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Abstract Background Recent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. The national UK governmental Department of Health’s Research Governance Framework (RGF) for Health and Social Care requires that appropriate checks be conducted before research involving human participants, their organs, tissues or data can commence in the NHS. As a result, medical research has been subjected to increased regulation and governance, with the requirement for approvals from numerous regulatory and monitoring bodies. In addition, the processes and outcomes of the attribution of costs in NHS research have caused additional difficulties for researchers. The purpose of this paper is to illustrate, through three trial case studies, the difficulties encountered during the set-up and recruitment phases of these trials, related to gaining the necessary ethical and governance approvals and applying for NHS costs to undertake and deliver the research. Methods Empirical evidence about delays and difficulties related to regulation and governance of medical research was gathered during the period 2009–2010 from three UK randomised controlled trials with sites in England, Wales and Scotland (1. SAFER 2- an emergency care based trial of a protocol for paramedics to refer patients directly to community based falls services; 2. COnStRUCT- a trial of two drugs for acute ulcerative colitis; and 3. Family Links - a trial of a public health intervention, a 10 week community based parenting programme). Findings and recommendations were reported in response to a call for evidence from The Academy of Medical Sciences regarding difficulties encountered in conducting medical research arising from R&D governance and regulation, to inform national policy. Results Difficulties and delays in navigating and gaining the appropriate approvals and NHS costs required to undertake the research were encountered in all three trials, at various points in the bureaucratic processes of ethical and research and information governance approvals. Conduct of each of the three trials was delayed by at least 12 months, with costs increasing by 30 – 40%. Conclusions Whilst the three trials encountered a variety of challenges, there were common issues. The processes for gaining approvals were overly complex and differed between sites and UK countries; guidance about processes was unclear; and information regarding how to define and claim NHS costs for undertaking the research was inconsistent. The competitive advantage of a publicly funded, open access health system for undertaking health services research and clinical trials within the UK has been outweighed in recent years by stifling bureaucratic structures and processes for governance of research. The recommendations of the Academy of Medical Sciences are welcomed, and the effects of their implementation are awaited with interest. Trial Registration numbers SAFER 2: ISRCTN 60481756; COnStRUCT: ISRCTN22663589; Family Links: ISRCTN 13929732

Background: Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies. Methods: Researchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made. Results: We articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement. Conclusions: This SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants. [ABSTRACT FROM AUTHOR]

This article presents four focus groups conducted with health professionals, part of a mixed-method evaluation of modernization of endoscopy services in England catalyzed by the UK National Health Service Modernisation Agency. Transcripts were analyzed adapting van Manen's "sententious" or "wholistic' approach to thematic analysis. Seven analysts worked to distil lengthy transcripts into summative paragraphs to capture the essentiality of text. Five major themes emerged: lack of senior management understanding and appropriate management systems, inadequate resources, loss of personal autonomy and erosion of professionalism, barriers and facilitators to change, and differences between English and Welsh units--the Welsh perspective. Achieving long-lasting, positive effects of modernization within complex systems demands senior management to actively support innovations, consider staff morale, and provide appropriate levels of funding. However, although professional morale was low, ambition to improve services was strong. The methodological framework offered a comprehensive and applicable approach to data analysis, and our analysis approach was inclusive and collaborative, with far-reaching possibilities for experimental studies and large-scale, mixed-method studies, including trials. [ABSTRACT FROM AUTHOR]

INTRODUCTION:Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. National United Kingdom (UK) guidelines recommend patients with TIA are seen in specialist clinics within 24 hours (high risk) or seven days (low risk).We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention is being tested in the TIER feasibility trial, in line with Medical Research Council (MRC) guidance on staged development and evaluation of complex interventions.METHODS:We conducted three interrelated activities to produce the TIER intervention: •Survey of UK Ambulance Services (n = 13) to gather information about TIA pathways already in use•Scoping review of literature describing prehospital care of patients with TIA•Synthesis of data and definition of intervention by specialist panel of: paramedics; Emergency Department (ED) and stroke consultants; service users; ambulance service managers.RESULTS:The panel used results to define the TIER intervention, to include: 1.Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt (< 7day) specialist review at TIA clinic2.Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic3.Referral process via ambulance control room4.Training package for paramedics5.Agreement with TIA clinic service provider including rapid review of referred patientsCONCLUSIONS:We followed MRC guidance to develop a clinical intervention for assessment and referral of low risk TIA patients attended by emergency ambulance paramedic. We are testing feasibility of implementing and evaluating this intervention in the TIER feasibility trial which may lead to fully powered multicentre randomized controlled trial (RCT) if predefined progression criteria are met. [ABSTRACT FROM PUBLISHER]

INTRODUCTION:Adequate pain relief at the scene of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilize and long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated (1).METHODS:We undertook a randomized controlled feasibility trial using novel audited scratchcard randomization to allocate eligible patients to FICB or usual care. Paramedics are recruited and trained to assess patients for hip fracture and carry out FICB. We will follow up patients to assess accuracy of paramedic diagnosis, acceptability to patients and paramedics, compliance of paramedics and also measures of pain, side effects, time in hospital and quality of life in order to plan a full trial if appropriate. The primary outcome measure is health related quality of life, measured using Short Form (SF)-12 at 1 and 6 months. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. This study was funded by Health and Care Research Wales (1003).RESULTS:We have developed: •paramedic pathway to assess patients for hip fracture and FICB•paramedic training package, delivered by Consultant Anaesthetist•randomization scratchcards.To date we have recruited nineteen paramedics; ten are fully trained and recruiting patients, the remainder are being trained. Fifty-four patients have been randomized and thirty-five have consented to follow-up. Thirteen 1-month and five 6-month follow-up questionnaires have been received.CONCLUSIONS:This study will enable us to recommend whether to undertake a definitive multi-centre randomized controlled trial of FICB by paramedics for hip fracture to determine if the procedure is effective for patients and worthwhile for the National Health Service. [ABSTRACT FROM PUBLISHER]

INTRODUCTION:Patients who experience Transient Ischaemic Attack (TIA) should be assessed and treated in a specialist clinic to reduce risk of further TIA or stroke. But referrals are often delayed. We aimed to identify published studies describing pathways for emergency assessment and referral of patients with suspected TIA at first medical contact: primary care; ambulance services; and emergency department.METHODS:We conducted a scoping literature review. We searched four databases (PubMed, CINAHL, Web of Science, Scopus). We screened studies for eligibility. We extracted and analysed data to describe setting, assessment and referral processes reported in primary research on referral of suspected TIA patients directly to specialist outpatient services.RESULTS:We identified eight studies in nine papers from five countries: 1/9 randomized trial; 6/9 before-and-after designs; 2/9 descriptive account. Five pathways were used by family doctors and three by Emergency Department (ED) physicians. None were used by paramedics. Clinicians identified TIA patients using a checklist incorporating the ABCD2 tool to describe risk of further stroke, online decision support tool or clinical judgement. They referred to a specialist clinic, either directly or via a telephone helpline. Anti-platelet medication was often given, usually aspirin unless contraindicated. Some patients underwent neurological and blood tests before referral and discharge. Five studies reported reduced incident of stroke at 90 days, from 6–10 percent predicted rate to 1.2-2.1 percent actual rate. Between 44 percent and 83 percent of suspected TIA cases in these studies were directly referred to stroke clinics through the pathways.CONCLUSIONS:Research literature has focused on assessment and referral by family doctors and ED physicians to reduce hospitalization of TIA patients. No pathways for paramedic use were reported. Since many suspected TIA patients present to ambulance services, effective pre-hospital assessment and referral pathways are needed. We will use review results to develop a paramedic referral pathway to test in a feasibility trial. [ABSTRACT FROM PUBLISHER]

INTRODUCTION:Patients presenting to emergency ambulance services with Transient Ischemic Attack (TIA) are usually conveyed to the Emergency Department (ED) with subsequent referral to specialist assessment at a TIA clinic within one week if at low risk of stroke. There is opportunity for paramedics to refer patients with TIA at low risk of recurrent stroke directly to a specialist TIA clinic, avoiding the transportation and care at the ED however evidence is lacking about current practice, safety and effectiveness of this intervention.We aimed to describe current service developments across the United Kingdom (UK) for the pre-hospital emergency care of patients with TIA, to inform the development of an intervention for testing.METHODS:We surveyed all UK Ambulance Trusts (n = 13) by email, asking them to identify initiatives related to the management of TIA, and followed up services reporting an alternative TIA pathway by telephone to gather further details.RESULTS:Twelve ambulance services responded to our survey. Eight reported that they had not developed or implemented TIA referral pathways. Three reported currently using a TIA referral pathway; one had discontinued their pathway due to service reconfiguration. All (4/4) pathways used the FAST test and ABCD2 tool to screen patients, in line with national guidelines, and classified patients as low risk if the ABCD2 score was ≤3. All indicated that eligible low-risk TIA patients should be referred by paramedics to specialist care, 2/4 by telephone, and 2/4 by fax.Although protocol compliance was audited in an initial pilot in one service, no formal evaluation of effectiveness was reported.CONCLUSIONS:Several UK ambulance services have introduced similar referral pathways for low risk TIA patients, avoiding transportation of patients to the ED. Existing initiatives can inform the development of an intervention for evaluation in a randomized trial. [ABSTRACT FROM PUBLISHER]