The effectiveness of immediate versus delayed tubal flushing with oil-based contrast in women with unexplained infertility (H2Oil-timing study): study protocol of a randomized controlled trial.

BACKGROUND: In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live births as compared to tubal flushing with water-based contrast during hysterosalpingography. However, it is unknown whether incorporating tubal flushing with oil-based contrast in the initial fertility work-up results to a reduced time to conception leading to live birth when compared to delayed tubal flushing that is performed six months after the initial fertility work-up. We also aim to evaluate the effectiveness of tubal flushing with oil-based contrast during hysterosalpingography versus no tubal flushing in the first six months of the study. METHODS: This study will be an investigator-initiated, open-label, international, multicenter, randomized controlled trial with a planned economic analysis alongside the study. Infertile women between 18 and 39 years of age, who have an ovulatory cycle, who are at low risk for tubal pathology and have been advised expectant management for at least six months (based on the Hunault prediction score) will be included in this study. Eligible women will be randomly allocated (1:1) to immediate tubal flushing (intervention) versus delayed tubal flushing (control group) by using web-based block randomization stratified per study center. The primary outcome is time to conception leading to live birth with conception within twelve months after randomization. We assess the cumulative conception rate at six and twelve months as two co-primary outcomes. Secondary outcomes include ongoing pregnancy rate, live birth rate, miscarriage rate, ectopic pregnancy rate, number of complications, procedural pain score and cost-effectiveness. To demonstrate or refute a shorter time to pregnancy of three months with a power of 90%, a sample size of 554 women is calculated. DISCUSSION: The H2Oil-timing study will provide insight into whether tubal flushing with oil-based contrast during hysterosalpingography should be incorporated in the initial fertility work-up in women with unexplained infertility as a therapeutic procedure. If this multicenter RCT shows that tubal flushing with oil-based contrast incorporated in the initial fertility work-up reduces time to conception and is a cost-effective strategy, the results may lead to adjustments of (inter)national guidelines and change clinical practice. TRIAL REGISTRATION NUMBER: The study was retrospectively registered in International Clinical Trials Registry Platform (Main ID: EUCTR2018-004153-24-NL).

Treatment effect of oil-based contrast is related to experienced pain at HSG: a post-hoc analysis of the randomised H2Oil study.

STUDY QUESTION: Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)? SUMMARY ANSWER: In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found. WHAT IS KNOWN ALREADY: We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear. STUDY DESIGN, SIZE, DURATION: We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy. PARTICIPANTS/MATERIALS, SETTING, METHODS: In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0-6.8) (oil group (n = 199) 4.8 (IQR 3.0-6.4); water group (n = 201) 5.0 (IQR 3.0-6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1-2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66-1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7-15.0) in the oil group versus 8.0 ml (IQR 5.9-13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23). LIMITATIONS, REASONS FOR CAUTION: This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features. WIDER IMPLICATIONS OF THE FINDINGS: The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG. STUDY FUNDING/COMPETING INTEREST(S): The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers' fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests. TRIAL REGISTRATION NUMBER: The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270). TRIAL REGISTRATION DATE: 1 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 3 February 2012.

Blood donation barriers and facilitators of Sub-Saharan African migrants and minorities in Western high-income countries: a systematic review of the literature.

OBJECTIVES: The present study aimed to gain more insight into, and summarise, blood donation determinants among migrants or minorities of Sub-Saharan heritage by systematically reviewing the current literature. BACKGROUND: Sub-Saharan Africans are under-represented in the blood donor population in Western high-income countries. This causes a lack of specific blood types for transfusions and prevention of alloimmunisation among Sub-Saharan African patients. METHODS/MATERIALS: Medline, EMBASE, PsycINFO and BIOSIS were searched for relevant empirical studies that focused on barriers and facilitators of blood donation among Sub-Saharan Africans in Western countries until 22 June 2017. Of the 679 articles screened by title and abstract, 152 were subsequently screened by full text. Paired reviewers independently assessed the studies based on predefined eligibility and quality criteria. RESULTS: Of the 31 included studies, 24 used quantitative and 7 used qualitative research methods. Target cohorts varied from Black African Americans and refugees from Sub-Sahara Africa to specific Sub-Saharan migrant groups such as Comorians or Ethiopians. Main recurring barriers for Sub-Saharan Africans were haemoglobin deferral, fear of needles and pain, social exclusion, lack of awareness, negative attitudes and accessibility problems. Important recurring facilitators for Sub-Saharan Africans were altruism, free health checks and specific recruitment and awareness-raising campaigns. CONCLUSION: The findings of this review can be used as a starting point to develop recruitment and retention strategies for Sub-Saharan African persons. Further research is needed to gain more insight in the role of these determinants in specific contexts as socioeconomic features, personal histories and host country regulations may differ per country.

European Veterinary Renal Pathology Service: A Survey Over a 7-Year Period (2008-2015).

BACKGROUND: The European Veterinary Renal Pathology Service (EVRPS) is the first Web-based registry for canine renal biopsy specimens in Europe. HYPOTHESIS/OBJECTIVES: The aim was to verify whether differences exist between the clinical and laboratory presentation of dogs with nephropathy according to renal pathological findings, as defined by light and electron microscopy of renal biopsy specimens submitted to EVRPS. ANIMALS: Renal biopsy specimens of dogs were collected from the archive of the service (n = 254). Cases were included if both light and electron microscopy were available (n = 162). METHODS: Renal biopsy specimens were classified based on the morphological diagnoses. Thereafter, they were grouped into 3 disease categories, including immune-complex-mediated glomerulonephritis (ICGN), non-immune-complex-mediated GN (non-ICGN), and renal lesions not otherwise specified (RL-NOS). Differences among morphological diagnoses and among disease categories were investigated for clinical and laboratory variables. RESULTS: Serum albumin concentration was lower in dogs with ICGN than in those with non-ICGN (P = 0.006) or RL-NOS (P = 0.000), and the urine protein-to-creatinine ratio (UPC) was significantly higher in ICGN than in the other 2 disease categories. Regarding morphological diagnoses, albumin was significantly lower in amyloidosis (AMY) and membranous (MGN), membranoproliferative (MPGN) or mixed glomerulonephritis (MixGN) than in minimal change disease, primary (FSGS I) or secondary (FSGS II) focal and segmental glomerulosclerosis and juvenile nephropathies (JN). The UPC was higher in MPGN than in FSGS I and FSGS II. CONCLUSIONS AND CLINICAL IMPORTANCE: Dogs with ICGN, in particular MPGN, had higher protein loss than those with non-ICGN or RL-NOS, leading to more severe hypoalbuminemia. Clinical and laboratory differentiation among dogs with the different morphological diagnoses and among dogs with different disease categories was difficult due to overlapping results.

Negative experiences and pre-donation blood pressure: the role of attitude and anxiety.

BACKGROUND/OBJECTIVES: Negative experiences (NEs) have been shown to result in an increased stress response, as indicated by blood pressure, at the subsequent donation. This response might be influenced by how the donor rates the donation in terms of importance and pleasantness [affective attitude (AA)/cognitive attitude (CA)] or by anxiety about donating blood. We investigated the effect of AA/CA/anxiety on the impact of NEs on pre-donation blood pressure (pd-BP) in the subsequent donation. MATERIALS/METHODS: pd-BP at visit 3 was compared between donors with and without a history of NEs during or after their first two visits (visit 1: medical check, visit 2: first donation). The effect of AA/CA/anxiety (measured 1 month prior to visit 1 on a 7-point scale) on visit 3 pd-BP was explored using linear regression and interaction analyses. Analyses were stratified for gender, age and pd-BP at visit 1, which were taken into account as confounders. RESULTS: In 1106 first-time blood donors (70% female), 632 donors (57% of total) indicated an NE at their first donation. Mean scores for AA/CA/anxiety were 5·2/6·5/2·2 (men without NE), 4·8/6·3/3·0 (men with NE), 5·2/6·6/2·6 (women without NE) and 4·8/6·6/3·2 (women with NE). No significant associations were found for NE and pd-BP at visit 3 after adjusting for confounding. Of 48 interaction effects, four were significant, but effects were small and inconsistent. CONCLUSION: In donors who had had negative experiences during their first donation, anxiety and attitude to donation did not influence their pre-donation blood pressure at their subsequent visit.

World Small Animal Veterinary Association Renal Pathology Initiative: Classification of Glomerular Diseases in Dogs.

Evaluation of canine renal biopsy tissue has generally relied on light microscopic (LM) evaluation of hematoxylin and eosin-stained sections ranging in thickness from 3 to 5 µm. Advanced modalities, such as transmission electron microscopy (TEM) and immunofluorescence (IF), have been used sporadically or retrospectively. Diagnostic algorithms of glomerular diseases have been extrapolated from the World Health Organization classification scheme for human glomerular disease. With the recent establishment of 2 veterinary nephropathology services that evaluate 3-µm sections with a panel of histochemical stains and routinely perform TEM and IF, a standardized objective species-specific approach for the diagnosis of canine glomerular disease was needed. Eight veterinary pathologists evaluated 114 parameters (lesions) in renal biopsy specimens from 89 dogs. Hierarchical cluster analysis of the data revealed 2 large categories of glomerular disease based on the presence or absence of immune complex deposition: The immune complex-mediated glomerulonephritis (ICGN) category included cases with histologic lesions of membranoproliferative or membranous patterns. The second category included control dogs and dogs with non-ICGN (glomerular amyloidosis or focal segmental glomerulosclerosis). Cluster analysis performed on only the LM parameters led to misdiagnosis of 22 of the 89 cases-that is, ICGN cases moved to the non-ICGN branch of the dendrogram or vice versa, thereby emphasizing the importance of advanced diagnostic modalities in the evaluation of canine glomerular disease. Salient LM, TEM, and IF features for each pattern of disease were identified, and a preliminary investigation of related clinicopathologic data was performed.

Cardiovascular-renal axis disorders in the domestic dog and cat: a veterinary consensus statement.

OBJECTIVES: There is a growing understanding of the complexity of interplay between renal and cardiovascular systems in both health and disease. The medical profession has adopted the term "cardiorenal syndrome" (CRS) to describe the pathophysiological relationship between the kidney and heart in disease. CRS has yet to be formally defined and described by the veterinary profession and its existence and importance in dogs and cats warrant investigation. The CRS Consensus Group, comprising nine veterinary cardiologists and seven nephrologists from Europe and North America, sought to achieve consensus around the definition, pathophysiology, diagnosis and management of dogs and cats with "cardiovascular-renal disorders" (CvRD). To this end, the Delphi formal methodology for defining/building consensus and defining guidelines was utilised. METHODS: Following a literature review, 13 candidate statements regarding CvRD in dogs and cats were tested for consensus, using a modified Delphi method. As a new area of interest, well-designed studies, specific to CRS/CvRD, are lacking, particularly in dogs and cats. Hence, while scientific justification of all the recommendations was sought and used when available, recommendations were largely reliant on theory, expert opinion, small clinical studies and extrapolation from data derived from other species. RESULTS: Of the 13 statements, 11 achieved consensus and 2 did not. The modified Delphi approach worked well to achieve consensus in an objective manner and to develop initial guidelines for CvRD. DISCUSSION: The resultant manuscript describes consensus statements for the definition, classification, diagnosis and management strategies for veterinary patients with CvRD, with an emphasis on the pathological interplay between the two organ systems. By formulating consensus statements regarding CvRD in veterinary medicine, the authors hope to stimulate interest in and advancement of the understanding and management of CvRD in dogs and cats. The use of a formalised method for consensus and guideline development should be considered for other topics in veterinary medicine.

Easy come, easy go. Retention of blood donors.

Retention of blood donors has benefits over recruitment of new blood donors. Retention is defined as preventing donors from lapsing and eventually becoming inactive. This review paper discusses literature on the importance of efforts to retain donors, specifically new donors, since lapsing is most common before the fifth donation. Studies have found that intention to donate, attitudes towards blood donation and self-efficacy (does one feel capable of donating blood) are predictors of blood donation. Feelings of 'warm glow' predict donation behaviour better than altruism. The existing literature further suggests that first time donors can be retained by paying extra attention to adverse events (vasovagal reactions and fatigue). These events could be reduced by drinking water and muscle tension exercises. Feelings of anxiety (in regular donors) and stress can further prevent donors from returning. Planning donations amongst busy lives can help retention, and suggestions are given on which interventions might be helpful.

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.

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.

Consensus recommendations for the diagnostic investigation of dogs with suspected glomerular disease.

BACKGROUND: The International Renal Interest Society (IRIS) offers guidelines for chronic kidney disease and acute kidney injury. As dogs with glomerular disease may present differently and require different treatment than those with whole nephron or tubular disease, the IRIS Canine Glomerulonephritis (GN) Study Group was convened to formulate guidelines for these cases. The Diagnosis Subgroup was asked to make recommendations for diagnostic evaluation of such cases. OBJECTIVE: To seek consensus among renal specialists for the evaluation of dogs with proteinuria because of suspected glomerular disease. METHODS: After reviewing the literature, subgroup members discussed and wrote the draft paper and recommendations, which members of the IRIS Canine GN Study Group voted upon by electronic secret ballot, with comments noted. Consensus was declared if votes showed strong or general agreement from 85% of the respondents. RESULTS: Diagnostic tests were categorized as essential, recommended, or potentially helpful, with prioritization dependent on case characteristics, eg, for cases with uncomplicated proteinuria versus complicated with hypoalbuminemia, azotemia, or both. Consensus was reached with 86-100% agreement on all questions posed. All cases should have basic examinations including blood pressure measurement, blood, and urine testing, and a search for infectious diseases relevant to their environs. The majority ranked imaging (chest radiographs, abdominal ultrasonogram) and renal biopsy procured and interpreted by experienced personnel as essential evaluations in complicated cases, but a few respondents deemed these to be essential in uncomplicated cases as well. CONCLUSIONS AND CLINICAL IMPORTANCE: Strong consensus about recommendations for diagnostic evaluation of dogs with suspected glomerular protein loss was attained. These guidelines help clinicians characterize disease processes for more informed therapeutic decision-making.

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.

Analysing completion times in an academic emergency department: coordination of care is the weakest link.

Congestion with prolonged stay in the emergency department (ED) is associated with poor health outcomes. Many factors contribute to ED congestion. This study investigates the length of time spent in the ED (time to completion) and the factors contributing to prolonged stay in an academic ED. Data of ED patients were prospectively collected during four weeks in February 2010. Presentation time, referrer, discharge destination, and medical specialities involved were registered in 2510 patients. Additional detailed data about relevant time steps were collected from 66 patients in the triage category Emergency Severity Index (ESI) 3. The Pearson's chi-square test and the Mann-Whitney test were used for statistical analysis. Time to completion was longer than four hours in 13% of patients (average in total population 2:23 hours). In ESI 3 patients, 24% stayed longer than four hours in the ED (p<0.001). Internal medicine had most patients exceeding the four-hour target (37%), followed by neurology (29%). Undergoing a CT scan, treatment by multiple specialities, age above 65 years and hospital admission were associated with exceeding the four-hour target (p<0.001). The elapsed time between receiving test results and admission/discharge also influenced the completion time (p<0.001). A significant percentage of vulnerable and ill patients with triage category ESI 3 exceeded the four-hour completion time in our ED. Absence of coordination of care when multiple specialists were involved and delay in the process of decision-making after completion of all diagnostics on the ED were among other factors responsible for this prolonged stay. Improving the coordination of care will, in our opinion, speed up the decision-making process and lead to shortening of completion times in many patients.

Blood product collection and supply: a matter of money?

BACKGROUND: Previous studies have shown that countries with a low or medium Human Development Index (HDI) transfuse far fewer blood products than countries with a high HDI. HDI comprises both economical and non-economical elements. We considered the hypothesis that non-economical, cultural differences may be additional factors in understanding blood donation and blood supply differences. METHODS: We quantified the explained variance, r(2), in: the number of donors, the number of whole blood collections and the number of red blood cell units supplied to hospitals for 25 European countries. Candidate predictors were Hofstede's cultural dimensions, the demographic factor Old Age Dependency Ratio and the three components of HDI: Gross National Income, Life Expectancy and the Educational Development Index. RESULTS: The cultural dimension Power Distance was the best sole predictor of whole blood collection (r(2) = 56.8%) and the number of donors (r(2) = 25.1%). The Educational Development Index best predicted the number of red blood cell units (r(2) = 45.0%). Multivariable models including the cultural dimension Power Distance and the Educational Development Index gave the best results in predicting the number of whole blood collections and red blood cell units supplied and, to a lesser extent, the number of donors, with adjusted r(2) values of 63.6%, 51.9% and 28.6%, respectively. In contrast, Gross National Income made no significant predictive contribution to any of the multivariable models. Neither did the other cultural dimensions, Life Expectancy or Old Age Dependency Ratio. CONCLUSION: The effects of education level and cultural aspects should be taken into account as influencers on donation behaviour. The concept of power distance, in particular, presents a challenge to blood donor managers in cross-cultural and multi-cultural donor management contexts.

(99M)Technetium-sestamibi scintimammography in non-palpable breast lesions found on screening X-ray mammography.

OBJECTIVE: The sensitivity and specificity of (99m)Tc-sestamibi scintimammography in patients with non-palpable breast lesions diagnosed by screening mammography and the value of (99m)Tc-sestamibi to detect axillary lymph node metastases was determined. METHODS: Between September 2000 and December 2003, 103 females with non-palpable breast lesions were included for further evaluation. X-ray mammography was repeated and 99mTc-sestamibi scintimammography performed within one-week. Anterior, and left and right lateral images were obtained. The scintimammography was analysed by 2 experienced observers who were blinded to the clinical, pathological, and radiological results. The sensitivity and specificity of scintimammography to diagnose non-palpable lesion(s), including the axillary regions, was compared with histopathology, clinical, and radiological follow up. RESULTS: Two patients (one non-small lung cancer and one non-Hodgkin's disease) were excluded. Both showed (99m)Tc-sestamibi avid lesions in the breast and axillary region. In the remaining 101 patients, 37 true positive (TP), 4 false positive (FP), 52 true negative (TN), and 8 false negative (FN) breast carcinomas were found. The specificity was 92.8%, sensitivity 82.2%, positive predictive value (PPV) 90.2%, and negative predictive value (NPV) 86.6%. (99m)Tc-sestamibi scintimammography showed axillary lesions in 5/15 (33%) patients with axillary lymph node metastasis. CONCLUSION: In patients with non-palpable lesions diagnosed by screening- X-ray-mammography, (99m)Tc-sestamibi scintimammography provided high specificity and PPV. Furthermore, (99m)Tc-sestamibi scintimammography detected 33% of patients with axillary lymph node metastases. Therefore, (99m)Tc-sestamibi scintimammography could be of incremental value in the surgical work-up of these patients.