Is point-of-care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-CoV-2.
Ontology highlight
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.
SUBMITTER: Micocci M
PROVIDER: S-EPMC8083194 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundOlder people living in care homes in England have complex health needs due to a range of medical conditions, mental health needs and frailty. Despite an increasing policy expectation that professionals should operate in an integrated way across organisational boundaries, there is a lack of understanding between care homes and the National Health Service (NHS) about how the two sectors should work together, meaning that residents can experience a poor "fit" between their needs, and services they can access. This paper describes a survey to establish the current extent of integrated working that exists between care homes and primary and community health and social services.MethodsA self-completion, online questionnaire was designed by the research team. Items on the different dimensions of integration (funding, administrative, organisational, service delivery, clinical care) were included. The survey was sent to a random sample of residential care homes with more than 25 beds (n = 621) in England in 2009. Responses were analysed using quantitative and qualitative methods.ResultsThe survey achieved an overall response rate of 15.8%. Most care homes (78.7%) worked with more than one general practice. Respondents indicated that a mean of 14.1 professionals/ services (other than GPs) had visited the care homes in the last six months (SD 5.11, median 14); a mean of .39 (SD.163) professionals/services per bed. The most frequent services visiting were district nursing, chiropody and community psychiatric nurses. Many (60%) managers considered that they worked with the NHS in an integrated way, including sharing documents, engaging in integrated care planning and joint learning and training. However, some care home managers cited working practices dictated by NHS methods of service delivery and priorities for care, rather than those of the care home or residents, a lack of willingness by NHS professionals to share information, and low levels of respect for the experience and knowledge of care home staff.ConclusionsCare homes are a hub for a wide range of NHS activity, but this is ad hoc with no recognised way to support working together. Integration between care homes and local health services is only really evident at the level of individual working relationships and reflects patterns of collaborative working rather than integration. More integrated working between care homes and primary health services has the potential to improve quality of care in a cost-effective manner, but strategic decisions to create more formal arrangements are required to bring this about. Commissioners of services for older people need to capitalise on good working relationships and address idiosyncratic patterns of provision to care homes.The low response rate is indicative of the difficulty of undertaking research in care homes.
| S-EPMC3534387 | biostudies-literature
Project description:BackgroundTesticular cancer survivors are at risk for cardiovascular disease, often preceded by early development of cardiovascular risk factors due to chemotherapeutic treatment. Therefore, close collaboration between oncologists and primary care physicians (PCPs) is needed during follow-up to monitor and manage cardiovascular risk factors. We designed a shared-care survivorship program, in which testicular cancer patients visit both their oncologist and their PCP. The objective of this study was to test the safety and feasibility of shared-care follow-up after treatment for metastatic testicular cancer.Patients and methodsThe study was designed as an observational cohort study with a stopping rule to check for the safety of follow-up. Safety boundaries were defined for failures in the detection of signals indicating cancer recurrence. Secondary outcomes were the proportion of carried out cardiovascular risk assessments, psychosocial status and patient preferences measured with an evaluation questionnaire.ResultsOne hundred and sixty-two patients were enrolled (69% of eligible testicular cancer patients). Almost all (99%, n = 150) PCPs of the enrolled patients agreed to participate in the study. In total, 364 primary care visits took place. No failures occurred in the detection of relapsed testicular cancer. Four follow-up visits were considered as failures because of organizational issues, without activation of the stopping rule. Eventually, the safe boundary was crossed indicating that this shared-care model is a safe alternative for follow-up after testicular cancer. Patients were satisfied with the knowledge level of PCPs. PCPs were willing to further extend their role in follow-up care after cancer.ConclusionsShared-care follow-up is safe and feasible in this patient population. Patients benefit from personalized care, partly close to their home. Within shared care, PCPs can have an important role in cardiovascular risk management and psychosocial survivorship issues.
| S-EPMC9271504 | biostudies-literature
Project description:COVID-19 poses a major challenge to care homes, as SARS-CoV-2 is readily transmitted and causes disproportionately severe disease in older people. Here, 1167 residents from 337 care homes were identified from a dataset of 6600 COVID-19 cases from the East of England. Older age and being a care home resident were associated with increased mortality. SARS-CoV-2 genomes were available for 700 residents from 292 care homes. By integrating genomic and temporal data, 409 viral clusters within the 292 homes were identified, indicating two different patterns - outbreaks among care home residents and independent introductions with limited onward transmission. Approximately 70% of residents in the genomic analysis were admitted to hospital during the study, providing extensive opportunities for transmission between care homes and hospitals. Limiting viral transmission within care homes should be a key target for infection control to reduce COVID-19 mortality in this population.
| S-EPMC7997667 | biostudies-literature
Project description:BackgroundThe accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values.MethodsFresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl. We measured the BG of each sample with 17 different commercially available glucose meters and the reference method (YSI 2300) at the same time. We determined the mean absolute relative difference (MARD) for each glucose meter, overall and stratified by reference BG and by hemoglobin level.ResultsThe accuracy of different meters widely, exhibiting a range of MARDs from 5.6% to 20.8%. Accuracy was lower in the hypoglycemic range, but was not consistently lower in samples with anemic blood hemoglobin levels.ConclusionsThe accuracy of commercially available glucose meters varies widely. Although the sample mix in this study was much more challenging than those that would be collected under most use conditions, some meters were robust to these challenges and exhibited high accuracy in this setting. These data on relative accuracy and robustness to challenging samples may be useful in informing the choice of a glucose meter.
| S-EPMC5505415 | biostudies-literature
Project description:Periodontitis is a chronic inflammation of the periodontium caused by persistent bacterial infection that leads to the breakdown of connective tissue and bone. Because the ability to reconstruct the periodontium is limited after alveolar bone loss, early diagnosis and intervention should be the primary goals of periodontal treatment. However, periodontitis often progresses without noticeable symptoms, and many patients do not seek professional dental care until the periodontal destruction progresses to the point of no return. Furthermore, the current diagnosis of periodontitis depends on time-consuming clinical measurements. Therefore, there is an unmet need for near-patient testing to diagnose periodontitis. Saliva is an optimal biological fluid to serve as a near-patient diagnostic tool for periodontitis. Recent developments in point-of-care (POC) testing indicate that a diagnostic test for periodontitis using saliva is now technically feasible. A number of promising salivary biomarkers associated with periodontitis have been reported. A panel of optimal biomarkers must be carefully selected based on the pathogenesis of periodontitis. The biggest hurdle for the POC diagnosis of periodontitis using saliva may be the process of validation in a large, diverse patient population. Therefore, we propose the organization of an International Consortium for Biomarkers of Periodontitis, which will gather efforts to identify, select, and validate salivary biomarkers for the diagnosis of periodontitis.
| S-EPMC4558535 | biostudies-literature
Project description:BackgroundIndications for endoscopic retrograde cholangiopancreatography (ERCP) in children differ from adults. Paucity of data and concerns about potential lower effectiveness and more side effects limit its use even in high volume centers. We retrospectively analyzed indications, success rates, limitations, and side effects of ERCPs in children <18 years.MethodsFrom January 2012 to March 2015, 54 ERCPs were performed in 31 children (median age 11 (0-17) years; median weight 22 (3.3-142.7) kg) with suspected choledocholithiasis (n = 13 interventions in 9 patients), post-transplantation anastomotic stenosis (10/4), malignancy (10/5), chronic pancreatitis (7/1), biliary atresia (6/6), anomaly (2/2), leak (4/3), or primary sclerosing cholangitis (PSC) (2/1). All patients were followed up as inpatients.ResultsThirty-six therapeutic and 18 diagnostic procedures were performed by adult ERCP expert endoscopists. Successful intervention was achieved in 90.7% of cases. Failed cannulation (n = 4) was associated with lower body weight (p = 0.023). In children younger than 1 year, ERCP was significantly more often diagnostic than in patients >1 year (p < 0.001). In three of six infants with suspected atresia, surgical exploration was avoided. Five complications were recorded (9.3%), and included four episodes of mild pancreatitis (7.4% post-ERCP pancreatitis (PEP) rate) and one cholangitis in PSC. A trend towards a protective effect of pancreatic stents on PEP was observed. All complications were managed conservatively. No complications were attributed to mechanical stress on the gastrointestinal tract.ConclusionsERCP in newborns, infants, and adolescents can be safely performed with high technical and clinical success. Endoscopists must be aware of differing spectrum of pediatric diseases. Failed cannulation was associated with lower body weight of young children. Complications were similar to rates reported in adults.
| S-EPMC5676540 | biostudies-literature
Project description:BackgroundCommunity Paramedics (CPs) require access to timely blood analysis in the field to guide treatment and transport decisions. Point of care testing (POCT), as opposed to laboratory analysis, may offer a solution, but limited research exists on CP POCT. The purpose of this study was to compare the validity of two devices (Abbott i-STAT® and Alere epoc®) by CPs in the community.MethodsIn a CP programme responding to 6000 annual patient care events, a split sample validation of POCT against traditional laboratory analysis for seven analytes (sodium, potassium, chloride, creatinine, hemoglobin, hematocrit, and glucose) was conducted on a consecutive sample of patients. The difference of proportion of discrepant results between POCT and laboratory was compared using a two sample proportion test. Usability was analysed by survey of CP experience, a linear mixed effects model of Systems Usability Scale (SUS) adjusted for CP clinical and POCT experience, an expert heuristic evaluation of devices, a review of device-logged errors, and coded observations of POCT use during quality control testing.ResultsOf 1649 episodes of care screened for enrollment, 174 required a blood draw, with 108 episodes (62.1%) enrolled from 73 participants. Participants had a mean age of 58.7 years (SD16.3); 49% were female. In 4 of 646 (0.6%) comparisons, POCT reported a critical value but the laboratory did not; with no statistically significant (p = 0.323) difference between i-STAT® (0.9%;95%CI:0.0,1.9%) compared with epoc® (0.3%;95%CI:0.0,0.9%). There were no instances of the laboratory reporting a critical value when POCT did not. In 88 of 1046 (8.4%) comparisons the a priori defined acceptable difference between POCT and the laboratory was exceeded; occurring more often in epoc® (10.7%;95%CI:8.1,13.3%) compared with i-STAT® (6.1%;95%CI:4.1,8.2%)(p = 0.007). Eighteen of 19 CP surveys were returned, with 11/18 (61.1%) preferring i-STAT® over epoc®. The i-STAT® had a higher mean SUS score (higher usability) compared with epoc® (84.0/100 vs. 59.6/100; p = 0.011). There were no statistically significant differences in device logged errors between i-STAT® and epoc® (p = 0.063).ConclusionsCP programmes can expect clinically valid results from POCT. Device usability assessments should be considered with any local implementation as the two POCT systems have different strengths.
| S-EPMC6498549 | biostudies-literature
Project description:ObjectiveTo assess the clinical accuracy (sensitivity (SEN), specificity (SPE), positive predictive value and negative predictive value) of two point-of-care (POC) urine culture tests for the identification of urinary tract infection (UTI) in general practice.DesignProspective diagnostic accuracy study comparing two index tests (Flexicult™ SSI-Urinary Kit or ID Flexicult™) with a reference standard (urine culture performed in the microbiological department).SettingGeneral practice in the Copenhagen area patients. Adult female patients consulting their general practitioner with suspected uncomplicated, symptomatic UTI.Main outcome measures(1) Overall accuracy of POC urine culture in general practice. (2) Individual accuracy of each of the two POC tests in this study. (3) Accuracy of POC urine culture in general practice with enterococci excluded, since enterococci are known to multiply in boric acid used for transportation for the reference standard. (4) Accuracy based on expert reading of photographs of POC urine cultures performed in general practice. Standard culture performed in the microbiological department was used as reference standard for all four measures.ResultsTwenty general practices recruited 341 patients with suspected uncomplicated UTI. The overall agreement between index test and reference was 0.76 (CI: 0.71-0.80), SEN 0.88 (CI: 0.83-0.92) and SPE 0.55 (CI: 0.46-0.64). The two POC tests produced similar results individually. Overall agreement with enterococci excluded was 0.82 (0.77-0.86) and agreement between expert readings of photographs and reference results was 0.81 (CI: 0.76-0.85).ConclusionsPOC culture used in general practice has high SEN but low SPE. Low SPE could be due to both misinterpretation in general practice and an imperfect reference standard. Registration number: ClinicalTrials.gov NCT02323087.
| S-EPMC5499317 | biostudies-literature
Project description:BackgroundOlder adults (OAs) residing in long-term care (LTC) homes are often unable to engage in adequate amounts of physical activity because of multiple comorbidities, including frailty and severe cognitive impairments. This level of physical inactivity is associated with declines in cognitive and functional abilities and can be further compounded by social isolation. Exergaming, defined as a combination of exercise and gaming, has the potential to engage OAs in exercise and encourage social interaction. However, previously used systems such as the Nintendo Wii are no longer commercially available, and the physical design of other exergames is not suitable for OAs (ie, fall risks, accessibility issues, and games geared toward a younger population) with diverse physical and cognitive impairments.ObjectiveThis study aims to design and develop a novel, user-centered, evidence-based exergaming system for use among OAs in LTC homes. In addition, we aim to identify facilitators and barriers to the implementation of our exergaming intervention, the MouvMat, into LTC homes according to staff input.MethodsThis study used a user-centered design (UCD) process that consisted of 4 rounds of usability testing. The exergame was developed and finalized based on existing evidence, end user and stakeholder input, and user testing. Semistructured interviews and standardized and validated scales were used iteratively to evaluate the acceptability, usability, and physical activity enjoyment of the MouvMat.ResultsA total of 28 participants, 13 LTC residents, and 15 staff and family members participated in the UCD process for over 18 months to design and develop the novel exergaming intervention, the MouvMat. The iterative use of validated scales (System Usability Scale, 8-item Physical Activity Enjoyment Scale, and modified Treatment Evaluation Inventory) indicated an upward trend in the acceptability, usability, and enjoyment scores of MouvMat over 4 rounds of usability testing, suggesting that identified areas for refinement and improvement were appropriately addressed by the team. A qualitative analysis of semistructured interview data found that residents enjoyed engaging with the prototype and appreciated the opportunity to increase their PA. In addition, staff and stakeholders were drawn to MouvMat's ability to increase residents' autonomous PA. The intended and perceived benefits of MouvMat use, that is, improved physical and cognitive health, were the most common facilitators of its use identified by study participants.ConclusionsThis study was successful in applying UCD to collaborate with LTC residents, despite the high number of physical and sensory impairments that this population experiences. By following a UCD process, an exergaming intervention that meets diverse requirements (ie, hardware design features and motivation) and considers environmental barriers and residents' physical and cognitive needs was developed. The effectiveness of MouvMat in improving physical and cognitive abilities should be explored in future multisite randomized controlled trials.
| S-EPMC7988392 | biostudies-literature
Project description:There is increasing recognition that point-of-care ultrasound (POCUS), performed by the clinician at the bedside, can be a natural extension of the clinical examination-the modern abdominal "stethoscope" and provides an opportunity to expedite the care pathway for patients with acute gallbladder disease. The primary aims of this study were to benchmark the accuracy of surgeon-performed POCUS in suspected acute gallbladder disease against standard radiology or pathology reports and to compare time to POCUS diagnosis with time to definitive imaging. This prospective single-arm observational cohort study was conducted in four hospitals in Ireland, Italy, and Portugal to assess the accuracy of POCUS against standard radiology in patients with suspected acute biliary disease (ClinicalTrials.govIdentifier: NCT02682368). The findings of surgeon-performed POCUS were compared with those on definitive imaging or surgery. Of 100 patients recruited, 89 were suitable for comparative analysis, comparing POCUS with radiological findings in 84 patients and with surgical/histological findings in five. The overall global accuracy of POCUS was 88.7% (95% CI, 80.3-94.4%), with a sensitivity of 94.7% (95% CI, 85.3-98.9%), a specificity of 78.1% (95% CI, 60.03-90.7%), a positive likelihood ratio (LR+) of 4.33 and negative likelihood ratio (LR) of 0.07. The mean time from POCUS to the final radiological report was 11.9 h (range 0.06-54.9). In five patients admitted directly to surgery, the mean time between POCUS and incision was 2.30 h (range 1.5-5), which was significantly shorter than the mean time to formal radiology report. Sixteen patients were discharged from the emergency department, of whom nine did not need follow-up. Our study is one of the very few to demonstrate a high concordance between surgeon-performed POCUS of patients without a priori radiologic diagnosis of gallstone disease and shows that the expedited diagnosis afforded by POCUS can be reliably leveraged to deliver earlier definitive care for patients with acute gallbladder pathology, as the general surgeon skilled in POCUS is uniquely positioned to integrate it into their bedside assessment.
| S-EPMC10093186 | biostudies-literature