The effects of music and auditory stimulation on autonomic arousal, cognition and attention: A systematic review.

According to the arousal-mood hypothesis, changes in arousal and mood when exposed to auditory stimulation underlie the detrimental effects or improvements in cognitive performance. Findings supporting or against this hypothesis are, however, often based on subjective ratings of arousal rather than autonomic/physiological indices of arousal. To assess the arousal-mood hypothesis, we carried out a systematic review of the literature on 31 studies investigating cardiac, electrodermal, and pupillometry measures when exposed to different types of auditory stimulation (music, ambient noise, white noise, and binaural beats) in relation to cognitive performance. Our review suggests that the effects of music, noise, or binaural beats on cardiac, electrodermal, and pupillometry measures in relation to cognitive performance are either mixed or insufficient to draw conclusions. Importantly, the evidence for or against the arousal-mood hypothesis is at best indirect because autonomic arousal and cognitive performance are often considered separately. Future research is needed to directly evaluate the effects of auditory stimulation on autonomic arousal and cognitive performance holistically.

The factor structure and measurement invariance of the Autism Spectrum Quotient-28: A cross-cultural comparison between Malaysia and the Netherlands.

LAY ABSTRACT: The AQ-28 is a questionnaire measuring autistic traits, that is, traits that are related to Autism Spectrum Conditions, but its reliability in other cultures has not been thoroughly evaluated. We, therefore, tested whether the properties of the AQ-28 are comparable between two countries with different cultures, Malaysia and the Netherlands. A total of 437 Malaysian and 818 Dutch participants completed the AQ-28 online. We measured whether the AQ-28 measures autistic traits similarly in Malaysia and the Netherlands. The AQ-28 measures autistic traits similarly, and the reliability was acceptable and good in the general population of Malaysia and the Netherlands, respectively. However, Malaysians scored higher than Dutch participants. Moreover, 11 AQ-28 items showed cultural bias, indicating that these items are answered/interpreted differently in Malaysia and the Netherlands. Cross-cultural differences in interpreting, reporting, and/or expressing autistic traits highlighted in this study could potentially explain why some items are culturally biased and why Malaysians score higher on these items. The findings of this work imply that cutoff scores derived from one culture should not be generalised to another culture. Moreover, the findings are informative for future development of culturally neutral or appropriate screening and diagnostic tools for autism.

Self-reported autistic traits and psychosocial outcomes among university students in Malaysia.

LAY ABSTRACT: Most research on autism spectrum conditions is done on young children and not as much on young adults with autism spectrum conditions. Because of this, not much is known about how common autism spectrum conditions are in young adults and how they affect their mental and social health, especially in Southeast Asia. Based on self-reports, 2.8% of the 2732 university students we looked at in Malaysia might have been diagnosed or thought to have an autism spectrum condition. Students who said they had or thought they had autism spectrum conditions had lower self-efficacy, more stress and a lower quality of life than students who said they did not have autism spectrum conditions. The results showed that university students with autism spectrum condition are more likely to have bad psychological and social outcomes than their peers without autism spectrum condition. Also, the link between autistic traits and psychosocial outcomes could depend on the culture.

Perspectives of extremely prematurely born adults on what to consider in prenatal decision-making: a qualitative focus group study.

OBJECTIVE: A shared decision-making (SDM) approach is recommended for prenatal decisions at the limit of viability, with a guiding role for parental values. People born extremely premature experience the consequences of the decision made, but information about their perspectives on prenatal decisions is lacking. Therefore, this study aims to describe their perspectives on what is important in decision-making at the limit of viability. DESIGN: Semi-structured focus group discussions were conducted, recorded and transcribed verbatim. The data were independently analysed by two researchers in Atlas.ti. RESULTS: Four focus groups were conducted in the Netherlands, with five to six participants each, born between 240/7 and 300/7 weeks gestation in the period between 1965 and 2002. Considering their personal life experiences and how their extremely premature birth affected their families, the participants reflected on decision-making at the limit of viability. Various considerations were discussed and summarised into the following themes: anticipated parental regret, the wish to look at the baby directly after birth, to give the infant a chance at survival, quality of life, long-term outcomes for the infant and the family, and religious or spiritual considerations. CONCLUSIONS: Insights into the perspectives of adults born extremely premature deepened our understanding of values considered in decision-making at the limit of viability. Results point out the need for a more individualised prediction of the prognosis and more extensive information on the lifelong impact of an extremely premature birth on both the infant and the family. This could help future parents and healthcare professionals in value-laden decision-making.

Identifying Womens' Needs in Making a Treatment Decision for Stress Urinary Incontinence: A Qualitative Study.

Background: Choosing a treatment option for female stress urinary incontinence (SUI) is a preference-sensitive decision. Nowadays, shared decision making (SDM) is the preferred way of decision making. SDM considers the needs patients have regarding the decision-making process. The aim of this study was to identify decisional needs of women who are making a treatment decision for SUI. Materials and Methods: Semistructured interviews were planned with women who had been seeking treatment for SUI. Patients were recruited in two teaching hospitals in the Netherlands. Interviewers used a topic list based on the Ottawa decision support framework. The interviews were transcribed and coded. Themes and subthemes of factors relating to the treatment decision-making process were identified and described. Results: We interviewed a total of 16 women. Four major themes of SUI patients' needs were identified: information on disorder and treatment, SDM, personalized health care, and consideration for social context. Within these themes, specific needs varied between individuals. In addition to the provision of objective information, other important identified needs were subjective, such as acknowledgment of symptoms and feeling understood by a physician. It was important for patients that they had a sufficient amount of time to make their decision. Conclusions: To ensure a good quality treatment decision in female SUI, several topics need to be addressed in an SDM process. The themes of decisional needs identified in this study can help improve the decision-making process.

A scoping review of parental values during prenatal decisions about treatment options after extremely premature birth.

AIM: To describe what is known in the literature about parental perspectives in making prenatal decisions regarding treatment after birth at the limit of viability, as a better understanding of parental values can help professionals support parents as they decide. METHODS: PubMed, Cochrane, Embase, CINAHL, PsycINFO and Web of Science were searched to identify relevant literature from 1 January 2010 to 22 April 2022 on parental decision making. Data were extracted from selected studies and organised into themes. The final themes were formed through collaboration with the parents of a premature infant born at 24 weeks. RESULTS: Of the 15,159 papers examined, 17 were included. Parental perspectives were described in terms of long-term outcomes for the infant, survival, protection against the burden of neonatal treatment, long-term impact on the family, religion and spiritual beliefs, to do everything possible, hope, sense of responsibility, wanting the best, doing what is right, giving a chance and the influence of experience. CONCLUSION: The extracted parental perspectives show the complexity of these decisions. Some perspectives were clear, but others were multi-interpretable. Increasing the understanding of common parental perspectives can help improve shared prenatal decisions and lead to further improvement and personalisation of the process.

Patients' and health-care professionals' perspectives on adverse drug reaction burden attributed to the use of biological DMARDs: a qualitative study.

BACKGROUND: Previous studies showed a discrepancy between health-care professionals' (HCPs') and patients' perspective on adverse drug reaction (ADR) burden. However, it is unclear which factors make an ADR burdensome. We aimed to give insight into why ADRs are perceived as burdensome by inflammatory rheumatic disease (IRD) patients, and whether this differs from the HCPs' perspective. RESEARCH DESIGN AND METHODS: A qualitative study was conducted using Dutch Biologic Monitor data. Participants received bimonthly questionnaires on experienced ADRs attributed to biological DMARDs and were asked to elaborate on ADR burden using a Likert-type scale and an open-ended question for clarification. Data of 440 IRD patients were analyzed following thematic analysis. A similar analysis was done with semi-structured interviews with 13 HCPs. RESULTS: We identified seven themes associated with ADR burden: 'effect on medication prescription,' 'impact on appearance,' 'impact on autonomy,' 'impact on daily life,' 'psychological consequences,' 'distressing aspects of ADR,' and 'physical consequences.' Identical themes were identified by HCPs, although they identified most subthemes in 'psychological consequences,' and less subthemes in 'impact on daily life' and 'impact on autonomy.' CONCLUSION: Patients describe perceived ADR burden in both physical and psychological themes. The HCPs' perspective is comparable, but mostly focuses on psychological impact.

The role of birth plans for shared decision-making around birth choices of pregnant women in maternity care: A scoping review.

BACKGROUND: Birth plans can be used to facilitate shared decision-making in childbirth. A birth plan is a document reflecting women's preferences for birth, which they discuss with their maternity care provider. AIM: This scoping review aims to synthesize current findings on the role of birth plans for shared decision-making around birth choices of pregnant women in maternity care. METHODS: We conducted a scoping review using the Joanna Briggs Institute three-step search strategy in multiple databases PubMed, EMBASE, CINAHL, Web of Science, PsycINFO. We synthesized the results using a metasynthesis approach to identify themes and subthemes. RESULTS: From the 21 articles included, five themes were identified: birth plan as a tool for shared decision-making, autonomy, sense of control, professionalism of the care provider, and trust. Primarily, midwives seemed to use birth plans to explore and facilitate women's choices around birth. Other healthcare providers involved in studies were obstetricians and nurses. The interrelationship between care providers and women, the attitude of care providers and women towards each other and the birth plan, and how providers and women use the birth plan influence shared decision-making. DISCUSSION AND CONCLUSION: Birth plans can facilitate shared decision-making, and women's sense of autonomy and control before, during, and after giving birth. When discussing the birth plan, exploring different scenarios may help women prepare for unforeseen circumstances. This will likely facilitate shared decision-making even if the birth process is not unfolding as hoped for.

Physicians' perspectives on using a patient decision aid in female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: A treatment choice for female stress urinary incontinence (SUI) is preference sensitive for both patients and physicians. Multiple treatment options are available, with none being superior to any other. The decision-making process can be supported by a patient decision aid (PDA). We aimed to assess physicians' perceptions concerning the use of a PDA. METHODS: In a mixed methods study, urologists, gynecologists and general practitioners in the Netherlands were asked to fill out a web-based questionnaire. Questions were based on the Tailored Implementation for Chronic Diseases checklist using the following domains: guideline factors, individual health professional factors, professional interactions, incentives and resources, and capacity for organizational change. Participants were asked to grade statements using a five-point Likert scale and to answer open questions on facilitators of and barriers to implementation of a PDA. Outcomes of statement rating were quantitatively analyzed and thematic analysis was performed on the outcomes regarding facilitators and barriers. RESULTS: The response rate was 11%, with a total of 120 participants completing the questionnaire. Ninety-two of the physicians (77%) would use a PDA in female SUI. Evidence-based and unbiased content, the ability to support shared decision making, and patient empowerment are identified as main facilitators. Barriers are the expected prolonged time investment and the possible difficulty using the PDA in less health-literate patient populations. CONCLUSIONS: The majority of physicians would use a PDA for female SUI. We identified facilitators and barriers that can be used when developing and implementing such a PDA.

The assessment of psychometric properties for the subjective wellbeing-5 dimensions (SWB-5D) questionnaire in the general Dutch population.

PURPOSE: Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure. METHODS: A quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS). RESULTS: A representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A. CONCLUSION: Compared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population.

Negotiating Awareness: Dutch Midwives' Experiences of Noninvasive Prenatal Screening Counseling.

BACKGROUND: Discussion of the topic of noninvasive prenatal screening (NIPS) has become a standard part of Dutch maternity care practice. This means that pregnant women who are contemplating NIPS can receive counseling from their midwife or obstetrician. The aim of this study is to understand the communicative practices and decision-making principles regarding first-tier use of NIPS, as experienced by Dutch midwives. METHODS: Qualitative analysis of in-depth interviews with Dutch midwives (n = 10) exploring their conversations about NIPS counseling and decision making. RESULTS: Midwives value the autonomy of women in decisions on NIPS. They consider it a midwifery task to assess women's awareness of the risks and implications of using or not using this mode of screening. The optimal level of awareness may differ between women and midwives, creating novel challenges for informed decision making in midwifery communication. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Negotiating awareness about NIPS in individual women is a relatively new and complex midwifery task in need of counseling time and skill. NIPS practices call for a reflection on midwifery values in the context of integrated maternity care.

Non-alcoholic fatty liver disease: identical etiologic factors in patients with type 1 and type 2 diabetes.

AIMS: To compare NAFLD prevalence, distribution and its etiologic determinants in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS: In this cross-sectional study, NAFLD was evaluated by transient elastography in adult outpatients with T1D and T2D. NAFLD was defined as hepatic steatosis with or without fibrosis. Associations between insulin resistance related factors and NAFLD and advanced fibrosis (≥ F3) were explored in T1D and T2D separately, using multivariate logistic regression models. Interaction analysis was performed to compare the associations in patients with T1D and T2D. RESULTS: One hundred and fifty patients with T1D (mean age 47 years, male 55%, mean diabetes duration 25 years, median BMI 25 kg/m2) and 100 patients with T2D (median age 67 years, male 56%, median diabetes duration 17 years, mean BMI 30 kg/m2) were included. NAFLD prevalence was 20% in patients with T1D and 76% in patients with T2D. Advanced fibrosis prevalence was 2.0% in patients with T1D and 22% in patients with T2D. In both patients with T1D and T2D, waist circumference, BMI and metabolic syndrome were positively associated, and estimated insulin sensitivity was negatively associated with the presence of NAFLD, adjusted for age, sex and diabetes duration. There was no effect modification by diabetes type for any of these associations. CONCLUSIONS: Despite differences in population characteristics and pathophysiology between T1D and T2D, insulin resistance related factors are similarly associated with NAFLD in both groups.

Prevalence of non-alcoholic fatty liver disease (NAFLD) and its association with surrogate markers of insulin resistance in patients with type 1 diabetes.

AIMS: Assess prevalence of hepatic steatosis (HS) and of fibrosis in an unselected population of patients with type 1 diabetes. Describe their clinical profile and explore the association between insulin resistance and NAFLD as secondary objectives. METHODS: We prospectively assessed NAFLD by transient elastography in adult outpatients with type 1 diabetes. Patients were eligible if they did not have any known secondary cause of liver disease. NAFLD was defined as HS with or without fibrosis/cirrhosis. Associations between estimated glucose disposal rate (eGDR) and metabolic syndrome, as surrogate markers of insulin resistance, and NAFLD were explored using multivariate logistic regression models, adjusting for age, sex and diabetes duration. RESULTS: We enrolled 150 consecutive subjects (age 47 ± 14 years, male 55%, diabetes duration 25 ± 14 years, median BMI 25 kg/m2). NAFLD prevalence was 20% (n = 30). Thirty patients (20%) had HS. Five patients (3.3%) had HS with fibrosis. eGDR and metabolic syndrome were statistically significantly associated with the presence of NAFLD (OR 0.62, 95% CI 0.49-0.77, OR 7.62, 95% CI 2.95-19.77). CONCLUSIONS: NAFLD prevalence in patients with type 1 diabetes is considerable, mainly restricted to isolated HS, while fibrosis is rare. Insulin resistance is associated with NAFLD in patients with type 1 diabetes.

Reliability and validity of the Netherlands Triage Standard in emergency care settings: a case scenario study.

BACKGROUND: The Netherlands Triage Standard (NTS) is a triage system that can be used by different types of emergency care organisations. Our objective was to determine the interrater reliability and construct validity of the NTS when applied to self-presenting patients. METHODS: We performed a cross-sectional case scenario study consisting of two parts: (1) paediatric triage in January-February 2019 and (2) adult triage in October-November 2020. In each part, we invited nurse triagists from three general practitioner cooperatives, three ambulance dispatching centres and three hospital emergency departments in the Netherlands to participate. We used 40 case scenarios involving paediatric patients and 41 involving adult patients who could self-present to any emergency care organisation. In advance, an expert panel determined the urgency (six levels) of the case scenarios (reference standard). The main outcome for reliability was the intraclass correlation coefficient (ICC) for urgency level. The main outcomes for validity were degree of agreement with the reference standard, for urgency level, and sensitivity and specificity for high versus low urgency. We used descriptive statistics and logistic multilevel modelling with both case and triagist as random effects. RESULTS: 218 out of 240 invited triagists participated. The ICC among all triagists was 0.73 for paediatric cases and 0.88 for adult cases and was highest in general practitioner cooperatives. For paediatric cases, there was 62.3% agreement with the reference standard about urgency, 17.4% underestimation and 20.2% overestimation. The sensitivity of the NTS for identifying highly urgent paediatric cases was 85.2%; the specificity was 89.7%. For adult cases, there was 68.3% agreement, 13.7% underestimation and 18.0% overestimation. The sensitivity of triage for high urgency in adults was 94.5% and the specificity 83.3%. CONCLUSION: NTS appears to have good reliability and construct validity for estimating the urgency of health complaints of non-referred patients presenting themselves in emergency care.

Language Matters: The Autism-Spectrum Quotient in English, Mandarin and Bahasa Malaysia.

The autism-spectrum quotient (AQ) measures autistic traits and has been studied in different countries, sometimes with the English version, and sometimes with translated versions. However, the language of the questionnaire might influence non-native English speakers' answering tendency. In the current study we compared the responses on the AQ of multilingual Malaysians (96 participants filled out the AQ in English and Mandarin, and 79 participants filled out English and Bahasa Malaysia). Participants scored higher on the English AQ compared to the Mandarin AQ, whereas there was no difference between the English and Bahasa Malaysia AQ score. Analysis of the response style suggests the same person might display discrepant response styles in different languages, which seems to be related to language proficiency.

Insulin resistance and risk of vascular events, interventions and mortality in type 1 diabetes.

OBJECTIVE: To identify determinants associated with insulin resistance and to assess the association between insulin resistance and cardiovascular events, vascular interventions and mortality in people with type 1 diabetes at high risk of cardiovascular disease. DESIGN: Prospective cohort study. METHODS: One hundred and ninety-five people with type 1 diabetes from the Secondary Manifestations of ARTerial disease (SMART) cohort were included. Insulin resistance was quantified by the estimated glucose disposal rate (eGDR) with higher eGDR levels indicating higher insulin sensitivity (i.e. lower eGDR levels indicating higher insulin resistance). Linear regression models were used to evaluate determinants associated with eGDR. The effect of eGDR on cardiovascular events, cardiovascular events or vascular interventions (combined endpoint) and on all-cause mortality was analysed using Cox proportional hazards models adjusted for confounders. RESULTS: In 195 individuals (median follow-up 12.9 years, IQR 6.7-17.0), a total of 25 cardiovascular events, 26 vascular interventions and 27 deaths were observed. High eGDR as a marker for preserved insulin sensitivity was independently associated with a lower risk of cardiovascular events (HR: 0.75; 95% CI: 0.61-0.91), a lower risk of cardiovascular events and vascular interventions (HR: 0.74; 95% CI: 0.63-0.87) and a lower risk of all-cause mortality (HR: 0.81; 95% CI: 0.67-0.98). CONCLUSIONS: Insulin resistance as measured by eGDR is an additional risk factor for cardiovascular disease in individuals with type 1 diabetes. Modification of insulin resistance by lifestyle interventions or pharmacological treatment could be a viable therapeutic target to lower the risk of cardiovascular disease.

Differences in treatment choices between prostate cancer patients using a decision aid and patients receiving care as usual: results from a randomized controlled trial.

OBJECTIVE: To determine whether or not decision aid (DA) use influences treatment decisions in patients with low and intermediate risk prostate cancer (PC). PATIENTS AND METHODS: In a cluster randomized controlled trial, patients were randomized to either DA use (DA group) or no DA use (control group). Between 2014 and 2016, newly diagnosed patients with low or intermediate risk PC were recruited in 18 hospitals in the Netherlands. DA users had access to a web-based DA that provided general PC information, PC-treatment information, and values clarification exercises to elicit personal preferences towards the treatment options. Control group patients received care as usual. Differences in treatment choice were analysed using multilevel logistic regressions. Differences in eligible treatment options between groups were compared using Pearson Chi-square tests. RESULTS: Informed consent was given by 382 patients (DA group N = 273, control group N = 109). Questionnaire response rate was 88% (N = 336). Active surveillance (AS) was an option for 38%, radical prostatectomy (RP) for 98%, external beam radiotherapy (EBRT) for 88%, and brachytherapy (BT) for 79% of patients. DA users received AS significantly more often than control group. Patients (29 vs 16%, p = 0.01), whereas the latter more often chose BT (29 vs 18%, p < 0.01). No differences were found between groups regarding RP and EBRT. DA users who were not eligible for AS, received surgery more often compared to the control group (53 vs 35%, p = 0.01). Patient and disease characteristics were evenly distributed between groups. CONCLUSION: DA-using PC patients chose the AS treatment option more often than non-DA-using patients did.

Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Patients With Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis.

CONTEXT: Nonalcoholic fatty liver disease (NAFLD) prevalence is high, especially in patients with obesity and type 2 diabetes, and is expected to rise steeply in the coming decades. OBJECTIVE: We estimated NAFLD prevalence in patients with type 1 diabetes and explored associated characteristics and outcomes. DATA SOURCES: We reviewed PubMed and Embase for studies on NAFLD and type 1 diabetes to March 2020. We screened references of included articles. STUDY SELECTION: Two authors independently screened titles/abstracts. One author screened full text articles. NAFLD was defined as described in the individual studies: steatosis and/or fibrosis. Studies not reporting alternative causes of hepatic steatosis or defining NAFLD only as elevated liver enzymes, were excluded. Initially, 919 articles met the selection criteria. DATA EXTRACTION: One researcher performed data extraction and risk of bias assessment using standardized tables. DATA SYNTHESIS: We assessed pooled prevalence rates by meta-analysis using a random-effects model, subsequently exploring heterogeneity by subgroup-, meta-regression-, and sensitivity analysis. Twenty studies between 2009 and 2019 were included (n = 3901). Pooled NAFLD prevalence was 19.3% (95% CI, 12.3%-27.5%), increasing to 22.0% (95% CI, 13.9%-31.2%) in adults only. Pooled prevalence of ultrasound studies was high (27.1%, 95% CI, 18.7%-36.3%) compared to studies using magnetic resonance imaging (8.6%, 95% CI, 2.1%-18.6%), liver biopsy (19.3%, 95% CI, 10.0%-30.7%), or transient elastography (2.3%, 95% CI, 0.6%-4.8%). CONCLUSION: NAFLD prevalence in patients with type 1 diabetes is considerable and is highly dependent on the specific diagnostic modality and NAFLD definition used. These data are helpful in directing actions to standardize NAFLD diagnosis, which will help defining contributing mechanisms and outcomes.

Stakeholders' perspectives on a patient-reported outcome measure-based drug safety monitoring system for immune-mediated inflammatory diseases.

BACKGROUND: Biologics are used as effective therapeutics to treat a variety of diseases. Even though biologics are widely used, knowledge on the post-marketing experience of patients is limited. Therefore, a framework was established for a patient-reported outcome measure (PROM)-based drug safety monitoring system for ADRs attributed to biologics, known as the 'Dutch Biologic Monitor'. OBJECTIVE: Generation of a multi-stakeholder perspective on the preferred setup, potential and added value of a PROM-based national drug safety monitoring system. METHODS: Nineteen stakeholders were interviewed following a structured interview guide. Transcribed data were coded and analyzed to count frequencies and to generate recurring themes. RESULTS: Stakeholders (84.2%) support the establishment of a national drug safety monitoring system, but the feasibility depends on the implementation process. The need for integration and assessment of PROMs on ADRs in clinical practice and the preference to monitor small molecules and new drugs were emphasized. Preferably, all pharmacological options per indication should be monitored. CONCLUSIONS: Stakeholders recommend to establish a PROM-based national drug safety monitoring system focused on ADRs attributed to biologics, small molecules, and new drugs. Moreover, PROMs on ADRs ideally need to become integrated in clinical practice to provide health-care providers more insight in patients' perspectives.