HIS-based Kaplan-Meier plots - a single source approach for documenting and reusing routine survival information

<p>Abstract</p> <p>Background</p> <p>Survival or outcome information is important for clinical routine as well as for clinical research and should be collected completely, timely and precisely. This information is relevant for multiple usages including quality control, clinical trials, observational studies and epidemiological registries. However, the local hospital information system (HIS) does not support this documentation and therefore this data has to generated by paper based or spreadsheet methods which can result in redundantly documented data. Therefore we investigated, whether integrating the follow-up documentation of different departments in the HIS and reusing it for survival analysis can enable the physician to obtain survival curves in a timely manner and to avoid redundant documentation.</p> <p>Methods</p> <p>We analysed the current follow-up process of oncological patients in two departments (urology, haematology) with respect to different documentation forms. We developed a concept for comprehensive survival documentation based on a generic data model and implemented a follow-up form within the HIS of the University Hospital Muenster which is suitable for a secondary use of these data. We designed a query to extract the relevant data from the HIS and implemented Kaplan-Meier plots based on these data. To re-use this data sufficient data quality is needed. We measured completeness of forms with respect to all tumour cases in the clinic and completeness of documented items per form as incomplete information can bias results of the survival analysis.</p> <p>Results</p> <p>Based on the form analysis we discovered differences and concordances between both departments. We identified 52 attributes from which 13 were common (e.g. procedures and diagnosis dates) and were used for the generic data model. The electronic follow-up form was integrated in the clinical workflow. Survival data was also retrospectively entered in order to perform survival and quality analyses on a comprehensive data set. Physicians are now able to generate timely Kaplan-Meier plots on current data. We analysed 1029 follow-up forms of 965 patients with survival information between 1992 and 2010. Completeness of forms was 60.2%, completeness of items ranges between 94.3% and 98.5%. Median overall survival time was 16.4 years; median event-free survival time was 7.7 years.</p> <p>Conclusion</p> <p>It is feasible to integrate survival information into routine HIS documentation such that Kaplan-Meier plots can be generated directly and in a timely manner.</p

Ontology-based data integration between clinical and research systems

Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL) are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it

Data completeness in healthcare: A literature survey.

As the adoption of eHealth has made it easier to access and aggregate healthcare data, there has been growing application for clinical decisions, health services planning, and public health monitoring with daily collected data in clinical care. Reliable data quality is a precursor of the aforementioned tasks. There is a body of research on data quality in healthcare, however, a clear picture of data completeness in this field is missing. This research aims to identify and classify current research themes related to data completeness in healthcare. In addition, the paper presents problems with data completeness in the reviewed literature and identifies methods that have been adopted to address those problems. This study has reviewed 24 papers (January 2011–April 2016) published in information and computing sciences, biomedical engineering, and medicine and health sciences journals. The paper uncovers three main research themes, including design and development, evaluation, and determinants. In conclusion, this paper improves our understanding of the current state of the art of data completeness in healthcare records and indicates future research directions.N

Pulmonary arterial hypertension in repaired congenital heart disease: a multicentre study

This doctoral thesis aims to investigate the demographics, treatment patterns and prognosis of paediatric pulmonary hypertension (PH) and the emerging group of children and adults with PH in the setting of repaired congenital heart disease (CHD). I have conducted three studies, each with a distinct focus. The first is a retrospective, longitudinal study of ten CHD centres across the UK that assesses the clinical characteristics and treatment patterns of adults with a Fontan-type circulation receiving pulmonary vasodilators. I have compared treated patients with a matched cohort of Fontan patients who are not receiving pulmonary vasodilator therapy, complemented by an expert survey to determine current practice and the goals of therapy. In the second study, I created a 20-year national UK registry of paediatric PH and derived estimates of incidence and prevalence for all groups of paediatric PH in different age categories. I determined the natural history of paediatric PH and performed survival analysis. I then focused on patients with CHD and described the changes in demographics, with a substantial increase in patients with previously repaired CHD, who now form the largest PAH-CHD subgroup. The third study focuses on this latter group of repaired PAH-CHD. I highlighted the heterogeneity in terms of severity and onset of PAH. I identified prognostic markers and variables associated with PH resolution and developed a novel risk score for predicting adverse clinical outcomes in this group. This score will form the basis for the risk stratification of this high-risk population, to inform prognostication and guide treatment.Open Acces

Improving the clinical pathway for Crohn’s perianal fistulas - novel approaches to aetiopathogenesis, treatment and outcome measurement

Crohn’s perianal fistulas are often complex and represent a challenging and disabling disease phenotype with unknown optimal treatment strategy. There are paucities in understanding of disease aetiopathogenesis, paucity in real word data on long-term outcomes in the biologic era, and the best medical / surgical treatment strategies remain unknown. There is limited ability to measure robust and comparative outcomes due to heterogeneity in outcome measurement with uncertain relevance to patients. Metabonomics (metabolic profiling/metabolomics) is a rapidly advancing field in systems biology that generates disease-relevant micro-molecular information downstream of the genome and proteome. Metabolic profiling studies utilising nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) have demonstrated early promise in inflammatory bowel disease research. In this thesis, I have implemented a metabolic profiling strategy using mass spectrometry for evaluation of fresh frozen fistula tissue from idiopathic and Crohn’s fistula patients and in so doing have distinguished these two groups of fistula patients by their fistula metabolic phenotype, developing corroborative hypotheses on factors involved in pathogenesis. Using real world data from a single institution I have catalogued the disease course for a cohort of patients with Crohn’s perianal fistula on anti-TNF therapy over an 11 year period, representing one of the longest follow-up durations / largest cohorts investigated. I have also investigated and chronicled the disease course and natural history for a cohort of patients refractory to anti-TNF, who inevitably have limited options in management. I have also characterised the disease burden in this group, using novel disease states to model transition probabilities between these over time. In order to attempt to streamline patients into avoiding futile treatments and stemming the burden of futile treatment and potential side effects in refractory patients, I have investigated the potential of tissue levels as a biomarker of treatment response. I demonstrate the absence of tissue anti-TNF (infliximab and adalimumab) in a small cohort of Crohn’s fistula patients on maintenance anti-TNF therapy for Crohn’s perianal fistula. Further work is required to corroborate this interesting finding and relate it to clinical outcome as well as develop the search for such a biomarker to facilitate personalised treatment pathways for these patients. I have explored novel minimally invasive surgical treatment options for perianal fistulas, describing early success with FiLaC, VAAFT and OTSC for idiopathic fistulas but with even more limited evidence in Crohn’s fistulas. This thesis introduces the concept of symptom amelioration for symptom refractory Crohn’s perianal fistulas, demonstrating patient reported benefit in amelioration of symptoms of pain and discharge. However, this was limited by the absence of a control arm and the lack of a validated patient reported outcome measure. To address the latter issue I have developed a new patient reported outcome measure, the Crohn’s Anal Fistula Quality of Life (CAF-QoL) questionnaire, using a qualitative exploration into the lives of patients with Crohn’s perianal fistulas as well as a multidisciplinary nationwide consensus exercise to inform a process of item generation and psychometric testing, and investigating stability, reliability, construct and content validity and sensitivity to change.Open Acces

Leg Ulcer Outcomes

Background Venous disease is the most common cause of leg ulceration. Treatment of superficial venous reflux has been shown to reduce the rate of ulcer recurrence but the effect of early endovenous ablation of superficial venous reflux on ulcer healing remains unclear. It is generally accepted that there is considerable global variation in the management of leg ulcers. Objectives To determine: the clinical and cost-effectiveness of early endovenous treatment of superficialvenous reflux in addition to standard care compared to standard care alone in patients with venous ulceration; the current standards of global management of venous leg management and the impact on these following the results of the randomised controlled trial. Methods i. The Early Venous Reflux Ablation Trial (EVRA) multi-centre randomised clinical trial of 450 participants compared early versus deferred intervention at 12 months and at 3.5 years. ii. Health professionals treating patients with leg ulcers globally were surveyed before and after the publication of the RCT results to gain insight on the management of venous leg ulceration, and subsequent impact on practice. Results i. EVRA: i. time to ulcer healing was shorter in the early group at 12 months; no clear difference in time to first ulcer recurrence at 3.5 years; early intervention at 3 years is 91% likely to be cost-effective at £20,000/QALY. ii. Surveys: ⁃ Pre/post-EVRA UK primary care: 90/643 responses received; Pre/post-EVRA global clinicians: 799/644 responses were received. Conclusions The EVRA RCT showed that early intervention reduces the time to healing of venous leg ulcers, does not affect the time to recurrent ulceration but is highly likely to be cost-effective and therefore is beneficial for both patients and healthcare providers. The surveys demonstrated that the management of venous ulceration is disparate globally. It is likely that the EVRA RCT results influenced the timing of intervention worldwide.Open Acces

The role of performance assessment in the management of facilities and support services in the public sector

Since the 1980s, successive governments have imposed a range of performance assessment regimes for incorporation within the service management processes of public bodies with the intention of emulating the success achieved from their use in delivering ‘effectiveness, efficiency and legitimacy’ within the private sector (De Bruijn 2007). Concurrently, increasingly knowledgeable and resourceful stakeholders have sought confirmation that as well as meeting its statutory obligations their local authority is consistently delivering its local community with a range of high quality, flexible services by working, where appropriate, in partnership with other public or private sector organisations. Given the above, soft facilities management (FM) services (ie those that provide support to the front line services, such as cleaning, reception, mail room), provide a significant overhead to the local authority, the research sets out to determine the role of facilities management within the local authority context and FMs’ awareness and use of performance assessment within this context, as part of the soft FM management process. Following a review of the literature, a theoretical model was proposed that outlined the factors affecting the effective use of performance assessment within the management of soft FM services within a local authority context. The factors were determined to be the organisational and wider environment, use of knowledge/information and education and awareness of performance assessment within the FMs. The research methodology comprised a questionnaire, a set of semi-structured interviews and case studies. Accordingly, the research evaluated - if there was a generic profile for soft FM services within the local authority context - the factors that affect the effective use (or result in non-use) of seven performance assessment techniques (operational and strategic) within the management of fourteen soft FM services, and - their value, if any, in assisting the FM to ensure the provision of accountable, value for money services that satisfy the customers/stakeholders they serve. 4 In order to ensure a consistent approach for assessing soft FM services within this context, the research proposed a four-step methodology for defining and assessing FM services and their performance. Despite the requirement for local authorities to evidence accountability, provide ‘value for money’ and customer responsive services, the research established an unexpectedly low level of knowledge of any performance assessment technique other than benchmarking and a corresponding low use of the evaluated techniques. This was despite recognition by FMs within a local authority context of the perceived value of performance assessment as part of the service management process. There also appeared to be limited endorsement from Senior Management and Council Members for its use within the management of soft FM services. Furthermore, a knowledge base or soft FM related information on the use of performance assessment both in a wider context, and more specifically within the local authority context proved limited, as did training of FMs in the selection and use of an appropriate performance assessment technique as part of the soft FM service management process. Benchmarking forms the basis of a range of mandatory performance assessment regimes within the public sector. Therefore, in case studies undertaken with local authority FMs, FMs higher and further education and within the National Health Service an assessment was made of its use within the performance assessment of soft FM services within these sectors, and including an evaluation of whether benefits may be gained, or ‘value added’ from cross sector comparisons. Again, the findings were that use within and across sectors proved disappointingly low. The research concluded that current use of performance assessment of soft FM services within this context is limited and ineffective. Improvements to this situation require the adoption of a generic soft FM service remit within local authorities, which would better support meaningful service comparisons, appropriate training for FMS in the use of performance assessment as part of the soft FM management process, a sound knowledge base from which soft FMs can draw best practice, and increased management support. If these cannot be achieved any requirement for its continued use must be questioned

Quality of surgery in oncology trials

Randomised controlled trials (RCTs) with surgical interventions often lack a framework to ensure surgical quality. Although recent oncology trials, such as ADDICT (D1+ vs. D2 gastrectomy), have sought to monitor surgery there has been no demonstrably reliable tool to assess surgical quality. We aimed to investigate SQA in oesophagogastric oncology trials and to develop a robust framework of consensus strategies to overcome challenges to design and implementation of SQA. A multi-method approach including both qualitative and quantitative methodologies were applied in order to address the research objectives. On systematic review of previously reported challenges to SQA in trials the most commonly encountered included: constraints of using case volume for credentialing surgeons; inter-centre variation in the definition and execution of interventions, and; insufficient monitoring of surgical quality. A meta-analysis of SQA and protocol utilisation within oesophagogastric RCTs revealed public availability of protocols and Eastern country of origin were associated with improved survival. Semi-structured interviews were subsequently conducted with expert stakeholders examining challenges to SQA in trials. Prominent mitigating strategies included operative monitoring using photographs and/or videos with a structured objective assessment tool. Expert consensus was reached for 59 strategies to overcome challenges to SQA in oncology trials. 14 (74%) of the 19 included expert stakeholder proposed strategies from chapter 4 gained consensus amongst ADDICT trial stakeholders within 2 Delphi rounds, indicating their relevance within oesophagogastric oncology RCTs. A patient focus group and survey, established to gain insight into service user perception of quality of surgery, reinforced the importance of considering operative volume and monitoring surgery using a structured methodology. Robust monitoring methods are required to assess surgical quality and oesophagectomy assessment tools were demonstrated to be reliable using generalisability theory. Condensing the expert Delphi consensus allowed formulation of a 33-item framework of strategies to overcome challenges to implementation of SQA in oncology trials (FOSQAT). Given the relevance of the expert Delphi strategies within ADDICT, in future we recommend trial committees and surgeons will not be required to conduct a Delphi process, but rather will be able to select relevant strategies for implementation from the FOSQAT consensus. Clinical validation of this framework assessing impact of implemented strategies on short and long-term outcomes should be the focus of future research in this area.Open Acces

Excess foundry sand characterization and experimental investigation in controlled low-strength material and hot-mixing asphalt

This report provides technical data regarding the reuse of excess foundry sand. The report addresses three topics: a statistically sound evaluation of the characterization of foundry sand, a laboratory investigation to qualify excess foundry sand as a major component in controlled low-strength material (CLSM), and the identification of the best methods for using foundry sand as a replacement for natural aggregates for construction purposes, specifically in asphalt paving materials. The survival analysis statistical technique was used to characterize foundry sand over a full spectrum of general chemical parameters, metallic elements, and organic compounds regarding bulk analysis and leachate characterization. Not limited to characterization and environmental impact, foundry sand was evaluated by factor analyses, which contributes to proper selection of factor and maximization of the reuse marketplace for foundry sand. Regarding the integration of foundry sand into CLSM, excavatable CLSM and structural CLSM containing different types of excess foundry sands were investigated through laboratory experiments. Foundry sand was approved to constitute a major component in CLSM. Regarding the integration of foundry sand into asphalt paving materials, the optimum asphalt content was determined for each mixture, as well as the bulk density, maximum density, asphalt absorption, and air voids at Nini, Ndes, and Nmax. It was found that foundry sands can be used as an aggregate in hot-mix asphalt production, but each sand should be evaluated individually. Foundry sands tend to lower the strength of mixtures and also may make them more susceptible to moisture damage. Finally, traditional anti-stripping additives may decrease the moisture sensitivity of a mixture containing foundry sand, but not to the level allowed by most highway agencies.Structural Engineerin