PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (197)
 

Clipboard (0)
None

Select a Filter Below

Year of Publication
more »
1.  Thanks to all those who reviewed for Trials in 2014 
Trials  2015;16:55.
Contributing reviewers
A peer-reviewed journal would not survive without the generous time and insightful comments of the reviewers, whose efforts often go unrecognized. Although final decisions are always editorial, they are greatly facilitated by the deeper technical knowledge, scientific insights, understanding of social consequences, and passion that reviewers bring to our deliberations. For these reasons, the Editors-in-Chief and staff of the journal warmly thank the 610 reviewers whose comments helped to shape Trials, for their invaluable assistance with review of manuscripts for the journal in Volume 15 (2014).
doi:10.1186/s13063-015-0571-y
PMCID: PMC4336513
3.  Processes, contexts, and rationale for disinvestment: a protocol for a critical interpretive synthesis 
Systematic Reviews  2014;3(1):143.
Background
Practical solutions are needed to support the appropriate use of available health system resources as countries are continually pressured to ‘do more with less’ in health care. Increasingly, health systems and organizations are exploring the reassessment of possibly obsolete, inefficient, or ineffective health system resources and potentially redirecting funds to those that are more effective and efficient. Such processes are often referred to as ‘disinvestment’. Our objective is to gain further understanding about: 1) whether how and under what conditions health systems decide to pursue disinvestment; 2) how health systems have chosen to undertake disinvestment; and 3) how health systems have implemented their disinvestment approach.
Methods/Design
We will use a critical interpretive synthesis (CIS) approach, to develop a theoretical framework based on insights drawn from a range of relevant sources. We will conduct systematic searches of databases as well as purposive searches to identify literature to fill conceptual gaps that may emerge during our inductive process of synthesis and analysis. Two independent reviewers will assess search results for relevance and conceptually map included references. We will include all empirical and non-empirical articles that focus on disinvestment at a system level. We will then extract key findings from a purposive sample of articles using frameworks related to government agendas, policy development and implementation, and health system contextual factors and then synthesize and integrate the findings to develop a framework about our core areas of interest. Lastly, we will convene a stakeholder dialogue with Canadian and international policymakers and other stakeholders to solicit targeted feedback about the framework (e.g., by identifying any gaps in the literature that we may want to revisit before finalizing it) and deliberating about barriers for developing and implementing approaches to disinvestment, strategies to address these barriers and about next steps that could be taken by different constituencies.
Discussion
Disinvestment is an emerging field and there is a need for evidence to inform the prioritization, development, and implementation of strategies in different contexts. Our CIS and the framework developed through it will support the actions of those involved in the prioritization, development, and implementation of disinvestment initiatives.
Systematic review registration
PROSPERO CRD42014013204
Electronic supplementary material
The online version of this article (doi:10.1186/2046-4053-3-143) contains supplementary material, which is available to authorized users.
doi:10.1186/2046-4053-3-143
PMCID: PMC4273322  PMID: 25495034
Disinvestment; Critical interpretive synthesis; Health technologies; Health system context; Policy development; Policy implementation; Reassessment; Appropriateness
4.  Barriers, facilitators and views about next steps to implementing supports for evidence-informed decision-making in health systems: a qualitative study 
Background
Mobilizing research evidence for daily decision-making is challenging for health system decision-makers. In a previous qualitative paper, we showed the current mix of supports that Canadian health-care organizations have in place and the ones that are perceived to be helpful to facilitate the use of research evidence in health system decision-making. Factors influencing the implementation of such supports remain poorly described in the literature. Identifying the barriers to and facilitators of different interventions is essential for implementation of effective, context-specific, supports for evidence-informed decision-making (EIDM) in health systems. The purpose of this study was to identify (a) barriers and facilitators to implementing supports for EIDM in Canadian health-care organizations, (b) views about emerging development of supports for EIDM, and (c) views about the priorities to bridge the gaps in the current mix of supports that these organizations have in place.
Methods
This qualitative study was conducted in three types of health-care organizations (regional health authorities, hospitals, and primary care practices) in two Canadian provinces (Ontario and Quebec). Fifty-seven in-depth semi-structured telephone interviews were conducted with senior managers, library managers, and knowledge brokers from health-care organizations that have already undertaken strategic initiatives in knowledge translation. The interviews were taped, transcribed, and then analyzed thematically using NVivo 9 qualitative data analysis software.
Results
Limited resources (i.e., money or staff), time constraints, and negative attitudes (or resistance) toward change were the most frequently identified barriers to implementing supports for EIDM. Genuine interest from health system decision-makers, notably their willingness to invest money and resources and to create a knowledge translation culture over time in health-care organizations, was the most frequently identified facilitator to implementing supports for EIDM. The most frequently cited views about emerging development of supports for EIDM were implementing accessible and efficient systems to support the use of research in decision-making (e.g., documentation and reporting tools, communication tools, and decision support tools) and developing and implementing an infrastructure or position where the accountability for encouraging knowledge use lies. The most frequently stated priorities for bridging the gaps in the current mix of supports that these organizations have in place were implementing technical infrastructures to support research use and to ensure access to research evidence and establishing formal or informal ties to researchers and knowledge brokers outside the organization who can assist in EIDM.
Conclusions
These results provide insights on the type of practical implementation imperatives involved in supporting EIDM.
doi:10.1186/s13012-014-0179-8
PMCID: PMC4299810  PMID: 25476735
Evidence informed decision-making; Knowledge transfer and exchange; Knowledge translation
5.  A Systematic Review of Instruments to Assess Organizational Readiness for Knowledge Translation in Health Care 
PLoS ONE  2014;9(12):e114338.
Background
The translation of research into practices has been incomplete. Organizational readiness for change (ORC) is a potential facilitator of effective knowledge translation (KT). However we know little about the best way to assess ORC. Therefore, we sought to systematically review ORC measurement instruments.
Methods
We searched for published studies in bibliographic databases (Pubmed, Embase, CINAHL, PsychINFO, Web of Science, etc.) up to November 1st, 2012. We included publications that developed ORC measures and/or empirically assessed ORC using an instrument at the organizational level in the health care context. We excluded articles if they did not refer specifically to ORC, did not concern the health care domain or were limited to individual-level change readiness. We focused on identifying the psychometric properties of instruments that were developed to assess readiness in an organization prior to implementing KT interventions in health care. We used the Standards for Educational and Psychological Testing to assess the psychometric properties of identified ORC measurement instruments.
Findings
We found 26 eligible instruments described in 39 publications. According to the Standards for Educational and Psychological Testing, 18 (69%) of a total of 26 measurement instruments presented both validity and reliability criteria. The Texas Christian University –ORC (TCU-ORC) scale reported the highest instrument validity with a score of 4 out of 4. Only one instrument, namely the Modified Texas Christian University – Director version (TCU-ORC-D), reported a reliability score of 2 out of 3. No information was provided regarding the reliability and validity of five (19%) instruments.
Conclusion
Our findings indicate that there are few valid and reliable ORC measurement instruments that could be applied to KT in the health care sector. The TCU-ORC instrument presents the best evidence in terms of validity testing. Future studies using this instrument could provide more knowledge on its relevance to diverse clinical contexts.
doi:10.1371/journal.pone.0114338
PMCID: PMC4256226  PMID: 25474622
6.  A cross-sectional survey of supports for evidence-informed decision-making in healthcare organisations: a research protocol 
Background
This protocol builds on the development of a) a framework that identified the various supports (i.e. positions, activities, interventions) that a healthcare organisation or health system can implement for evidence-informed decision-making (EIDM) and b) a qualitative study that showed the current mix of supports that some Canadian healthcare organisations have in place and the ones that are perceived to facilitate the use of research evidence in decision-making. Based on these findings, we developed a web survey to collect cross-sectional data about the specific supports that regional health authorities and hospitals in two Canadian provinces (Ontario and Quebec) have in place to facilitate EIDM.
Methods/design
This paper describes the methods for a cross-sectional web survey among 32 regional health authorities and 253 hospitals in the provinces of Quebec and Ontario (Canada) to collect data on the current mix of organisational supports that these organisations have in place to facilitate evidence-informed decision-making. The data will be obtained through a two-step survey design: a 10-min survey among CEOs to identify key units and individuals in regard to our objectives (step 1) and a 20-min survey among managers of the key units identified in step 1 to collect information about the activities performed by their unit regarding the acquisition, assessment, adaptation and/or dissemination of research evidence in decision-making (step 2). The study will target three types of informants: CEOs, library/documentation centre managers and all other key managers whose unit is involved in the acquisition, assessment, adaptation/packaging and/or dissemination of research evidence in decision-making. We developed an innovative data collection system to increase the likelihood that only the best-informed respondent available answers each survey question. The reporting of the results will be done using descriptive statistics of supports by organisation type and by province.
Discussion
This study will be the first to collect and report large-scale cross-sectional data on the current mix of supports health system organisations in the two most populous Canadian provinces have in place for evidence-informed decision-making. The study will also provide useful information to researchers on how to collect organisation-level data with reduced risk of self-reporting bias.
doi:10.1186/s13012-014-0146-4
PMCID: PMC4197221  PMID: 25294109
Health systems; Knowledge translation; Research evidence; Cross-sectional study
7.  Are multifaceted interventions more effective than single-component interventions in changing health-care professionals’ behaviours? An overview of systematic reviews 
Background
One of the greatest challenges in healthcare is how to best translate research evidence into clinical practice, which includes how to change health-care professionals’ behaviours. A commonly held view is that multifaceted interventions are more effective than single-component interventions. The purpose of this study was to conduct an overview of systematic reviews to evaluate the effectiveness of multifaceted interventions in comparison to single-component interventions in changing health-care professionals’ behaviour in clinical settings.
Methods
The Rx for Change database, which consists of quality-appraised systematic reviews of interventions to change health-care professional behaviour, was used to identify systematic reviews for the overview. Dual, independent screening and data extraction was conducted. Included reviews used three different approaches (of varying methodological robustness) to evaluate the effectiveness of multifaceted interventions: (1) effect size/dose-response statistical analyses, (2) direct (non-statistical) comparisons of multifaceted to single interventions and (3) indirect comparisons of multifaceted to single interventions.
Results
Twenty-five reviews were included in the overview. Three reviews provided effect size/dose-response statistical analyses of the effectiveness of multifaceted interventions; no statistical evidence of a relationship between the number of intervention components and the effect size was found. Eight reviews reported direct (non-statistical) comparisons of multifaceted to single-component interventions; four of these reviews found multifaceted interventions to be generally effective compared to single interventions, while the remaining four reviews found that multifaceted interventions had either mixed effects or were generally ineffective compared to single interventions. Twenty-three reviews indirectly compared the effectiveness of multifaceted to single interventions; nine of which also reported either a statistical (dose-response) analysis (N = 2) or a non-statistical direct comparison (N = 7). The majority (N = 15) of reviews reporting indirect comparisons of multifaceted to single interventions showed similar effectiveness for multifaceted and single interventions when compared to controls. Of the remaining eight reviews, six found single interventions to be generally effective while multifaceted had mixed effectiveness.
Conclusion
This overview of systematic reviews offers no compelling evidence that multifaceted interventions are more effective than single-component interventions.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0152-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0152-6
PMCID: PMC4194373  PMID: 25287951
8.  Local opinion leaders: effects on professional practice and health care outcomes 
Background
Clinical practice is not always evidence-based and, therefore, may not optimise patient outcomes. Opinion leaders disseminating and implementing ‘best evidence’ is one method that holds promise as a strategy to bridge evidence-practice gaps.
Objectives
To assess the effectiveness of the use of local opinion leaders in improving professional practice and patient outcomes.
Search methods
We searched Cochrane EPOC Group Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, HMIC, Science Citation Index, Social Science Citation Index, ISI Conference Proceedings and World Cat Dissertations up to 5 May 2009. In addition, we searched reference lists of included articles.
Selection criteria
Studies eligible for inclusion were randomised controlled trials investigating the effectiveness of using opinion leaders to disseminate evidence-based practice and reporting objective measures of professional performance and/or health outcomes.
Data collection and analysis
Two review authors independently extracted data from each study and assessed its risk of bias. For each trial, we calculated the median risk difference (RD) for compliance with desired practice, adjusting for baseline where data were available. We reported the median adjusted RD for each of the main comparisons.
Main results
We included 18 studies involving more than 296 hospitals and 318 PCPs. Fifteen studies (18 comparisons) contributed to the calculations of the median adjusted RD for the main comparisons. The effects of interventions varied across the 63 outcomes from 15% decrease in compliance to 72% increase in compliance with desired practice. The median adjusted RD for the main comparisons were: i) Opinion leaders compared to no intervention, +0.09; ii) Opinion leaders alone compared to a single intervention, +0.14; iii) Opinion leaders with one or more additional intervention(s) compared to the one or more additional intervention(s), +0.10; iv) Opinion leaders as part of multiple interventions compared to no intervention, +0.10. Overall, across all 18 studies the median adjusted RD was +0.12 representing a 12% absolute increase in compliance in the intervention group.
Authors’ conclusions
Opinion leaders alone or in combination with other interventions may successfully promote evidence-based practice, but effectiveness varies both within and between studies. These results are based on heterogeneous studies differing in terms of type of intervention, setting, and outcomes measured. In most of the studies the role of the opinion leader was not clearly described, and it is therefore not possible to say what the best way is to optimise the effectiveness of opinion leaders.
doi:10.1002/14651858.CD000125.pub4
PMCID: PMC4172331  PMID: 21833939
*Leadership; *Policy Making; Evidence-Based Medicine [*standards]; Information Dissemination; Physician’s Practice Patterns; Process Assessment (Health Care); Professional Practice [*standards]; Randomized Controlled Trials as Topic; Humans
9.  Linked publications from a single trial: a thread of evidence 
Trials  2014;15(1):369.
doi:10.1186/1745-6215-15-369
PMCID: PMC4183771  PMID: 25248292
10.  The effects of on-screen, point of care computer reminders on processes and outcomes of care 
Background
The opportunity to improve care by delivering decision support to clinicians at the point of care represents one of the main incentives for implementing sophisticated clinical information systems. Previous reviews of computer reminder and decision support systems have reported mixed effects, possibly because they did not distinguish point of care computer reminders from e-mail alerts, computer-generated paper reminders, and other modes of delivering ‘computer reminders’.
Objectives
To evaluate the effects on processes and outcomes of care attributable to on-screen computer reminders delivered to clinicians at the point of care.
Search methods
We searched the Cochrane EPOC Group Trials register, MEDLINE, EMBASE and CINAHL and CENTRAL to July 2008, and scanned bibliographies from key articles.
Selection criteria
Studies of a reminder delivered via a computer system routinely used by clinicians, with a randomised or quasi-randomised design and reporting at least one outcome involving a clinical endpoint or adherence to a recommended process of care.
Data collection and analysis
Two authors independently screened studies for eligibility and abstracted data. For each study, we calculated the median improvement in adherence to target processes of care and also identified the outcome with the largest such improvement. We then calculated the median absolute improvement in process adherence across all studies using both the median outcome from each study and the best outcome.
Main results
Twenty-eight studies (reporting a total of thirty-two comparisons) were included. Computer reminders achieved a median improvement in process adherence of 4.2% (interquartile range (IQR): 0.8% to 18.8%) across all reported process outcomes, 3.3% (IQR: 0.5% to 10.6%) for medication ordering, 3.8% (IQR: 0.5% to 6.6%) for vaccinations, and 3.8% (IQR: 0.4% to 16.3%) for test ordering. In a sensitivity analysis using the best outcome from each study, the median improvement was 5.6% (IQR: 2.0% to 19.2%) across all process measures and 6.2% (IQR: 3.0% to 28.0%) across measures of medication ordering.
In the eight comparisons that reported dichotomous clinical endpoints, intervention patients experienced a median absolute improvement of 2.5% (IQR: 1.3% to 4.2%). Blood pressure was the most commonly reported clinical endpoint, with intervention patients experiencing a median reduction in their systolic blood pressure of 1.0 mmHg (IQR: 2.3 mmHg reduction to 2.0 mmHg increase).
Authors’ conclusions
Point of care computer reminders generally achieve small to modest improvements in provider behaviour. A minority of interventions showed larger effects, but no specific reminder or contextual features were significantly associated with effect magnitude. Further research must identify design features and contextual factors consistently associated with larger improvements in provider behaviour if computer reminders are to succeed on more than a trial and error basis.
doi:10.1002/14651858.CD001096.pub2
PMCID: PMC4171964  PMID: 19588323
*Decision Support Systems, Clinical; *Outcome and Process Assessment (Health Care); *Point-of-Care Systems; *Reminder Systems; Decision Making, Computer-Assisted; Humans
11.  The Cochrane Collaboration 20 years in 
doi:10.1503/cmaj.131251
PMCID: PMC3778497  PMID: 23979868
12.  Interventions to improve outpatient referrals from primary care to secondary care 
Background
The primary care specialist interface is a key organisational feature of many health care systems. Patients are referred to specialist care when investigation or therapeutic options are exhausted in primary care and more specialised care is needed. Referral has considerable implications for patients, the health care system and health care costs. There is considerable evidence that the referral processes can be improved.
Objectives
To estimate the effectiveness and efficiency of interventions to change outpatient referral rates or improve outpatient referral appropriateness.
Search methods
We conducted electronic searches of the Cochrane Effective Practice and Organisation of Care (EPOC) group specialised register (developed through extensive searches of MEDLINE, EMBASE, Healthstar and the Cochrane Library) (February 2002) and the National Research Register. Updated searches were conducted in MEDLINE and the EPOC specialised register up to October 2007.
Selection criteria
Randomised controlled trials, controlled clinical trials, controlled before and after studies and interrupted time series of interventions to change or improve outpatient referrals. Participants were primary care physicians. The outcomes were objectively measured provider performance or health outcomes.
Data collection and analysis
A minimum of two reviewers independently extracted data and assessed study quality.
Main results
Seventeen studies involving 23 separate comparisons were included. Nine studies (14 comparisons) evaluated professional educational interventions. Ineffective strategies included: passive dissemination of local referral guidelines (two studies), feedback of referral rates (one study) and discussion with an independent medical adviser (one study). Generally effective strategies included dissemination of guidelines with structured referral sheets (four out of five studies) and involvement of consultants in educational activities (two out of three studies). Four studies evaluated organisational interventions (patient management by family physicians compared to general internists, attachment of a physiotherapist to general practices, a new slot system for referrals and requiring a second ‘in-house’ opinion prior to referral), all of which were effective. Four studies (five comparisons) evaluated financial interventions. One study evaluating change from a capitation based to mixed capitation and fee-for-service system and from a fee-for-service to a capitation based system (with an element of risk sharing for secondary care services) observed a reduction in referral rates. Modest reductions in referral rates of uncertain significance were observed following the introduction of the general practice fundholding scheme in the United Kingdom (UK). One study evaluating the effect of providing access to private specialists demonstrated an increase in the proportion of patients referred to specialist services but no overall effect on referral rates.
Authors’ conclusions
There are a limited number of rigorous evaluations to base policy on. Active local educational interventions involving secondary care specialists and structured referral sheets are the only interventions shown to impact on referral rates based on current evidence. The effects of ‘in-house’ second opinion and other intermediate primary care based alternatives to outpatient referral appear promising.
doi:10.1002/14651858.CD005471.pub2
PMCID: PMC4164370  PMID: 18843691
*Medicine [organization & administration; standards]; *Outpatients; *Practice Guidelines as Topic; *Primary Health Care [economics; organization & administration; standards]; *Specialization; Controlled Clinical Trials as Topic; Economics, Medical; Family Practice [economics; organization & administration; standards]; Information Dissemination; Referral and Consultation [economics; organization & administration; *standards]; Humans
13.  Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol 
Systematic Reviews  2014;3:88.
Background
To improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions.
Methods/Design
We will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results.
Discussion
This study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes.
Systematic review registration
PROSPERO registration no. CRD42013005165
doi:10.1186/2046-4053-3-88
PMCID: PMC4174390  PMID: 25115289
Diabetes care; Knowledge translation; Quality improvement interventions; Complex Interventions; Health system decision-makers; Systematic review; Meta-analysis; Implementation science; Heterogeneity; Hierarchical modeling
14.  Theory of planned behaviour can help understand processes underlying the use of two emergency medicine diagnostic imaging rules 
Background
Clinical decision rules (CDRs) can be an effective tool for knowledge translation in emergency medicine, but their implementation is often a challenge. This study examined whether the Theory of Planned Behaviour (TPB) could help explain the inconsistent results between the successful Canadian C-Spine Rule (CCR) implementation study and unsuccessful Canadian CT Head Rule (CCHR) implementation study. Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time. The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability. The rules subsequently underwent parallel implementations at 12 Canadian hospitals, yet only the CCR was observed to significantly reduce radiography ordering rates, while the CCHR failed to have any significant impact at all. The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules.
Methods
Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies, before any intervention had taken place. The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data, and subsequently analyzed using mixed effects linear and logistic models.
Results
A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey (CCR: 122 of 181; CCHR: 101 of 197). Attitudes were significantly associated with intention in both settings (CCR: ß = 0.40; CCHR: ß = 0.30), as were subjective norms (CCR: ß = 0.26; CCHR: ß = 0.73). Intention was significantly associated with actual image ordering for CCR (OR = 1.79), but not CCHR.
Conclusions
The TPB can be used to better understand processes underlying use of CDRs. TPB constructs were significantly associated with intention to perform both imaging behaviours, but intention was only associated with actual behaviour for CCR, suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0088-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0088-x
PMCID: PMC4243777  PMID: 25099167
Clinical decision rules; Canadian C-Spine Rule; Canadian CT-Head Rule; Theory of planned behaviour; Emergency physicians; Implementation study
15.  Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651] 
Background
Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control.
Methods
Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control.
Results
At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening.
Conclusions
Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior.
Trial registration
ISRCTN72772651.
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-86) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-86
PMCID: PMC4261878  PMID: 25098442
Process evaluation; Theory of planned behavior; Printed educational material; Healthcare professional behavior; Behavior change
16.  Printed educational messages aimed at family practitioners fail to increase retinal screening among their patients with diabetes: a pragmatic cluster randomized controlled trial [ISRCTN72772651] 
Background
Evidence of the effectiveness of printed educational messages in narrowing the gap between guideline recommendations and practice is contradictory. Failure to screen for retinopathy exposes primary care patients with diabetes to risk of eye complications. Screening is initiated by referral from family practitioners but adherence to guidelines is suboptimal. We aimed to evaluate the ability of printed educational messages aimed at family doctors to increase retinal screening of primary care patients with diabetes.
Methods
Design: Pragmatic 2×3 factorial cluster trial randomized by physician practice, involving 5,048 general practitioners (with 179,833 patients with diabetes). Setting: Ontario family practitioners. Interventions: Reminders (that retinal screening helps prevent diabetes-related vision loss and is covered by provincial health insurance for patients with diabetes) with prompts to encourage screening were mailed to each physician in conjunction with a widely-read professional newsletter. Alternative printed materials formats were an ‘outsert’ (short, directive message stapled to the outside of the newsletter), and/or a two-page, evidence-based article (‘insert’) and a pre-printed sticky note reminder for patients. Main outcome measure: A successful outcome was an eye examination (which includes retinal screening) provided to a patient with diabetes, not screened in the previous 12 months, within 90 days after visiting a family practitioner. Analysis accounted for clustering of doctors within practice groups.
Results
No intervention effect was detected (eye exam rates were 31.6% for patients of control physicians, 31.3% for the insert, 32.8% for the outsert, 32.3% for those who received both, and 31.2% for those who received both plus the patient reminder with the largest 95% confidence interval around any effect extending from −1.3% to 1.1%).
Conclusions
This large trial conclusively failed to demonstrate any impact of printed educational messages on screening uptake. Despite their low cost, printed educational messages should not be routinely used in attempting to close evidence-practice gaps relating to diabetic retinopathy screening.
Trial registration
ISRCTN72772651
Electronic supplementary material
The online version of this article (doi:10.1186/1748-5908-9-87) contains supplementary material, which is available to authorized users.
doi:10.1186/1748-5908-9-87
PMCID: PMC4261896  PMID: 25098587
17.  Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol 
Background
Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice.
Objectives
The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability.
Methods
Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability.
Discussion
This intervention development work reflects the UK Medical Research Council’s guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0092-1) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0092-1
PMCID: PMC4243714  PMID: 25070404
Audit and feedback; Blood transfusion; Implementation; Health services research; Study protocol; Health professional behaviour change
18.  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
20.  Growing Literature, Stagnant Science? Systematic Review, Meta-Regression and Cumulative Analysis of Audit and Feedback Interventions in Health Care 
Journal of General Internal Medicine  2014;29(11):1534-1541.
ABSTRACT
BACKGROUND
This paper extends the findings of the Cochrane systematic review of audit and feedback on professional practice to explore the estimate of effect over time and examine whether new trials have added to knowledge regarding how optimize the effectiveness of audit and feedback.
METHODS
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for randomized trials of audit and feedback compared to usual care, with objectively measured outcomes assessing compliance with intended professional practice. Two reviewers independently screened articles and abstracted variables related to the intervention, the context, and trial methodology. The median absolute risk difference in compliance with intended professional practice was determined for each study, and adjusted for baseline performance. The effect size across studies was recalculated as studies were added to the cumulative analysis. Meta-regressions were conducted for studies published up to 2002, 2006, and 2010 in which characteristics of the intervention, the recipients, and trial risk of bias were tested as predictors of effect size.
RESULTS
Of the 140 randomized clinical trials (RCTs) included in the Cochrane review, 98 comparisons from 62 studies met the criteria for inclusion. The cumulative analysis indicated that the effect size became stable in 2003 after 51 comparisons from 30 trials. Cumulative meta-regressions suggested new trials are contributing little further information regarding the impact of common effect modifiers. Feedback appears most effective when: delivered by a supervisor or respected colleague; presented frequently; featuring both specific goals and action-plans; aiming to decrease the targeted behavior; baseline performance is lower; and recipients are non-physicians.
DISCUSSION
There is substantial evidence that audit and feedback can effectively improve quality of care, but little evidence of progress in the field. There are opportunity costs for patients, providers, and health care systems when investigators test quality improvement interventions that do not build upon, or contribute toward, extant knowledge.
doi:10.1007/s11606-014-2913-y
PMCID: PMC4238192  PMID: 24965281
audit and feedback; scientific progress; quality improvement; systematic review; cumulative analysis
21.  Impact of stated barriers on proposed warfarin prescription for atrial fibrillation: a survey of Canadian physicians 
Thrombosis Journal  2014;12:13.
Background
Atrial fibrillation (AF) is a common cardiac arrhythmia, and leading cause of ischemic stroke. Despite proven effectiveness, warfarin remains an under-used treatment in atrial fibrillation patients. We sought to study, across three physician specialties, a range of factors that have been argued to have a disproportionate effect on treatment decisions.
Methods
Cross-sectional survey of Canadian Family Doctors (FD: n = 500), Geriatricians (G: n = 149), and Internal Medicine specialists (IMS: n = 500). Of these, 1032 physicians were contactable, and 335 completed and usable responses were received. Survey questions and clinical vignettes asked about the frequency with which they see patients with atrial fibrillation, treatment practices, and barriers to the prescription of anticoagulants.
Results
Stated prescribing practices did not significantly differ between physician groups. Falls risk, bleeding risk and poor patient adherence were all highly cited barriers to prescribing warfarin. Fewer geriatricians indicated that history of patient falls would be a reason for not treating with warfarin (G: 47%; FD: 71%; IMS: 72%), and significantly fewer changed reported practice in the presence of falls risk (χ2 (6) = 45.446, p < 0.01). Experience of a patient having a stroke whilst not on warfarin had a significant impact on vignette decisions; physicians who had had patients who experienced a stroke were more likely to prescribe warfarin (χ2 (3) =10.7, p = 0.013).
Conclusions
Barriers to treatment of atrial fibrillation with warfarin affect physician specialties to different extents. Prior experience of a patient suffering a stroke when not prescribed warfarin is positively associated with intention to prescribe warfarin, even in the presence of falls risk.
doi:10.1186/1477-9560-12-13
PMCID: PMC4144316  PMID: 25161388
22.  Design, implementation, and evaluation of a knowledge translation intervention to increase organ donation after cardiocirculatory death in Canada: a study protocol 
Background
A shortage of transplantable organs is a global problem. There are two types of organ donation: living and deceased. Deceased organ donation can occur following neurological determination of death (NDD) or cardiocirculatory death. Donation after cardiocirculatory death (DCD) accounts for the largest increments in deceased organ donation worldwide. Variations in the use of DCD exist, however, within Canada and worldwide. Reasons for these discrepancies are largely unknown. The purpose of this study is to develop, implement, and evaluate a theory-based knowledge translation intervention to provide practical guidance about how to increase the numbers of DCD organ donors without reducing the numbers of standard NDD donors.
Methods
We will use a mixed method three-step approach. In step one, we will conduct semi-structured interviews, informed by the Theoretical Domains Framework, to identify and describe stakeholders’ beliefs and attitudes about DCD and their perceptions of the multi-level factors that influence DCD. We will identify: determinants of the evidence-practice gap; specific behavioural changes and/or process changes needed to increase DCD; specific group(s) of clinicians or organizations (e.g., provincial donor organizations) in need of behaviour change; and specific targets for interventions. In step two, using the principles of intervention mapping, we will develop a theory-based knowledge translation intervention that encompasses behavior change techniques to overcome the identified barriers and enhance the enablers to DCD. In step three, we will roll out the intervention in hospitals across the 10 Canadian provinces and evaluate its effectiveness using a multiple interrupted time series design.
Discussion
We will adopt a behavioural approach to define and test novel, theory-based, and ethically-acceptable knowledge translation strategies to increase the numbers of available DCD organ donors in Canada. If successful, this study will ultimately lead to more transplantations, reducing patient morbidity and mortality at a population-level.
doi:10.1186/1748-5908-9-80
PMCID: PMC4082291  PMID: 24950719
23.  The use of segmented regression in analysing interrupted time series studies: an example in pre-hospital ambulance care 
Background
An interrupted time series design is a powerful quasi-experimental approach for evaluating effects of interventions introduced at a specific point in time. To utilize the strength of this design, a modification to standard regression analysis, such as segmented regression, is required. In segmented regression analysis, the change in intercept and/or slope from pre- to post-intervention is estimated and used to test causal hypotheses about the intervention. We illustrate segmented regression using data from a previously published study that evaluated the effectiveness of a collaborative intervention to improve quality in pre-hospital ambulance care for acute myocardial infarction (AMI) and stroke. In the original analysis, a standard regression model was used with time as a continuous variable. We contrast the results from this standard regression analysis with those from segmented regression analysis. We discuss the limitations of the former and advantages of the latter, as well as the challenges of using segmented regression in analysing complex quality improvement interventions.
Findings
Based on the estimated change in intercept and slope from pre- to post-intervention using segmented regression, we found insufficient evidence of a statistically significant effect on quality of care for stroke, although potential clinically important effects for AMI cannot be ruled out.
Conclusions
Segmented regression analysis is the recommended approach for analysing data from an interrupted time series study. Several modifications to the basic segmented regression analysis approach are available to deal with challenges arising in the evaluation of complex quality improvement interventions.
doi:10.1186/1748-5908-9-77
PMCID: PMC4068621  PMID: 24943919
Interrupted time series design; Segmented regression analysis; Quality improvement collaborative
24.  Effectiveness of brief interventions as part of the Screening, Brief Intervention and Referral to Treatment (SBIRT) model for reducing the nonmedical use of psychoactive substances: a systematic review 
Systematic Reviews  2014;3:50.
Background
The purpose of this systematic review is to assess the effectiveness of brief interventions (BIs) as part of the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model for reducing the nonmedical use of psychoactive substances.
Methods
Bibliographic databases (including MEDLINE, Embase, The Cochrane Library, CINAHL, and PsycINFO to April 2012) and gray literature sources were searched. We included randomized controlled trials that opportunistically screened adolescents or adults and then provided a one-to-one, verbal BI to those at risk of substance-use harm. Of interest was the nonmedical use of psychoactive substances (for example, drugs prohibited by international law), excluding alcohol, nicotine, and caffeine. Interventions comprised four or fewer sessions and were compared with no/delayed intervention or provision of information only. Studies were assessed for bias using the Cochrane risk of bias tool. Results were synthesized narratively. Evidence was interpreted according to the GRADE framework.
Results
We identified 8,836 records. Of these, five studies met our inclusion criteria. Two studies compared BI with no BI, and three studies compared BI with information only. Studies varied in characteristics such as substances targeted, screening procedures, and BI administered. Outcomes were mostly reported by a single study, leading to limited or uncertain confidence in effect estimates.
Conclusions
Insufficient evidence exists as to whether BIs, as part of SBIRT, are effective or ineffective for reducing the use of, or harms associated with nonmedical use of, psychoactive substances when these interventions are administered to nontreatment-seeking, screen-detected populations. Updating this review with emerging evidence will be important.
Trial registration
CRD42012002414
doi:10.1186/2046-4053-3-50
PMCID: PMC4042132  PMID: 24887418
brief intervention; drug use; psychoactive substance; SBIRT; screening; substance use; systematic review
25.  Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals 
Background
New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care.
Aim
To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes.
Design/methods
We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use.
Discussion
Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care.
Trial registration
ISRCTN66498413.
doi:10.1186/1748-5908-9-61
PMCID: PMC4049486  PMID: 24886606

Results 1-25 (197)