scholarly journals P-OGC97 Development and piloting of surgical quality assurance methods for randomised controlled trials (RCTs): an example from a trial comparing laparoscopically assisted oesophagectomy vs. open oesophagectomy

2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Jane Blazeby ◽  
Natalie Blencowe ◽  
Anni Skilton ◽  
Beverly Shirkey ◽  
Liz Ward

Abstract Background RCTs in surgery are frequently criticised because the standard to which operations are performed (quality assurance - QA) is not considered during study design and delivery, risking performance bias. Lack of clarity about surgical QA may also influence the successful implementation of RCT results into routine practice, because it is unclear how procedures were undertaken. We developed QA measures for an RCT comparing laparoscopically assisted and open oesophagectomy (LAO and OO). Methods Five QA categories were developed during the pilot and applied to the main trial, using data from patients receiving their randomized allocation in each group: i) entry criteria for centres; ii) entry criteria for surgeons; surgical protocols for key components of LAO and OO with mandated, prohibited and flexible components, monitored using iii) case report forms (CRFs) to record protocol adherence; and iv) intra-operative photographs to demonstrate protocol adherence (using the visible anatomical structures to determine if the component had been fully completed); and v) lymph node count and length of oesophagus.   Results 8 centres and 39 surgeons participated and met entry criteria. 145 (LAO) and 149 (OO) patients underwent their randomized surgical procedure. Key procedural components were reported as complete in CRFs at similar rates in both groups, with >70% undergoing mandated components. However, adherence assessed using photographs was consistently lower than the CRFs. For example, left gastric artery lymphadenectomies were reported as complete in > 98% CRFs (LAO and OO) whereas photographs found this to be complete in 42% (OO) and 54% (LAO). Median nodal count was similar in both groups (145 LAO=24.7, SD = 10.6 and 149 OO = 26.4, SD = 10.2) as was length of resected oesophagus. Conclusions Assessing surgical QA in a multi-centre trial is logistically challenging but feasible. Whilst video data from laparoscopic cases could be collected and assessed, it was not possible with open surgery. Understanding adherence to the study protocol using photographs in addition to CRFs was important because of marked differences between what surgeons reported had been undertaken and images of what had been achieved. It is recommended that surgical trials include QA processes to understand protocol adherence and examine performance bias between groups.

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026591
Author(s):  
Judith Dyson ◽  
Claire Marsh ◽  
Natalie Jackson ◽  
Donald Richardson ◽  
Muhammad Faisal ◽  
...  

ObjectivesThe Computer-Aided Risk Score (CARS) estimates the risk of death following emergency admission to medical wards using routinely collected vital signs and blood test data. Our aim was to elicit the views of healthcare practitioners (staff) and service users and carers (SU/C) on (1) the potential value, unintended consequences and concerns associated with CARS and practitioner views on (2) the issues to consider before embedding CARS into routine practice.SettingThis study was conducted in two National Health Service (NHS) hospital trusts in the North of England. Both had in-house information technology (IT) development teams, mature IT infrastructure with electronic National Early Warning Score (NEWS) and were capable of integrating NEWS with blood test results. The study focused on emergency medical and elderly admissions units. There were 60 and 39 acute medical/elderly admissions beds at the two NHS hospital trusts.ParticipantsWe conducted eight focus groups with 45 healthcare practitioners and two with 11 SU/Cs in two NHS acute hospitals.ResultsStaff and SU/Cs recognised the potential of CARS but were clear that the score should not replace or undermine clinical judgments. Staff recognised that CARS could enhance clinical decision-making/judgments and aid communication with patients. They wanted to understand the components of CARS and be reassured about its accuracy but were concerned about the impact on intensive care and blood tests.ConclusionRisk scores are widely used in healthcare, but their development and implementation do not usually involve input from practitioners and SU/Cs. We contributed to the development of CARS by eliciting views of staff and SU/Cs who provided important, often complex, insights to support the development and implementation of CARS to ensure successful implementation in routine clinical practice.


Author(s):  
Iryna Sokolova

The article analyzes the national context of higher education reforms in Southern Europe, based on broad source analysis. The author has found out that the countries of Southern Europe (Spain, Italy, Portugal, and Greece) are distinguished by the national peculiarities of institutional transformations in the field of higher education, demonstrate the experience of successful implementation of the EHEA educational policy, taking into account the national priorities and historical traditions of higher education. A qualitative approach was applied when judging the level of involvement in quality assurance (QA) agencies in Eastern Europe. To implement the national Laws on Higher Education, harmonized with «Standards and Guidelines for Quality Assurance in the EHEA», agencies & HEIs in Spain, Italy, Portugal and Greece emphasize quality assurance procedures focused on learning, teaching, and research output. The article highlights organizational, content and procedural activities of higher education QA agencies. The competencies of national agencies have been characterized in the article. Study findings identified the trends in the implementation of the European concept of QA in higher education: the institutionalization of national systems, articulation of consistency with EU documents, national legislation; the scientific and educational collaboration in different fields of activity; internationalization and visualization of the agencies’ activities in the international educational space. It is concluded that general trends determine the directions of dynamic organizational and procedural changes in national higher education systems. Particular attention in the article is paid to the internal QA systems in HEIs under the guidance and with methodological support national agencies provided. The general and specific procedures of external and internal quality assurance in the countries of Southern Europe have been described. From the material presented in this paper, the following theme may require further attention: examining quality frameworks and quality assurance standards in Eastern Europe.


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258343
Author(s):  
Katja Jarm ◽  
Maksimiljan Kadivec ◽  
Cveto Šval ◽  
Kristijana Hertl ◽  
Maja Primic Žakelj ◽  
...  

Setting The organised, population-based breast cancer screening programme in Slovenia began providing biennial mammography screening for women aged 50–69 in 2008. The programme has taken a comprehensive approach to quality assurance as recommended by the European guidelines for quality assurance in breast cancer screening and diagnosis (4th edition), including centralized assessment, training and supervision, and proactive monitoring of performance indicators. This report describes the progress of implementation and rollout from 2003 through 2019. Methods The screening protocol and key quality assurance procedures initiated during the planning from 2003 and rollout from 2008 of the screening programme, including training of the professional staff, are described. The organisational structure, gradual geographical rollout, and coverage by invitation and examination are presented. Results The nationwide programme was up and running in all screening regions by the end of 2017, at which time the nationwide coverage by invitation and examination had reached 70% and 50%, respectively. Nationwide rollout of the population-based programme was complete by the end of 2019. By this time, coverage by invitation and examination had reached 98% and 76%, respectively. The participation rates consistently exceeded 70% from 2014 to 2019. Conclusions The successful implementation of the screening programme can be attributed to an independent central management, external guidance, and strict adherence to quality assurance procedures, all of which contributed to increasing governmental and popular support. The benefits of quality assurance have influenced all aspects of breast care and have provided a successful model for multidisciplinary management of other diseases.


2007 ◽  
Vol 46 (04) ◽  
pp. 416-419 ◽  
Author(s):  
P. Yu ◽  
Y. Qiu

Summary Objective: In order to ensure the successful implementation of a nursing information system (NIS), nurses and nursing students must be adequately trained. In order to do this effectively, it is essential to understand their training needs. This study focuses on the training needs of nursing students in particular through the identification of the usage problems they encounter. Usability testing, which involves observing users’ interaction with an NIS, overcomes the deficiencies of traditional approaches of training needs analysis such as interviewand survey. The study applied usability test to assess training needs of nursing students to learn to use a specific NIS, the “Care Planning Assessment Tool” (CPAT). Methods: An experiment in which novice CPAT users were expected to learn to use the software through task-based exploration was conducted. Eight nursing undergraduate students who had never used the software were recruited. Participants’ interactionswith the system were captured by screen capture software. Meanwhile, participants’ “think aloud” verbal expression of their usage problems was audio-taped. Results: A coding schemewas used in analysing the captured audio and video data. Ten common usage problems were identified. From these problems, three areas of knowledge gap that this cohort of novice users experienced were identified. Conclusion: The training needs of nursing students learning to use an NIS was conceptualised in a model consisting of three types of knowledge, i.e. computer skills, knowledge about the NIS and knowledge about procedure of nursing documentation. The knowledge gap must be filled in order to ensure effective training.


2020 ◽  
Vol 5 (5) ◽  
pp. 1050-1060 ◽  
Author(s):  
Christopher P Price ◽  
Patrick McGinley ◽  
Andrew St John

Abstract Background The innovation pathway by which a newly discovered biomarker is developed into a medical test and used in routine clinical practice comprises a number of different processes split between 2 phases. The first follows on from biomarker discovery and involves the development of a robust analytical method, the accumulation of evidence to show its clinical and cost-effectiveness, and then adoption into clinical pathways. The second phase is one of implementation and sustainability, with active performance management to ensure that the test continues to deliver the benefits promised at the time of its adoption. Content To date there has been much more emphasis on the first phase of discovery and accumulation of evidence to demonstrate effectiveness. Insufficient attention has been paid to the second phase of translating that evidence into routine practice, with little real-world evidence to demonstrate the benefits to all of the stakeholders involved in delivering and receiving care. Changes in healthcare that include a move away from activity-based costing to a more value-based approach require more attention be paid to what happens after a test is adopted, including an understanding of the clinical pathway, the stakeholders within that pathway, and the benefits and “disbenefits” that accrue to these stakeholders. Summary The value proposition provides a guide for successful implementation of a test. Although it can address both adoption and implementation, it highlights that the requirements for test implementation are quite different to those of adoption, with an emphasis on real-world evidence and outcomes.


2017 ◽  
Vol 30 (5) ◽  
pp. 779-794 ◽  
Author(s):  
Maha Mourad

Purpose The purpose of this paper is to investigate the understanding of stakeholders of the Polish higher education sector to the internal quality assurance (QA) system and its role as a driver of information management strategy. Design/methodology/approach The paper employs a qualitative approach. It started with an exploratory research in the form of 12 in-depth interviews with the Bologna process experts, followed by empirical research via 30 face-to-face interviews with key educational informants in five selected universities in Poland. Findings The findings show that a key element for a successful implementation of the QA system is the stakeholders’ own understanding of the rationale behind it as an information management strategy. In addition, the study places emphasis on the priorities in front of the top-level management to create the quality and information culture within the academic community. Originality/value The study assists in finding global practical and creating a benchmark for policymakers concerning the information management strategies based on the Polish experience.


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Rebecca Patterson ◽  
Holly Standing ◽  
Mark Lee ◽  
Sonia Dalkin ◽  
Monique Lhussier ◽  
...  

Abstract Background Limited access to, understanding of, and trust in paper-based patient information is a key factor influencing paramedic decisions to transfer patients nearing end-of-life to hospital. Practical solutions to this problem are rarely examined in research. This paper explores the extent to which access to, and quality of, patient information affects the care paramedics provide to patients nearing end-of-life, and their views on a shared electronic record as a means of accessing up-to-date patient information. Method Semi-structured interviews with paramedics (n = 10) based in the north of England, drawn from a group of health and social care professionals (n = 61) participating in a study exploring data recording and sharing practices in end-of-life care. Data were analysed using thematic analysis. Results Two key themes were identified regarding paramedic views of patient information: 1) access to information on patients nearing end-of-life, and 2) views on the proposed EPaCCS. Paramedics reported they are typically unable to access up-to-date patient information, particularly advance care planning documents, and consequently often feel they have little option but to actively treat and transport patients to hospital – a decision not always appropriate for, or desired by, the patient. While paramedics acknowledged a shared electronic record (such as EPaCCs) could support them to provide community-based care where desired and appropriate, numerous practical and technical issues must be overcome to ensure the successful implementation of such a record. Conclusions Access to up-to-date patient information is a barrier to paramedics delivering appropriate end-of-life care. Current approaches to information recording are often inconsistent, inaccurate, and inaccessible to paramedics. Whilst a shared electronic record may provide paramedics with greater and timelier access to patient information, meaning they are better able to facilitate community-based care, this is only one of a series of improvements required to enable this to become routine practice.


2013 ◽  
Vol 2 (8) ◽  
pp. 204798161351196 ◽  
Author(s):  
Vilma Mannila ◽  
Outi Sipilä

Background Recommended phantom-based quality assurance measurements in B-mode ultrasound (US) may be tedious. For the purpose of cost-effective US quality assurance it is important to evaluate measurements that effectively reflect the quality of US scanner. Purpose To find out which recommended phantom-based quality assurance measurements are effective in detecting dead or weak transducer elements or channels in US scanners when visual image analysis and manual measurements are used. Material and Methods Altogether 66 transducers from 33 US scanners were measured using a general purpose phantom and a transducer tester. The measurements were divided into two groups. Group I consisted of phantom-based uniformity measurement, imaging the air with a clean transducer (air image) and measuring the transducer with the transducer tester, and group II of phantom-based measurements of depth of penetration, beam profile, near field, axial and lateral resolution, and vertical and horizontal distance accuracy. The group II measurements were compared to group I measurements. Results With group I measurements, the results with 20% of the transducers were found defective. With 35% of the transducers the results were considered defective in group II measurements. Concurrent flaws in both groups were found with 11% of the transducers. Conclusion Phantom-based measurements of depth of penetration, beam profile, near field, axial and lateral resolution, and vertical and horizontal distance accuracy did not consistently detect dead or weak transducer elements or channels in US scanners.


2018 ◽  
Vol 9 (1) ◽  
pp. 19-23
Author(s):  
Arathi Rao ◽  
Vinay Mavani ◽  
Karuna Y Mahabala ◽  
Ethel Suman ◽  
P Anupama Nayak

ABSTRACT Aim The aim of the study was to evaluate if vinegar and vinegar with 3.5% sodium chloride could be used as an alternative to chlorhexidine gluconate for disinfection of toothbrushes. Materials and methods The study consisted of three groups: group I: 0.12% chlorhexidine digluconate, group II: 38% white vinegar, and group III: 38% white vinegar with 3.5% sodium chloride. Two new toothbrushes were cultured to check their sterility before use. Eight children in the age group of 6 to 12 years were given oral hygiene instructions and four sets of oral hygiene kits. At the end of the 1st week, one set of used toothbrushes was cultured to check for total viable count. Again at the end of the 2nd, 3rd, and 4th weeks, the 2nd, 3rd, and 4th sets of brushes were collected, subjected to respective decontamination treatment for 12 hours, and then cultured for microbial analyses. The obtained data were analyzed using Fisher's exact test. Results In group I, three out of eight brushes showed 1 to 10,000 colonies, in group II, one out of eight cases showed >10,000 colonies and two out of eight showed 1 to 10,000 colonies, and in group III, all the eight cases showed no colonies upon culturing. Conclusion Out of all the tested decontaminating agents, combination of 38% white vinegar and 3.5% sodium chloride was found to be the most efficient. Clinical significance Toothbrushes become contaminated upon use and act as a reservoir for microorganisms. Thus, toothbrush decontamination should become a routine practice. Testing the disinfecting efficacy of vinegar and common salt is, thus, beneficial as they are available in every kitchen. How to cite this article Mavani V, Mahabala KY, Suman E, Natarajan S, Nayak PA, Srikrishna SB, Rao A. Evaluation of Effectiveness of Home Remedies for Toothbrush Decontamination using Vinegar and Vinegar with Common Salt. World J Dent 2018;9(1):19-23.


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