Challenges and recommendations for high quality research using electronic health records.

Harnessing Real World Data is vital to improve health care in the 21st Century. Data from Electronic Health Records (EHRs) are a rich source of patient centred data, including information on the patient's clinical condition, laboratory results, diagnoses and treatments. They thus reflect the true state of health systems. However, access and utilisation of EHR data for research presents specific challenges. We assert that using data from EHRs effectively is dependent on synergy between researchers, clinicians and health informaticians, and only this will allow state of the art methods to be used to answer urgent and vital questions for patient care. We propose that there needs to be a paradigm shift in the way this research is conducted - appreciating that the research process is iterative rather than linear. We also make specific recommendations for organisations, based on our experience of developing and using EHR data in trusted research environments.

Do national policies for complaint handling in English hospitals support quality improvement? Lessons from a case study.

OBJECTIVES: A range of public inquiries in the English National Health Service have indicated repeating failings in complaint handling, and patients are often left dissatisfied. The complex, bureaucratic nature of complaints systems is often cited as an obstacle to meaningful investigation and learning, but a detailed examination of how such bureaucratic rules, regulations, and infrastructure shape complaint handling, and where change is most needed, remains relatively unexplored. We sought to examine how national policies structure local practices of complaint handling, how they are understood by those responsible for enacting them, and if there are any discrepancies between policies-as-intended and their reality in local practice. DESIGN: Case study involving staff interviews and documentary analysis. SETTING: A large acute and multi-site NHS Trust in England. PARTICIPANTS: Clinical, managerial, complaints, and patient advocacy staff involved in complaint handling at the participating NHS Trust (n=20). MAIN OUTCOME MEASURES: Not applicable. RESULTS: Findings illustrate four areas of practice where national policies and regulations can have adverse consequences within local practices, and partly function to undermine an improvement-focused approach to complaints. These include muddled routes for raising formal complaints, investigative procedures structured to scrutinize the 'validity' of complaints, futile data collection systems, and adverse incentives and workarounds resulting from bureaucratic performance targets. CONCLUSION: This study demonstrates how national policies and regulations for complaint handling can impede, rather than promote, quality improvement in local settings. Accordingly, we propose a number of necessary reforms, including patient involvement in complaints investigations, the establishment of independent investigation bodies, and more meaningful data analysis strategies to uncover and address systemic causes behind recurring complaints.

Quantitative analysis of technological innovation in minimally invasive surgery.

BACKGROUND: In the past 30 years surgical practice has changed considerably owing to the advent of minimally invasive surgery (MIS). This paper investigates the changing surgical landscape chronologically and quantitatively, examining the technologies that have played, and are forecast to play, the largest part in this shift in surgical practice. METHODS: Electronic patent and publication databases were searched over the interval 1980-2011 for ('minimally invasive' OR laparoscopic OR laparoscopy OR 'minimal access' OR 'key hole') AND (surgery OR surgical OR surgeon). The resulting patent codes were allocated into technology clusters. Technology clusters referred to repeatedly in the contemporary surgical literature were also included in the analysis. Growth curves of patents and publications for the resulting technology clusters were then plotted. RESULTS: The initial search revealed 27,920 patents and 95,420 publications meeting the search criteria. The clusters meeting the criteria for in-depth analysis were: instruments, image guidance, surgical robotics, sutures, single-incision laparoscopic surgery (SILS) and natural-orifice transluminal endoscopic surgery (NOTES). Three patterns of growth were observed among these technology clusters: an S-shape (instruments and sutures), a gradual exponential rise (surgical robotics and image guidance), and a rapid contemporaneous exponential rise (NOTES and SILS). CONCLUSION: Technological innovation in MIS has been largely stagnant since its initial inception nearly 30 years ago, with few novel technologies emerging. The present study adds objective data to the previous claims that SILS, a surgical technique currently adopted by very few, represents an important part of the future of MIS.

Day of week of procedure and 30 day mortality for elective surgery: retrospective analysis of hospital episode statistics.

OBJECTIVES: To assess the association between mortality and the day of elective surgical procedure. DESIGN: Retrospective analysis of national hospital administrative data. SETTING: All acute and specialist English hospitals carrying out elective surgery over three financial years, from 2008-09 to 2010-11. PARTICIPANTS: Patients undergoing elective surgery in English public hospitals. MAIN OUTCOME MEASURE: Death in or out of hospital within 30 days of the procedure. RESULTS: There were 27,582 deaths within 30 days after 4,133,346 inpatient admissions for elective operating room procedures (overall crude mortality rate 6.7 per 1000). The number of weekday and weekend procedures decreased over the three years (by 4.5% and 26.8%, respectively). The adjusted odds of death were 44% and 82% higher, respectively, if the procedures were carried out on Friday (odds ratio 1.44, 95% confidence interval 1.39 to 1.50) or a weekend (1.82, 1.71 to 1.94) compared with Monday. CONCLUSIONS: The study suggests a higher risk of death for patients who have elective surgical procedures carried out later in the working week and at the weekend.

The role of robotic assisted laparoscopy for oesophagogastric oncological resection; an appraisal of the literature.

The introduction of surgical robotics to the field of surgical oncology brings with it an expectation not only of improved vision, instrumentation, and precision but also as a result, a potential for improved oncological outcomes. The current interest in the field of oesophagogastric oncology is explored in this review together with the benefits, real and potential, that robotic assistance offers surgical cancer resection as well as some of the limiting factors which may be hampering its uptake into current surgical practice. A systematic review of all the published literature up until April 2010 was examined across the field of esophageal and gastric cancer resection. A quantitative assessment of the oncological, operative, and functional outcomes was determined from each procedure. The level of evidence behind the results was determined using the Oxford Centre for Evidence-based Medicine Levels of Evidence; Therapy and Prevention. Three hundred and five cases from 19 independent studies were included for review. Nine studies explored the outcomes from robotic-assisted esophagectomy and eight, the robotic-assisted gastrectomy. Two articles included small case series of both procedures. The level of evidence was predominantly based on case series or expert opinion (Level 4 or 5) with only three unmatched or poorly matched comparative trials (Level 4) with no randomized trials evident. Improved operative outcomes and hospital stays were demonstrated with a reduction of 2 days when the robotic-assisted gastrectomy technique was employed compared with the open. No improvement in oncological outcomes could be identified with the use of the robot for either oesophageal or gastric cancer resection; however, in terms of short-term oncological outcomes, these were at least equivalent to the open approach for oesophageal cancer and early stage gastric cancer. Robotic-assisted laparoscopic surgery is a feasible technique to use to perform a safe and oncologically sound resection for oesophageal and early gastric cancer. Operative benefits appear to be encouragingly similar to the laparoscopic approach with some demonstration of improvement over the open technique despite a prolonged operative time. However, the level of evidence is suboptimal and more randomized controlled trials and long-term survival studies within a framework of measured and comparable outcomes is required.

Search your heart for a cause of syncope!

A 66-year-old female presented to casualty with recurrent syncopal episodes and a history of ischaemic heart disease. Initial investigations did not provide a definitive diagnosis. Subsequent CT scanning identified a giant pseudoaneurysm of the left anterior descending coronary artery, which is the largest reported to date. We include a short discussion on current literature surrounding coronary artery pseudoaneurysmal disease.

Robotic prostatectomy: the first UK experience.

BACKGROUND: We describe a teamwork approach to setting up the UK's first clinical programme for robotically assisted laparoscopic radical prostatectomy. METHODS: On 22 November 2004 the Imperial Robotic Urological Surgery Group performed their first robotically assisted prostatectomy. Robotically assisted prostatectomy lends itself to division into eight definable stages. A team of four consultant urological surgeons utilized a structured rotating system, using these stages, for time at the console and tableside assisting. Fluidity of surgery was maintained by a surgeon acting as the tableside assistant for the stage prior to moving to the console. Data was collected prospectively for the first 50 cases and parameters associated with the learning curve compared to other reported series. RESULTS: Median operative time of 369.5 mins, median blood loss of 700 ml, with 12% of patients requiring a blood transfusion. Four patients required conversion to an open procedure; one resulting from equipment failure and three due to failure of progression. Four patients had an anastomotic leak with resulting ileus and two patients sustained rectal injuries, which were repaired intraoperatively using the robot. Median hospital stay was 4 days with a 22% positive surgical margin rate. CONCLUSION: Parameters indicative of the learning curve are comparable to existing published initial series of other robotic centres. The use of teamwork has enabled us to provide safe and time-efficient training for four surgeons simultaneously. The structured approach used in this setting demonstrates that urological surgeons of varying laparoscopic experience can acquire the skills necessary to competently perform laparoscopic radical prostatectomy.

T-cell lines reactive to an immunodominant epitope of the tyrosine phosphatase-like autoantigen IA-2 in type 1 diabetes.

Type 1 diabetes is the result of destruction of the insulin-secreting beta-cells of the pancreas by a process in which T-cells play a central role. A tyrosine phosphatase-like protein, IA-2, is a major target for autoantibodies and T-cells in the disease. In this study, we have further characterized the T-cell response to IA-2 by the generation and characterization of T-cell lines. T-cell lines responsive to IA-2 antigen were generated from 17 of 32 patients and 3 of 10 control subjects. Antigen specificity was confirmed in lines from six diabetic patients and one control individual by demonstration of responses to synthetic IA-2 peptides and epitope mapping. Five lines from diabetic patients responded to one of two peptides representing amino acids 831-850 and 841-860 of IA-2. The overlapping portion may therefore represent an immunodominant region of the molecule. The sixth patient-derived line responded to a peptide representing amino acids 751-770 of IA-2 presented by the DR 4 (DRB1*0401) allele that confers susceptibility to type 1 diabetes. Primary T-cell responses to peptides of the immunodominant region were detected in 9 of 19 (47%) type 1 diabetic patients and 16 of 22 (73%) nondiabetic siblings, consistent with this region having immunostimulatory properties. The study reports for the first time T-cell lines reactive to IA-2 from diabetic patients and defines an immunodominant region of the molecule.