Cost-effectiveness of physiotherapy in childhood functional constipation: a randomized controlled trial in primary care.

OBJECTIVE: Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care. METHODS: A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed. RESULTS: One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome. CONCLUSIONS: Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use. TRIAL REGISTRATION: The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial.

PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

Physiotherapy for Children with Functional Constipation: A Pragmatic Randomized Controlled Trial in Primary Care.

OBJECTIVE: To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care. STUDY DESIGN: Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect. RESULTS: Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). CONCLUSIONS: We find no evidence to recommend physiotherapy for all children with functional constipation in primary care. TRIAL REGISTRATION: Netherlands Trial Registry: NTR4797.

Effects of caregiver dementia training in caregiver-patient dyads: A randomized controlled study.

OBJECTIVES: Caregivers for people with dementia (PWD) have reported needing emotional and social support, improved coping strategies, and better information about the illness and available support services. In this study, we aimed to determine the effectiveness of an Australian multicomponent community-based training program that we adapted and implemented in a non-medical Dutch health care setting. METHODS AND DESIGN: A randomized controlled trial was performed: 142 dyads of cohabiting caregivers and PwD were randomized to control (care as usual) or intervention (training program) groups and outcomes were compared. Programs lasted 1 week, comprised 14 sessions, and were delivered by specialist staff. We included 16 groups of two to six caregivers. The primary outcome was care-related quality of life (CarerQol-7D) at 3 months. The main secondary outcomes for caregivers were self-rated burden, health and mood symptoms, and for PwD were neuropsychiatric symptoms, quality of life, and agitation. RESULTS: No significant difference was observed for the primary outcome. However, caregivers experienced fewer role limitations due to physical function (adjusted mean difference, 13.04; 95% confidence interval [95%CI], 3.15-22.93), emotional function (13.52; 95%CI, 3.76-23.28), and pain reduction (9.43; 95%CI, 1.00-17.86). Positive outcomes identified by qualitative analysis included better acceptance and coping and improved knowledge of dementia and available community services and facilities. CONCLUSION: Quantitative analysis showed that the multicomponent course did not affect care-related quality of life but did have a positive effect on experienced role limitations and pain. Qualitative analysis showed that the course met the needs of participating dyads.

Development and construct validation of a parent-proxy quality of life instrument in children with bronchopulmonary dysplasia aged 4-8 years old.

PURPOSE: Children with bronchopulmonary dysplasia often develop complications that affect them well into adult life. Very little is known about how this affects their quality of life, since no sensitive instrument is available to measure health-related quality of life in this population. In this study, a Dutch parent-proxy instrument was developed for this purpose. METHODS: A list of items was generated after literature search and interviews with both parents of patients and clinical experts. Clinically relevant items were selected with the clinical impact method and item analysis. Results of clinical tests to measure complications in children with bronchopulmonary dysplasia were correlated with these items to select the items that show construct validity. Cronbach's alpha was calculated to estimate internal consistency of the items in the final questionnaire. RESULTS: In total, 92 children and their parents and 7 clinicians participated. Of 130 identified items, 47 showed clinical relevance. Spirometry, the Child Behavior Checklist, mean arterial pressure, and body mass index were used to determine construct validity of 33 items. These items were structured within five domains: pulmonary complaints, school functioning, growth and nutrition, exercise and locomotion, emotional functioning and health care concerns. The questionnaire showed excellent internal consistency with Cronbach's alpha of 0.919. CONCLUSION: This study developed a disease-specific parent-proxy instrument to measure health-related quality of life in children with bronchopulmonary dysplasia aged 4-8 years old, the BPD-QoL. All included items show construct validity and internal consistency reliability. Future research should focus on further validation and analysis of responsiveness and reliability.

Reducing inappropriate psychotropic drug use in nursing home residents with dementia: protocol for participatory action research in a stepped-wedge cluster randomized trial.

BACKGROUND: Psychotropic drugs are often prescribed to treat neuropsychiatric symptoms in nursing home residents with dementia, despite having limited efficacy and considerable side effects. To reduce the inappropriate prescribing of these psychotropic drugs, various non-pharmacological, psychosocial, person-centered, or multidisciplinary interventions are advocated. However, existing multidisciplinary interventions have shown variable effects, with limited effectiveness often resulting from suboptimal implementation. We hypothesize that an effective intervention needs to fit the local situation of a nursing home and that support should be offered during implementation. METHODS: We will embed participatory action research within a stepped-wedge cluster randomized controlled trial to study the effects of a tailored intervention and implementation plan to reduce inappropriate psychotropic drug prescribing. Nursing homes will be provided with tailored information about the perceived problems of managing neuropsychiatric symptoms and we will offer coaching support throughout. Alongside the participatory action research, we will perform a process evaluation to examine the quality of the study, the intervention, and the implementation. Our aim is to recruit 600 residents from 16 nursing homes throughout the Netherlands, with measurements taken at baseline, 8 months, and 16 months. Nursing homes will be randomly allocated to an intervention or a deferred intervention group. During each intervention stage, we will provide information about inappropriate psychotropic drug prescribing, neuropsychiatric symptoms, and difficulties in managing neuropsychiatric symptoms through collaboration with each nursing home. After this, a tailored intervention and implementation plan will be written and implemented, guided by a coach. The primary outcome will be the reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use In Dementia index. Secondary outcomes will be the frequency of psychotropic drug use and neuropsychiatric symptoms, plus quality of life. A mixed methods design will be used for the process evaluation. Effects will be assessed using multilevel analyses. The project leader of the nursing home and the coach will complete questionnaires and in-depth interviews. DISCUSSION: We anticipate that the proposed tailored intervention with coaching will reduce inappropriate psychotropic drug prescribing for nursing home residents with neuropsychiatric symptoms. This study should also provide insights into the barriers to, and facilitators of, implementation. TRIAL REGISTRATION: NTR5872 , registered on July 2, 2016.

Bladder Symptoms in Children With Functional Constipation: A Systematic Review.

OBJECTIVE: The aim of the review is to perform a systematic review of the literature examining the prevalence of bladder symptoms in children with functional constipation (FC) and to compare the prevalence of those symptoms between children with and without FC. METHODS: In this systematic review 4 databases were searched to July 2018. Studies investigating the prevalence of bladder symptoms in children aged 4 to 17 years with FC were included. There was no language restriction. Two reviewers independently extracted data and assessed study quality. Clinical heterogeneity between studies was investigated. Prevalence rates of bladder symptoms in children with FC were calculated. Relative risks were calculated to compare the prevalence of bladder symptoms between children with and without FC. RESULTS: Among 23 studies of children with FC, 22 reported the prevalence bladder symptoms (12,281 children) and 7 reported the prevalence of urinary tract infections (UTIs) (687 children). The prevalence rates of single bladder symptoms, lower urinary tract symptoms (LUTS), and UTI varied between 2% to 47%, 37% to 64%, and 6% to 53%. The relative risks were 1.24 to 6.73 for 20 single bladder symptoms (12 studies) and 2.18 to 6.55 for UTI (2 studies). The 95% confidence intervals indicated significance in 14 of 20 single bladder symptoms. CONCLUSIONS: Bladder symptoms seem common in children with FC, but the reported prevalence varies greatly. Children with FC are more likely to have bladder symptoms than children without FC. We recommend that clinicians be aware of concomitant bladder symptoms in children presenting with FC.

Parent-child Agreement on Health-Related Quality of Life in Children With Functional Constipation in Primary Care.

OBJECTIVE: Functional constipation (FC) has a major impact on the health-related quality of life (HRQoL) of children. The aim of this study was to evaluate parent-child agreement on HRQoL in children (8-17 years) with FC in primary care. METHODS: Children diagnosed with FC by their clinician were eligible. HRQoL was measured with the Defecation Disorder List (DDL, score 0-100), and the EuroQol-5-Dimension-Youth Visual Analogue Scale (EQ-5D-Y-VAS, scale 0-100). Parent-child agreement was examined with discrepancy scores, intraclass correlation coefficients and Bland-Altman plots. RESULTS: Fifty-six children, median age of 10 years (IQR 8-12) and their parents were included. Parent-child agreement at a group level was good, with an intraclass correlation coefficient of 0.80 (95% confidence interval 0.67 to 0.88) for the DDL, and 0.78 (95% confidence interval 0.65 to 0.87) for the EQ-5D-Y-VAS. Mean discrepancy scores for the DDL and EQ-5D-Y-VAS were small: -2.6 and -2.9, implying that parents were slightly more positive about the HRQoL than their children. Bland-Altman plots showed considerable discordance between individual parent-child pairs. Limits of agreement were -19.7 and 14.6 for the DDL and -27.6 and 21.8 for the EQ-5D-Y-VAS. CONCLUSIONS: There is good parent-child agreement on HRQoL in children with FC at group level. However, a substantial number of parent-child pairs differed considerably on their rating of the HRQoL of the child. Therefore, we recommend clinicians, if they want to have an impression of the impact of the FC on the HRQoL of the child, to ask both the child and the parent(s).

The "more at home with dementia" program: a randomized controlled study protocol to determine how caregiver training affects the well-being of patients and caregivers.

BACKGROUND: Caring for people with dementia imposes heavy burdens on caregivers, especially spouses. This can lead to depression, anxiety, and physical symptoms in the caregiver, with early institutionalization for the patient. An Australian study reported that a residential caregiver training program delivered in medical settings could delay nursing home admission, lower mortality, reduce psychological morbidity in caregivers, and lower healthcare costs. In this replication study, we aim to determine the effectiveness of an adaptation of this program to non-medical settings in the Dutch health care system. METHODS: A randomized controlled study design will be used, comparing an intervention group with a control group. The intervention will last for five days and will be delivered in either a holiday park or a bed and breakfast setting. The control group will receive care as usual. Data will be collected at baseline and after 3 and 6 months, and outcomes will be assessed in the caregiver group and in the dementia group. The primary outcome will be caregiver-related quality of life after 3 months. The main secondary outcome will be the neuropsychiatric symptoms in the dementia group. Secondary outcomes in the dementia group will be activities of daily living and instrumental activities of daily living, use of health facilities, quality of life, agitation, dementia severity, and use of psychotropic medication. Secondary outcomes in the caregiver group will be the subjective and objective burdens, health and health care facility use, psychotropic medication use, depression, anxiety, and perseverance time. DISCUSSION: We anticipate that the outcomes will allow us to confirm the effectiveness of the intervention, and in turn, potentially inform the introduction of this program into care plans. It is also expected that the experiences and recommendations of participants will help us to develop the training program further. TRIAL REGISTRATION: Registered in the Netherlands Trial Register on March 9, 2016, number 5775 .

Physiotherapy plus conventional treatment versus conventional treatment only in the treatment of functional constipation in children: design of a randomized controlled trial and cost-effectiveness study in primary care.

BACKGROUND: Our aim was to design a study to evaluate the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment. In this paper we describe the final study design and how the design was adapted, to overcome recruitment problems. METHODS: We designed a randomized controlled trial of children aged 4-17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. Follow-up measurements took place at 4 and 8 months. The primary outcome was treatment success defined according to the Rome-III criteria as the absence of functional constipation, with no laxative use. Secondary outcomes were absence of functional constipation irrespective of laxative use, quality of life, global perceived effect, and costs. Children were recruited from September 2014 to February 2017. Initially, we aimed to include children with recent symptom onset. However, in the first phase of enrollment we were confronted with an unforeseen recruitment problem: many children and their parents refused randomization because physiotherapy was considered too burdensome for the stage of disease. Therefore, we decided to also include children with a longer duration of symptoms. In total 134 children were included. DISCUSSION: The target number of participants is achieved. Therefore, the results may change thinking about the management of functional constipation in children. TRAIL REGISTRATION: Netherlands Trial Register ( NTR4797 ), registered 8 September 2014.

Minimal important change in the pelvic floor distress inventory-20 among women opting for conservative prolapse treatment.

BACKGROUND: The Pelvic Floor Distress Inventory-20 is used to evaluate symptoms and treatment effects in women with pelvic floor disorders. To interpret changes in the scores of this inventory, information is needed about what patients and clinicians perceive as the minimal important (meaningful) change. Although this change in the inventory score has been investigated previously in women who have undergone pelvic floor surgery, the results could not be generalized to women with milder symptoms (ie, lower scores) who often require only conservative treatment. OBJECTIVE: We aimed to estimate the minimal important change in the Pelvic Floor Distress Inventory-20 that was needed to demonstrate clinical improvement in women who qualify for conservative pelvic floor treatment. STUDY DESIGN: The data of 214 women aged ≥55 years were used. All participants were from 2 randomized controlled trials that compared conservative prolapse treatments in primary care in The Netherlands. The degree of prolapse was assessed with the use of the Pelvic Organ Prolapse Quantification system; participants completed the Pelvic Floor Distress Inventory-20 at baseline and at 12 months, with a global perception of improvement question at 12 months. To assess both the patient perspective and the clinical perspective, 2 anchors were assessed: (1) the global perception of improvement was considered the anchor for the patients' perspective, and (2) the difference in the degree of prolapse was considered the anchor for the clinical perspective. Provided that the anchors were correlated by at least 0.3 to the Pelvic Floor Distress Inventory-20 change scores, we estimated the following minimal important changes: (1) the optimal cutoff-point of the receiver operating characteristics curve that discriminates between women with and without improvement in the global perception of improvement scale and (2) the mean Pelvic Floor Distress Inventory-20 change score of participants who improved 1 assessment stage. We then calculated the smallest detectable change to check whether the minimal important change was larger than the measurement error of the questionnaire. RESULTS: Using the global perception of improvement as the anchor, we found a minimal important change for improvement of 13.5 points (95% confidence interval, 6.2-20.9). The Pelvic Organ Prolapse Quantification change scores correlated poorly to the Pelvic Floor Distress Inventory-20 change scores and therefore could not be used as an anchor. The smallest detectable change at the group level was 5.5 points. Thus, the minimal important change was larger than the smallest detectable change at the group level. CONCLUSION: In women with relatively mild pelvic floor symptoms, an improvement of 13.5 points (or a 23% reduction) in the Pelvic Floor Distress Inventory-20 score can be considered clinically relevant. This minimal important change can be used for clinical trial planning and evaluation of treatment effects in women whose condition is considered suitable for conservative treatment.

Migraine Nurses in Primary Care: Costs and Benefits.

OBJECTIVE: We examined the costs and benefits of introducing migraine nurses into primary care. BACKGROUND: Migraine is one of the most costly neurological diseases. METHODS: We analyzed data from our earlier nonrandomized cohort study comparing an intervention group of 141 patients, whose care was supported by nurses trained in migraine management, and a control group of 94 patients receiving usual care. Estimates of per-person direct costs were based on nurses' salaries and referrals to neurologists. Indirect costs were estimated as lost productivity, including numbers of days of absenteeism or with <50% productivity at work due to migraine, and notional costs related to lost days of household activities or days of <50% household productivity. Analysis was conducted from the payer's perspective. RESULTS: After 9 months the direct costs were €281.11 in the control group against €332.23 in the intervention group (mean difference -51.12; 95% CI: -113.20-15.56; P = .134); the indirect costs were €1985.51 in the control group against €1631.75 in the intervention group (mean difference 353.75; 95% CI: -355.53-1029.82; P = .334); and total costs were €2266.62 in the control group, against €1963.99 in the intervention group (mean difference 302.64; 95% CI: -433.46-1001.27; P = .438). When costs attributable to lost household productivity were included, total costs increased to €6076.62 in the control group and €5048.15 in the intervention group (mean difference 1028.47; 95% CI: -590.26-2603.67; P = .219). CONCLUSION: Migraine nurses in primary care seemed in this study to increase practice costs but decrease total societal costs. However, it was a nonrandomized study, and the differences did not reach significance. For policy-makers concerned with headache-service organization and delivery, the important messages are that we found no evidence that nurses increased overall costs, and investment in a definitive study would therefore be worthwhile.

Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common condition. There is inconsistency between predictors of unsuccessful pessary fitting in urological/gynaecological clinics. Research in general practice is scarce. The aim was to estimate the proportion of women in general practice with a symptomatic pelvic organ prolapse and unsuccessful pessary fitting, and to identify characteristics associated with unsuccessful pessary fitting. METHODS: A cross-sectional study in general practice (n = 20) was carried out among women (≥55 years) with symptomatic prolapse (n = 78). Multivariate logistic regression analysis was used to identify predictors of unsuccessful pessary fitting. RESULTS: In total, 33 women (42 %) had unsuccessful pessary fitting. Factors associated with unsuccessful pessary fitting were age (per year, OR 0.93 [95 % CI 0.87-1.00]), body mass index (per kg/m2, OR 1.14 [95 % CI 1.00-1.30]), and having underactive pelvic floor muscles (OR 2.60 [95 % CI 0.81-8.36]). CONCLUSIONS: Pessary fitting was successful in 58 %, indicating that pessary treatment may be suitable for many, but not for all women in general practice with symptomatic prolapse. The condition of the pelvic floor probably plays a role in the success of pessary fitting, as demonstrated by the association with underactive pelvic floor muscles, and body mass index. The association with age may reflect the higher acceptance of conservative treatments for prolapse in older women. This is the first study on predictive factors for unsuccessful pessary fitting in general practice. Therefore, further research should seek to confirm these associations before we can recommend the use of this information in patient counselling.

Incidence and treatment of heavy menstrual bleeding in general practice.

Background: Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age. In 2008, the Dutch guideline for general practitioners (GPs) was revised to recommend the levonorgestrel intrauterine system (LNG-IUS) as a first-choice treatment for HMB. However, GP prescribing practices have not been studied in depth. Objectives: To investigate the incidence and initial treatment of HMB in general practice, and to identify if there were changes in prescribing practices after the revision of the national guideline in 2008. Methods: Retrospective analysis of data from the Registration Network Groningen, the Netherlands. We selected data for prescriptions and referrals related to women consulting their GP for HMB between 2004 and 2013. We calculated the incidence rates and investigated potential trends in prescribing over time, with particular attention to the prescribing of LNG-IUS. Results: Over 10 years, 881 women consulted their GP for HMB, with a mean annual incidence of 9.3 per 1000 person years (95% confidence interval: 8.5-10.2). Most women received hormonal treatment (406/881; 46%) within three months of diagnosis, but many (387/881; 44%) received no medication. The LNG-IUS was prescribed for 2.4%, but there was no significant increase in the number of prescriptions over time. Conclusion: In this cohort, most women with HMB were treated with oral hormone therapy, and few received the LNG-IUS. If patients are to benefit from the LNG-IUS, further research is needed into the reasons for this lack of change in prescribing practices.

Evaluation of point-of-care test calprotectin and lactoferrin for inflammatory bowel disease among children with chronic gastrointestinal symptoms.

Background: Faecal calprotectin is considered to be a valid test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms in specialist care. In contrast, faecal lactoferrin has higher specificity. The recent availability of both as point-of-care tests (POCTs) makes them attractive for use in primary care. Objective: To evaluate the test characteristics of calprotectin and lactoferrin POCTs for diagnosing IBD in symptomatic children. Methods: We defined two prospective cohorts of children with chronic gastrointestinal symptoms: (i) children presenting to primary care (primary care cohort); (ii) children referred for specialist care (referred cohort). Baseline POCT results were compared with the outcome of either endoscopic assessment or 12 months follow-up. Clinicians were blinded to the POCT results. Results: In the primary care cohort, none of the 114 children had IBD, and the calprotectin and lactoferrin POCTs had specificities of 0.95 (0.89-0.98) and 0.98 (0.93-0.99), respectively. In the referred cohort, 17 of the 90 children had IBD: the sensitivity of POCT calprotectin and POCT lactoferrin were both 0.94 (0.72-0.99); and the specificity was 0.93 (0.84-0.97) and 0.99 (0.92-1.00), respectively. The POCT calprotectin could reduce the referral rate by 76% and POCT lactoferrin by 81%, while missing one child with IBD (6%). Conclusion: A diagnostic test strategy in primary care using a simple POCT calprotectin or lactoferrin has the potential to reduce the need for referral for further diagnostic work-up in specialist care, with a low risk of missing a child with IBD.

Nurses improve migraine management in primary care.

INTRODUCTION: Migraine is a common disorder with a high burden. Adequate treatment results in improvement of quality of life. Migraine patients are mainly treated by general practitioners (GPs), but there is still room for improvement. This study investigated whether primary care nurses could improve the treatment of migraine patients compared to usual care as provided by the GPs. PARTICIPANTS AND METHODS: We conducted a non-randomized controlled prospective trial in 235 patients diagnosed with migraine with or without aura according to ICHD-II criteria, aged between 18 and 65 years. Patients with migraine treated only by their GP were compared to management by a nurse supervised by a GP. RESULTS: In the intervention group, fewer migraine patients were referred to a neurologist (p < 0.001). The reduction in monthly migraine days compared to baseline was more apparent in the intervention group at six (p = 0.09) and nine months (p = 0.006). There was no significant change in dichotomized HIT score (p = 0.076). Change in satisfaction of patients did not differ significantly (p = 0.070). CONCLUSIONS: The care administered by a headache nurse in the primary care setting supervised by a GP resulted in fewer referrals to the neurologist and more migraine-free days per month, but no change in HIT score. There was no difference in satisfaction scores between both groups.

Diagnostic Accuracy of Fecal Calprotectin for Pediatric Inflammatory Bowel Disease in Primary Care: A Prospective Cohort Study.

PURPOSE: In specialist care, fecal calprotectin (FCal) is a commonly used noninvasive diagnostic test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms. The aim of this study was to evaluate the diagnostic accuracy of FCal for IBD in symptomatic children in primary care. METHODS: We studied 2 prospective cohorts of children with chronic diarrhea, recurrent abdominal pain, or both: children initially seen in primary care (primary care cohort) and children referred to specialist care (referred cohort). FCal (index test) was measured at baseline and compared with 1 of the 2 reference standards for IBD: endoscopic assessment or 1-year follow-up. Physicians were blinded to FCal results, and values greater than 50 µg/g feces were considered positive. We determined specificity in the primary care cohort and sensitivity in the referred cohort. RESULTS: None of the 114 children in the primary care cohort ultimately received a diagnosis of IBD. The specificity of FCal in the primary care cohort was 0.87 (95% CI, 0.80-0.92). Among the 90 children in the referred cohort, 17 (19%) ultimately received a diagnosis of IBD. The sensitivity of FCal in the referred cohort was 0.99 (95% CI, 0.81-1.00). CONCLUSIONS: The findings of this study suggest that a positive FCal result in children with chronic gastrointestinal symptoms seen in primary care is not likely to be indicative of IBD. A negative FCal result is likely to be a true negative, which safely rules out IBD in children in whom a primary care physician considers referral to specialist care.

Association of food allergy and atopic dermatitis exacerbations.

BACKGROUND: Atopic dermatitis (AD) and food allergy frequently coexist in children. OBJECTIVE: To examine the association between food allergy and AD. METHODS: Between 2001 and 2011, children referred to our tertiary care center underwent double-blind, placebo-controlled food challenges (DBPCFCs) for one or more suspected food allergies as part of regular care. Immediate reactions were observed and recorded by allergy nursing staff, whereas late reactions were ascertained by semistructured telephone interview 48 hours after challenge. To test to which degree specific IgE results were predictive in the outcome of DBPCFCs in children with and without (previous and current) AD, logistic regression analysis was performed. RESULTS: A total of 1186 DBPCFCs were studied. Sensitization to foods occurred significantly more often in children with previous AD. The association between specific IgE results and the outcome of DBPCFCs was significant for children with and without (previous and current) AD but stronger for children without current AD. The positivity rate of DBPCFCs in children with mild, moderate, and severe AD was 53.3%, 51.7%, and 100%, respectively. Children with AD and a history of worsening AD as their only symptom reacted as often to placebo as to challenge food. CONCLUSION: Children with current AD are more frequently asymptomatically sensitized to the foods in question than those without AD. In addition, children suspected of food allergy should be considered for testing, regardless of the severity of their AD. Our results suggest that children with exacerbation of AD in the absence of other allergic symptoms are unlikely to be food allergic.

Predictors for a positive outcome of adapted clinical dry bed training in adolescents and adults with enuresis.

AIMS: Adapted Dry Bed Training (Adapted DBT) has been shown to be effective in therapy-resistant adolescents and adults with enuresis. Given the substantial impact of enuresis and the time-consuming nature of Adapted DBT, we investigated which patients benefited most from Adapted DBT. Therefore, we identified predictors for a successful treatment response to Adapted DBT in this population. METHODS: Retrospective cohort study in 907 consecutive patients, aged 11-42 years, subjected to in-hospital Adapted DBT in our Dry Bed Center between January 2003 and July 2013. Outcome was defined as treatment success after six months (primary outcome) and six weeks. Results of logistic regression analyses are presented in odds ratios and 95% confidence intervals. RESULTS: Predictors for a successful treatment response to Adapted DBT in adolescents and adults with enuresis after six months are: gender (female), initial degree of enuresis (mild: 0-3 nights/week), current diaper use, never used anticholinergics in the past, and degree of enuresis six weeks after training. Predictors for successful treatment response after six weeks are: gender and initial degree of enuresis only. LIMITATION: The low explained variance of our model, showing that many other factors, not included in our study, could be of interest in the prediction of success. CONCLUSIONS: Several factors that predicted a successful treatment response of Adapted DBT after six weeks and six months were identified. However, the low explained variance of our model suggests that other non-identified factors are also important in predicting outcome. Neurourol. Urodynam. 35:1006-1010, 2016. © 2015 Wiley Periodicals, Inc.

Impact of the International Continence Society (ICS) report on the standardisation of terminology in nocturia on the quality of reports on nocturia and nocturnal polyuria: a systematic review.

OBJECTIVE: To systematically review and evaluate the impact of the International Continence Society (ICS)-2002 report on standardisation of terminology in nocturia, on publications reporting on nocturia and nocturnal polyuria (NP). In 2002, the ICS defined NP as a Nocturnal Polyuria Index (nocturnal urine volume/total 24-h urine volume) of >0.2-0.33, depending on age. MATERIALS AND METHODS: In April 2013 the PubMed and Embase databases were searched for studies (in English, German, French or Dutch) based on original data and adult participants, investigating the relationship between nocturia and NP. A methodological quality assessment was performed, including scores on external validity, internal validity and informativeness. Quality scores of items were compared between studies published before and after the ICS-2002 report. RESULTS: The search yielded 78 publications based on 66 studies. Quality scores of studies were generally high for internal validity (median 5, interquartile range [IQR] 4-6) but low for external validity. After publication of the ICS-2002 report, external validity showed a significant change from 1 (IQR 1-2) to 2 (IQR 1-2.5; P = 0.019). Nocturia remained undefined in 12 studies. In all, 19 different definitions were used for NP, most often being the ICS (or similar) definition: this covered 52% (n = 11) of studies before and 66% (n = 27) after the ICS-2002 report. Clear definitions of both nocturia and NP were identified in 67% and 76% before, and in 88% and 88% of the studies after the ICS-2002 report, respectively. CONCLUSION: The ICS-2002 report on standardisation of terminology in nocturia appears to have had a beneficial impact on reporting definitions of nocturia and NP, enabling better interpretation of results and comparisons between research projects. Because the external validity of most of the 66 studies is considered a problem, the results of these studies may not be validly extrapolated to other populations. The ICS definition of NP is used most often. However, its discriminative value seems limited due to the estimated difference of 0.6 nocturnal voids between individuals with and without NP. Refinement of current definitions based on robust research is required. Based on pathophysiological reasoning, we argue that it may be more appropriate to define NP based on nocturnal urine production or nocturnal voided volumes, rather than on a diurnal urine production pattern.