The Biomarker Toolkit - an evidence-based guideline to predict cancer biomarker success and guide development.

BACKGROUND: An increased number of resources are allocated on cancer biomarker discovery, but very few of these biomarkers are clinically adopted. To bridge the gap between Biomarker discovery and clinical use, we aim to generate the Biomarker Toolkit, a tool designed to identify clinically promising biomarkers and promote successful biomarker translation. METHODS: All features associated with a clinically useful biomarker were identified using mixed-methodology, including systematic literature search, semi-structured interviews, and an online two-stage Delphi-Survey. Validation of the checklist was achieved by independent systematic literature searches using keywords/subheadings related to clinically and non-clinically utilised breast and colorectal cancer biomarkers. Composite aggregated scores were generated for each selected publication based on the presence/absence of an attribute listed in the Biomarker Toolkit checklist. RESULTS: Systematic literature search identified 129 attributes associated with a clinically useful biomarker. These were grouped in four main categories including: rationale, clinical utility, analytical validity, and clinical validity. This checklist was subsequently developed using semi-structured interviews with biomarker experts (n=34); and 88.23% agreement was achieved regarding the identified attributes, via the Delphi survey (consensus level:75%, n=51). Quantitative validation was completed using clinically and non-clinically implemented breast and colorectal cancer biomarkers. Cox-regression analysis suggested that total score is a significant driver of biomarker success in both cancer types (BC: p>0.0001, 95.0% CI: 0.869-0.935, CRC: p>0.0001, 95.0% CI: 0.918-0.954). CONCLUSIONS: This novel study generated a validated checklist with literature-reported attributes linked with successful biomarker implementation. Ultimately, the application of this toolkit can be used to detect biomarkers with the highest clinical potential and shape how biomarker studies are designed/performed.

The INTESTINE study: INtended TEmporary STomas In crohN's diseasE. Protocol for an international multicentre study.

Surgery for ileocolonic Crohn's disease can result in temporary or permanent stoma formation which can be associated with morbidity as parastomal and incisional hernias, readmissions due to obstruction or high stoma output, and have a negative impact on quality of life. We propose an international retrospective trainee-led study of the outcomes of temporary stomas in patients with Crohn's disease. We aim to evaluate both the short-term (6 month) and mid-term (18 month) outcomes of temporary stomas in patients with Crohn's Disease. Retrospective, multicentre, observational study including all patients who underwent elective or emergency surgery for ileal, colonic and ileocolonic Crohn's disease during a 4-year study period. Primary outcome is the proportion of patients who still have an ileostomy or colostomy 18 months after the initial surgery. Secondary outcomes: complications related to stoma formation and stoma reversal surgery; time interval between stoma formation and stoma reversal; risk factors for stoma formation and non-reversal of the stoma. We present the study protocol for a trainee-led, multicentre, observational study. Previous research has demonstrated significant heterogeneity surrounding the formation and the timing of reversal surgery in patients having a temporary ileostomy following colorectal cancer surgery, highlighting the need to address these same questions in Crohn's disease, which is the aim of our research.

Perioperative experiences of anesthesia reported by children and parents.

BACKGROUND: The Sprint National Anaesthesia Project reported feedback from adults but not from children. We developed questionnaires for children and parents, and conducted a survey of perioperative anesthetic experiences in a large pediatric hospital. METHODS: Patients undergoing elective general anesthesia were selected randomly each weekday over 10 weeks. Parents and children were approached within 4 hours after awakening, and were asked to complete a short questionnaire. Personal or patient identifiable data were not collected. Questionnaires were processed by optical mark reading technology and descriptive data analysis was performed. RESULTS: Seven hundred and forty parents and 250 children completed questionnaires. The most common symptoms reported by parents were thirst and hunger (76%), drowsiness (75%), sore throat (41%), and pain of the surgery (38%). Sixty-four percent of children felt worried or scared about something before the procedure: common worries were about the "anesthetic," "procedure," or "needles/cannula." Fifty-five percent reported postoperative pain. Thirty-nine children (15.6%) remembered something between going to sleep and waking up although distress was not reported; of these, the most common experiences remembered included hearing voices (34%), feeling sore (20%), and being worried (14%). Twenty-two parents (2.9%) had any complaint and most were about fasting instructions. Only 3 parents would not recommend the anesthetic service. CONCLUSION: This study shows that the experiences of children and their parents are similar to those of adults reported by the Sprint National Anaesthesia Project. Thirst (and hunger), anxiety, and pain continue to be common problems for many children. This feedback may help direct interventions and research to improve the pediatric patient and parent experience with anesthesia.

Chemotherapeutic treatment of colorectal cancer in pregnancy: case report.

INTRODUCTION: Colon cancer in pregnancy is uncommon. Only a small number of case reports have been published in the literature on the use of chemotherapeutic drugs during pregnancy. Reports of such cases assist clinicians in further investigating the use of chemotherapy in pregnancy. CASE PRESENTATION: FOLFOX-6 was administered to a pregnant, 33-year-old Saudi woman with metastatic colon cancer from 22 to 30 weeks of gestation. Her cancer was diagnosed during her pregnancy. She tolerated the chemotherapy well and delivered a full-term baby girl with no obvious harm, and normal development was documented at her 2-year follow-up examination. CONCLUSION: Colon cancer during pregnancy is not easily detected and is difficult to manage. A detailed history and high clinical suspicion are needed in patients who present with symptoms and signs suggestive of malignancy. A multidisciplinary approach with patient involvement is needed to decrease morbidity and mortality caused by both treatment and the cancer in the mother and to limit side effects for the fetus. Further data and long-term follow-up are needed to better understand the potential long-term side effects of chemotherapeutic drugs on offspring.