bluuebunny/crossref_metadata_2025 huggingface dataset:
Ketamine for the treatment of prehospital acute pain: a systematic review of benefit and harm
Authors: Sandberg Mårten , Hyldmo Per Kristian , Kongstad Poul , Dahl Friesgaard Kristian , Raatiniemi Lasse , Larsen Robert , Magnusson Vidar , Rognås Leif , Kurola Jouni , Rehn Marius , Vist Gunn Elisabeth
Published: November 2020

Background

Few publications have addressed prehospital use of ketamine in analgesic doses. We aimed to assess the effect and safety profile of ketamine compared with other analgesic drugs (or no drug) in adult prehospital patients with acute pain.

Methods

A systematic review of clinical trials assessing prehospital administration of ketamine in analgesic doses compared with other analgesic drugs or no analgesic treatment in adults. We searched PubMed, EMBASE, Cochrane Library and Epistemonikos from inception until 15 February 2020, including relevant articles in English and Nordic languages. We used the Cochrane and Grading of Recommendations Assessment, Development and Evaluation methodologies and exclusively assessed patient-centred outcomes. Two independent authors screened trials for eligibility, extracted data and assessed risk of bias.

Results

We included eight studies (2760 patients). Ketamine was compared with various opioids given alone, and intranasal ketamine given with nitrous oxide was compared with nitrous oxide given alone. Four randomised controlled trials (RCTs) and one cluster randomised trial included 699 patients. One prospective cohort included 27 patients and two retrospective cohorts included 2034 patients. Five of the eight studies had high risks of bias. Pain score with ketamine is probably lower than after opioids as demonstrated in a cluster-RCT (308 patients) and a retrospective cohort (158 patients) study, Δvisual analogue scale −0.4 (−0.8 to 0.0) and Δnumeric pain rating scale −3.0 (−3.86 to −2.14), respectively. Ketamine probably leads to less nausea and vomiting (risk ratio (RR) 0.24 (0.11 to 0.52)) but more agitation (RR 7.81 (1.85 to 33)) than opioids.

Conclusions

This systematic literature review finds that ketamine probably reduces pain more than opioids and with less nausea and vomiting but higher risk of agitation. Risk of bias in included studies is high.

Other

Scandinavian society of anaesthesiology and intensive care medicine funded meetings and software. The Norwegian Air Ambulance Foundation funded publication. Otherwise this research received no grant from any agency in the public, commercial or not-for-profit sectors.

PROSPERO registration number

CRD42018114399.
Screening tools for early identification of children with developmental delay in low- and middle-income countries: a systematic review
Authors: Faruk Tasnuva , King Catherine , Muhit Mohammad , Islam Md Kafiul , Jahan Israt , Baset Kamran ul , Badawi Nadia , Khandaker Gulam
Published: November 2020

Objective

To systematically review, identify and report the screening tools used for early identification of developmental delay in low- and middle-income countries.

Design

Systematic review.

Data sources

Four bibliographic databases: Medline (1946 to 13 July 2020), Embase (1974 to 13 July 2020), Scopus (1823 to 11 July 2020) and PsycINFO (1987 to July week 1 2020).

Eligibility criteria

Peer-reviewed original articles published in English addressing validated culturally sensitive developmental screening tools among children aged <5 years were included in this review.

Data extraction and synthesis

One author (CK, medical librarian) developed the search strategy. Three authors conducted the database search (phase I: CK; phase II: IJ and MKI). Three authors (TF, IJ and MKI) independently screened the title and abstracts. TF, MKI and GK independently performed the full-text review of the screened articles. During each step of the study selection process, disagreements were resolved through discussion. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was used to guide the systematic review. Data extraction and analysis were performed using MS Excel. Meta-analysis was not possible due to heterogeneity of the study findings.

Results

We identified 3349 articles, of which 18 studies from 10 countries, reporting 16 screening tools, were selected for qualitative synthesis. Six cultural contexts were explored. Twelve general, two motor and two speech-language tools were identified. Seven of them found to be parent-completed ones. Five screening tools (American Speech-Language and Hearing Association, Guide for Monitoring Child Development, Infant Neurological International Battery, New Delhi-Development Screening Questionnaire and Woodside Screening Technique) reported relatively higher sensitivity (82.5%–100%) and specificity (83%–98.93%).

Conclusions

Limited number of culturally sensitive developmental screening tools were validated for children aged <5 years in low- and middle-income countries. Revising existing screening tools in different ethnic and cultural settings and subsequent validation with normative value should be a research priority.
Feedback of patient-reported outcomes to healthcare professionals for comparing health service performance: a scoping review
Authors: Hancock Shaun L , Ryan Olivia F , Marion Violet , Kramer Sharon , Kelly Paulette , Breen Sibilah , Cadilhac Dominique A
Published: November 2020

Objective

Patient-reported outcomes (PROs) provide self-reported patient assessments of their quality of life, daily functioning, and symptom severity after experiencing an illness and having contact with the health system. Feeding back summarised PROs data, aggregated at the health-service level, to healthcare professionals may inform clinical practice and quality improvement efforts. However, little is known about the best methods for providing these summarised data in a way that is meaningful for this audience. Therefore, the aim of this scoping review was to summarise the emerging approaches to PROs data for ‘service-level’ feedback to healthcare professionals.

Setting

Healthcare professionals receiving PROs data feedback at the health-service level.

Data sources

Databases selected for the search were Embase, Ovid Medline, Scopus, Web of Science and targeted web searching. The main search terms included: ‘patient-reported outcome measures’, ‘patient-reported outcomes’, ‘patient-centred care’, ‘value-based care’, ‘quality improvement’ and ‘feedback’. Studies included were those that were published in English between January 2009 and June 2019.

Primary and secondary outcome measures

Data were extracted on the feedback methods of PROs to patients or healthcare providers. A standardised template was used to extract information from included documents and academic publications. Risk of bias was assessed using Joanna Briggs Institute Levels of Evidence for Effectiveness.

Results

Overall, 3480 articles were identified after de-duplication. Of these, 19 academic publications and 22 documents from the grey literature were included in the final review. Guiding principles for data display methods and graphical formats were identified. Seven major factors that may influence PRO data interpretation and use by healthcare professionals were also identified.

Conclusion

While a single best format or approach to feedback PROs data to healthcare professionals was not identified, numerous guiding principles emerged to inform the field.
Development of a new tool for the assessment of patient-defined benefit in hospitalised older patients: the Patient Benefit Assessment Scale for Hospitalised Older Patients (P-BAS HOP)
Authors: van der Kluit Maria Johanna , Dijkstra Geke J , van Munster Barbara C , De Rooij Sophia
Published: November 2020

Objectives

To support the shift from disease-oriented towards goal-oriented care, we aimed to develop a tool which is capable both to identify priorities of an individual older hospitalised patient and to measure the outcomes relevant to him.

Design

Mixed-methods design with open interviews, three step test interviews (TSTIs) and a quantitative field test.

Setting

University teaching hospital and a regional teaching hospital.

Participants

Hospitalised patients ages 70 years and older.

Results

The Patient Benefit Assessment Scale for Hospitalised Older Patients (P-BAS HOP) consists of a baseline questionnaire and an evaluation questionnaire. Items were based on 15 qualitative interviews with hospitalised older patients. Feedback from a panel of four community-dwelling older persons resulted in some adaptations to wording and one additional item. Twenty-six hospitalised older patients participated in TSTIs with Version 1 of the baseline questionnaire, revealing indications for a good content validity and barriers in completion behaviour, global understanding and understanding of individual items, which were solved with several adaptations. Four additions were made by participants. After TSTIs with ten patients with the evaluation questionnaire, one adaptation was made. A field test with 91 hospitalised older patients revealed a small number of missing values.

To enhance the feasibility, the number of items was reduced from 32 to 22, based on correlations and mean impact score. The field test was repeated with 104 other patients in a regional teaching hospital. To enhance the understanding, the tool was split into two phases. This version was tested with TSTIs with eight patients and appeared to be understandable. The final version was an interview-based tool and took about 11 min to complete.

Conclusions

The P-BAS HOP is a potentially suitable tool to identify priorities and relevant outcomes of the individual patient. Further research is needed to investigate its validity, reliability and responsiveness.
Experiences and perceived health benefits of individuals with a disability participating in sport: A systematic review protocol
Authors: Aitchison Beth , Rushton Alison , Martin Paul , Soundy Andrew , Heneghan Nicola R
Published: November 2020

Introduction

Sports participation has many physical and mental health benefits for individuals with a disability, including improved functionality and reduced anxiety. Despite this, a large proportion of individuals with a disability are inactive. This review will be the first to synthesise the literature on the experiences and perceived health benefits of sport participation for children, adolescents, adults, elite athletes and veterans with a disability. Investigation of these phenomena will enable an understanding of the positive aspects and benefits of sport participation specific to each population, which may help to improve participation rates and ultimately improve health through promotion of these benefits.

Methods

A protocol for systematic review is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis-P. The phenomena of interest are the experiences and perceived health benefits of individuals with a disability participating in sport. There will be no age limit on participants and all study designs, besides reviews, will be included. Studies in languages other than English will be excluded. Two independent reviewers will conduct the searches, study selection, data collection and quality assessment independently. The online databases MEDLINE, EMBASE, PsychINFO, CINAHL Plus, Web of Science and SportDiscus will be electronically searched from database inception to February 2020. Grey literature will be searched and several sport-related journals will be hand-searched. The Quality Assessment Tool for Studies with Diverse Designs will be used for quality assessment of included studies. Thematic synthesis will be used to analyse the qualitative studies, narrative synthesis will be used to analyse the quantitative studies and the perceived health benefits will be analysed using content analysis. The strength of the overall body of evidence will be assessed and reported using GRADE-CERQual (Grading of Recommendations, Assessment, Development and Evaluation–Confidence in the Evidence from Reviews of Qualitative research) for qualitative studies and GRADE for quantitative studies. These approaches will be applied to mixed-methods studies, respectively, where necessary.

Ethics and dissemination

This systematic review raises no ethical issues. Results will be published in a peer reviewed journal and disseminated to key stakeholders to inform practice.

PROSPERO registration number

CRD42020169224.
Strategies for enhancing the initiation of cholesterol lowering medication among patients at high cardiovascular disease risk: a qualitative descriptive exploration of patient and general practitioners’ perspectives on a facilitated relay intervention in Alberta, Canada
Authors: Campbell David J T , Lee-Krueger Rachelle C W , McBrien Kerry , Anderson Todd , Quan Hude , Leung Alexander A , Chen Guanmin , Lu Mingshan , Naugler Christopher , Butalia Sonia
Published: November 2020

Objective

The objective of our study was to explore the perspectives of patients and general practitioners (GPs) regarding interventions to increase initiation of cholesterol lowering medication (or statins), including a proposed laboratory-based facilitated relay intervention.

Design

Qualitative descriptive study using interviews and focus groups for data collection, and thematic analysis for data analysis.

Setting

Primary care providers and patients in Calgary, Alberta, Canada.

Participants

17 GPs with primarily community-based, non-academic practices with at least 1 year of practice experience participated in semistructured interviews. 14 patients at high risk of cardiovascular disease participated in focus groups.

Main outcome measures

Exploration of strategies that might be used to enhance the prescription of, and adherence to statin therapy for patients with statin-indicated conditions.

Results

GPs proposed a variety of interventions to improve statin prescription, including electronic record audit solutions, GP directed education, and patient-oriented campaigns. Patients expressed that they may benefit from being provided access to their laboratory test results, as well as targeted education. Both parties provided positive feedback on the proposed laboratory-based facilitated relay intervention, while pointing out areas for improvement. Notably, GPs were concerned that the patient-directed component of the intervention might jeopardise therapeutic relationships, and patients were concerned about accidental disclosure of personal health information. Important considerations for the design of facilitated relay messaging should include brevity, simplicity and the provision of contact information for inquiries.

Conclusions

GPs and patients described several suggestions for increasing statin initiation and welcomed the proposal of a laboratory-based facilitated relay strategy. These findings support further testing of this intervention which may enhance GPs’ ability to successfully engage patients in cardiovascular risk reduction through statin therapy.
Patterns of multimorbidity and their effects on adverse outcomes in rheumatoid arthritis: a study of 5658 UK Biobank participants
Authors: McQueenie Ross , Nicholl Barbara I , Jani Bhautesh D , Canning Jordan , Macdonald Sara , McCowan Colin , Neary Joanne , Browne Susan , Mair Frances S , Siebert Stefan
Published: November 2020

Objective

To investigate how the type and number of long-term conditions (LTCs) impact on all-cause mortality and major adverse cardiovascular events (MACE) in people with rheumatoid arthritis (RA).

Design

Population-based longitudinal cohort study.

Setting

UK Biobank.

Participants

UK Biobank participants (n=502 533) aged between 37 and 73 years old.

Primary outcome measures

Primary outcome measures were risk of all-cause mortality and MACE.

Methods

We examined the relationship between LTC count and individual comorbid LTCs (n=42) on adverse clinical outcomes in participants with self-reported RA (n=5658). Risk of all-cause mortality and MACE were compared using Cox’s proportional hazard models adjusted for lifestyle factors (smoking, alcohol intake, physical activity), demographic factors (sex, age, socioeconomic status) and rheumatoid factor.

Results

75.7% of participants with RA had multimorbidity and these individuals were at increased risk of all-cause mortality and MACE. RA and >4 LTCs showed a threefold increased risk of all-cause mortality (HR 3.30, 95% CI 2.61 to 4.16), and MACE (HR 3.45, 95% CI 2.66 to 4.49) compared with those without LTCs. Of the comorbid LTCs studied, osteoporosis was most strongly associated with adverse outcomes in participants with RA compared with those without RA or LTCs: twofold increased risk of all-cause mortality (HR 2.20, 95% CI 1.55 to 3.12) and threefold increased risk of MACE (HR 3.17, 95% CI 2.27 to 4.64). These findings remained in a subset (n=3683) with RA diagnosis validated from clinical records or medication reports.

Conclusion

Those with RA and other LTCs, particularly comorbid osteoporosis, are at increased risk of adverse outcomes, although the role of corticosteroids could not be evaluated in this study. These results are clinically relevant for the monitoring and management of RA across the healthcare system, and future clinical guidelines for RA should acknowledge the importance of multimorbidity.
Healthcare provider counselling for weight management behaviours among adults with overweight or obesity: a cross-sectional analysis of National Health and Nutrition Examination Survey, 2011–2018
Authors: Greaney Mary L. , Cohen Steven A. , Xu Furong , Ward-Ritacco Christie L , Riebe Deborah
Published: November 2020

Objectives

To determine if adults with overweight or obesity received counselling from their healthcare providers (HCPs) to lose weight and/or adopt healthful behaviours associated with weight loss, and whether they took action on their HCPs’ recommendations.

Design

Cross-sectional analysis of 2011–2018 National Health and Nutrition Examination Survey (NHANES) data.

Sample

NHANES respondents aged 18+ who were overweight/obese and had seen an HCP in the previous 12 months (n=13 158).

Methods

Respondents reported if their HCPs recommended they control/lose weight, increase exercise/physical activity (PA) and/or reduce fat/calorie intake, and if they adopted the offered recommendation(s). Weighted logistic regression models examined receipt of HCP counselling by sex, age, race/ethnicity, and weight status accounting for demographic characteristics and complex sampling. Similar analyses examined reported adoption of HCPs’ recommendations.

Results

The sample was 53.1% women, 45.0% were overweight and 55.0% had obesity. In total, 40.4% received counselling to control/lose weight, 49.5% to increase exercise/PA and 38.9% to reduce fat/calorie intake. The following groups were less likely (p<0.001) to receive counselling: men; younger adults (aged 18–39) versus middle-aged (aged 40–64) and older adults (aged 65+); White versus Black and Hispanic respondents; overweight respondents versus respondents with obesity. Approximately half of those advised to make changes reported doing so (53.6% controlled/lost weight, 57.3% increased exercise/PA, 51.8% reduced fat/calorie intake). Differences in the adoption of recommendations were identified by sex, age group, race/ethnicity and weight status (all p<0.05); women, middle-aged and older adults, Black and Hispanic respondents and individuals with obesity were more likely to adopt one or more recommendations.

Conclusion

Most respondents did not receive HCP counselling, and approximately half of those who received counselling reported taking action. HCPs may need training to provide counselling and to offer recommendations tailored to the social contexts of populations less likely to adopt weight control related recommendations.
Manuscript review continuing medical education: a retrospective investigation of the learning outcomes from this peer reviewer benefit
Authors: Kawczak Steven , Mustafa Sultana
Published: November 2020

Objectives

This study investigates the learning outcomes for peer reviewers participating in a manuscript review continuing medical education (CME) process. CME from serving as a peer reviewer is one of the many benefits of serving as a reviewer.

Design

This is a descriptive study retrospectively analysing learning outcomes self-reported by peer reviewers from 2013 to 2017 using a CME assessment framework.

Setting, participants and primary outcome measures

Participant data are from 1985 peer reviewers who completed 2413 manuscript reviews over 32 medical journals from 2013 to 2017 and completed the CME process after their prepublication manuscript review. 417 reviewer responses were practice behaviour change(s) that were studied in depth using an assessment framework on changes in knowledge, competence and performance.

Results

The results show positive learning outcomes reported by reviewers at the knowledge, competence and performance behaviour levels as a result of reviewing manuscripts. Higher levels of learning outcomes are more frequently achieved when reviewers consult multiple sources when conducting reviews. Reviewer demographics, such as gender or years of experience, did not have a significant association to learning outcomes.

Conclusions

Manuscript Review CME is an effective way that learning within the peer reviewer process can occur and helps reviewers gain knowledge, improve competence and make changes to their professional practice at all stages of their careers. Journal publishers should emphasise and support reviewers through offering CME to reviewers and encourage consultation of multiple sources when conducting reviews, which is an added benefit and resource to help professionals continue their development.
Women’s health-related vulnerabilities in natural disaster-affected areas of Bangladesh: a mixed-methods study protocol
Authors: Riyad Fatema Syadani
Published: November 2020

Introduction

Global climate change has produced growing natural disasters across the world especially in Global South. Different countries experience varied vulnerabilities depending on their geographical location, economic status and ability of management. In a highly disaster susceptible developing country like Bangladesh, many individuals experience a greater rate of natural disasters with devastating health effects. Compare with men, women have a higher incidence of mortality and health effects following natural disasters. The study aims to explore women’s experience of physical and psychological health vulnerabilities with primary causes in natural disaster-affected areas of Bangladesh.

Methods and analysis

This is an exploratory mixed-method study comprising survey and in-depth interviews with equal priority to identify physical and psychological health vulnerabilities of women living in natural disaster-affected areas of Bangladesh. Quantitative data will be collected using self-administered sociodemographic and perceived severity instrument, 12-item Short-Form, Impact of Event Scale-Revised and Brief Coping Scale, while specific open-ended guidelines will be used for the qualitative part. The instruments will be translated into Bangla following the Brislin (1970) model of translation. The survey will be administered in paper copies, with at least 384 respondents, whereas 30 participants will be in-depth interviewed using an audio recorder. Survey data will be analysed using SPSS V.25 following descriptive and inferential statistics as required. The recorded open-ended responses will be transcribed and analysed using thematic analysis. Finally, both data sets will be integrated and synthesised according to the sequential mixed-method approach.

Ethics and dissemination

The study has been reviewed and approved by the Human Research Ethics Committee of the University of New England. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and various community engagement activities.
Role of formative assessment in predicting academic success among GP registrars: a retrospective longitudinal study
Authors: Heggarty Paula , Teague Peta-Ann , Alele Faith , Adu Mary , Malau-Aduli Bunmi S
Published: November 2020

Objectives

The James Cook University General Practice Training (JCU GPT) programme’s internal formative exams were compared with the Royal Australian College of General Practitioners (RACGP) pre-entry exams to determine ability to predict final performance in the RACGP fellowship exams.

Design

A retrospective longitudinal study.

Setting

General Practice (GP) trainees enrolled between 2016 and 2019 at a Registered Training Organisation in regional Queensland, Australia.

Participants

376 GP trainees enrolled in the training programme.

Exposure measures

The pre-entry exams were Multiple-Mini Interviews (MMI), Situational Judgement Test (SJT) and Candidate Assessment and Applied Knowledge Test. The internal formative exams comprised multiple choice questions (MCQ1 and MCQ2), short answer questions, clinical skills and clinical reasoning.

Primary outcome measure

The college exams were Applied Knowledge Test (AKT), Key Feature Problems (KFP) and Objective Structured Clinical Examination (OSCE).

Results

Correlations (r), coefficients of determination (R2) and OR were used as parameters for estimating strength of relationship and precision of predictive accuracy. SJT and MMI were moderately (r=0.13 to 0.31) and MCQ1 and MCQ2 highly (r=0.37 to 0.53) correlated with all college exams (p<0.05 to p<0.01), with R2 ranging from 0.070 to 0.376. MCQ1 was predictive of failure in all college exams (AKT: OR=2.32, KFP: OR=3.99; OSCE: OR=3.46); while MCQ2 predicted failure in AKT (OR=2.83) and KFP (OR=3.15).

Conclusion

We conclude that the internal MCQ formative exams predict performance in the RACGP fellowship exams. We propose that our formative assessment tools could be used as academic markers for early identification of potentially struggling trainees.
Azathioprine immunosuppression and disease modification in Parkinson’s disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial protocol
Authors: Greenland Julia C , Cutting Emma , Kadyan Sonakshi , Bond Simon , Chhabra Anita , Williams-Gray Caroline H
Published: November 2020

Introduction

The immune system is implicated in the aetiology and progression of Parkinson’s disease (PD). Inflammation and immune activation occur both in the brain and in the periphery, and a proinflammatory cytokine profile is associated with more rapid clinical progression. Furthermore, the risk of developing PD is related to genetic variation in immune-related genes and reduced by the use of immunosuppressant medication. We are therefore conducting a ‘proof of concept’ trial of azathioprine, an immunosuppressant medication, to investigate whether suppressing the peripheral immune system has a disease-modifying effect in PD.

Methods and analysis

AZA-PD is a phase II randomised placebo-controlled double-blind trial in early PD. Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated (azathioprine:placebo, 1:1) for 12 months, with a further 6-month follow-up. The primary outcome is the change in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period. Exploratory outcomes include additional measures of motor and cognitive function, non-motor symptoms and quality of life. In addition, peripheral and central immune markers will be investigated through analysis of blood, cerebrospinal fluid and PK-11195 positron emission tomography imaging.

Ethics and dissemination

The study was approved by the London-Westminster research ethics committee (reference 19/LO/1705) and has been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trials authorisation (reference CTA 12854/0248/001–0001). In addition, approval has been granted from the Administration of Radioactive Substances Advisory Committee. The results of this trial will be disseminated through publication in scientific journals and presentation at national and international conferences, and a lay summary will be available on our website.

Trial registration numbers

ISRCTN14616801 and EudraCT- 2018-003089-14.
Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial
Authors: He Xuan , Cheng Kun-Ming , Zhang Linlin , Gu Hongqiu , Qu Xin , Xu Yuan , Ma Penglin , Zhou Jian-Xin
Published: November 2020

Introduction

Postoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.

Methods and analysis

This is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.

Trial registration number

Trial registration number: NCT04399343; Pre-results.
Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study
Authors: Trouillet-Assant Sophie , Albert Vega Chloe , Bal Antonin , Nazare Julie Anne , Fascia Pascal , Paul Adèle , Massardier-Pilonchery Amélie , d Aubarede Constance , Guibert Nicolas , Pitiot Virginie , Lahousse Matthieu , Boibieux André , Makhloufi Djamila , Simon Chantal , Rabilloud Muriel , Trabaud Mary Anne , Gueyffier François , Fassier Jean-Baptiste
Published: November 2020

Introduction

The COVID-19 pandemic caused by SARS-CoV-2 threatens global public health, and there is an urgent public health need to assess acquired immunity to SARS-CoV-2. Serological tests might provide results that can be complementary to or confirm suspected COVID-19 cases and reveal previous infection. The performance of serological assays (sensitivity and specificity) has to be evaluated before their use in the general population. The neutralisation capacity of the produced antibodies also has to be evaluated.

Methods and analysis

We set up a prospective, multicentric clinical study to evaluate the performance of serological kits among a population of healthcare workers presenting mild symptoms suggestive of SARS-CoV-2 infection. Four hundred symptomatic healthcare workers will be included in the COVID-SER study. The values obtained from a control cohort included during the prepandemic time will be used as reference. A workflow was set up to study serological response to SARS-CoV-2 infection and to evaluate antibody neutralisation capacity in patients with a confirmed SARS-CoV-2 infection. The sensitivity and specificity of the tests will be assessed using molecular detection of the virus as a reference. The measurement of IgM and IgG antibodies will be performed once per week for 6 consecutive weeks and then at 6, 12, 18, 24 and 36 months after the diagnosis. The kinetics of IgM and IgG will determine the optimal period to perform serological testing. The proportion of false negative PCR tests in symptomatic subjects will be determined on the basis of subsequent seroconversions.

Ethics and dissemination

Ethical approval has been obtained from the national review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France) (ID RCB 2020-A00932-37). Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals.

Trial registration number

NCT04341142.
Cost-effectiveness analysis of population salt reduction interventions to prevent cardiovascular disease in Cameroon: mathematical modelling study
Authors: Aminde Leopold Ndemnge , Cobiac Linda , Veerman J. Lennert
Published: November 2020

Background

Reducing dietary sodium (salt) intake has been proposed as a population-wide strategy to reduce blood pressure and cardiovascular disease (CVD). The cost-effectiveness of such strategies has hitherto not been investigated in Cameroon.

Methods

A multicohort multistate life table Markov model was used to evaluate the cost-effectiveness of three population salt reduction strategies: mass media campaign, school-based salt education programme and low-sodium salt substitute. A healthcare system perspective was considered and adults alive in 2016 were simulated over the life course. Outcomes were changes in disease incidence, mortality, health-adjusted life years (HALYs), healthcare costs and incremental cost-effectiveness ratios (ICERs) over the lifetime. Probabilistic sensitivity analysis was used to quantify uncertainty.

Results

Over the life span of the cohort of adults alive in Cameroon in 2016, substantial numbers of new CVD events could be prevented, with over 10 000, 79 000 and 84 000 CVD deaths that could be averted from mass media, school education programme and salt substitute interventions, respectively. Population health gains over the lifetime were 46 700 HALYs, 348 800 HALYs and 368 400 HALYs for the mass media, school education programme and salt substitute interventions, respectively. ICERs showed that all interventions were dominant, with probabilities of being cost-saving of 84% for the school education programme, 89% for the mass media campaign and 99% for the low sodium salt substitute. Results were largely robust in sensitivity analysis.

Conclusion

All the salt reduction strategies evaluated were highly cost-effective with very high probabilities of being cost-saving. Salt reduction in Cameroon has the potential to save many lives and offers good value for money.
Unscheduled and out-of-hours care for people in their last year of life: a retrospective cohort analysis of national datasets
Authors: Mason Bruce , Kerssens Joannes Joseph , Stoddart Andrew , Murray Scott A , Moine Sébastien , Finucane Anne M , Boyd Kirsty
Published: November 2020

Objectives

To analyse patterns of use and costs of unscheduled National Health Service (NHS) services for people in the last year of life.

Design

Retrospective cohort analysis of national datasets with application of standard UK costings.

Participants and setting

All people who died in Scotland in 2016 aged 18 or older (N=56 407).

Main outcome measures

Frequency of use of the five unscheduled NHS services in the last 12 months of life by underlying cause of death, patient demographics, Continuous Unscheduled Pathways (CUPs) followed by patients during each care episode, total NHS and per-patient costs.

Results

53 509 patients (94.9%) had at least one contact with an unscheduled care service during their last year of life (472 360 contacts), with 34.2% in the last month of life. By linking patient contacts during each episode of care, we identified 206 841 CUPs, with 133 980 (64.8%) starting out-of-hours. People with cancer were more likely to contact the NHS telephone advice line (63%) (χ2 (4)=1004, p<0.001) or primary care out-of-hours (62%) (χ2 (4)=1924,p<0.001) and have hospital admissions (88%) (χ2 (4)=2644, p<0.001). People with organ failure (79%) contacted the ambulance service most frequently (χ2 (4)=584, p<0.001). Demographic factors associated with more unscheduled care were older age, social deprivation, living in own home and dying of cancer. People dying with organ failure formed the largest group in the cohort and had the highest NHS costs as a group. The cost of providing services in the community was estimated at 3.9% of total unscheduled care costs despite handling most out-of-hours calls.

Conclusions

Over 90% of people used NHS unscheduled care in their last year of life. Different underlying causes of death and demographic factors impacted on initial access and subsequent pathways of care. Managing more unscheduled care episodes in the community has the potential to reduce hospital admissions and overall costs.
T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX)
Authors: Thille Arnaud W , Coudroy Rémi , Gacouin Arnaud , Ehrmann Stephan , Contou Damien , Dangers Laurence , Romen Antoine , Guitton Christophe , Lacave Guillaume , Quenot Jean-Pierre , Lacombe Béatrice , Pradel Gael , Terzi Nicolas , Prat Gwenael , Labro Guylaine , Reignier Jean , Beduneau Gaetan , Dellamonica Jean , Nay Mai-Anh , Rouze Anahita , Delbove Agathe , Sedillot Nicholas , Mira Jean-Paul , Bourenne Jeremy , Lautrette Alexandre , Argaud Laurent , Levrat Quentin , Devaquet Jérôme , Vivier Emmanuel , Azais Marie-Ange , Leroy Christophe , Dres Martin , Robert René , Ragot Stéphanie , Frat Jean-Pierre
Published: November 2020

Introduction

In intensive care unit (ICU), the decision of extubation is a critical time because mortality is particularly high in case of reintubation. To reduce that risk, guidelines recommend to systematically perform a spontaneous breathing trial (SBT) before extubation in order to mimic the postextubation physiological conditions. SBT is usually performed with a T-piece disconnecting the patient from the ventilator or with low levels of pressure-support ventilation (PSV). However, work of breathing is lower during PSV than during T-piece. Consequently, while PSV trial may hasten extubation, it may also increase the risk of reintubation. We hypothesise that, compared with T-piece, SBT performed using PSV may hasten extubation without increasing the risk of reintubation.

Methods and analysis

This study is an investigator-initiated, multicentre randomised controlled trial comparing T-piece vs PSV for SBTs in patients at high risk of reintubation in ICUs. Nine hundred patients will be randomised with a 1:1 ratio in two groups according to the type of SBT. The primary outcome is the number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation between the initial SBT (day 1) and day 28. Secondary outcomes include the number of days between the initial SBT and the first extubation attempt, weaning difficulty, the number of patients extubated after the initial SBT and not reintubated within the following 72 hours, the number of patients extubated within the 7 days following the initial SBT, the number of patients reintubated within the 7 days following extubation, in-ICU length of stay and mortality in ICU, at day 28 and at day 90.

Ethics and dissemination

The study has been approved by the central ethics committee ‘Ile de France V’ (2019-A02151-56) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT04227639.
Household medication safety practices during the COVID-19 pandemic: a descriptive qualitative study protocol
Authors: Grimes Tamasine C , Garfield Sara , Kelly Dervla , Cahill Joan , Cromie Sam , Wheeler Carly , Franklin Bryony Dean
Published: November 2020

Introduction

Those who are staying at home and reducing contact with other people during the COVID-19 pandemic are likely to be at greater risk of medication-related problems than the general population. This study aims to explore household medication practices by and for this population, identify practices that benefit or jeopardise medication safety and develop best practice guidance about household medication safety practices during a pandemic, grounded in individual experiences.

Methods and analysis

This is a descriptive qualitative study using semistructured interviews, by telephone or video call. People who have been advised to ‘cocoon’/‘shield’ and/or are aged 70 years or over and using at least one long-term medication, or their caregivers, will be eligible for inclusion. We will recruit 100 patient/carer participants: 50 from the UK and 50 from Ireland. Recruitment will be supported by our patient and public involvement (PPI) partners, personal networks and social media. Individual participant consent will be sought, and interviews audio/video recorded and/or detailed notes made. A constructivist interpretivist approach to data analysis will involve use of the constant comparative method to organise the data, along with inductive analysis. From this, we will iteratively develop best practice guidance about household medication safety practices during a pandemic from the patient’s/carer’s perspective.

Ethics and dissemination

This study has Trinity College Dublin, University of Limerick and University College London ethics approvals. We plan to disseminate our findings via presentations at relevant patient/public, professional, academic and scientific meetings, and for publication in peer-reviewed journals. We will create a list of helpful strategies that participants have reported and share this with participants, PPI partners and on social media.
Revived call for consensus in the future of psychotherapy
Authors: Gaines Averi N , Goldfried Marvin R , Constantino Michael J
Published: November 2020

The emblem of success in psychotherapy research and practice has long been innovation. Although such ingenuity is commendable, it has nonetheless perpetuated fragmentation across the field. At least four decades ago, it was suggested that achieving consensus on what constitutes psychotherapy’s theoretical, empirical, and practical ‘core’ might allow the discipline to evolve beyond its siloed state, as is reflective of mature science. Yet, division remains the rule versus exception, owing in large part to power struggles among disparate schools of therapy and quarrels over whether theory-specific or theory-common factors most account for therapeutic change. We outline here a vision for psychotherapy’s future that is defined by consensus rather than disintegration. Namely, we reiterate the need for the field to invest in clinical strategies that transcend ostensibly incompatible theoretical models. We also argue that psychotherapy research should build on the growing evidence for such clinical strategies in an effort to establish core, evidence-based principles of therapeutic change. We then discuss how establishing consensus will require reconciliation among the mounting evidence for flexible, principle-informed practice with the current realities of training, dissemination, and implementation paradigms. Finally, we articulate ways in which practicing clinicians will serve a vital role in carrying out, and amending as needed, actionable efforts toward psychotherapy consensus.
Computational modelling suggests that Barrett’s oesophagus may be the precursor of all oesophageal adenocarcinomas
Authors: Curtius Kit , Rubenstein Joel H , Chak Amitabh , Inadomi John M
Published: November 2020

Objective

Barrett’s oesophagus (BE) is a known precursor to oesophageal adenocarcinoma (OAC) but current clinical data have not been consolidated to address whether BE is the origin of all incident OAC, which would reinforce evidence for BE screening efforts. We aimed to answer whether all expected prevalent BE, diagnosed and undiagnosed, could account for all incident OACs in the US cancer registry data.

Design

We used a multiscale computational model of OAC that includes the evolutionary process from normal oesophagus through BE in individuals from the US population. The model was previously calibrated to fit Surveillance, Epidemiology and End Results cancer incidence curves. Here, we also utilised age-specific and sex-specific US census data for numbers at-risk. The primary outcome for model validation was the expected number of OAC cases for a given calendar year. Secondary outcomes included the comparisons of resulting model-predicted prevalence of BE and BE-to-OAC progression to the observed prevalence and progression rates.

Results

The model estimated the total number of OAC cases from BE in 2010 was 9970 (95% CI: 9140 to 11 980), which recapitulates nearly all OAC cases from population data. The model simultaneously predicted 8%–9% BE prevalence in high-risk males age 45–55, and 0.1%–0.2% non-dysplastic BE-to-OAC annual progression in males, consistent with clinical studies.

Conclusion

There are likely few additional OAC cases arising in the US population outside those expected from individuals with BE. Effective screening of high-risk patients could capture the majority of population destined for OAC progression and potentially decrease mortality through early detection and curative removal of small (pre)cancers during surveillance.
Initial study of anaemia profile for primary care centres with automated laboratory algorithms reduces the demand for ferritin, iron, transferrin, vitamin B12and folate tests
Authors: Furundarena J R , Uranga Alasne , González Carmen , Martínez Bruno , Iriondo June , Ondarra Laida , Arambarri Amaia , San Vicente Ricardo , Sarasqueta Cristina , Lombardi Clara , Altuna Ane , Rois Nicolas
Published: November 2020

Aim

To evaluate the influence of an algorithm designed to incorporate reflex testing according to haemogram results for analytical tests ordered to investigate anaemia.

Methods

In 2020, a new request for ‘initial study of anaemia’ was created in three primary care pilot centres for suspected anaemia or new anaemias. A haemogram was ordered and the remainder of the tests were created in a reflex manner according to an algorithm integrated in the laboratory information system that also generates a comment that is completed and validated by a haematologist. The demand for tests was evaluated over three time periods.

Results

Of 396 requests, anaemia was detected in 80 (20.2%), with 26 microcytic anaemias (6.57%), 20 iron deficiency anaemias, 41 (10.3%) normocytic anaemias and 13 macrocytic anaemias (3.28%); 4 with folate deficiency; and 1 haemolytic anaemia. No haematological diseases were detected. Twenty-four (6.06%) cases exhibited microcytosis/hypochromia without anaemia, 12 of which exhibited iron deficiency. Four young women exhibiting within-limit haemoglobin levels had iron deficiency. There were 56 (14.1%) cases of macrocytosis without anaemia.

With the new profile of ‘initial study of anaemia’, the demand for tests was reduced and was significantly lower than in the remainder of primary centres for iron, transferrin, ferritin, vitamin B12and folate.

Conclusions

A new profile of ‘initial study of anaemia’ in the request form with algorithms integrated in the laboratory information system enabled submission of orders and decreased the demand for unnecessary iron, transferrin, ferritin, vitamin B12and folate tests.