M. Elske van den Akker-van Marle

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.

Domains of quality of life: results of a three-stage Delphi consensus procedure among patients, family of patients, clinicians, scientists and the general public

PurposeOur 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.MethodsWe 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.ResultsIn 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.ConclusionsIn 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.

Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

Objective To determine women’s satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. Intervention Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. Main outcome measures Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. Results 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference −2.8, 95% confidence interval −6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference −10.4, −13.9 to −7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. Conclusion In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia. Trial registration Netherlands Trial Register NTR2551.

Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.

BACKGROUND CONTEXT Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/SETTING This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patients report of perceived recovery. METHODS Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.

Effects of home-based training with telemonitoring guidance in low to moderate risk patients entering cardiac rehabilitation: short-term results of the FIT@Home study

Background Home-based exercise training in cardiac rehabilitation (CR) has the potential to improve CR uptake, decrease costs and increase self-management skills. The FIT@Home study evaluates home-based CR with telemonitoring guidance using coaching interventions including strategies for behavioural changes with the aim to maintain adherence to a healthy lifestyle and to improve long-term effects. In this interim analysis we provide short-term results on exercise capacity, quality of life and training adherence of the first 50 patients included in the FIT@Home study. Design The study design was a randomised controlled trial. Methods Low to moderate risk CR patients were randomised to a 12-week home-based training (HT) programme or a 12-week centre-based training (CT) programme. In both groups, training was performed at 70–85% of maximal heart rate (HRmax) for 45–60 min, 2–3 times per week. The HT group received three supervised training sessions, before commencing training with a heart rate monitor in their home environment. These patients received individual coaching by telephone weekly, based on training data uploaded on the Internet. The CT programme was performed under the direct supervision of a physical therapist. Exercise capacity and health-related quality of life were assessed at baseline and at 12 weeks. Results CT (n = 25) and HT (n = 25) both showed a significant improvement in peak oxygen uptake (peak VO2) (10% and 14% respectively) and quality of life after 12 weeks of training, without significant between-group differences. The average training intensity of the HT group was 73.3 ± 3.5% of HRmax. Training adherence was similar between groups. Conclusion This analysis shows that HT with telemonitoring guidance has similar short-term effects on exercise capacity and quality of life as CT in CR patients.

Urethral catheters: can we reduce use?

BackgroundIndwelling 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.MethodsThe 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.ResultsOf 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.ConclusionTargeted 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.

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial.

BackgroundPain 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/designThe 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.DiscussionThis 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 numberDutch Trial Register NTR2551, http://www.trialregister.nl

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomised controlled trial

STUDY QUESTION Is interspinous process device implantation more effective in the short term (eight weeks) than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis? SUMMARY ANSWER The use of interspinous implants did not result in a better outcome than conventional decompression, but the reoperation rate was significantly higher. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Bony decompression and treatment with interspinous process devices are superior to conservative and non-surgical treatment for intermittent neurogenic claudication due to lumbar spinal stenosis. Interspinous implants surgery is not superior to bony decompression, and the reoperation rate is significantly higher.

The Dutch Birth Centre Study: study design of a programmatic evaluation of the effect of birth centre care in the Netherlands

BackgroundBirth centres are regarded as settings where women with uncomplicated pregnancies can give birth, assisted by a midwife and a maternity care assistant. In case of (threatening) complications referral to a maternity unit of a hospital is necessary. In the last decade up to 20 different birth centres have been instituted in the Netherlands. This increase in birth centres is attributed to various reasons such as a safe and easy accessible place of birth, organizational efficiency in integration of care and direct access to obstetric hospital care if needed, and better use of maternity care assistance. Birth centres are assumed to offer increased integration and quality of care and thus to contribute to better perinatal and maternal outcomes. So far there is no evidence for this assumption as no previous studies of birth centres have been carried out in the Netherlands.DesignThe aims are 1) Identification of birth centres and measuring integration of organization and care 2) Measuring the quality of birth centre care 3) Effects of introducing a birth centre on regional quality and provision of care 4) Cost-effectiveness analysis 5) In depth longitudinal analysis of the organization and processes in birth centres.Different qualitative and quantitative methods will be used in the different sub studies. The design is a multi-centre, multi-method study, including surveys, interviews, observations, and analysis of registration data and documents.DiscussionThe results of this study will enable users of maternity care, professionals, policy makers and health care financers to make an informed choice about the kind of birth location that is appropriate for their needs and wishes.

Cost of rheumatic disorders in the Netherlands

Rheumatic disorders concern a broad spectrum of painful disorders affecting the musculoskeletal system, and are responsible for a considerable amount of disease burden and also a substantial economic burden. This economic burden consists of direct and indirect costs, but also the so-called intangible costs. In this study, we estimated the societal cost of rheumatic disorders in the Netherlands, including intangible costs. Data from the National Monitor on Musculoskeletal System 2010 were used to assess resource used, multiplied with standard prices for the Netherlands to obtain total costs for the 1.8 million people suffering from rheumatic disorders. These estimates were supplemented with data from secondary sources. Total societal costs of rheumatic disorders in the Netherlands amount to €4.7 million a year, that is, €2665 per person with rheumatic disorders. Rheumatic disorders have considerable costs, which justify more attention in discussing investments in facing the challenges in our ageing Western societies.