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Background: Standardized risk assessment tools can be used to identify patients at higher risk for postoperative complications and death. In this study, we validate the PreOperative Score to predict Post-Operative Mortality (POSPOM) for in-hospital mortality in a large cohort of non-cardiac surgery patients. In addition, the performance of POSPOM to predict postoperative complications was studied. Methods: Data from the control cohort of the TRACE (routine posTsuRgical Anesthesia visit to improve patient outComE) study was analysed. POSPOM scores for each patient were calculated post-hoc. Observed in-hospital mortality was compared with predicted mortality according to POSPOM. Discrimination was assessed by receiver operating characteristic curves with C-statistics for in-hospital mortality and postoperative complications. To describe the performance of POSPOM sensitivity, specificity, negative predictive values, and positive predictive values were calculated. For in-hospital mortality, calibration was assessed by a calibration plot. Results: In 2490 patients, the observed in-hospital mortality was 0.5%, compared to 1.3% as predicted by POSPOM. 27.1% of patients had at least one postoperative complication of which 22.4% had a major complication. For in-hospital mortality, POSPOM showed strong discrimination with a C-statistic of 0.86 (95% CI, 0.78–0.93). For the prediction of complications, the discrimination was poor to fair depending on the severity of the complication. The calibration plot showed poor calibration of POSPOM with an overestimation of in-hospital mortality. Conclusion: Despite the strong discriminatory performance, POSPOM showed poor calibration with an overestimation of in-hospital mortality. Performance of POSPOM for the prediction of any postoperative complication was poor but improved according to severity. [ABSTRACT FROM AUTHOR]

Background: The cesarean section (CS) rate has increased over recent decades with poor guideline adherence as a possible cause. The objective of this study was to explore barriers and facilitators for delivering optimal care as described in clinical practice guidelines.Methods: Key recommendations from evidence-based guidelines were used as a base to explore barriers and facilitators for delivering optimal CS care in The Netherlands. Both focus group and telephone interviews among 29 different obstetrical professionals were performed. Transcripts from the interviews were analysed. Barriers and facilitators were identified and categorised in six domains according to the framework developed by Grol: the guideline recommendations (I), the professional (II), the patient (III), the social context (IV), the organizational context (V) and the financial/legislation context (VI).Results: Most barriers were found in the professional and organizational domain. Barriers mentioned by healthcare professionals were disagreement with specific guideline recommendations, and hesitation to allow women to be part of the decision making process. Other barriers are lack of adequately trained personal staff, lack of collaboration between professionals, and lack of technical equipment.Conclusions: Clear facilitators and barriers for guideline adherence were identified in all domains. Several barriers may be addressed by using decision aids on mode of birth or prediction models to individualise care in women in whom both planned vaginal birth and CS are equal options. In women with an intended vaginal birth, adequate staffing and the availability of both fetal blood sampling and epidural analgesia are important. [ABSTRACT FROM AUTHOR]

Background: Approximately 25% of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score =66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP. Methods/Design: The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period. Discussion: Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a common health problem and a substantial part of LBP is presumed to be attributable to degeneration of the intervertebral disc. For patients suffering from intractable discogenic LBP, there are few evidence-based effective interventional treatment options available. In 2010, the results of a randomized controlled trial (RCT) were published concerning "intradiscal methylene blue injection" (IMBI), in which this intervention appeared to be very successful in relieving discogenic pain. Therefore, we decided to repeat this study to investigate whether we could replicate the published results. The results of our preliminary feasibility study gave reason to set up an RCT. The aim of this RCT is to evaluate if IMBI is a more effective treatment of discogenic low back pain as an intradiscal placebo intervention, and furthermore, to assess the cost-effectiveness of this intervention.Methods/design: Consecutive discogenic low back pain patients referred to four specialized pain treatment facilities are being screened for eligibility. After a positive standardized provocation discography and informed consent, patients are randomized into two groups. The treatment group receives an intradiscal injection with methylene blue, lidocaine, and contrast, and the control group receives intradiscal isotonic saline with lidocaine and contrast. Main outcome measures are pain at the 6-month follow-up, patient's global impression of change, cost-effectiveness, quality of life, disability, and analgesic intake.Discussion: The importance of this study is emphasized by the fact that for intractable discogenic low back pain patients, evidence-based effective pain treatments are rare. If this study establishes clinical success and cost-effectiveness, IMBI could become the "pain treatment of choice" for a selected group of patients with chronic discogenic low back pain for whom noninvasive treatment options have failed.Trial Registration: National Trial register NTR2547 Registered at 29 September 2010 and 31 March 2014. [ABSTRACT FROM AUTHOR]

Background: Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands.Methods: All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary outcome is length of postoperative hospital stay. Additional outcome measures are length of recovery, guideline adherence, and mean implementation costs per patient.Discussion: This study takes up the challenge to evaluate an efficient strategy for large-scale implementation. Comparing effectiveness and costs of two different approaches, this study will help to define a preferred strategy for nationwide dissemination of best practices.Trial Registration: Dutch Trial Register NTR4058. [ABSTRACT FROM AUTHOR]

Background: Despite the increased attention for assessing the effectiveness of implementation strategies, most implementation studies provide little or no information on its associated costs. The focus of the current study was to provide a detailed report of the resource use and costs associated with implementation of a short stay programme for breast cancer surgery in four Dutch hospitals. Methods: The analysis was performed alongside a multi-centre implementation study. The process of identification, measurement and valuation of the implementation activities was based on recommendations for the design, analysis and reporting of health technology assessments. A scoring form was developed to prospectively determine the implementation activities at professional and implementation expert level. A time horizon of 5 years was used to calculate the implementation costs per patient. Results: Identified activities were consisted of development and execution of the implementation strategy during the implementation project. Total implementation costs over the four hospitals were €83.293. Mean implementation costs, calculated for 660 patients treated over a period of 5 years, were €25 per patient. Subgroup analyses showed that the implementation costs ranged from €3.942 to €32.000 on hospital level. From a local hospital perspective, overall implementation costs were €21 per patient, after exclusion of the costs made by the expert centre. Conclusions: We provided a detailed case description of how implementation costs can be determined. Notable differences in implementation costs between hospitals were observed. Trial registration: ISRCTN: ISRCTN77253391 [ABSTRACT FROM AUTHOR]

Background A quality improvement collaborative is an intensive project involving a combination of implementation strategies applied in a limited "breakthrough" time window. After an implementation project, it is generally difficult to sustain its success. In the current study, sustainability was described as maintaining an implemented innovation and its benefits over a longer period of time after the implementation project has ended. The aim of the study was to explore potentially promising strategies for sustaining the Enhanced Recovery After Surgery (ERAS) programme in colonic surgery as perceived by professionals, three to six years after the hospital had successfully finished a quality improvement collaborative. Methods A qualitative case study was performed to identify promising strategies to sustain key outcome variables related to the ERAS programme in terms of adherence, time needed for functional recovery and hospital length of stay (LOS), as achieved immediately after implementation. Ten hospitals were selected which had successfully implemented the ERAS programme in colonic surgery (2006-2009), with success defined as a median LOS of 6 days or less and protocol adherence rates above 70%. Fourteen semi-structured interviews were held with eighteen key participants of the care process three to six years after implementation, starting with the project leader in every hospital. The interviews started by confronting them with the level of sustained implementation results. A direct content analysis with an inductive coding approach was used to identify promising strategies. The mean duration of the interviews was 37 minutes (min 26 minutes - max 51 minutes). Results The current study revealed strategies targeting professionals and the organisation. They comprised internal audit and feedback on outcomes, small-scale educational booster meetings, reminders, changing the physical structure of the organisation, changing the care process, making work agreements and delegating responsibility, and involving a coordinator. A multifaceted self-driven promising strategy was applied in most hospitals, and in most hospitals promising strategies were suggested to sustain the ERAS programme. Conclusions Joining a quality improvement collaborative may not be enough to achieve long-term normalisation of transformed care, and additional investments may be needed. The findings suggest that certain post-implementation strategies are valuable in sustaining implementation successes achieved after joining a quality improvement collaborative. [ABSTRACT FROM AUTHOR]

Background: The patient perspective is increasingly considered in healthcare policy decisions. The use of research on patient preferences seems however limited. Using the available research on patient preferences would make healthcare policy decisions more evidence-based regarding the patient perspective. Objective of this study is to investigate whether and how results of research on patient preferences are incorporated in current procedures for pharmaceutical coverage decisions and clinical practice guideline (CPG) development. Methods: A document analysis on procedure descriptions was combined with case studies. Analyses were performed for five European countries. In the document analysis we systematically checked whether the procedure provides guidance on the systematic use of research on patient preferences, and whether the search and use of research on patient preferences is mentioned in the decision making procedure. In the case studies, which were for exploratory purposes, we scored whether or not research question on patient preferences were formulated, whether or not a search strategy including terms relating to patient preferences was mentioned, whether results of this search strategy were shown and finally, how many references with preference-related terms were included in the reference list of the case. Results: None of the procedures for pharmaceutical coverage decisions mentions the systematic consideration of research on patient preferences. For CPG development, the Scottish procedure refers to a mandatory literature search. In the Netherlands this step is optional. In the case studies for pharmaceutical coverage decisions only one reference related to patient preferences was found. Some of the case studies for CPG included research questions, search strategies and references relating to patient preferences. Conclusions: This study illustrates that systematic consideration of research on patient preferences in pharmaceutical coverage decisions and guideline development is limited, or if taken into account, this is not visible. This contrasts the strong movement towards patient involvement in health care. Several potential barriers may explain the limited use of research on patient preferences. [ABSTRACT FROM AUTHOR]

Background: Despite a strong movement towards active patient involvement in healthcare policy decisions, systematic and explicit consideration of evidence of this research on patient preferences seems limited. Furthermore, little is known about the opinions of several stakeholders towards consideration of research evidence on patient preferences in healthcare policy decisions. This paper describes the protocol for an explorative study on the integration of research on patient preferences in healthcare policy decisions. The study questions: to what extent research evidence on patient preferences is considered in current procedures for healthcare policy decisions; opinions of stakeholders regarding the integration of this type of evidence in healthcare policy decisions; and what could be a decision framework for the integration of such research evidence in healthcare policy decisions. Methods/design: The study is divided in three sub-studies, predominantly using qualitative methods. The first sub-study is a scoping review in five European countries to investigate whether and how results of research on patient preferences are considered in current procedures for coverage decisions and clinical practice guideline development. The second sub-study is a qualitative study to explore the opinions of stakeholders with regard to the possibilities for integrating evidence on patient preferences in the process of healthcare decision-making in the Netherlands. The third sub-study is the development of a decision framework for research on patient preferences. The framework will consist of: a process description regarding the place of evidence on patient preferences in the decision-making process; and a taxonomy describing different terminologies and conceptualisations of 'preferences' and an overview of existing methodologies for investigating preferences. The concept framework will be presented to and discussed with experts. Discussion: This study will create awareness regarding the existence and potential value of research evidence on patient preferences for healthcare policy decision-making and provides insight in the methods for investigating patient preferences and the barriers and facilitators for integration of such research in healthcare policy decisions. Results of the study will be useful for researchers, clinical practice guideline developers, healthcare policy makers, and patient representatives. [ABSTRACT FROM AUTHOR]

Background: Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives). Methods: An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs. Discussion: This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child. [ABSTRACT FROM AUTHOR]

Background: Two healthcare innovations were successfully implemented using different implementation strategies. First, a Short Stay Programme for breast cancer surgery (MaDO) was implemented in four early adopter hospitals, using a hospital-tailored implementation strategy. Second, the Enhanced Recovery After Surgery (ERAS) programme for colonic surgery was implemented in 33 Dutch hospitals, using a generic breakthrough implementation strategy. Both strategies resulted in a shorter hospital length of stay without a decrease in quality of care. Currently, it is unclear to what extent these innovative programmes and their results have been sustained three to five years following implementation. The aim of the sustainability of healthcare innovations (SUSHI) study is to analyse sustainability and its determinants using two implementation cases. Methods: This observational study uses a mixed methods approach. The study will be performed in 14 hospitals in the Netherlands, from November 2010. For both implementation cases, the programme aspects and the effects will be evaluated by means of a follow-up measurement in 160 patients who underwent breast cancer surgery and 300 patients who underwent colonic surgery. A policy cost-effectiveness analysis from a societal perspective will be performed prospectively for the Short Stay Programme for breast cancer surgery in 160 patients. To study determinants of sustainability key professionals in the multidisciplinary care processes and implementation change agents will be interviewed using semi-structured interviews. Discussion: The concept of sustainability is not commonly studied in implementation science. The SUSHI study will provide insight in to what extent the short-term implementation benefits have been maintained and in the determinants of long-term continuation of programme activities. [ABSTRACT FROM AUTHOR]

Background: Pelvic organ prolapse (POP) is a condition affecting more than half of the women above age 40. The estimated lifetime risk of needing surgical management for POP is 11%. In patients undergoing POP surgery of the anterior vaginal wall, the re-operation rate is 30%. The recurrence risk is especially high in women with a levator ani defect. Such defect is present if there is a partially or completely detachment of the levator ani from the inferior ramus of the symphysis. Detecting levator ani defects is relevant for counseling, and probably also for treatment. Levator ani defects can be imaged with MRI and also with Translabial 3D ultrasonography of the pelvic floor. The primary aim of this study is to assess the diagnostic accuracy of translabial 3D ultrasonography for diagnosing levator defects in women with POP with Magnetic Resonance Imaging as the reference standard. Secondary goals of this study include quantification of the inter-observer agreement about levator ani defects and determining the association between levator defects and recurrent POP after anterior repair. In addition, the cost-effectiveness of adding translabial ultrasonography to the diagnostic work-up in patients with POP will be estimated in a decision analytic model. Methods/Design: A multicentre cohort study will be performed in nine Dutch hospitals. 140 consecutive women with a POPQ stage 2 or more anterior vaginal wall prolapse, who are indicated for anterior colporapphy will be included. Patients undergoing additional prolapse procedures will also be included. Prior to surgery, patients will undergo MR imaging and translabial 3D ultrasound examination of the pelvic floor. Patients will be asked to complete validated disease specific quality of life questionnaires before surgery and at six and twelve months after surgery. Pelvic examination will be performed at the same time points. Assuming a sensitivity and specificity of 90% of 3D ultrasound for diagnosing levator defects in a population of 120 women with POP, with a prior probability of levator ani defects of 40%, we will be able to estimate predictive values with good accuracy (i.e. confidence limits of at most 10% below or above the point estimates of positive and negative predictive values). [ABSTRACT FROM AUTHOR]

Background: Preeclampsia and HELLP syndrome may have serious consequences for both mother and fetus. Women who have suffered from preeclampsia or the HELLP syndrome, have an increased risk of developing preeclampsia in a subsequent pregnancy. However, most women will develop no or only minor complications. In this study, we intend to determine cost-effectiveness of recurrence risk guided care versus care as usual in pregnant women with a history of early-onset preeclampsia. Methods/design: We developed a prediction model to estimate the individual risk of recurrence of early-onset preeclampsia and the HELLP syndrome. In a before-after study, pregnant women with preeclampsia or HELLP syndrome in their previous pregnancy receiving care as usual (before introduction of the prediction model) will be compared with women receiving recurrence risk guided care (after introduction of the prediction model). Eligible and pregnant women will be recruited at six university hospitals and seven large non-university tertiary referral hospitals in the Netherlands. The primary outcome measure is the recurrence of early-onset preeclampsia or HELLP syndrome in women allocated to the regular monitoring group. For the economic evaluation, a modelling approach will be used. Costs and effects of recurrence risk guided care with those of care as usual will be compared by means of a decision model. Two incremental cost-effectiveness ratios will be calculated: 1) cost per Quality Adjusted Life Year (mother unit of analysis) and 2) cost per live born child (child unit of analysis). Discussion: This is, to our knowledge, the first study that evaluates prospectively the efficacy of a multivariable prediction rule for recurrent hypertensive disease in pregnancy. Results of this study could either be integrated into the current guideline on Hypertensive Disorders in Pregnancy, or be used to develop a new guideline. [ABSTRACT FROM AUTHOR]

Background: Current frequent follow-up after treatment for breast cancer does not meet its intended aims, but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations. The study described in this paper compared patient satisfaction with a reduced follow-up strategy, i.e. nurse-led telephone follow-up, to satisfaction with traditional hospital follow-up. Methods: Patient satisfaction was assessed among patients (n = 299) who were participants of a randomized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer. Data on patient satisfaction were collected at baseline, three, six and 12 months after treatment, using the Dutch version of Ware's Patient Satisfaction Questionnaire III (PSQ III). In addition to general satisfaction, the PSQ III reports on satisfaction scores for technical competence, interpersonal aspects, and access of care. Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received. Results: Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction (p = 0.379), satisfaction with technical competence (p = 0.249), and satisfaction with interpersonal aspects (p = 0.662). Regarding access of care, patient satisfaction scores were significantly higher for patients receiving telephone followup (p = 0.015). However, a mean difference at 12 months of 3.1 points was judged to be not clinically relevant. Conclusions: No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment. With high satisfaction scores and the potential to substantially reduce clinic visits, nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up. Trial registration number: ISRCTN 74071417. [ABSTRACT FROM AUTHOR]

Background: Pregnancies induced by in vitro fertilisation (IVF) often result in twin gestations, which are associated with both maternal and perinatal complications. An effective way to reduce the number of IVF twin pregnancies is to decrease the number of embryos transferred from two to one. The interpretation of current studies is limited because they used live birth as outcome measure and because they applied limited time horizons. So far, research on long-term outcomes of IVF twins and singletons is scarce and inconclusive. The objective of this study is to investigate the short (1-year) and long-term (5 and 18-year) costs and health outcomes of IVF singleton and twin children and to consider these in estimating the cost-effectiveness of single embryo transfer compared with double embryo transfer, from a societal and a healthcare perspective. Methods/Design: A multi-centre cohort study will be performed, in which IVF singletons and IVF twin children born between 2003 and 2005 of whom parents received IVF treatment in one of the five participating Dutch IVF centres, will be compared. Data collection will focus on children at risk of health problems and children in whom health problems actually occurred. First year of life data will be collected in approximately 1,278 children (619 singletons and 659 twin children). Data up to the fifth year of life will be collected in approximately 488 children (200 singletons and 288 twin children). Outcome measures are health status, health-related quality of life and costs. Data will be obtained from hospital information systems, a parent questionnaire and existing registries. Furthermore, a prognostic model will be developed that reflects the short and long-term costs and health outcomes of IVF singleton and twin children. This model will be linked to a Markov model of the short-term cost-effectiveness of single embryo transfer strategies versus double embryo transfer strategies to enable the calculation of the long-term cost-effectiveness. Discussion: This is, to our knowledge, the first study that investigates the long-term costs and health outcomes of IVF singleton and twin children and the long-term cost-effectiveness of single embryo transfer strategies versus double embryo transfer strategies. [ABSTRACT FROM AUTHOR]

Background/aim: The EQ-5D is a generic health-related quality of life (HRQoL) measure that is used for the purpose of economic evaluations of health interventions. Therefore, it has to be responsive to meaningful changes in health in the patient population under investigation. The aim of this study was to investigate the responsiveness of the EQ-5D in breast cancer patients in their first year after treatment. Methods: The subscale global health of the disease-specific HRQoL measure EORTC QLQ-C30 was used as a reference instrument to determine meaningful changes in health and identify subgroups of patients: patients reporting a moderate-large deterioration, small deterioration, a small improvement, moderate-large improvement, or no change in health status. Responsiveness was evaluated by calculating standardized response means (SRMs) in the five subgroups of patients and performing analysis of variance procedures. The two HRQoL measures were filled out two weeks and one year after finalizing curative treatment for breast cancer (n = 192). Results: The EQ-5D was able to capture both improvements and deteriorations in HRQoL. SRMs of the EQ VAS and EQ-5D Index were close to zero in the subgroup reporting no change and increased and decreased adequately in the subgroups reporting small and moderate changes. Additional analysis of variance procedures showed that the EQ-5D was able to differentiate between subgroups of patients with no change and moderate-large deterioration or improvement in health. Conclusion: The EQ-5D seems an appropriate measure for the purpose of economic evaluations of health intervention in breast cancer patients after treatment. [ABSTRACT FROM AUTHOR]

Background: The potential barriers and facilitators to change should guide the choice of implementation strategy. Implementation researchers believe that existing methods for the evaluation of potential barriers and facilitators are not satisfactory. Discrete choice experiments (DCE) are relatively new in the health care sector to investigate preferences, and may be of value in the field of implementation research. The objective of our study was to investigate the complementary value of DCE for the evaluation of barriers and facilitators in implementation research. Methods: Clinical subject was the implementation of the guideline for breast cancer surgery in day care. We identified 17 potential barriers and facilitators to the implementation of this guideline. We used a traditional questionnaire that was made up of statements about the potential barriers and facilitators. Respondents answered 17 statements on a five-point scale ranging from one (fully disagree) to five (fully agree). The potential barriers and facilitators were included in the DCE as decision attributes. Data were gathered among anaesthesiologists, surgical oncologists, and breast care nurses by means of a paper-and-pencil questionnaire. Results: The overall response was 10%. The most striking finding was that the responses to the traditional questionnaire hardly differentiated between barriers. Forty-seven percent of the respondents thought that DCE is an inappropriate method. These respondents considered DCE too difficult and too time-consuming. Unlike the traditional questionnaire, the results of a DCE provide implementation researchers and clinicians with a relative attribute importance ranking that can be used to prioritize potential barriers and facilitators to change, and hence to better fine-tune the implementation strategies to the specific problems and challenges of a particular implementation process. Conclusion: The results of our DCE and traditional questionnaire would probably lead to different implementation strategies. Although there is no 'gold standard' for prioritising potential barriers and facilitators to the implementation of change, theoretically, DCE would be the method of choice. However, the feasibility of using DCE was less favourable. Further empirical applications should investigate whether DCE can really make a valuable contribution to the implementation science. [ABSTRACT FROM AUTHOR]

Background: The EQ-5D is a reliable tool for measuring Health-Related Quality of Life (HRQoL). However, concern has been expressed that it may ignore elements of HRQoL, particularly cognition. In response to this concern, the EQ-5D has been extended with a cognitive dimension (EQ-5D+C). The aim of this study was to compare the performance of the EQ-5D and the EQ- 5D+C in elderly patients with cognitive impairments by assessing their construct validity and responsiveness. Methods: Data from the MEDICIE study (n = 196) were used, in which all questionnaires were rated by proxies. Results: Regarding construct validity, we found similar correlations between the EQ-5D and the Mini Mental State Examination (MMSE) and between the EQ-5D+C and the MMSE. Furthermore, both the EQ-5D and the EQ-5D+C were responsive to changes in the MMSE, with the EQ-5D performing slightly better. Conclusion: We conclude that the EQ-5D performs well for evaluating HRQoL in a population with cognitive impairments. Based on the results of this explorative study, it does not seem necessary to adjust the current classification system by adding a cognitive dimension. However, in order to compare both instruments regarding utility values, it is necessary to develop a new scoring algorithm for the EQ-5D+C by conducting a general population study. Considering the explorative nature of this study, it is recommended that more aspects of the validity of both the EQ-5D and the EQ-5D+C are explored in patients with cognitive impairments using a more tailored study design. [ABSTRACT FROM AUTHOR]

Background: Whereas ultra-short stay (day care or 24 hour hospitalisation) following breast cancer surgery was introduced in the US and Canada in the 1990s, it is not yet common practice in Europe. This paper describes the design of the MaDO study, which involves the implementation of ultra short stay admission for patients after breast cancer surgery, and evaluates whether the targets of the implementation strategy are reached. The ultra short stay programme and the applied implementation strategy will be evaluated from the economic perspective. Methods/design: The MaDO study is a pre-post-controlled multi-centre study, that is performed in four hospitals in the Netherlands. It includes a pre and post measuring period of six months each with six months of implementation in between in at least 40 patients per hospital per measurement period. Primary outcome measure is the percentage of patients treated in ultra short stay. Secondary endpoints are the percentage of patients treated according to protocol, degree of involvement of home care nursing, quality of care from the patient's perspective, cost-effectiveness of the ultra short stay programme and cost-effectiveness of the implementation strategy. Quality of care will be measured by the QUOTE-breast cancer instrument, cost-effectiveness of the ultra short stay programme will be measured by means of the EuroQol (administered at four time-points) and a cost book for patients. Cost-effectiveness analysis will be performed from a societal perspective. Cost-effectiveness of the implementation strategy will be measured by determination of the costs of implementation activities. Discussion: This study will reveal barriers and facilitators for implementation of the ultra short stay programme. Moreover, the results of the study will provide information about the cost-effectiveness of the ultra short stay programme and the implementation strategy. [ABSTRACT FROM AUTHOR]

Background: After curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2-3 years (2-4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local disease recurrence, or a second primary breast cancer, but also to provide information and psychosocial support. However, the cost-effectiveness of these frequent visits is under much debate, leading to a search for less intensive and more cost-effective follow-up strategies. In this paper the design of the MaCare trial is described. This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients. We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme. Methods/design: The MaCare trial is a multi centre randomised clinical trial in which 320 breast cancer patients are randomised into four follow-up strategies, focussed on the first 18 months after treatment: 1) standard follow-up; 2) nurse-led telephone follow-up; 3) arm 1 with the educational group programme; 4) arm 2 with the educational group programme. Data is collected at baseline and 3, 6, 12 and 18 months after treatment. The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30. Secondary outcomes are perceived feelings of control, anxiety, patients' satisfaction with follow-up and costs. A cost-effectiveness analysis will be performed from a societal perspective. Discussion: Reduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice. Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up. The MaCare trial combines a reduced follow-up strategy with additional psychosocial support. Less frequent follow-up can reduce the burden on medical specialists and costs. The educational group programme can improve QoL of patients, but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit. Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009. [ABSTRACT FROM AUTHOR]

Background: Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training (PFMT) peri-partum has been proven effective for up to 1 year post-partum; however, its long-term effects are unknown. Group PFMT, given by a physiotherapist, has been proven to be as equally effective as individual therapy. Motherfit is a group-PFMT therapy with an emphasis on pelvic floor exercises, adherence and general fitness. Care-as-usual (CAU), if guideline driven, should, as first treatment option, consist of PFMT. Cost-effective strategies are of relevance, given the rise of health care costs. Motherfit group therapy has the potential to be cost-effective in women with urinary incontinence. Therefore, the objectives of the two current studies are: (1) to investigate whether intensive, supervised, pre-partum (MOTHERFIT1) or post-partum (MOTHERFIT2) pelvic-floor-muscle group therapy reduces 18-month post-partum severity of SUI compared to CAU and (2) whether MOTHERFIT1 OR MOTHERFIT 2 is more (cost-)effective compared to CAU.Methods: Two multi-centred, randomised controlled trials (MOTHERFIT1, n = 150, MOTHERFIT2, n = 90) will be performed. Participants will be recruited by their midwife or gynaecologist during their routine check. Participants with SUI will receive either motherfit group therapy or CAU. Motherfit group therapy consists of eight group sessions of 60 min each, instructed and supervised by a registered pelvic physiotherapist. Motherfit group therapy includes instructions on pelvic floor anatomy and how to contract, relax and train the pelvic-floor muscles correctly and is combined with general physical exercises. Adherence during and after motherfit will be stimulated by reinforcement techniques and a mobile app. The primary outcome measure is the absence of self-reported SUI based on the severity sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) at 18 months post-partum. Secondary outcomes evaluate quality of life, subjective improvement and health care costs.Discussion: The motherfit studies are, to our knowledge, the first studies that evaluate both long-term results and health care costs compared to CAU in pregnant and post-partum women with SUI. If motherfit is shown to be (cost-)effective, implementation in peri-partum care should be considered.Trial Registration: Netherlands Trial Register, ID: NL5816 . Registered on 18 July 2016. [ABSTRACT FROM AUTHOR]

Background: The scope of implementation research is often restricted to the analysis of organizations that participate voluntarily in implementation interventions. The recruitment of participants for a quality improvement collaborative increases awareness of the specific innovation. The objective of this multiphase observational study was to identify differences between organizations that participated in a large-scale implementation project aiming to improve perioperative care, functional recovery, and length of hospital stay after gynecologic surgery and organizations that did not participate. A secondary objective was to explore how perioperative practice changed among nonparticipants.Methods: Of the seven gynecology departments of nonparticipating Dutch hospitals, five agreed to participate in a retrospective analysis. Baseline data of participating hospitals' (N = 19) characteristics, time to functional recovery, and length of hospital stay were compared. Outcome measures for the subsequent pre-post awareness study in the five nonparticipating hospitals were: (1) overall adherence to predefined evidence-based perioperative elements; and (2) change in functional recovery and length of hospital stay. Multivariable regression models, adjusted for baseline characteristics, were used for analysis.Results: In retrospect, nonparticipating and participating hospitals did not differ in baseline characteristics, functional recovery, and length of hospital stay. In three of the five nonparticipating hospitals, adherence to the selected evidence-based perioperative elements increased significantly after awareness of the trial (overall mean difference 9.7%, 95% CI 6.9 to 12.5%, p <  0.001). Linear regression models revealed no statistically significant or clinically relevant differences in time to functional recovery (mean difference - 0.2 days, 95% CI -0.7 to 0.2, p = 0.319) or length of hospital stay (mean difference - 0.4 days, 95% CI -1.3 to 0.5, p = 0.419) in the nonparticipating hospitals. None of these hospitals managed to reduce time to functional recovery or length of hospital stay significantly.Conclusions: No differences in perioperative outcomes between the nonparticipating and participating hospitals were identified at baseline. Despite the statistically significant improvement in overall evidence-based perioperative care, the awareness raised by recruitment activities alone was not enough to reduce time to functional recovery and length of hospital stay in nonparticipating hospitals. Insight into the trends of nonparticipants is valuable to existing implementation effectiveness research. [ABSTRACT FROM AUTHOR]

Background: Improvement of appropriate bed use and access to intensive care (ICU) beds is essential in optimizing utilization of ICU capacity. The introduction of an intermediate care unit (IMC) integrated in the ICU care may improve this utilization., Method: In a before-after prospective intervention study in a university hospital mixed ICU, the impact of introducing a six-bed mixed IMC unit supervised and staffed by ICU physicians was investigated. Changes in ICU utilization (length of stay, frequency of mechanical ventilation use), nursing workload assessed byTISS-28 score, as well as inappropriate bed use, accessibility of the ICU (number of referrals), and clinical outcome indicators (readmission and mortality rates) were measured., Results: During 17 months, data of 1027 ICU patients were collected. ICU utilization improved significantly with an increased appropriate use of ICU beds. However, the number of referrals, readmissions to the ICU and mortality rates did not decrease after the IMC was opened., Conclusion: The IMC contributed to a more appropriate use of ICU facilities and did result in a significant increase in mean nursing workload at the ICU.

Background: Current frequent follow-up after treatment for breast cancer does not meet its intended aims, but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations. The study described in this paper compared patient satisfaction with a reduced follow-up strategy, i.e. nurse-led telephone follow-up, to satisfaction with traditional hospital follow-up., Methods: Patient satisfaction was assessed among patients (n=299) who were participants of a randomized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer. Data on patient satisfaction were collected at baseline, three, six and 12 months after treatment, using the Dutch version of Ware's Patient Satisfaction Questionnaire III (PSQ III). In addition to general satisfaction, the PSQ III reports on satisfaction scores for technical competence, interpersonal aspects, and access of care. Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received., Results: Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction (p=0.379), satisfaction with technical competence (p=0.249), and satisfaction with interpersonal aspects (p=0.662). Regarding access of care, patient satisfaction scores were significantly higher for patients receiving telephone follow-up (p=0.015). However, a mean difference at 12 months of 3.1 points was judged to be not clinically relevant., Conclusions: No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment. With high satisfaction scores and the potential to substantially reduce clinic visits, nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up., Trial Registration Number: ISRCTN 74071417.