Abstract Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if no response to the letter, to determine reason for non-participation. A NIH-funded direct-to-participant digital research platform (the Eureka Research Platform) was used to onboard, consent and enroll participants for the digital follow-up. Participants were asked to answer health-related surveys at fixed intervals using the Eureka mobile app and desktop platform. To capture hospitalizations, participants could enable geofencing to allow background location tracking, which triggered surveys if a hospitalization was detected. Result(s) Letters were mailed to 893 of 929 eligible participants across 22 sites in the United States and Canada leading to 226 homepage visits and 118 registrations. There were 107 consents (12.0% of invited; mean age: 66.4±9.0; 19 females [18%]): 47 (44%) participants consented after the letter, 36 (34%) consented after the 1st call and 24 (22%) consented after a 2nd call. Among those who consented, 100 were eligible (7 did not have a smartphone) 81 downloaded the study mobile app and 73 agreed for geofencing (Figure 1). Among the 722 invited participants who were surveyed, 354 declined participation: due to lack of time (146; 20.2%), lack of smartphone (125; 17.3%), difficulty understanding (41; 5.7%), concern about using smartphone (34; 4.7%), concern of data privacy (14; 1.9%), concerns of location tracking (6; 0.8%) and other reasons (57; 7.9%). Conclusion Extended follow-up of a clinical trial using a digital platform is feasible but uptake in this study population was limited largely due to lack of time or a smartphone among participants. Based on data from other digital studies, uptake may also have been limited since digital follow-up consent was not incorporated at the time of consent for the main trial. Figure 1. Onboarding of the digital substudy Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Purpose/Objective(s)With an aging population and improved medical care, more patients (pts) are now alive with both a personal history of coronary artery disease and prior malignancy which required radiation (RT). The survivorship data in this group of pts is lacking.Materials/MethodsFrom May 1998 to Oct 2012, pts who received both EBRT which involved the heart and percutaneous coronary intervention (PCI) were identified. One hundred fifty-three pts received EBRT before coronary artery stenting (Group A), and 78 pts after (Group B). Demographics, oncologic history, and prior PCI dates were collected. All pts received a curative RT dose >30 Gy (except for Hodgkin disease), with a portion of the RT beams directed at the heart. Use of cardiac medication during RT, anthracycline, and volumes (vol.) and dosimetric parameters of the heart and bilateral lungs were recorded and correlated to both cardiac and cancer (ca.)-specific survival by Cox univariate and multivariate methods.ResultsOne hundred forty-one female and 90 male pts were included. The median age of ca. diagnosis was 67.0 yrs (range, 29-89 yrs). The median age at first PCI was also 67.0 yrs (range, 39-90 yrs). One hundred eleven pts (48%) had breast ca. (including DCIS), 70 (30%) NSCLC, 17 (7%) esophagus, 8 (4%) SCLC, and 5 (2%) Hodgkin disease. 44% had stage 0/I ca., 23% stage II, 30% stage III, and 4% stage IVa. Sixteen percent of the pts required 2 PCIs or more. With a median follow-up of 3.4 yrs, 113 pts had died: 64 (28%) of ca., 12 (5%) of a cardiac cause (excluding stroke), 18 (8%) others, and 19 (8%) unknown. Of all pts, 8% received anthracycline, and 63% took aspirin. A median dose of 50.4 Gy was prescribed. The median lung vol. was 3029 cc, and heart 690 cc. The max, mean dose and V20/13 Gy of the lungs, and the max, mean dose and V45/30 Gy of the heart were balanced between Groups A and B; lung ca. pts received more dose to the lungs, and esophageal ca. pts received more dose to the heart. Overall survival since ca. diagnosis was longer in Group A (12.6 vs 6.5 yrs, p < 0.02), having a breast ca. primary (p < 0.0001), and younger age (HR = 1.04, p < 0.003). However, 5-yr cardiac-specific survival since first PCI was lower in Group A (86.0 vs 98.5%, p < 0.0001), and worse with increasing mean bilateral lung dose (HR = 1.15 per Gy, p < 0.03). Ca.-specific survival was longer in Group A (p < 0.0001), but worse with increasing heart vol. receiving 30 Gy or more (HR = 1.02 per 100 additional cc irradiated, p < 0.002).ConclusionsThis represents one of the few data addressing the topic of both oncologic and cardiac survivorship in pts undergoing radiation therapy, and first to correlate the effects of lung and heart dosimetric parameters to outcome. Limiting lung dose may improve cardiac-specific survival. Selection bias in Group A must be considered (i.e., pts must survive their ca. long enough to receive PCI later in their lives) in the interpretation of our work. Purpose/Objective(s)With an aging population and improved medical care, more patients (pts) are now alive with both a personal history of coronary artery disease and prior malignancy which required radiation (RT). The survivorship data in this group of pts is lacking. With an aging population and improved medical care, more patients (pts) are now alive with both a personal history of coronary artery disease and prior malignancy which required radiation (RT). The survivorship data in this group of pts is lacking. Materials/MethodsFrom May 1998 to Oct 2012, pts who received both EBRT which involved the heart and percutaneous coronary intervention (PCI) were identified. One hundred fifty-three pts received EBRT before coronary artery stenting (Group A), and 78 pts after (Group B). Demographics, oncologic history, and prior PCI dates were collected. All pts received a curative RT dose >30 Gy (except for Hodgkin disease), with a portion of the RT beams directed at the heart. Use of cardiac medication during RT, anthracycline, and volumes (vol.) and dosimetric parameters of the heart and bilateral lungs were recorded and correlated to both cardiac and cancer (ca.)-specific survival by Cox univariate and multivariate methods. From May 1998 to Oct 2012, pts who received both EBRT which involved the heart and percutaneous coronary intervention (PCI) were identified. One hundred fifty-three pts received EBRT before coronary artery stenting (Group A), and 78 pts after (Group B). Demographics, oncologic history, and prior PCI dates were collected. All pts received a curative RT dose >30 Gy (except for Hodgkin disease), with a portion of the RT beams directed at the heart. Use of cardiac medication during RT, anthracycline, and volumes (vol.) and dosimetric parameters of the heart and bilateral lungs were recorded and correlated to both cardiac and cancer (ca.)-specific survival by Cox univariate and multivariate methods. ResultsOne hundred forty-one female and 90 male pts were included. The median age of ca. diagnosis was 67.0 yrs (range, 29-89 yrs). The median age at first PCI was also 67.0 yrs (range, 39-90 yrs). One hundred eleven pts (48%) had breast ca. (including DCIS), 70 (30%) NSCLC, 17 (7%) esophagus, 8 (4%) SCLC, and 5 (2%) Hodgkin disease. 44% had stage 0/I ca., 23% stage II, 30% stage III, and 4% stage IVa. Sixteen percent of the pts required 2 PCIs or more. With a median follow-up of 3.4 yrs, 113 pts had died: 64 (28%) of ca., 12 (5%) of a cardiac cause (excluding stroke), 18 (8%) others, and 19 (8%) unknown. Of all pts, 8% received anthracycline, and 63% took aspirin. A median dose of 50.4 Gy was prescribed. The median lung vol. was 3029 cc, and heart 690 cc. The max, mean dose and V20/13 Gy of the lungs, and the max, mean dose and V45/30 Gy of the heart were balanced between Groups A and B; lung ca. pts received more dose to the lungs, and esophageal ca. pts received more dose to the heart. Overall survival since ca. diagnosis was longer in Group A (12.6 vs 6.5 yrs, p < 0.02), having a breast ca. primary (p < 0.0001), and younger age (HR = 1.04, p < 0.003). However, 5-yr cardiac-specific survival since first PCI was lower in Group A (86.0 vs 98.5%, p < 0.0001), and worse with increasing mean bilateral lung dose (HR = 1.15 per Gy, p < 0.03). Ca.-specific survival was longer in Group A (p < 0.0001), but worse with increasing heart vol. receiving 30 Gy or more (HR = 1.02 per 100 additional cc irradiated, p < 0.002). One hundred forty-one female and 90 male pts were included. The median age of ca. diagnosis was 67.0 yrs (range, 29-89 yrs). The median age at first PCI was also 67.0 yrs (range, 39-90 yrs). One hundred eleven pts (48%) had breast ca. (including DCIS), 70 (30%) NSCLC, 17 (7%) esophagus, 8 (4%) SCLC, and 5 (2%) Hodgkin disease. 44% had stage 0/I ca., 23% stage II, 30% stage III, and 4% stage IVa. Sixteen percent of the pts required 2 PCIs or more. With a median follow-up of 3.4 yrs, 113 pts had died: 64 (28%) of ca., 12 (5%) of a cardiac cause (excluding stroke), 18 (8%) others, and 19 (8%) unknown. Of all pts, 8% received anthracycline, and 63% took aspirin. A median dose of 50.4 Gy was prescribed. The median lung vol. was 3029 cc, and heart 690 cc. The max, mean dose and V20/13 Gy of the lungs, and the max, mean dose and V45/30 Gy of the heart were balanced between Groups A and B; lung ca. pts received more dose to the lungs, and esophageal ca. pts received more dose to the heart. Overall survival since ca. diagnosis was longer in Group A (12.6 vs 6.5 yrs, p < 0.02), having a breast ca. primary (p < 0.0001), and younger age (HR = 1.04, p < 0.003). However, 5-yr cardiac-specific survival since first PCI was lower in Group A (86.0 vs 98.5%, p < 0.0001), and worse with increasing mean bilateral lung dose (HR = 1.15 per Gy, p < 0.03). Ca.-specific survival was longer in Group A (p < 0.0001), but worse with increasing heart vol. receiving 30 Gy or more (HR = 1.02 per 100 additional cc irradiated, p < 0.002). ConclusionsThis represents one of the few data addressing the topic of both oncologic and cardiac survivorship in pts undergoing radiation therapy, and first to correlate the effects of lung and heart dosimetric parameters to outcome. Limiting lung dose may improve cardiac-specific survival. Selection bias in Group A must be considered (i.e., pts must survive their ca. long enough to receive PCI later in their lives) in the interpretation of our work. This represents one of the few data addressing the topic of both oncologic and cardiac survivorship in pts undergoing radiation therapy, and first to correlate the effects of lung and heart dosimetric parameters to outcome. Limiting lung dose may improve cardiac-specific survival. Selection bias in Group A must be considered (i.e., pts must survive their ca. long enough to receive PCI later in their lives) in the interpretation of our work.
The level of awareness among Irish doctors of the appropriate indications for endoscopic ultrasound (EUS) is unknown. This study assessed knowledge of EUS indications among consultants and trainees in 3 Irish teaching hospitals. A questionnaire was designed to test knowledge of EUS indications in 4 organ systems: oesophagus, gastroduodenum, hepatopancreatobiliary system and colorectum. The questionnaire was distributed to consultants and trainees (both gastroenterology and non-gastroenterology) in 3 major Irish teaching hospitals. The survey was distributed to 86 doctors, all of whom replied: 18 consultants (11 gastroenterologists,) 40 registrars (28 gastroenterology) and 26 SHOs/interns. Knowledge of appropriate EUS indications was best among consultant gastroenterologists (82%) and GI registrars (79%), compared with non-GI consultants (74%), non-GI registrars (72%) and SHOs/interns (68%). Among gastroenterologists and GI registrars, knowledge levels of oesophageal (89%, 85%) and gastroduodenal applications (92%, 95%) was best while knowledge of colorectal applications (75%, 71%) was poorest. GI consultants and GI registrars display good knowledge of appropriate EUS indications although their knowledge of applications for colorectal disease is poorest. Future studies focusing on the education of non-gastroenterologists of the role of EUS would be helpful.
To evaluate the features and the mechanism of cardiac allograft coronary endothelial dysfunction.
An acute upper gastrointestinal haemorrhage (UGIH) is an expensive healthcare problem estimated to cost more than 2.5 billion dollars per annum in the United States. Recent British Society of Gastroenterology (BSG) guidelines (2002) advise that patients with low risk non variceal UGIH have a benign outcome and may be suitable for a relatively short hospital stay with attendant economic saving. We evaluated current clinical experience, endoscopy findings and length of hospital stay in our hospital. We carried out a two year retrospective data analysis of 395 Accident and Emergency Room triaged patients admitted with a low risk non variceal UGIH. Data variables included age, sex, presence of co morbid illness, endoscopic findings, Rockall Risk Score, mortality within the hospitalisation period and length and cost of hospital stay. Of the 395 haemodynamically stable patients identified, requiring 1,644 hospitalisation days, 320/395 (85.8%) had a Rockall Score < or =3. No endoscopic intervention was required in 366/395 (92.7%) of patients with a 2% overall mortality. The mean hospital length of stay (LOS) was 4.16, costing in excess of 1002,840 Euro. Following routine clinical practice for low risk non variceal UGIH, the subsequent duration of hospital stay was unnecessarily prolonged and costly. This highlights the need to initiate change, to monitor resource utilisation and implement early hospital discharge in appropriate patients.
Aims: Management of GI malignancy is determined by accurate staging (TNM) using CT, MRI and PET. These modalities have limitations with regard to tumour stage, local extension and the differentiation of benign and malignant adenopathy, which may be overcome by EUS / EUS FNAB. To assess the technical success, the diagnostic yield and complications of EUS FNAB.
Aim: Published colonoscopy-completion rates vary substantially and audits suggest they often fall short of the 90% completion-rate considered acceptable. Consequently, we undertook a retrospective-audit of colonoscopies performed in our unit over a six-month period from Oct 03– Mar 04.
The treatment of patients with refractory Crohn's disease can be problematic. Infliximab, a chimeric monoclonal antibody that specifically irreversibly binds to tumour necrosis factor alpha, is a biologic agent indicated for the treatment of such patients. Concomitant therapy with 6-mercaptopurine (MP)/azathioprine can prolong the effect of infliximab.1,2 Treatment with infliximab is particularly efficacious for fistulating Crohn's disease.3 In clinical studies, however, opportunistic infections occurred in 36% of patients receiving infliximab.
Aim: Endoscopic ultrasound fine needle aspiration (EUS-FNA) may be used to localise, delineate and histologically characterise pancreatic lesions. It has the ability to aspirate more than one site during the same procedure and offers an opportunity to prevent unnecessary surgical intervention. We aim to evaluate the clinical impact of EUS FNA in patients with suspected pancreatobiliary disease.
Background: International guidelines have recommended increasing the intervals for surveillance colonoscopy in patients with a history of colorectal polyps. The American Gastroenterological Association guidelines published in February 2003 suggest 5 yearly colonoscopy for patients with small tubular adenomas.
BACKGROUND:Endoscopic surveillance of patients with Barrett's oesophagus is recommended to detect early carcinoma. The practice patterns of endoscopists since the publication of more recent management guidelines remain unknown.METHODS:All endoscopists (n=68) in the Irish Medical Directory and their trainees were sent a postal questionnaire on Barrett's surveillance.RESULTS:Fifty-five per cent (30/54) perform surveillance on all patients with Barrett's oesophagus and 38% on selected patients. In patients with no dysplasia, repeat endoscopy was more commonly practiced annually (28/54) than every two to three years (23/54). Surgeons were more likely to perform surveillance annually than gastroenterologists (75% vs 40%). Only 26% of endoscopists took four-quadrant biopsies every 2 cm. Intervention was recommended by a majority (28/54) of endoscopists in a patient with high grade dysplasia. A majority of respondents (47/54) would have surveillance if they were found to have Barrett's oesophagus.CONCLUSION:Most endoscopists in Ireland do not adhere to recent guidelines in their management of Barrett's oesophagus. Surgical endoscopists perform surveillance more frequently than their medical colleagues.