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OBJECTIVE: To determine whether intercurrent infections are a risk factor for subsequent disease flares in systemic lupus erythematosus (SLE). METHODS: Demographic and clinical characteristics of 203 patients with SLE participating in the Amsterdam SLE cohort were collected at baseline and during follow-up. Collection of data on infections and SLE flares was registry-based and infections and flares were categorised as minor or major, based on predefined criteria. Proportional hazard models with recurrent events and time-varying covariates were used to estimate the HR of SLE flares. RESULTS: The incidence rates of major and minor infections were 5.3 per 100 patient years and 63.9 per 100 patient years, respectively. The incidence rates of flares were 3.6 and 15.1 per 100 patient years for major flares and minor flares, respectively.In the proportional hazard model, intercurrent infections (major and minor combined) were associated with the occurrence of SLE flares (major and minor combined; HR 1.9, 95% CI: 1.3 to 2.9). The hazard ratio for a major SLE flare following a major infection was 7.4 (95% CI: 2.2 to 24.6). Major infections were not associated with the occurrence of minor flares. CONCLUSIONS: The results of the present study show that intercurrent infections are associated with subsequent SLE flares, which supports the hypothesis that infections may trigger SLE flares.
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Infections , Lupus Erythematosus, Systemic , Proportional Hazards Models , Humans , Lupus Erythematosus, Systemic/complications , Female , Male , Risk Factors , Adult , Middle Aged , Infections/epidemiology , Infections/complications , Incidence , Symptom Flare Up , Netherlands/epidemiology , Registries , Cohort Studies , RecurrenceABSTRACT
AIM: Recommendations for surveillance after colonoscopy are based on risk factors for metachronous advanced colorectal neoplasia (AN) and colorectal cancer (CRC). The value of these risk factors remains unclear in populations enriched by individuals with a positive faecal immunochemical test and were investigated in a modern setting. METHODS AND RESULTS: This population-based cohort study included all individuals in the Netherlands of ≥55 years old with a first adenoma diagnosis in 2015. A total of 22,471 patients were included. Data were retrieved from the Dutch Nationwide Pathology Databank (Palga). Primary outcomes were metachronous AN and CRC. Patient and polyp characteristics were evaluated by multivariable Cox regression analyses. During follow-up, 2416 (10.8%) patients were diagnosed with AN, of which 557 (2.5% from the total population) were CRC. Adenomas with high-grade dysplasia (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.40-1.83), villous histology (HR 1.91, 95% CI 1.59-2.28), size ≥10 mm (HR 1.12, 95% CI 1.02-1.23), proximal location (HR 1.12, 95% CI 1.02-1.23), two or more adenomas (HR 1.28, 95% CI 1.16-1.41), and serrated polyps ≥10 mm (HR 1.67, 95% CI 1.42-1.97) were independent risk factors for metachronous AN. In contrast, only adenomas with high-grade dysplasia (HR 2.49, 95% CI 1.92-3.24) were an independent risk factor for metachronous CRC. CONCLUSIONS: Risk factors for metachronous AN and CRC were identified for populations with access to a faecal immunochemical test (FIT)-based screening programme. If only risk factors for metachronous CRC are considered, a reduction in criteria for surveillance seems reasonable.
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INTRODUCTION: Recently, the HEAR-aware app was developed to support adults who are eligible for hearing aids (HAs) but not yet ready to use them. The app serves as a self-management tool, offering assistance for a range of target behaviors (TBs), such as communication strategies and emotional coping. Using ecological momentary assessment and intervention, the app prompts users to complete brief surveys regarding challenging listening situations they encounter in their daily lives (ecological momentary assessment). In response, users receive educational content in the form of "snippets" (videos, texts, web links) on the TBs, some of which are customized based on the reported acoustic environmental characteristics (ecological momentary intervention). The primary objective of this study was to assess the effectiveness of the HEAR-aware app in enhancing readiness to take action on various TBs and evaluate its impact on secondary outcomes. The secondary objective was to examine the app's usability, usefulness, and user satisfaction. METHODS: A randomized controlled trial design with two arms was used. Participants with hearing loss aged 50 years and over were recruited via an HA retailer and randomly assigned to the intervention group (n = 42, mean age = 65 years [SD = 9.1]) or the control group (n = 45, mean age = 68 years [SD 8.7]). The intervention group used the app during 4 weeks. The control group received no intervention. All participants completed online questionnaires at baseline (T0), after 4 weeks (T1), and again 4 weeks later (T2). Participants' readiness to take action on five TBs was measured with The Line Composite. A list of secondary outcomes was used. Intention-to-treat analyses were performed using Linear Mixed effect Models including group (intervention/control), time (T0/T1/T2), and Group × Time Interactions. In addition, a per protocol analysis was carried out to explore whether effects depended on app usage. For the secondary aim the System Usability Scale (SUS), the Intrinsic Motivation Inventory, item 4 of the International Outcome Inventory-Alternative Intervention (IOI-AI), and a recommendation item were used (intervention group only at T1). RESULTS: For objective 1, there was no significant group difference for The Line Composite over the course of T0, T1, and T2. However, a significant (p = 0.033) Group × Time Interaction was found for The Line Emotional coping, with higher increase in readiness to take action on emotional coping in the intervention group than in the control group. The intention-to-treat analyses revealed no other significant group differences, but the per protocol analyses showed that participants in the intervention group were significantly more ready to take up Assistive Listening Devices (The Line Assistive Listening Devices) and less ready to take up HAs (Staging Algorithm HAs) than the control group (p = 0.049). Results for objective 2 showed that on average, participants rated the app as moderately useful (mean Intrinsic Motivation Inventory score 5 out of 7) and its usability as "marginal" (mean SUS score 68 out of 100) with about half of the participants rating the app as "good" (SUS score >70) and a minority rating is as "unacceptable" (SUS score ≤50). DISCUSSION/CONCLUSIONS: This study underscores the potential of self-management support tools like the HEAR-aware app in the rehabilitation of adults with hearing loss who are not yet ready for HAs. The range in usability scores suggest that it may not be a suitable intervention for everyone.
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BACKGROUND: Pancreatic ductal adenocarcinoma is an aggressive disease with a dismal prognosis. Stage III locally advanced pancreatic cancer is considered unresectable and current palliative chemotherapy regimens only modestly improve survival. Guidelines suggest chemoradiation or stereotactic ablative body radiotherapy (SABR) could be beneficial in certain circumstances. Other local treatments such as irreversible electroporation could enhance patient outcomes by extending survival while preserving quality of life. We aimed to compare the efficacy and safety of MRI-guided SABR versus CT-guided percutaneous irreversible electroporation following standard FOLFIRINOX chemotherapy. METHODS: CROSSFIRE was an open-label, randomised phase 2 superiority trial conducted at the Amsterdam University Medical Centre (Amsterdam, Netherlands). Eligible patients were aged 18 years or older with confirmed histological and radiological stage III locally advanced pancreatic cancer. The maximum tumour diameter was 5 cm and patients had to be pretreated with three to eight cycles of FOLFIRINOX. Patients were randomly assigned (1:1) to MRI-guided SABR (five fractions of 8 Gy delivered on non-consecutive days) or CT-guided percutaneous irreversible electroporation using a computer-generated variable block randomisation model. The primary endpoint was overall survival from randomisation, assessed in the intention-to-treat population. Safety was assessed in the per-protocol population. A prespecified interim futility analysis was done after inclusion of half the original sample size, with a conditional probability of less than 0·2 resulting in halting of the study. The trial was registered at ClinicalTrials.gov, NCT02791503. FINDINGS: Between May 1, 2016, and March 31, 2022, 68 patients were enrolled and randomly assigned to SABR (n=34) or irreversible electroporation (n=34), of whom 64 were treated according to protocol. Of the 68 participants, 36 (53%) were male and 32 (47%) were female, with a median age of 65 years (IQR 57-70). Median overall survival from randomisation was 16·1 months (95% CI 12·1-19·4) in the SABR group versus 12·5 months (10·9-17·0) in the irreversible electroporation group (hazard ratio [HR] 1·39 [95% CI 0·84-2·30]; p=0·21). The conditional probability to demonstrate superiority of either technique was 0·13; patient accrual was therefore stopped early for futility. 20 (63%) of 32 patients in the SABR group versus 19 (59%) of 32 patients in the irreversible electroporation group had adverse events (p=0·8) and five (16%) patients in the SABR group versus eight (25%) in the irreversible electroporation group had grade 3-5 adverse events (p=0·35). The most common grade 3-4 adverse events were cholangitis (two [6%] in the SABR group vs one [3%] in the irreversible electroporation group), abdominal pain (one [3%] vs two [6%]), and pancreatitis (none vs two [6%]). One (3%) patient in the SABR group and one (3%) in the irreversible electroporation group died from a treatment-related adverse event. INTERPRETATION: CROSSFIRE did not identify a difference in overall survival or incidence of adverse events between MRI-guided SABR and CT-guided percutaneous irreversible electroporation after FOLFIRINOX. Future studies should further assess the added value of local ablative treatment over chemotherapy alone. FUNDING: Adessium Foundation, AngioDynamics.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Pancreatic Neoplasms , Humans , Male , Female , Middle Aged , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Treatment Outcome , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/radiotherapy , Quality of Life , Electroporation , Magnetic Resonance Imaging , Tomography, X-Ray ComputedABSTRACT
BACKGROUND: This study examined the relationship between speech-in-noise recognition and incident/recurrent falls due to balance problems ten years later (RQ-1); 10-year change in speech-in-noise recognition and falls (RQ-2a), as well as the role of dizziness in this relationship (RQ-2b). The association between hearing aid use and falls was also examined (RQ-3). METHODS: Data was collected from the Netherlands Longitudinal Study on Hearing between 2006 and December 2022. Participants completed an online survey and digits-in-noise test every five years. For this study, data was divided into two 10-year follow-up time intervals: T0 (baseline) to T2 (10-year follow-up), and T1 (5-years) to T3 (15-years). For all RQs, participants aged ≥ 40 years at baseline, without congenital hearing loss, and non-CI users were eligible (n = 592). Additionally, for RQ-3 participants with a speech reception threshold in noise (SRTn) ≥ -5.5 dB signal-to-noise ratio were included (n = 422). Analyses used survey variables on hearing, dizziness, falls due to balance problems, chronic health conditions, and psychosocial health. Logistic regressions using General Estimating Equations were conducted to assess all RQs. RESULTS: Among individuals with obesity, those with poor baseline SRTn had a higher odds of incident falls ten years later (odds ratio (OR):14.7, 95% confidence interval (CI) [2.12, 103]). A 10-year worsening of SRTn was significantly associated with a higher odds of recurrent (OR: 2.20, 95% CI [1.03, 4.71]) but not incident falls. No interaction was found between dizziness and change in SRTn. Hearing aid use (no use/ < 2 years use vs. ≥ 2 years) was not significantly associated with incident nor recurrent falls. Although there was a significant interaction with sex for this association, the effect of hearing aid use on incident/recurrent falls was not statistically significant among males nor females. CONCLUSIONS: A longitudinal association between the deterioration in SRTn and recurrent falls due to balance problems after 10 years was confirmed in this study. This result stresses the importance of identifying declines in hearing earlier and justifies including hearing ability assessments within fall risk prevention programs. Mixed results of hearing aid use on fall risk warrant further investigation into the temporality of this association and possible differences between men and women.
Subject(s)
Dizziness , Speech Perception , Male , Humans , Female , Longitudinal Studies , Dizziness/epidemiology , Dizziness/etiology , Speech , Cohort StudiesABSTRACT
BACKGROUND: The simultaneous presence of colorectal liver metastases (CRLMs) and extrahepatic metastases in patients with colorectal cancer (CRC) can be considered a relative contraindication for local treatment with curative intent. This study aims to assess the survival outcomes of patients with CRLMs and extrahepatic metastases after comprehensive local treatment of all metastatic sites. METHODS: Patients with CRLMs who received local treatment of all metastatic sites were extracted from the prospective AmCORE registry database and subdivided into two groups: CRLM only vs. CRLM and extrahepatic metastasis. To address potential confounders, multivariate analysis was performed. The primary endpoint was overall survival (OS). RESULTS: In total, 881 patients with CRLM only and 60 with CRLM and extrahepatic disease were included, and the median OS was 55.7 months vs. 42.7 months, respectively. Though OS was significantly lower in patients with concomitant extrahepatic metastases (HR 1.477; 95% CI 1.029-2.121; p = 0.033), the survival curve plateaued after 6.2 years. Extrahepatic manifestations were pulmonary (43.3%), peritoneal (16.7%) and non-regional lymph node metastases (10.0%). In patients with pulmonary and non-regional lymph node metastases, OS did not significantly differ from patients with CRLM-only disease; concomitant peritoneal metastases showed an inferior OS (HR 1.976; 95% CI 1.017-3.841, p = 0.041). CONCLUSIONS: In this comparative series, OS was inferior for patients with multi-organ metastatic CRC versus patients with CRLMs alone. Nonetheless, the long-term survival curve plateau seemed to justify local treatment in a subset of patients with multi-organ metastatic CRC, especially for patients with CRLMs and pulmonary or lymph node metastases.
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BACKGROUND AND AIMS: The International Autoimmune Hepatitis Group retrospective registry (IAIHG-RR) is a web-based platform with subjects enrolled with a clinical diagnosis of autoimmune hepatitis (AIH). As prognostic factor studies with enough power are scarce, this study aimed to ascertain data quality and identify prognostic factors in the IAIHG-RR cohort. METHODS: This retrospective, observational, multicenter study included all patients with a clinical diagnosis of AIH from the IAIHG-RR. The quality assessment consisted of external validation of completeness and consistency for 29 predefined variables. Cox regression was used to identify risk factors for liver-related death and liver transplantation (LT). RESULTS: This analysis included 2559 patients across 7 countries. In 1700 patients, follow-up was available, with a completeness of individual data of 90% (range: 30-100). During a median follow-up period of 10 (range: 0-49) years, there were 229 deaths, of which 116 were liver-related, and 143 patients underwent LT. Non-White ethnicity (HR 4.1 95% CI: 2.3-7.1), cirrhosis (HR 3.5 95% CI: 2.3-5.5), variant syndrome with primary sclerosing cholangitis (PSC) (HR 3.1 95% CI: 1.6-6.2), and lack of complete biochemical response within 6 months (HR 5.7 95% CI: 3.4-9.6) were independent prognostic factors. CONCLUSIONS: The IAIHG-RR represents the world's largest AIH cohort with moderate-to-good data quality and a relevant number of liver-related events. The registry is a suitable platform for patient selection in future studies. Lack of complete biochemical response to treatment, non-White ethnicity, cirrhosis, and PSC-AIH were associated with liver-related death and LT.
Subject(s)
Cholangitis, Sclerosing , Hepatitis, Autoimmune , Liver Transplantation , Humans , Hepatitis, Autoimmune/diagnosis , Retrospective Studies , Liver Cirrhosis/complications , Pathologic Complete Response , Cholangitis, Sclerosing/complicationsABSTRACT
OBJECTIVES: The HEAR-aware project targets adults ≥50 years who were recently diagnosed with hearing loss and declined hearing aids, but were open for support via a smartphone app on different target behaviors (TBs). The HEAR-aware app, based on Ecological Momentary Assessment and Ecological Momentary Intervention (EMA, EMI), contains educational materials ("snippets") tailored partly to the user's experienced listening situations. The app aims to increase adults' TB-specific readiness to take action on hearing problems. The present study focused on examining feasibility regarding three novel aspects: (1) the app's acceptability, mainly regarding its EMA and EMI elements (compliance, usability, usefulness, satisfaction), (2) psychometric properties of 10 new TB-specific stages-of-change (SoC) measures (test-retest reliability, construct validity), and (3) the potential of tailoring snippets on a person's SoC. DESIGN: A nonrandomized intervention study including four measurements with 2-week intervals (T0-T3). (1) The intervention period lasted 4 weeks. App usage data were collected throughout (T1-T3). Usability, usefulness, and satisfaction were measured at T3 (n = 26). (2) Reliability concerned T0 and T1 data, in between which no intervention occurred. Intraclass correlation coefficients (ICCs) were calculated (n = 29). Construct validity was examined by calculating correlations between the different TB-specific scales (at T0), and also between each of them and self-reported hearing disability (n = 29). (3) Person-tailoring by SoC was examined using T0 and T1 data. Linear mixed models were applied to test whether users rated snippets corresponding to their SoC as more interesting and useful than noncorresponding snippets (n = 25). RESULTS: (1) The percentage of participants that complied with the intended usage varied across the five predefined compliance criteria (lowest: 8%; highest: 85%). Median snippet satisfaction scores were reasonably positive (3.5 to 4.0 of 5). Usability was good (System Usability Score, mean = 72.4, SD = 14.3) and usefulness satisfactory (Intrinsic Motivation Inventory, mean = 4.4, SD = 1.4), but showed large variance. (2) The 10 TB-specific scales showed fair-to-excellent reliabilities (range ICCs = 0.51 to 0.80). Correlations between the TB-specific scales ranged between -0.17 ( p > 0.05) and 0.74 ( p < 0.001), supporting only partly overlap between their underlying constructs. Only the correlation between TB-specific readiness for hearing aid uptake and self-reported hearing disability was significant. (3) Correspondence of a snippet's SoC with the person's SoC significantly related to "interesting" ratings ( p = 0.006). Unexpectedly, for snippets with a lower SoC than the participant's, further deviation of the snippet's SoC from the participant's SoC, increased the participant's interest in the snippet. The relationship with "usefulness" was borderline significant. CONCLUSIONS: (1) Overall usability, usefulness, and satisfaction scores indicated sufficient app acceptability. The high variance and fairly low compliance showed room for improving the app's EMA/EMI parts for part of the participants. (2) The 10 new TB-specific SoC measures showed sufficient reliability, supporting that they measured different types of readiness to take action on hearing problems (construct validity). (3) The unexpected findings regarding tailoring educational app materials to individuals' SoC deserve further study.
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Deafness , Hearing Loss , Mobile Applications , Adult , Humans , Reproducibility of Results , Feasibility Studies , Hearing Loss/rehabilitationABSTRACT
BACKGROUND: Extended interval dosing (EID) of natalizumab is a promising strategy to optimise treatment in multiple sclerosis (MS). Personalised EID by therapeutic drug monitoring can enable further extension of treatment intervals. METHODS: The NEXT-MS trial is an investigator-initiated prospective phase IV non-randomised study. Adults with a diagnosis of relapsing-remitting MS who received ≥6 natalizumab infusions were included in three groups: personalised EID with a target drug trough concentration of 10 µg/mL (EID10), an exploratory group of personalised EID with a target of 5 µg/mL (EID5) and standard interval dosing (SID) of 4 weeks. The primary outcome is radiological disease activity (new/newly enlarged T2 lesions) comparing the EID10 group to a historical cohort of SID (HSID). RESULTS: Results of the first phase of the NEXT-MS trial are reported here (n=376) as the study will continue with an amended protocol. In the EID10 group (n=251), incidence rate of radiological activity was 10.0 per 1000 person-years, which was non-inferior to the HSID cohort (24.7 per 1000 person-years (n=87), incidence rate difference 14.7, 90% CI -4.5 to 34.0). Incidence rate of radiological activity was 10.0 per 1000 person-years in the EID5 group (n=65), and 47.0 per 1000 person-years in the SID group (n=60). Serum neurofilament light levels did not increase over time within the EID groups. There were no cases of progressive multifocal leukoencephalopathy. CONCLUSIONS: MS disease activity is adequately controlled with personalised natalizumab EID. Interval extension to a drug trough concentration of 5 µg/mL is likely a safe target to extend natalizumab treatment intervals >6 weeks. TRIAL REGISTRATION NUMBER: NCT04225312.
Subject(s)
Leukoencephalopathy, Progressive Multifocal , Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Adult , Humans , Drug Monitoring/adverse effects , Immunologic Factors/therapeutic use , Leukoencephalopathy, Progressive Multifocal/etiology , Multiple Sclerosis/drug therapy , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/complications , Natalizumab/therapeutic use , Prospective StudiesABSTRACT
PURPOSE: The objective of the COLLISION RELAPSE trial is to prove or disprove superiority of neoadjuvant systemic therapy followed by repeat local treatment (either thermal ablation and/or surgical resection), compared to repeat local treatment alone, in patients with at least one recurrent locally treatable CRLM within one year and no extrahepatic disease. METHODS: A total of 360 patients will be included in this phase III, multicentre randomized controlled trial. The primary endpoint is overall survival. Secondary endpoints are distant progression-free survival, local tumour progression-free survival analysed per patient and per tumour, systemic therapy-related toxicity, procedural morbidity and mortality, length of hospital stay, pain assessment and quality of life, cost-effectiveness ratio and quality-adjusted life years. DISCUSSION: If the addition of neoadjuvant systemic therapy to repeat local treatment of CRLM proves to be superior compared to repeat local treatment alone, this may lead to a prolonged life expectancy and increased disease-free survival at the cost of possible systemic therapy-related side effects. LEVEL OF EVIDENCE: Level 1, phase III randomized controlled trial. TRIAL REGISTRATION: NCT05861505. May 17, 2023.
Subject(s)
Colorectal Neoplasms , Liver Neoplasms , Humans , Neoadjuvant Therapy , Colorectal Neoplasms/pathology , Quality of Life , Prospective Studies , Liver Neoplasms/surgery , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Recurrence , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Clinical Trials, Phase III as TopicABSTRACT
OBJECTIVE: To investigate utilization of mental healthcare among head and neck cancer (HNC) patients from diagnosis to 2 years after treatment, in relation to psychological symptoms, mental disorders, need for mental healthcare, and sociodemographic, clinical and personal factors. METHODS: Netherlands Quality of life and Biomedical Cohort study data as measured before treatment, at 3 and 6 months, and at 1 and 2 years after treatment was used (n = 610). Data on mental healthcare utilization (iMCQ), psychological symptoms (Hospital Anxiety and Depression Scale, Cancer Worry Scale), mental disorders (CIDI interview), need for mental healthcare (Supportive Care Needs Survey Short-Form 34, either as continuous outcome indicating the level of need or dichotomized into unmet need (yes/no)) and several sociodemographic, clinical and personal factors were collected. Factors associated with mental healthcare utilization were investigated using generalized estimating equations (p < 0.05). RESULTS: Of all HNC patients, 5%-9% used mental healthcare per timepoint. This was 4%-14% in patients with mild-severe psychological symptoms, 4%-17% in patients with severe psychological symptoms, 15%-35% in patients with a mental disorder and 5%-16% in patients with an unmet need for mental healthcare. Among all patients, higher symptoms of anxiety, a higher need for mental healthcare, lower age, higher disease stage, lower self-efficacy and higher social support seeking were significantly associated with mental healthcare utilization. CONCLUSION: Mental health care utilization among HNC patients is limited, and is related to psychological symptoms, need for mental healthcare, and sociodemographic, clinical and personal factors.
Subject(s)
Head and Neck Neoplasms , Quality of Life , Humans , Longitudinal Studies , Cohort Studies , Quality of Life/psychology , Head and Neck Neoplasms/therapy , Patient Acceptance of Health Care , Surveys and QuestionnairesABSTRACT
The aim of this study was to investigate changes in sexuality and sexual dysfunction in head and neck cancer (HNC) patients in the first two years after treatment, in relation to the type of treatment. Data were used of 588 HNC patients participating in the prospective NETherlands Quality of life and Biomedical Cohort Study (NET-QUBIC) from diagnosis to 3, 6, 12 and 24 months after treatment. Primary outcome measures were the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). The total scores of the IIEF and FSFI were dichotomized into sexual (dys)function. In men, type of treatment was significantly associated with change in erectile function, orgasm, satisfaction with intercourse, and overall satisfaction. In women, type of treatment was significantly associated with change in desire, arousal, and orgasm. There were significant differences between treatment groups in change in dysfunctional sexuality. A deterioration in sexuality and sexual dysfunction from baseline to 3 months after treatment was observed especially in patients treated with chemoradiation. Changes in sexuality and sexual dysfunction in HNC patients were related to treatment, with an acute negative effect of chemoradiation. This effect on the various domains of sexuality seems to differ between men and women.
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PURPOSE: Thermal ablation is widely recognized as the standard of care for small-size unresectable colorectal liver metastases (CRLM). For larger CRLM safety, local control and overall efficacy are not well established and insufficiently validated. The purpose of this comparative series was to analyze outcomes for intermediate-size versus small-size CRLM. MATERIAL AND METHODS: Patients treated with thermal ablation between December 2000 and November 2021 for small-size and intermediate-size CRLM were included. The primary endpoints were complication rate and local control (LC). Secondary endpoints included local tumor progression-free survival (LTPFS) and overall survival (OS). RESULTS: In total, 59 patients were included in the intermediate-size (3-5 cm) group and 221 in the small-size (0-3 cm) group. Complications were not significantly different between the two groups (p = 0.546). No significant difference between the groups was found in an overall comparison of OS (HR 1.339; 95% CI 0.824-2.176; p = 0.239). LTPFS (HR 3.388; p < 0.001) and LC (HR 3.744; p = 0.004) were superior in the small-size group. Nevertheless, the 1-, 3-, and 5-year LC for intermediate-size CRLM was still 93.9%, 85.4%, and 81.5%, and technical efficacy improved over time. CONCLUSIONS: Thermal ablation for intermediate-size unresectable CRLM is safe and induces long-term LC in the vast majority. The results of the COLLISION-XL trial (unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation-a phase II randomized controlled trial for CRLM 3-5 cm) are required to provide further clarification of the role of local ablative methods for intermediate-size unresectable CRLM.
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BACKGROUND: The Japanese Channel (J-Channel) score was introduced to aid in retrograde percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs). The predictive value of the J-Channel score has not been compared with established collateral grading systems such as the Rentrop classification and Werner grade. AIMS: To investigate the predictive value of the J-Channel score, Rentrop classification and Werner grade for successful collateral channel (CC) guidewire crossing and technical CTO PCI success. METHODS: A total of 600 prospectively recruited patients underwent CTO PCI. All grading systems were assessed under dual catheter injection. CC guidewire crossing was considered successful if the guidewire reached the distal segment of the CTO vessel through a retrograde approach. Technical CTO PCI success was defined as thrombolysis in myocardial infarction flow grade 3 and residual stenosis <30%. RESULTS: Of 600 patients, 257 (43%) underwent CTO PCI through a retrograde approach. Successful CC guidewire crossing was achieved in 208 (81%) patients. The predictive value of the J-Channel score for CC guidewire crossing (area under curve 0.743) was comparable with the Rentrop classification (0.699, p = 0.094) and superior to the Werner grade (0.663, p = 0.002). Technical CTO PCI success was reported in 232 (90%) patients. The Rentrop classification exhibited a numerically higher discriminatory ability (0.676) compared to the J-Channel score (0.664) and Werner grade (0.589). CONCLUSIONS: The J-channel score might aid in strategic collateral channel selection during retrograde CTO PCI. However, the J-Channel score, Rentrop classification, and Werner grade have limited value in predicting technical CTO PCI success.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Treatment Outcome , Coronary Angiography , Chronic Disease , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/therapy , Risk Factors , RegistriesABSTRACT
PURPOSE: The primary aim of this study was to investigate the effect of including the Dutch National Pharmacotherapy Assessment (DNPA) in the medical curriculum on the level and development of prescribing knowledge and skills of junior doctors. The secondary aim was to evaluate the relationship between the curriculum type and the prescribing competence of junior doctors. METHODS: We re-analysed the data of a longitudinal study conducted in 2016 involving recently graduated junior doctors from 11 medical schools across the Netherlands and Belgium. Participants completed three assessments during the first year after graduation (around graduation (+ / - 4 weeks), and 6 months, and 1 year after graduation), each of which contained 35 multiple choice questions (MCQs) assessing knowledge and three clinical case scenarios assessing skills. Only one medical school used the DNPA in its medical curriculum; the other medical schools used conventional means to assess prescribing knowledge and skills. Five medical schools were classified as providing solely theoretical clinical pharmacology and therapeutics (CPT) education; the others provided both theoretical and practical CPT education (mixed curriculum). RESULTS: Of the 1584 invited junior doctors, 556 (35.1%) participated, 326 (58.6%) completed the MCQs and 325 (58.5%) the clinical case scenarios in all three assessments. Junior doctors whose medical curriculum included the DNPA had higher knowledge scores than other junior doctors (76.7% [SD 12.5] vs. 67.8% [SD 12.6], 81.8% [SD 11.1] vs. 76.1% [SD 11.1], 77.0% [12.1] vs. 70.6% [SD 14.0], p < 0.05 for all three assessments, respectively). There was no difference in skills scores at the moment of graduation (p = 0.110), but after 6 and 12 months junior doctors whose medical curriculum included the DNPA had higher skills scores (both p < 0.001). Junior doctors educated with a mixed curriculum had significantly higher scores for both knowledge and skills than did junior doctors educated with a theoretical curriculum (p < 0.05 in all assessments). CONCLUSION: Our findings suggest that the inclusion of the knowledge focused DNPA in the medical curriculum improves the prescribing knowledge, but not the skills, of junior doctors at the moment of graduation. However, after 6 and 12 months, both the knowledge and skills were higher in the junior doctors whose medical curriculum included the DNPA. A curriculum that provides both theoretical and practical education seems to improve both prescribing knowledge and skills relative to a solely theoretical curriculum.
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Curriculum , Education, Medical , Humans , Longitudinal Studies , Netherlands , Medical Staff, Hospital/education , Clinical CompetenceABSTRACT
PURPOSE: The aim of this prospective cohort study was to estimate the relationship between the course of HRQOL in the first 2 years after diagnosis and treatment of head and neck cancer (HNC) and personal, clinical, psychological, physical, social, lifestyle, HNC-related, and biological factors. METHODS: Data were used from 638 HNC patients of the NETherlands QUality of life and BIomedical Cohort study (NET-QUBIC). Linear mixed models were used to investigate factors associated with the course of HRQOL (EORTC QLQ-C30 global quality of life (QL) and summary score (SumSc)) from baseline to 3, 6, 12, and 24 months after treatment. RESULTS: Baseline depressive symptoms, social contacts, and oral pain were significantly associated with the course of QL from baseline to 24 months. Tumor subsite and baseline social eating, stress (hyperarousal), coughing, feeling ill, and IL-10 were associated with the course of SumSc. Post-treatment social contacts and stress (avoidance) were significantly associated with the course of QL from 6 to 24 months, and social contacts and weight loss with the course of SumSc. The course of SumSc from 6 to 24 months was also significantly associated with a change in financial problems, speech problems, weight loss, and shoulder problems between baseline and 6 months. CONCLUSION: Baseline clinical, psychological, social, lifestyle, HNC-related, and biological factors are associated with the course of HRQOL from baseline to 24 months after treatment. Post-treatment social, lifestyle, and HNC-related factors are associated with the course of HRQOL from 6 to 24 months after treatment.
Subject(s)
Head and Neck Neoplasms , Quality of Life , Humans , Biological Factors , Cohort Studies , Prospective Studies , Life Style , Head and Neck Neoplasms/therapy , Weight LossABSTRACT
PURPOSE: This study assessed the diagnostic value of CT hepatic arteriography (CTHA) for the intraprocedural detection of previously unknown colorectal liver metastases (CRLM) and the impact on the definitive treatment plan. MATERIALS AND METHODS: All patients treated with CTHA-guided percutaneous ablation for CRLM between January 2012 and March 2022 were identified from the Amsterdam Colorectal Liver Met Registry (AmCORE). Radiology reports of the ablative procedure and follow-up imaging were reviewed to see if (a) previously unknown CRLM were detected intra-procedurally and if (b) new CRLM, potentially missed on CTHA, appeared within 6 months following the procedure; three abdominal radiologists re-reviewed the baseline CTHA scans of these patients with early recurrence. To ratify immediate ablations of concomitantly detected CRLM, the upper limit of false positives was predefined at 10%. RESULTS: One hundred and fifty-two patients were included. With CTHA, a total of 17 additional tumours in 15 patients were diagnosed and treated immediately, two representing disappeared tumours following systemic chemotherapy. Compared to the conventional contrast-enhanced (ce)CT, ceMRI and 18F-FDG PET-CT, adding CTHA was superior for the detection of CRLM (P < .001). Within 12 months of follow-up 121, new CRLM appeared in 49/152 patients (32.2%); retrospective blinded assessment revealed 56 to already be visible on the baseline CTHA scan (46%); four lesions without substrate on follow-up scans were considered false positives (n = 4/60; 7%). Arterial ring enhancement was the most frequently reported imaging characteristic (n = 45/60; 75%). CONCLUSION: The subsequent use of CTHA has added value for the detection of previously unknown and vanished CRLM. Taking into account the low number of false positives (7%) and the favourable safety profile of percutaneous ablation, we believe that immediate ablation of typical ring-enhancing supplementary tumours is justified and sufficiently validated. LEVEL OF EVIDENCE: Level 3; individual cross-sectional study with consistently applied reference standard and blinding.
Subject(s)
Catheter Ablation , Colorectal Neoplasms , Liver Neoplasms , Humans , Retrospective Studies , Cross-Sectional Studies , Positron Emission Tomography Computed Tomography , Colorectal Neoplasms/pathology , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/surgery , Angiography , Tomography, X-Ray Computed/methods , Catheter Ablation/methodsABSTRACT
PURPOSE: Personal continuity between patient and physician is a core value of primary care. Although previous studies suggest that personal continuity is associated with fewer potentially inappropriate prescriptions, evidence on continuity and prescribing in primary care is scarce. We aimed to determine the association between personal continuity and potentially inappropriate prescriptions, which encompasses potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), by family physicians among older patients. METHODS: We conducted an observational cohort study using routine care data from patients enlisted in 48 Dutch family practices from 2013 to 2018. All 25,854 patients aged 65 years and older having at least 5 contacts with their practice in 6 years were included. We calculated personal continuity using 3 established measures: the usual provider of care measure, the Bice-Boxerman Index, and the Herfindahl Index. We used the Screening Tool of Older Person's Prescriptions (STOPP) and the Screening Tool to Alert doctors to Right Treatment (START) specific to the Netherlands version 2 criteria to calculate the prevalence of potentially inappropriate prescriptions. To assess associations, we conducted multilevel negative binomial regression analyses, with and without adjustment for number of chronic conditions, age, and sex. RESULTS: The patients' mean (SD) values for the usual provider of care measure, the Bice-Boxerman Continuity of Care Index, and the Herfindahl Index were 0.70 (0.19), 0.55 (0.24), and 0.59 (0.22), respectively. In our population, 72.2% and 74.3% of patients had at least 1 PIM and PPO, respectively; 30.9% and 34.2% had at least 3 PIMs and PPOs, respectively. All 3 measures of personal continuity were positively and significantly associated with fewer potentially inappropriate prescriptions. CONCLUSIONS: A higher level of personal continuity is associated with more appropriate prescribing. Increasing personal continuity may improve the quality of prescriptions and reduce harmful consequences.
Subject(s)
Inappropriate Prescribing , Potentially Inappropriate Medication List , Humans , Aged , Cohort Studies , Inappropriate Prescribing/prevention & control , Physicians, Family , Primary Health CareABSTRACT
Background: Patients with haematological malignancies have impaired antibody responses to SARS-CoV-2 vaccination. We aimed to investigate whether a fourth mRNA COVID-19 vaccination improved antibody quantity and quality. Methods: In this cohort study, conducted at 5 sites in the Netherlands, we compared antibody concentrations 28 days after 4 mRNA vaccinations (3-dose primary series plus 1 booster vaccination) in SARS-CoV-2 naive, immunocompromised patients with haematological malignancies to those obtained by age-matched, healthy individuals who had received the standard primary 2-dose mRNA vaccination schedule followed by a first booster mRNA vaccination. Prior to and 4 weeks after each vaccination, peripheral blood samples and data on demographic parameters and medical history were collected. Concentrations of antibodies that bind spike 1 (S1) and nucleocapsid (N) protein of SARS-CoV-2 were quantified in binding antibody units (BAU) per mL according to the WHO International Standard for COVID-19 serological tests. Seroconversion was defined as an S1 IgG concentration >10 BAU/mL and a previous SARS-CoV-2 infection as N IgG >14.3 BAU/mL. Antibody neutralising activity was tested using lentiviral-based pseudoviruses expressing spike protein of SARS-CoV-2 wild-type (D614G), Omicron BA.1, and Omicron BA.4/5 variants. This study is registered with EudraCT, number 2021-001072-41. Findings: Between March 24, 2021 and May 4, 2021, 723 patients with haematological diseases were enrolled, of which 414 fulfilled the inclusion criteria for the current analysis. Although S1 IgG concentrations in patients significantly improved after the fourth dose, they remained significantly lower compared to those obtained by 58 age-matched healthy individuals after their first booster (third) vaccination. The rise in neutralising antibody concentration was most prominent in patients with a recovering B cell compartment, although potent responses were also observed in patients with persistent immunodeficiencies. 19% of patients never seroconverted, despite 4 vaccinations. Patients who received their first 2 vaccinations when they were B cell depleted and the third and fourth vaccination during B cell recovery demonstrated similar antibody induction dynamics as patients with normal B cell numbers during the first 2 vaccinations. However, the neutralising capacity of these antibodies was significantly better than that of patients with normal B cell numbers after two vaccinations. Interpretation: A fourth mRNA COVID-19 vaccination improved S1 IgG concentrations in the majority of patients with a haematological malignancy. Vaccination during B cell depletion may pave the way for better quality of antibody responses after B cell reconstitution. Funding: The Netherlands Organisation for Health Research and Development and Amsterdam UMC.
ABSTRACT
OBJECTIVE: This study assessed the impact of the COVID-19 pandemic on psychosocial health among individuals with different levels of hearing ability. DESIGN: For this cross-sectional study, adults completed an online digits-in-noise test and survey. Participants were categorised into "good", "insufficient", or "poor" hearing groups. Survey questions included topics on depression, anxiety, distress, somatisation, and loneliness levels. Multiple logistic, linear, and negative binomial regressions examined differences in psychosocial health between hearing groups. Moderation analyses identified vulnerable subgroups. Mediation analyses examined mediating effects of pandemic measures on hearing ability and psychosocial health. STUDY SAMPLE: Eight-hundred and sixty-five adults with or without hearing impairment. RESULTS: Individuals with poor hearing had a higher odds of having elevated anxiety levels and had higher somatisation levels compared to participants with good hearing. Chronic diseases significantly moderated the relationship between poor hearing ability and loneliness. Difficulties with communicating through facemasks, 1.5 m distance, plastic screens, and during video calls significantly mediated the relationships between hearing ability, anxiety and somatisation. CONCLUSIONS: Results highlight the elevated anxiety and somatisation levels experienced among individuals with hearing impairment during the COVID-19 pandemic. More awareness is needed of the negative impact pandemic measures can have on psychosocial health during future health crises.