Search

BackgroundAcute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting.AimTo determine the effectiveness of adding oral ondansetron to care as usual (CAU) to treat vomiting in children with AGE attending out-ofhours primary care (OOH-PC).Design and settingA pragmatic randomised controlled trial at three OOH-PC centres in the north of the Netherlands (Groningen, Zwolle, and Assen), with a follow-up of 7 days.MethodChildren were included if they were: aged 6 months–6 years; AGE diagnosed by a GP; ≥4 reported episodes of vomiting in the 24 hours before presentation; ≥1 reported episode of vomiting in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated to either the control group or the intervention group. The control group received CAU, namely oral rehydration therapy. The intervention group received CAU plus one dose of oral ondansetron (0.1 mg/kg).ResultsIn total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within 4 hours from 42.9% to 19.5%, with an odds ratio of 0.37 (95% confidence interval [CI] = 0.20 to 0.72, number needed to treat: four). Ondansetron also decreased the number of vomiting episodes within 4 hours (incidence rate ratio 0.51 [95% CI = 0.29 to 0.88]) and improved overall parental satisfaction with treatment (P = 0.027).ConclusionChildren with AGE and increased risk of dehydration due to vomiting could be treated with ondansetron in primary care to stop vomiting more quickly and increase parental satisfaction with treatment. These results could be used to improve the quality and efficacy of general practice medicine.

BackgroundAcute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work.AimTo determine the cost-effectiveness of adding oral ondansetron to care as usual (CAU) for children with acute gastroenteritis presenting to out-of-hours primary care (OOH-PC).Design and settingA pragmatic randomised controlled trial from December 2015 to January 2018, at three OOHPC centres in the north of the Netherlands (Groningen, Zwolle, and Assen) with a follow-up of 7 days.MethodChildren were recruited at the OOH-PC and parents kept a parental diary. Inclusion criteria were: aged 6 months–6 years; diagnosis of acute gastroenteritis; at least four reported episodes of vomiting 24 hours before presentation, at least one of which was in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated at a 1:1 ratio to either CAU (oral rehydration therapy) or CAU plus one dose of 0.1 mg/kg oral ondansetron.ResultsIn total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within the first 4 hours from 42.9% to 19.5%, (a decrease of 54.5%), with an odds ratio of 0.4 (95% confidence interval [CI] = 0.2 to 0.7; number needed to treat: four). Total mean costs in the ondansetron group were 31.2% lower (€488 [£420] versus €709 [£610]), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was −€9 (£8) (95% CI = −€41 [£35] to €3 [£3]).ConclusionA single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.

Purpose: the aim of expanded preconception carrier screening (ECS) is to inform any couple wishing to conceive about their chances of having children with severe autosomal or X-linked recessive conditions. Responsible implementation of ECS as reproductive genetic screening in routine care requires assessment of benefits and harms. We examined the psychological outcomes of couple-based ECS for 50 autosomal recessive (AR) conditions provided by general practitioners (GPs) to couples from the Dutch general population.Methods: Dutch GPs invited 4,295 women aged 18-40. We examined anxiety (State-Trait Anxiety Inventory, STAI-6), worry, decisional conflict (DCS) over time in participants declining GP counseling or attending GP counseling with/without testing.Results: one hundred ninety couples participated; 130 attended counseling, of whom 117 proceeded with testing. No carrier couples were identified. Before counseling, worry (median 6.0) and anxiety (mean 30-34) were low and lower than the population reference (36.4), although some individuals reported increased anxiety or worry. At follow-up, test acceptors reported less anxiety than test decliners (mean 29 vs. 35); differences in anxiety after testing compared to before counseling were not meaningful. Most participants (90%) were satisfied with their decision (not) to undergo testing.Conclusion: some individuals reported temporarily clinically relevant distress. Overall, the psychological outcomes are acceptable and no barrier to population-wide implementation.

Objective To evaluate the costs and non‐inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG‐IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). Design Cost‐effectiveness analysis from a societal perspective alongside a multicentre randomised non‐inferiority trial. Setting General practices and gynaecology departments in the Netherlands. Population In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. Methods Randomisation to a strategy starting with the LNG‐IUS (n = 132) or EA (n = 138). The incremental cost‐effectiveness ratio was estimated. Main outcome measures Direct medical costs and (in)direct non‐medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)‐score (non‐inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC‐score ≤75 points). Results Total costs per patient were €2,285 in the LNG‐IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC‐scores were 64.8 in the LNG‐IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3–96.7). In the LNG‐IUS group, 87% of women had a PBAC‐score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85–1.01). The ICER was €23 (95% CI €5–111) per PBAC‐point. Conclusions A strategy starting with the LNG‐IUS was cheaper than starting with EA, but non‐inferiority could not be demonstrated. The LNG‐IUS is reversible and less invasive and can be a cost‐effective treatment option, depending on the success rate women are willing to accept. Tweetable abstract Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation., Tweetable abstract Treatment of heavy menstrual bleeding starting with LNG‐IUS is cheaper but slightly less effective than endometrial ablation.

Background The aim of this article is to describe the courses of vomiting, diarrhea, fever, and clinical deterioration, in children with uncomplicated gastroenteritis at presentation. This study was performed as a 7-day prospective follow-up study in an out-of-hours primary care service. The course of vomiting, diarrhea, and fever was analyzed by generalized linear mixed modeling. Because young children (≤ 12 months) and children with severe vomiting are at increased risk of dehydration, the potentially more complicated courses of these groups are described separately. The day(s) most frequently associated with deterioration and the symptoms present in children who deteriorated during follow-up were also described. Results In total, 359 children presented with uncomplicated acute gastroenteritis to the out-of-hours primary care service. Of these, 31 (8.6%) developed a complicated illness and needed referral or hospitalization. All symptoms decreased within 5 days in most children (> 90%). Vomiting and fever decreased rapidly, but diarrhea decreased at a somewhat slower pace, especially among children aged 6–12 months. Children who deteriorated during follow-up had a higher frequency of vomiting at presentation and higher frequencies of vomiting and fever during follow-up. Conclusions The frequency of vomiting, not its duration, appears to be the more important predictor of deterioration. When advising parents, it is important to explain the typical symptom duration and to focus on alarm symptoms. Clinicians should be vigilant for children with higher vomiting frequencies at presentation and during follow-up because these children are more likely to deteriorate.

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 (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.

Background: Chemo- and radiotherapy for breast cancer (BC) can lead to cardiotoxicity even years after the initial treatment. The pathophysiology behind these late cardiac effects is poorly understood. Therefore, we studied a large panel of biomarkers from different pathophysiological domains in long-term BC survivors, and compared these to matched controls. Methods and results: In total 91 biomarkers were measured in 688 subjects: 342 BC survivors stratified either to treatment with chemotherapy ± radiotherapy (n = 170) or radiotherapy alone (n = 172) and matched controls. Mean age was 59 ± 9 years and 65 ± 8 years for women treated with chemotherapy ± radiotherapy and radiotherapy alone, respectively, with a mean time since treatment of 11 ± 5.5 years. No biomarkers were differentially expressed in survivors treated with radiotherapy alone vs. controls (P for all >0.1). In sharp contrast, a total of 19 biomarkers were elevated, relative to controls, in BC survivors treated with chemotherapy ± radiotherapy after correction for multiple comparisons (P

Next generation sequencing has enabled fast and relatively inexpensive expanded carrier screening (ECS) that can inform couples’ reproductive decisions before conception and during pregnancy. We previously showed that a couple-based approach to ECS for autosomal recessive (AR) conditions was acceptable and feasible for both health care professionals and the non-pregnant target population in the Netherlands. This paper describes the acceptance of this free test-offer of preconception ECS for 50 severe conditions, the characteristics of test-offer acceptors and decliners, their views on couple-based ECS and reasons for accepting or declining the test-offer. We used a survey that included self-rated health, intention to accept the test-offer, barriers to test-participation and arguments for and against test-participation. Fifteen percent of the expected target population—couples potentially planning a pregnancy—attended pre-test counselling and 90% of these couples proceeded with testing. Test-offer acceptors and decliners differed in their reproductive characteristics (e.g. how soon they wanted to conceive), educational level and stated barriers to test-participation. Sparing a child a life with a severe genetic condition was the most important reason to accept ECS. The most important reason for declining was that the test-result would not affect participants’ reproductive decisions. Our results demonstrate that previously uninformed couples of reproductive age, albeit a selective part, were interested in and chose to have couple-based ECS. Alleviating practical barriers, which prevented some interested couples from participating, is recommended before nationwide implementation.

OBJECTIVE: To assess the long-term effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care.DESIGN: A pragmatic, randomised controlled, superiority trial.SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months.POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended one year follow-up.INTERVENTIONS: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI.MAIN OUTCOME MEASURES: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL) with linear regression on an intention-to-treat basis.RESULTS: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871).CONCLUSION: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of effectiveness after one year.

Supplemental digital content is available in the text., Purpose Physical activity (PA) affects fatigue and mental health in cancer survivors favorably, but participation in PA interventions tends to be low. More participants may be reached by home-based PA owing to greater accessibility and self-monitoring. This systematic review therefore evaluated the effects of home-based PA of low to moderate intensity on symptoms of fatigue, depression, and anxiety among cancer survivors. Methods PubMed, CINAHL, PsycINFO, and Web of Science were systematically searched for randomized controlled trials. We included investigations of home-based PA interventions in adults treated curatively for cancer and evaluating fatigue, depression, or anxiety as outcomes. We performed a random-effect meta-analysis for the effects of PA interventions on fatigue in the short and long terms. Subgroup analyses were performed for the frequency of counseling. Standardized mean differences (SMD) and 95% confidence intervals are reported. Results Eleven articles comprising 1066 participants were included: 77% had a history of breast cancer; 14%, ovarian cancer; 4%, colorectal cancer; 4%, prostate cancer; and 1%, “other” cancer (not specified). Concerning the outcomes, nine articles reported on fatigue and two reported on depression or anxiety. Meta-analyses showed a significant effect of home-based PA on fatigue immediately after the intervention (SMD = 0.22 [0.06–0.37]), at 3 months’ follow-up (SMD = 0.27 [0.04–0.51]), and at 6–9 months’ follow-up (SMD = 0.31 [0.08–0.55]). PA interventions that used frequent counseling were associated with larger improvements in fatigue than those using no or infrequent counseling. Conclusions Home-based PA interventions can reduce fatigue among adult cancer survivors for up to 9 months, and frequent counseling may improve the benefits of these interventions.

Background App-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use. Objective The goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure. Methods We used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment. Results Four interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms). Conclusions This study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app. International Registered Report Identifier (IRRID) RR2-10.1002/nau.23507

OBJECTIVE: To examine the association between intrapartum synthetic oxytocin and child behavioral and emotional problems and to assess if maternal depressive or anxious symptoms or mother-to-infant bonding play a mediating role in this association.DESIGN: Prospective cohort study.SETTING: Population-based Pregnancy Anxiety and Depression Study.PARTICIPANTS: Pregnant women in their first trimester of pregnancy visiting a total of 109 primary and nine secondary obstetric care centers in the Netherlands between 2010 and 2014 were invited to participate. Follow-up measures used for the present study were collected from May 2010 to January 2019. Women with multiple gestations and with a preterm birth were excluded.MEASUREMENTS: Intrapartum synthetic oxytocin exposure status was based on medical birth records and was defined as its administration (Yes/No), either for labour induction or augmentation. Child behavioral and emotional problems were measured with the Child Behavior Checklist at up to 60 months postpartum. Maternal depressive symptoms, anxiety and mother-to infant bonding were measured with the Edinburgh Postnatal Depression Scale, State Trait Anxiety Inventory and the Mother-to-Infant Bonding Scale from 6 months postpartum. We used multivariable linear regression models to estimate standardized beta coefficients and unique variance explained.FINDINGS: 1,528 women responded. In total 607 women received intrapartum synthetic oxytocin. Intrapartum synthetic oxytocin administration was not associated with child behavioral and emotional problems, mother-to-infant bonding nor with postnatal anxiety. Intrapartum synthetic oxytocin was however significantly but weakly associated with more postnatal depressive symptoms (β=0.17, 95%CI of 0.03 to 0.30) explaining 0.6% of unique variance. Maternal postnatal depressive symptoms, postnatal anxiety symptoms and suboptimal mother-to-infant bonding were positively associated with child behavioral and emotional problems.KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: We found no evidence that intrapartum synthetic oxytocin is associated with child behavioral and emotional problems, mother-to-infant bonding, or with postnatal anxiety symptoms. Because there was no association between intrapartum synthetic oxytocin and behavioral and emotional problems in children no mediation analysis was carried out. However, intrapartum synthetic oxytocin was positively but weakly associated with postnatal depressive symptoms. The clinical relevance of this finding is negligible in the general population, but unknown in a population with a high risk of depression.

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

Background Continuity of care could reduce health care consumption by patients and reduce the number of referrals to specialist care, but it is unknown if there is a difference in referral rates to specific medical specialties. Aim We aimed to determine the relationship between continuity of care and both the referral rate (referrals per patient per year) and the medical specialties for which this relationship was strongest. Design and setting A retrospective cohort study of 19333 patients in primary care in the north of the Netherlands. Method Patients with at least two contacts with a general practitioner (GP) over a 2-year period (2013-2014) were included. The number of contacts with their own or other GPs were calculated, and referral rates were determined. Continuity of care was included as a dichotomous variable (absent or present). Results The odds of being referred were higher for older patients, females and patients with more practitioner contacts. However, the presence of continuity of care was associated with the highest odds of referral. The referral rate was significantly highest for patients with continuity of care when referred to paediatrics, as well as for patients without continuity of care who were referred to gastroenterology, ophthalmology and psychiatry. Conclusion Increased continuity of care decreases referral to specialist care, most notably for referrals to paediatrics. Despite continued pressures on continuity of care, policy makers should invest in this cornerstone of primary care to temper health care expenditures.

Background Although the effectiveness of pelvic floor muscle training in women with prolapse has been demonstrated in several studies, there seem to be subgroups of responders and nonresponders. Objective The objective of this study was to identify factors that predict treatment success in women receiving pelvic floor muscle training for prolapse. Design The design was a secondary analysis of data from 2 randomized controlled trials comparing conservative prolapse treatments. Methods After 12 months, 172 women subjectively assessed treatment success ("better") or failure ("the same" or "worse"). Potential predictors were identified by a literature search and by consultation with experts in the field of urogynecology and pelvic floor muscle training. The relationship between potential predictors and treatment success was explored using logistic regression analysis. Results Treatment was successful in 94 women (55%) and unsuccessful in 78 women (45%). The presence of ≥1 indicators of obstetric trauma (eg, high birth weight, episiotomy, perineal laceration during vaginal delivery, forceps delivery, or vacuum extraction) (odds ratio = 4.4; 95% CI = 1.6–12.0) and younger age (odds ratio = 0.94 per year; 95% CI = 0.9–1.0) independently predicted treatment success. The area under the receiver operating characteristic curve for the final model was 0.65 (95% CI = 0.57–0.74), and the model explained 11.7% of the variance. Limitations Although attempts were made to include all relevant predictors, the selection or operationalization of variables could have been incomplete or insufficient. Conclusions Identifying women who have prolapse and are likely to benefit most from pelvic floor muscle training is of great importance to clinical practice. In this study, 2 factors that independently predicted favorable outcomes were identified with this management approach. However, further research is needed to identify other predictive factors and to validate a new model in another population.

BackgroundResearch in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomised controlled trials (RCTs) set in primary care.AimTo describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT.Design & settingA pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis (AGE) in primary care out-of-hours services and a parallel cohort study.MethodConsecutive children aged 6 months to 6 years attending primary care out-of-hours services with AGE were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion and exclusion criteria.ResultsThe RCT's feasibility was reduced by the informed consent procedure because 39.0% (n = 325/834) of children were accompanied by only one parent. GPs prescribed ondansetron off-protocol to 34 children (4.1%) of which 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort study had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by GPs.ConclusionThe informed consent procedure and off-protocol use of study medication affect the inclusion rate, but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion.

BACKGROUND: Despite the health risks of smoking, some women continue during pregnancy. Professional smoking cessation support has shown to be effective in increasing the proportion of pregnant women who quit smoking. However, few women actually make use of professional support.AIM: To investigate the needs of women and their partners for professional smoking cessation support during pregnancy.METHODS: Semi-structured interviews were held with pregnant women and women who recently gave birth who smoked or quit smoking during pregnancy, and their partners, living in the north of the Netherlands. Recruitment was done via Facebook, LinkedIn, food banks, baby stores and healthcare professionals. The interviews were recorded, transcribed and thematically analysed.RESULTS: 28 interviews were conducted, 23 with pregnant women and women who recently gave birth, and five with partners of the women. The following themes were identified: 1) understanding women's needs, 2) responsibility without criticism, and 3) women and their social network. These themes reflect that women need support from an involved and understanding healthcare professional, who holds women responsible for smoking cessation but refrains from criticism. Women also prefer involvement of their social network in the professional support.CONCLUSION: For tailored support, the Dutch guideline for professional smoking cessation support may need some adaptations. The adaptations and recommendations, e.g. to involve women and their partners in the development of guidelines, might also be valuable for other countries. Women prefer healthcare professionals to address smoking cessation in a neutral way and to respect their autonomy in the decision to stop smoking.

Introduction Traditionally, follow‐up of colorectal cancer (CRC) is performed in secondary care. In new models of care, the screening part care could be replaced to primary care. We aimed to synthesise evidence on the diagnostic accuracy of commonly used screeners in CRC follow‐up applicable in primary care: carcinoembryonic antigen (CEA), ultrasound and physical examination. Methods Medline, EMBASE, Cochrane Trial Register and Web of Science databases were systematically searched. Studies were included if they provided sufficient data for a 2 × 2 contingency tables. QUADAS‐2 was used to assess methodological quality. We performed bivariate random effects meta‐analysis, generated a hypothetical cohort, and reported sensitivity and specificity. Results We included 12 studies (n = 3223, median recurrence rate 19.6%). Pooled estimates showed a sensitivity for CEA (≤ 5 μg/l) of 59% [47%–70%] and a specificity of 89% [80%–95%]. Only few studies reported sensitivities and specificities for ultrasound (36–70% and 97–100%, respectively) and clinical examination (23% and 27%, respectively). Conclusion In practice, GPs could perform CEA screening. Radiological examination in a hospital setting should remain part of the surveillance strategy. Personalised algorithms accounting for recurrence risk and changes of CEA‐values over time might add to the diagnostic value of CEA in primary care.

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

ObjectivesPatients who present in primary care with chronic functional somatic symptoms (FSS) have reduced quality of life and increased health care costs. Recognising these early is a challenge. The aim is to develop and internally validate a clinical prediction rule for repeated consultations with FSS.Design and settingRecords from the longitudinal population-based (‘Lifelines’) cohort study were linked to electronic health records from general practitioners (GPs).ParticipantsWe included patients consulting a GP with FSS within 1 year after baseline assessment in the Lifelines cohort.Outcome measuresThe outcome is repeated consultations with FSS, defined as ≥3 extra consultations for FSS within 1 year after the first consultation. Multivariable logistic regression, with bootstrapping for internal validation, was used to develop a risk prediction model from 14 literature-based predictors. Model discrimination, calibration and diagnostic accuracy were assessed.Results18 810 participants were identified by database linkage, of whom 2650 consulted a GP with FSS and 297 (11%) had ≥3 extra consultations. In the final multivariable model, older age, female sex, lack of healthy activity, presence of generalised anxiety disorder and higher number of GP consultations in the last year predicted repeated consultations. Discrimination after internal validation was 0.64 with a calibration slope of 0.95. The positive predictive value of patients with high scores on the model was 0.37 (0.29–0.47).ConclusionsSeveral theoretically suggested predisposing and precipitating predictors, including neuroticism and stressful life events, surprisingly failed to contribute to our final model. Moreover, this model mostly included general predictors of increased risk of repeated consultations among patients with FSS. The model discrimination and positive predictive values were insufficient and preclude clinical implementation.

Introduction Despite the health risks of smoking, some women continue smoking during pregnancy. Professional smoking cessation support (SCS) has shown to be effective in increasing the proportion of women who quit smoking during pregnancy. However, few women actually make use of professional SCS. The aim of this study is to investigate the needs of women and their partners for professional SCS. Methods Semi-structured interviews were held with pregnant women and recent mothers who smoked or quit smoking during pregnancy, and their partners, living in the North of the Netherlands. Recruitment was done via Facebook, LinkedIn, food banks, baby stores and healthcare professionals. The interviews were recorded, transcribed and thematically analyzed. Results 28 interviews were conducted, 23 with pregnant women and recent mothers, and five with partners of the women. The following themes were identified: 1) Understanding women's needs, 2) Responsibility without criticism, and 3) Women and their social network. These themes reflect that women need support from an involved and understanding healthcare professional, who holds women responsible for smoking cessation but refrains from criticism. Women also prefer involvement of their social network in the professional support. Conclusions For tailored support, the guideline for professional SCS may need some adaptations, and women and their partners should be involved in the development of future guidelines. Women prefer healthcare professionals to address smoking cessation in a neutral way and to respect their autonomy in the decision to stop smoking.

BackgroundHospital admission rates are increasing for children with acute gastroenteritis. However, it is unknown whether this increase is accompanied by an increase in referral rates from GPs due to increased workloads in primary care out-of-hours (OOH) services.AimTo assess trends in referral rates from primary care OOH services to specialist emergency care for children presenting with acute gastroenteritis.Design & settingThis retrospective cohort study covered a period from September 2007–September 2014. Children aged 6 months to 6 years presenting with acute gastroenteritis to a primary care OOH service were included.MethodPseudonymised data were obtained, and children were analysed overall and by age category. Χ2 trend tests were used to assess rates of acute gastroenteritis, referrals, face-to-face contacts, and oral rehydration therapy (ORT) prescriptions.ResultsThe data included 12 455 children (6517 boys), with a median age of 20.2 months (interquartile range [IQR] 11.6 to 36.0 months). Over 7 years, incidence rates of acute gastroenteritis decreased significantly, and face-to-face contact rates increased significantly (both, PP = 0.87) or prescription rates for ORT (P = 0.82). Subgroup analyses produced comparable results, although there was an increase in face-to-face contact rates for the older children.ConclusionIncidence rates for childhood acute gastroenteritis presenting in OOH services decreased and referral rates did not increase significantly. These findings may be useful as a reference for the impact of new interventions for childhood acute gastroenteritis.

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.

Background General practice is the centre of care for patients with medically unexplained symptoms (MUS). Providing explanations for MUS, i.e. making sense of symptoms, is considered to be an important part of care for MUS patients. However, little is known how general practitioners (GPs) do this in daily practice. Objective This study aimed to explore how GPs explain MUS to their patients during daily general practice consultations. Methods A thematic content analysis was performed of how GPs explained MUS to their patients based on 39 general practice consultations involving patients with MUS. Results GP provided explanations in nearly all consultations with MUS patients. Seven categories of explanation components emerged from the data: defining symptoms, stating causality, mentioning contributing factors, describing mechanisms, excluding explanations, discussing the severity of symptoms and normalizing symptoms. No pattern of how GPs constructed explanations with the various categories was observed. In general, explanations were communicated as a possibility and in a patient-specific way; however, they were not very detailed. Conclusion Although explanations for MUS are provided in most MUS consultations, there seems room for improving the explanations given in these consultations. Further studies on the effectiveness of explanations and on the interaction between patients and GP in constructing these explanations are required in order to make MUS explanations more suitable in daily primary care practice.

BACKGROUND: Previous studies identified demographic, reproduction-related and psychosocial correlates of suboptimal mother-to-infant bonding. Their joint informative value was still unknown. This study aimed to develop a multivariable model to screen early in pregnancy for suboptimal postnatal mother-to-infant bonding and to transform it into a risk classification model.METHODS: Prospective cohort study conducted at 116 midwifery centers between 2010-2014. 634 women reported on the Mother-to-Infant Bonding questionnaire in 2015-2016. A broad range of determinants before 13 weeks of gestation were considered. Missing data were described, analyzed and imputed by multiple imputation. Multivariable logistic regression with backward elimination was used to develop a screening model. The explained variance, the Area Under the Curve of the final model were calculated and a Hosmer and Lemeshow test performed. Finally, we designed a risk classification model.RESULTS: The prevalence of suboptimal mother-to-infant bonding was 11%. The estimated probability of suboptimal mother-to-infant can be calculated: P(MIBS≥4) = 1/(1+exp(-(-4.391+(parity× 0.519)+(Adult attachment avoidance score× 0.040))). The explained variance was 14% and the Area Under the Curve was 0.750 (95%CI 0.690-0.809). The Hosmer and Lemeshow test had a p-value of 0.21. This resulted in a risk classification model.CONCLUSION: Parity and adult attachment avoidance were the strongest independent determinants. Higher parity and higher levels of adult attachment avoidance are associated with an increased risk of suboptimal mother-to-infant bonding. The model and risk classification model should be externally validated and optimized before use in daily practice. Future research should include an external validation study, a study into the additional value of non-included determinants and finally a study on the impact and feasibility of the screening model.

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.

AIMS: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage.METHODS: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI ≥ 2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis.CONCLUSION: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.

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.

Objectives: The primary objective was to evaluate the ability of different anatomic cut-off points, as established in specialist urogynecology populations, to identify clinically relevant prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care.Study design: Cross-sectional study among 890 women (>= 55 years) screened for pelvic floor symptoms.Main outcome measures: The Pelvic Floor Distress Inventory 20 was used to measure symptoms, and the Pelvic Organ Prolapse Quantification (POP-Q) system was used to assess prolapse. Areas under the curves, sensitivity, and specificity were calculated for the hymen as a cut-off point for symptomatic prolapse of the anterior and posterior vaginal wall. For the apical compartment, a cut-off point of -5 cm relative to the hymen was used.Results: Vaginal bulging was the only symptom reported more often with increasing POP-Q stages. Areas under the curves (95% confidence intervals) to discriminate between women with and without vaginal bulging symptoms were 0.66 (0.61-0.72), 0.56 (0.50-0.63), and 0.61 (0.55-0.66) for the anterior (Ba), posterior (Bp) and apical (C) compartment, respectively. When the hymen was used as the cut-off point, Ba had a sensitivity of 38.1% and a specificity of 82.4%, and Bp had a sensitivity of 13.3% and a specificity of 96.5%. For C, the cut-off point of -5 cm relative to the hymen had a sensitivity of 37.9% and a specificity of 73.1%.Conclusions: The anatomic cut-off points for clinically relevant prolapse established in the specialist urogynecology population cannot adequately identify symptomatic prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care. (C) 2017 Elsevier B.V. All rights reserved.

OBJECTIVE: To compare effects and cost-effectiveness of pelvic floor muscle training (PFMT) and watchful waiting in women with pelvic organ prolapse.DESIGN: Randomised controlled trial.SETTING: Dutch general practice.POPULATION: Women (≥55 years) with symptomatic mild prolapse, identified by screening.METHODS: Linear multilevel analysis.MAIN OUTCOME MEASURES: Primary outcome was change of pelvic floor symptoms (Pelvic-Floor-Distress-Inventory-20 [PFDI-20]) during 24 months. Secondary outcomes were condition-specific and general quality of life, costs, sexual functioning, prolapse stage, pelvic floor muscle function and women's perceived improvement of symptoms.RESULTS: PFMT (n = 145) resulted in a 12.2-point (95% CI 7.2-17.2, P < 0.001) greater improvement in PFDI-20 score during 24 months compared with watchful waiting (n = 142). Participants randomised to PFMT more often reported improved symptoms (43% versus 14% for watchful waiting). Direct medical costs per person were €330 for PFMT and €91 for watchful waiting but costs for absorbent pads were lower in the PFMT group (€40 versus €77). Other secondary outcomes did not differ between groups. Post-hoc subgroup analysis demonstrated that PFMT was more effective in women experiencing higher pelvic floor symptom distress at baseline.CONCLUSION: PFMT resulted in greater pelvic floor symptom improvement compared with watchful waiting. The difference was statistically significant, but below the presumed level of clinical relevance (15 points). PFMT more often led to women's perceived improvement of symptoms, lower absorbent pads costs, and was more effective in women experiencing higher pelvic floor symptom distress. Therefore, PFMT could be advised in women with bothersome symptoms of mild prolapse.TWEETABLE ABSTRACT: Pelvic floor muscle training can be effective in women with bothersome symptoms of mild prolapse.

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.

Objective: We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period.Methods: Randomized controlled trial with women (>= 55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement.Results: There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively.Conclusions: In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.

Kool M, Elshout G, Bohnen AM, Koes BW, Berger MY. Better care for febrile children seen at out-of-hours services. Huisarts Wet 2016;59(11):474-7. Parents contact out-of-hours services relatively often because their child has a temperature and mention one or more alarm symptoms. The vast majority of these children have a non-serious infection and do not require further treatment. Children that appear to be seriously ill should be referred to secondary care. The Dutch Association of General Practitioners’ guideline ‘Children with fever’ recommends that children with only one alarm symptom be referred, but the majority of these referrals turn out to be a false alarm. General practitioners are relatively conservative in their referrals and score better in this respect than diagnostic algorithms, so it seems that they are guided by more than the alarm symptoms alone. It is more complex if GPs are uncertain about the seriousness of the illness. They often prescribe an antibiotic to reassure themselves and the parents, but this should be avoided because it gives a false sense of security. It would be better to clearly tell the parents when and where they should contact the service again. If the medical record is complete and unambiguous, the course of the disorder can be reviewed in the follow-up consultation, even if this occurs with a different GP.

Objective: To systematically review the literature on health-related quality of life (HRQoL) in children with functional constipation and to identify disease-related factors associated with HRQoL. Study design: The Pubmed, Embase, and PsycINFO database were searched. Studies were included if they prospectively assessed HRQoL in children with functional constipation according to the Rome criteria. Articles were excluded if patients had organic causes of constipation and if HRQoL was only assessed after successful therapeutic interventions. A meta-analysis was performed calculating sample size–weighted pooled mean and SD of HRQoL scores. The quality of the studies was also assessed. Results: A total of 20 of 2658 studies were included, providing HRQoL data for 2344 children. Quality of evidence was considered to be poor in 9 of the 20 studies (45%); 13 of the 20 studies reported sufficient data to be included in the meta-analysis. Pooled total HRQoL scores of children with functional constipation were found to be lower compared with healthy reference samples (65.6 vs 86.1; P < .01). Similar HRQoL scores were found according to self-report and parent proxy report. Hospital-based studies reported lower HRQoL scores as compared with community-based studies. Two studies reported on HRQoL scores of children with and without fecal incontinence, but no significant difference was found. Conclusions: HRQoL is compromised in children with functional constipation.

HYPOTHESIS/AIMS OF STUDY: Over 100 apps for urinary incontinence are available in the app store and google play, but evidence on their effective-ness is scarce. Available studies focused on the treatment of stress urinary incontinence only (1). Mobile applications may support women with urinary continence, but it is unclear if the effect of such treatment equals care as usual. In many countries, general practitioners (GPs) provide frst line treatment of urinary incontinence. We studied if the effectiveness of an app-based treatment for stress-urgency-and mixed urinary incontinence is non-inferior to care as usual provided by GPs after 4 months. To assess the beneft of an app in real clinical practice, we chose a non-inferiority comparison to care as usual. STUDY DESIGN, MATERIALS AND METHODS: This trial was a pragmatic, block-randomized, two arm, parallel, non-inferiority design with participants receiving app-based treatment or care as usual for stress-, urgency-or mixed urinary incontinence (UI). We recruited participants through primary care practices, lay press and social media. Adult woman, with ≥ 2 urinary incontinence episodes per week, with access to a smartphone or tablet and willing to receive treatment were eligible. We excluded woman with conditions possibly related to stress-, urgency-or mixed incontinence, those who had previous surgery for incontinence or any other treatment for incontinence in the previous year, or those that were unable to complete a questionnaire in Dutch or had a terminal or mental illness. Participants signed an informed consent form before entering the study. The app contains a step-by-step program for the self-management of urinary incontinence. The app ofered information on incontinence and lifestyle advices, exercises focusing on awareness of the pelvic foor muscle and exercises to train the pelvic foor muscle and/or bladder. The type of incontinence directed treatment advices. Care as usual consisted of any or more of the following: instructions on pelvic foor muscle and/or bladder training; prescribing a pessary, drugs, or absorbent products; or referral to a continence nurse, a pelvic physiotherapist, or to secondary care. After inclusion and baseline assessment, the randomization was carried out using the validated web-based computer program ALEA to ensure full allocation concealment. The primary outcome was diference in change in urinary incontinence severity (assessed with the ICIQ-UI-short form) from baseline to 4 months. We used linear regression to compare the change of ICIQ-UI-SF symptom score between groups, in a per-protocol analysis, which is the most conservative for the non-inferiority design. For this, we included women from the app-group that logged in in the app at least once and women from the care as usual group that visited their GP for incontinence at least once. The non-inferiority margin is set at 1.5 points diference of change in UI severity between groups. This is based on the 1.58 points between-treatment minimum important difer-ence in change (MID) for the ICIQ-UI-SF, previously identifed among participants with stress UI (2). Assuming a power of 0.80 with a one-sided type I error of 0.025, we needed a sample of 100 evaluable participants per group. RESULTS: Participants were recruited through 88 GPs (n=201) and through (social) media (n=149). Of 350 participants screened, 262 were eligible and randomly allocated to either App-based treatment (n=131) or care as usual (n=131). The mean age of included women was 53 years (range 20-86), median duration of incontinence was 7 years (Interquartile range 4-14). Fifty percent of participants reported a mixed type of incontinence, 42% stress incontinence and 8% urgency incontinence.The incontinence severity was slight (10%) moderate (64%) or severe (26%). The per-protocol analysis included 96 (app-group) and 75 participants (care as usual). Both groups showed improvement after treatment with a mean change in incontinence severity of-2.15 (SD 2.56) points in the app group and-2.75 (3.62) points in the care as usual group. The mean diference of change of incontinence severity between both groups was 0.071 points (95% CI:-0.837 to 0.979), which did not reach the pre-specifed boundary of 1.5 points but did cross zero (Figure1). This means that the app-based treatment effect was non-inferior to the care as usual treatment effect, but not superior. INTERPRETATION OF RESULTS: This RCT shows that an app-based treatment for woman with stress-, urgency and mixed urinary incontinence is at least as effective as the best current treatment provided by GPs at 4 months. This is the frst study with a pragmatic comparison of an app-based treatment for urinary incontinence to care as usual and we believe our results provide a realistic reffec-tion of the treatment effect in a real life setting. Symptom improvement shown was clinically relevant in both groups. The three main types of incontinence can be treated by the same app, therefore increasing the applicability and relevance of app treatment. CONCLUDING MESSAGE: This is the frst study on an app-based treatment for women with stress-, urgency-, and mixed UI, showing that it is non-inferior compared to care as usual in primary care after 4 months. Further research is needed to study long-term effectiveness, and the cost-effectiveness of app-based treatment, and to understand the process underlying treatment success.

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).

Heavy menstrual bleeding (HMB) can negatively influence physical activity, work productivity, and sexual life and therefore has a major impact on women's quality of life (QoL). The National Institute for Health and Care Excellence guidelines recommend the levonorgestrel-releasing intrauterine system (LNG-IUS) as the treatment of first choice for HMB. Surgical treatments for treating HMB in women without future pregnancy wish include endometrial ablation (EA) and hysterectomy. Because of potentially biased studies and conflicting results on bleeding scores, satisfaction, and reintervention rate, there is no consensus on the efficacy of LNG-IUS versus EA. This multicenter, randomized controlled, noninferiority trial aimed to compare the effectiveness of the LNG-IUS system with EA in women with HMB. This study was performed between 2012 and 2016 in 26 hospitals in the Netherlands. Women were considered eligible if they had a diagnosed HMB with a Pictorial Blood Loss Assessment Chart (PBAC) score exceeding 150 points, were older than 34 years, had no pregnancy wish, and had no abnormal cervix cytology in the past 5 years. Participants were randomized in a 1:1 ratio to either the LNG-IUS or EA cohort. The LNG-IUS cohort had implantation of the device containing a total of 52 mg of levonorgestrel, releasing 20 μg/d. The EA intervention was performed with a bipolar radiofrequency device either in the office under local anesthetics or in the operating room under general or spinal anesthesia. The primary study outcome was menstrual blood loss at 24 months after randomization in PBAC, measured by participants through standardized questionnaires. Participants completed questionnaires before treatment and at 3, 6, 12, and 24 months after randomization. The primary analysis was an intention-to-treat analysis with a hypothesis that LNG-IUS would be noninferior to EA. Noninferiority of the LNG-IUS protocol would be established if the upper limit of the 95% confidence interval (CI) for the difference in PBAC score did not exceed the predetermined noninferiority margin of 25 points with P < 0.05. A total of 270 participants were randomized to initial treatment with LNG-IUS (n = 132) or treatment with EA (n = 138) between April 2012 and January 2016. A total of 247 participants (91%) reported PBAC scores at 24 months. The mean PBAC score was 64.8 in the LNG-IUS group compared with 14.2 in the EA group (mean difference, 50.5; 95% CI, 4.3-96.7). Noninferiority of LNG-IUS could not be demonstrated (noninferiority, P = 0.87). At 3 months of follow-up, 60% of women in the LNG-IUS group had reached a PBAC score of less than 75 points compared with 83% of women in the EA group (relative risk, 0.72; 95% CI, 0.59-0.87). The LNG-IUS was removed in 49 women (39%), and those in the LNG-IUS cohort were more likely to receive a surgical or drug reintervention within 24 months compared with women in the EA group (35% vs 20%; relative risk, 1.77; 95% CI, 1.17-2.68). There was no statistically significant difference in participant satisfaction and QoL between the cohorts. This study found that both the LNG-IUS and EA protocols for HMB led to a large decrease in menstrual blood loss, with LNG-IUS resulting in an increased risk of needing additional treatment and EA achieving a greater decrease in blood loss, with comparable QoL and satisfaction scores. Noninferiority of LNG-IUS compared with EA could not be demonstrated.

Background. Dientamoeba fragilis is commonly identified in children in primary care and is suspected to cause gastrointestinal disease.Objective. To determine the association between D. fragilis colonization and gastrointestinal symptoms in children.Methods. We performed a cross-sectional study with children who presented in primary care with gastrointestinal symptoms. The associations between D. fragilis colonization and specific symptoms were explored by means of logistic regression analyses. Asymptomatic siblings of these cases were invited as control subjects for a case-control analysis, where we explored the association between D. fragilis and gastrointestinal symptoms with conditional logistic regression analysis.Results. In the cross-sectional study, 107 children were included. Their median age was 9 years (interquartile range = 6-12) and 38 (35.5%) were boys. Colonization of D. fragilis was present in 59 children (55.1%). The absence of D. fragilis was associated with soft to watery stool [odds ratio (OR) = 0.29; 95% confidence interval (CI) = 0.10-0.85], chronic diarrhoea (OR = 0.42; 95% CI = 0.180.97) and fatigue (OR = 0.45; 95% CI = 0.20-0.99). The case-control analyses included 44 children in each group. Dientamoeba fragilis colonization was not observed more often in cases than in controls after adjustment for age and sex (OR = 1.02; 95% CI = 0.28-3.65).Conclusion. Dientamoeba fragilis is a common parasite in children with and without gastrointestinal symptoms. The anomalous finding of the association between the absence of D. fragilis with soft to watery stools, chronic diarrhoea and fatigue are inexplicable. Our study suggests that D. fragilis colonization does not increase the risk for gastrointestinal symptoms.

Background In a small proportion of patients experiencing unspecified back pain, a specified underlying pathology is present. Objective The purposes of this study were: (1) to identify the prevalence of physician-specified causes of back pain and (2) to assess associations between “red flags” and vertebral fractures, as diagnosed by the patients' general practitioner (GP), in older adults with back pain. Methods The Back Complaints in the Elders (BACE) study is a prospective cohort study. Patients (aged >55 years) with back pain were included when consulting their GP. A questionnaire was administered and a physical examination and heel bone densitometry were performed, and the results determined back pain and patient characteristics, including red flags. Participants received a radiograph, and reports were sent to their GP. The final diagnoses established at 1 year were collected from the GP's patient registry. Results Of the 669 participants included, 6% were diagnosed with a serious underlying pathology during the 1-year follow-up. Most of these participants (n=33, 5%) were diagnosed with a vertebral fracture. Multivariable regression analysis showed that age of ≥75 years, trauma, osteoporosis, a back pain intensity score of ≥7, and thoracic pain were associated with a higher chance of getting the diagnosis of a vertebral fracture. Of these variables, trauma showed the highest positive predictive value for vertebral fracture of 0.25 (95% confidence interval=0.09, 0.41) and a positive likelihood ratio of 6.2 (95% confidence interval=2.8, 13.5). A diagnostic prediction model including the 5 red flags did not increase these values. Limitations Low prevalence of vertebral fractures could have led to findings by chance. Conclusions In these older adults with back pain presenting in general practice, 6% were diagnosed with serious pathology, mainly a vertebral fracture (5%). Four red flags were associated with the presence of vertebral fracture.

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.

Background and objective. A new payment system could curb primary health care costs. A differentiated capitation system based on patient characteristics could be the best mix for payment. To test the feasibility of such a system, we examined the number of contacts between patients and general practitioners (GPs), the related costs and the relationship with age, sex and comorbidity.Methods. A retrospective observational study included 29 304 primary care patients in the Netherlands. Age, sex and comorbidity were related to number of contacts per patients per year and costs using a negative binomial regression analysis.Results. Males, younger patients and patients with no comorbidities visit their GP least often. Medically unexplained physical symptoms, diabetes and severe back complaints generate the most contacts; diabetes is specifically related to higher costs.Conclusion. Several patient characteristics are related to the number of contacts patients have with their GP and the consecutive remuneration. This study can be used as an input to create a differentiated capitation system.

BackgroundFever in children in primary care is commonly caused by benign infections, but often worries parents. Information about the duration of fever and its predictors may help in reassuring parents, leading to diminished consultation of health care.AimTo determine which signs and symptoms predict a prolonged duration of fever in febrile children in primary care and evaluate whether C-reactive protein (CRP) measurement has an additive predictive value for these symptoms.Design and settingA prospective cohort study at a GPs' cooperative (GPC) out-of-hours service.MethodChildren (aged 3 months to 6 years) presenting with fever as stated by the parents were included. Exclusion criteria were no communication in Dutch possible, previous enrolment in the study within 2 weeks, referral to the hospital directly after visiting the GPC, or no informed consent. The main outcome measure was prolonged duration of fever (> 3 days) after initial contact.ResultsFour-hundred and eighty children were analysed, and the overall risk of prolonged duration was 13% (63/480). Multivariate analysis combined model of patient history and physical examination showed that 'sore throat' (OR 2.8; 95% CI = 1.30 to 6.01) and 'lymph nodes palpable' (OR 1.87; 95% CI = 1.01 to 3.49) are predictive for prolonged duration of fever. The discriminative value of the model was low (AUC 0.64). CRP had no additive value in the prediction of prolonged duration of fever (OR 1.00; 95% CI = 0.99 to 1.01).ConclusionThe derived prediction model indicates that only a few signs and symptoms are related to prolonged duration of fever. CRP has no additional value in this model. Overall, because the discriminative value of the model was low, the duration of fever cannot be accurately predicted.

PURPOSE: Abdominal pain is a frequent symptom among children but is rarely associated with organic disease. Although it may persist for years, no factors have been identified that predict its prognosis. Our aim was to determine whether patient characteristics at initial consultation can predict chronic abdominal pain severe enough to influence the child's well-being at 1 year of follow-up.METHODS: We conducted this prospective cohort study in primary care, including consecutive children aged 4 to 17 years seen for abdominal pain by their family physician. Multivariate logistic regression analysis was used to identify prognostic factors that predicted chronic abdominal pain 1 year later. Discriminative ability of identified predictors was assessed using the area under the receiver operating characteristic curve and explained variance.RESULTS: The risk of having chronic abdominal pain at 1 year of follow-up was 37.1% in the cohort overall. Increasing age, waking up at night with pain, high levels of other somatic complaints, and chronic abdominal pain at baseline independently predicted chronic abdominal pain at 1 year. These predictors had a poor to moderate discriminative ability, however; the area under the receiver operating characteristic curve was only 0.69, and the predictors collectively explained only 14.3% of variance in the development of chronic abdominal pain. The absolute risk ranged from 19.4% among children having none of the predictors to 65.5% among children having 3 or 4 predictors.CONCLUSIONS: Chronic abdominal pain sufficient to affect well-being is common among children initially seen for abdominal pain by family physicians. Although the risk of this outcome increases with number of predictors, these predictors are of limited value in identifying children in whom pain will become chronic, suggesting that other, as yet unidentified factors play an important role.

Background: Fever is common in young children and is assumed to be frequently caused by viral infections.Objectives: To document respiratory viruses in children with fever presenting at a general practice out-of-hours service (OHS), evaluate presenting symptoms in febrile children with a virus infection, and examine the association between antibiotic prescription and the presence of a viral infection.Methods: Nasopharyngeal swabs were obtained to detect respiratory viruses in non-hospitalized children aged >= three months to six years presenting with fever at an OHS. Symptoms were assessed using physical examinations and questionnaires. Logistic regression analysis was used to reveal associations between symptoms or diagnoses, and the presence of at least one virusResults: In total 257 nasopharyngeal swabs were obtained in 306 eligible children; 53% of these children were infected by at least one virus. The most frequently detected viruses were adenovirus (10.9%), RSV type A (10.5%) and PIV type 1 (8.6%). Cough (OR 2.6; 95% CI: 1.4-4.6) and temperature >= 38.0 degrees C (OR 2.1; 95% CI: 1.3-3.5) were independent predictors of the presence of a virus, but the discriminative ability was low (AUC 0.64; 95% CI: 0.58-0.71). Antibiotic prescription rate was 37.3%. In 57.4% of children with an antibiotic prescription, a virus was found.Conclusion: In over 50% of all febrile children presenting at an OHS, a virus was found. Antibiotic prescription rate was high and not associated to the outcome of viral testing.

Objectives The URINO trial investigated the effect of offering treatment to older women with urinary incontinence in the general population, who had not sought help on their own initiative. Study design In a cluster randomized trial, 14 general practitioners were matched into pairs and randomly allocated to an intervention or a control group. Women aged ≥55 years registered in the participating practices were asked about urinary incontinence via a postal questionnaire. Patients in the intervention group were assessed and treated whereas patients in the control group received standard care. Main outcome measures Primary outcome was improvement (yes or no) of the severity of symptoms at 12-month follow-up measured with the Incontinence Severity Index. Secondary outcomes were the number of incontinence episodes per day and quality of life. The primary analysis was on an intention-to-treat basis with multiple imputation of missing data. A logistic regression model with correction for cluster randomization was fitted to estimate odds ratios (ORs). Results At 12 months, the severity of symptoms had improved in more patients in the intervention group ( n 166) than in the controls ( n 184) (OR 1.9; 95% CI 1.1–3.3). Also, the number of patients with fewer episodes of incontinence had increased (OR 2.5; 95% CI 1.5–4.1). No between-group differences in changes in quality of life were apparent ( p 0.14). Conclusions It is recommended to encourage women in the general population aged ≥55 years with urinary incontinence to undergo diagnosis and treatment.

Background: Chemotherapy and radiotherapy for breast cancer may lead to cardiac dysfunction, but the prevalence of long-term echocardiographic evidence of cardiac dysfunction is unknown among survivors.Methods: In a cross-sectional study in primary care, we included 350 women who survived breast cancer for at least 5 years after diagnosis (treated with chemotherapy and/or radiotherapy) and 350 matched women (age and primary care physician). The primary outcome was cardiac dysfunction, defined as a left ventricular ejection fraction (LVEF) Results: The median age at diagnosis was 63 (interquartile range (IQR) 57-68) years for the breast cancer survivors. Median follow-up after diagnosis was 10 (IQR 7-14) years. LVEF Conclusions: In the long term, breast cancer survivors are at increased risk of mild LV systolic dysfunction, increased NT-proBNP levels, and cardiovascular disease compared with matched controls, even after adjustment for cardiovascular risk factors. Previous breast cancer treatment with chemotherapy, radiotherapy or both should be considered when assessing a patient's cardiovascular risk profile. (C) 2017 Elsevier Ltd. All rights reserved.

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.

The rising number of colorectal cancer (CRC) survivors is likely to impose a burden on healthcare systems. Effective resource allocation between primary and hospital care to ensure ongoing high-quality care is under discussion. Therefore, it is important to understand the current role of GPs during follow-up care of CRC. This study explores the primary healthcare use of patients 2-6 years after CRC treatment. Annual rates of face-to-face contacts, prescribed medication and referrals were compared between CRC patients and age, gender and GP matched controls in a historical prospective study. Reasons for contacts and prescribed medication were compared based on International Classification of Primary Care and Anatomical Therapeutic Chemical (ATC) Classification System codes, respectively. Negative binomial regression models and non-parametric test were used. Patients showed significantly more face-to-face contacts in the 2nd (63%), 3rd (32%) and 6th (23%) year, more drug prescriptions in the 2nd, 3rd and 6th year, and more referrals in the 2nd and 5th year after diagnosis. Differences in contacts and medication were related to the alimentary tract, blood and blood-forming organs, and psychological problems. This study suggests that GPs already play a substantial role during CRC follow-up and that there may be scope for formal services to be incorporated into the current model of GP care.

Screening for colorectal cancer (CRC) has both advantages (e.g. reduction in morbidity and mortality) and disadvantages (e.g. false positives and distress). A systematic review was therefore performed to improve our understanding of how false-positive CRC screening results affect patients psychologically (and to make recommendations for primary care). The PubMed, Embase, PsychINFO, CINAHL and Cochrane databases were searched in October 2014 and supplemented in December 2016 to identify studies on the psychological impact of false-positive CRC screening. Original studies were eligible when they assessed psychological impact in a screening setting, provided they also included false-positive CRC screening results. Two authors independently assessed 2,367 available manuscripts and included seven. Heterogeneity in their outcome measures meant that data could not be pooled. Two studies showed that a false-positive CRC screening result caused some moderate psychological distress shortly before and after colonoscopy. The remaining five studies illustrated that the psychological distress of patients with true-positive and false-positive CRC screening results was comparable. We conclude that a false-positive CRC screening result may cause some moderate psychological distress, especially just before or after colonoscopy. We recommend that general practitioners mention this when discussing CRC screening with patients and monitor those with a false-positive outcome for psychological distress.