Sequential simulation (SqS) of clinical pathways: a tool for public and patient engagement in point-of-care diagnostics

Objectives: Public and patient engagement (PPE) is fundamental to healthcare research. To facilitate effective engagement in novel point-of-care tests (POCTs), the test and downstream consequences of the result need to be considered. Sequential simulation (SqS) is a tool to represent patient journeys and the effects of intervention at each and subsequent stages. This case study presents a process evaluation of SqS as a tool for PPE in the development of a volatile organic compound-based breath test POCT for the diagnosis of oesophagogastric (OG) cancer. Setting: Three 3-hour workshops in central London. Participants: 38 members of public attended a workshop, 26 (68%) had no prior experience of the OG cancer diagnostic pathway. Interventions: Clinical pathway SqS was developed from a storyboard of a patient, played by an actor, noticing symptoms of oesophageal cancer and following a typical diagnostic pathway. The proposed breath testing strategy was then introduced and incorporated into a second SqS to demonstrate pathway impact. Facilitated group discussions followed each SqS. Primary and secondary outcome measures: Evaluation was conducted through pre-event and postevent questionnaires, field notes and analysis of audiovisual recordings. Results: 38 participants attended a workshop. All participants agreed they were able to contribute to discussions and like the idea of an OG cancer breath test. Five themes emerged related to the proposed new breath test including awareness of OG cancer, barriers to testing and diagnosis, design of new test device, new clinical pathway and placement of test device. 3 themes emerged related to the use of SqS: participatory engagement, simulation and empathetic engagement, and why participants attended. Conclusions: SqS facilitated a shared immersive experience for participants and researchers that led to the coconstruction of knowledge that will guide future research activities and be of value to stakeholders concerned with the invention and adoption of POCT

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

Evidence synthesis to inform model-based cost-effectiveness evaluations of diagnostic tests: a methodological systematic review of health technology assessments

Background: Evaluations of diagnostic tests are challenging because of the indirect nature of their impact on patient outcomes. Model-based health economic evaluations of tests allow different types of evidence from various sources to be incorporated and enable cost-effectiveness estimates to be made beyond the duration of available study data. To parameterize a health-economic model fully, all the ways a test impacts on patient health must be quantified, including but not limited to diagnostic test accuracy. Methods: We assessed all UK NIHR HTA reports published May 2009-July 2015. Reports were included if they evaluated a diagnostic test, included a model-based health economic evaluation and included a systematic review and meta-analysis of test accuracy. From each eligible report we extracted information on the following topics: 1) what evidence aside from test accuracy was searched for and synthesised, 2) which methods were used to synthesise test accuracy evidence and how did the results inform the economic model, 3) how/whether threshold effects were explored, 4) how the potential dependency between multiple tests in a pathway was accounted for, and 5) for evaluations of tests targeted at the primary care setting, how evidence from differing healthcare settings was incorporated. Results: The bivariate or HSROC model was implemented in 20/22 reports that met all inclusion criteria. Test accuracy data for health economic modelling was obtained from meta-analyses completely in four reports, partially in fourteen reports and not at all in four reports. Only 2/7 reports that used a quantitative test gave clear threshold recommendations. All 22 reports explored the effect of uncertainty in accuracy parameters but most of those that used multiple tests did not allow for dependence between test results. 7/22 tests were potentially suitable for primary care but the majority found limited evidence on test accuracy in primary care settings. Conclusions: The uptake of appropriate meta-analysis methods for synthesising evidence on diagnostic test accuracy in UK NIHR HTAs has improved in recent years. Future research should focus on other evidence requirements for cost-effectiveness assessment, threshold effects for quantitative tests and the impact of multiple diagnostic tests

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

A multi-dimensional evidence toolkit for the evaluation of point-of-care diagnostic tests

Point-of-care tests (POCT) allow for near patient or bedside tests that provide instant or rapid results that facilitate real time clinical decision making within patient pathways. Advances in technology has lead to more POCT becoming available and therefore an efficient evaluation process is required to identify the tests that bring demonstrable benefits to patients and society. This thesis provides a novel evidence-based toolkit for the multi-dimensional assessment of POCT that aims to improve the efficiency of the evidence generation process and increase the uptake of POCT devices into clinical practice where their impact can be realised. This is achieved through the development of an overarching framework, the point-of-care key evidence tool (POCKET). This generalisable checklist, developed through a mixed method approach, incorporating relevant POCT stakeholders, facilitates the robust reporting of POCT evaluation by outlining the evidence that is required for adoption by policy and decision makers. Public and patient engagement is a fundamental component of healthcare research and particularly important in the evaluation of POCT to ensure tests are acceptable to patients. To improve this process in the evaluation of POCT two innovative tools were piloted. Sequential simulation (SqS) of clinical pathways was used to demonstrate the downstream pathway implications of incorporating a POCT and the HT-36 questionnaire was created to measure the impact to life of home POCT for patients. This information will allow meaningful comparisons between different devices and inform device design. Finally, evidence alone is not enough to justify the adoption of POCT and barriers and facilitators exist. These factors are determined through the analysis of stakeholder interviews with the same methodology being applied to a case study to understand the barriers that apply to a specific device and develop mitigating strategies. The thesis concludes with an algorithm to guide the approach to the evaluation of POCT.Open Acces

Qualitative analysis of stakeholder interviews to identify the barriers and facilitators to the adoption of point-of-care diagnostic tests in the UK

Objectives This study investigated the barriers and facilitators to the adoption of point-of-care tests (POCTs).Design Qualitative study incorporating a constant comparative analysis of stakeholder responses to a series of interviews undertaken to design the Point-of-Care Key Evidence Tool.Setting The study was conducted in relation to POCTs used in all aspects of healthcare.Participants Forty-three stakeholders were interviewed including clinicians (incorporating laboratory staff and members of trust POCT committees), commissioners, industry, regulators and patients.Results Thematic analysis highlighted 32 barriers in six themes and 28 facilitators in eight themes to the adoption of POCTs. Six themes were common to both barriers and facilitators (clinical, cultural, evidence, design and quality assurance, financial and organisational) and two themes contained facilitators alone (patient factors and other (non-financial) resource use).Conclusions Findings from this study demonstrate the complex motivations of stakeholders in the adoption of POCT. Most themes were common to both barriers and facilitators suggesting that good device design, stakeholder engagement and appropriate evidence provision can increase the likelihood of a POCT device adoption. However, it is important to realise that while the majority of identified barriers may be perceived or mitigated some may be absolute and if identified early in device development further investment should be carefully considered

Nutritional optimization during neoadjuvant therapy prior to surgical resection of esophageal cancer - A narrative review.

This narrative review aims to evaluate the evidence for the different nutritional approaches employed during neoadjuvant therapy in patients with loco-regional esophageal cancer. Patients with esophageal cancer are often malnourished and difficult to optimise nutritionally. Whilst evidence suggests neoadjuvant therapy can offer a survival advantage, associated toxicity can exacerbate poor nutritional status. There is currently no accepted standard of care regarding optimal nutritional approach.A systematic literature search was undertaken. Studies describing the utilization of an additional nutritional intervention in patients with esophageal cancer receiving neoadjuvant therapy prior to esophagectomy were included. Primary outcome measure was 30-day postoperative mortality after esophagectomy. Secondary outcome measures were loss of weight during neoadjuvant therapy, completion rate of intended neoadjuvant therapy, complications from nutritional intervention, 30-day postoperative morbidity after esophagectomy and quality of life during neoadjuvant treatment. Given the heterogeneity of retrieved articles results were presented as a narrative review.Twenty-five studies were included of which 16 evaluated esophageal stenting, four feeding jejunostomy, three gastrostomy, one naso-gastric feeding, and one comparative study of esophageal stenting to feeding jejunostomy. 30-day postoperative mortality was only reported in two of the 26 included studies limiting comparison between nutritional strategies. All studies of esophageal stents reported improvements in dysphagia with reported weight change ranging from -5.4kg to + 6kg but none reported 30-day postoperative mortality. In patients undergoing oesophageal stenting for their neoadjuvant treatment overall migration rate was 29.9%. Studies of laparoscopically inserted jejunostomy were all retrospective reviews that demonstrated an increase in weight ranging from 0.4 to 11.8kg and similarly no study reported 30-day post-operative mortality. Only one comparative study was included that compared esophageal stents to jejunostomy. This study reported no significant difference between the two groups in respect to complication rates (stents 22% vs jejunostomy 4%, P = 0.11) or increase in weight (stents 4.4kg vs jejunostomy 4.2kg, P = 0.59). Quality of life was also poorly reported.This review demonstrates the uncertainty on the optimal nutritional approach for patients with resectable esophageal cancer undergoing neoadjuvant treatment prior to esophagectomy. A prospective, multicenter, observational cohort study is needed to determine current practice and inform a prospective clinical trial

Single port Billroth I gastrectomy

Introduction: Experience has allowed increasingly complex procedures to be undertaken by single port surgery. We describe a technique for single port Billroth I gastrectomy with a hand-sewn intracorporeal anastomosis in the resection of a benign tumour diagnosed incidentally on a background of cholelithiasis. Materials and Methods: Single port Billroth I gastrectomy and cholecystectomy was performed using a transumbilical quadport. Flexible tipped camera and straight conventional instruments were used throughout the procedure. The stomach was mobilised including a limited lymph node dissection and resection margins in the proximal antrum and duodenum were divided with a flexible tipped laparoscopic stapler. The lesser curve was reconstructed and an intracorporal hand sewn two layer end-to-end anastomosis was performed using unidirectional barbed sutures. Intraoperative endoscopy confirmed the anastomosis to be patent without leak. Results: Enteral feed was started on the day of surgery, increasing to a full diet by day 6. Analgesic requirements were a patient-controlled analgesia morphine pump for 4 postoperative days and paracetamol for 6 days. There were no postoperative complications and the patient was discharged on the eighth day. Histology confirmed gastric submucosal lipoma. Discussion: As technology improves more complex procedures are possible by single port laparoscopic surgery. In this case, flexible tipped cameras and unidirectional barbed sutures have facilitated an intracorporal hand-sewn two layer end-to-end anastomosis. Experience will allow such techniques to become mainstream

Enterocutaneous fistula as a complication of laparoscopic cholecystectomy

Laparoscopic cholecystectomy is the gold standard method for treating gallstone related disease. Despite its widespread and well established application, clear consensus is not arrived at regarding the comparative risks and benefits of acute versus interval cholecystectomy. The complications of this technique are well known, with respect to both the operative intervention and the technique used. This case describes a case of cholecystitis in a 76-year-old man, who underwent acute laparoscopic cholecystectomy for cholecystitis refractory to antibiotic therapy. Postoperative complications included subhepatic collections bilaterally, eventually leading to the formation of an enterocutaneous fistula to the left chest wall - a previously undocumented phenomenon. The protracted course of the disease is discussed, with reference to investigations performed and the eventual successful outcome