Connecting artificial intelligence and primary care challenges: findings from a multi stakeholder collaborative consultation.

Despite widespread advancements in and envisioned uses for artificial intelligence (AI), few examples of successfully implemented AI innovations exist in primary care (PC) settings. OBJECTIVES: To identify priority areas for AI and PC in Ontario, Canada. METHODS: A collaborative consultation event engaged multiple stakeholders in a nominal group technique process to generate, discuss and rank ideas for how AI can support Ontario PC. RESULTS: The consultation process produced nine ranked priorities: (1) preventative care and risk profiling, (2) patient self-management of condition(s), (3) management and synthesis of information, (4) improved communication between PC and AI stakeholders, (5) data sharing and interoperability, (6-tie) clinical decision support, (6-tie) administrative staff support, (8) practitioner clerical and routine task support and (9) increased mental healthcare capacity and support. Themes emerging from small group discussions about barriers, implementation issues and resources needed to support the priorities included: equity and the digital divide; system capacity and culture; data availability and quality; legal and ethical issues; user-centred design; patient-centredness; and proper evaluation of AI-driven tool implementation. DISCUSSION: Findings provide guidance for future work on AI and PC. There are immediate opportunities to use existing resources to develop and test AI for priority areas at the patient, provider and system level. For larger scale, sustainable innovations, there is a need for longer-term projects that lay foundations around data and interdisciplinary work. CONCLUSION: Study findings can be used to inform future research and development of AI for PC, and to guide resource planning and allocation.

PRECIS-2 for retrospective assessment of RCTs in systematic reviews.

BACKGROUND AND OBJECTIVES: A randomized controlled trial (RCT) may be intended either to support real-world decisions on choice between alternative interventions or to help researchers understand mechanisms of action of an intervention. PRECIS-2 is widely used to help investigators match detailed design elements to their main intention for that RCT. PRECIS-2 is increasingly being used retrospectively for assessing RCTs within reviews. In this commentary, we counter arguments that RCTs with a placebo control group, masking/blinding of participants or providers, or conducted in a single center should be retrospectively assessed as completely explanatory, overriding a detailed PRECIS-2 assessment. We also counter arguments that a trial cannot be assessed using only the main peer-reviewed trial report. STUDY DESIGN AND SETTING: This is a commentary on the use of PRECIS-2 for systematic reviews. RESULTS: Although placebos are seldom openly prescribed in real-world care, knowing that an intervention achieves its impact via the placebo effect might change some clinical and policy decisions, which means that this feature does not always preclude decision-making use and so should not override a full PRECIS-2 assessment. A domain describing the comparator should be added to PRECIS-2. Conduct of an RCT in only a single centre should also not override PRECIS-2 as the decision support value of a single-centre RCT could be high for decision makers in that centre and others like it. Many journals require that submitted RCT reports meet CONSORT reporting guidelines, which standardizes the available information for all RCTs in systematic reviews; whereas information from registration and protocol documents is unstandardized and undermines comparison between RCTs and across reviews. Published RCT reports are thus more suitable for retrospective PRECIS-2 assessments, but PRECIS-2 domains with missing information should be scored as blank. Wider use of the CONSORT extension specific to pragmatic trials may reduce domains with missing data. CONCLUSIONS: PRECIS-2 can be used for retrospective assessments of trials in systematic reviews. The PRECIS-2 instrument should be expanded by including a domain describing the control group(s). Published RCT reports are suitable for retrospective PRECIS-2 assessments.

Unpacking 'the cloud': a framework for implementing public health approaches to palliative care.

Designing and implementing population-based systems of care that address the social determinants of health, take action on multiple levels, and are guided by evidence-based principles is a pressing priority, and an international challenge. Aging persons are a priority demographic whose health needs span physical, psychosocial and existential care domains, increase in the last year of life, are often poorly coordinated and therefore remain unmet. Compassionate communities (CCs) are an example of a public health approach that fully addresses the holistic healthcare needs of those who are aging and nearing end of life. The sharing of resources, tools, and innovations among implementers of CCs is occurring globally. Although this can increase impact, it also generates complexity that can complicate robust evaluation. When initiating population health level projects, it is important to clearly define and organize concepts and processes that are proposed to influence the health outcomes. The Health Impact Change Model (HICM) was developed to unpack the complexities associated with the implementation and evaluation of a Canadian CC intervention. The HICM offers utility for citizens, leaders and decision-makers who are engaged in the implementation of population health level strategies or other social approaches to care, such as compassionate cities and age or dementia-friendly communities. The HICM's concepts can be adapted to address a community's healthcare context, needs, and goals for change. We share examples of how the model's major concepts have been applied in the development, evaluation and spread of a complex CC approach.

Building internal capacity in pragmatic trials: a workshop for program scientists at the US National Cancer Institute.

BACKGROUND: Building capacity in research funding organizations to support the conduct of pragmatic clinical trials is an essential component of advancing biomedical and public health research. To date, efforts to increase the ability to design and carry out pragmatic trials have largely focused on training researchers. To complement these efforts, we developed an interactive workshop tailored to meet the roles and responsibilities of program scientists at the National Cancer Institute-the leading cancer research funding agency in the USA. The objectives of the workshop were to improve the understanding of pragmatic trials and enhance the capacity to distinguish between elements that make a trial more pragmatic or more explanatory among key programmatic staff. To our knowledge, this is the first reported description of such a workshop. MAIN BODY: The workshop was developed to meet the needs of program scientists as researchers and stewards of research funds, which often includes promoting scientific initiatives, advising prospective applicants, collaborating with grantees, and creating training programs. The workshop consisted of presentations from researchers with expertise in the design and interpretation of trials across the explanatory-pragmatic continuum. Presentations were followed by interactive, small-group exercises to solidify participants' understanding of the purpose and conduct of these trials, which were tailored to attendees' areas of expertise across the cancer control continuum and designed to reflect their scope of work as program scientists at NCI. A total of 29 program scientists from the Division of Cancer Control and Population Sciences and the Division of Cancer Prevention participated; 19 completed a post-workshop evaluation. Attendees were very enthusiastic about the workshop: they reported improved knowledge, significant relevance of the material to their work, and increased interest in pragmatic trials across the cancer control continuum. CONCLUSION: Training program scientists at major biomedical research agencies who are responsible for developing funding opportunities and advising grantees is essential for increasing the quality and quantity of pragmatic trials. Together with workshops for other target audiences (e.g., academic researchers), this approach has the potential to shape the future of pragmatic trials and continue to generate more and better actionable evidence to guide decisions that are of critical importance to health care practitioners, policymakers, and patients.

National Survey of Indigenous primary healthcare capacity and delivery models in Canada: the TransFORmation of IndiGEnous PrimAry HEAlthcare delivery (FORGE AHEAD) community profile survey.

BACKGROUND: There is a significant deficiency of national health information for Indigenous peoples in Canada. This manuscript describes the Community Profile Survey (CPS), a community-based, national-level survey designed to identify and describe existing healthcare delivery, funding models, and diabetes specific infrastructure and programs in Indigenous communities. METHODS: The CPS was developed collaboratively through FORGE AHEAD and the First Nations and Inuit Health Branch of Health Canada. Regional and federal engagement and partnerships were built with Indigenous organizations to establish regionally-tailored distribution of the 8-page CPS to 440 First Nations communities. Results were collected (one survey per community) and reported in strata by region, with descriptive analyses performed on all variables. Results were shared with participating communities and regional/federal partners through tailored reports. RESULTS: A total of 84 communities completed the survey (19% response rate). The majority of communities had a health centre/office to provide service to their patients with diabetes, with limited on-reserve hospitals for ambulatory or case-sensitive conditions. Few healthcare specialists were located on-site, with patients frequently travelling off-site (> 40 km) for diabetes-related complications. The majority of healthcare professionals on-site were Health Directors, Community Health Nurses, and Home Care Nurses. Many communities had a diabetes registry but few reported a diabetes surveillance system. Regional variation in healthcare services, diabetes programs, and funding models were noted, with most communities engaging in some type of innovative strategy to improve care for patients with diabetes. CONCLUSIONS: The CPS is the first community-based, national-level survey of its kind in Canada. Although the response rate was low, the CPS was distributed and successfully administered across a broad range of First Nations communities, and future considerations would benefit from a governance structure and leadership that strengthens community engagement, and a longitudinal research approach to increase the representativeness of the data. This type of information is important for communities and regions to inform decision making (maintain successes, and identify areas for improvement), strengthen health service delivery and infrastructure, increase accessibility to healthcare personnel, and allocate funding and/or resources to build capacity and foster a proactive chronic disease prevention and management approach for Indigenous communities across Canada. TRIAL REGISTRATION: Current ClinicalTrial.gov protocol ID NCT02234973 . Registered: September 9, 2014.

A realist evaluation of value-based care delivery in home care: The influence of actors, autonomy and accountability.

The increasing demand for home care is occurring in tandem with the need for governments to contain health care costs, maximize appropriate resource utilization and respond to patient preferences for where they receive care. We describe the evaluation of the Integrated Client Care Project (ICCP), a government funded project designed to improve value for outcomes for patients referred to community wound care services in Ontario, Canada. We applied a realist evaluation methodology in order to unpack the influences of contextual and mechanistic choices on the intended outcomes of the ICCP implementation. We collected data through ethnographic methods including 36 months of field observation, 46 key informant interviews and contemporaneous document analysis. The findings presented here highlight how theoretical mechanisms were negatively impacted by strong contextual patterns and weak implementation which led to underwhelming outcomes. Autonomy of the participant organizations, lack of power within the implementation team to drive change, opacity of the goals of the program, and disregard for the impact of complex historical relations within the home care sector compounded to undermine the intended outcome.

Assessment of Long-term Follow-up of Randomized Trial Participants by Linkage to Routinely Collected Data: A Scoping Review and Analysis.

Importance: Follow-up of participants in randomized trials may be limited by logistic and financial factors. Some important randomized trials have been extended well beyond their original follow-up period by linkage of individual participant information to routinely collected data held in administrative records and registries. Objective: To perform a scoping review of randomized clinical trials extended by record linkage to characterize this literature and explore any additional insights into treatment effectiveness provided by long-term follow-up using record linkage. Data Sources: A literature search in Embase, CINAHL, MEDLINE, and the Cochrane Register of Controlled Trials was performed for the period January 1, 1945, through November 25, 2016. Study Selection: Various combinations of search terms were used, as there is no accepted terminology. Determination of study eligibility and extraction of information about trial characteristics and outcomes, for both original and extended trial reports, were performed in duplicate. Data Extraction and Synthesis: Assessment of study eligibility and data extraction were performed independently by 2 reviewers. All analyses were descriptive. Main Outcomes and Measures: Outcomes in the pairs of original and extended trials were categorized according to whether any benefits or harms from interventions were sustained, were lost, or emerged during long-term follow-up. Results: A total of 113 extended trials were included in the study. Linkage to administrative and registry data extended follow-up by between 1 and 55 years. The most common interventions were pharmaceuticals (47 [41.6%]), surgery (19 [16.8%]), and disease screening (19 [16.8%]). End points most frequently studied through record linkage included mortality (88 [77.9%]), cancer (41 [36.3%]), and cardiovascular events (37 [32.7%]). One hundred four trial extensions (92.0%) were analyzed according to the original trial randomization. The reports provided details of 155 analyses of study outcomes. Seventy-four analyses (47.7%) identified statistically significant benefits in the trial extension phase. In 21 of these (28.4%), benefits were significant only in this period. Null results in both the original and extended trials were seen in 34 of the analyses (21.9%). Loss of significant benefits of an intervention were seen in 12 analyses (7.7%). Statistically significant harms were seen in 16 trial extension analyses (10.3%), and in 14 of these (87.5%), the harms were significant only in the trial extension phase. Conclusions and Relevance: Trial extension by linkage to routinely collected data is a versatile underused approach that may add critical insights beyond those of the original trial. Some beneficial and harmful outcomes of interventions are captured only in the extension phase of randomized trials.

A large cluster randomized trial of outcome-based pathways to improve home-based wound care.

BACKGROUND: Although not always recognized as a pressing health care problem, wounds are a common, complex and costly condition. The burden of treating wounds is growing rapidly due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity worldwide. The Integrated Client Care (ICC) Project was a multi-year initiative to develop and test a new, integrated model of wound care within the home care sector in Ontario, Canada to improve health outcomes for patients and decrease system costs. METHODS: Cluster randomized trial, with allocation of intervention randomized at the cluster level (14 home care centers) and analysis of outcomes based on individual-level data (patients). Primary analysis was an intention-to-treat (ITT) analysis. Two wound types, diabetic foot ulcers and pilonidal sinus, were selected as tracer conditions to assess the impact of the intervention on two different patient populations. Time to successful discharge from home care was analyzed using multivariable Cox proportional hazards regression. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented. RESULTS: A total of 12,063 diabetic foot ulcer patients and 1954 pilonidal sinus patient records were available for analysis. No appreciable differences were observed between patients in the control and intervention arms for either of the primary or secondary analyses in either condition group. In the diabetic foot ulcer group, 72.7% patients in the control arm and 73.6% patients in the intervention arm were discharged in the follow-up period (HR 1.05; 95% CI 0.94 to 1.17). In the pilonidal sinus group, 91.0% patients in the control arm and 89.0% patients in the intervention arm were discharged in the follow-up period (HR 0.96; 95% CI 0.82 to 1.12). CONCLUSION: As implemented, the ICC intervention was not effective, most likely due to failure of implementation, and is, therefore, not ready for widespread implementation in Ontario. Significant work remains to be done to correct the implementation process so that the concept of outcome-based health care can be properly evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT01573832 . Registered on 12 January 2012.

Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans.

BACKGROUND: Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS: Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ≥28 kg/m2) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program optimization. DISCUSSION: Hockey FIT is a gender-sensitive program designed to engage overweight/obese male hockey fans to improve physical activity and healthy eating choices, thereby leading to weight loss and other positive changes in health outcomes. We expect this study to provide evidence for a full-scale confirmatory pRCT. TRIAL REGISTRATION: NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

A partial economic evaluation of blended learning in teaching health research methods: a three-university collaboration in South Africa, Sweden, and Uganda.

BACKGROUND: Novel research training approaches are needed in global health, particularly in sub-Saharan African universities, to support strengthening of health systems and services. Blended learning (BL), combining face-to-face teaching with computer-based technologies, is also an accessible and flexible education method for teaching global health and related topics. When organised as inter-institutional collaboration, BL also has potential for sharing teaching resources. However, there is insufficient data on the costs of BL in higher education. OBJECTIVE: Our goal was to evaluate the total provider costs of BL in teaching health research methods in a three-university collaboration. DESIGN: A retrospective evaluation was performed on a BL course on randomised controlled trials, which was led by Stellenbosch University (SU) in South Africa and joined by Swedish and Ugandan universities. For all three universities, the costs of the BL course were evaluated using activity-based costing with an ingredients approach. For SU, the costs of the same course delivered with a classroom learning (CL) approach were also estimated. The learning outcomes of both approaches were explored using course grades as an intermediate outcome measure. RESULTS: In this contextually bound pilot evaluation, BL had substantially higher costs than the traditional CL approach in South Africa, even when average per-site or per-student costs were considered. Staff costs were the major cost driver in both approaches, but total staff costs were three times higher for the BL course at SU. This implies that inter-institutional BL can be more time consuming, for example, due to use of new technologies. Explorative findings indicated that there was little difference in students' learning outcomes. CONCLUSIONS: The total provider costs of the inter-institutional BL course were higher than the CL course at SU. Long-term economic evaluations of BL with societal perspective are warranted before conclusions on full costs and consequences of BL in teaching global health topics can be made.

Student experiences of participating in five collaborative blended learning courses in Africa and Asia: a survey.

BACKGROUND: As blended learning (BL; a combination of face-to-face and e-learning methods) becomes more commonplace, it is important to assess whether students find it useful for their studies. ARCADE HSSR and ARCADE RSDH (African Regional Capacity Development for Health Systems and Services Research; Asian Regional Capacity Development for Research on Social Determinants of Health) were unique capacity-building projects, focusing on developing BL in Africa and Asia on issues related to global health. OBJECTIVE: We aimed to evaluate the student experience of participating in any of five ARCADE BL courses implemented collaboratively at institutions from Africa, Asia, and Europe. DESIGN: A post-course student survey with 118 students was conducted. The data were collected using email or through an e-learning platform. Data were analysed with SAS, using bivariate and multiple logistic regression. We focused on the associations between various demographic and experience variables and student-reported overall perceptions of the courses. RESULTS: In total, 82 students responded to the survey. In bivariate logistic regression, the course a student took [p=0.0067, odds ratio (OR)=0.192; 95% confidence interval (CI): 0.058-0.633], male gender of student (p=0.0474, OR=0.255; 95% CI: 0.066-0.985), not experiencing technical problems (p<0.001, OR=17.286; 95% CI: 4.629-64.554), and reporting the discussion forum as adequate for student needs (p=0.0036, OR=0.165; 95% CI: 0.049-0.555) were found to be associated with a more positive perception of BL, as measured by student rating of the overall helpfulness of the e-learning component to their studies. In contrast, perceiving the assessment as adequate was associated with a worse perception of overall usefulness. In a multiple regression, the course, experiencing no technical problems, and perceiving the discussion as adequate remained significantly associated with a more positively rated perception of the usefulness of the online component of the blended courses. DISCUSSION: The results suggest that lack of technical problems and functioning discussion forums are of importance during BL courses focusing on global health-related topics. Through paying attention to these aspects, global health education could be provided using BL approaches to student satisfaction.

Successes and challenges of north-south partnerships - key lessons from the African/Asian Regional Capacity Development projects.

INTRODUCTION: Increasing efforts are being made globally on capacity building. North-south research partnerships have contributed significantly to enhancing the research capacity in low- and middle-income countries (LMICs) over the past few decades; however, a lack of skilled researchers to inform health policy development persists, particularly in LMICs. The EU FP7 funded African/Asian Regional Capacity Development (ARCADE) projects were multi-partner consortia aimed to develop a new generation of highly trained researchers from universities across the globe, focusing on global health-related subjects: health systems and services research and research on social determinants of health. This article aims to outline the successes, challenges and lessons learned from the life course of the projects, focusing on the key outputs and experiences of developing and implementing these two projects together with sub-Saharan African, Asian and European institution partners. DESIGN: Sixteen participants from 12 partner institutions were interviewed. The data were analysed using thematic content analysis, which resulted in four themes and three sub-categories. These data were complemented by a review of project reports. RESULTS: The results indicated that the ARCADE projects have been successful in developing and delivering courses, and have reached over 920 postgraduate students. Some partners thought the north-south and south-south partnerships that evolved during the project were the main achievement. However, others found there to be a 'north-south divide' in certain aspects. Challenges included technical constraints and quality assurance. Additionally, adapting new teaching and learning methods into current university systems was challenging, combined with not being able to award students with credits for their degrees. CONCLUSION: The ARCADE projects were introduced as an innovative and ambitious project idea, although not designed appropriately for all partner institutions. Some challenges were underestimated from the beginning, and for such future projects, a more structured approach needs to be adopted. ARCADE partners learned that integrating courses into current university systems and awarding students credits are essential.

North-south collaboration and capacity development in global health research in low- and middle-income countries - the ARCADE projects.

BACKGROUND: Research capacity enhancement is needed in low- and middle-income countries (LMICs) for improved health, wellbeing, and health systems' development. In this article, we discuss two capacity-building projects, the African/Asian Regional Capacity Development (ARCADE) in Health Systems and Services Research (HSSR) and Research on Social Determinants of Health (RSDH), implemented from 2011 to 2015. The two projects focussed on providing courses in HSSR and social determinants of health research, and on developing collaborations between universities, along with capacity in LMIC universities to manage research grant submissions, financing, and reporting. Both face-to-face and sustainable online teaching and learning resources were used in training at higher postgraduate levels (Masters and Doctoral level). DESIGN: We collated project meeting and discussion minutes along with project periodic reports and deliverables. We extracted key outcomes from these, reflected on these in discussions, and summarised them for this paper. RESULTS: Nearly 55 courses and modules were developed that were delivered to over 920 postgraduate students in Africa, Asia, and Europe. Junior researchers were mentored in presenting, developing, and delivering courses, and in preparing research proposals. In total, 60 collaborative funding proposals were prepared. The consortia also developed institutional capacity in research dissemination and grants management through webinars and workshops. DISCUSSION: ARCADE HSSR and ARCADE RSDH were comprehensive programmes, focussing on developing the research skills, knowledge, and capabilities of junior researchers. One of the main strengths of these programmes was the focus on network building amongst the partner institutions, where each partner brought skills, expertise, and diverse work cultures into the consortium. Through these efforts, the projects improved both the capacity of junior researchers and the research environment in Africa, Asia, and Europe.

Antibiotic prescribing of village doctors for children under 15 years with upper respiratory tract infections in rural China: A qualitative study.

The aim of this study was to explore the knowledge, attitudes, and practices of village doctors regarding the prescribing of antibiotics for children under 15 years with upper respiratory tract infections (URTIs) in rural China. Twelve focus group discussions (FGDs) were conducted in Xianning, a prefecture-level city in rural China, during December 2014. We conducted 6 FGDs with 35 village doctors, 3 with 13 primary caregivers (11 parents), and 3 with 17 directors of township hospitals, county-level health bureaus, county-level Centers for Disease Control and Prevention, or county-level Chinese Food and Drug Administration offices. Audio records of the interviews were transcribed verbatim and analyzed using the thematic analysis approach. Participants believed that unnecessary antibiotic prescribing for children under 15 years with The occurrence of URTIs was a problem in village clinics in rural China. The discussions revealed that most of the village doctors had inadequate knowledge and misconceptions about antibiotic use, which was an important factor in the unnecessary prescribing. Village doctors and directors reported that the doctors' fear of complications, the primary caregivers' pressure for antibiotic treatment, and the financial considerations of patient retention were the main factors influencing the decision to prescribe antibiotics. Most of the primary caregivers insisted on antibiotics, even when the village doctors were reluctant to prescribe them, and they preferred to go to see those village doctors who prescribed antibiotics. The interviewees also gave their opinions on what would be the most effective measures for optimizing antibiotic prescriptions; these included educational/training campaigns, strict regulations on antibiotic prescription, and improved supervision. Findings emphasized the need to improve the dissemination of information and training/education, and implement legislation on the rational use of antibiotics. And it also provided helpful information to guide the design of more effective interventions to promote prudent antibiotic use and good antimicrobial stewardship.

The need for pragmatic clinical trials in low and middle income settings - taking essential neonatal interventions delivered as part of inpatient care as an illustrative example.

BACKGROUND: Pragmatic randomized trials aim to examine the effects of interventions in the full spectrum of patients seen by clinicians who receive routine care. Such trials should be employed in parallel with efforts to implement many interventions which appear promising but where evidence of effectiveness is limited. We illustrate this need taking the case of essential interventions to reduce inpatient neonatal mortality in low and middle income countries (LMIC) but suggest the arguments are applicable in most clinical areas. DISCUSSION: A set of basic interventions have been defined, based on available evidence, that could substantially reduce early neonatal deaths if successfully implemented at scale within district and sub-district hospitals in LMIC. However, we illustrate that there remain many gaps in the evidence available to guide delivery of many inpatient neonatal interventions, that existing evidence is often from high income settings and that it frequently indicates uncertainty in the magnitude or even direction of estimates of effect. Furthermore generalizing results to LMIC where conditions include very high patient staff ratios, absence of even basic technologies, and a reliance on largely empiric management is problematic. Where there is such uncertainty over the effectiveness of interventions in different contexts or in the broad populations who might receive the intervention in routine care settings pragmatic trials that preserve internal validity while promoting external validity should be increasingly employed. Many interventions are introduced without adequate evidence of their effectiveness in the routine settings to which they are introduced. Global efforts are needed to support pragmatic research to establish the effectiveness in routine care of many interventions intended to reduce mortality or morbidity in LMIC. Such research should be seen as complementary to efforts to optimize implementation.

Cost-effectiveness of a physician-nurse supplementary triage assessment team at an academic tertiary care emergency department.

OBJECTIVE: The purpose of this study was to evaluate the cost-effectiveness of physician-nurse supplementary triage assistance team (MDRNSTAT) from a hospital and patient perspective. METHODS: This was a cost-effectiveness evaluation of a cluster randomized control trial comparing the MDRNSTAT with nurse-only triage in the emergency department (ED) between the hours of 0800 and 1500. Cost was MDRNSTAT salary. Revenue was from Ontario's Pay-for-Results and patient volume-case mix payment programs. The incremental cost-effectiveness ratio was based on MDRNSTAT cost and three consequence assessments: 1) per additional patient-seen; 2) per physician initial assessment (PIA) hour saved; and 3) per ED length of stay (EDLOS) hour saved. Patient opportunity cost was determined. Patient satisfaction was quantified by a cost-benefit ratio. A sensitivity analysis extrapolating MDRNSTAT to different working hours, salary, and willingness-to-pay data was performed. RESULTS: The added cost of the MDRNSTAT was $3,597.27 [$1,729.47 to ∞] per additional patient-seen, $75.37 [$67.99 to $105.30] per PIA hour saved, and $112.99 [$74.68 to $251.43] per EDLOS hour saved. From the hospital perspective, the cost-benefit ratio was 38.6 [19.0 to ∞] and net present value of -$447,996 [-$435,646 to -$459,900]. For patients, the cost-benefit ratio for satisfaction was 2.8 [2.3 to 4.6]. If MDRNSTAT performance were consistently implemented from noon to midnight, it would be more cost-effective. CONCLUSIONS: The MDRNSTAT is not a cost-effective daytime strategy but appears to be more feasible during time periods with higher patient volume, such as late morning to evening.

The Karnataka Anemia Project 2--design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial.

BACKGROUND: Childhood anemia is highly prevalent worldwide. Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health. While evidence-based recommendations for reducing childhood anemia in high anemia prevalence countries are available, there is no experimental evidence of community centered education and counseling programs, as a route to improved acceptance of iron supplements, demonstrating beneficial effects on anemia outcomes. We report on the evaluation protocol of a complex educational intervention led by the community lay health worker (LHW) and delivered to mothers of 12-59-month-old anemic children living in and visiting village day care centers in a large district of southern India. METHODS AND DESIGN: The study is designed as a cluster randomized controlled trial. The intervention is based on the social cognitive theory and aims to promote among mothers, anemia awareness, dietary modifications to increase iron intake in the child, and recognition of the need for enhanced adherence to supplemental iron in the anemic child. From 270 eligible villages in the study area, a sample of 60 villages will be randomized to intervention [n = 30] or to treatment as usual [n = 30] of the study. LHWs in the intervention arm will be trained to administer the following intervention components to mothers of anemic children: 1] monthly distribution of Iron and folic acid (IFA) supplements to mothers of anemic children, and 2] five monthly counseling sessions of mothers of anemic children covering: a] anemia awareness education b] IFA adherence counseling and assessment, c] dietary modification to improve iron intake, and d] hygiene and sanitation. LHWs in the control arm will distribute IFA to mothers of anemic children as in the intervention arm but will not provide monthly education and counseling support. The primary outcome is the difference between the two experimental groups in anemia cure rates of children found to be anemic at baseline. Secondary outcomes, assessed as differences between all participants in both experimental groups, are: change in mothers' knowledge regarding anemia; 24 hour dietary iron intake; net improvement in individual hemoglobin values; serum ferritin; and the difference in overall cluster level childhood anemia prevalence. All outcomes will be measured 6 months after the start of the intervention. Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables. DISCUSSION: This trial is designed to evaluate the effectiveness of an intervention intended to improve anemia cure rates in anemic children living in villages of Chamarajnagar, Karnataka a large district in south India. The extensive study of secondary endpoints will be used to identify possible weak points in the compliance to intervention delivery and uptake. This evaluation is one of the few large randomized trials evaluating the impact of an education and counseling intervention to reduce childhood anemia prevalence. TRIAL REGISTRATION: This trial was registered with ISRCTN.com (identifier: ISRCTN68413407) on 17 September 2013.

Failure to cope: the hidden curriculum of emergency department wait times and the implications for clinical training.

PURPOSE: The study explored optimal intraprofessional collaboration between physicians in the emergency department (ED) and those from general internal medicine (GIM). Prior to the study, a policy was initiated that mandated reductions in ED wait times. The researchers examined the impact of these changes on clinical practice and trainee education. METHOD: In 2010-2011, an ethnographic study was undertaken to observe consults between GIM and ED at an urban teaching hospital in Ontario, Canada. Additional ad hoc interviews were conducted with residents, nurses, and faculty from both departments as well as formal one-on-one interviews with 12 physicians. Data were coded and analyzed using concepts of institutional ethnography. RESULTS: Participants perceived that efficiency was more important than education and was in fact the new definition of "good" patient care. The informal label "failure to cope" to describe high-needs patients suggested that in many instances, patients were experienced as a barrier to optimal efficiency. This resulted in tension during consults as well as reduced opportunities for education. CONCLUSIONS: The authors suggest that the emphasis on wait times resulted in more importance being placed on "getting the patient out" of the ED than on providing safe, compassionate, person-centered medical care. Resource constraints were hidden within a discourse that shifted the problem of overcrowding in the ED to patients with complex chronic conditions. The term "failure to cope" became activated when overworked physicians tried to avoid assuming care for high-needs patients, masking institutionally produced stress and possibly altering the way patients are perceived.

Systematically Identified Failure Is the Route to a Successful Health System.

Although we have a systematic approach to innovation and evaluation (and scale-up) for treatments, medical technologies and diagnostic tests in healthcare, we have no equivalent for service delivery innovations. Service delivery innovation is common but frequently goes unevaluated, leading to less systematic decisions about which innovations are scaled up and which ones are not. The absence of a formal evaluation system for service delivery innovation means that there is no objective standard for evaluating an innovation's success or failure, and thus no way to decide whether it should be scaled up, adapted and retested, or not scaled up at all. This results in "bad failure" - the scale-up of innovations that are untested, and the failure to scale-up other innovations that might have been effective but no one measured their effectiveness in a systematic way.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

BACKGROUND: The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada METHODS: We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. RESULTS: 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. CONCLUSION: Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01232764.