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The concept 'vulnerability' is prevalent in the public domain, health care, social institutions and multidisciplinary research. Conceptual heterogeneity is present, hampering the creation of a common evidence-base of research achievements and successful policies. Recently an international expert group combined a specific literature review with a 2-stage Delphi procedure, arriving at a seemingly universal concept of vulnerability for the elderly with applications for research instruments. We replicated and extended this study, to generalize this result to health in general, and perinatal health in particular. Two independent expert panels (general health, perinatal health) repeated the Delphi-procedure, using an extended and updated literature review to derive statements on the concept and defining pathways of vulnerability. Additional views were collected on research tools. Consensus-by-design was explicitly avoided. Data collection and processing was independent. Both panels showed surprising convergence on the pathways of vulnerability to health/ill-health, and their interaction. The agreed conceptual model describes a dynamic relation between health and ill-health and vulnerability. The 2 key pathways that link to vulnerability, are complementary, but not symmetrical as biological processes of maintaining health or obtaining better health are not reciprocal to recovery, so also not in terms of vulnerability impacts. An individual's degree of vulnerability is the net balance of risk effects and protective and healing factors (socially, biologically and in terms of health literacy and health care access). These factors can for measurement purposes (according to the panels: interview for exploration, checklists for population research) be grouped into 'material resources', 'taking responsibility for one's own health', 'risky activities and behaviors', and 'social support'. Supportive and transforming action can thus be undertaken. A universal concept of vulnerability in the context of health was successfully derived after careful replication and extension of an international Delphi study on vulnerability among the elderly.

IntroductionPrehabilitation aims to improve preoperative health before surgery to reduce complications. Reducing anxiety helps prevent postoperative pain, stress and sleep disturbances. Listening to music through headphones or earpieces in the hospital directly preoperatively, intraoperatively and postoperatively has been shown to ameliorate anxiety, stress, pain and sleep disorders. This randomised controlled trial will investigate the effect of active music listening at home 1 week before surgery as a prehabilitation modality on preoperative anxiety compared with standard care.Methods and analysisThis study is a multicentre randomised controlled trial that will include 116 patients. The study population consists of adults undergoing elective oncological colorectal surgery. The intervention group will be advised to listen to recorded music three times per day for 20 min, starting 1 week prior to surgery, using headphones or earpieces. Both groups will receive standard care during hospitalisation. The primary outcome is patient-reported preoperative anxiety using the State-Trait Anxiety IndexInventory 6. Secondary outcomes are patient-reported stress, delirium incidence, medication usage, postoperative pain, complication rate, length of stay, adherence to the intervention, quality of life and healthcare-related costs.Ethics and disseminationThis study protocol has been approved by the Medical Ethical Review Board of Erasmus Medical Center on 15 December 2022 (MEC-2022-9415). The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. Study results will be published and reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.Trial registration numberNCT05982184.

The primary aim of this study is to investigate the impact of a 13-week anomaly scan on the experienced levels of maternal anxiety and well-being. Secondly, to explore women's knowledge on the possibilities and limitations of the scan and the preferred timing of screening for structural abnormalities. In a prospective-cohort study conducted between 2013-2015, pregnant women in the North-Netherlands underwent a 13-week anomaly scan. Four online-questionnaires (Q1, Q2, Q3 and Q4) were completed before and after the 13- and the 20-week anomaly scans. In total, 1512 women consented to participate in the study and 1118 (74%) completed the questionnaires at Q1, 941 (64%) at Q2, 807 (55%) at Q3 and 535 (37%) at Q4. Psychological outcomes were measured by the state-trait inventory-scale (STAI), the patient's positive-negative affect (PANAS) and ad-hoc designed questionnaires. Nine-nine percent of women wished to be informed as early as possible in pregnancy about the absence/presence of structural abnormalities. In 87% of women levels of knowledge on the goals and limitations of the 13-week anomaly scan were moderate-to-high. In women with a normal 13-week scan result, anxiety levels decreased (P < .001) and well-being increased over time (P < .001). In women with false-positive results (n = 26), anxiety levels initially increased (STAI-Q1: 39.8 vs. STAI-Q2: 48.6, P = 0.025), but later decreased around the 20-week anomaly scan (STAI-Q3: 36.4 vs. STAI-Q4: 34.2, P = 0.36). The 13-week scan did not negatively impact the psychological well-being of pregnant women. The small number of women with screen-positive results temporarily experienced higher anxiety after the scan but, in false-positive cases, anxiety levels normalized again when the abnormality was not confirmed at follow-up scans. Finally, most pregnant women have moderate-to-high levels of knowledge and strongly prefer early screening for fetal structural abnormalities.

BackgroundFor metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain.MethodsIn a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain.Results62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB. ConclusionsThe combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study.Trial registration: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050.

Expanded carrier screening (ECS) aims to inform couples’ reproductive choice, preferably before conception. As part of an implementation study in which trained general practitioners (GPs) offered a population-based ECS couple-test, we evaluated the feasibility of the test-offer and degree of participant informed choice (IC). Trained GPs from nine practices in the northern Netherlands invited 4295 female patients aged 18–40 to take part in couple-based ECS. Inclusion criteria were having a male partner, planning for children and not being pregnant. We evaluated the feasibility of the organizational aspects, GP competence and the content of the pre-test counselling. Participant satisfaction, evaluation of pre-test counselling and degree of IC were measured using a longitudinal survey. We explored GP experiences and their views on future implementation through semi-structured interviews. 130 consultations took place. All participating GPs were assessed by genetic professionals to be competent to conduct pre-test counselling. Most (63/108 (58%)) consultations took place within the planned 20 min (median 20, IQR 18–28). GPs considered couples’ prior knowledge level an important determinant of consultation length. 91% of patients were (very) satisfied with the GP counselling. After pre-test counselling, 231/237(97%) participants had sufficient knowledge and 206/231(88%) had a positive attitude and proceeded with testing. Our pilot demonstrates that offering couple-based ECS through trained and motivated GPs is feasible. Future large-scale implementation requires a well-informed general public and a discussion about appropriate reimbursement for GPs and health care coverage for couples. Providing (more) test information pre-appointment may help reduce average consultation time.

First-trimester anatomical screening (FTAS) by ultrasound has been introduced in many countries as screening for aneuploidies, but also as early screening for fetal structural abnormalities. While a lot of emphasis has been put on the detection rates of FTAS, little is known about the performance of quality control programs and the sonographers' learning curve for FTAS. The aims of the study were to evaluate the performance of a score-based quality control system for the FTAS and to assess the learning curves of sonographers by evaluating the images of the anatomical planes that were part of the FTAS protocol. Between 2012-2015, pregnant women opting for the combined test in the North-Netherlands were also invited to participate in a prospective cohort study extending the ultrasound investigation to include a first-trimester ultrasound performed according to a protocol. All anatomical planes included in the protocol were documented by pictures stored for each examination in logbooks. The logbooks of six sonographers were independently assessed by two fetal medicine experts. For each sonographer, logbooks of examination 25-50-75 and 100 plus four additional randomly selected logbooks were scored for correct visualization of 12 organ-system planes. A plane specific score of at least 70% was considered sufficient. The intra-class correlation coefficient (ICC), was used to measure inter-assessor agreement for the cut-off scores. Organ-specific learning curves were defined by single-cumulative sum (CUSUM) analysis. Sixty-four logbooks were assessed. Mean duration of the scan was 22 ± 6 minutes and mean gestational age was 12+6 weeks. In total 57% of the logbooks graded as sufficient. Most sufficient scores were obtained for the fetal skull (88%) and brain (70%), while the lowest scores were for the face (29%) and spine (38%). Five sonographers showed a learning curve for the skull and the stomach, four for the brain and limbs, three for the bladder and kidneys, two for the diaphragm and abdominal wall and one for the heart and spine and none for the face and neck. Learning curves for FTAS differ per organ system and per sonographer. Although score-based evaluation can validly assess image quality, more dynamic approaches may better reflect clinical performance.

Maternity care is an integrated care process, which consists of different services, involves different professionals and covers different time windows. To measure performance of maternity care based on clients' experiences, we developed and validated a questionnaire. We used the 8-domain WHO Responsiveness model, and previous materials to develop a self-report questionnaire. A dual study design was used for development and validation. Content validity of the ReproQ-version-0 was determined through structured interviews with 11 pregnant women (≥28 weeks), 10 women who recently had given birth (≤12 weeks), and 19 maternity care professionals. Structured interviews established the domain relevance to the women; all items were separately commented on. All Responsiveness domains were judged relevant, with Dignity and Communication ranking highest. Main missing topic was the assigned expertise of the health professional. After first adaptation, construct validity of the ReproQ-version-1 was determined through a web-based survey. Respondents were approached by maternity care organizations with different levels of integration of services of midwives and obstetricians. We sent questionnaires to 605 third trimester pregnant women (response 65%), and 810 women 6 weeks after delivery (response 55%). Construct validity was based on: response patterns; exploratory factor analysis; association of the overall score with a Visual Analogue Scale (VAS), known group comparisons. Median overall ReproQ score was 3.70 (range 1-4) showing good responsiveness. The exploratory factor analysis supported the assumed domain structure and suggested several adaptations. Correlation of the VAS rating and overall ReproQ score (antepartum, postpartum) supported validity (r = 0.56; 0.59, p<0.001 Spearman's correlation coefficient). Pre-stated group comparisons confirmed the expected difference following a good vs. adverse birth outcome. Fully integrated organizations performed slightly better (median = 3.78) than less integrated organizations (median = 3.63; p<0.001). Participation rate of women with a low educational level and/or a non-western origin was low. The ReproQ appears suitable for assessing quality of maternity care from the clients' perspective. Recruitment of disadvantaged groups requires additional non-digital approaches.

Purpose The aim of expanded preconception carrier screening (ECS) is to inform any couple wishing to conceive about their chances of having children with severe autosomal or X-linked recessive conditions. Responsible implementation of ECS as reproductive genetic screening in routine care requires assessment of benefits and harms. We examined the psychological outcomes of couple-based ECS for 50 autosomal recessive (AR) conditions provided by general practitioners (GPs) to couples from the Dutch general population. Methods Dutch GPs invited 4,295 women aged 18–40. We examined anxiety (State-Trait Anxiety Inventory, STAI-6), worry, decisional conflict (DCS) over time in participants declining GP counseling or attending GP counseling with/without testing. Results One hundred ninety couples participated; 130 attended counseling, of whom 117 proceeded with testing. No carrier couples were identified. Before counseling, worry (median 6.0) and anxiety (mean 30–34) were low and lower than the population reference (36.4), although some individuals reported increased anxiety or worry. At follow-up, test acceptors reported less anxiety than test decliners (mean 29 vs. 35); differences in anxiety after testing compared to before counseling were not meaningful. Most participants (90%) were satisfied with their decision (not) to undergo testing. Conclusion Some individuals reported temporarily clinically relevant distress. Overall, the psychological outcomes are acceptable and no barrier to population-wide implementation.

Patient empowerment has been identified as a key outcome goal in genetic counselling, and a patient reported outcome measure (PROM) has been developed to measure empowerment in genetic services: the Genetic Counselling Outcome Scale (GCOS). Here we validate the GCOS for a large and diverse Dutch study sample of 2194 patients referred to two clinical genetic centres for counselling about a wide range of conditions (heart disease, neurological disorders, cancer, congenital syndromes, intellectual disability and prenatal pathology). Our results suggest that the GCOS consists of a hierarchical 6-factor structure, with a main scale for empowerment and six subscales: uncertainty about heredity, hope, negative emotions, knowledge about the condition, knowledge about genetic services and uncertainty about the treatment. Six of the original 24 GCOS items were removed due to low factor loadings and small inter-item correlations. Internal consistency and test-retest reliability of the main scale and most subscales were satisfactory. Convergent validity was confirmed by moderate positive and moderate/strong negative associations between the GCOS main scale and other validated outcome measures. Responsiveness was comparable to that of other validated outcome measures. We saw significant improvement in the GCOS main scale and all the subscales after the first genetic counselling session. This study contributes to the international validation process of the GCOS, with the ultimate goal of using this instrument as a PROM, with empowerment as an outcome measure, to evaluate and improve the quality of genetic counselling in various clinical genetics settings.

Next generation sequencing has enabled fast and relatively inexpensive expanded carrier screening (ECS) that can inform couples’ reproductive decisions before conception and during pregnancy. We previously showed that a couple-based approach to ECS for autosomal recessive (AR) conditions was acceptable and feasible for both health care professionals and the non-pregnant target population in the Netherlands. This paper describes the acceptance of this free test-offer of preconception ECS for 50 severe conditions, the characteristics of test-offer acceptors and decliners, their views on couple-based ECS and reasons for accepting or declining the test-offer. We used a survey that included self-rated health, intention to accept the test-offer, barriers to test-participation and arguments for and against test-participation. Fifteen percent of the expected target population—couples potentially planning a pregnancy—attended pre-test counselling and 90% of these couples proceeded with testing. Test-offer acceptors and decliners differed in their reproductive characteristics (e.g. how soon they wanted to conceive), educational level and stated barriers to test-participation. Sparing a child a life with a severe genetic condition was the most important reason to accept ECS. The most important reason for declining was that the test-result would not affect participants’ reproductive decisions. Our results demonstrate that previously uninformed couples of reproductive age, albeit a selective part, were interested in and chose to have couple-based ECS. Alleviating practical barriers, which prevented some interested couples from participating, is recommended before nationwide implementation.