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To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care.A pragmatic, randomised controlled, superiority trial.Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months.Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment.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.Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires).In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [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 incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379).App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care.App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.

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.

IntroductionChildren often present to primary care with functional abdominal pain (FAP) or irritable bowel syndrome (IBS), and around half still have abdominal complaints 1 year later. Hypnotherapy is an evidence-based treatment that is used in specialist care, but it lacks evidence in primary care. This study will investigate the (cost) effectiveness of home-based guided hypnotherapy for children with FAP or IBS in primary care.Methods and analysisWe report the design of a pragmatic randomised controlled trial among children aged 7–17 years, diagnosed with FAP or IBS by their general practitioner (GP), with assessments over 12 months. The control group will receive care as usual (CAU) by their GP (eg, communication, education and reassurance), while the intervention group will receive CAU plus 3 months of home-based guided hypnotherapy via a website. The primary outcome will be the proportion of children with adequate relief from abdominal pain/discomfort at 12 months, analysed on an intention-to-treat basis. Secondary outcomes will include the adequacy of pain relief at 3 and 6 months, pain/discomfort severity, pain frequency and intensity, daily functioning and impact on function, anxiety and depression, pain beliefs, sleep disturbances, school absence, somatisation, and healthcare use and costs. We must include 200 children to determine a 20% difference in those with adequate relief (55% control vs 75% intervention).Ethics and disseminationThe Medical Ethics Review Committee of the University Medical Center Groningen, the Netherlands, approved this study (METc2020/237). The results will be disseminated to patients, GPs and other stakeholders via email, a dedicated website, peer-reviewed publications and presentations at national and international conferences. We plan to collaborate with the Dutch Society of GPs to implement the results in clinical practice.Trial registration numberNCT05636358.

The electronic cigarette (e-cigarette) became commercially available around 2004, yet the characteristics of pregnant women who use these devices and their effects on maternal and infant health remain largely unknown. This study aimed to investigate maternal characteristics and pregnancy outcomes according to maternal smoking status. We conducted a cross-sectional study of Dutch women with reported pregnancies between February 2019 and May 2022, using an online questionnaire to collect data on smoking status and demographic, lifestyle, pregnancy, and infant characteristics. Smoking status is compared among non-smokers, tobacco cigarette users, e-cigarette users, and dual users (tobacco and e-cigarette). We report descriptive statistics and calculate differences in smoking status between women with the chi-square or Fisher (Freeman–Halton) test. Of the 1937 included women, 88.1% were non-smokers, 10.8% were tobacco cigarette users, 0.5% were e-cigarette users, and 0.6% were dual users. Compared with tobacco users, e-cigarette users more often reported higher education, having a partner, primiparity, and miscarriages. Notably, women who used e-cigarettes more often had small infants for gestational age. Despite including few women in the e-cigarette subgroup, these exploratory results indicate the need for more research to examine the impact of e-cigarettes on pregnancy outcomes.

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.

De behandeling van urine-incontinentie bij vrouwen blijkt met een app net zo goed te werken als de standaardzorg van de huisarts. Huisartsen hebben met deze app een nieuwe, bewezen werkzame behandeloptie in handen. De app biedt nog andere voordelen. Zo verlaagt het drempels tot de zorg, verbetert het therapietrouw en verlaagt het kosten.

To improve medical care for young people in the Netherlands, various professional groups representing physicians who provide medical care to children have developed a vision called ‘strengthening medical care for young people’. The purpose of this viewpoint is to reflect on the implementation of proposals to augment cooperation and coordination between the professional groups involved. Our reflection demonstrates that additional action regarding cooperation and coordination is still necessary to strengthen this care for young people. First, regarding the practical implementation of collaboration, the guidelines are unclear, and many are out-of-date. Second, adequate structured interdisciplinary training and intervision are lacking for physicians frequently collaborating in the care of young people. Third, interdisciplinary access to patient files is too complex and time-consuming. We recommend structured monitoring of the implementation of all improvement proposals, regarding both processes and outcomes. In addition, we recommend collaboration with physicians treating mentally disabled individuals to improve medical care for this group.

The anti-inflammatory agents dexamethasone (corticosteroid), and tocilizumab and sarilumab (IL6-inhibitors) are effective in the treatment of late COVID-19. Other anti-inflammatory agents, like anakinra (IL1-inhibitor), baricitinib and tofacitinib (JAK-inhibitors) and lenzilumab (GM-CSF-inhibitor) have also shown positive results in late COVID-19. For the treatment of early COVID-19, the inhalation corticosteroid budesonide is regarded as an off-label treatment option. Virus-inhibitors, like remdesivir, molnupiravir and nirmatrelvir/ritonavir decrease the risk of hospitalization and the development of severe COVID-19 by patients with early symptoms. Monoclonal antibodies have shown limited or no efficacy against the omicron-variant of SARS-CoV-2. Fluvoxamine, l-arginine, AT-527 and ensovibep are considered as potential promising new therapies for the treatment of early COVID-19.

ObjectivesChronic gastrointestinal symptoms are common among children and affect their daily activities and quality of life. The majority will be diagnosed with a functional gastrointestinal disorder. Effective reassurance and education are, therefore, key components of the physician’s management. Qualitative studies have shown how parents and children experience specialist paediatric care, yet less is known about general practitioners (GPs), who manage most cases in the Netherlands and have a more personal and enduring relationship with their patients. Therefore, this study evaluates the expectations and experiences of parents of children visiting a GP for chronic gastrointestinal symptoms.DesignWe conducted a qualitative interview study. Online interviews were audio and video recorded, transcribed verbatim and independently analysed by the first two authors. Data were collected and analysed concurrently until data saturation was reached. Using thematic analysis, we developed a conceptual framework reflecting respondent expectations and experiences. We performed a member check of the interview synopsis and the conceptual framework.SettingDutch primary care.ParticipantsWe purposively sampled participants from a randomised controlled trial evaluating the effectiveness of faecal calprotectin testing in children with chronic gastrointestinal complaints in primary care. Thirteen parents and two children participated.ResultsThree key themes emerged: disease burden, GP–patient relationship and reassurance. Often, the experienced disease burden and the pre-existing GP–patient relationship influenced expectations (eg, for further investigations or a sympathetic ear), and when a GP fulfilled these expectations, a trusting GP–patient relationship ensued that facilitated reassurance. We found that individual needs influenced these themes and their interrelationships.ConclusionInsights provided by this framework could help GPs managing children with chronic gastrointestinal symptoms in daily practice and may therewith improve the consultation experience for parents. Further research should evaluate whether this framework also holds true for children.Trial registration numberNL7690.

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.

ObjectiveTo develop a prediction model and illustrate the practical potential of personalisation of treatment decisions between app-based treatment and care as usual for urinary incontinence (UI).DesignA prediction model study using data from a pragmatic, randomised controlled, non-inferiority trial.SettingDutch primary care from 2015, with social media included from 2017. Enrolment ended on July 2018.ParticipantsAdult women were eligible if they had ≥2 episodes of UI per week, access to mobile apps and wanted treatment. Of the 350 screened women, 262 were eligible and randomised to app-based treatment or care as usual; 195 (74%) attended follow-up.PredictorsLiterature review and expert opinion identified 13 candidate predictors, categorised into two groups: Prognostic factors (independent of treatment type), such as UI severity, postmenopausal state, vaginal births, general physical health status, pelvic floor muscle function and body mass index; and modifiers (dependent on treatment type), such as age, UI type and duration, impact on quality of life, previous physical therapy, recruitment method and educational level.Main outcome measurePrimary outcome was symptom severity after a 4-month follow-up period, measured by the International Consultation on Incontinence Questionnaire the Urinary Incontinence Short Form. Prognostic factors and modifiers were combined into a final prediction model. For each participant, we then predicted treatment outcomes and calculated a Personalised Advantage Index (PAI).ResultsBaseline UI severity (prognostic) and age, educational level and impact on quality of life (modifiers) independently affected treatment effect of eHealth. The mean PAI was 0.99±0.79 points, being of clinical relevance in 21% of individuals. Applying the PAI also significantly improved treatment outcomes at the group level.ConclusionsPersonalising treatment choice can support treatment decision making between eHealth and care as usual through the practical application of prediction modelling. Concerning eHealth for UI, this could facilitate the choice between app-based treatment and care as usual.Trial registration numberNL4948t.

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.

De hormoonspiraal en endometriumablatie zijn 2 veelgebruikte behandelingen bij hevig menstrueel bloedverlies. Omdat de hormoonspiraal minder invasief is en geen onomkeerbare werking heeft, onderzochten we in een gerandomiseerde non-inferioriteitstrial met 270 patienten of starten met een hormoonspiraal niet onderdeed voor starten met endometriumablatie. Na 24 maanden was in de groep die startte met endometriumablatie het gemiddelde bloedverlies lager en de kans op een vervolgbehandeling kleiner. Maar het percentage vrouwen dat tevreden was en het bloedverlies uiteindelijk onder controle kreeg, was vergelijkbaar.

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.

Doel Chemotherapie en/of radiotherapie bij borstkanker kunnen op de lange termijn leiden tot een verminderde hartfunctie. Wij onderzochten hoe vaak cardiale disfunctie voorkomt bij overlevenden van borstkanker die weer onder de zorg van de huisarts vallen. Methode Crosssectioneel onderzoek met 350 vrouwen die meer dan vijf jaar geleden chemo- en/of radiotherapie gekregen hadden voor borstkanker en een gematchte controlegroep van 350 vrouwen van dezelfde leeftijd en huisartsenpraktijk zonder kanker in de voorgeschiedenis. De primaire uitkomstmaat was een linkerventrikelejectiefractie (LVEF) < 54%, gemeten met echocardiografie. Secundaire uitkomstmaten waren de concentratie NT-proBNP, hart- en vaatziekten en het gebruik van cardiovasculaire medicatie. Resultaten Mediaan was de diagnose borstkanker tien jaar voor de meting gesteld (interkwartielafstand 7-14 jaar). Van de overlevenden had 15,3% een LVEF < 54%, van de controlepersonen 7% (OR 2,4; 95%-BI 1,4 tot 4,0). Het percentage met een LVEF < 50% verschilde niet significant tussen beide groepen. Wel was in de groep overlevenden het NT-proBNP hoger, werden meer hart- en vaatziekten gediagnosticeerd en werd meer cardiovasculaire medicatie voorgeschreven. De associaties waren significant, ook na correctie voor cardiovasculaire risicofactoren. Conclusie Wanneer bij een vrouw een cardiovasculair risicoprofiel wordt opgesteld, lijkt het van belang te informeren of zij ooit chemo- of radiotherapie heeft gehad voor borstkanker.

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.

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 RR2-10.1002/nau.23507

IntroductionPhysical activity (PA) favourably affects various health outcomes in cancer survivors, but little is known about how to implement a PA programme in primary care. We therefore aim to implement and evaluate such a programme for cancer survivors in general practice.Methods and analysesThe Stimulation of Daily Activity study is an implementation study with a single-arm longitudinal design in 15 Dutch general practices. Patients aged ≥18 years who finished cancer treatment more than 6 months ago will be eligible for inclusion. The intervention will comprise six coaching sessions with the practice nurse in 9 months, seeking to increase PA in daily activities and using an activity tracker for goal setting and feedback. TheReach, Effectiveness, Adoption, Implementation and Maintenanceframework will be used to evaluate implementation in terms of the health outcomes, extent of implementation and barriers and facilitators to implementation, using a mixed methods approach. Descriptive analyses and linear mixed model analyses will be performed on the quantitative data, while qualitative data from focus groups and interviews will be analysed by thematic analyses.Ethics and disseminationThe Medical Research Ethics Committee of the University Medical Centre Groningen, the Netherlands, concluded that this study was not subject to the Dutch Medical Research Involving Human Subjects Act (registration number: 201900586). The study results will be made available to patients and general practitioners via (inter)national publications and conferences, newsletters, public summaries and via (social) media.

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.

BackgroundPatient recruitment to clinical research is often challenging and, when inadequate, can result in delayed or underpowered studies. Recruitment problems were experienced during a study of women with heavy menstrual bleeding in general practice (the MIRA trial). Although efforts were made to reduce the burden of the study for those participating, patient recruitment was still an issue.AimTo identify the barriers and facilitators associated with patient recruitment to clinical trials, as experienced by GPs.Design & settingA qualitative study was performed in Dutch general practice, using semi-structured interviews.MethodGPs participating in the MIRA trial were selected by purposive sampling and interviewed until saturation was reached. Three independent researchers performed data coding and thematic analysis. Consensus on the identified themes was reached by discussion among the researchers.ResultsSixteen GPs were interviewed. The following factors were noted to influence recruitment: the incidence of the disease under study; awareness of the study; attitude towards scientific research; perceived burden for the patient; usual care by the GP; time investment; characteristics of the GP and their practice; and patient experience of research participation.ConclusionThe identified barriers and facilitators associated with patient recruitment highlight the areas in which future studies can be improved. Indeed, benefits could be gained by simply ensuring that study procedures are clear, by requiring limited (time) investment from the GP, and by investing in personal communication and reminders to keep the GP motivated and interested. Placing greater importance on scientific research during the GP training programme could also serve as a means to motivate future GPs to integrate scientific research in their clinical practice.

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.