bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA)
Authors: Iivanainen Sanna , Baird Anne-Marie , Balas Bogdana , Bustillos Alberto , Castro Sanchez Amparo Yovanna , Eicher Manuela , Golding Sophie , Mueller-Ohldach Mathis , Reig Maria , Welslau Manfred , Ammann Johannes 
Published: April 2023

IntroductionDigital patient monitoring (DPM) tools can enable more effective clinical care and improved patient outcomes in cancer. However, their broad adoption requires ease of use and demonstration of real-world clinical utility/impact. ORIGAMA (MO42720) is an interventional, open-label, multicountry platform study investigating the clinical utility of DPM tools and specific treatments. ORIGAMA will begin with two cohorts that aim to assess the impact of the atezolizumab-specific Roche DPM Module (hosted on the Kaiku Health DPM platform (Helsinki, Finland)) on health outcomes and healthcare resource usage, and its feasibility to support at-home treatment administration, in participants receiving systemic anticancer treatment. Other digital health solutions may be added to future cohorts.Methods and analysisIn Cohort A, participants with metastatic non-small cell lung cancer (NSCLC), extensive-stage SCLC or Child Pugh A unresectable hepatocellular carcinoma will be randomised to a locally approved anticancer regimen containing intravenous atezolizumab (TECENTRIQ, F. Hoffmann-La Roche Ltd/Genentech) and local standard-of-care support, with/without the Roche DPM Module. Cohort B will assess the feasibility of the Roche DPM Module in supporting administration of three cycles of subcutaneous atezolizumab (1875 mg; Day 1 of each 21-day cycle) in the hospital, followed by 13 cycles at home by a healthcare professional (ie, flexible care), in participants with programmed cell-death ligand 1-positive, early-stage NSCLC. The primary endpoints are the mean difference in change of the participant-reported Total Symptom Interference Score at Week 12 from baseline (Cohort A) and flexible care adoption rate at Cycle 6 (Cohort B).Ethics and disseminationThis study will be conducted according to the Declaration of Helsinki, and/or the applicable laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. The study received its first Ethics Committee approval in Spain in October 2022. Participants will provide written informed consent in a face-to-face setting. The results of this study will be presented at national and/or international congresses and disseminated via publication in peer-reviewed journals.Trial registration numberNCT05694013.
Cost-utility analysis of a multispecialty interprofessional team dementia care model in Ontario, Canada
Authors: Wong William W L , Lee Linda , Walker Sasha , Lee Catherine , Patel Tejal , Hillier Loretta M , Costa Andrew P , Sinha Samir K 
Published: April 2023

ObjectivesTo examine the cost-effectiveness of Multi-specialty INterprofessional Team (MINT) Memory Clinic care in comparison to the provision of usual care.DesignUsing a Markov-based state transition model, we performed a cost-utility (costs and quality-adjusted life years, QALY) analysis of MINT Memory Clinic care and usual care not involving MINT Memory Clinics.SettingA primary care-based Memory Clinic in Ontario, Canada.ParticipantsThe analysis included data from a sample of 229 patients assessed in the MINT Memory Clinic between January 2019 and January 2021.Primary outcome measuresEffectiveness as measured in QALY, costs (in Canadian dollars) and the incremental cost-effectiveness ratio calculated as the incremental cost per QALY gained between MINT Memory Clinics versus usual care.ResultsMINT Memory Clinics were found to be less expensive ($C51 496 (95% Crl $C4806 to $C119 367) while slightly improving quality of life (+0.43 (95 Crl 0.01 to 1.24) QALY) compared with usual care. The probabilistic analysis showed that MINT Memory Clinics were the superior treatment compared with usual care 98% of the time. Variation in age was found to have the greatest impact on cost-effectiveness as patients may benefit from the MINT Memory Clinics more if they receive care beginning at a younger age.ConclusionMultispecialty interprofessional memory clinic care is less costly and more effective compared with usual care and early access to care significantly reduces care costs over time. The results of this economic evaluation can inform decision-making and improvements to health system design, resource allocation and care experience for persons living with dementia. Specifically, widespread scaling of MINT Memory Clinics into existing primary care systems may assist with improving quality and access to memory care services while decreasing the growing economic and social burden of dementia.
Parents’ experience of children with acquired brain injury undergoing neuro-rehabilitation: thematic synthesis protocol
Authors: Fernandes Marta , Rathinam Chandrasekar , Topping Anne Elizabeth 
Published: April 2023

IntroductionChildren with moderate to severe acquired brain injury frequently require a period of demanding medical and rehabilitative care to optimise their long-term capabilities and quality of life. Usually, the initial acute care is provided in tertiary centres and can last up to 12 months following the original injury. Parents of children with acquired brain injury share that experience with their child and face many different challenges encountered as their child’s long-term needs become apparent. Parents are essential partners in care, hence there is a need to better understand their experiences to support them as they face those challenges and adapt to the needs of their child. We aim to synthesise the qualitative evidence exploring parents’ experiences of children undergoing neuro-rehabilitative care.Methods and analysisThe Enhancing Transparency in Reporting the Synthesis of Qualitative Research guideline was used in the design of this protocol. The Population, Exposure and Outcome model was used to define inclusion and exclusion criteria and refine search terms. The databases Ovid Embase, Ovid MEDLINE, CINAHL, Scopus and PsychINFO will be searched from 2009 to 2022. Two independent reviewers will review studies, assess quality using the Critical Appraisal Skills Programme and scrutinise and extract the data. Disagreements will be resolved after discussion with the third reviewer. Thematic synthesis using Thomas and Harden’s approach will be undertaken to provide the evidence to develop a model for parental support during the first year of their child’s neuro-rehabilitation.Ethics and disseminationEthical committee approval will not be required as no new data will be collected. The findings will be disseminated through presentations at professional conferences, publications in peer-reviewed journals and shared with the public through relevant charities and local family support groups and networks.PROSPERO registration numberCRD42022333182.
Integrating post-fracture care into the primary care setting (interFRACT): Protocol for a mixed-methods study to co-design a care program to improve rates of osteoporosis and fracture treatment
Authors: Talevski Jason , Beauchamp Alison , Bird Stefanie , Daly Robin M 
Published: April 2023

IntroductionDespite evidence showing that timely diagnosis and appropriate pharmacological treatment of osteoporosis reduces subsequent fracture rates, osteoporosis remains significantly underdiagnosed and undertreated. The large and ongoing treatment gap for osteoporosis and associated fragility fractures could be addressed by considering systematic approaches for post-fracture care in the primary care setting. This study will develop the Integrating Post-Fracture Care into Primary Care (interFRACT) care program that aims to enhance diagnosis and treatment of osteoporosis and improve initiation and adherence to fracture prevention strategies for older adults in the primary care setting.Methods and analysisThis mixed-methods study will follow an established co-design approach that involves six steps; the first three aim to gain an understanding of the consumer experience and needs, while the latter three focus on how to improve that experience through design and action. This will include: development of a Stakeholder Advisory Committee to provide guidance on all aspects of study design, including implementation, evaluation and dissemination; interviews with primary care physicians to explore beliefs and attitudes towards osteoporosis and fracture treatment; interviews with consumers (older adults with a diagnosis of osteoporosis and/or fragility fracture) to identify current needs for osteoporosis treatment and fracture prevention; a series of co-design workshops to develop the components of the interFRACT care program based on published guidance and findings from interviews; and a feasibility study with primary care physicians to determine the usability and acceptability of the interFRACT care program.Ethics and disseminationEthical approval was obtained from Deakin University Human Research Ethics Committee (approval number: HEAG-H 56_2022). Study results will be published in peer-reviewed journals, presented at national and international conferences, and collated in reports for participating primary care practices.
Development of an artificial intelligence system to identify hypoglycaemia via ECG in adults with type 1 diabetes: protocol for data collection under controlled and free-living conditions
Authors: Cisuelo Owain , Stokes Katy , Oronti Iyabosola B , Haleem Muhammad Salman , Barber Thomas M , Weickert Martin O , Pecchia Leandro , Hattersley John 
Published: April 2023

IntroductionHypoglycaemia is a harmful potential complication in people with type 1 diabetes mellitus (T1DM) and can be exacerbated in patients receiving treatment, such as insulin therapies, by the very interventions aiming to achieve optimal blood glucose levels. Symptoms can vary greatly, including, but not limited to, trembling, palpitations, sweating, dry mouth, confusion, seizures, coma, brain damage or even death if untreated. A pilot study with healthy (euglycaemic) participants previously demonstrated that hypoglycaemia can be detected non-invasively with artificial intelligence (AI) using physiological signals obtained from wearable sensors. This protocol provides a methodological description of an observational study for obtaining physiological data from people with T1DM. The aim of this work is to further improve the previously developed AI model and validate its performance for glycaemic event detection in people with T1DM. Such a model could be suitable for integrating into a continuous, non-invasive, glucose monitoring system, contributing towards improving surveillance and management of blood glucose for people with diabetes.Methods and analysisThis observational study aims to recruit 30 patients with T1DM from a diabetes outpatient clinic at the University Hospital Coventry and Warwickshire for a two-phase study. The first phase involves attending an inpatient protocol for up to 36 hours in a calorimetry room under controlled conditions, followed by a phase of free-living, for up to 3 days, in which participants will go about their normal daily activities unrestricted. Throughout the study, the participants will wear wearable sensors to measure and record physiological signals (eg, ECG and continuous glucose monitor). Data collected will be used to develop and validate an AI model using state-of-the-art deep learning methods.Ethics and disseminationThis study has received ethical approval from National Research Ethics Service (ref: 17/NW/0277). The findings will be disseminated via peer-reviewed journals and presented at scientific conferences.Trial registration numberNCT05461144.
Impact of slack resources on healthcare costs in tertiary and secondary hospitals: a panel data study of public hospitals in Beijing from 2015 to 2019
Authors: Chen Chen , Song Xinrui , Zhu Junli 
Published: April 2023

ObjectiveThis study aims to explore the relationship between slack resources and cost consumption index in tertiary and secondary hospitals and to provide targeted healthcare resource utilisation recommendations for tertiary and secondary hospital managers.DesignThis is a panel data study of 51 public hospitals in Beijing from 2015 to 2019.SettingTertiary and secondary public hospitals in Beijing. Data envelope analysis was used to calculate the slack resources. Regression models were used to explore the relationship between slack resources and healthcare costs.ParticipantsA total of 255 observations were collected from 33 tertiary hospitals and 18 secondary hospitals.Outcome measuresSlack resources and healthcare costs in tertiary and secondary public hospitals in Beijing from 2015 to 2019. Linear or curve relationship between slack resources and healthcare costs in tertiary and secondary hospitals.ResultsThe cost of healthcare in tertiary hospitals has always been higher than in secondary hospitals, and the slack resources in secondary hospitals have always been worse than in tertiary hospitals. For tertiary hospitals, the cubic coefficient of slack resources is significant (β=−12.914, p<0.01) and the R2of cubic regression is increased compared with linear and quadratic regression models, so there is a transposed S-shaped relationship between slack resources and cost consumption index. For secondary hospitals, only the first-order coefficient of slack resources in the linear regression was significant (β=0.179, p<0.05), so slack resources in secondary hospitals were positively related to the cost consumption index.ConclusionsThis study shows that slack resources’ impact on healthcare costs differs in tertiary and secondary public hospitals. For tertiary hospitals, slack should be kept within a reasonable range to control excessive growth in healthcare costs. In secondary hospitals, keeping too many slack resources is not ideal, so managers should adopt strategies to improve competitiveness and service transformation.
Views of leaders in under-represented and equity-denied communities on organ and tissue donation in Nova Scotia, Canada, in light of the Human Organ and Tissue Donation Act: a qualitative descriptive study
Authors: Urquhart Robin , Kendell Cynthia , Weiss Matthew , Kureshi Nelofar , Dirk Jade , Cordoba Wendy , Beed Stephen 
Published: April 2023

ObjectiveTo explore the views of underserved and equity-denied communities in Nova Scotia, Canada, regarding organ and tissue donation and deemed consent legislation.DesignA qualitative descriptive study was undertaken, employing both interviews and focus groups.SettingThe province of Nova Scotia, Canada—the first jurisdiction in North America to implement deemed consent legislation for organ and tissue donation.ParticipantsLeaders of African Nova Scotian, Lesbian, Gay, Bisexual, Trans, Queer, Two Spirit (LGBTQ2S+) and Faith-based communities (Islam and Judaism) were invited to participate (n=11). Leaders were defined as persons responsible for community organisations or in other leadership roles, and were purposively recruited by the research team.ResultsThrough thematic analysis, four main themes were identified: (1) alignment with personal values as well as religious beliefs and perspectives; (2) trust and relationships, which need to be acknowledged and addressed in the context of deemed consent legislation; (3) cultural competence, which is essential to the roll-out of the new legislation and (4) communication and information to combat misconceptions and misinformation, facilitate informed decision-making, and mitigate conflict within families.ConclusionsLeaders of African Nova Scotian, LGBTQ2S+ and Faith-based communities in Nova Scotia are highly supportive of deemed consent legislation. Despite this, many issues exemplify the need for cultural competence at all levels. These findings should inform ongoing implementation of the legislation and other jurisdictions considering a deemed consent approach to organ and tissue donation.
Seroprevalence of antibodies to herpes simplex virus 1 and 2 in patients with HIV positive from Ebonyi State, Nigeria: a cross-sectional study
Authors: Onu Euslar Nnenna , Ekuma Uchechukwu Onyeukwu , Judi Hawraa K , Ogbu Ogbonnaya , Okoro Nworie , Ajugwo Gloria C , Akrami Sousan , Okoli Chukwudum S , Anyanwu Chioma Ngozi , Saki Morteza , Edeh Peter Anyigor 
Published: April 2023

ObjectivesTo assess the seroprevalence of herpes simplex virus (HSV) types 1 and 2 in patients infected with HIV in Nigeria.DesignCross-sectional design from January to June 2019.SettingFederal Teaching Hospital, Ebonyi State, Nigeria.ParticipantsA total of 276 patients with HIV were analysed using ELISA method for the presence of HSV-1 and HSV-2 specific IgG antibodies.OutcomesFisher’s exact test was used to determine the association between the seroprevalence of HSV and demographic variables (statistically significant=p value ≤0.05).ResultsTotally, 212 (76.8%) and 155 (56.2%) patients with HIV were seropositive for HSV-1 and HSV-2 IgG antibodies, respectively. The seroprevalence of HSV-1 was significantly higher than the HSV-2 in patients with HIV (p value <0.0001). HSV-1 and HSV-2 seroprevalence were higher in patients aged more than 30 years. The seroprevalence of HSV-1 was significantly higher (p=0.01) in females (82.4%, 131/159) than males (69.2%, 81/117), but there was no significant difference in seroprevalence of HSV-2 in females (57.9%, 92/159) compared with males (53.8%, 63/117) (p=0.51). Professional drivers had a higher seroprevalence of HSV-1 and HSV-2 and there was a significant association between the occupation and the HSV-1 and HSV-2 seropositivity (p>0.05). The seroprevalence of HSV-1 was significantly higher in the singles (87.4%, 90/103) than the married patients with HIV (p=0.001). However, HSV-2 seroprevalence was significantly higher in the married patients with HIV (63.6%, 110/173) (p=0.001).ConclusionsPrevalence of 76.8% for HSV-1 and 56.2% for HSV-2 among patients with HIV was seen. The HSV-1 was significantly higher in the singles while HSV-2 seroprevalence was significantly higher in the married patients with HIV with HSV-1 and HSV-2 coinfection rate of 7.6%. This study became very imperative to provide an important insight into the hidden dynamics of HSV infections.
Longitudinal faculty development to improve interprofessional collaboration and practice: a multisite qualitative study at five US academic health centres
Authors: Rider Elizabeth A , Chou Calvin , Abraham Corrine , Weissmann Peter , Litzelman Debra K , Hatem David , Branch William 
Published: April 2023

ObjectivesInterprofessional (IP) collaboration and effective teamwork remain variable in healthcare organisations. IP bias, assumptions and conflicts limit the capacity of healthcare teams to leverage the expertise of their members to meet growing complexities of patient needs and optimise healthcare outcomes. We aimed to understand how a longitudinal faculty development programme, designed to optimise IP learning, influenced its participants in their IP roles.DesignIn this qualitative study, using a constructivist grounded theory approach, we analysed participants’ anonymous narrative responses to open-ended questions about specific knowledge, insights and skills acquired during our IP longitudinal faculty development programme and applications of this learning to teaching and practice.SettingFive university-based academic health centres across the USA.ParticipantsIP faculty/clinician leaders from at least three different professions completed small group-based faculty development programmes over 9 months (18 sessions). Site leaders selected participants from applicants forecast as future leaders of IP collaboration and education.InterventionsCompletion of a longitudinal IP faculty development programme designed to enhance leadership, teamwork, self-knowledge and communication.ResultsA total of 26 programme participants provided 52 narratives for analysis. Relationships and relational learning were the overarching themes. From the underlying themes, we developed a summary of relational competencies identified at each of three learning levels: (1) Intrapersonal (within oneself): reflective capacity/self-awareness, becoming aware of biases, empathy for self and mindfulness. (2) Interpersonal (interacting with others): listening, understanding others’ perspectives, appreciation and respect for colleagues and empathy for others. (3) Systems level (interacting within organisation): resilience, conflict engagement, team dynamics and utilisation of colleagues as resources.ConclusionsOur faculty development programme for IP faculty leaders at five US academic health centres achieved relational learning with attitudinal changes that can enhance collaboration with others. We observed meaningful changes in participants with decreased biases, increased self-reflection, empathy and understanding of others’ perspectives and enhanced IP teamwork.
Reporting of retrospective registration in clinical trial publications: a cross-sectional study of German trials
Authors: Haslberger Martin , Gestrich Stefanie , Strech Daniel 
Published: April 2023

ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.DesignWe used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009–2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2or Fisher exact test.ResultsIn the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.ConclusionsContrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.