Background

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.

Methods

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.

Results

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.

Conclusions

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.

Introduction

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.

Methods

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 (%).

Results

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.

Conclusion

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.

Trial Registration

Controlled-Trials.com ISRCTN65246961

Background

The prevalence of obesity is over 25 % in many developed countries. Obesity is strongly associated with an increased risk of fatal and chronic conditions such as cardiovascular disease and type 2 diabetes. Therefore it has become a major public health concern for many economies. E-learning devices are a relatively novel approach to promoting dietary change. The new generation of devices are ‘adaptive’ and use interactive electronic media to facilitate teaching and learning. E-Learning has grown out of recent developments in information and communication technology, such as the Internet, interactive computer programmes, interactive television and mobile phones. The aim of this study is to assess the cost-effectiveness of e-learning devices as a method of promoting weight loss via dietary change.

Methods

An economic evaluation was performed using decision modelling techniques. Outcomes were expressed in terms of Quality-Adjusted Life-Years (QALYs) and costs were estimated from a health services perspective. All parameter estimates were derived from the literature. A systematic review was undertaken to derive the estimate of relative treatment effect.

Results

The base case results from the e-Learning Economic Evaluation Model (e-LEEM) suggested that the incremental cost-effectiveness ratio was approximately £102,000 per Quality-Adjusted Life-Year (QALY) compared to conventional care. This finding was robust to most alternative assumptions, except a much lower fixed cost of providing e-learning devices. Expected value of perfect information (EVPI) analysis showed that while the individual level EVPI was arguably negligible, the population level value was between £37 M and £170 M at a willingness to pay between £20,000 to £30,000 per additional QALY.

Conclusion

The current economic evidence base suggests that e-learning devices for managing the weight of obese individuals are unlikely to be cost-effective unless their fixed costs are much lower than estimated or future devices prove to be much more effective.

Background

There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research.

Methods

The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood?

Results

A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change.

Conclusions

We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Background

An integrative theoretical framework, developed for cross-disciplinary implementation and other behaviour change research, has been applied across a wide range of clinical situations. This study tests the validity of this framework.

Methods

Validity was investigated by behavioural experts sorting 112 unique theoretical constructs using closed and open sort tasks. The extent of replication was tested by Discriminant Content Validation and Fuzzy Cluster Analysis.

Results

There was good support for a refinement of the framework comprising 14 domains of theoretical constructs (average silhouette value 0.29): ‘Knowledge’, ‘Skills’, ‘Social/Professional Role and Identity’, ‘Beliefs about Capabilities’, ‘Optimism’, ‘Beliefs about Consequences’, ‘Reinforcement’, ‘Intentions’, ‘Goals’, ‘Memory, Attention and Decision Processes’, ‘Environmental Context and Resources’, ‘Social Influences’, ‘Emotions’, and ‘Behavioural Regulation’.

Conclusions

The refined Theoretical Domains Framework has a strengthened empirical base and provides a method for theoretically assessing implementation problems, as well as professional and other health-related behaviours as a basis for intervention development.

Introduction

Chiropractors commonly provide care to people with acute low-back pain (LBP). The aim of this survey was to determine how chiropractors intend to support and manage people with acute LBP and if this management is in accordance with two recommendations from an Australian evidence-based acute LBP guideline. The two recommendations were directed at minimising the use of plain x-ray and encouraging the patient to stay active.

Methods

This is a cross sectional survey of chiropractors in Australia. This paper is part of the ALIGN study in which a targeted implementation strategy was developed to improve the management of acute LBP in a chiropractic setting. This implementation strategy was subsequently tested in a cluster randomised controlled trial. In this survey phase of the ALIGN study we approached a random sample of 880 chiropractors in three States of Australia. The mailed questionnaire consisted of five patient vignettes designed to represent people who would typically present to chiropractors with acute LBP. Four vignettes represented people who, according to the guideline, would not require a plain lumbar x-ray, and one vignette represented a person with a suspected vertebral fracture. Respondents were asked, for each vignette, to indicate which investigation(s) they would order, and which intervention(s) they would recommend or undertake.

Results

Of the 880 chiropractors approached, 137 were deemed ineligible to participate, mostly because they were not currently practising, or mail was returned to sender. We received completed questionnaires from 274 chiropractors (response rate of 37%). Male chiropractors made up 66% of respondents, 75% practised in an urban location and their mean number of years in practice was 15. Across the four vignettes where an x-ray was not indicated 68% (95% Confidence Intervals (CI): 64%, 71%) of chiropractors responded that they would order or take an x-ray. In addition 51% (95%CI: 47%, 56%) indicated they would give advice to stay active when it was indicated. For the vignette where a fracture was suspected, 95% (95% CI: 91%, 97%) of chiropractors would order an x-ray.

Conclusion

The intention of chiropractors surveyed in this study shows low adherence to two recommendations from an evidence-based guideline for acute LBP. Quality of care for these patients could be improved through effective implementation of evidence-based guidelines. Further research to find cost-effective methods to increase implementation is warranted.

Genetic testing for hereditary breast and ovarian cancer reveals significant risk information regarding one's chances of developing cancer that has potential implications for patients and their families. This study reports on the motivations and attitudes of index patients and their relatives towards genetic testing for hereditary breast and ovarian cancer. In total, 10 female index patients and 20 of their relatives were interviewed regarding their experiences of communicating genetic information within their families, and their motivations and attitudes towards genetic testing. The analysis found two types of ‘family groups': groups strongly committed to genetic testing and groups uncertain about testing. Within committed family groups, index patients and their relatives felt obliged to be tested for others, leading some relatives to be tested without having fully thought through their decision or the implications of knowing their mutation status. These family groups also described considerations in relation to the value of testing for themselves. In family groups uncertain about testing, relatives had not attended for predictive testing, had postponed decision making until some point in the future or had expressed ambivalence about the value of testing for themselves. Results suggest the value of explicitly acknowledging motivations for genetic testing within the context of family obligations, relationships and communication, and the possible value of involving family members in genetic counselling and decision making from a family's first contact with genetic services.

Background

The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs) and Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients.

Methods/ Design

This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour), and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking.

The trial will recruit 20 PN/HCAs (10 per arm), who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA). This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in constructs specified by the Theory of Planned Behaviour lead to changes in objectively assessed walking behaviour.

Discussion

This trial addresses the current lack of evidence for interventions that are effective at increasing walking and that can be offered to patients in primary care. The intervention being evaluated has demonstrated efficacy, and has been through an extensive process of adaptation to ensure acceptability to both provider and recipient, thus optimising fidelity of intervention delivery and treatment receipt. It therefore provides a strong test of the hypothesis that a self-regulation intervention can help primary care patients increase their walking.

Trial registration

Current Controlled Trials ISRCTN95932902

Background

Tobacco use adversely affects oral health. Clinical guidelines recommend that dental providers promote tobacco abstinence and provide patients who use tobacco with brief tobacco use cessation counselling. Research shows that these guidelines are seldom implemented, however. To improve guideline adherence and to develop effective interventions, it is essential to understand provider behaviour and challenges to implementation. This study aimed to develop a theoretically informed measure for assessing among dental providers implementation difficulties related to tobacco use prevention and cessation (TUPAC) counselling guidelines, to evaluate those difficulties among a sample of dental providers, and to investigate a possible underlying structure of applied theoretical domains.

Methods

A 35-item questionnaire was developed based on key theoretical domains relevant to the implementation behaviours of healthcare providers. Specific items were drawn mostly from the literature on TUPAC counselling studies of healthcare providers. The data were collected from dentists (n = 73) and dental hygienists (n = 22) in 36 dental clinics in Finland using a web-based survey. Of 95 providers, 73 participated (76.8%). We used Cronbach's alpha to ascertain the internal consistency of the questionnaire. Mean domain scores were calculated to assess different aspects of implementation difficulties and exploratory factor analysis to assess the theoretical domain structure. The authors agreed on the labels assigned to the factors on the basis of their component domains and the broader behavioural and theoretical literature.

Results

Internal consistency values for theoretical domains varied from 0.50 ('emotion') to 0.71 ('environmental context and resources'). The domain environmental context and resources had the lowest mean score (21.3%; 95% confidence interval [CI], 17.2 to 25.4) and was identified as a potential implementation difficulty. The domain emotion provided the highest mean score (60%; 95% CI, 55.0 to 65.0). Three factors were extracted that explain 70.8% of the variance: motivation (47.6% of variance, α = 0.86), capability (13.3% of variance, α = 0.83), and opportunity (10.0% of variance, α = 0.71).

Conclusions

This study demonstrated a theoretically informed approach to identifying possible implementation difficulties in TUPAC counselling among dental providers. This approach provides a method for moving from diagnosing implementation difficulties to designing and evaluating interventions.

Background

Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations.

Methods

A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity.

Results

Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity.

Conclusions

Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.

Background

Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers.

Methods

Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used.

Discussion

To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers.

Trial registration

Current Controlled Trials ISRCTN15427433

Background

The importance of behaviour change in improving health is illustrated by the increasing investment by funding bodies in the development and evaluation of complex interventions to change population, patient, and practitioner behaviours. The development of effective interventions is hampered by the absence of a nomenclature to specify and report their content. This limits the possibility of replicating effective interventions, synthesising evidence, and understanding the causal mechanisms underlying behaviour change. In contrast, biomedical interventions are precisely specified (e.g., the pharmacological 'ingredients' of prescribed drugs, their dose and frequency of administration). For most complex interventions, the precise 'ingredients' are unknown; descriptions (e.g., 'behavioural counseling') can mean different things to different researchers or implementers. The lack of a method for specifying complex interventions undermines the precision of evidence syntheses of effectiveness, posing a problem for secondary, as well as primary, research.

We aim to develop a reliable method of specifying intervention components ('techniques') aimed at changing behaviour.

Methods/Design

The research will be conducted in three phases. The first phase will develop the nomenclature. We will refine a preliminary list of techniques and definitions. Using a formal consensus method, experts will then define the key attributes of each technique and how it relates to, and differs from, others. They will evaluate the techniques and their definitions until they achieve an agreed-upon list of clearly defined, nonredundant techniques. The second phase will test the nomenclature. Trained experts (primary researchers and systematic reviewers), equipped with a coding manual and guidance, will use the nomenclature to code published descriptions of complex interventions. Reliability between experts, over time, and across types of users will be assessed. We will assess whether using the nomenclature to write intervention descriptions enhances the clarity and replicability of interventions. The third phase will develop a web-based users' resource of clearly specified and nonredundant techniques, which will aid the scientific understanding of, and development of, effective complex interventions. Dissemination throughout the project will be through stakeholder meetings, targeted multidisciplinary workshops, conference presentation, journal publication, and publication in an interactive web-based platform (a Wiki).

Discussion

The development of a reliable method of specifying intervention components aimed at changing behaviour will strengthen the scientific basis for developing, evaluating, and reporting complex interventions. It will improve the precision of evidence syntheses of effectiveness, thus enhancing secondary, as well as primary, research.

Background

There has been relatively little research on the role of web-based support for self-care in the management of minor, acute symptoms, in contrast to the wealth of recent research into Internet interventions to support self-management of long-term conditions.

Objective

This study was designed as an evaluation of the usage and effects of the “Internet Doctor” website providing tailored advice on self-management of minor respiratory symptoms (eg, cough, sore throat, fever, runny nose), in preparation for a definitive trial of clinical effectiveness. The first aim was to evaluate the effects of using the Internet Doctor webpages on patient enablement and use of health services, to test whether the tailored, theory-based advice provided by the Internet Doctor was superior to providing a static webpage providing the best existing patient information (the control condition). The second aim was to gain an understanding of the processes that might mediate any change in intentions to consult the doctor, by comparing changes in relevant beliefs and illness perceptions in the intervention and control groups, and by analyzing usage of the Internet Doctor webpages and predictors of intention change.

Methods

Participants (N = 714) completed baseline measures of beliefs about their symptoms and self-care online, and were then automatically randomized to the Internet Doctor or control group. These measures were completed again by 332 participants after 48 hours. Four weeks later, 214 participants completed measures of enablement and health service use.

Results

The Internet Doctor resulted in higher levels of satisfaction than the control information (mean 6.58 and 5.86, respectively; P = .002) and resulted in higher levels of enablement a month later (median 3 and 2, respectively; P = .03). Understanding of illness improved in the 48 hours following use of the Internet Doctor webpages, whereas it did not improve in the control group (mean change from baseline 0.21 and -0.06, respectively, P = .05). Decline in intentions to consult the doctor between baseline and follow-up was predicted by age (beta = .10, P= .003), believing before accessing the website that consultation was necessary for recovery (beta = .19, P < .001), poor understanding of illness (beta = .11, P = .004), emotional reactions to illness (beta = .15, P <.001), and use of the Diagnostic section of the Internet Doctor website (beta = .09, P = .007).

Conclusions

Our findings provide initial evidence that tailored web-based advice could help patients self-manage minor symptoms to a greater extent. These findings constitute a sound foundation and rationale for future research. In particular, our study provides the evidence required to justify carrying out much larger trials in representative population samples comparing tailored web-based advice with routine care, to obtain a definitive evaluation of the impact on self-management and health service use.

Background

Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition.

Aims

This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP.

Methods

The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009)

Background

It is well documented that the translation of knowledge into clinical practice is a slow and haphazard process. This is no less true for dental healthcare than other types of healthcare. One common policy strategy to help promote knowledge translation is the production of clinical guidance, but it has been demonstrated that the simple publication of guidance is unlikely to optimise practice. Additional knowledge translation interventions have been shown to be effective, but effectiveness varies and much of this variation is unexplained. The need for researchers to move beyond single studies to develop a generalisable, theory based, knowledge translation framework has been identified.

For dentistry in Scotland, the production of clinical guidance is the responsibility of the Scottish Dental Clinical Effectiveness Programme (SDCEP). TRiaDS (Translation Research in a Dental Setting) is a multidisciplinary research collaboration, embedded within the SDCEP guidance development process, which aims to establish a practical evaluative framework for the translation of guidance and to conduct and evaluate a programme of integrated, multi-disciplinary research to enhance the science of knowledge translation.

Methods

Set in General Dental Practice the TRiaDS programmatic evaluation employs a standardised process using optimal methods and theory. For each SDCEP guidance document a diagnostic analysis is undertaken alongside the guidance development process. Information is gathered about current dental care activities. Key recommendations and their required behaviours are identified and prioritised. Stakeholder questionnaires and interviews are used to identify and elicit salient beliefs regarding potential barriers and enablers towards the key recommendations and behaviours. Where possible routinely collected data are used to measure compliance with the guidance and to inform decisions about whether a knowledge translation intervention is required. Interventions are theory based and informed by evidence gathered during the diagnostic phase and by prior published evidence. They are evaluated using a range of experimental and quasi-experimental study designs, and data collection continues beyond the end of the intervention to investigate the sustainability of an intervention effect.

Discussion

The TRiaDS programmatic approach is a significant step forward towards the development of a practical, generalisable framework for knowledge translation research. The multidisciplinary composition of the TRiaDS team enables consideration of the individual, organisational and system determinants of professional behaviour change. In addition the embedding of TRiaDS within a national programme of guidance development offers a unique opportunity to inform and influence the guidance development process, and enables TRiaDS to inform dental services practitioners, policy makers and patients on how best to translate national recommendations into routine clinical activities.

Background

The composition of habitual diets is associated with adverse or protective effects on aspects of health. Consequently, UK public health policy strongly advocates dietary change for the improvement of population health and emphasises the importance of individual empowerment to improve health. A new and evolving area in the promotion of dietary behavioural change is e-Learning, the use of interactive electronic media to facilitate teaching and learning on a range of issues, including diet and health. The aims of this systematic review are to determine the effectiveness and cost-effectiveness of adaptive e-Learning for improving dietary behaviours.

Methods/Design

The research will consist of a systematic review and a cost-effectiveness analysis. Studies will be considered for the review if they are randomised controlled trials, involving participants aged 13 or over, which evaluate the effectiveness or efficacy of interactive software programmes for improving dietary behaviour. Primary outcome measures will be those related to dietary behaviours, including estimated intakes of energy, nutrients and dietary fibre, or the estimated number of servings per day of foods or food groups. Secondary outcome measures will be objective clinical measures that are likely to respond to changes in dietary behaviours, such as anthropometry or blood biochemistry. Knowledge, self-efficacy, intention and emotion will be examined as mediators of dietary behaviour change in order to explore potential mechanisms of action. Databases will be searched using a comprehensive four-part search strategy, and the results exported to a bibliographic database. Two review authors will independently screen results to identify potentially eligible studies, and will independently extract data from included studies, with any discrepancies at each stage settled by a third author. Standardised forms and criteria will be used.

A descriptive analysis of included studies will describe study design, participants, the intervention, and outcomes. Statistical analyses appropriate to the data extracted, and an economic evaluation using a cost-utility analysis, will be undertaken if sufficient data exist, and effective components of successful interventions will be investigated.

Discussion

This review aims to provide comprehensive evidence of the effectiveness and cost-effectiveness of adaptive e-Learning interventions for dietary behaviour change, and explore potential psychological mechanisms of action and the effective components of effective interventions. This can inform policy makers and healthcare commissioners in deciding whether e-Learning should be part of a comprehensive response to the improvement of dietary behaviour for health, and if so which components should be present for interventions to be effective.

Background

The Internet is increasingly used as a medium for the delivery of interventions designed to promote health behavior change. However, reviews of these interventions to date have not systematically identified intervention characteristics and linked these to effectiveness.

Objectives

The present review sought to capitalize on recently published coding frames for assessing use of theory and behavior change techniques to investigate which characteristics of Internet-based interventions best promote health behavior change. In addition, we wanted to develop a novel coding scheme for assessing mode of delivery in Internet-based interventions and also to link different modes to effect sizes.

Methods

We conducted a computerized search of the databases indexed by ISI Web of Knowledge (including BIOSIS Previews and Medline) between 2000 and 2008. Studies were included if (1) the primary components of the intervention were delivered via the Internet, (2) participants were randomly assigned to conditions, and (3) a measure of behavior related to health was taken after the intervention.

Results

We found 85 studies that satisfied the inclusion criteria, providing a total sample size of 43,236 participants. On average, interventions had a statistically small but significant effect on health-related behavior (d+ = 0.16, 95% CI 0.09 to 0.23). More extensive use of theory was associated with increases in effect size (P = .049), and, in particular, interventions based on the theory of planned behavior tended to have substantial effects on behavior (d+ = 0.36, 95% CI 0.15 to 0.56). Interventions that incorporated more behavior change techniques also tended to have larger effects compared to interventions that incorporated fewer techniques (P < .001). Finally, the effectiveness of Internet-based interventions was enhanced by the use of additional methods of communicating with participants, especially the use of short message service (SMS), or text, messages.

Conclusions

The review provides a framework for the development of a science of Internet-based interventions, and our findings provide a rationale for investing in more intensive theory-based interventions that incorporate multiple behavior change techniques and modes of delivery.

Background

The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorisation for a pharmacotherapy.

Design/Methods

We will conduct a non-inferiority randomised trial of rapid reduction versus standard abrupt cessation among smokers who want to stop smoking. In the reduction arm, participants will be advised to reduce smoking consumption by half in the first week and to 25% of baseline in the second, leading up to a quit day at which participants will stop smoking completely. This will be assisted by nicotine patches and an acute form of nicotine replacement therapy. In the abrupt arm participants will use nicotine patches only, whilst smoking as normal, for two weeks prior to a quit day, at which they will also stop smoking completely. Smokers in either arm will have standard withdrawal orientated behavioural support programme with a combination of nicotine patches and acute nicotine replacement therapy post-cessation.

Outcomes/Follow-up

The primary outcome of interest will be prolonged abstinence from smoking, with secondary trial outcomes of point prevalence, urges to smoke and withdrawal symptoms. Follow up will take place at 4 weeks, 8 weeks and 6 months post-quit day.

Trial Registration

Current Controlled Trials ISRCTN22526020

Background

Multidisciplinary guideline development groups (GDGs) have considerable influence on UK healthcare policy and practice, but previous research suggests that research evidence is a variable influence on GDG recommendations. The Evidence into Recommendations (EiR) study has been set up to document social-psychological influences on GDG decision-making. In this paper we aim to evaluate the relevance of existing qualitative methodologies to the EiR study, and to develop a method best-suited to capturing influences on GDG decision-making.

Methods

A research team comprised of three postdoctoral research fellows and a multidisciplinary steering group assessed the utility of extant qualitative methodologies for coding verbatim GDG meeting transcripts and semi-structured interviews with GDG members. A unique configuration of techniques was developed to permit data reduction and analysis.

Results

Our method incorporates techniques from thematic analysis, grounded theory analysis, content analysis, and framework analysis. Thematic analysis of individual interviews conducted with group members at the start and end of the GDG process defines discrete problem areas to guide data extraction from GDG meeting transcripts. Data excerpts are coded both inductively and deductively, using concepts taken from theories of decision-making, social influence and group processes. These codes inform a framework analysis to describe and explain incidents within GDG meetings. We illustrate the application of the method by discussing some preliminary findings of a study of a National Institute for Health and Clinical Excellence (NICE) acute physical health GDG.

Conclusion

This method is currently being applied to study the meetings of three of NICE GDGs. These cover topics in acute physical health, mental health and public health, and comprise a total of 45 full-day meetings. The method offers potential for application to other health care and decision-making groups.

Complex behaviour change interventions are not well described; when they are described, the terminology used is inconsistent. This constrains scientific replication, and limits the subsequent introduction of successful interventions. Implementation Science is introducing a policy of initially encouraging and subsequently requiring the scientific reporting of complex behaviour change interventions.

In October 2006, the Chief Medical Officer (CMO) of England asked Professor Sir John Tooke to chair a High Level Group on Clinical Effectiveness in response to the chapter 'Waste not, want not' in the CMOs 2005 annual report 'On the State of the Public Health'. The high level group made recommendations to the CMO to address possible ways forward to improve clinical effectiveness in the UK National Health Service (NHS) and promote clinical engagement to deliver this. The report contained a short section on research needs that emerged from the process of writing the report, but in order to more fully identify the relevant research agenda Professor Sir John Tooke asked Professor Martin Eccles to convene an expert group – the Clinical Effectiveness Research Agenda Group (CERAG) – to define the research agenda. The CERAG's terms of reference were 'to further elaborate the research agenda in relation to pursuing clinically effective practice within the (UK) National Health Service'. This editorial presents the summary of the CERAG report and recommendations.

Background

In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objectively measured physical activity among adults at risk of Type 2 diabetes. We aimed to illuminate these findings by assessing whether the intervention program changed cognitions about increasing activity, defined by the Theory of Planned Behaviour, in ways consistent with the theory.

Methods

N = 365 sedentary participants aged 30–50 years with a parental history of Type 2 diabetes were randomised to brief advice alone or to brief advice plus the intervention program delivered face-to-face or by telephone. Questionnaires at baseline, 6 and 12 months assessed cognitions about becoming more physically active. Analysis of covariance was used to test intervention impact. Bootstrapping was used to test multiple mediation of intervention impact.

Results

At 6 months, combined intervention groups (face-to-face and telephone) reported that they found increasing activity more enjoyable (affective attitude, d = .25), and they perceived more instrumental benefits (e.g., improving health) (d = .23) and more control (d = .32) over increasing activity than participants receiving brief advice alone. Stronger intentions (d = .50) in the intervention groups than the brief advice group at 6 months were partially explained by affective attitude and perceived control. At 12 months, intervention groups perceived more positive instrumental (d = .21) and affective benefits (d = .29) than brief advice participants. The intervention did not change perceived social pressure to increase activity.

Conclusion

Lack of effect of the intervention program on physical activity over and above brief advice was consistent with limited and mostly small short-term effects on cognitions. Targeting affective benefits (e.g., enjoyment, social interaction) and addressing barriers to physical activity may strengthen intentions, but stronger intentions did not result in more behaviour change. More powerful interventions which induce large changes in TPB cognitions may be needed. Other interventions deserving further evaluation include theory-based brief advice, intensive measurement of physical and psychological factors, and monitoring of physical activity. Future research should consider a wider range of mediators of physical activity change, assess participants' use of self-regulatory strategies taught in the intervention, and conduct experimental studies or statistical modelling prior to trial evaluation. ISRCTN61323766.

Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance

Background

Evidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.

Aim

This study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.

Methods/Design

This study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN012606000098538 (date registered 14/03/2006).

Background

Health care practice based on research evidence requires that evidence is synthesised, and that recommendations based on this evidence are implemented. It also requires an intermediate step: translating synthesised evidence into practice recommendations. There is considerable literature on evidence synthesis and implementation, but little on how guideline development groups (GDGs) produce recommendations. This is a complex process, with many influences on communication and decision-making, e.g., the quality of evidence, methods of presentation, practical/resource constraints, individual values, professional and scientific interests, social and psychological processes. To make this process more transparent and potentially effective, we need to understand these influences. Psychological theories of decision-making and social influence provide a framework for this understanding.

Objectives

This study aims to investigate the processes by which GDGs formulate recommendations, drawing on psychological theories of decision-making and social influence. The findings will potentially inform the further evolution of GDG methods, such as choice of members and procedures for presenting evidence, conducting discussion and formulating recommendations.

Methods

Longitudinal observation of the meetings of three National Institute of Health and Clinical Excellence (NICE) GDGs, one from each of acute, mental health and public health, will be tape recorded and transcribed. Interviews with a sample of GDG members at the beginning, middle, and end of the GDG's work will be recorded and transcribed. Site documents including relevant e-mail interchanges, GDG meeting minutes, and stakeholders' responses to the drafts of the recommendations will be collected. Data will be selected for analysis if they refer to either evidence or recommendations; the focus is on "hot spots", e.g., dilemmas, conflicts, and uncertainty. Data will be analysed thematically and by content analysis, drawing on psychological theories of decision-making and social influence.