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"Baan, Paul"
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Key Characteristics of Carcinogens as a Basis for Organizing Data on Mechanisms of Carcinogenesis
A recent review by the International Agency for Research on Cancer (IARC) updated the assessments of the > 100 agents classified as Group 1, carcinogenic to humans (IARC Monographs Volume 100, parts A-F). This exercise was complicated by the absence of a broadly accepted, systematic method for evaluating mechanistic data to support conclusions regarding human hazard from exposure to carcinogens.
IARC therefore convened two workshops in which an international Working Group of experts identified 10 key characteristics, one or more of which are commonly exhibited by established human carcinogens.
These characteristics provide the basis for an objective approach to identifying and organizing results from pertinent mechanistic studies. The 10 characteristics are the abilities of an agent to 1) act as an electrophile either directly or after metabolic activation; 2) be genotoxic; 3) alter DNA repair or cause genomic instability; 4) induce epigenetic alterations; 5) induce oxidative stress; 6) induce chronic inflammation; 7) be immunosuppressive; 8) modulate receptor-mediated effects; 9) cause immortalization; and 10) alter cell proliferation, cell death, or nutrient supply.
We describe the use of the 10 key characteristics to conduct a systematic literature search focused on relevant end points and construct a graphical representation of the identified mechanistic information. Next, we use benzene and polychlorinated biphenyls as examples to illustrate how this approach may work in practice. The approach described is similar in many respects to those currently being implemented by the U.S. EPA's Integrated Risk Information System Program and the U.S. National Toxicology Program.
Smith MT, Guyton KZ, Gibbons CF, Fritz JM, Portier CJ, Rusyn I, DeMarini DM, Caldwell JC, Kavlock RJ, Lambert P, Hecht SS, Bucher JR, Stewart BW, Baan R, Cogliano VJ, Straif K. 2016. Key characteristics of carcinogens as a basis for organizing data on mechanisms of carcinogenesis. Environ Health Perspect 124:713-721; http://dx.doi.org/10.1289/ehp.1509912.
Journal Article
Efficacy and Safety of Outpatient Treatment Based on the Hestia Clinical Decision Rule with or without N-Terminal Pro–Brain Natriuretic Peptide Testing in Patients with Acute Pulmonary Embolism. A Randomized Clinical Trial
Abstract
Rationale
Outpatient treatment of pulmonary embolism (PE) may lead to improved patient satisfaction and reduced healthcare costs. However, trials to assess its safety and the optimal method for patient selection are scarce.
Objectives
To validate the utility and safety of selecting patients with PE for outpatient treatment by the Hestia criteria and to compare the safety of the Hestia criteria alone with the Hestia criteria combined with N-terminal pro–brain natriuretic peptide (NT-proBNP) testing.
Methods
We performed a randomized noninferiority trial in 17 Dutch hospitals. We randomized patients with PE without any of the Hestia criteria to direct discharge or additional NT-proBNP testing. We discharged the latter patients as well if NT-proBNP did not exceed 500 ng/L or admitted them if NT-proBNP was greater than 500 ng/L. The primary endpoint was 30-day adverse outcome defined as PE- or bleeding-related mortality, cardiopulmonary resuscitation, or intensive care unit admission. The noninferiority margin for the primary endpoint was 3.4%.
Measurements and Main Results
We randomized 550 patients. In the NT-proBNP group, 34 of 275 (12%) had elevated NT-proBNP values and were managed as inpatients. No patient (0 of 34) with an elevated NT-proBNP level treated in hospital (0%; 95% confidence interval [CI], 0–10.2%), versus no patient (0 of 23) with a post hoc–determined elevated NT-proBNP level from the direct discharge group (0%; 95% CI, 0–14.8%), experienced the primary endpoint. In both trial cohorts, the primary endpoint occurred in none of the 275 patients (0%; 95% CI, 0–1.3%) subjected to NT-proBNP testing, versus in 3 of 275 patients (1.1%; 95% CI, 0.2–3.2%) in the direct discharge group (P = 0.25). During the 3-month follow-up, recurrent venous thromboembolism occurred in two patients (0.73%; 95% CI, 0.1–2.6%) in the NT-proBNP group versus three patients (1.1%; 95% CI, 0.2–3.2%) in the direct discharge group (P = 0.65).
Conclusions
Outpatient treatment of patients with PE selected on the basis of the Hestia criteria alone was associated with a low risk of adverse events. Given the low number of patients with elevated NT-proBNP levels, this trial was unable to draw definite conclusions regarding the incremental value of NT-proBNP testing in patients who fulfill the Hestia criteria.
Clinical trial registered with www.trialregister.nl/trialreg/admin/rctview.asp?TC=2603 (NTR2603).
Journal Article
Meeting Report: Summary of IARC Monographs on Formaldehyde, 2-Butoxyethanol, and 1-tert-Butoxy-2-Propanol
An international, interdisciplinary working group of expert scientists met in June 2004 to develop IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans (IARC Monographs) on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Each IARC Monograph includes a critical review of the pertinent scientific literature and an evaluation of an agent's potential to cause cancer in humans. After a thorough discussion of the epidemiologic, experimental, and other relevant data, the working group concluded that formaldehyde is carcinogenic to humans, based on sufficient evidence in humans and in experimental animals. In the epidemiologic studies, there was sufficient evidence that formaldehyde causes nasopharyngeal cancer, \"strong but not sufficient\" evidence of leukemia, and limited evidence of sinonasal cancer. The working group also concluded that 2-butoxyethanol and 1-tert-butoxy-2-propanol are not classifiable as to their carcinogenicity to humans, each having limited evidence in experimental animals and inadequate evidence in humans. These three evaluations and the supporting data will bepublished as Volume 88 of the IARC Monographs.
Journal Article
Development and validation of crosswalks between the EORTC QLQ-C30 physical, role, social and emotional functioning, fatigue and global health status/quality of life scales and their corresponding PROMIS® scales
Across patient-reported outcome measures (PROMs), the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is one of the most widely used among patients with cancer. Patients may also complete other PROMs such as forms of the Patient-Reported Outcomes Measurement Information System (PROMIS®). The objective of this study was to develop crosswalks between the EORTC QLQ-C30 physical, role, social and emotional functioning, fatigue and global health status/quality of life (QoL) scales and their corresponding PROMIS® scales.
In a single group-design, using the Netherlands Patient-Reported Outcomes Following Initial Treatment and Long-term Evaluation of Survivorship (PROFILES) registry, patients of various cancers were invited to complete the EORTC QLQ-C30 and PROMIS® forms from September to December 2022. Data were randomly divided into a calibration and validation set. Crosswalks were developed using equipercentile equating and their predictive performance was assessed in terms of standardized mean absolute errors (SMAEs) and intraclass correlations (ICCs).
The total sample consisted of 1972 cancer patients (mean age 61 years; 55% female). We developed 15 crosswalks. Their SMAE was generally satisfactory (below 0.50) and comparable in the calibration and validation datasets. The highest precision was found for the physical functioning and fatigue crosswalks, followed by role functioning, emotional functioning and depression. The lowest precision was found for the EORTC QLQ-C30 to PROMIS® general health, general QoL, and anxiety scores. Almost all ICC were above 0.70, except for EORTC QLQ-C30 to PROMIS® anxiety/depression and PROMIS® to EORTC social functioning.
We developed valid crosswalks for multiple scales of the EORTC QLQ-C30 and PROMIS®. The established concordance tables can be used to convert scores in both directions and are valid for group level analyses. The crosswalks from EORTC emotional functioning toward PROMIS® anxiety and depression demonstrate suboptimal performance and should therefore be used carefully.
•Patient-reported outcome data are essential in cancer clinical research.•EORTC QLQ-C30 and PROMIS® are often used measures.•The development of crosswalks could facilitate direct comparison.•15 valid crosswalks were developed and validated.•Conversion tables for functioning and symptoms can now be used.
Journal Article
Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development
Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention (\"ikherstel\" intervention or \"I recover\" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures.
This study aimed to further develop the \"ikherstel\" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population.
The IM protocol was used to guide further development of the \"ikherstel\" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed \"ikherstel\" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed.
The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as \"achieving earlier recovery including return to normal activities and work.\" The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands.
The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed.
Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.
Journal Article
The Science and Practice of Carcinogen Identification and Evaluation
Several national and international health agencies have established programs with the aim of identifying agents and exposures that cause cancer in humans. Carcinogen identification is an activity grounded in the scientific evaluation of the results of human epidemiologic studies, long-term bioassays in experimental animals, and other data relevant to an evaluation of carcinogenicity and its mechanisms. In this commentary, after a brief discussion of the science basis common to the evaluation of carcinogens across different programs, we discuss in more detail the principles and procedures currently used by the IARC Monographs program.
Journal Article
Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis
Permanent pacemaker implantation (PPI) is a widely recognized complication associated with TAVI (incidence up to 20%). Smaller registries have identified several variables associated with PPI. The objective was to validate patient- and transcatheter aortic valve implantation (TAVI)-related procedural variables associated with PPI. We performed a retrospective analysis of patients from six European centers undergoing TAVI with the Edwards SAPIEN 3 prosthesis. Baseline variables and pre-procedural ECG characteristics and CT-scans were taken into account. Data for 1745 patients were collected; 191 (10.9%) required PPI after TAVI. The baseline variables pulmonary hypertension (OR 1.64; 95% CI 1.01–2.59), QRS duration > 117 ms (OR 2.58; 95% CI 1.73–3.84), right bundle branch block (RBBB; OR 5.14; 95% CI 3.39–7.72), left anterior hemi block (OR 1.92; 95% CI 1.19–3.02) and first-degree atrioventricular block (AVB, OR 1.63; 95%CI 1.05–2.46) were significantly associated with PPI. RBBB (OR 8.11; 95% CI 3.19–21.86) and first-degree AVB (OR 2.39; 95% CI 1.18–4.66) remained significantly associated in a multivariate analysis. Procedure-related variables included access site (TF; OR 1.97; 95% CI 1.07–4.05), implanted valve size (29 mm; OR 1.88; 95% CI 1.35–2.59), mean TAVI valve implantation depth below the annulus > 30% (OR 3.75; 95% CI 2.01–6.98). Patients receiving PPI had longer ICU stays and later discharges. Acute kidney injury stage 2/3 was more common in patients with PPI until discharge (15.2 vs. 3.1%;
p
= 0.007), but was not statistically significant thereafter. Further differences in outcomes at 30 days did not reach significance. The data will aid pre- and post-procedural patient management and prevent adverse long-term outcomes.
Clinical Trial: NCT03497611.
Journal Article
Carcinogenicity of polychlorinated biphenyls and polybrominated biphenyls
Carcinogenicity of polychlorinated biphenyls and polybrominated biphenyls
Journal Article