General practitioners' adherence to work-up and referral recommendations in fertility care.

STUDY QUESTION: What is the current guideline adherence by general practitioners (GPs) for work-up and subsequent referral from primary to secondary care for patients suffering from infertility? SUMMARY ANSWER: Guideline adherence by GPs concerning infertility was 9.2% in couples referred. WHAT IS KNOWN ALREADY: Adherence to recommendations can decrease unnecessary referral, diagnostics and treatments, and consequently result in lower expenditures. Moreover, patients can be saved from unnecessary hospital visits, emotional burden and out of pocket costs. STUDY DESIGN, SIZE, AND DURATION: A retrospective cohort study among 306 patients referred for basic fertility work-up between January 2011 and June 2013 from primary care to a secondary care teaching hospital or a tertiary hospital with IVF facilities. PARTICIPANTS/MATERIALS, SETTING AND METHODS: Couples were eligible to participate when there was no previous referral for fertility problems and the duration of the child wish was <2 years. Data to assess guideline adherence were collected from the referral letter and the medical records. A patient questionnaire was used to determine patients' general and fertility-related characteristics. MAIN RESULTS AND THE ROLE OF CHANCE: The GP performed a Chlamydia Antibody Titre (CAT) testing and semen analysis as recommended in 15.9% and 42.2% of the referred patients, respectively. According to the guideline, 39% of the couples were under referred (i.e. not immediately referred as recommended), 8.8% were unnecessarily referred and the CAT and semen analysis were unnecessarily repeated in secondary care in 80.0% and 57.1% of cases, respectively. LIMITATIONS REASONS FOR CAUTION: We could not include non-referred patients with expectant management in primary care, an unknown number of whom became pregnant in this period. This may have resulted in an underestimation of primary care performance. WIDER IMPLICATIONS OF THE FINDINGS: Our findings show that guideline adherence concerning work-up and subsequent referral for fertility problems is low. The influence of patient demands for referral remains largely unknown. Barriers and facilitators for guideline adherence should be determined to develop interventions to improve guideline adherence in the areas of work-up and referral for fertility care and to diminish duplicate tests in secondary care. STUDY FUNDING/COMPETING INTEREST(S): Funded by CZ, a Dutch healthcare insurer (grant number AFVV 11-232). CZ 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: Not applicable.

Total motile sperm count: a better indicator for the severity of male factor infertility than the WHO sperm classification system.

STUDY QUESTION: Does the prewash total motile sperm count (TMSC) have a better predictive value for spontaneous ongoing pregnancy (SOP) than the World Health Organization (WHO) classification system? SUMMARY ANSWER: The prewash TMSC shows a better correlation with the spontaneous ongoing pregnancy rate (SOPR) than the WHO 2010 classification system. WHAT IS KNOWN ALREADY: According to the WHO classification system, an abnormal semen analysis can be diagnosed as oligozoospermia, astenozoospermia, teratozoospermia or combinations of these and azoospermia. This classification is based on the fifth percentile cut-off values of a cohort of 1953 men with proven fertility. Although this classification suggests accuracy, the relevance for the prognosis of an infertile couple and the choice of treatment is questionable. The TMSC is obtained by multiplying the sample volume by the density and the percentage of A and B motility spermatozoa. STUDY DESIGN, SIZE, DURATION: We analyzed data from a longitudinal cohort study among unselected infertile couples who were referred to three Dutch hospitals between January 2002 and December 2006. Of the total cohort of 2476 infertile couples, only the couples with either male infertility as a single diagnosis or unexplained infertility were included (n = 1177) with a follow-up period of 3 years. PARTICIPANTS/MATERIALS, SETTING, METHODS: In all couples a semen analysis was performed. Based on the best semen analysis if more tests were performed, couples were grouped according to the WHO classification system and the TMSC range, as described in the Dutch national guidelines for male infertility. The primary outcome measure was the SOPR, which occurred before, during or after treatments, including expectant management, intrauterine insemination, in vitro fertilization or intracytoplasmic sperm injection. After adjustment for the confounding factors (female and male age, duration and type of infertility and result of the postcoital test) the odd ratios (ORs) for risk of SOP for each WHO and TMSC group were calculated. The couples with unexplained infertility were used as reference. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 514 couples did and 663 couples did not achieve a SOP. All WHO groups have a lower SOPR compared with the unexplained group (ORs varying from 0.136 to 0.397). Comparing the couples within the abnormal WHO groups, there are no significant differences in SOPR, except when oligoasthenoteratozoospermia is compared with asthenozoospermia [OR 0.501 (95% CI 0.311-0.809)] and teratozoospermia [OR 0.499 (95% CI: 0.252-0.988)], and oligoasthenozoospermia is compared with asthenozoospermia [OR 0.572 (95% CI: 0.373-0.877)]. All TMSC groups have a significantly lower SOPR compared with the unexplained group (ORs varying from 0.171 to 0.461). Couples with a TMSC of <1 × 10(6) and 1-5 × 10(6) have significantly lower SOPR compared with couples with a TMSC of 5-10 × 10(6) [respectively, OR 0.371 (95% CI: 0.215-0.64) and OR 0.505 (95% CI: 0.307-0.832)]. LIMITATIONS, REASON FOR CAUTION: To include all SOPs during the follow-up period of 3 years, couples were not censured at the start of treatment. WIDER IMPLICATIONS OF THE FINDINGS: Roughly, three prognostic groups can be discerned: couples with a TMSC <5, couples with a TMSC between 5 and 20 and couples with a TMSC of more than 20 × 10(6) spermatozoa. We suggest using TMSC as the method of choice to express severity of male infertility. STUDY FUNDING/COMPETING INTERESTS: None.

Development of guideline-based indicators for patient-centredness in fertility care: what patients add.

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.

Quality indicators for all dimensions of infertility care quality: consensus between professionals and patients.

STUDY QUESTION: What is the relative importance of the six dimensions of quality of care according to different stakeholders and can a quality indicator set address all six quality dimensions and incorporate the views from professionals working in different disciplines and from patients? SUMMARY ANSWER: Safety, effectiveness and patient centeredness were the most important quality dimensions. All six quality dimensions can be assessed with a set of 24 quality indicators, which is face valid and acceptable according to both professionals from different disciplines and patients. WHAT IS KNOWN ALREADY: To our knowledge, no study has weighted the relative importance of all quality dimensions to infertility care. Additionally, there are very few infertility care-specific quality indicators and no quality indicator set covers all six quality dimensions and incorporated the views of professionals and patients. STUDY DESIGN, SIZE AND DURATION: A three-round iterative Delphi survey including patients and professionals from four different fields, conducted in two European countries over the course of 2011 and 2012. PARTICIPANTS/MATERIALS, SETTINGS AND METHODS: Dutch and Belgian gynaecologists, embryologists, counsellors, nurses/midwifes and patients took part (n = 43 in round 1 and finally 30 in round 3). Respondents ranked the six quality dimensions twice for importance and their agreement was evaluated. Furthermore, in round 1, respondents gave suggestions, which were subsequently uniformly formulated as quality indicators. In rounds 2 and 3, respondents rated the quality indicators for preparedness to measure and for importance (relation to quality and prioritization for benchmarking). Providing feedback allowed selecting indicators based on consensus between stakeholder groups. Measurable indicators, important to all stakeholder groups, were selected for each quality dimension. MAIN RESULTS: All stakeholder groups and most individuals agreed that safety, effectiveness and patient centeredness were the most important quality dimensions. A total of 498 suggestions led to the development of 298 indicators. Professionals were sufficiently prepared to measure 204 of these indicators. Based on importance, 52 (7-15 per dimension; round 2) and finally 24 (4 per dimension; round 3) quality indicators were selected. LIMITATIONS, REASONS FOR CAUTION: The final quality indicator set does not cover the entire care process, but rather takes a 'sample' of each quality dimension. Although the quality indicators are face valid and acceptable, their psychometric characteristics need to be tested by further research. WIDER IMPLICATIONS OF THE FINDINGS: Quality management should focus on safety, effectiveness and patient centeredness of care. Clinics can use the quality indicator set to assess all quality dimensions of their care.

Guideline adherence is worth the effort: a cost-effectiveness analysis in intrauterine insemination care.

STUDY QUESTION: Is optimal adherence to guideline recommendations in intrauterine insemination (IUI) care cost-effective from a societal perspective when compared with suboptimal adherence to guideline recommendations? SUMMARY ANSWER: Optimal guideline adherence in IUI care has substantial economic benefits when compared with suboptimal guideline adherence. WHAT IS KNOWN ALREADY: Fertility guidelines are tools to help health-care professionals, and patients make better decisions about clinically effective, safe and cost-effective care. Up to now, there has been limited published evidence about the association between guideline adherence and cost-effectiveness in fertility care. STUDY DESIGN, SIZE, DURATION: In a retrospective cohort study involving medical record analysis and a patient survey (n = 415), interviews with staff members (n = 13) and a review of hospitals' financial department reports and literature, data were obtained about patient characteristics, process aspects and clinical outcomes of IUI care and resources consumed. In the cost-effectiveness analyses, restricted to four relevant guideline recommendations, the ongoing pregnancy rate per couple (effectiveness), the average medical and non-medical costs of IUI care, possible additional IVF treatment, pregnancy, delivery and period from birth up to 6 weeks after birth for both mother and offspring per couple (costs) and the incremental net monetary benefits were calculated to investigate if optimal guideline adherence is cost-effective from a societal perspective when compared with suboptimal guideline adherence. PARTICIPANTS/MATERIALS, SETTING, METHODS: Seven hundred and sixty five of 1100 randomly selected infertile couples from the databases of the fertility laboratories of 10 Dutch hospitals, including 1 large university hospital providing tertiary care and 9 public hospitals providing secondary care, were willing to participate, but 350 couples were excluded because of ovulatory disorders or the use of donated spermatozoa (n = 184), still ongoing IUI treatment (n = 143) or no access to their medical records (n = 23). As a result, 415 infertile couples who started a total of 1803 IUI cycles were eligible for the cost-effectiveness analyses. MAIN RESULTS AND THE ROLE OF CHANCE: Optimal adherence to the guideline recommendations about sperm quality, the total number of IUI cycles and dose of human chorionic gonadotrophin was cost-effective with an incremental net monetary benefit between € 645 and over € 7500 per couple, depending on the recommendation and assuming a willingness to pay € 20 000 for an ongoing pregnancy. LIMITATIONS, REASONS FOR CAUTION: Because not all recommendations applied to all 415 included couples, smaller groups were left for some of the cost-effectiveness analyses, and one integrated analysis with all recommendations within one model was impossible. WIDER IMPLICATIONS OF THE FINDINGS: Optimal guideline adherence in IUI care has substantial economic benefits when compared with suboptimal guideline adherence. For Europe, where over 144,000 IUI cycles are initiated each year to treat ≈ 32 000 infertile couples, this could mean a possible cost saving of at least 20 million euro yearly. Therefore, it is valuable to make an effort to improve guideline development and implementation.

Evaluation of an effective multifaceted implementation strategy for elective single-embryo transfer after in vitro fertilization.

STUDY QUESTION: What is the relationship between the rate of elective single-embryo transfer (eSET) and couples' exposure to different elements of a multifaceted implementation strategy? SUMMARY ANSWER: Additional elements in a multifaceted implementation strategy do not result in an increased eSET rate. WHAT IS KNOWN ALREADY: A multifaceted eSET implementation strategy with four different elements is effective in increasing the eSET rate by 11%. It is unclear whether every strategy element contributes equally to the strategy's effectiveness. STUDY DESIGN AND SIZE: An observational study was performed among 222 subfertile couples included in a previously performed randomized controlled trial. PARTICIPANTS, SETTINGS AND METHODS: Of the 222 subfertile couples included, 109 couples received the implementation strategy and 113 couples received standard IVF care. A multivariate regression analysis assessed the effectiveness of four different strategy elements on the decision about the number embryos to be transferred. Questionnaires evaluated the experiences of couples with the different elements. MAIN RESULTS AND ROLE OF CHANCE: Of the couples who received the implementation strategy, almost 50% (52/109) were exposed to all the four elements of the strategy. The remaining 57 couples who received two or three elements of the strategy could be divided into two further classes of exposure. Our analysis demonstrated that additional elements do not result in an increased eSET rate. In addition to the physician's advice, couples rated a decision aid and a counselling session as more important for their decision to transfer one or two embryos, compared with a phone call and a reimbursement offer (P < 0.001). LIMITATIONS AND REASONS FOR CAUTION: The differences in eSET rate between exposure groups failed to reach significance, probably because of the small numbers of couples in each exposure group. WIDER IMPLICATIONS OF THE FINDINGS: Adding more elements to an implementation strategy does not always result in an increased effectiveness, which is in concordance with recent literature. This in-depth evaluation of a multifaceted intervention strategy could therefore help to modify strategies, by making them more effective and less expensive.

Predicting dropout in fertility care: a longitudinal study on patient-centredness.

STUDY QUESTION: Are clinic factors, including patients' experiences with patient-centred care, associated with dropout in fertility care? SUMMARY ANSWER: Clinic factors, including patients' experiences with patient-centred care, are not related to dropout. WHAT IS KNOWN ALREADY: In fertility care, a significant proportion of patients do not achieve pregnancy because they discontinue treatment prematurely. Many studies have tried to identify factors predicting dropout, showing incompatible results. However, these studies mainly focus on factors at the treatment and patient level, while clinic factors have received little attention. STUDY DESIGN, SIZE, DURATION: This prospective, longitudinal study was nested within a large RCT, which aims to improve the level of patient-centredness of Dutch fertility care. Of the 1620 infertile women who were invited to participate, the baseline measurement of the study (T0) included 693 women who completed a questionnaire about their experiences with patient-centred fertility care. The follow-up of the patients was 1 year (T1). PARTICIPANTS/MATERIALS, SETTING, METHODS: All included women suffered from infertility and were undergoing treatment in one of the 32 Dutch clinics involved in the trial. Levels of patient-centredness were determined using the Patient-Centredness Questionnaire-Infertility (PCQ-Infertility) at T0. Meanwhile, a professionals' questionnaire was used to gather additional information on characteristics of the clinic (e.g. the number of patients per year or the presence of a fertility nurse). After 1 year, at T1 measurement, patients completed a questionnaire on their current status in fertility care, including their main reason for discontinuation if applicable. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 693 non-pregnant women completed the questionnaire set at T0 and 534 women (77.1%) provided consent for follow-up. At T1 measurement, 434 women (81.3%) completed the questionnaire and 153 of these women (35.2%) continued treatment while 76 women (17.5%) dropped out. Another 175 women (40.3%) had achieved pregnancy and 30 patients (7.9%) were advised to discontinue treatment for medical reasons. Neither levels of patient-centredness nor the additional clinic characteristics differed significantly between dropouts and compliers. However, patients who did not receive assisted reproduction treatment (ART; e.g. underwent intrauterine insemination, IUI) before they dropped out had significantly lower scores on the PCQ-Infertility subscale 'Respect for patients' values' than patients who continued their treatment [odds ratio (OR) 0.57; 95% confidence interval (CI) 0.34-0.95]. Patients who received ART and, subsequently, dropped out had higher scores on the PCQ-Infertility subscale 'Patient involvement' than those receiving non-ART (OR 2.39; 95% CI 1.02-5.59). LIMITATIONS, REASONS FOR CAUTION: We were not able to follow-up a significant proportion (ca. 19%) of the 1620 women who were invited for T0 measurement, which might have biased our results. We also excluded patients who were still in the diagnostic work-up stage and this might have influenced our results as it is known that patients dropout at this stage. As the PCQ-Infertility was validated in patients who were already undergoing treatment, we decided to focus on this patient group only. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study provide a better insight into those factors influencing dropout from the perspective of factors in the clinic itself. Although most clinic factors were not related to dropout, clinic factors might be of use when predicting dropout for specific patient groups, such as patients receiving ART and non-ART. Future research should involve an exploration of more specific predictors of dropout at the patient, treatment and clinic levels. STUDY FUNDING/COMPETING INTERESTS: This work was supported by Merck Serono, the Netherlands. No competing interests declared.

Differences in quality of life and emotional status between infertile women and their partners.

STUDY QUESTION: Do the quality of life (QoL) and the risk factors for emotional problems during and after treatment of infertile women differ from their partners? SUMMARY ANSWER: Women have lower levels of fertility-related QoL, and more and differing risk factors for emotional problems during and after treatment than their partners. WHAT IS KNOWN ALREADY?: The psychological impact of infertility in patients negatively affects their QoL and is also related to increased discontinuation of treatment. Moreover, psychological factors might positively affect pregnancy rates. However, it is still unclear if differences in QoL and emotional status exist between infertile women and their partners. So far, research mainly focused on generic instruments to measure patients' QoL in the area of fertility care. STUDY DESIGN, SIZE, DURATION: A cross-sectional study of infertile couples within 32 Dutch fertility clinics. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included infertile women and their partners (both heterosexual and lesbian couples) under any treatment and at any stage of treatment in one of the 32 participating clinics. Per clinic, 25-75 patients were randomly selected depending on clinic size. In total, 1620 women and their partners were invited separately to complete the FertiQoL and SCREENIVF questionnaires to measure their level of QoL and risk factors for emotional problems during and after treatment, respectively. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 946 women (response rate 58%) and 670 partners (response rate 41%) completed the questionnaire set. As 250 women and 150 partners were already pregnant, questionnaires from 696 women and 520 partners could be analysed. Women scored significantly lower on the FertiQoL total scores [B = -6.31; 95% confidence interval (CI) = -7.63 to 4.98] and three of the FertiQoL subscales (Emotional, Mind-Body and Social) than their partners, indicating lower QoL. Scores on the SCREENIVF questionnaire were significantly higher for women (B = 0.22; 95% CI = 0.06-0.38), indicating that women are more at risk for developing emotional problems (and these factors differed from those of their partners) during and after fertility treatment than their partners. LIMITATIONS, REASONS FOR CAUTION: Although the number of participants is high (n = 1216), the relatively low response rate, especially for partners (41%), may have influenced the results through selection bias. An analysis of non-responders could not be performed. The FertiQoL and SCREENIVF questionnaires, which have been validated only in women starting a first IVF cycle, should also be validated for studying partners. In addition, the SCREENIVF questionnaire has been validated in Dutch women only and further research in an international setting is also required. WIDER IMPLICATIONS OF THE FINDINGS: Our study results represent the Dutch infertile population as more than one-third of all Dutch clinics participated in the study. As the FertiQoL questionnaire is an internationally validated questionnaire already, these results can be put in a more broader and international perspective. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by Merck Sharp & Dohme (MSD), The Netherlands. There are no competing interests.

Recurrent miscarriage: do professionals adhere to their guidelines.

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.

Feasibility of screening patients for emotional risk factors before in vitro fertilization in daily clinical practice: a process evaluation.

STUDY QUESTION: Is patient screening for emotional risk factors before starting IVF treatment feasible? SUMMARY ANSWER: Introduction of screening for emotional risk factors by a validated instrument (SCREENIVF) in couples treated by IVF or ICSI is feasible, indicated by a moderate to high and stable uptake rate, a high acceptance of the process of SCREENIVF, and a high acceptability of the presented risk profile by the patients. WHAT IS KNOWN ALREADY: SCREENIVF is a validated screening tool to identify women at risk for emotional maladjustment preceding the start of their IVF/ICSI treatment. STUDY DESIGN, SIZE AND DURATION: This was a prospective cohort study, including data of two cohorts of patients (304 and 342 patients), with a duration of 3 months per cohort. For the first cohort, we sent a process evaluation to 210 patients and it was completed by 91 patients. PARTICIPANTS/MATERIALS, SETTING AND METHODS: All 304 patients (male and female) who started IVF/ICSI between 1 December 2009 and 28 February 2010 in our tertiary IVF clinic were eligible. The uptake rate of SCREENIVF was assessed as the response rate to the screening questionnaire. One year later, we re-assessed the uptake rate in 342 new patients to assess the stability of the uptake rate. A non-responder assessment in patients who did not complete SCREENIVF was carried out. Finally, patients' characteristics and their experiences with SCREENIVF as well as their consequent actions were assessed by an additional process evaluation questionnaire sent some months later to 210 patients. MAIN RESULTS AND THE ROLE OF CHANCE: The uptake rate of SCREENIVF was 78-80%. One-third of the responders were found to be at risk for emotional maladjustment, which was comparable with previous studies using SCREENIVF. Of 27 non-responders to SCREENIVF, 41% explained non-response by 'no actual need for psychological help' and 19% forgot to complete the screening. The response rate to the process evaluation was 43% (n = 91). Of these, 90% found the screening was useful, and almost all patients were positive about the SCREENIVF questionnaire. Furthermore, 93% recognized themselves in the risk profile based on SCREENIVF. Of the patients at risk, 21% reported planning to seek professional help, but 46% of the at-risk patients experienced travelling distance as an obstacle to seek psychological help. We concluded that screening patients for emotional risk factors is feasible. In future, psychosocial care offered by the Internet may be promising in meeting the barrier of travelling distance. LIMITATIONS, REASONS FOR CAUTION: People were asked to fill in SCREENIVF for clinical purposes pretreatment. There might be a selection bias in the people who did not fill in SCREENIVF, which may be due to already existing psychological problems or language problems. The low response rate of the process evaluation questionnaire and the mono-centre evaluation may be confounders and may have influenced our analysis opportunities. WIDER IMPLICATIONS OF THE FINDINGS: The generalizability of this data is unknown with respect to other ethnic groups. Furthermore, more research is needed to evaluate psychosocial factors in male partners. Future research should also focus on the barriers and facilitators for help-seeking behaviour. STUDY FUNDING/COMPETING INTEREST(S): There was no funding for this study and no conflict of interest.

How patient-centred care relates to patients' quality of life and distress: a study in 427 women experiencing infertility.

BACKGROUND: The aim of this study was to investigate to what extent patients' experiences with fertility care are associated with their quality of life (QoL), and levels of anxiety and depression. METHODS: We performed a cross-sectional questionnaire study within 29 Dutch fertility clinics, including women with fertility problems. Through multilevel regression analyses, associations between patients' QoL (FertiQoL) and distress [anxiety and depression; Hospital Anxiety and Depression Scale (HADS)] and their experiences with fertility care [patient-centredness questionnaire (PCQ)-infertility] were determined. For all multilevel models, R² and intra-cluster correlation coefficients were calculated. RESULTS: This study included 427 non-pregnant patients who filled out the FertiQoL, HADS and PCQ-infertility (response rate 76%). Multilevel regression analysis showed significant associations between the PCQ total scale, the total FertiQoL scale (B = 0.25), and HADS subscales (B = -0.22 and -0.18). Of the variance in patients' experiences, 13% (=R²) could be explained by their perceived QoL, 12% by their level of anxiety and 10% by their level of depression. CONCLUSIONS: Patient-centredness in fertility care and the patients' QoL and anxiety and depression scores are related. Paying attention to these variables could lead to positive care experiences and improved patient-centredness of care. Future research should focus on identifying causal relationships among these variables.

Tailored expectant management: a nationwide survey to quantify patients' and professionals' barriers and facilitators.

BACKGROUND: Prognostic models for natural conception help to identify subfertile couples with high chances of natural conception, who do not need fertility treatment yet. The use of such models and subsequent tailored expectant management (TEM) is not always practiced. Previous qualitative research has identified barriers and facilitators of TEM among patients and professionals. The aim of this study was to assess the prevalence of those barriers and facilitators and to evaluate which factors predict patients' appreciation of TEM and professionals' adherence to TEM. METHODS: We performed a nationwide survey. Based on the previously identified barriers and facilitators two questionnaires were developed and sent to 195 couples and 167 professionals. Multivariate analysis was performed to evaluate which factors predicted patients' appreciation of TEM and professional adherence to TEM. RESULTS: In total, 118 (61%) couples and 117 (70%) professionals responded and 96 couples and 117 professionals were included in the analysis. Patients' mean appreciation of TEM was 5.7, on a 10-point Likert scale. Patients with a lower appreciation of TEM had a higher need for patient information (P = 0.047). The professionals reported a mean adherence to TEM of 63%. Adherence to TEM was higher when professionals were fertility doctors (P = 0.041). Facilitators in the clinical domain were associated with a higher adherence to TEM (P = 0.091). Barriers in the professional domain had a negative impact on adherence to TEM (P = 0.008). CONCLUSIONS: The limited implementation of TEM is caused by both patient and professional-related factors. This study provides practical tools to improve the implementation of TEM.

The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.

STUDY QUESTION: How patient-centered are two included specialized endometriosis clinics relative to each other and how can they improve the patient-centeredness of their care? SUMMARY ANSWER: The validated ENDOCARE questionnaire (ECQ) reliably concluded that the adjusted overall patient-centeredness did not differ between the clinics, that each clinic was significantly more patient-centered for 2 out of 10 dimensions of patient-centered endometriosis care and that clinics 1 and 2 had to improve 8 and 13 specific care aspects, respectively. WHAT IS KNOWN ALREADY: Patient-centered endometriosis care is essential to high-quality care and is defined by 10 dimensions. The ECQ was developed, validated and proved to be reliable in a European setting of self-reported endometriosis patients but had not yet been used at a clinic level for quality management. STUDY DESIGN, SIZE, DURATION: A cross-sectional survey was disseminated in 2011 to all 514 women diagnosed with endometriosis during a laparoscopy indicated for pain and/or infertility during a retrospective 2-year period (2009-2010) in two university clinics from two different European countries. PARTICIPANTS/MATERIALS, SETTING, METHODS: In total 337 patients completed the ECQ (216 and 121 per clinic). Respondents had a mean age of 34.3 years. Three in four reported a surgical diagnosis of moderate or severe endometriosis and the majority reported surgical treatment by a multidisciplinary team. The ECQ assessed the 10 dimensions of patient-centeredness, more specifically whether the health-care performance, as perceived by patients, measured up to what is important to patients in general. MAIN RESULTS: The ECQ was completed by 337 respondents (response rate = 65.6%). Reliability and validity of the ECQ for use on clinic level were confirmed. Clinics did not differ in overall mean importance scores; importance rankings of the ECQ dimensions were almost identical. The overall patient-centeredness scores (PCS), adjusted for education level, did not discriminate between the clinics. However, the adjusted PCS for the dimensions 'clinic staff' and 'technical skills' were significantly better in clinic 1, whereas the dimensions 'physical comfort' and 'access to care' were significantly better in clinic 2. There were 8 (clinic 1) and 13 (clinic 2) targets identified for joint and cross-clinic improvement. LIMITATIONS, REASONS FOR CAUTION: Response rates were relatively high. Recall bias was the most important limitation and research in more clinics is needed to define the statistical discriminative value of the ECQ. WIDER IMPLICATIONS OF THE FINDINGS: European endometriosis clinics can use the validated ECQ for reliable assessment of their 'patient-centeredness', for comparison with others and for setting specific targets to improve the patient-centeredness of their endometriosis care, to plan interventions, and to evaluate their effectiveness. STUDY FUNDING/COMPETING INTEREST: This work was funded by KU Leuven and European Network of Endometriosis (ENE), supported by the European Commission (Public Health Executive Agency). No competing interests are declared.

Patients from across Europe have similar views on patient-centred care: an international multilingual qualitative study in infertility care.

BACKGROUND: International patient centredness concepts were suggested but never conceptualized from the patients' perspective. Previously, a literature review and a monolingual qualitative study defined 'patient-centred infertility care' (PCIC). The present study aimed to test whether patients from across Europe value the same aspects of infertility care. METHODS: An international multilingual focus group (FG) study with 48 European patients from fertility clinics in Austria, Spain, the UK and Belgium, with deductive content analysis. RESULTS: All specific care aspects important to participants from all countries could be allocated to the 10 dimensions of PCIC, each discussed in every FG, including: 'information provision', 'attitude of and relationship with staff', 'competence of clinic and staff', 'communication', 'patient involvement and privacy', 'emotional support', 'coordination and integration', 'continuity and transition', 'physical comfort' and 'accessibility'. Most specific care aspects (65%) were discussed in two or more countries and only a few new codes (11%) needed to be added to the previously published coding tree. Rankings from across Europe clearly showed that 'information provision' is a top priority. CONCLUSIONS: The PCIC-model is the first patient-centred care (PCC) model based on the patients' perspective to be validated in an international setting. Although health-care organization and performance differ, the similarities between countries in the infertile patients' perspective were striking, as were the similarities with PCC models from other clinical conditions. A non-condition specific international PCC model and a European instrument for the patient centredness of infertility care could be developed. European professionals can learn from each other on how to provide PCC.

Relationship between quality of life and distress in infertility: a validation study of the Dutch FertiQoL.

BACKGROUND: This study examined the relationship between emotional distress as measured by the Hospital Anxiety and Depression Scale (HADS) and the Fertility Quality of Life (FertiQoL) questionnaire. METHODS: The FertiQoL and HADS were distributed to a random sample of 785 patients attending 29 Dutch clinics for medically assisted reproduction. FertiQoL was psychometrically tested for reliability. Pearson's correlations were calculated between subscales of FertiQoL and HADS. Using an independent t-test, differences between patient subgroups were computed for both instruments. The threshold for clinically meaningful depression/anxiety on the HADS subscales was used to ascertain the critical threshold for high distress on the FertiQoL scales. RESULTS: FertiQoL and HADS were completed by 583 patients (response 74%). Reliability of FertiQoL scales was high (reliability coefficient between 0.72 and 0.91). Significant negative correlations were found between FertiQoL subscales and HADS scores for anxiety and depression, ranging from -0.29 to -0.71. Means on FertiQoL scales and HADS scales of couples undergoing an assisted reproductive technology (ART) treatment and a non-ART treatment did not differ significantly. Patients scoring above the HADS threshold for pathology on anxiety had an average FertiQoL score of 58.8, whereas patients exceeding the HADS depression threshold had a FertiQoL total score of 51.9 (range 0-100). CONCLUSIONS: Our study confirms the expected negative relation between quality of life as measured by FertiQoL and anxiety and depression. The data support that FertiQoL reliably measures QoL in women facing infertility. FertiQoL enables clinicians to tailor care more specifically to the patient in a comprehensive way.

Selective karyotyping in recurrent miscarriage: are recommended guidelines adopted in daily clinical practice?

BACKGROUND: Couples with recurrent miscarriage (RM) have an increased risk of one of the partners carrying a structural chromosome abnormality. On the basis of four independent risk factors, an evidence-based model was developed, which allows limiting karyotyping to high-risk couples. The aim of this study was to assess the level of adoption of selective karyotyping, its clinical consequences and the factors at the patient and hospital level that determine adoption. METHODS: A retrospective cohort study was performed in nine Departments of Obstetrics and Gynaecology, the Netherlands, in 2006. Selective karyotyping was defined as offering karyotyping to high-risk couples and refraining from karyotyping in low-risk couples. Data were collected for risk factors as described in the model for selective karyotyping, cytogenetic results as a measure for clinical consequences, and information about determinants and costs. RESULTS: A total of 530 couples were included; 252 (48%) high-risk couples and 278 (52%) low-risk couples. Among the high-risk couples, 186 (74%) were offered karyotyping. Although not advised, karyotyping was still performed in 198 (71%) low-risk couples. Overall, selective karyotyping was offered to 50% of the couples. The main determinants for adoption of the model were maternal age, obstetric history, treatment by specialists in RM and the number of patients per centre. If selective karyotyping was adopted adequately, a potential reduction of 34% of all karyotyping tests performed is possible. CONCLUSION: Selective karyotyping is applied in only half of the couples with RM in daily practice. Implementation of selective karyotyping should be a topic of future research.

Professionals' perceptions of their patients' experiences with fertility care.

BACKGROUND: Patient-centredness is one of the core dimensions of quality of care. It can be monitored with surveys measuring patients' experiences with care. The objective of the present study was to determine to what extent gynaecologists, physicians specializing in infertility and nurses can estimate the level of patient-centredness of their clinic. METHODS: A random sample of 1189 couples with fertility problems and 194 physicians and nurses from 29 Dutch fertility clinics participated in this cross-sectional study. Differences between patients' experiences with fertility care and professionals' perceptions of these experiences as measured with the patient-centredness questionnaire-infertility (PCQ-infertility) were calculated. The questionnaire's structure, comprising one total scale (level 1), seven subscales (level 2) and 46 single items (level 3), was used as a framework. RESULTS: Response rates were 75% (n = 888) in the patient sample and 83% (n = 160) in the professional sample. Independent sample t-tests, corrected for multiple comparisons with the Bonferroni correction method (P < 0.05), showed no significant differences in mean scores on the total scale of patient-centredness for either professionals or patients. At level 2, professionals underestimated most subscales, namely, 'Accessibility', 'Communication', 'Patient involvement' and 'Competence', whereas 'Continuity of care' was overestimated. Professionals significantly and clinically relevantly misjudged 29 care aspects. CONCLUSIONS: Professionals within fertility care cannot adequately evaluate their performance regarding patient-centredness, and specifically the care aspects to which their own patients attribute the greatest improvement potential. Providing detailed feedback might start improvement of patient-centredness and quality of care.

Patient-centred infertility care: a qualitative study to listen to the patient's voice.

BACKGROUND High-quality care for patients faced with infertility should be patient-centred. Few studies have provided in-depth insights into the patient's perspective on care and, to the best of our knowledge, no study has provided a model of the complex concept 'patient-centred infertility care'. Therefore, a qualitative study aimed at understanding 'patient-centred infertility care' from the patient's perspective was conducted. METHODS Fourteen focus group discussions were organized with patients (n = 103) from two European countries to find out about patients' positive and negative experiences with infertility care. Content analysis of the transcripts and analysis of patients' priority lists were conducted. RESULTS The patient-centredness of infertility care depends on 10 detailed dimensions, which can be divided into system and human factors, and there is a two-way interaction between both kinds of factors. System factors, in order of patient's priority, are: provision of information, competence of clinic and staff, coordination and integration, accessibility, continuity and transition and physical comfort. Human factors, in order of patient's priority, are: attitude of and relationship with staff, communication, patient involvement and privacy and emotional support. CONCLUSIONS This study provides a detailed patient's description of the concept 'patient-centred infertility care' and an interaction model that aids understanding of the concept. Fertility clinics are encouraged to improve the patient-centredness of their care by taking into account the detailed description of the dimensions of patient-centred infertility care, and by paying attention to both system and human factors and their interaction when setting up 'patient-centred improvement projects'.

Unexplained infertility: overall ongoing pregnancy rate and mode of conception.

BACKGROUND: Unexplained infertility is one of the most common diagnoses in fertility care. The aim of this study was to evaluate the outcome of current fertility management in unexplained infertility. METHODS: In an observational, longitudinal, multicentre cohort study, 437 couples were diagnosed with unexplained infertility and were available for analysis. They were treated according to their prognosis using standing national treatment protocols: (i) expectant management-IUI-IVF (main treatment route), (ii) IUI-IVF and (iii) directly IVF. Primary outcome measures were: ongoing pregnancy rate, patient flow over the strategies, numbers of protocol violation and drop out rates. A secondary outcome measure was the prediction of ongoing pregnancy and mode of conception. RESULTS: Of all couples 81.5% (356/437) achieved an ongoing pregnancy and 73.9% (263/356) of the pregnancies were conceived spontaneously. There were 408 couples (93.4%) in strategy-1, 21 (5.0%) in strategy-2 and 8 (1.8%) in strategy-3. In total, 33 (7.6%) couples entered the wrong strategy. There were 104 couples (23.8%) who discontinued fertility treatment prematurely: 26 on doctor's advice (with 4 still becoming pregnant) and 78 on their own initiative (with 33 still achieving a pregnancy). Predictors for overall pregnancy chance and mode of conception were duration of infertility, female age and obstetrical history. CONCLUSIONS: Overall success rate in couples with unexplained infertility is high. Most pregnancies are conceived spontaneously. We recommend that if the pregnancy prognosis is good, expectant management should be suggested. The prognosis criteria for treatment with IUI or IVF needs to be investigated in randomized controlled trials.

Follow-up of children born after ICSI with epididymal spermatozoa.

BACKGROUND: To evaluate the safety of ICSI with epididymal sperm, this study compared children born after ICSI treatment with epididymal sperm and children conceived after IVF and ICSI with ejaculated sperm. Additionally, the results of a multidisciplinary, multicentre follow-up of the children conceived with epididymal sperm at 2 years of age are described. METHODS: This follow-up study included 378 children conceived after ICSI with epididymal sperm (percutaneous epididymal sperm aspiration: PESA group) and a control group of 1192 IVF and 1126 ICSI (with ejaculated sperm) children, all with a gestational age of 20 weeks or more. Questionnaires were sent at birth, 1 year and 4 years of age, collecting data on parental, pregnancy and child factors. A total of 148 PESA children were assessed at 2 years of age for motor performance, mental- and language development and compared with the Dutch norms. RESULTS: PESA children showed no increased risks for stillbirths, total deaths and malformations. They also did not differ from IVF and ICSI children in gender rate, birthweight and gestational age. The mental Bayley score was higher (P < 0.05) for PESA singletons and parents reported fewer (P < 0.05) behavioural problems in the PESA group than the Dutch reference group. The scores for syntactic and lexical development for the PESA singletons were better (P < 0.05) than the Dutch standards. CONCLUSIONS: ICSI with epididymal sperm does not lead to more stillbirths or congenital malformations in comparison to IVF and ICSI with ejaculated sperm and does not lead to poor development in comparison with the Dutch reference group.