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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 anad hocway, 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.

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)

Background: As the worldwide prevalence of chronic illness increases so too does the demand for novel treatments to improve chronic illness care. Quantifying improvement in chronic illness care from the patient perspective relies on the use of validated patient-reported outcome measures. In this analysis we examine the psychometric and scaling properties of the Patient Assessment of Chronic Illness Care (PACIC) questionnaire for use in the United Kingdom by applying scale data to the non-parametric Mokken double monotonicity model. Methods: Data from 1849 patients with long-term conditions in the UK who completed the 20-item PACIC were analysed using Mokken analysis. A three-stage analysis examined the questionnaire's scalability, monotonicity and item ordering. An automated item selection procedure was used to assess the factor structure of the scale. Analysis was conducted in an 'evaluation' dataset (n = 956) and results were confirmed using an independent 'validation' (n = 890) dataset. Results: Automated item selection procedures suggested that the 20 items represented a single underlying trait representing "patient assessment of chronic illness care": this contrasts with the multiple domains originally proposed. Six items violated invariant item ordering and were removed. The final 13-item scale had no further issues in either the evaluation or validation samples, including excellent scalability (Ho = .50) and reliability (Rho = .88). Conclusions: Following some modification, the 13-items of the PACIC were successfully fitted to the non-parametric Mokken model. These items have psychometrically robust and produce a single ordinal summary score. This score will be useful for clinicians or researchers to assess the quality of chronic illness care from the patient's perspective.

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).

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.

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.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.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.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.

During recruitment, potential trial participants are usually given a written study patient information sheet (PIS). These are often long, complex and visually unappealing documents, which may have a negative impact on recruitment. Improving their readability by employing user testing, and their presentation by using graphic designers may improve patient understanding and aid recruitment. We undertook an embedded randomised controlled trial within the NIHR-funded REFORM study, as part of the MRC START initiative, to evaluate whether enhancing PIS improves trial recruitment and retention. 6,900 patients due to be mailed a REFORM recruitment pack were randomised in a 1:1:1 ratio to receive one of three types of PIS: the original based on the NHS ethics template (n=2,298); an enhanced, user tested PIS (n=2,301); or a ‘template’ PIS which was developed using an enhanced PIS from another trial in a similar population (n=2,301). 193 participants (2.8%) were randomised to the trial: 62 (2.7%) in the control group; 63 (2.7%) in the user tested group; and 68 (3.0%) in the template group (OR: template vs control 1.10 (95% CI 0.77-1.56, p=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)). Logistic regression analysis demonstrated that PIS allocation did not significantly predict recruitment (p= 0.33) or retention in the trial (p=0.83). There was no evidence to suggest that enhanced PIS increased recruitment and retention rates to the REFORM trial. However, the number of patients randomised was low and we may be underpowered to detect a difference.

Psychiatric interviews were carried out to validate the General Health Questionnaire-12 (GHQ-12; Goldberg, 1972) for use with staff of England's National Health Service (NHS), and to determine the appropriate threshold score to identify probable cases. In a sample of 551 NHS staff, the correlation between the GHQ-12 and the Clinical Interview Schedule-Revised (CIS-R) was found to be .70. The receiver operating characteristic showed that a 3/4 threshold, higher than used in all but one previous study, gave the best conservative estimate of minor psychiatric morbidity. This threshold gave an estimated sensitivity of the GHQ-12 of.69 and specificity of.88. It reduced case rates by between 8% and 17% as compared with lower possible thresholds. Convergent and discriminant validation of the GHQ-12 was demonstrated through comparison with other measures of mental and physical health.

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.

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.

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 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.

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. © 2012 The Author.

A self-completion questionnaire survey of coping behaviours and associated perceptions amongst 675 white collar public sector employees is reported. In addition to identifying underlying dimensions of coping behaviour, the relationship between reported use of coping strategies and perceptions related to work stress, general mental well-being, and job satisfaction were explored. From the responses concerning frequency of use of various coping methods, five dimensions of coping strategy were identified: problem-focused, health and leisure-oriented, social support seeking, avoidant, and formal relaxation. It was found that use of avoidant coping methods was significantly associated with perceived problems with coping at work, with lower job satisfaction, and with poorer levels of general mental health. Higher reported use of problem-focused methods was significantly associated with fewer problems with coping at work, higher job satisfaction, and better levels of general mental health.

Background In recent years human resource management (HRM) has been seen as an important factor in the successful realisation of organisational change programmes. The UK NHS is undergoing substantial organisational change and there is a need to establish which human resource (HR) initiatives may be most effective. Objectives To assess the results from a wide-ranging series of systematic reviews of the evidence on HRM and performance. The first part assesses evidence on use of HRM in the UK and fidelity of practice implemented. The second part considers evidence for the impact of HRM practices on intermediate outcomes, which can impact on final outcomes, such as organisational performance or patient care. Data sources The following databases were searched: Applied Social Sciences Index and Abstracts (ASSIA), British Nursing Index (BNI), Business Source Premier, Campbell Collaboration, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Database of Abstracts of Reviews of Effectiveness (DARE), DH-Data, EMBASE, Health Management Information Consortium (HMIC), International Bibliography of the Social Sciences (IBSS), King's Fund database, MEDLINE, NHS Economic Evaluation Database (NHS EED), National Research Register (NRR), PREMEDLINE, PsycINFO, ReFeR, Social Sciences Citation Index (SSCI) and Science Citation Index (SCI). The searches were conducted in May/June 2006. Review methods Broad categories of HRM interventions and intermediate outcomes were generated: 10 HRM categories and 12 intermediate outcome categories. Seven patient final outcomes were derived from the NHS Performance Indicators and the NHS Improvement Plan. The quality criteria used to select papers incorporated a longitudinal study design filter to provide evidence of the causal direction of relationships between HRM and relevant outcomes. Single HRM practices were considered. Within the health-specific literature, focus was on the impact of HRM on patient outcomes. Information is presented on the reliability of measures in each of the intermediate outcome areas. Results Work design practices that enhance employee autonomy and control influenced a number of outcomes and there was consistent evidence for the positive impact of increased job control on employee outcomes, such as job satisfaction, absence and health. For employee participation, the small number of studies reviewed supported the involvement of employees in design/implementation of changes that affect their work. In health literature in particular, employee involvement through quality improvement teams resulted in improved patient outcomes. Findings were positive for the impact of training on the intended outcomes of the initiatives. Support for the impact of performance management practices was apparent, in particular feedback on performance outcomes and the use of participative goal setting. Strong associations were found among all intermediate outcomes, and the relationship between most intermediate behaviours and outcomes were significant. Limitations Limited evidence was available on the use of HRM and on the implementation of policy. Also, the specific practices studied within each HRM category differ so there was little evidence to show whether similar practices have the same effects in health and non-health settings. Conclusions Some potentially effective practices for both health and non-health areas were identified, and HRM methods could be used to support change processes within the NHS; the findings relating to work organisation are particularly promising with regard to changes in methods of service delivery. Using training to support the implementation of change is highlighted. However, future multilevel studies that embrace the individual, team and organisational level are needed. Studies should look into interventions aimed at improving HR outcomes and performance, and allow for pre- and post-intervention measurement of practices and outcomes.

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.

Testing the effectiveness of user-tested patient information on recruitment rates across multiple trials: meta-analysis of data from the start programme Peter Bower, Jo Rick, Anne Kennedy, Chris Salisbury, David Collier, David Torgerson, Jonathan Graffy, Shaun Treweek, Sandra Eldridge, Vichithranie Madurasinghe, Peter Knapp, Adwoa Hughes-Morley, Nicola Small, CASPER Research team, Healthlines Research team, ECLS Research team

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 guide- lines 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 complex- ity of protocol-based care when introducing this way of working.

SummaryPeople 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.

BackgroundIt is widely suggested that many National Health Service (NHS) workers experience high levels of minor psychiatric disorder. However, inadequacies of sampling and measurement in studies to date have not allowed this suggestion to be properly evaluated.MethodThe present study was designed to overcome these methodological weaknesses by using a sample of over 11 000 employees from 19 NHS trusts and a well-established measure of minor psychiatric disorder for which there are comparative data.ResultsThe findings show that 26.8% of the health service workers reported significant levels of minor psychiatric disorder, compared with 17.8% of people in the general population. Psychiatric morbidity was highest among managers, doctors, nurses and professions allied to medicine, with each of these groups recording higher rates than their professional counterparts outside the health service. It was lower among those in support occupations, such as administrative and ancillary staff. A feature of the findings was that female doctors and managers showed a much higher prevalence of minor psychiatric disorder than their male colleagues.ConclusionStudies are required to establish the organisational, occupational and individual determinants of minor psychiatric disorder among NHS employees.

Background\ud 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.\ud \ud Methods\ud 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.\ud \ud Results\ud 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.\ud \ud Conclusion\ud 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.

Results Nineteen reviews were included. Multimedia interventions offer a platform for learning which can include study-specific information (e.g. study purpose, risks), and generic information (e.g. confidentiality). There was evidence that multimedia interventions improved various outcomes including perceived risk, personal choice and feeling informed. PPI forum members and qualitative experts developed study-specific components involving bespoke themes such as investigator details and benefits of participation, and generic information components including informed consent, randomisation and confidentiality. Existing video clips of patients discussing their experiences of participation were carefully matched to these components.