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Help-seeking behaviours among older adults: a scoping review protocol

Por: Teo · K. · Churchill · R. · Riadi · I. · Kervin · L. · Cosco · T.
Introduction

Despite evidence that illustrates the unmet healthcare needs of older adults, there is limited research examining their help-seeking behaviour, of which direct intervention can improve patient outcomes. Research in this area conducted with a focus on ethnic minority older adults is also needed, as their help-seeking behaviours may be influenced by various cultural factors. This scoping review aims to explore the global literature on the factors associated with help-seeking behaviours of older adults and how cultural values and backgrounds may impact ethnic minority older adults’ help-seeking behaviours in different ways.

Methods and analysis

The scoping review process will be guided by the methodology framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews guidelines. The following electronic databases will be systematically searched from January 2005 onwards: MEDLINE/PubMed, Web of Science, PsycINFO, CINAHL and Scopus. Studies of various designs and methodologies consisting of older adults aged 65 years or older, who are exhibiting help-seeking behaviours for the purpose of remedying a physical or mental health challenge, will be considered for inclusion. Two reviewers will screen full texts and chart data. The results of this scoping review will be summarised quantitatively through numerical counts and qualitatively through a narrative synthesis.

Ethics and dissemination

As this is a scoping review of published literature, ethics approval is not required. Results will be disseminated through publication in a peer-reviewed journal.

Discussion

This scoping review will synthesise the current literature related to the help-seeking behaviours of older adults and ethnic minority older adults. It will identify current gaps in research and potential ways to move forward in developing or implementing strategies that support the various health needs of the diverse older adult population.

Registration

This scoping review protocol has been registered with the Open Science Framework (https://osf.io/69kmx).

Coping and support-seeking in out-of-home care: a qualitative study of the views of young people in care in England

Por: Hiller · R. M. · Halligan · S. L. · Meiser-Stedman · R. · Elliott · E. · Rutter-Eley · E. · Hutt · T.
Objectives

Young people who have been removed from their family home and placed in out-of-home care have commonly experienced abuse, neglect and/or other forms of early adversity. High rates of mental health difficulties have been well documented in this group. The aim of this research was to explore the experiences of these young people within the care system, particularly in relation to support-seeking and coping with emotional needs, to better understand feasible and acceptable ways to improve outcomes for these young people.

Design and study setting

This study used 1:1 semistructured qualitative interviews with young people in out-of-home care in England, to provide an in-depth understanding of their views of coping and support for their emotional needs, both in terms of support networks and experiences with mental health services. Participants were 25 young people aged 10–16 years old (56% female), and included young people living with non-biological foster carers, kinship carers and in residential group homes.

Results

Participants described positive (eg, feeling safe) and negative (eg, feeling judged) aspects to being in care. Carers were identified as the primary source of support, with a supportive adult central to coping. Views on support and coping differed for young people who were experiencing more significant mental health difficulties, with this group largely reporting feeling unsupported and many engaging in self-harm. The minority of participants had accessed formal mental health support, and opinions on usefulness were mixed.

Conclusions

Results provide insight, from the perspective of care-experienced young people, about both barriers and facilitators to help-seeking, as well as avenues for improving support.

Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial

Por: Tonna · J. E. · Pierce · J. · Hatton · N. · Lewis · G. · Phillips · J. D. · Messina · A. · Skidmore · C. R. · Taylor · K. · Selzman · C. H.
Introduction

Human amniotic fluid (hAF) has been shown to reduce inflammation in multiple experimental models. hAF has previously been approved by the US Food and Drug Administration (FDA) as a human cellular and tissue product for tissue injury for human administration, and used safely in thousands of patients as a therapeutic treatment for diverse conditions. Given the profound inflammatory response observed in patients with COVID-19, and the successful completion of 10-patient pilot study of intravenous hAF, we present a trial design for a larger clinical trial of intravenous hAF for the treatment of COVID-19.

Methods and analysis

This paper describes the methodology of a phase I/II randomised, double-blinded, placebo-controlled clinical trial to determine the safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19. Primary outcome will be the change in C-reactive protein. Secondary outcomes include safety, biomarker inflammatory levels and clinically relevant outcomes at 30 days, including mortality, ventilator-free days and hospital and intensive care unit length of stay. Exploratory outcomes of health-related quality-of-life patient-reported outcomes will be collected. Hospitalised patients with laboratory-confirmed COVID-19 will be recruited.

Ethics and dissemination

This study was approved by the University of Utah Institutional Review Board (IRB_0013292), approved by the US FDA under Investigational New Drug (No 23369) and is registered on ClinicalTrials.gov. Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT04497389; 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.

International study of definitions of English-language terms for suicidal behaviours: a survey exploring preferred terminology

Por: De Leo · D. · Goodfellow · B. · Silverman · M. · Berman · A. · Mann · J. · Arensman · E. · Hawton · K. · Phillips · M. R. · Vijayakumar · L. · Andriessen · K. · Chavez-Hernandez · A.-M. · Heisel · M. · Kolves · K.
Objectives

Explore international consensus on nomenclatures of suicidal behaviours and analyse differences in terminology between high-income countries (HICs) and low/middle-income countries (LMICs).

Design

An online survey of members of the International Organisation for Suicide Prevention (IASP) used multiple-choice questions and vignettes to assess the four dimensions of the definition of suicidal behaviour: outcome, intent, knowledge and agency.

Setting

International.

Participants

Respondents included 126 individuals, 37 from 30 LMICs and 89 from 33 HICs. They included 40 IASP national representatives (65% response rate), IASP regular members (20% response rate) and six respondents from six additional countries identified by other organisations.

Outcome measures

Definitions of English-language terms for suicidal behaviours.

Results

The recommended definition of ‘suicide’ describes a fatal act initiated and carried out by the actors themselves. The definition of ‘suicide attempt’ was restricted to non-fatal acts with intent to die, whereas definition of ‘self-harm’ more broadly referred to acts with varying motives, including the wish to die. Almost all respondents agreed about the definitions of ‘suicidal ideation’, ‘death wishes’ and ‘suicide plan’. ‘Aborted suicide attempt’ and ‘interrupted suicide attempt’ were not considered components of ‘preparatory suicidal behaviour’. There were several differences between representatives from HICs and LMICs.

Conclusion

This international opinion survey provided the basis for developing a transcultural nomenclature of suicidal behaviour. Future developments of this nomenclature should be tested in larger samples of professionals, including LMICs may be a challenge.

Rates and risk factors for suicidal ideation, suicide attempts and suicide deaths in persons with HIV: a protocol for a systematic review and meta-analysis

Por: Wisnousky · H. · Lazzara · N. · Ciarletta · M. · Pelton · M. · Chinchilli · V. M. · Ssentongo · A. E. · Ssentongo · P.
Introduction

The prevalence of HIV/AIDS is high and is associated with psychiatric morbidity and suicide risk. The objective of this study will be to assess the rates of suicidal ideation, suicide attempts and suicide deaths in people living with HIV/AIDS (PLWHA).

Methods and analysis

We present a study protocol for a systematic review and meta-analysis of studies reporting the suicidality outcomes (suicidal ideation, suicide attempts and suicide deaths) in PLWHA. PubMed (MEDLINE), Scopus, EMBASE, Cochrane Library, OVID (HEALTH STAR), OVID (MEDLINE), Joanna Briggs Institute EBP Database, Web of Science and PsychINFO databases will be searched from their inception until 1 January 2020. The primary outcome of interest will be the incidence of suicidality in PLWHA. In addition, we will delineate risk factors associated with suicidality in PLWHA. Citations, full-text articles and abstracts will be screened by four reviewers independently. Disagreements will be resolved through discussion. The study methodological quality (or bias) will be appraised using an appropriate tool. Random-effects meta-analysis will be conducted if we find that the studies are very heterogenous. For the suicidality outcome, probability of suicide risk will be reported. Relative risk ratios (with 95% CIs) will be reported for the effects of the risk factors. Potential publication bias will be assessed by conducting Egger’s test and creating funnel plots. We will conduct additional analyses to explore the potential sources of heterogeneity (eg, age, sex and geographical location).

Ethics and dissemination

No ethics clearance is required as no primary data will be collected. The results of this systematic review and meta-analysis will be presented at scientific conferences and published in a peer-reviewed journal. The results may inform clinical management of PLWHA and may guide future population-specific interventions.

We will search PubMed (MEDLINE), Scopus, EMBASE, Cochrane Library, OVID (HEALTH STAR), OVID (MEDLINE), Joanna Briggs Institute EBP Database, Web of Science and PsychINFO from their inception until 1 January 2020.

PROSPERO registration number

CRD42020161501.

The impact of surgical site infection on hospitalisation, treatment costs, and health‐related quality of life after vascular surgery

Abstract

Surgical site infections (SSI) substantially increase costs for healthcare providers because of additional treatments and extended patient recovery. The objective of this study was to assess the cost and health‐related quality of life impact of SSI, from the perspective of a large teaching hospital in England. Data were available for 144 participants undergoing clean or clean‐contaminated vascular surgery. SSI development, length of hospital stay, readmission, and antibiotic use were recorded over a 30‐day period. Patient‐reported EQ‐5D scores were obtained at baseline, day 7 and day 30. Linear regressions were used to control for confounding variables. A mean SSI‐associated length of stay of 9.72 days resulted in an additional cost of £3776 per patient (including a mean antibiotic cost of £532). Adjusting for age, smoking status, and procedure type, SSI was associated with a 92% increase in length of stay (P < 0.001). The adjusted episode cost was £3040. SSI reduced patient utility between baseline and day 30 by 0.156 (P = 0.236). Readmission rates were higher with SSI (P = 0.017), and the rate to return to work within 90 days was lower. Therefore, strategies to reduce the risk of surgical site infection for high‐risk vascular patients should be investigated.

Implementation Science Meets Software Development to Create eHealth Components for an Integrated Care Model for Allogeneic Stem Cell Transplantation Facilitated by eHealth: The SMILe Study as an Example

Abstract

Purpose

To describe a process of creating eHealth components for an integrated care model using an agile software development approach, user‐centered design and, via the Behavior Change Wheel, behavior theory‐guided content development. Following the principles of implementation science and using the SMILe project (integrated care model for allogeneic stem cell transplantation facilitated by eHealth) as an example, this study demonstrates how to narrow the research‐to‐practice gap often encountered in eHealth projects.

Methods

We followed a four‐step process: (a) formation of an interdisciplinary team; (b) a contextual analysis to drive the development process via behavioral theory; (c) transfer of content to software following agile software development principles; and (d) frequent stakeholder and end user involvement following user‐centered design principles.

Findings

Our newly developed comprehensive development approach allowed us to create a running eHealth component and embed it in an integrated care model. An interdisciplinary team’s collaboration at specified interaction points supported clear, timely communication and interactions between the specialists. Because behavioral theory drove the content development process, we formulated user stories to define the software features, which were prioritized and iteratively developed using agile software development principles. A prototype intervention module has now been developed and received high ratings on the System Usability Scale after two rounds of usability testing.

Conclusions

Following an agile software development process, structured collaboration between nursing scientists and software specialists allowed our interdisciplinary team to develop meaningful, theory‐based eHealth components adapted to context‐specific needs.

Clinical Relevance

The creation of high‐quality, accurately fitting eHealth components specifically to be embedded in integrated care models should increase the chances of uptake, adoption, and sustainable implementation in clinical practice.

The impact of surgical site infection on hospitalisation, treatment costs, and health‐related quality of life after vascular surgery

Abstract

Surgical site infections (SSI) substantially increase costs for healthcare providers because of additional treatments and extended patient recovery. The objective of this study was to assess the cost and health‐related quality of life impact of SSI, from the perspective of a large teaching hospital in England. Data were available for 144 participants undergoing clean or clean‐contaminated vascular surgery. SSI development, length of hospital stay, readmission, and antibiotic use were recorded over a 30‐day period. Patient‐reported EQ‐5D scores were obtained at baseline, day 7 and day 30. Linear regressions were used to control for confounding variables. A mean SSI‐associated length of stay of 9.72 days resulted in an additional cost of £3776 per patient (including a mean antibiotic cost of £532). Adjusting for age, smoking status, and procedure type, SSI was associated with a 92% increase in length of stay (P < 0.001). The adjusted episode cost was £3040. SSI reduced patient utility between baseline and day 30 by 0.156 (P = 0.236). Readmission rates were higher with SSI (P = 0.017), and the rate to return to work within 90 days was lower. Therefore, strategies to reduce the risk of surgical site infection for high‐risk vascular patients should be investigated.

Statins used for secondary prevention in patients with stroke reduce the risk of further ischaemic strokes and cardiovascular events

Por: Hill · J. · Hare · M.

Commentary on: Tramacere, I, Boncoraglio, GB, Banzi, R, et al. Comparison of statins for secondary prevention in patients with ischemic stroke or transient ischemic attack: a systematic review and network meta-analysis. BMC Med 2019;17:67. doi:10.1186/s12916-019-1298-5.

Implications for practice and research

  • The secondary use of statins is effective in reducing the absolute risk of ischaemic stroke and cardiac events in patients who previously have had an ischaemic stroke or transient ischaemic attack (TIA).

  • Further research is required to ascertain which statin is the most effective.

  • Context

    Stroke is one of the major causes of worldwide death and disability, with one in four people predicted to experience a stroke within their lifetime.1 After a stroke or a TIA, there remains a substantial long-term risk of recurrent stroke.2 It is recommended that statins should be used to reduce the risk of recurrent stroke...

    Social, financial and psychological stress during an emerging pandemic: observations from a population survey in the acute phase of COVID-19

    Por: Robillard · R. · Saad · M. · Edwards · J. · Solomonova · E. · Pennestri · M.-H. · Daros · A. · Veissiere · S. P. L. · Quilty · L. · Dion · K. · Nixon · A. · Phillips · J. · Bhatla · R. · Spilg · E. · Godbout · R. · Yazji · B. · Rushton · C. · Gifford · W. A. · Gautam · M. · Boafo · A. · Swar
    Introduction

    The negative impacts of COVID-19 have rippled through every facet of society. Understanding the multidimensional impacts of this pandemic is crucial to identify the most critical needs and to inform targeted interventions. This population survey study aimed to investigate the acute phase of the COVID-19 outbreak in terms of perceived threats and concerns, occupational and financial impacts, social impacts and stress between 3 April and 15 May 2020.

    Methods

    6040 participants are included in this report. A multivariate linear regression model was used to identify factors associated with stress changes (as measured by the Cohen’s Perceived Stress Scale (PSS)) relative to pre-outbreak retrospective estimates.

    Results

    On average, PSS scores increased from low stress levels before the outbreak to moderate stress levels during the outbreak (p

    Conclusion

    Cross-sectional analyses showed a significant increase from low to moderate stress during the COVID-19 outbreak. Identified modifiable factors associated with increased stress may be informative for intervention development.

    Trial registration number

    NCT04369690; Results.

    Methods for estimating economic benefits of surgical interventions in low-income and middle-income countries: a scoping review

    Por: Hilla · A. · Reese · V. · Nonvignon · J. · Dolan · C. B.
    Objectives

    Studies indicate that many types of surgical care are cost-effective compared with other health interventions in low-income and middle-income countries (LMICs). However, global health investments to support these interventions remain limited. This study undertakes a scoping review of research on the economic impact of surgical interventions in LMICs to determine the methodologies used in measuring economic benefits.

    Design

    The Arksey and O’Malley methodological framework for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist were used to review the data systematically. Online databases were used to identify papers published between 2005 and 2020, from which we selected 19 publications that quantitatively examined the economic benefits of surgical interventions in LMICs.

    Results

    Majority of publications (79%) reported the use of disability-adjusted life-years (DALYs) to assess economic impact. In comparison, 21% used other measures, such as the value of statistical life or cost-effectiveness ratios, or no measure at all. 31% were systematic or retrospective reviews of the literature on surgical procedures in LMICs, while 69% either directly assessed economic impact in a specific area or evaluated the need for surgical procedures in LMICs. All studies reviewed related to the economic impact of surgical procedures in LMICs, with most about paediatric surgical procedures or a specific surgical specialty.

    Conclusion

    To make informed policy decisions regarding global health investments, the economic impact must be accurately measured. Researchers employ a range of techniques to quantify the economic benefit of surgeries in LMICs, which limits understanding of overall economic value. We conclude that the literature would benefit from a careful selection of methods, incorporating age and disability weights based on the Global Burden of Disease weights, and converting DALYs to dollars using the value of statistical life approach and the human capital approach, reporting both estimates.

    Practice nurses’ perceptions of their immunization role and strategies used to promote measles, mumps, and rubella vaccine uptake in 2014 – 2018: A qualitative study

    Abstract

    Aim

    The aim of this study was to explore which aspects of their role practice nurses perceive to be most influential and the strategies they employ to promote the MMR vaccine.

    Design

    Qualitative study employing in depth interviews.

    Method

    Fifteen London based practice nurses, nine in 2014 and six in 2018, took part in semi‐structured interviews that were audio recorded and transcribed verbatim. Qualitative content analysis was used to systematically manage, analyse, and identify themes.

    Results

    Analysis of data identified aspects of their role practice nurses perceived to be most influential (the themes) including: promoting vaccination, assisting parents’ to make informed decisions, and provided insight into how they used specific strategies to achieve these in practice. These themes were consistent over both phases of the study.

    Conclusion

    The findings provide an understanding of: (i) the practice nurses perceptions of the most important aspects of their role when promoting the measles, mumps, and rubella vaccine; and (ii) the strategies they implemented in practice to achieve these. The latter included assisting parents in their immunization decisions and was facilitated by practice nurses engaging with parents to provide relevant evidence to address parent queries, dispel misconceptions and tailor strategies to promote the measles, mumps, and rubella vaccine.

    Impact

    This study addresses the paucity of literature available that specifically explores practice nurses’ perceptions of their role concerning the measles, mumps, and rubella vaccine. The findings reveal how practice nurses promote the measles, mumps, and rubella vaccine by identifying strategies to enable parents to make informed decisions. At a time of an increasing incidence of measles, practice nurses have an important public health role in achieving herd immunity levels for measles, mumps, and rubella.

    Socioenvironmental criteria and postoperative complications in ambulatory surgery in a French university hospital: a prospective cross-sectional observational study

    Por: Mihailescu · S.-D. · Marechal · I. · Thillard · D. · Gillibert · A. · Compere · V.
    Background

    Ambulatory surgery lowers hospitalisation costs, shortens the time to return to work but requires caution regarding socioenvironmental risk factors for complications and rehospitalisation.

    Methods

    This was a single-centre prospective cross-sectional observational study conducted in a university hospital centrein January 2017. The primary objective was to assess the rate of conversion from ambulatory surgery to conventional hospitalisation or emergency department visit within 30 days following discharge from ambulatory unit. Secondary objectives were to describe the socioenvironmental characteristics of outpatients and to identify risk factors for severe postoperative complications.

    Results

    598 outpatients were included. The most represented surgical specialties were ophthalmology (23.5%), gynaecology (19%) and orthopaedics (17.7%). Patients’ mean age was 50.8 years (SD, 19.8) and the male/female sex ratio was 0.68. There were 22 (3.68%, 95% CI 2.32% to 5.52%) severe complications, including 11 (1.84%, 95% CI 0.92% to 3.27%) conversions to conventional hospitalisation and 11 (1.84%) conversions to emergency department visit, 3 of which led to readmission. Regarding socioenvironmental characteristics, 116 outpatients (19.7%) lived alone but were not isolated and 15 (2.6%) lived alone and were socially isolated. Following ambulatory surgery, 9 outpatients (1.6%) returned home on foot, 20 (3.4%) by public transportation and 8 (1.4%) drove home; 133 outpatients (13.7%) were alone the first night following surgery. Severe complication rates were not significantly different according to socioenvironmental subgroups.

    Conclusion

    In our study, the prevalence of severe complications was low, conforming to the literature. The study was underpowered to estimate the effect of socioenvironmental variables.

    Modelling retailer-based exemptions in flavoured tobacco sales restrictions: national estimates on the impact of product availability

    Por: Schillo · B. A. · Benson · A. F. · Czaplicki · L. · Anesetti-Rothermel · A. · Kierstead · E. C. · Simpson · R. · Phelps · N. C. · Herman · P. · Zhao · C. · Rose · S. W.
    Objectives

    More than 250 US localities restrict sales of flavoured tobacco products (FTPs), but comprehensiveness varies, and many include retailer-based exemptions. The purpose of this study is to examine resulting changes in the US retail environment for FTPs if there was a hypothetical national tobacco control policy that would prohibit FTP sales in all retailers except (1) tobacco specialty stores or (2) tobacco specialty stores and alcohol outlets.

    Design and setting

    A cross-sectional analysis of the FTP retail environment in every US Census tract (n=74 133). FTP retailers (n=3 10 090) were enumerated using nine unique codes from a national business directory (n=296 716) and a national vape shop directory (n=13 374).

    Outcome measures

    We assessed FTP availability using static-bandwidth and adaptive-bandwidth kernel density estimation. We then calculated the proportion of FTP stores remaining and the mean density of FTP retailers under each policy scenario for the overall population, as well as across populations vulnerable to FTP use.

    Results

    Exempting tobacco specialty stores alone would leave 25 276 (8.2%) FTP retailers nationwide, while exempting both tobacco specialty stores and alcohol outlets would leave 54 091 (17.4%) retailers. On average, the per cent remaining FTP availability per 100 000 total population was 7.1% for a tobacco specialty store exemption and 18.1% for a tobacco specialty store and alcohol outlet exemption. Overall, density estimate trends for remaining FTP availability among racial/ethnic populations averaged across Census tracts mirrored total population density. However, estimates varied when stratified by metropolitan status. Compared with the national average, FTP availability would remain 47%–49% higher for all racial/ethnic groups in large metropolitan areas.

    Conclusions

    Retailer-based exemptions allow greater FTP availability compared with comprehensive policies which would reduce FTP availability to zero. Strong public policies have the greatest potential impact on reducing FTP availability, particularly among urban, and racial/ethnic minority populations.

    Household medication safety practices during the COVID-19 pandemic: a descriptive qualitative study protocol

    Por: Grimes · T. C. · Garfield · S. · Kelly · D. · Cahill · J. · Cromie · S. · Wheeler · C. · Franklin · B. D.
    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.

    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)

    Por: Thille · A. W. · Coudroy · R. · Gacouin · A. · Ehrmann · S. · Contou · D. · Dangers · L. · Romen · A. · Guitton · C. · Lacave · G. · Quenot · J.-P. · Lacombe · B. · Pradel · G. · Terzi · N. · Prat · G. · Labro · G. · Reignier · J. · Beduneau · G. · Dellamonica · J. · Nay · M.-A. · Rouze · A.
    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.

    Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study

    Por: Manchira Krishnan · S. · Gc · V. S. · Sandhu · H. K. · Underwood · M. · Eldabe · S. · Manca · A. · Iglesias Urrutia · C. P. · I-WOTCH team · Sandhu · Eldabe · Abraham · Alleyne · Balasubramanian · Betteley · Booth · Carnes · Furlan · Haywood · Hill · Lall · Manca · Mistry · Nichols
    Introduction

    Over the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.

    Methods and analysis

    Economic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model’s states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.

    Ethics and dissemination

    Full ethics approval was granted by Yorkshire & The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.

    Trial registration number

    International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

    Optimisation, validation and field applicability of a 13C-sucrose breath test to assess intestinal function in environmental enteropathy among children in resource poor settings: study protocol for a prospective study in Bangladesh, India, Kenya, Jamaica,

    Por: Lee · G. O. · Schillinger · R. · Shivakumar · N. · Whyte · S. · Huq · S. · Ochieng Konyole · S. · Chileshe · J. · Paredes-Olortegui · M. · Owino · V. · Yazbeck · R. · Kosek · M. N. · Kelly · P. · Morrison · D.
    Introduction

    Environmental enteropathy (EE) is suspected to be a cause of growth faltering in children with sustained exposure to enteric pathogens, typically in resource-limited settings. A major hindrance to EE research is the lack of sensitive, non-invasive biomarkers. Current biomarkers measure intestinal permeability and inflammation, but not the functional capacity of the gut. Australian researchers have demonstrated proof of concept for an EE breath test based on using naturally 13C-enriched sucrose, derived from maize, to assay intestinal sucrase activity, a digestive enzyme that is impaired in villus blunting. Here, we describe a coordinated research project to optimise, validate and evaluate the usability of a breath test protocol based on highly enriched 13C-sucrose to quantify physiological dysfunction in EE in relevant target populations.

    Methods and analysis

    We use the 13C-sucrose breath test (13C-SBT) to evaluate intestinal sucrase activity in two phases. First, an optimisation and validation phase will (1) confirm that a 13C-SBT using highly enriched sucrose tracers reports similar information to the naturally enriched 13C-SBT; (2) examine the dose–response relationship of the test to an intestinal sucrase inhibitor; (3) validate the 13C-SBT in paediatric coeliac disease (4) validate the highly enriched 13C-SBT against EE defined by biopsy in adults and (5) validate the 13C-SBT against EE defined by the urinary lactulose:rhamnose ratio (LR) among children in Peru. Second, a cross-sectional study will be conducted in six resource-limited countries (Bangladesh, India, Jamaica, Kenya, Peru and Zambia) to test the usability of the optimised 13C-SBT to assess EE among 600 children aged 12–15 months old.

    Ethics and dissemination

    Ethical approval will be obtained from each participating study site. By working as a consortium, the test, if shown to be informative of EE, will demonstrate strong evidence for utility across diverse, low-income and middle-income country paediatric populations.

    Trial registration number

    NCT04109352; Pre-results.

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