bluuebunny/crossref_metadata_2025_split huggingface dataset:
Reflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND): protocol and baseline outcomes for a stepped-wedge cluster-randomised prevention trial
Authors: Whelan Jillian , Hayward Joshua , Nichols Melanie , Brown Andrew D , Orellana Liliana , Brown Victoria , Becker Denise , Bell Colin , Swinburn Boyd , Peeters Anna , Moodie Marj , Geddes Sandy A , Chadwick Craig , Allender Steven , Strugnell Claudia 
Published: September 2022

IntroductionSystems science methodologies have been used in attempts to address the complex and dynamic causes of childhood obesity with varied results. This paper presents a protocol for the Reflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND) trial. RESPOND represents a significant advance on previous approaches by identifying and operationalising a clear systems methodology and building skills and knowledge in the design and implementation of this approach among community stakeholders.Methods and analysisRESPOND is a 4-year cluster-randomised stepped-wedge trial in 10 local government areas in Victoria, Australia. The intervention comprises four stages: catalyse and set up, monitoring, community engagement and implementation. The trial will be evaluated for individuals, community settings and context, cost-effectiveness, and systems and implementation processes. Individual-level data including weight status, diet and activity behaviours will be collected every 2 years from school children in grades 2, 4 and 6 using an opt-out consent process. Community-level data will include knowledge and engagement, collaboration networks, economic costs and shifts in mental models aligned with systems training. Baseline prevalence data were collected between March and June 2019 among >3700 children from 91 primary schools.Ethics and disseminationEthics approval: Deakin University Human Research Ethics Committee (HREC 2018-381) or Deakin University’s Faculty of Health Ethics Advisory Committee (HEAG-H_2019-1; HEAG-H 37_2019; HEAG-H 173_2018; HEAG-H 12_2019); Victorian Government Department of Education and Training (2019_003943); Catholic Archdiocese of Melbourne (Catholic Education Melbourne, 2019-0872) and Diocese of Sandhurst (24 May 2019). The results of RESPOND, including primary and secondary outcomes, and emerging studies developed throughout the intervention, will be published in the academic literature, presented at national and international conferences, community newsletters, newspapers, infographics and relevant social media.Trial registration numberACTRN12618001986268p.
Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial
Authors: Romero Sally A D , Emard Nicholas , Baser Raymond E , Panageas Katherine , MacLeod Jodi , Walker Desiree , Barton-Burke Margaret , Liou Kevin , Deng Gary , Farrar John , Xiao Han , Mao Jun J , Epstein Andrew 
Published: September 2022

IntroductionPain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.Methods and analysisWe describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.Ethics and disseminationThe Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.Trial registration numberNCT04095234.
Implementation of a colorectal cancer screening intervention in Malaysia (CRC-SIM) in the context of a pandemic: study protocol
Authors: Schliemann Désirée , Ramanathan Kogila , Ibrahim Tamin Nor Saleha Binti , O'Neill Ciaran , Cardwell Christopher R , Ismail Roshidi , Nanu Prathibha , Mohd Ghazali Ahmad Nizal bin , Kee Frank , Su Tin Tin , Donnelly Michael 
Published: September 2022

IntroductionColorectal cancer (CRC) is the second most common cancer in Malaysia and cases are often detected late. Improving screening uptake is key in down-staging cancer and improving patient outcomes. The aim of this study is to develop, implement and evaluate an intervention to improve CRC screening uptake in Malaysia in the context of the COVID-19 pandemic. The evaluation will include ascertaining the budgetary impact of implementing and delivering the intervention.Methods and analysisThe implementation research logic model guided the development of the study and implementation outcome measures were informed by the 'Reach, Effectiveness, Adoption, Implementation and Maintenance' (RE-AIM) framework. This CRC screening intervention for Malaysia uses home-testing and digital, small media, communication to improve CRC screening uptake. A sample of 780 people aged 50–75 years living in Segamat district, Malaysia, will be selected randomly from the South East Asia Community Observatory (SEACO) database. Participants will receive a screening pack as well as a WhatsApp video of a local doctor to undertake a stool test safely and to send a photo of the test result to a confidential mobile number. SEACO staff will inform participants of their result. Quantitative data about follow-up clinic attendance, subsequent hospital tests and outcomes will be collected. Logistic regression will be used to investigate variables that influence screening completion and we will conduct a budget impact-analysis of the intervention and its implementation. Qualitative data about intervention implementation from the perspective of participants and stakeholders will be analysed thematically.Ethics and disseminationEthics approval has been granted by Monash University Human Research Ethics Committee (MUHREC ID: 29107) and the Medical Review and Ethics Committee (Reference: 21-02045-O7G(2)). Results will be disseminated through publications, conferences and community engagement activities.Trial registration numberNational Medical Research Register Malaysia: 21-02045-O7G(2).
Minimally invasive surgical techniques for oesophageal cancer and nutritional recovery: a prospective population-based cohort study
Authors: Kauppila Joonas H , Rosenlund Helen , Klevebro Fredrik , Johar Asif , Anandavadivelan Poorna , Mälberg Kalle , Lagergren Pernilla 
Published: September 2022

ObjectivesTo explore whether the minimally invasive oesophagectomy (MIE) or hybrid minimally invasive oesophagectomy (HMIE) are associated with better nutritional status and less weight loss 1 year after surgery, compared with open oesophagectomy (OE).DesignProspective cohort study.SettingAll patients undergoing oesophagectomy for cancer in Sweden during 2013–2018.ParticipantsA total of 424 patients alive at 1 year after surgery were eligible, and 281 completed the 1-year assessment. Of these, 239 had complete clinical data and were included in the analysis.Primary and secondary outcome measuresThe primary outcome was nutritional status at 1 year after surgery, assessed using the abbreviated Patient-Generated Subjective Global Assessment questionnaire. The secondary outcomes included postoperative weight loss at 6 months and 1 year after surgery.ResultsOf the included patients, 78 underwent MIE, 74 HMIE while 87 patients underwent OE. The MIE group had the highest prevalence of malnutrition (42% vs 22% after HMIE vs 25% after OE), reduced food intake (63% vs 45% after HMIE vs 39% after OE), symptoms reducing food intake (60% vs 45% after HMIE vs 60% after OE) and abnormal activities/function (45% vs 32% after HMIE vs 43% after OE). After adjustment for confounders, MIE was associated with a statistically significant increased risk of reduced food intake 1 year after surgery (OR 2.87, 95% CI 1.47 to 5.61), compared with OE. Other outcomes were not statistically significantly different between the groups. No statistically significant associations were observed between surgical techniques and weight loss up to 1 year after surgery.ConclusionsMIE was statistically significantly associated with reduced food intake 1 year after surgery. However, no differences were observed in weight loss between the surgical techniques. Further studies on nutritional impact of surgical techniques in oesophageal cancer are needed.
Development of a screening tool for the need of specialist palliative care in oncologic inpatients: study protocol for the ScreeningPALL Study
Authors: Müller Evelyn , Müller Michael Josef , Boehlke Christopher , Ramsenthaler Christina , Jäger Helga , Schäfer Henning , Ostgathe Christoph , Klein Carsten , Simon Steffen , Becker Gerhild 
Published: September 2022

IntroductionA range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II).Methods and analysisInclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss’ Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need.Ethics and disseminationOur findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs—University Freiburg, Germany (approval no. 20-1103).Trial registration numberGerman Clinical Trials Register, DRKS00021686, registered on 17 December 2020.
Retrospective study of medical student scholarship and career trajectory following a mentored preclinical cardiovascular summer research fellowship
Authors: Wahlberg Kramer , Mughal Amreen , Li Zhaojin , Cipolla Marilyn J , Cushman Mary , Flyer Jonathan N 
Published: September 2022

ObjectivesDeveloping a preclinical training infrastructure for cardiovascular clinician-scientists is an academic workforce priority. The Cardiovascular Research Institute of Vermont developed a cardiovascular summer research fellowship (SRF), wherein medical student awardees were selected by merit-based application and completed mentored research between the first and second years. We aimed to study the impact of the SRF on medical student scholarship and career planning.DesignRetrospective survey study.SettingSingle academic medical centre.ParticipantsAll SRF participants from 2015 to 2020.InterventionsNot applicable.Primary and secondary outcome measuresPrior SRF participants were surveyed to ascertain current position, research engagement and perspectives regarding SRF experience. Comparisons to American Association of Medical Colleges Graduation Questionnaire data from equivalent years were made using χ2 tests.ResultsSurvey response rate was 87% (20/23), 55% were women. Median time from SRF completion was 2 years (IQR 0.75–2.25), with 75% still enrolled in medical school and 25% in residency. As a result of the first-year summer programme, 45% published a peer-reviewed abstract or manuscript, which was equivalent to the national rate for graduating students (53%, p=0.4). Most respondents (80%) were active in additional research projects during school separate from the SRF, 90% anticipated a career involving research (vs 53% nationally, p<0.001) and 75% planned to pursue a career in cardiovascular medicine.ConclusionMedical students completing a mentored cardiovascular SRF after their first year have a high rate of academic scholarship, with publication rate already equivalent to national peer graduates. Preclinical SRF students strongly anticipate cardiovascular medicine and research careers.
Needs of people with rare diseases that can be supported by electronic resources: a scoping review
Authors: Long Janet C , Best Stephanie , Nic Giolla Easpaig Bróna , Hatem Sarah , Fehlberg Zoe , Christodoulou John , Braithwaite Jeffrey 
Published: September 2022

ObjectivesRare diseases are characterised by low incidence, often with little evidence for effective treatments. Isolated patients and specialist centres for rare diseases are increasingly connected, thanks to the internet. This scoping review aimed to identify issues facing people with a rare disease that authors report may be addressed by electronic resources (mobile applications, websites, social media platforms, telehealth and online portals).DesignScoping review guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines.Data sourcesMedline, Embase and PsycInfo were searched, supplemented by hand searches of selected journals, in July 2021.Eligibility criteriaPeer-reviewed literature in English was searched using terms for rare disease (incidence <1:2000), electronic modalities (eg, mobile phone) and patient support terms. No date limit was set. Conference abstracts were included.Data extraction and synthesisData extracted: rare disease/group of diseases, name of the e-resource, need identified in the patient cohort, features of the e-resource, any other findings or observations of interest. From this, a framework was developed synthesising features across diseases and resources.ResultsSeventy-two papers were found (from 383). Fifty-six electronic resources were described in 64 papers, while 12 papers were exploratory studies. Cystic fibrosis (n=28) was the most frequently addressed, followed by haemophilia (n=16).Four domains and 23 subdomains of needs were extracted from the papers. The domains of needs were: support for self-management, access to high-quality information, access to appropriate specialist services, and social support. Subdomains are sometimes related to needs of individual rare diseases (eg, social isolation due to infection risk in people with cystic fibrosis). Fifteen electronic resources were identified that supported parents of children with rare disorders.ConclusionsWhile it can be argued that rare diseases, per se, may be no less distressing or onerous to care for than a high prevalence disease, rare diseases have unique features: the lengthy odyssey to find a diagnosis, then appropriate specialists, the lack of evidence around effective treatments, guidelines or access to knowledgeable general health service providers. Designers of electronic resources are urged to consult key stakeholders to enhance the effectiveness and usability of resources for people with a rare disease.
Measuring professional stigma towards patients with a forensic mental health status: protocol for a Delphi consensus study on the design of a questionnaire
Authors: Vorstenbosch Ellen , Masoliver-Gallach Ruth , Escuder-Romeva Gemma 
Published: September 2022

IntroductionNegative attitudes towards individuals with a mental illness and/or criminal background are widely studied, but empirical interest in the attitudes towards patients with a forensic mental health status is lacking. Negative attitudes among mental healthcare (MHC) professionals can have a significant impact on treatment outcomes and hence, affect patients’ rehabilitation. This study will elaborate an instrument to assess stigmatising attitudes among community MHC professionals towards patients with a forensic mental health status.Methods and analysisThe instrument will be developed by means of a Delphi study and depart from pre-existing instruments that assess public and professional stigma towards individuals with a mental illness and/or criminal background. Relevant instruments were identified through a targeted literature review. A longlist of items has been selected for the Delphi survey. Five expert panels (ie, academic experience in stigma or forensic MHC, clinical experience in community or forensic MHC or patient experience in forensic and community MHC) will be asked to score the relevance of each item on a 7-point Likert scale and to agree on the wording (yes/no). Participants will be provided with the option to suggest additional items or alternative wording. Adapted Delphi methodology will be applied with an expectation of at least three rounds to achieve consensus: ≥60% of the participants of at least four of five expert panels rank the item in the top three (inclusion) or bottom three (exclusion). Items will be reworded for a consecutive round based on a ‘yes minus no’ score and participants’ suggestions.Ethics and disseminationThis study has been approved by the ethics committee of Fundación Sant Joan de Déu. Dissemination of results will be through peer-reviewed publications, presentations and (inter-)national academic conferences. A summary of the results will be shared with the participants and key persons in community and forensic MHC.
Multimorbidity patterns and the relation to self-rated health among older Japanese people: a nationwide cross-sectional study
Authors: Honda Yuki , Nakamura Mieko , Aoki Takuya , Ojima Toshiyuki 
Published: September 2022

ObjectivesClassifying individuals into multimorbidity patterns can be useful to identify the target population with poorer clinical outcomes. Self-rated health (SRH) is one of the core outcomes in multimorbidity patients. Although studies have reported that multimorbidity is associated with poor SRH, whether certain patterns have stronger associations remains unknown. Therefore, this study aimed to identify the prevalence and patterns of multimorbidity and investigate the association between multimorbidity patterns and SRH in an older Japanese population.DesignCross-sectional study.SettingData were obtained from the 2013 Comprehensive Survey of Living Conditions, a nationally representative survey of the general Japanese population.ParticipantsThis study mainly examined 23 730 participants aged ≥65 years who were not hospitalised or institutionalised.Primary outcome measurePoor SRH was defined as choosing ‘not very good’ or ‘bad’ from five options: ‘excellent’, ‘fairly good’, ‘average’, ‘not very good’ and ‘bad’.ResultsThe prevalence of multimorbidity was 40.9% and that of poor SRH was 23.8%. Three multimorbidity patterns were identified by exploratory factor analysis: (1) degenerative/mental health, (3) malignant/digestive/urological/haematological and (3) cardiovascular/metabolic. Multivariable modified Poisson regression analysis revealed that high malignant/digestive/urological/haematological, degenerative/mental health and cardiovascular/metabolic pattern scores, corresponding to the number of affected body systems in each pattern, were significantly associated with poor SRH (adjusted risk ratio (aRR)=1.68, 95% CI: 1.60 to 1.76; aRR=1.63, 95% CI: 1.58 to 1.69; and aRR=1.31, 95% CI: 1.26 to 1.36, respectively). When including the Kessler 6 score, a screening scale for psychological distress, in the analysis, the association between each multimorbidity pattern score and poor SRH decreased.ConclusionsMalignant/digestive/urological/haematological and degenerative/mental health patterns may be associated with a high risk for poor SRH. Further research should focus on interventions to improve SRH in multimorbidity patients.
Detailed analysis of the curvature bounce: background dynamics and imprints in the CMB
Authors: Renevey Cyril , Barrau Aurélien , Martineau Killian 
Published: September 2022

AbstractIf the spatial sections of the Universe are positively curved, extrapolating the inflationary stage backward in time inevitably leads to a classical bounce. This simple scenario, non-singular and free of exotic physics, deserves to be investigated in details. The background dynamics exhibits interesting features and is shown to be mostly insensitive to initial conditions as long as observational consequences are considered. The primordial scalar power spectrum is explicitly computed, for different inflaton potentials, and the subsequent CMB temperature anisotropies are calculated. The results are compatible with current measurements. Some deviations with respect to the standard paradigm can however appear at large scales and we carefully disentangle what is associated with the vacuum choice with what is more fundamentally due to the bounce itself.