Cluster analysis of functional independence in community-dwelling older people.

BACKGROUND: The concept of Functional Independence (FI), defined as 'functioning physically safe and independent from other persons, within one's context", plays an important role in maintaining the functional ability to enable well-being in older age. FI is a dynamic and complex concept covering four clinical outcomes: physical capacity, empowerment, coping flexibility, and health literacy. As the level of FI differs widely between older adults, healthcare professionals must gain insight into how to best support older people in maintaining their level of FI in a personalized manner. Insight into subgroups of FI could be a first step in providing personalized support This study aims to identify clinically relevant, distinct subgroups of FI in Dutch community-dwelling older people and subsequently describe them according to individual characteristics. RESULTS: One hundred fifty-three community-dwelling older persons were included for participation. Cluster analysis identified four distinctive clusters: (1) Performers - Well-informed; this subgroup is physically strong, well-informed and educated, independent, non-falling, with limited reflective coping style. (2) Performers - Achievers: physically strong people with a limited coping style and health literacy level. (3) The reliant- Good Coper representing physically somewhat limited people with sufficient coping styles who receive professional help. (4) The reliant - Receivers: physically limited people with insufficient coping styles who receive professional help. These subgroups showed significant differences in demographic characteristics and clinical FI outcomes. CONCLUSIONS: Community-dwelling older persons can be allocated to four distinct and clinically relevant subgroups based on their level of FI. This subgrouping provides insight into the complex holistic concept of FI by pointing out for each subgroup which FI domain is affected. This way, it helps to better target interventions to prevent the decline of FI in the community-dwelling older population.

Effectiveness of professional and patient-oriented strategies in reducing vitamin D and B12 test ordering in primary care: a cluster randomised intervention study.

BACKGROUND: Vitamin tests are increasingly ordered by GPs, but a clinical and evidence-based indication is often lacking. Harnessing technology (that is, decision support tools and redesigning request forms) have been shown to reduce vitamin requests. AIM: To investigate whether the number of vitamin tests may be reduced by providing a multi-level intervention programme based on training, monitoring, and feedback. DESIGN & SETTING: This was a cluster randomised intervention study performed in 26 primary care health centres (>195 000 patients) in the Netherlands. The relative reduction in ordered vitamin D and B12 tests was determined after introduction of two de-implementation strategies (1 May 2017 to 30 April 2018). METHOD: Health centres randomised to de-implementation strategy 1 received education and benchmarking of their own vitamin test ordering behaviour every 3 months. Health centres in de-implementation strategy 2 received the same education and benchmarking, but supplemented with educational material for patients. RESULTS: The number of vitamin D tests decreased by 23% compared to the 1-year pre-intervention period (1 May 2016 to 30 April 2017). For vitamin B12 tests an overall reduction of 20% was found. Provision of patient educational information showed additional value over training and benchmarking of GPs alone for vitamin D test ordering (10% extra reduction, odds ratio [OR] 0.88, 95% confidence interval [CI] = 0.83 to 0.92), but not for vitamin B12 ordering (4% extra reduction, OR 0.96, 95% CI = 0.91 to 1.02). Nationwide, this would result in over €3 200 000 in savings on healthcare expenditure a year. CONCLUSION: A structured intervention programme, including training and benchmarking of GPs regarding their diagnostic test ordering, resulted in a significant reduction in ordered vitamin tests. Additional information provision to patients resulted in a small but still relevant additional reduction. If implemented on a national level, a substantial cost saving could be achieved.

Clinical pharmacists in Dutch general practice: an integrated care model to provide optimal pharmaceutical care.

Background Medication-related harm is a major problem in healthcare. New models of integrated care are required to guarantee safe and efficient use of medication. Aim To prevent medication-related harm by integrating a clinical pharmacist in the general practice team. This best practice paper provides an overview of 1. the development of this function and the integration process and 2. its impact, measured with quantitative and qualitative analyses. Setting Ten general practices in the Netherlands. Development and implementation of the (pragmatic) experiment We designed a 15-month workplace-based post-graduate learning program to train pharmacists to become clinical pharmacists integrated in general practice teams. In close collaboration with general practitioners, clinical pharmacists conduct clinical medication reviews (CMRs), hold patient consultations for medication-related problems, carry out quality improvement projects and educate the practice staff. As part of the Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT) intervention study, ten pharmacists worked full-time in general practices for 15 months and concurrently participated in the training program. Evaluation of this integrated care model included both quantitative and qualitative analyses of the training program, professional identity formation and effectiveness on medication safety. Evaluation The integrated care model improved medication safety: less medication-related hospitalisations occurred compared to usual care (rate ratio 0.68 (95% CI: 0.57-0.82)). Essential hereto were the workplace-based training program and full integration in the GP practices: this supported the development of a new professional identity as clinical pharmacist. This new caregiver proved to align well with the general practitioner. Conclusion A clinical pharmacist in general practice proves a feasible integrated care model to improve the quality of drug therapy.

Measurement properties of oral health assessments for non-dental healthcare professionals in older people: a systematic review.

BACKGROUND: Regular inspection of the oral cavity is required for prevention, early diagnosis and risk reduction of oral- and general health-related problems. Assessments to inspect the oral cavity have been designed for non-dental healthcare professionals, like nurses. The purpose of this systematic review was to evaluate the content and the measurement properties of oral health assessments for use by non-dental healthcare professionals in assessing older peoples' oral health, in order to provide recommendations for practice, policy, and research. METHODS: A systematic search in PubMed, EMBASE.com, and Cinahl (via Ebsco) has been performed. Search terms referring to 'oral health assessments', 'non-dental healthcare professionals' and 'older people (60+)' were used. Two reviewers individually performed title/abstract, and full-text screening for eligibility. The included studies have investigated at least one measurement property (validity/reliability) and were evaluated on their methodological quality using "The Consensus-based Standards for the selection of health Measurement Instruments" (COSMIN) checklist. The measurement properties were then scored using quality criteria (positive/negative/indeterminate). RESULTS: Out of 879 hits, 18 studies were included in this review. Five studies showed good methodological quality on at least one measurement property and 14 studies showed poor methodological quality on some of their measurement properties. None of the studies assessed all measurement properties of the COSMIN. In total eight oral health assessments were found: the Revised Oral Assessment Guide (ROAG); the Minimum Data Set (MDS), with oral health component; the Oral Health Assessment Tool (OHAT); The Holistic Reliable Oral Assessment Tool (THROAT); Dental Hygiene Registration (DHR); Mucosal Plaque Score (MPS); The Brief Oral Health Screening Examination (BOHSE) and the Oral Assessment Sheet (OAS). Most frequently assessed items were: lips, mucosa membrane, tongue, gums, teeth, denture, saliva, and oral hygiene. CONCLUSION: Taken into account the scarce evidence of the proposed assessments, the OHAT and ROAG are most complete in their included oral health items and are of best methodological quality in combination with positive quality criteria on their measurement properties. Non-dental healthcare professionals, policymakers and researchers should be aware of the methodological limitations of the available oral health assessments and realize that the quality of the measurement properties remains uncertain.

Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.

BACKGROUND & AIMS: Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. METHODS: We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. RESULTS: Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005). CONCLUSIONS: In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.

Efficacy of individual and group hypnotherapy in irritable bowel syndrome (IMAGINE): a multicentre randomised controlled trial.

BACKGROUND: Hypnotherapy for irritable bowel syndrome (IBS) has been used primarily in patients with refractory symptoms in specialised departments and delivered on an individual basis. We aimed to test the hypothesis that hypnotherapy would be more effective than educational supportive therapy, and that group hypnotherapy would be non-inferior to individual hypnotherapy for patients with IBS referred from primary and secondary care. METHODS: We did a multicentre randomised controlled trial (IMAGINE) in 11 hospitals in the Netherlands. Patients with IBS, aged 18-65 years, who were referred from primary or secondary care were randomly allocated (3:3:1) in blocks of six using a computer-based random number table procedure by staff not involved in the treatment to receive six sessions of individual or group hypnotherapy or group educational supportive therapy (control group). The primary outcome was adequate relief of IBS symptoms, with responders defined as patients who reported adequate relief when asked once weekly on three or four occasions in 4 consecutive weeks. We compared hypnotherapy (both groups) with control in the intention-to-treat population (excluding individuals subsequently found to be ineligible for enrolment), and assessed non-inferiority of group hypnotherapy versus individual hypnotherapy in the per-protocol population (with a non-inferiority margin of 15%) at 3 months and 12 months. This trial is registered with ISRCTN, number ISRCTN22888906, and is completed. FINDINGS: Between May 31, 2011, and April 6, 2016, 494 patients referred for psychological treatment for IBS were assessed for eligibility, of whom 354 were randomly allocated to the three groups: 150 to individual hypnotherapy, 150 to group hypnotherapy, and 54 to educational supportive therapy. After exclusion of individuals subsequently found to be ineligible for enrolment, 142 patients in the individual hypnotherapy group, 146 in the group hypnotherapy group, and 54 in the control group were included in the intention-to-treat population. Of these, 22 (15%) patients in the individual hypnotherapy group, 22 (15%) in the group hypnotherapy group, and 11 (20%) in the control group dropped out before or during therapy. In the intention-to-treat analysis, the adequate response rate was 40·8% (95% CI 31·7-50·5) in the individual hypnotherapy group, 33·2% (24·3-43·5) in the group hypnotherapy group, and 16·7% (7·6-32·6) in the control group at 3 months. At 12 months, 40·8% (31·3-51·1) of patients in the individual hypnotherapy group, 49·5% (38·8-60·0) of patients in the group hypnotherapy group, and 22.6% (11·5-39·5) of patients in the control group reported adequate relief. Hypnotherapy was more effective than control at 3 months (odds ratio 2·9, 95% CI 1·2-7·4, p=0·0240) and 12 months (2·8, 1·2-6·7, p=0·0185). In the per-protocol analysis, 49·9% (39·2-60·6) in the individual hypnotherapy group and 42·7% (32·3-53·8) in the group hypnotherapy group had adequate relief at 3 months, and 55·5% (43·4-67·1) of individual and 51·7% (40·2-63·0) of group hypnotherapy patients reported adequate relief at 12 months. Group hypnotherapy was therefore non-inferior to individual hypnotherapy. Eight unexpected serious adverse reactions (six in the individual hypnotherapy group and two in the group hypnotherapy group) were reported, most of which were cancer or inflammatory bowel disease, and were judged by the medical ethics committee as not being related to the therapy. INTERPRETATION: Hypnotherapy should be considered as a possible treatment for patients with IBS in primary and secondary care. Furthermore, group therapy could allow many more patients to be treated for the same cost. FUNDING: None.

Learning Through Boundary Crossing: Professional Identity Formation of Pharmacists Transitioning to General Practice in the Netherlands.

PURPOSE: To unravel boundary crossing as it relates to professional identity formation in pharmacists transitioning from a community pharmacy to working as nondispensing clinical pharmacists in general practice, with the aim of optimizing their education. METHOD: This was a multiple-case study, including two-stage interviews, peer feedback, and individual reflection, that collected data in 2014-2016 from eight clinical pharmacists working in general practice in the Netherlands. These pharmacists acted-without a workplace role model-as pharmaceutical care providers in general practices during a 15-month training program. In within-case and cross-case analysis, data were collected regarding pharmacists' role development in practice and perceptions of learning processes, and examined through the lens of professional identity formation and boundary crossing. RESULTS: Analysis of data collected during and after the training program demonstrated that the clinical pharmacists who applied the learning mechanisms of reflection and transformation developed a patient-care-oriented professional identity. Some clinical pharmacists, who learned mainly through the mechanism of identification, did not integrate the new patient-care-oriented role into their professional identity. They felt that their workplace provided limited opportunities for reflection and transformation. Learning with peers on formal training days was seen as highly valuable for professional identity formation; it counterbalanced the lack of a role model in the workplace. CONCLUSIONS: Professional identity formation in the transition from community pharmacist to clinical pharmacist in general practice benefited from reflective, on-the-job training. This permitted transformative, boundary-crossing learning with peers and supported professional identity formation oriented to providing practice-based pharmaceutical care.

Mammals divert endogenous genotoxic formaldehyde into one-carbon metabolism.

The folate-driven one-carbon (1C) cycle is a fundamental metabolic hub in cells that enables the synthesis of nucleotides and amino acids and epigenetic modifications. This cycle might also release formaldehyde, a potent protein and DNA crosslinking agent that organisms produce in substantial quantities. Here we show that supplementation with tetrahydrofolate, the essential cofactor of this cycle, and other oxidation-prone folate derivatives kills human, mouse and chicken cells that cannot detoxify formaldehyde or that lack DNA crosslink repair. Notably, formaldehyde is generated from oxidative decomposition of the folate backbone. Furthermore, we find that formaldehyde detoxification in human cells generates formate, and thereby promotes nucleotide synthesis. This supply of 1C units is sufficient to sustain the growth of cells that are unable to use serine, which is the predominant source of 1C units. These findings identify an unexpected source of formaldehyde and, more generally, indicate that the detoxification of this ubiquitous endogenous genotoxin creates a benign 1C unit that can sustain essential metabolism.

Systematic review: The placebo effect of psychological interventions in the treatment of irritable bowel syndrome.

AIM: To determine the placebo response rate associated with different types of placebo interventions used in psychological intervention studies for irritable bowel syndrome. METHODS: Randomized controlled trials comparing psychological interventions (stress management/relaxation therapy (cognitive) behavioral therapy, short-term psychodynamic therapy, and hypnotherapy) for the treatment of adult patients with irritable bowel syndrome (IBS) diagnosed with the Manning or Rome criteria with an adequate placebo control treatment and reporting data on IBS symptom severity were identified by searching PubMed, Embase, the Cochrane Library, CINAHL and PsycINFO databases. Full-text articles that were written in English and published between 1966 and February 2016 in peer-reviewed journals were selected for the present review. Placebo interventions were considered to be adequate if the number of sessions and the amount of time spent with the therapist were the same as in the active treatment. The placebo response rate (PRR) was computed for IBS symptom severity (primary outcome measure) as well as for anxiety, depression and quality of life (secondary outcome measures). RESULTS: Six studies, with a total of 555 patients met the inclusion criteria. Four studies used an educational intervention, whereas two studies used a form of supportive therapy as the placebo intervention. The PRR for IBS symptom severity ranged from 25% to 59%, with a pooled mean of 41.4%. The relative PRR for the secondary outcome measures ranged from 0% to 267% for anxiety, 6% to 52% for depression 20% to 125% for quality of life. The PRR associated with pharmacological treatments, treatment with dietary bran and complementary medicine ranged from 37.5% to 47%. Contrary to our expectations, the PRR in studies on psychological interventions was comparable to that in studies on pharmacological, dietary and alternative medical interventions. CONCLUSION: The PRR is probably determined to a larger extent by patient-related factors, such as expectations and desire for the treatment to be effective, than the content of the placebo intervention.

The expanding role of primary care in cancer control.

The nature of cancer control is changing, with an increasing emphasis, fuelled by public and political demand, on prevention, early diagnosis, and patient experience during and after treatment. At the same time, primary care is increasingly promoted, by governments and health funders worldwide, as the preferred setting for most health care for reasons of increasing need, to stabilise health-care costs, and to accommodate patient preference for care close to home. It is timely, then, to consider how this expanding role for primary care can work for cancer control, which has long been dominated by highly technical interventions centred on treatment, and in which the contribution of primary care has been largely perceived as marginal. In this Commission, expert opinion from primary care and public health professionals with academic and clinical cancer expertise­from epidemiologists, psychologists, policy makers, and cancer specialists­has contributed to a detailed consideration of the evidence for cancer control provided in primary care and community care settings. Ranging from primary prevention to end-of-life care, the scope for new models of care is explored, and the actions needed to effect change are outlined. The strengths of primary care­its continuous, coordinated, and comprehensive care for individuals and families­are particularly evident in prevention and diagnosis, in shared follow-up and survivorship care, and in end-of-life care. A strong theme of integration of care runs throughout, and its elements (clinical, vertical, and functional) and the tools needed for integrated working are described in detail. All of this change, as it evolves, will need to be underpinned by new research and by continuing and shared multiprofessional development.

Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT).

BACKGROUND: In the Netherlands, 5.6 % of acute hospital admissions are medication-related. Almost half of these admissions are potentially preventable. Reviewing medication in patients at risk in primary care might prevent these hospital admissions. At present, implementation of medication reviews in primary care is suboptimal: pharmacists lack access to patient information, pharmacists are short of clinical knowledge and skills, and working processes of pharmacists (focus on dispensing) and general practitioners (focus on clinical practice) match poorly. Integration of the pharmacist in the primary health care team might improve pharmaceutical care outcomes. The aim of this study is to evaluate the effect of integration of a non-dispensing pharmacist in general practice on the safety of pharmacotherapy in the Netherlands. METHODS: The POINT study is a non-randomised controlled intervention study with pre-post comparison in an integrated primary care setting. We compare three different models of pharmaceutical care provision in primary care: 1) a non-dispensing pharmacist as an integral member of a primary care team, 2) a pharmacist in a community pharmacy with a predefined training in performing medication reviews and 3) a pharmacist in a community pharmacy (care as usual). In all models, GPs remain accountable for individual medication prescription. In the first model, ten non-dispensing clinical pharmacists are posted in ten primary care practices (including 5 - 10 000 patients each) for a period of 15 months. These non-dispensing pharmacists perform patient consultations, including medication reviews, and share responsibility for the pharmaceutical care provided in the practice. The two other groups consist of ten primary care practices with collaborating pharmacists. The main outcome measurement is the number of medication-related hospital admissions during follow-up. Secondary outcome measurements are potential medication errors, drug burden index and costs. Parallel to this study, a qualitative study is conducted to evaluate the feasibility of introducing a NDP in general practice. DISCUSSION: As the POINT study is a large-scale intervention study, it should provide evidence as to whether integration of a non-dispensing clinical pharmacist in primary care will result in safer pharmacotherapy. The qualitative study also generates knowledge on the optimal implementation of this model in primary care. Results are expected in 2016. TRIAL REGISTRATION NUMBER: NTR4389 , The Netherlands National Trial Register, 07-01-2014.

Design of the INTEGRATE study: effectiveness and cost-effectiveness of a cardiometabolic risk assessment and treatment program integrated in primary care.

BACKGROUND: The increasing prevalence of cardiometabolic disease (CMD) in combination with an ageing population is a major public health problem. Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs. General practice is the optimal health care setting to accomplish this goal. Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible. However, the effectiveness and cost-effectiveness have yet to be demonstrated. The 'Personalized Prevention Approach for CardioMetabolic Risk' (PPA CMR) is such a prevention program. The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR, as well as to establish determinants for participation and compliance. METHODS: The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group. In approximately 40 general practices, all enlisted patients without CMD aged 45-70 years, are invited to participate in PPA CMR. After an online risk estimation, patients with a score above risk threshold are invited to the GP for additional measurements, detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling. At baseline and after twelve months of follow-up lifestyle, health and work status of all participants are established with online questionnaires. Additionally after twelve months, we will determine health care utilization, costs of PPA CMR and compliance. Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group. Medical data will be extracted from the GPs' electronic medical records. In order to assess factors related to participation, we will send questionnaires to non-participants and assess characteristics of participating practices. For all participants, additional demographic characteristics will be available through Statistics Netherlands. DISCUSSION: The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance, which represents essential information to guide further large-scale implementation of primary prevention programs for CMD. TRIAL REGISTRATION NUMBER: NTR4277, The Netherlands National Trial Register, 26-11-2013.

Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT).

BACKGROUND: Currently, primary care for frail older people is reactive, time consuming and does not meet patients' needs. A transition is needed towards proactive and integrated care, so that daily functioning and a good quality of life can be preserved. To work towards these goals, two interventions were developed to enhance the care of frail older patients in general practice: a screening and monitoring intervention using routine healthcare data (U-PRIM) and a nurse-led multidisciplinary intervention program (U-CARE). The U-PROFIT trial was designed to evaluate the effectiveness of these interventions. The aim of this paper is to describe the U-PROFIT trial design and to discuss methodological issues and challenges. METHODS/DESIGN: The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate. The primary outcome is the effect on activities of daily living as measured with the Katz ADL index. Secondary outcomes are quality of life, mortality, nursing home admission, emergency department and out-of-hours General Practice (GP), surgery visits, and caregiver burden. DISCUSSION: In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur. Recruitment and retention of patients and feasibility of the interventions are important issues. To enable broad generalizability of results, careful choices of the design and outcome measures are required. Taking this into account, the U-PROFIT trial aims to provide robust evidence for a structured and integrated approach to provide care for frail older people in primary care. TRIAL REGISTRATION: NTR2288.

A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

BACKGROUND: Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. METHODS/DESIGN: The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. DISCUSSION: If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN22888906.

Bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder. The role of pharmacotherapy for IBS is limited and focused mainly on symptom control. OBJECTIVES: The objective of this systematic review was to evaluate the efficacy of bulking agents, antispasmodics and antidepressants for the treatment of irritable bowel syndrome. SEARCH STRATEGY: Computer assisted structured searches of MEDLINE, EMBASE, The Cochrane library, CINAHL and PsychInfo were conducted for the years 1966-2009. An updated search in April 2011 identified 10 studies which will be considered for inclusion in a future update of this review. SELECTION CRITERIA: Randomized controlled trials comparing bulking agents, antispasmodics or antidepressants with a placebo treatment in patients with irritable bowel syndrome aged over 12 years were considered for inclusion. Only studies published as full papers were included. Studies were not excluded on the basis of language. The primary outcome had to include improvement of abdominal pain, global assessment or symptom score. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from the selected studies. Risk Ratios (RR) and Standardized Mean Differences (SMD) with 95% confidence intervals (CI) were calculated. A proof of practice analysis was conducted including sub-group analyses for different types of  bulking agents, spasmolytic agents or antidepressant medication. This was followed by a proof of principle analysis where only the studies with adequate allocation concealment were included. MAIN RESULTS: A total of 56 studies (3725 patients) were included in this review. These included 12 studies of bulking agents (621 patients), 29 of antispasmodics (2333 patients), and 15 of antidepressants (922 patients). The risk of bias was low for most items. However, selection bias is unclear for many of the included studies because the methods used for randomization and allocation concealment were not described. No beneficial effect for bulking agents over placebo was found for improvement of abdominal pain (4 studies; 186 patients; SMD 0.03; 95% CI -0.34 to 0.40; P = 0.87), global assessment (11 studies; 565 patients; RR 1.10; 95% CI 0.91 to 1.33; P = 0.32) or symptom score (3 studies; 126 patients SMD -0.00; 95% CI -0.43 to 0.43; P = 1.00). Subgroup analyses for insoluble and soluble fibres also showed no statistically significant benefit. Separate analysis of the studies with adequate concealment of allocation did not change these results. There was a beneficial effect for antispasmodics over placebo for improvement of abdominal pain (58% of antispasmodic patients improved compared to 46% of placebo; 13 studies; 1392 patients; RR 1.32; 95% CI 1.12 to 1.55; P < 0.001; NNT = 7), global assessment (57% of antispasmodic patients improved compared to 39% of placebo; 22 studies; 1983 patients; RR 1.49; 95% CI 1.25 to 1.77; P < 0.0001; NNT = 5) and symptom score (37% of antispasmodic patients improved compared to 22% of placebo; 4 studies; 586 patients; RR 1.86; 95% CI 1.26 to 2.76; P < 0.01; NNT = 3). Subgroup analyses for different types of antispasmodics found statistically significant benefits for cimteropium/ dicyclomine, peppermint oil, pinaverium and trimebutine. Separate analysis of the studies with adequate allocation concealment found a significant benefit for improvement of abdominal pain. There was a beneficial effect for antidepressants over placebo for improvement of abdominal pain (54% of antidepressants patients improved compared to 37% of placebo; 8 studies; 517 patients; RR 1.49; 95% CI 1.05 to 2.12; P = 0.03; NNT = 5), global assessment (59% of antidepressants patients improved compared to 39% of placebo; 11 studies; 750 patients; RR 1.57; 95% CI 1.23 to 2.00; P < 0.001; NNT = 4) and symptom score (53% of antidepressants patients improved compared to 26% of placebo; 3 studies; 159 patients; RR 1.99; 95% CI 1.32 to 2.99; P = 0.001; NNT = 4). Subgroup analyses showed a statistically significant benefit for selective serotonin releasing inhibitors (SSRIs) for improvement of  global assessment and for tricyclic antidepressants (TCAs) for improvement of abdominal pain and symptom score. Separate analysis of studies with adequate allocation concealment found a significant benefit for improvement of symptom score and global assessment. Adverse events were not assessed as an outcome in this review. AUTHORS' CONCLUSIONS: There is no evidence that bulking agents are effective for treating IBS.  There is evidence that antispasmodics are effective for the treatment of IBS. The individual subgroups which are effective include: cimetropium/dicyclomine, peppermint oil, pinaverium and trimebutine. There is good evidence that antidepressants are effective for the treatment of IBS. The subgroup analyses for SSRIs and TCAs are unequivocal and their effectiveness may depend on the individual patient. Future research should use rigorous methodology and valid outcome measures.

Training innovations in gastroenterology and educational resources: a new vision of gastrointestinal education across Europe.

To define a new educational strategy for the United European Gastroenterology Federation (UEGF) to be followed and implemented in the near future. UEGF organized a consensus-based strategy meeting with stakeholders and key decision makers in European Gastroenterology on Training Innovations in Gastroenterology and Educational Resources. In May 2010, in an 'open-face conference' at Starnberg, Germany, 59 specialists in gastroenterology, hepatology, and related fields from 15 countries and 16 societies participated. Breakout sessions identified the key problem areas, possible solutions, and formulated statements subsequently voted upon in plenum. A majority of the formulated statements (59%) reached a strong agreement. Topics in which UEGF should focus are the future educational activities that include developing ways to advocate multidisciplinarity and integration between levels of care and specialties, ways to improve quality of care, and the development of training tools. The successful outcome of the Training Innovations in Gastroenterology and Educational Resources conference was achieved with the production of a strategy layout for new UEGF educational activities. There was an agreement that improvement in topics related to multidisciplinarity and professionalism, which is crucial for further development. An open-face conference, such as that embodied by the Training Innovations in Gastroenterology and Educational Resources meeting, was shown to be an effective tool in identifying the key problem areas in education and in formulating new strategies.

Psychological treatments for the management of irritable bowel syndrome.

BACKGROUND: No consensus exists on the optimal treatment for irritable bowel syndrome (IBS). Psychological treatments are increasingly advocated but their effectiveness is unclear. OBJECTIVES: To evaluate the efficacy of psychological interventions for the treatment of irritable bowel syndrome. SEARCH STRATEGY: A computer assisted search of MEDLINE, EMBASE, PsychInfo, CINAHL, Web of Science, The Cochrane Library and Google Scholar was performed for the years 1966-2008. Local databases were searched in Europe. SELECTION CRITERIA: Randomised trials comparing single psychological interventions with either usual care or mock interventions in patients over 16 years of age. No language criterion was applied. DATA COLLECTION AND ANALYSIS: The search identified 25 studies that fulfilled the inclusion criteria. The relative risk (RR), risk difference (RD), number needed to treat (NNT) and standardized mean difference (SMD) along with 95% confidence intervals were calculated using a random effects model for each outcome. MAIN RESULTS: Psychological interventions as a group The SMD for symptom score improvement at 2 and 3 months was 0.97 (95% CI 0.29 to 1.65) and 0.62 (95% CI 0.45 to 0.79) respectively compared to usual care. Against placebo, the SMDs were 0.71 (95% CI 0.08 to 1.33) and -0.17 (95% CI -0.45 to 0.11) respectively. For improvement of abdominal pain, the SMDs at 2 and 3 months were 0.54 (95%CI 0.10 to 0.98) and 0.26 (95% CI 0.07 to 0.45) compared to usual care. The SMD from placebo at 3 months was 0.31 (95% CI -0.16 to 0.79). For improvement in quality of life, the SMD from usual care at 2 and 3 months was 0.47 (95%CI 0.11 to 0.84) and 0.31 (95%CI -0.16 to 0.77) respectively. Cognitive behavioural therapy The SMD for symptom score improvement at 2 and 3 months was 0.75 (95% CI -0.20 to 1.70) and 0.58 (95% CI 0.36 to 0.79) respectively compared to usual care. Against placebo, the SMDs were 0.68 (95% CI -0.01 to 1.36) and -0.17 (95% CI -0.45 to 0.11) respectively. For improvement of abdominal pain, the SMDs at 2 and 3 months were 0.45 (95% CI 0.00 to 0.91) and 0.22 (95% CI -0.04 to -0.49) compared to usual care. Against placebo the SMD at 3 months was 0.33 (95% CI -0.16 to 0.82). For improvement in quality of life, the SMDs at 2 and 3 months compared to usual care were 0.44 (95% CI 0.04 to 0.85) and 0.92 (95% CI 0.07 to 1.77) respectively.Interpersonal psychotherapy The RR for adequate relief of symptoms was 2.02 (95% CI 1.13 to 3.62), RD 0.30 (95% CI 0.13 to 0.46), NNT 4 for comparison with care as usual. The SMD for improvement of symptom score was 0.35 (95% CI -0.75 to 0.05) compared with usual care. Relaxation/Stress management The SMD in symptom score improvement at 2 months was 0.50 (95%CI 0.02 to 0.98) compared with usual care. The SMD in improvement of abdominal pain at 3 months was 0.02 (95%CI -0.56 to 0.61) compared with usual care. Long term results Very few long term follow-up results were available. There was no convincing evidence that treatment effects were sustained following completion of treatment for any treatment modality. AUTHORS' CONCLUSIONS: Psychological interventions may be slightly superior to usual care or waiting list control conditions at the end of treatment although the clinical significance of this is debatable. Except for a single study, these therapies are not superior to placebo and the sustainability of their effect is questionable. The meta-analysis was significantly limited by issues of validity, heterogeneity, small sample size and outcome definition. Future research should adhere to current recommendations for IBS treatment trials and should focus on the long-term effects of treatment.