bluuebunny/crossref_metadata_2025_split huggingface dataset:
Health economic evaluation of the ‘Flying Intervention Team’ as a novel stroke care concept for rural areas: study protocol of the TEMPiS-GÖA study
Authors: Coors Marie , Flemming Ronja , Schüttig Wiebke , Hubert Gordian Jan , Hubert Nikolai Dominik , Sundmacher Leonie 
Published: September 2022

IntroductionProviding comprehensive stroke care poses major organisational and financial challenges to the German healthcare system. The quasi-randomised TEMPiS–Flying Intervention Team (TEMPiS-FIT) study aims to close the gap in the treatment of patients who had ischaemic stroke in rural areas of Southeast Bavaria by flying a team of interventionalists via helicopter directly to patients in the regional TEMPiS hospitals instead of transporting the patients to the next comprehensive stroke centre. The objective of the present paper is to describe the methods for the economic evaluation (TEMPiS-Gesundheitsökonomische Analyse (TEMPiS-GÖA)) alongside the TEMPiS-FIT study to determine whether the new form of care is cost-effective compared with standard care.Methods and analysisThe within-trial cost-effectiveness analysis (CEA) and cost–utility analysis (CUA) will be performed from a statutory health insurance perspective as well as from a societal perspective over the time horizon of 12 months after the patients’ hospital discharge. Direct costs from outpatient and inpatient care are collected from routine data of the participating health insurance funds, while medical and non-medical costs from a patient’s perspective are retrieved from primary data collected during the TEMPiS-FIT study and follow-up questionnaires. Results will be presented as incremental cost-effectiveness ratio and incremental cost-utility ratio quantifying the incremental costs and health benefits compared with standard care practice. The outcome of the CEA will be measured in costs per minute reduction in mean process time to thrombectomy. The outcome of the CUA will be presented as costs per quality-adjusted life year gained.Ethics and disseminationEthical approval for the TEMPiS-FIT study was granted by the Bavarian State Medical Association Ethics Committee (# 17056). Results will be disseminated via reports, presentations of the results in publications and at conferences and on the TEMPiS website.Trial registration numberGerman Clinical Trials Register DRKS00023885. Registered on 2 July 2021 – retrospectively registered.
Improving prediction of response to neoadjuvant treatment in patients with breast cancer by combining liquid biopsies with multiparametric MRI: protocol of the LIMA study – a multicentre prospective observational cohort study
Authors: Janssen Liselore M , Suelmann Britt B M , Elias Sjoerd G , Janse Markus H A , van Diest Paul J , van der Wall Elsken , Gilhuijs Kenneth G A 
Published: September 2022

IntroductionThe response to neoadjuvant chemotherapy (NAC) in breast cancer has important prognostic implications. Dynamic prediction of tumour regression by NAC may allow for adaption of the treatment plan before completion, or even before the start of treatment. Such predictions may help prevent overtreatment and related toxicity and correct for undertreatment with ineffective regimens. Current imaging methods are not able to fully predict the efficacy of NAC. To successfully improve response prediction, tumour biology and heterogeneity as well as treatment-induced changes have to be considered. In the LIMA study, multiparametric MRI will be combined with liquid biopsies. In addition to conventional clinical and pathological information, these methods may give complementary information at multiple time points during treatment.AimTo combine multiparametric MRI and liquid biopsies in patients with breast cancer to predict residual cancer burden (RCB) after NAC, in adjunct to standard clinico-pathological information. Predictions will be made before the start of NAC, approximately halfway during treatment and after completion of NAC.MethodsIn this multicentre prospective observational study we aim to enrol 100 patients. Multiparametric MRI will be performed prior to NAC, approximately halfway and after completion of NAC. Liquid biopsies will be obtained immediately prior to every cycle of chemotherapy and after completion of NAC. The primary endpoint is RCB in the surgical resection specimen following NAC. Collected data will primarily be analysed using multivariable techniques such as penalised regression techniques.Ethics and disseminationMedical Research Ethics Committee Utrecht has approved this study (NL67308.041.19). Informed consent will be obtained from each participant. All data are anonymised before publication. The findings of this study will be submitted to international peer-reviewed journals.Trial registration numberNCT04223492.
Is the analogue cognitive test from the ISPOCD equivalent to the digital cognitive test Mindmore? A protocol for a randomised cross-over study including qualitative interviews with self-reported healthy seniors
Authors: Amirpour Anahita , Bergman Lina , Liander Karin , Eriksson Lars I , Eckerblad Jeanette , Nilsson Ulrica 
Published: September 2022

IntroductionPostoperative cognitive decline affects cognitive domains such as executive functions, memory, concentration and information processing. The analogue neuropsychological test developed by the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) is a well-established test for assessing cognitive performance. However, analogue tests are time-consuming, rarely cost-effective and can be at risk of administration bias. Digital solutions are comparable to analogue ones, have higher degrees of compliance and enable more standardised execution than analogue tests. Currently, there is a lack of recommendations for clinical evaluation of the patient’s cognition in the perioperative setting, standard care usually means no cognitive assessments prior or after the surgery. There is a need to find an equivalent neuropsychological test to the ISPOCD to make it accessible and easier to implement in a clinical context for perioperative patients. This study aims to examine how healthy seniors perform on two neuropsychological tests, analogue versus digital and measure equivalency between tests with correlation analysis.Methods and analysisThis study will use a randomised cross-over design, including qualitative interviews regarding test experiences. Healthy participants ≥60 years of age will be eligible to participate in the study. Cognitive function will be measured by using the ISPOCD test and the Mindmore digital test. The participants will self-report depressive symptoms with the Geriatric Depression Scale-15, user experience of the digital test using a modified version of the System Usability Scale and answer questionnaires targeting their experiences after the tests. Furthermore, according to the Swedish Quality of Recovery Scale, self-reported concentration difficulties will also be measured.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority (Dnr 2021-05486-01) and will follow the principles outlined in the 1964 Helsinki Declaration and its later amendments. Results from this study will be disseminated in peer-reviewed journals, at scientific conferences, and in social media.Trial registration number2021-01095; ClinicalTrials.gov.
Conditions for the success and the feasibility of health mediation for healthcare use by underserved populations: a scoping review
Authors: Richard Elodie , Vandentorren Stephanie , Cambon Linda 
Published: September 2022

ObjectiveThis article aims to analyse the conditions under which health mediation for healthcare use is successful and feasible for underserved populations.MethodWe conducted a scoping review on the conditions for effective health mediation according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews standards. We searched for articles in the following databases: PubMed, PsychINFO, Scopus and Cairn published between 1 January 2015 and 18 December 2020. We selected the articles concerning health mediation interventions or similar, implemented in high-income countries and conducted among underserved populations, along with articles that questioned their effectiveness conditions. We created a two-dimensional analysis grid of the data collected: a descriptive dimension of the intervention and an analytical dimension of the conditions for the success and feasability of health mediation.Results22 articles were selected and analysed. The scoping review underlines many health mediation characteristics that articulate education and healthcare system navigation actions, along with mobilisation, engagement, and collaboration of local actors among themselves and with the populations. The conditions for the success and the feasability were grouped in a conceptual framework of health mediation.ConclusionThe scoping review allows us to establish an initial framework for analysing the conditions for the success and the feasability of health mediation and to question the consistency of the health mediation approach regarding cross-cutting tensions and occasionally divergent logic.
Challenges in detecting and managing mild cognitive impairment in primary care: a focus group study in Shanghai, China
Authors: Lu Yuan , Liu Chaojie , Wells Yvonne , Yu Dehua 
Published: September 2022

IntroductionDetection of mild cognitive impairment (MCI) is essential in slowing progression to dementia. Primary care plays a vital role in detecting and managing MCI. The chronic care model (CCM) provides effective methods to manage chronic diseases.ObjectiveThis study aimed to explore how MCI services are delivered in primary care in China.MethodsFocus group interviews were conducted face to face among MCI stakeholders from six community health centres (CHCs) involved in the ‘friendly community programme’ in Shanghai, China. A total of 124 MCI stakeholders were interviewed, consisting of 6 groups (n=42) of general practitioners (GPs), 3 groups (n=18) of CHC managers, 4 groups (n=32) of people with MCI and 4 groups (n=32) of informal caregivers. Content and thematic analyses were performed using a combination of induction and deduction approaches.ResultsThree major themes emerged from the data corresponding to the CCM framework: hesitant patients, unprepared providers and misaligned environments. While the public are hesitant to seek medical attention for MCI problems, due to misunderstanding, social stigma and a lack of perceived benefits, GPs and CHCs are not well prepared either, due to lack of knowledge and a shortage of GPs, and a lack of policy, funding and information support. None of these issues can be addressed separately without tackling the others.ConclusionThis study combined the diverse perceptions of all the main stakeholders to detect and manage MCI in primary care settings in China. A vicious circle was found among the three interconnected CCM domains, creating a gridlock that should be addressed through a system’s approach targeting all of the above-mentioned aspects.
Do general practitioners working in or alongside the emergency department improve clinical outcomes or experience? A mixed-methods study
Authors: Scantlebury Arabella , Adamson Joy , Salisbury Chris , Brant Heather , Anderson Helen , Baxter Helen , Bloor Karen , Cowlishaw Sean , Doran Tim , Gaughan James , Gibson Andy , Gutacker Nils , Leggett Heather , Purdy Sarah , Voss Sarah , Benger Jonathan Richard 
Published: September 2022

ObjectivesTo examine the effect of general practitioners (GPs) working in or alongside the emergency department (GPED) on patient outcomes and experience, and the associated impacts of implementation on the workforce.DesignMixed-methods study: interviews with service leaders and NHS managers; in-depth case studies (n=10) and retrospective observational analysis of routinely collected national data. We used normalisation process theory to map our findings to the theory’s four main constructs of coherence, cognitive participation, collective action and reflexive monitoring.Setting and participantsData were collected from 64 EDs in England. Case site data included: non-participant observation of 142 clinical encounters; 467 semistructured interviews with policy-makers, service leaders, clinical staff, patients and carers. Retrospective observational analysis used routinely collected Hospital Episode Statistics alongside information on GPED service hours from 40 hospitals for which complete data were available.ResultsThere was disagreement at individual, stakeholder and organisational levels regarding the purpose and potential impact of GPED (coherence). Participants criticised policy development and implementation, and staff engagement was hindered by tensions between ED and GP staff (cognitive participation). Patient ‘streaming’ processes, staffing and resource constraints influenced whether GPED became embedded in routine practice. Concerns that GPED may increase ED attendance influenced staff views. Our quantitative analysis showed no detectable impact on attendance (collective action). Stakeholders disagreed whether GPED was successful, due to variations in GPED model, site-specific patient mix and governance arrangements. Following statistical adjustment for multiple testing, we found no impact on: ED reattendances within 7 days, patients discharged within 4 hours of arrival, patients leaving the ED without being seen; inpatient admissions; non-urgent ED attendances and 30-day mortality (reflexive monitoring).ConclusionsWe found a high degree of variability between hospital sites, but no overall evidence that GPED increases the efficient operation of EDs or improves clinical outcomes, patient or staff experience.Trial registration numberISCRTN5178022.
Understanding people’s experiences of extrication while being trapped in motor vehicles: a qualitative interview study
Authors: Nutbeam Tim , Brandling Janet , Wallis Lee A , Stassen Willem 
Published: September 2022

ObjectiveTo explore patient’s experience of entrapment and subsequent extrication following a motor vehicle collision and identify their priorities in optimising this experience.DesignSemistructured interviews exploring the experience of entrapment and extrication conducted at least 6 weeks following the event. Thematic analysis of interviews.SettingSingle air ambulance and spinal cord injury charity in the UK.Participants10 patients were recruited and consented; six air ambulance patients and two spinal cord injury charity patients attended the interview. 2 air ambulance patients declined to participate following consent due to the perceived potential for psychological sequelae.ResultsThe main theme across all participants was that of the importance of communication; successful communication to the trapped patient resulted in a sense of well-being and where communication failures occurred this led to distress. The data generated three key subthemes: ‘on-scene communication’, ‘physical needs’ and ‘emotional needs’. Specific practices were identified that were of use to patients during entrapment and extrication.ConclusionsExtrication experience was improved by positive communication, companionship, explanations and planned postincident follow-up. Extrication experience was negatively affected by failures in communication, loss of autonomy, unmanaged pain, delayed communication with remote family and onlooker use of social media. Recommendations which will support a positive patient-centred extrication experience are the presence of an ‘extrication buddy’, the use of clear and accessible language, appropriate reassurance in relation to co-occupants, a supportive approach to communication with family and friends, the minimisation of onlooker photo/videography and the provision of planned (non-clinical) follow-up.
Knowledge, attitudes and practices of ICU nurses regarding subsyndromal delirium among 20 hospitals in China: a descriptive cross-sectional survey
Authors: Xing Huanmin , Zhu Shichao , Liu Shiqing , Xia Ming , Jing Mengjuan , Dong Guangyan , Ni Weiwei , Li Liming 
Published: September 2022

ObjectivesThis study sought to investigate nurses’ knowledge, attitudes and practices, and analyse the influencing factors for subsyndromal delirium (SSD).DesignA descriptive cross-sectional survey.SettingE-questionnaires were distributed to intensive care unit (ICU) nurses from 20 tertiary-grade, A-class hospitals in Henan Province, China.ParticipantsA total of 740 ICU nurses participated in the questionnaire survey.Main outcome measuresEach dimension score is converted to a percentage scale. A score of ≤60% on each dimension of the questionnaire was considered a negative score, <80% was considered a intermediate score and ≥80% was considered an excellent score.ResultsA total of 733 questionnaires were included in the study. More than half of the nurses were at the intermediate level, and a few nurses were at the excellent level. Nurses self-assessed their level of knowledge was intermediate. In the attitudes dimension, nurses’ attitudes were negative. The results of the practical dimension showed that most nurses could carry out the clinical practice. Multiple linear regression analysis showed that educational level and received SSD training were influencing factors.ConclusionsICU nursing staff overestimated their knowledge of SSD and showed a negative attitude towards it. Various forms of education and training are necessary.
Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial)
Authors: Jacobsen Julie Sandell , Thorborg Kristian , Nielsen Rasmus Østergaard , Jakobsen Stig Storgaard , Foldager Casper , Sørensen Dorthe , Oestergaard Lisa Gregersen , van Tulder Maurits W , Mechlenburg Inger 
Published: September 2022

IntroductionSurgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation.Methods and analysisIn a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors.Ethics and disseminationThe study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences.Trial registration numberNCT04795843.
Association between nutritional, inflammatory and oxidative status (NIOS) and risk of adverse outcomes in patients on haemodialysis (HD): the NIOS-HD prospective cohort study protocol
Authors: Foshati Sahar , Askari Gholamreza , Bagherniya Mohammad , Mortazavi Mojgan , Moeinzadeh Firouzeh , Taheri Shahram , Heidari Zahra , Rouhani Mohammad Hossein 
Published: September 2022

IntroductionThe mortality of patients on chronic haemodialysis is 10–30 times greater than that of the general population and over 60% of these individuals die within the first 5 years of beginning haemodialysis. Although causes for excessive mortality in haemodialysis patients are not clearly defined, it seems that nutrition, inflammation and oxidative stress play key roles in this regard. Until now, no cohort study has focused on the association between nutritional, inflammatory or oxidative status and risk of complications and adverse outcomes in Iranian haemodialysis patients. Therefore, we sought to fill this gap and designed the Nutritional, Inflammatory, and Oxidative Status in Hemodialysis (NIOS-HD) prospective cohort study to determine the association of dietary factors, malnutrition, anthropometric indices, body composition, inflammation and oxidative stress with quality of life, dialysis access infections, hospitalisation, potential years of life lost and mortality in adults on maintenance haemodialysis in Isfahan, Iran.Methods and analysisThe sample size of this cohort was estimated to be 300 participants. At baseline, demographic, medical and dialysis-related data of eligible patients will be recorded. In addition, participants will undergo anthropometric measurements, malnutrition assessment and body composition analysis. Also, their dietary intake and quality of life will be evaluated through interviewer-administered questionnaires. Moreover, their fasting blood samples will be collected and stored for biochemical assays including transthyretin, albumin, serum amyloid A, pentraxin-3, trimethylamine N-oxide, myeloperoxidase, paraoxonase-1 and superoxide dismutase. After baseline evaluation, patients will be followed up to 3 years to update exposure information (except biochemical assays) and measure adverse outcomes. Finally, collected data will be analysed using descriptive and inferential statistics.Ethics and disseminationThe NIOS-HD is in agreement with the Declaration of Helsinki and has been approved by the Ethics Committee of Isfahan University of Medical Sciences (reference number: IR.MUI.RESEARCH.REC.1399.605). Findings of this study will be published in academic journals.