1
|
Shen Y, Gao XJ, Zhang XX, Zhao JM, Hu FF, Han JL, Tian WY, Yang M, Wang YF, Lv JL, Zhan Q, An FM. Endoscopists and endoscopic assistants' qualifications, but not their biopsy rates, improve gastric precancerous lesions detection rate. World J Gastrointest Endosc 2025; 17:104097. [PMID: 40291134 PMCID: PMC12019122 DOI: 10.4253/wjge.v17.i4.104097] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/23/2024] [Revised: 02/27/2025] [Accepted: 03/24/2025] [Indexed: 04/14/2025] Open
Abstract
BACKGROUND Detecting gastric precancerous lesions (GPLs) is critical for the early diagnosis and treatment of gastric cancer. Endoscopy combined with tissue examination is an important method for detecting GPLs. However, negative biopsy results often increase patients' risks, economic burdens, and lead to additional healthcare costs. Improving the detection rate of GPLs and reducing the rate of negative biopsies is currently a key focus in endoscopic quality control. AIM To explore the relationships between the endoscopist biopsy rate (EBR), qualifications of endoscopists and endoscopic assistants, and detection rate of GPLs. METHODS EBR, endoscopists, and endoscopic assistants were divided into four groups: Low, moderate, high, and very high levels. Multivariable logistic regression analysis was used to analyze the relationships between EBR and the qualifications of endoscopists with respect to the detection rate of positive lesions. Pearson and Spearman correlation analyses were used to evaluate the correlation between EBR, endoscopist or endoscopic assistant qualifications, and the detection rate of positive lesions. RESULTS Compared with those in the low EBR group, the odds ratio (OR) values for detecting positive lesions in the moderate, high, and very high EBR groups were 1.12 [95% confidence interval (CI): 1.06-1.19, P < 0.001], 1.22 (95%CI: 1.14-1.31, P < 0.001), and 1.38 (95%CI: 1.29-1.47, P < 0.001), respectively. EBR was positively correlated with the detection rate of gastric precancerous conditions (atrophic gastritis/intestinal metaplasia) (ρ = 0.465, P = 0.004). In contrast, the qualifications of the endoscopists were positively correlated with GPLs detection (ρ = 0.448, P = 0.005). Compared to endoscopists with low qualification levels, those with moderate, high, and very high qualification levels endoscopists demonstrated increased detection rates of GPLs by 13% (OR = 1.13, 95%CI: 0.98-1.31), 20% (OR = 1.20, 95%CI: 1.03-1.39), and 32% (OR = 1.32, 95%CI: 1.15-1.52), respectively. Further analysis revealed that the qualifications of endoscopists were positively correlated with the detection rates of GPLs in the cardia (ρ = 0.350, P = 0.034), angularis (ρ = 0.396, P = 0.015) and gastric body (ρ = 0.453, P = 0.005) but not in the antrum (ρ = 0.292, P = 0.079). Moreover, the experience of endoscopic assistants was positively correlated with the detection rate of precancerous lesions by endoscopists with low or moderate qualifications (ρ = 0.427, P = 0.015). CONCLUSION Endoscopists and endoscopic assistants with high/very high qualifications, but not EBR, can improve the detection rate of GPLs. These results provide reliable evidence for the development of gastroscopic quality control indicators.
Collapse
Affiliation(s)
- Yao Shen
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Xiao-Juan Gao
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Xiao-Xue Zhang
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Jia-Min Zhao
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Fei-Fan Hu
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Jing-Lue Han
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Wen-Ying Tian
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Mei Yang
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Yun-Fei Wang
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Jia-Le Lv
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Qiang Zhan
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| | - Fang-Mei An
- Department of Gastroenterology, Affiliated Wuxi People’s Hospital of Nanjing Medical University, Wuxi People’s Hospital, Wuxi Medical Center, Nanjing Medical University, National Clinical Research Center for Digestive Diseases (Xi’an) Jiangsu Branch, Wuxi 214023, Jiangsu Province, China
| |
Collapse
|
2
|
Barnard M, Casey M, O'Connor L. A realist review protocol of the role and contribution of the advanced nurse practitioner (ANP) in gastroenterology nursing. HRB Open Res 2021. [DOI: 10.12688/hrbopenres.13451.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Background: The role and contribution of advanced nurse practitioners (ANP) has been well researched and found to be of great value for improving quality patient care and enhancing patient outcomes through education and health promotion. However, the role and the contribution of the ANP to gastroenterology nursing have not been evaluated either nationally or internationally. A review to determine the role and contribution of the ANP in gastroenterology nursing will inform on the contribution of the role and whether the role makes a difference to patient outcomes and cost effectiveness of patient care. Objective: This review aims to investigate the nursing role and contribution of the advanced nurse practitioner in gastroenterology. Furthermore, improved understanding of the underlying causal mechanisms explaining how the ANP role in gastroenterology nursing works, will provide a deeper understanding of how, why, for whom and in what contexts the role and contribution of the ANP to gastroenterology nursing are most successful. Methods: A realist review will consolidate evidence on how, when why and where the ANP role in gastroenterology works or fails through identifying programme theories underlying to the role’s introduction. The following steps will be operationalised; locating existing theories, searching the literature, documenting literature selection, engaging in data extraction and synthesis and refining programme theory. As an iterative approach, review cycles will uncover explanatory and contingent theories through context-mechanism-outcome configurations (CMOCc). Due to the variation in context and mechanisms, different outcomes will be likely across different clinical settings although similar patterns may be identified. Conclusions: Due to the theory-oriented approach of realist reviews, the pragmatic consequences of the review, will lend itself to deeper understanding of how the role and contribution of the ANP in gastroenterology nursing works in practice.
Collapse
|
3
|
Donnelly L, Bone B, Kennair T. Accelerated non-medical endoscopy training: one trust's experience. ACTA ACUST UNITED AC 2019. [DOI: 10.12968/gasn.2019.17.7.32] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
Endoscopy services are under considerable pressure to meet the increasing demand expected by 2020. A large hospital foundation trust was offered the opportunity to develop its endoscopy workforce by two of its endoscopy nurses obtaining a place on Health Education England's accelerated non-medical endoscopy training programme. The training took place over a period of 7 months and combined comprehensive endoscopy training supported by a robust academic component. A thematic analysis was carried out on the trainees' reflective journals kept during the course, and this highlighted the frequently occurring themes. The trust has benefited greatly from the experience, and, although challenging, the rewards can be far-reaching and have a positive impact on staff and patients.
Collapse
Affiliation(s)
- Leigh Donnelly
- Upper GI Clinical Nurse Specialist/Endoscopy Training Lead
| | - Barbara Bone
- Clinical Endoscopist, Northumbria Healthcare NHS Foundation Trust
| | - Trudi Kennair
- Clinical Endoscopist, Northumbria Healthcare NHS Foundation Trust
| |
Collapse
|
4
|
Roberts SLE, Healey A, Sevdalis N. Use of health economic evaluation in the implementation and improvement science fields-a systematic literature review. Implement Sci 2019; 14:72. [PMID: 31307489 PMCID: PMC6631608 DOI: 10.1186/s13012-019-0901-7] [Citation(s) in RCA: 81] [Impact Index Per Article: 13.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2018] [Accepted: 04/29/2019] [Indexed: 01/09/2023] Open
Abstract
Background Economic evaluation can inform whether strategies designed to improve the quality of health care delivery and the uptake of evidence-based practices represent a cost-effective use of limited resources. We report a systematic review and critical appraisal of the application of health economic methods in improvement/implementation research. Method A systematic literature search identified 1668 papers across the Agris, Embase, Global Health, HMIC, PsycINFO, Social Policy and Practice, MEDLINE and EconLit databases between 2004 and 2016. Abstracts were screened in Rayyan database, and key data extracted into Microsoft Excel. Evidence was critically appraised using the Quality of Health Economic Studies (QHES) framework. Results Thirty studies were included—all health economic studies that included implementation or improvement as a part of the evaluation. Studies were conducted mostly in Europe (62%) or North America (23%) and were largely hospital-based (70%). The field was split between improvement (N = 16) and implementation (N = 14) studies. The most common intervention evaluated (43%) was staffing reconfiguration, specifically changing from physician-led to nurse-led care delivery. Most studies (N = 19) were ex-post economic evaluations carried out empirically—of those, 17 were cost effectiveness analyses. We found four cost utility analyses that used economic modelling rather than empirical methods. Two cost-consequence analyses were also found. Specific implementation costs considered included costs associated with staff training in new care delivery pathways, the impacts of new processes on patient and carer costs and the costs of developing new care processes/pathways. Over half (55%) of the included studies were rated ‘good’ on QHES. Study quality was boosted through inclusion of appropriate comparators and reporting of incremental analysis (where relevant); and diminished through use of post-hoc subgroup analysis, limited reporting of the handling of uncertainty and justification for choice of discount rates. Conclusions The quantity of published economic evaluations applied to the field of improvement and implementation research remains modest; however, quality is overall good. Implementation and improvement scientists should work closely with health economists to consider costs associated with improvement interventions and their associated implementation strategies. We offer a set of concrete recommendations to facilitate this endeavour.
Collapse
Affiliation(s)
- Sarah Louise Elin Roberts
- King's Health Economics, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, David Goldberg Centre, De Crespigny Park, London, SE5 8AF, UK.
| | - Andy Healey
- King's Health Economics, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, David Goldberg Centre, De Crespigny Park, London, SE5 8AF, UK.,Centre for Implementation Science, King's College London, London, UK
| | - Nick Sevdalis
- Centre for Implementation Science, King's College London, London, UK
| |
Collapse
|
5
|
|
6
|
Ghaneh P, Hanson R, Titman A, Lancaster G, Plumpton C, Lloyd-Williams H, Yeo ST, Edwards RT, Johnson C, Abu Hilal M, Higginson AP, Armstrong T, Smith A, Scarsbrook A, McKay C, Carter R, Sutcliffe RP, Bramhall S, Kocher HM, Cunningham D, Pereira SP, Davidson B, Chang D, Khan S, Zealley I, Sarker D, Al Sarireh B, Charnley R, Lobo D, Nicolson M, Halloran C, Raraty M, Sutton R, Vinjamuri S, Evans J, Campbell F, Deeks J, Sanghera B, Wong WL, Neoptolemos JP. PET-PANC: multicentre prospective diagnostic accuracy and health economic analysis study of the impact of combined modality 18fluorine-2-fluoro-2-deoxy-d-glucose positron emission tomography with computed tomography scanning in the diagnosis and management of pancreatic cancer. Health Technol Assess 2018; 22:1-114. [PMID: 29402376 PMCID: PMC5817411 DOI: 10.3310/hta22070] [Citation(s) in RCA: 80] [Impact Index Per Article: 11.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Pancreatic cancer diagnosis and staging can be difficult in 10-20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer. OBJECTIVE To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer. DESIGN A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy. PARTICIPANTS Patients with suspected pancreatic malignancy. INTERVENTIONS All patients to undergo PET/CT following standard diagnostic work-up. MAIN OUTCOME MEASURES The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients' diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours. RESULTS Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUVmax.) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity (p = 0.01) and specificity (p = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all scenarios (p < 0.0002). PET/CT correctly changed the staging of pancreatic cancer in 56 patients (p = 0.001). PET/CT influenced management in 250 (45%) patients. PET/CT stopped resection in 58 (20%) patients who were due to have surgery. The benefit of PET/CT was limited in patients with chronic pancreatitis or other pancreatic tumours. PET/CT was associated with a gain in quality-adjusted life-years of 0.0157 (95% confidence interval -0.0101 to 0.0430). In the base-case model PET/CT was seen to dominate MDCT alone and is thus highly likely to be cost-effective for the UK NHS. PET/CT was seen to be most cost-effective for the subgroup of patients with suspected pancreatic cancer who were thought to be resectable. CONCLUSION PET/CT provided a significant incremental diagnostic benefit in the diagnosis of pancreatic cancer and significantly influenced the staging and management of patients. PET/CT had limited utility in chronic pancreatitis and other pancreatic tumours. PET/CT is likely to be cost-effective at current reimbursement rates for PET/CT to the UK NHS. This was not a randomised controlled trial and therefore we do not have any information from patients who would have undergone MDCT only for comparison. In addition, there were issues in estimating costs for PET/CT. Future work should evaluate the role of PET/CT in intraductal papillary mucinous neoplasm and prognosis and response to therapy in patients with pancreatic cancer. STUDY REGISTRATION Current Controlled Trials ISRCTN73852054 and UKCRN 8166. FUNDING The National Institute for Health Research Health Technology Assessment programme.
Collapse
Affiliation(s)
- Paula Ghaneh
- Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK
| | - Robert Hanson
- Liverpool Cancer Research UK Cancer Trials Unit, University of Liverpool, Liverpool, UK
| | - Andrew Titman
- Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
| | - Gill Lancaster
- Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
| | - Catrin Plumpton
- Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK
| | - Huw Lloyd-Williams
- Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK
| | - Seow Tien Yeo
- Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK
| | | | - Colin Johnson
- Faculty of Medicine, University of Southampton, Southampton, UK
| | - Mohammed Abu Hilal
- Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | | | - Tom Armstrong
- Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Andrew Smith
- Department of Gastrointestinal Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Andrew Scarsbrook
- Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Colin McKay
- Department of Surgery, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Ross Carter
- Department of Surgery, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Robert P Sutcliffe
- Department of Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
| | - Simon Bramhall
- Department of General Surgery, Wye Valley NHS Trust, Hereford, UK
| | - Hemant M Kocher
- Barts Cancer Institute, Barts and the London School of Medicine and Dentistry, London, UK
| | - David Cunningham
- Gastrointestinal and Lymphoma Unit, Royal Marsden NHS Foundation Trust, London, UK
| | - Stephen P Pereira
- Institute for Liver and Digestive Health, University College London Hospitals NHS Foundation Trust, London, UK
| | - Brian Davidson
- Department of Surgery, Royal Free London NHS Foundation Trust, London, UK
| | - David Chang
- Department of Surgery, Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust, Blackburn, UK
| | - Saboor Khan
- Department of Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
| | - Ian Zealley
- Department of Surgery, Ninewells Hospital and Medical School, NHS Tayside, Dundee, UK
| | - Debashis Sarker
- Department of Oncology, King's College Hospital NHS Foundation Trust, London, UK
| | - Bilal Al Sarireh
- Department of Surgery, Morriston Hospital, Abertawe Bro Morgannwg University Health Board, Swansea, UK
| | - Richard Charnley
- Department of Surgery, Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Dileep Lobo
- Faculty of Medicine and Life Sciences, University of Nottingham, Nottingham, UK
| | - Marianne Nicolson
- Department of Oncology, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK
| | - Christopher Halloran
- Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK
| | - Michael Raraty
- Department of Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Robert Sutton
- Department of Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Sobhan Vinjamuri
- Department of Nuclear Medicine, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Jonathan Evans
- Department of Radiology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Fiona Campbell
- Department of Pathology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK
| | - Jon Deeks
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
| | - Bal Sanghera
- Paul Strickland Scanner Centre, Mount Vernon Hospital, Middlesex, UK
| | - Wai-Lup Wong
- Paul Strickland Scanner Centre, Mount Vernon Hospital, Middlesex, UK
| | - John P Neoptolemos
- Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK
| |
Collapse
|
7
|
Gibson V, Needham S, Nayer M, Thompson NP. Do non-targeted gastric biopsies affect the management of patients, and can a simple protocol and education reduce the rate? Frontline Gastroenterol 2018; 9:67-72. [PMID: 29484163 PMCID: PMC5824772 DOI: 10.1136/flgastro-2017-100813] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/17/2017] [Revised: 06/01/2017] [Accepted: 07/03/2017] [Indexed: 02/04/2023] Open
Abstract
OBJECTIVE To determine whether development of localised protocol could reduce the number of non-targeted gastric biopsies taken at endoscopy, without risking harm from non-detection of malignant conditions. DESIGN Retrospective analysis of patient records over a 3-month period in 2013, repeated in 2015 following intervention. SETTING Two UK teaching hospitals. PATIENTS Patient record data on indication for endoscopy, endoscopy findings, histopathology results and patient outcome. INTERVENTIONS Guidance on upper gastrointestinal biopsy in the form of a new trust-wide protocol, as well as lecture-based education. MAIN OUTCOME MEASURES Rates of non-targeted and targeted biopsies before and after intervention, and differences between grade of endoscopist. RESULTS Between 2013 and 2015, there was a 36% reduction in non-targeted biopsies (10.4% vs 6.7%, p=0.001), predominantly within registrar and nurse endoscopist groups, with reduction in non-targeted biopsies of 9.5% and 64%, respectively. Percentage of targeted biopsies remained relatively static, 7.9% and 8.2%. In 2013, 92% of non-targeted biopsies had no management change based on histology; in 2015 this was 90%. Of patients with alteration to management, only 0.4% and 0.7% were due to malignancy, in known high-risk patients. Reduction in non-targeted biopsies resulted in estimated annual savings in this trust of £36,000. CONCLUSION Development of local protocol reduces the numbers of non-targeted biopsies taken, without risk of harm from non-detection of malignant conditions, enabling a significant reduction in workload within busy histopathology services, with significant cost savings. Localised protocols are adaptable to local population demographics.
Collapse
Affiliation(s)
- Victoria Gibson
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
| | - Stephanie Needham
- Department of Cellular Pathology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK
| | - Manu Nayer
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
| | - Nick P Thompson
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK
| |
Collapse
|
8
|
Baumgardner JM, Sewell JL, Day LW. Assessment of quality indicators among nurse practitioners performing upper endoscopy. Endosc Int Open 2017; 5:E818-E824. [PMID: 28879227 PMCID: PMC5585072 DOI: 10.1055/s-0043-115384] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2017] [Accepted: 06/21/2017] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND AND STUDY AIMS Limited international data have shown that non-physicians can safely perform upper endoscopy, but no such study has been performed in the United States. Our aim was to assess the quality of outpatient upper endoscopies performed by nurse practitioners (NPs). PATIENTS AND METHODS Retrospective chart review of upper endoscopies performed by 3 NPs between 2010 and 2013 was performed. Comparisons among all NPs performing upper endoscopy and assessment of individual NP performance over time with respect to quality indicators were performed. RESULTS Three NPs performed 333 upper endoscopies (distribution of 166, 44, and 123, respectively). Of the cases, 98.2 %s were successfully completed to the second portion of the duodenum. In most cases, photo-documentation of required anatomical landmarks was performed: GE junction (84.2 %), GE junction in retroflexed view (84.2 %), antrum (82.1 %) and duodenum (80.9 %). Photo-documentation improved with increasing experience. NPs appropriately performed biopsies for specific medical conditions: 10/11 (90.9 %) gastric ulcers were biopsied and 63/66 (95.5) of patients with iron deficiency had duodenal biopsies performed for celiac disease. A physician endoscopist was required during the procedure 22.5 % of the time. Important parameters such as documenting informed consent (100 %) and documenting a discharge plan (99.4 %) in the procedure reports were overwhelming present. There was a single adverse event during the study period. CONCLUSION In the first US study of NPs performing upper endoscopy, they were able to perform high-quality and safe upper endoscopies. These findings support incorporation of non-physicians alongside physicians to help meet the growing demand for endoscopic services across the United States.
Collapse
Affiliation(s)
- Jeffrey M. Baumgardner
- Division of Gastroenterology, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States,Corresponding author Jeffrey M. Baumgardner Zuckerberg San Francisco General Hospital and Trauma Center1001 Potrero AveSan Francisco CA 941101-415-206-5199
| | - Justin L. Sewell
- Division of Gastroenterology, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States
| | - Lukejohn W. Day
- Division of Gastroenterology, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States
| |
Collapse
|
9
|
Chiu WK, Brand RM, Camp D, Edick S, Mitchell C, Karas S, Zehmisch A, Ho K, Brand RE, Harrison J, Abo S, Cranston RD, McGowan I. The Safety of Multiple Flexible Sigmoidoscopies with Mucosal Biopsies in Healthy Clinical Trial Participants. AIDS Res Hum Retroviruses 2017; 33:820-826. [PMID: 28296471 PMCID: PMC5564058 DOI: 10.1089/aid.2016.0293] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
During Phase 1 pharmacokinetic/pharmacodynamics studies, participants may undergo multiple sigmoidoscopies, with a collection of 10-20 biopsies during each procedure. This article characterizes the safety of flexible sigmoidoscopies in clinical trial participants. We determined the number of flexible sigmoidoscopies and rectal biopsies that participants underwent and analyzed the frequency, duration, and severity of flexible sigmoidoscopy-related adverse events (AEs). During the study period, 278 participants underwent 1,004 flexible sigmoidoscopies with the collection of 15,930 rectal biopsies. The average number of procedures per participant was 3.6 (median 3; range 1-25), with an average time interval between procedures of 61.8 days (median 28 days; range 1-1,159). There were no serious AEs. Sixteen AEs were related to flexible sigmoidoscopy and occurred in 16 participants, leading to an overall 1.6% (16/1,004) AE rate per procedure and 0.1% (16/15,930) AE rate per biopsy. Of the 16 AEs, 8 (50%) involved abdominal pain, diarrhea, bleeding, flatulence, and bloating, with an average duration of 4.7 days (median 1 day; range 1-28). Most (14/16) AEs were categorized as Grade 1 (mild), whereas two of the AEs were Grade 2 (moderate). No participant withdrew due to procedure-related AEs. Overall, the number of AEs caused by flexible sigmoidoscopy with multiple biopsies was low and the severity was mild, suggesting that this procedure can be safely integrated into protocols requiring repeated intestinal mucosal sampling.
Collapse
Affiliation(s)
- Wai Kan Chiu
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Rhonda M. Brand
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- Department of Dermatology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Danielle Camp
- Magee-Women's Research Institute, Pittsburgh, Pennsylvania
| | - Stacey Edick
- Magee-Women's Research Institute, Pittsburgh, Pennsylvania
| | - Carol Mitchell
- Magee-Women's Research Institute, Pittsburgh, Pennsylvania
| | - Sherri Karas
- Magee-Women's Research Institute, Pittsburgh, Pennsylvania
| | | | - Ken Ho
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Randall E. Brand
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Janet Harrison
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Steven Abo
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Ross D. Cranston
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
| | - Ian McGowan
- Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- Magee-Women's Research Institute, Pittsburgh, Pennsylvania
| |
Collapse
|
10
|
Crews NR, Gorospe EC, Johnson ML, Wong Kee Song LM, Katzka DA, Iyer PG. Comparative quality assessment of esophageal examination with transnasal and sedated endoscopy. Endosc Int Open 2017; 5:E340-E344. [PMID: 28484734 PMCID: PMC5419847 DOI: 10.1055/s-0042-122008] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
Background Unsedated transnasal esophagoscopy (TNE) may offer a less expensive, mobile alternative to sedated esophagogastroduodenoscopy (EGD) for evaluations of reflux related complications. Comparisons of imaging quality by these methods are lacking. Methods Two reviewers evaluated videos of TNE and EGD procedures, performed during a community randomized study comparing endoscopic techniques. Subjects were randomized to EGD, TNE in endoscopy suite, or TNE in mobile research unit. Endoscopic quality was assessed using a validated scoring tool. Results In total, 115 videos (58 EGD, 28 endoscopy suite TNE, and 29 mobile TNE) were reviewed. Overall quality scores for TNE and EGD were excellent without a statistically significant difference (P = 0.30). There were no differences in gastroesophageal junction (GEJ) visualization scores, though EGD scored higher in esophageal passage (P < 0.05) and TNE scored higher in esophageal intubation (P < 0.05). There was no significant difference in any quality score between mobile TNE and gastrointestinal suite TNE. Conclusion Esophageal assessment with TNE or EGD was comparable in overall quality and GEJ visualization. TNE quality was not affected by procedure location. TNE is a feasible option for endoscopic assessment of reflux complications.
Collapse
Affiliation(s)
| | - Emmanuel C. Gorospe
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Michele L. Johnson
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | | | - David A. Katzka
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Prasad G. Iyer
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA,Corresponding author Prasad G. Iyer, MD MS Barrett’s Esophagus UnitDivision of Gastroenterology & HepatologyMayo Clinic200 1st St SWRochesterMNUSA+1-507-255-7652
| |
Collapse
|
11
|
Raftery J, Young A, Stanton L, Milne R, Cook A, Turner D, Davidson P. Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. Health Technol Assess 2015; 19:1-138. [PMID: 25671821 DOI: 10.3310/hta19110] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND By 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot 'metadata' on clinical trials funded by the HTA programme. OBJECTIVES The aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility. DATA SOURCES Published monographs and internal HTA documents. REVIEW METHODS A database was developed, 'populated' using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped. RESULTS One hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term 'randomised trial' in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data. LIMITATIONS The study was limited by being confined to 125 randomised trials by one funder. CONCLUSIONS Metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here. FUNDING The National Institute for Health Research HTA programme.
Collapse
Affiliation(s)
- James Raftery
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Amanda Young
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Louise Stanton
- University of Southampton Clinical Trials Unit, Southampton General Hospital, Southampton, UK
| | - Ruairidh Milne
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Andrew Cook
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| | - David Turner
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| | - Peter Davidson
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
| |
Collapse
|
12
|
Hutchings HA, Thorne K, Jerzembek GS, Cheung WY, Cohen D, Durai D, Rapport FL, Seagrove AC, Williams JG, Russell IT. Successful development and testing of a Method for Aggregating The Reporting of Interventions in Complex Studies (MATRICS). J Clin Epidemiol 2015; 69:193-8. [PMID: 26327489 DOI: 10.1016/j.jclinepi.2015.08.006] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2015] [Revised: 08/14/2015] [Accepted: 08/21/2015] [Indexed: 12/29/2022]
Abstract
OBJECTIVES To develop a tool for the accurate reporting and aggregation of findings from each of the multiple methods used in a complex evaluation in an unbiased way. STUDY DESIGN AND SETTING We developed a Method for Aggregating The Reporting of Interventions in Complex Studies (MATRICS) within a gastroenterology study [Evaluating New Innovations in (the delivery and organisation of) Gastrointestinal (GI) endoscopy services by the NHS Modernisation Agency (ENIGMA)]. We subsequently tested it on a different gastroenterology trial [Multi-Institutional Nurse Endoscopy Trial (MINuET)]. We created three layers to define the effects, methods, and findings from ENIGMA. We assigned numbers to each effect in layer 1 and letters to each method in layer 2. We used an alphanumeric code based on layers 1 and 2 to every finding in layer 3 to link the aims, methods, and findings. We illustrated analogous findings by assigning more than one alphanumeric code to a finding. We also showed that more than one effect or method could report the same finding. We presented contradictory findings by listing them in adjacent rows of the MATRICS. RESULTS MATRICS was useful for the effective synthesis and presentation of findings of the multiple methods from ENIGMA. We subsequently successfully tested it by applying it to the MINuET trial. CONCLUSION MATRICS is effective for synthesizing the findings of complex, multiple-method studies.
Collapse
Affiliation(s)
- Hayley A Hutchings
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK.
| | - Kymberley Thorne
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| | - Gabi S Jerzembek
- Institute of Health Service Effectiveness (IHSE), Aston University Business School, Aston Triangle, Birmingham B4 7ET, UK
| | - Wai-Yee Cheung
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| | - David Cohen
- Faculty of Health Sport and Science, University of South Wales, Treforest, Pontypridd CF37 1DL, UK
| | - Dharmaraj Durai
- Department of Medicine, University Hospital of Wales, Heath Park, Cardiff CF4 4XW, UK
| | - Frances L Rapport
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| | - Anne C Seagrove
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| | - John G Williams
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| | - Ian T Russell
- Patient and Population Health and Informatics Research (PPHI), Swansea University Medical School, Institute of Life Sciences 2, Swansea University, Singleton Park, Swansea SA2 8PP, UK
| |
Collapse
|
13
|
Ridyard CH, Hughes DA. Taxonomy for methods of resource use measurement. HEALTH ECONOMICS 2015; 24:372-8. [PMID: 24442966 DOI: 10.1002/hec.3029] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/22/2012] [Revised: 09/12/2013] [Accepted: 12/04/2013] [Indexed: 05/21/2023]
Abstract
Resource use measures, including forms, diaries and questionnaires, are ubiquitous in trial-based economic evaluations in the UK. However, there are concerns about the accuracy of how they are described, which limits the transparency of reporting. We developed a simple and structured taxonomy for methods of resource use measurement by examining 94 resource use measures (RUMs) employed within clinical trials, conducting a descriptive synthesis of the extracted data and soliciting wider opinion during a period of consultation. The reporting of RUMs was found to be varied and inconsistent. Our new taxonomy, which considered the views of 20 consultees, requires that RUMs are reported with a description of the following: (i) the source of data (patient; patient proxy, e.g. carer, parent or guardian; observation of contemporary events; medical records; or other databases); (ii) who completes the RUM (patient or their proxy, and researcher or health care professional); (iii) how it is administered (to self [the patient], face to face or telephone); (iv) how it is recorded (form, questionnaire, log or diary); and (v) medium of recording (e.g. paper or electronically). Based on the present analysis, we have developed a taxonomy for RUMs that should result in data collection methods being described more accurately.
Collapse
Affiliation(s)
- Colin H Ridyard
- Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Wales, UK
| | | |
Collapse
|
14
|
Alashkar B, Faulx AL, Hepner A, Pulice R, Vemana S, Greer KB, Isenberg GA, Falck-Ytter Y, Chak A. Development of a program to train physician extenders to perform transnasal esophagoscopy and screen for Barrett's esophagus. Clin Gastroenterol Hepatol 2014; 12:785-92. [PMID: 24161352 PMCID: PMC3995840 DOI: 10.1016/j.cgh.2013.10.014] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2013] [Revised: 10/01/2013] [Accepted: 10/04/2013] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Screening for Barrett's esophagus (BE) and esophageal adenocarcinoma is not recommended because it was not found to be cost effective. However, physician extenders (PEs) are able to perform unsedated procedures; their involvement might reduce the costs of BE screening. We examined the feasibility of training PEs to independently perform transnasal esophagoscopy (TNE) and screen patients for BE and measured their learning curve. METHODS Two PEs at a Veterans Affairs (VA) medical center underwent a structured didactic training program and observed nasopharyngoscopies before performing TNE under the supervision of attending endoscopists. Individual technical and cognitive components of TNE were rated on a 9-point structured scale. Learning curves were constructed using cumulative summation. Once the PEs were judged to be technically competent, each PE performed 10 independent videotaped TNEs, which were graded. RESULTS Both PEs identified anatomic landmarks after 18 consecutive procedures. PE1 and PE2 performed satisfactory nasal intubations after 20 and 25 procedures and esophageal intubations after 29 and 35 procedures, respectively. They acquired overall competence after supervised training on 43 and 47 procedures, respectively. CONCLUSIONS We developed a program at a VA medical center to train PEs to perform TNE to screen for BE. The PEs were able to perform TNE and recognize esophageal landmarks independently after a modest number of supervised procedures.
Collapse
Affiliation(s)
- Bronia Alashkar
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
| | - Ashley L. Faulx
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
,Division of Gastroenterology and Hepatology, University Hospitals Case Medical Center, Cleveland, OH
| | - Ashley Hepner
- Division of Gastroenterology and Hepatology, University Hospitals Case Medical Center, Cleveland, OH
| | - Richard Pulice
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
| | - Srikrishna Vemana
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
| | - Katarina B. Greer
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
,Division of Gastroenterology and Hepatology, University Hospitals Case Medical Center, Cleveland, OH
| | - Gerard A. Isenberg
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
,Division of Gastroenterology and Hepatology, University Hospitals Case Medical Center, Cleveland, OH
| | - Yngve Falck-Ytter
- Section of Gastroenterology, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH
| | - Amitabh Chak
- Division of Gastroenterology and Hepatology, University Hospitals Case Medical Center, Cleveland, Ohio.
| |
Collapse
|
15
|
Massl R, van Putten PG, Steyerberg EW, van Tilburg AJP, Lai JYL, de Ridder RJJ, Brouwer JT, Verburg RJ, Alderliesten J, Schoon EJ, van Leerdam ME, Kuipers EJ. Comparing quality, safety, and costs of colonoscopies performed by nurse vs physician trainees. Clin Gastroenterol Hepatol 2014; 12:470-7. [PMID: 24036056 DOI: 10.1016/j.cgh.2013.08.049] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/22/2013] [Revised: 08/03/2013] [Accepted: 08/22/2013] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS We evaluated the quality and safety of colonoscopies performed by nurse and physician endoscopy trainees as well as the cost differences. METHODS We performed a study of 7 nurse and 8 physician (gastroenterology fellows) endoscopy trainees at 2 medical centers in the Netherlands from September 2008 through April 2012. At the beginning of the study, the subjects had no experience in endoscopy; they were trained in gastrointestinal endoscopy according to the regulations of the Dutch Society of Gastroenterology, performing a minimum of 100 colonoscopies. Each trainee then performed 135 consecutive colonoscopies (866 total by nurse trainees and 1080 by physician trainees) under supervision of a gastroenterologist; the colonoscopies were evaluated for quality and safety. We performed statistical analyses of data, assessing multilevel and cost minimization. The mean age of the patients was 57 years, and about half were women in each group. RESULTS The endoscopic quality and safety were comparable between nurse and physician trainees. Overall rates of cecal intubation were 95% for nurses and 93% for physicians (P = .38), including procedures that required assistance from a supervisor; mean withdrawal times were 10.4 and 9.8 minutes, respectively (P = .44). Each group detected 27% of adenomas and had a 0.5% rate of complication. In both groups, the rates of unassisted cecal intubation gradually increased with the number of colonoscopies performed, from 70% for nurses and 74% for physicians at the beginning to 89% and 86%, respectively, at the end of the assessment period. Using a strategy in which 1 gastroenterologist supervises 3 nurses, the personnel costs decreased from $64.65 to $54.58. CONCLUSIONS In a supervised setting, nurse endoscopists perform colonoscopies according to quality and safety standards that are comparable with those of physician endoscopist and can substantially reduce costs.
Collapse
Affiliation(s)
- Renate Massl
- Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
| | - Paul G van Putten
- Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands
| | - Ewout W Steyerberg
- Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, the Netherlands
| | - Anthonie J P van Tilburg
- Department of Gastroenterology and Hepatology, Sint Franciscus Gasthuis, Rotterdam, the Netherlands
| | - Jonathan Y L Lai
- Department of Gastroenterology and Hepatology, Groene Hart Hospital, Gouda, the Netherlands
| | - Rogier J J de Ridder
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands
| | - Johnannes T Brouwer
- Department of Gastroenterology and Hepatology, Reinier de Graaf Medical Center, Delft, the Netherlands
| | - Robert J Verburg
- Department of Gastroenterology and Hepatology, Medical Center Haaglanden, The Hague, the Netherlands
| | - Joyce Alderliesten
- Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
| | - Erik J Schoon
- Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, the Netherlands
| | - Monique E van Leerdam
- Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands; Department of Gastroenterology and Hepatology, Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands
| | - Ernst J Kuipers
- Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands; Department of Internal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands
| |
Collapse
|
16
|
Meltzer AC, Pinchbeck C, Burnett S, Buhumaid R, Shah P, Ding R, Fleischer DE, Gralnek IM. Emergency physicians accurately interpret video capsule endoscopy findings in suspected upper gastrointestinal hemorrhage: a video survey. Acad Emerg Med 2013; 20:711-5. [PMID: 23859585 DOI: 10.1111/acem.12165] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2013] [Revised: 02/19/2013] [Accepted: 02/20/2013] [Indexed: 01/10/2023]
Abstract
BACKGROUND Acute upper gastrointestinal (GI) hemorrhage is a common emergency department (ED) presentation whose severity ranges from benign to life-threatening and the best tool to risk stratify the disease is an upper endoscopy, either by scope or by capsule, a procedure performed almost exclusively by gastroenterologists. Unfortunately, on-call gastroenterology specialists are often unavailable, and emergency physicians (EPs) currently lack an alternative method to endoscopically visualize a suspected acute upper GI hemorrhage. Recent reports have shown that video capsule endoscopy is well tolerated by ED patients and has similar sensitivity and specificity to endoscopy for upper GI hemorrhage. OBJECTIVES The study objective was to determine if EPs can detect upper GI bleeding on capsule endoscopy after a brief training session. METHODS A survey study was designed to demonstrate video examples of capsule endoscopy to EPs and determine if they could detect upper GI bleeding after a brief training session. All videos were generated from a prior ED-based study on patients with suspected acute upper GI hemorrhage. The training session consisted of less than 10 minutes of background information and capsule endoscopy video examples. EPs were recruited at the American College of Emergency Physicians Scientific Assembly in Denver, Colorado, from October 8, 2012, to October 10, 2012. Inclusion criteria included being an ED resident or attending physician and the exclusion criteria included any formal endoscopy training. The authors analyzed the agreement between the EPs and expert adjudicated capsule endoscopy readings for each capsule endoscopy video. For the outcome categories of blood (fresh or coffee grounds type) or no blood detected, the sensitivity and specificity were calculated. RESULTS A total of 126 EPs were enrolled. Compared to expert gastroenterology-adjudicated interpretation, the sensitivity to detect blood was 0.94 (95% confidence interval [CI] = 0.91 to 0.96) and specificity was 0.87 (95% CI = 0.80 to 0.92). CONCLUSIONS After brief training, EPs can accurately interpret video capsule endoscopy findings of presence of gross blood or no blood with high sensitivity and specificity.
Collapse
Affiliation(s)
| | | | - Sarah Burnett
- George Washington University School of Medicine; Washington; DC
| | - Rasha Buhumaid
- Emergency Medicine; George Washington University; Washington; DC
| | - Payal Shah
- Emergency Medicine; George Washington University; Washington; DC
| | - Ru Ding
- Emergency Medicine; George Washington University; Washington; DC
| | | | - Ian M. Gralnek
- Rappaport Faculty of Medicine; Technion-Israel Institute of Technology and the GI Outcomes Unit; Department of Gastroenterology; Rambam Health Care Campus; Haifa; Israel
| |
Collapse
|
17
|
Rapport F, Storey M, Porter A, Snooks H, Jones K, Peconi J, Sánchez A, Siebert S, Thorne K, Clement C, Russell I. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit. Trials 2013; 14:54. [PMID: 23433341 PMCID: PMC3599333 DOI: 10.1186/1745-6215-14-54] [Citation(s) in RCA: 43] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2013] [Accepted: 02/05/2013] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. METHODS Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). RESULTS The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. CONCLUSIONS We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.
Collapse
Affiliation(s)
- Frances Rapport
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Mel Storey
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Alison Porter
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Helen Snooks
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Kerina Jones
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Julie Peconi
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Antonio Sánchez
- Department of Medicine, Cardiff University Llandough Hospital, CF64 2XX, Penarth, UK
| | - Stefan Siebert
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Kym Thorne
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Clare Clement
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| | - Ian Russell
- College of Medicine, Swansea University, Singleton Park, Swansea SA2 8PP,UK
| |
Collapse
|
18
|
Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2010; 13:867-72. [PMID: 20946187 DOI: 10.1111/j.1524-4733.2010.00788.x] [Citation(s) in RCA: 75] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/12/2023]
Abstract
BACKGROUND The UK Health Technology Assessment (HTA) program funds trials that address issues of clinical and cost-effectiveness to meet the needs of the National Health Service (NHS). The objective of this review was to systematically assess the methods of resource use data collection and costing; and to produce a best practice guide for data capture within economic analyses alongside clinical trials. METHODS All 100 HTA-funded primary research papers published to June 2009 were reviewed for the health economic methods employed. Data were extracted and summarized by: health technology assessed, costing perspective adopted, evidence of planning and piloting, data collection method, frequency of data collection, and sources of unit cost data. RESULTS Ninety-five studies were identified as having conducted an economic analysis, of which 85 recorded patient-level resource use. The review identified important differences in how data are collected. These included: a priori evidence of analysts having identified important cost drivers; the piloting and validation of patient-completed resource use questionnaires; choice of costing perspective; and frequency of data collection. Areas of commonality included: the extensive use of routine medical records and reliance on patient recall; and the use of standard sources of unit costs. CONCLUSION Economic data collection is variable, even among a homogeneous selection of trials designed to meet the needs of a common organization (NHS). Areas for improvement have been identified, and based on our findings and related reviews and guidelines, a checklist is proposed for good practice relating to economic data collection within clinical trials.
Collapse
Affiliation(s)
- Colin H Ridyard
- Centre for Economics & Policy in Health, Institute of Medical and Social Care Research, Bangor University, Bangor, Gwynedd, UK
| | | |
Collapse
|
19
|
Barkun A, Ginsberg GG, Hawes R, Cotton P. The future of academic endoscopy units: challenges and opportunities. Gastrointest Endosc 2010; 71:1033-7. [PMID: 20438889 DOI: 10.1016/j.gie.2010.01.044] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/13/2009] [Accepted: 01/20/2010] [Indexed: 01/08/2023]
|
20
|
Djukic M, Kovner CT. Overlap of registered nurse and physician practice: implications for U.S. health care reform. Policy Polit Nurs Pract 2010; 11:13-22. [PMID: 20457728 DOI: 10.1177/1527154410365564] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/29/2023]
Abstract
This review offers an analysis of practice overlap between physicians and registered nurses (RNs) who are not advanced practice nurses. Additionally, it spotlights opportunities for expanding traditional professional boundaries to establish novel care delivery models. The examples of RN role expansion offer a beginning for discussion regarding how the health professionals' knowledge and skills can be best used in designing an effective and efficient health care system. Although limited data exist on cost effectiveness and workload implications of the novel care delivery models, policy makers can use the findings of this review to begin to inform U.S. health care reform.
Collapse
Affiliation(s)
- Maja Djukic
- New York University, College of Nursing, New York, NY 10003, USA.
| | | |
Collapse
|
21
|
Ylinen ER, Vehviläinen-Julkunen K, Pietilä AM, Hannila ML, Heikkinen M. Medication-free colonoscopy--factors related to pain and its assessment. J Adv Nurs 2009; 65:2597-607. [PMID: 19824909 DOI: 10.1111/j.1365-2648.2009.05119.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
AIM This paper is a report of a study conducted to determine the possibility of performing colonoscopy without medication, elucidate the factors related to a painful colonoscopy experience and compare colonoscopy patients' reported pain assessment to nurses' and endoscopists' observations. BACKGROUND Sedation and pain medication are routinely administered for colonoscopies in many countries. However, medication-free colonoscopies have attracted attention because the use of medication requires a time commitment from patients and increases complications. Earlier studies show that, for instance, gender, age and pelvic operations may increase the risk of painful colonoscopy and those healthcare professionals and patients appear to assess pain differently. METHOD A cross-sectional descriptive study was conducted in a Finnish university hospital using questionnaires developed for this study and analysed statistically. The sample of 138 colonoscopy patients, 11 nurses and 11 endoscopists was recruited in 2006. RESULTS Over three-quarters of patients reported mild pain or no pain at all. Patients' nervousness is a risk factor for experiencing pain during colonoscopy. Both nurses and endoscopists slightly underestimated the intensity of pain experienced by patients. CONCLUSION It is possible to perform colonoscopy without medication with most patients and focus sedation and pain medication on at-risk patients, especially those who are nervous. Before the procedure, nurses must devote time to discovering which patients are nervous and at risk of having a painful colonoscopy to present them for sedation. To improve pain management for patients having colonoscopy, endoscopists and nurses should participate systematically in pain education and use pain scales.
Collapse
|
22
|
van Putten PG, van Leerdam ME, Kuipers EJ. The views of gastroenterologists about the role of nurse endoscopists, especially in colorectal cancer screening. Aliment Pharmacol Ther 2009; 29:892-7. [PMID: 19183151 DOI: 10.1111/j.1365-2036.2009.03936.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
BACKGROUND Nurse endoscopists may provide a solution for the insufficient endoscopic capacity in colorectal cancer (CRC) screening. AIM To determine the views of gastroenterologists about the potential role of nurse endoscopists in gastrointestinal endoscopy. METHODS A postal questionnaire was sent to all registered gastroenterologists (n = 301) and gastroenterology residents (n = 79) in the Netherlands. RESULTS Two hundred and thirty five of 380 (62%) gastroenterologists and residents completed the questionnaire. Overall, 48% were positive towards introduction of nurse endoscopists, whereas 18% were neutral and 34% negative. Respondents expected no major differences in endoscopic quality between physicians and nurse endoscopists. Nevertheless, 69% expected that patient experiences would be better met by physicians. Multivariate analysis showed that actual experience with nurse endoscopists and beliefs that nurse endoscopists are able to provide adequate endoscopic quality and good patient experiences, were independent predictors for a positive attitude towards introduction of nurse endoscopists [OR 6.6 (2.3-18.4), OR 1.9 (1.2-3.5) and OR 2.1 (1.2-2.9), respectively]. Respectively 89% and 66% of the respondents considered sigmoidoscopy and colonoscopy for CRC screening as appropriate procedures to be performed by nurse endoscopists. Diagnostic and therapeutic endoscopies were considered less appropriate. CONCLUSION A majority of gastroenterologists have a positive attitude towards introduction of nurse endoscopists, especially for CRC screening endoscopies.
Collapse
Affiliation(s)
- P G van Putten
- Department of Gastroenterology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
| | | | | |
Collapse
|
23
|
Ikenberry SO, Anderson MA, Banerjee S, Baron TH, Dominitz JA, Gan SI, Harrison ME, Jagannath S, Levy M, Lichtenstein D, Shen B, Fanelli RD, Stewart L, Khan K. Endoscopy by nonphysicians. Gastrointest Endosc 2009; 69:767-70. [PMID: 19327469 DOI: 10.1016/j.gie.2008.11.006] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2008] [Accepted: 11/03/2008] [Indexed: 02/08/2023]
|
24
|
Colonoscopy training for nurse endoscopists: a feasibility study. Gastrointest Endosc 2009; 69:688-95. [PMID: 19251011 DOI: 10.1016/j.gie.2008.09.028] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2008] [Accepted: 09/17/2008] [Indexed: 12/13/2022]
Abstract
BACKGROUND Screening by using colonoscopy is recommended in many countries to reduce the risk of death from colorectal cancer. Given the limited supply of medical endoscopists, nurse endoscopists may represent an economic alternative. OBJECTIVE To develop a colonoscopy training program for nurse endoscopists and to evaluate the feasibility of this program. DESIGN Two nurse endoscopists and 1 first-year GI fellow were enrolled in a colonoscopy training protocol, including computer-simulator training, flexible sigmoidoscopies, and colonoscopies under direct supervision. SETTING A single-center prospective study. PATIENTS The first 150 complete colonoscopies of each trainee endoscopist were evaluated and compared with 150 colonoscopies performed by an experienced endoscopist. MAIN OUTCOME MEASUREMENTS Objective criteria for competency were diagnostic accuracy, cecal-intubation rate, cecal-intubation time, the need for assistance, and complications. Subjective criteria included patient satisfaction, pain, and discomfort scores. RESULTS The nurse endoscopists' unassisted cecal-intubation rate was 80% for the first 25 procedures, gradually increasing in subsequent cases to 96% for the last 25 procedures. The mean cecal-intubation time at the end of the training period was 10 minutes. Cecal-intubation rates and times were comparable between the nurse trainees and the fellow. The patients reported low degrees of pain and discomfort, and high satisfaction scores, irrespective of the type of endoscopist. Diagnostic accuracy of the trainees was good. The complication rate was 0.3%. LIMITATION Nonrandomized design. CONCLUSIONS This pilot study suggests that nurses can be trained to perform colonoscopy in an effective manner, with results similar to a GI fellow. The learning curve indicated that 150 procedures are required before independent examinations are attempted.
Collapse
|
25
|
Williams J, Russell I, Durai D, Cheung WY, Farrin A, Bloor K, Coulton S, Richardson G. Effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET). BMJ 2009; 338:b231. [PMID: 19208714 PMCID: PMC2643440 DOI: 10.1136/bmj.b231] [Citation(s) in RCA: 35] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/24/2008] [Indexed: 11/20/2022]
Abstract
OBJECTIVE To compare the clinical effectiveness of doctors and nurses in undertaking upper and lower gastrointestinal endoscopy. DESIGN Pragmatic trial with Zelen's randomisation before consent to minimise distortion of existing practice. SETTING 23 hospitals in the United Kingdom. In six hospitals, nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 centres. PARTICIPANTS 67 doctors and 30 nurses. Of 4964 potentially eligible patients, we randomised 4128 (83%) and recruited 1888 (38%) from July 2002 to June 2003. INTERVENTIONS Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy, undertaken with or without sedation, with the standard preparation, techniques, and protocols of participating hospitals. After referral for either procedure, patients were randomised between doctors and nurses. MAIN OUTCOME MEASURES Gastrointestinal symptom rating questionnaire (primary outcome), gastrointestinal endoscopy satisfaction questionnaire and state-trait anxiety inventory (all analysed by intention to treat); immediate and delayed complications; quality of examination and corresponding report; patients' preferences for operator; and new diagnoses at one year (all analysed according to who carried out the procedure). RESULTS There was no significant difference between groups in outcome at one day, one month, or one year after endoscopy, except that patients were more satisfied with nurses after one day. Nurses were also more thorough than doctors in examining the stomach and oesophagus. While quality of life scores were slightly better in patients the doctor group, this was not statistically significant. CONCLUSIONS Diagnostic endoscopy can be undertaken safely and effectively by nurses. TRIAL REGISTRATION International standard RCT 82765705.
Collapse
Affiliation(s)
- John Williams
- Centre for Health Information, Research and Evaluation, School of Medicine, Swansea University, Swansea SA2 8PP
| | | | | | | | | | | | | | | |
Collapse
|
26
|
Richardson G, Bloor K, Williams J, Russell I, Durai D, Cheung WY, Farrin A, Coulton S. Cost effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET). BMJ 2009; 338:b270. [PMID: 19208715 PMCID: PMC2643438 DOI: 10.1136/bmj.b270] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/15/2008] [Indexed: 12/14/2022]
Abstract
OBJECTIVE To compare the cost effectiveness of nurses and doctors in performing upper gastrointestinal endoscopy and flexible sigmoidoscopy. DESIGN As part of a pragmatic randomised trial, the economic analysis calculated incremental cost effectiveness ratios, and generated cost effectiveness acceptability curves to address uncertainty. SETTING 23 hospitals in the United Kingdom. PARTICIPANTS 67 doctors and 30 nurses, with a total of 1888 patients, from July 2002 to June 2003. INTERVENTION Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy carried out by doctors or nurses. MAIN OUTCOME MEASURE Estimated health gains in QALYs measured with EQ-5D. Probability of cost effectiveness over a range of decision makers' willingness to pay for an additional quality adjusted life year (QALY). RESULTS Although differences did not reach traditional levels of significance, patients in the doctor group gained 0.015 QALYs more than those in the nurse group, at an increased cost of about pound56 (euro59, $78) per patient. This yields an incremental cost effectiveness ratio of pound3660 (euro3876, $5097) per QALY. Though there is uncertainty around these results, doctors are probably more cost effective than nurses for plausible values of a QALY. CONCLUSIONS Though upper gastrointestinal endoscopies and flexible sigmoidoscopies carried out by doctors cost slightly more than those by nurses and improved health outcomes only slightly, our analysis favours endoscopies by doctors. For plausible values of decision makers' willingness to pay for an extra QALY, endoscopy delivered by nurses is unlikely to be cost effective compared with endoscopy delivered by doctors. TRIAL REGISTRATION International standard RCT 82765705.
Collapse
Affiliation(s)
- Gerry Richardson
- Centre for Health Economics and Hull York Medical School (HYMS), University of York, York YO10 5DD.
| | | | | | | | | | | | | | | |
Collapse
|
27
|
Tomkins S, Allen E, Savenko O, McCambridge J, Saburova L, Kiryanov N, Oralov A, Gil A, Leon DA, McKee M, Elbourne D. The HIM (Health for Izhevsk Men) trial protocol. BMC Health Serv Res 2008; 8:69. [PMID: 18377650 PMCID: PMC2364619 DOI: 10.1186/1472-6963-8-69] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2008] [Accepted: 03/31/2008] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Russia is one of the very few industrialised countries in the world where life expectancy has been declining. Alcohol has been implicated as a major contributor to the rapid fluctuations observed in male life expectancy since 1985 that have been particularly marked among working-age men. One approach to reducing the alcohol problem in Russia is 'brief interventions' which seek to change views of the personal acceptability of excessive drinking and to encourage self-directed behaviour change. There is limited understanding in Russia of the salience and applicability of Motivational Interviewing (MI), a well-defined brief intervention commonly used to target alcohol-related behaviour, but MI may have important potential for success within the Russian context. METHODS/DESIGN The study will be an individually randomised two-armed parallel group exploratory trial. The primary hypothesis is that a brief adaptation of MI will be effective in reducing self-reported hazardous drinking at 3 months. The secondary hypothesis is that it will be effective in reducing self-reported past week beverage alcohol consumption, alcohol dependence and related problems at 3 months and at 12 months. MI will also be effective at 12 months in reducing self-reported hazardous drinking, alcohol dependence and related problems, proxy reported hazardous drinking, and recent alcohol use as indicated by bio-markers. Participants are drawn from the Izhevsk Family Study II, with eligibility determined based on proxy reports of hazardous drinking in the past year. All participants undergo a health check, with MI subsequently delivered to those in the intervention arm. Signed consent is obtained from those in the intervention arm at this point. Both groups are then invited for 3 and 12 month follow ups. The control group will not receive any additional intervention. TRIAL REGISTRATION ISRCTN82405938.
Collapse
Affiliation(s)
- Susannah Tomkins
- Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
| | | | | | | | | | | | | | | | | | | | | |
Collapse
|
28
|
Dobrow MJ, Cooper MA, Gayman K, Pennington J, Matthews J, Rabeneck L. Referring patients to nurses: outcomes and evaluation of a nurse flexible sigmoidoscopy training program for colorectal cancer screening. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2007; 21:301-8. [PMID: 17505566 PMCID: PMC2657712 DOI: 10.1155/2007/719634] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
Colorectal cancer is a significant health burden. Several screening options exist that can detect colorectal cancer at an early stage, leading to a more favourable prognosis. However, despite years of knowledge on best practice, screening rates are still very low in Canada, particularly in Ontario. The present paper reports on efforts to increase the flexible sigmoidoscopy screening capacity in Ontario by training nurses to perform this traditionally physician-performed procedure. Drawing on American, British and local experience, a professional regulatory framework was established, and training curriculum and assessment criteria were developed. Training was initiated at Princess Margaret Hospital and Sunnybrook and Women's College Health Sciences Centre in Toronto, Ontario. (During the study, Sunnybrook and Women's College Health Sciences Centre was deamalgamated into two separate hospitals: Women's College Hospital and Sunnybrook Health Sciences Centre.) Six registered nurses participated in didactic, simulator and practical training. These nurses performed a total of 77 procedures in patients, 23 of whom had polyps detected and biopsied. Eight patients were advised to undergo colonoscopy because they had one or more neoplastic polyps. To date, six of these eight patients have undergone colonoscopy, one patient has moved out of the province and another patient is awaiting the procedure. Classifying the six patients according to the most advanced polyp histology, one patient had a negative colonoscopy (no polyps found), one patient's polyps were hyperplastic, one had a tubular adenoma, two had advanced neoplasia (tubulovillous adenomas) and one had adenocarcinoma. All these lesions were excised completely at colonoscopy. Overall, many difficulties were anticipated and addressed in the development of the training program; ultimately, the project was affected most directly by challenges in encouraging family physicians to refer patients to the program. As health human resource strategies continue to evolve, it is believed that lessons learned from experience make an important contribution to the knowledge of how nontraditional health services can be organized and delivered.
Collapse
Affiliation(s)
- Mark J Dobrow
- Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
| | | | | | | | | | | |
Collapse
|
29
|
Moayyedi P. The promises and perils of nurse-led flexible sigmoidoscopy screening. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2007; 21:280-2. [PMID: 17571449 PMCID: PMC2657707 DOI: 10.1155/2007/238687] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Affiliation(s)
- Paul Moayyedi
- Correspondence: Dr Paul Moayyedi, Department of Medicine, McMaster University Medical Centre, 1200 Main Street West, Health Sciences Centre – 4W8B, Hamilton, Ontario L8N 3Z5. Telephone 905-521-2100 ext 76764, fax 905-521-4958, e-mail
| |
Collapse
|
30
|
Affiliation(s)
- Karen Bloor
- Department of Health Sciences, University of York, York YO10 5DD, UK.
| | | | | |
Collapse
|