bluuebunny/crossref_metadata_2025 huggingface dataset:
Overt gastrointestinal bleeding secondary to left inferior phrenic artery pseudoaneurysm postgastric bypass surgery
Authors: Chen Mei-Ting , Choy Kay Tai , Ong Ferdinand
Published: January 2024

Bleeding from a visceral artery pseudoaneurysm (VAPA) is a rare but significant complication of bariatric surgery. Patients may present with gastrointestinal (GI) haemorrhage in the forms of haematemesis, melaena, haematochezia or haemodynamic compromise. Although CT angiogram, endoscopy and laparoscopy form essential parts of diagnostic assessment, small pseudoaneurysms with intermittent bleeding may be overlooked. We report the case of a man in his 40s who presented to the emergency department with massive GI bleeding and subsequent haemodynamic instability, secondary to a pseudoaneurysm from a vascular injury during a recent bariatric procedure. This case highlights the diagnostic challenges of obscure, intermittent bleeding involving the bypassed stomach with unremarkable investigation findings, and aims to raise awareness among clinicians in considering the less common postgastric-bypass complications.
Fetal choroid plexus arteriovenous malformation, masquerading as a neoplastic lesion
Authors: Shaikh Afshan , Khan Anam , Mohsin Farwa , Haq Tanveer Ul
Published: January 2024

A woman in her 20s, who was pregnant, underwent a routine antenatal ultrasound revealing organised intraventricular haemorrhage and a vascular area in the left thalamic region. Fetal MRI raised suspicion of arteriovenous malformation (AVM). The baby was delivered at 36 weeks via C-section, and initial brain MRI suggested a possible neoplastic lesion.

Cerebral angiography confirmed a large AVM involving the left choroid plexus with arterial feeders from the left anterior and posterior choroidal arteries and a large venous varix draining into the vein of Galen. Both arterial feeders were successfully embolised with Onyx and glue, achieving complete occlusion.

Choroid plexus AVMs are rare and often lead to intraventricular or intraparenchymal haemorrhage. Surgical treatment has shown success, but endovascular management is effective, especially for small, deep-seated AVMs, offering a better prognosis.
Cerebellar progressive multifocal leucoencephalopathy identified by the shrimp sign
Authors: Suri Vinit , Sinha Ajay kumar , Priyaranjan Mayank , Patel Vipin
Published: January 2024

Progressive multifocal leucoencephalopathy (PML) is a demyelinating disease caused by the John Cunningham (JC) virus, which may get reactivated under certain immunosuppressive states such as AIDS, immunomodulatory therapy and haematological malignancies. PML has been reported rarely even in immunocompetent individuals where no immunodeficiency was present. PML characteristically involves periventricular and juxtacortical white matter. Isolated cerebellar or brainstem PML may be seen rarely. We present a case of a man in his 70s who presented with rapidly progressive cerebellar ataxia, ptosis and bipyramidal signs. Investigations excluded a direct viral cerebellar infection, acute disseminated encephalomyelitis, paraneoplastic cerebellar degeneration or any structural cerebellar lesion. MRI PET study revealed the classical shrimp sign which raised the possibility of cerebellar PML, and the same was confirmed by a positive JC virus PCR in the cerebrospinal fluid. Our patient had no known immune-compromising state, but further workup revealed a low CD4 count suggestive of idiopathic CD4 lymphopenia. The case illustrates the importance of the shrimp sign on MRI, the possibility of cerebellar involvement of PML as well as the need to consider a differential diagnosis of PML even in individuals with no obvious immunocompromised state.
Prosthodontic rehabilitation of patients with a unilateral subtotal maxillectomy using a customised subperiosteal zygomatic implant: a post-COVID-19 mucormycosis
Authors: Basavaraju Ravi Marballi , Shetty Sujeeth , Pugazhendhi Prakash , Aradya Anupama
Published: January 2024

Restoring the maxillary resection defect involving the alveolar process, the hard and soft palate and the paranasal sinuses in terms of phonetics, mastication and deglutition is more challenging, especially with young patients with aesthetic concerns.

This case report describes the prosthodontic rehabilitation of a young patient with a unilateral subtotal maxillectomy due to post-COVID-19 mucormycosis. A patient-specific subperiosteal implant was planned to rehabilitate the patient’s bony defect. Using postsurgical CT, a customised subperiosteal titanium framework was fabricated by the direct metal laser sintering method using grade IV titanium alloy. The fabricated framework was implanted over the patient’s zygomatic anatomic contour. Three months later, the patient-specific implant was unveiled to the oral cavity, an open-tray impression was made and the fixed implant prosthesis was fabricated.

This case report opens a new realm of rehabilitation for severely compromised maxillary bony defects and impaired oral functioning with no other viable conventional reconstruction options.
Left hepatic hydrothorax without ascites
Authors: Garin Dorian , Voirol Ulysse , Vaucher Julien , Grandmaison Gaël
Published: January 2024

Hepatic hydrothorax (HH) is a complication in patients with cirrhosis and portal hypertension. It predominantly presents in the right pleural cavity and usually associates with ascites. Few cases of HH occurring without detectable ascites have been reported. This case report comprehensively presents a case of a refractory left unilateral HH without ascites. The patient benefited from palliative care and the HH was managed using a semipermanent indwelling pleural catheter until she died 3 months after diagnosis.
Neuroimaging features of accidental fentanyl overdose in a toddler
Authors: Chau Lianne Q , Crawford John Ross
Published: January 2024

The opioid epidemic has become a significant public health crisis worldwide. With the rise in popularity of fentanyl, opioid overdoses continue to rise at unprecedented rates. Unfortunately, young children have become collateral damage in the face of the opioid epidemic. Accidental exposures and ingestions are the leading cause of opioid overdose in this age group and can result in significant acute complications, long-term sequelae and even death. We present the case of a toddler with accidental fentanyl ingestion who experienced seizures and required intubation for respiratory distress. He was found to have notable diffusion restriction cerebellar changes on MRI and ultimately discharged with normal neurological function. Our case adds to the growing literature of the clinical presentation and neuroimaging features associated with opioid toxicity in young children.
Clinical and exercise professional opinion on designing a postpartum return-to-running training programme: an international Delphi study and consensus statement
Authors: Deering Rita E , Donnelly Gráinne M. , Brockwell Emma , Bo Kari , Davenport Margie H , De Vivo Marlize , Dufour Sinead , Forner Lori , Mills Hayley , Moore Isabel S , Olson Amanda , Christopher Shefali Mathur
Published: January 2024

Returning to running postpartum presents challenges such as musculoskeletal pain and pelvic floor dysfunction for some females, but there is little guidance on developing and progressing postpartum training programmes. This study aims to establish expert consensus recommendations on designing and modifying a postpartum return-to-running training programme, highlight costs and access to qualified professionals as potential barriers and discuss clinical, research and sports policy implications.

A three-round Delphi survey of clinical and exercise professionals working with postpartum runners was conducted. Round I consisted of open-ended questions related to designing the training plan, modifications based on biopsychosocial factors, key muscle groups to train and referral and payment sources. Rounds II and III involved Likert-scale voting to identify consensus (≥75% agreement).

118 participants completed Round I, 107 completed Round II (response rate 90.6%) and 95 completed Round III (response rate 80.5%). Consensus was reached in 42/47 (89%) statements, including recommendations for a period of relative rest, gradual increases in duration and intensity, starting with a walk-run protocol and incorporating strength training. Training should be modified based on musculoskeletal or pelvic symptoms, sleep, mental health, lactation or energy availability concerns. Cost and access to experienced postpartum running professionals were identified as potential barriers for runners to receive care.

Consensus recommendations for a postpartum return-to-running programme include an individualised exercise prescription, gradual increases in physical activity, walk-run protocols and targeted muscle strengthening. Further research and improved access to clinical and exercise professionals are needed to inform and facilitate best practices.
Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review
Authors: Wood Lianne , Foster Nadine E , Dean Sarah Gerard , Booth Vicky , Hayden Jill A , Booth Andrew
Published: January 2024

Objective

Therapeutic exercises are a core treatment for low back pain (LBP), but it is uncertain how rehabilitative exercise facilitates change in outcomes. Realist reviews explore how the context (C) of certain settings or populations and underlying mechanisms (M) create intended or unintended outcomes (O). Our objective was to explore and understand the behavioural mechanisms by which therapeutic exercise creates change in outcomes of adherence, engagement and clinical outcomes for patients with LBP.

Methods

This was a realist review reported following the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidance. We developed initial programme theories, modified with input from a steering group (experts, n=5), stakeholder group (patients and clinicians, n=10) and a scoping search of the published literature (n=37). Subsequently, an information specialist designed and undertook an iterative search strategy, and we refined and tested CMO configurations.

Results

Of 522 initial papers identified, 75 papers were included to modify and test CMO configurations. We found that the patient–clinician therapeutic consultation builds a foundation of trust and was associated with improved adherence, engagement and clinical outcomes, and that individualised exercise prescription increases motivation to adhere to exercise and thus also impacts clinical outcomes. Provision of support such as timely follow-up and supervision can further facilitate motivation and confidence to improve adherence to therapeutic exercises for LBP.

Conclusions

Engagement in and adherence to therapeutic exercises for LBP, as well as clinical outcomes, may be optimised using mechanisms of trust, motivation and confidence. These CMO configurations provide a deeper understanding of ways to optimise exercise prescription for patients with LBP.
Impact of the COVID-19 pandemic on prescription drug use and costs in British Columbia: a retrospective interrupted time series study
Authors: Zeitouny Seraphine , McGrail Kimberlyn , Tadrous Mina , Wong Sabrina T , Cheng Lucy , Law Michael
Published: January 2024

Objectives

To assess the impact of the COVID-19 pandemic on prescription drug use and costs.

Design

Interrupted time series analysis of comprehensive administrative health data linkages in British Columbia, Canada, from 1 January 2018 to 28 March 2021.

Setting

Retrospective population-based analysis of all prescription drugs dispensed in community pharmacies and outpatient hospital pharmacies and irrespective of the drug insurance payer.

Participants

Between 4.30 and 4.37 million individuals (52% women) actively registered with the publicly funded medical services plan.

Intervention

COVID-19 pandemic and associated mitigation measures.

Main outcome measures

Weekly dispensing rates and costs, both overall and stratified by therapeutic groups and pharmacological subgroups, before and after the declaration of the public health emergency related to the COVID-19 pandemic. Relative changes in post-COVID-19 outcomes were expressed as ratios of observed to expected rates.

Results

After the onset of the pandemic and subsequent COVID-19 mitigation measures, overall medication dispensing rates dropped by 2.4% (p<0.01), followed by a sustained weekly increase to return to predicted levels by the end of January 2021. We observed abrupt level decreases in antibacterials (30.3%, p<0.01) and antivirals (22.4%, p<0.01) that remained below counterfactuals over the first year of the pandemic. In contrast, there was a week-to-week trend increase in nervous system drugs, yielding an overall increase of 7.3% (p<0.01). No trend changes in the dispensing of respiratory system agents, ACE inhibitors, antidiabetic drugs and antidepressants were detected.

Conclusion

The COVID-19 pandemic impact on prescription drug dispensing was heterogeneous across medication subgroups. As data become available, dispensing trends in nervous system agents, antibiotics and antivirals warrant further monitoring and investigation.
Predictive factors for the treatment success of peri-implantitis: a protocol for a prospective cohort study
Authors: Zhu Yuanxi , Lu Hongye , Yang Shuo , Liu Yang , Zhu Peijun , Li Ping , Waal Yvonne C M De , Visser Anita , Tjakkes Geerten-Has E , Li An , Xu Shulan
Published: January 2024

Introduction

Peri-implantitis, a common biological complication of dental implant, has attracted considerable attention due to its increasing prevalence and limited treatment efficacy. Previous studies have reported several risk factors associated with the onset of peri-implantitis (eg, history of periodontitis, poor plaque control and smoking). However, inadequate data are available on the association between these risk factors and successful outcome after peri-implantitis therapy. This prospective cohort study aims to identify the local and systemic predictive factors for the treatment success of peri-implantitis.

Methods and analysis

A single-centre cohort study will be conducted by recruiting 275 patients diagnosed with peri-implantitis. Sociodemographic variables, healthy lifestyles and systemic disorders will be obtained using questionnaires. In addition, clinical and radiographic examinations will be conducted at baseline and follow-up visits. Treatment success is defined as no bleeding on probing on more than one point, no suppuration, no further marginal bone loss (≥0.5 mm) and probing pocket depth ≤5 mm at the 12-month follow-up interval. After adjustment for age, sex and socioeconomic status, potential prognostic factors related to treatment success will be identified using multivariable logistic regression models.

Ethics and dissemination

This cohort study in its current version (2.0, 15 July 2022) is in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Stomatological Hospital, Southern Medical University (EC-CT-(2022)34). The publication will be on behalf of the study site.

Trial registration number

ChiCTR2200066262.
Service readiness for the management of non-communicable diseases in publicly financed facilities in Malawi: findings from the 2019 Harmonised Health Facility Assessment census survey
Authors: Ahmed Sali , Cao Yanjia , Wang Zicheng , Coates Matthew M , Twea Pakwanja , Ma Mingyang , Chiwanda Banda Jonathan , Wroe Emily , Bai Lan , Watkins David A , Su Yanfang
Published: January 2024

Introduction

Non-communicable diseases (NCDs) are rising in low-income and middle-income countries, including Malawi. To inform policy-makers and planners on the preparedness of the Malawian healthcare system to respond to NCDs, we estimated NCD service readiness in publicly financed healthcare facilities in Malawi.

Methods

We analysed data from 564 facilities surveyed in the 2019 Harmonised Health Facility Assessment, including 512 primary healthcare (PHC) and 52 secondary and tertiary care (STC) facilities. To characterise service readiness, applying the law of minimum, we estimated the percentage of facilities with functional equipment and unexpired medicines required to provide NCD services. Further, we estimated permanently unavailable items to identify service readiness bottlenecks.

Results

Fewer than 40% of PHC facilities were ready to deliver services for each of the 14 NCDs analysed. Insulin and beclomethasone inhalers had the lowest stock levels at PHC facilities (6% and 8%, respectively). Only 17% of rural and community hospitals (RCHs) have liver and kidney diagnostics. STC facilities had varying service readiness, ranging from 27% for managing acute diabetes complications to 94% for chronic type 2 diabetes management. Only 38% of STC facilities were ready to manage chronic heart failure. Oral pain medicines were widely available at all levels of health facilities; however, only 22% of RCHs and 29% of STCs had injectable morphine or pethidine. Beclomethasone was never available at 74% of PHC and 29% of STC facilities.

Conclusion

Publicly financed facilities in Malawi are generally unprepared to provide NCD services, especially at the PHC level. Targeted investments in PHC can substantially improve service readiness for chronic NCD conditions in local communities and enable STC to respond to acute NCD complications and more complex NCD cases.
Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)
Authors: Lu Changyin , Kang Yin , Luo Quehua , Zhong Fei , Cai Yujing , Zhang Guangyan , Guo Zhimin , Zhang Shaoting , Ma Jue , Shu HaiHua
Published: January 2024

Introduction

It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.

Methods and analysis

This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.

Ethics and dissemination

This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.

Trial registration number

ChiCTR2200062520
Evaluation of an outreach programme for patients with COVID-19 in an integrated healthcare delivery system: a retrospective cohort study
Authors: Myers Laura C , Lawson Brian L , Escobar Gabriel J , Daly Kathleen A , Chen Yi-fen Irene , Dlott Richard , Lee Catherine , Liu Vincent
Published: January 2024

Objectives

In the first year of the COVID-19 pandemic, health systems implemented programmes to manage outpatients with COVID-19. The goal was to expedite patients’ referral to acute care and prevent overcrowding of medical centres. We sought to evaluate the impact of such a programme, the COVID-19 Home Care Team (CHCT) programme.

Design

Retrospective cohort.

Setting

Kaiser Permanente Northern California.

Participants

Adult members before COVID-19 vaccine availability (1 February 2020–31 January 2021) with positive SARS-CoV-2 tests.

Intervention

Virtual programme to track and treat patients with ‘CHCT programme’.

Outcomes

The outcomes were (1) COVID-19-related emergency department visit, (2) COVID-19-related hospitalisation and (3) inpatient mortality or 30-day hospice referral.

Measures

We estimated the average effect comparing patients who were and were not treated by CHCT. We estimated propensity scores using an ensemble super learner (random forest, XGBoost, generalised additive model and multivariate adaptive regression splines) and augmented inverse probability weighting.

Results

There were 98 585 patients with COVID-19. The majority were followed by CHCT (n=80 067, 81.2%). Patients followed by CHCT were older (mean age 43.9 vs 41.6 years, p<0.001) and more comorbid with COmorbidity Point Score, V.2, score ≥65 (1.7% vs 1.1%, p<0.001). Unadjusted analyses showed more COVID-19-related emergency department visits (9.5% vs 8.5%, p<0.001) and hospitalisations (3.9% vs 3.2%, p<0.001) in patients followed by CHCT but lower inpatient death or 30-day hospice referral (0.3% vs 0.5%, p<0.001). After weighting, there were higher rates of COVID-19-related emergency department visits (estimated intervention effect −0.8%, 95% CI −1.4% to −0.3%) and hospitalisation (−0.5%, 95% CI −0.9% to −0.1%) but lower inpatient mortality or 30-day hospice referral (−0.5%, 95% CI −0.7% to −0.3%) in patients followed by CHCT.

Conclusions

Despite CHCT following older patients with higher comorbidity burden, there appeared to be a protective effect. Patients followed by CHCT were more likely to present to acute care and less likely to die inpatient.
Risk factors for SARS-CoV-2 infection: a test-negative case–control study with additional population controls in Norway
Authors: Sarjomaa Marjut , Zhang Chi , Tveten Yngvar , Kersten Hege , Reiso Harald , Eikeland Randi , Kongerud Johny , Berg Kristine Karlsrud , Thilesen Carina , Nordbø Svein Arne , Aaberge Ingeborg S , Vandenbroucke Jan , Pearce Neil , Fell Anne Kristin Moeller
Published: January 2024

Objectives

This study aims to assess risk factors for SARS-CoV-2 infection by combined design; first comparing positive cases to negative controls as determined by PCR testing and then comparing these two groups to an additional prepandemic population control group.

Design and setting

Test-negative design (TND), multicentre case–control study with additional population controls in South-Eastern Norway.

Participants

Adults who underwent SARS-CoV-2 PCR testing between February and December 2020. PCR-positive cases, PCR-negative controls and additional age-matched population controls.

Primary outcome measures

The associations between various risk factors based on self- reported questionnaire and SARS-CoV-2 infection comparing PCR-positive cases and PCR-negative controls. Using subgroup analysis, the risk factors for both PCR-positive and PCR-negative participants were compared with a population control group.

Results

In total, 400 PCR-positive cases, 719 PCR-negative controls and 14 509 population controls were included. Male sex was associated with the risk of SARS-CoV-2 infection only in the TND study (OR 1.9, 95% CI 1.4 to 2.6), but not when PCR-positive cases were compared with population controls (OR 1.2, 95% CI 0.9. to 1.5). Some factors were positively (asthma, wood heating) or negatively (hypertension) associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but lacked convincing association in the TND study. Smoking was negatively associated with the risk of SARS-CoV-2 infection in both analyses (OR 0.5, 95% CI 0.3 to 0.8 and OR 0.6, 95% CI 0.4 to 0.8).

Conclusions

Male sex was a possible risk factor for SARS-CoV-2 infection only in the TND study, whereas smoking was negatively associated with SARS-CoV-2 infection in both the TND study and when using population controls. Several factors were associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but not in the TND study, highlighting the strength of combining case–control study designs during the pandemic.
Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study
Authors: Lesaine Emilie , Francis Florence , Domecq Sandrine , Miganeh-Hadi Sahal , Sevin Floriane , Sibon Igor , Rouanet François , Pradeau Catherine , Coste Pierre , Cetran Laura , Vandentorren Stephanie , Saillour Florence
Published: January 2024

Objective

This study aims to evaluate whether the first wave of the COVID-19 pandemic resulted in a deterioration in the quality of care for socially and/or clinically vulnerable stroke and ST-segment elevation myocardial infarction (STEMI) patients.

Design

Two cohorts of STEMI and stroke patients in the Aquitaine neurocardiovascular registry.

Setting

Six emergency medical services, 30 emergency units, 14 hospitalisation units and 11 catheterisation laboratories in the Aquitaine region in France.

Participants

This study involved 9218 patients (6436 stroke and 2782 STEMI patients) in the neurocardiovascular registry from January 2019 to August 2020.

Primary outcome measures

Care management times in both cohorts: first medical contact-to-procedure time for the STEMI cohort and emergency unit admission-to-imaging time for the stroke cohort. Associations between social (deprivation index) and clinical (age >65 years, neurocardiovascular history) vulnerabilities and care management times were analysed using multivariate linear mixed models, with an interaction on the time period (pre-wave, per-wave and post-first COVID-19 wave).

Results

The first medical contact procedure time was longer for elderly (p<0.001) and ‘very socially disadvantaged’ (p=0.003) STEMI patients, with no interaction regarding the COVID-19 period (age, p=0.54; neurocardiovascular history, p=0.70; deprivation, p=0.64). We found no significant association between vulnerabilities and the admission imaging time for stroke patients, and no interaction with respect to the COVID-19 period (age, p=0.81; neurocardiovascular history, p=0.34; deprivation, p=0.95).

Conclusions

This study revealed pre-existing inequalities in care management times for vulnerable STEMI and stroke patients; however, these inequalities were neither accentuated nor reduced during the first COVID-19 wave. Measures implemented during the crisis did not alter the structured emergency pathway for these patients.

Trial registration number

NCT04979208
Exercise therapy for knee osteoarthritis pain: how does it work? A study protocol for a randomised controlled trial
Authors: Beckwée David , Nijs Jo , Bierma-Zeinstra Sita M A , Leemans Lynn , Leysen Laurence , Puts Sofie , Rice David , Schiphof Dieuwke , Bautmans Ivan
Published: January 2024

Introduction

Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on knee osteoarthritic (KOA) pain, but the mechanisms of action remain unclear. Both exercise-induced anti-inflammation and central sensitisation are promising pathways for pain relief in response to exercise therapy in patients with KOA: MST has the potential to decrease inflammation and BGA has the potential to decrease central sensitisation. Hence, this study aims to examine inflammation and central sensitisation as mediators for the effect of MST and/or BGA on pain in patients with KOA.

Methods and analysis

The Knee OsteoArthritis PAIN trial started on 10 January 2020 (anticipated end: April 2024). The three-arm clinical trial aims to recruit 90 KOA patients who will be randomly allocated to 12 weeks of (1) MST, (2) BGA or (3) care as usual. Assessments will be performed at baseline, 13 and 52 weeks after finishing the intervention. Outcomes, including pain (Knee injury and Osteoarthritis Outcome Score), were chosen in line with the OARSI recommendations for clinical trials of rehabilitation interventions for OA and the IMMPACT/OMERACT recommendations for the assessment of physical function in chronic pain clinical trials. Inflammation as well as features of central sensitisation (including conditioned pain modulation, offset analgesia, temporal summation of pain and event-related potentials following electrical stimulation), will be considered as treatment mediators. A multiple mediators model will be estimated with a path-analysis using structural equation models. In July 2023, all 90 KOA patients have been included and 42 participants already finished the study.

Ethics and dissemination

This study obtained ethics approval (B.U.N. 143201941843). Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists and clinicians.

Trial registration number

NCT04362618.
Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2)
Authors: Faravel Kerstin , Jarlier Marta , Meignant Laetitia , Thomaso Muriel , Del Rio Maguy , Jacot William , Stoebner Anne
Published: January 2024

Introduction

Osteoarticular pain is experienced by approximately 50% of patients with breast cancer under hormone therapy and can increase the risk of therapy discontinuation. Among complementary therapies, yoga has shown efficacy regarding reduction of fatigue, anxiety, pain due to hormone therapy and inflammation. Personalised patient education programmes increase engagement and motivation, and induce effective behavioural changes. The SKYPE programme, an integrated intervention combining physiotherapy, yoga and patient education, showed promising efficacy on hormone therapy-induced pain in a previous pilot study. In this study, we hypothesised that using theory-based patient education favour learning and practising 15 min of at-home yoga every day to decrease hormone therapy-induced pain.

Methods and analysis

This multicentre randomised study will assess the efficacy of the SKYPE programme on pain reduction compared with standard care in patients with breast cancer reporting osteoarticular pain due to hormone therapy. Main secondary objectives will describe pain evolution and characteristics, patient adhesion to yoga sessions and home practice, forward flexibility, quality of life, fatigue, anxiety and compliance to hormone therapy. Patients in the intervention group will participate in 1 weekly educational yoga session of 90 min for 6 weeks, supervised by physiotherapists (period 1). They will also perform daily at-home 15 min yoga sessions for 12 weeks, the total duration of the intervention (periods 1 and 2). Pain will be evaluated during physiotherapy check-ups at baseline (T0), at 6 weeks (T1) and at 12 weeks (T2).

Ethics and dissemination

This study was approved by the ethics committee (CPP Ile de France 8 on 22 June 2020). The results will be disseminated to patients and healthcare professionals, and published in a peer-reviewed journal.

Trial registration number

NCT04457895.
Assessment of quality of life for frail, elderly patients post-ICU discharge: a protocol for a scoping review
Authors: Kjaergaard-Andersen Gunhild , Bauer Eithne Hayes , Bhavsar Rajesh Prabhakar , Jensen Hanne Irene , Ahrenfeldt Linda Juel , Hvidt Niels Christian , Stroem Thomas
Published: January 2024

Introduction

Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.

Methods and analysis

The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.

Ethics and dissemination

Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.
Lipid-focused dietary education intervention in pregnant women: study protocol for an open-label, parallel, randomised, intervention study addressing adverse pregnancy outcomes in China
Authors: Zhang Yadi , Gao Xiaoge , Zhu Haiyan , Sun Shengzhi , Contento Isobel R , Koch Pamela Ann , Yu Huanling
Published: January 2024

Introduction

The incidence of infants who are large-for-gestational-age (LGA) is on the rise in China, and its detrimental effects on health have received increasing attention. Diet-based interventions have the potential to reduce adverse birth outcomes, particularly in decreasing the occurrence of LGA infants. We aim to evaluate the effect of lipid-focused diet education based on the theories of behaviour change in pregnant women on maternal and offspring outcomes through a randomised controlled trial.

Methods and analysis

We have designed an open-label, parallel, multicentre randomised controlled trial in collaboration with three hospitals in Beijing, China.

Pregnant women will be recruited before reaching 12 weeks of gestation and will be randomised in a 1:1:1 ratio into three arms: (1) online education arm, (2) pregnancy nutrition checklist and ‘one-page flyer’ arm and (3) routine antenatal education. The primary outcome LGA will be recorded at birth. Demographic information, physical activity, sleep and medical history will be collected through questionnaires and case cards prior to enrolment. Questionnaires will also be used to collect dietary behaviours and psychosocial factors of pregnant women at enrolment, at 24–28 weeks and 34–36 weeks of gestation. Additionally, information on breastfeeding and complementary food supplementation for infants and young children will be obtained through questionnaires. Physical development indicators of children and taste tests will be assessed 3 years after delivery.

Ethics and dissemination

The study has received ethical approval from the Capital Medical University Ethics Committee and other collaborating study centres. Informed consent will be introduced to pregnant women, and their consent will be obtained. The findings will be reported in relevant national and international academic conferences and peer-reviewed publications.

Trial registration number

ChiCTR2300071126.
Diabetes-related distress and its associated factors among people with type 2 diabetes in Southeast Ethiopia: a cross-sectional study
Authors: Adugnew Mulugeta , Fetene Deriba , Assefa Tesfaye , Kedir Sana'a , Asmamaw Kidist , Feleke Zegeye , Gomora Degefa , Mamo Hailye
Published: January 2024

Background

Diabetes-related distress lowers the motivation for self-care, often leading to lowered physical and emotional well-being, poor diabetes control, poor medication adherence and increased mortality among individuals with diabetes.

Objective

To assess factors associated with diabetes-related distress among people living with type 2 diabetes in Southeast Ethiopia.

Design

Institution-based cross-sectional study was conducted.

Setting

Six diabetic follow-up care units at public hospitals in Southeast Ethiopia.

Participants

All adult people living with type 2 diabetes from the diabetic follow-up clinic.

The main outcome measures

Diabetes Distress Scale-17 questionnaire was used to assess diabetes-related distress.

Results

Out of the total 871 study participants intended, 856 participated in the study with a response rate of 98.3%. The findings showed that about 53.9% (95% CI 50.4% to 57.2%) of the patients have diabetes-related distress. Physical activity (adjusted OR, AOR 2.22; 95% CI 1.36 to 3.63), social support (AOR 4.41; 95% CI 1.62 to 12.03), glycaemic control (AOR 2.36; 95% CI 1.35 to 4.12) and other comorbidities (AOR 3.94; 95% CI 2.01 to 7.73) were factors that significantly associated with diabetes-related distress at p<0.05.

Conclusion

This study demonstrated that more than half of the participants had diabetes-related distress. Therefore, the identified factors of diabetes-related distress need to be a concern for health institutions and clinicians in the management of people living with type 2 diabetes.
Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study
Authors: O'Dowd Emma , Berovic Marko , Callister Matthew , Chalitsios Christos V , Chopra Disha , Das Indrajeet , Draper Adrian , Garner Justin L , Gleeson Fergus , Janes Sam , Kennedy Martyn , Lee Richard , Mauri Fabrizio , McKeever Tricia M , McNulty William , Murray James , Nair Arjun , Park John , Rawlinson Janette , Sagoo Gurdeep Singh , Scarsbrook Andrew , Shah Pallav , Sudhir Rajini , Talwar Ambika , Thakrar Ricky , Watkins Johnathan , Baldwin David R
Published: January 2024

Introduction

In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management. While these guidelines seem to be effective in clinical practice, recent data suggest that artificial intelligence (AI)-based malignant-nodule prediction solutions might outperform existing models.

Methods and analysis

This study is a prospective, observational multicentre study to assess the clinical utility of an AI-assisted CT-based lung cancer prediction tool (LCP) for managing incidental solid and part solid pulmonary nodule patients vs standard care. Two thousand patients will be recruited from 12 different UK hospitals. The primary outcome is the difference between standard care and LCP-guided care in terms of the rate of benign nodules and patients with cancer discharged straight after the assessment of the baseline CT scan. Secondary outcomes investigate adherence to clinical guidelines, other measures of changes to clinical management, patient outcomes and cost-effectiveness.

Ethics and dissemination

This study has been reviewed and given a favourable opinion by the South Central—Oxford C Research Ethics Committee in UK (REC reference number: 22/SC/0142).

Study results will be available publicly following peer-reviewed publication in open-access journals. A patient and public involvement group workshop is planned before the study results are available to discuss best methods to disseminate the results. Study results will also be fed back to participating organisations to inform training and procurement activities.

Trial registration number

NCT05389774.
Adverse outcomes of cannabis use in Canada, before and after legalisation of non-medical cannabis: cross-sectional analysis of the International Cannabis Policy Study
Authors: Marquette Anastasia , Iraniparast Maryam , Hammond David
Published: January 2024

Objectives

To date, there is little evidence on the extent to which cannabis legalisation affects the prevalence of adverse events from cannabis at the population level. The current study examined trends in the prevalence of adverse events among people who consumed cannabis before and after Canada’s legalisation of recreational cannabis.

Design

Data come from the first four survey waves of the International Cannabis Policy Study, which were conducted online annually immediately prior to non-medical cannabis legalisation in Canada in October 2018, and in the three following years (2019–2021).

Participants

The current analysis included 18 285 Canadian respondents aged 16–65 who reported cannabis use in the past 12 months.

Outcome measures

Primary outcomes included types of adverse events experienced from cannabis use, medical help-seeking and the types of products used. Weighted logistic regression models examined differences in help-seeking, emergency room usage and the experience of cannabinoid hyperemesis syndrome across survey years.

Results

Approximately one-third of people who consume cannabis reported experiencing at least one adverse event within the past 12 months, including 5% of consumers who sought medical help for an adverse event, most commonly for panic attacks, feeling faint/dizzy/passing out, heart/blood pressure problems and nausea/vomiting. The prevalence of seeking help and the types of adverse events were similar before (2018) and after legalisation (2019–2021); however, the proportion of consumers seeking help from emergency rooms increased postlegalisation (F=2.77, p=0.041). Adverse events were associated with various product types, with dried flower and oral oils accounting for the largest proportion of events. Help-seeking associated with cannabis edibles significantly decreased after legalisation (p=0.001).

Conclusions

Substantial proportions of people who consume cannabis report adverse events, suggesting widespread difficulty in ‘dosing’. Few changes were observed in the prevalence of adverse events reported by consumers since legalisation; however, the location of medical help-seeking and associated products used have changed postlegalisation.
Trends in inequalities in avoidable hospitalisations across the COVID-19 pandemic: a cohort study of 23.5 million people in England
Authors: Green Mark Alan , McKee Martin , Massey Jon , Mackenna Brian , Mehrkar Amir , Bacon Seb , Macleod John , Sheikh Aziz , Shah Syed Ahmar ,   The OpenSAFELY Consortium,   The Longitudinal Health and Wellbeing National Core Study Collaborative, Katikireddi Srinivasa Vittal
Published: January 2024

Objective

To determine whether periods of disruption were associated with increased ‘avoidable’ hospital admissions and wider social inequalities in England.

Design

Observational repeated cross-sectional study.

Setting

England (January 2019 to March 2022).

Participants

With the approval of NHS England we used individual-level electronic health records from OpenSAFELY, which covered ~40% of general practices in England (mean monthly population size 23.5 million people).

Primary and secondary outcome measures

We estimated crude and directly age-standardised rates for potentially preventable unplanned hospital admissions: ambulatory care sensitive conditions and urgent emergency sensitive conditions. We considered how trends in these outcomes varied by three measures of social and spatial inequality: neighbourhood socioeconomic deprivation, ethnicity and geographical region.

Results

There were large declines in avoidable hospitalisations during the first national lockdown (March to May 2020). Trends increased post-lockdown but never reached 2019 levels. The exception to these trends was for vaccine-preventable ambulatory care sensitive admissions which remained low throughout 2020–2021. While trends were consistent by each measure of inequality, absolute levels of inequalities narrowed across levels of neighbourhood socioeconomic deprivation, Asian ethnicity (compared with white ethnicity) and geographical region (especially in northern regions).

Conclusions

We found no evidence that periods of healthcare disruption from the COVID-19 pandemic resulted in more avoidable hospitalisations. Falling avoidable hospital admissions has coincided with declining inequalities most strongly by level of deprivation, but also for Asian ethnic groups and northern regions of England.
Gap analysis of service quality and associated factors at the oncology center of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2022: a cross-sectional study
Authors: Wasihun Girmachew Admasu , Addise Mesfin , Nega Adiam , Kifle Awgichew , Taye Girma , Gebrekidan Amanuel Yosef
Published: January 2024

Objective

To measure the gap between expectations of patients with cancer for oncology services and their perceptions of the actual service and to identify associated factors at the oncology centre of Tikur Anbessa Specialized Hospital, Ethiopia.

Design

An institutional-based cross-sectional study design was conducted using the service quality (SERVQUAL) tool from March to April 2022 on a sample of 256 hospitalised patients with cancer at the oncology centre of Tikur Anbessa Specialized Hospital. A paired Wilcoxon test and Kruskal-Wallis tests were used to determine the statistically significant difference between expectation and perception and to quantify the strength of association between the level of gap in the quality of oncology service and dependent variables, respectively.

Results

Out of 256 patients with cancer included in the study, all of them agreed and participated, making the response rate 100%. The overall gap in service quality explained by the mean and SD is −1.42 (±0.41). The overall score for expectation and perception is 4.24 (±0.31) and 2.82 (±0.37), respectively. Being female, age greater than 65, having a college degree and above, being a patient with cervical cancer, patients with stage 4 cancer and patients who waited for more than 12 months for radiotherapy were found to have a statistically significant higher expectation compared with their perceived care in one or more dimensions of the SERVQUAL tool.

Conclusion

Patient perceptions of the quality of service they received were lower than their expectations of the quality of service in all service quality aspects at Tikur Anbessa Specialized Hospital’s oncology centre, implying unmet quality expectations from the oncology service users, with tangibility, assurance and empathy being the dimensions with the highest gap recorded, respectively. Therefore, the hospital and other stakeholders should strive to exceed patient expectations and the overall quality of care.