Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism.

Preliminary data and clinical experience have suggested an increased risk of abnormal uterine bleeding (AUB) in women of reproductive age treated with anticoagulants, but solid data are lacking. The TEAM-VTE study was an international multicenter prospective cohort study in women aged 18 to 50 years diagnosed with acute venous thromboembolism (VTE). Menstrual blood loss was measured by pictorial blood loss assessment charts at baseline for the last menstrual cycle before VTE diagnosis and prospectively for each cycle during 3 to 6 months of follow-up. AUB was defined as an increased score on the pictorial blood loss assessment chart (>100 or >150) or self-reported AUB. AUB-related quality of life (QoL) was assessed at baseline and the end of follow-up using the Menstrual Bleeding Questionnaire. The study was terminated early because of slow recruitment attributable to the COVID-19 pandemic. Of the 98 women, 65 (66%) met at least one of the 3 definitions of AUB during follow-up (95% confidence interval [CI], 57%-75%). AUB occurred in 60% of women (36 of 60) without AUB before VTE diagnosis (new-onset AUB; 95% CI, 47%-71%). Overall, QoL decreased over time, with a mean Menstrual Bleeding Questionnaire score increase of 5.1 points (95% CI, 2.2-7.9), but this decrease in QoL was observed only among women with new-onset AUB. To conclude, 2 of every 3 women who start anticoagulation for acute VTE experience AUB, with a considerable negative impact on QoL. These findings should be a call to action to increase awareness and provide evidence-based strategies to prevent and treat AUB in this setting. This was an academic study registered at www.clinicaltrials.gov as #NCT04748393; no funding was received.

Reflections from the OARSI 2022 clinical trials symposium: The pain of OA-Deconstruction of pain and patient-reported outcome measures for the benefit of patients and clinical trial design.

OBJECTIVE: Osteoarthritis (OA) drug development is hampered by a number of challenges. One of the main challenges is the apparent discordance between pain and structure, which has had a significant impact on drug development programs and has led to hesitance among stakeholders. Since 2017, the Clinical Trials Symposium (CTS) has been hosted under the Osteoarthritis Research Society International (OARSI) leadership. OARSI and the CTS steering committee yearly invite and encourage discussions on selected special subject matter between regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists to progress drug development in the OA field. METHOD: The main topic for the 2022 OARSI CTS was to elucidate the many facets of pain in OA and to enable a discussion between regulators (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)) and drug developers to clarify outcomes and study designs for OA drug development. RESULTS: Signs or symptoms indicative of nociceptive pain occur in 50-70% of OA patients, neuropathic-like pain in 15-30% of patients, and nociplastic pain in 15-50% of patients. Weight-bearing knee pain is associated with bone marrow lesions and effusions. There are currently no simple objective functional tests whose improvements correlate with patient perceptions. CONCLUSIONS: The CTS participants, in collaboration with the FDA and EMA, raised several suggestions that they consider key to future clinical trials in OA including the need for more precise differentiation of pain symptoms and mechanisms, and methods to reduce placebo responses in OA trials.

Long COVID and return to work: a qualitative study.

BACKGROUND: The COVID-19 pandemic has given rise to an increasing number of patients with 'long COVID'. Long COVID is the persistence of symptoms for weeks or months after an infection by SARS-CoV-2. It often impacts on the professional life of affected people. AIMS: The aim of this study is to understand the experiences and needs of people with long COVID in relation to their return to work. METHODS: A qualitative study, combining individual interviews and online forum discussions, was performed early 2021, as part of a larger mixed method study on the needs of long COVID patients in Belgium. RESULTS: One hundred and thirty-four people participated in the study. Participants described various clinical symptoms precluding their return to work. They also face sceptical reactions from employers and colleagues and a lack of support from the social welfare system to facilitate their return to work. These barriers have various impacts, including psychological ones, likely to compromise the professional future of long COVID patients. CONCLUSIONS: While the analysis of patients' experiences shows variation in long COVID patients' experiences with return to work, it may help occupational physicians and healthcare practitioners to better take up their crucial role in the return to work of long COVID patients, including raising employers' and colleagues' awareness of the specific difficulties related to long COVID.

Evaluation of kurtosis-corrected sound exposure level as a metric for predicting onset of hearing threshold shifts in harbor porpoises (Phocoena phocoena).

Application of a kurtosis correction to frequency-weighted sound exposure level (SEL) improved predictions of risk of hearing damage in humans and terrestrial mammals for sound exposures with different degrees of impulsiveness. To assess whether kurtosis corrections may lead to improved predictions for marine mammals, corrections were applied to temporary threshold shift (TTS) growth measurements for harbor porpoises (Phocoena phocoena) exposed to different sounds. Kurtosis-corrected frequency-weighted SEL predicted accurately the growth of low levels of TTS (TTS1-4 < 10 dB) for intermittent sounds with short (1-13 s) silence intervals but was not consistent with frequency-weighted SEL data for continuous sound exposures.

The Course of Cognitive Performance during Inpatient Treatment in Patients with Alcohol Use Disorder with No, Mild or Major Neurocognitive Disorders.

AIMS: In patients with a history of chronic alcohol abuse, neurocognitive disorders (NCD) are not uncommon. The current study aimed to explore the course of cognitive performance, as measured by the Montreal Cognitive Assessment (MoCA), and everyday cognitive functioning, as measured by the Patient Competency Rating Scale (PCRS), in a large group of patients with alcohol use disorder (AUD) admitted to the Center of Excellence for Korsakov and Alcohol-related Cognitive Impairments. METHODS: A multiple time-series design was used, in which the MoCA was administered at three time points of assessment, and the PCRS was completed by both the patient and a clinician at two time points, all during clinical treatment. RESULTS: A total of 524 patients were included, 71 of whom were diagnosed with AUD only, 284 with AUD and mild NCD (ARCI) and 169 with AUD, major NCD and fulfilling criteria for Korsakoff's syndrome (KS). CONCLUSIONS: Cognitive performance improved for all three groups during treatment, sustained abstinence and recovery from AUD. A low memory performance on the MoCA without improvement over time was predictive for KS, while improvement on this domain did not differentiate between AUD and ARCI. Changes in overall cognitive performance and orientation in patients with KS were positively related to changes in everyday cognitive functioning.

Clinical relevance of Scedosporium spp. and Exophiala dermatitidis in patients with cystic fibrosis: A nationwide study.

An increased prevalence of various filamentous fungi in sputum samples of patients with cystic fibrosis (CF) has been reported. The clinical significance, however, is mostly unclear. The aim of this study was to investigate the clinical relevance of Scedosporium spp. and Exophiala dermatitidis from sputum samples of patients with CF in the Netherlands. In this cross-sectional study, all CF patients of the Dutch national CF registry who were treated at five of the seven recognized CF centers during a 3-year period were included. We linked clinical data of the national CF registry with the national Dutch filamentous fungal database. We investigated the association between clinical characteristics and a positive sputum sample for Scedosporium spp. and E. dermatitidis, using logistic regression. Positive cultures for fungi were obtained from 3787 sputum samples from 699 of the 1312 patients with CF. Scedosporium spp. was associated with severe genotype, CF-related diabetes, several microorganisms, and inhaled antibiotics. E. dermatitidis was associated with older age, female sex, and Aspergillus spp. CF patients with and without Scedosporium spp. or E. dermatitidis seemed comparable in body mass index and lung function. This study suggests that Scedosporium spp. and E. dermatitidis are probably no major pathogens in CF patients in the Netherlands. Greater understanding of epidemiologic trends, risk factors, and pathogenicity of filamentous fungi in the respiratory tracts of patients with CF is needed.

Time of year, age class and body condition predict Hendra virus infection in Australian black flying foxes (Pteropus alecto).

Hendra virus (HeV) continues to cause fatal infection in horses and threaten infection in close-contact humans in eastern Australia. Species of Pteropus bats (flying-foxes) are the natural reservoir of the virus. We caught and sampled flying-foxes from a multispecies roost in southeast Queensland, Australia on eight occasions between June 2013 and June 2014. The effects of sample date, species, sex, age class, body condition score (BCS), pregnancy and lactation on HeV antibody prevalence, log-transformed median fluorescent intensity (lnMFI) values and HeV RNA status were assessed using unbalanced generalised linear models. A total of 1968 flying-foxes were sampled, comprising 1012 Pteropus alecto, 742 P. poliocephalus and 214 P. scapulatus. Sample date, species and age class were each statistically associated with HeV RNA status, antibody status and lnMFI values; BCS was statistically associated with HeV RNA status and antibody status. The findings support immunologically naïve sub-adult P. alecto playing an important role in maintaining HeV infection at a population level. The biological significance of the association between BCS and HeV RNA status, and BCS and HeV antibody status, is less clear and warrants further investigation. Contrary to previous studies, we found no direct association between HeV infection and pregnancy or lactation. The findings in P. poliocephalus suggest that HeV exposure in this species may not result in systemic infection and virus excretion, or alternatively, may reflect assay cross-reactivity with another (unidentified) henipavirus.

[Demoralisation in alcohol-dependent patients with co-occurring psychiatric disorders]. / Demoralisatie bij patiënten met alcoholafhankelijkheid en comorbide psychiatrische stoornissen.

BACKGROUND: Demoralisation is a multidimensional concept, with helplessness and hopelessness as its key elements. Many patients, both in somatic and in mental health care, suffer from demoralisation. In the process of recovery, remoralisation constitutes a first step.
AIM: To investigate demoralisation in alcohol-dependent inpatients with co-occurring psychiatric disorders.
METHOD: Included in this study were 159 alcohol-dependent inpatients admitted to clinics for dual diagnosis. Demoralisation was assessed at treatment entry and again one month later.
RESULTS: A strong level of demoralisation was found, particularly in the co-occurrence of depression, anxiety and personality disorders. At treatment entry, 92% of patients was clinically demoralised and, one month later, this was 89%. In patients with co-occurring depression, mood and personality disorders, a significant decrease of demoralisation was found after one month, whereas in patients with developmental and psychotic disorders this was not the case. In 11% of patients there was clinically relevant improvement and in 7.5% there was clinically relevant deterioration; the latter mainly in patients with co-occurring developmental and psychotic disorders.
CONCLUSION: At start of treatment, these alcohol-dependent patients were strongly demoralised, especially in the co-occurrence of psychiatric disorders. Although there was a significant improvement in demoralisation after one month of treatment, patients remained strongly demoralised. In one in ten patients there was clinically relevant remoralisation. As a first step in the process of recovery, clinicians should pay more attention to remoralisation. Targeted interventions, aimed at this specific population, are necessary.

Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of copd health status tools.

BACKGROUND: The Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George's Respiratory Questionnaire (SGRQ). METHODS: Moderate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency. RESULTS: In total 451 patients were included (57.9 ± 6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2 ± 7.3 (CAT), 2.9 ± 1.2 (CCQ) and 50.7 ± 17.3 (SGRQ). MCID estimates for improvement ranged - 3.1 to - 1.4 for CAT, - 0.6 to - 0.3 for CCQ, and - 10.3 to - 7.6 for SGRQ. Absolute higher - though not significant - MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference - 1.4: CI -2.3 to - 0.5) and CCQ (difference - 0.2: CI -0.3 to -0.1) using a five-point GRC. CONCLUSIONS: The recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ. TRIAL REGISTRATION: RIMTCORE trial # DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).

Predictive value of simulated SAR and temperature for changes in measured temperature after phase-amplitude steering during locoregional hyperthermia treatments.

INTRODUCTION: On-line adaptive hyperthermia treatment planning can be useful to suppress treatment limiting hot spots and improve tumor temperatures during locoregional hyperthermia. This requires adequate prediction of changes in heating patterns after phase-amplitude steering. We investigated the predictive value of simulated SAR and temperature for changes in measured temperature after phase-amplitude steering during locoregional hyperthermia. METHODS: All treatment sessions of 75 patients with pelvic malignancies treated between September 2013 and March 2018 were evaluated. Phase-amplitude adaptations during the 60 min steady-state period were analyzed. Treatment planning was performed using Plan2Heat, based on CT scans with (thermometry) catheters in the vagina, rectum, and bladder in situ. The predicted SAR and temperature along the thermometry tracks were extracted from the simulated distributions. Correlations between changes in average measured temperature and the simulated SAR and temperature were evaluated for single phase-amplitude steering events, unaccompanied by other (steering) actions. RESULTS: A total of 67 phase-amplitude steering events were suitable for analysis. Simulated changes in both SAR and temperature correlated with the measured temperature changes. For the vagina, R2 = 0.44 and R2 = 0.55 for SAR and temperature, respectively. For the rectum, these values were 0.53 for SAR and 0.66 for temperature. Correlations for the bladder were weaker: R2 = 0.15 and R2 = 0.14 for SAR and temperature, respectively. This can be explained by convection in the bladder fluid, unaccounted for by present treatment planning. CONCLUSION: Treatment planning can predict changes in an average temperature after phase-amplitude steering. This allows on-line support with phase-amplitude steering to optimize hyperthermia treatments.

[A boy with treatment-resistant psychiatric problems: X-linked adrenoleukodystrophy]. / Een adolescent met psychiatrische problemen die niet reageerden op behandeling: X-gebonden adrenoleukodystrofie.

In this case report we describe a 17-year-old boy with severe behavioural disorders, apathy and cognitive decline who was eventually diagnosed with X-linked adrenoleukodystrophy (x-ald). If a patient presents with a combination of psychiatric and neurological problems, metabolic diseases such as x-ald should be included in the differential diagnosis.

Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial.

RATIONALE: Reduced physical activity (PA) in patients with COPD is associated with a poor prognosis. Increasing PA is a key therapeutic target, but thus far few strategies have been found effective in this patient group. OBJECTIVES: To investigate the effectiveness of a 12-week semiautomated telecoaching intervention on PA in patients with COPD in a multicentre European randomised controlled trial. METHODS: 343 patients from six centres, encompassing a wide spectrum of disease severity, were randomly allocated to either a usual care group (UCG) or a telecoaching intervention group (IG) between June and December 2014. This 12-week intervention included an exercise booklet and a step counter providing feedback both directly and via a dedicated smartphone application. The latter provided an individualised daily activity goal (steps) revised weekly and text messages as well as allowing occasional telephone contacts with investigators. PA was measured using accelerometry during 1 week preceding randomisation and during week 12. Secondary outcomes included exercise capacity and health status. Analyses were based on modified intention to treat. MAIN RESULTS: Both groups were comparable at baseline in terms of factors influencing PA. At 12 weeks, the intervention yielded a between-group difference of mean, 95% CI (lower limit - upper limit; ll-ul) +1469, 95% CI (971 to 1965) steps/day and +10.4, 95% CI (6.1 to 14.7) min/day moderate PA; favouring the IG (all p≤0.001). The change in 6-min walk distance was significantly different (13.4, 95% CI (3.40 to 23.5) m, p<0.01), favouring the IG. In IG patients, an improvement could be observed in the functional state domain of the clinical COPD questionnaire (p=0.03) compared with UCG. Other health status outcomes did not differ. CONCLUSIONS: The amount and intensity of PA can be significantly increased in patients with COPD using a 12-week semiautomated telecoaching intervention including a step counter and an application installed on a smartphone. TRIAL REGISTRATION NUMBER: NCT02158065.

Use of the Control of Allergic Rhinitis and Asthma Test (CARATkids) in children and adolescents: Validation in Dutch.

BACKGROUND: Allergic rhinitis and asthma are common and closely related diseases. Recently, a Portuguese questionnaire has been developed 'The Control of Allergic Rhinitis and Asthma Test' (CARATkids) that measures disease control of both diseases in children. This study aims to validate the CARATkids in Dutch children and for the first time in adolescents and, in addition, to calculate the minimal clinically important difference (MCID). METHODS: A prospective observational study was conducted in an outpatient clinic. After translation of the CARATkids from Portuguese to Dutch, patients (6-18 years) with asthma or asthma and allergic rhinitis completed the CARATkids, Asthma Control Test, and visual analog scale questionnaire three times. Baseline characteristics, mean scores, internal consistency, test-retest reliability, cross-sectional and longitudinal validity, discriminative properties, responsiveness, and MCID of the CARATkids were assessed. RESULTS: A total of 111 patients were included. In total, 86% and 79%, respectively, completed the questionnaires at the second and third visits. All children had asthma, and 85% had concomitant allergic rhinitis. The internal consistency was good with all expected a priori correlations met. CARATkids scores were higher in patients with uncontrolled asthma and patients with moderate-severe rhinitis compared to better controlled subjects. Patients with a variable asthma control had significantly higher scores during periods of uncontrolled asthma. Also the Guyatt's responsiveness index was good. The MCID was 2.8. CONCLUSIONS: The CARATkids questionnaire is a reliable and valid tool to assess allergic rhinitis and asthma control among Dutch children. The tool can be used in adolescents.

ALPPS Procedure in Insufficient Hypertrophy After Portal Vein Embolization (PVE).

BACKGROUND: The main limiting factor for major liver resections is the volume and function of the future remnant liver (FLR). Portal vein embolization (PVE) is now standard in most centers for preoperative hypertrophy of FLR. However, it has a failure rate of about 20-30 %. In these cases, the "Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy" (ALPPS) may represent a suitable and possibly the only alternative. METHODS: We performed a retrospective analysis of nine patients who had ALPPS following an insufficient hypertrophy after PVE. Computed tomography volumetry were performed before and after PVE as well as the first step of ALPPS. Furthermore, complications, 30-day mortality and outcome were analyzed. RESULTS: The FLR volume rose significantly by 77.7 ± 40.7 % (FLR/TLV: 34.9 ± 9.7 %) as early as 9 days after the first stage despite insufficient hypertrophy after preoperative portal vein embolization. Major complications (Grade > IIIb) occurred in 33 % of the patients, and 30-day mortality was 11.1 %. The OS at 1 and 2 years was 78 and 44 %. Four patients are presently still alive at a median of 33.4 (range 15-48) months (survival rate 44.4 %). CONCLUSION: The ALPPS procedure could be a suitable alternative for patients following insufficient PVE or indeed the last chance of a potentially curative treatment in this situation. Nevertheless, the high morbidity and mortality rates and the lack of data on the long-term oncological outcome must also be taken into account.

Modern imaging of acute pulmonary embolism.

The first-choice imaging test for visualization of thromboemboli in the pulmonary vasculature in patients with suspected acute pulmonary embolism (PE) is multidetector computed tomography pulmonary angiography (CTPA) - a readily available and widely used imaging technique. Through technological advancements over the past years, alternative imaging techniques for the diagnosis of PE have become available, whilst others are still under investigation. In particular, the evolution of artificial intelligence (AI) is expected to enable further innovation in diagnostic management of PE. In this narrative review, current CTPA techniques and the emerging technology photon-counting CT (PCCT), as well as other modern imaging techniques of acute PE are discussed, including CTPA with iodine maps based on subtraction or dual-energy acquisition, single-photon emission CT (SPECT), magnetic resonance angiography (MRA), and magnetic resonance direct thrombus imaging (MRDTI). Furthermore, potential applications of AI are discussed.

The underwater soundscape of the North Sea.

As awareness on the impact of anthropogenic underwater noise on marine life grows, underwater noise measurement programs are needed to determine the current status of marine areas and monitor long-term trends. The Joint Monitoring Programme for Ambient Noise in the North Sea (JOMOPANS) collaborative project was funded by the EU Interreg to collect a unique dataset of underwater noise levels at 19 sites across the North Sea, spanning many different countries and covering the period from 2019 to 2020. The ambient noise from this dataset has been characterised and compared - setting a benchmark for future measurements in the North Sea area. By identifying clusters with similar sound characteristics in three broadband frequency bands (25-160 Hz, 0.2-1.6 kHz, and 2-10 kHz), geographical areas that are similarly affected by sound have been identified. The measured underwater sound levels show a persistent and spatially uniform correlation with wind speed at high frequencies (above 1 kHz) and a correlation with the distance from ships at mid and high frequencies (between 40 Hz and 4 kHz). Correlation with ocean current velocity at low frequencies (up to 200 Hz), which are susceptible to nonacoustic contamination by flow noise, was also evaluated. These correlations were evaluated and simplified linear scaling laws for wind and current speeds were derived. The presented dataset provides a baseline for underwater noise measurements in the North Sea and shows that spatial variability of the dominant sound sources must be considered to predict the impact of noise reduction measures.

[Detoxification of patients with GHB dependence]. / Detoxificatie van patiënten met GHB-afhankelijkheid.

BACKGROUND: A new detoxification method for GHB dependence was developed recently in the Netherlands. The method involves the use of pharmaceutical GHB. AIM: To describe the characteristics of GHB dependent inpatients, the course of the detoxification process and patients' progress in the three months following inpatient detoxification. METHOD: 229 GHB dependent patients were monitored during and after inpatient detoxification. Records were kept of the psychiatric symptoms, withdrawal symptoms and relapses. RESULTS: The average age of the patients was 29 years; 69% of the patients were male. They reported severe symptoms of co-occurring depression and anxiety. Detoxification was successful in 86% of the patients and, on a whole, the procedure ran smoothly, without complications. However, within three months following detoxification two-thirds of the patients had relapsed and were again taking GHB. CONCLUSION: Pharmaceutical GHB can be used as an alternative to the benzodiazepine method for detoxifying patients with GHB dependence. However, the high relapse rates following detoxification are of great concern.

Managing a dual role--experiences and coping strategies of parents donating haploidentical G-CSF mobilized peripheral blood stem cells to their children.

UNLABELLED: Hematopoietic stem cell transplantation is an effective therapy for life-threatening hematological diseases. Parents may be asked to donate hematopoietic stem cells for their child when no compatible related or unrelated donor is available. OBJECTIVE: Parents donating G-CSF mobilized peripheral blood stem cells simultaneously and uniquely fulfill the dual role of donor and caregiver for their ill child. The experiences of both sibling and unrelated stem cell donors have been extensively reported but not those of parental donors. METHODS: We therefore undertook a study specifically to investigate the experiences and coping strategies of parental stem cell donors. In-depth qualitative interviews were conducted with 13 parental donors, which were subsequently transcribed and subjected to thematic analysis. In addition, parental coping was assessed utilizing the Utrecht Coping List. RESULTS: Qualitative analyses revealed four main thematic categories describing the way parental stem cell donation was experienced, namely 'Hope and Fear', 'Need for Information', 'Do Anything for your Child' and 'Transplant Outcome' In addition parents noted similar difficulties which were unrelated to their specific role as a donor, for example they felt socially isolated. CONCLUSIONS: Individual information for the parents needs to address not only the transplantation procedure but particularly those aspects related to the donation process. We feel there is a need for a protocol specifically designed to support and coach parental donors.

Multi-site validation of shipping noise maps using field measurements.

Underwater radiated noise from shipping is globally pervasive and can cause deleterious effects on marine life, ranging from behavioural responses to physiological effects. Acoustic modelling makes it possible to map this noise over large areas and long timescales, and to test mitigation scenarios such as ship speed reduction or spatial restrictions. However, such maps must be validated against measurements to ensure confidence in their predictions. This study carried out a multi-site validation of the monthly and annual shipping noise maps for 2019 produced as part of the Joint Monitoring of Ambient Noise in the North Sea (JOMOPANS) programme. Spectral, spatial, and temporal differences between predictions and measurements were analysed, with differences linked to uncertainty in model input data and additional sources of anthropogenic noise in the measurements. Validating shipping noise models in this way ensures they can be applied with confidence in future management decisions to address shipping noise pollution.