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1.  The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework 
Background
The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework.
Methods
The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets.
Results
A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes.
Conclusions
This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.
Trial registration
ISRCTN18046709 - Peri-operative Implementation Study Evaluation (PoISE).
doi:10.1186/1748-5908-8-28
PMCID: PMC3636004  PMID: 23497438
2.  A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial 
PLoS Medicine  2011;8(4):e1001018.
Philip Ayieko and colleagues report the outcomes of a cluster-randomized trial carried out in eight Kenyan district hospitals evaluating the effects of a complex intervention involving improved training and supervision for clinicians. They found a higher performance of hospitals assigned to the complex intervention on a variety of process of care measures, as compared to those receiving the control intervention.
Background
In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.
Methods and Findings
This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n = 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n = 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline.
In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean = 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05–0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%–26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [−3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%–48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; −6.5% [−12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; −6.8% [−11.9% to −1.6%]).
Conclusions
Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.
Trial registration
Current Controlled Trials ISRCTN42996612
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2008, nearly 10 million children died in early childhood. Nearly all these deaths were in low- and middle-income countries—half were in Africa. In Kenya, for example, 74 out every 1,000 children born died before they reached their fifth birthday. About half of all childhood (pediatric) deaths in developing countries are caused by pneumonia, diarrhea, and malaria. Deaths from these common diseases could be prevented if all sick children had access to quality health care in the community (“primary” health care provided by health centers, pharmacists, family doctors, and traditional healers) and in district hospitals (“secondary” health care). Unfortunately, primary health care facilities in developing countries often lack essential diagnostic capabilities and drugs, and pediatric hospital care is frequently inadequate with many deaths occurring soon after admission. Consequently, in 1996, as part of global efforts to reduce childhood illnesses and deaths, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) introduced the Integrated Management of Childhood Illnesses (IMCI) strategy. This approach to child health focuses on the well-being of the whole child and aims to improve the case management skills of health care staff at all levels, health systems, and family and community health practices.
Why Was This Study Done?
The implementation of IMCI has been evaluated at the primary health care level, but its implementation in district hospitals has not been evaluated. So, for example, interventions designed to encourage the routine use of WHO disease-specific guidelines in rural pediatric hospitals have not been tested. In this cluster randomized trial, the researchers develop and test a multifaceted intervention designed to improve the implementation of treatment guidelines and admission pediatric care in district hospitals in Kenya. In a cluster randomized trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions and the outcomes in different “clusters” of patients are compared. In this trial, each cluster is a district hospital.
What Did the Researchers Do and Find?
The researchers randomly assigned eight Kenyan district hospitals to the “full” or “control” intervention, interventions that differed in intensity but that both included more strategies to promote implementation of best practice than are usually applied in Kenyan rural hospitals. The full intervention included provision of clinical practice guidelines and training in their use, six-monthly survey-based hospital assessments followed by face-to-face feedback of survey findings, 5.5 days training for health care workers, provision of job aids such as structured pediatric admission records, external supervision, and the identification of a local facilitator to promote guideline use and to provide on-site problem solving. The control intervention included the provision of clinical practice guidelines (without training in their use) and job aids, six-monthly surveys with written feedback, and a 1.5-day lecture-based seminar to explain the guidelines. The researchers compared the implementation of various processes of care (activities of patients and doctors undertaken to ensure delivery of care) in the intervention and control hospitals at baseline and 18 months later. The performance of both groups of hospitals improved during the trial but more markedly in the intervention hospitals than in the control hospitals. At 18 months, the completion of admission assessment tasks and the uptake of guideline-recommended clinical practices were both higher in the intervention hospitals than in the control hospitals. Moreover, a lower proportion of children received inappropriate doses of drugs such as quinine for malaria in the intervention hospitals than in the control hospitals.
What Do These Findings Mean?
These findings show that specific efforts are needed to improve pediatric care in rural Kenya and suggest that interventions that include more approaches to changing clinical practice may be more effective than interventions that include fewer approaches. These findings are limited by certain aspects of the trial design, such as the small number of participating hospitals, and may not be generalizable to other hospitals in Kenya or to hospitals in other developing countries. Thus, although these findings seem to suggest that efforts to implement and scale up improved secondary pediatric health care will need to include more than the production and dissemination of printed materials, further research including trials or evaluation of test programs are necessary before widespread adoption of any multifaceted approach (which will need to be tailored to local conditions and available resources) can be contemplated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001018.
WHO provides information on efforts to reduce global child mortality and on Integrated Management of Childhood Illness (IMCI); the WHO pocket book “Hospital care for children contains guidelines for the management of common illnesses with limited resources (available in several languages)
UNICEF also provides information on efforts to reduce child mortality and detailed statistics on child mortality
The iDOC Africa Web site, which is dedicated to improving the delivery of hospital care for children and newborns in Africa, provides links to the clinical guidelines and other resources used in this study
doi:10.1371/journal.pmed.1001018
PMCID: PMC3071366  PMID: 21483712
3.  A Multifaceted Intervention to Improve the Quality of Care of Children in District Hospitals in Kenya: A Cost-Effectiveness Analysis 
PLoS Medicine  2012;9(6):e1001238.
A cost-effective analysis conducted by Edwine Barasa and colleagues estimates that a complex intervention aimed at improving quality of pediatric care would be affordable and cost-effective in Kenya.
Background
To improve care for children in district hospitals in Kenya, a multifaceted approach employing guidelines, training, supervision, feedback, and facilitation was developed, for brevity called the Emergency Triage and Treatment Plus (ETAT+) strategy. We assessed the cost effectiveness of the ETAT+ strategy, in Kenyan hospitals. Further, we estimate the costs of scaling up the intervention to Kenya nationally and potential cost effectiveness at scale.
Methods and Findings
Our cost-effectiveness analysis from the provider's perspective used data from a previously reported cluster randomized trial comparing the full ETAT+ strategy (n = 4 hospitals) with a partial intervention (n = 4 hospitals). Effectiveness was measured using 14 process measures that capture improvements in quality of care; their average was used as a summary measure of quality. Economic costs of the development and implementation of the intervention were determined (2009 US$). Incremental cost-effectiveness ratios were defined as the incremental cost per percentage improvement in (average) quality of care. Probabilistic sensitivity analysis was used to assess uncertainty. The cost per child admission was US$50.74 (95% CI 49.26–67.06) in intervention hospitals compared to US$31.1 (95% CI 30.67–47.18) in control hospitals. Each percentage improvement in average quality of care cost an additional US$0.79 (95% CI 0.19–2.31) per admitted child. The estimated annual cost of nationally scaling up the full intervention was US$3.6 million, approximately 0.6% of the annual child health budget in Kenya. A “what-if” analysis assuming conservative reductions in mortality suggests the incremental cost per disability adjusted life year (DALY) averted by scaling up would vary between US$39.8 and US$398.3.
Conclusion
Improving quality of care at scale nationally with the full ETAT+ strategy may be affordable for low income countries such as Kenya. Resultant plausible reductions in hospital mortality suggest the intervention could be cost-effective when compared to incremental cost-effectiveness ratios of other priority child health interventions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
According to latest global estimates from UNICEF, 7.6 million children currently die every year before they reach five years of age. Half of these deaths occur in children in sub-Saharan Africa and tragically, most of these deaths are due to a few treatable and preventable diseases, such as pneumonia, malaria, and diarrhea, for which effective interventions are already available. In order to meet the target of the 4th Millennium Development Goal—which aims to reduce the under-five child mortality rate by two-thirds from 1990 levels by 2015—delivering these interventions is essential.
In Kenya, the under-five child mortality rate must be reduced by half from its 2008 level in order to meet the Millennium Development Goal (MDG) target and so improving the management of serious child illness might help achieve this goal. A study published last year in PLoS Medicine described such an approach and included the development and implementation of evidence-based clinical practice guidelines linked to health worker training, follow-up supervision, performance feedback, and facilitation in eight district hospitals in Kenya.
Why Was This Study Done?
In the study mentioned above, the researchers compared the implementation of various processes of care in intervention and control hospitals at baseline and 18 months later and found that performance improved more in the intervention hospitals than in the control hospitals. However, while this strategy was effective at improving the quality of health care, it is unclear whether scaling up the approach would be a good use of limited resources. So in this study, the same researchers performed a cost-effectiveness analysis (which they conducted alongside the original trial) of their quality improvement intervention and estimated the costs and effects of scaling up this approach to cover the entire population of Kenya.
What Did the Researchers Do and Find?
In order to perform the cost part of the analysis, the researchers collected the relevant information on costs by using clinical and accounting record reviews and interviews with those involved in developing and implementing the intervention. The researchers evaluated the effectiveness part of the analysis by comparing the implementation of their improved quality of care strategy as delivered in the intervention hospitals with the partial intervention as delivered in the control hospitals by calculating the mean percentage improvement in the 14 process of care indicators at 18 months. Finally, the researchers calculated the costs of scaling up the intervention by applying their results to the whole of Kenya—121 hospital facilities with an estimated annual child admission rate of 2,000 per facility.
The researchers found that the quality of care (as measured by the process of care indicators) was 25% higher in intervention hospitals than in control hospitals, while the cost per child admission was US$50.74 in intervention hospitals compared to US$31.1 in control hospitals. The researchers calculated that each percentage improvement in the average quality of care was achieved at an additional cost of US$0.79 per admitted child. Extrapolating these results to all of Kenya, the estimated annual cost of scaling up the intervention nationally was US$3.6 million, about 0.6% of the annual child health budget in Kenya.
What Do These Findings Mean?
The findings of this cost-effectiveness analysis suggests that a comprehensive quality improvement intervention is effective at improving standards of care but at an additional cost, which may be relatively cost effective compared with basic care if the improvements observed are associated with decreases in child inpatient mortality. The absolute costs for scaling up are comparable to, or even lower than, costs of other, major child health interventions. As the international community is giving an increasing focus to strengthening health systems, these findings provide a strong case for scaling up this intervention, which improves quality of care and service provision for the major causes of child mortality, in rural hospitals throughout Kenya and other district hospitals in sub-Saharan Africa.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001238.
The researchers' original article appeared in PLoS Medicine in 2011: Ayieko P, Ntoburi S, Wagai J, Opondo C, Opiyo N, et al. (2011) A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial. PLoS Med 8(4): e1001018. doi:10.1371/journal.pmed.1001018
The IDOC Africa provides further information on the ETAT+ strategy
The World Health Organization (WHO) provides information on MDG 4, including strategies to reduce global child mortality) and the WHO pocket-book “Hospital care for children” includes guidelines for the management of common but serious childhood illnesses in resource-limited settings
UNICEF www.unicef.org also publishes information on global child mortality rates and the Countdown to 2015 website tracks coverage levels for health interventions proven to reduce child mortality
doi:10.1371/journal.pmed.1001238
PMCID: PMC3373608  PMID: 22719233
4.  Long-Term Survival and Dialysis Dependency Following Acute Kidney Injury in Intensive Care: Extended Follow-up of a Randomized Controlled Trial 
PLoS Medicine  2014;11(2):e1001601.
Martin Gallagher and colleagues examine the long-term outcomes of renal replacement therapy (RRT) dosing in patients with acute kidney injury randomized to normal vs. augmented RRT.
Please see later in the article for the Editors' Summary
Background
The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI.
Methods and Findings
We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0–48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96–1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63–2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration.
Conclusions
Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis.
Trial registration
www.ClinicalTrials.gov NCT00221013
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Throughout life, the kidneys perform the essential task of filtering waste products (from the normal breakdown of tissues and from food) and excess water from the blood to make urine. Chronic kidney disease (caused, for example, by diabetes) gradually destroys the kidneys' filtration units (the nephrons), eventually leading to life-threatening end-stage kidney disease. However, the kidneys can also stop working suddenly because of injury, infection, or poisoning. Acute kidney injury (AKI) is much more common than end-stage kidney disease and its incidence is increasing worldwide. In the US, for example, the number of hospitalizations that included an AKI diagnosis rose from 4,000 in 1996 to 23,000 in 2008. Moreover, nearly half of patients with AKI will die shortly after the condition develops. Symptoms of AKI include changes in urination, swollen feet and ankles, and tiredness. Treatments for AKI aim to prevent fluid and waste build up in the body and treat the underlying cause (e.g., severe infection or dehydration) while allowing the kidneys time to recover. In some patients, it is sufficient to limit the fluid intake and to reduce waste build-up by eating a diet that is low in protein, salt, and potassium. Other patients need renal replacement therapy (RRT), life-supporting treatments such as hemodialysis and hemofiltration, two processes that clean the blood by filtering it outside the body.
Why Was This Study Done?
The long-term outcomes of AKI (specifically, death and chronic kidney disease) and the effects of different RRT modalities on these outcomes are unclear. A recent controlled trial that randomly assigned patients with AKI who were managed in intensive care units (ICUs) to receive two different intensities of continuous hemodiafiltration (a combination of hemodialysis and hemofiltration) found no difference in all-cause mortality (death) at 90 days. Here, the researchers extend the follow-up of this trial (the Randomized Evaluation of Normal vs. Augmented Levels of renal replacement therapy [RENAL] study) to investigate longer-term mortality, the variables that predict mortality, treatment with long-term dialysis (an indicator of chronic kidney disease), and functional outcomes in patients with AKI treated with different intensities of continuous RRT.
What Did the Researchers Do and Find?
For the Prolonged Outcomes Study of RENAL (POST-RENAL), the researchers extended the follow-up of the RENAL participants up to 4 years. Over an average follow-up of 43.9 months, 63% of patients in the lower intensity treatment group died compared to 62% of patients in the higher intensity group. Overall, a third of patients who survived to 90 days died during the extended follow-up. Among the survivors to day 90, 5.1% and 5.8% of patients in the lower and higher intensity groups, respectively, were treated with maintenance dialysis during the extended follow-up. Among survivors who consented to analysis, 40% and 44% of patients in the lower and higher intensity groups, respectively, had albuminuria (protein in the urine, an indicator of kidney damage). Patients in both groups had a similar quality life (determined through telephone interviews). Finally, increasing age, APACHE III score (a scoring system that predicts the survival of patients in ICU), and serum creatinine level (an indicator of kidney function) at randomization were all predictors of long-term mortality.
What Do These Findings Mean?
These findings indicate that patients with AKI in ICUs who require RRT have a high long-term mortality. They show that few survivors require maintenance dialysis for chronic kidney disease but that there is a substantial rate of albuminuria among survivors despite relative preservation of kidney function. The findings also suggest that the intensity of RRT has no significant effect on mortality or the need for dialysis. Because these findings were obtained in a randomized controlled trial, they may not be generalizable to other patient populations. Moreover, although data on mortality and maintenance dialysis were available for all the trial participants, clinical and biochemical outcomes were only available for some participants and may not be representative of all the participants. Despite these study limitations, these findings suggest that survivors of AKI may be at a high risk of death or of developing chronic kidney disease. Survivors of AKI are, therefore, at high risk of further illness and long-term albuminuria reduction strategies may offer a therapeutic intervention for this group of patients.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001601.
The US National Kidney and Urologic Diseases Information Clearinghouse provides information about the kidneys and about all aspects of kidney disease and its treatment; the US National Kidney Disease Education Program provides resources to help improve the understanding, detection, and management of kidney disease (in English and Spanish)
The Mayo Clinic provides information for patients about acute kidney injury
Wikipedia has a page on acute kidney injury (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The not-for-profit UK National Kidney Federation provides support and information for patients with kidney disease and for their carers, including a link to a video about acute kidney injury
World Kidney Day, a joint initiative between the International Society of Nephrology and the International Federation of Kidney Foundations (IFKF), aims to raise awareness about kidneys and kidney disease; its website provides information about acute kidney injury
The MedlinePlus Encyclopedia has a pages about acute kidney failure and about renal dialysis
The UK National Institute for Health and Care Excellence (NICE) recently published new guidelines on the treatment of acute kidney injury; a clinical practice guideline for acute kidney injury produced by KDIGO (a not-for-profit organization that aims to improve the care and outcomes of kidney disease patients worldwide through the development and implementation of global clinical practice guidelines) is available; the Acute Kidney Injury app provides a fast and simple way to explore guidelines on the diagnosis, prevention, and management of AKI
doi:10.1371/journal.pmed.1001601
PMCID: PMC3921111  PMID: 24523666
5.  The Effectiveness of Community Action in Reducing Risky Alcohol Consumption and Harm: A Cluster Randomised Controlled Trial 
PLoS Medicine  2014;11(3):e1001617.
In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.
Background
The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.
Methods and Findings
We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000–20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department–based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001–2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = −3.37 to −0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates.
Conclusions
This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000123448
Please see later in the article for the Editors' Summary
Editors' Summary
Background
People have consumed alcoholic beverages throughout history, but alcohol use is now an increasing global public health problem. According to the World Health Organization's 2010 Global Burden of Disease Study, alcohol use is the fifth leading risk factor (after high blood pressure and smoking) for disease and is responsible for 3.9% of the global disease burden. Alcohol use contributes to heart disease, liver disease, depression, some cancers, and many other health conditions. Alcohol also affects the well-being and health of people around those who drink, through alcohol-related crimes and road traffic crashes. The impact of alcohol use on disease and injury depends on the amount of alcohol consumed and the pattern of drinking. Most guidelines define long-term risky drinking as more than four drinks per day on average for men or more than two drinks per day for women (a “drink” is, roughly speaking, a can of beer or a small glass of wine), and short-term risky drinking (also called binge drinking) as seven or more drinks on a single occasion for men or five or more drinks on a single occasion for women. However, recent changes to the Australian guidelines acknowledge that a lower level of alcohol consumption is considered risky (with lifetime risky drinking defined as more than two drinks a day and binge drinking defined as more than four drinks on one occasion).
Why Was This Study Done?
In 2010, the World Health Assembly endorsed a global strategy to reduce the harmful use of alcohol. This strategy emphasizes the importance of community action–a process in which a community defines its own needs and determines the actions that are required to meet these needs. Although community action is highly acceptable to community members, few studies have looked at the effectiveness of community action in reducing risky alcohol consumption and alcohol-related harm. Here, the researchers undertake a cluster randomized controlled trial (the Alcohol Action in Rural Communities [AARC] project) to quantify the effectiveness of community action in reducing risky alcohol consumption and harms in rural communities in Australia. A cluster randomized trial compares outcomes in clusters of people (here, communities) who receive alternative interventions assigned through the play of chance.
What Did the Researchers Do and Find?
The researchers pair-matched 20 rural Australian communities according to the proportion of their population that was Aboriginal (rates of alcohol-related harm are disproportionately higher among Aboriginal individuals than among non-Aboriginal individuals in Australia; they are also higher among young people and males, but the proportions of these two groups across communities was comparable). They randomly assigned one member of each pair to the experimental group and implemented 13 interventions in these communities by negotiating with key individuals in each community to define and implement each intervention. Examples of interventions included general practitioner training in screening for alcohol use disorders and in implementing a brief intervention, and a school-based interactive session designed to reduce alcohol harm among young people. The researchers quantified the effectiveness of the interventions using routinely collected data on alcohol-related crime and road traffic crashes, and on hospital inpatient admissions for alcohol dependence or abuse (which were expected to increase in the experimental group if the intervention was effective because of more people seeking or being referred for treatment). They also examined drinking habits and experiences of alcohol-related harm, such as verbal abuse, among community members using pre- and post-intervention surveys. After implementation of the interventions, the rates of alcohol-related crime, road traffic crashes, and hospital admissions, and of risky and hazardous/harmful alcohol consumption (measured using a validated tool called the Alcohol Use Disorders Identification Test) were not statistically significantly different in the experimental and control communities (a difference in outcomes that is not statistically significantly different can occur by chance). However, the reported average weekly consumption of alcohol was 20% lower in the experimental communities after the intervention than in the control communities (equivalent to 1.9 fewer standard drinks per week per respondent) and there was less alcohol-related verbal abuse post-intervention in the experimental communities than in the control communities.
What Do These Findings Mean?
These findings provide little evidence that community action reduced risky alcohol consumption and alcohol-related harms in rural Australian communities. Although there was some evidence of significant reductions in self-reported weekly alcohol consumption and in experiences of alcohol-related verbal abuse, these findings must be interpreted cautiously because they are based on surveys with very low response rates. A larger or differently designed study might provide statistically significant evidence for the effectiveness of community action in reducing risky alcohol consumption. However, given their findings, the researchers suggest that legislative approaches that are beyond the control of individual communities, such as alcohol taxation and restrictions on alcohol availability, may be required to effectively reduce alcohol harms. In other words, community action alone may not be the most effective way to reduce alcohol-related harm.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001617.
The World Health Organization provides detailed information about alcohol; its fact sheet on alcohol includes information about the global strategy to reduce the harmful use of alcohol; the Global Information System on Alcohol and Health provides further information about alcohol, including information on control policies around the world
The US National Institute on Alcohol Abuse and Alcoholism has information about alcohol and its effects on health
The US Centers for Disease Control and Prevention has a website on alcohol and public health that includes information on the health risks of excessive drinking
The UK National Health Service Choices website provides detailed information about drinking and alcohol, including information on the risks of drinking too much, tools for calculating alcohol consumption, and personal stories about alcohol use problems
MedlinePlus provides links to many other resources on alcohol
More information about the Alcohol Action in Rural Communities project is available
doi:10.1371/journal.pmed.1001617
PMCID: PMC3949675  PMID: 24618831
6.  Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for breastfeeding women living in disadvantaged areas 
BMJ Open  2012;2(2):e001039.
Objective
To assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.
Design
Participatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.
Setting
A postnatal ward in Scotland.
Sample
Women initiating breast feeding and living in disadvantaged areas.
Methods
Quantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.
Main outcome measures
Quantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.
Results
A median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff–team–woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.
Conclusions
Implementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.
Trial registration
ISRCTN27207603. The study protocol and final report is available on request.
Article summary
Article focus
To use a participatory approach to design, deliver and implement a feeding support team intervention integrated into routine postnatal ward care and to deliver a pilot randomised controlled trial (RCT) of proactive and reactive telephone support for breast feeding for up to 14 days after hospital discharge for women living in more disadvantaged areas.
To use a mixed qualitative and quantitative methods process evaluation to assess the study acceptability, feasibility and intervention fidelity from the perspectives of women and National Health Service staff.
To inform the design of a future definitive RCT.
Key messages
Women living in disadvantaged areas are unlikely to initiate calls for help with breast feeding and proactive telephone calls may help to counteract the inverse care law.
Women undervalue both breast feeding and their own needs compared with the needs of others as a reason to ask for help in the context of overstretched maternity services.
A caring, reassuring woman-centred communication style with continuity of care from hospital to home was valued and increased women's confidence.
Strengths and limitations of this study
The participatory approach embedding a rigorous RCT within a before-and-after cohort study with mixed-methods data to evaluate implementation processes and costs are strengths that will enable us to design a feasible and acceptable definitive trial.
The contribution of the personal characteristics and skills of the feeding team to the intervention was important and may be challenging to replicate.
The low number of women who reported having an entire breast feed observed is a limitation and warrants further investigation.
More research is required before feeding teams and proactive calls are widely implemented as there are likely to be unintended consequences to such an organisational change in postnatal care.
doi:10.1136/bmjopen-2012-001039
PMCID: PMC3341595  PMID: 22535794
7.  Effect of an Educational Toolkit on Quality of Care: A Pragmatic Cluster Randomized Trial 
PLoS Medicine  2014;11(2):e1001588.
In a pragmatic cluster-randomized trial, Baiju Shah and colleagues evaluated the effectiveness of printed educational materials for clinician education focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Please see later in the article for the Editors' Summary
Background
Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Methods and Findings
All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.
Conclusions
The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.
Trial Registration
http://www.ClinicalTrials.gov NCT01411865 and NCT01026688
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Clinical practice guidelines help health care providers deliver the best care to patients by combining all the evidence on disease management into specific recommendations for care. However, the implementation of evidence-based guidelines is often far from perfect. Take the example of diabetes. This common chronic disease, which is characterized by high levels of sugar (glucose) in the blood, impairs the quality of life of patients and shortens life expectancy by increasing the risk of cardiovascular diseases (conditions that affect the heart and circulation) and other life-threatening conditions. Patients need complex care to manage the multiple risk factors (high blood sugar, high blood pressure, high levels of fat in the blood) that are associated with the long-term complications of diabetes, and they need to be regularly screened and treated for these complications. Clinical practice guidelines for diabetes provide recommendations on screening and diagnosis, drug treatment, and cardiovascular disease risk reduction, and on helping patients self-manage their disease. Unfortunately, the care delivered to patients with diabetes frequently fails to meet the standards laid down in these guidelines.
Why Was This Study Done?
How can guideline adherence and the quality of care provided to patients be improved? A common approach is to send printed educational materials to clinicians. For example, when the Canadian Diabetes Association (CDA) updated its clinical practice guidelines in 2008, it mailed educational toolkits that contained brochures and other printed materials targeting key themes from the guidelines to family physicians. In this pragmatic cluster randomized trial, the researchers investigate the effect of the CDA educational toolkit that targeted cardiovascular disease screening and treatment on the quality of care of people with diabetes. A pragmatic trial asks whether an intervention works under real-life conditions and whether it works in terms that matter to the patient; a cluster randomized trial randomly assigns groups of people to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers randomly assigned family practices in Ontario, Canada to receive the educational toolkit in June 2009 (intervention group) or in May 2010 (control group). They examined outcomes between July 2009 and April 2010 in all patients with diabetes in Ontario aged over 40 years (933,789 people) using population-level administrative data. In Canada, administrative databases record the personal details of people registered with provincial health plans, information on hospital visits and prescriptions, and physician service claims for consultations, assessments, and diagnostic and therapeutic procedures. They also examined clinical outcome data from a random sample of 1,592 patients at high risk of cardiovascular complications. In the administrative data study, death or non-fatal heart attack (the primary outcome) occurred in about 11,500 patients in both the intervention and control group. In the clinical data study, the primary outcome―use of a statin to lower blood fat levels―occurred in about 700 patients in both study groups. Secondary outcomes, including other clinical events, processes of care, and measures of risk factor control were also not improved by the intervention. Indeed, in the administrative data study, some processes of care outcomes related to screening for heart disease were statistically significantly worse in the intervention group than in the control group, and in the clinical data study, fewer patients in the intervention group reached blood pressure targets than in the control group.
What Do These Findings Mean?
These findings suggest that the CDA cardiovascular diseases educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Indeed, the toolkit may have led to worsening in some secondary outcomes although, because numerous secondary outcomes were examined, this may be a chance finding. Limitations of the study include its length, which may have been too short to see an effect of the intervention on clinical outcomes, and the possibility of a ceiling effect—the control group in the clinical data study generally had good care, which left little room for improvement of the quality of care in the intervention group. Overall, however, these findings suggest that printed educational materials may not be an effective way to improve the quality of care for patients with diabetes and other complex conditions and highlight the need for a rigorous, scientific approach to the development, dissemination, and evaluation of quality improvement interventions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001588.
The US National Diabetes Information Clearinghouse provides information about diabetes for patients, health care professionals, and the general public (in English and Spanish)
The UK National Health Service Choices website provides information (including some personal stories) for patients and carers about type 2 diabetes, the commonest form of diabetes
The Canadian Diabetes Association also provides information about diabetes for patients (including some personal stories about living with diabetes) and health care professionals; its latest clinical practice guidelines are available on its website
The UK National Institute for Health and Care Excellence provides general information about clinical guidelines and about health care quality standards in the UK
The US Agency for Healthcare Research and Quality aims to improve the quality, safety, efficiency, and effectiveness of health care for all Americans (information in English and Spanish); the US National Guideline Clearinghouse is a searchable database of clinical practice guidelines
The International Diabetes Federation provides information about diabetes for patients and health care professionals, along with international statistics on the burden of diabetes
doi:10.1371/journal.pmed.1001588
PMCID: PMC3913553  PMID: 24505216
8.  Rational Prescribing in Primary Care (RaPP): A Cluster Randomized Trial of a Tailored Intervention 
PLoS Medicine  2006;3(6):e134.
Background
A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.
Methods and Findings
We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals.
The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49–2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
Conclusions
Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.
Editors' Summary
Background.
An important issue in health care is “getting research into practice,” in other words, making sure that, when evidence from research has established the best way to treat a disease, doctors actually use that approach with their patients. In reality, there is often a gap between evidence and practice.
  An example concerns the treatment of people who have high blood pressure (hypertension) and/or high cholesterol. These are common conditions, and both increase the risk of having a heart attack or a stroke. Research has shown that the risks can be lowered if patients with these conditions are given drugs that lower blood pressure (antihypertensives) and drugs that lower cholesterol. There are many types of these drugs now available. In many countries, the health authorities want family doctors (general practitioners) to make better use of these drugs. They want doctors to prescribe them to everyone who would benefit, using the type of drugs found to be most effective. When there is a choice of drugs that are equally effective, they want doctors to use the cheapest type. (In the case of antihypertensives, an older type, known as thiazides, is very effective and also very cheap, but many doctors prefer to give their patients newer, more expensive alternatives.) Health authorities have issued guidelines to doctors that address these issues. However, it is not easy to change prescribing practices, and research in several countries has shown that issuing guidelines has only limited effects.
Why Was This Study Done?
The researchers wanted—in two parts of Norway—to compare the effects on prescribing practices of what they called the “passive dissemination of guidelines” with a more active approach, where the use of the guidelines was strongly promoted and encouraged.
What Did the Researchers Do and Find?
They worked with 146 general practices. In half of them the guidelines were actively promoted. The remaining were regarded as a control group; they were given the guidelines but no special efforts were made to encourage their use. It was decided at random which practices would be in which group; this approach is called a randomized controlled trial. The methods used to actively promote use of the guidelines included personal visits to the practices by pharmacists and use of a computerized reminder system. Information was then collected on the number of patients who, when first treated for hypertension, were prescribed a thiazide. Other information collected included whether patients had been properly assessed for their level of risk (for strokes and heart attacks) before antihypertensive or cholesterol-lowering drugs were given. In addition, the researchers recorded whether the recommended targets for improvement in blood pressure and cholesterol level had been reached.
Only 11% of those patients visiting the control group of practices who should have been prescribed thiazides, according to the guidelines, actually received them. Of those seen by doctors in the practices where the guidelines were actively promoted, 17% received thiazides. According to statistical analysis, the increase achieved by active promotion is significant. Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
What Do These Findings Mean?
Even in the active promotion group, the great majority of patients (83%) were still not receiving treatment according to the guidelines. However, active promotion of guidelines is more effective than simply issuing the guidelines by themselves. The study also demonstrates that it is very hard to change prescribing practices. The efforts made here to encourage the doctors to change were considerable, and although the results were significant, they were still disappointing. Also disappointing is the fact that achievement of treatment goals was no better in the active-promotion group. These issues are discussed further in a Perspective about this study (DOI: 10.1371/journal.pmed.0030229).
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030134.
• The Web site of the American Academy of Family Physicians has a page on heart disease
• The MedlinePlus Medical Encyclopedia's pages on heart diseases and vascular diseases
• Information from NHS Direct (UK National Health Service) about heart attack and stroke
• Another PLoS Medicine article has also addressed trends in thiazide prescribing
Passive dissemination of management guidelines for hypertension and hypercholesterolaemia was compared with active promotion. Active promotion led to significant improvement in antihypertensive prescribing but not other aspects of management.
doi:10.1371/journal.pmed.0030134
PMCID: PMC1472695  PMID: 16737346
9.  Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial 
PLoS Medicine  2013;10(9):e1001518.
In a randomized controlled trial, Hugh MacPherson and colleagues investigate the effectiveness of acupuncture and counseling compared with usual care alone for the treatment of depression symptoms in primary care settings.
Please see later in the article for the Editors' Summary
Background
Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care.
Methods and Findings
In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2∶2∶1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat.
PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (−2.46, 95% CI −3.72 to −1.21) and counselling (−1.73, 95% CI −3.00 to −0.45), and over 12 months for acupuncture (−1.55, 95% CI −2.41 to −0.70) and counselling (−1.50, 95% CI −2.43 to −0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported.
Conclusions
In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.
Trial Registration
Controlled-Trials.com ISRCTN63787732
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Depression–overwhelming sadness and hopelessness–is responsible for a substantial proportion of the global disease burden and is a major cause of suicide. It affects more than 350 million people worldwide and about one in six people will have an episode of depression during their lifetime. Depression is different from everyday mood fluctuations. For people who are clinically depressed, feelings of severe sadness, anxiety, hopelessness, and worthlessness can last for months and years. Affected individuals lose interest in activities they used to enjoy and sometimes have physical symptoms such as disturbed sleep. Clinicians can diagnose depression and determine its severity by asking patients to complete a questionnaire (for example, the Beck Depression Inventory [BDI-II] or the Patient Health Questionnaire 9 [PHQ-9]) about their feelings and symptoms. The answer to each question is given a score and the total score from the questionnaire (“depression rating scale”) indicates the severity of depression. Antidepressant drugs are usually the front-line treatment for depression in primary care.
Why Was This Study Done?
Unfortunately, antidepressants don't work for more than half of patients. Moreover, many patients would like to be offered non-pharmacological treatment options for depression such as acupuncture–a therapy originating from China in which fine needles are inserted into the skin at specific points of the body–and counseling–a “talking therapy” that provides patients with a safe, non-judgmental place to express feelings and emotions and that helps them recognize their capacity for growth and fulfillment. However, it is unclear whether either of these treatments is effective in depression. In this pragmatic randomized controlled trial, the researchers investigate the clinical effectiveness of acupuncture or counseling in patients with depression compared to usual care in primary care in northern England. A randomized controlled trial compares outcomes in groups of patients who are assigned to different interventions through the play of chance. A pragmatic trial asks whether the intervention works under real-life conditions. Patient selection reflects routine practice and some aspects of the intervention are left to the discretion of clinician, By contrast, an explanatory trial asks whether an intervention works under ideal conditions and involves a strict protocol for patient selection and treatment.
What Did the Researchers Do and Find?
The researchers recruited 755 patients who had consulted their primary health care provider about depression within the past 5 years and who had a score of more than 20 on the BDI-II–a score that is defined as moderate-to-severe depression on this depression rating scale–at the start of the study. Patients were randomized to receive up to 12 weekly sessions of acupuncture plus usual care (302 patients), up to 12 weekly sessions of counseling plus usual care (302 patients), or usual care alone (151 patients). Both the acupuncture protocol and the counseling protocols allowed for some individualization of treatment. Usual care, including antidepressants, was available according to need and monitored in all three groups. Compared to usual care alone, there was a significant reduction (a reduction unlikely to have occurred by chance) in the average PHQ-9 scores at both 3 and 6 months for both the acupuncture and counseling interventions. The difference between the mean PHQ-9 score for acupuncture and counseling was not significant. At 9 months and 12 months, because of improvements in the PHQ-9 scores in the usual care group, acupuncture and counseling were no longer significantly better than usual care.
What Do These Findings Mean?
These findings suggest that, compared to usual care alone, both acupuncture and counseling when provided alongside usual care provided significant benefits at 3 months in primary care to patients with recurring depression. Because this trial was a pragmatic trial, these findings cannot indicate which aspects of acupuncture and counseling are likely to be most or least beneficial. Nevertheless they do provide an estimate of the overall effects of these complex interventions, an estimate that is of most interest to patients, practitioners, and health care providers. Moreover, because this trial only considers the effect of these interventions on patients with moderate-to-severe depression as classified by the BDI-II; it provides no information about the effectiveness of acupuncture or counseling compared to usual care for patients with mild depression. Importantly, however, these findings suggest that further research into optimal treatment regimens for the treatment of depression with acupuncture and counseling is merited.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001518.
The US National Institute of Mental Health provides information on all aspects of depression (in English and Spanish)
The UK National Health Service Choices website provides detailed information about depression, including personal stories about depression, and information on counseling and acupuncture
The UK charity Mind provides information on depression, on talking treatments, and on complementary and alternative therapies including acupuncture; Mind also includes personal stories about depression on its website
More personal stories about depression are available from Healthtalkonline
MedlinePlus provides links to other resources about depression and about acupuncture (in English and Spanish)
doi:10.1371/journal.pmed.1001518
PMCID: PMC3782410  PMID: 24086114
10.  FIRE (facilitating implementation of research evidence): a study protocol 
Background
Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS) framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated) affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids.
Objectives
This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community.
Setting and sample
Four European countries, each with six long-term nursing care sites (total 24 sites) for people aged 60 years and over with documented urinary incontinence
Methods and design
Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation), with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline, then at 6, 12, 18, and 24 months after the start of the facilitation interventions. Detailed contextual and process data are collected throughout, using interviews with staff, residents and next of kin, observations, assessment of context using the Alberta Context Tool, and documentary evidence. A realistic evaluation framework is used to develop explanatory theory about what works for whom in what circumstances.
Trial registration
Current Controlled Trials ISRCTN11598502.
doi:10.1186/1748-5908-7-25
PMCID: PMC3356232  PMID: 22453077
11.  Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients? – Study protocol of a cluster randomised trial [ISRCTN41456865] 
Background
Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways.
We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT), the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster randomised trial.
Methods/design
Two-arm cluster-randomised trial (C-RCT). 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (no intervention, current practice). Arm 1 participants (152 physicians, 280 nurses, 50 drivers) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses.
Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the intervention. We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to: 1) promptness of interventions for hyperacute ischaemic stroke; 2) promptness of interventions for hyperacute haemorrhagic stroke 3) appropriate diagnosis. Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset <= 6 hour admitted to the stroke unit.
Discussion
The fields in which this trial will play are usually neglected by Randomised Controlled Trial (RCT). We have chosen the Cluster-randomised Controlled Trial (C-RCT) to address the issues of contamination, adherence to real practice, and community dimension of the intervention, with a complex definition of clusters and an extensive use of routine data to collect the outcomes.
doi:10.1186/1472-6963-5-66
PMCID: PMC1262716  PMID: 16219099
12.  Research on Implementation of Interventions in Tuberculosis Control in Low- and Middle-Income Countries: A Systematic Review 
PLoS Medicine  2012;9(12):e1001358.
Cobelens and colleagues systematically reviewed research on implementation and cost-effectiveness of the WHO-recommended interventions for tuberculosis.
Background
Several interventions for tuberculosis (TB) control have been recommended by the World Health Organization (WHO) over the past decade. These include isoniazid preventive therapy (IPT) for HIV-infected individuals and household contacts of infectious TB patients, diagnostic algorithms for rule-in or rule-out of smear-negative pulmonary TB, and programmatic treatment for multidrug-resistant TB. There is no systematically collected data on the type of evidence that is publicly available to guide the scale-up of these interventions in low- and middle-income countries. We investigated the availability of published evidence on their effectiveness, delivery, and cost-effectiveness that policy makers need for scaling-up these interventions at country level.
Methods and Findings
PubMed, Web of Science, EMBASE, and several regional databases were searched for studies published from 1 January 1990 through 31 March 2012 that assessed health outcomes, delivery aspects, or cost-effectiveness for any of these interventions in low- or middle-income countries. Selected studies were evaluated for their objective(s), design, geographical and institutional setting, and generalizability. Studies reporting health outcomes were categorized as primarily addressing efficacy or effectiveness of the intervention. These criteria were used to draw landscapes of published research. We identified 59 studies on IPT in HIV infection, 14 on IPT in household contacts, 44 on rule-in diagnosis, 19 on rule-out diagnosis, and 72 on second-line treatment. Comparative effectiveness studies were relatively few (n = 9) and limited to South America and sub-Saharan Africa for IPT in HIV-infection, absent for IPT in household contacts, and rare for second-line treatment (n = 3). Evaluations of diagnostic and screening algorithms were more frequent (n = 19) but geographically clustered and mainly of non-comparative design. Fifty-four studies evaluated ways of delivering these interventions, and nine addressed their cost-effectiveness.
Conclusions
There are substantial gaps in published evidence for scale-up for five WHO-recommended TB interventions settings at country level, which for many countries possibly precludes program-wide implementation of these interventions. There is a strong need for rigorous operational research studies to be carried out in programmatic settings to inform on best use of existing and new interventions in TB control.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Tuberculosis (TB), caused by Mycobacterium tuberculosis, is curable and preventable, but according to the World Health Organization (WHO), in 2011, 8.7 million people had symptoms of TB (usually a productive cough and fever) and 1.4 million people—95% from low- and middle-income countries—died from TB. TB is also the leading cause of death in people with HIV worldwide, and in 2010 about 10 million children were orphaned as a result of their parents dying from TB. To help reduce the considerable global burden of TB, a global initiative called the Stop TB Partnership, led by WHO, has implemented a strategy to reduce deaths from TB by 50% by 2015—even greater than the target of Millennium Development Goal 6 (to reverse the increase in TB incidence by 2015).
Why Was This Study Done?
Over the past few years, WHO has recommended that countries implement several interventions to help control the spread of tuberculosis through measures to improve prevention, diagnosis, and treatment. Five such interventions currently recommended by WHO are: treatment with isoniazid to prevent TB among people who are HIV positive, and also among household contacts of people infected with TB; the use of clinical pathways (algorithms) for diagnosing TB in people accessing health care who have a negative smear test—the most commonly used diagnostic test, which relies on sputum samples—(“rule-in algorithms”); screening algorithms for excluding TB in people who have HIV (“rule-out algorithms”); and finally, provision of second-line treatment for multidrug-resistant tuberculosis (a form of TB that does not respond to the most commonly used drugs) under programmatic conditions. The effectiveness of these interventions, their costs, and the practicalities of implementation are all important information for countries seeking to control TB following the WHO guidelines, but little is known about the availability of this information. Therefore, in this study the researchers systematically reviewed published studies to find evidence of the effectiveness of each of these interventions when implemented in routine practice, and also for additional information on the setting and conditions of implemented interventions, which might be useful to other countries.
What Did the Researchers Do and Find?
Using a specific search strategy, the researchers comprehensively searched through several key databases of publications, including regional databases, to identify 208 (out of 11,489 found initially) suitable research papers published between January 1990 and March 2012. For included studies, the researchers also noted the geographical location and setting and the type and design of study.
Of the 208 included studies, 59 focused on isoniazid prevention therapy in HIV infection, and only 14 on isoniazid prevention therapy for household contacts. There were 44 studies on “rule-in” clinical diagnosis, 19 on “rule-out” clinical diagnosis, and 72 studies on second-line treatment for TB. Studies on each intervention had some weaknesses, and overall, researchers found that there were very few real-world studies reporting on the effectiveness of interventions in program settings (rather than under optimal conditions in research settings). Few studies evaluated the methods used to implement the intervention or addressed delivery and operational issues (such as adherence to treatment), and there were limited economic evaluations of the recommended interventions. Furthermore, the researchers found that in general, the South Asian region was poorly represented.
What Do These Findings Mean?
These findings suggest that there is limited evidence on effectiveness, delivery, and cost-effectiveness to guide the scale-up of five WHO recommended interventions to control tuberculosis in the countries and settings, despite the urgent need for such interventions to be implemented. The poor evidence base identified in this review highlights the tension between the decision to adopt the recommendation and its implementation adapted to local circumstances, and may be an important reason as to why these interventions are not implemented in many countries. This study also suggests creative thinking is necessary to address the gaps between WHO recommendations and global health policy on new interventions and their real-world implementation in country-wide TB control programs. Future research should focus more on operational studies, the results of which should be made publicly available, and researchers, donors, and medical journals could perhaps re-consider their priorities to help bridge the knowledge gap identified in this study.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001358.
WHO has a wide range of information about TB and research on TB, including more about the STOP TB strategy and the STOP TB Partnership
The UN website has more information about MDG 6
The Global Fund to Fight AIDS, Tuberculosis and Malaria has specific information about progress on TB control
doi:10.1371/journal.pmed.1001358
PMCID: PMC3525528  PMID: 23271959
13.  An implementation-focused process evaluation of an incentive intervention effectiveness trial in substance use disorders clinics at two Veterans Health Administration medical centers 
Background
One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers.
Methods
Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators.
Results
Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers.
Conclusions
Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.
doi:10.1186/1940-0640-9-12
PMCID: PMC4106217  PMID: 25008457
Substance use disorders treatment; Abstinence incentive intervention; Implementation; Process evaluation; Hybrid design
14.  Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care interface 
BMJ : British Medical Journal  2001;322(7297):1282.
Objective
To investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface.
Design
Cluster randomised controlled trial.
Setting
General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area.
Participants
All 221 general practices in Glasgow; 214 completed the trial.
Intervention
General practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings.
Main outcome measures
The time from presentation to referral, investigations completed in general practice, the number and content of visits as a hospital outpatient, the time to reach a management plan, and costs for referrals from the two groups.
Results
Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P=0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected.
Conclusions
Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors. Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care.
What is already known on this topicMost previous research into clinical guidelines has focused on their development and implementationEvidence is lacking about the outcomes and costs associated with the use of clinical guidelinesWhat this study addsClinical guidelines that may alter the balance of care between general practice and hospital settings require more intensive implementation than guidelines aimed at either setting on its ownThe cost effectiveness of clinical guidelines should not be assumed
PMCID: PMC31924  PMID: 11375232
15.  Screening and brief interventions for hazardous and harmful alcohol use in primary care: a cluster randomised controlled trial protocol 
BMC Public Health  2009;9:287.
Background
There have been many randomized controlled trials of screening and brief alcohol intervention in primary care. Most trials have reported positive effects of brief intervention, in terms of reduced alcohol consumption in excessive drinkers. Despite this considerable evidence-base, key questions remain unanswered including: the applicability of the evidence to routine practice; the most efficient strategy for screening patients; and the required intensity of brief intervention in primary care. This pragmatic factorial trial, with cluster randomization of practices, will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in primary care and different intensities of brief intervention to reduce excessive drinking in primary care patients.
Methods and design
GPs and nurses from 24 practices across the North East (n = 12), London and South East (n = 12) of England will be recruited. Practices will be randomly allocated to one of three intervention conditions: a leaflet-only control group (n = 8); brief structured advice (n = 8); and brief lifestyle counselling (n = 8). To test the relative effectiveness of different screening methods all practices will also be randomised to either a universal or targeted screening approach and to use either a modified single item (M-SASQ) or FAST screening tool. Screening randomisation will incorporate stratification by geographical area and intervention condition. During the intervention stage of the trial, practices in each of the three arms will recruit at least 31 hazardous or harmful drinkers who will receive a short baseline assessment followed by brief intervention. Thus there will be a minimum of 744 patients recruited into the trial.
Discussion
The trial will evaluate the impact of screening and brief alcohol intervention in routine practice; thus its findings will be highly relevant to clinicians working in primary care in the UK. There will be an intention to treat analysis of study outcomes at 6 and 12 months after intervention. Analyses will include patient measures (screening result, weekly alcohol consumption, alcohol-related problems, public service use and quality of life) and implementation measures from practice staff (the acceptability and feasibility of different models of brief intervention.) We will also examine organisational factors associated with successful implementation.
Trial registration
Current Controlled Trials ISRCTN06145674.
doi:10.1186/1471-2458-9-287
PMCID: PMC2734851  PMID: 19664255
16.  A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework 
Background
The Promoting Action on Research Implementation in Health Services framework, or PARIHS, is a conceptual framework that posits key, interacting elements that influence successful implementation of evidence-based practices. It has been widely cited and used as the basis for empirical work; however, there has not yet been a literature review to examine how the framework has been used in implementation projects and research. The purpose of the present article was to critically review and synthesize the literature on PARIHS to understand how it has been used and operationalized, and to highlight its strengths and limitations.
Methods
We conducted a qualitative, critical synthesis of peer-reviewed PARIHS literature published through March 2009. We synthesized findings through a three-step process using semi-structured data abstraction tools and group consensus.
Results
Twenty-four articles met our inclusion criteria: six core concept articles from original PARIHS authors, and eighteen empirical articles ranging from case reports to quantitative studies. Empirical articles generally used PARIHS as an organizing framework for analyses. No studies used PARIHS prospectively to design implementation strategies, and there was generally a lack of detail about how variables were measured or mapped, or how conclusions were derived. Several studies used findings to comment on the framework in ways that could help refine or validate it. The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships. Strengths identified included its flexibility, intuitive appeal, explicit acknowledgement of the outcome of 'successful implementation,' and a more expansive view of what can and should constitute 'evidence.'
Conclusions
While we found studies reporting empirical support for PARIHS, the single greatest need for this and other implementation models is rigorous, prospective use of the framework to guide implementation projects. There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements; greater conceptual discrimination among sub-elements may be necessary first. In general, it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies.
doi:10.1186/1748-5908-5-82
PMCID: PMC2988065  PMID: 20973988
17.  The Effectiveness of Emergency Obstetric Referral Interventions in Developing Country Settings: A Systematic Review 
PLoS Medicine  2012;9(7):e1001264.
In a systematic review of the literature, Julia Hussein and colleagues seek to determine the effect of referral interventions that enable emergency access to health facilities for pregnant women living in developing countries.
Background
Pregnancy complications can be unpredictable and many women in developing countries cannot access health facilities where life-saving care is available. This study assesses the effects of referral interventions that enable pregnant women to reach health facilities during an emergency, after the decision to seek care is made.
Methods and findings
Selected bibliographic databases were searched with no date or language restrictions. Randomised controlled trials and quasi experimental study designs with a comparison group were included. Outcomes of interest included maternal and neonatal mortality and other intermediate measures such as service utilisation. Two reviewers independently selected, appraised, and extracted articles using predefined fields. Forest plots, tables, and qualitative summaries of study quality, size, and direction of effect were used for analysis.
Nineteen studies were included. In South Asian settings, four studies of organisational interventions in communities that generated funds for transport reduced neonatal deaths, with the largest effect seen in India (odds ratio 0·48 95% CI 0·34–0·68). Three quasi experimental studies from sub-Saharan Africa reported reductions in stillbirths with maternity waiting home interventions, with one statistically significant result (OR 0.56 95% CI 0.32–0.96). Effects of interventions on maternal mortality were unclear. Referral interventions usually improved utilisation of health services but the opposite effect was also documented. The effects of multiple interventions in the studies could not be disentangled. Explanatory mechanisms through which the interventions worked could not be ascertained.
Conclusions
Community mobilisation interventions may reduce neonatal mortality but the contribution of referral components cannot be ascertained. The reduction in stillbirth rates resulting from maternity waiting homes needs further study. Referral interventions can have unexpected adverse effects. To inform the implementation of effective referral interventions, improved monitoring and evaluation practices are necessary, along with studies that develop better understanding of how interventions work.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 350,000 women die from pregnancy- or childbirth-related complications. Almost all of these “maternal” deaths occur in developing countries. In sub-Saharan Africa, for example, the maternal mortality ratio (MMR, the number of maternal deaths per 100,000 live births) is 500 and a woman's life-time risk of dying from complications of pregnancy or childbirth is 1 in 39. By contrast, the MMR in industrialized countries is 12 and women have a life-time risk of maternal death of 1 in 4,700. Most maternal deaths are caused by hemorrhage (severe bleeding after childbirth), post-delivery infections, obstructed (difficult) labor, and blood pressure disorders during pregnancy, all of which are preventable or treatable conditions. Unfortunately, it is hard to predict which women will develop pregnancy complications, many complications rapidly become life-threatening and, in developing countries, women often deliver at home, far from emergency obstetric services; obstetrics deals with the care of women and their children during pregnancy, childbirth, and the postnatal period.
Why Was This Study Done?
It should be possible to reduce maternal deaths (and the deaths of babies during pregnancy, childbirth, and early life) in developing countries by ensuring that pregnant women are referred to emergency obstetric services quickly when the need arises. Unfortunately, in such countries referral to emergency obstetric care is beset with problems such as difficult geographical terrain, transport costs, lack of vehicles, and suboptimal location and distribution of health care facilities. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers assess the effectiveness of interventions designed to reduce the “phase II delay” in referral to emergency obstetric care in developing countries—the time it takes a woman to reach an appropriate health care facility once a problem has been recognized and the decision has been taken to seek care. Delays in diagnosis and the decision to seek care are phase I delays in referral, whereas delays in receiving care once a women reaches a health care facility are phase III delays.
What Did the Researchers Do and Find?
The researchers identified 19 published studies that described 14 interventions designed to overcome phase II delays in emergency obstetric referral and that met their criteria for inclusion in their systematic review. About half of the interventions were organizational. That is, they were designed to overcome barriers to referral such as costs. Most of the remaining interventions were structural. That is, they involved the provision of, for example, ambulances and maternity waiting homes—placed close to a health care facility where women can stay during late pregnancy. Although seven studies provided data on maternal mortality, none showed a sustained, statistically significant reduction (a reduction unlikely to have occurred by chance) in maternal deaths. Four studies in South Asia in which communities generated funds for transport reduced neonatal deaths (deaths of babies soon after birth), but the only statistically significant effect of this community mobilization intervention was seen in India where neonatal deaths were halved. Three studies from sub-Saharan Africa reported that the introduction of maternity waiting homes reduced stillbirths but this reduction was only significant in one study. Finally, although referral interventions generally improved the utilization of health services, in one study the provision of bicycle ambulances to take women to the hospital reduced the proportion of women delivering in health facilities, probably because women felt that bicycle ambulances drew unwanted attention to them during labor and so preferred to stay at home.
What Do These Findings Mean?
These findings suggest that community mobilization interventions may reduce neonatal mortality and that maternity waiting rooms may reduce stillbirths. Importantly, they also highlight how referral interventions can have unexpected adverse effects. However, because the studies included in this systematic review included multiple interventions designed to reduce delays at several stages of the referral process, it is not possible to disentangle the contribution of each component of the intervention. Moreover, it is impossible at present to determine why (or even if) any of the interventions reduced maternal mortality. Thus, the researchers conclude, improved monitoring of interventions and better evaluation of outcomes is essential to inform the implementation of effective referral interventions, and more studies are needed to improve understanding of how referral interventions work.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001264.
The United Nations Children's Fund (UNICEF) provides information on maternal mortality, including the WHO/UNICEF./UNFPA/World Bank 2008 country estimates of maternal mortality
The World Health Organization provides information on maternal health, including information about Millennium Development Goal 5, which aims to reduce maternal mortality (in several languages); the Millennium Development Goals, which were agreed by world leaders in 2000, are designed to eradicate extreme poverty worldwide by 2015
Immpact is a global research initiative for the evaluation of safe motherhood intervention strategies
Veil of Tears contains personal stories from Afghanistan about loss in childbirth; the non-governmental health development organization AMREF provides personal stories about maternal health in Africa
Maternal Death: The Avoidable Crisis is a briefing paper published by Médecins Sans Frontières (MSF) in March 2012
doi:10.1371/journal.pmed.1001264
PMCID: PMC3393680  PMID: 22807658
18.  An initiative to improve adherence to evidence-based guidelines in the treatment of URIs, sinusitis, and pharyngitis 
Background
Upper respiratory infections, acute sinus infections, and sore throats are common symptoms that cause patients to seek medical care. Despite well-established treatment guidelines, studies indicate that antibiotics are prescribed far more frequently than appropriate, raising a multitude of clinical issues.
Methods
The primary goal of this study was to increase guideline adherence rates for acute sinusitis, pharyngitis, and upper respiratory tract infections (URIs). This study was the first Plan-Do-Study-Act (PDSA) cycle in a quality improvement program at an internal medicine resident faculty practice at a university-affiliated community hospital internal medicine residency program. To improve guideline adherence for respiratory infections, a package of small-scale interventions was implemented aimed at improving patient and provider education regarding viral and bacterial infections and the necessity for antibiotics. The data from this study was compared with a previously published study in this practice, which evaluated the adherence rates for the treatment guidelines before the changes, to determine effectiveness of the modifications. After the first PDSA cycle, providers were surveyed to determine barriers to adherence to antibiotic prescribing guidelines.
Results
After the interventions, antibiotic guideline adherence for URI improved from a rate of 79.28 to 88.58% with a p-value of 0.004. The increase of adherence rates for sinusitis and pharyngitis were 41.7–57.58% (p=0.086) and 24.0–25.0% (p=0.918), respectively. The overall change in guideline adherence for the three conditions increased from 57.2 to 78.6% with the implementations (p<0.001). In planning for future PDSA cycles, a fishbone diagram was constructed in order to identify all perceived facets of the problem of non-adherence to the treatment guidelines for URIs, sinusitis, and pharyngitis. From the fishbone diagram and the provider survey, several potential directions for future work are discussed.
Conclusions
Passive interventions can result in small changes in antibiotic guideline adherence, but further PDSA cycles using more active methodologies are needed.
doi:10.3402/jchimp.v4.22958
PMCID: PMC3937558  PMID: 24596644
antibiotic; guideline; adherence
19.  The challenges of real-world implementation of web-based shared care software: the HopSCOTCH Shared-Care Obesity Trial in Children 
Background
E-health initiatives hold promise to improve shared-care models of health care. In 2008–2011 we developed and trialled web-based software to facilitate a randomised trial of a shared-care approach for childhood obesity involving General Practitioners (GPs) working with tertiary specialists. We describe the software’s development, implementation and evaluation, and make recommendations for future e-health initiatives. The web-based software was designed with the goals of allowing both GPs and specialists to communicate and review patient progress; integrating with existing GP software; and supporting GPs to deliver the structured intervention. Specifically, we aimed to highlight the challenges inherent in this process, and report on the extent to which the software ultimately met its implementation and user aims.
Methods
The study was conducted at the Royal Children’s Hospital and 22 general practices across Melbourne, Australia. Participants comprised 30 GPs delivering the shared-care intervention. Outcomes included the following. (1) GPs’ pre-specified software requirements: transcribed from two focus groups and analysed for themes using content analysis. (2) Software implementation and performance based on the experience of the research team and GPs. (3) GP users’ evaluation collected via questionnaire. (4) Software usage collected via GP questionnaire and qualified through visual inspection of the software meta-data.
Results
Software implementation posed difficult and at times disabling technological barriers (e.g. out-dated hardware, poor internet connections). The software’s speed and inability to seamlessly link with day-to-day software was a source of considerable frustration. Overall, GPs rated software usability as poor, although most (68%) felt that the structure and functionality of the software was useful. Recommendations for future e-health initiatives include thorough scoping of IT systems and server speed, testing across diverse environments, automated pre-requisite checks and upgrades of processors/memory where necessary, and user-created usernames and passwords.
Conclusions
GPs are willing to embrace novel technologies to support their practice. However, implementation remains challenging mainly for technical reasons, and this precludes further evaluation of potential user-specific barriers. These findings could inform future e-health ventures into shared-care, and highlight the need for an appropriate infrastructure.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN126080000553.
doi:10.1186/1472-6947-14-61
PMCID: PMC4115470  PMID: 25056431
Software; Patient care team; Electronic health records; Pediatric obesity; Primary health care; Tertiary healthcare
20.  Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study) 
Background
Potentially inappropriate prescribing (PIP) in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. The prevalence of PIP in Ireland is estimated at 36% with an associated expenditure of over €45 million in 2007. The aim of this paper is to describe the application of the Medical Research Council (MRC) framework to the development of an intervention to decrease PIP in Irish primary care.
Methods
The MRC framework for the design and evaluation of complex interventions guided the development of the study intervention. In the development stage, literature was reviewed and combined with information obtained from experts in the field using a consensus based methodology and patient cases to define the main components of the intervention. In the pilot stage, five GPs tested the proposed intervention. Qualitative interviews were conducted with the GPs to inform the development and implementation of the intervention for the main randomised controlled trial.
Results
The literature review identified PIP criteria for inclusion in the study and two initial intervention components - academic detailing and medicines review supported by therapeutic treatment algorithms. Through patient case studies and a focus group with a group of 8 GPs, these components were refined and a third component of the intervention identified - patient information leaflets. The intervention was tested in a pilot study. In total, eight medicine reviews were conducted across five GP practices. These reviews addressed ten instances of PIP, nine of which were addressed in the form of either a dose reduction or a discontinuation of a targeted medication. Qualitative interviews highlighted that GPs were receptive to the intervention but patient preference and time needed both to prepare for and conduct the medicines review, emerged as potential barriers. Findings from the pilot study allowed further refinement to produce the finalised intervention of academic detailing with a pharmacist, medicines review with web-based therapeutic treatment algorithms and tailored patient information leaflets.
Conclusions
The MRC framework was used in the development of the OPTI-SCRIPT intervention to decrease the level of PIP in primary care in Ireland. Its application ensured that the intervention was developed using the best available evidence, was acceptable to GPs and feasible to deliver in the clinical setting. The effectiveness of this intervention is currently being tested in a pragmatic cluster randomised controlled trial.
Trial registration
Current controlled trials ISRCTN41694007
doi:10.1186/1472-6963-13-307
PMCID: PMC3751793  PMID: 23941110
Medical research council framework; Multifaceted intervention; Potentially inappropriate prescribing; Randomised controlled trial
21.  Developing an active implementation model for a chronic disease management program 
Background
Introduction and diffusion of new disease management programs in healthcare is usually slow, but active theory-driven implementation seems to outperform other implementation strategies. However, we have only scarce evidence on the feasibility and real effect of such strategies in complex primary care settings where municipalities, general practitioners and hospitals should work together. The Central Denmark Region recently implemented a disease management program for chronic obstructive pulmonary disease (COPD) which presented an opportunity to test an active implementation model against the usual implementation model. The aim of the present paper is to describe the development of an active implementation model using the Medical Research Council’s model for complex interventions and the Chronic Care Model.
Methods
We used the Medical Research Council’s five-stage model for developing complex interventions to design an implementation model for a disease management program for COPD. First, literature on implementing change in general practice was scrutinised and empirical knowledge was assessed for suitability. In phase I, the intervention was developed; and in phases II and III, it was tested in a block- and cluster-randomised study. In phase IV, we evaluated the feasibility for others to use our active implementation model.
Results
The Chronic Care Model was identified as a model for designing efficient implementation elements. These elements were combined into a multifaceted intervention, and a timeline for the trial in a randomised study was decided upon in accordance with the five stages in the Medical Research Council’s model; this was captured in a PaTPlot, which allowed us to focus on the structure and the timing of the intervention. The implementation strategies identified as efficient were use of the Breakthrough Series, academic detailing, provision of patient material and meetings between providers. The active implementation model was tested in a randomised trial (results reported elsewhere).
Conclusion
The combination of the theoretical model for complex interventions and the Chronic Care Model and the chosen specific implementation strategies proved feasible for a practice-based active implementation model for a chronic-disease-management-program for COPD. Using the Medical Research Council’s model added transparency to the design phase which further facilitated the process of implementing the program.
Trial registration: http://www.clinicaltrials.gov/(NCT01228708).
PMCID: PMC3718271  PMID: 23882169
implementation; disease management; Denmark; Chronic Care Model; Breakthrough Series; PaTPlot
22.  The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease 
Background
The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology. It is being evaluated using the Medical Research Council's framework for the evaluation of complex interventions. This paper describes the feasibility results of Phase II: a single-blinded fast-track pragmatic randomised controlled trial.
Methods
A single-blinded fast-track pragmatic randomised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service. Patients were randomised to either receive the intervention immediately for an eight-week period, or receive the intervention after an eight-week period on a waiting list during which time they received standard care. Outcomes examined included: response rates to the trial; response rates to the individual questionnaires and items; comments relating to the trial functioning made during interviews with patients, carers, referrers and service providers; and, researcher fieldwork notes.
Results
16 of the 20 eligible patients agreed to participate in a recruitment visit (16/20); 14 respondents went on to complete a recruitment visit/baseline interview. The majority of those who completed a recruitment visit/baseline interview completed the RCT protocol (13/14); 12 of their carers were recruited and completed the protocol. An unblinding rate of 6/25 respondents (patients and carers) was identified. Missing data were minimal and only one patient was lost to follow up. The fast-track trial methodology proved feasible and acceptable. Two of the baseline/outcome measures proved unsuitable: the WHO performance scale and the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW).
Conclusion
This study adds to the evidence that fast-track randomised controlled trials are feasible and acceptable in evaluations of palliative care interventions for patients with non-malignant conditions. Reasonable response rates and low attrition rates were achieved. Further, with adequate preparation of the research and randomisation teams, clinicians, and responders, and effective liaison with the clinicians, single-blinding proved possible. Methods were identified to reduce unblinding through careful attention to the type of data collected at unblinded measurement points; the content of interviews should be carefully considered when designing blinded-trial protocols.
Trial registration
Clinical Trials.gov NCT00711438
doi:10.1186/1472-684X-8-9
PMCID: PMC2731082  PMID: 19583857
23.  Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial 
BMC Public Health  2014;14:608.
Background
To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.
Methods
Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program.
Discussion
Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally.
Trial registration
ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012
doi:10.1186/1471-2458-14-608
PMCID: PMC4071794  PMID: 24930478
Obesity; Prevention; Lifestyle; Women; Rural; Implementation; Translation; Population; RE-AIM
24.  Clustered randomised trial of an intervention to improve the management of asthma: Greenwich asthma study 
BMJ : British Medical Journal  1999;318(7193):1251-1255.
Objectives
To evaluate the effectiveness of an asthma resource centre in improving treatment and quality of life for asthmatic patients.
Design
Community based randomised controlled trial.
Setting
41 general practices in Greenwich with a practice nurse.
Subjects
All registered patients aged 15-50 years.
Intervention
Nurse specialists in asthma who educated and supported practice nurses, who in turn educated patients in the management of asthma according to the British Thoracic Society's guidelines.
Main outcome measures
Quality of life of asthmatic patients, attendance at accident and emergency departments, admissions to local hospitals, and steroid prescribing by general practitioners.
Results
Of 24 400 patients randomly selected and surveyed in 1993, 12 238 replied; 1621 were asthmatic of whom 1291 were sent a repeat questionnaire in 1996 and 780 replied. Of 24 400 patients newly surveyed in 1996, 10 783 (1616 asthmatic) replied. No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practices compared with control practices. Neither was there evidence of an improvement in other measures of the quality of asthma care. Weak evidence was found for an improvement in quality of life in intervention practices among asthmatics registered with study practices in 1993 and followed up in 1996. Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practices over the study period. Steroid prescribing rates rose steadily during the study period. The average annual increase in steroid prescribing was 3% per year higher in intervention than control practices (95% confidence interval −1% to 6%, P=0.10).
Conclusions
This model of service delivery is not effective in improving the outcome of asthma in the community. Further development is required if cost effective management of asthma is to be introduced.
Key messagesSmall randomised trials suggest that implementation of management guidelines can improve outcomes for asthmatic patients treated in specialist unitsRandomised trials also suggest that guidelines can improve the process of care in general practiceAn intervention in which specialist nurses trained and supported practice nurses in running asthma clinics on the basis of British Thoracic Society guidelines failed to improve asthma outcomes for patients over a 3 year periodFactors that may have reduced the potential impact of the measures include the large number of asthmatic patients that need to be cared for in primary care, and the high turnover of practice nurses in inner city areasFurther research is required on how best to implement good practice in inner city areas if cost effective interventions are to be devised
PMCID: PMC27864  PMID: 10231256
25.  Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial 
Trials  2014;15:281.
Background
Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed.
Methods/design
The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).
doi:10.1186/1745-6215-15-281
PMCID: PMC4107995  PMID: 25012235
Mild traumatic brain injury; Cluster trial; Emergency department

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