Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.

OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials. ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.

Quality improvement for cancer multidisciplinary teams: lessons learned from the Anglian Germ Cell Cancer Collaborative Group.

Shamash and colleagues describe how their supra-regional germ cell tumour multidisciplinary team achieved standardisation of treatment and improved survival. We discuss some of the insights the study provides into prioritising complex patients, streamlining processes, the use of telemedicine, and the centrality of good data collection to continuous quality improvement.

Systemness Taps the Power of Interdependence in Healthcare.

SUMMARY: While the term systemness has been used in the healthcare sector for decades, its definition varies from organization to organization. Still, the goals are consistent: to improve patient experience, lower costs, reduce risk, and provide insights into a wide range of care and management issues. Most health systems face similar challenges, such as margin enhancement, quality improvement, increased access, and fending off disruptive competition. Systemness is a way to address these challenges while improving the overall interdependence of the organization. Although embraced by and advantageous to healthcare organizations, systemness efforts often fail. The obstacles are surmountable when organizations thoroughly analyze the achievable scale of systemness, community resources, and current mindset regarding the good of the whole. Leaders must play a vital role in promoting systemness by providing education and a routine review of day-to-day organizational activities. Sometimes, systemness requires a change in leadership or an updating of leadership skills.Organizations must recognize and assess their culture as it relates to principles of independence versus interdependence, and refocus clinical standardization through best-practice protocols and policies as COVID-19 affects the already-fractured healthcare sector. Fortunately, current and developing artificial intelligence, wearables, at-home testing, and improved technologies promise to provide a needed break for a contracting physician field and fatigued front line, and they present an opportunity for those organizations poised to meet the systemness challenge.

The new Care Quality Commission inspection procedures.

Emeritus Professor Alan Glasper, from the University of Southampton, discusses recent changes to the way in which the Care Quality Commission (CQC) conducts its health and social care inspections.

Home- and Community-Based Provider Preparation for Pennsylvania's Managed Long-term Services and Supports.

As Pennsylvania implements its managed long-term services and supports program, we explore how home- and community-based providers are preparing for and perceiving the transition through an online survey. We summarize responses and conduct chi-square analysis to measure differences between select provider groups. Despite high levels of uncertainty about program impact, over 84% of respondents plan to participate. We found that providers in the first implementation phase had more strategic and operational discussions with MCOs than the other two phases (p < .03). As program rollout continues, we anticipate changes in MCO-provider conversation frequency and topics based upon implementation zone.

The central role of provider training in implementing resource-stratified guidelines for palliative care in low-income and middle-income countries: Lessons from the Jamaica Cancer Care and Research Institute in the Caribbean and Universidad Católica in Latin America.

Individuals in low-income and middle-income countries (LMICs) account for approximately two-thirds of cancer deaths worldwide, and the vast majority of these deaths occur without access to essential palliative care (PC). Although resource-stratified guidelines are being developed that take into account the actual resources available within a given country, and several components of PC are available within health care systems, PC will never improve without a trained workforce. The design and implementation of PC provider training programs is the lynchpin for ensuring that all seriously ill patients have access to quality PC services. Building on the Breast Health Global Initiative's resource-stratified recommendations for provider education in PC, the authors report on efforts by the Jamaica Cancer Care and Research Institute in the Caribbean and the Universidad Católica in successfully developing and implementing PC training programs in the Caribbean and Latin America, respectively. Key aspects of this approach include: 1) fostering strategic academic partnerships to bring additional expertise and support to the effort; 2) careful adaptation of the curriculum to the local context and culture; 3) early identification of feasible metrics to facilitate program evaluation and future outcomes research; and 4) designing PC training programs to meet local health system needs.

Impact of suspending minimum volume requirements for knee arthroplasty on hospitals in Germany: an uncontrolled before-after study.

BACKGROUND: In 2004, the Federal Joint Committee, supreme decision-making body in German healthcare, introduced minimum volume requirements (MVRQs) as a quality instrument. Since then, MVRQs were implemented for seven hospital procedures. This study evaluates the effect of a system-wide intermission of MVRQ for total knee arthroplasty (TKA), demanding 50 annual cases per hospital. METHODS: An uncontrolled before-after study based on federal-level data including the number of hospitals performing TKA, and TKA cases from the external hospital quality assurance programme in Germany (2004-2017). Bi- and multivariate analyses based on hospital-level secondary data of TKA cases and TKA quality indicators extracted from hospital quality reports in Germany (2006-2014). RESULTS: The number of TKAs performed in Germany decreased by 11% after suspending the TKA-MVRQ in 2011, and rose by 13% after its reintroduction in 2015. The number of hospitals with less than 50 cases rose from 10 to 25% and their case share from 2 to 5.5% during suspension. Change in hospital volume after the suspension of TKA-MVRQ was not associated with hospital size, ownership, or region. All four evaluable quality indicators increased significantly in the year after their first public reporting. Compared to hospitals meeting the TKA-MVRQ, three indicators show slight but statistically significant better quality in hospitals below the TKA-MVRQ. CONCLUSIONS: In Germany, TKA-MVRQs seem to induce in-hospital caseload adjustments rather than foster regional inter-hospital case transfers as intended.

Conclusion: the road ahead: where should we go now to improve healthcare quality in acute settings?

This final article in our 12-part series articulating a suite of quality improvement studies completes our report on the Deepening our Understanding of Quality in Australia (DUQuA) program of work. Here, we bring the Supplement's key findings and contributions together, tying up loose ends. Traversing the DUQuA articles, we first argued the case for the research, conducted so that an in-depth analysis of one country's health system, completed 5 years after the landmark Deepening our Understanding of Quality Improvement in Europe (DUQuE), was available. We now provide a digest of the learning from each article. Essentially, we have contributed an understanding of quality and safety activities in 32 of the largest acute settings in Australia, developed a series of scales and tools for use within Australia, modifiable for other purposes elsewhere, and provided a platform for future studies of this kind. Our main message is, despite the value of publishing an intense study of quality activities in 32 hospitals in one country, there is no gold standard, one-size-fits-all methodology or guarantee of success in quality improvement activities, whether the initiatives are conducted at departmental, organization-wide or whole-of-systems levels. Notwithstanding this, armed with the tools, scales and lessons from DUQuA, we hope we have provided many more options and opportunities for others going about strengthening their quality improvement activities, but we do not claim to have solved all problems or provided a definitive approach. In our view, quality improvement initiatives are perennially challenging, and progress hard-won. Effective measurement, evaluating progress over time, selecting a useful suite of quality methods and having the persistence to climb the improvement gradient over time, using all the expertise and tools available, is at the core of the work of quality improvement and will continue to be so.

Bending the quality curve.

With this paper, we initiate the Supplement on Deepening our Understanding of Quality in Australia (DUQuA). DUQuA is an at-scale, cross-sectional research programme examining the quality activities in 32 large hospitals across Australia. It is based on, with suitable modifications and extensions, the Deepening our Understanding of Quality improvement in Europe (DUQuE) research programme, also published as a Supplement in this Journal, in 2014. First, we briefly discuss key data about Australia, the health of its population and its health system. Then, to provide context for the work, we discuss previous activities on the quality of care and improvement leading up to the DUQuA studies. Next, we present a selection of key interventional studies and policy and institutional initiatives to date. Finally, we conclude by outlining, in brief, the aims and scope of the articles that follow in the Supplement. This first article acts as a framing vehicle for the DUQuA studies as a whole. Aggregated, the series of papers collectively attempts an answer to the questions: what is the relationship between quality strategies, both hospital-wide and at department level? and what are the relationships between the way care is organised, and the actual quality of care as delivered? Papers in the Supplement deal with a multiplicity of issues including: how the DUQuA investigators made progress over time, what the results mean in context, the scales designed or modified along the way for measuring the quality of care, methodological considerations and provision of lessons learnt for the benefit of future researchers.

Using accreditation surveyors to conduct health services research: a qualitative, comparative study in Australia.

OBJECTIVE: Healthcare accreditation surveyors are well positioned to gain access to hospitals and apply their existing data collection skills to research. Consequently, we contracted and trained a surveyor cohort to collect research data for the Deepening our Understanding of Quality in Australia (DUQuA) project. The aim of this study is to explore and compare surveyors' perceptions and experiences in collecting quality and safety data for accreditation and for health services research. DESIGN: A qualitative, comparative study. SETTING AND PARTICIPANTS: Ten surveyors participated in semi-structured interviews, which were audio recorded, transcribed and coded using Nvivo11. Interview transcripts of participants were analysed thematically and separately, providing an opportunity for comparison and for identifying common themes and subthemes. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Topics addressed data collection for healthcare accreditation and research, including preparation and training, structure, organization, attitudes and behaviours of staff and perceptions of their role. RESULTS: Five themes and ten subthemes emerged from the interviews: (1) overlapping facilitators for accreditation and research data collection, (2) accreditation-specific facilitators, (3) overlapping barriers for accreditation and research data collection, (4) research data collection-specific barriers and (5) needs and recommendations. Subthemes were (1.1) preparation and training availability, (1.2) prior knowledge and experiences; (2.1) ease of access, (2.2) high staff engagement, (3.1) time, (4.1) poor access and structure, (4.2) lack of staff engagement, (4.3) organizational changes; (5.1) short-notice accreditation and (5.2) preparation for future research. CONCLUSIONS: Although hospital accreditation and research activities require different approaches to data collection, we found that suitably trained accreditation surveyors were able to perform both activities effectively. The barriers surveyors encountered when collecting data for research provide insight into the challenges that may be faced when visiting hospitals for short-notice accreditation.

Deepening our Understanding of Quality in Australia (DUQuA): An overview of a nation-wide, multi-level analysis of relationships between quality management systems and patient factors in 32 hospitals.

OBJECTIVE: The Deepening our Understanding of Quality in Australia (DUQuA) project is a multisite, multi-level, cross-sectional study of 32 of the largest hospitals in Australia. This overview examines relationships between (i) organization-level quality management systems and department-level quality management strategies and (ii) patient-level measures (clinical treatment processes, patient-reported perceptions of care and clinical outcomes) within Australian hospitals. DESIGN: We examined hospital quality improvement structures, processes and outcomes, collecting data at organization, department and patient levels for acute myocardial infarction (AMI), hip fracture and stroke. Data sources included surveys of quality managers, clinicians and patients, hospital visits, medical record reviews and national databases. Outcomes data and patient admissions data were analysed. Relationships between measures were evaluated using multi-level models. We based the methods on the Deepening our Understanding of Quality Improvement in Europe (DUQuE) framework, extending that work in parts and customizing the design to Australian circumstances. SETTING, PARTICIPANTS AND OUTCOME MEASURES: The 32 hospitals, containing 119 participating departments, provided wide representation across metropolitan, inner and outer regional Australia. We obtained 31 quality management, 1334 clinician and 857 patient questionnaires, and conducted 2401 medical record reviews and 151 external assessments. External data via a secondary source comprised 14 460 index patient admissions across 14 031 individual patients. Associations between hospital, Emergency Department (ED) and department-level systems and strategies and five patient-level outcomes were assessed: 19 of 165 associations (11.5%) were statistically significant, 12 of 79 positive associations (15.2%) and 7 of 85 negative associations (8.2%). RESULTS: We did not find clear relationships between hospital-level quality management systems, ED or department quality strategies and patient-level outcomes. ED-level clinical reviews were related to adherence to clinical practice guidelines for AMI, hip fracture and stroke, but in different directions. The results, when considered alongside the DUQuE results, are suggestive that front line interventions may be more influential than department-level interventions when shaping quality of care and that multi-pronged strategies are needed. Benchmark reports were sent to each participating hospital, stimulating targeted quality improvement activities. CONCLUSIONS: We found no compelling relationships between the way care is organized and the quality of care across three targeted patient-level outcome conditions. The study was cross-sectional, and thus we recommend that the relationships studied should be assessed for changes across time. Tracking care longitudinally so that quality improvement activities are monitored and fed back to participants is an important initiative that should be given priority as health systems strive to develop their capacity for quality improvement over time.

Do organization-level quality management systems influence department-level quality? A cross-sectional study across 32 large hospitals in Australia.

OBJECTIVE: Little is known about the influence that hospital quality systems have on quality at department level, in Australia and elsewhere. This study assessed the relationships between organizational-level quality management systems, and the extent to which hospital-level quality management systems and department-level quality management strategies are related. DESIGN: A multi-level, cross-sectional, mixed-method study. SETTING AND PARTICIPANTS: As part of the Deepening our Understanding of Quality in Australia (DUQuA) project, we invited all large hospitals in Australia (~200 or more beds) which provided acute myocardial infarction (AMI), hip fracture and stroke care. The quality managers of these hospitals were the respondents for one of seven measures of hospital quality management systems and strategies. Data across the six remaining measures were collected through site visits by external surveyors assessing the participating hospitals. MAIN OUTCOME MEASURES: Relationships were assessed between three organization-level quality management system measures: a self-report measure assessing organization-level quality activities (quality management systems index, QMSI); externally assessed organization-level compliance to procedures used to plan, monitor and improve quality of care (quality management compliance index, QMCI); and externally assessed implementation of quality systems (clinical quality implementation index, CQII). Associations were also assessed between organization-level quality management systems and department-level quality management strategies: how clinical responsibilities are assigned for a particular condition; whether department organization processes are organized to facilitate evidence-based care recommendations; compliance with selected recommendations of international agencies; and whether clinical reviews are performed systematically. RESULTS: Of 78 invited hospitals, 32 participated in the study. QMSI was positively associated with QMCI and CQII, but after controlling for QMSI, no relationship was found between QMCI and CQII. There appears to be a cluster of relationships between QMSI and department-level measures, but this was not consistent across all departments. CONCLUSION: This is the first national study undertaken in Australia to assess relationships within and between organization-level and department-level quality management systems. These quality management system tools align with many components of accreditation standards and may be useful for hospitals in continuously monitoring and driving improvement.

Do quality management systems influence clinical safety culture and leadership? A study in 32 Australian hospitals.

OBJECTIVE: This study aimed to explore the associations between the organization-level quality arrangements, improvement and implementation and department-level safety culture and leadership measures across 32 large Australian hospitals. DESIGN: Quantitative observational study, using linear and multi-level modelling to identify relationships between quality management systems and clinician safety culture and leadership. SETTING: Thirty-two large Australian public hospitals. PARTICIPANTS: Quality audit at organization level, senior quality manager at each participating hospital, 1382 clinicians (doctors, nurses and allied health professionals). MAIN OUTCOME MEASURES: Associations between organization-level quality measures and department-level clinician measures of teamwork climate, safety climate and leadership for acute myocardial infarction (AMI), hip fracture and stroke treatment conditions. RESULTS: We received 1332 valid responses from participants. The quality management systems index (QMSI, a questionnaire-based measure of the hospitals' quality management structures) was 'positively' associated with all three department-level scales in the stroke department, with safety culture and leadership in the emergency department, but with none of the three scales in the AMI and hip fracture departments. The quality management compliance index (QMCI, an external audit-based measure of the quality improvement activities) was 'negatively' associated with teamwork climate and safety climate in AMI departments, after controlling for QMSI, but not in other departments. There was no association between QMCI and leadership in any department, after controlling for QMSI, and there was no association between the clinical quality implementation index (CQII, an external audit-based measure of the level of implementation of quality activities) and any of the three department-level scales in any of the four departments, after controlling for both QMSI and QMCI. CONCLUSIONS: The influence of organization-level quality management systems on clinician safety culture and leadership varied depending on the hospital department, suggesting that whilst there was some consistency on patient safety attitudes and behaviours throughout the organizations, there were also other factors at play.

Organization quality systems and department-level strategies: refinement of the Deepening our Understanding in Quality in Australia (DUQuA) organization and department-level scales.

OBJECTIVE: The aim of this study was to develop and refine indices to measure organization and care pathway-level quality management systems in Australian hospitals. DESIGN: A questionnaire survey and audit tools were derived from instruments validated as part of the Deepening Our Understanding of Quality improvement in Europe (DUQuE) study, adapted for Australian hospitals through expert opinion. Statistical processes were used to explore the factor structure, reliability and non-redundancy and descriptive statistics of the scales. SETTING: Thirty-two large Australian public hospitals. PARTICIPANTS: Audit of quality management processes at organization-level and care pathway processes at department level for three patient conditions (acute myocardial infarction (AMI), hip fracture and stroke) and senior quality manager, at each of the 32 participating hospitals. MAIN OUTCOME MEASURE(S): The degree of quality management evident at organization and care pathway levels. RESULTS: Analysis yielded seven quality systems and strategies scales. The three hospital-level measures were: the Quality Management Systems Index (QMSI), the Quality Management Compliance Index (QMCI) and the Clinical Quality Implementation Index (CQII). The four department-level measures were: Specialised Expertise and Responsibility (SER), Evidence-Based Organisation of Pathways (EBOP), Patient Safety Strategies (PSS) and Clinical Review (CR). For QMCI, and for seven out of eight subscales in QMSI, adequate internal consistency (Cronbach's $\alpha$ >0.8) was achieved. For CQII, lack of variation and ceiling effects in the data resulted in very low internal consistency scores, but items were retained for theoretical reasons. Internal consistency was high for CR (Cronbach's $\alpha$ 0.74-0.88 across the three conditions), and this was supported by all item-total correlations exceeding the desired threshold. For EBOP, Cronbach's $\alpha$ was acceptable for hip fracture (0.80) and stroke (0.76), but only moderate for AMI (0.52). PSS and SER scales were retained for theoretical reasons, although internal consistencies were only moderate (SER) to poor (PSS). CONCLUSIONS: The Deepening our Understanding of Quality in Australia (DUQuA) organization and department scales can be used by Australian hospital managers to assess and measure improvement in quality management at organization and department levels within their hospitals and are readily modifiable for other health systems depending on their needs.

The Mayo Clinic Hospital Mortality Reduction Project: Description and Results.

EXECUTIVE SUMMARY: Quality improvement, regulatory, and payer organizations use various definitions of hospital mortality as clinical outcome measures. In this prospective study, the authors evaluated a multicomponent intervention aimed at reducing inpatient mortality in a multistate healthcare delivery system. The project was initiated because of a statistically nonsignificant upward trend in mortality suggested by a six-quarter rise in the observed/expected mortality ratio generated by the Vizient Clinical Data Base and Resource Manager. The design of the mortality reduction plan was influenced by the known limitations of using hospital-wide mortality as a quality improvement measure. The primary objective was to reduce mortality through focused care redesign. The project leadership team attempted to implement standardized system-wide improvements while allowing individual hospitals to simultaneously pursue site-specific practice redesign opportunities. Between Q3, 2015, and Q4, 2017, system-wide mortality reduced from 1.78 to 1.53 (per 100 admissions; p = .01). The actual plan implemented in Mayo Clinic's hospitals is included as Appendix A to this article, published online as Supplemental Digital Content. The authors included it to allow comparison with similar efforts at other healthcare systems, as well as to stimulate criticism and discussion by readers.

Bureaucracy and the balanced scorecard in health care settings.

PURPOSE: We explore the relationship between the balanced scorecard (BSC) and neo-bureaucracy by investigating whether the operationalization of the BSC incorporates "neo-bureaucratic" ideas and whether the BSC implemented in a Portuguese Local Health Unit (LHU) demonstrates a neo-bureaucratic approach. DESIGN/METHODOLOGY/APPROACH: We conduct semi-structured interviews with LHU staff and analyse documents to assess whether features of bureaucratic organization were evident in the use of a BSC by the LHU. FINDINGS: We found nine bureaucratic features evident in the LHU's BSC. These were systematization, rationality, authority, jurisdiction, professional qualification, knowledge, discipline, transparency and accountability. The BSC used at the LHU demonstrated a neo-bureaucratic approach. ORIGINALITY/VALUE: Our study helps to demystify bureaucracy and overcome prevailing prejudices regarding some of its principles. Health care managers should recognize and endorse neo-bureaucratic principles in developing a BSC. They should recognize the BSC as involving a neo-bureaucratic approach. The BSC is a valuable management tool that hospital managers should find useful in fostering flexibility, collaboration, innovation and adaptation - all of which should help lead to improved healthcare outcomes.

Healthcare regulators' responses to the COVID-19 pandemic.

Professor Alan Glasper, from the University of Southampton, discusses how the Care Quality Commission and the Nursing and Midwifery Council are working during the COVID-19 pandemic.

Health systems preparedness for COVID-19 pandemic.

Some nations in the world and some states in India have had more success in containing this pandemic. Recent efforts in strengthening the health sector have focused largely on reforms in modes of financing, but as the pandemic brings home to us, the main challenge in India remains the challenge of the organization of public services using a health systems understanding. A close to community comprehensive primary health care, quality assurance, and planned excess capacity in public health systems, a more robust disease surveillance systems that can integrate data on new outbreaks and the indigenous technological capacity to scale up innovation and manufacture of essential health commodities are some of our most important requirements for both epidemic preparedness and response.

Progress in clinical research in surgery and IDEAL.

The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement in the quality of surgical evidence would therefore be valuable. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations specify desirable qualities for surgical studies, and outline an integrated evaluation pathway for surgery, and similar complex interventions. We used the IDEAL Recommendations to assess methodological progress in surgical research over time, assessed the uptake and influence of IDEAL, and identified the challenges to further methodological progress. Comparing studies from the periods 2000-04 and 2010-14, we noted apparent improvement in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves, but no progress in the use of qualitative research or reporting of modifications during procedure development. Better education about research, integration of rigorous evaluation into routine practice and training, and linkage of such work to awards systems could foster further improvements in surgical evidence. IDEAL has probably contributed only slightly to the improvements described to date, but its uptake is accelerating rapidly. The need for the integrated evaluation template IDEAL offers for surgery and other complex treatments is becoming more widely accepted.

Practical Guidance to Implementing Quality Management Systems in Public Health Laboratories Performing Next-Generation Sequencing: Personnel, Equipment, and Process Management (Phase 1).

Quality standards as part of an effective quality management system (QMS) are the cornerstone for generating high-quality test results. Next-generation sequencing (NGS) has the potential to improve both clinical diagnostics and public health surveillance efforts in multiple areas, including infectious diseases. However, the laboratories adopting NGS methods face significant challenges due to the complex and modular process design. This document summarizes the first phase of quality system guidance developed by the Centers for Disease Control and Prevention (CDC) NGS Quality Workgroup. The quality system essentials of personnel, equipment, and process management (quality control and validation) were prioritized based on a risk assessment using information gathered from participating CDC laboratories. Here, we present a prioritized QMS framework, including procedures and documentation tools, to assist laboratory implementation and maintenance of quality practices for NGS workflows.