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Risk of COVID-19 hospital admission and COVID-19 mortality during the first COVID-19 wave with a special emphasis on ethnic minorities: an observational study of a single, deprived, multiethnic UK health economy

Por: Singh · B. M. · Bateman · J. · Viswanath · A. · Klaire · V. · Mahmud · S. · Nevill · A. · Dunmore · S. J.
Objectives

The objective of this study was to describe variations in COVID-19 outcomes in relation to local risks within a well-defined but diverse single-city area.

Design

Observational study of COVID-19 outcomes using quality-assured integrated data from a single UK hospital contextualised to its feeder population and associated factors (comorbidities, ethnicity, age, deprivation).

Setting/participants

Single-city hospital with a feeder population of 228 632 adults in Wolverhampton.

Main outcome measures

Hospital admissions (defined as COVID-19 admissions (CA) or non-COVID-19 admissions (NCA)) and mortality (defined as COVID-19 deaths or non-COVID-19 deaths).

Results

Of the 5558 patients admitted, 686 died (556 in hospital); 930 were CA, of which 270 were hospital COVID-19 deaths, 47 non-COVID-19 deaths and 36 deaths after discharge; of the 4628 NCA, there were 239 in-hospital deaths (2 COVID-19) and 94 deaths after discharge. Of the 223 074 adults not admitted, 407 died. Age, gender, multimorbidity and black ethnicity (OR 2.1 (95% CI 1.5 to 3.2), p

Conclusions

Wolverhampton’s results, reflecting high ethnic diversity and deprivation, are similar to other studies of black ethnicity, age and comorbidity risk in COVID-19 but strikingly different in South Asians and for deprivation. Sequentially considering population and then hospital-based NCA and CA outcomes, we present a complete single health economy picture. Risk factors may differ within ethnic groups; our data may be more representative of communities with high Black, Asian and minority ethnic populations, highlighting the need for locally focused public health strategies. We emphasise the need for a more comprehensible and nuanced conveyance of risk.

False-negative RT-PCR for COVID-19 and a diagnostic risk score: a retrospective cohort study among patients admitted to hospital

Por: Gupta-Wright · A. · Macleod · C. K. · Barrett · J. · Filson · S. A. · Corrah · T. · Parris · V. · Sandhu · G. · Harris · M. · Tennant · R. · Vaid · N. · Takata · J. · Duraisingham · S. · Gandy · N. · Chana · H. · Whittington · A. · McGregor · A. · Papineni · P.
Objective

To describe the characteristics and outcomes of patients with a clinical diagnosis of COVID-19 and false-negative SARS-CoV-2 reverse transcription-PCR (RT-PCR), and develop and internally validate a diagnostic risk score to predict risk of COVID-19 (including RT-PCR-negative COVID-19) among medical admissions.

Design

Retrospective cohort study.

Setting

Two hospitals within an acute NHS Trust in London, UK.

Participants

All patients admitted to medical wards between 2 March and 3 May 2020.

Outcomes

Main outcomes were diagnosis of COVID-19, SARS-CoV-2 RT-PCR results, sensitivity of SARS-CoV-2 RT-PCR and mortality during hospital admission. For the diagnostic risk score, we report discrimination, calibration and diagnostic accuracy of the model and simplified risk score and internal validation.

Results

4008 patients were admitted between 2 March and 3 May 2020. 1792 patients (44.8%) were diagnosed with COVID-19, of whom 1391 were SARS-CoV-2 RT-PCR positive and 283 had only negative RT-PCRs. Compared with a clinical reference standard, sensitivity of RT-PCR in hospital patients was 83.1% (95% CI 81.2%–84.8%). Broadly, patients with false-negative RT-PCR COVID-19 and those confirmed by positive PCR had similar demographic and clinical characteristics but lower risk of intensive care unit admission and lower in-hospital mortality (adjusted OR 0.41, 95% CI 0.27–0.61). A simple diagnostic risk score comprising of age, sex, ethnicity, cough, fever or shortness of breath, National Early Warning Score 2, C reactive protein and chest radiograph appearance had moderate discrimination (area under the receiver–operator curve 0.83, 95% CI 0.82 to 0.85), good calibration and was internally validated.

Conclusion

RT-PCR-negative COVID-19 is common and is associated with lower mortality despite similar presentation. Diagnostic risk scores could potentially help triage patients requiring admission but need external validation.

Temporal variation and geospatial clustering of dengue in Delhi, India 2015-2018

Por: Singh · P. S. · Chaturvedi · H. K.
Objectives

The study was focused on geographical mapping of dengue cases and also to identify the hotspots or high-risk areas of dengue in Delhi.

Design

A retrospective spatial–temporal (ecological) study. Descriptive analysis was used to know the distribution of dengue cases by age, sex, seasons and districts of Delhi. The spatiotemporal analysis was performed using inverse distance weighting and Getis-Ord Gi* statistic to know the geographical distribution and identify the hotspot areas.

Settings

All the confirmed and diagnosed dengue cases (IgM +ve or NS1 Antigen +ve ELISA) recorded by the Municipal Corporation of Delhi for the last 4 years (2015–2018) were collected with their local address. The location of all the dengue cases was geocoded using their address to prepare the spatiotemporal dengue database.

Participants

Record of all the dengue cases (4179) reported for treatment in the hospitals during the past 4 years were extracted and included in the study. Data were not collected directly from dengue patients.

Results

Seasonal occurrence of dengue cases (4179) shows that the cases start emerging in July, peaked in September–October and declined in December. The proportions of dengue cases were recorded high among the males 57.3% compared with females 42.6%, and differences were also recorded in all the age groups with more cases in age groups

Conclusion

Dengue occurrence shows significant association with age, sex and seasons. The spatial analysis identified the high-risk areas, which can aid health administrators to take necessary action for prevention and better disease management.

Physical activity reduces symptoms of anxiety, but further research is needed to determine a preventative effect

Por: Singh · S. · Yang · L.

Commentary on: McDowell, C, Dishman, RK, Gordon, BR, et al. Physical activity and anxiety: a systematic review and meta-analysis of prospective cohort studies. Am J Prev Med 2019;574:545–56.

Implications for practice and research

  • The burden of anxiety disorders and symptoms can potentially be reduced by increasing physical activity at the population level.

  • More studies require using prospective designs and rigorous measures for assessing anxiety and dosing of physical activity.

  • Context

    Anxiety is a debilitating1 and costly chronic illness.2 Pharmacological treatment of anxiety disorders and symptoms can be challenging with side effects and expensive for many,3 which makes prevention strategies critical. Physical activity has been previously shown to reduce the symptoms of anxiety and depression.4 Whether physical activity may be effective in preventing anxiety has not yet been previously investigated, presenting a knowledge gap and an opportunity...

    Attitudes of pharmacy students towards patient safety: a cross-sectional study from six developing countries

    Por: Naser · A. Y. · Alsairafi · Z. K. · Awaisu · A. · Alwafi · H. · Awwad · O. · Dahmash · E. Z. · Hussain · S. · Alyami · H. S. · Alsharif · A. · Singh · A. K. · Jeragh-Alhaddad · F. B. · Kautsar · A. P. · AbuAlhommos · A. K.
    Objective

    To evaluate the attitudes of undergraduate pharmacy students towards patient safety in six developing countries.

    Design

    A cross-sectional study.

    Setting

    Participants were enrolled from the participating universities in six countries.

    Participants

    Undergraduate pharmacy students from the participating universities in six developing countries (Jordan, Saudi Arabia, Kuwait, Qatar, India and Indonesia) were invited to participate in the study between October 2018 and September 2019.

    Primary outcome

    Attitudes towards patient safety was measured using 14-item questionnaire that contained five subscales: being quality-improvement focused, internalising errors regardless of harm, value of contextual learning, acceptability of questioning more senior healthcare professionals’ behaviour and attitude towards open disclosure. Multiple-linear regression analysis was used to identify predictors of positive attitudes towards patient safety.

    Results

    A total of 2595 students participated in this study (1044 from Jordan, 514 from Saudi Arabia, 134 from Kuwait, 61 from Qatar, 416 from India and 429 from Indonesia). Overall, the pharmacy students reported a positive attitude towards patient safety with a mean score of 37.4 (SD=7.0) out of 56 (66.8%). The ‘being quality-improvement focused’ subscale had the highest score, 75.6%. The subscale with the lowest score was ‘internalising errors regardless of harm’, 49.2%. Female students had significantly better attitudes towards patient safety scores compared with male students (p=0.001). Being at a higher level of study and involvement in or witnessing harm to patients while practising were important predictors of negative attitudes towards patient safety (p

    Conclusion

    Patient safety content should be covered comprehensively in pharmacy curricula and reinforced in each year of study. This should be more focused on students in their final year of study and who have started their training. This will ensure that the next generation of pharmacists are equipped with the requisite knowledge, core competencies and attitudes to ensure optimal patient safety when they practice.

    British Thoracic Society survey of rehabilitation to support recovery of the post-COVID-19 population

    Por: Singh · S. J. · Barradell · A. C. · Greening · N. J. · Bolton · C. · Jenkins · G. · Preston · L. · Hurst · J. R.
    Objective

    A proportion of those recovering from COVID-19 are likely to have significant and ongoing symptoms, functional impairment and psychological disturbances. There is an immediate need to develop a safe and efficient discharge process and recovery programme. Established rehabilitation programmes are well placed to deliver a programme for this group but will most likely need to be adapted for the post-COVID-19 population. The purpose of this survey was to rapidly identify the components of a post-COVID-19 rehabilitation assessment and elements of a successful rehabilitation programme that would be required to deliver a comprehensive service for those post-COVID-19 to inform service delivery.

    Design

    A survey comprising a series of closed questions and a free-text comment box allowing for a qualitative analysis.

    Setting

    Online survey.

    Participants

    Multiprofessional clinicians across specialties were invited to take part.

    Results

    1031 participants responded from a broad range of specialties. There was overwhelming support for an early posthospital discharge recovery programme to advise patients about the management of fatigue (95% agreed/strongly agreed), breathlessness (94%) and mood disturbances (including symptoms of anxiety and depression, 92%). At the time point of 6–8 weeks, an assessment was considered important, focusing on a broad range of possible symptoms and supporting a return to work. Recommendations for the intervention described a holistic programme focusing on symptom management, return of function and return to employment. The free-text comments added depth to the survey and the need ‘not to reinvent the wheel’ but rather adapt well-established rehabilitation services to individually tailor needs-based care with continued learning for service development.

    Conclusion

    The responses indicate a huge interest and the urgent need to establish a programme to support and mitigate the long-term impact of COVID-19 by optimising and individualising existing rehabilitation programmes.

    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.

    Enhancing early detection of neurological and developmental disorders and provision of intervention in low-resource settings in Uttar Pradesh, India: study protocol of the G.A.N.E.S.H. programme

    Por: Toldo · M. · Varishthananda · S. · Einspieler · C. · Tripathi · N. · Singh · A. · Verma · S. K. · Vishwakarma · K. · Zhang · D. · Dwivedi · A. · Gupta · R. · Karn · S. · Kerketta · N. · Narayan · R. · Nikam Singh · K. · Rani · S. · Singh · A. · Singh · D. · Singh · K. P. · Singh · N. · Singh
    Introduction

    Around 9% of India’s children under six are diagnosed with neurodevelopmental disorders. Low-resource, rural communities often lack programmes for early identification and intervention. The Prechtl General Movement Assessment (GMA) is regarded as the best clinical tool to predict cerebral palsy in infants

    Methods

    This 3-year observational cohort study will comprise at least 2000 infants born across four districts of Uttar Pradesh, India. Community health workers, certified for GMA, video record and assess the infants’ GMs twice, that is, within 2 months after birth and at 3–5 months. In case of abnormal GMs and/or reduced MOSs, infants are further examined by a paediatrician and a neurologist. If necessary, early intervention strategies (treatment as usual) are introduced. After paediatric and neurodevelopmental assessments at 12–24 months, outcomes are categorised as normal or neurological/developmental disorders. Research objective (1): to relate the GMA to the outcome at 12–24 months. Research objective (2): to investigate the impact of predefined exposures. Research objective (3): to evaluate the interscorer agreement of GMA.

    Ethics and dissemination

    G.A.N.E.S.H. received ethics approval from the Indian Government Chief Medical Officers of Varanasi and Mirzapur and from the Ramakrishna Mission Home of Service in Varanasi. GMA is a worldwide used diagnostic tool, approved by the Ethics Committee of the Medical University of Graz, Austria (27-388 ex 14/15). Apart from peer-reviewed publications, we are planning to deploy G.A.N.E.S.H. in other vulnerable settings.

    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.

    Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

    Por: Chattopadhyay · K. · Mishra · P. · Singh · K. · Harris · T. · Hamer · M. · Greenfield · S. M. · Lewis · S. A. · Manjunath · N. K. · Nair · R. · Mukherjee · S. · Harper · D. R. · Tandon · N. · Kinra · S. · Prabhakaran · D. · On behalf of YOGA-DP Study Team
    Introduction

    A huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.

    Intervention

    YOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.

    Methods and analysis

    This is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18–74 years, at high risk of T2DM (fasting plasma glucose level 5.6–6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20–30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.

    Ethics and dissemination

    Ethics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.

    Trial registration number

    CTRI/2019/05/018893.

    Intensive Care Weaning (iCareWean) protocol on weaning from mechanical ventilation: a single-blinded multicentre randomised control trial comparing an open-loop decision support system and routine care, in the general intensive care unit

    Por: Vizcaychipi · M. P. · Martins · L. · White · J. R. · Karbing · D. S. · Gupta · A. · Singh · S. · Osman · L. · Moreno-Cuesta · J. · Rees · S.
    Introduction

    Automated systems for ventilator management to date have been either fully heuristic rule-based systems or based on a combination of simple physiological models and rules. These have been shown to reduce the duration of mechanical ventilation in simple to wean patients. At present, there are no published studies that evaluate the effect of systems that use detailed physiological descriptions of the individual patient.

    The BEACON Caresystem is a model-based decision support system that uses mathematical models of patients’ physiology in combination with models of clinical preferences to provide advice on appropriate ventilator settings. An individual physiological description may be particularly advantageous in selecting the appropriate therapy for a complex, heterogeneous, intensive care unit (ICU) patient population.

    Methods and analysis

    Intenive Care weaning (iCareWean) is a single-blinded, multicentre, prospective randomised control trial evaluating management of mechanical ventilation as directed by the BEACON Caresystem compared with that of current care, in the general intensive care setting. The trial will enrol 274 participants across multiple London National Health Service ICUs. The trial will use a primary outcome of duration of mechanical ventilation until successful extubation.

    Ethics and dissemination

    Safety oversight will be under the direction of an independent committee of the study sponsor. Study approval was obtained from the regional ethics committee of the Health Research Authority (HRA), (Research Ethic Committee (REC) reference: 17/LO/0887. Integrated Research Application System (IRAS) reference: 226610. Results will be disseminated through international critical care conference/symposium and publication in peer-reviewed journal.

    Trial registration number

    ClinicalTrials.gov under NCT03249623. This research is registered with the National Institute for Health Research under CPMS ID: 34831.

    Protocol for the Sri Lankan Cerebral Palsy Register pilot study

    Por: Heiyanthuduwage · T. M. · Sumanasena · S. P. · Kitnasamy · G. · Smithers Sheedy · H. · Khandaker · G. · Fernando · R. · Wijesekara · S. · Jagoda · J. · Ratnayake · P. · Wanigasinghe · J. · Mclntyre · S. · Goldsmith · S. · Waight · E. · Badawi · N. · Muhit · M. · Muttiah · N.
    Introduction

    Cerebral palsy (CP) describes a heterogeneous group of motor disorders resulting from disturbance in the developing brain. CP occurs in approximately 2.1 per 1000 live births in high-income countries, but in low- and middle-income countries (LMICs) the prevalence and severity of CP may be greater and aetiological risk factors different. In Sri Lanka, a LMIC, there have been no epidemiological studies of CP to date. Systematically collected data are required to identify opportunities for primary and secondary prevention, to plan and establish services to support children and adults with CP and their families and to act as a sampling frame for new research. Here we describe a pilot study protocol for a CP register in Sri Lanka.

    Methods and analysis

    The aim of this study is to establish a CP register in Sri Lanka. We will use different surveillance methodologies in two provinces of Sri Lanka: hospital and community surveillance in the Western Province and community surveillance in the Eastern Province. A common record form will collect demographic, clinical and service data for children with CP

    Ethics and dissemination

    This study has ethical clearance from The University of Kelaniya, National Health Research Council, the Institutional Ethics Review Committee of the Lady Ridgeway Hospital, Colombo South Teaching Hospital and the Director of the North Colombo Teaching Hospital. Results from this research will be disseminated through local and international conferences and through publications in peer-reviewed journals.

    ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder

    Por: Whittingham · K. · McGlade · A. · Kulasinghe · K. · Mitchell · A. E. · Heussler · H. · Boyd · R. N.
    Introduction

    Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.

    Methods and analysis

    We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent–child interactions to improve early social reciprocity, while supporting parental mental health and the parent–child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent–infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.

    Ethics and dissemination

    This protocol has been approved by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.

    Trial registration number

    Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).

    SAFety, Effectiveness of care and Resource use among Australian Hospitals (SAFER Hospitals): a protocol for a population-wide cohort study of outcomes of hospital care

    Por: Ranasinghe · I. · Hossain · S. · Ali · A. · Horton · D. · Adams · R. J. · Aliprandi-Costa · B. · Bertilone · C. · Carneiro · G. · Gallagher · M. · Guthridge · S. · Kaambwa · B. · Kotwal · S. · O'Callaghan · G. · Scott · I. A. · Visvanathan · R. · Woodman · R. J.
    Introduction

    Despite global concerns about the safety and quality of health care, population-wide studies of hospital outcomes are uncommon. The SAFety, Effectiveness of care and Resource use among Australian Hospitals (SAFER Hospitals) study seeks to estimate the incidence of serious adverse events, mortality, unplanned rehospitalisations and direct costs following hospital encounters using nationwide data, and to assess the variation and trends in these outcomes.

    Methods and analysis

    SAFER Hospitals is a cohort study with retrospective and prospective components. The retrospective component uses data from 2012 to 2018 on all hospitalised patients age ≥18 years included in each State and Territories’ Admitted Patient Collections. These routinely collected datasets record every hospital encounter from all public and most private hospitals using a standardised set of variables including patient demographics, primary and secondary diagnoses, procedures and patient status at discharge. The study outcomes are deaths, adverse events, readmissions and emergency care visits. Hospitalisation data will be linked to subsequent hospitalisations and each region’s Emergency Department Data Collections and Death Registries to assess readmissions, emergency care encounters and deaths after discharge. Direct hospital costs associated with adverse outcomes will be estimated using data from the National Cost Data Collection. Variation in these outcomes among hospitals will be assessed adjusting for differences in hospitals’ case-mix. The prospective component of the study will evaluate the temporal change in outcomes every 4 years from 2019 until 2030.

    Ethics and dissemination

    Human Research Ethics Committees of the respective Australian states and territories provided ethical approval to conduct this study. A waiver of informed consent was granted for the use of de-identified patient data. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journals.

    Challenges and facilitators of hospice decision-making: a retrospective review of family caregivers of home hospice patients in a rural US-Mexico border region--a qualitative study

    Por: Ko · E. · Fuentes · D. · Singh-Carlson · S. · Nedjat-Haiem · F.
    Objectives

    Hospice care (HC) is seen as a comprehensive approach, that enhances quality of end-of-life (EOL) care, for terminally ill patients. Despite its positive aspects, HC enrolment is disproportionate for rural patients, who are less likely to use HC in comparison to their urban counterparts. The purpose of this study was to explore decision-making experiences, related to utilisation of HC programmes from a retrospective perspective, with family caregivers (FCGs) in a rural US–Mexico border region.

    Design

    This qualitative study was conducted from May 2017 to January 2018 using semistructured face to face interviews with FCGs. Data were analysed using thematic analysis.

    Setting

    The HC programme was situated at a local home health agency, located in rural Southern California, USA.

    Participants

    Twenty-eight informal FCGs of patients who were actively enrolled in the HC programme agreed to participate in the study.

    Results

    Conversation about HC as an option was initiated by home healthcare staff (39.3%), followed by physicians (32.1%). Emerging themes related to challenges in utilisation of HC and decision-making included: (1) communication barriers; (2) lack of knowledge/misperception about HC; (3) emotional difficulties, including fear of losing their patient, doubt and uncertainty about the decision, denial and (4) patients are not ready for HC. Facilitators included: (1) patient’s known EOL wishes; (2) FCG-physician EOL communication; (3) the patient’s deteriorating health and (4) home as the place for death.

    Conclusions

    HC patients’ FCGs in this rural region reported a lack of knowledge or misunderstanding of HC. It is recommended that healthcare providers need to actively engage family members in patient’s EOL care planning. Optimal transition to an HC programme can be facilitated when FCGs are informed and have a clear understanding about patients’ medical status along with information about HC.

    Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol

    Por: Raja · T. · Tuomainen · H. · Madan · J. · Mistry · D. · Jain · S. · Singh · S.
    Introduction

    Low-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.

    Methods and analysis

    Structured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18–60 years with a hospital stay of 12–120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.

    Ethics and dissemination

    The study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick’s Biomedical and Scientific Research Ethics Committee (REGO-2019–2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

    Implications of multimorbidity on healthcare utilisation and work productivity by socioeconomic groups: Cross-sectional analyses of Australia and Japan

    by Grace Sum, Marie Ishida, Gerald Choon-Huat Koh, Ankur Singh, Brian Oldenburg, John Tayu Lee

    Background

    Multimorbidity, the presence of 2 or more non-communicable diseases (NCDs), is a major contributor to inequalities of health in Australia and Japan. We use nationally representative data to examine (i) the relationships between multimorbidity with healthcare utilisation and productivity loss and (ii) whether these relationships differed by socioeconomic groups.

    Methods

    Cross-sectional analyses using the Household, Income, and Labour Dynamics in Australia (HILDA) and the Japanese Study of Aging and Retirement (JSTAR) surveys. We examined 6,382 (HILDA) and 3,503 (JSTAR) adults aged ≥50 years. We applied multivariable regression, logistic and negative binomial models.

    Results

    Prevalence of multimorbidity was overall 38.6% (46.0%, 36.1%, 28.9% amongst those in the lowest, middle and highest education group, respectively) in Australia, and 28.4% (33.9%, 24.6%, 16.6% amongst those in the lowest, middle and highest education group, respectively) in Japan. In Australia and Japan, more NCDs was associated with greater healthcare utilisation. In Australia and Japan, more NCDs was associated with higher mean number of sick leave days amongst the employed and lower odds of being employed despite being in the labour force. The association between multimorbidity and lower retirement age was found in Australia only.

    Conclusion

    Having more NCDs pose significant economic burden to the health system and wider society in Australia and Japan. Targeted policies are critical to improve financial protection, especially for lower income groups who are more likely to have multiple NCDs. These individuals incur both high direct and indirect costs, which lead to a greater risk of impoverishment.

    Promoting family integrated early child development (during first 1000 days) in urban slums of India (fine child 3‐3‐1000): Study protocol 促进印度城市贫民窟家庭早期儿童的综合发育(头1000天)(优良儿童3‐3‐1000):研究方案

    Abstract

    Aims

    This project tests a novel, targeted home visitation programme for child development targeted behaviour change during the first 1,000 days for families in Delhi urban slums.

    Background

    The first 1,000 days have highest brain development potential and is dependent on the available nutrition, health, social and cognitive stimulus. Over 1.3 million children are born annually in the slums of India and are at risk of limited development potential. The children in urban slums at multiplicity of adversities at family, society and environmental levels. No tools are available for the community health functionaries to support the families to promote child development.

    Design

    This cohort study targets provision of behaviour change interventions targeted at three groups (pregnant women, infants and children in year 2) to document the impact on child development.

    Methods

    This implementation project delivers nutrition, health and child stimulation integrated services for the families through existing government community health workers and nurses. These workers shall train the families using audio‐visual messages in tablets and demonstration kits for practice through quarterly home visits. Data on health, nutrition and child development shall be collected at baseline, midterm and after one year. The data from these participants shall be compared with data from recently delivered women, children aged 13 months and 25 months without intervention to document the impact.

    Discussion

    The successful implementation of the project has potential for future integration of the child development components into the existing programme at scale. The learning from this project shall be useful for India and other developing countries.

    Impact

    The first 1,000 days are critical period in human brain development and cognitive function acquisition potential, which is dependent on the available nutrition, health, social and cognitive stimulus. The development potential in children born and living in the slums, who are exposed to various adversities, can be mitigated through appropriate family‐level practices with support from the community health workers and Nurses. This study is documenting the feasibility and impact of home visit linked coaching of families for improving child development status during the first 1,000 days in three sums of Delhi, India.

    目标

    该项目针对德里城市贫民窟家庭头1000天儿童发育的行为变化开展一个新颖的、有针对性的家庭探访计划。

    背景信息

    头1000天的大脑发育潜力最大,其依赖于可获得的营养、健康、社会和认知激发。印度贫民窟出生的儿童每年有130多万,但发育的潜力有限。城市贫民窟儿童在家庭、社会和环境层面均面临多重的困境。社区卫生工作人员没有工具支持家庭促进儿童的发育。

    设计

    这项队列研究的目标是提供针对三组(孕妇、婴儿和2岁以下儿童)的行为改变介入治疗,以记录对儿童发育的影响。

    方法

    通过现有的政府社区卫生工作者和护士,为家庭提供营养、保健和儿童激发的综合服务。这些工作人员应通过季度家访,对使用平板电脑和演示工具包中的视听信息的家庭进行培训。应在基线、中期和一年后收集健康、营养和儿童发育数据。这些受访者的数据应与最近分娩的妇女、13个月和25个月大的儿童的数据进行比较,以记录其影响。

    讨论

    该项目的成功实施有可能使儿童的发育工作在未来按比例纳入现有方案。从这个项目中吸取的经验教训将对印度和其他发展中国家有益。

    影响

    头1000天是人类大脑发育和获得认知功能潜能的关键时期,这取决于可获得的营养、健康、社会和认知激发。在社区卫生工作者和护士的支持下,通过家庭层面采取的适当做法,可以推动在贫民窟出生和生活的儿童面临各种逆境的发育潜力。这项研究记录了家访相关的家庭辅导对于改善印度德里三个城市贫民窟的孩子前1000天发育状况的可行性和影响。

    Hospital-based sentinel surveillance for Streptococcus pneumoniae and other invasive bacterial diseases in India (HBSSPIBD): design and methodology

    Por: Rajkumar · P. · Bharathy · S. · Girish Kumar · C. P. · Veeraraghavan · B. · Verghese · V. · Gupta · N. · Kangusamy · B. · Ravi · M. · Jayaraman · Y. · HBSSPIBD network team · HBSSPIBD network team* · Malik · Biswas · Kumar · Singh · Nag · Sharma · Kumar · Varghese · Kumar D · Sharma
    Introduction

    Streptococcus pneumoniae is one of the frequently isolated organisms and an important aetiological agent of invasive bacterial diseases (IBD) like pneumonia, meningitis and sepsis. As a measure to control the burden of IBD, the Government of India introduced Pneumoccocal Conjugate Vaccine-13 (PCV-13) in the Universal Immunization Program in high burden districts of five states in a phased manner from 2017 onwards. It is essential to understand the trend of circulating pneumococcal serotypes associated with IBD in the prevaccination and postvaccination scenarios to decide on the expansion of vaccination programmes and PCV reformulation. This manuscript describes the protocol for hospital-based sentinel surveillance for S. pneumoniae and other organisms causing IBD across various geographical regions in India.

    Methods and analysis

    Hospital-based surveillance is established in selected hospitals to recruit children aged 1–59 months with symptoms of pneumonia and other IBD. Diagnostic criteria were adapted from standard WHO case definitions. Case Report Forms (CRFs) are used to collect data from the enrolled children. Blood, cerebrospinal fluid (CSF) and other normally sterile body fluids are collected and subjected to microscopy, cytology, latex agglutination, biochemistry, bacteriological culture and real-time PCR as applicable. Pneumococcal isolates are serotyped and tested for assessing antimicrobial resistance patterns. Data will be analysed by simple descriptive statistics to estimate the proportion of pneumonia and other IBD due to S. pneumoniae, Hemophilus influenzae type b and Neisseria meningitidis. Prevalence of bacterial infection, circulating pneumococcal serotypes, antibiotic resistance patterns, serotype variability across seasons and regions will be described in terms of percentage with 95% confidence interval.

    Ethics and dissemination

    The institutional review boards of the coordinating centre, all sentinel sites, regional and national reference laboratories approved the project. The results will be published in peer-reviewed journals and shared with stakeholders for deciding on revising vaccination strategy appropriately.

    Pressure injury development in critically ill patients with a cervical collar in situ: A retrospective longitudinal study

    Abstract

    Trauma patients with a serious injury to the head or neck can remain immobilised with a cervical collar (C‐collar) device in situ and are subsequently exposed to device‐related skin integrity threats. This study aimed to determine the incidence and risk factors associated with the development of C‐collar‐related pressure injures (CRPIs) in an intensive care unit. This retrospective longitudinal cohort study was conducted in an Australian metropolitan intensive care unit. Following ethical approval, data from patients over 18 years, who received a C‐collar were retrieved over a 9‐year period. Chi square and t‐tests were used to identify variables associated with CRPI development. A logistic regression model was employed to analyse the risk factors. Data from 906 patients were analysed. Nine‐year pressure injury incidence was 16.9% (n = 154/906). Pressure injury development directly associated with a C‐collar increased by 33% with each repositioning episode (odds ratio 1.328, 95% confidence interval 1.024‐1.723, P = .033). Time in the C‐collar (10.4 to 2.5 days, P = .002) and length of stay in intensive care unit (ICU) (20.1 to 16.1 days, P < .001) were associated with pressure injury development. Patients with C‐collar devices are a vulnerable group at risk for pressure injury development because of their immobility and length of ICU stay.

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