Web-based Guidance for Assisted Reproductive Technology With an Online App (myFertiCare): Quantitative Evaluation With the HOT-fit Framework.

BACKGROUND: Assisted reproductive technologies (ARTs) are considered to be physically and mentally stressful. During their treatment trajectory, couples express high information and communication needs. They appreciate using the internet to obtain fertility-related information. In a previous study, we developed myFertiCare, an eHealth tool providing personalized information and interactive functionalities for infertile couples in order to improve patient-centered care. The app has already been successful in qualitative evaluations of usability. OBJECTIVE: The aim of the current study is to quantitatively evaluate the implementation of myFertiCare by using the human, organizational, and technology-fit (HOT-fit) framework and to study the effects of using myFertiCare on couples' knowledge about infertility, their experience of the burden of infertility, and their experience of patient-centered care. With these results, implementation can be further improved, and patient-centered care can be enhanced. METHODS: A quantitative study was performed based on the HOT-fit framework using validated questionnaires focusing on the human, organizational, and technology domains. Questions were added on the effect of using myFertiCare on couples' knowledge about infertility and treatment. Questions regarding the burden of infertility, the burden of infertility treatment, and the experience of patient-centeredness were based on the main items of the validated fertility quality of life (FertiQoL) and Patient-Centredness Questionnaire-Infertility questionnaires, respectively. Also, nonusers of the app were included to explore motivations for not using the app and identify opportunities for improvement. Finally, user data were analyzed to provide insight into multiple variables concerning app use. RESULTS: In the human and technology domains, myFertiCare showed good system usability, high user satisfaction, and high information and interface quality. In the organizational domain, implementation was considered to be sufficient by both patients and staff. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. User data showed that women were the main app users and that use of the app gradually declined during the treatment trajectory. CONCLUSIONS: A multi-faceted online app, myFertiCare, has been successfully evaluated quantitatively for implementation by using the HOT-fit framework. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. App use could be improved by creating more publicity. By providing myFertiCare, professionals in fertility care are supported in guiding patients through their treatment trajectory and in delivering patient-centered care.

The Relation between Patient-Centered Care and Quality of Life in Women with Endometriosis.

OBJECTIVE: The objective of this study was to examine the hypothesis that experiences with patient-centered endometriosis care are related to the endometriosis-specific quality of life dimensions "emotional well-being" and "social support." DESIGN: A secondary regression analysis of two cross-sectional studies was conducted. Participants/Materials: In total, data from 300 women were eligible for analysis. The participating women all had surgically proven endometriosis. SETTING: The study was conducted in one secondary and two tertiary endometriosis clinics in the Netherlands. Questionnaires were disseminated between 2011 and 2016. METHODS: Both included studies investigated patient-centeredness of endometriosis care and endometriosis-specific quality of life using, respectively, the ENDOCARE questionnaire (ECQ) and the Endometriosis Health Profile 30 (EHP-30). To increase power, the regression analysis focused on the previously found relation between the ten dimensions of the ECQ and the EHP-30 domains "emotional well-being" and "social support" rather than all five EHP-30 domains. After the Bonferroni correction to limit type 1 errors, the adjusted p value was 0.003 (0.05/20). RESULTS: The participating women had a mean age of 35.7 years and had predominantly been diagnosed with moderate to severe endometriosis. None of the relations between patient-centered endometriosis care and the EHP-30 domain "emotional well-being" were significant. Three dimensions of patient-centered endometriosis care proved to be significantly related to the EHP-30 domain "social support": "information, communication, and education" (p < 0.001, beta = 0.436), "coordination and integration of care" (p = 0.001, beta = 0.307), and "emotional support and alleviation of fear and anxiety" (p = 0.002, beta = 0.259). LIMITATIONS: This cross-sectional study identified relations rather than proving causality between experiencing less patient-centeredness of care and having lower quality of life. Nevertheless, it is very tangible that some causality exists, either directly or indirectly (e.g., through empowerment) and that by improving patient-centeredness, quality of life might be improved as well. CONCLUSION: "Information, communication, and education"; "coordination and integration of care"; and "emotional support and alleviation of fear and anxiety" as dimensions of patient-centered endometriosis care are related to the quality of life domain "social support" of women with endometriosis. Improving the patient-centeredness of endometriosis care was already considered an important goal, but even more so given its relation with women's quality of life, which is increasingly considered the ultimate measure of health care quality. Quality improvement projects focusing on "information, communication, and education" are expected to impact women's quality of life the most.

Exploration of fertility and early menopause related information needs and development of online information for young breast cancer survivors.

BACKGROUND: Approximately half of premenopausal women diagnosed with breast cancer desire to conceive after they finish treatment. Counseling about the risk of infertility prior to cancer treatment has been proven to improve quality of life after cancer treatment. As a result of this, guidelines focus on informing women on this topic prior to treatment. However, it is equally important to provide fertility related information after primary treatment has been completed, when the wish to conceive might become actual. Therefore, the aim of this study was to identify the fertility and early menopause related information needs of young breast cancer survivors and to design, develop and implement online information material with input of stakeholders. METHODS: A phenomenological qualitative study consisting of four phases was performed: identification of information needs through semi-structured interviews from a professional perspective (1) and a patient perspective (2). Exploration of stakeholders perspective regarding development and implementation of online information material (3) and development and implementation of the information material (4). RESULTS: Professionals indicated that there are no guidelines regarding the provision of fertility related information during cancer survivorship. Survivors reported unmet information needs. Women identified the following as most important information needs (a) fertility preservation options, (b) the risk of menopause or infertility, and (c) long term consequences of early menopause. A wide range of stakeholders involved in breast cancer care were interviewed. Based on their proposed design the information material was implemented on a nationwide website aiming at informing and supporting breast cancer patients. CONCLUSIONS: Fertility and early menopause related information needs of young breast cancer survivors and their professionals were identified. Information material has been designed, developed and nationally implemented. This way, professionals in breast cancer care are provided with an information tool that helps them meet the information needs and preferences of their patients.

The Tell me tool: The development and feasibility of a tool for person-centred infertility care.

BACKGROUND: An important-and often missing-element of person-centred care is the inclusion of individual patients' values and preferences. This is challenging but especially important for high-burden fertility treatments. We describe the development of a clinical tool that aims to facilitate the delivery of person-centred fertility care by giving insight into the patients' values and preferences. METHODS: We developed the Tell me tool following the three principles of user-centred design: (1) early and continual focus on users; (2) iterative design; (3) measurement of user behaviour. Accordingly, our methods consisted of three phases: (1) conducting semi-structured interviews with 18 couples undergoing fertility treatment, followed by a consensus meeting with relevant stakeholders; (2) performing seven iterative improvement rounds; (3) testing the feasibility of the tool in 10 couples. RESULTS: The Tell me tool consists of a ranking assignment of 13 themes and two open-ended questions. These themes relate to the couples' wellbeing and experience of the treatment, such as mental health and shared decision making. The open-ended questions ask them to write down what matters most to them. The field test showed variation between the individual patients' answers. The tool proved to highlight what is important to the individual patient and gives insight into patients' personal contexts. CONCLUSIONS: We developed a tool that gives insight into the values and preferences of the individual patient. The tool seems feasible for facilitating person-centred fertility care. PATIENT OR PUBLIC CONTRIBUTION: The tool was developed with a user-centred design that strongly involved patients.

Web-Based Guidance Through Assisted Reproductive Technology (myFertiCare): Patient-Centered App Development and Qualitative Evaluation.

BACKGROUND: Providing patient-centered fertility care is known to improve quality of life and can reduce anxiety and depression. In a previous study, we established the need for a web-based app providing personalized information and interactive functionalities among couples undergoing intracytoplasmic sperm injection with surgically retrieved sperm. OBJECTIVE: This study aimed to design, develop, and qualitatively evaluate a multifaceted web-based app for infertile couples undergoing intracytoplasmic sperm injection with surgically retrieved sperm during their treatment trajectory. METHODS: The web-based app was developed in three phases: (1) we established a patient-centered functional design, (2) developed the app in collaboration with medical and technical professionals, and (3) qualitatively evaluated the app among couples using a think-aloud method. RESULTS: The basis of the app is the couple's visualized treatment trajectory. The app provides personalized and interactive functionalities; for example, customized information and communication options. During qualitative evaluation, myFertiCare was highly appreciated and received a median score of 8 out of 10. The main improvements made upon conclusion of the think-aloud sessions were related to faster login and easier app navigation. CONCLUSIONS: A patient-centered web-based app aimed at guiding couples through their fertility treatment course was systematically designed, developed, and positively evaluated by patients and medical and technical professionals.

Key recommendations for high-quality female oncofertility care based on international clinical practice guidelines.

RESEARCH QUESTION: Which guideline-based key recommendations can be selected for high-quality female oncofertility care? DESIGN: The Delphi method was used to select a set of key recommendations for female oncofertility care. First, recommendations from (inter)national clinical practice guidelines were selected in four domains: risk communication, referral, counselling and decision-making. Thereafter, they were scored, per domain, on their importance for high-quality oncofertility care by a multidisciplinary, oncofertility expert panel, consisting of patients, referrers and counsellors, in two Delphi rounds. Finally, the selected key recommendations were presented for approval in a third round. Differences in perspectives between subgroups of the expert panel were analysed. RESULTS: A panel of 86 experts was asked to select key recommendations for high-quality oncofertility care. Eleven key recommendations were selected. Key recommendations in the domains risk communication and referral focused on information provision and offering referral to a reproductive specialist to female cancer patients. With the counselling domain, key recommendations focused on all aspects of counselling, including different methods, safety, pros and cons. In the decision-making domain, key recommendations focused on shared decision-making and supporting the decision with written information. The final set of key recommendations was approved by 91% of the experts. Differences in perspectives were found between subgroups. Patients found recommendations on decision-making and information provision more important. CONCLUSION: A set of 11 key recommendations for high-quality female oncofertility care was selected by a multidisciplinary expert panel. The involvement of the perspectives of patients, referrers and counsellors led to this valid, acceptable and credible set of key recommendations.

Barriers and facilitators to the timely diagnosis of endometriosis in primary care in the Netherlands.

BACKGROUND: Endometriosis is an invalidating gynaecological condition in women of reproductive age, and a frequent cause of infertility. Unfortunately, the condition is characterized by a long interval between onset of symptoms and diagnosis. GPs in the Netherlands are educated to provide basic gynaecological care and serve as gatekeepers for specialist medical care. Therefore, it is of great importance that they recognize signs and symptoms possibly caused by endometriosis to initiate adequate actions. OBJECTIVE: The main objective of this study was to identify barriers and facilitators to the timely diagnosis of endometriosis from the GPs' perspective. METHODS: Semi-structured focus group discussions with GPs were organized throughout the Netherlands. The participants were encouraged to brainstorm about their perspective on daily practice regarding endometriosis and suggestions for interventions to enable early diagnosis and treatment. Analysis was based on grounded theory methodology. RESULTS: Forty-three GPs participated in six focus groups. Analysis of the transcripts revealed relevant determinants of practice in four main themes: professionals' experience and competence, patient characteristics, guideline factors and professional collaboration. A lack of knowledge and awareness appeared to result in a low priority for establishing the diagnosis of endometriosis, especially in young women. Infertility, patient engagement and a recent serious case or training facilitated referral. CONCLUSION: Several factors in daily primary health care contribute to the diagnostic delay in endometriosis. Future interventions to reduce this delay may be aimed at increasing awareness by means of education, incorporating the subject into national clinical guidelines and improvements in interdisciplinary collaboration.

Assessment of reflectance confocal microscopy for non-invasive selection of optimal ovarian cortex fragments for autotransplantation.

RESEARCH QUESTION: Can reflectance confocal microscopy (RCM) be used to determine follicle density in human ovarian cortex fragments that are intended for fertility restoration? DESIGN: RCM was used on living cortex tissue fragments derived from five bovine ovaries and 13 human ovaries. All tissue fragments were cryopreserved and thawed before RCM analysis. Follicle numbers and distribution were determined by RCM and histology. Before and after RCM, general tissue viability and follicle integrity were assessed by a glucose uptake assay and neutral red staining, respectively. RESULTS: RCM can detect all stages of follicle development in living ovarian tissue to a maximum depth of 250 µm. In bovine tissue, all follicles were located within this 0-250 µm range. In human ovarian tissue, follicles were also present below the 250 µm RCM threshold, implying that only a percentage of the total number of follicles could be detected with RCM. The percentage of follicles detected by RCM appeared to be age dependent. The RCM procedure did not affect the glucose uptake by the tissue, whereas neutral red staining indicated a high level of follicle survival. CONCLUSION: In this proof of concept study, we have shown that RCM is a promising technique to determine the density of follicles ex vivo in living human ovarian cortex fragments, apparently without compromising the vitality of the tissue. Safety studies and further optimization of the RCM technique with a focus on increasing the penetration depth are required before clinical use of RCM.

Clinical practice guidelines for fertility preservation in young women undergoing gonadotoxic treatment: an overview and critical appraisal of methodological quality and content.

RESEARCH QUESTION: What is the methodological quality and content of internationally available clinical practice guidelines (CPGs) on fertility preservation (FP) care in adult women? DESIGN: Internationally available CPGs on FP care in adult women were identified after conducting an extensive literature search and consulting (inter)national key experts. The methodological quality of the CPGs was appraised by an (inter)national panel of experts using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. The content of the best CPGs, scoring ≥60% for the domain 'Rigour of development' of the AGREE II instrument, was extracted and categorized according to their topic. RESULTS: Thirty of the 1808 documents found were included. After consulting (inter)national key experts, 30 CPGs were included, six of which scored ≥60% for their 'Rigour of development'. The number of FP-related topics discussed by these six CPGs ranged from 4 to 12. The number of recommendations provided by the CPGs on these topics varied. The number of topics to which ≥5 recommendations were dedicated ranged from 0 to 4 between CPGs. CONCLUSION: CPGs on the subject of FP care are available, but there is room for improvement in quality and content. Although written for use in daily practice, the CPGs can also be used to develop quality indicators to monitor the quality of current FP care or to evaluate future improvement initiatives.

The association between experiences with patient-centred care and health-related quality of life in women with endometriosis.

In this cross-sectional study, we investigated whether patient-centred endometriosis care (PCEC) is associated with health-related quality of life (HRQOL). Dutch-speaking women with endometriosis, treated by laparoscopy in a university clinic between 2009 and 2010, were eligible (n = 194). Endometriosis Health Profile-30 and ENDOCARE questionnaire were used to assess HRQOL and PCEC, respectively. Overall and subscale scores were converted to a scale from 0 (best score) to 100 (worst score). Linear regression analyses were conducted while controlling for confounders. Participants (n = 109) had a mean age of 35.4 years; 79.6% had moderate-severe endometriosis. Mean scores for overall HRQOL and PCEC were 29.3/100 and 38.0/100, respectively. The PCEC-subscale 'continuity' was significantly associated with overall HRQOL (P = 0.029). A significant association was found between overall PCEC and the HRQOL-subscale 'social support' (P = 0.026). The PCEC-subscales 'information' and 'continuity' were significantly associated with the HRQOL-subscales 'emotional wellbeing' and 'social support' (P < 0.05). The PCEC-subscale 'respect' was significantly associated with the HRQOL-subscale 'emotional wellbeing' (P = 0.023). Multivariable regression analyses produced no significant associations, including all subscales of PCEC. Providing PCEC could lead to better HRQOL, especially if paying attention to 'continuity', 'respect' and 'information'. Large-scale longitudinal research is needed.

De-implementation of urodynamics in The Netherlands after the VALUE/VUSIS-2 results: a nationwide survey.

INTRODUCTION AND HYPOTHESIS: We aimed to estimate the level of de-implementation of preoperative routine urodynamics (UDS) before stress urinary incontinence (SUI) surgery in The Netherlands and to analyze facilitators and barriers. Routine UDS was performed by 37% of the medical specialists in 2010. We hypothesized that the recommendations from the recent Value of Urodynamics prior to Stress Incontinence Surgery (VUSIS) and Value of Urodynamic Evaluation (ValUE) studies would have been followed by a reduction of routine UDS. METHODS: A national survey was performed among all Dutch gynecologists and urologists dealing with SUI in daily practice. The questionnaire contained two parts: (1) respondents' characteristics and their actual care concerning preoperative UDS, and (2) facilitators and barriers. RESULTS: The response rate was 41% (127/308). Of the respondents, 93% (n = 118) did not perform routine UDS in the preoperative workup for women in this group. Professional characteristics associated with not following the recommendations were profession urologist, academic hospital, and a lower number of midurethral sling (MUS) placed yearly. Facilitators to follow the recommendation not to perform routine UDS were adequate design of the VUSIS-II study and outcome and recommendations from the studies. Barriers not to follow the recommendation were believe in the additional value of UDS, especially the pressure transmission ratio, and the presence of detrusor overactivity. CONCLUSION: According to respondents to this questionnaire, VUSIS-II and ValUE study results are well implemented in The Netherlands. The vast majority of respondents replied as not performing routine preoperative UDS in women with primary, uncomplicated (predominant) SUI. Therefore, there is no need for a further de-implementation strategy.

Global oncofertility index-data gap slows progress.

The number of pediatric and young adult cancer survivors is increasing globally due to earlier diagnostics and expansion of targeted chemo- and biological-based therapeutics. As a consequence, cancer-related infertility and reproductive hormone loss is of increasing concern for both male and female survivors. We attempted to estimate the reproductive loss in oncofertility-practicing countries and to develop a global oncofertility index (OFI). This would allow an accounting of the level of urgency of the issue and would provide national comparisons of fertility loss, which differ based on the prevalence and/or diagnosis frequency and treatment variables by countries or region. While the goal is laudable, an index such as this is unachievable due to the lack of the kind of information that would be necessary to calculate such a meaningful index. Without this metric, we will be unable to assess how oncofertility concerns are being addressed and what lessons can be learned from countries that improve such an index over time.

e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial.

STUDY QUESTION: Is it feasible to evaluate a personalized e-therapy program (Internet based) for women during fertility treatment aimed to reduce the chance of having clinically relevant symptoms of anxiety and/or depression after unsuccessful assisted reproductive technology (ART) treatment within a randomized controlled trial (RCT)? STUDY ANSWER: The evaluation of a personalized e-therapy program is feasible, reflected by good acceptability and integration within current guidelines, but adjustments to the e-therapy program and study design of the RCT have to be made to enhance demand, practicality and efficacy. WHAT IS KNOWN ALREADY: Internet-based interventions are promising in reducing psychological distress, especially when treatment is personalized to specific risk profiles of patients. However in fertility care, the beneficial effects of personalized e-therapy on psychological distress and its implementation in daily clinical care still have to be evaluated. STUDY DESIGN, SIZE, DURATION: To evaluate the feasibility of a personalized e-therapy program, we conducted a two-arm, parallel group, single-blind feasibility randomized controlled trial with a 1:1 allocation. Feasibility was assessed in terms of demand, acceptability, practicality, implementation, integration and limited efficacy. Women were included between 1 February 2011 and 1 June 2013. Women in the control group received care as usual, whereas women in the intervention group received in addition to their usual care access to a personalized e-therapy program. Women were monitored until 3 months after the start of their first ART cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS: In a university hospital in the Netherlands women who were screened as at risk for emotional adjustment problems and intended to start their first ART cycle were invited, and of them 120 were randomized. Of these women, 48% in the intervention group were compliant to the intervention. Outcome measures associated with the feasibility to analyse this e-therapy program within an RCT were assessed. MAIN RESULTS AND THE ROLE OF CHANCE: It is feasible to evaluate a personalized e-therapy program within an RCT. The acceptability was good, as was the integration within current clinical guidelines and care. However, the demand reflected by a participation rate of 44% was low, since most women declined participation because they felt no need for support at that moment. The practicality of the intervention was moderate illustrated by a relatively high dropout rate (30%) due to practical concerns. The intervention was effective, shown by a reduction in the percentage women having clinically relevant symptoms of anxiety and/or depression in the compliant intervention group compared with the control group 3 months after the first ART cycle; risk difference of 24% (95% CI: 2-46%; ITALIC! P = 0.03). LIMITATIONS, REASONS FOR CAUTION: The large non-participation rate (56%) needs further evaluation. This also could have influenced results on limited efficacy. Barriers for participation could be assessed more in-depth. Moreover, ∼30% dropped out. This percentage is comparable with other e-health studies. Finally, this is a single-centre study. Generalizability could be enlarged by a multi-centre approach. WIDER IMPLICATIONS OF THE FINDINGS: In clinical fertility care, personalizing an e-therapy program to the patients' risk profile is promising and feasible. However, in future studies, we recommend modification of the study protocol by for example offering the intervention to the preferred moment in the treatment process. Moreover, adjustment of the study protocol tailored to the found barriers and facilitators is needed. When performing a multi-centre consecutive RCT to assess the effectiveness of personalized e-therapy in fertility care, the findings of this study, for example concerning the preferred timing or reasons for non-participation, could be helpful. STUDY FUNDING/COMPETING INTERESTS: NutsOhra (Study Number 0702-94) funded this study with an unrestricted grant. There were no competing interests. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT 01283607. TRIAL REGISTRATION DATE: 21 January 2011. DATE OF FIRST PATIENT'S ENROLMENT: February, 2011.

Psychological and educational interventions for subfertile men and women.

BACKGROUND: Approximately one-fifth of all subfertile couples seeking fertility treatment show clinically relevant levels of anxiety, depression, or distress. Psychological and educational interventions are frequently offered to subfertile couples, but their effectiveness, both in improving mental health and pregnancy rates, is unclear. OBJECTIVES: To assess the effectiveness of psychological and educational interventions for subfertile couples on psychological and fertility treatment outcomes. SEARCH METHODS: We searched (from inception to 2 April 2015) the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 2, 2015), MEDLINE, EMBASE, PsycINFO, EBSCO CINAHL, DARE, Web of Science, OpenGrey, LILACS, PubMed, and ongoing trials registers. We handsearched reference lists and contacted experts in the field. SELECTION CRITERIA: We included published and unpublished randomised controlled trials (RCTs), cluster randomised trials, and cross-over trials (first phase) evaluating the effectiveness of psychological and educational interventions on psychological and fertility treatment outcomes in subfertile couples. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial risk of bias and extracted data. We contacted study authors for additional information. Our primary outcomes were psychological measures (anxiety and depression) and fertility rates (live birth or ongoing pregnancy). We assessed the overall quality of the evidence using GRADE criteria.As we did not consider the included studies to be sufficiently similar to permit meaningful pooling, we summarised the results of the individual studies by presenting the median and interquartile range (IQR) of effects as well as the minimum and maximum values. We calculated standardised mean differences (SMDs) for continuous variables and odds ratios (ORs) for dichotomous outcomes. MAIN RESULTS: We included 39 studies involving 4925 participants undergoing assisted reproductive technology. Studies were heterogeneous with respect to a number of factors, including nature and duration of interventions, participants, and comparator groups. As a result, we judged that pooling results would not result in a clinically meaningful estimate of a treatment effect. There were substantial methodological weaknesses in the studies, all of which were judged to be at high risk of bias for one or more quality assessment domains. There was concern about attrition bias (24 studies), performance bias for psychological outcomes (27 studies) and fertility outcomes (18 studies), and detection bias for psychological outcomes (26 studies). We therefore considered study-specific estimates of intervention effects to be unreliable. Thirty-three studies reported the outcome mental health. Only two studies reported the outcome live birth, and both of these had substantial attrition. One study reported ongoing pregnancy, again with substantial attrition. We have combined live birth and ongoing pregnancy in one outcome. Psychological outcomesStudies utilised a variety of measures of anxiety and depression. In all cases a low score denoted benefit from the intervention.SMDs for anxiety were as follows: psychological interventions versus attentional control or usual care: median (IQR) = -0.30 (-0.84 to 0.00), minimum value -5.13; maximum value 0.84, 17 RCTs, 2042 participants; educational interventions versus attentional control or usual care: median = 0.03, minimum value -0.38; maximum value 0.23, 4 RCTs, 330 participants.SMDs for depression were as follows: psychological interventions versus attentional control or usual care: median (IQR) = -0.45 (-0.68 to -0.08), minimum value -3.01; maximum value 1.23, 12 RCTs, 1160 participants; educational interventions versus attentional control or usual care: median = -0.33, minimum value -0.46; maximum value 0.17, 3 RCTs, 304 participants. Fertility outcomesWhen psychological interventions were compared with attentional control or usual care, ORs for live birth or ongoing pregnancy ranged from minimum value 1.13 to maximum value 10.05. No studies of educational interventions reported this outcome. AUTHORS' CONCLUSIONS: The effects of psychological and educational interventions on mental health including distress, and live birth or ongoing pregnancy rates is uncertain due to the very low quality of the evidence. Existing trials of psychological and educational interventions for subfertility were generally poorly designed and executed, resulting in very serious risk of bias and serious inconsistency in study findings. There is a need for studies employing appropriate methodological techniques to investigate the benefits of these treatments for this population. In particular, attentional control groups should be employed, that is groups receiving a treatment that mimics the amount of time and attention received by the treatment group but is not thought to have a specific effect upon the participants, in order to distinguish between therapeutic and non-specific effects of interventions. Where attrition cannot be minimised, appropriate statistical techniques for handling drop-out must be applied. Failure to address these issues in study design has resulted in studies that do not provide a valid basis for answering questions about the effectiveness of these interventions.

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

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.

Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care.

QUESTION: What is the effect of a multifaceted intervention with participation of patients on improvement of patient-centredness in fertility care? SUMMARY ANSWER: A multifaceted intervention with participation of patients did not improve total patient-centredness scores provided by women in fertility care. WHAT IS KNOWN ALREADY: We should provide care that takes into account the preferences and needs of patients, i.e. patient-centred care. Especially infertile patients who suffer from a high emotional burden of treatment could benefit from a more patient-centred approach in healthcare. However, the improvement of patient-centred care is still needed, because effective strategies to come to improvement are lacking. STUDY DESIGN, SIZE AND DURATION: A cluster RCT was performed within 32 Dutch fertility clinics, covering about one-third of all Dutch hospitals. After randomization, 16 clinics in the intervention group were exposed to a multifaceted improvement strategy for patient-centred fertility care for 1 year. This strategy comprised audit and feedback, educational outreach visits and patient-mediated interventions. The remaining 16 clinics in the control group performed care as usual. PARTICIPANTS/MATERIALS, SETTING AND METHODS: The clinics' levels of patient-centredness were measured, using the validated Patient-centredness Questionnaire-Infertility (PCQ-Infertility). At baseline measurement, a total of 1620 women in couples undergoing fertility care (this included both male, female, mixed infertility and infertility of unknown cause) in one of the participating clinics were randomly selected to participate in the study and complete the questionnaire. For the after measurement, we randomly selected a comparable sample of 1565 women in infertile couples. Both women who had already started their treatment before the start of the study (67%) and women who started their treatment after the start of this study (33%) were included. To avoid bias, we only included the responses of non-pregnant respondents. MAIN RESULTS AND ROLE OF CHANCE: The final analysis involved 30 clinics. A total of 946 women (response 58.4%) completed their questionnaire at baseline measurement and also a total of 946 women (response 60.4%) at after measurement. After excluding the pregnant patients, respectively 696 and 730 questionnaires were eligible for analysis at baseline and after measurement. The total score of case-mix adjusted PCQ-Infertility at after measurement did not differ significantly between the intervention and control group (B = 0.06; 95% confidence interval (CI) = -0.04-0.15; P = 0.25). However, scores on the continuity of care subscale were significantly higher in the intervention group compared with the control group (B = 0.20; 95% CI = 0.00-0.40; P < 0.05). The addition of three interaction terms to the model had a significant impact: (i) being younger than 36 years, (ii) beginning treatment after the study had started and (iii) using complementary and alternative medicine. If women met all three conditions, the scores in the intervention group were on average 0.31 points higher compared with the control group (95% CI = 0.14-0.48; P = <0.001). LIMITATIONS, REASONS FOR CAUTION: Our response rates are sufficient, but the responses of many women are still lacking which might have biased our results. Furthermore, the PCQ-Infertility scores at baseline measurement were already reasonably high, which could have limited the effect of the multifaceted improvement strategy. Because we only included women in infertile couples in our study, we cannot draw conclusions on the effect of an improvement strategy for patient-centred fertility care for partners. WIDER IMPLICATION OF THE FINDINGS: A multifaceted intervention with participation of patients did not improve total patient-centredness scores, although some effect could be observed in specific groups of women and in specific dimensions of patient-centredness. These results can guide future research, in which we should focus more on personalized strategies and outcome measures. STUDY FUNDING/COMPETING INTERESTS: This work was supported by Merck Sharp & Dohme (MSD), The Netherlands. There are no competing interests. TRIAL REGISTRATION: Clinical Trials NCT01481064.

Assisted reproductive technology: an overview of Cochrane Reviews.

BACKGROUND: As many as one in six couples will encounter problems with fertility, defined as failure to achieve a clinical pregnancy after regular intercourse for 12 months. Increasingly, couples are turning to assisted reproductive technology (ART) for help with conceiving and ultimately giving birth to a healthy live baby of their own. Fertility treatments are complex, and each ART cycle consists of several steps. If one of the steps is incorrectly applied, the stakes are high as conception may not occur. With this in mind, it is important that each step of the ART cycle is supported by good evidence from well-designed studies. OBJECTIVES: To summarise the evidence from Cochrane systematic reviews on procedures and treatment options available to couples with subfertility undergoing assisted reproductive technology (ART). METHODS: Published Cochrane systematic reviews of couples undergoing ART (in vitro fertilisation or intracytoplasmic sperm injection) were eligible for inclusion in the overview. We also identified Cochrane reviews in preparation, for future inclusion.The outcomes of the overview were live birth (primary outcome), clinical pregnancy, multiple pregnancy, miscarriage and ovarian hyperstimulation syndrome (secondary outcomes). Studies of intrauterine insemination and ovulation induction were excluded.Selection of systematic reviews, data extraction and quality assessment were undertaken in duplicate. Review quality was assessed by using the AMSTAR tool. Reviews were organised by their relevance to specific stages in the ART cycle. Their findings were summarised in the text and data for each outcome were reported in 'Additional tables'. MAIN RESULTS: Fifty-nine systematic reviews published in The Cochrane Library up to July 2015 were included. All were high quality. Thirty-two reviews identified interventions that were effective (n = 19) or promising (n = 13), 14 reviews identified interventions that were either ineffective (n = 2) or possibly ineffective (n = 12), and 13 reviews were unable to draw conclusions due to lack of evidence.An additional 11 protocols and five titles were identified for future inclusion in this overview. AUTHORS' CONCLUSIONS: This overview provides the most up to date evidence on ART cycles from systematic reviews of randomised controlled trials. Fertility treatments are costly and the stakes are high. Using the best available evidence to optimise outcomes is best practice. The evidence from this overview could be used to develop clinical practice guidelines and protocols for use in daily clinical practice, in order to improve live birth rates and reduce rates of multiple pregnancy, cycle cancellation and ovarian hyperstimulation syndrome.

Personal health communities: a phenomenological study of a new health-care concept.

CONTEXT: Fragmentation of care, complexity of diseases and the need to involve patients actively in their individual health care led to the development of the personal health community (PHC). In a PHC, patients can -regardless of the nature of their condition- invite all professionals that are involved in their health care process. Once gathered, the patient and health care team can exchange information about the patient's health and communicate through several functionalities, in a secured environment. OBJECTIVES: Exploring the use, first experiences and potential consequences of using PHCs in health care. DESIGN: Qualitative phenomenological study. PARTICIPANTS: Eighteen respondents, consisting of women experiencing infertility (n = 5), persons with Parkinson's disease (n = 6), a gynaecologist, a fertility doctor, a fertility nurse, three Parkinson's specialist nurses and a neurologist. RESULTS: First experiences with PHCs showed that patients use their PHC differently, dependending on their condition and people involved. Various (potential) advantages for future health care were mentioned relating to both organizational aspects of care (e.g. continuity of care) and the human side of care (e.g. personal care). Patient involvement in care was facilitated. Disadvantages were the amount of work that it took and technological issues. CONCLUSIONS: Using PHCs leads to promising improvements in both the organization of care and care experience, according to the participants in this study. They indicate that patients with different diseases and in different circumstances can benefit from these improvements. The PHC seem to be an online tool that can be applied in a personalized way. When (technically) well facilitated, it could stimulate active involvement of patients in their own health and health care. It warrants further research to study its effect on concrete health outcomes.

The monetary value of patient-centred care: results from a discrete choice experiment in Dutch fertility care.

STUDY QUESTION: What are patients and insurers willing to pay for different aspects of fertility care, with a particular focus on patient-centredness? SUMMARY ANSWER: In fertility care, both patients and health insurers place a high value on patient-centred factors, also when taking into account the effectiveness of fertility care. WHAT IS KNOWN ALREADY?: The benefit patients derive from fertility treatment may arise from several aspects of their care, such as the effectiveness, safety or patient-centred factors. Patient-centredness is recognized as an important, multi-dimensional concept, including domains on the organizational level (e.g. information provision) and on the human level (e.g. patient involvement). STUDY DESIGN, SIZE, AND DURATION: We performed a discrete choice experiment (DCE) within 32 Dutch fertility clinics and five large health insurance companies in the Netherlands. A total of 996 infertile patients who underwent at least one treatment cycle for their fertility problem and 84 healthcare insurers participated in the study which was executed in the summer of 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: All participating patients and health insurers completed a DCE about their preferences in fertility care regarding the effectiveness, patient-centredness of care and additional costs. Logistic regression analysis was subsequently used to determine what both patients and health insurers were willing to pay for a one-step increase in patient-centred care and 1% higher pregnancy rates. MAIN RESULTS AND THE ROLE OF CHANCE: Five hundred and fifty patients (55.2%) and 45 healthcare insurers (53.6%) completed the DCE questionnaire. Patients were willing to pay a median amount of €463 for a relevant one-step increase in patient-centred care and €107 for 1% increase in pregnancy rates. Healthcare insurers' valuations were lower: €191 for more patient-centred care and €60 for 1% increase in pregnancy rates. The willingness-to-pay values depended on patients' age, patients' ethnicity, income, and treatment type and on health insurers' age. LIMITATIONS, REASONS FOR CAUTION: An important limitation of a DCE study is that other attributes, that were not included in our study, are relevant as well. Therefore, our study participants might make other choices in real life compared with our hypothetical DCE scenarios. We tried to prevent this potential bias by selecting the most important attributes from the literature, using the input of an expert panel and performing a pilot study to test the validity of our questionnaire. WIDER IMPLICATIONS OF THE FINDINGS: This study emphasizes the importance of patient-centredness aspects of care for both infertile patients and their insurers. Therefore, efforts by policymakers and clinicians to improve these aspects of care would increase the overall value patients derive from their fertility treatment. Moreover, although insurers placed a lower monetary value on patient-centredness aspects than patients, it is arguable that insurers' purchasing decisions should be guided by patient rather than insurer preferences. Finally, given the relatively high monetary value patients place on patient-centred aspects of their fertility care, there may be a willingness to allow for some optional co-payments for this quality of care dimension. STUDY FUNDING/COMPETING INTERESTS: This work was supported by Merck Sharp and Dohme, the Netherlands. No competing interests declared. TRIAL REGISTRATION NUMBER: Clinical Trials NCT01834313.

Aromatase inhibitors for subfertile women with polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common cause of infrequent periods (oligomenorrhoea) and absence of periods (amenorrhoea). It affects about 4% to 8% of women worldwide and often leads to anovulatory subfertility. Aromatase inhibitors (AIs) are a novel class of drugs that were introduced for ovulation induction in 2001. Over the last ten years clinical trials have reached differing conclusions as to whether the AI letrozole is at least as effective as the first-line treatment clomiphene citrate (CC). OBJECTIVES: To evaluate the effectiveness and safety of aromatase inhibitors for subfertile women with anovulatory PCOS. SEARCH METHODS: We searched the following sources from inception to 24/10/2013 to identify relevant randomised controlled trials (RCTs): the Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, Pubmed, LILACS, Web of Knowledge, the World Health Organisation (WHO) clinical trials register and Clinicaltrials.gov. Furthermore, we manually searched the references of relevant articles.The search was not restricted by language or publication status. SELECTION CRITERIA: We included all RCTs of aromatase inhibitors used alone or with other medical therapies for ovulation induction in women of reproductive age with anovulatory PCOS. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted the data and assessed trial quality. Studies were pooled where appropriate using a fixed effect model to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs) for most outcomes and risk differences (RDs) for ovarian hyperstimulation syndrome (OHSS). The primary outcomes were live birth and OHSS. Secondary outcomes were pregnancy, miscarriage and multiple pregnancy. The quality of the evidence for each comparison was assessed using GRADE methods. MAIN RESULTS: We included 26 RCTs (5560 women). In all studies the aromatase inhibitor was letrozole. Live birth (12 RCTs) One RCT compared letrozole with placebo in women who were clomiphene resistant and the results were inconclusive (OR 3.17, 95% CI 0.12 to 83.17, n=36)Nine RCTs compared letrozole with clomiphene citrate (with or without adjuncts) followed by timed intercourse. The birth rate was higher in the letrozole group (OR 1.63, 95% CI 1.31 to 2.03, n=1783, I²=3%)Two RCTs compared letrozole with laparoscopic ovarian drilling. There was no evidence of a difference between the groups in live birth rate (OR 1.19, 95% CI 0.76 to 1.86, n=407, I²=0%) OHSS (16 RCTs) There was no evidence of a difference in OHSS rates when letrozole was compared with placebo (one RCT, n=36), clomiphene citrate (with or without adjuncts) followed by timed intercourse (nine RCTs, n=2179), clomiphene citrate (with or without adjuncts) followed by intrauterine insemination (IUI) (two RCTs, n=1494), laparoscopic ovarian drilling (one RCT, n=260) or anastrozole (one RCT, n=220). Events were absent or very rare, and no study had more than 2 cases of OHSS. Clinical pregnancy (25 RCTs) One RCT compared letrozole versus placebo in women who were clomiphene resistant and the results were inconclusive (OR 3.17, 95% CI 0.12 to 83.17, n=36)Fourteen RCTs compared letrozole versus clomiphene citrate (with or without adjuncts) followed by timed intercourse. The pregnancy rate was higher in the letrozole group (OR 1.32, 95% CI 1.09 to 1.60, n=2066, I²=25%)Three RCTs compared letrozole versus clomiphene citrate (with or without adjuncts) followed by IUI. The pregnancy rate was higher in the letrozole group (OR 1.71, 95% CI 1.30 to 2.25, n=1597)Three RCTs compared letrozole versus laparoscopic ovarian drilling. There was no evidence of a difference in the clinical pregnancy rate (OR 1.14, 95% CI 0.80 to 1.65, n=553, I²=0%)Two RCTs compared letrozole versus anastrozole, one RCT compared a five day versus a 10 day administration protocol for letrozole and another RCT compared 5 mg of letrozole versus 7.5 mg of letrozole. There was no evidence of a difference in the clinical pregnancy rate in these comparisons.The quality of the evidence was rated as low for live birth and pregnancy outcomes. The reasons for downgrading the evidence were poor reporting of study methods, possible publication bias and the tendency for studies that reported live birth to report higher clinical pregnancy rates in the letrozole group than studies that failed to report live birth (suggesting that results might be somewhat less favourable to letrozole if all studies reported live birth). AUTHORS' CONCLUSIONS: Letrozole appears to improve live birth and pregnancy rates in subfertile women with anovulatory PCOS, compared to clomiphene citrate. The quality of this evidence is low and findings should be regarded with some caution. There appears to be no difference in effectiveness between letrozole and laparoscopic ovarian drilling, though there were few relevant studies. OHSS was a very rare event, with no occurrences in most studies.