Search

OBJECTIVE: When deciding how many embryos to transfer during in vitro fertilisation (IVF), clinicians and patients have to balance optimizing the chance of pregnancy against preventing multiple pregnancies and the associated complications. This paper describes the development and pilot test of a patient decision aid (DA) for this purpose. METHODS: The development of the DA consisted of a literature search, establishment of the format, and a pilot test among IVF patients. The DA development was supervised by a panel of experts in the fields of subfertility, obstetrics and DA-research and it was based on the criteria of the International Patient Decision Aid Standards. RESULTS: One Cochrane review and 34 articles were selected for the DA content. The DA presents information in text, summaries, tables, figures and through an interactive worksheet. The DA was reviewed positively and as acceptable for use in clinical practice by patients and professionals. CONCLUSION: The DA was thoroughly developed and is likely to be helpful for the decision-making process for the number of embryos transferred after IVF. PRACTICE IMPLICATIONS: Physicians and researchers can use the DA without restriction in clinical practice or research related to decision-making. [ABSTRACT FROM AUTHOR]

Background: Dose reduction of tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukaemia (CML) with an optimal response to TKIs may support cost-effective medication use by maintaining therapeutic effectiveness while reducing adverse events and medication costs. As the choice for dose reduction depends on patients' individual needs and preferences, a patient-centred approach is warranted. Therefore, a study to evaluate the effectiveness of patient-guided dose reduction in patients with CML who are in a major or deep molecular response is designed., Methods: This study is a prospective, multicentre, single-arm study. 147 patients with CML (aged ≥ 18 years) in chronic phase, who are treated with imatinib, bosutinib, dasatinib, nilotinib or ponatinib, and have reached at least major molecular response (defined as having BCR-ABL levels < 0.1% for an uninterrupted period of 6 months) are eligible. Patients will use an online patient decision aid and a shared decision making consultation will be held, after which patients who choose to will receive a personalised, lower TKI dose. Primary outcome is the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response. For this, BCR-ABL1 levels will be analysed from blood samples drawn at baseline, 6 weeks after dose reduction and 3-monthly thereafter. Secondary outcomes include the proportion of patients with intervention failure at 6 and 18 months after dose reduction. Other outcomes include differences before and after dose reduction regarding the number and severity of patient-reported side effects; quality of life; beliefs about medicines; and medication adherence. Patients' level of decisional conflict and regret after choosing dose reduction will be assessed, as will the decisional process experienced by patients and healthcare providers., Discussion: Outcomes of this trial using a personalised approach will provide clinical and patient-reported data to guide future dose reduction of TKIs in CML. If the strategy appears to be effective, it may be implemented as another valid option to offer next to standard of care to prevent potential unnecessary exposure to higher TKI doses in this selected group of patients., Trial Registration: EudraCT number 2021-006581-20., (© 2023. The Author(s).)

Background: Substantial proliferation of eHealth has enabled a move in patient-centred cancer care from the traditional in-person care model to real-time, dynamic, and technology supported on-demand care. However, in general, the uptake of these innovations is low. Studies show that eHealth is helpful in providing patient empowerment through e.g. providing high quality and timely information, enabling self-monitoring and shared decision making, but dropout rates are high and guidance for optimal implementation is lacking., Aim: To explore barriers to and facilitators for nationwide implementation and consolidation of CMyLife, a multi-component, patient-centred, digital care platform, and to construct a comprehensive implementation guide for launching digital care platforms in daily clinical practice., Methods: The first qualitative case study of a digital care platform like CMyLife was performed including five focus group- and eighteen in-depth interviews with stakeholders. Data were collected using a semi-structured interview guide, based on the frameworks of Grol and Flottorp. Transcripts of the interviews were analysed and barriers and facilitators were identified and categorized according to the frameworks. An iterative process including participation of main stakeholders and using the CFIR-ERIC framework led to creating a comprehensive implementation guide for digital care platforms., Results: In total, 45 barriers and 41 facilitators were identified. Main barriers were lack of connectivity between information technology systems, changing role for both health care providers and patients, insufficient time and resources, doubts about privacy and security of data, and insufficient digital skills of users. Main facilitators mentioned were motivating patients and health care providers by clarifying the added value of use of a digital care platform, clear business case with vision, demonstrating (cost) effectiveness, using an implementation guide, and educating patients and health care providers about how to use CMyLife. Based on these barriers and facilitators a clear and comprehensive implementation guide was developed for digital care platforms., Conclusion: Several barriers to and facilitators for implementation were identified, a clear overview was presented, and a unique comprehensive implementation guide was developed for launching future digital care platforms in daily clinical practice. The next step is to validate the implementation guide in other (oncological) diseases., (© 2022. The Author(s).)

Background: For patients with chronic myeloid leukemia, a web-based platform CMyLife was developed. Its aim is to enhance patient empowerment, by adequate information provision, among others. Before evaluating its effect, information provision and needs in current care were assessed., Objective: To assess patients' evaluation of received information and information needs before CMyLife utilization and whether this information source is used correspondingly. Additionally, we explored predicting patient factors in information perception., Patient Involvement: CMyLife platform was developed with active patient participation., Methods: We conducted a cross-sectional survey among 203 CML patients before launch of the CMyLife platform, using validated questionnaires on information provision and predictive factors. We focused on website utilization during the first 3 years, using Google Analytics. Regression analyses were performed to determine influence of patient factors on information perception., Results: Global perceived information provision was scored 42.8 (0-100). Information on other services such as rehabilitation and psychological support, and effects of treatment on sexuality showed room for improvement. One out of 3 knew where to find useful health information online. But more information was desired by 36% of them. Age ≥65 years, time since diagnosis and low education were positively associated with this need. Pages on medication and side effects were visited the most., Discussion: To fill the gap in perceived provision and needs, information should be adjusted more to the individual in content, manner and timing. Age, time since diagnosis, and educational level are of influence in perceived information, and specific needs within these groups should be further explored., Practical Value: CMyLife provides reliable and up-to-date information for low eHealth literacy skilled patients concerning multiple topics indicated by patients., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objectives: Discussing the individual probability of a successful vaginal birth after caesarean (VBAC) can support decision making. The aim of this study is to externally validate a prediction model for the probability of a VBAC in a Dutch population., Methods: In this prospective cohort study in 12 Dutch hospitals, 586 women intending VBAC were included. Inclusion criteria were singleton pregnancies with a cephalic foetal presentation, delivery after 37 weeks and one previous caesarean section (CS) and preference for intending VBAC. The studied prediction model included six predictors: pre-pregnancy body mass index, previous vaginal delivery, previous CS because of non-progressive labour, Caucasian ethnicity, induction of current labour, and estimated foetal weight ≥90th percentile. The discriminative and predictive performance of the model was assessed using receiver operating characteristic curve analysis and calibration plots., Results: The area under the curve was 0.73 (CI 0.69-0.78). The average predicted probability of a VBAC according to the prediction model was 70.3% (range 33-92%). The actual VBAC rate was 71.7%. The calibration plot shows some overestimation for low probabilities of VBAC and an underestimation of high probabilities., Conclusions: The prediction model showed good performance and was externally validated in a Dutch population. Hence it can be implemented as part of counselling for mode of delivery in women choosing between intended VBAC or planned CS after previous CS., (© 2020 Walter de Gruyter GmbH, Berlin/Boston.)

Background: With the global rise in chronic health conditions, health care is transforming, and patient empowerment is being emphasized to improve treatment outcomes and reduce health care costs. Patient-centered innovations are needed. We focused on patients with chronic myeloid leukemia (CML), a chronic disease with a generally good long-term prognosis because of the advent of tyrosine kinase inhibitors. However, both medication adherence by patients and guideline adherence by physicians are suboptimal, unnecessarily jeopardizing treatment outcomes., Objective: The aim of this study was to develop a patient-centered innovation for patients with CML using a design thinking methodology., Methods: The 5 phases of design thinking (ie, empathize, define, ideate, prototype, and test) were completed, and each phase started with the patient. Stakeholders and end users were identified and interviewed, and observations in the care system were made. Using tools in human-centered design, problems were defined and various prototypes of solutions were generated. These were evaluated by patients and stakeholders and then further refined., Results: The patients desired (1) insights into their own disease; (2) insights into the symptoms experienced, both in terms of knowledge and comprehension; and (3) improvements in the organization of care delivery. A web-based platform, CMyLife, was developed and pilot-tested. It has multiple features, all targeting parts of the bigger solution, including a website with reliable information and a forum, a guideline app, personal medical records with logs of symptoms and laboratory results (including a molecular marker and linked to the guideline app), tailored feedback based on the patients' symptoms and/or results, screen-to-screen consulting, delivery of medication, and the collection of blood samples at home., Conclusions: The multifeatured innovation, CMyLife, was developed in a multidisciplinary way and with active patient participation. The aim of developing CMyLife was to give patients the tools to monitor their results, interpret these results, and act on them. With this tool, they are provided with the know-how to consider their results in relation to their personal care process. Whether CMyLife achieves its goal and the evaluation of the added value will be the focus of future studies. CML could become the first malignancy for which patients are able to monitor and manage their disease by themselves., (©Geneviève ICG Ector, Peter E Westerweel, Rosella PMG Hermens, Karin AE Braspenning, Barend CM Heeren, Oscar MF Vinck, Jan JM de Jong, Jeroen JWM Janssen, Nicole MA Blijlevens. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.05.2020.)

Background: Shared decision-making (SDM) and decision-support tools have attracted broad support in healthcare as they improve medical decision-making. Experts disagree on how these can help patients evaluate their present situation and possible outcomes of therapy, and how they might reduce decisional conflict. Little is known about their implementation, especially in anaesthesiology., Objective: To obtain a more fundamental understanding of pre-operative SDM and evaluate the use of a decision-support tool for postoperative analgesia after major thoracic and abdominal surgery., Design: A qualitative study with semistructured, in-depth interviews of patients and professionals., Setting: Patient recruitment took place at the Radboud University Medical Centre in Nijmegen and the Canisius Wilhelmina Hospital in Nijmegen, a nonacademic teaching centre. Professionals of the Radboud University Medical Centre were invited to participate in the interviews., Participants: Interviews were performed with 10 individual patients and two focus groups both consisting of eight different professionals., Main Outcome Measures: To gain insight into the provision of pre-operative information, decision-making processes and the clarity and usability of a prototype decision-support tool., Results: Professionals seemed to provide their patients with information directed towards the application of epidural analgesia, providing little attention to its negative effects. For many patients, the information was not tailored to their needs. Patients' involvement in decision-making was minimal, but they did not feel a need for more involvement. They were positive about the decision-support tool, although they indicated that it would not have influenced their treatment decision. Professionals expressed their doubt about the capacity of their patients to fully understand the decisions involved and about the clinical usability of the decision-support tool, because patients might misinterpret the information provided., Conclusion: The results of this study suggest that both patients and professionals did not adhere to some 'self-evident' principles of SDM when postoperative analgesia after major thoracic and abdominal surgery was discussed.

Introduction: Demoralization is a relatively neglected issue in which low morale and poor coping result from a stressor such as familial cancer risk. Female BRCA1/2 mutation carriers are highly susceptible for developing breast and ovarian cancer. The aim of this study was to evaluate demoralization in oophorectomized BRCA1/2 mutation carriers and its relation to quality of life., Methods: This cross-sectional study examined 288 oophorectomized BRCA1/2 mutation carriers using the following standardized self-report measures: Demoralization Scale, EORTC Quality of Life Questionnaire-C30, State-Trait Anxiety Inventory and the Cancer Worry Scale., Results: The mean score on the Demoralization Scale was 17.8 (SD 14.0). A clinically significant level of demoralization, defined as a score ≥30, was found in 45 BRCA1/2 mutation carriers (16%). Being highly demoralized was associated with a significantly lower quality of life, and higher levels of physical problems, anxiety and cancer worries. No demographic or clinical factors could predict higher levels of demoralization., Conclusions: Our findings established that a clear proportion of oophorectomized BRCA1/2 mutation carriers experience demoralization impacting on their well-being. Further research is needed to explore the natural trajectory of demoralization and the resultant need for support in these women.

Survivors of childhood and adult-onset cancer are at lifelong risk for the development of late effects of treatment that can lead to serious morbidity and premature mortality. Regular long-term follow-up aiming for prevention, early detection and intervention of late effects can preserve or improve health. The heterogeneous and often serious character of late effects emphasizes the need for specialized cancer survivorship care clinics. Multidisciplinary cancer survivorship care requires a coordinated and well integrated health care environment for risk based screening and intervention. In addition survivors engagement and adherence to the recommendations are also important elements. We developed an innovative model for integrated care for cancer survivors, the "Personalized Cancer Survivorship Care Model", that is being used in our clinic. This model comprises 1. Personalized follow-up care according to the principles of Person Centered Care, aiming to empower survivors and to support self management, and 2. Organization according to a multidisciplinary and risk based approach. The concept of person centered care is based on three components: initiating, integrating and safeguarding the partnership with the patient. This model has been developed as a universal model of care that will work for all cancer survivors in different health care systems. It could be used for studies to improve self efficacy and the cost-effectiveness of cancer survivorship care.

Objectives: Oncological care is very complex, and delivery of integrated care with optimal alignment and collaboration of several disciplines is crucial. To monitor and effectively improve high-quality integrated oncological care, a dashboard of valid and reliable quality indicators (QIs) is indispensable. The aim was to develop multidisciplinary QIs to measure quality of integrated oncological care, specifically for head and neck cancer (HNC) patients., Design: The RAND-modified Delphi method was used to decide on the outcome, process and structure QIs form three different perspectives. In addition, case-mix factors were determined., Setting: Integrated HNC in the Netherlands., Participants: Head and neck cancer patients, chairmen of both patient organisations and medical specialists and allied health professionals involved in HNC care in the Netherlands., Main Outcome Measures: Outcome, process and structure indicators., Results: Outcome indicators were assigned to healthcare status, tumour recurrence, complications, quality of life and patient experiences. The process indicators focused on the (allied health) care aspects during the diagnostic, treatment and follow-up phases, for example regarding waiting times, multidisciplinary team meetings and screening for the need of allied health care., Conclusions: This is the first set of multidisciplinary QIs for HNC care, to assess quality of integrated care agreed by patients and professionals. This set can be used to build other oncological quality dashboards for integrated care., (© 2016 John Wiley & Sons Ltd.)

Introduction: Large practice variation exists in mode of delivery after cesarean section, suggesting variation in implementation of contemporary guidelines. We aim to evaluate this practice variation and to what extent this can be explained by risk factors at patient level., Material and Methods: This retrospective cohort study was performed among 17 Dutch hospitals in 2010. Women with one prior cesarean section without a contraindication for a trial of labor were included. We used multivariate logistic regression analysis to develop models for risk factor adjustments. One model was derived to adjust the elective repeat cesarean section rates; a second model to adjust vaginal birth after cesarean rates. Standardized rates of elective repeat cesarean section and vaginal birth after cesarean per hospital were compared. Pseudo-R 2 measures were calculated to estimate the percentage of practice variation explained by the models. Secondary outcomes were differences in practice variation between hospital types and the correlation between standardized elective repeat cesarean section and vaginal birth after cesarean rates., Results: In all, 1068 women had a history of cesarean section, of whom 71% were eligible for inclusion. A total of 515 women (67%) had a trial of labor, of whom 72% delivered vaginally. The elective repeat cesarean section rate at hospital level ranged from 6 to 54% (mean 29.8, standard deviation 11.8%). Vaginal birth after cesarean rates ranged from 50 to 90% (mean 71.8%, standard deviation 11.1%). More than 85% of this practice variation could not be explained by risk factors at patient level., Conclusion: A large practice variation exists in elective repeat cesarean section and vaginal birth after cesarean rates that can only partially be explained by risk factors at patient level., (© 2016 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective Postpartum hemorrhage (PPH) has a continuously rising incidence worldwide, suggesting suboptimal care. An important step in optimizing care is the translation of evidence-based guidelines into comprehensive hospital protocols. However, knowledge about the quality of these protocols is lacking. The objective of this study was to evaluate the quality of PPH-protocols on structure and content in the Netherlands. Methods We performed an observational multicenter study. Eighteen PPH-protocols from 3 University Hospitals (UH), 8 Teaching Hospitals (TH) and 7 Non-Teaching hospitals (NTH) throughout the Netherlands were acquired. The structure of the PPH-protocols was assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) Instrument. The content was appraised using previously developed quality indicators, based on international guidelines and Advance-Trauma-Life-Support (ATLS)-based course instructions. Results The quality of the protocols for postpartum hemorrhage for both structure and content varied widely between different hospitals, but all of them showed room for improvement. The protocols scored mainly below average on the different items of the AGREE-II instrument (8 of the 10 items scored <4 on a 1-7 scale). Regarding the content, adoption of guideline recommendations in protocols was 46 %. In addition, a timely indication of 'when to perform' a recommendation was lacking in three-fourths of the items. Conclusion This study shows that the quality of the PPH-protocols for both structure and content in the Netherlands is suboptimal. This makes adherence to the guideline and ATLS-based course instructions difficult.

Background: Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase., Objective: To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility., Design: Qualitative interview study., Setting and Participants: We conducted interviews among 12 infertile couples and 17 professionals., Intervention: We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care., Main Outcome Measures: Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared., Results: Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values., Conclusions: Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective., (© The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.)

Background: There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates., Method: Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery., Results: The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adherence 46%), 2) non-progressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%., Conclusions: We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.

Study Question: Do couples who were eligible for tailored expectant management (TEM) and did not start treatment within 6 months after the fertility work-up, have different experiences with the quality of care than couples that were also eligible for TEM but started treatment right after the fertility work-up?, Summary Answer: Tailored expectant management of at least 6 months in couples with unexplained infertility is not associated with the experiences with quality of care or trust in their physician., What Is Known Already: In couples with unexplained infertility and a good prognosis of natural conception within 1 year, expectant management for 6-12 months does not compromise ongoing birth rates and is equally as effective as starting medically assisted reproduction immediately. Therefore, TEM is recommended by various international clinical guidelines. Implementation of TEM is still not optimal because of existing barriers on both patient and professional level. An important barrier is the hesitance of professionals to counsel their patients for TEM because they fear that patients will be dissatisfied with care. However, if and how adherence to TEM actually affects the couples' experience with care is unknown. Experiences with the quality care can be measured by evaluating the patient-centredness of care and the patients' trust in their physician., Study Design, Size, Duration: This is a retrospective cross-sectional study. A survey with written questionnaires was performed among all couples who participated in the retrospective audit of guideline adherence on TEM in 25 Dutch clinics., Participants/materials, Setting, Methods: Couples were eligible to participate if they were diagnosed with unexplained infertility and had a good prognosis (>30%) of natural conception within 1 year based on the Hunault prediction model. We used patient's questionnaires to collect data on the couples' experience with the quality of care and possible confounders for their experiences other than having undergone TEM or not. Multilevel regression analyses were performed to investigate case-mix adjusted association of TEM with the patient-centredness of care (PCQ-Infertility) and the patients' trust in their physician (Wake Forest Trust Scale)., Main Results and the Role of Chance: Couples who adhered to TEM experienced the quality of care on the same level as couples who were exposed to early treatment, i.e. started fertility treatment within 6 months after fertility work-up. There were no associations between adherence to TEM and the patient-centredness of care or the patients' trust in their physician., Limitations, Reasons for Caution: Because this study is retrospective, recall bias might occur. Furthermore, we were unable to measure the difference in experience with care over time. Therefore, our results have to be interpreted carefully., Wider Implications of the Findings: Prospective research on couples undergoing TEM have to be performed to provide more detailed insight in the patients' experiences with the decision making process and subsequently the expectant period. Tackling the barriers surrounding TEM, i.e. better counselling and more patient information material, could further improve patient experiences with the quality of care for couples who are advised TEM., Study Funding/competing Interests: Supported by Netherlands Organisation for Health Research and Development (ZonMW). ZonMW had no role in designing the study, data collection, analysis and interpretation of data or writing of the report. Competing interests: none., Trial Registration Number: www.trialregister.nl NTR3405., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Germline mutations in BRCA1 and BRCA2 genes were discovered twenty years ago. Female BRCA mutation carriers have an increased risk of breast and ovarian cancer at a relatively young age. Several choices have to be made with respect to cancer risk management, and consequences of these choices may affect quality of life. A review of the literature was performed to evaluate quality of life in unaffected BRCA mutation carriers and the influence of these medical choices. Overall, general quality of life appears not to be permanently affected in BRCA mutation carriers or by their choices. Risk-reducing salpingo-oophorectomy and its subsequent premature menopause affect (menopause specific) quality of life most. Hormone replacement therapy does not fully alleviate climacteric symptoms and therefore, there is a strong need for alternative strategies to reduce ovarian cancer risk and/or for improvements in postoperative care. Future research should focus on these needs., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Postpartum haemorrhage (PPH) remains a major contributor to maternal morbidity even in high resource settings, despite the development and dissemination of evidence-based guidelines and Advance-Trauma-Life-Support (ATLS) based courses for optimal management of PPH. We aimed to assess current influencing factors (obstacles and facilitators) for the delivery of high quality PPH-care from both patient and professional perspective., Methods: We qualitatively explored influencing factors for delivering high quality PPH-care, by having individual interviews with PPH-patients and focus group interviews with the different types of professionals working in the delivery room. For both perspectives, the theoretical frameworks of Grol and Cabana were used to classify the influencing factors for optimal PPH-care (factors of the guidelines, of professionals, of patients, of the social setting and of the organisation). In order to assess the importance of the influencing factors found among the professionals, we quantified these factors in a web-based questionnaire., Results: A total of 12 patients and 41 professionals participated in the interviews, and 315 complete surveys were analyzed. The main obstacle for high quality PPH-care identified by patients was the lack of information given by the professionals to the patient and partner before, during and after the PPH event. An informative patient website, a patient leaflet and a follow-up consultation were mentioned as facilitators. The main obstacles according to the professionals were: lack of clarity of the guidelines, lack of knowledge and failing team-communication. Team training and checklists/ flowcharts were considered facilitators., Conclusions: Different obstacles to the delivery of high quality PPH-care were identified by both patients and professionals. These data can be used to develop a focused strategy to improve PPH-care., Trial Registration: NCT 00928863.

Introduction: To systematically develop a set of guideline-based quality indicators for postpartum hemorrhage (PPH) as a tool to measure guideline adherence in actual PPH care., Material and Methods: A Rand-modified Delphi procedure was used to systematically achieve consensus among a panel of 22 experts on PPH care on recommendations extracted from evidence-based guidelines, Managing-Obstetrics-Emergencies-Trauma (MOET) instructions and international literature. The selected recommendations were individually rated on health gain (prevention of maternal mortality and morbidity) and overall efficiency by the expert panel. Subsequently, consensus about the most important recommendations to measure quality of PPH care among the panel members was reached, followed by a final approval. Last, definition of the final set by critical appraisal of the recommendations regarding measurability took place. The main outcome measure was a set of valid quality indicators for prevention and management of PPH., Results: From the 69 extracted recommendations, 50 were selected and translated into 22 quality indicators on professional performance (n = 17) and organization of PPH care (n = 5). The professional performance indicators covered all fields of PPH care, such as prevention (n = 2) and management of PPH, including communication and documentation (n = 4), monitoring and prevention of shock (n = 3), use of blood products (n = 3) and treatment of PPH (n = 5). Organizational indicators (n = 5) were clustered into protocols and agreements, audit, accessibility and documentation., Conclusions: This study describes a stepwise systematic development of 22 performance and organizational indicators to use for measuring the whole care process of prevention and management of PPH., (© 2015 Nordic Federation of Societies of Obstetrics and Gynecology.)

Background: The need for physical cancer rehabilitation programmes (PCRPs), addressing adverse effects from cancer, is growing. Implementing these programmes into daily practice is still a challenge. Since barriers for successful implementation often arise at different levels in healthcare, multi-faceted strategies focusing on multiple levels are likely more effective than single-faceted strategies. Nevertheless, most studies implementing PCRPs used strategies directed at patients only. The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy., Methods/design: We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care. A stepwise approach will be followed: Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital). Step 2: Selection and development of interventions to create a PD and MF strategy during expert roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs. Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n = 50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital., Main Outcome Measures: % screened patients, % referrals to PCRPs, incremental costs and incremental cost-effectiveness ratios (ICERs)., Trail Registration: NCT02205853 (ClinicalTrials.gov).

Background: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated., Methods: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed., Discussion: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL., Trial Registration: ClinicalTrials.gov ( NCT02321228 ).

Background: The objective of this observational study was to assess the influence of patient, tumor, professional and hospital related characteristics on hospital variation concerning guideline adherence in non-Hodgkin's lymphoma (NHL) care., Methods: Validated, guideline-based quality indicators (QIs) were used as a tool to assess guideline adherence for NHL care. Multilevel logistic regression analyses were used to calculate variation between hospitals and to identify characteristics explaining this variation. Data for the QIs regarding diagnostics, therapy, follow-up and organization of care, together with patient, tumor and professional related characteristics were retrospectively collected from medical records; hospital characteristics were derived from questionnaires and publically available data., Results: Data of 423 patients diagnosed with NHL between October 2010 and December 2011 were analyzed. Guideline adherence, as measured with the QIs, varied considerably between the 19 hospitals: >20 % variation was identified in all 20 QIs and high variation between the hospitals (>50 %) was seen in 12 QIs, most frequently in the treatment and follow-up domain. Hospital variation in NHL care was associated more than once with the characteristics age, extranodal involvement, multidisciplinary consultation, tumor type, tumor aggressiveness, LDH level, therapy used, hospital region and availability of a PET-scanner., Conclusion: Fifteen characteristics identified at the patient level and at the hospital level could partly explain hospital variation in guideline adherence for NHL care. Particularly age was an important determinant: elderly were less likely to receive care as measured in the QIs. The identification of determinants can be used to improve the quality of NHL care, for example, for standardizing multidisciplinary consultations in daily practice.

This study outlines trends in quality of delivered non-Hodgkin's lymphoma (NHL) care in the Netherlands between 2007 and 2011 and to what extend this was influenced by the national Visible Care program, which aimed at increasing transparency by providing insight into the quality of healthcare. We analyzed data collected from medical records in two observational studies, combined into 20 validated quality indicators (QIs) of which 6 were included in the national program. A random sample of 771 patients, diagnosed with NHL in 26 Dutch hospitals, was examined. Multilevel regression analyses were used to assess differences in quality of NHL care and to provide insight into the effect of the national program. We reported improved adherence to only 3 out of 6 QIs involved in the national program and none of the other 14 validated QIs. Improvement was shown for performance of all recommended staging techniques (from 26  to  43 %), assessment of International Prognostic Index (from 21  to  43 %), and multidisciplinary discussion of patients (from 23  to  41 %). We found limited improvement in quality of NHL care between 2007 and 2011; improvement potential (<80 % adherence) was still present for 13 QIs. The national program seems to have a small positive effect, but has not influenced all 20 indicators which represent the most important, measurable parts in quality of NHL care. These results illustrate the need for tailored implementation and quality improvement initiatives.

Background: Decision aids (DAs) effectively support patient decision making but are rarely used in daily practice., Objective: To explore nurses' and oncologists' views on routinely offering DAs on palliative chemotherapy to patients by nurses. Most interviewees had clinical experience with the DAs, which were booklets administered to patients by nurses., Methods: The study was guided by 3 theoretical implementation models of innovations in clinical practice, including factors related to the innovation, the professionals (nurses and oncologists), the patient, and the organization. Semistructured interviews were conducted among 12 nurses and 14 oncologists. Interviews were audio taped and fully transcribed., Results: The main barriers to routinely offering DAs to patients were found in nurses' and oncologists' opinions and attitudes (eg, concerns about the impact in this vulnerable population) and in the logistics of organizations (eg, the decision is already made before the nurse sees the patient). Twenty-two of 26 interviewees were open to the future use of the DAs. Disseminating information to professionals (eg, about positive effects of DAs) and embedding DAs in the existing workflow would facilitate implementation., Conclusions: Most nurses and oncologists were open to the future use of the DAs by nurses, provided that certain barriers, particularly related to professionals' opinions and attitudes and logistical procedures in the organization, could be overcome., Implications for Practice: These findings can inform a tailored strategy to implement DAs on palliative chemotherapy. Implementation should start with interventions to motivate professionals, for example, educational meetings.

Aim: Only 12-49% of colorectal cancer (CRC) patients and their first-degree relatives with an increased familial CRC risk are referred for cancer prevention measures (surveillance colonoscopies or genetic counselling). The study was performed to evaluate the effectiveness and feasibility of a novel strategy to improve the uptake of genetic counselling for high risk individuals and surveillance colonoscopy for moderate risk groups., Method: Eighteen hospitals participated in a clustered randomized controlled trial. Patients in nine hospitals received usual care (group A). Nine other hospitals received the novel strategy (group B) including access to a website for patients and clinicians, patient-targeted brochures and clinician-targeted education and pocket referral cards. Data before and after dissemination of the strategy were collected from questionnaires and medical records., Results: Data were complete for 358 (44%) of 820 CRC patients and 50 (36%) of 137 clinicians before dissemination of the strategy and 392/862 patients (45%) and 47/137 clinicians (34%) after. Referral for cancer prevention measures was assessed at a median of 8 (2-12) months after CRC diagnosis in groups A and B before the dissemination of the strategy and in group A after. In group B referral was assessed at a median of 9 (4-11) months after the dissemination of the strategy. Uptake of genetic counselling by high risk patients was equal in groups A and B, being 33% before and 15% after (P = 0.003). Uptake of surveillance colonoscopy by moderate risk relatives did not change significantly (group A, 36% before vs 41% after; group B, 33% before vs 19% after). In group B 94/140 patients (67%) and 25/72 clinicians (35%) visited the website and 34/140 (24%) patients read the brochure. Patients valued clinicians' information as most useful, followed by the patient brochure. Clinicians preferred pocket cards and education., Conclusion: Our strategy did not improve referral for cancer prevention measures. Although the newly offered strategy elements were appreciated, patients preferred clinicians' advice regarding referral for cancer prevention measures. It may be useful to aim future interventions at healthcare professionals rather than patients to improve the prevention of familial cancer., (Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.)

Objective: To identify influencing factors of BRCA1/2 mutation carriers and their professionals for risk-reducing salpingectomy (RRS) with delayed oophorectomy (RRO) as a substitute for risk-reducing salpingo-oophorectomy (RRSO) and for study participation on this concept., Methods: A qualitative study was performed by four focus group interviews with 39 BRCA1/2 mutation carriers and semi-structured in-depth interviews with 23 professionals in the field of hereditary cancer. We used a theoretical framework of determinants of innovation within healthcare organizations to classify influencing factors (barriers and facilitators)., Results: Among BRCA1/2 mutation carriers, main barriers for RRS with delayed RRO were seriousness of ovarian cancer, family history, and previous breast cancer. Among professionals, delay of risk-reducing effect of oophorectomy on breast cancer risk and a second operation were recognized as main barriers. Both BRCA1/2 mutation carriers and professionals found uncertainty about the effect of RRS with delayed RRO and ease of the decision to undergo RRSO important barriers. The main facilitator mentioned by both was longer maintenance of ovarian function thereby delaying negative effects of early surgical menopause. For study participation, BRCA1/2 mutation carriers mentioned a randomized study design as the main barrier, whereas professionals identified two facilitators, namely willingness of BRCA1/2 mutation carriers for study participation and uniform counseling. Furthermore, most BRCA1/2 mutation carriers and professionals were willing to consider participation in a future non-randomized study., Conclusions: We identified several barriers and facilitators for RRS with delayed RRO, and for study participation which can be addressed to optimize the design and implementation of a non-randomized study., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: An overload of health-related information is available for patients on numerous websites, guidelines, and information leaflets. However, the increasing need for personalized health-related information is currently unmet., Objective: This study evaluates an educational e-tool for patients with non-Hodgkin's lymphoma (NHL) designed to meet patient needs with respect to personalized and complete health-related information provision. The e-tool aims to help NHL patients manage and understand their personal care pathway, by providing them with insight into their own care pathway, the possibility to keep a diary, and structured health-related information., Methods: Together with a multidisciplinary NHL expert panel, we developed an e-tool consisting of two sections: (1) a personal section for patients' own care pathway and their experiences, and (2) an informative section including information on NHL. We developed an ideal NHL care pathway based on the available (inter)national guidelines. The ideal care pathway, including date of first consultation, diagnosis, and therapy start, was used to set up the personal care pathway. The informative section was developed in collaboration with the patient association, Hematon. Regarding participants, 14 patients and 6 laymen were asked to evaluate the e-tool. The 24-item questionnaire used discussed issues concerning layout (6 questions), user convenience (3 questions), menu clarity (3 questions), information clarity (5 questions), and general impression (7 questions). In addition, the panel members were asked to give their feedback by email., Results: A comprehensive overview of diagnostics, treatments, and aftercare can be established by patients completing the questions from the personal section. The informative section consisted of NHL information regarding NHL in general, diagnostics, therapy, aftercare, and waiting times. Regarding participants, 6 patients and 6 laymen completed the questionnaire. Overall, the feedback was positive, with at least 75% satisfaction on each feedback item. Important strengths mentioned were the use of a low health-literacy level, the opportunity to document the personal care pathway and experiences, and the clear overview of the information provided. The added value of the e-tool in general was pointed out as very useful for preparing the consultation with one's doctor and for providing all information on one website, including the opportunity for a personalized care pathway and diary. The majority of the revisions concerned wording and clarity. In addition, more explicit information on immunotherapy, experimental therapy, and psychosocial support was added., Conclusions: We have developed a personal care management e-tool for NHL patients. This tool contains a unique way to help patients manage their personal care pathway and give them insight into their NHL by providing health-related information and a personal diary. This evaluation showed that our e-tool meets patients' needs concerning personalized health-related information, which might serve as a good example for other oncologic diseases. Future research should focus on the possible impact of the e-tool on doctor-patient communication during consultations.

Objective: To assess adherence to expectant management of 6-12 months in couples with unexplained subfertility, as recommended by the Dutch Networkguideline Subfertility., Design: A retrospective cohort study in 25 clinics., Method: Couples were eligible to participate if they were diagnosed with unexplained subfertility and had a good prognosis of natural conception within one year (>30%), for these couples the network guideline recommends an expectant management. Outcomes measures are overtreatment, i.e. couples that started treatment within six months, and three quality indicators: 1) prognosis not calculated, 2) no correct expectant management advised, 3) starting treatment too soon despite a correct advise. Data collection was obtained from medical records. Multilevel regression analyses were performed to investigate associations of overtreatment with patient and clinic characteristics., Results: We included 544 couples. Overtreatment occurred in 36% (N=198). In 34% (N=186) of all couples no prognosis was calculated (1), and in 42% (N=230) of all couples expectant management was not advised correctly (2). When a correct expectant management of six to twelve months was advised, 16% (N=51) started treatment too soon anyway. Overtreatment occurred more frequently in childless couples, a higher female age, and a longer duration of infertility., Conclusion: Our findings show that developing and publishing guideline recommendations on expectant management is not enough and that overtreatment still occurs frequently. To improve future care the next step is to evaluate a tailored implementation strategy to improve adherence to the recommendations on expectant management by the Dutch Networkguideline Subfertility.

Background: Guideline development and uptake are still suboptimal; they focus on clinical aspects of diseases rather than on improving the integration of care. We used a patient-centered network approach to develop five harmonized guidelines (one multidisciplinary and four monodisciplinary) around clinical pathways in fertility care. We assessed the feasibility of this approach with a detailed process evaluation of the guideline development, professionals' experiences, and time invested., Methods: The network structure comprised the centrally located patients and the steering committee; a multidisciplinary guideline development group (gynecologists, physicians, urologists, clinical embryologists, clinical chemists, a medical psychologist, an occupational physician, and two patient representatives); and four monodisciplinary guideline development groups. The guideline development addressed patient-centered, organizational, and medical-technical key questions derived from interviews with patients and professionals. These questions were elaborated and distributed among the groups. We evaluated the project performance, participants' perceptions of the approach, and the time needed, including time for analysis of secondary sources, interviews with eight key figures, and a written questionnaire survey among 35 participants., Results: Within 20 months, this approach helped us develop a multidisciplinary guideline for treating infertility and four related monodisciplinary guidelines for general infertility, unexplained infertility, male infertility, and semen analysis. The multidisciplinary guideline included recommendations for the main medical-technical matters and for organizational and patient-centered issues in clinical care pathways. The project was carried out as planned except for minor modifications and three extra consensus meetings. The participants were enthusiastic about the approach, the respect for autonomy, the project coordinator's role, and patient involvement. Suggestions for improvement included timely communication about guideline formats, the timeline, participants' responsibilities, and employing a librarian and more support staff. The 35 participants spent 4497 hours in total on this project., Conclusions: The novel patient-centered network approach is feasible for simultaneously and collaboratively developing a harmonized set of multidisciplinary and monodisciplinary guidelines around clinical care pathways for patients with fertility problems. Further research is needed to compare the efficacy of this approach with more traditional approaches.

Objective: To externally validate two models from the USA (entry-to-care [ETC] and close-to-delivery [CTD]) that predict successful intended vaginal birth after caesarean (VBAC) for the Dutch population., Design: A nationwide registration-based cohort study., Setting: Seventeen hospitals in the Netherlands., Population: Seven hundred and sixty-three pregnant women, each with one previous caesarean section and a viable singleton cephalic pregnancy without a contraindication for an intended VBAC., Methods: The ETC model comprises the variables maternal age, prepregnancy body mass index (BMI), ethnicity, previous vaginal delivery, previous VBAC and previous nonprogressive labour. The CTD model replaces prepregnancy BMI with third-trimester BMI and adds estimated gestational age at delivery, hypertensive disease of pregnancy, cervical examination and induction of labour. We included consecutive medical records of eligible women who delivered in 2010. For validation, individual probabilities of women who had an intended VBAC were calculated., Main Outcome Measures: Discriminative performance was assessed with the area under the curve (AUC) of the receiver operating characteristic and predictive performance was assessed with calibration plots and the Hosmer-Lemeshow (H-L) statistic., Results: Five hundred and fifteen (67%) of the 763 women had an intended VBAC; 72% of these (371) had an actual VBAC. The AUCs of the ETC and CTD models were 68% (95% CI 63-72%) and 72% (95% CI 67-76%), respectively. The H-L statistic showed a P-value of 0.167 for the ETC model and P = 0.356 for the CTD model, indicating no lack of fit., Conclusion: External validation of two predictive models developed in the USA revealed an adequate performance within the Dutch population., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Background: Despite the presence of non-Hodgkin's lymphoma (NHL) guidelines, there are still gaps between best evidence as described in guidelines and quality of care in daily practice. Little is known about factors that affect this discrepancy. We aim to identify barriers that influence the delivery of care and to explore differences between patients' and physicians' experiences, as well as between the different disciplines involved., Methods: Patients and physicians involved in NHL care were interviewed about their experiences with NHL care. The barriers identified in these interviews were quantified in a web-based survey. Differences were tested using Chi-square tests., Results: Barriers frequently perceived by patients concerned lack of patient information and emphatic contact (12-43%), long waiting times (19-35%) and lack of guidance and support (39%). Most barriers mentioned by physicians concerned the unavailability of the guideline (32%), lack of an up-to-date guideline (66%), lack of standardised forms for diagnostics (56-70%) and of multidisciplinary meetings (56%). Perceived barriers concerning the guideline and standardised forms significantly varied between the disciplines involved (range 14-84%, p.

Aim: Currently only 12-30% of individuals with a high risk of Lynch syndrome, the most common hereditary colorectal cancer (CRC) syndrome, are referred for genetic counselling. We assessed the sensitivity, usability and user experiences of a new online referral test aimed at improving referral of high-risk individuals for genetic counselling., Method: Sensitivity was assessed by entering pedigree data from high-risk individuals (i.e. Lynch syndrome mutation carriers) into the referral test to determine whether genetic counselling was recommended. For usability, we assessed nonmedical staff members' ability to determine referral, according to guidelines, in seven fictive clinical cases using the referral test after minimal training. Real-life users answered questions about their experience with the referral test., Result: Sensitivity of the referral test was 91% for mutation carriers with CRC (n = 164) and 73% for all affected and nonaffected mutation carriers (n = 420). Nonmedical staff members (n = 20) determined referral according to guidelines in 84% of cases using the referral test. Ten per cent (256/2470) of real-life users provided feedback about experiences; of those, 71% reported that the referral test increased reassurance, certainty about their familial risk and/or certainty about referral., Conclusion: The referral test has a high sensitivity in detecting individuals with a high risk of Lynch syndrome and is suitable for use in clinical practice. Widespread use of the referral test should improve cancer prevention in high-risk patients and their relatives., (Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.)

Objective: To develop a patient decision aid (PtDA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean (VBAC) with the elicitation of patient preferences and evidence-based information., Design: A PtDA was developed and pilot tested using the International Patients Decision Aid Standards (IPDAS) criteria., Setting: Obstetric health care in the Netherlands., Population: A multidisciplinary steering group, an expert panel, and 25 future users of the PtDA, i.e. women with a previous caesarean section., Methods: The development consisted of a construction phase (definition of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group., Main Outcome Measures: Usability, clarity, and relevance., Results: The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The PtDA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness (n = 7) were not evaluated., Conclusions: An evidence-based PtDA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the PtDA enhances the quality of decision-making on mode of birth after caesarean section., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Objective: To develop and internally validate a model that predicts the outcome of an intended vaginal birth after caesarean (VBAC) for a Western European population that can be used to personalise counselling for deliveries at term., Design: Registration-based retrospective cohort study., Setting: Five university teaching hospitals, seven non-university teaching hospitals, and five non-university non-teaching hospitals in the Netherlands., Population: A cohort of 515 women with a history of one caesarean section and a viable singleton pregnancy, without a contraindication for intended VBAC, who delivered at term., Methods: Potential predictors for a vaginal delivery after caesarean section were chosen based on literature and expert opinions. We internally validated the prediction model using bootstrapping techniques., Main Outcome Measures: Predictors for VBAC. For model validation, the area under the receiver operating characteristic curve (AUC) for discriminative capacity and calibration-per-risk-quantile for accuracy were calculated., Results: A total of 371 out of 515 women had a VBAC (72%). Variables included in the model were: estimated fetal weight greater than the 90(th) percentile in the third trimester; previous non-progressive labour; previous vaginal delivery; induction of labour; pre-pregnancy body mass index; and ethnicity. The AUC was 71% (95% confidence interval, 95% CI = 69-73%), indicating a good discriminative ability. The calibration plot shows that the predicted probabilities are well calibrated, especially from 65% up, which accounts for 77% of the total study population., Conclusion: We developed an appropriate Western European population-based prediction model that is aimed to personalise counselling for term deliveries., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Study Question: Is the actual care for recurrent miscarriage in clinical practice in accordance with 23 guideline-based quality indicators?, Summary Answer: The accordance of actual care with the guidelines was poor and there is evident room for improvement., What Is Known Already: Evidence-based guidelines are important instruments to improve quality of care, but implementation of guidelines is often problematic., Study Design, Size, Duration: A retrospective cohort study was performed within a 12-month period (2006) in nine departments of Obstetrics and Gynaecology in the Netherlands., Participants, Setting, Methods: Five hundred and thirty women with recurrent miscarriage were included. Actual care was assessed with 23 guideline-based quality indicators (covering diagnostics, therapy and counselling) by calculating per indicator the percentage of women for whom the indicator was followed. Thereafter we did multilevel analyses, to relate the adherence to the indicator to determinants of women, professionals and hospitals., Main Results and the Role of Chance: Homocysteine and antiphospholipid antibodies were determined in 39 and 47%, respectively. Thrombophilia screening (54%) and karyotyping (50%) were offered to women regardless of their underlying risk for inherited thrombophilia or chromosome abnormalities. Higher maternal age at the time of presentation and a lower number of preceding miscarriages were improperly used to decide on diagnostic tests and were both associated with lower guideline adherence by professionals. Professionals with a subspecialization in recurrent miscarriage performed better standard care, i.e. screening for antiphospholipid antibodies and homocysteine, but also showed overuse of diagnostics in women at low risk of inherited thrombophilia., Limitations, Reasons for Caution: Retrospective cohort study., Wider Implications of the Findings: Quality indicators used will enable measurement of quality of care., Study Funding: The study was funded by The Netherlands Organisation for Health Research and Development (ZonMw) (Grant no. 94517005). None of the authors has any conflict of interest to declare.

International collaboration could facilitate systematic development of guidelines to regulate and improve clinical practice. Insight into existing international guidelines regarding hypertensive disorders in pregnancy (HDP) is essential. Aim was to evaluate the content and quality of international clinical guidelines on HDP. Quality was assessed with the internationally validated Appraisal of Guidelines for Research and Evaluation (AGREE II) Instrument. Six guidelines were identified. Quality was moderate to high. Major flaws were applicability, editorial independence and stakeholder involvement. Recommendations differed considerably, particularly their extensiveness. The number of international HDP guidelines is small and the extensiveness of their recommendations varies considerably.

Background: Malignant lymphomas constitute a diverse group of cancers of lymphocytes. One well-known disease is Hodgkin's lymphoma; the others are classified as non-Hodgkin's lymphoma (NHL). NHLs are the most common hematologic neoplasms in adults worldwide, and in 2012 over 170,000 new cases were estimated in the United States and Europe.In previous studies, several practice gaps in hospital care for patients with NHL have been identified. To decrease this variation in care, the present study aims to perform a problem analysis in which barriers to and facilitators for optimal NHL care will be identified and, based on these findings, to develop (tailored) improvement strategies. Subsequently, we will assess the effectiveness, feasibility and costs of the improvement strategies., Methods/design: Barriers and facilitators will be explored using the literature, using interviews and questionnaires among physicians involved in NHL care, and patients diagnosed with NHL. The results will be used to develop a tailored improvement strategy. A cluster randomized controlled trial involving 19 Dutch hospitals will be conducted. Hospitals will be randomized to receive either an improvement strategy tailored to the barriers and facilitators found or, a standard strategy of audit and feedback.The effects of both strategies will be evaluated using previously developed quality indicators. Adherence to the indicators will be measured before and after the intervention period based on medical records from newly diagnosed NHL patients. To study the feasibility of both strategies, a process evaluation will be additionally performed. Data about exposure to the different elements of the strategies will be collected using questionnaires. Economic evaluation from a healthcare perspective will compare the two implementation strategies, where the costs of the implementation strategy and changes in healthcare consumption will be assessed., Discussion: The presence of variation in the use of diagnostic tests, treatment, and follow-up between different physicians in different hospitals in the Netherlands is important for patients. To reduce the existing variation in care, implementation of tailored interventions to improve NHL care is necessary., Trial Registration: This trial is registered at ClinicalTrial.gov as the PEARL study, registration number NCT01562509.

Background: Prognostic models in reproductive medicine can help to identify subfertile couples who would benefit from fertility treatment. Expectant management in couples with a good chance of natural conception, i.e., tailored expectant management (TEM), prevents unnecessary treatment and is therefore recommended in international fertility guidelines. However, current implementation is not optimal, leaving room for improvement. Based on barriers and facilitators for TEM that were recently identified among professionals and subfertile couples, we have developed a multifaceted implementation strategy. The goal of this study is to assess the effects of this implementation strategy on the guideline adherence on TEM., Methods/design: In a cluster randomized trial, 25 clinics and their allied practitioners units will be randomized between the multifaceted implementation strategy and care as usual. Randomization will be stratified for in vitro fertilization (IVF) facilities (full licensed, intermediate/no IVF facilities). The effect of the implementation strategy, i.e., the percentage guideline adherence on TEM, will be evaluated by pre- and post-randomization data collection. Furthermore, there will be a process and cost evaluation of the strategy. The implementation strategy will focus on subfertile couples and their care providers i.e., general practitioners (GPs), fertility doctors, and gynecologists. The implementation strategy addresses three levels: patient level: education materials in the form of a patient information leaflet and a website; professional level: audit and feedback, educational outreach visit, communication training, and access to a digital version of the prognostic model of Hunault on a website; organizational level: providing a protocol based on the guideline. The primary outcome will be the percentage guideline adherence on TEM. Additional outcome measures will be treatment-, patient-, and process-related outcome measures., Discussion: This study will provide evidence about the effectiveness and costs of a multifaceted implementation strategy to improve guideline adherence on TEM., Trial Registration: http://www.trialregister.nlNTR3405. This study is sponsored by ZonMW.

Study Question: What value can patients add to the development of guideline-based quality indicators for patient-centredness in fertility care?, Summary Answer: Infertile patients mainly select different indicators and value different dimensions of patient-centredness (e.g. information and communication and access to care) than professionals (e.g. coordination and integration of care) during an indicator development process., What Is Known Already: Patient-centredness is an important dimension for the quality of fertility care. However, this dimension is not adequately evaluated by professionals, due to a lack of quality indicators. Furthermore, it is suggested that patients select different indicators for patient-centredness than professionals, although exact differences are unknown., Study Design, Size and Duration: The RAND-modified Delphi method (a two-step systematic consensus method) was used to develop two sets of quality indicators for patient-centredness. Similarities and differences in the indicators as well as in aspects of patient-centredness between patients' and professionals' sets of indicators were analysed descriptively., Participants, Setting, Methods: The development of quality indicators for patient-centredness was based on the national multidisciplinary Network Guideline on infertility. Two panels participated: one patients' panel (n = 19) and one multidisciplinary professionals' panel (n = 15)., Main Results and the Role of Chance: From 119 formulated potential indicators of patient-centredness, the patients' panel selected a representative set of 16, while the professionals' panel selected 18. Five indicators were included in both sets. These regarded the need to perform IUI at least 6 days a week; report on treatment outcomes and complications; report on results of semen analyses in a standardized way; counsel infertile couples about the positive effects on their chance of pregnancy of the elimination of a harmful lifestyle and provide information on the negative consequences for achieving a pregnancy in case of a high BMI. Both patients and professionals put highest value on potential indicators of information and communication in fertility care. Patients also emphasized accessibility of care, whereas professionals emphasized coordination and integration as important quality measures for patient-centredness in fertility care., Limitations, Reasons for Caution: First, the total number of developed indicators in the final set is relatively large (n = 29), which could be a first potential limitation in its use for accreditation and quality monitoring. Secondly, although panel members were asked to take reliability into account during the selection procedure, the indicators still need an evaluation of the measurability and the intra- and inter-observer reliability., Wider Implications of the Findings: The final guideline-based indicator set consisting of 29 indicators represents a balanced set that is based on the expertise of all stakeholders, including patients. A next step should be the application of this set in a future practice test to assess the feasibility in daily practice. In our opinion, most quality indicators for patient-centredness could be used for monitoring and improving the quality of fertility care internationally, occasionally by a more broad interpretation (e.g. by replacing the general practitioners with other healthcare professionals engaged in the care process)., Study Funding/competing Interest(s): This study was supported by a research grant (number 150020015) from the Dutch Organisation for Health Research and Development (ZonMw) in a research programme on broadening and acceleration in multidisciplinary guideline development. The authors have no conflicts of interest to declare.

Aim: Twelve to thirty % of colorectal cancer (CRC) patients and relatives with an increased familial risk of CRC are referred for preventive measures. New guidelines recommend genetic counselling for high-risk families and surveillance colonoscopy for moderate-risk families. Assessment of familial risk of CRC and referral rates for these preventive measures were determined 1 year after the introduction of new guidelines., Method: Assessment of familial risk of CRC and referral for preventive measures were measured in clinical practice among 358 patients with CRC in 18 hospitals using medical records and questionnaires. Additionally, a knowledge survey was performed among 312 clinicians., Results: Sixty-seven % of patients with an increased familial risk (n = 65/97) were referred for preventive measures, as were 23% (61/261) of low-risk patients. The uptake of genetic counselling in high-risk families was 33% (12/36). The uptake of surveillance colonoscopy in moderate-risk families was 34% (21/61). In the knowledge survey clinicians correctly determined familial risk in 55% and preventive measures in 65% of cases., Conclusion: Currently 67% of individuals with an increased familial risk of CRC were referred for preventive measures. Only one-third were referred in accordance with guidelines., (© 2013 The Authors. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.)

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., Trial Registration: http://www.clinicaltrials.gov: NCT01261676.

Objective: Hypertensive disorders in pregnancy are one of the main causes of maternal morbidity and mortality. Internationally, several organizations have developed clinical guidelines to assist professionals and to supply patients with the best possible care. To improve the care for this group of patients, insight into the application of clinical guidelines in daily practise is needed. Valid quality indicators are necessary to estimate actual guideline adherence. In this study, we developed a set of valid guideline-based quality indicators for hypertensive diseases in pregnancy., Methods: A systematic RAND-modified Delphi method was used to develop a set of quality indicators on the basis of evidence-based guidelines and literature on hypertension and pregnancy. Experts' opinions were used to select the indicators regarding specific criteria such as efficacy, level of health gain, and potential for care improvement., Results: A representative set of 14 quality indicators was selected from 48 initial guideline recommendations. Indicators concerned both professional performance and organization of care for patients with hypertension in pregnancy., Conclusions: This study describes the systematic, stepwise method used to develop quality indicators that can be used to monitor care for hypertensive diseases in pregnancy.

Background: Patient participation is essential in developing high-quality guidelines but faces practical challenges. Evidence on timing, methods, evaluations, and outcomes of methodologies for patient participation in guideline development is lacking., Objective: To assess the feasibility of a wiki as a participatory tool for patients in the development of a guideline on infertility determined by (1) use of the wiki (number of page views and visitors), (2) benefits of the wiki (ie, number, content, and eligibility of the recommendations to be integrated into the guideline), and (3) patients' facilitators of and barriers to adoption, and the potential challenges to be overcome in improving this wiki., Methods: To obtain initial content for the wiki, we conducted in-depth interviews (n = 12) with infertile patients. Transcripts from the interviews were translated into 90 draft recommendations. These were presented on a wiki. Over 7 months, infertile patients were invited through advertisements or mailings to formulate new or modify existing recommendations. After modifying the recommendations, we asked patients to select their top 5 or top 3 recommendations for each of 5 sections on fertility care. Finally, the guideline development group assessed the eligibility of the final set of recommendations within the scope of the guideline. We used a multimethod evaluation strategy to assess the feasibility of the wiki as a participatory tool for patients in guideline development., Results: The wiki attracted 298 unique visitors, yielding 289 recommendations. We assessed the 21 recommendations ranked as the top 5 or top 3 for their eligibility for being integrated into the clinical practice guideline. The evaluation identified some challenges needed to be met to improve the wiki tool, concerning its ease of use, website content and layout, and characteristics of the wiki tool., Conclusions: The wiki is a promising and feasible participatory tool for patients in guideline development. A modified version of this tool including new modalities (eg, automatically limiting the number and length of recommendations, using a fixed format for recommendations, including a motivation page, and adding a continuous prioritization system) should be developed and evaluated in a patient-centered design.

Background: Beside traditional outcomes of safety and (cost-)effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients' quality of life (QoL) and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients' QoL and distress levels. This paper presents the study protocol., Methods/design: In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire - Infertility), patients' QoL (FertiQoL) and levels of distress (SCREENIVF). The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients' QoL and levels of distress will be collected by an addendum to the patients' questionnaire and a professionals' questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic's culture as a possible determinant of an increase in patient-centered care., Discussion: The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients' QoL and distress in fertility care. Furthermore, determinants associated with a change in these outcome measures will be studied. With knowledge of these results, patient-centered care and thus the quality of healthcare can be improved. Moreover, the results of this study could be useful for similar initiatives to improve the quality of care delivery. The results of this project are expected at the end of 2013., Trial Registration: Clinicialtrials.gov NCT01481064.

Background: Providing high-quality care for children with cancer could improve treatment outcomes, survival and quality of life of the children and parents. The aim of this study is to select high-quality care recommendations for all children with cancer based on literature and consensus for future development of quality indicators., Materials and Methods: We performed an extensive search in databases for scientific literature and in websites of international health care and guideline development organizations to create an inventory of recommendations for the care for all children with cancer. The RAND modified Delphi method was used to grade and select recommendations for high-quality care., Results: Our search resulted in a list of 131 recommendations on care for all children with cancer. The expert panel graded, discussed and prioritized these recommendations. Analysis of these ratings resulted ultimately in a list of 109 high-quality care recommendations for all children with cancer, including 31 prioritized recommendations., Conclusions: This study defines a set of high-quality care recommendations based on literature and consensus. These recommendations provide a basis for the development of a comprehensive set of quality indicators to evaluate care in paediatric oncology.

Discussing a patient in an oncology multidisciplinary team meeting (MTM) increases the value of the quality of the treatment chosen. MTMs are increasingly mentioned in guidelines and indicator sets. Based on literature review and observations, the Comprehensive Cancer Centre Netherlands (CCCNL), in collaboration with IQ Healthcare and the Department of Medical Oncology of the UMC St Radboud Nijmegen in the Netherlands, has conducted research into the quality criteria for a good MTM. Two of our studies show that the organisation of MTMs can be significantly improved. Based on the results, we developed a checklist to accomplish this. The most significant areas of improvement for optimising the organisation of MTMs are: (a) the presence of specialists from all relevant disciplines; (b) a capable chairman who promotes the efficiency of the MTM; and (c) the reduction of intruding factors, such as mobile phones and participants who walk in and out.