Cadaveric aortic aneurysm creation: A life-like model for training endovascular repair.

The recent decline in RAAA incidence and the fast paced scenario with associated challenges regarding training calls for initiative for a better training environment to maximize learning. This led us to the creation of a pulsatile human cadaveric RAAA model. Fresh frozen cadaver was used to create RAAA with BioTissue in hybrid suite with ability to perform CBCTA for sizing. As a proof of concept, the model was used to perform REVAR with proximal CODA balloon control. The model proved to be feasible and we believe it is a better environment to train and gain adequate proficiency in RAAA management.

Agreement between patient's description of abdominal symptoms of possible upper gastrointestinal cancer and general practitioner consultation notes: a qualitative analysis of video-recorded UK primary care consultation data.

INTRODUCTION: Abdominal symptoms are common in primary care but infrequently might be due to an upper gastrointestinal (UGI) cancer. Patients' descriptions may differ from medical terminology used by general practitioners (GPs). This may affect how information about abdominal symptoms possibly due to an UGI cancer are documented, creating potential missed opportunities for timely investigation. OBJECTIVES: To explore how abdominal symptoms are communicated during primary care consultations, and identify characteristics of patients' descriptions that underpin variation in the accuracy and completeness with which they are documented in medical records. METHODS AND ANALYSIS: Primary care consultation video recordings, transcripts and medical records from an existing dataset were screened for adults reporting abdominal symptoms. We conducted a qualitative content analysis to capture alignments (medical record entries matching patient verbal and non-verbal descriptions) and misalignments (symptom information omitted or differing from patient descriptions). Categories were informed by the Calgary-Cambridge guide's 'gathering information' domains and patterns in descriptions explored. RESULTS: Our sample included 28 consultations (28 patients with 18 GPs): 10 categories of different clinical features of abdominal symptoms were discussed. The information GPs documented about these features commonly did not match what patients described, with misalignments more common than alignments (67 vs 43 instances, respectively). Misalignments often featured patients using vague descriptors, figurative speech, lengthy explanations and broad hand gestures. Alignments were characterised by patients using well-defined terms, succinct descriptions and precise gestures for symptoms with an exact location. Abdominal sensations reported as 'pain' were almost always documented compared with expressions of 'discomfort'. CONCLUSIONS: Abdominal symptoms that are well defined or communicated as 'pain' may be more salient to GPs than those expressed vaguely or as 'discomfort'. Variable documentation of abdominal symptoms in medical records may have implications for the development of clinical decision support systems and decisions to investigate possible UGI cancer.

Selection of motion management in liver stereotactic body radiotherapy and its impact on treatment time.

Background and purpose: Reduction of respiratory tumour motion is important in liver stereotactic body radiation therapy (SBRT) to reduce side effects and improve tumour control probability. We have assessed the distribution of use of voluntary exhale breath hold (EBH), abdominal compression (AC), free breathing gating (gating) and free breathing (FB), and the impact of these on treatment time. Materials and Methods: We assessed all patients treated in a single institution with liver SBRT between September 2017 and September 2021. Data from pre-simulation motion management assessment using fluoroscopic assessment of liver dome position in repeat breath holds, and motion with and without AC, was reviewed to determine liver dome position consistency in EBH and the impact of AC on motion. Treatment time was assessed for all fractions as time from first image acquisition to last treatment beam off. Results: Of 136 patients treated with 145 courses of liver SBRT, 68 % were treated in EBH, 20 % with AC, 7 % in gating and 5 % in FB. AC resulted in motion reduction < 1 mm in 9/26 patients assessed. Median treatment time was higher using EBH (39 min) or gating (42 min) compared with AC (30 min) or FB (24 min) treatments. Conclusions: Motion management in liver SBRT needs to be assessed per-patient to ensure appropriate techniques are applied. Motion management significantly impacts treatment time therefore patient comfort must also be taken into account when selecting the technique for each patient.

Evaluation of a Novel System for RFID Intraoperative Cardiovascular Analytics.

Objective: To evaluate a novel technology for real time tracking of RF-Identified (RFID) surgical tools (Biotic System), providing intraoperative data analytics during simulated cardiovascular procedures. Ineffective asset management in the Operating Room (OR) leads to inefficient utilization of resources and contributes to prolonged operative times and increased costs. Analysis of captured data can assist in quantifying instrument utilization, procedure flow, performance and prevention of retained instruments. Methods & Results: Five surgeons performed thirteen simulated surgical cases on three human cadavers. Procedures included (i) two abdominal aortic aneurysm (AAA) repairs, (ii) three carotid endarterectomies (CE), (iii) two femoropopliteal (fem-pop) bypasses, (iv) thoracic aortic aneurysm repair, (v) coronary artery bypass graft, (vi) aortic valve replacement, (vii) ascending aortic aneurysm repair, (viii) heart transplants, and (ix) mitral valve replacement. For each case an average of 139 surgical instruments were RFID-tagged and tracked intraoperatively. Data was captured and analyzed retrospectively. Of the 139 instruments tracked across each of the 13 cases, 55 instruments (39.5%) were actually used, demonstrating a high level of redundancy. For repeat cases (i.e. CE/AAA/fem-pop): (i) average instrument usage was 41 ± 3.6 (8.8% variation) for CE (n=3); (ii) average instrument usage was 69 ± 4.0 (5.8% variation) for AAA (n=2); and (iii) average instrument usage was 48 ± 2.5 (5.3% variation) for fem- pop (n=2). Results also showed a reduction in end-of-procedure instrument counting times of 58-87%. Conclusions: We report on a method for collecting intraoperative data analytics regarding instrument usage via RFID technology. This system will help refine instrument selection, quantitate instrument utilization and prevent inadvertent retention in a patient. This should help increase efficiency in packaging and sterilization and let surgeons make objective decisions in the composition of surgical trays. Clinical and Translational Impact Statement-Intraoperative analytics of surgical tools and associated equipment may ultimately lead to safer more efficient surgeries that increase patient outcomes while decreasing the cost of care.

Endovascular Porcine Model of Iliocaval Venous Thrombosis.

OBJECTIVE: To develop a large animal model of iliocaval deep venous thrombosis (DVT), which enables development and evaluation of interventional management and existing imaging modalities. METHODS: The experimental protocol consisted of a total endovascular approach. Pigs were percutaneously accessed through the right internal jugular and bilateral femoral veins. Three balloon catheters were inflated to induce venous stasis in the infrarenal inferior vena cava (IVC) and bilateral common iliac veins (CIVs). Hypercoagulability was induced by injecting 10 000 IU of thrombin. After 2.5 hours, the balloon catheters were removed before animal recovery. After seven, 14, 21, 28, or 35 days, animals were euthanised; the IVC and CIV were harvested en bloc, cross sectioned and prepared for histological examination. Multimodal imaging was performed before and after thrombus creation, and before animal euthanasia. RESULTS: Thirteen female domestic pigs with a mean weight of 59.3 kilograms were used. The mean maximum IVC diameter and area were 16.4 mm and 1.2 cm2, respectively. The procedure was successful in 12 animals with occlusive venous thrombosis in the region of interest on immediate post-operative magnetic resonance venography and a mean thrombus volume of 19.8 cm3. Clinical pathology results showed platelet consumption, D dimer increase, and inflammatory response. Histological evaluation demonstrated a red cell, fibrin, and platelet rich thrombus on day 1, with progressive inflammatory cell infiltration from day 7. Collagen deposition appeared in week 2 and neovascularisation in week 3. CONCLUSION: Endovascular occlusion combined with thrombin infusion is a reliable minimally invasive approach to produce acute and subacute DVT in a large animal model.

The old and familiar meets the new and unknown: patient and clinician perceptions on e-cigarettes for smoking reduction in UK general practice, a qualitative interview study.

BACKGROUND AND AIMS: Clinicians could promote e-cigarettes for harm reduction to people who smoke but cannot stop, but many clinicians feel uneasy doing so. In a randomized controlled trial (RCT), primary care clinicians offered free e-cigarettes and encouraged people with chronic diseases who were unwilling to stop smoking to switch to vaping. We interviewed clinicians and patients to understand how to adopt harm reduction in routine practice. DESIGN: Qualitative analysis nested within an RCT, comprising thematic analysis of semi-structured interviews with primary care clinicians who delivered the trial intervention, and patients who took part. SETTING: Primary care clinics in England. PARTICIPANTS/CASES: Twenty-one patients and 11 clinicians, purposively sampled from an RCT. MEASUREMENTS: We qualitatively explored patients' and clinicians' experiences of: being offered/offering an e-cigarette, past and current perceptions about e-cigarettes and applying a harm reduction approach. FINDINGS: Four themes captured clinicians' and patients' reported perspectives. These were: (1) concepts of safety/risk, with clinicians concerned about recommending a product with unknown long-term risks and patients preferring the known risks of cigarettes; (2) clinicians felt they were going out on a limb by offering these as though they were prescribing them, whereas patients did not share this view; (3) equating quitting with success, as both patients and clinicians conceptualized e-cigarettes as quitting aids; and (4) unchanged views, as clinicians reported that training did not change their existing views about e-cigarettes. These themes were united by the higher-order concept: 'The old and familiar meets the new and unknown', as a contradiction between this new approach and long-established methods underpinned these concerns. CONCLUSIONS: A qualitative analysis found barriers obstructing clinicians and patients from easily accepting e-cigarettes for harm reduction, rather than as aids to support smoking cessation: clinicians had difficulty reconciling harm reduction with their existing ethical models of practice, even following targeted training, and patients saw e-cigarettes as quitting aids.

"The child's got a complete circle around him". The care of younger children (5-11 years) with CFS/ME. A qualitative study comparing families', teachers' and clinicians' perspectives'.

Society needs to improve the care of children with complex needs. Guidelines recommend integrating care across health and educational settings, however, there is little research on whether this is achieved or how this can be done in practice. Our aim was to address this gap by examining how the care of children (aged 5-11 years) with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME) is shared across home, education and health settings, in order to generate recommendations for integrating care. We undertook semi-structured interviews with families (22 participants), teachers (11 participants) and healthcare providers (9 participants), analysing the data thematically and comparatively. Our analysis of the data was informed by a socio-ecological perspective as we sought to understand the complexity of the relationships and systems around the child. The first theme focuses on the child ("individual level"); child-centred care is seen as essential whilst acknowledging that the child has limited capacity to manage their own care. The second theme presents the distinct roles of parents, teachers and clinicians ("interpersonal and organisational levels"). The third describes how these three levels interact in the management of the child's care, in the context of the health and education systems and policies ("policy levels"). The fourth explores optimal ways to integrate care across home, school and clinical settings. In conclusion, there is opportunity to support a child with complex health needs by targeting the systems around the child; parents, teachers and clinicians, as well as education and health policy that can enable shared-care. Involving schools in assessment, communicating diagnosis across settings and using a stepped-care approach to integrated care may be beneficial. Further work is needed to explore these recommendations, with attention to the policy factors that may act as barriers and enablers.

Comparison and Analysis of Two Internationally Recognized Biobanking Standards.

Impactful biobanking is underpinned by quality assurance and standardization. Several general biobank standards exist that can be associated with programs to provide different levels of conformity assessment, including the Canadian Tissue Repository Network (CTRNet) Certification program and the International Organization for Standardization (ISO) 20387 and accreditation bodies. We examined the CTRNet Required Operational Practices (2017) and ISO 20387 (2018), to compare them. Although the organization of each standard is different, both describe a set of discrete requirements (elements or subclauses) that comprise the standards that are contained in sections called chapters (CTRNet) or clauses (ISO). The standards have a similar number of requirements (CTRNet: 362, ISO: 322). To compare these standards, we reclassified the requirements in the ISO standard into 13 categories based on a combination of the chapter headings used in the ISBER and NCI Best Practices that represent important areas of biobanking activity. This categorization of requirements showed that each standard has a different emphasis reflected in different densities of requirements within distinct areas of biobanking. The ISO standard emphasizes Quality Management Systems whereas the CTRNet standard has an even coverage across the full spectrum of biobanking areas, including activities that are relevant to participant enrollment. Nevertheless, ∼60% of the requirements in the CTRNet standard match with those of the ISO standard. We conclude that these two standards have much in common but recommend that individual biobanks consider each standard carefully in the context of the purpose, focus, scale, and scope of their biobank to determine the appropriate standard to be followed.

Can linguistic analysis be used to identify whether adolescents with a chronic illness are depressed?

Comorbid depression is common in adolescents with chronic illness. We aimed to design and test a linguistic coding scheme for identifying depression in adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), by exploring features of e-consultations within online cognitive behavioural therapy treatment. E-consultations of 16 adolescents (aged 11-17) receiving FITNET-NHS (Fatigue in teenagers on the interNET in the National Health Service) treatment in a national randomized controlled trial were examined. A theoretically driven linguistic coding scheme was developed and used to categorize comorbid depression in e-consultations using computerized content analysis. Linguistic coding scheme categorization was subsequently compared with classification of depression using the Revised Children's Anxiety and Depression Scale published cut-offs (t-scores ≥65, ≥70). Extra linguistic elements identified deductively and inductively were compared with self-reported depressive symptoms after unblinding. The linguistic coding scheme categorized three (19%) of our sample consistently with self-report assessment. Of all 12 identified linguistic features, differences in language use by categorization of self-report assessment were found for "past focus" words (mean rank frequencies: 1.50 for no depression, 5.50 for possible depression, and 10.70 for probable depression; p < .05) and "discrepancy" words (mean rank frequencies: 16.00 for no depression, 11.20 for possible depression, and 6.40 for probable depression; p < .05). The linguistic coding profile developed as a potential tool to support clinicians in identifying comorbid depression in e-consultations showed poor value in this sample of adolescents with CFS/ME. Some promising linguistic features were identified, warranting further research with larger samples.

Development of a tool for coding safety-netting behaviours in primary care: a mixed-methods study using existing UK consultation recordings.

BACKGROUND: Safety netting is recommended in a variety of clinical settings, yet there are no tools to record clinician safety-netting communication behaviours. AIM: To develop and assess the inter-rater reliability (IRR) of a coding tool designed to assess safety-netting communication behaviours in primary care consultations. DESIGN AND SETTING: A mixed-methods study using an existing dataset of video-and audio-recorded UK primary care consultations. METHOD: Key components that should be assessed in a coding tool were identified using the published literature and relevant guidelines. An iterative approach was utilised to continuously refine and generate new codes based on the application to real-life consultations. After the codebook had been generated, it was applied to 35 problems in 24 consultations independently by two coders. IRR scores were then calculated. RESULTS: The tool allows for the identification and quantification of the key elements of safety-netting advice including: who initiates the advice and at which stage of the consultation; the number of symptoms or conditions the patient is advised to look out for; what action patients should take and how urgently; as well as capturing how patients respond to such advice plus important contextual codes such as the communication of diagnostic uncertainty, the expected time course of an illness, and any follow-up plans. The final tool had substantial levels of IRR with the mean average agreement for the final tool being 88% (κ = 0.66). CONCLUSION: The authors have developed a novel tool that can reliably code the extent of clinician safety-netting communication behaviours.

Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.

BACKGROUND: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.

Is Your Biobank Up to Standards? A Review of the National Canadian Tissue Repository Network Required Operational Practice Standards and the Controlled Documents of a Certified Biobank.

Ongoing quality management is an essential part of biobank operations and the creation of high quality biospecimen resources. Adhering to the standards of a national biobanking network is a way to reduce variability between individual biobank processes, resulting in cross biobank compatibility and more consistent support for health researchers. The Canadian Tissue Repository Network (CTRNet) implemented a set of required operational practices (ROPs) in 2011 and these serve as the standards and basis for the CTRNet biobank certification program. A review of these 13 ROPs covering 314 directives was conducted after 5 years to identify areas for revision and update, leading to changes to 7/314 directives (2.3%). A review of all internal controlled documents (including policies, standard operating procedures and guides, and forms for actions and processes) used by the BC Cancer Agency's Tumor Tissue Repository (BCCA-TTR) to conform to these ROPs was then conducted. Changes were made to 20/106 (19%) of BCCA-TTR documents. We conclude that a substantial fraction of internal controlled documents require updates at regular intervals to accommodate changes in best practices. Reviewing documentation is an essential aspect of keeping up to date with best practices and ensuring the quality of biospecimens and data managed by biobanks.

Effect of median household income on surgical approach and survival in renal cell carcinoma.

PURPOSE: We sought to determine whether median household income (MHI) independently predicts surgical approach (partial vs. radical nephrectomy) and survival in patients with renal cell carcinoma. METHODS: The U.S. Surveillance Epidemiology and End Results Database (1988-2011) was queried to examine kidney cancer cases and linked to the Area Health Resources File. We correlated surgical approach and survival, both overall and cancer-specific, with tumor stage, age, race, sex, and income data. RESULTS: Of 152,589 patients diagnosed with renal cell carcinoma, 24,221 (16%) patients underwent partial nephrectomy, 102,771 (67%) patients underwent radical nephrectomy, and 25,597 (17%) patients had no surgery. There was no significant difference in stage of presentation between the wealthiest and poorest MHI quartiles, with approximately 35% of patients in each quartile presenting with T1aN0M0 disease and 17% of patients presenting with metastatic disease. Despite this, 18% of patients in the wealthiest quartile underwent partial nephrectomy compared to 14% of patients in the poorest quartile. Although the percentage of patients undergoing partial nephrectomy rose over the timeframe studied in both the wealthiest and poorest quartiles, the rate of rise was highest in the wealthier group. Those in the poorest quartile were 0.10 times more likely to die of all causes (95% CI: 1.09-1.11, P<0.001) and 0.09 times more likely to die of kidney cancer (95% CI: 1.05-1.10, P<0.001) than those in the wealthiest quartile over the timeframe studied. CONCLUSIONS: Despite presenting with similar stage, patients with lower MHI less commonly undergo partial nephrectomy and are more likely to die of kidney cancer than those in the highest MHIs.

Targeting the parasite's DNA with methyltriazenyl purine analogs is a safe, selective, and efficacious antitrypanosomal strategy.

The human and veterinary disease complex known as African trypanosomiasis continues to inflict significant global morbidity, mortality, and economic hardship. Drug resistance and toxic side effects of old drugs call for novel and unorthodox strategies for new and safe treatment options. We designed methyltriazenyl purine prodrugs to be rapidly and selectively internalized by the parasite, after which they disintegrate into a nontoxic and naturally occurring purine nucleobase, a simple triazene-stabilizing group, and the active toxin: a methyldiazonium cation capable of damaging DNA by alkylation. We identified 2-(3-acetyl-3-methyltriazen-1-yl)-6-hydroxypurine (compound 1) as a new lead compound, which showed submicromolar potency against Trypanosoma brucei, with a selectivity index of >500, and it demonstrated a curative effect in animal models of acute trypanosomiasis. We investigated the mechanism of action of this lead compound and showed that this molecule has significantly higher affinity for parasites over mammalian nucleobase transporters, and it does not show cross-resistance with current first-line drugs. Once selectively accumulated inside the parasite, the prodrug releases a DNA-damaging methyldiazonium cation. We propose that ensuing futile cycles of attempted mismatch repair then lead to G2/M phase arrest and eventually cell death, as evidenced by the reduced efficacy of this purine analog against a mismatch repair-deficient (MSH2(-/-)) trypanosome cell line. The observed absence of genotoxicity, hepatotoxicity, and cytotoxicity against mammalian cells revitalizes the idea of pursuing parasite-selective DNA alkylators as a safe chemotherapeutic option for the treatment of human and animal trypanosomiasis.

Funding sources for Canadian biorepositories: the role of user fees and strategies to help fill the gap.

Biorepositories, the coordinating hubs for the collection and annotation of biospecimens, are under increasing financial pressure and are challenged to remain sustainable. To gain a better understanding of the current funding situation for Canadian biorepositories and the relative contributions they receive from different funding sources, the Canadian Tumour Repository Network (CTRNet) conducted two surveys. The first survey targeted CTRNet's six main nodes to ascertain the relative funding sources and levels of user fees. The second survey was targeted to a broader range of biorepositories (n=45) to ascertain business practices in application of user fees. The results show that >70% of Canadian biorepositories apply user fees and that the majority apply differential fees to different user groups (academic vs. industry, local vs. international). However, user fees typically comprise only 6% of overall operational budgets. We conclude that while strategies to drive up user fee levels need to be implemented, it is essential for the many stakeholders in the biomedical health research sector to consider this issue in order to ensure the ongoing availability of research biospecimens and data that are standardized, high-quality, and that are therefore capable of meeting research needs.

Trust in the health-care provider-patient relationship: a systematic mapping review of the evidence base.

PURPOSE: Trust is important for patients and may be used as an indicator and potential 'marker' for how patients evaluate the quality of health care. The review aimed to classify the current evidence base on trust in the patient-provider relationship in order to identify strengths and weaknesses and to point towards areas for future research. DATA SOURCES: Nine electronic databases were searched from 2004 onwards using text and subject heading keywords relating to 'trust' and 'health care' and 'relationships'. STUDY SELECTION: Abstracts were identified for empirical studies carried out in health-care settings that explicitly examined trust or reported trust-related findings as a secondary outcome. Data extraction Two review authors assessed the relevance of abstracts and extracted data relating to year published, country of study, clinical speciality, STUDY DESIGN: and participants. RESULTS OF DATA SYNTHESIS: Five hundred and ninety-six abstracts were included. Most reported on patients' trust in providers; were carried out in the USA; collected data in family care or oncology/palliative care settings; used questionnaires and interviews and elicited patients' perspectives. Only one study explicitly set out to examine providers' trust in patients and <5% of included studies reported on providers' trust in patients. CONCLUSION: Providers' trust in patients remains a neglected area on the trust research agenda. Empirical studies examining the factors that influence providers' trust in patients and how this might affect the quality of care and patient health-related behaviours are urgently needed to readdress this imbalance. Further exploration of this area using observational methods is recommended.

Generating a comprehensive set of standard operating procedures for a biorepository network-The CTRNet experience.

Despite the integral role of biorepositories in fueling translational research and the advancement of medicine, there are significant gaps in harmonization of biobanking practices, resulting in variable biospecimen collection, storage, and processing. This significantly impacts accurate downstream analysis and, in particular, creates a problem for biorepository networks or consortia. The Canadian Tumour Repository Network (CTRNet; www.ctrnet.ca ) is a consortium of Canadian tumor biorepositories that aims to enhance biobanking capacity and quality through standardization. To minimize the issue of variable biobanking practices throughout its network, CTRNet has developed and maintained a comprehensive set of 45 standard operating procedures (SOPs). There were four key elements to the CTRNet SOP development process: 1) an SOP development team was formed from members across CTRNet to co-produce each SOP; 2) a principal author was appointed with responsibility for overall coordination of the SOP development process; 3) the CTRNet Management Committee (composed of principal investigators for each member biorepository) reviewed/revised each SOP completed by the development team; and 4) external expert reviewers provided feedback and recommendations on each SOP. Once final Management Committee approval was obtained, the ratified SOP was published on the CTRNet website for public access. Since the SOPs were first published on the CTRNet website (June 2008), there have been approximately 15,000 downloads of one or more CTRNet SOPs/Policies by users from over 60 countries. In accordance with biobanking best practices, CTRNet performs an exhaustive review of its SOPs at set intervals, to coincide with each granting cycle. The last revision was completed in May 2012.

Permission to contact (PTC)--a strategy to enhance patient engagement in translational research.

UNLABELLED: Improving patient recruitment and consent to participate in clinical studies is an important issue. The process of consent involves three steps: patient referral for contact, the preliminary interview to determine patient interest, and the informed consent discussion. We hypothesized that putting the first step of the consent process into a 'Permission to Contact' (PTC) platform would improve patient engagement, would improve the efficiency of the other steps of the process, and would be acceptable to diverse patient groups. METHODS: To test this hypothesis, four PTC platforms were established in three types of outpatient health clinics (cancer, cardiac, maternal health) in different British Columbia health centers. Each began as a research project where clinic personnel were engaged, clinic flow processes were mapped, and a design for each PTC was derived by consensus. All patients at these clinics were asked for 'permission to be contacted for future research purposes.' Patient approach and permission response rates were assessed and operational costs were estimated. RESULTS: Overall permission rates were high for all projects, but ranged from 94% of 'cancer' patients to 80% of 'congenital heart' patients who were approached (p<0.0001). Sustainability was demonstrated by stable enrollment levels after several years, and ongoing costs averaged $25 (range $12-$39) for each 'permission' across all four platforms. CONCLUSIONS: A PTC platform is a feasible mechanism to engage patients in research programs such as biobanking. It is well supported by clinic staff and receives high engagement and acceptance from patients. Patient-approach rates vary in different clinics, likely due to both clinic and PTC process factors, but this strategy provides an efficient means of engaging patients in research and sets the stage for enhanced enrollment into translational research programs.

Certification for biobanks: the program developed by the Canadian Tumour Repository Network (CTRNet).

Two core aspects of the discipline of biobanking are biospecimen quality and good governance. Meeting the demands of both sample quality and governance can be challenging, especially in a resource limited environment. Frequently, differences between biobank processes reduce the ability for cooperative action and specimen sharing with researchers. In the Canadian context, we have made an attempt to identify these gaps and have provided a framework to support excellence, initially for tumor biobanks. The Canadian Tumour Repository Network (CTRNet) was established with funding from the Canadian Institute of Health Sciences (CIHR) Institute of Cancer Research (ICR) to foster translational research through improved access to high quality tumour biospecimens. Consistent with this mandate, CTRNet has focused on the establishment and deployment of common standards to harmonize biospecimen quality and approaches to governance. More recently, CTRNet has implemented a certification program to communicate these standards in conjunction with simultaneous exposure to education focusing on the rationale and foundations underlying these standards. The CTRNet certification program comprises registration and certification steps as two linked phases. In the registration phase, launched in November 2011, biobanks are registered into the system and individuals complete an introductory educational module. In the subsequent certification phase, the type of biobank is classified and assigned relevant educational modules and adoption of relevant standards of practice is confirmed through review of documentation including policies and protocols that address the CTRNet Required Operational Practices (ROPs). An important feature of the program is that it is intended for all types of tumor biobanks, so the scope and extent of assessment is scaled to the type of biobank. This program will provide an easily adoptable and flexible mechanism to communicate common standards through education and address both quality assurance and governance across the broad spectrum of biobanks.

Fusobacterium nucleatum infection is prevalent in human colorectal carcinoma.

An estimated 15% or more of the cancer burden worldwide is attributable to known infectious agents. We screened colorectal carcinoma and matched normal tissue specimens using RNA-seq followed by host sequence subtraction and found marked over-representation of Fusobacterium nucleatum sequences in tumors relative to control specimens. F. nucleatum is an invasive anaerobe that has been linked previously to periodontitis and appendicitis, but not to cancer. Fusobacteria are rare constituents of the fecal microbiota, but have been cultured previously from biopsies of inflamed gut mucosa. We obtained a Fusobacterium isolate from a frozen tumor specimen; this showed highest sequence similarity to a known gut mucosa isolate and was confirmed to be invasive. We verified overabundance of Fusobacterium sequences in tumor versus matched normal control tissue by quantitative PCR analysis from a total of 99 subjects (p = 2.5 × 10(-6)), and we observed a positive association with lymph node metastasis.