Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption

OBJECTIVES: Point-of-care (POC) C reactive protein (CRP) is incorporated in National Institute of Health and Care Excellence (NICE) guidelines for the diagnosis of pneumonia, reduces antibiotic prescribing and is cost effective. AIM: To determine the barriers and facilitators to adoption of POC CRP testing in National Health Service (NHS) primary care for the diagnosis of lower respiratory tract infection. DESIGN: The study followed a qualitative methodology based on grounded theory. The study was undertaken in 2 stages. Stage 1 consisted of semistructured interviews with 8 clinicians from Europe and the UK who use the test in routine practice, and focused on their subjective experience in the challenges of implementing POC CRP testing. Stage 2 was a multidisciplinary-facilitated workshop with NHS stakeholders to discuss barriers to adoption, impact of adoption and potential adoption scenarios. Emergent theme analysis was undertaken. PARTICIPANTS: Participants included general practitioners (including those with commissioning experience), biochemists, pharmacists, clinical laboratory scientists and industry representatives from the UK and abroad. RESULTS: Barriers to the implementation of POC CRP exist, but successful adoption has been demonstrated abroad. Analysis highlighted 7 themes: reimbursement and incentivisation, quality control and training, laboratory services, practitioner attitudes and experiences, effects on clinic flow and workload, use in pharmacy and gaps in evidence. CONCLUSIONS: Successful adoption models from the UK and abroad demonstrate a distinctive pattern and involve collaboration with central laboratory services. Incorporating antimicrobial stewardship into quality improvement frameworks may incentivise adoption. Further research is needed to develop scaling-up strategies to address the resourcing, clinical governance and economic impact of widespread NHS implementation

A research protocol for developing a Point-Of-Care Key Evidence Tool 'POCKET': a checklist for multidimensional evidence reporting on point-of-care in vitro diagnostics.

INTRODUCTION: Point-of-care in vitro diagnostics (POC-IVD) are increasingly becoming widespread as an acceptable means of providing rapid diagnostic results to facilitate decision-making in many clinical pathways. Evidence in utility, usability and cost-effectiveness is currently provided in a fragmented and detached manner that is fraught with methodological challenges given the disruptive nature these tests have on the clinical pathway. The Point-of-care Key Evidence Tool (POCKET) checklist aims to provide an integrated evidence-based framework that incorporates all required evidence to guide the evaluation of POC-IVD to meet the needs of policy and decisionmakers in the National Health Service (NHS). METHODS AND ANALYSIS: A multimethod approach will be applied in order to develop the POCKET. A thorough literature review has formed the basis of a robust Delphi process and validation study. Semistructured interviews are being undertaken with POC-IVD stakeholders, including industry, regulators, commissioners, clinicians and patients to understand what evidence is required to facilitate decision-making. Emergent themes will be translated into a series of statements to form a survey questionnaire that aims to reach a consensus in each stakeholder group to what needs to be included in the tool. Results will be presented to a workshop to discuss the statements brought forward and the optimal format for the tool. Once assembled, the tool will be field-tested through case studies to ensure validity and usability and inform refinement, if required. The final version will be published online with a call for comments. Limitations include unpredictable sample representation, development of compromise position rather than consensus, and absence of blinding in validation exercise. ETHICS AND DISSEMINATION: The Imperial College Joint Research Compliance Office and the Imperial College Hospitals NHS Trust R&D department have approved the protocol. The checklist tool will be disseminated through a PhD thesis, a website, peer-reviewed publication, academic conferences and formal presentations

Why you need to include human factors in clinical and empirical studies of in vitro point of care devices? Review and future perspectives

Use of in-vitro point of care devices - intended as tests performed out of laboratories and near patient - is increasing in clinical environments. International standards indicate that interaction assessment should not end after the product release, yet human factors methods are frequently not included in clinical and empirical studies of these devices. Whilst the literature confirms some advantages of bed-side tests compared to those in laboratories there is a lack of knowledge of the risks associated with their use. This article provides a review of approaches applied by clinical researchers to model the use of in-vitro testing. Results suggest that only a few studies have explored human factor approaches. Furthermore, when researchers investigated people-device interaction these were predominantly limited to qualitative and not standardised approaches. The methodological failings and limitations of these studies, identified by us, demonstrate the growing need to integrate human factors methods in the medical field

Biomarkers of acute appendicitis: systematic review and cost–benefit trade-off analysis

BACKGROUND: Acute appendicitis is the most common surgical emergency and can represent a challenging diagnosis, with a negative appendectomy rate as high as 20 %. This review aimed to evaluate the clinical utility of individual biomarkers in the diagnosis of appendicitis and appraise the quality of these studies. METHODS: A systematic review of the literature between January 2000 and September 2015 using of PubMed, OvidMedline, EMBASE and Google Scholar was conducted. Studies in which the diagnostic accuracy, statistical heterogeneity and predictive ability for severity of several biomarkers could be elicited were included. Information regarding costs and process times was retrieved from the regional laboratory. European surgeons blinded to these reviews were independently asked to rank which characteristics of biomarkers were most important in acute appendicitis to inform a cost-benefit trade-off. Sensitivity testing and the QUADAS-2 tool were used to assess the robustness of the analysis and study quality, respectively. RESULTS: Sixty-two studies met the inclusion criteria and were assessed. Traditional biomarkers (such as white cell count) were found to have a moderate diagnostic accuracy (0.75) but lower costs in the diagnosis of acute appendicitis. Conversely, novel markers (pro-calcitonin, IL 6 and urinary 5-HIAA) were found to have high process-related costs including analytical times, but improved diagnostic accuracy. QUADAS-2 analysis revealed significant potential biases in the literature. CONCLUSION: When assessing biomarkers, an appreciation of the trade-offs between the costs and benefits of individual biomarkers is needed. Further studies should seek to investigate new biomarkers and address concerns over bias, in order to improve the diagnosis of acute appendicitis

Flexible multimode endoscope for tissue reflectance and autofluorescence hyperspectral imaging

A dual reflectance and autofluorescence spectral imaging probe compatible with the biopsy channels of standard flexible endoscopes is demonstrated. Spatially-resolved haemoglobin and autofluorescent signals from porcine bowel were obtained in vivo

Micronutrient deficiency following esophagectomy for cancer of the upper gastrointestinal tract

Objectives: For those patients who achieve long-term survival following esophagectomy, altered digestion and malabsorption may lead to a range of adverse gastrointestinal sequelae, including micronutrient deficiencies. The aim of the current study was to determine the prevalence of specific micronutrient deficiencies in patients following esophagectomy. Methods: Levels of vitamin A, vitamin E, vitamin D, vitamin B1, vitamin B12, folate, ferritin, zinc and calcium were measured in a single non-fasting blood sample in patients who has undergone esophagectomy. Findings were compared to both patients who had undergone gastrectomy and an age matched Western control population. Results: Forty-Four patients (33 male, 65.5 ± 10.2 yrs) a median of 26 months (IQR 12-46) following either two or three stage esophagectomy were recruited. Deficiency in one or more micronutrients was observed in 64% of patients who underwent esophagectomy. Micronutrients most commonly deficient following esophagectomy were vitamin D (21%), vitamin B12 (32%), ferritin (16%) and zinc (25%). Compared to patients who underwent gastrectomy, levels of vitamin B12 and red cell folate were significantly lower, and levels of vitamin E were significantly higher in the blood of patients following esophagetomy. Compared to a Western control population the mean levels of vitamins A, E, D and B12, ferritin and zinc were lower in patients following esophagectomy. Conclusion: Micronutrient deficiency is common after esophagectomy affecting two thirds of all patients. Regular screening of vitamin D, vitamin B12, ferritin and Zinc levels should be considered as well as prophylactic supplementation in this patient group to prevent deficiency

COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer

Total mesorectal excision (TME) is an essential component of surgical management of rectal cancer. Both open and laparoscopic TME have been proven to be oncologically safe. However, it remains a challenge to achieve complete TME with clear circumferential resections margin (CRM) with the conventional transabdominal approach, particularly in mid and low rectal tumours. Transanal TME (TaTME) was developed to improve oncological and functional outcomes of patients with mid and low rectal cancer.An international, multicentre, superiority, randomised trial was designed to compare TaTME and conventional laparoscopic TME as the surgical treatment of mid and low rectal carcinomas. The primary endpoint is involved CRM. Secondary endpoints include completeness of mesorectum, residual mesorectum, morbidity and mortality, local recurrence, disease-free and overall survival, percentage of sphincter-saving procedures, functional outcome and quality of life. A Quality Assurance Protocol including centralised MRI review, histopathology re-evaluation, standardisation of surgical techniques, and monitoring and assessment of surgical quality will be conducted.The difference in involvement of CRM between the two treatment strategies is thought to be in favour of the TaTME. TaTME is therefore expected to be superior to laparoscopic TME in terms of oncological outcomes in case of mid and low rectal carcinomas