bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cohort profile: development and characteristics of a retrospective cohort of individuals dispensed prescription opioids for non-cancer pain in British Columbia, Canada
Authors: Wilton James , Chong Mei , Abdia Younathan , Purssell Roy , MacInnes Aaron , Gomes Tara , Dart Richard C , Balshaw Robert F , Otterstatter Michael , Wong Stanley , Yu Amanda , Alvarez Maria , Janjua Naveed Zafar , Buxton Jane A 
Published: April 2021

PurposePrescription opioids (POs) are widely prescribed for chronic non-cancer pain but are associated with several risks and limited long-term benefit. Large, linked data sources are needed to monitor their harmful effects. We developed and characterised a retrospective cohort of people dispensed POs.ParticipantsWe used a large linked administrative database to create the Opioid Prescribing Evaluation and Research Activities cohort of individuals dispensed POs for non-cancer pain in British Columbia (BC), Canada (1996–2015). We created definitions to categorise episodes of PO use based on a review of the literature (acute, episodic, chronic), developed an algorithm for inferring clinical indication and assessed patterns of PO use across a range of characteristics.Findings to dateThe current cohort includes 1.1 million individuals and 3.4 million PO episodes (estimated to capture 40%–50% of PO use in BC). The majority of episodes were acute (81%), with most prescribed for dental or surgical pain. Chronic use made up 3% of episodes but 88% of morphine equivalents (MEQ). Across the acute to episodic to chronic episode gradient, there was an increasing prevalence of higher potency POs (hydromorphone, oxycodone, fentanyl, morphine), long-acting formulations and chronic pain related indications (eg, back, neck, joint pain). Average daily dose (MEQ) was similar for acute/episodic but higher for chronic episodes. Approximately 7% of the cohort had a chronic episode and chronic pain was the characteristic most strongly associated with chronic PO use. Individuals initiating a chronic episode were also more likely to have higher social/material deprivation and previous experience with a mental health condition or a problem related to alcohol or opioid use. Overall, these findings suggest our episode definitions have face validity and also provide insight into characteristics of people initiating chronic PO therapy.Future plansThe cohort will be refreshed every 2 years. Future analyses will explore the association between POs and adverse outcomes.
Feasibility and acceptability of breath research in primary care: a prospective, cross-sectional, observational study
Authors: Woodfield Georgia , Belluomo Ilaria , Boshier Piers R , Waller Annabelle , Fayyad Maya , von Wagner Christian , Cross Amanda J , Hanna George B 
Published: April 2021

ObjectivesTo examine the feasibility and acceptability of breath research in primary care.DesignNon-randomised, prospective, mixed-methods cross-sectional observational study.SettingTwenty-six urban primary care practices.Participants1002 patients aged 18–90 years with gastrointestinal symptoms.Main outcome measuresDuring the first 6 months of the study (phase 1), feasibility of patient enrolment using face-to-face, telephone or SMS-messaging (Short Message Service) enrolment strategies, as well as processes for breath testing at local primary care practices, were evaluated. A mixed-method iterative study design was adopted and outcomes evaluated using weekly Plan-Do-Study-Act cycles, focus groups and general practitioner (GP) questionnaires.During the second 6 months of the study (phase 2), patient and GP acceptability of the breath test and testing process was assessed using questionnaires. In addition a ‘single practice’ recruitment model was compared with a ‘hub and spoke’ centralised recruitment model with regards to enrolment ability and patient acceptability.Throughout the study feasibility of the collection of a large number of breath samples by clinical staff over multiple study sites was evaluated and quantified by the analysis of these samples using mass spectrometry.Results1002 patients were recruited within 192 sampling days. Both ‘single practice’ and ‘hub and spoke’ recruitment models were effective with an average of 5.3 and 4.3 patients accrued per day, respectively. The ‘hub and spoke’ model with SMS messaging was the most efficient combined method of patient accrual. Acceptability of the test was high among both patients and GPs. The methodology for collection, handling and analysis of breath samples was effective, with 95% of samples meeting quality criteria.ConclusionsLarge-scale breath testing in primary care was feasible and acceptable. This study provides a practical framework to guide the design of Phase III trials examining the performance of breath testing in primary care.
Association between postsurgical pain and heart rate variability: protocol for a scoping review
Authors: So Vincent , Klar Gregory , Leitch Jordan , McGillion Michael , Devereaux P J , Arellano Ramiro , Parlow Joel , Gilron Ian 
Published: April 2021

IntroductionSurgical interventions can elicit neuroendocrine responses and sympathovagal imbalance, ultimately affecting cardiac autonomic function. Cardiac complications account for 30% of postoperative complications and are the leading cause of morbidity and mortality following non-cardiac surgery. One cardiovascular parameter, heart rate variability (HRV), has been found to be predictive of postoperative morbidity and mortality. HRV is defined as variation in time intervals between heartbeats and is affected by cardiac autonomic balance. Furthermore, altered HRV has been shown to predict cardiovascular events in non-surgical settings. In multiple studies, experimentally induced pain in healthy humans leads to reduced HRV suggesting a causal relationship. In a different studies, chronic pain has been associated with altered HRV, however, in the setting of clinical pain conditions, it remains unclear how much HRV impairment is due to pain itself versus autonomic changes related to analgesia. We aim to review the available evidence describing the association between postsurgical pain and HRV alterations in the early postoperative period.Methods and analysisWe will conduct a scoping review of relevant studies using detailed searches of MEDLINE and EMBASE, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Included studies will involve participants undergoing non-cardiac surgery and investigate outcomes of (1) measures of pain intensity; (2) measures of HRV and (3) statistical assessment of association between #1 and #2. As secondary review outcomes included studies will also be examined for other cardiovascular events and for their attempts to control for analgesic treatment and presurgical HRV differences among treatment groups in the analysis. This work aims to synthesise available evidence to inform future research questions related to postsurgical pain and cardiac complications.Ethics and disseminationEthics review and approval is not required for this review. The results will be submitted for publication in peer-reviewed journals.
Feasibility of a ballet-inspired low-impact at-home workout programme for adults with stroke: a mixed-methods exploratory study protocol
Authors: Lo Suzanne Hoi Shan , Chau Janita Pak Chun , Choi Kai Chow , Yeung Jonas , Li Siu Hung , Demers Marika 
Published: April 2021

IntroductionBalancing problems are prominent in stroke survivors with unilateral paresis. Recent evidence supports that dance interventions are associated with significant improvements in gait, stability and walking endurance in people with neurological conditions. The aim of this study is to explore the feasibility of a novel ballet-inspired at-home workout programme (Footprints to Better Balance (FBB)) for stroke survivors.Methods and analysisA mixed-methods exploratory study incorporating a randomised controlled trial and qualitative evaluation will be conducted. We will recruit 40 adults with a first-ever ischaemic or haemorrhagic stroke and mild-moderate lower limb paresis from two acute stroke units. The intervention group will receive usual care plus FBB, an 8-week home-based programme with ballet-inspired workouts underpinned by Bandura’s principles of self-efficacy and outcome expectation. FBB will be delivered by trained lay and peer volunteers, with the support of volunteer healthcare professionals. Multiple data will be collected: Recruitment rate, adherence to FBB, semi-structured interviews and questionnaires on outcomes (balance, gait and memory) assessed at baseline and immediately post-intervention. The generalised estimating equations model will be used to compare differential changes on outcomes across time points between the two arms. Qualitative data will be coded and grouped to form themes and subthemes.Ethics and disseminationEthical approval from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has been obtained. All eligible participants will provide written informed consent. Study results will be disseminated via publications in peer-reviewed journals and presentations at international conferences.Trial registration numberNCT04460794
Protocol for a scoping review exploring the use of patient-reported outcomes in adult social care
Authors: Hughes Sarah E , Aiyegbusi Olalekan Lee , Lasserson Daniel S , Collis Philip , Cruz Rivera Samantha , McMullan Christel , Turner Grace M , Glasby Jon , Calvert Melanie 
Published: April 2021

IntroductionPatient-reported outcomes (PROs) are measures of a person’s own views of their health, functioning and quality of life. They are typically assessed using validated, self-completed questionnaires known as patient-reported outcome measures (PROMs). PROMs are used in healthcare settings to support care planning, clinical decision-making, patient–practitioner communication and quality improvement. PROMs have a potential role in the delivery of social care where people often have multiple and complex long-term health conditions. However, the use of PROMs in this context is currently unclear. The objective of this scoping review is to explore the evidence relating to the use of PROMs in adult social care.Methods and analysesThe electronic databases Medline (Ovid), PsychInfo (Ovid), ASSIA (ProQuest), Social Care Online (SCIE), Web of Science and EMBASE (Ovid) were searched on 29 September 2020 to identify eligible studies and other publically available documents published since 2010. A grey literature search and hand searching of citations and reference lists of the included studies will also be undertaken. No restrictions on study design or language of publication will be applied. Screening and data extraction will be completed independently by two reviewers. Quality appraisal of the included documents will use the Critical Appraisal Skills Programme and AACODS (Authority, Accuracy, Coverage, Objectivity, Date, Significance) checklists. A customised data charting table will be used for data extraction, with analysis of qualitative data using the framework method. The review findings will be presented as tables and in a narrative summary.Ethics and disseminationEthical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publically available sources. Review findings will be shared with service users and other relevant stakeholders and disseminated through a peer-reviewed publication and conference presentations. This protocol is registered on the Open Science Framework (www.osf.io).
MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients
Authors: Meyerheim Marcel , Karamanidou Christina , Payne Sheila , Garani-Papadatos Tina , Sander Annette , Downing Julia , Stamatopoulos Kostas , Ling Julie , Payne Cathy , Scarfò Lydia , Lokaj Petr , Maramis Christos , Graf Norbert 
Published: April 2021

IntroductionElectronic patient-reported outcomes (ePROs) have tremendous potential to optimise palliative and supportive care for children with cancer, their families and healthcare providers. Particularly, these children and their families are subjected to multiple strains caused by the disease and its treatment. The MyPal digital health platform is designed to address these complex demands by offering pursuant ePRO-based functionalities via two mobile applications, one developed for children and the other for their parents.Methods and analysisIn this observational prospective feasibility study, 100 paediatric oncology patients aged between 6 and 17 years and at least one of their parents/legal guardians will be recruited at three clinical sites in two European countries (Germany and Czech Republic). They will use the mobile applications which are part of the novel digital health platform. During a 6-month study period, participants will complete various ePROs via the applications addressing quality of life, satisfaction with care and impact of the disease on the family at monthly intervals. Additionally, priority-based symptom reporting is integrated into a serious game for children. Outcomes that will be assessed concern the feasibility and the evaluation of the newly designed digital health platform to contribute to the evidence base of clinical ePRO use in paediatric oncology and palliative care process.Ethics and disseminationThe MyPal-Child study obtained ethical approval from the Ethics Committee responsible for the University of Saarland, that is, the Ärztekammer des Saarlandes, the Ethics Committee of the Medical School Hannover and the Ethics Committee of the University of Brno. Study results will be disseminated through scientific publications, presentations at international conferences, congresses and a final report to the European Commission. General publicly accessible information can be found on the project website (www.mypal-project.eu) and social media.Trial registration numbersU1111-1251-0043, DRKS00021458,NCT04381221.
Cognitive Outcomes after DEXmedetomidine sedation in cardiac surgery: CODEX randomised controlled trial protocol
Authors: Choi Stephen , Jerath Angela , Jones Philip , Avramescu Sinziana , Djaiani George , Syed Summer , Saha Tarit , Kaustov Lilia , Kiss Alex , D"Aragon Frédérick , Hedlin Peter , Rajamohan Raja , Couture Etienne J. , Singh Amara , Mapplebeck Josiane CS , Wong Sophia , Orser Beverley Anne 
Published: April 2021

IntroductionOlder patients undergoing cardiac surgery carry the highest risk for developing major postoperative neurocognitive disorder (postoperative NCD or P-NCD) with up to 25% incidence 3 months after surgery. P-NCD is associated with significant morbidity, mortality, loss of independence, premature retirement and increased healthcare costs. This multicentre randomised trial is investigating the efficacy of postoperative dexmedetomidine sedation in reducing the incidence of major P-NCD after cardiac surgery compared with standard protocols. CODEX will be the largest interventional trial with major P-NCD as the primary outcome.Methods and analysisCODEX is recruiting patients ≥60 years old, undergoing elective cardiac surgery and without pre-existing major cognitive dysfunction or dementia. Eligible participants are randomised to receive postoperative dexmedetomidine or standard institutional sedation protocols in the intensive care unit. Baseline preoperative cognitive function is assessed with the computer-based Cogstate Brief Battery. The primary outcome, major P-NCD, 3 months after surgery is defined as a decrease in cognitive function ≥1.96 SD below age-matched, non-operative controls. Secondary outcomes include delirium, major P-NCD at 6/12 months, depressive symptoms, mild P-NCD and quality of surgical recovery at 3/6/12 months. The specific diagnostic criteria used in this protocol are consistent with the recommendations for clinical assessment and management of NCD from the Nomenclature Consensus Working Group on perioperative cognitive changes. Intention-to-treat analysis will compare major P-NCD at 3 months between study groups.Ethics and disseminationCODEX was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB) (Project ID 1743). This will be the first multicentre, randomised controlled trial to assess the efficacy of a pharmacological intervention to reduce the incidence of major P-NCD after cardiac surgery in patients ≥60 years old. Dissemination of the study results will include briefings of key findings and interpretation, conference presentations and peer-reviewed publications.Trial registration numberNCT04289142.
Patient outcomes and costs associated with functional medicine-based care in a shared versus individual setting for patients with chronic conditions: a retrospective cohort study
Authors: Beidelschies Michelle , Alejandro-Rodriguez Marilyn , Guo Ning , Postan Anna , Jones Tawny , Bradley Elizabeth , Hyman Mark , Rothberg Michael B 
Published: April 2021

ObjectiveTo compare outcomes and costs associated with functional medicine-based care delivered in a shared medical appointment (SMA) to those delivered through individual appointments.DesignA retrospective cohort study was performed to assess outcomes and cost to deliver care to patients in SMAs and compared with Propensity Score (PS)-matched patients in individual appointments.SettingA single-centre study performed at Cleveland Clinic Center for Functional Medicine.ParticipantsA total of 9778 patients were assessed for eligibility and 7323 excluded. The sample included 2455 patients (226 SMAs and 2229 individual appointments) aged ≥18 years who participated in in-person SMAs or individual appointments between 1 March 2017 and 31 December 2019. Patients had a baseline Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) score and follow-up score at 3 months. Patients were PS-matched 1:1 with 213 per group based on age, sex, race, marital status, income, weight, body mass index, blood pressure (BP), PROMIS score and functional medicine diagnostic category.Primary and secondary outcome measuresThe primary outcome was change in PROMIS GPH at 3 months. Secondary outcomes included change in PROMIS Global Mental Health (GMH), biometrics, and cost.ResultsAmong 213 PS-matched pairs, patients in SMAs exhibited greater improvements at 3 months in PROMIS GPH T-scores (mean difference 1.18 (95% CI 0.14 to 2.22), p=0.03) and PROMIS GMH T-scores (mean difference 1.78 (95% CI 0.66 to 2.89), p=0.002) than patients in individual appointments. SMA patients also experienced greater weight loss (kg) than patients in individual appointments (mean difference −1.4 (95% CI −2.15 to −0.64), p<0.001). Both groups experienced a 5.5 mm Hg improvement in systolic BP. SMAs were also less costly to deliver than individual appointments.ConclusionSMAs deliver functional medicine-based care that improves outcomes more than care delivered in individual appointments and is less costly to deliver.
Testing for SARS-CoV-2 seroprevalence: experiences of a tertiary eye centre
Authors: Ziemssen Focke , Feng You-Shan , Schnichels Sven , Bayyoud Tarek , Ueffing Marius , Bartz-Schmidt Karl Ulrich , Martus Peter , Peter Andreas 
Published: April 2021

IntroductionThe actual prevalence of a SARS-CoV-2 infection and the individual assessment of being or having been infected may differ. Facing the great uncertainty—especially at the beginning of the pandemic—and the possibility of asymptomatic or mildly symptomatic, subclinical infections, we evaluate the experience of SARS-CoV-2 antibody screening at a tertiary clinical setting.Methods and analysisAll employees of a tertiary eye centre and a research institute of ophthalmology were offered antibody testing in May 2020, using a sequential combination of different validated assays/antigens and point-of-care (POC) testing for a subset (NCT04446338). Before taking blood, a systematic inquiry into past symptoms, known contacts and a subjective self-assessment was documented. The correlations between serostatus, patient contacts and demographic characteristics were analysed. Different tests were compared by Kappa statistics.ResultsAmong 318 participants, SARS-CoV-2 antibodies were detected in 9 employees. Chemiluminescence assays (chemiluminescence immunoassay and electrochemiluminescence) showed superior specificity and high reproducibility, compared with ELISA and POC results.In contrast to the low seropositivity (2.8%) of healthcare workers, higher than that of the other departments of the hospital, a large proportion mistakenly assumed that they might have already been infected. Antiviral antibody titres increased and remained on a plateau for at least 3 months.ConclusionsThe great demand and acceptance confirmed the benefit of highly sensitive testing methods in the early phase of the pandemic. The coincidence of low seroprevalence and anxious employees may have contributed to internalising the need of hygiene measures.
Virtual tabletop simulations for primary care pandemic preparedness and response
Authors: Blaak Marlot Johanna , Fadaak Raad , Davies Jan M , Pinto Nicole , Conly John , Leslie Myles 
Published: April 2021

IntroductionThe COVID-19 pandemic prompted widescale use of clinical simulations to improve procedures and practices. We outline our deployment of a virtual tabletop simulation (TTS) method in primary care (PC) clinics across Alberta, Canada. We summarise the quality and safety improvements from this method and report end users’ perspectives on key elements.MethodsOur virtual TTS used teleconferencing software alongside digital whiteboards to walk clinic stakeholders through patient scenarios. Participants reviewed and rehearsed their workflows and care practices. The goal was for staff to take ownership over gaps and codesigned solutions. After simulation sessions, follow-up interviews were conducted to collect feedback.ResultsThese sessions helped PC staff identify and codesign solutions for clinical hazards and threats. These included the flow of patients through clinics, communications, redesignation of physical spaces, and adaptation of guidance for cleaning and personal protective equipment use. End users reported sessions provided neutral spaces to discuss practice changes and built confidence in delivering safe care during the pandemic.DiscussionTTS has not been extensively deployed to improve clinical practice in outpatient environments. We show how virtual TTS can bridge gaps between knowledge and practice by offering a guided space to rehearse clinical changes. We show that virtual TTS can be used in multiple contexts to help identify hazards, improve safety and build confidence in professional teams adapting to rapid changes in both policies and practices. While our sessions were conducted in Alberta, our results suggest this method may be deployed in other contexts, including low-resource settings.