[Irritable bowel syndrome]. / Prikkelbaredarmsyndroom.

Irritable bowel syndrome (IBS) is a prevalent disorder of the gut-brain interaction, of which the multifactorial pathophysiology is still incompletely understood. IBS is a symptom-based diagnosis based on the Rome IV criteria, and additional diagnostics are only indicated when history or physical examination point towards the presence of other (organic) disorders. Diagnosis and treatment should take place in primary care. However, management of IBS can be challenging due to the heterogenous clinical presentation. Furthermore, a variety of treatment options are available, yet only effective in subgroups of patients. Early positive diagnosis, patient education, and shared-decision making are of utmost importance in order to limit individual disease burden and the socioeconomic impact of IBS. In this review we discuss diagnosis, indications for additional investigations or referral to secondary care, and treatment of IBS, based on both the recently updated Dutch guideline and general practice standard on IBS.

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.

BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.

Recruiting families for an intervention study to prevent second-hand smoke exposure in children.

BACKGROUND: We evaluated the effectiveness of different recruitment strategies used in a study aimed at eliminating/reducing second-hand smoke (SHS) exposure in Dutch children 0-13 years of age with a high risk of asthma. METHODS: The different strategies include: 1) questionnaires distributed via home addresses, physicians or schools of the children; 2) cohorts from other paediatric studies; 3) physicians working in the paediatric field (family physicians, paediatricians and Youth Health Care (YHC) physicians); and 4) advertisements in a local newsletter, at child-care facilities, and day-care centres. RESULTS: More than 42,782 families were approached to take part in the screening of which 3663 could be assessed for eligibility. Of these responders, 196 families met the inclusion criteria for the study. However, only 58 (one third) could be randomised in the trial, mainly because of no interest or time of the parents. The results showed that recruiting families who expose their children to SHS exposure is very challenging, which may be explained by lack of 'recognition' or awareness that SHS occurs in homes. The presence of asthma in the family, respiratory symptoms in the children, and even incentives did not increase parental motivation for participation in the study. CONCLUSIONS: The recruitment process for an intervention program addressing SHS exposure in children was considerably more challenging and time consuming than anticipated. Barriers at both a parents level and a doctor's level can be discriminated.

Stakeholder perspectives on workplace-based performance assessment: towards a better understanding of assessor behaviour.

Workplace-Based Assessment (WBA) plays a pivotal role in present-day competency-based medical curricula. Validity in WBA mainly depends on how stakeholders (e.g. clinical supervisors and learners) use the assessments-rather than on the intrinsic qualities of instruments and methods. Current research on assessment in clinical contexts seems to imply that variable behaviours during performance assessment of both assessors and learners may well reflect their respective beliefs and perspectives towards WBA. We therefore performed a Q methodological study to explore perspectives underlying stakeholders' behaviours in WBA in a postgraduate medical training program. Five different perspectives on performance assessment were extracted: Agency, Mutuality, Objectivity, Adaptivity and Accountability. These perspectives reflect both differences and similarities in stakeholder perceptions and preferences regarding the utility of WBA. In comparing and contrasting the various perspectives, we identified two key areas of disagreement, specifically 'the locus of regulation of learning' (i.e., self-regulated versus externally regulated learning) and 'the extent to which assessment should be standardised' (i.e., tailored versus standardised assessment). Differing perspectives may variously affect stakeholders' acceptance, use-and, consequently, the effectiveness-of assessment programmes. Continuous interaction between all stakeholders is essential to monitor, adapt and improve assessment practices and to stimulate the development of a shared mental model. Better understanding of underlying stakeholder perspectives could be an important step in bridging the gap between psychometric and socio-constructivist approaches in WBA.

Use of Rome criteria for the diagnosis of irritable bowel syndrome in primary care: a survey among European countries.

BACKGROUND AND OBJECTIVES: The majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care. The aim of this study was to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS. PATIENTS AND METHODS: A survey consisting of 18 questions was distributed across 11 European countries and was used to assess GPs' diagnostic approach of IBS, the use of Rome criteria in daily practice and GPs' perspective on the aetiology of the disorder. RESULTS: Overall, 185 GPs completed the survey. In daily clinical practice, 32% of GPs reported that they usually make a positive diagnosis on the basis of symptoms only, whereas 36% of GPs reported regular use of the Rome criteria to diagnose IBS. Furthermore, 62% of the responders reported that they applied additional diagnostics, such as blood tests, 31% found it necessary to perform endoscopy to make a positive diagnosis of IBS and 29% referred patients with IBS to a specialist. Psychological factors were the most frequently selected potential aetiological factor of IBS (88% of GPs). Overall, 52% of GPs reported systematically including questions on psychological symptoms in the assessment of history of IBS. CONCLUSION: Only about one-third of GPs regularly used the Rome criteria to diagnose IBS. In daily primary care practice, IBS largely remains a diagnosis of exclusion. This has implications in terms of GPs' specialty training and questions the applicability of IBS guidelines in daily care, which advocate an early, positive, symptom-based diagnosis.

Burden of COPD in patients treated in different care settings in the Netherlands.

INTRODUCTION: Care for patients with chronic obstructive pulmonary disease (COPD) can be provided in primary, secondary or tertiary care. Whether and to what extent patients with COPD treated in various healthcare settings differ in disease burden and healthcare utilization remains unknown. Therefore, daily symptoms, functional mobility, mood status, health status and healthcare utilization were compared between COPD patients in various care settings, to explore possibilities for healthcare-optimization. METHODS: Current data are part of the Chance study. Demographics, functional mobility (Care Dependency Scale (CDS); Timed-Up-and-Go (TUG) test), mood status (Hospital Anxiety and Depression scale (HADS)), health status (COPD Assessment test (CAT); Clinical COPD questionnaire (CCQ); COPD specific St. George Respiratory questionnaire (SGRQ-C)), received treatments and severity of physical and psychological symptoms were assessed in subjects with and without COPD. RESULTS: 836 subjects (100 primary care patients, 100 secondary care patients, 518 tertiary care patients and 118 non-COPD subjects) were included. The burden of disease significantly increased from primary care to tertiary care. However, in all three healthcare settings a high percentage of patients with an impaired health status was observed (i.e. CAT ≥10 points, 68.0% vs. 91.0% vs. 94.5%, respectively). Furthermore, many patients treated in secondary care remain highly symptomatic despite treatment, while others with low burden of disease would allow for de-intensification of care. CONCLUSION: This study revealed important shortcomings and challenges for the care of COPD patients in the Netherlands. It emphasizes the need for detailed patient characterization and more individualized treatment, independent of the healthcare setting.

Impact of cardiovascular comorbidities on COPD Assessment Test (CAT) and its responsiveness to pulmonary rehabilitation in patients with moderate to very severe COPD: protocol of the Chance study.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. Patients with COPD are characterised by a reduced health status, which can be easily assessed by the COPD Assessment Test (CAT). Previous studies show that health status can be worsened by the presence of comorbidities. However, the impact of cardiovascular comorbidities on health status as assessed with CAT is not sufficiently investigated. Therefore, the current study has the following objectives: (1) to study the clinical, (patho)physiological and psychosocial determinants of the CAT, and impact of previously established and/or newly diagnosed cardiovascular comorbidities on health status in tertiary care patients with COPD; (2) to assess the effects of pulmonary rehabilitation on CAT scores in patients with COPD; (3) to develop reference values for the CAT in Dutch elderly patients without COPD; and (4) to validate the CAT in a broad sample of Dutch patients with COPD. METHODS AND ANALYSIS: The COPD, Health status and Comorbidities (Chance) study is a monocentre study consisting of an observational cross-sectional part and a longitudinal part. Demographic and clinical characteristics will be assessed in primary care, secondary care and tertiary care patients with COPD, and in patients without COPD. To assess health status, the CAT, Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ) will be used. The longitudinal part consists of a comprehensive pulmonary rehabilitation programme in 500 tertiary care patients. For the cross-sectional part of the study, 150 patients without COPD, 100 primary care patients and 100 secondary care patients will be assessed during a single home visit. ETHICS AND DISSEMINATION: The Medical Ethical Committee of the Maastricht University Medical Centre+ (MUMC+), Maastricht, the Netherlands (METC 11-3-070), has approved this study. The study has been registered at the Dutch Trial Register (NTR 3416).

An economic evaluation of a video- and text-based computer-tailored intervention for smoking cessation: a cost-effectiveness and cost-utility analysis of a randomized controlled trial.

BACKGROUND: Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. OBJECTIVE: The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. METHODS: In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. RESULTS: No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. CONCLUSION: The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. TRIAL REGISTRATION: Nederlands Trial Register NTR3102.

Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial.

BACKGROUND: Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation. METHODS/DESIGN: A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength, physical activity level, health related quality of life, patients' perceived benefit, physical therapy compliance, motivation level, level of effective mucus clearance, exacerbation symptoms and health care contacts due to COPD will be recorded. Follow-up measurements are scheduled at 3 and 6 weeks, 3, 6, 12 and 24 months after inclusion. DISCUSSION: Ways to minimise potential problems regarding the execution of this study will be discussed. TRIAL REGISTRATION: The Netherlands National Trial Register NTR1972.

Early detection of COPD in general practice: implementation, workload and socioeconomic status. A mixed methods observational study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is underdiagnosed in general practice. Our aim was to implement a population-based approach for the early detection of COPD and to assess its impact on primary care workload and costs, and the influence of socioeconomic status (SES). METHODS: An observational study with mixed methods was performed in 10 Dutch general practices of either low or moderate to high SES. The Respiratory Health Screening Questionnaire was posted during a three-month period to all persons aged 45, 55, and 65 years (one age group per month). The practices calculated the risk, and patients at high risk of COPD were invited for spirometry at the practice. The general practitioner used the spirometric results and a consultation to establish a clinical diagnosis. Qualitative and quantitative data on workload, cost, and barriers were evaluated. RESULTS: Ten practices returned 293 (35.3%) COPD risk tests for the three age groups. Participants from low SES practices responded better than those from moderate to high SES practices (40.8% vs. 30.5%). In practices with low SES 17.9% of the tests indicated high risk compared with 16.1% in practices with moderate to high SES. Nine patients (23%) were newly diagnosed with COPD. The healthcare providers' extra workload averaged 18.5 hours during the three months for one standard practice. The average cost of this survey programme (three age groups in three months) was €520 for low SES practices and €398 for moderate to high SES practices. All healthcare providers affirmed that the extra workload in this survey model is acceptable and feasible when finances are compensated. CONCLUSIONS: Early detection of COPD is feasible in daily life primary care. In moderate to high SES practices the costs of detecting COPD were less than in low SES practices.

Rentabilidad de la prevención primaria del asma en lactantes de alto riesgo: 0-2 años / Cost-effectiveness of primary prevention of asthma in high-risk infants: 0-2 years

Con el fin de investigar la rentabilidad de la prevención primaria del asma en lactantes de alto riesgo, de hasta 2 años, desde la perspectiva de la sociedad (PREVASC) y con un diagnóstico clínico de asma realizado por un médico generalista (MG) y un diagnóstico epidemiológico de asma basado en un modelo de predicción (EPM), se seleccionaron 476 lactantes de un ensayo aleatorizado y controlado (242 en el grupo de intervención, 234 en el grupo control). Por medio de informes semanales se evaluó la utilización de los recursos de salud. El margen de error acerca de los índices de rentabilidad incremental se determinó por análisis bootstrap. El 26.8% de los niños del grupo de intervención y el 25.5% de los controles recibieron el diagnóstico de asma por parte de un MG, mientras que el 69.9% y el 63.5%, respectivamente, tuvo el diagnóstico basado en un EPM. Con ambas definiciones no hubo diferencias en el diagnóstico de asma entre los participantes del grupo de intervención y el grupo control (odds ratio [OR]: 1.1, intervalo de confianza del 95% [IC]: 0.6-1.8 y OR: 1.3, IC: 0.8-2.2). La media de los costos totales en el grupo de intervención y el grupo control fue de 1564 euros (rango intercuartiles: 669-6 499 euros) y de 967 euros (rango intercuartiles: 29-7 136 euros). El índice de rentabilidad incremental del programa fue de -46 157 euros para el diagnóstico de asma por un MG y de -9 671 euros para la definición EPM, lo cual señala la inferioridad de la situación experimental. Todas las replicaciones bootstrap indicaron que el programa PREVASC es más costoso, con una probabilidad del 37% y del 13%, respectivamente, de que éste fuese más eficaz que la atención usual. La prevención primaria del asma en los primeros 2 años de vida no fue rentable con ambos modelos.

Diagnostic accuracy of point-of-care fecal calprotectin and immunochemical occult blood tests for diagnosis of organic bowel disease in primary care: the Cost-Effectiveness of a Decision Rule for Abdominal Complaints in Primary Care (CEDAR) study.

BACKGROUND: Fecal biomarker tests that differentiate between organic bowel disease (OBD) and non-OBD in primary care patients with persistent lower-abdomen complaints could reduce the number of unnecessary referrals for endoscopy. We quantified the accuracy of fecal calprotectin and immunochemical occult blood (iFOBT) point-of-care (POC) tests and a calprotectin ELISA in primary care patients with suspected OBD. METHODS: We performed biomarker tests on fecal samples from 386 patients with lower-abdomen complaints suggestive for OBD. Endoscopic and histological diagnosis served as reference. RESULTS: OBD was diagnosed in 99 patients (prevalence 25.9%); 19 had adenocarcinoma, 53 adenoma, and 27 inflammatory bowel disease. Sensitivity for OBD was 0.64 (95% CI 0.54-0.72) for calprotectin POC, 0.56 (0.46-0.66) for iFOBT POC, and 0.74 (0.65-0.82) for calprotectin ELISA; specificities were 0.53 (0.48-0.59), 0.83 (0.78-0.87), and 0.47 (0.41-0.53), respectively. Negative predictive values (NPVs) were 0.81 (0.74-0.86), 0.85 (0.80-0.88), and 0.84 (0.78-0.89); positive predictive values (PPVs) varied from 0.32 (0.26-0.39) and 0.33 (0.27-0.39) (calprotectin tests) to 0.53 (0.44-0.63) (iFOBT POC). Combining the 2 POC tests improved sensitivity [0.79 (0.69-0.86)] and NPV [0.87 (0.81-0.91)] but lowered specificity [0.49 (0.44-0.55)] and PPV [0.35 (0.29-0.42)]. When adenomas ≤1 cm were considered non-OBD, the NPV of all tests improved to >0.90 [combined POC tests, 0.97 (0.93-0.99)]. CONCLUSIONS: Diagnostic accuracy of the tests alone or combined was insufficient when all adenomas were considered OBD. When only adenomas >1 cm were considered OBD, all tests could rule out OBD to a reasonable extent, particularly the combined POC tests. The tests were less useful for inclusion of OBD.

Study protocol of a Dutch smoking cessation e-health program.

BACKGROUND: The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES) and higher socio-economic status (HSES) smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages). The paper aims to describe the development and design of the two computer-tailored programs. METHODS/DESIGN: Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text) * 2(LSES/HSES) design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback) or to the control group (non-tailored generic advice). In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. DISCUSSION: The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. TRIAL REGISTRATION: Dutch Trial Register NTR3102.

Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2-receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial.

BACKGROUND: Substantial physician workload and high costs are associated with the treatment of dyspepsia in primary health care. Despite the availability of consensus statements and guidelines, the most cost-effective empirical strategy for initial management of the condition remains to be determined. We compared step-up and step-down treatment strategies for initial management of patients with new onset dyspepsia in primary care. METHODS: Patients aged 18 years and older who consulted with their family doctor for new onset dyspepsia in the Netherlands were eligible for enrolment in this double-blind, randomised controlled trial. Between October, 2003, and January, 2006, 664 patients were randomly assigned to receive stepwise treatment with antacid, H(2)-receptor antagonist, and proton pump inhibitor (step-up; n=341), or these drugs in the reverse order (step-down; n=323), by use of a computer-generated sequence with blocks of six. Each step lasted 4 weeks and treatment only continued with the next step if symptoms persisted or relapsed within 4 weeks. Primary outcomes were symptom relief and cost-effectiveness of initial management at 6 months. Analysis was by intention to treat (ITT); the ITT population consisted of all patients with data for the primary outcome at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00247715. FINDINGS: 332 patients in the step-up, and 313 in the step-down group reached an endpoint with sufficient data for evaluation; the main reason for dropout was loss to follow-up. Treatment success after 6 months was achieved in 238 (72%) patients in the step-up group and 219 (70%) patients in the step-down group (odds ratio 0.92, 95% CI 0.7-1.3). The average medical costs were lower for patients in the step-up group than for those in the step-down group (euro228 vs euro245; p=0.0008), which was mainly because of costs of medication. One or more adverse drug events were reported by 94 (28%) patients in the step-up and 93 (29%) patients in the step-down group. All were minor events, including (other) dyspeptic symptoms, diarrhoea, constipation, and bad/dry taste. INTERPRETATION: Although treatment success with either step-up or step-down treatment is similar, the step-up strategy is more cost effective at 6 months for initial treatment of patients with new onset dyspeptic symptoms in primary care.