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1.  A comprehensive representation of the birth-experience: identification and prioritization of birth-specific domains based on a mixed-method design 
Background
In obstetrics, effectiveness and cost-effectiveness studies often present several specific outcomes with likely contradicting results and may not reflect what is important for women. A birth-specific outcome measure that combines the core domains into one utility score would solve this problem. The aim of this study was to investigate which domains are most relevant for women’s overall experience of labor and birth and should be included in such a measure.
Methods
A sequential mixed-method design with three steps was applied. First, the domains were identified by literature review and online focus groups consisting of pregnant women, women who recently gave birth, and their partners. Second, in a prioritizing task, women who recently gave birth and professionals (midwives, gynecologists, and researchers) selected and ranked their top seven domains. Third, the domains that were most frequently selected and had the highest ranking scores determined the basis for a consensus discussion with experts, whereby the definitive list of domains was formed.
Results
In the first step, 34 birth-specific domains were identified, which cover domains regarding the caregivers, intrapersonal aspects of the mother, partner support, and contextual and medical aspects of birth. Based on the prioritizing task results (step 2) of 96 women and 89 professionals, this list was reduced to 14 most relevant domains. In a consensus discussion, the final seven domains were selected by combining several of the 14 remaining domains and giving priority to the domains indicated to be relevant by mothers. The seven definite domains were: 1) availability of competent health professionals; 2) health professionals’ support; 3) provision of information; 4) health professionals’ response to needs and requests; 5) feelings of safety; 6) worries about the child’s health; and 7) experienced duration until the first contact with the child.
Conclusions
The experienced availability and quality of received care, concerns about safety and the baby’s health, and first contact with the baby are regarded as key aspects for a mother’s overall birth experience. Therefore, these domains are considered to be the most crucial for inclusion in a birth-specific outcome measure.
doi:10.1186/1471-2393-14-147
PMCID: PMC4021407  PMID: 24758274
Labor and birth experience; Utility measure; Patient-reported outcomes; Questionnaire; Cost-effectiveness
2.  De-implementation of expensive blood saving measures in hip and knee arthroplasties: study protocol for the LISBOA-II cluster randomized trial 
Background
Despite evidence that erythropoietin and intra- and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands, Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion. To actually change physicians’ practice, a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed. The study aims to examine the effectiveness, feasibility and costs of this tailored de-implementation strategy compared to a control strategy.
Methods/Design
A cluster randomized controlled trial including an effect, process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals. Randomisation takes place at hospital level. The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components: interactive education, feedback in educational outreach visits, electronically sent reports on hospital performance (all aimed at orthopedic surgeons and anesthesiologists), and information letters or emails aimed at other involved professionals within the intervention hospital (transfusion committee, OR-personnel, pharmacists). The hospitals in the control group will receive a control strategy (i.e., passive dissemination of available evidence). Outcomes will be measured at patient level, using retrospective medical record review. This will be done in all hospitals at baseline and after completion of the intervention period. The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied. The actual exposure to the tailored strategy and users’ experiences will be assessed in the process evaluation. In the economic evaluation, the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared.
Discussion
This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy. This knowledge can be used in national and international initiatives to make healthcare more efficient. It also provides more generalized knowledge regarding de-implementation strategies.
Trial registration
This trial is registered at the Dutch Trial Register NTR4044.
doi:10.1186/1748-5908-9-48
PMCID: PMC4049434  PMID: 24755214
Hip/knee arthroplasties; Blood transfusion; Patient blood management; Blood saving measures; De-implementation
3.  Domains of quality of life: results of a three-stage Delphi consensus procedure among patients, family of patients, clinicians, scientists and the general public 
Quality of Life Research  2013;23(5):1543-1556.
Purpose
Our key objective is to identify the core domains of health-related quality of life (QoL). Health-related QoL utility scales are commonly used in economic evaluations to assess the effectiveness of health-care interventions. However, health-care interventions are likely to affect QoL in a broader sense than is quantifiable with traditional scales. Therefore, measures need to go beyond these scales. Unfortunately, there is no consensus in the scientific literature on the essential domains of QoL.
Methods
We conducted a three-stage online Delphi consensus procedure to identify the key domains of health-related QoL. Five stakeholder groups (i.e., patients, family of patients, clinicians, scientists and general public) were asked, on three consecutive occasions, what they perceive as the most important domains of health-related QoL. An analysis of existing (health-related) QoL and well-being measurements formed the basis of the Delphi-procedure.
Results
In total, 42 domains of QoL were judged, covering physical, mental and social aspects. All participants rated ‘self-acceptance’, ‘self-esteem’ and ‘good social contacts’ as essential. Strikingly, mental and social domains are perceived as more essential than physical domains across stakeholders groups.
Conclusions
In traditionally used health-related QoL utility measures, physical domains like ‘mobility’ are prominently present. The Delphi-procedure shows that health-related QoL (utility) scales need to put sufficient emphasis on mental and social domains to capture aspects of QoL that are essential to people.
doi:10.1007/s11136-013-0578-3
PMCID: PMC4031380  PMID: 24241818
Quality of life; Delphi technique; Quality of health care; Cost–benefit analysis
4.  Effects and costs of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: The FIT@Home study 
Background
Physical training has beneficial effects on exercise capacity, quality of life and mortality in patients after a cardiac event or intervention and is therefore a core component of cardiac rehabilitation. However, cardiac rehabilitation uptake is low and effects tend to decrease after the initial rehabilitation period. Home-based training has the potential to increase cardiac rehabilitation uptake, and was shown to be safe and effective in improving short-term exercise capacity. Long-term effects on physical fitness and activity, however, are disappointing. Therefore, we propose a novel strategy using telemonitoring guidance based on objective training data acquired during exercise at home. In this way, we aim to improve self-management skills like self-efficacy and action planning for independent exercise and, consequently, improve long-term effectiveness with respect to physical fitness and physical activity. In addition, we aim to compare costs of this strategy with centre-based cardiac rehabilitation.
Methods/design
This randomized controlled trial compares a 12-week telemonitoring guided home-based training program with a regular, 12-week centre-based training program of equal duration and training intensity in low to moderate risk patients entering cardiac rehabilitation after an acute coronary syndrome or cardiac intervention. The home-based group receives three supervised training sessions before they commence training with a heart rate monitor in their home environment. Participants are instructed to train at 70-85% of their maximal heart rate for 45–60 minutes, twice a week. Patients receive individual coaching by telephone once a week, based on measured heart rate data that are shared through the internet. Primary endpoints are physical fitness and physical activity, assessed at baseline, after 12 weeks and after one year. Physical fitness is expressed as peak oxygen uptake, assessed by symptom limited exercise testing with gas exchange analysis; physical activity is expressed as physical activity energy expenditure, assessed by tri-axial accelerometry and heart rate measurements. Secondary endpoints are training adherence, quality of life, patient satisfaction and cost-effectiveness.
Discussion
This study will increase insight in long-term effectiveness and costs of home-based cardiac rehabilitation with telemonitoring guidance. This strategy is in line with the trend to shift non-complex healthcare services towards patients’ home environments.
Trial registration
Dutch Trial Register: NTR3780. Clinicaltrials.gov register: NCT01732419
doi:10.1186/1471-2261-13-82
PMCID: PMC3851796  PMID: 24103384
Cardiac rehabilitation; Home-based training; Telemonitoring; Physical fitness; Physical activity
5.  Implementation of a cost-effective strategy to prevent neonatal early-onset group B haemolytic streptococcus disease in the Netherlands 
Background
Early-onset Group B haemolytic streptococcus infection (EOGBS) is an important cause of neonatal morbidity and mortality in the first week of life. Primary prevention of EOGBS is possible with intra-partum antibiotic prophylaxis (IAP.) Different prevention strategies are used internationally based on identifying pregnant women at risk, either by screening for GBS colonisation and/or by identifying risk factors for EOGBS in pregnancy or labour. A theoretical cost-effectiveness study has shown that a strategy with IAP based on five risk factors (risk-based strategy) or based on a positive screening test in combination with one or more risk factors (combination strategy) was the most cost-effective approach in the Netherlands. IAP for all pregnant women with a positive culture in pregnancy (screening strategy) and treatment in line with the current Dutch guideline (IAP after establishing a positive culture in case of pre-labour rupture of membranes or preterm birth and immediate IAP in case of intra-partum fever, previous sibling with EOGBS or GBS bacteriuria), were not cost-effective. Cost-effectiveness was based on the assumption of 100% adherence to each strategy. However, adherence in daily practice will be lower and therefore have an effect on cost-effectiveness.
Method/Design
The aims are to: a.) implement the current Dutch guideline, the risk-based strategy and the combination strategy in three pilot regions and b.) study the effects of these strategies in daily practice. Regions where all the care providers in maternity care implement the allocated strategy will be randomised. Before the introduction of the strategy, there will be a pre-test (use of the current guideline) involving 105 pregnant women per region. This will be followed by a post-test (use of the allocated strategy) involving 315 women per region. The outcome measures are: 1.) adherence to the specific prevention strategy and the determinants of adherence among care providers and pregnant women, 2.) outcomes in pregnant women and their babies and 3.) the costs of each strategy in relation to the effects.
Discussion
This study will provide recommendations for the implementation of the most cost-effective prevention strategy for EOGBS in the Netherlands on the basis of feasibility in daily practice.
Trial registration
Dutch Trial Register, NTR3965
doi:10.1186/1471-2393-13-155
PMCID: PMC3733882  PMID: 23899463
Early-onset Group B streptococcus; Prevention; Dutch maternity care; Implementation; Guidelines
6.  Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial 
Background
Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.
Methods/design
The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.
Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.
Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.
The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.
Discussion
This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day.
Trial registration number
Dutch Trial Register NTR2551, http://www.trialregister.nl
doi:10.1186/1471-2393-12-63
PMCID: PMC3464937  PMID: 22748068
Analgesia; Labour; Remifentanil; Patient controlled analgesia; Epidural
7.  Urethral catheters: can we reduce use? 
BMC Urology  2011;11:10.
Background
Indwelling urinary catheters are the main cause of healthcare-associated urinary tract infections. It can be expected that reduction of the use of urinary catheters will lead to decreased numbers of urinary tract infection.
Methods
The efficacy of an intervention programme to improve adherence to recommendations to reduce the use of urethral catheters was studied in a before-after comparison in ten Dutch hospitals. The programme detected barriers and facilitators and each individual facility was supported with developing their own intervention strategy. Outcome was evaluated by the prevalence of catheters, alternatives such as diapers, numbers of urinary tract infections, the percentage of correct indications and the duration of catheterization. The costs of the implementation as well as the catheterization were evaluated.
Results
Of a population of 16,495 hospitalized patients 3335 patients of whom 2943 were evaluable for the study, had a urethral catheter. The prevalence of urethral catheters decreased insignificantly in neurology (OR 0.93; 95% CI 0.77 - 1.13) and internal medicine wards (OR 0.97; 95% CI 0.83 - 1.13), decreased significantly in surgical wards (OR 0.84; 95% CI 0.75 - 0.96), but increased significantly in intensive care (IC) and coronary care (CC) units (OR 1.48; 95% CI 1.01 - 2.17). The use of alternatives was limited and remained so after the intervention. Duration of catheterization decreased insignificantly in IC/CC units (ratio after/before 0.95; 95% CI 0.78 - 1.16) and neurology (ratio 0.97; 95% CI 0.80 - 1.18) and significantly in internal medicine (ratio 0.81; 95% CI 0.69 - 0.96) and surgery wards (ratio 0.80; 95% CI 0.71 - 0.90). The percentage of correct indications on the day of inclusion increased from 50 to 67% (p < 0.0001). The prevalence of urinary tract infections in catheterized patients did not change. The mean cost saved per 100 patients was € 537.
Conclusion
Targeted implementation of recommendations from an existing guideline can lead to better adherence and cost savings. Especially, hospitals which use a lot of urethral catheters or where catheterization is prolonged, can expect important improvements.
doi:10.1186/1471-2490-11-10
PMCID: PMC3121730  PMID: 21605403
8.  Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial 
Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis.
Design Randomized controlled trial.
Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.
Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized.
Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression.
Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time.
Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001).
Conclusions This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional “simple” decompression and even showed a fairly high reoperation rate after interspinous process device implantation.
Trial registration Dutch Trial Register NTR1307.
doi:10.1136/bmj.f6415
PMCID: PMC3898636  PMID: 24231273

Results 1-8 (8)