Introduction: This study was set up to investigate if and to what extent non-pharmacological analgesia is able to provide comfort to very preterm infants (VPI) during less invasive surfactant... Show moreIntroduction: This study was set up to investigate if and to what extent non-pharmacological analgesia is able to provide comfort to very preterm infants (VPI) during less invasive surfactant administration (LISA). Methods: This was a prospective non-randomized multicenter observational study performed in level IV NICUs. Inborn VPI with a gestational age between 220/7 and 316/7 weeks, signs of respiratory distress syndrome, and the need for surfactant replacement were included. Non-pharmacological analgesia was performed in all infants during LISA. In case of failure of the first LISA attempt, additional analgosedation could be administered. COMFORTneo scores during LISA were assessed. Results: 113 VPI with a mean gestational age of 27 weeks (+/− 2.3 weeks) and mean birth weight of 946 g (+/− 33 g) were included. LISA was successful at the first laryngoscopy attempt in 81%. COMFORTneo scores were highest during laryngoscopy. At this time point, non-pharmacological analgesia provided adequate comfort in 61% of the infants. 74.4% of lower gestational aged infants (i.e., 220–266 weeks) were within the comfort zone during laryngoscopy compared to 51.6% of higher gestational aged infants (i.e., 270–320 weeks) (p = 0.016). The time point of surfactant administration did not influence the COMFORTneo scores during the LISA procedure. Conclusion: Non-pharmacological analgesia provided comfort in as much as 61% of the included VPI during LISA. Further research is needed to both develop strategies to identify infants who, despite receiving non-pharmacological analgesia, are at high risk for experiencing discomfort during LISA and define patient-tailored dosage and choice of analgosedative drugs. Show less
Melisse, B.; Blankers, M.; Berg, E. van den; Jonge, M. de; Lommerse, N.; Furth, E. van; ... ; Beurs, E. de 2023
IntroductionThe aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder ... Show moreIntroductionThe aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder (BED) to a waiting list control condition. MethodsBED patients (N = 212) were randomly assigned to guided self-help CBT-E or the 3-month waiting list. Measurements took place at baseline and the end-of-treatment. The cost-effectiveness analysis was performed using the number of binge-eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost-utility analysis was performed using the EuroQol-5D. ResultsThe difference in societal costs over the 3 months of the intervention between both conditions was euro679 (confidence interval [CI] 50-1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self-help condition was approximately euro18 (CI 1-41). From a societal perspective there was a 96% likelihood that guided self-help CBT-E led to a greater number of binge-eating episodes prevented, but at higher costs. Each additional quality-adjusted life year (QALY) gained was associated with incremental costs of euro34,000 (CI 2494-154,530). With a 95% likelihood guided self-help CBT-E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness-to-pay threshold of euro35,000 per QALY, guided self-help CBT-E can be considered cost-effective with a likelihood of 95% from a societal perspective. DiscussionGuided self-help CBT-E is likely a cost-effective treatment for BED in the short-term (3-month course of treatment). Comparison to treatment-as-usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. Public SignificanceOffering treatment remotely has several benefits for patients suffering from binge-eating disorders. Guided self-help CBT-E is an efficacious and likely cost-effective treatment, reducing binge eating and improving quality-of-life, albeit at higher societal costs. Show less
Melisse, B.; Blankers, M.; Berg, E. van den; Jonge, M. de; Lommerse, N.; Furth, E. van; ... ; Beurs, E. de 2023
Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to... Show moreBackground: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.Objective: The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Show less
ObjectiveApplication of a face mask may provoke the trigeminocardiac reflex, leading to apnoea and bradycardia. This study investigates whether re-application of a face mask in preterm infants at... Show moreObjectiveApplication of a face mask may provoke the trigeminocardiac reflex, leading to apnoea and bradycardia. This study investigates whether re-application of a face mask in preterm infants at birth alters the risk of apnoea compared with the initial application, and identify factors that influence this risk. MethodsResuscitation videos and respiratory function monitor data collected from preterm infants ResultsIn total, 111 infants were included with 404 mask applications (102 initial and 302 subsequent mask applications). In 254/404 (63%) applications, infants were breathing prior to mask application, followed by apnoea after 67/254 (26%) mask applications. Apnoea and bradycardia occurred significantly more often after the initial mask application compared with subsequent applications (apnoea initial: 32/67 (48%) and subsequent: 44/187 (24%), p<0.001; bradycardia initial: 61% and subsequent 21%, p<0.001). Apnoea was followed by bradycardia in 73% and 71% of the initial and subsequent mask applications, respectively (p=0.607).In a logistic regression model, a lower breathing rate (OR 0.908 (95% CI 0.847 to 0.974), p=0.007) and heart rate (OR 0.935 (95% CI 0.901 to 0.970), p<0.001) prior to mask application were associated with an increased likelihood of becoming apnoeic following subsequent mask applications. ConclusionIn preterm infants at birth, apnoea and bradycardia occurs more often after an initial mask application than subsequent applications, with lower heart and breathing rates increasing the risk of apnoea in subsequent applications. Show less
Melisse, B.; Dekker, J.; Berg, E. van den; Jonge, M. de; Furth, E.F. van; Peen, J.; Beurs, E. de 2023
Introduction: Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among... Show moreIntroduction: Cognitive behaviour therapy-enhanced (CBT-E) is an effective treatment for non-underweight patients with eating disorders. Its efficacy and effectiveness is investigated mostly among transdiagnostic samples and remains unknown for binge eating disorder. The aim of present study was to assess several treatment outcome predictors and to compare effectiveness of CBT-E among adult outpatients with bulimia nervosa (N=370), binge eating disorder (N=113), and those with a restrictive food pattern diagnosed with other specified feeding and eating disorder (N=139).Method: Effectiveness of CBT-E was assessed in routine clinical practice in a specialised eating disorders centre. Eating disorder pathology was measured with the EDE-Q pre- and post-treatment, and at 20 weeks follow-up. Linear mixed model analyses with fixed effect were performed to compare treatment outcome among the eating disorder groups. Several predictors of treatment completion and outcome were examined with a regression analysis.Results: No predictors for drop-out were found, except the diagnosis of bulimia nervosa. Eating disorder pathology decreased among all groups with effect sizes between 1.43-1.70 on the EDE-Q total score. There were no differences in remission rates between the three groups at end of treatment or at follow-up. Eating disorder severity at baseline affected treatment response.Discussion: The results can be generalised to other specialised treatment centres. No subgroup of patients differentially benefited from CBT-E supporting the transdiagnostic perspective for the treatment of eating disorders. Longer-term follow-up data are necessary to measure persistence of treatment benefits. Show less
ObjectiveTo compare the effect of two different automated oxygen control devices on time preterm infants spent in different oxygen saturation (SpO(2)) ranges during their entire stay in the... Show moreObjectiveTo compare the effect of two different automated oxygen control devices on time preterm infants spent in different oxygen saturation (SpO(2)) ranges during their entire stay in the neonatal intensive care unit (NICU). DesignRetrospective cohort study of prospectively collected data. SettingTertiary level neonatal unit in the Netherlands. PatientsPreterm infants (OxyGenie 75 infants, CLiO2 111 infants) born at 24-29 weeks' gestation receiving at least 72 hours of respiratory support between October 2015 and November 2020. InterventionsInspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) between February 2019 and November 2020 and the CLiO2 controller (AVEA ventilator) between October 2015 and December 2018 as standard of care. Main outcome measuresTime spent within SpO(2) target range (TR, 91-95% for either epoch) and other SpO(2) ranges. ResultsTime spent within the SpO(2) TR when receiving supplemental oxygen was higher during OxyGenie control (median 71.5 [IQR 64.6-77.0]% vs 51.3 [47.3-58.5]%, p<0.001). Infants under OxyGenie control spent less time in hypoxic and hyperoxic ranges (SpO(2)<80%: 0.7 [0.4-1.4]% vs 1.2 [0.7-2.3]%, p98%: 1.0 [0.5-2.4]% vs 4.0 [2.0-7.9]%, p<0.001). Both groups received a similar FiO(2) (29.5 [28.0-33.2]% vs 29.6 [27.7-32.1]%, p=not significant). ConclusionsOxygen saturation targeting was significantly different in the OxyGenie epoch in preterm infants, with less time in hypoxic and hyperoxic SpO(2) ranges during their stay in the NICU. Show less
Beurs, E. de; Rademacher, C.; Peen, J.; Blankers, M.; Dekker, J. 2023
Very preterm infants are a unique and highly vulnerable group of patients that have a narrow physiological margin within which interventions are safe and effective. The increased understanding of... Show moreVery preterm infants are a unique and highly vulnerable group of patients that have a narrow physiological margin within which interventions are safe and effective. The increased understanding of the foetal to neonatal transition marks the intricacy of the rapid and major physiological changes that take place, making delivery room stabilisation and resuscitation an increasingly complex and sophisticated activity for caregivers to perform. While modern, automated technologies are pro-gressively implemented in the neonatal intensive care unit (NICU) to enhance the caregivers in providing the right care for these patients, the technology in the delivery room still lags far behind. Diligent translation of well-known and promising technological solutions from the NICU to the delivery room will allow for better support of the caregivers in performing their tasks. In this review we will discuss the current technology used for stabilisation of preterm infants in the delivery room and how this could be optimised in order to further improve care and outcomes of preterm infants in the near future. Show less
Very preterm infants are a unique and highly vulnerable group of patients that have a narrow physiological margin within which interventions are safe and effective. The increased understanding of... Show moreVery preterm infants are a unique and highly vulnerable group of patients that have a narrow physiological margin within which interventions are safe and effective. The increased understanding of the foetal to neonatal transition marks the intricacy of the rapid and major physiological changes that take place, making delivery room stabilisation and resuscitation an increasingly complex and sophisticated activity for caregivers to perform. While modern, automated technologies are pro-gressively implemented in the neonatal intensive care unit (NICU) to enhance the caregivers in providing the right care for these patients, the technology in the delivery room still lags far behind. Diligent translation of well-known and promising technological solutions from the NICU to the delivery room will allow for better support of the caregivers in performing their tasks. In this review we will discuss the current technology used for stabilisation of preterm infants in the delivery room and how this could be optimised in order to further improve care and outcomes of preterm infants in the near future. Show less
O'Donnell, C.P.F.; Dekker, J.; Rudiger, M.; Pas, A.B. te 2022
Despite increased amounts of research, most of the evidence that supports treatment of newborns in the delivery room is rated 'low' rather than 'high' quality. This assessment stems largely from a... Show moreDespite increased amounts of research, most of the evidence that supports treatment of newborns in the delivery room is rated 'low' rather than 'high' quality. This assessment stems largely from a lack of evidence from clinical trials. When trials have been performed, the evidence has often been downgraded due to enrolment of small or poorly representative samples, and for lack of blinding of caregivers and outcome assessors. Delivery room trials present particular challenges when obtaining consent, enrolling participants, taking measures to limit bias and identifying appropriate outcome measures. We hope our suggestions as to how future delivery room trials could be more pragmatic will inform the design of large studies that are necessary to allow clinical practice to evolve. Show less
Beurs E. de; Blankers, M.; Peen, J.; Rademacher, C.; Podgorski, A.; Dekker, J. 2022
OBJECTIVE\nMETHOD\nRESULTS\nDISCUSSION\nThe uptake of digital interventions in mental health care (MHC) has been slow, as many therapists and patients believe that in-person contact is essential... Show moreOBJECTIVE\nMETHOD\nRESULTS\nDISCUSSION\nThe uptake of digital interventions in mental health care (MHC) has been slow, as many therapists and patients believe that in-person contact is essential for establishing a good working relationship and good outcomes in treatment. The public health policies regarding social distancing during the coronavirus disease-2019 (COVID-19) pandemic forced an abrupt transformation of MHC provisions for outpatients: Since mid-March 2020, nearly all in-person contact was replaced with videoconferencing. The COVID-19 crisis offered a unique opportunity to investigate whether MHC with videoconferencing yields inferior results as compared to in-person interventions.\nIn a large urban MHC facility in the Netherlands, measurement-based care is routine practice. Outcome data are regularly collected to support shared decision making and monitor patient progress. For this study, pretest and post-test data were used to compare outcomes for three cohorts: treatments performed prior to, partially during and entirely during the COVID-19 lockdown. Outcomes were compared in two large data sets: Basic MHC (N = 1392) and Specialized MHC (N = 1040).\nTherapeutic outcomes appeared robust for COVID-19 conditions across the three cohorts: No differences in outcomes were found between treatments that were conducted during lockdown compared to in-person treatments prior to COVID-19, or treatments which started in-person, but needed to be continued by means of videoconferencing.\nVideoconferencing care during the COVID-19 pandemic had similar outcomes compared to traditional in-person care. These real-world results corroborate findings of previous randomized controlled studies and meta-analyses in which videoconferencing and in-person care has been directly compared in terms of clinical effectiveness. Show less
Question: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup,... Show moreQuestion: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? Design: Pragmatic cluster randomised controlled trial in a primary care setting. Participants: A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. Intervention: Physiotherapy practices were randomised into an experimental arm providing stratified ex-ercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. Outcome measures: Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. Results: Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. Conclusion: This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. Registration: Netherlands National Trial Register NL7463. [Knoop J, Dekker J, van Dongen JM, van der Leeden M, de Rooij M, Peter WFH, de Joode W, van Bodegom-Vos L, Lopuhaa N, Bennell KL, Lems WF, van der Esch M, Vliet Vlieland TPM, Ostelo RWJG (2022) Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial. Journal of Physiotherapy 68:182-190] (c) 2022 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Show less
Background: Internationally recognized guidelines recommend the judicious use of low oxygen (21-30%), titrated to peripheral oxygen saturation targets, for the initiation of re- suscitation of very... Show moreBackground: Internationally recognized guidelines recommend the judicious use of low oxygen (21-30%), titrated to peripheral oxygen saturation targets, for the initiation of re- suscitation of very and extremely preterm infants (<32 weeks' gestation). However, despite more than 10 randomized controlled trials on this question, the ideal initial oxygen concentration for this group of vulnerable infants remains uncertain. Aims: This study aims to assess the effect of various initial oxygen concentrations on (1) all-cause mortality, chronic lung disease, intraventricular hemorrhage, and retinopathy of prematurity; and (2) reaching the prescribed oxygen saturation targets by 5 min after birth, in preterm infants requiring resuscitation. Methods: We will conduct a system- atic review and network meta-analysis using individual participant data. Studies of preterm infants <32 weeks' gestation, randomized to initial oxygen concentration, will be included. We will systematically search medical databases and trial registriesfor eligible studies (published or unpublished). Records will be screened by two independent reviewers, with conflicts resolved by the inclusion of a third reviewer. Identified initial oxygen concentrations will be grouped into the following nodes: low (<= 30%), intermediate (60%), and high (>= 90%) oxygen. A two-step random-effects contrastbased network meta-regression will be calculated to compare and rank different oxygen concentrations. Analyses will be intention-to-treat, with the primary outcome of all-cause mortality. Discussion: This is the first individual participant data network meta-analysis of initial oxygen concentrations for the resuscitation of preterm infants. This novel approach may address long-standing uncertainty regarding optimal oxygen supplementation practice for the resuscitation of preterm infants <32 weeks' gestation. (C) 2022 S. Karger AG, Basel Show less
Melisse, B.; Berg, E. van den; Jonge, M. de; Blankers, M.; Furth, E. van; Dekker, J.; Beurs, E. de 2022
Background: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to... Show moreBackground: Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy–enhanced (CBT-E) may have great advantages for patients if its efficacy can be established.Objective: The aim of this study is to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition.Methods: A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90) or the delayed-treatment control condition (n=90) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination–Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions.Results: During the last 4 weeks of treatment, objective binges reduced from an average of 19 (16) to 3 (5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between groups. Of the 180 participants, 142 (78.9%) completed treatment. Overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition.Conclusions: This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study’s findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Show less
Background: Large amounts of data are collected in neonatal intensive care units, which could be used for research. It is unclear whether these data, usually sampled at a lower frequency, are... Show moreBackground: Large amounts of data are collected in neonatal intensive care units, which could be used for research. It is unclear whether these data, usually sampled at a lower frequency, are sufficient for retrospective studies. We investigated what to expect when using one-per-minute data for descriptive statistics. Methods: One-per-second inspiratory oxygen and saturation were processed to one-per-minute data and compared, on average, standard deviation, target range time, hypoxia, days of supplemental oxygen, and missing signal. Results: Outcomes calculated from data recordings (one-per-minute = 92, one-per-second = 92) showed very little to no difference. Sub analyses of recordings under 100 and 200 h showed no difference. Conclusion: In our study, descriptive statistics of one-per-minute data were comparable to one-per-second and could be used for retrospective analyses. Comparable routinely collected one-per-minute data could be used to develop algorithms or find associations, retrospectively. Show less
Dekker, J.; Dongen, J.J.M. van; Reinders, M.J.T.; Khatri, I. 2022
The IMGT database profiles the TR germline alleles for all four TR loci (TRA, TRB, TRG and TRD), however, it does not comprise of the information regarding population specificity and allelic... Show moreThe IMGT database profiles the TR germline alleles for all four TR loci (TRA, TRB, TRG and TRD), however, it does not comprise of the information regarding population specificity and allelic frequencies of these germline alleles. The specificity of allelic variants to different human populations can, however, be a rich source of information when studying the genetic basis of population-specific immune responses in disease and in vaccination. Therefore, we meticulously identified true germline alleles enriched with complete TR allele sequences and their frequencies across 26 different human populations, profiled by "1000 Genomes data". We identified 205 TRAY, 249 TRBV, 16 TRGV and 5 TRDV germline alleles supported by at least four haplotypes. The diversity of germline allelic variants in the TR loci is the highest in Africans, while the majority of the Non-African alleles are specific to the Asian populations, suggesting a diverse profile of TR germline alleles in different human populations. Interestingly, the alleles in the IMGT database are frequent and common across all five super-populations. We believe that this new set of germline TR sequences represents a valuable new resource which we have made available through the new population-matched TR (pmTR) database, accessible via https://pmtrig.lumc.nl/. Show less
