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1.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-322998

ABSTRACT

Introduction: Care homes have been severely affected by the SARS-CoV-2 pandemic. Rapid antigen testing could identify most SARS-CoV-2 infected staff and visitors before they enter homes. We explored implementation of staff and visitor testing protocols using lateral flow devices (LFDs). Methods: An evaluation of a SARS-CoV-2 LFD based testing protocol in 11 care homes in Liverpool, UK, including staff and visitor testing, plus a qualitative exploratory study in 9 of these homes. The proportion of pilot homes with outbreaks, and outbreak size, were compared to non-pilot homes in Liverpool. Adherence to testing protocols was evaluated. Fifteen staff were interviewed, and transcript data were thematically coded using an iterative analysis to identify and categorize factors influencing testing implementation. Results: 1638 LFD rapid tests were performed on 407 staff. Protocol adherence was poor with 8.6% of staff achieving &gt;75% protocol adherence, and 25.3% achieving ≥50%. Six care homes had outbreaks during the study. Compared to non-pilot care homes, there was no evidence of significant difference in the proportion of homes with outbreaks, or the size of outbreaks. Qualitative data showed difficulty implementing testing strategies due to excessive work burden. Factors influencing adherence related to test integration and procedural factors, socio-economic factors, cognitive overload, and the emotional value of testing. Conclusion: Implementation of staff and visitor care home LFD testing protocols was poorly adhered to and did not reduce the number or scale of COVID-19 outbreaks. More focus is needed on the contextual and behavioural factors that influence protocol adherence.<br>

2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-314159

ABSTRACT

Introduction: Antigen-based lateral flow devices (LFDs) offer the potential of widespread rapid testing. The scientific literature has primarily focused on mathematical modelling of their use and test performance characteristics. For these tests to be implemented successfully, an understanding of the real-world contextual factors that allow them to be integrated into the workplace is vital. Objectives: To address this gap in knowledge, we aimed to explore staff’s experiences of integrating LFDs into routine practice for visitors and staff testing with a view to understand implementation facilitators and barriers.Methods: Semi-structured interviews and thematic analysis.Results: We identified two main themes and five subthemes. The main themes included: visitor-related testing factors and staff-related testing factors. Subthemes included: restoring a sense of normality, visitor-related testing challenges, staff-related testing challenges, and pre-pilot antecedent factors.Conclusion: Our study demonstrates that the real-world implementation of LFDs to test visitors and staff faces significant challenges as a result of several contextual factors negatively affecting the work practice and environment. More comprehensive studies are needed to identify and inform effective implementation strategies to ensure that LFDs can be adopted in an agile way that better supports an already exhausted and morally depleted workforce.

3.
2021.
Preprint in English | Other preprints | ID: ppcovidwho-295483

ABSTRACT

Introduction Successful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of contextual and usability factors that affect test results and minimise biosafety risks. This paper presents findings from a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes. Methods A mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was carried out to explore biosafety issues. Results The agreement analysis was carried out on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI: 1.3%-98.7%) positive agreement and 96% (95% CI: 92.5%-98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857-0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 100% (95% CI: 63.1%-100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549-1). The dry run showed four main sources of contamination that led to the modification of the standard operating procedures. Simulation after modification showed no further evidence of contamination. Conclusion Careful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

4.
Journal of Patient Safety and Risk Management ; : 25160435211054207, 2021.
Article in English | Sage | ID: covidwho-1523271

ABSTRACT

IntroductionSuccessful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of the contextual and usability factors that affect test results and minimise biosafety risks. This paper presents a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes.MethodsA mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was conducted to explore biosafety issues.ResultsThe agreement analysis was conducted on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI:1.3%?98.7%) positive agreement and 96% (95% CI: 92.5%?98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857?0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%?99.6%) positive agreement and 100% (95% CI: 63.1%?100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549?1). The dry run highlighted four main sources of contamination that led to the modification of the standard operating procedures. Simulation post-modification showed no further evidence of contamination.ConclusionCareful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

5.
BMC Health Serv Res ; 21(1): 1153, 2021 Oct 25.
Article in English | MEDLINE | ID: covidwho-1484313

ABSTRACT

INTRODUCTION: Antigen-based lateral flow devices (LFDs) offer the potential of widespread rapid testing. The scientific literature has primarily focused on mathematical modelling of their use and test performance characteristics. For these tests to be implemented successfully, an understanding of the real-world contextual factors that allow them to be integrated into the workplace is vital. To address this gap in knowledge, we aimed to explore staff's experiences of integrating LFDs into routine practice for visitors and staff testing with a view to understand implementation facilitators and barriers. METHODS: Semi-structured interviews and thematic analysis. RESULTS: We identified two main themes and five subthemes. The main themes included: visitor-related testing factors and staff-related testing factors. Subthemes included: restoring a sense of normality, visitor-related testing challenges, staff-related testing challenges, and pre-pilot antecedent factors. CONCLUSION: Our study demonstrates that the real-world implementation of LFDs to test visitors and staff faces significant challenges as a result of several contextual factors negatively affecting the work practice and environment. More comprehensive studies are needed to identify and inform effective implementation strategies to ensure that LFDs can be adopted in an agile way that better supports an already exhausted and morally depleted workforce.


Subject(s)
COVID-19 , Long-Term Care , Humans , Nursing Homes , Qualitative Research , SARS-CoV-2
6.
Age Ageing ; 50(6): 1868-1875, 2021 11 10.
Article in English | MEDLINE | ID: covidwho-1316792

ABSTRACT

INTRODUCTION: Care homes have been severely affected by the SARS-CoV-2 pandemic. Rapid antigen testing could identify most SARS-CoV-2 infected staff and visitors before they enter homes. We explored implementation of staff and visitor testing protocols using lateral flow devices (LFDs). METHODS: An evaluation of a SARS-CoV-2 LFD-based testing protocol in 11 care homes in Liverpool, UK, including staff and visitor testing, plus a qualitative exploratory study in nine of these homes. The proportion of pilot homes with outbreaks, and outbreak size, were compared to non-pilot homes in Liverpool. Adherence to testing protocols was evaluated. Fifteen staff were interviewed, and transcript data were thematically coded using an iterative analysis to identify and categorize factors influencing testing implementation. RESULTS: In total, 1,638 LFD rapid tests were performed on 407 staff. Protocol adherence was poor with 8.6% of staff achieving >75% protocol adherence, and 25.3% achieving $\ge$50%. Six care homes had outbreaks during the study. Compared to non-pilot care homes, there was no evidence of significant difference in the proportion of homes with outbreaks, or the size of outbreaks. Qualitative data showed difficulty implementing testing strategies due to excessive work burden. Factors influencing adherence related to test integration and procedural factors, socio-economic factors, cognitive overload and the emotional value of testing. CONCLUSION: Implementation of staff and visitor care home LFD testing protocols was poorly adhered to and consequently did not reduce the number or scale of COVID-19 outbreaks. More focus is needed on the contextual and behavioural factors that influence protocol adherence.


Subject(s)
COVID-19 , COVID-19 Testing , Disease Outbreaks/prevention & control , Humans , Pandemics , SARS-CoV-2
7.
Age Ageing ; 50(5): 1442-1444, 2021 09 11.
Article in English | MEDLINE | ID: covidwho-1226520

ABSTRACT

COVID-19 has devastated care homes. Point-of-care tests (POCTs), mainly using lateral flow devices (LFDs), have been deployed hurriedly without much consideration of their usability or impact on care workflow. Even after the pandemic, POCTs, particularly multiplex tests, may be an important control against spread of SARS-CoV-2 and other respiratory infections in care homes by enabling identification of cases. They should not, however, replace other infection control measures such as barrier methods and quarantine. Adherence to LFDs as implemented among care home staff is suboptimal. Other tests-such as point-of-care polymerase chain reaction and automated antigen tests-would also need to be accommodated into care home workflows to improve adherence. The up-front costs of POCTs are straightforward but additional costs, including staffing preparation and reporting processes and the impacts of false positive and negative tests on absence rates and infection days, are more complex and as yet unquantified. A detailed appraisal is needed as the future of testing in care homes is considered.


Subject(s)
COVID-19 , Humans , Pandemics , Point-of-Care Testing , Policy , SARS-CoV-2
8.
Age Ageing ; 50(5): 1464-1472, 2021 09 11.
Article in English | MEDLINE | ID: covidwho-1196971

ABSTRACT

INTRODUCTION: Reliable rapid testing for COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. This study aimed to examine the usability and test performance of a point of care polymerase chain reaction (PCR) test for detection of SARS-CoV-2 (POCKITTM Central) in care homes. METHODS: POCKITTM Central was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and used errors were assessed. RESULTS: No significant usability-related hazards emerged, and the sources of error identified were found to be amendable with minor changes in training or test workflow. POCKITTM Central has acceptable sensitivity and specificity based on RT-PCR as the reference standard, especially for symptomatic cases.Asymptomatic specimens showed 83.3% (95% confidence interval (CI): 35.9-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932- 0.999). Symptomatic specimens showed 100% (95% CI: 2.5-100%) positive agreement and 100% negative agreement (95% CI: 85.8-100%), with overall PABAK of 1.Recommendations are provided to mitigate the frequency of occurrence of the residual use errors observed. Integration pathways were discussed to identify opportunities and limitations of adopting POCKIT™ Central for screening and diagnostic testing purposes. CONCLUSIONS: Point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19 Testing , Humans , Point-of-Care Systems , Point-of-Care Testing , Polymerase Chain Reaction , Sensitivity and Specificity
9.
Age Ageing ; 50(3): 668-672, 2021 05 05.
Article in English | MEDLINE | ID: covidwho-1043239

ABSTRACT

INTRODUCTION: Care home residents are at high risk of dying from coronavirus disease 2019 (COVID-19). Regular testing, producing rapid and reliable results is important in this population because infections spread quickly, and presentations are often atypical or asymptomatic. This study evaluated current testing pathways in care homes to explore the role of point-of-care tests (POCTs). METHODS: A total of 10 staff from eight care homes, purposively sampled to reflect care organisational attributes that influence outbreak severity, underwent a semi-structured remote videoconference interview. Transcripts were analysed using process mapping tools and framework analysis focussing on perceptions about, gaps within and needs arising from current pathways. RESULTS: Four main steps were identified in testing: infection prevention, preparatory steps, swabbing procedure and management of residents. Infection prevention was particularly challenging for mobile residents with cognitive impairment. Swabbing and preparatory steps were resource-intensive, requiring additional staff resource. Swabbing required flexibility and staff who were familiar to the resident. Frequent approaches to residents were needed to ensure they would participate at a suitable time. After-test management varied between sites. Several homes reported deviating from government guidance to take more cautious approaches, which they perceived to be more robust. CONCLUSION: Swab-based testing is organisationally complex and resource-intensive in care homes. It needs to be flexible to meet the needs of residents and provide care homes with rapid information to support care decisions. POCT could help address gaps but the complexity of the setting means that each technology must be evaluated in context before widespread adoption in care homes.


Subject(s)
COVID-19 Testing , COVID-19 , Nursing Homes , Point-of-Care Testing , COVID-19/diagnosis , COVID-19/prevention & control , Humans , Interviews as Topic , Qualitative Research , SARS-CoV-2
10.
PLoS One ; 15(11): e0242125, 2020.
Article in English | MEDLINE | ID: covidwho-922707

ABSTRACT

There is an urgent requirement to identify which clinical settings are in most need of COVID-19 tests and the priority role(s) for tests in these settings to accelerate the development of tests fit for purpose in health and social care across the UK. This study sought to identify and prioritize unmet clinical needs for COVID-19 tests across different settings within the UK health and social care sector via an online survey of health and social care professionals and policymakers. Four hundred and forty-seven responses were received between 22nd May and 15th June 2020. Hospitals and care homes were recognized as the settings with the greatest unmet clinical need for COVID-19 diagnostics, despite reporting more access to laboratory molecular testing than other settings. Hospital staff identified a need for diagnostic tests for symptomatic workers and patients. In contrast, care home staff expressed an urgency for screening at the front door to protect high-risk residents and limit transmission. The length of time to test result was considered a widespread problem with current testing across all settings. Rapid tests for staff were regarded as an area of need across general practice and dental settings alongside tests to limit antibiotics use.


Subject(s)
Clinical Laboratory Techniques/statistics & numerical data , Coronavirus Infections/diagnosis , Health Services Needs and Demand , Pneumonia, Viral/diagnosis , Betacoronavirus , COVID-19 , COVID-19 Testing , Hospitals , Humans , Nursing Homes , Pandemics , SARS-CoV-2 , Surveys and Questionnaires , United Kingdom
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