Hannah Patrick

Management of the open abdomen: a national study of clinical outcome and safety of negative pressure wound therapy.

Objective:To determine clinical outcome of open abdomen therapy and assess the influence of negative pressure wound therapy on outcome. Background:Leaving the abdomen open (laparostomy) is an option following laparotomy for severe abdominal sepsis or trauma. Negative pressure wound therapy (NPWT) has become a popular means of managing laparostomy wounds. It may facilitate nursing care and delayed primary wound closure but the evidence to support its use is poor and concern has arisen about the risk of intestinal fistulation from exposed bowel, leading to an increased risk of death. Methods:Prospective observational study of 578 patients treated with an open abdomen in 105 hospitals in the United Kingdom between January 1, 2010, and June 30, 2011. Propensity analysis was used to compare adverse outcomes (fistulation, death, intestinal failure, bleeding requiring intervention) and delayed primary closure rates in patients who did and did not receive NPWT. Findings:The most common indication for an open abdomen (n = 398, 68.9%) was abdominal sepsis. Overall hospital mortality was 28.2%. The majority of patients (n = 355, 61.4%) were treated with NPWT. Intestinal fistulation [relative risk (RR) = 0.83, 95% confidence interval (CI): 0.44–1.58], death (RR = 0.87, 95% CI: 0.64–1.20), bleeding (RR = 0.74, 95% CI: 0.45–1.23), and intestinal failure (RR = 1.00, 95% CI: 0.64–1.57) were no more common in patients receiving NPWT, but the rate of delayed primary closure was significantly lower (RR = 0.74, 95% CI: 0.60–0.90, P = 0.002) when NPWT was used. Conclusions:The indications for an open abdomen in the United Kingdom appear to be significantly different to those described in N. America, where its use in the management of trauma predominates. NPWT in patients with an open abdomen is not associated with an increase in mortality or intestinal fistulation. It is, however, associated with a reduced rate of delayed primary closure. Although this may be related to patient selection, NPWT may leave patients with abdominal wall defects that require further treatment.

Registers needed for new interventional procedures

1734 www.thelancet.com Vol 371 May 24, 2008 improve practice through advocacy-based evidence and analysis, to be set up in 2009. This platform of the many global-health participants in Europe would promote: European health values (eg, universality, access to good-quality care, equity, and solidarity) in the international arena and good governance; coherence of broad policy making and synergy of policies for health benefi ts (eg, as development, trade, environment, and agriculture), especially for the social and economic determinants of health; and European commitment to global-health equity, with a focus on the health of the poorest populations. The meeting welcomed the possibility that such a European Council on Global Health could become part of a larger alliance of similar councils from other regions of the world. The participants proposed that, during the constitution of such a council, dialogue with colleagues from the developing world would be ensured, along with continued dialogue with the Global Health Council, USA, and the Canadian Society for International Health (both of whom were at the meeting). Those at the meeting further suggested making use of European presidencies and that the initiative should aim to include global health in the agenda of the next EU presidencies. This suggestion implies a structured dialogue with the European Commission on global-health matters via the European Health Strategy and building relations with WHO, in particular its Brussels offi ce. There is also a need to keep abreast of the development of a European foreign policy and, in line with the Oslo Ministerial Declaration on Health in Foreign Policy, to ensure that health is considered as part of this agenda. The meeting also proposed that a taskforce be created to extend the proposals for the goals and objectives, governance, structure, membership, benefi ciaries, partnerships, location, fi nancing, and performance measures of a European Council on Global Health. This taskforce will meet in May, 2008 in Geneva on the occasion of the Geneva Health Forum. Revising and updating the European Foundation Centre’s globalhealth policy glossary could be a useful method of communication for the initiative. The initiative will set up a small secretariat to support the members and taskforce. The initial organisers were made responsible for pressing the initiative forward, along with fundraising. A strong plea was made to European institutions to continue their support on matters of global health, and assist as well as engage in the initiative.

Usefulness of a short-term register for health technology assessment where the evidence base is poor.

UNLABELLED This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure). METHODS Coverage of the register during 2004-07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICEs original guidance from 2003. RESULTS The register reported 260 cases from thirteen UK hospitals during nearly 9 years. During a coverage evaluation period of 3 years, there were 152 registered Nuss procedures. An additional 246 repairs of pectus excavatum were undertaken in twenty-six previously unidentified hospitals. Of the 246, 23 were Nuss procedures (from two hospitals), 140 were open procedures (from eleven hospitals), and 3 were coding errors. No details were available for eighty cases undertaken at ten hospitals. The quantity of published literature had increased substantially since publication of original guidance in 2003. It related mostly to technical and safety outcomes, whereas the register included patient reported outcomes. The literature and the register reported similar rates of major adverse events such as bar displacement (2-10 percent). Committee members considered that the Register made a useful contribution to guidance development. CONCLUSIONS This study shows that a register set up to support a health technology assessment process can produce useful data both about safety and about patient-reported outcomes. Coverage may be improved by active follow-up based on routine hospital statistics. Improvement in coding for new procedures is needed in the United Kingdom.

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were identified from the Hospital Episode Statistics database. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. 92,246 first-time surgical mesh procedures (56,648 TVT, 34,704 TOT, 834 SS and 60 combinations) were identified, including 68,002 unconfounded procedures. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 [2.3–2.5]% and 1.7 [1.6–1.8]% respectively; 5.9 [5.7–6.1]% were readmitted at least once within 5 years for further mesh intervention or symptoms of complications, the highest risk being within the first 2 years. Complication rates were higher in the potentially confounded cohort. The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% This evidence can inform future decision-making on this procedure.

Effect of procedure volume on outcomes after iliac artery angioplasty and stenting.

Service reorganization to concentrate complex vascular services in hospitals with high caseload volume aims to reduce mortality and complication rates. The present study assessed the relationship between caseload volume and outcome for iliac artery angioplasty and stenting in England using a routinely available national data set (Hospital Episode Statistics, HES).

International collaboration in the use of registries for new devices and procedures.

The evaluation of new medical devices and interventional procedures (including surgical operations and transluminal interventions) is more challenging than the evaluation of new drugs. Fewer regulatory demands mean that the evidence base for devices is typically much more limited than for pharmaceuticals. There are no legal frameworks for regulation of procedures, although some countries have systems for producing guidance on their use1. The fact that some devices require novel procedures for their use, and that some novel procedures may be done using a variety of different devices whose design may be evolving, complicates the issue still further. Postmarketing surveillance of devices is variable and may fail to provide timely and reliable information about the incidence of serious adverse events2. Diffusion of procedures in the absence of good evidence increases the risk of poor outcomes for patients, and may have damaging effects on health services by disturbing established care pathways, altering use of resources and adding unexpected requirements for training3. Gathering good observational data would enhance the typically poor evidence base related to devices and procedures, and allow better planning of their use4. This is a well recognized need but has been achieved only in limited areas and on a limited scale5,6. International collaboration in collection and collation of data would be the ideal, to accrue information about real-world use in the shortest possible time. For international initiatives to be successful, there needs to be a shared view about which devices and procedures to prioritize for the allocation of resources. Registers need to be well conceived, with an agreed common purpose and compatible data items. This demands close links between clinicians in the countries involved (typically through their professional organizations) and significant infrastructure for support. Regulators such as the Medicines and Healthcare products Regulatory Agency in the UK and the Food and Drugs Administration (FDA) in the USA, and guidance-producing organizations such as the National Institute for Health and Clinical Excellence have considerable interest in the organization and success of registers. Some surgical specialties have already established registers that cross national boundaries, such as the European Cardiac Surgical Registry7. In the USA, the FDA recently held an exploratory meeting of those supervising joint replacement registers in several countries and is developing the capacity to collate data from these (MDEpiNet mission and strategic goals). The European network for health technology assessment (EUnetHTA) has developed the EVIDENT database (http://www. eunethta.eu), which aims to support collaboration between health technology assessment agencies and reduce duplication of work on additional evidence generation, while the Agency for Healthcare, Research and Quality in the USA is developing a ‘Registry of Patient Registers’8. Postmarket surveillance data from manufacturers could also be a valuable resource. Manufacturers hold unique information about all the devices they have sold and they often span national boundaries. For manufacturers’ data to be sufficiently useful and reliable for use in national assessments, their registers would need to be overseen by independent health professionals, scientists and others free from conflicts of interest, with all data on all patients available. Clinicians play a fundamental role in all stages of register development. Their engagement is vital to achieve comprehensive and valid submission of data9. Features of any register that help secure this engagement include a small data set, a ‘user friendly’ web-based data entry system that allows easy data submission, and easy retrieval of their own data for local audit and review of practice. Some registers (for example for joint replacements) are likely to continue in perpetuity. However, for any register there should be a clear plan about how long data submission will continue, in order to fulfil the specific purpose for which it was established. The burden of data submission and long-term followup may be reduced, and the likelihood of capturing certain outcomes may be enhanced, by linking registry data with other healthcare databases and national statistics systems. Such linkages may complicate data governance and international collaborations, but these issues will

Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics.

ABSTRACT Objective: Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. Methods: Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. Results: Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. Conclusions: A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.

Patient reported outcome measures for cardiac ablation procedures: a multicentre pilot to develop a new questionnaire

Aim To assess the feasibility of administering Patient Reported Outcomes Measures (PROMs) in patients treated with ablation for cardiac arrhythmias, and to conduct the first stage of development and testing of a new PROM tool. Methods and results A new tool was developed by a multidisciplinary team and tested alongside an adaptation of the patient perception of arrhythmia questionnaire (PPAQ) and EQ-5D-5L in a multicentre retrospective audit involving 791 consecutive cardiac arrhythmia patients treated with catheter ablation at three UK centres over 13 months. Data were recorded in the National Cardiac Rhythm Management Database, part of the National Institute for Cardiovascular Outcomes Research. The response rate was 71.9% (n = 569). Patients reported significant improvements across all outcomes and impacts, with reductions in symptoms of 51.7% (heart racing), 33.9% (fatigue) 31.8% (heart flutters), 43.5% (dizziness), 38.6% (breathlessness), 44.2% (chest pressure), 33.1% (trouble concentrating), 15.9% (headache), 28.3% (neck pressure), and 23.4% (fainting) (P < 0.001). The mean number of social days affected reduced by 7.49 days/month (P < 0.001); mean work/school days affected/month reduced by 6.26 (P < 0.001); mean GP/hospital visits reduced by 1.36 days/month (P < 0.001). The procedure met patient expectations in 72% of responders. Conclusions The high response rate suggests that the use of PROMs in this patient group is feasible, with rates equalling those of the National PROMs Programme. The results showed that patients experienced significant improvements in their quality of life following ablation, while feedback allowed the tools to be improved. Further work is required to validate these tools; however, the findings suggest that PROMs could be useful in the audit of ablation techniques.

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes

BackgroundSeveral authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures.MethodsA literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index – Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed.ResultsFrom 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes.ConclusionsThe four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

Prevalence and management of recurrent respiratory papillomatosis (RRP) in the UK: cross-sectional study

To estimate the number of patients with recurrent respiratory papillomatosis currently managed in secondary and tertiary health care in the UK and the frequency of its treatment with radiofrequency cold ablation (Coblation™).