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Mapping the characteristics, concepts and methodologies of matching-adjusted indirect comparison studies assessing pharmacological therapies in oncology: a scoping review protocol

Por: Farinasso · C. M. · Rocha · A. P. · Medeiros · F. C. · Marra · L. P. · Silva Parreira · P. C. · Oliveira · L. A. · Ferreira · V. L. · Lucchetta · R. C. · De Oliveira Junior · H. A.
Introduction

Matching-adjusted indirect comparison (MAIC) studies are a subtype of indirect comparison, which uses propensity score weighting to enhance comparability. This method adjusts aggregated data based on covariables from individual patient data from studies to produce population-adjusted indirect comparisons. Some national Health Technology Assessment agencies have recently received submissions containing MAIC models. However, there can be a lack of confidence in its estimates when they are poorly reported and inconsistent with other techniques. The objective of this study is to map the characteristics, concepts and methodology of MAIC studies used for pharmacological therapies in the field of oncology.

Methods and analysis

A scoping review methodology will be applied following the Joanna Briggs Institute framework and the results will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews. Studies that used MAIC to compare treatments in oncology conditions will be considered eligible. A systematic search will be conducted in PubMed, Embase and the Cochrane Library. No restriction of location or language will be applied. Study screening will be documented and presented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow diagram. Data will be extracted and recorded on a predefined data form and will be presented in a tabular form accompanied by a descriptive summary.

Ethics and dissemination

No ethical approval is required for this study. The results of this scoping review will be disseminated through peer-reviewed publications.

Characteristics of RCTs focusing on health promotion in community samples: a scoping review protocol based on the d-CoSPICO framework

Introduction

Developing the capabilities of individuals, groups and communities to enhance their health has received a great deal of attention in the literature. One essential source of results is evidence-based intervention programmes, which often involve a number of different variables. This paper describes a methodology for carrying out a scoping review that maps available evidence on randomised controlled trials focusing on health promotion intervention programmes.

Methods and analysis

The scoping review protocol follows the general Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Joanna Briggs Institute guidelines. It also incorporates some modifications to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review flowchart and complements its methodological framework. This new format, called documents, Concept, Studies, Participants, Interventions, Comparator, and Outcomes (d-CoSPICO), guides the review sequence, which is represented in a flowchart. The search will focus on different sources of information using formal (searches in thematic –PubPsych, ERIC, MedLine, PsychINFO– and multidisciplinary databases –Academic Search Ultimate, Core Collection Web of Science, Scopus and ProQuest–, repositories and other websites), informal (contact with researchers), and retrospective (previous reviews on this topic) strategies to identify relevant publications until 2021, including grey literature. Coding, identification, selection, and data extraction will be carried out following the generation of a database in which each retrieved record’s content (abstract and/or full text) can be analysed. The review is expected to be completed in 2023.

Ethics and dissemination

Ethical approval is not required for this review. The d-CoSPICO framework and the results will be disseminated through (a) peer-reviewed publications; (b) presentations at scientific dissemination events and (c) training activities for applying this protocol.

Well-being and flourishing mental health in adults with inflammatory bowel disease, multiple sclerosis and rheumatoid arthritis in Manitoba, Canada: a cross-sectional study

Objectives

Among people with immune-mediated inflammatory disease (IMID), including multiple sclerosis (MS), inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) most research has focused on mental illness rather than on mental health. We assessed dimensions of mental health among persons with IMID and compared them across IMID. We also evaluated demographic and clinical characteristics associated with flourishing mental health.

Design

Participants: Adults with an IMID (MS, 239; IBD, 225; RA 134; total 598) who were participating in a cohort study.

Setting

Tertiary care centre in Manitoba, Canada.

Primary outcome measure

Participants completed the Mental Health Continuum Short-Form (MHC-SF), which measures emotional, psychological and social well-being, and identifies flourishing mental health. This outcome was added midway through the study on the advice of the patient advisory group. Depression, anxiety, pain, fatigue and physical function were also assessed.

Results

Total MHC-SF and subscale scores were similar across IMID groups. Nearly 60% of participants were considered to have flourishing mental health, with similar proportions across disease types (MS 56.5%; IBD 58.7%; RA 59%, p=0.95). Older age was associated with a 2% increased odds of flourishing mental health per year of age (OR 1.02; 95% CI: 1.01 to 1.04). Clinically meaningful elevations in anxiety (OR 0.25; 95% CI: 0.12 to 0.51) and depressive symptoms (OR 0.074; 95% CI: 0.009 to 0.61) were associated with lower odds. Higher levels of pain, anxiety and depressive symptoms were associated with lower total Mental Health Continuum scores at the 50th quantile.

Conclusions

Over half of people with MS, IBD and RA reported flourishing mental health, with levels similar across the disease groups. Interventions targeting symptoms of depression and anxiety, and upper limb impairments, as well as resilience training may help a higher proportion of the IMID population achieve flourishing mental health.

Known groups validity of the SPARK36: To guide nurse‐led consultations for the early detection of child developmental and parenting problems

Abstract

Aim

Early detection of child developmental and parenting problems is important for timely prevention. The SPARK36 (Structured Problem Analysis of Raising Kids aged 36 months) is a novel broad-scope structured interview guide aimed at assessing parenting concerns and needs for support for child developmental and parenting problems, using the parental and professional's (Youth Health Care nurses) perspective. The applicability of the SPARK36 in practice was already demonstrated. Our aim was to evaluate its known groups validity.

Desing/Methods

SPARK36 data were collected in a cross-sectional study in 2020–2021. The known groups validity was assessed by testing two hypotheses: the SPARK36 risk assessment shows a higher risk of parenting and child developmental problems in children (1) from parents with a lower socioeconomic status and (2) from families with ≥4 risk factors for child maltreatment. To test the hypotheses, Fisher's exact tests were applied.

Results

In total, 29 Youth Health Care nurses from four School Health Services performed SPARK36-led consultations with 599 parent–child pairs to assess the risk for child developmental and parenting problems. Both hypotheses were accepted at a significant p level.

Conclusion

The results of the known groups validity support the hypothesis that the SPARK36 risk assessment for child developmental and parenting problems is carried out in a valid way. Future research is needed to assess other aspects of the validity and reliability of the SPARK36.

Impact

This is a first step in validating the instrument for use during a nurse-led consultation with parents of 3-year-olds in Flemish School Health Services. Thereby, SPARK36 supports the nurses in accomplishing their assignment, making a risk assessment, and contributes to quality of care.

Patient or Public Contribution

This study aimed to evaluate the known groups validity of the SPARK36. Therefore, it was not conducted using input from the public or the patient population.

Experience of loneliness during the COVID-19 pandemic: a cross-sectional study of 50 968 adult Danes

Por: Christoffersen · L. A. · Helenius · D. · Schwinn · M. · Erikstrup · C. · Hjalgrim · H. · Nissen · J. · Banasik · K. · Nielsen · K. · Kaspersen · K. A. · Dinh · K. M. · Bruun · M. T. · Ostrowski · S. R. · Saekmose · S. · Hansen · T. F. · Werge · T. · Didriksen · M. · Pedersen · O. B.
Objectives

To examine the level of loneliness experienced during the COVID-19 pandemic in Denmark and to identify associated behavioural patterns and demographic factors.

Design

Cross-sectional cohort study.

Setting

Includes Danish active and former blood donors.

Participants

A questionnaire was sent to 124 307 active and former blood donors, of these a total of 50 968 participants completed the study questionnaire (response rate=41%).

Primary and secondary outcome measures

Subjective experience of loneliness was measured using the 3-item University of California, Los Angeles Loneliness Scale (UCLA-3). Besides the UCLA-3, the respondents answered items on sociodemographic and economic characteristics, items on precautionary measures taken to avoid COVID-19 infection as well as on COVID-19 anxiety.

Results

The participants indicated their experienced level of loneliness both before and during the pandemic. Comparing the two reports yielded a mean increase in loneliness scores of 14.1% (pwell-being, which comprised three questionnaire items related to emotional heath, physical health and happiness. A high score on the factor well-being was associated with reduced levels of loneliness (coefficient=–0.47, 95% CI –0.49 to –0.46)). Furthermore, women were more likely than men to have experienced increased levels of loneliness during the pandemic (coefficient=0.27, 95% CI 0.25 to 0.29). Furthermore, a negative correlation between higher age and change in loneliness score was observed.

Conclusions

The findings document an increase in the level of experienced loneliness during the COVID-19 pandemic, particularly affecting individuals with low well-being, women and younger individuals.

Self-reported sexually transmitted infections among adolescent girls and young women in Mali: analysis of prevalence and predictors

Por: Appiah · C. K. · Dowou · R. K. · Balame · S. K. · Adzigbli · L. A. · Yeboah · P. A. · Aboagye · R. G. · Cadri · A.
Objective

To examine the prevalence and predictors of self-reported sexually transmitted infections (SR-STIs) among adolescent girls and young women in Mali.

Design

We performed a cross-sectional analysis of data from the Demographic and Health Survey of Mali, which was conducted in 2018. A weighted sample of 2105 adolescent girls and young women aged 15–24 was included. Percentages were used to summarise the results of the prevalence of SR-STIs. We used a multilevel binary logistic regression analysis to examine the predictors of SR-STIs. The results were presented using an adjusted odds ratio (aOR) with 95% confidence interval (CI). Statistical significance was set at p

Setting

Mali.

Participants

Adolescent girls (15–19 years) and young women (20–24 years).

Outcome measure

SR-STIs.

Results

The prevalence of SR-STIs among the adolescent girls and young women was 14.1% (95% CI=12.3 to 16.2). Adolescent girls and young women who had ever tested for HIV, those with one parity, those with multiparity, those with two or more sexual partners, those residing in urban areas, and those exposed to mass media were more likely to self-report STIs. However, those residing in Sikasso and Kidal regions were less likely to report STIs.

Conclusion

Our study has shown that SR-STIs are prevalent among adolescent girls and young women in Mali. Health authorities in Mali and other stakeholders should formulate and implement policies and programmes that increase health education among adolescent girls and young women and encourage free and easy access to STI prevention and treatment services.

Cohort profile: Netherlands Longitudinal Study on Hearing (NL-SH)

Por: van Wier · M. F. · Jansen · L. A. · Goderie · T. · Stam · M. · Nachtegaal · J. · van Beek · J. H. M. · Lemke · U. · Anema · J. R. · Lissenberg-Witte · B. I. · Smits · C. · Kramer · S. E.
Purpose

The Netherlands Longitudinal Study on Hearing (NL-SH) was set up to examine associations of hearing ability with psychosocial, work and health outcomes in working age adults.

Participants

Inclusion started in 2006 and is ongoing. Currently the sample comprises 2800 adults with normal and impaired hearing, aged 18–70 years at inclusion. Five-year follow-up started in 2011, 10-year follow-up in 2016 and 15-year follow-up in 2021. All measurements are web-based. Participants perform a speech-in-noise recognition test to measure hearing ability and fill out questionnaires about their hearing status, hearing aid use, self-reported hearing disability and coping, work status and work-related outcomes (work performance, need for recovery), physical and psychosocial health (depression, anxiety, distress, somatisation, loneliness), healthcare usage, lifestyle (smoking, alcohol), and technology use.

Findings to date

The NL-SH has shown the vast implications of reduced hearing ability for the quality of life and health of working-age adults. A selection of results published in 27 papers is presented. Age-related deterioration of hearing ability accelerates after the age of 50 years. Having a history of smoking is associated with a faster decline in hearing ability, but this relationship is not found for other cardiovascular risk factors. Poorer hearing ability is associated with increased distress, somatisation, depression and loneliness. Adults with impaired hearing ability are more likely to be unemployed or unfit for work, and need more time to recuperate from work effort.

Future plans

Participant data will be linked to a national database to enable research on the association between hearing ability and mortality. Linking to environmental exposure data will facilitate insight in relations between environmental factors, hearing ability and psychosocial outcomes. The unique breadth of the NL-SH data will also allow for further research on other functional problems, for instance, hearing ability and fall risk.

Trial registration number

NL12015.029.06.

Identifying women who may benefit from higher dose omega-3 supplementation during pregnancy to reduce their risk of prematurity: exploratory analyses from the ORIP trial

Por: Yelland · L. N. · Sullivan · T. R. · Gibson · R. A. · Simmonds · L. A. · Thakkar · S. K. · Huang · F. · Devaraj · S. · Best · K. P. · Zolezzi · I. S. · Makrides · M.
Objectives

The risk factors for prematurity are multifactorial and include low omega-3 status. Omega-3 supplementation in pregnancy has been found to reduce prematurity risk, particularly among women with low omega-3 levels. This study aimed to identify maternal characteristics that predict whether women with a singleton pregnancy will benefit from omega-3 supplementation to reduce their risk of prematurity.

Design

Exploratory analyses of a multicentre, double-blind randomised trial.

Setting

6 tertiary care centres in four states in Australia.

Participants

5328 singleton pregnancies in 5305 women recruited before 20 weeks of gestation.

Interventions

Fish oil capsules containing 900 mg omega-3 long-chain polyunsaturated fatty acids per day versus vegetable oil capsules consumed from enrolment until 34 weeks’ gestation.

Outcome measures

Early preterm birth (EPTB,

Results

Omega-3 supplementation reduced the odds of EPTB for women with low total omega-3 status in early pregnancy (OR=0.30, 95% CI 0.10–0.93). No additional maternal characteristics influenced whether omega-3 supplementation reduced the odds of EPTB. For PTB, women were more likely to benefit from omega-3 supplementation if they were multiparous (OR=0.65, 95% CI 0.49–0.87) or avoided alcohol in the lead up to pregnancy (OR=0.62, 95% CI 0.45–0.86).

Conclusions

Our results support previous findings that women with low total omega-3 levels in early pregnancy are most likely to benefit from taking omega-3 supplements to reduce their risk of EPTB. Understanding how other maternal characteristics influence the effectiveness of omega-3 supplementation on reducing PTB requires further investigation.

Trial registration number

ACTRN12613001142729.

Physical performance testing in post-COVID-19 patients: protocol for a systematic review of psychometric measurement properties

Por: Nascimento · L. F. E. d. · Mendes · L. A. · Torres-Castro · R. · Fregonezi · G. A. · Gimeno-Santos · E. · Vilaro · J. · Resqueti · V. R.
Introduction

COVID-19 is an infectious disease that causes severe acute respiratory syndrome. A large variety of exercise capacity tests are used for the evaluation of post-COVID-19 patients, but the psychometric properties of these exercise tests remain undetermined in this population. This study aims to critically appraise, compare and summarise the psychometric properties (validity, reliability and responsiveness) of all physical performance tests that are used to assess exercise capacity in post-COVID-19 patients.

Methods and analysis

This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will include studies with hospitalised adult post-COVID-19 patients (aged 18 years or older and with a confirmed diagnosis of COVID-19). The research will cover randomised controlled trials (RCTs), quasi-RCTs and observational studies published in English and performed in the following settings: hospital, rehabilitation centre, outpatient clinic. We will search the following databases with no date restrictions: PubMed/MEDLINE, EMBASE, SciELO, Cochrane Library, CINAHL and Web of Science. Two authors will independently assess the risk of bias (using the Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of bias checklist) and the certainty of evidence (using the Grading of Recommendations, Assessment, Development and Evaluations). According to the results obtained, data will be meta-analysed or reported narratively.

Ethics and dissemination

No ethical approval is required for this publication since it will be based on published data. Results of this review will be disseminated via peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42021242334.

HIV testing and counselling among women in Benin: a cross-sectional analysis of prevalence and predictors from demographic and health survey data

Por: Adu · C. · Adzigbli · L. A. · Cadri · A. · Yeboah · P. A. · Mohammed · A. · Aboagye · R. G.
Objective

To examine the uptake of HIV testing and counselling (HTC) and its associated factors among women in Benin.

Design

We performed a cross-sectional analysis of data from the 2017–2018 Benin Demographic and Health Survey. A weighted sample of 5517 women was included in the study. We used percentages to present the results of the uptake of HTC. Multilevel binary logistic regression analysis was used to examine the predictors of HTC uptake. The results were presented using adjusted odds ratios (aORs), with 95% confidence intervals (CIs).

Setting

Benin.

Participants

Women aged 15–49.

Outcome measure

Uptake of HTC.

Results

The overall uptake of HTC among women in Benin was found to be 46.4% (44.4%–48.4%). The odds of HTC uptake was higher among women covered by health insurance (aOR 3.04, 95% CI 1.44 to 6.43) and those with comprehensive HIV knowledge (aOR 1.77, 95% CI 1.43 to 2.21). The odds of HTC uptake increased with increasing level of education, with the highest odds among those in the secondary or higher level (aOR 2.06, 95% CI 1.64 to 2.61). Also, the age of the women, mass media exposure, region of residence, high community literacy level, and high community socioeconomic status were associated with higher odds of HTC uptake. Women residing in rural areas were less likely to use HTC. Religious affiliation, number of sexual partners, and place of residence were associated with lower odds of HTC uptake.

Conclusion

Our study has shown that the uptake of HTC among women in Benin is relatively low. There is a need to enhance efforts to empower women, as well as reduce health inequities as they all have a substantial impact on HTC uptake among women in Benin, taking into consideration the factors identified in this study.

Monitoring SARS-CoV-2 incidence and seroconversion among university students and employees: a longitudinal cohort study in California, June-August 2020

Por: Hunter · L. A. · Wyman · S. · Packel · L. J. · Facente · S. N. · Li · Y. · Harte · A. · Nicolette · G. · the IGI SARS-CoV-2 Testing Consortium · Di Germanio · C. · Busch · M. P. · Reingold · A. L. · Petersen · M. L. · Urnov · McDevitt · Hirsch · Ehrenberg · Doudna · Amen · Barry · Bo
Objectives

To identify incident SARS-CoV-2 infections and inform effective mitigation strategies in university settings, we piloted an integrated symptom and exposure monitoring and testing system among a cohort of university students and employees.

Design

Prospective cohort study.

Setting

A public university in California from June to August 2020.

Participants

2180 university students and 738 university employees.

Primary outcome measures

At baseline and endline, we tested participants for active SARS-CoV-2 infection via quantitative PCR (qPCR) test and collected blood samples for antibody testing. Participants received notifications to complete additional qPCR tests throughout the study if they reported symptoms or exposures in daily surveys or were selected for surveillance testing. Viral whole genome sequencing was performed on positive qPCR samples, and phylogenetic trees were constructed with these genomes and external genomes.

Results

Over the study period, 57 students (2.6%) and 3 employees (0.4%) were diagnosed with SARS-CoV-2 infection via qPCR test. Phylogenetic analyses revealed that a super-spreader event among undergraduates in congregate housing accounted for at least 48% of cases among study participants but did not spread beyond campus. Test positivity was higher among participants who self-reported symptoms (incidence rate ratio (IRR) 12.7; 95% CI 7.4 to 21.8) or had household exposures (IRR 10.3; 95% CI 4.8 to 22.0) that triggered notifications to test. Most (91%) participants with newly identified antibodies at endline had been diagnosed with incident infection via qPCR test during the study.

Conclusions

Our findings suggest that integrated monitoring systems can successfully identify and link at-risk students to SARS-CoV-2 testing. As the study took place before the evolution of highly transmissible variants and widespread availability of vaccines and rapid antigen tests, further research is necessary to adapt and evaluate similar systems in the present context.

Innovative models of healthcare delivery: an umbrella review of reviews

Por: Roberts · N. · Carrigan · A. · Clay-Williams · R. · Hibbert · P. D. · Mahmoud · Z. · Pomare · C. · Fajardo Pulido · D. · Meulenbroeks · I. · Knaggs · G. T. · Austin · E. E. · Churruca · K. · Ellis · L. A. · Long · J. C. · Hutchinson · K. · Best · S. · Nic Giolla Easpaig · B. · Sarkies
Objective

To undertake a synthesis of evidence-based research for seven innovative models of care to inform the development of new hospitals.

Design

Umbrella review.

Setting

Interventions delivered inside and outside of acute care settings.

Participants

Children and adults with one or more identified acute or chronic health conditions.

Data sources

PsycINFO, Ovid MEDLINE and CINAHL.

Primary and secondary outcome measures

Clinical indicators and mortality, healthcare utilisation, quality of life, self-management and self-care and patient knowledge.

Results

A total of 66 reviews were included, synthesising evidence from 1272 primary studies across the 7 models of care. Virtual care was the most common model studied, addressed by 47 (73%) of the reviews. Common outcomes evaluated across reviews were clinical indicators and mortality, healthcare utilisation, self-care and self-management, patient knowledge, quality of life and cost-effectiveness. The findings indicate that the innovative models of healthcare we identified in this review may be effective in managing patients with a range of acute and chronic conditions. Most of the included reviews reported evidence of comparable or improved care.

Conclusions

A consideration of local infrastructure and individual patient characteristics, such as health literacy, may be critical in determining the suitability of models of care for patients and their implementation in local health systems.

Trial registration number

10.17605/OSF.IO/PS6ZU.

Evaluating the implementation of community engagement guidelines (EVALUA GPS project): a study protocol

Por: Cassetti · V. · Lopez-Ruiz · M. V. · Dominguez · M. · Gallego-Royo · A. · Garcia · A. M. · Gea-Caballero · V. · Nunez · C. · Paredes-Carbonell · J. J. · Perula-De Torres · L. A. · Pola-Garcia · M. · EvaluAGPS Research Group · Benede Azagra · C. B. · Susana · Pilar · Dory · Pilar
Introduction

The EVALUA GPS project aims to evaluate the impact of the implementation of the National Institute for Health Care and Excellence (NICE) guideline ‘Community engagement: improving health and well-being and reducing health inequalities’ adapted to the Spanish context.

Methods and analysis

Phase I: A tool will be designed to evaluate the impact of implementing the recommendations of the adapted NICE guideline. The tool will be developed through a review of the literature on implementation of public health guidelines between 2000 and 2021 and an expert’s panel consensus. Phase II: The developed tool will be implemented in 16 community-based programmes, acting as intervention sites, and 4 controls through a quasi-experimental pre–post study. Phase III: A final online web tool, based on all previously collected information, will be developed to support the implementation of the adapted NICE guidelines recommendations in other contexts and programmes.

Data collection and analysis

Data will be collected through surveys and semistructured interviews. Quantitative and qualitative data will be analysed to identify implementation scenarios, changes in community engagement approaches, and barriers and facilitators to the implementation of the recommendations. All this information will be further synthesised to develop the online tool.

Ethics and dissemination

The proposed research has been approved by the Clinical Research Ethics Committee of Aragon. Results will be presented at national and international conferences and published in peer-reviewed open access journals. The interactive online tool (phase III) will include examples of its application from the fieldwork.

Protocol for an OpenSAFELY cohort study collecting patient-reported outcome measures using the TPP Airmid smartphone application and linked big data to quantify the health and economic costs of long COVID (OpenPROMPT)

Por: Herrett · E. · Tomlin · K. · Lin · L.-Y. · Tomlinson · L. A. · Jit · M. · Briggs · A. · Marks · M. · Sandmann · F. · Parry · J. · Bates · C. · Morley · J. · Bacon · S. · Butler-Cole · B. · Mahalingasivam · V. · Dennison · A. · Smith · D. · Gabriel · E. · Mehrkar · A. · Goldacre · B. · Smeeth
Introduction

The impact of long COVID on health-related quality of-life (HRQoL) and productivity is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS) and society, so that strategies like booster vaccines can be prioritised to the right people. OpenPROMPT aims to understand the impact of long COVID on HRQoL in adults attending English primary care.

Methods and analysis

We will ask people to participate in this cohort study through a smartphone app (Airmid), and completing a series of questionnaires held within the app. Questionnaires will ask about HRQoL, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for 90 days. Questionnaire responses will be linked, where possible, to participants’ existing health records from primary care, secondary care, and COVID testing and vaccination data. Analysis will take place using the OpenSAFELY data platform and will estimate the impact of long COVID on HRQoL, productivity and cost to the NHS.

Ethics and dissemination

The Proportionate Review Sub-Committee of the South Central—Berkshire B Research Ethics Committee has reviewed and approved the study and have agreed that we can ask people to take part (22/SC/0198). Our results will provide information to support long-term care, and make recommendations for prevention of long COVID in the future.

Trial registration number

NCT05552612.

Developing a machine learning algorithm to predict probability of retear and functional outcomes in patients undergoing rotator cuff repair surgery: protocol for a retrospective, multicentre study

Introduction

The effectiveness of rotator cuff tear repair surgery is influenced by multiple patient-related, pathology-centred and technical factors, which is thought to contribute to the reported retear rates between 17% and 94%. Adequate patient selection is thought to be essential in reaching satisfactory results. However, no clear consensus has been reached on which factors are most predictive of successful surgery. A clinical decision tool that encompassed all aspects is still to be made. Artificial intelligence (AI) and machine learning algorithms use complex self-learning models that can be used to make patient-specific decision-making tools. The aim of this study is to develop and train an algorithm that can be used as an online available clinical prediction tool, to predict the risk of retear in patients undergoing rotator cuff repair.

Methods and analysis

This is a retrospective, multicentre, cohort study using pooled individual patient data from multiple studies of patients who have undergone rotator cuff repair and were evaluated by advanced imaging for healing at a minimum of 6 months after surgery. This study consists of two parts. Part one: collecting all potential factors that might influence retear risks from retrospective multicentre data, aiming to include more than 1000 patients worldwide. Part two: combining all influencing factors into a model that can clinically be used as a prediction tool using machine learning.

Ethics and dissemination

For safe multicentre data exchange and analysis, our Machine Learning Consortium adheres to the WHO regulation ‘Policy on Use and Sharing of Data Collected by WHO in Member States Outside the Context of Public Health Emergencies’. The study results will be disseminated through publication in a peer-reviewed journal. Institutional Review Board approval does not apply to the current study protocol.

FLUID trial: a hospital-wide open-label cluster cross-over pragmatic comparative effectiveness randomised pilot trial comparing normal saline to Ringers lactate

Por: McIntyre · L. A. · Fergusson · D. A. · McArdle · T. · Fox-Robichaud · A. · English · S. W. · Martin · C. · Marshall · J. · Cook · D. J. · Graham · I. D. · Hawken · S. · McCartney · C. · Menon · K. · Saginur · R. · Seely · A. · Stiell · I. · Thavorn · K. · Weijer · C. · Iyengar · A. · Musce
Objectives

Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important outcomes. We conducted a pilot trial to explore the feasibility of a large trial powered for clinically important outcomes.

Design

FLUID was a pragmatic pilot cluster randomised cross-over trial.

Setting

Four hospitals in the province of Ontario, Canada

Participants

All hospitalised adult and paediatric patients with an incident admission to the hospital over the course of each study period.

Interventions

A hospital wide policy/strategy which stocked either NS or RL throughout the hospital for 12 weeks before crossing over to the alternate fluid for the subsequent 12 weeks.

Primary and secondary outcome measures

The primary feasibility outcome was study fluid protocol adherence. Secondary feasibility outcomes included time to Research Ethics Board (REB) approval and trial initiation. Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes were analysed descriptively.

Results

Among 24 905 included patients, mean age 59.1 (SD 20.5); 13 977 (56.1%) were female and 21 150 (85.0%) had medical or surgical admitting diagnoses. Overall, 96 821 L were administered in the NS arm, and 78 348 L in the RL arm. Study fluid adherence to NS and RL was 93.7% (site range: 91.6%–98.0%) and 79.8% (site range: 72.5%–83.9%), respectively. Time to REB approval ranged from 2 to 48 days and readiness for trial initiation from 51 to 331 days. 5544 (22.3%) patients died or required hospital re-admission in the first 90 days.

Conclusions

The future large trial is feasible. Anticipating and addressing logistical challenges during the planning stages will be imperative.

Trial registration number

NCT02721485.

Body mass index, waist circumference and pre-frailty/frailty: the Tromso study 1994-2016

Por: Uchai · S. · Andersen · L. F. · Hopstock · L. A. · Hjartaker · A.
Objective

This study investigated the association between obesity, assessed using body mass index (BMI) and waist circumference (WC), and pre-frailty/frailty among older adults over 21 years of follow-up.

Design

Prospective cohort study.

Setting

Population-based study among community-dwelling adults in Tromsø municipality, Norway.

Participants

2340 women and 2169 men aged ≥45 years attending the Tromsø study in 1994–1995 (Tromsø4) and 2015–2016 (Tromsø7), with additional BMI and WC measurements in 2001 (Tromsø5) and 2007–2008 (Tromsø6).

Primary outcome measure

Physical frailty was defined as the presence of three or more and pre-frailty as the presence of one to two of the five frailty components suggested by Fried et al: low grip strength, slow walking speed, exhaustion, unintentional weight loss and low physical activity.

Results

Participants with baseline obesity (adjusted OR 2.41, 95% CI 1.93 to 3.02), assessed by BMI, were more likely to be pre-frail/frail than those with normal BMI. Participants with high (OR 2.14, 95% CI 1.59 to 2.87) or moderately high (OR 1.57, 95% CI 1.21 to 2.03) baseline WC were more likely to be pre-frail/frail than those with normal WC. Those at baseline with normal BMI but moderately high/high WC or overweight with normal WC had no significantly increased odds for pre-frailty/frailty. However, those with both obesity and moderately high/high WC had increased odds of pre-frailty/frailty. Higher odds of pre-frailty/frailty were observed among those in ‘overweight to obesity’ or ‘increasing obesity’ trajectories than those with stable normal BMI. Compared with participants in a stable normal WC trajectory, those with high WC throughout follow-up were more likely to be pre-frail/frail.

Conclusion

Both general and abdominal obesity, especially over time during adulthood, is associated with an increased risk of pre-frailty/frailty in later years. Thus maintaining normal BMI and WC throughout adult life is important.

Understanding COVID-19 reporting behaviour to support political decision-making: a retrospective cross-sectional study of COVID-19 data reported to WHO

Por: Abbood · A. · Ullrich · A. · Denkel · L. A.
Objective

Daily COVID-19 data reported by WHO may provide the basis for political ad hoc decisions including travel restrictions. Data reported by countries, however, are heterogeneous and metrics to evaluate its quality are scarce. In this work, we analysed COVID-19 case counts provided by WHO and developed tools to evaluate country-specific reporting behaviours.

Methods

In this retrospective cross-sectional study, COVID-19 data reported daily to WHO from 3 January 2020 until 14 June 2021 were analysed. We proposed the concepts of binary reporting rate and relative reporting behaviour and performed descriptive analyses for all countries with these metrics. We developed a score to evaluate the consistency of incidence and binary reporting rates. Further, we performed spectral clustering of the binary reporting rate and relative reporting behaviour to identify salient patterns in these metrics.

Results

Our final analysis included 222 countries and regions. Reporting scores varied between –0.17, indicating discrepancies between incidence and binary reporting rate, and 1.0 suggesting high consistency of these two metrics. Median reporting score for all countries was 0.71 (IQR 0.55–0.87). Descriptive analyses of the binary reporting rate and relative reporting behaviour showed constant reporting with a slight ‘weekend effect’ for most countries, while spectral clustering demonstrated that some countries had even more complex reporting patterns.

Conclusion

The majority of countries reported COVID-19 cases when they did have cases to report. The identification of a slight ‘weekend effect’ suggests that COVID-19 case counts reported in the middle of the week may represent the best data basis for political ad hoc decisions. A few countries, however, showed unusual or highly irregular reporting that might require more careful interpretation. Our score system and cluster analyses might be applied by epidemiologists advising policy makers to consider country-specific reporting behaviours in political ad hoc decisions.

Drivers of healthcare costs in patients with ischaemic stroke: a hospital-based retrospective cohort study

Por: Mensing · L. A. · Kappelle · L. J. · Koffijberg · H. · Ruigrok · Y. M.
Objectives

To evaluate how costs of healthcare can be reduced, there is an increasing need to gain insight into the main drivers of such costs. We evaluated drivers of costs of predefined subgroups of patients who had a stroke by linking cost registration with clinical data.

Methods

We retrospectively selected 555 consecutive patients with ischaemic stroke participating between June 2011 and December 2016 in the Dutch Parelsnoer Initiative. Patient characteristics and costs of healthcare activities during hospital admission and the first 3 months after discharge were linked. Patients were divided in subgroups based on age, severity of stroke, stroke subtype, discharge destination and functional outcome. Unit cost per healthcare activity was based on 2018 rates for mutual service in euros. Mean total costs per subgroup were calculated. Multivariate analysis was performed to identify factors associated with costs.

Results

Number of admitted days was the main driver of total hospital costs (range 82%–93%) in all predefined subgroups of patients. Second driver was radiological diagnostic investigations (range 2%–9%). Highest costs were observed in patients with a younger age at the time of admission, a higher modified Rankin Scale at the time of discharge and a nursing home as discharge destination. The distribution of costs over the different healthcare activities was associated with stroke subtype; for example, in patients with a cardiac embolism most costs were spent on cardiology-related healthcare activities.

Conclusion

The number of admitted days was the most important driver of costs in all subgroups of patients with ischaemic stroke. This implicates that to reduce healthcare costs for patients who had a stroke, focus should be on reducing length of hospital stay.

Engagement with healthcare providers and healthcare system navigation among Australians with chronic conditions: a descriptive survey study

Por: Zurynski · Y. · Ellis · L. A. · Pomare · C. · Meulenbroeks · I. · Gillespie · J. · Root · J. · Ansell · J. · Holt · J. · Wells · L. · Braithwaite · J.
Objectives

With the rate of chronic conditions increasing globally, it is important to understand whether people with chronic conditions have the capacity to find the right care and to effectively engage with healthcare providers to optimise health outcomes.

We aimed to examine associations between care navigation, engagement with health providers and having a chronic health condition among Australian adults.

Design and Setting

This is a cross-sectional, 39-item online survey including the navigation and engagement subscales of the Health Literacy Questionnaire, completed in December 2018, in Australia. Binary variables (low/high health literacy) were created for each item and navigation and engagement subscale scores. Logistic regression analyses (estimating ORs) determined the associations between having a chronic condition and the navigation and engagement scores, while controlling for age, gender, level of education and income.

Participants

1024 Australians aged 18–88 years (mean=46.6 years; 51% female) recruited from the general population.

Results

Over half (n=605, 59.0%) of the respondents had a chronic condition, mostly back pain, mental disorders, arthritis and asthma. A greater proportion of respondents with chronic conditions had difficulty ensuring that healthcare providers understood their problems (32.2% vs 23.8%, p=0.003), having good discussions with their doctors (29.1% vs 23.5%, p=0.05), discussing things with healthcare providers until they understand all they needed (30.5% vs 24.5%, p=0.04), accessing needed healthcare providers (35.7% vs 29.7%, p=0.05), finding the right place to get healthcare services (36.3% vs 29.2%, p=0.02) and services they were entitled to (48.3% vs 40.6%, p=0.02), and working out what is the best healthcare for themselves (34.2% vs 27.7%, p=0.03). Participants with chronic conditions were 1.5 times more likely to have low scores on the engagement (adjusted OR=1.48, p=0.03, 95% CI 1.05 to 2.08) and navigation (adjusted OR=1.43, p=0.026, 95% CI 1.043 to 1.970) subscales after adjusting for age, gender, income and education.

Conclusion

Upskilling in engagement and communication for healthcare providers and people with chronic conditions is needed. Codesigned, clearly articulated and accessible information about service entitlements and pathways through care should be made available to people with chronic conditions. Greater integration across health services, accessible shared health records and access to care coordinators may improve navigation and engagement.

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