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Formative independent evaluation of a digital change programme in the English National Health Service: study protocol for a longitudinal qualitative study

Por: Cresswell · K. · Sheikh · A. · Dean Franklin · B. · Krasuska · M. · Nguyen · H. · Hinder · S. · Lane · W. · Mozaffar · H. · Mason · K. · Eason · S. · Potts · H. · Williams · R.
Introduction

Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations.

Methods and analysis

This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders.

Ethics and dissemination

This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.

Single assessment of delirium severity during postacute intensive care of chronically critically ill patients and its associated factors: post hoc analysis of a prospective cohort study in Germany

Por: Wintermann · G.-B. · Weidner · K. · Strauss · B. · Rosendahl · J.
Objectives

To assess the delirium severity (DS), its risk factors and association with adverse patient outcomes in chronically critically ill (CCI) patients.

Design

A prospective cohort study.

Setting

A tertiary care hospital with postacute intensive care units (ICUs) in Germany.

Participants

N=267 CCI patients with critical illness polyneuropathy and/or critical illness myopathy, aged 18–75 years, who had undergone elective tracheotomy for weaning failure.

Interventions

None.

Measures

Primary outcomes: DS was assessed using the Confusion Assessment Method for the Intensive Care Unit-7 delirium severity score, within 4 weeks (t1) after the transfer to a tertiary care hospital. In post hoc analyses, univariate linear regressions were employed, examining the relationship of DS with clinical, sociodemographic and psychological variables. Secondary outcomes: additionally, correlations of DS with fatigue (using the Multidimensional Fatigue Inventory-20), quality of life (using the Euro-Quality of Life) and institutionalisation/mortality at 3 (t2) and 6 (t3) months follow-up were computed.

Results

Of the N=267 patients analysed, 9.4% showed severe or most severe delirium symptoms. 4.1% had a full-syndromal delirium. DS was significantly associated with the severity of illness (p=0.016, 95% CI –0.1 to –0.3), number of medical comorbidities (p

Conclusions

Illness severity is positively associated with DS during postacute care in CCI patients. An adequate management of delirium is essential in order to mitigate functional and cognitive long-term sequelae following ICU.

Trial registration number

DRKS00003386.

Predicting the chance on live birth per cycle at each step of the IVF journey: external validation and update of the van Loendersloot multivariable prognostic model

Por: Devroe · J. · Peeraer · K. · Verbeke · G. · Spiessens · C. · Vriens · J. · Dancet · E.
Objective

To study the performance of the ‘van Loendersloot’ prognostic model for our clinic’s in vitro fertilisation (IVF) in its original version, the refitted version and in an adapted version replacing previous by current cycle IVF laboratory variables.

Methods

This retrospective cohort study in our academic tertiary fertility clinic analysed 1281 IVF cycles of 591 couples, who completed at least one 2nd–6th IVF cycle with own fresh gametes after a previous IVF cycle with the same partner in our clinic between 2010 and 2018. The outcome of interest was the chance on a live birth after one complete IVF cycle (including all fresh and frozen embryo transfers from the same episode of ovarian stimulation). Model performance was expressed in terms of discrimination (c-statistics) and calibration (calibration model, comparison of prognosis to observed ratios of five disjoint groups formed by the quintiles of the IVF prognoses and a calibration plot).

Results

A total of 344 live births were obtained (26.9%). External validation of the original van Loendersloot model showed a poor c-statistic of 0.64 (95% CI: 0.61 to 0.68) and an underestimation of IVF success. The refitted and the adapted models showed c-statistics of respectively 0.68 (95% CI: 0.65 to 0.71) and 0.74 (95% CI: 0.70 to 0.77). Similar c-statistics were found with cross-validation. Both models showed a good calibration model; refitted model: intercept=0.00 (95% CI: –0.23 to 0.23) and slope=1.00 (95% CI: 0.79 to 1.21); adapted model: intercept=0.00 (95% CI: –0.18 to 0.18) and slope=1.00 (95% CI: 0.83 to 1.17). Prognoses and observed success rates of the disjoint groups matched well for the refitted model and even better for the adapted model.

Conclusion

External validation of the original van Loendersloot model indicated that model updating was recommended. The good performance of the refitted and adapted models allows informing couples about their IVF prognosis prior to an IVF cycle and at the time of embryo transfer. Whether this has an impact on couple’s expected success rates, distress and IVF discontinuation can now be studied.

Understanding the importance of non-material factors in retaining community health workers in low-income settings: a qualitative case-study in Ethiopia

Por: Arora · N. · Hanson · K. · Spicer · N. · Estifanos · A. S. · Keraga · D. W. · Welearegay · A. T. · Tela · F. G. · Hussen · Y. A. · Mandefro · Y. S. · Quaife · M.
Objectives

The motivation and retention of community health workers (CHWs) is a challenge and inadequately addressed in research and policy. We sought to identify factors influencing the retention of CHWs in Ethiopia and ways to avert their exit.

Design

A qualitative study was undertaken using in-depth interviews with the study participants. Interviews were audio-recorded, and then simultaneously translated into English and transcribed for analysis. Data were analysed in NVivo 12 using an iterative inductive-deductive approach.

Setting

The study was conducted in two districts each in the Tigray and Southern Nations, Nationalities and People’s Republic (SNNPR) regions in Ethiopia. Respondents were located in a mix of rural and urban settings.

Participants

Leavers of health extension worker (HEW) positions (n=20), active HEWs (n=16) and key informants (n=11) in the form of policymakers were interviewed.

Results

We identified several extrinsic and intrinsic motivational factors affecting the retention and labour market choices of HEWs. While financial incentives in the form of salaries and material incentives in the form of improvements to health facility infrastructure, provision of childcare were reported to be important, non-material factors like HEWs’ self-image, acceptance and validation by the community and their supervisors were found to be critical. A reduction or loss of these non-material factors proved to be the catalyst for many HEWs to leave their jobs.

Conclusion

Our study contributes new empirical evidence to the global debate on factors influencing the motivation and retention of CHWs, by being the first to include job leavers in the analysis. Our findings suggest that policy interventions that appeal to the social needs of CHWs can prove to be more acceptable and potentially cost-effective in improving their retention in the long run. This is important for government policymakers in resource constrained settings like Ethiopia that rely heavily on lay workers for primary healthcare delivery.

Stroke incidence and subtypes in Aboriginal people in remote Australia: a healthcare network population-based study

Por: Balabanski · A. H. · Goldsmith · K. · Giarola · B. · Buxton · D. · Castle · S. · McBride · K. · Brady · S. · Thrift · A. G. · Katzenellenbogen · J. · Brown · A. · Burrow · J. · Donnan · G. A. · Koblar · S. · Kleinig · T. J.
Objectives

We aimed to compare the incidence, subtypes and aetiology of stroke, and in-hospital death due to stroke, between Aboriginal and non-Aboriginal people in Central Australia, a remote region of Australia where a high proportion Aboriginal people reside (40% of the population). We hypothesised that the rates of stroke, particularly in younger adults, would be greater in the Aboriginal population, compared with the non-Aboriginal population; we aimed to elucidate causes for any identified disparities.

Design

A retrospective population-based study of patients hospitalised with stroke within a defined region from 1 January 2011 to 31 December 2014.

Setting

Alice Springs Hospital, the only neuroimaging-capable acute hospital in Central Australia, serving a network of 50 healthcare facilities covering 672 000 km2.

Participants

161 residents (63.4% Aboriginal) of the catchment area admitted to hospital with stroke.

Primary and secondary outcome measures

Rates of first-ever stroke, overall (all events) stroke and in-hospital death.

Results

Of 121 residents with first-ever stroke, 61% identified as Aboriginal. Median onset-age (54 years) was 17 years younger in Aboriginal patients (p

Conclusions

Stroke incidence (both subtypes) and in-hospital deaths for remote Aboriginal Australians are dramatically greater than in non-Aboriginal people, especially in patients aged

Exploring how people with dementia can be best supported to manage long-term conditions: a qualitative study of stakeholder perspectives

Por: Rees · J. L. · Burton · A. · Walters · K. R. · Leverton · M. · Rapaport · P. · Herat Gunaratne · R. · Beresford-Dent · J. · Cooper · C.
Objectives

To explore how the self-management of comorbid long-term conditions is experienced and negotiated by people with dementia and their carers.

Design

Secondary thematic analysis of 82 semi-structured interviews.

Setting

Community settings across the United Kingdom.

Participants

11 people with dementia, 22 family carers, 19 health professionals and 30 homecare staff.

Results

We identified three overarching themes: (1) The process of substituting self-management: stakeholders balanced the wishes of people with dementia to retain autonomy with the risks of lower adherence to medical treatments. The task of helping a person with dementia to take medication was perceived as intermediate between a personal care and a medical activity; rules about which professionals could perform this activity sometimes caused conflict. (2) Communication in the care network: family carers often communicated with services and made decisions about how to implement medical advice. In situations where family carers or homecare workers were not substituting self-management, it could be challenging for general practitioners to identify changes in self-management and decide when to intervene. (3) Impact of physical health on and from dementia: healthcare professionals acknowledged the inter-relatedness of physical health and cognition to adapt care accordingly. Some treatments prescribed for long-term conditions were perceived as unhelpful when not adapted to the context of dementia. Healthcare professionals and homecare workers sometimes felt that family carers were unable to accept that available treatments may not be helpful to people with dementia and that this sometimes led to the continuation of treatments of questionable benefit.

Conclusion

The process of substituting self-management evolves with advancement of dementia symptoms and relies on communication in the care network, while considering the impact on and from dementia to achieve holistic physical health management. Care decisions must consider people with dementia as a whole, and be based on realistic outcomes and best interests.

Effects of crowding in the emergency department on the diagnosis and management of suspected acute coronary syndrome using rapid algorithms: an observational study

Por: Stoyanov · K. M. · Biener · M. · Hund · H. · Mueller-Hennessen · M. · Vafaie · M. · Katus · H. A. · Giannitsis · E.
Objectives

Fast diagnostic algorithms using high-sensitivity troponin (hsTn) in suspected acute coronary syndrome (ACS) are regarded as beneficial to expedite diagnosis and safe discharge of patients in crowded emergency departments (ED). This study investigates the effects of crowding on process times related to the diagnostic protocol itself or other time delays, and outcomes.

Design

Prospective single-centre observational study.

Setting

ED (Germany).

Participants

Final study population of 2525 consecutive patients with suspected ACS within 12 months, after exclusion of patients with ST-elevation myocardial infarction, missing blood samples, referral from other hospitals or repeated visits.

Interventions

Use of fast algorithms as per 2015 European Society of Cardiology guidelines.

Main outcome measures

Crowding was defined as mismatch between patient numbers and monitoring capacities, or mean physician time per case, categorised as normal, high and very high crowding. Outcome measures were length of ED stay, direct discharge from ED, laboratory turn around times (TAT), utilisation of fast algorithms, absolute and relative non-laboratory time, as well as mortality.

Results

Crowding was associated with increased length of ED stay (3.75–4.89 hours, p

Conclusions

Process times, and particularly non-laboratory times, are prolonged in a crowded ED diminishing some positive effects of fast diagnostic algorithms in suspected ACS. Higher crowding levels were not significantly associated with higher all-cause mortality rates.

Trial registration number

NCT03111862.

Establishment of sex-specific reference intervals for automated haematology analyser-delivered research parameters in healthy Korean adults: a retrospective database review

Por: Jeon · K. · Kim · M. · Han · J. · Lee · J. · Lee · J.-s. · Kim · H.-S. · Kang · H. J. · Lee · Y. K.
Objectives

Automated haematology analysers measure various parameters of relevance to clinical research along with routine complete blood count (CBC)-related components. We aimed to establish ethnicity-specific and sex-specific reference intervals for 26 research-specific parameters as well as 18 routinely reported components using a large cohort of healthy Korean adults. The necessity of requiring separate sex-specific reference intervals for each parameter was also examined.

Design

A retrospective database review.

Setting

Single tertiary-care hospital of approximately 375 physicians and 530 nurses.

Participants

This study included 1383 reference individuals (840 men and 543 women).

Primary and secondary outcome measures

Following the Clinical and Laboratory Standards Institute guidelines for establishing reference intervals, routine CBCs as well as research parameters were measured using an ADVIA 2120i instrument.

Results

All the routine components except for mean platelet volume and per cent lymphocytes differed significantly between men and women. Most research parameters also differed between the sexes; the exceptions were large platelets, platelet dry mass distribution width, per cent basophil saturation, per cent peroxidase saturation and per cent abnormal peroxidase absorption. Despite these differences, separate reference intervals for men and women were required only for two research-specific parameters: ‘percentage high cellular haemoglobin’ and ‘percentage of hyperchromic red blood cells (RBCs)’.

Conclusion

Even though most parameters showed significant differences between men and women, none of the evaluated parameters except two RBC-related factors required separate reference intervals for each sex.

Changes in the quality of care of colorectal cancer in Estonia: a population-based high-resolution study

Por: Reima · H. · Soplepmann · J. · Elme · A. · Lohmus · M. · Tiigi · R. · Uksov · D. · Innos · K.
Objectives

Large disparities in colorectal cancer (CRC) management and survival have been observed across Europe. Despite recent increases, the survival deficit of Estonian patients with CRC persists, particularly for rectal cancer. The aim of this study was to examine diagnostic, staging and treatment patterns of CRC in Estonia, comparing clinical data from 1997 and 2011.

Design

Nationwide population-based retrospective study.

Setting

Estonia.

Participants

All incident cases of colon and rectal cancer diagnosed in 1997 and 2011 identified from the Estonian Cancer Registry. Clinical data gathered from medical records.

Outcome measures

Differences in diagnostic, staging and treatment patterns; 5-year relative survival ratios.

Results

The number of colon cancer cases was 337 in 1997 and 498 in 2011; for rectal cancer, the respective numbers were 209 and 349. From 1997 to 2011, large increases were seen in the use of colonoscopy and lung and liver imaging. Radical resection rate increased from 48% to 59%, but emergency surgeries showed a rise from 18% to 26% in colon and from 7% to 14% in rectal cancer. The proportion of radically operated patients with ≥12 lymph nodes examined pathologically increased from 2% to 58% in colon cancer and from 2% to 50% in rectal cancer. The use of neoadjuvant radiotherapy increased from 6% to 39% among stage II and from 20% to 50% among patients with stage III rectal cancer. The use of adjuvant chemotherapy in stage III colon cancer increased from 42% to 63%. The 5-year RSR increased from 50% to 58% in colon cancer and from 37% to 64% in patients with rectal cancer.

Conclusions

Major improvements were seen in the diagnostics, staging and treatment of CRC in Estonia contributing to better outcomes. Increase in emergency surgeries highlights possible shortcomings in timely diagnosis and treatment.

Impact of National Drug Pricing Policy 2018 on access to medicines in Lahore division, Pakistan: a pre-post survey study using WHO/HAI methodology

Por: Saeed · A. · Saeed · H. · Saleem · Z. · Yang · C. · Jiang · M. · Zhao · M. · Ji · W. · Aziz · M. M. · Khan · F. U. · Gillani · A. H. · Atif · N. · Fang · Y. · Babar · Z. U. D.
Objective

To evaluate the impact of new National Drug Pricing Policy (NDPP) 2018 on access to medicines in terms of prices, availability and affordability.

Design

Two cross-sectional surveys were undertaken before and after the launch of NDPP 2018, using a modified WHO/Health Action International (WHO/HAI) methodology.

Setting

Four districts of Lahore division, Pakistan.

Participants

16 public sector hospitals and 16 private sector retail pharmacies.

Measures

The pre and post survey data on prices and availability of lowest price generics (LPGs) and originator brands (OBs) of 50 medicines were obtained by visiting the same public and private sector health facilities (n=32). Out of 50, 46 surveyed medicines were from the National Essential Medicines List. Inflation-adjusted median unit prices (MUPs) and median price ratios (MPRs) from 2019 were used for price comparison. Affordability was calculated in terms of number of days’ wages required to get a standard treatment by the lowest paid unskilled government worker.

Results

The overall mean percent availabilities remained poor in both years, that is, far less than 80%. In the public sector, the mean percent availability of OBs improved from 6.8% to 33.1%, whereas, in the case of LPGs, it was reduced from 35.1% to 9%. In the private sector, the mean percent availability of both OBs and LPGs demonstrated slight improvements in 2019, that is, 55.0%–58.3% and 20.3%–32.3%. The adjusted MUPs and MPRs of OBs significantly increased by a median of 4.29% (Wilcoxon test p=0.001, p=0.0001), whereas the adjusted MUPs and MPRs of LPGs increased by a median of 15.7% (p=0.002, p=0.0002). Overall, the affordability of many medicines for common ailments was reduced significantly in 2019.

Conclusions

The availability of medicines slightly improved, except in the case of LPGs, which was reduced in the public sector. The implementation of NDPP 2018 led to increase in drug prices, making the standard treatment for some of the most prevalent ailments unaffordable. So verily, the drug pricing policy must be reviewed to ensure access to essential medicines.

Patient or family perceived deterioration in functional status and outcome after intensive care admission: a retrospective cohort analysis of routinely collected data

Por: Gross · J. L. · Borkowski · J. · Brett · S. J.
Objective

To explore the association of patient or family reported functional deterioration (defined by a single question) in the preceding year, with mortality outcome for those admitted to the intensive care unit (ICU).

Design

Retrospective observational analysis of a routinely collected data source.

Participants

Patients that were admitted to the ICU at Northwick Park and St Marks Hospitals, London North West University Healthcare NHS Trust between 01 October 2017 to 15 June 2019 were included. Patients were excluded if they had a prior ICU admission during the existing hospital episode or if information on functional deterioration could not be retrieved from either the patient or their advocate.

Primary outcomes

Mortality at the point of hospital discharge and 1 year following admission to the ICU.

Results

Of the 1006 patients who were admitted to the ICU during the study period, information on functional deterioration was available for 621 patients who were included in the analysis. From these, 251 (40.4%) patients had patient or family reported functional deterioration in the preceding year, while 370 (59.6%) patients had a perceived stable functional baseline. Comparing the two groups, mortality was significantly higher in those who had functionally deteriorated compared with those with stable baseline function, at the point of hospital discharge (45.4% vs 25.9%; p

Conclusion

Patient or family reported functional deterioration was significantly associated with higher mortality at the point of hospital discharge and at 1 year. The concept of functional deterioration in the lead up to ICU admission warrants further exploration.

Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity

Por: McGuinty · M. · Angel · J. B. · Cooper · C. L. · Cowan · J. · MacPherson · P. A. · Kumar · A. · Murthy · S. · Sy · R. · Dennehy · M. · Tremblay · N. · Byrareddy · S. N. · Cameron · D. W.
Introduction

Continuous antiretroviral therapy (ART) suppresses HIV plasma viral load (pVL) to very low levels, which allows for some immune recovery. Discontinuation of ART leads to pVL rebound from reservoirs of persistence and latency, and progressive immunodeficiency. One promising but controversial strategy targeting CD4+ T lymphocytes with a monoclonal antibody (mAb) against α4β7 integrin has shown promise through sustained virological remission of pVL (SVR) in SIV239-infected rhesus macaques. We propose to assess the safety and tolerability of vedolizumab, a licensed humanised mAb against human α4β7 integrin, in healthy HIV-infected adults on ART. This study will also assess, by analytical treatment interruption (ATI), whether vedolizumab treatment can induce SVR beyond ART and vedolizumab treatment.

Methods and analysis

The HIV-ART-vedolizumab-ATI (HAVARTI) trial is a single-arm, dose-ranging pilot trial in healthy HIV-positive adult volunteers receiving ART. Twelve consenting persons will be enrolled in sequential groups of 4 to each serial dosing vedolizumab regimen (300 mg, 150 mg, 75 mg). The primary outcomes are: (1) to assess the safety and tolerability of seven serial infusions of vedolizumab at each of three doses; (2) to identify the immunovirological measures, including pVL and T-cell kinetics, that characterise HIV/ART cases before, during, after vedolizumab treatment and ATI; and (3) to seek SVR of pVL after ATI. Secondary outcomes will include immune reconstitution and pVL suppression as well as immune reconstitution and long-term safety following re-initiation of ART in the absence of SVR.

Ethics and dissemination

The study protocol was approved by the Ottawa Health Science Network-REB and by the Health Canada Therapeutic Products Directorate. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open access journal within a year of study completion.

Trial registration number

ClinicalTrials.gov NCT03147859; https://clinicaltrials.gov/ct2/show/NCT03147859

Healthcare utilisation in overweight and obese children: a systematic review and meta-analysis

Por: Hasan · T. · Ainscough · T. S. · West · J. · Fraser · L. K.
Objective

This systematic review and meta-analysis aims to systematically analyse the association of overweight and obesity with health service utilisation during childhood.

Data sources

PubMed, MEDLINE, CINAHL, EMBASE and Web of Science.

Methods

Observational studies published up to May 2020 that assessed the impact of overweight and obesity on healthcare utilisation in children and adolescents were included. Studies were eligible for inclusion if the included participants were ≤19 years of age. Findings from all included studies were summarised narratively. In addition, rate ratios (RRs) and 95% CIs were calculated in a meta-analysis on a subgroup of eligible studies.

Outcome measures

Included studies reported association of weight status with healthcare utilisation measures of outpatient visits, emergency department (ED) visits, general practitioner visits, hospital admissions and hospital length of stay.

Results

Thirty-three studies were included in the review. When synthesising the findings from all studies narratively, obesity and overweight were found to be positively associated with increased healthcare utilisation in children for all the outcome measures. Six studies reported sufficient data to meta-analyse association of weight with outpatient visits. Five studies were included in a separate meta-analysis for the outcome measure of ED visits. In comparison with normal-weight children, rates of ED (RR 1.34, 95% CI 1.07 to 1.68) and outpatient visits (RR 1.11, 95% CI 1.02 to 1.20) were significantly higher in obese children. The rates of ED and outpatient visits by overweight children were only slightly higher and non-significant compared with normal-weight children.

Conclusions

Obesity in children is associated with increased healthcare utilisation. Future research should assess the impact of ethnicity and obesity-associated health conditions on increased healthcare utilisation in children with overweight and obesity.

PROSPERO registration number

CRD42018091752

Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial

Por: Pocovi · N. C. · Lin · C.-W. C. · Latimer · J. · Merom · D. · Tiedemann · A. · Maher · C. · van Tulder · M. W. · Macaskill · P. · Clavisi · O. · Tong · S. Y. K. · Hancock · M. J.
Introduction

Low back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).

Methods and analysis

A pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.

Ethics and dissemination

Approved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.

Trial registration number

ACTRN12619001134112.

Factors influencing management of agitation in aged care facilities: a qualitative study of staff perceptions

Abstract

Background

Agitation in older people is commonly associated with cognitive decline, complex medical diagnoses and polypharmacy. Impaired communication and comprehension within a dementia trajectory adds complexity to assessment and management. Despite high prevalence, agitated behaviours remain challenging to manage in residential aged care settings.

Aim

To explore staff perceptions of agitation in residents of aged care facilities, including the influence of dementia, when selecting management strategies to reduce agitated behaviour.

Design

Qualitative descriptive.

Methods

Semi‐structured interviews with 11 aged care staff were conducted at two aged care sites. Transcripts were examined using content analysis to identify common issues and categories. The study complied with COREQ guidelines. (see. Supplementary file)

Results

Participants reported managing resident agitation at least once per shift; most frequently manifesting as wandering, restlessness, or aggression. Management strategies included distraction, providing space, knowing the resident, identifying causative factors, spending individual time, and if necessary medication administration. Agitation management was more challenging for residents with dementia due to impaired communication or comprehension of instruction.

Conclusions

While participants strived to deliver individualised person‐centred care, this was difficult given time and resource constraints. Contemporary management of agitation therefore remains variable in everyday practice, with resident preference used when causative factors were known. Conversely, for residents with impaired communication and/or comprehension, distraction and chemical restraint were commonly used. Nuanced education for assessment and management is recommended to better address this unmet need for some residents.

Relevance to clinical practice

For optimal care, appropriate allocation of time and resources is necessary to identify causative and contextual factors for individual residents. Recommendations are for additional staff training in communication and attitude, and collaborating with frontline staff to develop a practical guide for management of agitation in aged care. These simple initiatives may help to improve consistency of care delivery and resident outcomes.

Recovery Experiences of Younger Stroke Survivors Who Are Parents: A Qualitative Content Analysis

Abstract

Aims and objectives

To explore the experience of parenting for younger stroke survivors (aged 18 to 64 years at the time of the stroke).

Background

Stroke among younger adults increased 43% between 2000 and 2010. The social, emotional, and physical functioning of younger adults affects multiple aspects of their lives including parenting. There is limited research on the experience of parenting after stroke.

Design

This is a qualitative descriptive study.

Methods

We conducted individual semi‐structured interviews with 10 younger adults who were actively parenting children under the age of 18 years at the time of the stroke. Conventional content analysis was used to analyze the data. We report the methods and results using the COREQ checklist.

Results

Impairments from stroke disrupted participants’ identity, relationships, and roles as a parent. The degree to which parenting abilities and behaviors were affected by stroke was contingent upon the type and severity of impairments as well as the children's age. Participants also observed emotional and behavioral changes in their children in response to their stroke. Support from family, friends, healthcare providers, and children's school/daycare was crucial to participants throughout their stroke recovery. Two major themes emerged: 1) finding a new normal and 2) support for parenting post‐stroke.

Conclusions

Findings enable a deeper understanding of the distinct parenting challenges younger stroke survivors face and can inform future research on this population.

Relevance for clinical practice

Study findings highlight the need for continual and tailored follow‐up by nurses and other allied healthcare professionals to decrease the difficulty stroke survivors experience when trying to resume their role as parents.

Nurses’ experiences of compassionate care in the palliative pathway

Abstract

Aims and objectives

The aim was to explore how nurses experience compassionate care for patients with cancer and family caregivers in different phases of the palliative pathway.

Background

Compassion is fundamental to palliative care and viewed as a cornerstone of high‐quality care provision. Healthcare authorities emphasize that patients should have the opportunity to stay at home for as long as possible. There are, however, care deficiencies in the palliative pathway.

Design

This study employed a qualitative design using focus groups and a hermeneutic approach.

Methods

Four focus groups with three to seven female nurses in each group were conducted in Mid‐Norway in 2018. Nurses’ ages ranged from 28‐60 years (mean age =45 years), and they were recruited through purposive sampling (N = 21). Compassionate care was chosen as the theoretical framework. Reporting followed the COREQ guidelines.

Results

Three themes expressing compassionate care related to different phases of the pathway were identified: (a) information and dialogue, (b) the creation of a space for dying, and (c) family caregivers’ acceptance of death.

Conclusions

This study showed that it was crucial to create a space for dying, characterized by trust, collaboration, good relationships, empathy, attention, silence, caution, slowness, symptom relief, and the absence of noise and conflict.

Relevance to clinical practice

The quality of compassion possessed by individual practitioners, as well as the overall design of the healthcare system, must be considered when creating compassionate care for patients and their family caregivers. Nursing educators and health authorities should pay attention to the development of compassion in education and practice. Further research should highlight patients’ and family caregivers’ experiences of compassionate care and determine how healthcare systems can support compassionate care.

Impact

What does this paper contribute to the wider global clinical community? It provides insight into nurses’ role in compassionate care in different phases of the palliative pathway. It highlights the importance of early engagement with family caregivers, as a key element of compassionate care. Nurses play a crucial role in creating a space for dying, which is important for patients’ and their family members’ preparation for death.

Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design

Por: Raywood · E. · Douglas · H. · Kapoor · K. · Filipow · N. · Murray · N. · O'Connor · R. · Stott · L. · Saul · G. · Kuzhagaliyev · T. · Davies · G. · Liakhovich · O. · Van Schaik · T. · Furtuna · B. · Booth · J. · Shannon · H. · Bryon · M. · Main · E.
Introduction

Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes.

Methods and analysis

A cohort of 145 children and young people with CF aged 6–16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.

This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes.

Ethics and dissemination

Ethical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment.

Trial registration number

ISRCTN51624752; Pre-results.

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

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

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

Design

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

Setting and participants

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

Main outcome measures

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

Results

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

Conclusion

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

Do components of adult height predict body composition and cardiometabolic risk in a young adult South Asian Indian population? Findings from a hospital-based cohort study in Pune, India: Pune Childrens Study

Por: Kumaran · K. · Joshi · S. M. · Di Gravio · C. · Lubree · H. · Joglekar · C. · Bhat · D. · Kinare · A. · Bavdekar · A. · Bhave · S. · Pandit · A. · Osmond · C. · Yajnik · C. · Fall · C.
Objectives

We investigated whether the relationship between components of height and cardiovascular disease (CVD) risk may be explained by body composition. We also examined relationships between parental heights and offspring CVD risk.

Design

A cohort study using cross-sectional data.

Setting

A secondary care hospital setting in Pune, India.

Participants

We studied 357 young adults and their parents in the Pune Children’s Study. Primary and secondary outcomes: we measured weight, total height, leg length, sitting height, plasma glucose, insulin and lipids, and blood pressure (BP). Total and regional lean and fat mass were measured by dual X-ray absorptiometry.

Results

Leg length was inversely related, and sitting height was directly related to BMI. Total height and leg length were directly related to lean mass, while sitting height was directly related to both lean and fat mass. Leg length was inversely related to systolic BP and 120 min glucose, independent of lean and fat mass. Sitting height was directly related to systolic BP and triglycerides; these relationships were attenuated on adjustment for lean and fat mass. When examined simultaneously, greater leg length was protective and greater sitting height was associated with a more detrimental CVD risk profile.

Conclusions

Shorter adult leg length and greater sitting height are associated with a more adverse CVD risk factor profile. The mechanisms need further study, but our findings suggest a role for lean and fat mass.

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