Patient online access to general practice medical records: A qualitative study on patients' needs and expectations.

BACKGROUND: Patient online access to medical records is assumed to foster patient empowerment and advance patient-centred healthcare. Since July 2020, patients in the Netherlands have been legally entitled to electronically access their medical record in general practice. Experience from pioneering countries has shown that despite high patient interest, user rates often remain low. How to best support implementation depends on individual needs and expectations of patient populations, which are as yet unknown in the Dutch context. OBJECTIVE: To understand Dutch patients' needs and expectations with regard to online access to their medical record in general practice. METHOD: Twenty participants completed semi-structured individual interviews via video or telephone call. Transcripts of interviews underwent template analysis combining deductive and inductive coding using Atlas.ti software. RESULTS: Patients' needs and expectations ranged across three overlapping areas: (i) prerequisites for getting online access; (ii) using online access; and (iii) the impact on interaction with healthcare providers. Patients expected benefits from online access such as better overview, empowerment and improved communication with their general practitioner but identified needs regarding technological difficulties, data privacy and complex medical language in their record. CONCLUSION: The concerns and obstacles participants identified point towards the need for organisational changes in general practice, for example, adjusted documentation practices, and the key role of the general practitioner and staff in promoting and facilitating online access. IMPLICATIONS: Implementation strategies addressing needs identified in this study may help to unlock the full potential of online access to achieve desired outcomes of patient involvement and satisfaction.

Toward Systems Models for Obesity Prevention: A Big Role for Big Data.

The relation among the various causal factors of obesity is not well understood, and there remains a lack of viable data to advance integrated, systems models of its etiology. The collection of big data has begun to allow the exploration of causal associations between behavior, built environment, and obesity-relevant health outcomes. Here, the traditional epidemiologic and emerging big data approaches used in obesity research are compared, describing the research questions, needs, and outcomes of 3 broad research domains: eating behavior, social food environments, and the built environment. Taking tangible steps at the intersection of these domains, the recent European Union project "BigO: Big data against childhood obesity" used a mobile health tool to link objective measurements of health, physical activity, and the built environment. BigO provided learning on the limitations of big data, such as privacy concerns, study sampling, and the balancing of epidemiologic domain expertise with the required technical expertise. Adopting big data approaches will facilitate the exploitation of data concerning obesity-relevant behaviors of a greater variety, which are also processed at speed, facilitated by mobile-based data collection and monitoring systems, citizen science, and artificial intelligence. These approaches will allow the field to expand from causal inference to more complex, systems-level predictive models, stimulating ambitious and effective policy interventions.

Machine Learning in Nutrition Research.

Data currently generated in the field of nutrition are becoming increasingly complex and high-dimensional, bringing with them new methods of data analysis. The characteristics of machine learning (ML) make it suitable for such analysis and thus lend itself as an alternative tool to deal with data of this nature. ML has already been applied in important problem areas in nutrition, such as obesity, metabolic health, and malnutrition. Despite this, experts in nutrition are often without an understanding of ML, which limits its application and therefore potential to solve currently open questions. The current article aims to bridge this knowledge gap by supplying nutrition researchers with a resource to facilitate the use of ML in their research. ML is first explained and distinguished from existing solutions, with key examples of applications in the nutrition literature provided. Two case studies of domains in which ML is particularly applicable, precision nutrition and metabolomics, are then presented. Finally, a framework is outlined to guide interested researchers in integrating ML into their work. By acting as a resource to which researchers can refer, we hope to support the integration of ML in the field of nutrition to facilitate modern research.

Image-guided navigation for locally advanced primary and locally recurrent rectal cancer: evaluation of its early cost-effectiveness.

BACKGROUND: A first pilot study showed that an image-guided navigation system could improve resection margin rates in locally advanced (LARC) and locally recurrent rectal cancer (LRRC) patients. Incremental surgical innovation is often implemented without reimbursement consequences, health economic aspects should however also be taken into account. This study evaluates the early cost-effectiveness of navigated surgery compared to standard surgery in LARC and LRRC. METHODS: A Markov decision model was constructed to estimate the expected costs and outcomes for navigated and standard surgery. The input parameters were based on pilot data from a prospective (navigation cohort n = 33) and retrospective (control group n = 142) data. Utility values were measured in a comparable group (n = 63) through the EQ5D-5L. Additionally, sensitivity and value of information analyses were performed. RESULTS: Based on this early evaluation, navigated surgery showed incremental costs of €3141 and €2896 in LARC and LRRC. In LARC, navigated surgery resulted in 2.05 Quality-Adjusted Life Years (QALYs) vs 2.02 QALYs for standard surgery. For LRRC, we found 1.73 vs 1.67 QALYs respectively. This showed an Incremental Cost-Effectiveness Ratio (ICER) of €136.604 for LARC and €52.510 for LRRC per QALY gained. In scenario analyses, optimal utilization rates of the navigation technology lowered the ICER to €61.817 and €21.334 for LARC and LRRC. The ICERs of both indications were most sensitive to uncertainty surrounding the risk of progression in the first year after surgery, the risk of having a positive surgical margin, and the costs of the navigation system. CONCLUSION: Adding navigation system use is expected to be cost-effective in LRRC and has the potential to become cost-effective in LARC. To increase the probability of being cost-effective, it is crucial to optimize efficient use of both the hybrid OR and the navigation system and identify subgroups where navigation is expected to show higher effectiveness.

DIetary ASSessment (DIASS) Study: Design of an Evaluation Study to Assess Validity, Usability and Perceived Burden of an Innovative Dietary Assessment Methodology.

During recent years, the integration of technology has substantially improved self-reported dietary assessment methods, such as food frequency questionnaires (FFQ), food records, and 24-h recalls. To further reduce measurement error, additional innovations are urgently needed. Memory-related measurement error is one of the aspects that warrants attention, which is where new smartphone technologies and ecological momentary assessment (EMA) approaches provide a unique opportunity. In this article, we describe the DIASS study, which was designed to evaluate an innovative 2-h recall (2hR) smartphone-based methodology, against traditional 24-h recalls, FFQ, and biomarkers, to assess both actual and habitual dietary intake. It is hypothesized that a 2-h reporting window decreases reliance on memory and reporting burden, and increases data accuracy. We included 215 men (28%) and women (72%), with a mean ± SD age of 39 ± 19 years and a mean ± SD BMI of 23.8 ± 4.0. Most participants were highly educated (58%). Response rates for the various dietary assessment methods were >90%. Besides the evaluation of the accuracy, usability, and perceived burden of the 2hR methodology, the study set-up also allows for (further) evaluation of the other administrated dietary assessment tools.

Quaternary ammonium silane (k21) based intracanal medicament triggers biofilm destruction.

BACKGROUND: Compare antimicrobial efficacy of a quarternary ammonium silane (QAS)/k21 as an intracanal medicament against E. faecalis and C. albicans biofilms formed on root dentin. METHODOLOGY: Dentin blocks were sterilized and E. faecalis and C. albicans microbial colonies were counted for colony-forming-units against 2%k21, 2%CHX and Ca(OH)2 medicaments. Biofilm colonies after 7 days on dentin were analysed using confocal laser scanning microscopy with live/dead bacterial viability staining. TEM was done to study dentin collagen matrix. Dentin discs from 3rd day and 7th day well plate was used for Raman spectra and observed under fluorescent-microscope. Docking studies were carried out on MMP-2 S1 binding-domain with k21. RESULTS: There was reduction of E. faecalis/C. albicans when k21, chlorhexidine and calcium hydroxide were used with highest percentage in 2%k21 treated specimens. 2%k21 showed dense and regular collagen network with intact cross-banding and decreased Raman intensity for 2%k21 on 3rd day. NaOCl + k21 showed least adherence, whereas saline groups showed highest adherence of E. faecalis and C. albicans to root-canal dentin. Alizarin red staining of hDPSCs revealed calcium deposition in all groups with significant difference seen amongst 2%k21 groups. MMP-2 ligand binding was seen accurately indicating possible target sites for k21 intervention. CONCLUSION: 2%k21 can be considered as alternative intracanal medicament.

GMO Genetic Elements Thesaurus (GMO-GET): a controlled vocabulary for the consensus designation of introduced or modified genetic elements in genetically modified organisms.

BACKGROUND: Various databases on genetically modified organisms (GMOs) exist, all with their specific focus to facilitate access to information needed for, e. g., the assistance in risk assessment, the development of detection and identification strategies or inspection and control activities. Each database has its unique approach towards the subject. Often these databases use different terminology to describe the GMOs. For adequate GMO addressing and identification and exchange of GMO-related information it is necessary to use commonly agreed upon concepts and terminology. RESULT: A hierarchically structured controlled vocabulary describing the genetic elements inserted into conventional GMOs, and GMOs developed by the use of gen(om)e-editing is presented: the GMO genetic element thesaurus (GMO-GET). GMO-GET can be used for GMO-related documentation, including GMO-related databases. It has initially been developed on the basis of two GMO databases, i.e. the Biosafety Clearing-House and the EUginius database. CONCLUSION: The use of GMO-GET will enable consistent and compatible information (harmonisation), also allowing an accurate exchange of information between the different data systems and thereby facilitating their interoperability. GMO-GET can also be used to describe genetic elements that are altered in organisms obtained through current targeted genome-editing techniques.

Application of the Safe-By-Design Concept in Crop Breeding Innovation.

The present paper proposes the application of the safe-by-design concept to crop breeding innovation with the aim to accommodate safety considerations for new agricultural food and feed products. Safe-by-design can be implemented in all stages of the innovation cycle of agricultural products, from the early stages of research and development towards the post-market stage. Our proposed application of safe-by-design can be part of "responsible research and innovation" concepts, because they share features such as risk prevention strategies and a participatory approach. Early awareness of potential safety issues can guide the development of agricultural products towards safe options, both at the process and product level, and thus may help to reduce extensive pre-market assessment studies that might otherwise be needed further downstream for regulatory product approval. Here, it is discussed how the proposed safe-by-design approach can be introduced into the development of safe food crops using emerging technologies, such as gene editing and synthetic biology, and how this may help to safeguard the safety of our food and feed supply in the light of the ongoing global innovations in agricultural crop breeding.

Molecular Characterization and Event-Specific Real-Time PCR Detection of Two Dissimilar Groups of Genetically Modified Petunia (Petunia x hybrida) Sold on the Market.

Petunia plants with unusual orange flowers were noticed on the European market and confirmed to be genetically modified (GM) by the Finnish authorities in spring 2017. Later in 2017, inspections and controls performed by several official laboratories of national competent authorities in the European Union detected several GM petunia varieties with orange flowers, but also another group of unusually colored flowers. In the latter group, a so far undetected gene coding for a flavonoid 3'5' hydroxylase (F3'5'H) responsible for the purple color was identified by German and Dutch authorities, suggesting that the petunias found on the markets contain different genetic constructs. Here, a strategy is described for the identification of GM petunia varieties. It is based on an initial GMO screening for known elements using (real-time) PCR and subsequent identification of the insertion sites by a gene walking-like approach called ALF (amplification of linearly-enriched fragments) in combination with Sanger and MinION sequencing. The results indicate that the positively identified GM petunias can be traced back to two dissimilar GM events used for breeding of the different varieties. The test results also confirm that the transgenic petunia event RL01-17 used in the first German field trial in 1991 is not the origin of the GM petunias sold on the market. On basis of the obtained sequence data, event-specific real-time PCR confirmatory methods were developed and validated. These methods are applicable for the rapid detection and identification of GM petunias in routine analysis. In addition, a decision support system was developed for revealing the most likely origin of the GM petunia.

Association of Image-Guided Navigation With Complete Resection Rate in Patients With Locally Advanced Primary and Recurrent Rectal Cancer: A Nonrandomized Controlled Trial.

Importance: The percentage of tumor-positive surgical resection margin rates in patients treated for locally advanced primary or recurrent rectal cancer is high. Image-guided navigation may improve complete resection rates. Objective: To ascertain whether image-guided navigation during rectal cancer resection improves complete resection rates compared with surgical procedures without navigation. Design, Setting, and Participants: This prospective single-center nonrandomized controlled trial was conducted at the Netherlands Cancer Institute-Antoni van Leeuwenhoek in Amsterdam, the Netherlands. The prospective or navigation cohort included adult patients with locally advanced primary or recurrent rectal cancer who underwent resection with image-guided navigation between February 1, 2016, and September 30, 2019, at the tertiary referral hospital. Clinical results of this cohort were compared with results of the historical cohort, which was composed of adult patients who received rectal cancer resection without image-guided navigation between January 1, 2009, and December 31, 2015. Intervention: Rectal cancer resection with image-guided navigation. Main Outcomes and Measures: The primary end point was the complete resection rate, measured by the amount of tumor-negative resection margin rates. Secondary outcomes were safety and usability of the system. Safety was evaluated by the number of navigation system-associated surgical adverse events. Usability was assessed from responses to a questionnaire completed by the participating surgeons after each procedure. Results: In total, 33 patients with locally advanced or recurrent rectal cancer were included (23 men [69.7%]; median [interquartile range] age at start of treatment, 61 [55.0-69.0] years). With image-guided navigation, a radical resection (R0) was achieved in 13 of 14 patients (92.9%; 95% CI, 66.1%-99.8%) after primary resection of locally advanced tumors and in 15 of 19 patients (78.9%; 95% CI, 54.4%-94.0%) after resection of recurrent rectal cancer. No navigation system-associated complications occurred before or during surgical procedures. In the historical cohort, 142 patients who underwent resection without image-guided navigation were included (95 men [66.9%]; median [interquartile range] age at start of treatment, 64 [55.0-70.0] years). In these patients, an R0 resection was accomplished in 85 of 101 patients (84.2%) with locally advanced rectal cancer and in 20 of 41 patients (48.8%) with recurrent rectal cancer. A significant difference was found between the navigation and historical cohorts after recurrent rectal cancer resection (21.1% vs 51.2%; P = .047). For locally advanced primary tumor resection, the difference was not significant (7.1% vs 15.8%; P = .69). Surgeons stated in completed questionnaires that the navigation system improved decisiveness and helped with tumor localization. Conclusions and Relevance: Findings of this study suggest that image-guided navigation used during rectal cancer resection is safe and intuitive and may improve tumor-free resection margin rates in recurrent rectal cancer. Trial Registration: Netherlands Trial Register Identifier: NTR7184.

Correction to: Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats.

In the original publication, the starting point in time for the three feeding trials.

Accurate surgical navigation with real-time tumor tracking in cancer surgery.

In the past decades, image-guided surgery has evolved rapidly. In procedures with a relatively fixed target area, like neurosurgery and orthopedics, this has led to improved patient outcomes. In cancer surgery, intraoperative guidance could be of great benefit to secure radical resection margins since residual disease is associated with local recurrence and poor survival. However, most tumor lesions are mobile with a constantly changing position. Here, we present an innovative technique for real-time tumor tracking in cancer surgery. In this study, we evaluated the feasibility of real-time tumor tracking during rectal cancer surgery. The application of real-time tumor tracking using an intraoperative navigation system is feasible and safe with a high median target registration accuracy of 3 mm. This technique allows oncological surgeons to obtain real-time accurate information on tumor location, as well as critical anatomical information. This study demonstrates that real-time tumor tracking is feasible and could potentially decrease positive resection margins and improve patient outcome.

High versus low dose Stereotactic Body Radiation Therapy for hepatic metastases.

INTRODUCTION: Stereotactic Body Radiation Therapy (SBRT) is a treatment option for patients with liver metastases. This study evaluated the impact of high versus low dose image-guided SBRT of hepatic metastases. METHODS AND MATERIALS: This is a single-center retrospective study of patients with liver metastases treated with SBRT. For analyses, patients were divided into two groups: ≤100 Gy and >100 Gy near-minimum Biological Effective Doses (BED98%). The main outcomes were local control (LC), toxicity and overall survival (OS). Cox regression analyses were performed to determine prognostic variables on LC and OS. RESULTS: Ninety patients with 97 liver metastases (77% colorectal) were included. Median follow-up was 28.6 months. The two-year LC rates in the ≤100 Gy and >100 Gy BED98% group were 60% (CI: 41-80%) and 90% (CI: 80-100%), respectively (p = 0.004). Grade 3 toxicity occurred in 7% vs 2% in the ≤100 Gy and >100 Gy group (p = 0.23). Two-year OS rates in the ≤100 Gy and >100 Gy group were 48% (CI: 32-65%) and 85% (CI: 73-97%), respectively (p = 0.007). In multivariable Cox regression analyses, group dose and tumor volume were significantly correlated with LC (HR: 3.61; p = 0.017 and HR: 1.01; p = 0.005) and OS (HR: 2.38; p = 0.005 and HR: 1.01; p = <0.0001). CONCLUSION: High dose SBRT provides significantly better local control and overall survival than low dose SBRT without increasing toxicity. When surgical resection is not feasible, high dose SBRT provides an effective and safe treatment for liver metastases.

Coping styles in patients with hypospadias.

OBJECTIVE: The objective of this study is to investigate the coping styles used by patients with hypospadias. Long-term hypospadias studies generally show satisfying outcomes, but some report a lower quality of life (QoL) or poorer psychosocial adjustment, particularly in patients with proximal hypospadias. A lower QoL or psychosocial adjustment was found to be associated with passive coping styles in other pediatric patient populations. Hypothetically, patients with hypospadias also develop different coping styles due to medical experiences in childhood, leading to the lower QoL outcomes on the long term. However, coping styles of patients with hypospadias have never been analyzed. PATIENTS AND METHODS: Adult men with hypospadias repair in childhood were recruited (n = 55; aged 19.9 [IQR 19.2-22.1]). Coping styles were determined with the Utrecht Coping List (UCL) and results compared with a reference group of male students (n = 55, age 20-30 years, no medical history). Sub analysis of coping styles of the hypospadias groups was done based on three items: severity of hypospadias, time of last hypospadias surgery and occurrence of postoperative complications. RESULTS: Compared to the reference groups, patients with hypospadias had higher scores on Avoidance (P < 0.05), particularly patients who had ≥1 postoperative complication or proximal hypospadias. Patients with proximal hypospadias also had lower scores on Seeking Social Support compared to the reference group (P < 0.05). Within the hypospadias group, coping style scores did not differ based on severity of hypospadias, timing of surgery or postoperative complications. CONCLUSION: Patients with hypospadias, particularly those with proximal hypospadias or a postoperative complication, more often use an avoiding coping style compared to a reference population. Attention to coping styles during the follow-up of patients with hypospadias might help to improve the QoL in these patients.

Toward on-site food authentication using nanopore sequencing.

•MinION DNA metabarcoding is a promising tool for species identification in food.•MinION and Illumina MiSeq sequencing platforms perform equally accurate.•Species identification with MinION sequencing requires dedicated bioinformatics.

Regulation and safety considerations of somatic cell nuclear transfer-cloned farm animals and their offspring used for food production.

This document discusses recent developments in cloning of husbandry animals through somatic cell nuclear transfer, particularly with a view on improvements in their efficacy. Commercial developments in North and South America, Australia-New Zealand, and China are noted. The regulations and safety aspects surrounding the use of clones and their offspring for the purpose of food production are discussed. It is generally considered that foods from offspring of clones are no different than similar foods from conventional animals, yet besides safety, also ethical and animal welfare considerations come into play at the policy level. The related topic of detection and traceability of clones is discussed, which covers both molecular and documentary methods.

Omics analyses of potato plant materials using an improved one-class classification tool to identify aberrant compositional profiles in risk assessment procedures.

The objective of this study was to quantitatively assess potato omics profiles of new varieties for meaningful differences from analogous profiles of commercial varieties through the SIMCA one-class classification model. Analytical profiles of nine commercial potato varieties, eleven experimental potato varieties, one GM potato variety that had acquired Phytophtora resistance based on a single insert with potato-derived DNA sequences, and its non-GM commercial counterpart were generated. The ten conventional varieties were used to construct the one-class model. Omics profiles from experimental non-GM and GM varieties were assessed using the one-class SIMCA models. No potential unintended effects were identified in the case of the GM variety. The model showed that varieties that were genetically more distant from the commercial varieties were recognized as aberrant, highlighting its potential in determining whether additional evaluation is required for the risk assessment of materials produced from any breeding technique, including genetic modification.

Use of omics analytical methods in the study of genetically modified maize varieties tested in 90 days feeding trials.

Genetically modified (GM) maize and their non-modified counterparts were compared using MON810 varieties, the only GMO event cultivated in Europe. The differences in grain samples were analysed by omics profiles, including transcriptomics, proteomics and metabolomics. Other cultivated maize varieties were analysed as a reference for the variability that will exist between cultivated varieties. The observed differences between modified and non-modified maize varieties do not exceed typical differences between non-modified varieties. The use of these advanced analytical approaches to analyse novel plant materials as compared to the results from animal feeding trials with whole foods is assessed. No indications were observed for changes in the GM varieties that warrant further investigations. Furthermore, it was shown that such indications will be obtained if maize samples of inferior quality are analysed similarly. Omics data provide detailed analytical information of the plant material, which facilitates a risk assessment procedure of new (GM) plant varieties.

Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats.

In 2012, a controversial study on the long-term toxicity of a Roundup herbicide and the glyphosate-tolerant genetically modified (GM) maize NK603 was published. The EC-funded G-TwYST research consortium tested the potential subchronic and chronic toxicity as well as the carcinogenicity of the glyphosate-resistant genetically modified maize NK603 by performing two 90-day feeding trials, one with GM maize inclusion rates of 11 and 33% and one with inclusion rates of up to 50%, as well as a 2-year feeding trial with inclusion rates of 11 and 33% in male and female Wistar Han RCC rats by taking into account OECD Guidelines for the testing of chemicals and EFSA recommendations on the safety testing of whole-food/feed in laboratory animals. In all three trials, the NK603 maize, untreated and treated once with Roundup during its cultivation, and the conventional counterpart were tested. Differences between each test group and the control group were evaluated. Equivalence was assessed by comparing the observed difference to differences between non-GM reference groups in previous studies. In case of significant differences, whether the effects were dose-related and/or accompanied by changes in related parameters including histopathological findings was evaluated. It is concluded that no adverse effects related to the feeding of the NK603 maize cultivated with or without Roundup for up to 2 years were observed. Based on the outcome of the subchronic and combined chronic toxicity/carcinogenicity studies, recommendations on the scientific justification and added value of long-term feeding trials in the GM plant risk assessment process are presented.