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Multicentre methodological study to create a publicly available score of hospital financial standing in the USA

Por: Zinoviev · R. · Krumholz · H. M. · Ciccarone · R. · Antle · R. · Forman · H. P.
Objectives

To create a straightforward scoring procedure based on widely available, inexpensive financial data that provides an assessment of the financial health of a hospital.

Design

Methodological study.

Setting

Multicentre study.

Participants

All hospitals and health systems reporting the required financial metrics in the USA in 2017 were included for a total of 1075 participants.

Interventions

We examined a list of 232 hospital financial indicators and used existing models and financial literature to select 30 metrics that sufficiently describe hospital operations. In a set of hospital financial data from 2017, we used principal coordinate analysis to assess collinearity among variables and eliminated redundant variables. We isolated 10 unique variables, each assigned a weight equal to the share of its coefficient in a regression onto Moody’s Credit Rating, our predefined gold standard. The sum of weighted variables is a single composite score named the Yale Hospital Financial Score (YHFS).

Primary outcome measures

Ability to reproduce both financial trends from a ‘gold-standard’ metric and known associations with non-fiscal data.

Results

The validity of the YHFS was evaluated by: (1) cross-validating it with previously excluded data; (2) comparing it to existing models and (3) replicating known associations with non-fiscal data. Ten per cent of the initial dataset had been reserved for validation and was not used in creating the model; the YHFS predicts 96.7% of the variation in this reserved sample, demonstrating reproducibility. The YHFS predicts 90.5% and 88.8% of the variation in Moody’s and Standard and Poor’s bond ratings, respectively, supporting its validity. As expected, larger hospitals had higher YHFS scores whereas a greater share of Medicare discharges correlated with lower YHFS scores.

Conclusions

We created a reliable and publicly available composite score of hospital financial stability.

Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

Por: Jaspers · N. E. M. · Visseren · F. L. J. · van der Graaf · Y. · Smulders · Y. M. · Damman · O. C. · Brouwers · C. · Rutten · G. E. H. M. · Dorresteijn · J. A. N.
Objective

To determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.

Design

Hypothesis-blinded, three-armed randomised controlled trial

Setting and participants

303 statin users with stable CVD enrolled in a cohort

Intervention

Participants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).

Outcome

Primary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).

Results

Decisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.

Conclusion

In patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.

Trial registration

NTR6227/NL6080.

Vocational rehabilitation for mental health service users with chronic mental illness in low-income to upper-middle-income countries: a scoping review protocol

Por: Chimara · M. · van Niekerk · L. · van Biljon · H. M.
Introduction

Work is integral to the occupations of human beings and accounts for up to a third of time spent in an average adult life. Occupational therapists play a role in vocational rehabilitation of mental health service users (MHSUs) with the aim of optimising their work participation. It is advisable that occupational therapists providing vocational rehabilitation to MHSUs with chronic mental illness in mental healthcare settings are guided by a practice framework developed for that particular context. This scoping review aims to summarise existing evidence on vocational rehabilitation for MHSUs in low-income to upper-middle-income countries. The findings will inform subsequent phases of research undertaken to formulate a vocational rehabilitation practice framework for MHSUs in Namibia.

Methods and analysis

The scoping review will employ the five stage methodological framework proposed by Arksey and O’Malley. This will be used in conjunction with the Preferred Reporting Items for Systematic Reviews extension for Scoping Reviews (PRISM-ScR) and Joanna Briggs scoping review guidelines. MESH terms, Boolean operators and truncation strategies will be employed for a comprehensive article search in electronic scholarly databases. These databases will include PsycINFO, EBSCOhost, HINARI, Google scholar, Medline, CINAHL, PubMed, Cochrane Library, Scopus, Science Direct and Wiley Online Library. Mendeley and Rayyan, both open source platforms, will be used for title, abstract and full-text screening, as well as data extraction. Data will be sifted and sorted by key categories and themes using a data charting form.

Ethics and dissemination

The scoping review findings will be published in a peer-reviewed journal and presented at local and international conferences. Ethical clearance for this study will not be required as secondary data will be utilised and there are no patients involved.

Trends and geographical variation in population thriving, struggling and suffering across the USA, 2008-2017: a retrospective repeated cross-sectional study

Por: Riley · C. · Herrin · J. · Lam · V. · Hamar · B. · Witters · D. · Liu · D. · Krumholz · H. M. · Roy · B.
Objectives

Well-being is a holistic, positively framed conception of health, integrating physical, emotional, social, financial, community and spiritual aspects of life. High well-being is an intrinsically worthy goal for individuals, communities and nations. Multiple measures of well-being exist, yet we lack information to identify benchmarks, geographical disparities and targets for intervention to improve population life evaluation in the USA.

Design

Using data from the Gallup National Health and Well-Being Index, we conducted retrospective analyses of a series of cross-sectional samples.

Setting/participants

We summarised select well-being outcomes nationally for each year, and by county (n=599) over two time periods, 2008–2012 and 2013–2017.

Main outcome measures

We report percentages of people thriving, struggling and suffering using the Cantril Self-Anchoring Scale, percentages reporting high or low current life satisfaction, percentages reporting high or low future life optimism, and changes in these percentages over time.

Results

Nationally, the percentage of people that report thriving increased from 48.9% in 2008 to 56.3% in 2017 (p

Conclusions

The percentage of the US population thriving increased from 2008 to 2017 while the percentage suffering remained unchanged. Marked geographical variation exists indicating priority areas for intervention.

Association between health behaviours and cardiometabolic dysregulation: a population-based survey among healthy adults in Hong Kong

Por: Yu · E. Y. T. · Yeung · C. H. N. · Wan · E. Y. F. · Tang · E. H. M. · Wong · C. K. H. · Cheung · B. M. Y. · Lam · C. L. K.
Objective

To explore the association between cardiometabolic dysregulation, an integral component of allostatic load, and health risk behaviours (HRBs) of the Hong Kong healthy adult population.

Design

Secondary analysis of cross-sectional anonymous data.

Setting

Data on sociodemographics, self-reported health status, HRBs and biomarkers were extracted from the Hong Kong Population Health Survey 2014/2015.

Participants

One thousand five hundred and fifty-one participants aged 18–64 years without self-reported diagnoses of hypertension, diabetes mellitus, hyperlipidaemia, cardiovascular disease, cognitive impairment or cancer.

Primary outcome measures

Cardiometabolic dysregulation index (CMDI), ranging from 0 to 6, was calculated by counting the number of biomarkers including systolic blood pressure, diastolic blood pressure, waist to hip ratio, glycated haemoglobin, total cholesterol to high-density lipoprotein cholesterol ratio, and triglycerides that were above the respective normal level suggested by international guidelines and literature. HRBs including smoking, dietary habits and sleeping hours were collected by self-report questionnaire. Alcohol consumption was assessed by the 10-item Alcohol Use Disorders Identification Test, while physical activity level was measured using the Global Physical Activity Questionnaire. A composite HRB score, ranging from 0 to 5, was calculated as the cumulative number of HRBs. The effect of HRB on CMDI was evaluated by negative binomial regression with adjustment for socioeconomic status, health awareness and comorbidities of the participants.

Results

The mean CMDI of the studied population was 1.6; 29.5% had a CMDI of 0, whereas 1.5% had a CMDI of 6. Significant difference was observed in mean CMDI between gender and different age groups. Sleeping less than 6 hours (incidence rate ratio (IRR)=1.26, p

Conclusion

Smoking, physical inactivity and inadequate sleep—an essential yet often overlooked health behaviour—were associated with higher CMDI in the Hong Kong healthy adult population.

Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study

Por: Bruhn · S. M. · Ingelsrud · L. H. · Bandholm · T. · Skou · S. T. · Schroder · H. M. · Reventlow · S. · Moller · A. · Kjellberg · J. · Kallemose · T. · Troelsen · A.
Introduction

Knee osteoarthritis (OA) is associated with chronic knee pain and functional disability that negatively affect the ability to carry out normal daily activities. Patients are offered a large variety of non-surgical treatments, often not in accordance with clinical guidelines. This observational study will provide a comprehensive overview of treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon, including timing and order of treatment modalities, predictors of treatment outcomes, cost-effectiveness of treatment pathways and patients’ views on different treatment pathways.

Methods and analysis

Patients with primary referrals to an orthopaedic surgeon due to knee OA are consecutively invited to participate and fill out a questionnaire prior to their consultation with an orthopaedic surgeon. Follow-up questionnaires will be obtained at 6 and 24 months after inclusion. Based on a prospective cohort study design, including questionnaires and register data, we will (1) describe treatment pathways for knee OA during the first 2 years after consulting an orthopaedic surgeon; (2) describe the characteristics of patients choosing different treatment pathways; (3) develop predictive models for patient-self-determined classifications of good and poor treatment outcomes; (4) evaluate the cost-effectiveness of treatment pathways that live up to clinical guidelines versus pathways that do not; based on a qualitative study design using semistructured individual interviews, we will (5) describe the patients’ perspectives on treatment pathways for knee OA.

Ethics and dissemination

The study is approved by the Danish regional ethical committee (journal number H-17017295) and the Danish Data Protection Agency (journal number AHH-2017–072). Data will be anonymised and handled in line with the General Data Protection Regulation and the Danish Data Protection Act. The study results will be submitted to international open-access peer-reviewed journals and disseminated at conferences.

Trial registration number

NCT03746184, pre-results.

Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

Por: Menczel Schrire · Z. · Phillips · C. L. · Duffy · S. L. · Marshall · N. S. · Mowszowski · L. · La Monica · H. M. · Gordon · C. J. · Chapman · J. L. · Saini · B. · Lewis · S. J. G. · Naismith · S. L. · Grunstein · R. R. · Hoyos · C. M.
Introduction

Melatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).

Methods and analysis

The study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.

Ethics and dissemination

This protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.

Trial registration number

Australian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).

Protocol version

V.8 15 October 2020.

Psychometric properties and use of the DEMQOL suite of instruments in research: a systematic review protocol

Por: Hoben · M. · Chamberlain · S. A. · O'Rourke · H. M. · Elliott · B. · Shrestha · S. · Devkota · R. · Thorne · T. · Lam · J. · Banerjee · S. · Hughes · L. · Estabrooks · C. A.
Introduction

Dementia is a public health issue and a major risk factor for poor quality of life among older adults. In the absence of a cure, enhancing health-related quality of life (HRQoL) of people with dementia is the primary goal of care. Robust measurement of HRQoL is a prerequisite to effective improvement. The DEMQOL suite of instruments is considered among the best available to measure HRQoL in people with dementia; however, no review has systematically and comprehensively examined the use of the DEMQOL in research and summarised evidence to determine its feasibility, acceptability and appropriateness for use in research and practice.

Methods and analysis

We will systematically search 12 electronic databases and reference lists of all included studies. We will include systematically conducted reviews, as well as, quantitative and qualitative research studies that report on the development, validation or use in research studies of any of the DEMQOL instruments. Two reviewers will independently screen all studies for eligibility, and assess the quality of each included study using one of four validated checklists appropriate for different study designs. Discrepancies at all stages of the review will be resolved by consensus. We will use descriptive statistics (frequencies, proportions, ranges), content analysis of narrative data and vote counting (for the measures of association) to summarise the data elements. Using narrative synthesis, we will summarise what is known about the development, validation, feasibility, acceptability, appropriateness and use of the DEMQOL. Our review methods will follow the reporting and conduct guidelines of the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis.

Ethics and dissemination

Ethical approval is not required as this project does not involve primary data collection. We will disseminate our findings through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42020157851.

Experiences with traumatic events, consequences and care among people with visual impairment and post-traumatic stress disorder: a qualitative study from The Netherlands

Objective

Having a visual impairment is known to be associated with an increased vulnerability to (potentially) traumatic events. Little is known about how people with visual impairment experience and process such events. This qualitative study aimed to provide more insight into experiences with traumatic events, consequences of traumatic events and post-traumatic stress disorder (PTSD)-related care among people with visual impairment and PTSD.

Methods

Eighteen persons with visual impairment and (a history of) PTSD were interviewed. Among them were 14 women and 4 men aged between 23 and 66 years. Recruitment of participants was done through health professionals from two low-vision service centres and a patient association for people with eye diseases and visual impairment in The Netherlands. Interviews focused on experiences with (1) traumatic events, (2) consequences of traumatic events and (3) PTSD-related care. Thematic content analysis of interview data was performed using ATLAS.ti. The COnsolidated criteria for REporting Qualitative research (COREQ) checklist was used to check for completeness and transparency of the study. Data were collected between 2018 and 2020.

Results

The most commonly reported traumatic events were sexual and physical abuse. Many participants experienced that their impairment had negatively affected their acceptance by others, independence and self-esteem, increasing their vulnerability for traumatic events. Additionally, having a visual impairment negatively impacted participants’ ability to respond to situations and aggravated post-traumatic stress reactions. Existing treatments seem suitable for people with visual impairment when accommodated to the impairment.

Conclusions

Having a visual impairment may affect traumatic events and post-traumatic stress reactions, particularly by contributing to low self-esteem, problems in social interactions and a lack of visual information. Insights from this study provide starting points for adapting pretraumatic and post-traumatic care to the needs of people with visual impairment.

Comparison of the effects of intravenous propofol and inhalational desflurane on the quality of early recovery after hand-assisted laparoscopic donor nephrectomy: a prospective, randomised controlled trial

Por: Park · J. · Kim · M. · Park · Y. H. · Shim · J.-W. · Lee · H. M. · Kim · Y.-S. · Moon · Y. E. · Hong · S. H. · Chae · M. S.
Objectives

We compared early recovery outcomes between living kidney donors who received total intravenous (IV) propofol versus inhalational desflurane during hand-assisted laparoscopic nephrectomy.

Design

A single-centre, prospective randomised controlled trial.

Setting

University hospital.

Participants

Study participants were enrolled between October 2019 and February 2020. A total of 80 living donors were randomly assigned to an intravenous propofol group (n=40) or a desflurane group (n=40).

Intervention

Propofol group received intravenous propofol and desflurane group received desflurane, as a maintenance anaesthetic.

Primary and secondary outcome measures

The quality of postoperative functional recovery was primarily assessed using the Korean version of the Quality of Recovery-40 (QoR-40K) questionnaire on postoperative day 1. Secondarily, ambulation, pain score, rescue analgesics, complications and total hospital stay were assessed postoperatively.

Results

Our study population included 35 males and 45 females. The mean age was 46±13 years. The global QoR-40K score (161 (154–173) vs 152 (136–161) points, respectively, p=0.001) and all five subdimension scores (physical comfort, 49 (45–53) vs 45 (42–48) points, respectively, p=0.003; emotional state, 39 (37–41) vs 37 (33–41) points, respectively, p=0.005; psychological support, 30 (26–34) vs 28 (26–32) points, respectively, p=0.04; physical independence, 16 (11–18) vs 12 (8-14) points, respectively, p=0.004; and pain, 31 (28–33) vs 29 (25-31) points, respectively, p=0.021) were significantly higher in the intravenous propofol group than the desflurane group. The early ambulation success rate and numbers of early and total steps were higher, but the incidence of nausea/vomiting was lower, in the intravenous propofol group than the desflurane group. The total hospital stay after surgery was shorter in the intravenous propofol group than the desflurane group.

Conclusions

Intravenous propofol may enhance the quality of postoperative recovery in comparison to desflurane in living kidney donors.

Trial registration number

KCT0004365.

Protocol for an implementation study of an evidence-based home cardiac rehabilitation programme for people with heart failure and their caregivers in Scotland (SCOT:REACH-HF)

Por: Purcell · C. · Daw · P. · Kerr · C. · Cleland · J. · Cowie · A. · Dalal · H. M. · Ibbotson · T. · Murphy · C. · Taylor · R.
Introduction

Despite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based programmes might improve accessibility. The aim of SCOT: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is to assess the implementation of the REACH-HF home-based CR intervention in the context of the National Health Service (NHS) in Scotland.

This paper presents the design and protocol for this observational implementation study. Specific objectives of SCOT:REACH-HF are to: (1) assess service-level facilitators and barriers to the implementation of REACH-HF; (2) compare real-world patient and caregiver outcomes to those seen in a prior clinical trial; and (3) estimate the economic (health and social) impact of implementing REACH-HF in Scotland.

Methods and analysis

The REACH-HF intervention will be delivered in partnership with four ‘Beacon sites’ across six NHS Scotland Health Boards, covering rural and urban areas. Health professionals from each site will be trained to facilitate delivery of the 12-week programme to 140 people with heart failure and their caregivers. Patient and caregiver outcomes will be assessed at baseline and 4-month follow-up. Assessments include the Minnesota Living with Heart Failure Questionnaire (MLHFQ), five-dimension EuroQol 5L, Hospital Anxiety and Depression Scale, and the Caregiver Burden Questionnaire. Qualitative interviews will be conducted with up to 20 health professionals involved in programme delivery (eg, cardiac nurses, physiotherapists). 65 facilitator-patient consultations will be audio recorded and assessed for fidelity. Integrative analysis will address key research questions on fidelity, context and CR participant-related outcomes. The SCOT:REACH-HF findings will inform the future potential roll-out of REACH-HF in Scotland.

Ethics and dissemination

The study has been given ethical approval by the West of Scotland Research Ethics Service (reference 20/WS/0038, approved 25 March 2020). Written informed consent will be obtained from all participants. The study is listed on the ISRCTN registry with study ID ISRCTN53784122. The research team will ensure that the study is conducted in accordance with both General Data Protection Regulations and the University of Glasgow’s Research Governance Framework. Findings will be reported to the funder and shared with Beacon Sites, to facilitate service evaluation, planning and good practice. To broaden interest in, and understanding of REACH-HF, we will seek to publish in peer-reviewed scientific journals and present at stakeholder events, national and international conferences.

Computerised cognitive training in Parkinsons disease: a protocol for a systematic review and updated meta-analysis

Por: Gavelin · H. M. · Domellöf · M. · Leung · I. · Neely · A. S. · Finke · C. · Lampit · A.
Introduction

Cognitive impairment is recognised as an important non-motor symptom in Parkinson’s disease (PD) and there is a need for evidence-based non-pharmacological interventions that may prevent or slow cognitive decline in this patient group. One such intervention is computerised cognitive training (CCT), which has shown efficacious for cognition across older adult populations. This systematic review aims to investigate the efficacy of CCT across cognitive, psychosocial and functional domains for people with PD and examine study and intervention design factors that could moderate CCT effects on cognition.

Methods and analysis

Randomised controlled trials investigating the effects of CCT in patients with PD without dementia, on cognitive, psychosocial or functional outcomes, will be included. The primary outcome is overall cognitive function. Secondary outcomes are domain-specific cognitive function, psychosocial functioning and functional abilities. We systematically searched MEDLINE, Embase and PsycINFO through 14 May 2020 to identify relevant literature. Risk of bias will be assessed using the revised Cochrane Risk of Bias tool. Effect sizes will be calculated as standardised mean difference of baseline to postintervention change (Hedges’ g) with 95% CI for each eligible outcome measure. Pooling of outcomes across studies will be conducted using random-effects models, accounting for dependency structure of effect sizes within studies. Heterogeneity will be assessed using 2 and I2 statistic. Potential moderators, based on key study and intervention design factors, will be investigated using mixed-effects meta-regression models.

Ethics and dissemination

No ethical approval is required. The findings will be disseminated in a peer-reviewed scientific journal.

PROSPERO registration number

CRD42020185386.

Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study

Por: Boudewijns · E. A. · Claessens · D. · Joore · M. · Keijsers · L. C. E. M. · van Schayck · O. C. P. · Winkens · B. · Gidding-Slok · A. H. M.
Introduction

The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure.

Methods and analysis

The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients’ activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models.

Ethics and dissemination

Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences.

Trial registration number

ClinicalTrials.gov Registry (NCT04127383).

Mapping mental health recovery tools developed by mental health service users and ex-users: protocol for a scoping review

Por: Sampietro · H. M. · Carmona · V. R. · Rojo · J. E. · Gomez-Benito · J.
Introduction

Since the emergence in 1997 of the Wellness Recovery Action Plan, a number of other tools developed by users and/or ex-users of mental health services have been published and implemented. All these tools aim to promote self-determination in mental health recovery processes. A scoping review will be carried out in order to (1) identify existing tools, (2) describe their distinctive characteristics and (3) examine how they have been implemented and evaluated.

Methods and analysis

The scoping review will be guided by the methodological framework proposed by Arksey and O’Malley and expanded by Levac et al. It will involve, primarily, a literature search of the following electronic databases: Cochrane database, Cumulative Index to Nursing and Allied Health Literature, PsycInfo, PsycArticles, Scopus, PubMed and Web of Science. In addition, the search process will consider grey literature databases. Users, ex-users and survivors organisations and networks will be contacted in order to identify any relevant material. The reference lists of the articles identified through the literature search will be inspected. Finally, hand searches of journals will be conducted in order to increase the confidence in the search. Two main approaches will be used to present the charted data: a descriptive analysis and a thematic analysis. The study will be performed between April and December 2020. The results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination

This study does not require ethical approval because the data used are from publicly available materials. The study results will be disseminated through an article submitted for publication to a scientific journal and presented at relevant conferences. The results will also be shared in future workshops and seminars as part of continuing education programmes for mental health professionals.

Application of the theory of regulatory fit to promote adherence to evidence-based breast cancer screening recommendations: experimental versus longitudinal evidence

Por: Petrocchi · S. · Ludolph · R. · Labrie · N. H. M. · Schulz · P.
Objectives

To reduce overtreatment caused by overuse of screening, it is advisable to reduce the demand for mammography screening outside the recommended guidelines among women who are not yet eligible for inclusion in systematic screening programmes. According to principles of regulatory fit theory, people make decisions motivated by either orientation to achieving and maximising gains or avoiding losses. A study developed in two phases investigated whether video messages, explaining the risks and benefits of mammography screening for those not yet eligible, are perceived as persuasive

Design

Phase 1 was an experimental study in which women’s motivation orientation was experimentally induced and then they were exposed to a matching video message about mammography screening. A control group received a neutral stimulus. Phase 2 introduced a longitudinal component to study 1, adding a condition in which the messages did not match with the group’s motivation orientation. Participants’ natural motivation orientation was measured through a validated questionnaire

Participants

360 women participated in phase 1 and another 292 in phase 2. Participants’ age ranged from 30 to 45 years, and had no history of breast cancer or known BReast CAncer gene (BRCA) 1/2 mutation.

Results

In phase 1, a match between participants’ motivation orientation and message content decreased the intention to seek mammography screening outside the recommended guidelines. Phase 2, however, did not show such an effect. Fear of breast cancer and risk perception were significantly related to intention to seek mammography screening

Conclusions

Public health researchers should consider reducing the impact of negative emotions (ie, fear of breast cancer) and risk perception when promoting adherence to evidence-based breast cancer screening recommendations.

Exercise for people living with frailty and receiving haemodialysis: a mixed-methods randomised controlled feasibility study

Por: Young · H. M. L. · March · D. S. · Highton · P. J. · Graham-Brown · M. P. M. · Churchward · D. C. · Grantham · C. · Goodliffe · S. · Jones · W. · Cheung · M.-M. · Greenwood · S. A. · Eborall · H. C. · Conroy · S. · Singh · S. J. · Smith · A. C. · Burton · J. O.
Objectives

Frailty is highly prevalent in haemodialysis (HD) patients, leading to poor outcomes. This study aimed to determine whether a randomised controlled trial (RCT) of intradialytic exercise is feasible for frail HD patients, and explore how the intervention may be tailored to their needs.

Design

Mixed-methods feasibility.

Setting and participants

Prevalent adult HD patients of the CYCLE-HD trial with a Clinical Frailty Scale Score of 4–7 (vulnerable to severely frail) were eligible for the feasibility study.

Interventions

Participants in the exercise group undertook 6 months of three times per week, progressive, moderate intensity intradialytic cycling (IDC).

Outcomes

Primary outcomes were related to feasibility. Secondary outcomes were falls incidence measured from baseline to 1 year following intervention completion, and exercise capacity, physical function, physical activity and patient-reported outcomes measured at baseline and 6 months. Acceptability of trial procedures and the intervention were explored via diaries and interviews with n=25 frail HD patients who both participated in (n=13, 52%), and declined (n=12, 48%), the trial.

Results

124 (30%) patients were eligible, and of these 64 (52%) consented with 51 (80%) subsequently completing a baseline assessment. n=24 (71% male; 59±13 years) dialysed during shifts randomly assigned to exercise and n=27 (81% male; 65±11 years) shifts assigned to usual care. n=6 (12%) were lost to follow-up. The exercise group completed 74% of sessions. 27%–89% of secondary outcome data were missing. Frail HD patients outlined several ways to enhance trial procedures. Maintaining ability to undertake activities of daily living and social participation were outcomes of primary importance. Participants desired a varied exercise programme.

Conclusions

A definitive RCT is feasible, however a comprehensive exercise programme may be more efficacious than IDC in this population.

Trial registration numbers

ISRCTN11299707; ISRCTN12840463.

Epidemiological investigation of the first 5685 cases of SARS-CoV-2 infection in Qatar, 28 February-18 April 2020

Por: Al Kuwari · H. M. · Abdul Rahim · H. F. · Abu-Raddad · L. J. · Abou-Samra · A.-B. · Al Kanaani · Z. · Al Khal · A. · Al Kuwari · E. · Al Marri · S. · Al Masalmani · M. · Al Romaihi · H. E. · Al Thani · M. H. · Coyle · P. V. · Latif · A. N. · Owen · R. · Bertollini · R. · Butt · A. A.
Objective

To define the epidemiological curve of COVID-19 in Qatar and determine factors associated with severe or critical illness.

Design

Case series of first 5685 COVID-19 cases in Qatar.

Setting and participants

All confirmed COVID-19 cases in the State of Qatar between 28 February and 18 April 2020.

Main outcome measures

Number of total and daily new COVID-19 infections; demographic characteristics and comorbidity burden and severity of infection; factors associated with severe or critical illness.

Results

Between 28 February and 18 April 2020, 5685 cases of COVID-19 were identified. Median age was 34 (IQR 28–43) years, 88.9% were male and 8.7% were Qatari nationals. Overall, 83.6% had no concomitant comorbidity, and 3.0% had three or more comorbidities. The overwhelming majority (90.9%) were asymptomatic or with minimal symptoms, with 2.0% having severe or critical illness. Seven deaths were observed during the time interval studied. Presence of hypertension or diabetes was associated with a higher risk of severe or critical illness, but age was not. The epidemiological curve indicated two distinct patterns of infection, a larger cluster among expatriate craft and manual workers and a smaller one among Qatari nationals returning from abroad during the epidemic.

Conclusion

COVID-19 infections in Qatar started in two distinct clusters, but then became more widespread in the population through community transmission. Infections were mostly asymptomatic or with minimal symptoms and associated with very low mortality. Severe/critical illness was associated with presence of hypertension or diabetes but not with increasing age.

Protocol for project recovery after cardiac surgery: a single-center cohort study leveraging digital platform to characterise longitudinal patient-reported postoperative recovery patterns

Por: Mori · M. · Brooks · C. · Spatz · E. · Mortazavi · B. J. · Dhruva · S. S. · Linderman · G. C. · Grab · L. A. · Zhang · Y. · Geirsson · A. · Chaudhry · S. I. · Krumholz · H. M.
Introduction

Improving postoperative patient recovery after cardiac surgery is a priority, but our current understanding of individual variations in recovery and factors associated with poor recovery is limited. We are using a health-information exchange platform to collect patient-reported outcome measures (PROMs) and wearable device data to phenotype recovery patterns in the 30-day period after cardiac surgery hospital discharge, to identify factors associated with these phenotypes and to investigate phenotype associations with clinical outcomes.

Methods and analysis

We designed a prospective cohort study to enrol 200 patients undergoing valve, coronary artery bypass graft or aortic surgery at a tertiary centre in the USA. We are enrolling patients postoperatively after the intensive care unit discharge and delivering electronic surveys directly to patients every 3 days for 30 days after hospital discharge. We will conduct medical record reviews to collect patient demographics, comorbidity, operative details and hospital course using the Society of Thoracic Surgeons data definitions. We will use phone interview and medical record review data for adjudication of survival, readmission and complications. We will apply group-based trajectory modelling to the time-series PROM and device data to classify patients into distinct categories of recovery trajectories. We will evaluate whether certain recovery pattern predicts death or hospital readmissions, as well as whether clinical factors predict a patient having poor recovery trajectories. We will evaluate whether early recovery patterns predict the overall trajectory at the patient-level.

Ethics and dissemination

The Yale Institutional Review Board approved this study. Following the description of the study procedure, we obtain written informed consent from all study participants. The consent form states that all personal information, survey response and any medical records are confidential, will not be shared and are stored in an encrypted database. We plan to publish our study findings in peer-reviewed journals.

'I also take part in caring for the sick child: a qualitative study on fathers roles and responsibilities in seeking care for children in Southwest Ethiopia

Por: Funk · T. · Källander · K. · Abebe · A. · Alfven · T. · Alvesson · H. M.
Objectives

Fathers play an important role in household decision-making processes and child health development. Nevertheless, they are under-represented in child health research, especially in low-income settings. Little is known about what roles fathers play in the care-seeking processes or how they interact with the health system when their child is sick. This study aimed to understand Ethiopian fathers’ roles and responsibilities in caring for their children when they are or become ill.

Design

Qualitative study using semistructured interviews with fathers.

Setting

This study was conducted in three rural districts of the Southern Nations, Nationalities and People’s Region of Ethiopia.

Participants

Twenty-four fathers who had at least one child between 2 and 59 months who visited a health extension worker with fever.

Results

The overarching theme of this study was ‘changing perceptions of paternal responsibilities during children’s ill health’. It constituted three subthemes, namely, ‘fathers’ burden of earning money for care’, ‘fatherhood entails advocating children’s healthcare needs’ and ‘investing in children’s health can benefit the family in the future’. Fathers described that they were the ones mainly responsible for the financial arrangement of care and that this financial responsibility can involve stress when resources are scarce. Fathers knew what health services were available and accessible to them and were involved in different ways in the care seeking of the child. Changes in the importance ascribed to child health were expressed by fathers who described being more alert to children’s ill-health.

Conclusion

Fathers play various roles in the care-seeking process during children’s illness episodes. This included, for instance, arranging resources to seek care, (co)-deciding where to seek care as well as accompanying the child to the health facility. The inability to organise necessary resources for care can lead to involuntary delays in care seeking for the child. This demonstrates the importance of including fathers in future interventions on maternal and child health.

Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study

Por: Umans · D. S. · Timmerhuis · H. C. · Hallensleben · N. D. · Bouwense · S. A. · Anten · M.-P. G. · Bhalla · A. · Bijlsma · R. A. · Boermeester · M. A. · Brink · M. A. · Hol · L. · Bruno · M. J. · Curvers · W. L. · van Dullemen · H. M. · van Eijck · B. C. · Erkelens · G. W. · Fockens
Introduction

Idiopathic acute pancreatitis (IAP) remains a dilemma for physicians as it is uncertain whether patients with IAP may actually have an occult aetiology. It is unclear to what extent additional diagnostic modalities such as endoscopic ultrasonography (EUS) are warranted after a first episode of IAP in order to uncover this aetiology. Failure to timely determine treatable aetiologies delays appropriate treatment and might subsequently cause recurrence of acute pancreatitis. Therefore, the aim of the Pancreatitis of Idiopathic origin: Clinical added value of endoscopic UltraSonography (PICUS) Study is to determine the value of routine EUS in determining the aetiology of pancreatitis in patients with a first episode of IAP.

Methods and analysis

PICUS is designed as a multicentre prospective cohort study of 106 patients with a first episode of IAP after complete standard diagnostic work-up, in whom a diagnostic EUS will be performed. Standard diagnostic work-up will include a complete personal and family history, laboratory tests including serum alanine aminotransferase, calcium and triglyceride levels and imaging by transabdominal ultrasound, magnetic resonance imaging or magnetic resonance cholangiopancreaticography after clinical recovery from the acute pancreatitis episode. The primary outcome measure is detection of aetiology by EUS. Secondary outcome measures include pancreatitis recurrence rate, severity of recurrent pancreatitis, readmission, additional interventions, complications, length of hospital stay, quality of life, mortality and costs, during a follow-up period of 12 months.

Ethics and dissemination

PICUS is conducted according to the Declaration of Helsinki and Guideline for Good Clinical Practice. Five medical ethics review committees assessed PICUS (Medical Ethics Review Committee of Academic Medical Center, University Medical Center Utrecht, Radboud University Medical Center, Erasmus Medical Center and Maastricht University Medical Center). The results will be submitted for publication in an international peer-reviewed journal.

Trial registration number

Netherlands Trial Registry (NL7066). Prospectively registered.

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