breathe). A control group will be encouraged to attend
non-singing sessions in the community or online for 10 weeks. A package
of assessments will be collected from participants for clinical,
mechanistic and implementation outcomes, at different stages of the
trial. Clinical assessments will include questionnaires and interviews
for demographics, mental health and social measures, together with
biological samples for measurement of stress markers; the study visits
are at baseline, week 6 (mid-trial) and week 10 (end of trial), with
follow ups at weeks 20 and 36. Multiple imputation will be used to deal
with possible missing data and multivariable models will be fitted to
assess differences between groups in the outcomes of the study.

Ethics and dissemination
Ethical approval has been granted by the London-West London and GTAC
Research Ethics Committee, REC reference: 20/PR/0813.

Trial registration number
NCT04834622; Pre-results.
Implementation of medicinal cannabis in Australia: innovation or
upheaval? Perspectives from physicians as key informants, a qualitative
analysis
Authors: Hallinan Christine Mary , Gunn Jane Maree , Bonomo Yvonne Ann 
Published: November 2022

Objective
We sought to explore physician perspectives on the prescribing of
cannabinoids to patients to gain a deeper understanding of the issues
faced by prescriber and public health advisors in the rollout of
medicinal cannabis.

Design
A thematic qualitative analysis of 21 in-depth interviews was
undertaken to explore the narrative on the policy and practice of
medicinal cannabis prescribing. The analysis used the Diffusion of
Innovations (DoI) theoretical framework to model the conceptualisation
of the rollout of medicinal cannabis in the Australian context.

Setting
Informants from the states and territories of Victoria, New South
Wales, Tasmania, Australian Capital Territory, and Queensland in
Australia were invited to participate in interviews to explore the
policy and practice of medicinal cannabis prescribing.

Participants
Participants included 21 prescribing and non-prescribing key
informants working in the area of neurology, rheumatology, oncology,
pain medicine, psychiatry, public health, and general practice.

Results
There was an agreement among many informants that medicinal cannabis
is, indeed, a pharmaceutical innovation. From the analysis of the
informant interviews, the factors that facilitate the diffusion of
medicinal cannabis into clincal practice include the adoption of
appropriate regulation, the use of data to evaluate safety and efficacy,
improved prescriber education, and the continuous monitoring of product
quality and cost. Most informants asserted the widespread assimilation
of medicinal cannabis into practice is impeded by a lack of health
system antecedents that are required to facilitate safe, effective, and
equitable access to medicinal cannabis as a therapeutic.

Conclusions
This research highlights the tensions that arise and the factors
that influence the rollout of cannabis as an unregistered medicine.
Addressing these factors is essential for the safe and effective
prescribing in contemporary medical practice. The findings from this
research provides important evidence on medicinal cannabis as a
therapeutic, and also informs the rollout of potential novel
therapeutics in the future.
Effects of mindfulness-based stress reduction on adults with sleep disturbance: an updated systematic review and meta-analysis
Authors: Kim Seong Min , Park Jeong Min , Seo Hyun-Ju , Kim Jinhee , Noh Jin-Won , Kim Hyun Lye 
Published: November 2022

ObjectiveMindfulness-based stress reduction (MBSR) is a meditation-based therapy originally recommended for stress management. However, it is currently used to alleviate sleep disturbances. Therefore, this contemporary systematic review aimed to elucidate the clinical effects of MBSR on sleep quality and sleep-related daytime impairment in adults with sleep disturbances, including chronic insomnia disorders.DesignSystematic review and meta-analysis of randomised controlled trials (RCTs).MethodsA comprehensive search was conducted using the following databases: Ovid MEDLINE, AMED, Ovidembase, PsycINFO, Cochrane Library, CINAHL, and four domestic databases: KoreaMed, KISS, KMbase and NDSL. The final search update was performed in June 2022. Two researchers independently selected relevant studies, assessed the risk of bias and extracted the data.ResultsOf the 7516 records searched, 20 RCTs and 21 reports were included. In the subgroup analysis, MBSR did not improve objective or subjective sleep quality in chronic insomnia and cancers. However, MBSR versus waitlist control might have been effective in improving subjective sleep quality, but with substantial heterogeneity (standardised mean difference=−0.32; 95% CI: −0.56 to –0.08; I2=71%). In addition, MBSR compared with active control did not improve the sleep-related daytime impairments including depression, anxiety, stress, fatigue and quality of life. The overall risk of bias included in this review was a concern because of performance and detection bias.ConclusionsMBSR might be ineffective for improving sleep quality in patients with chronic insomnia and cancers. In addition, more than half of the RCTs included in this review had small sample sizes and were vulnerable to performance and detection biases. Therefore, well-designed RCTs with larger sample sizes are required to confirm the clinical effects of MBSR in adults with sleep disturbances.PROSPERO registration numberCRD42015027963.
Common mental disorders and associated factors among high school students in Debre Markos Town, Northwest Ethiopia: an institutional-based cross-sectional study
Authors: Melkam Mamaru , Nenko Goshu , Demilew Demeke 
Published: November 2022

BackgroundCommon mental disorders include anxiety, depression and somatic symptoms. These pose significant public health problems because of their serious effects on personal well-being, social and occupational functions. They also can affect the health and quality of life of people in adolescence, because this age group has been vulnerable to different factors. According to the American Psychiatry Association, more than 60% of adolescents fulfil the criteria for at least one common mental disorder. Despite the high burden of the disorders, there are limited studies in Ethiopia; therefore, this study provided the prevalence of common mental disorders among students in Ethiopia.MethodsFrom 5 May to 30 May 2021, an institutional-based cross-sectional study was undertaken. Simple random sampling was used to select study participants from each class level across all high schools. A self-administered survey was used that included Self-Reporting Questionnaire 20, Oslo Social Support Scale-3 and other semistructured instruments for the screening of common mental disorders. Data were checked, coded and entered into Epi-Data V.4.6.0, then exported to SPSS V.20 for analysis. Bivariable and multivariable logistic regression analyses were done to identify factors associated with common mental disorders. Adjusted ORs with 95% CIs were calculated and variables with a p value of <0.05 were considered as significantly associated with common mental disorders.ResultsA total of 600 high school students were recruited with a response rate of 93.2%. The overall prevalence of common mental disorders among the participants was 181 (32.4%). Being female (adjusted OR (AOR)=1.93; 95% CI: 1.27 to 2.99), a family history of mental illness (AOR=2.23; 95% CI: 1.15 to 4.35), poor social support (AOR=3.14; 95% CI: 1.51 to 6.54), a history of non-physical sexual abuse (AOR=2.09; 95% CI: 1.21 to 3.62) and a history of physical sexual abuse (AOR=2.43; 95% CI: 1.29 to 4.59) were significantly associated with common mental disorders.Conclusion and recommendationThe prevalence of common mental disorders was 32.4% among students; therefore, it is recommended facilitating institutional-based intervention services in the school to decrease the contributing factors for the common mental disorders.
‘It’s a Dance Between Managing Both’: a qualitative study exploring perspectives of persons with knee osteoarthritis and type 2 diabetes mellitus on the impact of osteoarthritis on diabetes management and daily life
Authors: King Lauren K , Waugh Esther , MacKay Crystal , Stanaitis Ian , Stretton Jane , Weisman Alanna , Ivers Noah M , Lipscombe Lorraine L , Hawker Gillian , Parsons Janet A 
Published: November 2022

ObjectivesType 2 diabetes (T2DM) and knee osteoarthritis (OA) commonly co-occur and epidemiologic studies suggest concomitant symptomatic knee OA increases the risk of T2DM complications. We sought to explore the experiences and perspectives of individuals’ living with both symptomatic knee OA and T2DM, with a focus on the impact of OA on T2DM management and daily life.DesignWe conducted qualitative semistructured telephone interviews with persons living with T2DM and knee OA. We inductively coded and analysed interview transcripts, informed by interpretative description.SettingWe recruited participants from a community arthritis self-management programme and an academic hospital’s family medicine clinic in Ontario, Canada.ParticipantsWe included 18 participants who had a physician diagnosis of both T2DM and knee OA, with variation age, gender, and duration of T2DM and knee OA.ResultsParticipants with T2DM described how concomitant painful and disabling knee OA made it difficult to engage in physical activity, negatively impacting blood glucose control. Joint pain itself, associated sleep disturbance and emotional distress were also seen to affect blood glucose control. Beyond diabetes management, the impact of OA-related pain and functional limitations on nearly all aspects of daily life led participants to view their OA as important. Despite this, many participants described that their health professionals paid little attention to their OA, which left them to self-manage. Balancing both conditions also required navigating a medical system that provided piecemeal care.ConclusionsIndividuals with T2DM view symptomatic knee OA as an important barrier to both T2DM management and overall well-being, yet are frequently met with insufficient support from health professionals. Greater recognition and management of knee OA in persons with T2DM could help improve patient-centred care and potentially disease outcomes.
Radiofrequency-assisted transection of the pancreas versus stapler in distal pancreatectomy: study protocol for a multicentric randomised clinical trial (TRANSPAIRE)
Authors: Sánchez-Velázquez Patricia , Pueyo-Périz Eva , Álamo J M , Suarez Artacho Gonzalo , Gómez Bravo Miguel Ángel , Marcello Manuel , Vicente Emilio , Quijano Yolanda , Ferri Valentina , Caruso Riccardo , Dorcaratto Dimitri , Sabater Luis , González Chávez Pilarena , Noguera Jose , Navarro Gonzalo Ana , Bellido-Luque Juan , Téllez-Marques Clara , Ielpo Benedetto , Burdio Fernando 
Published: November 2022

IntroductionTo date, no pancreatic stump closure technique has been shown to be superior to any other in distal pancreatectomy. Although several studies have shown a trend towards better results in transection using a radiofrequency device (radiofrequency-assisted transection (RFT)), no randomised trial for this purpose has been performed to date. Therefore, we designed a randomised clinical trial, with the hypothesis that this technique used in distal pancreatectomies is superior in reducing clinically relevant postoperative pancreatic fistula (CR-POPF) than mechanical closures.Methods and analysisTRANSPAIRE is a multicentre randomised controlled trial conducted in seven Spanish pancreatic centres that includes 112 patients undergoing elective distal pancreatectomy for any indication who will be randomly assigned to RFT or classic stapler transections (control group) in a ratio of 1:1. The primary outcome is the CR-POPF percentage. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1−β), expected POPF in control group of 32%, expected POPF in RFT group of 10% and a clinically relevant difference of 22%. Secondary outcomes include postoperative results, complications, radiological evaluation of the pancreatic stump, metabolomic profile of postoperative peritoneal fluid, survival and quality of life. Follow-ups will be carried out in the external consultation at 1, 6 and 12 months postoperatively.Ethics and disseminationTRANSPAIRE has been approved by the CEIM-PSMAR Ethics Committee. This project is being carried out in accordance with national and international guidelines, the basic principles of protection of human rights and dignity established in the Declaration of Helsinki (64th General Assembly, Fortaleza, Brazil, October 2013), and in accordance with regulations in studies with biological samples, Law 14/2007 on Biomedical Research will be followed. We have defined a dissemination strategy, whose main objective is the participation of stakeholders and the transfer of knowledge to support the exploitation of activities.Registration detailsClinicalTrials.gov Registry (NCT04402346).
Adolescents’ and professionals’ experiences of metabolic and bariatric surgery and requirements for preoperative and postoperative support through mHealth: a qualitative study
Authors: Müssener Ulrika , Örn Malin , Olbers Torsten , Löf Marie , Sjögren Lovisa 
Published: November 2022

ObjectivesThis study aimed to explore adolescents’ and professionals’ incentives and experiences of metabolic and bariatric surgery (MBS) and to explore perceived needs and requirements for preoperative and postoperative support through an mHealth intervention to improve long-term healthy lifestyle behaviour and health outcomes.DesignAn inductive qualitative study using in-depth semistructured interviews.SettingThree hospital-based specialist paediatric obesity treatment units in Sweden.ParticipantsA total of 18 participants (14 women and 4 men). Nine adolescents aged between 17 and 22 years who had undergone or were about to undergo surgery, and nine professionals, including researchers and clinicians working in various professional roles such as physiotherapist, dietician, nurse, psychologist, physician and pedagogue.ResultsBoth informant groups of participants highlighted that undergoing MBS is a complex process, and hence actions are required on several levels to optimise the positive, long-term effects of surgery. Efficient communication between the healthcare professionals and adolescents was considered crucial and a key success factor. Informants acknowledged the need for additional support that relates to psychosocial well-being and mental health in order to understand, form and accept new behaviours and identity. An mHealth intervention should be seen as complementary to physical appointments, and informants acknowledged that an app could be a way of improving access to healthcare, and a useful tool to allow for individually tailored and easily available support.ConclusionsThe findings address the importance of a personal encounter and a need for additional support that relates to psychosocial well-being, mental health and healthy lifestyle behaviour. These findings should be incorporated into future research concerning mHealth interventions in MBS during adolescence.
Factors associated with adolescents’ sexual experience based on the biopsychosocial model: a cross-sectional study using the Korea Youth Risk Behavior Web-based Survey (KYRBS)
Authors: Kim Ka Young , Shin Hye Young 
Published: November 2022

ObjectivesSexual activity is an important integrative behaviour that interacts with biological, psychological and social factors among various changes in adolescence. However, starting sex at an early age is associated with adverse outcomes. Thus, this study aimed to investigate the factors associated with adolescents’ sexual experience based on the biopsychosocial model.DesignA cross-sectional study.SettingThe participants were selceted through a complex sample design at high schools and middle schools nationwide in Korea.ParticipantsWe employed 4-year data (2017–2020) of the cross-sectional Korea Youth Risk Behavior Web-based Survey. In total, 234567 participants attending middle school and high school were analysed. Sexual experience was defined as having had sexual intercourse (oral, anal or vaginal) in their lifetime. To identify variables associated with adolescents’ sexual experiences, we used a biopsychosocial model. Logistic regression analysis was performed to identify the variables associated with sexual experience.Results3.4% of boys and 1.6% of girls attending middle school had sexual experiences, showing a significant difference. A total of 10.4% of boys and 5.1% of girls attending high school had sexual experiences (p<0.001). Among the biological factors of the biopsychosocial model, age and gender were significantly associated with sexual experiences in adolescents. Regarding the psychological factors, suicidal thoughts were a significant risk factor associated with sexual experience. Furthermore, social factors including drinking, smoking and family structure were associated with sexual experience in adolescents. Particularly, a significantly higher sexual experience was found in the three groups living with a single parent, step-parents and no parents compared with the group living with both parents in family structure.ConclusionsThis study demonstrated the factors associated with adolescents’ sexual experience based on the biopsychosocial model. Further research and policy strategies that consider supporting family communication and mental health and preventing substance use are required to prevent adolescents’ sexual health.