Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of 'studies within a trial' (SWATs).

BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment. METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part. RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes. CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates. TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BACKGROUND: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. METHODS: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. RESULTS: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). CONCLUSIONS: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

BACKGROUND: Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates. METHODS: We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS. RESULTS: In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565). CONCLUSIONS: Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016.

Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials.

BACKGROUND: Randomised controlled trials are the cornerstone of evidence-based health care, yet many trials struggle with recruitment and retention. All too often the methodologies employed to address these problems are not evidence-based, as rigorous methodological research on these issues is rare. The current research sought to identify barriers to the routine implementation of methodology research around recruitment and retention. METHODS: All registered UK clinical trials unit directors were sent a short questionnaire and invited to interview. Representatives of funding bodies and other stakeholders were also approached. Interviews were recorded and the content analysed. RESULTS: Data were grouped into four themes: acceptance of the need for methodological research; trial funding and development; trial processes; and organisational factors. The need to improve the evidence base for trials methodology is well established, but numerous barriers to implementation were perceived. CONCLUSIONS: The knowledge and expertise required to routinely implement methodology research exists within the current research structures, and there are clear opportunities to develop the evidence base. However, for this to be achieved there is also a need for clear strategic coordination within the sector and promotion of the necessary resources.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

BACKGROUND: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. METHODS: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials.

BACKGROUND: Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. METHODS: The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). RESULTS: In Healthlines Depression (n = 1364), 6.3% of patients receiving the optimised patient information materials were randomised into the study compared to 4.0% in those receiving standard materials (OR = 1.63, 95% CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0% of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9% in those receiving standard materials (OR = 1.12, 95% CI = 0.78 to 1.61). CONCLUSIONS: Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population. TRIAL REGISTRATION: Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012.

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials.

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.

Care plans and care planning in the management of long-term conditions in the UK: a controlled prospective cohort study.

BACKGROUND: In the UK, the use of care planning and written care plans has been proposed to improve the management of long-term conditions, yet there is limited evidence concerning their uptake and benefits. AIM: To explore the implementation of care plans and care planning in the UK and associations with the process and outcome of care. DESIGN AND SETTING: A controlled prospective cohort study among two groups of patients with long-term conditions who were similar in demographic and clinical characteristics, but who were registered with general practices varying in their implementation of care plans and care planning. METHOD: Implementation of care plans and care planning in general practice was assessed using the 2009-2010 GP Patient Survey, and relationships with patient outcomes (self-management and vitality) were examined using multilevel, mixed effects linear regression modelling. RESULTS: The study recruited 38 practices and 2439 patients. Practices in the two groups (high and low users of written documents) were similar in structural and population characteristics. Patients in the two groups of practices were similar in demographics and baseline health. Patients did demonstrate significant differences in reported experiences of care planning, although the differences were modest. Very few patients in the cohort reported a written plan that could be confirmed. Analysis of outcomes suggested that most patients show limited change over time in vitality and self-management. Variation in the use of care plans at the practice level was very limited and not related to patient outcomes over time. CONCLUSION: The use of written care plans in patients with long-term conditions is uncommon and unlikely to explain a substantive amount of variation in the process and outcome of care. More proactive efforts at implementation may be required to provide a rigorous test of the potential of care plans and care planning.

Care plans and care planning in long-term conditions: a conceptual model.

The prevalence and impact of long-term conditions continues to rise. Care planning for people with long-term conditions has been a policy priority for chronic disease management in a number of health-care systems. However, patients and providers appear unclear about the formulation and implementation of care planning. Further work in this area is therefore required to inform the development, implementation and evaluation of future care planning initiatives. We distinguish between 'care planning' (the process by which health-care professionals and patients discuss, agree and review an action plan to achieve the goals or behaviour change of most relevance and concern to the patient) and a 'care plan' (a written document recording the outcome of a care planning process). We propose a typology of care planning and care plans with three core dimensions: perspective (patient or professional), scope (a focus on goals or on behaviours) and networks (confined to the professional-patient dyad or extending to the entire care network). In addition, we draw on psychological models of mediation and moderation to outline potential mechanisms through which care planning and care plans may lead to improved outcomes for both patients and the wider health-care system. The proposed typology of care planning and care plans offered here, along with the model of the process by which care planning may influence outcomes, provide a useful framework for future policy developments and evaluations. Empirical work is required to explore the degree to which current care planning approaches and care plans can be described according to these dimensions, and the factors that determine which types of patients and professionals use which type of care plans.

A qualitative evidence synthesis of employees' views of workplace smoking reduction or cessation interventions.

BACKGROUND: The need to reduce smoking rates is a recognised public health policy issue in many countries. The workplace offers a potential context for offering smokers' programmes and interventions to assist smoking cessation or reduction. A qualitative evidence synthesis of employees' views about such programmes might explain why some interventions appear effective and others not, and can be used to develop evidence-based interventions for this population and setting. METHODS: A qualitative evidence synthesis of primary research exploring employees' views about workplace interventions to encourage smoking cessation, including both voluntary programmes and passive interventions, such as restrictions or bans. The method used was theory-based "best fit" framework synthesis. RESULTS: Five relevant theories on workplace smoking cessation were identified and used as the basis for an a priori framework. A comprehensive literature search, including interrogation of eight databases, retrieved 747 unique citations for the review. Fifteen primary research studies of qualitative evidence were found to satisfy the inclusion criteria. The synthesis produced an evidence-based conceptual model explaining employees' experiences of, and preferences regarding, workplace smoking interventions. CONCLUSION: The synthesis suggests that workplace interventions should employ a range of different elements if they are to prove effective in reducing smoking among employees. This is because an employee who feels ready and able to change their behaviour has different needs and preferences from an employee who is not at that stage. Only a multi-faceted intervention can satisfy the requirements of all employees.

Multimorbidity and delivery of care for long-term conditions in the English National Health Service: baseline data from a cohort study.

OBJECTIVES: Many patients with long-term conditions have multiple conditions. Current delivery of care is not designed around their needs and they may face barriers to effective self-management. This study assessed the relationships between multimorbidity, the delivery of care, and self-management. METHODS: We surveyed 2439 patients with long-term conditions concerning their experience of the delivery of care and self-management in England in 2011. We assessed multimorbidity in terms of a count of long-term conditions and the presence of 'probable depression'. We explored the relationships between multimorbidity, patient experience of the delivery of care, and self-management RESULTS: Neither measure of multimorbidity was a significant predictor of patients' experience of the delivery of care. Patients with multimorbidity reported higher levels of self-management behaviour, while the presence of depression was associated with less positive attitudes towards self-management. CONCLUSIONS: The current data do not demonstrate a consistent impact of multimorbidity on patients' experience of care or on self-management. Further research is required to assess those types of multimorbidity that are associated with significant deficits, or to identify other aspects of care that might be problematic in the context of multiple conditions.

"Best fit" framework synthesis: refining the method.

BACKGROUND: Following publication of the first worked example of the "best fit" method of evidence synthesis for the systematic review of qualitative evidence in this journal, the originators of the method identified a need to specify more fully some aspects of this particular derivative of framework synthesis. METHODS AND RESULTS: We therefore present a second such worked example in which all techniques are defined and explained, and their appropriateness is assessed. Specified features of the method include the development of new techniques to identify theories in a systematic manner; the creation of an a priori framework for the synthesis; and the "testing" of the synthesis. An innovative combination of existing methods of quality assessment, analysis and synthesis is used to complete the process. This second worked example was a qualitative evidence synthesis of employees' views of workplace smoking cessation interventions, in which the "best fit" method was found to be practical and fit for purpose. CONCLUSIONS: The method is suited to producing context-specific conceptual models for describing or explaining the decision-making and health behaviours of patients and other groups. It offers a pragmatic means of conducting rapid qualitative evidence synthesis and generating programme theories relating to intervention effectiveness, which might be of relevance both to researchers and policy-makers.

Psychometric properties of the Patient Assessment Of Chronic Illness Care measure: acceptability, reliability and validity in United Kingdom patients with long-term conditions.

BACKGROUND: The Patient Assessment of Chronic Illness Care (PACIC) is a US measure of chronic illness quality of care, based on the influential Chronic Care Model (CCM). It measures a number of aspects of care, including patient activation; delivery system design and decision support; goal setting and tailoring; problem-solving and contextual counselling; follow-up and coordination. Although there is developing evidence of the utility of the scale, there is little evidence about its performance in the United Kingdom (UK). We present preliminary data on the psychometric performance of the PACIC in a large sample of UK patients with long-term conditions. METHOD: We collected PACIC, demographic, clinical and quality of care data from patients with long-term conditions across 38 general practices, as part of a wider longitudinal study. We assess rates of missing data, present descriptive and distributional data, assess internal consistency, and test validity through confirmatory factor analysis, and through associations between PACIC scores, patient characteristics and related measures. RESULTS: There was evidence that rates of missing data were high on PACIC (9.6% - 15.9%), and higher than on other scales used in the same survey. Most PACIC sub-scales showed reasonable levels of internal consistency (alpha = 0.68 - 0.94), responses did not demonstrate high skewness levels, and floor effects were more frequent (up to 30.4% on the follow up and co-ordination subscale) than ceiling effects (generally <5%). PACIC demonstrated preliminary evidence of validity in terms of measures of long-term condition care. Confirmatory factor analysis suggested that the five factor PACIC structure proposed by the scale developers did not fit the data: reporting separate factor scores may not always be appropriate. CONCLUSION: The importance of improving care for long-term conditions means that the development and validation of measures is a priority. The PACIC scale has demonstrated potential utility in this regard, but further assessment is required to assess low levels of completion of the scale, and to explore the performance of the scale in predicting outcomes and assessing the effects of interventions.

Better care for depression in the workplace: integrating occupational and mental health services.

People with depression in the workplace are less productive and at risk of losing their job. Many never work again. Intervention should ideally begin before sickness absence occurs and early return to work should be the focus of care. This will require closer integration of primary care, mental health and occupational health services.

Cost-effectiveness of interventions to return employees to work following long-term sickness absence due to musculoskeletal disorders.

BACKGROUND: Sickness absence costs the UK economy around £20 billion per year. This study aims to assess the cost-effectiveness of interventions to return employees with musculoskeletal disorders to work, one of the major causes of long-term sickness absence, using a mathematical model. METHODS: A Markov model was developed to assess the cost-effectiveness of three interventions: a workplace intervention; a physical activity and education intervention and a physical activity, education and workplace visit intervention. Extensive sensitivity analyses were undertaken to assess the impact of uncertainties upon the model results. RESULTS: All interventions assessed are estimated to have a cost per quality-adjusted life year gained below £3000 compared with usual care within the UK from a National Health Service (NHS) or societal perspective. Moreover, any intervention which returns at least an additional 3% of employees to work and costs less than an additional £3000 per employee, is likely to be considered economically attractive compared with usual care, relative to other interventions routinely funded by the NHS. CONCLUSIONS: This is the first economic evaluation in this area which extrapolates data beyond trial follow-up and synthesizes evidence from numerous sources. This sort of modelling approach should be considered for informing other public health policy decisions.

A pragmatic quasi-experimental multi-site community intervention trial evaluating the impact of Emergency Care Practitioners in different UK health settings on patient pathways (NEECaP Trial).

BACKGROUND: Emergency Care Practitioners (ECPs) are operational in the UK in a variety of emergency and urgent care settings. However, there is little evidence of the effectiveness of ECPs within these different settings. The aim of this study was to evaluate the impact of ECPs on patient pathways and care in different emergency care settings. METHODS: A pragmatic quasi-experimental multi-site community intervention trial comprising five matched pairs of intervention (ECP) and control services (usual care providers): ambulance, care home, minor injury unit, urgent care centre and GP out-of-hours. The main outcome being assessed was patient disposal pathway following the care episode. RESULTS: 5525 patient episodes (n=2363 intervention and n=3162 control) were included in the study. A significantly greater percentage of patients were discharged by ECPs working in mobile settings such as the ambulance service (percentage diff. 36.7%, 95% CI 30.8% to 42.7%) and care home service (36.8%, 26.7% to 46.8%). In static services such as out-of-hours (-17.9%, -30.8% to -42.7%) and urgent care centres (-11.5%, -18.0% to -5.1%), a significantly greater percentage of patients were discharged by usual care providers. CONCLUSIONS: ECPs have a differential impact compared with usual care providers dependent on the operational service settings. Maximal impact occurs when they operate in mobile settings when care is taken to the patient. In these settings ECPs have a broader range of skills than the usual care providers (eg, paramedic), and are targeted to specific clinical groups who can benefit from alternative pathways of care (such as older people who have fallen). Trial Registration No ISRCTN22085282 (Controlled trials.com).

Workplace involvement improves return to work rates among employees with back pain on long-term sick leave: a systematic review of the effectiveness and cost-effectiveness of interventions.

PURPOSE: Long-term sickness absence among workers is a major problem in industrialised countries. The aim of the review is to determine whether interventions involving the workplace are more effective and cost-effective at helping employees on sick leave return to work than those that do not involve the workplace at all. METHODS: A systematic review of controlled intervention studies and economic evaluations. Sixteen electronic databases and grey literature sources were searched, and reference and citation tracking was performed on included publications. A narrative synthesis was performed. RESULTS: Ten articles were found reporting nine trials from Europe and Canada, and four articles were found evaluating the cost-effectiveness of interventions. The population in eight trials suffered from back pain and related musculoskeletal conditions. Interventions involving employees, health practitioners and employers working together, to implement work modifications for the absentee, were more consistently effective than other interventions. Early intervention was also found to be effective. The majority of trials were of good or moderate quality. Economic evaluations indicated that interventions with a workplace component are likely to be more cost effective than those without. CONCLUSION: Stakeholder participation and work modification are more effective and cost effective at returning to work adults with musculoskeletal conditions than other workplace-linked interventions, including exercise.

How do nurses, midwives and health visitors contribute to protocol-based care? A synthesis of the UK literature.

OBJECTIVES: To explore how nurses, midwives and health visitors contribute to the development, implementation and audit of protocol-based care. Protocol-based care refers to the use of documents that set standards for clinical care processes with the intent of reducing unacceptable variations in practice. Documents such as protocols, clinical guidelines and care pathways underpin evidence-based practice throughout the world. METHODS: An interpretative review using the five-stage systematic literature review process. The data sources were the British Nursing Index, CINAHL, EMBASE, MEDLINE and Web of Science from onset to 2005. The Journal of Integrated Care Pathways was hand searched (1997-June 2006). Thirty three studies about protocol-based care in the United Kingdom were appraised using the Qualitative Assessment and Review Instrument (QARI version 2). The literature was synthesized inductively and deductively, using an official 12-step guide for development as a framework for the deductive synthesis. RESULTS: Most papers were descriptive, offering practitioner knowledge and positive findings about a locally developed and owned protocol-based care. The majority were instigated in response to clinical need or service re-design. Development of protocol-based care was a non-linear, idiosyncratic process, with steps omitted, repeated or completed in a different order. The context and the multiple purposes of protocol-based care influenced the development process. Implementation and sustainability were rarely mentioned, or theorised as a change. The roles and activities of nurses were so understated as to be almost invisible. There were notable gaps in the literature about the resource use costs, the engagement of patients in the decision-making process, leadership and the impact of formalisation and new roles on inter-professional relations. CONCLUSIONS: Documents that standardise clinical care are part of the history of nursing as well as contemporary evidence-based care and expanded roles. Considering the proliferation and contested nature of protocol-based care, the dearth of literature about the contribution, experience and outcomes for nurses, midwives and health visitors is noteworthy and requires further investigation.

A conceptual framework for implementation fidelity.

BACKGROUND: Implementation fidelity refers to the degree to which an intervention or programme is delivered as intended. Only by understanding and measuring whether an intervention has been implemented with fidelity can researchers and practitioners gain a better understanding of how and why an intervention works, and the extent to which outcomes can be improved. DISCUSSION: The authors undertook a critical review of existing conceptualisations of implementation fidelity and developed a new conceptual framework for understanding and measuring the process. The resulting theoretical framework requires testing by empirical research. SUMMARY: Implementation fidelity is an important source of variation affecting the credibility and utility of research. The conceptual framework presented here offers a means for measuring this variable and understanding its place in the process of intervention implementation.

What is protocol-based care? A concept analysis.

AIM: To define protocol-based care to make this way of delivering health care amenable to theoretical and empirical studies. BACKGROUND: Although protocol-based care is associated with the evidence-based practice and standardization movements, it is an ill-defined and understood concept. METHOD: A multiphase concept analysis, inspired by an evolutionary view was used to clarify 'what is protocol-based care'. The inductive, five-phase process drew upon content analysis of policy documents and the literature, plus interviews with a purposive sample of 35 opinion leaders. RESULTS: The term was used interchangeably with protocols, pathways and guidelines in policy and guidance documents. A search of seven databases produced only 57 references to protocol-based care. The concept analysis revealed a continuum of scope and specificity and also distinguished specialist and generic applications of protocol-based care. CONCLUSIONS: Managers need to take cognizance of the significance and complexity of protocol-based care when introducing this way of working.