Academic literature on the topic 'Healthcare Systems Design'

The healthcare system is facing several major quality challenges. In 2005, the Institute of Medicine published a report on how systems engineering and improvements in information technology can help address and solve some of these challenges. Systems engineering (SE) and health informatics (HI) have been undergoing advancements over the years. Health systems engineering is an interdisciplinary field that has grown to encompass the design, analysis, and management of complex health systems to improve quality and performance. HI is another interdisciplinary field around collection, storage, retrieval and analysis of data, reporting and enabling use of information, and (re)design and maintenance of systems to do all of these. SE and HI are complementary in their approach to identification of problems and solution procedure for (re)design and improvement. This combination has major implications for care delivery, research, and education to address the challenges.

The objective of this article is to bring awareness to the changing landscape of the healthcare ecosystem and the clinician’s role with respect to medical devices, medical systems, technology, and processes involved in the system. Clinicians interact with them every day and have a huge implication for them directly, and to their patients indirectly. Clinicians are actively involved in clinical research which involves the knowledge and practice of the disease, diagnosis and management, etc. Recently, the role of non-clinical aspects such as medical devices, processes and systems of the healthcare ecosystem is gaining popularity. Hence, there is potential to explore this aspect of the healthcare delivery system to redesign and innovate for improving clinical outcomes. To achieve this, the clinicians need to understand these systems from a perspective that will help them to identify the problems and develop innovative solutions. Just like the clinical research is systematic and methodical, the improvement of the medical systems is also methodical to a large extent. This includes concepts and techniques that are quite fresh and new to a clinician who probably has never been exposed to these in their medical careers. These general principles of Innovation and Design thinking applied to other domains have yielded fantastic results and for the same to be applied in the medical domain, the role of the practicing clinician is central. As clinicians, we have always practiced innovation at some point of time in our career when we would have faced a resource crunch and were compelled to save the children and hence have tried to innovate on the devices, processes, etc., in our own way and has worked many a times. To generate many such solutions at large scale, the whole process needs to be methodical and systematic so that the solutions developed are safe and consistent at all times. Such a solution can be scaled up and made to reach across such setups where it is needed and there can be a measurable improvement in efficiency, quality, effectiveness, or economics of patient care delivery on a large scale.

AbstractThe healthcare sector is facing significant challenges that require a systems approach, resulting in a rapid growth in the application of systems approaches in healthcare since the beginning of the 21st century. Consequently, healthcare practitioners and policymakers now desire to understand the evidence-base for the approach, but little evidence of the kind desired exists. This paper is a first step in conducting a narrative review of the application of systems approaches in healthcare based on a systematic review of the academic and grey literature. First, the emergence of the approach in healthcare is explored. Second, specific examples of applications of systems approaches in healthcare are examined to identify any missing elements in current practice. Third, fourteen reviews of the approach in healthcare published in the last ten years are analysed. The results suggest that the use of the approach in healthcare will most likely continue to increase, however, significant work remains for the design and systems community to demonstrate the effectiveness of systems approaches, specifically in providing convincing measures of impact on patient and service outcomes.

Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, Engineering Systems Division, 2015.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 85-90).
Since the HITECH Act of 2009, adoption of Electronic Health Record (EHR) systems in US healthcare organizations has increased significantly. Along with the rapid increase in usage of EHR, cybercrimes are on the rise as well. Two recent cybercrime cases from early 2015, the Anthem and Premera breaches, are examples of the alarming increase of cybercrimes in this domain. Although modem Information Technology (IT) systems have evolved to become very complex and dynamic, cybersecurity strategies have remained static. Cyber attackers are now adopting more adaptive, sophisticated tactics, yet the cybersecurity counter tactics have proven to be inadequate and ineffective. The objective of this thesis is to analyze the recent Anthem security breach to assess the vulnerabilities of Anthem's data systems using current cybersecurity frameworks and guidelines and the Systems-Theoretic Accident Model and Process (STAMP) method. The STAMP analysis revealed Anthem's cybersecurity strategy needs to be reassessed and redesigned from a systems perspective using a holistic approach. Unless our society and government understand cybersecurity from a sociotechnical perspective, we will never be equipped to protect valuable information and will always lose this battle.
by Kristie Chung.
S.M. in Engineering and Management

Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 60-63).
This thesis is a study on the adoption of cloud computing in healthcare information technology industry. It provides a guideline for people who are trying to bring cloud computing into healthcare information systems through the use of a framework of tools and processes to overcome both technical and business challenges.
by Haiying Ren.
S.M.in Engineering and Management

Healthcare information systems (HISs), as a class of systems, are not currently addressed in the MIS literature. This is in spite of a sharp increase in use over the past few years, and the uniquely qualified role that MIS has in the development of, impact and general understanding of HISs. In this project the design science paradigm frames the development of a set of design principles derived from the synthesis of the design literature, ethics literature, and professional guidelines, from both the medical and computing professions. The resulting principles are offered to address the design of healthcare information systems. Action research, a widely accepted methodology for testing design principles derived from the design science paradigm, is employed to test the HIS principles and to implement change in a healthcare organization through the use of an HIS. The action research project was a collaborative effort between a Central Florida hospice and the researcher, the result of which was an advanced directives decision support system. The system was design to meet a number of organizational goals that ranged from tracking compliance with federal regulations to increasing the autonomy of the patients that used the system. The result is a set of tested design principles and lessons learned from both anticipated and unanticipated consequences of the action research project.
Ph.D.
Department of Management Information Systems
Business Administration
Business Administration: Ph.D.

Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, February 2015.
Cataloged from PDF version of thesis.
Includes bibliographical references (page 77).
Usage in information technology (IT) have improved efficiency and quality in many industries. Healthcare has not been one of them. Although some administrative IT systems, such as those for billing, scheduling, and inventory management, are already in place in the healthcare industry, little adoption of clinical IT, such as Electronic Medical Record Systems (EMR-S) and Clinical Decision Support tools, has occurred. India's healthcare information technology market is slow with technology adoption but there is little traction shown in last couple of years. This growth is expected to hit US $1.45 billion in 2018, more than three times the US $381.3 million reached in 2012. The increase in adoption of electronic health records, mHealth, telemedicine, and Web-based services has made electronic patient data expand, necessitating the implementation of robust IT systems in Indian healthcare institutions. Information technology (IT) has the potential to improve the quality, safety, and efficiency of health care. Diffusion of IT in health care is generally low (varying, however, with the application and setting) but surveys indicate that providers plan to increase their investments. Drivers of investment in IT include the promise of quality and efficiency gains. Barriers include the cost and complexity of IT implementation, which often necessitates significant work process and cultural changes. Given IT's potential, both the private and public sectors have engaged in numerous efforts to promote its use within and across health care settings. Delivering quality health care requires providers and patients to integrate complex information from many different sources. Thus, increasing the ability of physicians, nurses, clinical technicians, and others to readily access and use the right information about their patients should improve care. The purpose of this thesis is to assess the current state of healthcare in India and specifically look into the emerging technology trends in healthcare IT. During analysis secondary data has been used. Various articles and research papers published in national and international journals are used. India is hub of IT and its use is increasing in health sector.
by Sanjay Kumar Gautam.
S.M. in Engineering and Management

Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, Engineering Systems Division, 2015.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages [66]-[67]).
Affordability of healthcare is a growing concern across the world. For India, with a population of over 1.2 billion people and one third of world's poorest, to provide affordable and sustainable healthcare to all its citizens becomes even more challenging. The country faces the triple burden of controlling communicable diseases, managing non communicable diseases, and limiting the deaths from injury and mental health. The public healthcare system is underfunded and underutilized while the private facilities are unregulated and unaccountable for quality and cost of care. The high reliance of the population on the private facilities, low insurance coverage, and high emphasis on curative care than the preventive care is further making the cost prohibitive for the general population. There is a lot to be desired in the areas of Pharmaceuticals, Medical Devices, and Research and Development for a holistic development of healthcare system in India. This thesis attempts to model the current healthcare system and how different entities of the system interact to influence the affordability. The simulation of the model projects the affordability in the next 50 years. The study also checks the impact of three different policies on the affordability of care.
by Anjali Chaudhary.
S.M. in Engineering and Management

Thesis (S.M. in Management and Engineering)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 63-64).
In the current shift in the US healthcare system, lower cost, higher quality of care, access and safety are the main drivers that are effecting changes. Patient compliance with medication and technology enabled wellness and engagement programs play an important role in ensuring the cost and quality of care is reduced. In a recent study, the overall cost of poor medication adherence, measured in otherwise avoidable medical spending, is close to $310 billion annually, representing approximately 14% of total healthcare expenditures. There have been several studies analyzing the reasons for and impact of non-adherence and solutions to achieve increasing compliance. With the recent wave in healthcare technology, the scope of prescription medication adherence needs to be expanded to include patient engagement and their awareness towards lifestyle changes and managing their own health. This thesis engages in an analysis of these compliance issues and in understanding the relationships among the various stakeholders involved. It also analyses the several technology platforms and solutions from mobile health to "gamification" and social networks from a business, user and regulatory standpoint. It looks into how these newer health technologies helps the individual in adhering and realizing novel insights into their own patterns related to medication, lifestyle and general health. Further, working with a health technology startup catering to the behavioral care market, a real world application of a health technology product that utilizes technology based patient assessment, decision support and patient communication, will be evaluated to explore how it will help in delivering value to several stakeholders.
by Chetan R. Jog.
S.M.in Management and Engineering

Increasing number of ageing population and people who need continuous health monitoring and rising the costs of health care have triggered the concept of the novel wireless technology-driven human body monitoring. Human body monitoring can be performed using a network of small and intelligent wireless medical sensors which may be attached to the body surface or implanted into the tissues. It enables carers to predict, diagnose, and react to adverse events earlier than ever. The concept of Wireless Body Area Network (WBAN) was introduced to fully exploit the benefits of wireless technologies in telemedicine and m-health. The main focus of this research is the design and performance evaluation of strategies and architectures that would allow seamless and efficient interconnection of patient’s body area network and the stationary (e.g., hospital room or ward) wireless networks. I first introduce the architecture of a healthcare system which bridges WBANs and Wireless Local Area Networks (WLANs). I adopt IEEE 802.15.6 standard for the patient’s body network because it is specifically designed for WBANs. Since IEEE 802.15.6 has strict Quality of Service (QoS) and priorities to transfer the medical data to the medical server a QoS-enabled WLAN for the next hop is needed to preserve the end-to-end QoS. IEEE 802.11e standard is selected for the WLAN in the hospital room or ward because it provides prioritization for the stations in the network. I investigate in detail the requirements posed by different healthcare parameters and to analyze the performance of various alternative interconnection strategies, using the rigorous mathematical apparatus of Queuing Theory and Probabilistic Analysis; these results are independently validated through discrete event simulation models. This thesis has three main parts; performance evaluation and MAC parameters settings of IEEE 802.11e Enhanced Distributed Channel Access (EDCA), performance evaluation and tuning the MAC parameters of IEEE 802.15.6, and designing a seamless and efficient interconnection strategy which bridges IEEE 802.11e EDCA and IEEE 802.15.6 standards for a healthcare system.

Healthcare is in urgent need of an effective way to manage the complexity it of its systems and to prepare quickly for immense changes in the economics of healthcare delivery and reimbursement. Centers for Medicare & Medicaid Services (CMS) releases policies affecting inpatient and long-term care hospitals policies that directly affect reimbursement and payment rates. One of these policy changes, a quality-reporting program called Hospital Inpatient Quality Reporting (IQR), will effect approximately 3,400 acute-care and 440 long-term care hospitals. IQR sets guidelines and measures that will contain financial incentives and penalties based on the quality of care provided. CMS, the largest healthcare payer, is aggressively promoting high quality of care by linking payment incentives to outcomes. With CMS assessing each hospital's performance by comparing its Quality Achievements and Quality Improvement scores, there is a growing need and demand to understand these quality measures under the context of patient care, data management and system integration. This focus on patient-centered quality care is difficult for healthcare systems due to the lack of a systemic view of the patient and patient care. This research uniquely addresses the hospital's need to meet these challenges by presenting a healthcare specific framework and methodology for translating data on quality metrics into actionable processes and feedback to produce the desired quality outcome. The solution is based on a patient-care level process ontology, rather than the technology itself, and creates a bridge that applies systems engineering principles to permit observation and control of the system. This is a transformative framework conceived to meet the needs of the rapidly changing healthcare landscape. Without this framework, healthcare is dealing with outcomes that are six to seven months old, meaning patients may not have been cared for effectively. In this research a framework and methodology called the Healthcare Ontology Based Systems Engineering Model (HOB-SEM) is developed to allow for observability and controllability of compartmental healthcare systems. HOB-SEM applies systems and controls engineering principles to healthcare using ontology as the method and the data lifecycle as the framework. The ontology view of patient-level system interaction and the framework to deliver data management and quality lifecycles enables the development of an agile systemic healthcare view for observability and controllability

Review question / Objective: The objective of this study was to review impact of telecare interventions on quality of life in older adults. Condition being studied: Recently, an increase in the older adult population, their chronic diseases, and functional disabilities have resulted in the need for more healthcare services. Telecare is one of the solutions for caring these people and can improve their quality of life. However, examining the impact of telecare interventions, especially in terms of quality of life in older adults, can help to improve current systems and design better telecare technologies for a wider population in the future. Information sources: Searching articles was conducted in PubMed, Web of Science, Scopus, the Cochrane Library, Embase, IEEExplore, and ProQuest databases, and Google Scholar. If the full text of an article was not available, the corresponding author would be contacted.

The urban population of Africa, the fastest urbanizing continent, has increased from 19% to 39% in the past 50 years, and the number of urban dwellers is projected to reach 770 million by 2030. However, while rapid urbanization has increased mobility and created a subsequent growth in demand for public transport in cities, this has not been met by the provision of adequate and sustainable infrastructure and services. The majority of low-income residents and the urban poor still lack access to adequate transport services and rely on non-motorized and public transport, which is often informal and characterized by poor service delivery. Lack of access to transport services limits access to opportunities that aren’t in the proximity of residential areas, such as education, healthcare, and employment. The urban public transport sector not only faces the challenge of poor service provision, but also of gender inequality. Research shows that, in the existing urban transport systems, there are significant differences in the travel patterns of and modes of transport used by women and men, and that these differences are associated with their roles and responsibilities in society. Moreover, the differences in travel patterns are characterized by unequal access to transport facilities and services. Women are generally underrepresented in the sector, in both its operation and decision-making. Women’s mobility needs and patterns are rarely integrated into transport infrastructure design and services and female users are often victims of harassment and assault. As cities rapidly expand, meeting the transport needs of their growing populations while paying attention to gender-differentiated mobility patterns is a prerequisite to achieving sustainability, livability and inclusivity. Gender mainstreaming in urban public transport is therefore a critical issue, but one which is under-researched in East Africa. This research explores gender issues in public transport in East Africa, focusing in particular on women’s inclusion in both public transport systems and transport policy decision-making processes and using case studies from three cities: Nairobi, Kampala and Dar es Salaam.

Background: Healthcare decision makers strive to operate on the best available evidence. The Agency for Healthcare Research and Quality Evidence-based Practice Center (EPC) Program aims to support healthcare decision makers by producing evidence reviews that rate the strength of evidence. However, the evidence base is often sparse or heterogeneous, or otherwise results in a high degree of uncertainty and insufficient evidence ratings. Objective: To identify and suggest strategies to make insufficient ratings in systematic reviews more actionable. Methods: A workgroup comprising EPC Program members convened throughout 2020. We conducted interative discussions considering information from three data sources: a literature review for relevant publications and frameworks, a review of a convenience sample of past systematic reviews conducted by the EPCs, and an audit of methods used in past EPC technical briefs. Results: Several themes emerged across the literature review, review of systematic reviews, and review of technical brief methods. In the purposive sample of 43 systematic reviews, the use of the term “insufficient” covered both instances of no evidence and instances of evidence being present but insufficient to estimate an effect. The results of the literature review and review of the EPC Program systematic reviews illustrated the importance of clearly stating the reasons for insufficient evidence. Results of both the literature review and review of systematic reviews highlighted the factors decision makers consider when making decisions when evidence of benefits or harms is insufficient, such as costs, values, preferences, and equity. We identified five strategies for supplementing systematic review findings when evidence on benefit or harms is expected to be or found to be insufficient, including: reconsidering eligible study designs, summarizing indirect evidence, summarizing contextual and implementation evidence, modelling, and incorporating unpublished health system data. Conclusion: Throughout early scoping, protocol development, review conduct, and review presentation, authors should consider five possible strategies to supplement potential insufficient findings of benefit or harms. When there is no evidence available for a specific outcome, reviewers should use a statement such as “no studies” instead of “insufficient.” The main reasons for insufficient evidence rating should be explicitly described.

Overview Skin cancer prevention is a component of the new Cancer Plan 2022–27, which guides the work of the Cancer Institute NSW. To lessen the impact of skin cancer on the community, the Cancer Institute NSW works closely with the NSW Skin Cancer Prevention Advisory Committee, comprising governmental and non-governmental organisation representatives, to develop and implement the NSW Skin Cancer Prevention Strategy. Primary Health Networks and primary care providers are seen as important stakeholders in this work. To guide improvements in skin cancer prevention and inform the development of the next NSW Skin Cancer Prevention Strategy, an up-to-date review of the evidence on the effectiveness and feasibility of skin cancer prevention activities in primary care is required. A research team led by the Daffodil Centre, a joint venture between the University of Sydney and Cancer Council NSW, was contracted to undertake an Evidence Check review to address the questions below. Evidence Check questions This Evidence Check aimed to address the following questions: Question 1: What skin cancer primary prevention activities can be effectively administered in primary care settings? As part of this, identify the key components of such messages, strategies, programs or initiatives that have been effectively implemented and their feasibility in the NSW/Australian context. Question 2: What are the main barriers and enablers for primary care providers in delivering skin cancer primary prevention activities within their setting? Summary of methods The research team conducted a detailed analysis of the published and grey literature, based on a comprehensive search. We developed the search strategy in consultation with a medical librarian at the University of Sydney and the Cancer Institute NSW team, and implemented it across the databases Embase, MEDLINE, PsycInfo, Scopus, Cochrane Central and CINAHL. Results were exported and uploaded to Covidence for screening and further selection. The search strategy was designed according to the SPIDER tool for Qualitative and Mixed-Methods Evidence Synthesis, which is a systematic strategy for searching qualitative and mixed-methods research studies. The SPIDER tool facilitates rigour in research by defining key elements of non-quantitative research questions. We included peer-reviewed and grey literature that included skin cancer primary prevention strategies/ interventions/ techniques/ programs within primary care settings, e.g. involving general practitioners and primary care nurses. The literature was limited to publications since 2014, and for studies or programs conducted in Australia, the UK, New Zealand, Canada, Ireland, Western Europe and Scandinavia. We also included relevant systematic reviews and evidence syntheses based on a range of international evidence where also relevant to the Australian context. To address Question 1, about the effectiveness of skin cancer prevention activities in primary care settings, we summarised findings from the Evidence Check according to different skin cancer prevention activities. To address Question 2, about the barriers and enablers of skin cancer prevention activities in primary care settings, we summarised findings according to the Consolidated Framework for Implementation Research (CFIR). The CFIR is a framework for identifying important implementation considerations for novel interventions in healthcare settings and provides a practical guide for systematically assessing potential barriers and facilitators in preparation for implementing a new activity or program. We assessed study quality using the National Health and Medical Research Council (NHMRC) levels of evidence. Key findings We identified 25 peer-reviewed journal articles that met the eligibility criteria and we included these in the Evidence Check. Eight of the studies were conducted in Australia, six in the UK, and the others elsewhere (mainly other European countries). In addition, the grey literature search identified four relevant guidelines, 12 education/training resources, two Cancer Care pathways, two position statements, three reports and five other resources that we included in the Evidence Check. Question 1 (related to effectiveness) We categorised the studies into different types of skin cancer prevention activities: behavioural counselling (n=3); risk assessment and delivering risk-tailored information (n=10); new technologies for early detection and accompanying prevention advice (n=4); and education and training programs for general practitioners (GPs) and primary care nurses regarding skin cancer prevention (n=3). There was good evidence that behavioural counselling interventions can result in a small improvement in sun protection behaviours among adults with fair skin types (defined as ivory or pale skin, light hair and eye colour, freckles, or those who sunburn easily), which would include the majority of Australians. It was found that clinicians play an important role in counselling patients about sun-protective behaviours, and recommended tailoring messages to the age and demographics of target groups (e.g. high-risk groups) to have maximal influence on behaviours. Several web-based melanoma risk prediction tools are now available in Australia, mainly designed for health professionals to identify patients’ risk of a new or subsequent primary melanoma and guide discussions with patients about primary prevention and early detection. Intervention studies have demonstrated that use of these melanoma risk prediction tools is feasible and acceptable to participants in primary care settings, and there is some evidence, including from Australian studies, that using these risk prediction tools to tailor primary prevention and early detection messages can improve sun-related behaviours. Some studies examined novel technologies, such as apps, to support early detection through skin examinations, including a very limited focus on the provision of preventive advice. These novel technologies are still largely in the research domain rather than recommended for routine use but provide a potential future opportunity to incorporate more primary prevention tailored advice. There are a number of online short courses available for primary healthcare professionals specifically focusing on skin cancer prevention. Most education and training programs for GPs and primary care nurses in the field of skin cancer focus on treatment and early detection, though some programs have specifically incorporated primary prevention education and training. A notable example is the Dermoscopy for Victorian General Practice Program, in which 93% of participating GPs reported that they had increased preventive information provided to high-risk patients and during skin examinations. Question 2 (related to barriers and enablers) Key enablers of performing skin cancer prevention activities in primary care settings included: • Easy access and availability of guidelines and point-of-care tools and resources • A fit with existing workflows and systems, so there is minimal disruption to flow of care • Easy-to-understand patient information • Using the waiting room for collection of risk assessment information on an electronic device such as an iPad/tablet where possible • Pairing with early detection activities • Sharing of successful programs across jurisdictions. Key barriers to performing skin cancer prevention activities in primary care settings included: • Unclear requirements and lack of confidence (self-efficacy) about prevention counselling • Limited availability of GP services especially in regional and remote areas • Competing demands, low priority, lack of time • Lack of incentives.

Background Lung cancer is the number one cause of cancer death worldwide.(1) It is the fifth most commonly diagnosed cancer in Australia (12,741 cases diagnosed in 2018) and the leading cause of cancer death.(2) The number of years of potential life lost to lung cancer in Australia is estimated to be 58,450, similar to that of colorectal and breast cancer combined.(3) While tobacco control strategies are most effective for disease prevention in the general population, early detection via low dose computed tomography (LDCT) screening in high-risk populations is a viable option for detecting asymptomatic disease in current (13%) and former (24%) Australian smokers.(4) The purpose of this Evidence Check review is to identify and analyse existing and emerging evidence for LDCT lung cancer screening in high-risk individuals to guide future program and policy planning. Evidence Check questions This review aimed to address the following questions: 1. What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? 2. What is the evidence of potential harms from lung cancer screening for higher-risk individuals? 3. What are the main components of recent major lung cancer screening programs or trials? 4. What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Summary of methods The authors searched the peer-reviewed literature across three databases (MEDLINE, PsycINFO and Embase) for existing systematic reviews and original studies published between 1 January 2009 and 8 August 2019. Fifteen systematic reviews (of which 8 were contemporary) and 64 original publications met the inclusion criteria set across the four questions. Key findings Question 1: What is the evidence for the effectiveness of lung cancer screening for higher-risk individuals? There is sufficient evidence from systematic reviews and meta-analyses of combined (pooled) data from screening trials (of high-risk individuals) to indicate that LDCT examination is clinically effective in reducing lung cancer mortality. In 2011, the landmark National Lung Cancer Screening Trial (NLST, a large-scale randomised controlled trial [RCT] conducted in the US) reported a 20% (95% CI 6.8% – 26.7%; P=0.004) relative reduction in mortality among long-term heavy smokers over three rounds of annual screening. High-risk eligibility criteria was defined as people aged 55–74 years with a smoking history of ≥30 pack-years (years in which a smoker has consumed 20-plus cigarettes each day) and, for former smokers, ≥30 pack-years and have quit within the past 15 years.(5) All-cause mortality was reduced by 6.7% (95% CI, 1.2% – 13.6%; P=0.02). Initial data from the second landmark RCT, the NEderlands-Leuvens Longkanker Screenings ONderzoek (known as the NELSON trial), have found an even greater reduction of 26% (95% CI, 9% – 41%) in lung cancer mortality, with full trial results yet to be published.(6, 7) Pooled analyses, including several smaller-scale European LDCT screening trials insufficiently powered in their own right, collectively demonstrate a statistically significant reduction in lung cancer mortality (RR 0.82, 95% CI 0.73–0.91).(8) Despite the reduction in all-cause mortality found in the NLST, pooled analyses of seven trials found no statistically significant difference in all-cause mortality (RR 0.95, 95% CI 0.90–1.00).(8) However, cancer-specific mortality is currently the most relevant outcome in cancer screening trials. These seven trials demonstrated a significantly greater proportion of early stage cancers in LDCT groups compared with controls (RR 2.08, 95% CI 1.43–3.03). Thus, when considering results across mortality outcomes and early stage cancers diagnosed, LDCT screening is considered to be clinically effective. Question 2: What is the evidence of potential harms from lung cancer screening for higher-risk individuals? The harms of LDCT lung cancer screening include false positive tests and the consequences of unnecessary invasive follow-up procedures for conditions that are eventually diagnosed as benign. While LDCT screening leads to an increased frequency of invasive procedures, it does not result in greater mortality soon after an invasive procedure (in trial settings when compared with the control arm).(8) Overdiagnosis, exposure to radiation, psychological distress and an impact on quality of life are other known harms. Systematic review evidence indicates the benefits of LDCT screening are likely to outweigh the harms. The potential harms are likely to be reduced as refinements are made to LDCT screening protocols through: i) the application of risk predication models (e.g. the PLCOm2012), which enable a more accurate selection of the high-risk population through the use of specific criteria (beyond age and smoking history); ii) the use of nodule management algorithms (e.g. Lung-RADS, PanCan), which assist in the diagnostic evaluation of screen-detected nodules and cancers (e.g. more precise volumetric assessment of nodules); and, iii) more judicious selection of patients for invasive procedures. Recent evidence suggests a positive LDCT result may transiently increase psychological distress but does not have long-term adverse effects on psychological distress or health-related quality of life (HRQoL). With regards to smoking cessation, there is no evidence to suggest screening participation invokes a false sense of assurance in smokers, nor a reduction in motivation to quit. The NELSON and Danish trials found no difference in smoking cessation rates between LDCT screening and control groups. Higher net cessation rates, compared with general population, suggest those who participate in screening trials may already be motivated to quit. Question 3: What are the main components of recent major lung cancer screening programs or trials? There are no systematic reviews that capture the main components of recent major lung cancer screening trials and programs. We extracted evidence from original studies and clinical guidance documents and organised this into key groups to form a concise set of components for potential implementation of a national lung cancer screening program in Australia: 1. Identifying the high-risk population: recruitment, eligibility, selection and referral 2. Educating the public, people at high risk and healthcare providers; this includes creating awareness of lung cancer, the benefits and harms of LDCT screening, and shared decision-making 3. Components necessary for health services to deliver a screening program: a. Planning phase: e.g. human resources to coordinate the program, electronic data systems that integrate medical records information and link to an established national registry b. Implementation phase: e.g. human and technological resources required to conduct LDCT examinations, interpretation of reports and communication of results to participants c. Monitoring and evaluation phase: e.g. monitoring outcomes across patients, radiological reporting, compliance with established standards and a quality assurance program 4. Data reporting and research, e.g. audit and feedback to multidisciplinary teams, reporting outcomes to enhance international research into LDCT screening 5. Incorporation of smoking cessation interventions, e.g. specific programs designed for LDCT screening or referral to existing community or hospital-based services that deliver cessation interventions. Most original studies are single-institution evaluations that contain descriptive data about the processes required to establish and implement a high-risk population-based screening program. Across all studies there is a consistent message as to the challenges and complexities of establishing LDCT screening programs to attract people at high risk who will receive the greatest benefits from participation. With regards to smoking cessation, evidence from one systematic review indicates the optimal strategy for incorporating smoking cessation interventions into a LDCT screening program is unclear. There is widespread agreement that LDCT screening attendance presents a ‘teachable moment’ for cessation advice, especially among those people who receive a positive scan result. Smoking cessation is an area of significant research investment; for instance, eight US-based clinical trials are now underway that aim to address how best to design and deliver cessation programs within large-scale LDCT screening programs.(9) Question 4: What is the cost-effectiveness of lung cancer screening programs (include studies of cost–utility)? Assessing the value or cost-effectiveness of LDCT screening involves a complex interplay of factors including data on effectiveness and costs, and institutional context. A key input is data about the effectiveness of potential and current screening programs with respect to case detection, and the likely outcomes of treating those cases sooner (in the presence of LDCT screening) as opposed to later (in the absence of LDCT screening). Evidence about the cost-effectiveness of LDCT screening programs has been summarised in two systematic reviews. We identified a further 13 studies—five modelling studies, one discrete choice experiment and seven articles—that used a variety of methods to assess cost-effectiveness. Three modelling studies indicated LDCT screening was cost-effective in the settings of the US and Europe. Two studies—one from Australia and one from New Zealand—reported LDCT screening would not be cost-effective using NLST-like protocols. We anticipate that, following the full publication of the NELSON trial, cost-effectiveness studies will likely be updated with new data that reduce uncertainty about factors that influence modelling outcomes, including the findings of indeterminate nodules. Gaps in the evidence There is a large and accessible body of evidence as to the effectiveness (Q1) and harms (Q2) of LDCT screening for lung cancer. Nevertheless, there are significant gaps in the evidence about the program components that are required to implement an effective LDCT screening program (Q3). Questions about LDCT screening acceptability and feasibility were not explicitly included in the scope. However, as the evidence is based primarily on US programs and UK pilot studies, the relevance to the local setting requires careful consideration. The Queensland Lung Cancer Screening Study provides feasibility data about clinical aspects of LDCT screening but little about program design. The International Lung Screening Trial is still in the recruitment phase and findings are not yet available for inclusion in this Evidence Check. The Australian Population Based Screening Framework was developed to “inform decision-makers on the key issues to be considered when assessing potential screening programs in Australia”.(10) As the Framework is specific to population-based, rather than high-risk, screening programs, there is a lack of clarity about transferability of criteria. However, the Framework criteria do stipulate that a screening program must be acceptable to “important subgroups such as target participants who are from culturally and linguistically diverse backgrounds, Aboriginal and Torres Strait Islander people, people from disadvantaged groups and people with a disability”.(10) An extensive search of the literature highlighted that there is very little information about the acceptability of LDCT screening to these population groups in Australia. Yet they are part of the high-risk population.(10) There are also considerable gaps in the evidence about the cost-effectiveness of LDCT screening in different settings, including Australia. The evidence base in this area is rapidly evolving and is likely to include new data from the NELSON trial and incorporate data about the costs of targeted- and immuno-therapies as these treatments become more widely available in Australia.