№ files_lp_3_process_7_060988
Test SensitivityTP/TP+FN SpecificityTN/FP+TN PPVTP/TP+FP NPVTN/TN+FN Limitations USC pathway1 80.4% 47.2% 3.5% 99.0% low no’s of confirmed CRCAUC=0.65 Raman-CRC blood test* 85.7% 68% 14% 98.7: //doi.org/10.1111/apt.13846
2. Lung PF, Burling D, Kallarackel L, et al. Implementation of a new CT colonography service: 5 year experience. Clin Radiol. 2014; 69(6): 597-605. doi: 10.1016/j.crad.2014.01.007.3. Bowles CJ, Leicester R, Romaya C, et al. A prospective study of colonoscopy practice in the UK today: are we adequately prepared for national colorectal cancer screening tomorrow? Gut 2004; 53: 277-283.1) Can you describe the current colorectal cancer USC referral pathway?What are your perceptions of it? (Prompt: memorised or need to refer to it, makes secondary care the gatekeeper for tests, NICE criteria, timeliness, capacity, reassurance to have a guideline to follow, ignores GP’s ‘instinct’)2) Experience of the timeframe from referral to colonoscopy/CTC? How do you manage patient’s expectation? Frequency of repeat consultations between referral and test being done?(Prompt: 37 days average)3) Do you consider your personal volume of USC pathway referrals to be just right, too few, or too many?(Prompt: how much does knowledge of waiting times and resource capacity affect your likelihood to refer a patient? 4). If resources weren’t a problem and if you could wave a magic wand tomorrow what do you think we should do about improving outcomes from CRC? What do you perceive are the barriers to early diagnosis of CRC?(Prompt: Wales is 22nd of 28 in the European league table of CRC survival, screening problems, resources, effective tests, patient choice, patient education). Perception of need for better access to diagnostics in primary care (invasive and non-invasive)5). Which situation would the Raman-CRC blood test be of most value to a GP:-non-specific symptoms? eg constipation, abdominal pain -younger age group below USC age? -all USC patients? What would a USC pathway look like with Raman-CRC embedded? -should it be a secondary care tool ie decision to perform colonoscopy or not: help with triage/prioritisation of referral in secondary care6). Given the Raman-CRC test performance described (on vignette sheet) would you have confidence to use it? If not, what sens/spec/PPV/NPV would it need to have?(Prompt: to seek to understand what is most important for a GP, ability to exclude (NPV) or to correctly identify cancer (PPV))7).What additional clinical trials would you like to see with the blood test before implementation?Further observational work with larger numbers/centres/situations?Release test for use and observe outcomes? RCT test v no test?Comparison with FIT?NICE guidance?1) Can you describe the current colorectal cancer USC referral pathway?What are your perceptions of it? (Prompt: memorised or need to refer to it, makes secondary care the gatekeeper for tests, NICE criteria, timeliness, capacity, reassurance to have a guideline to follow, ignores GP’s ‘instinct’)2) Experience of the timeframe from referral to colonoscopy/CTC? How do you manage patient’s expectation? Frequency of repeat consultations between referral and test being done?(Prompt: 37 days average)3) Do you consider your personal volume of USC pathway referrals to be just right, too few, or too many?(Prompt: how much does knowledge of waiting times and resource capacity affect your likelihood to refer a patient? 4). If resources weren’t a problem and if you could wave a magic wand tomorrow what do you think we should do about improving outcomes from CRC? What do you perceive are the barriers to early diagnosis of CRC?(Prompt: Wales is 22nd of 28 in the European league table of CRC survival, screening problems, resources, effective tests, patient choice, patient education). Perception of need for better access to diagnostics in primary care (invasive and non-invasive)5). Which situation would the Raman-CRC blood test be of most value to a GP:-non-specific symptoms? eg constipation, abdominal pain -younger age group below USC age? -all USC patients? What would a USC pathway look like with Raman-CRC embedded? -should it be a secondary care tool ie decision to perform colonoscopy or not: help with triage/prioritisation of referral in secondary care6). Given the Raman-CRC test performance described (on vignette sheet) would you have confidence to use it? If not, what sens/spec/PPV/NPV would it need to have?(Prompt: to seek to understand what is most important for a GP, ability to exclude (NPV) or to correctly identify cancer (PPV))7).What additional clinical trials would you like to see with the blood test before implementation?Further observational work with larger numbers/centres/situations?Release test for use and observe outcomes? RCT test v no test?Comparison with FIT?NICE guidance?Box S1. GP focus group questions.VIGNETTESAssumptions: Colonoscopy/CTC capacity is the same as present Raman-CRC blood test is routinely available under local guidelines.Raman-CRC test performance is 85.7% sensitivity, 68% specificity, 14% PPV, 98.7% NPV, based on interim analysis of 120 cases and controls.1. 60 y.o. male presents with tiredness. His wife (also in the practice) diagnosed with breast cancer a year ago and just completing adjuvant chemotherapy. He has had time off work himself when she has been ill with side effects. On deeper questioning he describes 6 weeks of increased stool frequency (usually once/day, now 3 times per day). No history of rectal bleeding or mucous, abdominal pain or weight loss. Doesn’t smoke. Abdominal and rectal examinations are normal. Simple diagnostics show he is not anaemic and a stool culture is negative.a) Refer to secondary care on USC pathway without further testingb) Request Raman-CRC blood test to risk stratifyc) Involve patient in decision making? Explore patient expectations/underlying concerns....d) Other?2. A 50 year old patient who is a frequent attender describes three or four episodes of rectal bleeding. This is fresh blood, noticed in the toilet water. No anal pain or itching. No change on bowel habit. Appetite and weight stable. On citalopram for anxiety. No relevant family history. Abdominal examination: appendicectomy scar, nil else. Rectal exam: small skin tags, no masses felt, no blood on glove, no proctoscope available. FBC normal. Action?3. 45 year old female patient, complains of tiredness and self limiting looser stools for 3 weeks, but does have a FH of bowel cancer. Examination normal.Decision made to perform a Raman-CRC blood test. The test returns positive 2 days later. How would you go about discussing this with the patient in the fol
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