bluuebunny/crossref_metadata_2025 huggingface dataset:
Effects of local handwashing agents on microbial contamination of the hands in a rural setting in Northwest Ethiopia: a cluster randomised controlled trial
Authors: Gizaw Zemichael , Yalew Alemayehu Worku , Bitew Bikes Destaw , Lee Jiyoung , Bisesi Michael
Published: May 2022

Objective

To evaluate the effectiveness of handwashing with water and wood ash in reducing faecal contamination of the hands.

Design

A cluster randomised controlled trial was employed with two arms: handwashing with water and wood ash versus handwashing with water alone.

Setting

Rural households of East Dembiya District, Central Gondar Zone, Amhara National Regional State, Ethiopia.

Participants

440 mothers and caregivers of children younger than 5 years assigned (1:1, 220 in each group) in clusters, with buffer zones between each cluster.

Intervention

Health education on effective handwashing was given to the intervention and control groups. Participants in the intervention group used wood ash of the same quantity (ie, one closed palm).

Outcome measures

The primary outcome was microbial contamination of the hands, measured by means of Escherichia coli counts before and after handwashing.

Results

At baseline, 75.9% and 67.7% of the participants in the intervention and control groups, respectively, had dirt on their fingernails, and the hands of all participants in both groups were contaminated with E. coli. The mean E. coli counts recovered at baseline were 3.07 log10 colony forming unit (CFU)/swab in the intervention group and 3.03 log10 CFU/swab in the control group, while at endline it was 1.4 log10 CFU/swab in the intervention group and 3.02 log10 CFU/swab in the control group. The mean E.coli counts was reduced by 1.65 log10 due to the intervention (difference-in-differences: β= −1.65, 95% CI= −1.84 to –1.46).

Conclusion

Two-thirds of the swab samples tested positive for E. coli after handwashing with water and wood ash, which indicates wood ash is not very effective in terms of completely removing micro-organisms on the hands. However, wood ash was significantly better than water alone in reducing the concentration of faecal coliform organisms on the hands. Local health authorities should primarily promote handwashing with soap. However, in the absence of soap, use of wood ash over water alone might be appropriate.

Trial registration number

PACTR202011855730652.
Intimate partner violence against women with disability and associated mental health concerns: a cross-sectional survey in Mumbai, India
Authors: Riley Andrew , Daruwalla Nayreen , Kanougiya Suman , Gupta Apoorwa , Wickenden Mary , Osrin David
Published: May 2022

Objectives

The risk of intimate partner violence (IPV) against women with disability is believed to be high. We aimed to compare the prevalence of past-year IPV against women with and without functional difficulties in urban informal settlements, to review its social determinants and to explore its association with mental health.

Design

Cross-sectional survey.

Setting

Fifty clusters within four informal settlements.

Participants

5122 women aged 18–49 years.

Primary and secondary outcome measures

We used the Washington Group Short Set of Questions to assess functional difficulties. IPV in the past year was described by binary composites of questions about physical, sexual and emotional violence. We screened for symptoms of depression using the Patient Health Questionnaire-9 and of anxiety using the Generalised Anxiety Disorder-7. Multivariable logistic regression models examined associations between functional difficulties, IPV and mental health.

Results

10% of participants who screened positive for functional disability had greater odds of experiencing physical or sexual IPV (adjusted OR (AOR) 1.68, 95% CI 1.23 to 2.29) and emotional IPV (1.52, 95% CI 1.16 to 2.00) than women who screened negative. Women who screened positive for functional disability had greater odds than women who screened negative of symptoms suggesting moderate or severe anxiety (AOR 2.50, 95% CI 1.78 to 3.49), depression (2.91, 95% CI 2.13 to 3.99) and suicidal thinking (AOR 1.94, 95% CI 1.50 to 2.50).

Conclusions

The burden of IPV fell disproportionately on women with functional difficulties, who were also more likely to screen positive for common mental disorder. Public health initiatives need to respond at local and national levels to address the overlapping and mutually reinforcing determinants of violence, while existing policy needs to be better utilised to ensure protection for the most vulnerable.
Can we accurately forecast non-elective bed occupancy and admissions in the NHS? A time-series MSARIMA analysis of longitudinal data from an NHS Trust
Authors: Eyles Emily , Redaniel Maria Theresa , Jones Tim , Prat Marion , Keen Tim
Published: May 2022

Objectives

The main objective of the study was to develop more accurate and precise short-term forecasting models for admissions and bed occupancy for an NHS Trust located in Bristol, England. Subforecasts for the medical and surgical specialties, and for different lengths of stay were realised

Design

Autoregressive integrated moving average models were specified on a training dataset of daily count data, then tested on a 6-week forecast horizon. Explanatory variables were included in the models: day of the week, holiday days, lagged temperature and precipitation.

Setting

A secondary care hospital in an NHS Trust in South West England.

Participants

Hospital admissions between September 2016 and March 2020, comprising 1291 days.

Primary and secondary outcome measures

The accuracy of the forecasts was assessed through standard measures, as well as compared with the actual data using accuracy thresholds of 10% and 20% of the mean number of admissions or occupied beds.

Results

The overall Autoregressive Integrated Moving Average (ARIMA) admissions forecast was compared with the Trust’s forecast, and found to be more accurate, namely, being closer to the actual value 95.6% of the time. Furthermore, it was more precise than the Trust’s. The subforecasts, as well as those for bed occupancy, tended to be less accurate compared with the overall forecasts. All of the explanatory variables improved the forecasts.

Conclusions

ARIMA models can forecast non-elective admissions in an NHS Trust accurately on a 6-week horizon, which is an improvement on the current predictive modelling in the Trust. These models can be readily applied to other contexts, improving patient flow.
Comparison of clinical practice of tonsil surgery from quality register data from Sweden and Norway and one clinic in Denmark
Authors: Stalfors Joacim , Ovesen Therese , Bertelsen Jannik Buus , Bugten Vegard , Wennberg Siri , Sunnergren Ola
Published: May 2022

Objectives

To compare the application of indications, demographics, surgical and haemostatic techniques in tonsil surgery in three countries.

Design

Non-randomised, prospective, observational cohort.

Setting

All patients registered in the National Tonsil Surgery Quality Registers in Sweden, Norway and West Jutland, Denmark.

Participants

Data were retrieved from 2017 to 2019; registered surgeries: Sweden: 20 833; Norway: 10 294 and West Jutland, Denmark: 505.

Results

Tonsil surgery for obstruction was twice as common in Sweden (62.2%) compared with Norway (31%) and Denmark (27.7%). Recurrent tonsillitis was registered twice as frequently in Norway (35.7%) and Denmark (39%) compared with Sweden (16.7%). Chronic tonsillitis was registered more frequently in Norway (29.8%) than in Sweden (13.8%) and Denmark (12.7%). Day surgery (>76%) was comparable. The higher frequency of obstruction in Sweden affected age and gender distributions: Sweden (7 years, 50.4% boys), Norway (17 y, 42.1%) and Denmark (19 y, 38.4%). For obstructive disorders, tonsillotomy with adenoidectomy was used in a majority of Swedish children (72%), whereas tonsillectomy with or without adenoidectomy dominated in Norway (53.5%) and Denmark (57.9%). Cold steel was the technique of choice for tonsillectomy in all three countries. For tonsillotomy, hot dissection techniques dominated in all countries. Disparities were observed with regard to haemostatic techniques. Bipolar diathermy was commonly used in all countries. Monopolar diathermy was practically only used in Sweden. Infiltration with epinephrine in the tonsillar bed was registered in Sweden and Norway but not at all in Denmark. Combined cold surgical and cold haemostatic techniques were more commonly used in Sweden (22.7%) than in Norway (10.4%) and Denmark (6.2%).

Conclusions

This study demonstrates disparities among the Nordic countries in tonsil surgery in terms of indications plus surgical and haemostatic techniques. Increased coverage and further monitoring of outcomes is needed to identify best practices and ideal guidelines for improved care.
Societal economic burden of hypertension at selected hospitals in southern Ethiopia: a patient-level analysis
Authors: Sorato Mende Mensa , Davari Majid , Kebriaeezadeh Abbas , Sarrafzadegan Nizal , Shibru Tamiru
Published: May 2022

Objectives

There is inadequate information on the economic burden of hypertension treatment in Ethiopia. Therefore, this study was conducted to determine the societal economic burden of hypertension at selected hospitals in Southern Ethiopia.

Methods

Prevalence-based cost of illness study from a societal perspective was conducted. Disability-adjusted life years (DALYs) were determined by the current WHO’s recommended DALY valuation method. Adjustment for comorbidity and a 3% discount was done for DALYs. The data entry, processing and analysis were done by using SPSS V.21.0 and Microsoft Excel V.2013.

Results

We followed a cohort of 406 adult patients with hypertension retrospectively for 10 years from September 2010 to 2020. Two hundred and fifty (61.6%) of patients were women with a mean age of 55.87±11.03 years. Less than 1 in five 75 (18.5%) of patients achieved their blood pressure control target. A total of US$64 837.48 direct cost was incurred due to hypertension. A total of 11 585 years and 579.57 years were lost due to hypertension-related premature mortality and morbidity, respectively. Treated and uncontrolled hypertension accounted for 50.83% (6027) of total years lost due to premature mortality from treated hypertension cohort. Total productivity loss due to premature mortality and morbidity was US$449 394.69. The overall economic burden of hypertension was US$514 232.16 (US$105.55 per person per month).

Conclusion

Societal economic burden of hypertension in Southern Ethiopia was substantial. Indirect costs accounted for more than 8 out of 10 dollars. Treated and uncontrolled hypertension took the lion’s share of economic cost and productivity loss due to premature mortality and morbidity. Therefore, designing and implanting strategies for the prevention of hypertension, early screening and detection, and improving the rate of blood pressure control by involving all relevant stakeholders at all levels is critical to saving scarce health resources.
Sociocultural perspectives on suicidal behaviour at the Coast Region of Kenya: an exploratory qualitative study
Authors: Ongeri Linnet , Nyawira Miriam , Kariuki Symon M , Theuri Cyrus , Bitta Mary , Penninx Brenda , Newton Charles RJC , Tijdink Joeri
Published: May 2022

Objectives

To explore perceived sociocultural factors that may influence suicidality from key informants residing in coastal Kenya.

Design

We used an exploratory qualitative study design.

Setting

Mombasa and Kilifi Counties of Coastal Kenya.

Participants

25 key informants including community leaders, professionals and community members directly and indirectly affected by suicidality.

Methods

We conducted in-depth interviews with purposively selected key informants to collect data on sociocultural perspectives of suicide. Thematic analysis was used to identify key themes using both inductive and deductive processes.

Results

Four key themes were identified from the inductive content analysis of 25 in-depth interviews as being important for understanding cultural perspectives related to suicidality: (1) the stigma of suicidal behaviour, with suicidal victims perceived as weak or crazy, and suicidal act as evil and illegal; (2) the attribution of supernatural causality to suicide, for example, due to sorcery or inherited curses; (3) the convoluted pathway to care, specifically, delayed access to biomedical care and preference for informal healers; and (4) gender and age differences influencing suicide motivation, method of suicide and care seeking behaviour for suicidality.

Conclusions

This study provides an in depth understanding of cultural factors attributed to suicide in this rural community that may engender stigma, discrimination and poor access to mental healthcare in this community. We recommend multipronged and multilevel suicide prevention interventions targeted at changing stigmatising attitudes, beliefs and behaviours, and improving access to mental healthcare in the community.
Postural control in Chiari I malformation: protocol for a paediatric prospective, observational cohort – potential role of posturography for surgical indication
Authors: Stella Irene , Remen Thomas , Petel Arthur , Joud Anthony , Klein Olivier , Perrin Philippe
Published: May 2022

Introduction

Chiari I malformation (CM1) is an anatomical abnormality characterised by the cerebellar tonsils descending at least 5 mm below the foramen magnum. CM1 causes obstruction of cerebrospinal fluid (CSF) circulation as well as direct compression on the brainstem, thus causing typical consequences (syringomyelia), and typical clinical features (characteristic headaches and neurological impairment). Surgery is the only available treatment, indicated when symptomatology is present. However, sometimes patients have atypical complaints, which are often suggestive of otolaryngological (ears, nose and throat, ENT) involvement. This may be difficult for a neurosurgeon to explain. Our study aims to investigate the relationship between one of these atypical symptoms, for example, postural instability, in a paediatric population using a Computerised Dynamic Posturography (Equitest, NeuroCom, Clackamas, OR). To our knowledge, there are no previously published studies carried out on children with CM1, using dynamic posturography.

Methods and analysis

Forty-five children aged 6–18 years old presenting with radiologically confirmed CM1 and presenting ENT clinical complaints will be included in the study for a duration of 3 years. As primary endpoint, posturographic results will be described in the population study. Second, posturographic results will be compared between patients with and without indication for surgery. Finally, preoperative and postoperative posturographic results, as well as CSF circulation quality at foramen magnum level, syringomyelia, sleep apnoea syndrome, scoliosis and behaviour will be compared in the operated patient group.

Ethics and dissemination

This protocol received ethical approval from the Clinical Research Delegation of Nancy University Hospital, in accordance with the National Commission on Informatics and Liberties (Commission Nationale de l'Informatique et des Libertés) (protocol number 2019PI256-107). Our data treatment was in accordance with the Methodology of reference Methodology Reference-004 specification for data policy. The study findings will be disseminated via peer-reviewed publications and conference presentations, especially to the Neurosphynx’s rare disease healthcare network.

Trial registration number

NCT04679792; Pre-results.
Effect of esketamine on perioperative depressive symptoms in major surgery patients (PASSION II): study protocol for a randomised controlled trial
Authors: Zhou Yang , Ma Bo , Sun Wanchen , Wang Juan , Fu Yuxuan , Wang Anxin , Wang Gang , Han Ruquan
Published: May 2022

Introduction

Depressive symptoms are common for patients undergoing major surgery and may worsen their mental health and lead to poor clinical outcomes. It is essential to seek a safe rapid-acting treatment for relieving moderate-to-severe depressive symptoms in patients undergoing major surgery.

Methods and analysis

This study is a randomised, placebo-controlled and double-blinded trial aiming to determine the effect of esketamine on moderate-to-severe depressive symptoms in patients undergoing major surgery. Five hundred and sixty-four participants, aged 18–65 years old, undergoing major surgery will be randomly allocated into the esketamine and placebo groups at a 1:1 ratio. Esketamine or placebo will be given intravenously at the same speed on suturing the incision by anaesthesiologists in charge who are blinded to the randomisation. In the esketamine group, the total dosage of esketamine will be 0.2 mg/kg body weight. To estimate the efficacy and safety endpoints, blinded evaluation by trained researchers will be completed at 3 days, 5 days, 1 month, 3 months and 6 months after surgery. The primary outcome is the remission rate at the third postoperative day. The secondary outcomes include depression-related scores, severe pain events and safety-related endpoints such as psychotic symptoms, manic symptoms and dissociative symptoms.

Ethics and dissemination

This study was approved by the Institutional Review Board of Beijing Tiantan Hospital, Capital Medical University, Beijing, China on 30 October 2020 (KY-2020-058-02). This trial is designed to explore whether the administration of esketamine could improve the mental health of patients with depressive symptoms undergoing major surgery. The conclusions of this study will be published in peer-reviewed journals.

Trial registration number

NCT04425473.
Does the trauma associated with out-of-home care transmit across generations? Evidence from the 1970 British Cohort Study during a major health pandemic
Authors: Parsons Sam , Schoon Ingrid
Published: May 2022

Objectives

Children with experience of out-of-home care (OHC) are at an increased risk of adverse outcomes in later life, including poorer levels of psycho-social adjustment. Less is known about the intergenerational transmission of the trauma associated with OHC and psychosocial outcomes in mid-adulthood, particularly during a major health pandemic.

Design

To examine if there is evidence of intergenerational transmission of trauma associated with OHC in mid-adulthood, we used data from the 1970 British Cohort Study 2020 COVID-19 Survey.

Participants

Cases were defined as cohort members (CMs) who had themselves experienced OHC (OHC1) and those whose mother reported to have been in OHC (OHC2). Among the 5320 CMs who participated in the second COVID-19 Survey, we have OHC information for n=4236. Our analytical samples range from n=2472 to 3864 depending on outcome: the largest sample comprised 105 (2.5%) CMs with direct OHC experience (OHC1), 93 (2.2%) CMs with a mother who had OHC experience (OHC2) and 3666 CMs with no OHC experience (OHC0).

Outcome measures

Self-reported outcomes at age 50 included indicators of depression, health and psychological well-being. Multivariate logistic regression models control for socioeconomic childhood background and current circumstances.

Results

Compared with the majority OHC0, the OHC1 group report higher levels of depression (OR 2.18 (95% CI 1.09 to 4.36) p<.05) and are at a greater risk of poor mental (OR 2.23 (95% CI 1.24 to 4.02) p<0.01) and general health (OR 3.32 (95% CI 1.65 to 6.67) p<0.001) during the pandemic. OHC2 was more than twice as likely to report poor mental health prepandemic (OR 2.52 (95% CI 1.37 to 4.64) p<0.01), but not during the pandemic.

Conclusion

Children of care leaver mothers (OHC2) appear to be better adjusted than those who were themselves in care (OHC1), although compared with those without care experience (OHC0) both groups had an increased risk of poorer adult outcomes. However, the findings point to both continuity and discontinuity of disadvantage.
Maternal mental health of adolescent mothers: a cross-sectional mixed-method study protocol to determine cultural and social factors and mental health needs in Lilongwe, Malawi
Authors: Tembo Chimwemwe Pindani , Burns Sharyn , Portsmouth Linda
Published: May 2022

Introduction

Adolescence marks a transition of life from childhood to adulthood. Becoming a mother during adolescence presents unique challenges that have a significant mental and physical burden and may increase the likelihood of developing common mental disorders (CMDs). Untreated CMDs have serious effects on both the mother and her child. Culture constitutes an important context for most experiences, and affects how individuals seek help. However, there is limited research that has investigated how culture and social factors influence the adolescent mother’s mental health during the postpartum period in Malawi.

Methods/design

A cross-sectional sequential mixed methods design will be carried out in four phases. Phase one will include the preparatory phase and scoping review. The second phase will comprise a survey with adolescent mothers. The sample for the survey consists of adolescent postpartum mothers aged 14–19 years (with infants of up to 6 months of age) who have the capacity to consent for the study. Phase three will be a qualitative study in which in-depth interviews and focus group discussions will be employed to collect data from health workers and informal healthcare providers in the community (eg, traditional healers, traditional birth attendants). The fourth phase will involve developing recommendations for policy and practice

Ethics and dissemination

This study will provide an understanding of the impact of culture and social factors that influence adolescent mother’s mental health and well-being, including the identification of potential risk and protective factors. The findings will inform recommendations for an appropriate, culturally accepted spectrum of interventions, including universal, selective and indicated prevention strategies. The findings will be disseminated to stakeholders working in maternal health in Malawi. Ethical approval was received from the Curtin University Human Research Ethics Committee (HRE2021-0223) and (P.05/21/575) Malawian Ethics Board National Committee on Research Ethics in the Social Sciences and Humanities.
Sociodemographic differences in patient experience with primary care during COVID-19: results from a cross-sectional survey in Ontario, Canada
Authors: Agarwal Payal , Wang Ri , Meaney Christopher , Walji Sakina , Damji Ali , Gill Navsheer , Yip Gina , Elman Debbie , Florindo Tiffany , Fung Susanna , Witty Melissa , Pham Thuy-Nga , Ramji Noor , Kiran Tara
Published: May 2022

Purpose

We sought to understand patients’ care-seeking behaviours early in the pandemic, their use and views of different virtual care modalities, and whether these differed by sociodemographic factors.

Methods

We conducted a multisite cross-sectional patient experience survey at 13 academic primary care teaching practices between May and June 2020. An anonymised link to an electronic survey was sent to a subset of patients with a valid email address on file; sampling was based on birth month. For each question, the proportion of respondents who selected each response was calculated, followed by a comparison by sociodemographic characteristics using χ2 tests.

Results

In total, 7532 participants responded to the survey. Most received care from their primary care clinic during the pandemic (67.7%, 5068/7482), the majority via phone (82.5%, 4195/5086). Among those who received care, 30.53% (1509/4943) stated that they delayed seeking care because of the pandemic. Most participants reported a high degree of comfort with phone (92.4%, 3824/4139), video (95.2%, 238/250) and email or messaging (91.3%, 794/870). However, those reporting difficulty making ends meet, poor or fair health and arriving in Canada in the last 10 years reported lower levels of comfort with virtual care and fewer wanted their practice to continue offering virtual options after the pandemic.

Conclusions

Our study suggests that newcomers, people living with a lower income and those reporting poor or fair health have a stronger preference and comfort for in-person primary care. Further research should explore potential barriers to virtual care and how these could be addressed.
Efficacy of systemic lidocaine in postoperative delirium in elderly patients undergoing laparoscopic colorectal surgery: study protocol for a multicentre, prospective, double-blind, randomised, parallel-group, superiority, placebo-controlled trial
Authors: Liao Xincheng , Fu Bingbing , Yun Jia , Lin Huifen , Qian Bin , Yao Yusheng
Published: May 2022

Introduction

Systemic lidocaine may reduce pain intensity and accelerate postoperative recovery. However, the efficacy of systemic lidocaine in cognitive function has not been established. This study protocol is designed to clarify the effectiveness of lidocaine in postoperative delirium (POD) in elderly patients scheduled for elective laparoscopic colorectal surgery.

Methods and analysis

This is a prospective, multicentre, randomised, double-blind, parallel-group, placebo-controlled trial. One thousand and twenty elderly patients will be randomly allocated in a ratio of 1:1 to receive either systemic lidocaine (a bolus of 1.5 mg/kg, followed by an infusion of 1.5 mg/kg/hour until the end of the surgery) or identical volumes and rates of 0.9% saline. The primary outcome measure is the prevalence of POD during the first 5 postoperative days. Secondary outcomes include emergence agitation, the area under the curve of the Numeric Rating Scale pain scores over 48 hours, postoperative 48-hour cumulative opioid consumption, postoperative nausea and vomiting (PONV), recovery of bowel function, quality of recovery, and patient satisfaction with postoperative analgesia.

Ethics and dissemination

The Ethical Committee of the Fujian Provincial Hospital approved the study protocol (ref: K2021-06-018). Other participating subcentres must also obtain ethics committee approval before the start of the study. We will obtain written informed consent from each patient before they are randomised. This study will be presented at scientific conferences and submitted to international journals.

Trial registration number

ChiCTR2100050314.
Ten-year trends of clinical outcomes after percutaneous coronary intervention: a Korean nationwide longitudinal cohort study
Authors: Choi Jung Min , Lee Seung-Hwa , Choi Jin-Ho
Published: May 2022

Objectives

Mortality following percutaneous coronary intervention (PCI) is a key quality measurement in clinical practice. This study investigated the 10-year trends of mortality following PCI in an unselected nationwide cohort.

Design

Retrospective cohort study.

Setting

A nationwide study in South Korea.

Participants

PCI claim data from 2006 to 2015 of the National Health Insurance Service and the Statistics of Korea.

Measures

1-year cardiovascular or non-cardiovascular death.

Results

In total, 437 436 patients were included. The annual number of PCI cases increased from 32 098 to 51 990 over the decade studied (p<0.001). Patients were divided into quartile subgroups according to an estimated adjusted probability for predicting 1-year all-cause death. The proportion of patients in the high-risk quartiles increased whereas those in the low-risk quartiles decreased (p<0.001). The 1-year cumulative incidence rate of all-cause death did not change in the population with risk scores in the 1st (0.9% to 0.8%) and 2nd (1.3% to 1.3%) quartiles, whereas it increased in the population with risk scores in the 3rd (3.4% to 5.1%) and 4th (15.5% to 19.4%) quartiles (p<0.001). Compared with year 2006, the mean survival time in year 2015 was shorter by 0, 3.3 and 12.4 days in patients with risk scores in the 1st or 2nd, 3rd and 4th quartiles, respectively. These findings were also consistent for cardiovascular or non-cardiovascular deaths.

Conclusion

The number, proportion and the overall risk of patients with a high risk for mortality after PCI increased over the decade in Korea.
Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial
Authors: Matsuyama Nao , Shimizu Shinobu , Ueda Kazuto , Suzuki Toshihiko , Suzuki Sakiko , Miura Ryosuke , Katayama Akemi , Ando Masahiko , Mizuno Masaaki , Hirakawa Akihiro , Hayakawa Masahiro , Sato Yoshiaki
Published: May 2022

Introduction

Neonatal hypoxic-ischaemic encephalopathy (HIE) is an important illness associated with death or cerebral palsy. This study aims to assess the safety and tolerability of the allogenic human multilineage-differentiating stress-enduring cell (Muse cell)-based product (CL2020) cells in newborns with HIE. This is the first clinical trial of CL2020 cells in neonates.

Methods and analysis

This is a single-centre, open-label, dose-escalation study enrolling up to 12 patients. Neonates with HIE who receive a course of therapeutic hypothermia therapy, which cools to a body temperature of 33°C–34°C for 72 hours, will be included in this study. A single intravenous injection of CL2020 cells will be administered between 5 and 14 days of age. Subjects in the low-dose and high-dose cohorts will receive 1.5 and 15 million cells per dose, respectively. The primary outcome is the occurrence of any adverse events within 12 weeks after administration. The main secondary outcome is the Bayley Scales of Infant and Toddler Development Third Edition score and the developmental quotient per the Kyoto Scale of Psychological Development 2001 at 78 weeks.

Ethics and dissemination

This study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The Nagoya University Hospital Institutional Review Board (No. 312005) approved this study on 13 November 2019. The results of this study will be published in peer-reviewed journal and reported in international conferences.

Trial registration numbers

NCT04261335, jRCT2043190112.
Multimorbidity in patients living with and beyond cancer: protocol for a scoping review
Authors: Ahmad Tahania , Gopal Dipesh , Dayem Ullah Abu Z M , Taylor Stephanie
Published: May 2022

Introduction

The number of people living with and beyond cancer is increasing rapidly. Many of them will experience ongoing physical or psychological sequelae as a result of their original cancer diagnosis or comorbidities arising from risk factors common to cancers and other long-term conditions. This poses the complex problem of managing cancer as a ‘chronic’ illness along with other existing comorbidities. This scoping review aims to map the literature available on multimorbidity in patients living with and beyond cancer, to explore, quantify and understand the impact of comorbid illnesses to inform work around cancer care in UK primary care settings.

Methods and analysis

This review will be guided by Joanna Briggs Institute Reviewer’s manual for scoping reviews. A systematic literature search using Medical Subject Heading and text words related to cancer survivors and multimorbidity will be performed in MEDLINE, CINAHL, Embase and Web of Science, from 1990. Results will be described in a narrative style, reported in extraction tables and diagrams, and where appropriate in themes and text.

Ethics and dissemination

The scoping review will undertake secondary analysis of published literature; therefore, ethics committee approval is not required. Results will be disseminated through a peer-reviewed scientific journal and presented in relevant conferences. The scoping review will inform understanding of the burden of multimorbidity for cancer survivors, thus allow families, practitioners, clinicians and researchers to take the steps necessary to improve patient-centred care.
Evaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: protocol for a pilot randomised, single-blind, controlled trial
Authors: Magee Michael , Gholamrezaei Ali , McNeilage Amy Gray , Dwyer Leah , Sim Alison , Ferreira Manuela , Darnall Beth , Glare Paul , Ashton-James Claire
Published: May 2022

Introduction

Opioid medications are no longer recommended as long-term therapy for chronic non-cancer pain, and many patients are advised to reduce or discontinue opioid medications. Many patients report difficulties in tapering opioid medications, necessitating supporting interventions. This protocol describes a pilot randomised controlled trial (RCT) to investigate the acceptability, feasibility and potential efficacy of a mobile health intervention to improve the opioid tapering self-efficacy of patients with chronic non-cancer pain.

Methods and analysis

The trial will be a single-blind (clinician, data collector and statistician-blinded) pilot RCT with two parallel arms. Forty adult patients with chronic non-cancer pain who are voluntarily reducing their prescribed opioid medications under medical guidance will be recruited from two tertiary pain clinics (Start date 25 August 2021). Participants will be randomly assigned to an intervention or control group. Both groups will receive usual care, including multidisciplinary pain management. In addition to usual care, the intervention group will receive a short informational and testimonial video about opioid tapering and will receive two specifically text messages per day for 28 days. The intervention is codesigned with patients and clinicians to provide evidence-based informational, motivational and emotional support to patients with chronic pain to taper opioid medications. Feasibility of the intervention and a future definitive RCT will be evaluated by measuring patient acceptability, delivery of the intervention, rates and reasons of exclusions and drop-outs, completion rates and missing data in the study questionnaires, and obtaining estimates for sample size determination. Potential efficacy will be evaluated by comparing changes in opioid tapering self-efficacy between the two groups.

Ethics and dissemination

The study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.

Trial registration number

ACTRN12621000795897.
Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care
Authors: Juntunen Michael B , Liedl Chad P , Carlson Peter N , Myers Lucas A , Stickler Zachary R , Ryan Schultz Jill A , Meilander Angela K , Behnken Emma , Lampman Michelle A , Rogerson M Carson , Fischer Karen M , McCoy Rozalina G
Published: May 2022

Introduction

Diabetes is one of the most common serious chronic health conditions in the USA. People living with diabetes face multiple barriers to optimal diabetes care, including gaps in access to medical care and self-management education, diabetes distress, and high burden of treatment. Community paramedics (CPs) are uniquely positioned to support multidisciplinary care for patients with diabetes by delivering focused diabetes self-management education and support and bridging the gaps between patients and the clinical and community resources they need to live well with their disease.

Methods and analysis

We will conduct a pragmatic single-arm prospective trial of a CP-led Diabetes Rescue, Engagement and Management (D-REM) programme that seeks to reduce diabetes distress. We will enrol 70 adults (≥18 years) with diabetes who have haemoglobin A1c (HbA1c)≥9.0%, experienced an emergency department (ED) visit or hospitalisation for any cause within the prior 6 months, and reside in areas with available CP support in Southeast Minnesota (Olmsted, Freeborn and Mower counties) and Northwest Wisconsin (Barron, Rusk and Dunn counties). Participants will be identified using Mayo Clinic electronic health records, contacted for consent and enrolled into the D-REM programme. Visit frequency will be individualised for each patient, but will be an average of four CP visits over the course of approximately 1 month. Outcomes will be change in diabetes distress (primary outcome), confidence in diabetes self-management, health-related quality of life, self-reported hypoglycaemia and hyperglycaemia, HbA1c, ED visits and hospitalisations. Outcomes will be assessed on enrolment, programme completion and 3 months after programme completion.

Ethics and dissemination

The study was approved by Mayo Clinic Institutional Review Board. Findings will be disseminated through peer-reviewed publications and presentations. If demonstrated to be successful, this model of care can be implemented across diverse settings and populations to support patients living with diabetes.

Trial registration number

NCT04385758.
Cohort profile: Scotland’s record-linkage e-cohorts of people with intellectual disabilities, and autistic people (SCIDA)
Authors: Cooper Sally-Ann , Henderson Angela , Kinnear Deborah , Mackay Daniel , Fleming Michael , Smith Gillian S , Hughes-McCormack Laura Anne , Rydzewska Ewelina , Dunn Kirsty , Pell J P , Melville Craig
Published: May 2022

Purpose

To investigate health, mortality and healthcare inequalities experienced by people with intellectual disabilities, and autistic people, and their determinants; an important step towards identifying and implementing solutions to reduce inequalities. This paper describes the cohorts, record-linkages and variables that will be used.

Participants

Scotland’s Census, 2011 was used to identify Scotland’s citizens with intellectual disabilities, and autistic citizens, and representative general population samples with neither. Using Scotland’s community health index, the Census data (demography, household, employment, long-term conditions) were linked with routinely collected health, death and healthcare data: Scotland’s register of deaths, Scottish morbidity data 06 (SMR06: cancer incidence, mortality, treatments), Prescribing Information System (identifying asthma/chronic obstructive pulmonary disease; angina/congestive heart failure/hypertension; peptic ulcer/reflux; constipation; diabetes; thyroid disorder; depression; bipolar disorders; anxiety/sleep; psychosis; attention deficit hyperactivity disorder; epilepsy; glaucoma), SMR01 (general/acute hospital admissions and causes, ambulatory care sensitive admissions), SMR04 (mental health admissions and causes), Scottish Care Information–Diabetes Collaboration (diabetic care quality, diabetic outcomes), national bowel screening programme and cervical screening.

Findings to date

Of the whole population, 0.5% had intellectual disabilities, and 0.6% were autistic. Linkage was successful for >92%. The resultant e-cohorts include: (1) 22 538 people with intellectual disabilities (12 837 men and 9701 women), 4509 of whom are children <16 years, (2) 27 741 autistic people (21 390 men and 6351 women), 15 387 of whom are children <16 years and (3) representative general population samples with neither condition. Very good general health was reported for only 3389 (15.0%) people with intellectual disabilities, 10 510 (38.0%) autistic people, compared with 52.4% general population. Mental health conditions were reported for 4755 (21.1%) people with intellectual disabilities, 3998 (14.4%) autistic people, compared with 4.2% general population.

Future plans

Analyses will determine the extent of premature mortality, causes of death, and avoidable deaths, profile of health conditions and cancers, healthcare quality and screening and determinants of mortality and healthcare.
Burnout syndrome in intensive care physicians in time of the COVID-19: a cross-sectional study
Authors: Fumis Renata Rego Lins , Costa Eduardo Leite Vieira , Dal’Col Shoraya Virginio Carneiro , Azevedo Luciano Cesar Pontes , Pastore Junior Laerte
Published: May 2022

Objectives

To assess the prevalence of burnout syndrome among intensive care physicians working in a tertiary private hospital as well as their perceived impact of the COVID-19 pandemic on their life.

Design

A cross-sectional study.

Setting

Intensive care units dedicated to the care of COVID-19 in Hospital Sirio-Libanes, Sao Paulo, Southeastern part of Brazil.

Participants

Intensive care physicians.

Interventions

Each participant received an envelope with a questionnaire composed of demographic and occupational variables, information related to their personal and professional experiences facing the COVID-19 pandemic and the Maslach Burnout Inventory questionnaire.

Primary and secondary outcomes measures

The primary outcome was to assess the prevalence of burnout syndrome among physicians working in an intensive care unit dedicated to the care of COVID-19.

Results

A total of 51 from the universe of 63 (82%) intensive care physicians participated in the study. Nineteen (37.2%) met the criteria for burnout syndrome. In the three domains that characterise burnout syndrome, we found a low level of personal achievement in 96.1% of physicians interviewed, a high level of depersonalisation in 51.0% and 51.0% with a high level of emotional exhaustion. Decision-making conflicts between the intensive care unit team and other attending physicians were frequent (50% of all conflicts). A third of the participants had been diagnosed with COVID-19, 22 (43.1%) reported having a family member infected and 8 (15.7%) lost someone close to the COVID-19 pandemic. Participants felt that fear of infecting their loved ones was the aspect of their lives that changed most as compared with the prepandemic period.

Conclusions

Burnout syndrome was frequent among intensive care unit physicians treating patients with COVID-19 in a large tertiary private hospital. Future studies should expand our results to other private and public hospitals and test strategies to promote intensive care unit physicians’ mental health.
Missing Piece Study protocol: prospective surveillance to determine the epidemiology of group A streptococcal pharyngitis and impetigo in remote Western Australia
Authors: Barth Dylan D , Mullane Marianne J , Sampson Claudia , Chou Coco , Pickering Janessa , Nicol Mark P , Davies Mark R , Carapetis Jonathan , Bowen Asha C
Published: May 2022

Introduction

Group A β-haemolytic Streptococcus (GAS), a Gram-positive bacterium, causes skin, mucosal and systemic infections. Repeated GAS infections can lead to autoimmune diseases acute rheumatic fever (ARF) and rheumatic heart disease (RHD). Aboriginal and Torres Strait Islander peoples in Australia have the highest rates of ARF and RHD in the world. Despite this, the contemporaneous prevalence and incidence of GAS pharyngitis and impetigo in remote Australia remains unknown. To address this, we have designed a prospective surveillance study of GAS pharyngitis and impetigo to collect coincident contemporary evidence to inform and enhance primary prevention strategies for ARF.

Methods and analysis

The Missing Piece Study aims to document the epidemiology of GAS pharyngitis and impetigo through collection of clinical, serological, microbiological and bacterial genomic data among remote-living Australian children. The study comprises two components: (1) screening of all children at school for GAS pharyngitis and impetigo up to three times a year and (2) weekly active surveillance visits to detect new cases of pharyngitis and impetigo. Environmental swabbing in remote schools will be included, to inform environmental health interventions. In addition, the application of new diagnostic technologies, microbiome analysis and bacterial genomic evaluations will enhance primary prevention strategies, having direct bearing on clinical care, vaccine development and surveillance for vaccine clinical trials.

Ethics and dissemination

Ethical approval has been obtained from the Western Australian Aboriginal Health Ethics Committee (Ref: 892) and Human Research Ethics Committee of the University of Western Australia (Ref: RA/4/20/5101). Study findings will be shared with community members, teachers and children at participating schools, together with academic and medical services. Sharing findings in an appropriate manner is important and will be done in a suitable way which includes plain language summaries and presentations. Finally, findings and updates will also be disseminated to collaborators, researchers and health planners through peer-reviewed journal publications.
Links between evidence-based medicine and shared decision-making in courses for doctors in training: a scoping review
Authors: Simons Mary , Rapport Frances , Zurynski Yvonne , Stoodley Marcus , Cullis Jeremy , Davidson Andrew S
Published: May 2022

Objectives

This scoping review aims to synthesise the current evidence on the inclusion and effectiveness of integrating evidence-based medicine (EBM) and shared decision-making (SDM) into training courses for doctors in training to enhance patient care. Both EBM and SDM appear to be taught separately and their combined role in providing high-quality patient care has not yet been explored.

Design

Scoping review of literature from January 2017 to June 2021.

Setting

Any setting where doctors in training could undertake EBM and/or SDM courses (hospitals, universities, clinics and online).

Participants

Doctors in training (also known as junior doctors, residents, registrars, trainees, fellows) defined as medical graduates undertaking further training to establish a career pathway.

Methods

Searches were conducted in the databases Medline, Embase, Scopus and Cochrane Library. Bibliographies of included articles and their cited references were hand searched and assessed for inclusion. Included studies described training and outcomes of either EBM, SDM or both. Reported outcomes included EBM knowledge and skill tests, attitude surveys, SDM checklists and surveys and patient and doctor experience data obtained from surveys, focus groups and interviews.

Results

Of the 26 included studies, 15 described EBM training courses, 10 described SDM training courses and 1 course combined both EBM and SDM. Courses were heterogeneous in their content and outcomes, making comparisons difficult. EBM courses prioritised quantitative outcome assessments and linked knowledge and skills, such as critical appraisal, but overlooked other key elements of patient-centred care including SDM.

Conclusions

SDM and EBM are taught separately in most training courses. The inclusion of SDM, evaluated by qualitative assessments, is currently omitted, yet could provide a more person-centred care focus in EBM courses and should be investigated to increase our knowledge of the effectiveness of such courses and their role in improving doctors’ skills and patient care.

Protocol

A protocol for this review has been published and contains further details of the methodology.