ABSTRACT
Objectives:
Knowledge on long‐term outcomes in patients with Hirschsprung disease is progressing. Nevertheless, differences in outcomes according to aganglionic lengths are unclear. We ...compared long‐term bowel function and generic quality of life in Hirschsprung patients with total colonic or long‐segment versus rectosigmoid aganglionosis.
Methods:
In this nationwide, cross‐sectional study participants with proven Hirschsprung disease received the Defecation and Fecal Continence questionnaire, and the Child Health Questionnaire Child Form‐87, or the WHO Quality of Life‐100. We excluded deceased patients, patients who were younger than 8 years, lived abroad, had a permanent enterostomy, or were intellectually impaired.
Results:
The study population (n = 334) was operated for rectosigmoid (83.9%), long‐segment (8.7%), or total colonic aganglionosis (7.5%). Fecal incontinence in general was not significantly different between the three groups, but liquid fecal incontinence was significantly associated with total colonic aganglionosis (odds ratio OR = 6.00, 95% confidence interval CI 2.07–17.38, P = 0.001). Regarding constipation, patients with total colonic or long‐segment aganglionosis were less likely to suffer from constipation than the rectosigmoid group (OR = 0.21, 95% CI, 0.05–0.91, P = 0.038 and OR = 0.11, 95% CI, 0.01–0.83, P = 0.032). Quality of life was comparable between the three groups, except for a lower physical score in children with total colonic aganglionosis (P = 0.016).
Conclusions:
Over time Hirschsprung patients with total colonic or long‐segment aganglionosis do not suffer from worse fecal incontinence in general. A difference in stool consistency may underlie the association between liquid fecal incontinence and total colonic aganglionosis and constipation in patients with rectosigmoid aganglionosis. Despite these differences, generic quality of life is comparable on reaching adulthood.
Acute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work.
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).
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.
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.
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).
A single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.
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.
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.
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.
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.
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.
•Participation rates in cervical cancer screening are usually estimated using time windows of 15 months or shorter.•The participation rate increases significantly when using a 36-month time ...window.•Younger age, pregnancy, and higher education are associated with delayed participation.
Research has long since confirmed the benefits of regular cervical cancer screening (CCS) worldwide. However, some developed countries have low participation rates despite well-organized screening programs. Given that studies in Europe typically define participation in 12-month windows from an invitation, we evaluated both whether extending this defined time window could reveal the true participation rate and how sociodemographic determinants affect participation delays. This involved linking data from the Lifelines population-based cohort with CCS-related data from the Dutch Nationwide Pathology Databank and including data for 69 185 women eligible for screening in the Dutch CCS program between 2014 and 2018. We then estimated and compared the participation rates for 15- and 36-month time windows and categorized women by the primary screening window into timely participation (within 15 months) and delayed participation (within 15–36 months) groups, before performing multivariable logistic regression to evaluate the association between delayed participation and the sociodemographic determinants. Participation rates for the 15- and 36-month windows were 71.1% and 77.0%, respectively, with participation considered timely in 49 224 cases and delayed in 4047 cases. Delayed participation was associated with age 30–35 years (odds ratio OR: 2.88, 95 %CI: 2.67–3.11), higher education (OR: 1.50, 95 %CI: 1.35–1.67), the high-risk human papillomavirus test-based program (OR: 1.67, 95 %CI: 1.56–1.79), and pregnancy (OR: 4.61, 95 %CI: 3.88–5.48). These findings show that a 36-month window for monitoring attendance at CCS better reflects the actual participation rate by accommodating possible delayed uptake among younger, pregnant, and highly educated women.
We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period.
Randomized ...controlled trial with women (≥55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement.
There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points 95% CI, -6.3 to -0.0; P = 0.05). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively.
In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.
Wound healing and scar formation depends on a plethora of factors. Given the impact of abnormal scar formation, interventions aimed to improve scar formation would be most advantageous. Tissue ...stromal vascular fraction (tSVF) of adipose tissue is composed of a heterogenous mixture of cells embedded in extracellular matrix. It contains growth factors and cytokines involved in wound healing processes, eg, parenchymal proliferation, inflammation, angiogenesis, and matrix remodeling.
In this study, we hypothesized that tSVF reduces post-surgical scar formation.
This prospective, double-blind, placebo-controlled, randomized trial was conducted between 2016 and 2020. Forty mammoplasty patients were enrolled and followed for 1 year. At the end of the mammoplasty procedure, all patients received tSVF in the lateral 5 cm of the horizontal scar of one breast and a placebo injection in the contralateral breast to serve as an intra-patient control. Primary outcome was scar quality using the patient and observer scar assessment scale (POSAS). Secondary outcomes were obtained with photograph evaluation and histological analysis of scar tissue samples.
Thirty-four of 40 patients completed follow-up. Six months postoperatively, injection of tSVF had significantly improved postoperative scar appearance as assessed by POSAS questionnaire (observer and patient questionnaire). No difference was observed at 12 months postoperatively. No improvement was seen based on the evaluation of photographs and histological analysis of postoperative scars between both groups.
Injection of tSVF resulted in improved wound healing and reduced scar formation at 6 months postoperative, without any noticeable advantageous effects seen at 12 months.
The automatic tendency to attend to and focus on substance-related cues in the environment (attentional bias), has been found to contribute to the persistence of addiction. Attentional bias ...modification (ABM) interventions might, therefore, contribute to treatment outcome and the reduction of relapse rates. Based on some promising research findings, we designed a study to test the clinical relevance of ABM as an add-on component of regular intervention for alcohol and cannabis patients.
The current protocol describes a study which will investigate the effectiveness and cost-effectiveness of a newly developed home-delivered, multi-session, internet-based ABM (iABM) intervention as an add-on to treatment as usual (TAU). TAU consists of cognitive behavioural therapy-based treatment according to the Dutch guidelines for the treatment of addiction. Participants (N = 213) will be outpatients from specialized addiction care institutions diagnosed with alcohol or cannabis dependency who will be randomly assigned to one of three conditions: TAU + iABM; TAU + placebo condition; TAU-only. Primary outcome measures are substance use, craving, and rates of relapse. Changes in attentional bias will be measured to investigate whether changes in primary outcome measures can be attributed to the modification of attentional bias. Indices of cost-effectiveness and secondary physical and psychological complaints (depression, anxiety, and stress) are assessed as secondary outcome measures.
This randomized control trial will be the first to investigate whether a home-delivered, multi-session iABM intervention is (cost-) effective in reducing relapse rates in alcohol and cannabis dependency as an add-on to TAU, compared with an active and a waiting list control group. If proven effective, this ABM intervention could be easily implemented as a home-delivered component of current TAU.
Netherlands Trial Register, NTR5497 , registered on 18th September 2015.
To conduct an exploration of the hospital costs of extracorporeal life support therapy. Extracorporeal life support seems an efficient therapy for acute, potentially reversible cardiac or respiratory ...failure, when conventional therapy has been inadequate, or as bridge to transplant, but unfortunately, no evidence in randomized controlled trials is delivered yet.
Single-center retrospective exploratory cohort cost study. The study is performed from a hospital perspective with a time horizon of patients' complete hospital admission in which they received extracorporeal life support.
ICU of a university teaching hospital in The Netherlands.
All 67 consecutive adult patients who were admitted to the ICU of the University Medical Center Groningen in the period 2010-2013 and received extracorporeal life support treatment.
None.
The bottom-up microcosting method was used except when stated otherwise. Medical costs were estimated by multiplying every registered healthcare consumption with unit prices. Unit prices were largely based on Dutch reference prices. For each patient, the personnel costs and material costs were assessed in detail. The costs of extracorporeal life support were differentiated in costs of procedures and costs of daily surcharge of therapy. Procedure-related costs were subdivided in costs of devices and disposables, costs of additional human resources, and surgery hours. The mean total hospital costs were € 106.263 (€ 83.841 to € 126.266) per patient ($145,580). On average, 52% of the total costs arose from hospital nursing days and 11% of direct procedure-related extracorporeal life support costs. Surgery and diagnostics represented a vast amount of the remaining costs.
This large and detailed economic evaluation of hospital costs of extracorporeal life support therapy in the Netherlands showed that mean total hospital cost of extracorporeal life support treatment is € 106.263 per patient. The majority of the costs are composed of nursing days.
Objectives
There are several instruments to assess health‐related quality of life (HRQoL) in chronic rhinosinusitis (CRS). Unfortunately, none of them evaluates all three health domains (physical, ...social and psychological) important to assess the overall well‐being of the patient. The Endoscopic Endonasal Sinus and Skull Base Surgery Questionnaire (EES‐Q) does assess all these elements. Initially, the EES‐Q is validated to evaluate the impact of endoscopic endonasal surgery (EES) on HRQoL. The aim of this study is to assess whether EES‐Q outcomes differ in patients with CRS compared with healthy individuals. Therefore, extending the use of the EES‐Q for all CRS patients.
Design
Cross‐sectional study.
Setting
Tertiary referral hospital.
Participants
One hundred patients with uncontrolled CRS (50% with nasal polyps) scheduled to receive EES. The questionnaire was completed preoperatively. Healthy control subjects (n = 100) without any history of sinusitis or a known current medical treatment at a hospital were included.
Main outcome measures
Mann–Whitney U test was performed to identify differences in EES‐Q scores (domain scores and EES‐Q score).
Results
The median EES‐Q score in CRS patients (33.8) was significantly higher (p < 0.001) than in the control group (10.4). As well as the physical (52.5 vs. 16.4, p < 0.001), psychological (13.8 vs. 5.0, p < 0.001) and social (37.5 vs. 2.5, p < 0.001) domain scores.
Conclusions
With this study, we are extending the use of the EES‐Q. It indicates that the EES‐Q can be a valuable clinical tool to assess multidimensional HRQoL in all patients with CRS.
In child and youth care, quantitative estimates of the impact of serious behaviour problems have not yet been made. Such input is needed to support decision making on investments in treatment. The ...aim of this paper was to elicit valuations of social and conduct disorders in children and adolescents from three different perspectives: professionals, youth, and parents.
We obtained valuations from 25 youth care professionals, 50 children (age 9-10) without serious behaviour problems and 36 adolescents (age 16-17) with and without serious behaviour disorders, and 46 parents with children in the aforementioned age categories. Valuations were estimated from 18 descriptions of behaviour disorders in youth aged 9 and 15 years. Descriptions included Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), and Disruptive Behaviour Disorder (DBD). Comorbid conditions were Attention Deficit Hyperactivity Disorder and substance abuse. Valuations were obtained with the EuroQol questionnaire (EQ-5D-3 L) and a visual analogue scale (VAS).
Valuations were generally severe; problems were by and large reported to worsen quality of life by 50% compared to being fully healthy. Professionals regarded DBD with substance abuse as most severe (VAS values 0.41 for children, and 0.43 for adolescents, i.e. less than half of normal). They rated ODD as least severe (VAS values 0.58 for children, 0.59 for adolescents). Children, adolescents and parents gave lower valuations than professionals, and had a wider range of scores, particularly at the lower end of the scale.
Behaviour disorders pose a formidable burden from the perspectives of professionals as well as children, adolescents and parents. These results may support medical decision making to set priorities with regard to prevention and treatment based on perceived severity.