A purple patch for evidence-based health policy?

The global focus on nation states' responses to the COVID-19 pandemic has rightly highlighted the importance of science and evidence as the basis for policy action. Those with a lifelong passion for evidence-based policy (EBP) have lauded Australia's and other nations' policy responses to COVID-19 as a breakthrough moment for the cause. This article reflects on the complexity of the public policy process, the perspectives of its various actors, and draws on Alford's work on the Blue, Red and Purple zones to propose a more nuanced approach to advocacy for EBP in health. We contend that the pathway for translation of research evidence into routine clinical practice is relatively linear, in contrast to the more complex course for translation of evidence to public policy - much to the frustration of health researchers and EBP advocates. Cairney's description of the characteristics of successful policy entrepreneurs offers useful guidance to advance EBP and we conclude with proposing some practical mechanisms to support it. Finally, we recommend that researchers and policy makers spend more time in the Purple zone to enable a deeper understanding of, and mutual respect for, the unique contributions made by research, policy and political actors to sound public policy.

A Dual-Antigen Enzyme-Linked Immunosorbent Assay Allows the Assessment of Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Seroprevalence in a Low-Transmission Setting.

Estimates of seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies have been hampered by inadequate assay sensitivity and specificity. Using an enzyme-linked immunosorbent assay-based approach that combines data about immunoglobulin G responses to both the nucleocapsid and spike receptor binding domain antigens, we show that excellent sensitivity and specificity can be achieved. We used this assay to assess the frequency of virus-specific antibodies in a cohort of elective surgery patients in Australia and estimated seroprevalence in Australia to be 0.28% (95% Confidence Interval, 0-1.15%). These data confirm the low level of transmission of SARS-CoV-2 in Australia before July 2020 and validate the specificity of our assay.

Measuring the migration of surgical specialists.

BACKGROUND: The lack of access to essential surgical care in low-income countries is aggravated by emigration of locally-trained surgical specialists to more affluent regions. Yet, the global diaspora of surgeons, obstetricians, and anesthesiologists from low-income and middle-income countries has never been fully described and compared with those who have remained in their country of origin. It is also unclear whether the surgical workforce is more affected by international migration than other medical specialists. In this study, we aimed to quantify the proportion of surgical specialists originating from low-income and middle-income countries that currently work in high-income countries. METHODS: We retrieved surgical workforce data from 48 high-income countries and 102 low-income and middle-income countries using the database of the World Health Organization Global Surgical Workforce. We then compared this domestic workforce with more granular data on the country of initial medical qualification of all surgeons, anesthesiologists, and obstetricians made available for 14 selected high-income countries to calculate the proportion of surgical specialists working abroad. RESULTS: We identified 1,118,804 specialist surgeons, anesthesiologists, or obstetricians from 102 low-income and middle-income countries, of whom 33,021 (3.0%) worked in the 14 included high-income countries. The proportion of surgical specialists abroad was greatest for the African and South East Asian regions (12.8% and 12.1%). The proportion of specialists abroad was not greater for surgeons, anesthesiologists, or obstetricians than for physicians and other medical specialists (P = .465). Overall, the countries with the lowest remaining density of surgical specialists were also the countries from which the largest proportion of graduates were now working in high-income countries (P = .011). CONCLUSION: A substantial proportion of all surgeons, anesthesiologists, and obstetricians from low-income and middle-income countries currently work in high-income countries. In addition to decreasing migration from areas of surgical need, innovative strategies to retain and strengthen the surgical workforce could involve engaging this large international pool of surgical specialists and instructors.

Economic evaluation of the NET intervention versus guideline dissemination for management of mild head injury in hospital emergency departments.

BACKGROUND: Evidence-based guidelines for the management of mild traumatic brain injury (mTBI) in the emergency department (ED) are now widely available, and yet, clinical practice remains inconsistent with the guidelines. The Neurotrauma Evidence Translation (NET) intervention was developed to increase the uptake of guideline recommendations and improve the management of minor head injury in Australian emergency departments (EDs). However, the adoption of this type of intervention typically entails an upfront investment that may or may not be fully offset by improvements in clinical practice, health outcomes and/or reductions in health service utilisation. The present study estimates the cost and cost-effectiveness of the NET intervention, as compared to the passive dissemination of the guideline, to evaluate whether any improvements in clinical practice or health outcomes due to the NET intervention can be obtained at an acceptable cost. METHODS AND FINDINGS: Study setting: The NET cluster randomised controlled trial [ACTRN12612001286831]. STUDY SAMPLE: Seventeen EDs were randomised to the control condition and 14 to the intervention. One thousand nine hundred forty-three patients were included in the analysis of clinical practice outcomes (NET sample). A total of 343 patients from 14 control and 10 intervention EDs participated in follow-up interviews and were included in the analysis of patient-reported health outcomes (NET-Plus sample). OUTCOME MEASURES: Appropriate post-traumatic amnesia (PTA) screening in the ED (primary outcome). Secondary clinical practice outcomes: provision of written information on discharge (INFO) and safe discharge (defined as CT scan appropriately provided plus PTA plus INFO). Secondary patient-reported, post-discharge health outcomes: anxiety (Hospital Anxiety and Depression Scale), post-concussive symptoms (Rivermead), and preference-based health-related quality of life (SF6D). METHODS: Trial-based economic evaluations from a health sector perspective, with time horizons set to coincide with the final follow-up for the NET sample (2 months post-intervention) and to 1-month post-discharge for the NET-Plus sample. RESULTS: Intervention and control groups were not significantly different in health service utilisation received in the ED/inpatient ward following the initial mTBI presentation (adjusted mean difference $23.86 per patient; 95%CI - $106, $153; p = 0.719) or over the longer follow-up in the NET-plus sample (adjusted mean difference $341.78 per patient; 95%CI - $58, $742; p = 0.094). Savings from lower health service utilisation are therefore unlikely to offset the significantly higher upfront cost of the intervention (mean difference $138.20 per patient; 95%CI $135, $141; p < 0.000). Estimates of the net effect of the intervention on total cost (intervention cost net of health service utilisation) suggest that the intervention entails significantly higher costs than the control condition (adjusted mean difference $169.89 per patient; 95%CI $43, $297, p = 0.009). This effect is larger in absolute magnitude over the longer follow-up in the NET-plus sample (adjusted mean difference $505.06; 95%CI $96, $915; p = 0.016), mostly due to additional health service utilisation. For the primary outcome, the NET intervention is more costly and more effective than passive dissemination; entailing an additional cost of $1246 per additional patient appropriately screened for PTA ($169.89/0.1363; Fieller's 95%CI $525, $2055). For NET to be considered cost-effective with 95% confidence, decision-makers would need to be willing to trade one quality-adjusted life year (QALY) for 25 additional patients appropriately screened for PTA. While these results reflect our best estimate of cost-effectiveness given the data, it is possible that a NET intervention that has been scaled and streamlined ready for wider roll-out may be more or less cost-effective than the NET intervention as delivered in the trial. CONCLUSIONS: While the NET intervention does improve the management of mTBI in the ED, it also entails a significant increase in cost and-as delivered in the trial-is unlikely to be cost-effective at currently accepted funding thresholds. There may be a scope for a scaled-up and streamlined NET intervention to achieve a better balance between costs and outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001286831 , date registered 12 December 2012.

Systematic Review of the Volume-Outcome Relationship for Radical Prostatectomy.

CONTEXT: Radical prostatectomy (RP) is one of the most complex urological procedures performed. Higher surgical volume has been found previously to be associated with better patient outcomes and reduced costs to the health care system. This has resulted in some regionalization of care toward high-volume facilities and providers; however, the preponderance of RPs is still performed at low-volume institutions. OBJECTIVE: To provide an updated systematic review of the association of hospital and surgeon volume on patient and system outcomes after RP, including robot-assisted RP. EVIDENCE ACQUISITION: A systematic review of literature was undertaken, searching PubMed (1959-2016) for original articles. Selection criteria included RP, hospital and/or surgeon volumes as predictor variables, categorization of hospital and/or surgeon volumes, and measurable end points. EVIDENCE SYNTHESIS: Overall 49 publications fulfilled the inclusion criteria. Most of the studies demonstrated that higher-volume surgeries are associated with better outcomes including reduced mortality, morbidity, postoperative complications, length of stay, readmission, and cost-associated factors. The volume-outcome relationship is maintained in robotic surgery. Eleven studies assessed hospital and surgeon volume simultaneously, and findings reflect that neither is an independent predictor variable affecting outcomes. The studies varied in how volume cutoffs were categorized as well as how the volume-outcome relationship was methodologically evaluated. CONCLUSIONS: Contemporary evidence continues to support the relationship between high-volume surgeries with improved RP outcomes. Recent studies demonstrate that the volume-outcome relationship applies to robot-assisted RP and may be applied for potential cost savings in health care. An increase in the number of international studies suggests reproducibility of the association. Although regionalization of surgical care remains a contentious issue, there is an increasing body of evidence that short-term outcomes are improved at high-volume centers for RP. PATIENT SUMMARY: This systematic review of the latest literature found that higher surgical volume was associated with improved outcomes for radical prostatectomy.

Implementation of the World Health Organization Trauma Care Checklist Program in 11 Centers Across Multiple Economic Strata: Effect on Care Process Measures.

BACKGROUND: Trauma contributes more than ten percent of the global burden of disease. Initial assessment and resuscitation of trauma patients often requires rapid diagnosis and management of multiple concurrent complex conditions, and errors are common. We investigated whether implementing a trauma care checklist would improve care for injured patients in low-, middle-, and high-income countries. METHODS: From 2010 to 2012, the impact of the World Health Organization (WHO) Trauma Care Checklist program was assessed in 11 hospitals using a stepped wedge pre- and post-intervention comparison with randomly assigned intervention start dates. Study sites represented nine countries with diverse economic and geographic contexts. Primary end points were adherence to process of care measures; secondary data on morbidity and mortality were also collected. Multilevel logistic regression models examined differences in measures pre- versus post-intervention, accounting for patient age, gender, injury severity, and center-specific variability. RESULTS: Data were collected on 1641 patients before and 1781 after program implementation. Patient age (mean 34 ± 18 vs. 34 ± 18), sex (21 vs. 22 % female), and the proportion of patients with injury severity scores (ISS) ≥ 25 (10 vs. 10 %) were similar before and after checklist implementation (p > 0.05). Improvement was found for 18 of 19 process measures, including greater odds of having abdominal examination (OR 3.26), chest auscultation (OR 2.68), and distal pulse examination (OR 2.33) (all p < 0.05). These changes were robust to several sensitivity analyses. CONCLUSIONS: Implementation of the WHO Trauma Care Checklist was associated with substantial improvements in patient care process measures among a cohort of patients in diverse settings.

Bellwether Procedures for Monitoring and Planning Essential Surgical Care in Low- and Middle-Income Countries: Caesarean Delivery, Laparotomy, and Treatment of Open Fractures.

BACKGROUND: Surgical conditions represent a significant proportion of the global burden of disease, and therefore, surgery is an essential component of health systems. Achieving universal health coverage requires effective monitoring of access to surgery. However, there is no widely accepted standard for the required capabilities of a first-level hospital. We aimed to determine whether a group of operations could be used to describe the delivery of essential surgical care. METHODS: We convened an expert panel to identify procedures that might indicate the presence of resources needed to treat an appropriate range of surgical conditions at first-level hospitals. Using data from the World Health Organization Emergency and Essential Surgical Care Global database, collected using the WHO Situational Analysis Tool (SAT), we analysed whether the ability to perform each of these procedures-which we term "bellwether procedures"-was associated with performing a full range of essential surgical procedures. FINDINGS: The ability to perform caesarean delivery, laparotomy, and treatment of open fracture was closely associated with performing all obstetric, general, basic, emergency, and orthopaedic procedures (p < 0.001) in the population that responded to the WHO SAT Survey. Procedures including cleft lip, cataract, and neonatal surgery did not correlate with performing the bellwether procedures. INTERPRETATION: Caesarean delivery, laparotomy, and treatment of open fractures should be standard procedures performed at first-level hospitals. With further validation in other populations, local managers and health ministries may find this useful as a benchmark for what first-level hospitals can and should be able to perform on a 24/7 basis in order to ensure delivery of emergency and essential surgical care to their population. Those procedures which did not correlate with the bellwether procedures can be referred to a specialized centre or collected for treatment by a visiting specialist team.

Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate.

BACKGROUND: Surgery is a foundational component of health-care systems. However, previous efforts to integrate surgical services into global health initiatives do not reflect the scope of surgical need and many health systems do not provide essential interventions. We estimate the minimum global volume of surgical need to address prevalent diseases in 21 epidemiological regions from the Global Burden of Disease Study 2010 (GBD). METHODS: Prevalence data were obtained from GBD 2010 and organised into 119 disease states according to the WHO's Global Health Estimate (GHE). These data, representing 187 countries, were then apportioned into the 21 GBD epidemiological regions. Using previously defined values for the incident need for surgery for each of the 119 GHE disease states, we calculate minimum global need for surgery based on the prevalence of each condition in each region. FINDINGS: We estimate that at least 321·5 million surgical procedures would be needed to address the burden of disease for a global population of 6·9 billion in 2010. Minimum rates of surgical need vary across regions, ranging from 3383 operations per 100 000 in central Latin America to 6495 operations per 100 000 in western sub-Saharan Africa. Global surgical need also varied across subcategories of disease, ranging from 131 412 procedures for nutritional deficiencies to 45·8 million procedures for unintentional injuries. INTERPRETATION: The estimated need for surgical procedures worldwide is large and addresses a broad spectrum of disease states. Surgical need varies between regions of the world according to disease prevalence and many countries do not meet the basic needs of their populations. These estimates could be useful for policy makers, funders, and ministries of health as they consider how to incorporate surgical capacity into health systems. FUNDING: US National Institutes of Health.

Perioperative mortality rate (POMR): a global indicator of access to safe surgery and anaesthesia.

INTRODUCTION: The unmet global burden of surgical disease is substantial. Currently, two billion people do not have access to emergency and essential surgical care. This results in unnecessary deaths from injury, infection, complications of pregnancy, and abdominal emergencies. Inadequately treated surgical disease results in disability, and many children suffer deformity without corrective surgery. METHODS: A consensus meeting was held between representatives of Surgical and Anaesthetic Colleges and Societies to obtain agreement about which indicators were the most appropriate and credible. The literature and state of national reporting of perioperative mortality rates was reviewed by the authors. RESULTS: There is a need for a credible national and/or regional indicator that is relevant to emergency and essential surgical care. We recommend introducing the perioperative mortality rate (POMR) as an indicator of access to and safety of surgery and anaesthesia. POMR should be measured at two time periods: death on the day of surgery and death before discharge from hospital or within 30 days of the procedure, whichever is sooner. The rate should be expressed as the number of deaths (numerator) over the number of procedures (denominator). The option of before-discharge or 30 days is practical for those low- to middle-income countries where postdischarge follow-up is likely to be incomplete, but it allows those that currently can report 30-day mortality rates to continue to do so. Clinical interpretation of POMR at a hospital or health service level will be facilitated by risk stratification using age, urgency (elective and emergency), procedure/procedure group, and the American Society of Anesthesiologists grade. CONCLUSIONS: POMR should be reported as a health indicator by all countries and regions of the world. POMR reporting is feasible, credible, achieves a consensus of acceptance for reporting at national level. Hospital and Service level POMR requires interpretation using simple measures of risk adjustment such as urgency, age, the condition being treated or the procedure being performed and ASA status.

Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial.

BACKGROUND: Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. METHODS/DESIGN: The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).

Prevention and self-management interventions are top priorities for osteoarthritis systematic reviews.

OBJECTIVE: To identify high-priority research questions for osteoarthritis systematic reviews with consideration of health equity and the social determinants of health (SDH). STUDY DESIGN AND SETTING: We consulted with experts and conducted a literature search to identify a priority-setting method that could be adapted to address the health equity and SDH. We selected the Global Evidence Mapping priority-setting method, and through consultations and consensus, we adapted the method to meet our objectives. This involves developing an evidence map of the existing systematic reviews on osteoarthritis; conducting one face-to-face workshop with patients and another one with clinicians, researchers, and patients; and conducting an online survey of patients to rank the top 10 research questions. We piloted the adapted method with the Cochrane Musculoskeletal Review Group to set research priorities for osteoarthritis. RESULTS: Our focus was on systematic reviews: we identified 34 high-priority research questions for osteoarthritis systematic reviews. Prevention and self-management interventions, mainly diet and exercise, are top priorities for osteoarthritis systematic reviews. Evaluation against our predefined objectives showed that this method did prioritize SDH (50% of the research questions considered SDH). There were marked gaps: no high-priority topics were identified for access to care until patients had advanced disease-lifestyle changes once the disease was diagnosed. This method was felt feasible if conducted annually. CONCLUSION: We confirmed the utility of an adapted priority-setting method that is feasible and considers SDH. Further testing of this method is needed to assess whether considerations of health equity are prioritized and involve disadvantaged groups of the population.

Australian health policy makers' priorities for research synthesis: a survey.

OBJECTIVES: Health policy making is complex, but can be informed by evidence of what works, including systematic reviews. We aimed to inform the work of the Cochrane Effective Practice and Organisation of Care (EPOC) Group by identifying systematic review topics relevant to Australian health policy makers and exploring whether existing Cochrane reviews address these topics. METHODS: We interviewed 30 senior policy makers from State and Territory Government Departments of Health to identify topics considered important for systematic reviews within the scope of health services research, including professional, financial, organisational and regulatory interventions to improve professional practice and the organisation of services. We then looked for existing Cochrane reviews relevant to these topics. RESULTS: Eighty-five priority topics were identified by policy makers, including advanced practice roles, care for Indigenous Australians, care for chronic disease, coordinating across jurisdictions, admission avoidance, and eHealth. Sixty published Cochrane reviews address these issues, and 34 additional reviews are in progress. Thirty-four topics are yet to be addressed. CONCLUSIONS: This survey has identified questions for which Australian policy makers have indicated a need for systematic reviews. Further, it has confirmed that existing reviews do address issues of importance to policy makers, with the potential to inform policy processes.

When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints.

OBJECTIVE: To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent. DESIGN AND SETTING: Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008. MAIN OUTCOME MEASURES: Case frequency (by medical specialty), type of allegation, type of treatment. RESULTS: A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types - procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) - accounted for 46% of all cases. CONCLUSIONS: The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

Supporting the use of health technology assessments in policy making about health systems.

OBJECTIVES: The objective of this study is to profile the health technology assessments (HTAs) produced in Canada and other selected countries and assess their potential to inform policy making about health systems in jurisdictions other than the ones for which they were produced, and to develop and pilot test prototypes for packaging and assessing the relevance of HTAs for health system managers and policy makers. METHODS: We compiled an inventory of all HTAs that were produced by nine HTA agencies between September 2003 and August 2006; coded the title and abstract of each HTA according to the technologies assessed, methods used, and whether or not context-specific actionable messages were provided; developed a prototype for a structured, decision-relevant HTA summary and for a relevance-assessment form; and pilot-tested the prototypes using semistructured telephone interviews with a purposive sample of Canadian healthcare managers and policy makers. RESULTS: Our review of the 223 HTAs identified that: (i) 44 HTAs addressed health system arrangements (20 percent); (ii) 205 incorporated a systematic review (92 percent), whereas only 12 incorporated a sociopolitical assessment using explicit methods (5 percent); and (iii) 50 contained context-specific actionable messages (22 percent). Our interviews identified significant support for both the general idea of an HTA summary and the prototype's specific elements, but mixed views about using peer assessments of relevance. CONCLUSIONS: Those involved in supporting the use of HTAs in policy making about health systems may wish to produce structured decision-relevant summaries for their systematic review-containing HTAs to increase the prospects for their HTAs being used outside the jurisdiction for which they were produced.

Sustainability science: an integrated approach for health-programme planning.

Planning for programme sustainability is a key contributor to health and development, especially in low-income and middle-income countries. A consensus evidence-based operational framework would facilitate policy and research advances in understanding, measuring, and improving programme sustainability. We did a systematic review of both conceptual frameworks and empirical studies about health-programme sustainability. On the basis of the review, we propose that sustainable health programmes are regarded as complex systems that encompass programmes, health problems targeted by programmes, and programmes' drivers or key stakeholders, all of which interact dynamically within any given context. We show the usefulness of this approach with case studies drawn from the authors' experience.