Jeremy R Huddy

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.

Exocrine pancreatic insufficiency following esophagectomy

Weight loss following esophagectomy is a management challenge for all patients. It is multifactorial with contributing factors including loss of gastric reservoir, rapid small bowel transit, malabsorption, and adjuvant chemotherapy. The development of a postoperative malabsorption syndrome, as a result of exocrine pancreatic insufficiency (EPI), is recognized in a subgroup of patients following gastrectomy. This has not previously been documented following esophageal resection. EPI can result in symptoms of flatulence, diarrhea, steatorrhea, vitamin deficiencies, and weight loss. It therefore has the potential to pose a significant level of morbidity in postoperative patients. There is some evidence that patients with proven EPI (fecal elastase-1 < 200 μg/g) may benefit from a trial of pancreatic enzyme replacement therapy (PERT). We observed symptoms compatible with EPI in a subgroup of patients following esophagectomy. We hypothesized that this was contributing to malabsorption and malnutrition in these patients. To investigate this, fecal elastase-1 was measured in postoperative patients, and in those with proven EPI, a trial of PERT was commenced in combination with specialist dietary education. At routine postoperative follow-up, which included assessment by a specialist dietitian, those patients with symptoms suggestive of malabsorption were given the opportunity to have their fecal elastase-1 measured. PERT was then offered to patients with fecal elastase-1 less than 200 μg/g (EPI) as well as those in the 200-500 μg/g range (mild EPI) with more severe symptoms. Fecal elastase-1 was measured in 63 patients between June 2009 and January 2011 at a median of 4 months (range 1-42) following surgery. Ten patients had fecal elastase-1 less than 200 μg/g, and all had failed to maintain preoperative weight. All accepted a trial of PERT. Nine (90%) had symptomatic improvement, and seven (70%) increased their weight. Thirty-nine patients had a fecal elastase-1 in the 200-500 μg/g range. Twelve were given a trial of PERT based on level of symptoms, five (42%) reported an improvement in symptoms, but only two (17%) gained weight. Our early results support the observation that EPI is a factor contributing to postoperative morbidity in patients recovering from esophagectomy and that these patients can benefit from a trial of PERT. Our study has limitations, and a formal trial is required to evaluate the impact of EPI and PERT following esophagectomy. Currently, our practice is to measure fecal elastase-1 in any patient with unexplained weight loss or symptoms of malabsorption. In patients with proven EPI or those who are symptomatic with mild EPI, a trial of PERT should be offered and symptoms reassessed.

Liver metastases from esophageal carcinoma: is there a role for surgical resection?

Esophageal cancer recurrence rates after esophagectomy are high, and locally recurrent or distant metastatic disease has poor prognosis. Management is limited to palliative chemotherapy and symptomatic interventions. We report our experience of four patients who have undergone successful liver resection for metastases from esophageal cancer. All underwent esophagectomy and were referred to our unit with metastatic recurrent liver disease, two with solitary metastases and two with multi-focal disease. The patients underwent multidisciplinary assessment and proceeded to a course of neoadjuvant chemotherapy followed by open or laparoscopic liver resection. Three patients were male, and the mean age was 57.5 (range 44-71) years. Response to chemotherapy ranged from partial to complete response. Following liver resection, two patients developed recurrent disease at 5 and 15 months, and both had disease-specific mortality at 10 and 21 months, respectively. The other two patients remain disease free at 22 and 92 months. Recurrent metastatic esophageal cancer continues to have a poor prognosis, and the majority of patients with liver involvement will not be candidates for hepatic resection. However, this series suggests that in selected patients, liver resection of metastases from esophageal cancer combined with neoadjuvant and adjuvant chemotherapy is feasible, but further research is required to determine whether this can offer a survival advantage.

Point-of-care testing in the diagnosis of gastrointestinal cancers: Current technology and future directions

Point-of-care (POC) tests enable rapid results and are well established in medical practice. Recent advances in analytical techniques have led to a new generation of POC devices that will alter gastrointestinal diagnostic pathways. This review aims to identify current and new technologies for the POC diagnosis of gastrointestinal cancer. A structured search of the Embase and Medline databases was performed. Papers reporting diagnostic tests for gastrointestinal cancer available as a POC device or containing a description of feasibility for POC application were included. Studies recovered were heterogeneous and therefore results are presented as a narrative review. Six diagnostic methods were identified (fecal occult blood, fecal proteins, volatile organic compounds, pyruvate kinase isoenzyme type M2, tumour markers and DNA analysis). Fecal occult blood testing has a reported sensitivity of 66%-85% and specificity greater than 95%. The others are at a range of development and clinical application. POC devices have a proven role in the diagnosis of gastrointestinal cancer. Barriers to their implementation exist and the transition from experimental to clinical medicine is currently slow. New technologies demonstrate potential to provide accurate POC tests and an ability to diagnose gastrointestinal cancer at an early stage with improved clinical outcome and survival.

The influence of procedural volume and proficiency gain on mortality from upper GI endoscopic mucosal resection

Objective Endoscopic mucosal resection (EMR) is established for the management of benign and early malignant upper GI disease. The aim of this observational study was to establish the effect of endoscopist procedural volume on mortality. Design Patients undergoing upper GI EMR between 1997 and 2012 were identified from the Hospital Episode Statistics database. The primary outcome was 30-day mortality and secondary outcomes were 90-day mortality, requirement for emergency intervention and elective cancer re-intervention. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to assess patient mortality risk during initial stage of endoscopist proficiency gain and the effect of endoscopist and hospital volume. Mortality was compared before and after the change point or threshold in the RA-CUSUM curve. Results 11 051 patients underwent upper GI EMR. Endoscopist procedure volume was an independent predictor of 30-day mortality. Fifty-eight per cent of EMR procedures were performed by endoscopists with annual volume of 2 cases or less, and had a higher 30-day and 90-day mortality rate for patients with cancer, 6.1% vs 0.4% (p<0.001) and 12% vs 2.1% (p<0.001), respectively. The requirement for emergency intervention after EMR for cancer was also greater with low volume endoscopists (1.8% vs 0.1%, p=0.002). In patients with cancer, the RA-CUSUM curve change points for 30-day mortality and elective re-intervention were 4 cases and 43 cases, respectively. Conclusions EMR performed by high volume endoscopists is associated with reduced adverse outcomes. In order to reach proficiency, appropriate training and procedural volume accreditation training programmes are needed nationally.

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.

Usability study of pH strips for nasogastric tube placement

Aims (1) To model the process of use and usability of pH strips (2) to identify, through simulation studies, the likelihood of misreading pH strips, and to assess professional’s acceptance, trust and perceived usability of pH strips. Methods This study was undertaken in four phases and used a mixed method approach (an audit, a semi-structured interview, a survey and simulation study). The three months audit was of 24 patients, the semi-structured interview was performed with 19 health professionals and informed the process of use of pH strips. A survey of 134 professionals and novices explored the likelihood of misinterpreting pH strips. Standardised questionnaires were used to assess professionals perceived usability, trust and acceptance of pH strip use in a simulated study. Results The audit found that in 45.7% of the cases aspiration could not be achieved, and that 54% of the NG-tube insertions required x-ray confirmation. None of those interviewed had received formal training on pH strips use. In the simulated study, participants made up to 11.15% errors in reading the strips with important implications for decision making regarding NG tube placement. No difference was identified between professionals and novices in their likelihood of misinterpreting the pH value of the strips. Whilst the overall experience of usage is poor (47.3%), health professionals gave a positive level of trust in both the interview (62.6%) and the survey (68.7%) and acceptance (interview group 65.1%, survey group 74.7%). They also reported anxiety in the use of strips (interview group 29.7%, survey group 49.7%). Conclusions Significant errors occur when using pH strips in a simulated study. Manufacturers should consider developing new pH strips, specifically designed for bedside use, that are more usable and less likely to be misread.

The psychological impact of symptoms related to esophagogastric cancer resection presenting in primary care: A national linked database study

BACKGROUND The objective was to evaluate incidence, risk factors and impact of postoperative symptoms following esophagogastric cancer resection in primary care. METHODS Patients undergoing esophagogastrectomy for cancer from 1998 to 2010 with linked records in Clinical Practice Research Datalink, Hospital Episodes Statistics and Office of National Statistics databases were studied. The recording of codes for reflux, dysphagia, dyspepsia, nausea, vomiting, dumping, diarrhea, steatorrhea, appetite loss, weight loss, pain and fatigue were identified up to 12 months postoperatively. Psychiatric morbidity was also examined and its risk evaluated by logistic regression analysis. RESULTS Overall, 58.6% (1029/1755) of patients were alive 2 years after surgery. Of these, 41.1% had recorded postoperative symptoms. Reflux, dysphagia, dyspepsia and pain were more frequent following esophagectomy compared with gastrectomy (p < 0.05). Complications (OR = 1.40 95%CI 1.00-1.95) and surgical procedure predicted postoperative symptoms (p < 0.05). When compared with partial gastrectomy, esophagectomy (OR = 2.03 95%CI 1.26-3.27), total gastrectomy (OR = 2.44 95%CI 1.57-3.79) and esophagogastrectomy (OR = 2.66 95%CI 1.85-2.86) were associated with postoperative symptoms (p < 0.05). The majority of patients with postoperative psychiatric morbidity had depression or anxiety (98%). Predictors of postoperative depression/anxiety included younger age (OR = 0.97 95%CI 0.96-0.99), complications (OR = 2.40 95%CI 1.51-3.83), psychiatric history (OR = 6.73 95%CI 4.25-10.64) and postoperative symptoms (OR = 1.78 95%CI 1.17-2.71). CONCLUSIONS Over 40% of patients had symptoms related to esophagogastric cancer resection recorded in primary care, and were associated with an increase in postoperative depression and anxiety.

Selecting pH cut-offs for the safe verification of nasogastric feeding tube placement: a decision analytical modelling approach

Objectives The existing British National Patient Safety Agency (NPSA) safety guideline recommends testing the pH of nasogastric (NG) tube aspirates. Feeding is considered safe if a pH of 5.5 or lower has been observed; otherwise chest X-rays are recommended. Our previous research found that at 5.5, the pH test lacks sensitivity towards oesophageal placements, a major risk identified by feeding experts. The aim of this research is to use a decision analytic modelling approach to systematically assess the safety of the pH test under cut-offs 1–9. Materials and methods We mapped out the care pathway according to the existing safety guideline where the pH test is used as a first-line test, followed by chest x-rays. Decision outcomes were scored on a 0–100 scale in terms of safety. Sensitivities and specificities of the pH test at each cut-off were extracted from our previous research. Aggregating outcome scores and probabilities resulted in weighted scores which enabled an analysis of the relative safety of the checking procedure under various pH cut-offs. Results The pH test was the safest under cut-off 5 when there was ≥30% of NG tube misplacements. Under cut-off 5, respiratory feeding was excluded; oesophageal feeding was kept to a minimum to balance the need of chest X-rays for patients with a pH higher than 5. Routine chest X-rays were less safe than the pH test while to feed all without safety checks was the most risky. Discussion The safety of the current checking procedure is sensitive to the choice of pH cut-offs, the impact of feeding delays, the accuracy of the pH in the oesophagus, as well as the extent of tube misplacements. Conclusions The pH test with 5 as the cut-off was the safest overall. It is important to understand the local clinical environment so that appropriate choice of pH cut-offs can be made to maximise safety and to minimise the use of chest X-rays. Trial registration number ISRCTN11170249; Pre-results.

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.