Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website.

BACKGROUND: Many patients with IBS suffer on-going symptoms. The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines. Cognitive Behavioural Therapy (CBT) can be helpful, but availability is poor in the NHS. We developed a web-based CBT self-management programme (Regul8) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial. METHODS: Patients, 16 to 60 years, with IBS symptoms fulfilling Rome III criteria were recruited via GP practices and randomised to over-encapsulated mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 website conditions: Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website. RESULTS: 135 patients recruited from 26 GP practices. Mean IBS SSS score 241.9 (sd 87.7), IBS-QOL 64 (sd 20) at baseline. 91% follow-up at 12 weeks. Mean IBS SSS decreased by 35 points from baseline to 12 weeks. There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12 weeks, or in medication groups at 6 weeks, or IBS-QOL in website groups at 6 weeks. However, IBS SSS at 6 weeks was lower in the No website group than the website groups (IBS SSS no website =162.8 (95% CI 137.4-188.3), website 197.0 (172.4 - 221.7), Website + telephone support 208.0 (183.1-233.0) p = 0.037). CONCLUSIONS: This exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial. Primary outcomes (IBS SS and IBS QOL) did not reach significance at 6 or 12 weeks, apart from IBS SSS being lower in the no-website group at 6 weeks - this disappeared by 12 weeks. Improved Enablement suggests patients with access to the Regul8 website felt better able to cope with their symptoms than the non-website group. Improved SGA score in the Regul8 groups may indicate some overall improvement not captured on other measures. TRIAL REGISTRATION: ClinicalTrials.gov Identifier (NCT number): NCT00934973.

Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial).

BACKGROUND: IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. METHODS/DESIGN: The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. OUTCOMES: Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. DISCUSSION: This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will enable economic analysis to be undertaken.

Facilitating organisational development using a group-based formative assessment and benchmarking method: design and implementation of the International Family Practice Maturity Matrix.

INTRODUCTION: Well-organised practices deliver higher-quality care. Yet there has been very little effort so far to help primary care organisations achieve higher levels of team performance and to help them identify and prioritise areas where quality improvement efforts should be concentrated. No attempt at all has been made to achieve a method which would be capable of providing comparisons--and the stimulus for further improvement--at an international level. METHODS: The development of the International Family Practice Maturity Matrix took place in three phases: (1) selection and refinement of organisational dimensions; (2) development of incremental scales based on a recognised theoretical framework; and (3) testing the feasibility of the approach on an international basis, including generation of an automated web-based benchmarking system. RESULTS: This work has demonstrated the feasibility of developing an organisational assessment tool for primary care organisations that is sufficiently generic to cross international borders and is applicable across a diverse range of health settings, from state-organised systems to insurer-based health economies. It proved possible to introduce this assessment method in 11 countries in Europe and one in Africa, and to generate comparison benchmarks based on the data collected. The evaluation of the assessment process was uniformly positive with the view that the approach efficiently enables the identification of priorities for organisational development and quality improvement at the same time as motivating change by virtue of the group dynamics. CONCLUSIONS: We are not aware of any other organisational assessment method for primary care which has been 'born international,' and that has involved attention to theory, dimension selection and item refinement. The principal aims were to achieve an organisational assessment which gains added value by using interaction, engagement comparative benchmarks: aims which have been achieved. The next step is to achieve wider implementation and to ensure that those who undertake the assessment method ensure linkages are made to planned investment in organisational development and quality improvement. Knowing the problems is only half the story.

Quality improvement in general practice: enabling general practitioners to judge ethical dilemmas.

Quality improvement (QI) is fundamental to maintaining high standards of health care. Significant debate exists concerning the necessity for an ethical approval system for those QI projects that push the boundaries, appearing more similar to research than QI. The authors discuss this issue identifying the core ethical issues in family medicine (FM), drawing upon the fundamental principles of medical ethics, including principles of autonomy, utility, justice and non-maleficence. Recent debate concerning the application of QI ethics boards is discussed with relevance to primary care and issues such as general practitioner (GP) intentions, the impact of QI on patients and the use of confidential patient data and the impact of dissemination. The authors conclude that a system of QI ethical approval leaves many issues unresolved and potentially creates several barriers to implementing QI. To ensure ethical QI work is generated within FM it is essential for GPs to learn about and engage in more ethical reflection so that they can better judge and resolve these issues.

Quality improvement in primary care: ethical issues explored.

PURPOSE: Quality improvement (QI) processes in family medicine are becoming increasingly complex. Their influence on the organisation of the sector and on the daily work processes is profound and increasing. The literature indicates that many ethical issues are arising from QI work. Therefore this paper aims to identify the experiences of professionals involved in planning and performing QI programmes in European family medicine on the ethical implications involved in those processes. DESIGN/METHODOLOGY/APPROACH: Four focus groups were carried out with 29 general practitioners (GPs) and administrators of general practice quality work in Europe. Two focus groups comprised EQuiP members and two focus groups comprised attendees to an invitational conference on QI in family medicine held by EQuiP in Barcelona in November 2006. FINDINGS: Four overarching themes were identified, including implications of using patient data, prioritising QI projects, issues surrounding the ethical approval dilemma and the impact of QI. Each theme was accompanied by an identified solution. PRACTICAL IMPLICATIONS: Prioritising is necessary and in doing that GPs should ensure that a variety of work is conducted so that some patient groups are not neglected. Transparency and flexibility on various levels is necessary to avoid harmful consequences of QI in terms of bureaucratisation, increased workload and burnout on part of the GP and harmful effects on the doctor-patient relationship. There is a need to address the system of approval for national QI programmes and QI projects utilising more sophisticated methodologies. ORIGINALITY/VALUE: This study provides data from GPs who are experienced quality improvers across 17 countries. Many ethical issues were identified and it was possible to clearly map the themes and their relationships and to summarise the identified solutions from an international perspective.