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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 The workplace is an important setting for reaching potentially large numbers of smokers. Aims To review the evidence about smoking cessation in the workplace. Methods Literature review including a synthesis of findings from recent systematic reviews and meta-analyses of workplace smoking cessation programmes, a separate review of the qualitative evidence, case studies and an expert panel assessment. Results We found advantages, identified or confirmed from the mixed methods used in this work to holding smoking cessation programmes in the workplace. These included: (i) easy access to large numbers of worker populations for large workplaces, (ii) the potential improved recruitment to such programmes given this, (iii) the opportunity to access young men, traditionally difficult to achieve, (iv) access to occupational health and other staff who can assist with support and delivery and (v) ability for workers to attend relatively easily. Evidence on the importance of developing peer support at work was mixed. The simple provision or availability of programmes and interventions was unlikely to provide any beneficial behaviour change. Interventions should target workers that actively want to stop smoking, use elements that workers have identified as useful or focus on altering beliefs about smoking and the need to stop. Conclusions Smoking cessation programmes at work can provide useful support for workers wishing to stop smoking. They are only likely to be effective if participants have moved beyond the contemplation stage regarding smoking cessation, so that stopping smoking is a personal priority.

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.

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 Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users.

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.

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

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.

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.

RCTs are critical to evidence-based medicine, but recruitment is routinely problematic. Robust tests of recruitment methods, where alternative approaches are compared within RCTs, are rare. The MRC funded START programme aims to test the feasibility of routinely nesting recruitment interventions in host RCTs. This will rapidly extend the evidence base, allow promising recruitment interventions to be tested across multiple trials, and improve our understanding of the impact of contextual factors on recruitment. Newly commissioned or recruiting trials were identified via PCRN and HTA portfolios. A total of 225 PIs were sent a flyer describing the MRC START programme with a covering email (from PCRN or HTA) inviting them to contact the team if they would like to know more about the study. Preliminary discussions were held with interested trials to screen them for suitability. Formal agreements were then put in place and trial specific intervention content was developed. Nearly a third (32%) of PIs approached expressed an interest in the study. Just over half (52%) were excluded, reasons included incompatible recruitment strategies, timetable issues or trial size. Reaction to the additional burden placed on trials has so far been positive. Documentation has been found fit for purpose and the process of implementation supported by a ‘can do' culture and complex research skills in trial managers. This presentation will: • (a) describe START and report on progress to date, • (b) discuss early findings in relation to feasibility and host trial experience, • (c) present materials to support the recruitment of host trials.

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.