Publications by authors named "Marjolein Y Berger"

135 Publications

[Anxiety and mood disorders are independent risk factors for cardiovascular diseases].

Ned Tijdschr Geneeskd 2021 Oct 28;165. Epub 2021 Oct 28.

Wilhelmina Ziekenhuis Assen, Wilhelmina Apotheek, Assen.

Objective: Psychiatric conditions are insufficiently highlighted as cardiovascular risk factors in the CVRM guideline. Objectives of this review are 1) to determine if anxiety and mood symptoms/disorders are independent cardiovascular risk factors; 2) to compare this risk to a population without these psychiatric conditions and 3) to ascertain the influence of psychiatric disease severity.

Design: Narrative systematic review METHOD: We searched for meta-analyses and systematic reviews in PubMed. Quality assessment by AMSTAR criteria.

Results: 10 reviews were included from 172 hits. (Sub)clinical depression and mood disorders are associated with an increased independent risk to develop cardiovascular diseases, coronary artery disease, myocardial infarction and cerebrovascular disease. Bipolar disorders increase the cerebrovascular risk, but not myocardial infarction. Anxiety disorders/symptoms heighten the cardiovascular, myocardial and cerebrovascular risk.

Conclusion: Anxiety and mood symptoms/disorders are independent cardiovascular risk factors. Severe anxiety and mood disorders should be included as separate risk factors in the CVRM guideline.
View Article and Find Full Text PDF

Download full-text PDF

Source
October 2021

Home-based Physical Activity to Alleviate Fatigue in Cancer Survivors: A Systematic Review and Meta-analysis.

Med Sci Sports Exerc 2021 Dec;53(12):2661-2674

Department of General Practice and Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, THE NETHERLANDS.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1249/MSS.0000000000002735DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594505PMC
December 2021

Barriers and Facilitators Associated With App-Based Treatment for Female Urinary Incontinence: Mixed Methods Evaluation.

JMIR Mhealth Uhealth 2021 09 17;9(9):e25878. Epub 2021 Sep 17.

Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/25878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8486988PMC
September 2021

One year effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in Dutch general practice: A pragmatic randomised controlled trial over 12 months.

BJOG 2021 Aug 26. Epub 2021 Aug 26.

University of Groningen, University Medical Centre Groningen, Department of General Practice and Elderly Care medicine, FA21, PO Box 196, 9700AD, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/1471-0528.16875DOI Listing
August 2021

Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial.

Br J Gen Pract 2021 10 30;71(711):e728-e735. Epub 2021 Sep 30.

Department of General Practice and Elderly Care Medicine, University of Groningen, The Netherlands.

Background: Acute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting.

Aim: To 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 Setting: A 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.

Method: Children 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).

Results: In 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 ( = 0.027).

Conclusion: Children 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3399/BJGP.2021.0211DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8407859PMC
October 2021

Appendicitis in children with acute abdominal pain in primary care, a retrospective cohort study.

Fam Pract 2021 Nov;38(6):758-765

Department of General Practice and Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Background: General practitioners (GPs) face a diagnostic challenge when assessing acute abdominal pain in children. However, no information is available on the current diagnostic process or the diagnostic accuracy of history and physical examination in primary care settings.

Objective: To describe the diagnostic process for acute abdominal pain among children in primary care, focusing on appendicitis, and to assess the diagnostic accuracy of individual clinical features.

Methods: A retrospective cohort study in Dutch primary care, using the Integrated Primary Care Information database. Children aged 4-18 years were included if they had no history of appendicitis and presented with acute abdominal pain during 2010-2016. We evaluated GP management and the diagnostic accuracy of clinical features for appendicitis. Pre- and post-test probabilities were calculated for each clinical feature and compared with the probability of appendicitis after GP assessment.

Results: Out of 5691 children, 944 (16.6%) were referred and 291 (5.1%) had appendicitis, of whom 55 (18.9%) were initially misdiagnosed. The pre-test probability (i.e. of appendicitis in evaluated children) varied from 3% (rigidity) to 28% (migratory pain). Concerning post-test probabilities, positive values for rebound pain (32.1%) and guarding (35.8%) and the negative value for right lower quadrant tenderness (0.6%) were superior to overall GP assessment (29.6% and 1.1%, respectively).

Conclusions: GP assessment will miss almost one-fifth of children with appendicitis at their first presentation, and about two-third of GP referrals will be negative. The presence of specific signs can increase or decrease the likelihood of appendicitis, emphasising the importance of a physical examination.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/fampra/cmab039DOI Listing
November 2021

Couple-based expanded carrier screening provided by general practitioners to couples in the Dutch general population: psychological outcomes and reproductive intentions.

Genet Med 2021 09 10;23(9):1761-1768. Epub 2021 Jun 10.

Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/s41436-021-01199-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460434PMC
September 2021

Intrapartum synthetic oxytocin, behavioral and emotional problems in children, and the role of postnatal depressive symptoms, postnatal anxiety and mother-to-infant bonding: A Dutch prospective cohort study.

Midwifery 2021 Sep 20;100:103045. Epub 2021 May 20.

University of Groningen, University Medical Centre Groningen, Department of General Practice and Elderly Care Medicine, the Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.midw.2021.103045DOI Listing
September 2021

Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial.

Br J Gen Pract 2021 10 30;71(711):e736-e743. Epub 2021 Sep 30.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, The Netherlands.

Background: Acute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work.

Aim: To 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 Setting: A 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.

Method: Children 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.

Results: In 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]).

Conclusion: A single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3399/BJGP.2020.1093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8407860PMC
October 2021

Diagnostic accuracy of follow-up tests for detecting colorectal cancer recurrences in primary care: A systematic review and meta-analysis.

Eur J Cancer Care (Engl) 2021 Sep 11;30(5):e13432. Epub 2021 Mar 11.

Department of General Practice & Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/ecc.13432DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518902PMC
September 2021

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

Ann Fam Med 2021 Mar-Apr;19(2):102-109

Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

Purpose: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting.

Methods: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis.

Results: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment.

Conclusions: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1370/afm.2585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7939722PMC
October 2021

Developing a clinical prediction rule for repeated consultations with functional somatic symptoms in primary care: a cohort study.

BMJ Open 2021 01 8;11(1):e040730. Epub 2021 Jan 8.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Objectives: Patients 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 Setting: Records from the longitudinal population-based ('Lifelines') cohort study were linked to electronic health records from general practitioners (GPs).

Participants: We included patients consulting a GP with FSS within 1 year after baseline assessment in the Lifelines cohort.

Outcome Measures: The 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.

Results: 18 810 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).

Conclusions: Several 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-040730DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799137PMC
January 2021

Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study.

BJGP Open 2021 Apr 26;5(2). Epub 2021 Apr 26.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands

Background: Research 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.

Aim: To 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 & Setting: A 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.

Method: Consecutive 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.

Results: The RCT's feasibility was reduced by the informed consent procedure because 39.0% ( = 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.

Conclusion: The 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3399/bjgpopen20X101154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170614PMC
April 2021

Development of a risk classification model in early pregnancy to screen for suboptimal postnatal mother-to-infant bonding: A prospective cohort study.

PLoS One 2020 4;15(11):e0241574. Epub 2020 Nov 4.

Department of General Practice & Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0241574PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641412PMC
December 2020

Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.

Am J Obstet Gynecol 2021 02 12;224(2):187.e1-187.e10. Epub 2020 Aug 12.

Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Research School Grow, University of Maastricht, Maastricht, Netherlands.

Background: Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding.

Objective: This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding.

Study Design: This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function.

Results: We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups.

Conclusion: Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajog.2020.08.016DOI Listing
February 2021

Factors affecting patient recruitment to trials: qualitative research in general practice.

BJGP Open 2020 Aug 25;4(3). Epub 2020 Aug 25.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen (UMCG), Groningen, The Netherlands.

Background: Patient 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.

Aim: To identify the barriers and facilitators associated with patient recruitment to clinical trials, as experienced by GPs.

Design & Setting: A qualitative study was performed in Dutch general practice, using semi-structured interviews.

Method: GPs 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.

Results: Sixteen 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.

Conclusion: The 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3399/bjgpopen20X101056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465591PMC
August 2020

Long-term survivors of early breast cancer treated with chemotherapy are characterized by a pro-inflammatory biomarker profile compared to matched controls.

Eur J Heart Fail 2020 07 20;22(7):1239-1246. Epub 2020 Feb 20.

Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

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 <0.05 for all). Network analysis revealed upregulation of pathways relating to collagen degradation and activation of matrix metalloproteinases. Furthermore, several inflammatory biomarkers including growth differentiation factor 15, monocyte chemoattractant protein 1, chemokine (C-X-C motif) ligand 16, tumour necrosis factor super family member 13b and proprotein convertase subtilisin/kexin type 9, elevated in survivors treated with chemotherapy, showed an independent association with lower left ventricular ejection fraction.

Conclusion: Breast cancer survivors treated with chemotherapy ± radiotherapy show a distinct biomarker profile associated with mild cardiac dysfunction even 10 years after treatment. These results suggest that an ongoing pro-inflammatory state and activation of matrix metalloproteinases following initial treatment with chemotherapy might play a role in the observed cardiac dysfunction in late BC survivors.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ejhf.1758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540448PMC
July 2020

Quality of life in children with functional constipation: Are child self-reports and parent proxy-reports interchangeable?

J Pediatr 2020 02 20;217:216. Epub 2019 Nov 20.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, The Netherlands.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpeds.2019.10.066DOI Listing
February 2020

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

J Pediatr 2020 01 12;216:25-31.e2. Epub 2019 Nov 12.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center, Groningen, the Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpeds.2019.09.048DOI Listing
January 2020

GP-provided couple-based expanded preconception carrier screening in the Dutch general population: who accepts the test-offer and why?

Eur J Hum Genet 2020 02 30;28(2):182-192. Epub 2019 Sep 30.

Department of Genetics, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/s41431-019-0516-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6974594PMC
February 2020

Correlates of prenatal and postnatal mother-to-infant bonding quality: A systematic review.

PLoS One 2019 24;14(9):e0222998. Epub 2019 Sep 24.

Amsterdam UMC, Vrije Universiteit Amsterdam, Midwifery Science, AVAG, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Background: Mother-to-infant bonding is defined as the emotional tie experienced by a mother towards her child, which is considered to be important for the socio-emotional development of the child. Numerous studies on the correlates of both prenatal and postnatal mother-to-infant bonding quality have been published over the last decades. An up-to-date systematic review of these correlates is lacking, however.

Objective: To systematically review correlates of prenatal and postnatal mother-to-infant bonding quality in the general population, in order to enable targeted interventions.

Methods: MEDLINE, Embase, CINAHL, and PsychINFO were searched through May 2018. Reference checks were performed. Case-control, cross-sectional or longitudinal cohort studies written in English, German, Swedish, Spanish, Norwegian, French or Dutch defining mother-to-infant bonding quality as stipulated in the protocol (PROSPERO CRD42016040183) were included. Two investigators independently reviewed abstracts, full-text articles and extracted data. Methodological quality was assessed using the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-sectional studies and was rated accordingly as poor, fair or good. Clinical and methodological heterogeneity were examined.

Main Results: 131 studies were included. Quality was fair for 20 studies, and poor for 111 studies. Among 123 correlates identified, 3 were consistently associated with mother-to-infant bonding quality: 1) duration of gestation at assessment was positively associated with prenatal bonding quality, 2) depressive symptoms were negatively associated with postnatal mother-to-infant bonding quality, and 3) mother-to-infant bonding quality earlier in pregnancy or postpartum was positively associated with mother-to-infant bonding quality later in time.

Conclusion: Our review suggests that professionals involved in maternal health care should consider monitoring mother-to-infant bonding already during pregnancy. Future research should evaluate whether interventions aimed at depressive symptoms help to promote mother-to-infant bonding quality. More high-quality research on correlates for which inconsistent results were found is needed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0222998PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759162PMC
April 2020

Explanations for medically unexplained symptoms: a qualitative study on GPs in daily practice consultations.

Fam Pract 2020 02;37(1):124-130

Department of Primary and Community Care, Radboud University Medical Center, Donders Institute for Brain Cognition and Behaviour, Nijmegen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/fampra/cmz032DOI Listing
February 2020

Development of practical recommendations for diagnostic accuracy studies in low-prevalence situations.

J Clin Epidemiol 2019 10 28;114:38-48. Epub 2019 May 28.

Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, University of Oxford, Oxford OX2 6GG, UK; Academic Centre of General Practice, University of Leuven, Kapucijnenvoer 33 blok J, Bus 7001, 3000 Leuven, Belgium.

Objective: Low disease prevalence poses challenges for diagnostic accuracy studies because of the large sample sizes that are required to obtain sufficient precision. The aim is to collate and discuss designs of diagnostic accuracy studies suited for use in low-prevalence situations.

Study Design And Setting: We conducted a literature search including backward citation tracking and expert consultation. Two reviewers independently selected studies on designs for estimating diagnostic accuracy in a low-prevalence situation. During a 1-day expert meeting, all designs were discussed and recommendations were formulated.

Results: We identified six designs for diagnostic accuracy studies that are suitable in low-prevalence situations because they reduced the total sample size or the number of patients undergoing the index test or reference standard depending on which poses the highest burden. We described the advantages and limitations of these designs and evaluated efficiencies in sample sizes, risk of bias, and alignment with the clinical pathway for applicability in routine care.

Conclusion: Choosing a study design for diagnostic accuracy studies in low-prevalence situations should depend on whether the aim is to limit the number of patients undergoing the index test or reference standard, and the risk of bias associated with a particular design type.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2019.05.018DOI Listing
October 2019

[Increase in opioid prescribing in extramural care in the Netherlands: assessment of use and prescription behaviour, based on claims data].

Ned Tijdschr Geneeskd 2019 04 2;163. Epub 2019 Apr 2.

UMC Groningen, afd. Huisartsgeneeskunde en Ouderengeneeskunde, Groningen.

Objective: Describe the trends in extramural prescription of opioids in the Netherlands.

Design: Descriptive, retrospective research based on claims data of Dutch health insurers.

Method: For each healthcare-insured Dutch resident we selected claims data for all opioids, except codeine and buprenorphine, for the period 2010-2017. We calculated the total numbers of opioid and oxycodone users, and stratified these numbers by age and sex. The average number of prescribed Defined Daily Doses (DDD), the chronicity of use, the type of prescriber, and regional patterns in opioid use were investigated.

Results: A total of 3,655,265 different insured persons used opioids during the research period. The yearly number of opioid users increased from 650,864 in 2010 to 1,010,474 in 2017. This increase was mainly driven by an increase in oxycodone prescriptions. Elderly and female patients were more frequent users of opioids. The ratio of short- versus long-term opioid users remained steady during the research period, with opioids being used for four months or longer in 21% of cases. General practitioners prescribed 82% of the DDDs of all opioids in 2017. The percentage of DDDs of oxycodone prescribed by medical specialists increased from 2.8% in 2010 to 14.2% in 2017.

Conclusion: Opioid use is increasing in the Netherlands, but the long-term vs short-term use ratio has not changed in recent years. General practitioners prescribe the largest share of opioids, but a growing number of prescriptions originates from medical specialists.
View Article and Find Full Text PDF

Download full-text PDF

Source
April 2019

Addressing transition to motherhood, guideline adherence by midwives in prenatal booking visits: Findings from video recordings.

Midwifery 2019 Feb 31;69:76-83. Epub 2018 Oct 31.

Amsterdam UMC, Vrije Universiteit Amsterdam, Midwifery Science, AVAG, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.

Objective: To assess if and how primary care midwives adhere to the guideline by addressing transition to motherhood at the first prenatal booking visit and to what extent there was a difference in addressing transition to motherhood between nulliparous and multiparous women.

Design: Cross-sectional observational study of video-recorded prenatal booking visits.

Setting And Participants: 126 video recordings of prenatal booking visits with 18 primary care midwives in the Netherlands taking place between August 2010 and April 2011.

Measurements: Five observers assessed dichotomously if midwives addressed seven topics of transition to motherhood according to the Dutch guideline prenatal midwifery care from the Royal Dutch Organization of Midwives and used six communication techniques. Frequencies and percentages of addressing each topic and communication technique were calculated. Differences between nulliparous and multiparous women were examined with Chi-Square tests or Fischer Exact tests, were appropriate. The agreement between the five observers was quantified using Fleiss' Kappa.

Findings: During all visits at least one of the seven topics of transition to motherhood was addressed. The topics mother-to-infant bonding and support were addressed respectively in 2% and 16% of the visits. In almost all visits the topics desirability of the pregnancy, experience with the ultrasound examination or abdominal palpation or hearing the foetal heartbeat and practical preparation were addressed. Open questions for addressing transition to motherhood were used in 6% of the prenatal booking visits. Dutch midwives addressed transition to motherhood mostly by giving information (100%) and by using closed-ended questions (94%) and following woman's initiative (90%). Nulliparous women brought up transition to motherhood on their own initiative more often than multiparous women (97% versus 84%). For the topics 'desirability of the pregnancy 'and' practical preparations' and for conversation techniques 'giving information' and 'closed-ended questions', 100% agreement was achieved. However, the topic 'Support' had poor agreement (kappa = 0.19).

Key Conclusions And Implications For Practice: Although during every visit the transition of motherhood was addressed, the topics mother-to-infant bonding and support should get more attention. Midwives should improve adherence to the guideline by addressing transition to motherhood and by using more open questions. Furthermore, they should focus on taking the initiative to address the transition to motherhood in multiparous women themselves.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.midw.2018.10.021DOI Listing
February 2019

Predictors of Success for Pelvic Floor Muscle Training in Pelvic Organ Prolapse.

Phys Ther 2019 01;99(1):109-117

Department of General Practice, University Medical Center Groningen, University of Groningen, Antonius Deusinglaan 1, Postbus 196/FA21, Groningen, the Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ptj/pzy114DOI Listing
January 2019

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

J Pediatr Gastroenterol Nutr 2018 11;67(5):552-560

Department of General Practice and Elderly Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MPG.0000000000002138DOI Listing
November 2018

Effects of Shared Decision Making on Distress and Health Care Utilization Among Patients With Lung Cancer: A Systematic Review.

J Pain Symptom Manage 2018 12 24;56(6):975-987.e5. Epub 2018 Aug 24.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Context: Lung cancer is associated with significant distress, poor quality of life, and a median prognosis of less than one year. Benefits of shared decision making (SDM) have been described for multiple diseases, either by the use of decisions aids or as part of supportive care interventions.

Objectives: The objective of this study was to summarize the effects of interventions facilitating SDM on distress and health care utilization among patients with lung cancer.

Methods: We performed a systematic literature search in the CINAHL, Cochrane, EMBASE, MEDLINE, and PsychINFO databases. Studies were eligible when conducted in a population of patients with lung cancer, evaluated the effects of an intervention that facilitated SDM, and measured distress and/or health care utilization as outcomes.

Results: A total of 12 studies, detailed in 13 publications, were included: nine randomized trials and three retrospective cohort studies. All studies reported on a supportive care intervention facilitating SDM as part of their intervention. Eight studies described effects on distress, and eight studies measured effects on health care utilization. No effect was found in studies measuring generic distress. Positive effects, in favor of the intervention groups, were observed in studies using anxiety-specific measures (n = 1) or depression-specific measures (n = 3). Evidence for reductions in health care utilization was found in five studies.

Conclusion: Although not supported by all studies, our findings suggest that facilitating SDM in the context of lung cancer may lead to improved emotional outcomes and less aggressive therapies. Future studies, explicitly studying the effects of SDM by using decision aids, are needed to better elucidate potential benefits.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpainsymman.2018.08.011DOI Listing
December 2018

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

J Pediatr Gastroenterol Nutr 2018 12;67(6):726-731

Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

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).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MPG.0000000000002124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282676PMC
December 2018

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

BMC Pediatr 2018 07 31;18(1):249. Epub 2018 Jul 31.

Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12887-018-1231-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069950PMC
July 2018
-->