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1.  Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial 
PLoS Medicine  2016;13(11):e1002178.
Background
In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses’ role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses’ capacity to manage NCDs.
Methods and Findings
In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses’ expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up.
Conclusions
Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa.
Trial Registration
The trial is registered with Current Controlled Trials (ISRCTN20283604)
In a cluster-randomized trial done in South Africa, Lara Fairall and co-workers investigate the effectiveness of a clinical management tool for non-communicable diseases in primary care.
Author Summary
Why Was This Study Done?
Non-communicable diseases (NCDs) are the leading cause of deaths worldwide, even in low- and middle-income countries (LMICs) that continue to battle to control communicable diseases like HIV and tuberculosis (TB).
Effective and affordable treatments prevent complications from NCDs like heart attacks and strokes, but access is limited by the variable availability and limited capacity of primary care health workers to detect and effectively manage these conditions. In many LMICs, non-physicians such as nurses provide primary care for NCDs.
Over the past 16 years, we have developed, evaluated, and refined integrated clinical management tools and training programmes that employ problem-based approaches to common symptoms like cough and priority health conditions including TB, HIV, asthma, and emphysema. We have shown them to be effective in improving the quality and outcomes of care for communicable diseases.
We have expanded this programme to include almost all NCDs and mental health. This study evaluated the impact, both benefits and harms, of introducing the expanded programme, called Primary Care 101 (PC101), in terms of the quality of primary care for four common chronic diseases: hypertension, diabetes, chronic respiratory disease, and depression.
What Did the Researchers Do and Find?
We compared the care offered to patients with one of these four chronic diseases in 18 clinics in which primary care health workers were trained in the use of PC101 with that in 18 clinics where nurses continued to use the predecessor tool, which focused on communicable diseases.
The trial had a pragmatic design, meaning it was conducted under usual conditions of health system operational constraints. Clinics in urban and rural areas serving people living in socio-economically deprived areas of South Africa were selected.
We enrolled 4,393 patients with one or more of the NCDs of interest and followed them up for 14 mo after introduction of PC101 at the intervention clinics. The primary outcome of interest was intensification of treatment (or diagnosis, in the case of depression) for the four NCDs, analysed separately.
The results confirmed very high rates of multimorbidity (patients having more than one condition at a time), under-diagnosis, under-treatment, and poor disease control.
Introducing PC101 did not result in intensification of treatment for the four NCDs, but neither was there evidence of harm from the nurses’ expanded scope of practice.
What Do These Findings Mean?
The trial confirmed that multimorbidity and poor detection and control of NCDs and depression are common in this setting. Interventions are necessary to limit the impact of these conditions on people’s health and quality of life.
PC101 offered a practical and acceptable tool to help expand the scope of practice of non-physician clinicians to include NCD care, but we were not able to show improvements in care, as we have previously done for communicable diseases.
The study illustrates the limitations of trials designed to study the effects of complex system interventions in real life, where even small changes across many endpoints, as seen in our study, may be useful to decision-makers under pressure to respond constructively to the rise of multimorbidity and NCDs.
PC101 has been adopted for country-wide implementation in primary care clinics in South Africa.
doi:10.1371/journal.pmed.1002178
PMCID: PMC5119726  PMID: 27875542
2.  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 
BMC Public Health  2016;16:1096.
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.
doi:10.1186/s12889-016-3730-5
PMCID: PMC5070306  PMID: 27756351
Overweight/Obese men; Lifestyle intervention; Health promotion; Hockey; Sport fan; Masculinity; Health technology; Weight loss; Physical activity; Healthy eating
3.  A partial economic evaluation of blended learning in teaching health research methods: a three-university collaboration in South Africa, Sweden, and Uganda 
Global Health Action  2016;9:10.3402/gha.v9.28058.
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.
doi:10.3402/gha.v9.28058
PMCID: PMC5056980  PMID: 27725076
cost analysis; education; public health professional; students; public health; blended learning; health systems research
4.  Student experiences of participating in five collaborative blended learning courses in Africa and Asia: a survey 
Global Health Action  2016;9:10.3402/gha.v9.28145.
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.
doi:10.3402/gha.v9.28145
PMCID: PMC5056983  PMID: 27725077
blended learning; capacity building; global health; student experience
5.  ‘Research clinics’: online journal clubs between south and north for student mentoring 
Global Health Action  2016;9:10.3402/gha.v9.30434.
Background
Capacity development in health research is high on the agenda of many low- and middle-income countries.
Objective
The ARCADE projects, funded by the EU, have been working in Africa and Asia since 2011 in order to build postgraduate students’ health research capacity. In this short communication, we describe one initiative in these projects, that of research clinics – online journal clubs connecting southern and northern students and experts.
Design
We describe the implementation of these research clinics together with student and participant experiences.
Results
From 2012 to 2015, a total of seven journal clubs were presented by students and junior researchers on topics related to global health. Sessions were connected through web conferencing, connecting experts and students from different countries.
Conclusions
The research clinics succeeded in engaging young researchers across the globe and connecting them with global experts. The contacts and suggestions made were appreciated by students. This format has potential to contribute toward research capacity building in low- and middle-income countries.
doi:10.3402/gha.v9.30434
PMCID: PMC5056984  PMID: 27725079
capacity building; postgraduate education; global health; developing countries
6.  Successes and challenges of north–south partnerships – key lessons from the African/Asian Regional Capacity Development projects 
Global Health Action  2016;9:10.3402/gha.v9.30522.
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.
doi:10.3402/gha.v9.30522
PMCID: PMC5056985  PMID: 27725080
institutions; partners; students; north–south collaboration; global health; course development
7.  North–south collaboration and capacity development in global health research in low- and middle-income countries – the ARCADE projects 
Global Health Action  2016;9:10.3402/gha.v9.30524.
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.
doi:10.3402/gha.v9.30524
PMCID: PMC5057000  PMID: 27725081
capacity building; health determinants; global health
8.  Ontario's Emergency Department Process Improvement Program: The Experience of Implementation 
Academic Emergency Medicine  2015;22(6):720-729.
Abstract
Objectives
In recent years, Lean manufacturing principles have been applied to health care quality improvement efforts to improve wait times. In Ontario, an emergency department (ED) process improvement program based on Lean principles was introduced by the Ministry of Health and Long‐Term Care as part of a strategy to reduce ED length of stay (LOS) and to improve patient flow. This article aims to describe the hospital‐based teams’ experiences during the ED process improvement program implementation and the teams’ perceptions of the key factors that influenced the program's success or failure.
Methods
A qualitative evaluation was conducted based on semistructured interviews with hospital implementation team members, such as team leads, medical leads, and executive sponsors, at 10 purposively selected hospitals in Ontario, Canada. Sites were selected based, in part, on their changes in median ED LOS following the implementation period. A thematic framework approach as used for interviews, and a standard thematic coding framework was developed.
Results
Twenty‐four interviews were coded and analyzed. The results are organized according to participants’ experience and are grouped into four themes that were identified as significantly affecting the implementation experience: local contextual factors, relationship between improvement team and support players, staff engagement, and success and sustainability. The results demonstrate the importance of the context of implementation, establishing strong relationships and communication strategies, and preparing for implementation and sustainability prior to the start of the project.
Conclusions
Several key factors were identified as important to the success of the program, such as preparing for implementation, ensuring strong executive support, creation of implementation teams based on the tasks and outcomes of the initiative, and using multiple communication strategies throughout the implementation process. Explicit incorporation of these factors into the development and implementation of future similar interventions in health care settings could be useful.
doi:10.1111/acem.12688
PMCID: PMC5032978  PMID: 25996451
9.  Printed educational messages fail to increase use of thiazides as first-line medication for hypertension in primary care: a cluster randomized controlled trial [ISRCTN72772651] 
Background
Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes.
This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system.
Methods
The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group).
Setting
The setting involves all Ontario general/family practice physicians.
Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an “insert” (two-page evidence-based article) and/or one of two different versions of an “outsert” (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides).
The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices.
Results
Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54.
Conclusions
The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension.
Trial registration
ISRCTN72772651
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-016-0486-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-016-0486-3
PMCID: PMC5027087  PMID: 27640126
10.  A theory-based process evaluation alongside a randomised controlled trial of printed educational messages to increase primary care physicians’ prescription of thiazide diuretics for hypertension [ISRCTN72772651] 
Implementation Science : IS  2016;11(1):121.
Background
Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians’ guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT.
Methods
We developed and sent TPB postal questionnaires to a random sub-sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs. We used analysis of covariance to test for group differences using a 2 × 3 factorial design. We content-analysed an open-ended question about perceived barriers to thiazide prescription. Using control group data, we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up.
Results
Four hundred twenty-six physicians completed pre- and post-intervention questionnaires. Baseline scores on measures of TPB constructs were high: intention mean = 5.9 out of 7 (SD = 1.4), attitude mean = 5.8 (SD = 1.1), subjective norm mean = 5.8 (SD = 1.1) and PBC mean = 6.2 (SD = 1.0). The arms did not significantly differ post-intervention on any of the theory-based constructs, suggesting a possible ceiling effect. Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient clinical characteristics and potential side effects. Baseline intention (β = 0.63, p < 0.01) but not PBC (β = 0.04, p = 0.78) predicted 42.6 % of the variance in self-reported behaviour at follow-up in the control group.
Conclusions
Congruent with the Ontario Printed Educational Messages trial results and aligned with the TPB, we saw no impact of the intervention on any TPB constructs. The theoretical basis of this evaluation suggests possible explanations for the failure of the PEM intervention to change professional behaviour, which can directly inform the design and content of future theory-based PEM interventions to change professional behaviour.
Trial registration
ISRCTN, Canada ISRCTN72772651
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-016-0485-4) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-016-0485-4
PMCID: PMC5020459  PMID: 27619339
11.  The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial 
Trials  2016;17(1):439.
Background
Despite availability of effective treatment, tuberculosis (TB) remains an important cause of morbidity and mortality globally, with low- and middle-income countries most affected. In many such settings, including Malawi, the high burden of disease and severe shortage of skilled healthcare workers has led to task-shifting of outpatient TB care to lay health workers (LHWs). LHWs improve access to healthcare and some outcomes, including TB completion rates, but lack of training and supervision limit their impact. The goals of this study are to improve TB care provided by LHWs in Malawi by refining, implementing, and evaluating a knowledge translation strategy designed to address a recognized gap in LHWs’ TB and job-specific knowledge and, through this, to improve patient outcomes.
Methods/design
We are employing a mixed-methods design that includes a pragmatic cluster randomized controlled trial and a process evaluation using qualitative methods. Trial participants will include all health centers providing TB care in four districts in the South East Zone of Malawi. The intervention employs educational outreach, a point-of-care reminder tool, and a peer support network. The primary outcome is proportion of treatment successes, defined as the total of TB patients cured or completing treatment, with outcomes taken from Ministry of Health treatment records. With an alpha of 0.05, power of 0.80, a baseline treatment success of 0.80, intraclass correlation coefficient of 0.1 based on our pilot study, and an estimated 100 clusters (health centers providing TB care), a minimum of 6 patients per cluster is required to detect a clinically significant 0.10 increase in the proportion of treatment successes. Our process evaluation will include interviews with LHWs and patients, and a document analysis of LHW training logs, quarterly peer trainer meetings, and mentorship meeting notes. An estimated 10–15 LHWs and 10–15 patients will be required to reach saturation in each of 2 planned interview periods, for a total of 40–60 interview participants.
Discussion
This study will directly inform the efforts of knowledge users within TB care and, through extension of the approach, other areas of care provided by LHWs in Malawi and other low- and middle-income countries.
Trial registration
ClinicalTrials.gov NCT02533089. Registered 20 August 2015. Protocol Date/Version 29 May 2016/Version 2.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-016-1563-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-016-1563-2
PMCID: PMC5015212  PMID: 27604571
Lay health workers; Community health workers; Educational outreach; Reminders; Peer support network; TB; Tuberculosis; Cluster randomized trial
12.  Blended learning across universities in a South–North–South collaboration: a case study 
Background
Increased health research capacity is needed in low- and middle-income countries to respond to local health challenges. Technology-aided teaching approaches, such as blended learning (BL), can stimulate international education collaborations and connect skilled scientists who can jointly contribute to the efforts to address local shortages of high-level research capacity. The African Regional Capacity Development for Health Systems and Services Research (ARCADE HSSR) was a European Union-funded project implemented from 2011 to 2015. The project consortium partners worked together to expand access to research training and to build the research capacity of post-graduate students. This paper presents a case study of the first course in the project, which focused on a meta-analysis of diagnostic accuracy studies and was delivered in 2013 through collaboration by universities in Uganda, Sweden and South Africa.
Methods
We conducted a mixed-methods case study involving student course evaluations, participant observation, interviews with teaching faculty and student feedback collected through group discussion. Quantitative data were analysed using frequencies, and qualitative data using thematic analysis.
Results
A traditional face-to-face course was adapted for BL using a mixture of online resources and materials, synchronous online interaction between students and teachers across different countries complemented by face-to-face meetings, and in-class interaction between students and tutors. Synchronous online discussions led by Makerere University were the central learning technique in the course. The learners appreciated the BL design and reported that they were highly motivated and actively engaged throughout the course. The teams implementing the course were small, with individual faculty members and staff members carrying out many extra responsibilities; yet, some necessary competencies for course design were not available.
Conclusions
BL is a feasible approach to simultaneously draw globally available skills into cross-national, high-level skills training in multiple countries. This method can overcome access barriers to research methods courses and can offer engaging formats and personalised learning experiences. BL enables teaching and learning from experts and peers across the globe with minimal disruption to students’ daily schedules. Transforming a face-to-face course into a blended course that fulfils its full potential requires concerted effort and dedicated technological and pedagogical support.
doi:10.1186/s12961-016-0136-x
PMCID: PMC5010676  PMID: 27589996
Blended learning; e-learning; Higher education; Doctoral training; Research capacity building; Health services; Health systems
13.  Antibiotic prescribing of village doctors for children under 15 years with upper respiratory tract infections in rural China 
Medicine  2016;95(23):e3803.
Abstract
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.
doi:10.1097/MD.0000000000003803
PMCID: PMC4907660  PMID: 27281082
antibiotic stewardship; primary health care; qualitative research
14.  Promoting development and uptake of health innovations: The Nose to Tail Tool 
F1000Research  2016;5:361.
Introduction
Health sector management is increasingly complex as new health technologies, treatments, and innovative service delivery strategies are developed. Many of these innovations are implemented prematurely, or fail to be implemented at scale, resulting in substantial wasted resources.  
Methods
A scoping review was conducted to identify articles that described the scale up process conceptually or that described an instance in which a healthcare innovation was scaled up. We define scale up as the expansion and extension of delivery or access to an innovation for all end users in a jurisdiction who will benefit from it.
Results
Sixty nine articles were eligible for review. Frequently described stages in the innovation process and contextual issues that influence progress through each stage were mapped. 16 stages were identified: 12 deliberation and 4 action stages. Included papers suggest that innovations progress through stages of maturity and the uptake of innovation depends on the innovation aligning with the interests of 3 critical stakeholder groups (innovators, end users and the decision makers) and is also influenced by 3 broader contexts (social and physical environment, the health system, and the regulatory, political and economic environment). The 16 stages form the rows of the Nose to Tail Tool (NTT) grid and the 6 contingency factors form columns. The resulting stage-by-issue grid consists of 72 cells, each populated with cell-specific questions, prompts and considerations from the reviewed literature.
Conclusion
We offer a tool that helps stakeholders identify the stage of maturity of their innovation, helps facilitate deliberative discussions on the key considerations for each major stakeholder group and the major contextual barriers that the innovation faces. We believe the NTT will help to identify potential problems that the innovation will face and facilitates early modification, before large investments are made in a potentially flawed solution.
doi:10.12688/f1000research.8145.1
PMCID: PMC4863676  PMID: 27239275
Health innovation; pilot test; implementation; scale up; stakeholders; researchers; end users; decision makers
15.  Lay Health Workers experience of a tailored knowledge translation intervention to improve job skills and knowledge: a qualitative study in Zomba district Malawi 
BMC Medical Education  2016;16:54.
Background
Like many sub-Saharan African countries, Malawi is facing a critical shortage of skilled healthcare workers. In response to this crisis, a formal cadre of lay health workers (LHW) has been established and now carries out several basic health care services, including outpatient TB care and adherence support. While ongoing training and supervision are recognized as essential to the effectiveness of LHW programs, information is lacking as to how these needs are best addressed. The objective of this qualitative study was to explore LHWs responses to a tailored knowledge translation intervention they received, designed to address a previously identified training and knowledge gap.
Methods
Forty-five interviews were conducted with 36 healthcare workers. Fourteen to sixteen interviews were done at each of 3 evenly spaced time blocks over a one year period, with 6 individuals interviewed more than once to assess for change both within and across individuals overtime.
Results
Reported benefits of the intervention included: increased TB, HIV, and job-specific knowledge; improved clinical skills; and increased confidence and satisfaction with their work. Suggestions for improvement were less consistent across participants, but included: increasing the duration of the training, changing to an off-site venue, providing stipends or refreshments as incentives, and adding HIV and drug dosing content.
Conclusions
Despite the significant departure of the study intervention from the traditional approach to training employed in Malawi, the intervention was well received and highly valued by LHW participants. Given the relative low-cost and flexibility of the methods employed, this appears a promising approach to addressing the training needs of LHW programs, particularly in Low- and Middle-income countries where resources are most constrained.
Electronic supplementary material
The online version of this article (doi:10.1186/s12909-016-0580-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s12909-016-0580-x
PMCID: PMC4748491  PMID: 26861834
Lay health workers; Community health workers; Training; Knowledge translation; Educational outreach; Reminders
16.  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 
BMC Medicine  2016;14:5.
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.
Summary
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.
doi:10.1186/s12916-016-0556-z
PMCID: PMC4717536  PMID: 26782822
17.  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 
Trials  2015;16:599.
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.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-1135-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-1135-x
PMCID: PMC4697328  PMID: 26718897
Iron deficiency anemia; Hemoglobin; Cluster randomization; Controlled trial; Counseling; Evaluation
18.  Innovating to improve primary care in less developed countries: towards a global model 
BMJ Innovations  2015;1(4):196-203.
One of the biggest problems in global health is the lack of well trained and supported health workers in less developed settings. In many rural areas there are no physicians, and it is important to find ways to support and empower nurses and other health workers. The Knowledge Translation Unit of the University of Cape Town Lung Institute has spent 14 years developing a series of innovative packages to support and empower nurses and other health workers. PACK (Practical Approach to Care Kit) Adult comprises policy-based and evidence-informed guidelines; onsite, team and case-based training; non-physician prescribing; and a cascade system of scaling up. A series of randomised trials has shown the effectiveness of the packages, and methods are now being developed to respond cost-effectively and sustainably to global demand for implementing PACK Adult. Global health would probably benefit from less time and money spent developing new innovations and more spent on finding ways to spread those we already have.
doi:10.1136/bmjinnov-2015-000045
PMCID: PMC4680195  PMID: 26692199
Accessible; Affordable; Delivery; Global Health; Terminal Care
22.  A knowledge translation intervention to improve tuberculosis care and outcomes in Malawi: a pragmatic cluster randomized controlled trial 
Background
Lay health workers (LHWs) play a pivotal role in addressing the high TB burden in Malawi. LHWs report lack of training to be a key barrier to their role as TB care providers. Given the cost of traditional off-site training, an alternative approach is needed. Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs.
Methods
The study design is a pragmatic cluster randomized trial. The study was embedded within a larger trial, PALMPLUS, and compared three arms which included 28 health centers in Zomba district, Malawi. The control arm included 14 health centers randomized as controls in the larger trial and maintained as control sites. Seven of 14 PALMPLUS intervention sites were randomized to the LHW intervention (PALM/LHW intervention arm), and the remaining 7 PALMPLUS sites maintained as a PALM only arm. PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers. LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs. Control sites received no intervention. The main outcome measure is the proportion of treatment successes.
Results
Among the 28 sites, there were 178 incident TB cases with 46/80 (0.58) successes in the control group, 44/68 (0.65) successes in the PALMPLUS group, and 21/30 (0.70) successes in the PALM/LHW intervention group. There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster randomization (p = 0.578) or multivariate analysis controlling for covariates with significant model effects (p = 0.760). The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance (p = 0.056), with the interaction significant only in the control arm [RR of treatment success for pulmonary TB relative to non-pulmonary TB, 1.18, 95% CI 1.05–1.31].
Conclusions
We found no significant treatment effect of our intervention. Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training, further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted.
Trial registration
ClinicalTrials.gov NCT01356095.
doi:10.1186/s13012-015-0228-y
PMCID: PMC4437452  PMID: 25890186
Lay health workers; Community health workers; Educational outreach; Reminders; TB; Cluster randomized trial
23.  Evaluation as evolution: a Darwinian proposal for health policy and systems research 
Background
Health systems are complex and health policies are political. While grand policies are set by politicians, the detailed implementation strategies which influence the shape and impact of these policies are delegated to technical personnel. This is an underappreciated opportunity for optimising health systems. We propose that selective ‘breeding’ through successive evaluations of and selection among implementation strategies is a metaphor that health system thinkers can use to improve health care.
Discussion
Similar to Darwinian evolution, the acceptance and accumulation of successful choices and the detection and discarding of unsuccessful ones would improve health systems in small and uncontroversial ways, over time. The effects of better implementation choices would be synergistic and cumulative, accumulating large impact (and lessons) from small changes. Just as with evolution of species, this means that even slight improvements over usual outcomes makes these numerous small choices as important a focus for system improvement as the overarching policy itself. Several alternative implementation approaches can be compared under real-world conditions in prospective head-to-head experimental and non-experimental explorations to understand whether and to what extent a strategy works and what works for whom, how, and under what circumstances in different locations. As in breeding or evolution, the best variants would spread to become the new, proven superior, implementation strategies for that policy in those settings.
Conclusions
Evolution does not produce a new species whole, in a single transaction. Instead it gathers new parts and powers over time as different combinations are tested through competition with one another, to survive and spread or become extinct. Without necessarily changing or challenging grand policies, extending this idea to health systems innovation can facilitate thinking around how local, small – but cumulative – improvements in implementation potentially contribute to a pattern of successive adaptation spreading within its viable niche and ultimately providing locally-derived, long-term improvements in health systems.
doi:10.1186/s12961-015-0007-x
PMCID: PMC4359525  PMID: 25888822
Evaluation; Evolution; Health policy; Health systems
24.  Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651] 
Background
Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control.
Methods
Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control.
Results
At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening.
Conclusions
Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior.
Trial registration
ISRCTN72772651.
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-86) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-86
PMCID: PMC4261878  PMID: 25098442
Process evaluation; Theory of planned behavior; Printed educational material; Healthcare professional behavior; Behavior change
25.  Printed educational messages aimed at family practitioners fail to increase retinal screening among their patients with diabetes: a pragmatic cluster randomized controlled trial [ISRCTN72772651] 
Background
Evidence of the effectiveness of printed educational messages in narrowing the gap between guideline recommendations and practice is contradictory. Failure to screen for retinopathy exposes primary care patients with diabetes to risk of eye complications. Screening is initiated by referral from family practitioners but adherence to guidelines is suboptimal. We aimed to evaluate the ability of printed educational messages aimed at family doctors to increase retinal screening of primary care patients with diabetes.
Methods
Design: Pragmatic 2×3 factorial cluster trial randomized by physician practice, involving 5,048 general practitioners (with 179,833 patients with diabetes). Setting: Ontario family practitioners. Interventions: Reminders (that retinal screening helps prevent diabetes-related vision loss and is covered by provincial health insurance for patients with diabetes) with prompts to encourage screening were mailed to each physician in conjunction with a widely-read professional newsletter. Alternative printed materials formats were an ‘outsert’ (short, directive message stapled to the outside of the newsletter), and/or a two-page, evidence-based article (‘insert’) and a pre-printed sticky note reminder for patients. Main outcome measure: A successful outcome was an eye examination (which includes retinal screening) provided to a patient with diabetes, not screened in the previous 12 months, within 90 days after visiting a family practitioner. Analysis accounted for clustering of doctors within practice groups.
Results
No intervention effect was detected (eye exam rates were 31.6% for patients of control physicians, 31.3% for the insert, 32.8% for the outsert, 32.3% for those who received both, and 31.2% for those who received both plus the patient reminder with the largest 95% confidence interval around any effect extending from −1.3% to 1.1%).
Conclusions
This large trial conclusively failed to demonstrate any impact of printed educational messages on screening uptake. Despite their low cost, printed educational messages should not be routinely used in attempting to close evidence-practice gaps relating to diabetic retinopathy screening.
Trial registration
ISRCTN72772651
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-87) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-87
PMCID: PMC4261896  PMID: 25098587

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