Integrating data to facilitate clinical research : a case study

The integration of routine clinical administrative activities into ongoing rigorous clinical research poses challenges for both clinicians and researchers. This case study describes the development of a responsive database system used to facilitate comprehensive longitudinal research into the outcomes of patients waiting for hip and knee replacement surgery in a large public teaching hospital. The initial research procedure was paper-based, with manual patient matching and data entry. This process was time-consuming and associated with substantial risk of error and omissions, necessitating the design of a better system. An integrated database system was designed to receive daily electronic updates of the orthopaedic waiting-list and scheduled clinic and surgery dates. Using readily available software (Microsoft Access), new patients were identified through specifying inclusion and exclusion criteria which allowed rapid and complete recruitment at time of entry to the waiting-list. The integrated system specified the appropriate timing of multiple follow-up assessments, provided prompt information on recruitment for reporting purposes and integrated multiple linked research projects within one database. Seamless exporting of data to statistical programs for analysis was also enabled. This simple integrated approach facilitated efficient execution of a longitudinal study from recruitment to statistical analysis while maximising confidentiality and minimising resources required. This case study describes the development and design of a simple system which could be easily adapted for database management in hospital or clinic-based settings according to local requirements.<br /

Supporting the clinical trial recruitment process through the grid

Patient recruitment for clinical trials and studies is a large-scale task. To test a given drug for example, it is desirable that as large a pool of suitable candidates is used as possible to support reliable assessment of often moderate effects of the drugs. To make such a recruitment campaign successful, it is necessary to efficiently target the petitioning of these potential subjects. Because of the necessarily large numbers involved in such campaigns, this is a problem that naturally lends itself to the paradigm of Grid technology. However the accumulation and linkage of data sets across clinical domain boundaries poses challenges due to the sensitivity of the data involved that are atypical of other Grid domains. This includes handling the privacy and integrity of data, and importantly the process by which data can be collected and used, and ensuring for example that patient involvement and consent is dealt with appropriately throughout the clinical trials process. This paper describes a Grid infrastructure developed as part of the MRC funded VOTES project (Virtual Organisations for Trials and Epidemiological Studies) at the National e-Science Centre in Glasgow that supports these processes and the different security requirements specific to this domain

Business models in health care: Accounting for the sustainability of palliative and end of life care provision by voluntary hospices' in England

This study evaluates the sustainability of palliative and end of life care provision by voluntary hospices in England. Using a mixed methods, inductive approach, we construct a ‘descriptive business model’ for hospices which is grounded in analysis of relevant accounting information, and supported by narratives extracted from interviews with senior clinical and non clinical managers from four large and medium sized hospices. The study reveals the strengths and weaknesses of the hospice business model and evaluates its robustness against forthcoming challenges. Our findings highlight the gradual transition from a basic voluntary sector business model to a complex, highly sophisticated, and institutionalized care establishment, sharing many of the characteristics found in large private and public organizations. The sustainability however of the business model is threatened due to its exposure to a number of contradictory forces. Whilst demand for palliative and end of life care going forward is set to increase, due to both demographic and regulatory factors, hospices' voluntary income is highly volatile. Dependency on sustaining a complex network of stakeholder groups to underwrite income, challenges the hospice business model’s ability to cope with the anticipated challenges

Employers skill survey : case study : health and social care

"This report examines the relationship between service delivery strategies and processes, and the deployment of skills, recruitment problems and skill gaps within selected sub-sectors of health and social care. The sub-sectors within health are physiotherapy and radiography. Within social care the focus is on care of the elderly (both residential and domiciliary care). Although subject to similar drivers and associated pressures, the two sub-sectors of health and social care display markedly different characteristics, particularly in terms of service delivery strategies, qualification frameworks and utilisation of skills. In simple terms, the health and social care subsectors considered within this report may be thought of as being situated at opposite poles of the ‘skills spectrum’: with radiography and physiotherapy characterised by high level skills, while care of the elderly is traditionally associated with low level skills. Hence, the two sub-sectors are discussed separately throughout this report. The greater complexity and range of skills required in the two health sub-sectors is reflected in the comparative length of the two sections of the report" - page 9

Understanding Occupational and Skill Demand in New Jersey's Health Care Industry

The health care industry in New Jersey employs almost 350,000 people. However, state, national, and international shortages of nurses is raising widespread concern in the industry. Jobs in the industry are changing in response to pressures to control costs and the demands of an increasingly consolidated industry. This report summarizes the skill, knowledge, and educational requirements of key health care occupations and identifies strategies for meeting the workforce challenges facing the industry

Using electronic health records to support clinical trials: a report on stakeholder engagement for EHR4CR

Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform

Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: The trigeminal neuralgia experience

Background: This study aimed to describe recruitment challenges encountered during a phase IIa study of vixotrigine, a state and use-dependent Nav1.7 channel blocker, in individuals with trigeminal neuralgia. Methods: This was an international, multicenter, placebo-controlled, randomized withdrawal study that included a 7-day run-in period, a 21-day open-label phase, and a 28-day double-blind phase in which patients (planned n = 30) were randomized to vixotrigine or placebo. Before recruitment, all antiepileptic drugs had to be stopped, except for gabapentin or pregabalin. After the trial, patients returned to their original medications. Patient recruitment was expanded beyond the original five planned (core) centers in order to meet target enrollment (total recruiting sites N = 25). Core sites contributed data related to patient identification for study participation (prescreening data). Data related to screening failures and study withdrawal were also analyzed using descriptive statistics. Results: Approximately half (322/636; 50.6%) of the patients who were prescreened at core sites were considered eligible for the study and 56/322 (17.4%) were screened. Of those considered eligible, 26/322 (8.1%) enrolled in the study and 6/322 (1.9%) completed the study. In total, 125 patients were screened across all study sites and 67/125 (53.6%) were enrolled. At prescreening, reasons for noneligibility varied by site and were most commonly diagnosis change (78/314; 24.8%), age &gt; 80 years (75/314; 23.9%), language/distance/mobility (61/314; 19.4%), and noncardiac medical problems (53/314; 16.9%). At screening, frequently cited reasons for noneligibility included failure based on electrocardiogram, insufficient pain, and diagnosis change. Conclusions: Factors contributing to recruitment challenges encountered in this study included diagnosis changes, anxiety over treatment changes, and issues relating to distance, language, and mobility. Wherever possible, future studies should be designed to address these challenges. Trial registration: ClinicalTrials.gov, NCT01540630. EudraCT, 2010-023963-16. 07 Aug 2015

Health Center Financial Check-Up: Prescriptions for Strengthening New York's Diagnostic and Treatment Centers

Analyzes evidence of financial distress among nonprofit health centers and contributing factors for individual centers as well as the sector. Makes recommendations for the state, philanthropic organizations, public and private payers, and health centers

The relative clinical effectiveness and cost-effectiveness of three contrasting approaches to partner notification for curable sexually transmitted infections: a cluster randomised trial in primary care

Since 1998 there has been a substantial increase in reported cases of sexually transmitted infection (STI), most strikingly in the 16–24 years age group.1 Across genitourinary medicine (GUM) clinics in the UK in 2007, young people accounted for 65% of chlamydia cases, 50% of cases of genital warts and 50% of gonorrhoea infections.1 Chlamydia is the most common STI in under-25s. Since 1998, the rate of diagnosed chlamydia has more than doubled in the 16–24 years age group (from 447 per 100,000 in 1998 to 1102 per 100,000 in 2007). This may be because of a combination of a higher proportion of young people testing, improved diagnostic methods and increased risk behaviour.1 Chlamydia infection can frequently go undetected, particularly in women, as it is often asymptomatic.1 If left untreated, chlamydia can lead to pelvic inflammatory disease and infertility in women. This highlights the importance of testing this higher-risk age group to ensure prompt diagnosis and treatment. It is estimated that 11–12% of 16- to 19-year-olds presenting at a GUM clinic with an acute STI will become reinfected within a year.2 In order to minimise reinfection, preventative measures are required, including effective methods of notifying partners to ensure rapid diagnosis and treatment and reduce the likelihood of index patients being reinfected from the same source