Implementation Science has been published for six years and over that time has gone from receiving 100 articles in 2006 to receiving 354 in 2011; our impact factor has risen from 2.49 in June 2010 to ...3.10 in June 2012. Whilst our article publication rate has also risen, it has risen much less slowly than our submission rate--we published 29 papers in 2006 and 134 papers in 2011 and we now publish only around 40 % of submissions. About one-half of submitted manuscripts are rejected without being sent out for peer review; it has become clear that there are a number of common issues that result in manuscripts being rejected at this stage. We hope that by publishing this editorial on our common reasons for rejection without peer review we can help authors to better judge the relevance of their papers to Implementation Science.
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry ...that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.
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.
Accurate measures of health professionals' clinical practice are critically important to guide health policy decisions, as well as for professional self-evaluation and for research-based ...investigation of clinical practice and process of care. It is often not feasible or ethical to measure behaviour through direct observation, and rigorous behavioural measures are difficult and costly to use. The aim of this review was to identify the current evidence relating to the relationships between proxy measures and direct measures of clinical behaviour. In particular, the accuracy of medical record review, clinician self-reported and patient-reported behaviour was assessed relative to directly observed behaviour.
We searched: PsycINFO; MEDLINE; EMBASE; CINAHL; Cochrane Central Register of Controlled Trials; science/social science citation index; Current contents (social & behavioural med/clinical med); ISI conference proceedings; and Index to Theses.
empirical, quantitative studies; and examining clinical behaviours. An independent, direct measure of behaviour (by standardised patient, other trained observer or by video/audio recording) was considered the 'gold standard' for comparison. Proxy measures of behaviour included: retrospective self-report; patient-report; or chart-review. All titles, abstracts, and full text articles retrieved by electronic searching were screened for inclusion and abstracted independently by two reviewers. Disagreements were resolved by discussion with a third reviewer where necessary.
Fifteen reports originating from 11 studies met the inclusion criteria. The method of direct measurement was by standardised patient in six reports, trained observer in three reports, and audio/video recording in six reports. Multiple proxy measures of behaviour were compared in five of 15 reports. Only four of 15 reports used appropriate statistical methods to compare measures. Some direct measures failed to meet our validity criteria. The accuracy of patient report and chart review as proxy measures varied considerably across a wide range of clinical actions. The evidence for clinician self-report was inconclusive.
Valid measures of clinical behaviour are of fundamental importance to accurately identify gaps in care delivery, improve quality of care, and ultimately to improve patient care. However, the evidence base for three commonly used proxy measures of clinicians' behaviour is very limited. Further research is needed to better establish the methods of development, application, and analysis for a range of both direct and proxy measures of behaviour.
There is a large quality of care gap for patients with osteoporosis. As a fragility fracture is a strong indicator of underlying osteoporosis, it offers an ideal opportunity to initiate investigation ...and treatment. However, studies of post-fracture populations document screening and treatment rates below 20% in most settings. This is despite the fact that bone mineral density (BMD) scans are effective at identifying patients at high risk of fracture, and effective drug treatments are widely available. Effective interventions are required to remedy this incongruity in current practice.
This study reviewed randomised controlled trials (RCT) involving fully qualified healthcare professionals caring for patients with a fragility fracture in all healthcare settings. Any intervention designed to modify the behaviour of healthcare professionals or implement a service delivery change was considered. The main outcomes were BMD scanning and osteoporosis treatment with anti-resorptive therapy. The electronic databases Medline and Embase were searched from 1994 to June 2010 to identify relevant articles in English. Post-intervention risk differences (RDs) were calculated for the main outcomes and any additional study primary outcomes; the trials were meta-analysed.
A total of 2814 potentially relevant articles were sifted; 18 were assessed in full text. Nine RCTs evaluating ten interventions met the inclusion criteria for the review. All were from North America. Four studies focused on patients with a hip fracture, three on fractures of the wrist/distal forearm, and two included several fracture sites consistent with a fragility fracture. All studies reported positive effects of the intervention for the main study outcomes of BMD scanning and osteoporosis treatment. For BMD scanning the overall risk ratio (95% CI) was 2.8 (2.16 to 3.64); the RD was 36% (21% to 50%). For treatment with anti-resorptive therapy the overall risk ratio (95% CI) was 2.48 (1.92 to 3.2); the RD was 20% (10% to 30%).
All interventions produced positive effects on BMD scanning and osteoporosis treatment rates post-fracture. Despite sizeable increases, investigation and treatment rates remain sub-optimal. Long-term compliance with osteoporosis medications needs to be addressed, as the majority of studies reported treatment rates at six-month follow up only. Studies would be more informative if treatment criteria were defined a priori to facilitate understanding of whether patients were being treated appropriately and integrated economic analyses would be helpful for informing policy implementation decisions.
Traditional approaches to disseminating research findings have failed to achieve optimal healthcare.
In a systematic review of 235 studies of guideline dissemination and implementation strategies, we ...observed the following:
➢there was a median 10% improvement across studies, suggesting that it is possible to change healthcare provider behaviour and improve quality of care;
➢most dissemination and implementation strategies resulted in small to moderate improvements in care;
➢multifaceted interventions did not appear more effective than single interventions.
The interpretation of our systematic review is hindered by the lack of a robust theoretical base for understanding healthcare provider and organisational behaviour.
Future research is required to develop a better theoretical base and to evaluate further guideline dissemination and implementation strategies.
The English mass media campaign 'Act FAST' aimed to raise stroke awareness and the need to call emergency services at the onset of suspected stroke. We examined the perceived impact and views of the ...campaign in target populations to identify potential ways to optimise mass-media interventions for stroke.
Analysis of semi-structured interviews conducted as part of two qualitative studies, which examined factors influencing patient/witness response to acute stroke symptoms (n = 19 stroke patients, n = 26 stroke witnesses) and perceptions about raising stroke awareness in primary care (n = 30 clinicians). Both studies included questions about the 'Act FAST' campaign. Interviews were content analysed to determine campaign awareness, perceived impact on decisions and response to stroke, and views of the campaign.
Most participants were aware of the Act FAST campaign. Some patients and witnesses reported that the campaign impacted upon their stroke recognition and response, but the majority reported no impact. Clinicians often perceived campaign success in raising stroke awareness, but few thought it would change response behaviours. Some patients and witnesses, and most primary care clinicians expressed positive views towards the campaign. Some more critical participant comments included perceptions of dramatic, irrelevant, and potentially confusing content, such as a prominent 'fire in the brain' analogy.
Act FAST has had some perceived impact on stroke recognition and response in some stroke patients and witnesses, but the majority reported no campaign impact. Primary care clinicians were positive about the campaign, and believed it had impacted on stroke awareness and recognition but doubted impact on response behaviour. Potential avenues for optimising and complementing mass media campaigns such as 'Act FAST' were identified.
In this editorial, we reflect on the arguments for starting a scientific society focused on research on how to improve healthcare. This society would take an inclusive approach to what constitutes ...healthcare. For instance, it should include mental health healthcare, treatment for substance abuse, the work of allied health professions, and preventive healthcare. The society would be open to researchers from all traditions. Thus, we take an inclusive approach to what constitutes scientific research, as long as it uses rigorous methods, is focused on improving healthcare, and aims at knowledge that can be transferred across settings. The society would primarily target scientific researchers but would invite others with an interest in this area of research, regardless of their discipline, position, field of application, or group affiliation (e.g., improvement science, behavioral medicine, knowledge translation). A society would need fruitful collaboration with related societies and organizations, which may include having combined meetings. Special links may be developed with one or more journals. A website to provide information on relevant resources, events, and training opportunities is another key activity. It would also provide a voice for the field at funding agencies, political arenas, and similar institutions. An organizational structure and financial resources are required to develop and run these activities. Our aim is to start an international debate, to discover if we can establish a shared vision across academics and stakeholders engaged with creating scientific knowledge on how to improve healthcare. We invite readers to express their views in the online questionnaire accessed by following the URL link provided at the end of the editorial.
The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in ...developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
Falls are common in older people and increase in prevalence with advancing old age. There is limited knowledge about their impact in those aged 85 years and older, the fastest growing age group of ...the population. We investigated the prevalence and impact of falls, and the overlap between falls, dizziness and blackouts, in a population-based sample of 85 year olds.
Cross-sectional analysis of baseline data from Newcastle 85+ Cohort Study.
Primary care, North-East England.
816 men and women aged 85 years.
Structured interview with research nurse. Cost-consequence analysis of fall-related healthcare costs.
Over 38% (313/816) of participants had fallen at least once in the previous 12 months and of these: 10.6% (33/312) sustained a fracture, 30.1% (94/312) attended an emergency department, and 12.8% (40/312) were admitted to hospital. Only 37.2% (115/309) of fallers had specifically discussed their falls problem with their general practitioner and only 12.7% (39/308) had seen a falls specialist. The average annual healthcare cost per faller was estimated at £202 (inter-quartile range £174-£231) or US$329 ($284-$377). 'Worry about falling' was experienced by 42.0% (128/305) of fallers, 'loss of confidence' by 40.0% (122/305), and 'going out less often' by 25.9% (79/305); each was significantly more common in women, odds ratios (95% confidence interval) for women: men of 2.63 (1.45-4.55), 4.00 (2.27-7.14), and 2.86 (1.54-5.56) respectively. Dizziness and blackouts were reported by 40.0% (318/796) and 6.4% (52/808) of participants respectively. There was marked overlap in the report of falls, dizziness and blackouts.
Falls in 85 year olds are very common, associated with considerable psychological and physical morbidity, and have high impact on healthcare services. Wider use of fall prevention services is needed. Significant expansion in acute and preventative services is required in view of the rapid growth in this age group.
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