Little is known about the effectiveness of mobile apps in aiding smoking cessation or their validity for automated collection of data on smoking cessation outcomes.
We conducted a preliminary evaluation of SF28 (SF28 is the name of the app, short for SmokeFree28)—an app aimed at helping smokers to be smoke-free for 28 days.
Data on sociodemographic characteristics, smoking history, number of logins, and abstinence at each login were uploaded to a server from SF28 between August 2012 and August 2013. Users were included if they were aged 16 years or over, smoked cigarettes at the time of registration, had set a quit date, and used the app at least once on or after their quit date. Their characteristics were compared with data from a representative sample of smokers trying to stop smoking in England. The percentage of users recording 28 days of abstinence was compared with a value of 15% estimated for unaided quitting. Correlations were assessed between recorded abstinence for 28 days and well-established abstinence predictors.
A total of 1170 users met the inclusion criteria. Compared with smokers trying to quit in England, they had higher consumption, and were younger, more likely to be female, and had a non-manual rather than manual occupation. In total, 18.9% (95% CI 16.7-21.1) were recorded as being abstinent from smoking for 28 days or longer. The mean number of logins was 8.5 (SD 9.0). The proportion recording abstinence for 28 days or longer was higher in users who were older, in a non-manual occupation, and in those using a smoking cessation medication.
The recorded 28-day abstinence rates from the mobile app, SF28, suggest that it may help some smokers to stop smoking. Further evaluation by means of a randomized trial appears to be warranted.
smoking cessation intervention; mobile; smartphone; apps; PRIME theory
Internet-based health behaviour interventions have variable effects on health-related outcomes. Effectiveness may be improved by optimizing the design of interventions. This study examined the specific effect on engagement of providing two different design features – tailoring and self-assessment.
Three versions of an Internet-delivered intervention to support the self-care of mild bowel problems were developed that provided (1) self-assessment without tailored feedback, (2) self-assessment with tailored feedback, and (3) generic information only.
A qualitative study explored participants’ engagement with each version of the intervention (N = 24). A larger quantitative study systematically compared participants’ use of the intervention and self-reported engagement using a partial factorial design (n = 178).
Findings from the qualitative study suggested that self-assessment without tailored feedback appeared to be less acceptable to participants because it was viewed as offering no personal benefit in the absence of personalized advice. In the quantitative study, self-assessment without tailored feedback was associated with greater dropout than when provided in conjunction with tailored feedback. There were significant group differences in participants’ engagement with the intervention and perceptions of the intervention. Self-assessment without tailored feedback was rated as marginally less engaging and was associated with fewer positive perceptions than the generic information condition.
The acceptability of self-assessment or monitoring components may be optimized by also providing tailored feedback. Without tailored feedback, these components do not appear to be any more engaging than generic information provision.
Internet; tailoring; intervention; mixed methods; self-assessment; engagement; health
Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions. The development of smartphone-based health interventions (apps) is a rapidly growing field of research, yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines, particularly within the context of a hybrid Web- and app-based intervention.
This study used an in-depth mixed-methods design to examine individual variation in (1) impact on self-reported goal engagement (ie, motivation, self-efficacy, awareness, effort, achievement) of access to a weight management app (POWeR Tracker) when provided alongside a Web-based weight management intervention (POWeR) and (2) usage and views of POWeR Tracker.
Thirteen adults were provided access to POWeR and were monitored over a 4-week period. Access to POWeR Tracker was provided in 2 alternate weeks (ie, weeks 1 and 3 or weeks 2 and 4). Participants’ goal engagement was measured daily via self-report. Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants. Usage of POWeR and POWeR Tracker was automatically recorded for each participant. Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants’ experiences using POWeR and POWeR Tracker.
Access to POWeR Tracker was associated with a significant increase in participants’ awareness of their eating (β1=0.31, P=.04) and physical activity goals (β1=0.28, P=.03). The level of increase varied between individual participants. Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was (mean 29 minutes, SD 31 minutes) and was not available (mean 27 minutes, SD 33 minutes). POWeR Tracker was mostly accessed in short bursts (mean 3 minutes, SD 2 minutes) during convenient moments or moments when participants deemed the intervention content most relevant. The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer. However, participants varied in their views and usage of the Web- versus app-based components and the informational versus tracking tools provided by POWeR Tracker.
This study provides evidence that smartphones have the potential to improve individuals’ engagement with their health-related goals when used as a supplement to an existing online intervention. The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement. A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools.
qualitative research; weight loss; behavioral research; mobile apps; Internet; health; program acceptability; behavior; mixed-methods
Fabrizio Faggiano and colleagues discuss how a central, transparent, and evidence-based approval process is needed for behavioral prevention interventions in Europe and propose a way forward.
Please see later in the article for the Editors' Summary
Paul Glasziou and colleagues discuss methods to guide selection of an intervention from individual trials within a systematic review.
Please see later in the article for the Editors' Summary
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.
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.
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.
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.
Audit and feedback; Blood transfusion; Implementation; Health services research; Study protocol; Health professional behaviour change
Internet-based Smoking Cessation Interventions could help pregnant women quit smoking, especially those who do not wish to, or cannot, access face-to-face or telephone support. This study aimed to preliminarily evaluate the effectiveness and usage of a fully automated smoking cessation website targeted to pregnancy, ‘MumsQuit’, and obtain an initial effect-size estimate for a full scale trial.
We recruited 200 UK-based pregnant adult smokers online to a two-arm double-blind pilot RCT assessing the effectiveness of MumsQuit compared with an information-only website. MumsQuit was adapted from a generic internet smoking cessation intervention, ‘StopAdvisor’. The primary outcome was self-reported continuous 4-week abstinence assessed at 8 weeks post-baseline. Secondary outcomes were automatically collected data on intervention usage.
Participants smoked 15 cigarettes per day on average, 73% were in the first trimester of their pregnancy, 48% were from lower socioeconomic backgrounds, and 43% had never used evidence-based cessation support. The point estimate of odds ratio for the primary outcome was 1.5 (95% CI = 0.8–2.9; 28% vs. 21%). Compared with control participants, those in the MumsQuit group logged in more often (3.5 vs. 1.3, p < 0.001), viewed more pages (67.4 vs. 5.7, p < 0.001) and spent more time browsing the website (21.3 min vs. 1.0 min, p < 0.001).
MumsQuit is an engaging and potentially helpful form of support for pregnant women who seek cessation support online, and merits further development and evaluation in a full-scale RCT.
Smoking cessation; Pregnancy; Internet; Self-help
E-cigarettes may be effective smoking cessation aids and their use by smokers has been growing rapidly. It is important to observe and assess natural patterns in the use of e-cigarettes whilst experimental data accumulates. This paper reports the prevalence of e-cigarette awareness, beliefs and usage, including brand choice, and characterises the socio-demographic and smoking profile associated with current use, among the general population of smokers and recent ex-smokers.
Data were obtained from 3538 current and 579 recent ex-smokers in a cross-sectional online survey of a national sample of smokers in Great Britain in November and December 2012. Differences between current and recent ex-smokers in the prevalence of e-cigarette awareness, beliefs and usage were examined and the socio-demographic and smoking profile associated with current use of e-cigarettes was assessed in a series of simple and multiple logistic regressions.
Ninety-three percent of current and recent ex-smokers (n = 3841) were aware of e-cigarettes. Approximately a fifth (n = 884) were currently using e-cigarettes, whilst just over a third (n = 1507) had ever used them. Sixty-seven percent of the sample (n = 2758) believed e-cigarettes to be less harmful than cigarettes; however, almost a quarter (n = 994) remained unsure. Among both current and recent ex-smokers, the most popular reasons for using were health, cutting down and quitting (each > 80%) and 38% used the brand ‘E-lites’. Among current smokers who were aware of but had never used e-cigarettes, approximately half (n = 1040) were interested in using them in the future. Among current smokers, their use was associated with higher socio-economic status (OR = 1.48, 95%CI = 1.25–1.75), smoking more cigarettes (OR = 1.02, 95%CI = 1.01–1.03) and having a past-year quit attempt (OR = 2.82, 95%CI = 2.38–3.34).
There is a near universal awareness of e-cigarettes and their use appears to be common among smokers in Great Britain although a quarter of all smokers are unsure as to whether e-cigarettes are less harmful than cigarettes. E-lites – a brand that delivers a low dose of nicotine – is the most popular. E-cigarette users appear to have higher socio-economic status, to smoke more cigarettes per day and to have attempted to quit in the past year.
•There is now near universal awareness of e-cigarettes.•Use is common among smokers.•Quarter of all smokers unsure as to whether they are less harmful than cigarettes.•E-lites – a brand that delivers a low dose of nicotine – is the most popular.•Users have higher SES, smoke more heavily and have attempted to quit recently.
Smoking; Cessation; Quitting; E-cigarettes; Electronic cigarettes
A wide range of diverse and inconsistent terminology exists in the field of knowledge translation. This limits the conduct of evidence syntheses, impedes communication and collaboration, and undermines knowledge translation of research findings in diverse settings. Improving uniformity of terminology could help address these challenges. In 2012, we convened an international working group to explore the idea of developing a common terminology and an overarching framework for knowledge translation interventions.
Methods included identifying and summarizing existing frameworks, mapping together a subset of those frameworks, and convening a multi-disciplinary group to begin working toward consensus. The group considered four potential approaches to creating a simplified framework: melding existing taxonomies, creating a framework of intervention mechanisms rather than intervention strategies, using a consensus process to expand one of the existing models/frameworks used by the group, or developing a new consensus framework.
The work group elected to draft a new, simplified consensus framework of interventions to promote and integrate evidence into health practices, systems and policies. The framework will include four key components: strategies and techniques (active ingredients), how they function (causal mechanisms), how they are delivered (mode of delivery), and what they aim to change (intended targets). The draft framework needs to be further developed by feedback and consultation with the research community and tested for usefulness through application and evaluation.
Knowledge translation; Implementation science; Classification; Consensus; Dissemination; Implementation
Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes.
We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss.
Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report.
Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ2
1=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F
2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not.
In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up.
International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy).
weight loss; obesity; Internet; adherence; behavioral; randomized controlled trial
Dementia is a growing problem, causing substantial burden for patients, their families, and society. General practitioners (GPs) play an important role in diagnosing and managing dementia; however, there are gaps between recommended and current practice. The aim of this study was to explore GPs’ reported practice in diagnosing and managing dementia and to describe, in theoretical terms, the proposed explanations for practice that was and was not consistent with evidence-based guidelines.
Semi-structured interviews were conducted with GPs in Victoria, Australia. The Theoretical Domains Framework (TDF) guided data collection and analysis. Interviews explored the factors hindering and enabling achievement of 13 recommended behaviours. Data were analysed using content and thematic analysis. This paper presents an in-depth description of the factors influencing two behaviours, assessing co-morbid depression using a validated tool, and conducting a formal cognitive assessment using a validated scale.
A total of 30 GPs were interviewed. Most GPs reported that they did not assess for co-morbid depression using a validated tool as per recommended guidance. Barriers included the belief that depression can be adequately assessed using general clinical indicators and that validated tools provide little additional information (theoretical domain of ‘Beliefs about consequences’); discomfort in using validated tools (‘Emotion’), possibly due to limited training and confidence (‘Skills’; ‘Beliefs about capabilities’); limited awareness of the need for, and forgetting to conduct, a depression assessment (‘Knowledge’; ‘Memory, attention and decision processes’). Most reported practising in a manner consistent with the recommendation that a formal cognitive assessment using a validated scale be undertaken. Key factors enabling this were having an awareness of the need to conduct a cognitive assessment (‘Knowledge’); possessing the necessary skills and confidence (‘Skills’; ‘Beliefs about capabilities’); and having adequate time and resources (‘Environmental context and resources’).
This is the first study to our knowledge to use a theoretical approach to investigate the barriers and enablers to guideline-recommended diagnosis and management of dementia in general practice. It has identified key factors likely to explain GPs’ uptake of the guidelines. The results have informed the design of an intervention aimed at supporting practice change in line with dementia guidelines, which is currently being evaluated in a cluster randomised trial.
Dementia; General practitioners (GPs); Cognitive assessment; Depression assessment; Theoretical Domains Framework (TDF); Guideline implementation
Self-management by people with type 2 diabetes is central to good health outcomes and the prevention of associated complications. Structured education to teach self-management is recommended by the National Institute for Heath and Clinical Excellence; however, only a small proportion of patients report being offered this education and even fewer attend. This study aims to evaluate the implementation of a new internet-based self-management intervention: HeLP-Diabetes (Healthy Living for People with type 2 Diabetes) within the National Health Service. Specific objectives are to a) determine the uptake and use of HeLP-Diabetes by services and patients; b) identify the factors which inhibit or facilitate use; c) identify the resources needed for effective implementation; d) explore possible effects of HeLP-Diabetes use on self-reported patient outcome measures.
This study will use an iterative design to implement HeLP-Diabetes into existing health services within the National Health Service. A two stage implementation process will be taken, whereby batches of General Practice surgeries and diabetes clinics will be offered HeLP-Diabetes and will subsequently be asked to participate in evaluating the implementation. We will collect data to describe the number of services and patients who sign up to HeLP-Diabetes, the types of services and patients who sign up and the implementation costs. Semi-structured interviews will be conducted with patients and health professionals and cohorts of patient participants will be asked to complete self-report measures at baseline, 3 months, and 12 months.
This study will evaluate the implementation of a new online self-management intervention and describe what happens when it is made available to existing National Health Services and patients with type 2 diabetes. We will collect data to describe the uptake and use of the intervention and the resources needed for widespread implementation. We will report on patient benefits from using HeLP-Diabetes and the resources needed to achieve these in routine practice. Interviews with key stake holders will identify, define and explain factors that promote or inhibit the normalization of new patterns of patient and professional activity arising from HeLP-Diabetes.
Implementation; Diabetes; Health services research; Internet; Self-management
A national smoking cessation campaign based on behaviour change theory and operating through both traditional and new media was launched across England during late 2012 (‘Stoptober’). In addition to attempting to start a movement in which smokers would quit at the same time in response to a positive mass quitting trigger, the campaign set smokers the goal of being smoke-free for October and embodied other psychological principles in a range of tools and communications.
Data on quit attempts were obtained from 31,566 past-year smokers during nationally representative household surveys conducted monthly between 2007 and 2012. The effectiveness of the campaign was assessed by the increase in national quit attempt rate in October relative to other months in 2012 vs. 2007–2011.
Relative to other months in the year, more people tried to quit in October in 2012 compared with 2007–2011 (OR = 1.79, 95%CI = 1.20–2.68). In 2012 there was an approximately 50% increase in quitting during October compared with other months of the same year (9.6% vs. 6.6%; OR = 1.50, 95%CI = 1.05–2.15), whereas in 2007–2011 the rate in October was non-significantly less than in other months of the same period (6.4% vs. 7.5%; OR = 0.84, 95%CI = 0.70–1.00). Stoptober is estimated to have generated an additional 350,000 quit attempts and saved 10,400 discounted life years (DLY) at less than £415 per DLY in the modal age group.
Designing a national public health campaign with a clear behavioural target (making a serious quit attempt) using key psychological principles can yield substantial behaviour change and public health impact.
Smoking; Cessation; Quitting; Mass media; Cost-effectiveness; Stoptober
Audit and feedback interventions in healthcare have been found to be effective, but there has been little progress with respect to understanding their mechanisms of action or identifying their key ‘active ingredients.’
Given the increasing use of audit and feedback to improve quality of care, it is imperative to focus further research on understanding how and when it works best. In this paper, we argue that continuing the ‘business as usual’ approach to evaluating two-arm trials of audit and feedback interventions against usual care for common problems and settings is unlikely to contribute new generalizable findings. Future audit and feedback trials should incorporate evidence- and theory-based best practices, and address known gaps in the literature.
We offer an agenda for high-priority research topics for implementation researchers that focuses on reviewing best practices for designing audit and feedback interventions to optimize effectiveness.
Audit and feedback; Synthesis; Best practice; Implementation; Optimization
Mild traumatic brain injury is a frequent cause of presentation to emergency departments. Despite the availability of clinical practice guidelines in this area, there is variation in practice. One of the aims of the Neurotrauma Evidence Translation program is to develop and evaluate a targeted, theory- and evidence-informed intervention to improve the management of mild traumatic brain injury in Australian emergency departments. This study is the first step in the intervention development process and uses the Theoretical Domains Framework to explore the factors perceived to influence the uptake of four key evidence-based recommended practices for managing mild traumatic brain injury.
Semi-structured interviews were conducted with emergency staff in the Australian state of Victoria. The interview guide was developed using the Theoretical Domains Framework to explore current practice and to identify the factors perceived to influence practice. Two researchers coded the interview transcripts using thematic content analysis.
A total of 42 participants (9 Directors, 20 doctors and 13 nurses) were interviewed over a seven-month period. The results suggested that (i) the prospective assessment of post-traumatic amnesia was influenced by: knowledge; beliefs about consequences; environmental context and resources; skills; social/professional role and identity; and beliefs about capabilities; (ii) the use of guideline-developed criteria or decision rules to inform the appropriate use of a CT scan was influenced by: knowledge; beliefs about consequences; environmental context and resources; memory, attention and decision processes; beliefs about capabilities; social influences; skills and behavioral regulation; (iii) providing verbal and written patient information on discharge was influenced by: beliefs about consequences; environmental context and resources; memory, attention and decision processes; social/professional role and identity; and knowledge; (iv) the practice of providing brief, routine follow-up on discharge was influenced by: environmental context and resources; social/professional role and identity; knowledge; beliefs about consequences; and motivation and goals.
Using the Theoretical Domains Framework, factors thought to influence the management of mild traumatic brain injury in the emergency department were identified. These factors present theoretically based targets for a future intervention.
Emergency department management; Mild traumatic brain injury; Theoretical Domains Framework; Semi-structured interviews
There has been significant investment in developing guidelines to improve clinical and public health practice. Though much is known about the processes of evidence synthesis and evidence-based guidelines implementation, we know little about how evidence presented to advisory groups is interpreted and used to form practice recommendations or what happens where evidence is lacking. This study investigates how members of advisory groups of NICE (National Institute of Health and Clinical Excellence) conceptualize evidence and experience the process.
Members of three advisory groups for acute physical, mental and public health were interviewed at the beginning and end of the life of the group. Seventeen were interviewed at both time points; five were interviewed just once at time one; and 17 were interviewed only once after guidance completion. Using thematic and content analysis, interview transcripts were analysed to identify the main themes.
Three themes were identified:
1. What is the task? Different members conceptualized the task differently; some emphasized the importance of evidence at the top of the quality hierarchy while others emphasized the importance of personal experience.
2. Who gets heard? Managing the diversity of opinion and vested interests was a challenge for the groups; service users were valued and as was the importance of fostering good working relationships between group members.
3. What is the process? Group members valued debate and recognized the need to marshal discussion; most members were satisfied with the process and output.
Evidence doesn’t form recommendations on its own, but requires human judgement. Diversity of opinion within advisory groups was seen as key to making well-informed judgments relevant to forming recommendations. However, that diversity can bring tensions in the evaluation of evidence and its translation into practice recommendations.
Advisory groups; Content analysis; Evidence; NICE guidelines; Qualitative
Determining the effectiveness of social and psychological interventions is important for improving individual and population health. Such interventions are complex and, where possible, are best evaluated by randomised controlled trials (RCTs). The use of research findings in policy and practice decision making is hindered by poor reporting of RCTs. Poor reporting limits the ability to replicate interventions, synthesise evidence in systematic reviews, and utilise findings for evidence-based policy and practice. The lack of guidance for reporting the specific methodological features of complex intervention RCTs contributes to poor reporting. We aim to develop an extension of the Consolidated Standards of Reporting Trials Statement for Social and Psychological Interventions (CONSORT-SPI).
This research project will be conducted in five phases. The first phase was the project launch, which consisted of the establishment of a Project Executive and International Advisory Group, and recruitment of journal editors and the CONSORT Group. The second phase involves a Delphi process that will generate a list of possible items to include in the CONSORT Extension. Next, there will be a formal consensus meeting to select the reporting items to add to, or modify for, the CONSORT-SPI Extension. Fourth, guideline documents will be written, including an explanation and elaboration (E&E) document that will provide detailed advice for each item and examples of good reporting. The final phase will comprise guideline dissemination, with simultaneous publication and endorsement of the guideline in multiple journals, endorsement by funding agencies, presentations at conferences and other meetings, and a dedicated website that will facilitate feedback about the guideline.
As demonstrated by previous CONSORT guidelines, the development of an evidence-based reporting guideline for social and psychological intervention RCTs should improve the accuracy, comprehensiveness, and transparency of study reports. This, in turn, promises to improve the critical appraisal of research and its use in policy and practice decision making. We invite readers to participate in the project by visiting our website (http://tinyurl.com/CONSORT-study).
CONSORT-SPI; Randomised controlled trial; RCT; Reporting guidelines; Complex interventions
Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers.
This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs’ (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial).
The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs’ detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In addition to receipt of the printed guideline, practitioners in the intervention group will be invited to participate in an interactive, opinion leader-led, educational face-to-face workshop. The theory-informed intervention aims to address identified barriers to and enablers of implementation of recommendations. Researchers responsible for identifying the cohort of patients with suspected cognitive impairment, and their detection and diagnosis outcomes, will be blind to group allocation.
Australian New Zealand Clinical Trials Registry: ACTRN12611001032943 (date registered 28 September, 2011).
This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice.
General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation.
47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan.
The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour.
Australian New Zealand Clinical Trials Registry ACTRN012606000098538
Audit and feedback is one of the most widely used and promising interventions in implementation research, yet also one of the most variably effective. Understanding this variability has been limited in part by lack of attention to the theoretical and conceptual basis underlying audit and feedback. Examining the extent of theory use in studies of audit and feedback will yield better understanding of the causal pathways of audit and feedback effectiveness and inform efforts to optimize this important intervention.
A total of 140 studies in the 2012 Cochrane update on audit and feedback interventions were independently reviewed by two investigators. Variables were extracted related to theory use in the study design, measurement, implementation or interpretation. Theory name, associated reference, and the location of theory use as reported in the study were extracted. Theories were organized by type (e.g., education, diffusion, organization, psychology), and theory utilization was classified into seven categories (justification, intervention design, pilot testing, evaluation, predictions, post hoc, other).
A total of 20 studies (14%) reported use of theory in any aspect of the study design, measurement, implementation or interpretation. In only 13 studies (9%) was a theory reportedly used to inform development of the intervention. A total of 18 different theories across educational, psychological, organizational and diffusion of innovation perspectives were identified. Rogers’ Diffusion of Innovations and Bandura’s Social Cognitive Theory were the most widely used (3.6% and 3%, respectively).
The explicit use of theory in studies of audit and feedback was rare. A range of theories was found, but not consistency of theory use. Advancing our understanding of audit and feedback will require more attention to theoretically informed studies and intervention design.
Audit and feedback; Systematic review; Theory; Intervention design
Effectiveness of evidence-based behaviour change interventions is likely to be undermined by failure to deliver interventions as planned. Behavioural support for smoking cessation can be a highly cost-effective, life-saving intervention. However, in practice, outcomes are highly variable. Part of this may be due to variability in fidelity of intervention implementation. To date, there have been no published studies on this. The present study aimed to: evaluate a method for assessing fidelity of behavioural support; assess fidelity of delivery in two English Stop-Smoking Services; and compare the extent of fidelity according to session types, duration, individual practitioners, and component behaviour change techniques (BCTs).
Treatment manuals and transcripts of 34 audio-recorded behavioural support sessions were obtained from two Stop-Smoking Services and coded into component BCTs using a taxonomy of 43 BCTs. Inter-rater reliability was assessed using percentage agreement. Fidelity was assessed by examining the proportion of BCTs specified in the manuals that were delivered in individual sessions. This was assessed by session type (i.e., pre-quit, quit, post-quit), duration, individual practitioner, and BCT.
Inter-coder reliability was high (87.1%). On average, 66% of manual-specified BCTs were delivered per session (SD 15.3, range: 35% to 90%). In Service 1, average fidelity was highest for post-quit sessions (69%) and lowest for pre-quit (58%). In Service 2, fidelity was highest for quit-day (81%) and lowest for post-quit sessions (56%). Session duration was not significantly correlated with fidelity. Individual practitioner fidelity ranged from 55% to 78%. Individual manual-specified BCTs were delivered on average 63% of the time (SD 28.5, range: 0 to 100%).
The extent to which smoking cessation behavioural support is delivered as specified in treatment manuals can be reliably assessed using transcripts of audiotaped sessions. This allows the investigation of the implementation of evidence-based practice in relation to smoking cessation, a first step in designing interventions to improve it. There are grounds for believing that fidelity in the English Stop-Smoking Services may be low and that routine monitoring is warranted.
Behaviour change interventions; Smoking cessation; Delivery; Fidelity; Implementation
Despite strong evidence of the benefits of preconception interventions for improving pregnancy outcomes, the delivery and uptake of preconception care and periconceptional folate supplementation remain low. General practitioners play a central role in the delivery of preconception care. Understanding general practitioners’ perceptions of the barriers and enablers to implementing preconception care allows for more appropriate targeting of quality improvement interventions. Consequently, the aim of this study was to examine the barriers and enablers to the delivery and uptake of preconception care guidelines from general practitioners’ perspective using theoretical domains related to behaviour change.
We conducted a qualitative study using focus groups consisting of 22 general practitioners who were recruited from three regional general practice support organisations. Questions were based on the theoretical domain framework, which describes 12 domains related to behaviour change. General practitioners’ responses were classified into predefined themes using a deductive process of thematic analysis.
Beliefs about capabilities, motivations and goals, environmental context and resources, and memory, attention and decision making were the key domains identified in the barrier analysis. Some of the perceived barriers identified by general practitioners were time constraints, the lack of women presenting at the preconception stage, the numerous competing preventive priorities within the general practice setting, issues relating to the cost of and access to preconception care, and the lack of resources for assisting in the delivery of preconception care guidelines. Perceived enablers identified by general practitioners included the availability of preconception care checklists and patient brochures, handouts, and waiting room posters outlining the benefits and availability of preconception care consultations.
Our study has identified some of the barriers and enablers to the delivery and uptake of preconception care guidelines, as perceived by general practitioners. Relating these barriers to a theoretical domain framework provides a clearer understanding of some of the psychological aspects that are involved in the behaviour of general practitioners towards the delivery and uptake of preconception care. Further research prioritising these barriers and the theoretical domains to which they relate to is necessary before a methodologically rigorous intervention can be designed, implemented, and evaluated.
Preconception care; Focus groups; Family practice; Practice guideline; Barrier analysis
Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness.
Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. Primary outcome: direct blinded hand hygiene compliance (%).
All 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used).
Intention to Treat Analysis
Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7–9% absolute increase in compliance.
Per-Protocol Analysis for Implementing Wards
OR for compliance rose for both ACE (1.67 [1.28–2.22]; p<0.001) & ITUs (2.09 [1.55–2.81];p<0.001) equating to absolute increases of 10–13% and 13–18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20];p = 0.003 per completed form) but not ACE wards.
Despite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention’s effect in different settings.