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Protocol for assessing whether cognition of preterm infants <29 weeks gestation can be improved by an intervention with the omega-3 long-chain polyunsaturated fatty acid docosahexaenoic acid (DHA): a follow-up of a randomised controlled trial

Por: Gould · J. F. · Makrides · M. · Sullivan · T. R. · Anderson · P. J. · Gibson · R. A. · Best · K. P. · McPhee · A. J. · Doyle · L. W. · Opie · G. · Travadi · J. · Cheong · J. · Davis · P. G. · Sharp · M. · Simmer · K. · Collins · C. T.
Introduction

Docosahexaenoic acid (DHA) is an omega-3 (n-3) fatty acid that accumulates into neural tissue during the last trimester of pregnancy, as the fetal brain is undergoing a growth spurt. Infants born

Methods and analysis

N3RO was a randomised controlled trial of enteral DHA supplementation (60 mg/kg/day) or a control emulsion (without DHA) in 1273 infants born

In this follow-up at 5 years’ corrected age, a predefined subset (n=655) of children from five Australian sites will be invited to attend a cognitive assessment with a psychologist. Children will be administered the Wechsler Preschool and Primary Scale of Intelligence (fourth edition) and a measure of inhibitory control (fruit stroop), while height, weight and head circumference will be measured.

The primary outcome is full-scale IQ. To ensure 90% power, a minimum of 592 children are needed to detect a four-point difference in IQ between the groups.

Research personnel and families remain blinded to group assignment.

Ethics and dissemination

The Women’s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/17/WCHN/187). Caregivers will give informed consent prior to taking part in this follow-up study. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

ACTRN12612000503820.

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.

Changing mindsets about side effects

Por: Leibowitz · K. A. · Howe · L. C. · Crum · A. J.

Given research showing that the very act of communicating side effects can increase their likelihood, how can providers inform patients about side effects while upholding their oath to do no unnecessary harm? An emerging approach provides a potential solution: truthfully describe certain minor side effects as a sign the treatment is active and working in the body. This approach focuses on instilling adaptive mindsets about the meaning of side effects while still keeping patients informed. This article describes existing research suggesting that this approach can be helpful in improving experience and outcomes in treatments for pain, hypertension and allergy. Compared with control groups given a standard, empathetic message about side effects, patients who were informed that side effects are a sign treatment is working were less anxious about side effects and rated them as less threatening and intense. A longitudinal, randomised controlled trial of this approach in patients receiving oral immunotherapy for food allergies found that describing side effects as a sign treatment was working reduced the rate at which patients contacted providers with concerns about side effects and led to greater increases in a biomarker of allergic tolerance from pretreatment to post-treatment (peanut-specific blood IgG4). In unveiling this approach, this article also raises important issues regarding which treatments and symptoms this approach should be applied to. Finally, we outline questions future research should address to further understand and leverage this approach.

Healthcare professionals must communicate with patients and relatives. They must enable informed, realistic and appropriate decisions in end-of-life pharmacotherapy

Por: Lee · A. J.

Commentary on: Morin L, Wastesson JW, Laroche ML, et al. How many older adults receive drugs of questionable clinical benefit near the end of life? A cohort study. Palliat Med 2019;33:1080–90. doi: 10.1177/0269216319854013.

Implications for practice and research

  • Healthcare professionals must review medications for appropriateness, efficacy and benefits to their patients and must communicate effectively with patients and relatives.

  • We need to re-examine and review drug use and prescribing practices to assert clinically and contextually appropriate care. However, qualitative research is needed to evaluate clinician prescribing with patients.

  • Context

    Use of a variety of drugs (polypharmacy) is required to manage complex disease processes. At the end of life, the focus of ‘treatment’ changes from extending survival to symptom management—therefore, aims of treatments change, requiring different pharmaceutical approaches.1 A recent Delphi study used consensus opinion of 40 experts to label drugs as ‘often...

    Coping with multiple morbidities: Asian perspectives to inform culturally appropriate caregiving

    Por: Zhan · X. · Wenchung · W. · Lin · H. · Jingran · L. · Li · B. · Li · M. T. · Tian Fu · R. · Wu · Y. · Wu · X. · Shi · X. · Lee · A. J. · Shengxiao · X.

    Commentary on: Cheng Cheng, Bai Jie, Yang Cong-Yan et al. Patients' experiences of coping with multiple chronic conditions: a qualitative descriptive study. J Clin Nurs, 2019, 28: 4400–11.

    Implications for practice and research

  • Healthcare professionals must acknowledge cultural differences in coping strategies and must communicate effectively to inform caregiving.

  • Further qualitative, descriptive studies are required to explore the needs of patients so this information can inform culturally sensitive and appropriate care.

  • Context

    As prevalence of multiple chronic conditions (MCC) increases, financial, personal and institutional burdens will rise.1 Complexities require more information on polypharmacy, disease management and assessments of impact on service provision.2 This qualitative study3 evaluates how patients cope with their diagnoses and manage their own symptoms. It offers a cultural perspective on the burdens of chronic disease management and presents guidance on coping strategies used in Chinese...

    Optimising antimicrobial stewardship interventions in English primary care: a behavioural analysis of qualitative and intervention studies

    Por: Borek · A. J. · Wanat · M. · Atkins · L. · Sallis · A. · Ashiru-Oredope · D. · Beech · E. · Butler · C. C. · Chadborn · T. · Hopkins · S. · Jones · L. · McNulty · C. A. M. · Roberts · N. · Shaw · K. · Taborn · E. · Tonkin-Crine · S.
    Objective

    While various interventions have helped reduce antibiotic prescribing, further gains can be made. This study aimed to identify ways to optimise antimicrobial stewardship (AMS) interventions by assessing the extent to which important influences on antibiotic prescribing are addressed (or not) by behavioural content of AMS interventions.

    Settings

    English primary care.

    Interventions

    AMS interventions targeting healthcare professionals’ antibiotic prescribing for respiratory tract infections.

    Methods

    We conducted two rapid reviews. The first included qualitative studies with healthcare professionals on self-reported influences on antibiotic prescribing. The influences were inductively coded and categorised using the Theoretical Domains Framework (TDF). Prespecified criteria were used to identify key TDF domains. The second review included studies of AMS interventions. Data on effectiveness were extracted. Components of effective interventions were extracted and coded using the TDF, Behaviour Change Wheel and Behaviour Change Techniques (BCTs) taxonomy. Using prespecified matrices, we assessed the extent to which BCTs and intervention functions addressed the key TDF domains of influences on prescribing.

    Results

    We identified 13 qualitative studies, 41 types of influences on antibiotic prescribing and 6 key TDF domains of influences: ‘beliefs about consequences’, ‘social influences’, ‘skills’, ‘environmental context and resources’, ‘intentions’ and ‘emotions’. We identified 17 research-tested AMS interventions; nine of them effective and four nationally implemented. Interventions addressed all six key TDF domains of influences. Four of these six key TDF domains were addressed by 50%–67% BCTs that were theoretically congruent with these domains, whereas TDF domain 'skills' was addressed by 24% of congruent BCTs and 'emotions' by none.

    Conclusions

    Further improvement of antibiotic prescribing could be facilitated by: (1) national implementation of effective research-tested AMS interventions (eg, electronic decision support tools, training in interactive use of leaflets, point-of-care testing); (2) targeting important, less-addressed TDF domains (eg, 'skills', 'emotions'); (3) using relevant, under-used BCTs to target key TDF domains (eg, ‘forming/reversing habits’, ‘reducing negative emotions’, ‘social support’). These could be incorporated into existing, or developed as new, AMS interventions.

    How do we assess resilience and grit among internal medicine residents at the Mayo Clinic? A longitudinal validity study including correlations with medical knowledge, professionalism and clinical performance

    Por: Alahdab · F. · Halvorsen · A. J. · Mandrekar · J. N. · Vaa · B. E. · Montori · V. M. · West · C. P. · Murad · M. H. · Beckman · T. J.
    Background

    There has been limited research on the positive aspects of physician wellness and to our knowledge there have been no validity studies on measures of resilience and grit among internal medicine (IM) residents.

    Objectives

    To investigate the validity of resilience (10 items Connor-Davidson Resilience Scale (CD-RISC 10)) and grit (Short Grit Scale (GRIT-S)) scores among IM residents at a large academic centre, and assess potential associations with previously validated measures of medical knowledge, clinical performance and professionalism.

    Methods

    We evaluated CD-RISC 10 and GRIT-S instrument scores among IM residents at the Mayo Clinic Rochester, Minnesota between July 2017 and June 2019. We analysed dimensionality, internal consistency reliability and criterion validity in terms of relationships between resilience and grit, with standardised measures of residents’ medical knowledge (in-training examination (ITE)), clinical performance (faculty and peer evaluations and Mini-Clinical Evaluation Examination (mini-CEX)) and professionalism/dutifulness (conference attendance and evaluation completion).

    Results

    A total of 213 out of 253 (84.2%) survey-eligible IM residents provided both CD-RISC 10 and GRIT-S survey responses. Internal consistency reliability (Cronbach alpha) was excellent for CD-RISC 10 (0.93) and GRIT-S (0.82) overall, and for the GRIT subscales of consistency of interest (0.84) and perseverance of effort (0.71). CD-RISC 10 scores were negatively associated with ITE percentile (β=–3.4, 95% CI –6.2 to –0.5, p=0.02) and mini-CEX (β=–0.2, 95% CI –0.5 to –0.02, p=0.03). GRIT-S scores were positively associated with evaluation completion percentage (β=2.51, 95% CI 0.35 to 4.67, p=0.02) and conference attendance (β=2.70, 95% CI 0.11 to 5.29, p=0.04).

    Conclusions

    This study revealed favourable validity evidence for CD-RISC 10 and GRIT-S among IM residents. Residents demonstrated resilience within a competitive training environment despite less favourable test performance and grittiness that was manifested by completing tasks. This initial validity study provides a foundation for further research on resilience and grit among physicians in training.

    Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial

    Por: Holland · A. E. · Corte · T. · Chambers · D. C. · Palmer · A. J. · Ekström · M. P. · Glaspole · I. · Goh · N. S. L. · Hepworth · G. · Khor · Y. H. · Hoffman · M. · Vlahos · R. · Sköld · M. · Dowman · L. · Troy · L. K. · Prasad · J. D. · Walsh · J. · McDonald · C. F.
    Introduction

    Interstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.

    Methods and analysis

    A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.

    Ethics and dissemination

    Ethical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.

    Trial registration number

    ClinicalTrials.gov Registry (NCT03737409).

    Comparing the prevalence of multimorbidity using different operational definitions in primary care in Singapore based on a cross-sectional study using retrospective, large administrative data

    Por: Lee · Y. A. J. · Xie · Y. · Lee · P. S. S. · Lee · E. S.
    Objectives

    Multimorbidity is a norm in primary care. A consensus on its operational definition remains lacking especially in the list of chronic conditions considered. This study aimed to compare six different operational definitions of multimorbidity previously reported in the literature for the context of primary care in Singapore.

    Design, setting and participants

    This is a retrospective study using anonymised primary care data from a study population of 787 446 patients. We defined multimorbidity as having three or more chronic conditions in an individual. The prevalence of single conditions and multimorbidity with each operational definition was tabulated and standardised prevalence rates (SPRs) were obtained by adjusting for age, sex and ethnicity. We compared the operational definitions based on (1) number of chronic diseases, (2) presence of chronic diseases of high burden and (3) relevance in primary care in Singapore. IBM SPSS V.23 and Microsoft Office Excel 2019 were used for all statistical calculations and analyses.

    Results

    The SPRs of multimorbidity in primary care in Singapore varied from 5.7% to 17.2%. The lists by Fortin et al, Ge et al, Low et al and Quah et al included at least 12 chronic conditions, the recommended minimal number of conditions. Quah et al considered the highest proportion of chronic diseases (92.3%) of high burden in primary care in Singapore, with SPRs of at least 1.0%. Picco et al and Subramaniam et al considered the fewest number of conditions of high relevance in primary care in Singapore.

    Conclusions

    Fortin et al’s list of conditions is most suitable for describing multimorbidity in the Singapore primary care setting. Prediabetes and ‘physical disability’ should be added to Fortin et al’s list to augment its comprehensiveness. We propose a similar study methodology be performed in other countries to identify the most suitable operational definition in their own context.

    Needlestick and sharps injuries in an Indonesian tertiary teaching hospital from 2014 to 2017: a cohort study

    Por: Yunihastuti · E. · Ratih · D. M. · Aisyah · M. R. · Hidayah · A. J. · Widhani · A. · Sulaiman · A. S. · Karjadi · T. H. · Soejono · C. H.
    Objective

    Needlestick and sharps injuries among healthcare workers (HCWs) pose significant occupational health problems. We aim to provide incidence and other epidemiological aspects of needlestick and sharp injuries (NSSIs) among HCWs in a tertiary teaching hospital in Indonesia, to inform the evaluation of NSSIs prevention programme.

    Methods

    A cohort study was conducted at Cipto Mangunkusumo Hospital in Jakarta. We analysed data of the sharps injury programme at the hospital between January 2014 and December 2017. Incidence of NSSIs was calculated per 1000 person-years (1000-PY).

    Results

    Over the 4-year period, a total of 286 NSSIs were reported. The mean NSSIs incidence rate for 4 years was 13.3/1000-PY, peaking in 2015 (15.5/1000-PY) then decreasing afterward. Most NSSIs were experienced by nurses (42.7%), but the highest incidence was among midwives (18.9/1000-PY), followed by nurses, medical students and medical doctors (15.2/1000-PY, 12.6/1000-PY and 11.8/1000-PY, respectively). The devices causing the highest proportion of NSSIs were hollow-bore needles (66.8%), followed by suture needles (14.3%) and solid needles (10.8%). 9.4% of NSSIs were related to insulin pen injection. Of all the incidents, 31.3% occurred during surgical procedures, 25.9% during blood collections, 14.3% during administering injection of drugs and 13.3% during waste cleaning.

    Conclusion

    In conclusion, this study showed varied incidences of NSSI among different occupations, with the highest among midwives and nurses. Many unsafe work practices still continue, which is of utmost concern. We suggest opportunities for prevention including training and cultivating safer workplace practices.

    Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis

    Por: Baldwin · M. · Nagra · N. S. · Greenall · G. · Carr · A. J. · Beard · D. · Rees · J. L. · Rangan · A. · Merritt · N. · Dritsaki · M. · Hopewell · S. · Cook · J. A.
    Objective

    To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs).

    Design

    Systematic review and meta-analysis.

    Data sources

    MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020.

    Eligibility criteria

    All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions.

    Data extraction and synthesis

    Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane).

    Results

    We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.

    Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI –0.74 to –0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%).

    Conclusions

    While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations.

    Prospero registration number

    CRD42017057908.

    Environmental factors associated with general practitioner consultations for allergic rhinitis in London, England: a retrospective time series analysis

    Por: Todkill · D. · de Jesus Colon Gonzalez · F. · Morbey · R. · Charlett · A. · Hajat · S. · Kovats · S. · Osborne · N. J. · McInnes · R. · Vardoulakis · S. · Exley · K. · Edeghere · O. · Smith · G. · Elliot · A. J.
    Objectives

    To identify key predictors of general practitioner (GP) consultations for allergic rhinitis (AR) using meteorological and environmental data.

    Design

    A retrospective, time series analysis of GP consultations for AR.

    Setting

    A large GP surveillance network of GP practices in the London area.

    Participants

    The study population was all persons who presented to general practices in London that report to the Public Health England GP in-hours syndromic surveillance system during the study period (3 April 2012 to 11 August 2014).

    Primary measure

    Consultations for AR (numbers of consultations).

    Results

    During the study period there were 186 401 GP consultations for AR. High grass and nettle pollen counts (combined) were associated with the highest increases in consultations (for the category 216-270 grains/m3, relative risk (RR) 3.33, 95% CI 2.69 to 4.12) followed by high tree (oak, birch and plane combined) pollen counts (for the category 260–325 grains/m3, RR 1.69, 95% CI 1.32 to 2.15) and average daily temperatures between 15°C and 20°C (RR 1.47, 95% CI 1.20 to 1.81). Higher levels of nitrogen dioxide (NO2) appeared to be associated with increased consultations (for the category 70–85 µg/m3, RR 1.33, 95% CI 1.03 to 1.71), but a significant effect was not found with ozone. Higher daily rainfall was associated with fewer consultations (15–20 mm/day; RR 0.812, 95% CI 0.674 to 0.980).

    Conclusions

    Changes in grass, nettle or tree pollen counts, temperatures between 15°C and 20°C, and (to a lesser extent) NO2 concentrations were found to be associated with increased consultations for AR. Rainfall has a negative effect. In the context of climate change and continued exposures to environmental air pollution, intelligent use of these data will aid targeting public health messages and plan healthcare demand.

    Randomised controlled trial of tailored support to increase physical activity and reduce smoking in smokers not immediately ready to quit: protocol for the Trial of physical Activity-assisted Reduction of Smoking (TARS) Study

    Por: Taylor · A. · Thompson · T. P. · Ussher · M. · Aveyard · P. · Murray · R. L. · Harris · T. · Creanor · S. · Green · C. · Streeter · A. J. · Chynoweth · J. · Ingram · W. · Greaves · C. J. · Hancocks · H. · Snowsill · T. · Callaghan · L. · Price · L. · Horrell · J. · King · J. · Gude · A. · Ge
    Introduction

    Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.

    Methods and analysis

    A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.

    Ethics and dissemination

    Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.

    Trial registration number

    ISRCTN47776579; Pre-results.

    Retrospective cohort study of clinical characteristics of 2199 hospitalised patients with COVID-19 in New York City

    Por: Paranjpe · I. · Russak · A. J. · De Freitas · J. K. · Lala · A. · Miotto · R. · Vaid · A. · Johnson · K. W. · Danieletto · M. · Golden · E. · Meyer · D. · Singh · M. · Somani · S. · Kapoor · A. · O'Hagan · R. · Manna · S. · Nangia · U. · Jaladanki · S. K. · OReilly · P. · Huckins · L. M. · G
    Objective

    The COVID-19 pandemic is a global public health crisis, with over 33 million cases and 999 000 deaths worldwide. Data are needed regarding the clinical course of hospitalised patients, particularly in the USA. We aimed to compare clinical characteristic of patients with COVID-19 who had in-hospital mortality with those who were discharged alive.

    Design

    Demographic, clinical and outcomes data for patients admitted to five Mount Sinai Health System hospitals with confirmed COVID-19 between 27 February and 2 April 2020 were identified through institutional electronic health records. We performed a retrospective comparative analysis of patients who had in-hospital mortality or were discharged alive.

    Setting

    All patients were admitted to the Mount Sinai Health System, a large quaternary care urban hospital system.

    Participants

    Participants over the age of 18 years were included.

    Primary outcomes

    We investigated in-hospital mortality during the study period.

    Results

    A total of 2199 patients with COVID-19 were hospitalised during the study period. As of 2 April, 1121 (51%) patients remained hospitalised, and 1078 (49%) completed their hospital course. Of the latter, the overall mortality was 29%, and 36% required intensive care. The median age was 65 years overall and 75 years in those who died. Pre-existing conditions were present in 65% of those who died and 46% of those discharged. In those who died, the admission median lymphocyte percentage was 11.7%, D-dimer was 2.4 μg/mL, C reactive protein was 162 mg/L and procalcitonin was 0.44 ng/mL. In those discharged, the admission median lymphocyte percentage was 16.6%, D-dimer was 0.93 μg/mL, C reactive protein was 79 mg/L and procalcitonin was 0.09 ng/mL.

    Conclusions

    In our cohort of hospitalised patients, requirement of intensive care and mortality were high. Patients who died typically had more pre-existing conditions and greater perturbations in inflammatory markers as compared with those who were discharged.

    Study to evaluate the effectiveness and cost-effectiveness of different screening strategies for identifying undiagnosed COPD among residents (>=40 years) in four cities in China: protocol for a multicentre cross-sectional study on behalf of the Breath

    Por: Pan · Z. · Dickens · A. P. · Chi · C. · Kong · X. · Enocson · A. · Adab · P. · Cheng · K. K. · Sitch · A. J. · Jowett · S. · Jordan · R. · on behalf of the Breathe Well Group
    Introduction

    The latest chronic obstructive pulmonary disease (COPD) epidemiology survey in China estimated that there were 99 million potential COPD patients in the country, the majority of whom are undiagnosed. Screening for COPD in primary care settings is of vital importance for China, but it is not known which strategy would be the most suitable for adoption in primary care. Studies have been conducted to test the accuracy of questionnaires, expiratory peak flow meters and microspirometers to screen for COPD, but no study has directly evaluated and compared the effectiveness and cost-effectiveness of these methods in the Chinese setting.

    Methods and analysis

    We present the protocol for a multicentre cross-sectional study, to be conducted in eight community hospitals from four cities among Chinese adults aged 40 years or older to investigate the effectiveness and cost-effectiveness of different case-finding methods for COPD, and determine the test performance of individual and combinations of screening tests and strategies in comparison with quality diagnostic spirometry. Index tests are screening questionnaires (COPD Diagnostic Questionnaire (CDQ), COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk Questionnaire (CAPTURE), symptom-based questionnaire, COPD Screening Questionnaire (COPD-SQ)), microspirometer and peak flow. Each participant will complete all of these tests in one assessment. The primary analysis will compare the performance of a screening questionnaire with a handheld device. Secondary analyses will include the comparative performance of each index test, as well as a comparison of strategies where we use a screening questionnaire and a handheld device. Approximately 2000 participants will be recruited over 9 to 12 months.

    Ethics and dissemination

    The study has been approved by Peking University Hospital and University of Birmingham. All study participants will provide written informed consent. Study results will be published in appropriate journal and presented at national and international conferences, as well as relevant social media and various community/stakeholder engagement activities.

    Trial registration number

    ISRCTN13357135.

    How can patient experience scores be used to predict quality inspection ratings? A retrospective cross-sectional study of national primary care datasets in the UK

    Por: Tallett · A. · Poots · A. J. · Graham · C. · Peters · M. · Corbett · R. · Sizmur · S. · Forder · J.
    Objectives

    The relationship between patient feedback in the General Practice Patient Survey (GPPS) and Care Quality Commission (CQC) inspections of practices was investigated to understand whether there is an association between patient views and regulator ratings of quality. The specific aims were to understand whether patients’ self-reported experiences of primary care can predict CQC inspection ratings of GP practices by: (i) Measuring the association between GPPS results and CQC inspection ratings of GP practices; (ii) Building a predictive model of GP practice quality ratings that use GPPS results; and (iii) Evaluating the predictive model for risk stratification.

    Design

    Retrospective analysis of routinely collected data using decision tree modelling.

    Setting

    Primary care: GP practices in England.

    Primary and secondary outcome measures

    GPPS scores and GP practice CQC inspection ratings during 2018.

    Results

    Most GP practices (72%, 974/1350) were rated as ‘Good’ overall by CQC. Simply assuming that all practices will be rated as ‘Good’ results in a correct prediction 72% of the time, and it was not possible to improve on this overall level of predictive accuracy using decision tree modelling (correct in 73% of cases). However, a set of GPPS questions were found to have value in identifying practices at elevated risk of a poor inspection rating.

    Conclusions

    Although there were some associations between GPPS data and CQC inspection ratings, there were limitations to the use of GPPS data for predictive analysis. This is a likely result of the majority of CQC inspections of GPs resulting in a ‘Good’ or ‘Outstanding’ rating. However, some GPPS questions were found to have value in identifying practices at higher risk of an ‘Inadequate’ or ‘Requires Improvement’ rating, and this may be valuable for surveillance purposes. For example, the CQC could use key questions from the survey to target inspection planning.

    Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study

    Por: de Maar · J. S. · Suelmann · B. B. M. · Braat · M. N. G. J. A. · van Diest · P. J. · Vaessen · H. H. B. · Witkamp · A. J. · Linn · S. C. · Moonen · C. T. W. · van der Wall · E. · Deckers · R.
    Introduction

    In breast cancer, local tumour control is thought to be optimised by administering higher local levels of cytotoxic chemotherapy, in particular doxorubicin. However, systemic administration of higher dosages of doxorubicin is hampered by its toxic side effects. In this study, we aim to increase doxorubicin deposition in the primary breast tumour without changing systemic doxorubicin concentration and thus without interfering with systemic efficacy and toxicity. This is to be achieved by combining Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox, Celsion Corporation, Lawrenceville, NJ, USA) with mild local hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated above 39.5°C, LTLD releases a high concentration of doxorubicin intravascularly within seconds. In the absence of hyperthermia, LTLD leads to a similar biodistribution and antitumour efficacy compared with conventional doxorubicin.

    Methods and analysis

    This is a single-arm phase I study in 12 chemotherapy-naïve patients with de novo stage IV HER2-negative breast cancer. Previous endocrine treatment is allowed. Study treatment consists of up to six cycles of LTLD at 21-day intervals, administered during MR-HIFU-induced hyperthermia to the primary tumour. We will aim for 60 min of hyperthermia at 40°C–42°C using a dedicated MR-HIFU breast system (Profound Medical, Mississauga, Canada). Afterwards, intravenous cyclophosphamide will be administered. Primary endpoints are safety, tolerability and feasibility. The secondary endpoint is efficacy, assessed by radiological response.

    This approach could lead to optimal loco-regional control with less extensive or even no surgery, in de novo stage IV patients and in stage II/III patients allocated to receive neoadjuvant chemotherapy.

    Ethics and dissemination

    This study has obtained ethical approval by the Medical Research Ethics Committee Utrecht (Protocol NL67422.041.18, METC number 18-702). Informed consent will be obtained from all patients before study participation. Results will be published in an academic peer-reviewed journal.

    Trial registration numbers

    NCT03749850, EudraCT 2015-005582-23.

    Is the perceived impact of disciplinary procedures on medical doctors professional practice associated with working in an open culture and feeling supported? A questionnaire among medical doctors in the Netherlands who have been disciplined

    Por: Laarman · B. S. · Bouwman · R. J. R. · de Veer · A. J. E. · Friele · R. D.
    Introduction

    Disciplinary procedures can have a negative impact on the professional functioning of medical doctors. In this questionnaire study, doctors’ experience with open culture and support during a disciplinary procedure is studied to determine whether open culture and support are associated with perceived changes in the professional practice of doctors.

    Methods

    All doctors who received a warning or a reprimand from the Dutch Medical Disciplinary Board between July 2012 and August 2016 were invited to fill in a 60-item questionnaire concerning open culture, perceived support during the disciplinary procedure and the impact of the procedure on professional functioning as reported by doctors themselves. The response rate was 43% (n=294).

    Results

    A majority of doctors perceive their work environment as a safe environment in which to talk about and report incidents (71.2% agreed). Respondents felt supported by a lawyer or legal representative and colleagues (92.8% and 89.2%, respectively). The disciplinary procedure had effects on professional practice. Legal support and support from a professional confidant and a professional association were associated with fewer perceived changes to professional practice.

    Conclusion

    Our study shows that doctors who had been disciplined perceive their working environment as open. Doctors felt supported by lawyers and/or legal representatives and colleagues. Legal support was associated with less of a perceived impact on doctors’ professional practice.

    Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial

    Por: Powell · C. · Breen · L. · Fylan · B. · Ismail · H. · Alderson · S. L. · Gale · C. P. · Gardner · P. · Farrin · A. J. · Alldred · D. P. · ISCOMAT Programme Management Team · Silcock · Raynor · Turner · Wright · Kellar · Longo · Holloway · Bojke
    Introduction

    A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention.

    Methods and analysis

    The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021.

    Ethics and dissemination

    Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media.

    Trial registration number

    ISRCTN66212970.

    Feasibility and acceptability of implementing early infant diagnosis of HIV in Papua New Guinea at the point of care: a qualitative exploration of health worker and key informant perspectives

    Por: Mohamed · Y. · Kupul · M. · Gare · J. · Badman · S. G. · Silim · S. · Vallely · A. J. · Luchters · S. · Kelly-Hanku · A. · AAMI Study Group · Luchters · Crowe · Stoove · Anderson · Nightingale · Agius · Mohamed · Htay · Yee · Kelly-Hanku · Vallely · Badman · Kombati · Zaw · Chen · Tin
    Introduction

    Early infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and middle-income settings, particularly those in which standard care involves dried blood spots (DBS) sent to centralised laboratories, such as in Papua New Guinea (PNG). We conducted a qualitative exploration of the feasibility and acceptability of implementing a point-of-care (POC) EID test (Xpert HIV-1 Qualitative assay) among health workers and key stakeholders working within the prevention of mother-to-child transmission of HIV (PMTCT) programme in PNG.

    Methods

    This qualitative substudy was conducted as part of a pragmatic trial to investigate the effectiveness of the Xpert HIV-1 Qualitative test for EID in PNG and Myanmar. Semistructured interviews were undertaken with 5 health workers and 13 key informants to explore current services, experiences of EID testing, perspectives on the Xpert test and the feasibility of integrating and scaling up POC EID in PNG. Coding was undertaken using inductive and deductive approaches, drawing on existing acceptability and feasibility frameworks.

    Results

    Health workers and key informants (N=18) felt EID at POC was feasible to implement and beneficial to HIV-exposed infants and their families, staff and the PMTCT programme more broadly. All study participants highlighted starting HIV-positive infants on treatment immediately as the main advantage of POC EID compared with standard care DBS testing. Health workers identified insufficient resources to follow up infants and caregivers and space constraints in hospitals as barriers to implementation. Participants emphasised the importance of adequate human resources, ongoing training and support, appropriate coordination and a sustainable supply of consumables to ensure effective scale-up of the test throughout PNG.

    Conclusions

    Implementation of POC EID in a low HIV prevalence setting such as PNG is likely to be both feasible and beneficial with careful planning and adequate resources.

    Trial registration number

    12616000734460.

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