Making do by getting real: Psychological contract violations and proactive career agency among medical professionals.

BACKGROUND: Health care professionals face greater uncertainty in their careers as traditional jobs wither and new, organizationally controlled jobs proliferate, reducing economic security and professional autonomy. PURPOSE: We apply psychological contract and self-efficacy theory to examine the career agency of early-career physicians. We ask the following: (a) What are the unfulfilled expectations and emotions experienced by young physicians at the training and early career stages? (b) What are the forms of career agency exhibited by young physicians in response to unfulfillment? METHODOLOGY: We conducted a study on 48 U.K. early-career primary care physicians, known as general practitioners. The sample comprised both trainees as well as newly qualified physicians. Data were collected through in-depth interviews and focus group discussions. RESULTS: Physicians interpreted their early-career experiences based on predominantly ideological expectations around what it means to be a successful professional. However, the realities of practice resulted in highly emotional experiences of violation that were associated with a "reactive" agency and job behaviors that were more transactional and less relational. CONCLUSION: This study identifies the expectations of early career professionals, which helps understand how and why psychological contract violations occur. It also expands the conceptualization of career agency from a positively framed aspect of professional behavior to one that includes haphazard and self-serving elements. PRACTICE IMPLICATIONS: Our study highlights several implications of the shifts in physician career agency for primary care practice. It discusses the potential effects of the purposeful self-interest among doctors on professional identity and power, as well as patient care.

The organisational climate of NHS Early Intervention Services (EIS) for psychosis: a qualitative analysis.

BACKGROUND: Cognitive remediation (CR) therapy for psychosis significantly improves recovery but is yet to be widely implemented in NHS services. It is likely to be of value at the earliest stages of psychosis development - at the first episode. Organisational climate is one factor likely to affect implementation into Early Intervention Services (EIS), which serve those experiencing first episode psychosis. We aimed to understand the organisational climate within UK NHS Early Intervention for Psychosis (EIP) services and the barriers and facilitators for the introduction of CR. METHODS: We conducted semi structured interviews with 42 EIS members of four teams in four NHS Trusts. Thematic analysis was used to analyse the data. RESULTS: There were differences between teams, including leadership style, involvement in decision making and willingness to adopt CR. Resource shortages were considered the main barrier for implementation across all teams. The evidence base behind CR and the recognition of there being a clinical need was seen as the main facilitator. Teams with more democratic leadership, and knowledge of both the evidence base and need for CR, may feel better able to successfully incorporate it into their service. CONCLUSION: Despite enthusiasm for novel treatments, EIS teams are limited by their resources. An understanding of the local organisational variables can help teams establish a culture that values innovation. Clear communication of the evidence base for CR is key to help enable staff to implement novel treatments successfully despite these limited resources and time pressures.

Merger and post-merger integration at Oxford University Hospitals: mixed-methods evaluation and lessons learned.

PURPOSE: Hospital mergers are common in the United Kingdom and internationally. However, mergers rarely achieve their intended benefits and are often damaging. This study builds on existing literature by presenting a case study evaluating a merger of two hospitals in Oxford, United Kingdom with three distinct characteristics: merger between two university hospitals, merger between a generalist and specialist hospital and merger between two hospitals of differing size. In doing so, the study draws practical lessons for other healthcare organisations. DESIGN/METHODOLOGY/APPROACH: Mixed-methods single-case evaluation. Qualitative data from 19 individual interviews and three focus groups were analysed thematically, using constant comparison to synthesise and interpret findings. Qualitative data were triangulated with quantitative clinical and financial data. To maximise research value, the study was co-created with practitioners. FINDINGS: The merger was a relative success with mixed improvement in clinical performance and strong improvement in financial and organisational performance. The merged organisation received an improved inspection rating, became debt-free and achieved Foundation Trust status. The study draws six lessons relating to the contingencies that can make mergers a success: (1) Develop a strong clinical rationale, (2) Communicate the change strategy widely and early, (3) Increase engagement and collaboration at all levels, (4) Be transparent and realistic about the costs and benefits, (5) Be sensitive to the feelings of the other organisation and (6) Integrate different organizational cultures effectively. ORIGINALITY/VALUE: This case study provides empirical evidence on the outcome of merger in a university hospital setting. Despite the relatively positive outcome, there is no strong evidence that the benefits could not have been achieved without merger. Given that mergers remain prevalent worldwide, the practical lessons might be useful for other healthcare organisations considering merger.

How do frontline staff use patient experience data for service improvement? Findings from an ethnographic case study evaluation.

OBJECTIVES: Improving patient experience is widely regarded as a key component of health care quality. However, while a considerable amount of data are collected about patient experience, there are concerns this information is not always used to improve care. This study explored whether and how frontline staff use patient experience data for service improvement. METHODS: We conducted a year-long ethnographic case study evaluation, including 299 hours of observations and 95 interviews, of how frontline staff in six medical wards at different hospital sites in the United Kingdom used patient experience data for improvement. RESULTS: In every site, staff undertook quality improvement projects using a range of data sources. Teams of health care practitioners and ancillary staff engaged collectively in a process of sense-making using formal and informal sources of patient experience data. While survey data were popular, 'soft' intelligence - such as patients' stories, informal comments and observations - also informed staff's improvement plans, without always being recognized as data. Teams with staff from different professional backgrounds and grades tended to make more progress than less diverse teams, being able to draw on a wider net of practical, organizational and social resources, support and skills, which we describe as team-based capital. CONCLUSIONS: Organizational recognition, or rejection, of specific forms of patient experience intelligence as 'data' affects whether staff feel the data are actionable. Teams combining a diverse range of staff generated higher levels of 'team-based capital' for quality improvement than those adopting a single disciplinary approach. This may be a key mechanism for achieving person-centred improvement in health care.

Staff Perceptions of Improving Emergency Care for Children: A Qualitative Study.

The objective of this study was to identify staff perceptions of a service improvement for pediatric emergency care at a university teaching hospital. Semistructured qualitative interviews of stakeholders were conducted, and grounded theory approach was used for analysis. Forty-one interviews were conducted with physicians, nurses, managers, and health care workers. Major themes emerging from the analysis included the physical space of and flow within the pediatric emergency department (ED), impact of technology, staffing in the ED, the effects of frontline pediatricians and emergency physicians managing children in the ED, and the need for and expectations of a pediatric emergency medicine (PEM) consultant. Human interactions among health care providers, leadership, and teaching are considered as equally important as providing the appropriate environment and qualified professionals for improving care for children in the ED. Appointment of a PEM consultant was suggested to provide leadership and education to manage relationships and implement changes. Subsequent to the study, the model of care for PEM was changed, the pediatric care delivery became more integrated with the main ED, and two PEM consultants were appointed to the institution.

Making sense of effective partnerships among senior leaders in the National Health Service.

BACKGROUND: Changing health care systems depend on strong organizational leadership that realizes the collaborative potential of both physician and nonphysician leaders. PURPOSE: The aim of this study was to seek insight into the everyday health care leader experience by examining 24 physician and nonphysician leaders working in the U.K. National Health Service. We explored (a) how they make sense of and act with respect to specific collaborative tensions in their interactions and (b) which aspects of their everyday leadership contexts heighten the probability for producing and resolving such tensions. METHODOLOGY: We conducted 24 in-depth interviews with physician and nonphysician leaders in job titles including Chief Operating Officer, Managing Director, Medical Director, and Clinical Director. Ideas from the social psychological perspectives of sensemaking, organizational role theory, and organizational citizenship behavior helped frame the study. RESULTS: We identified four areas of ongoing tension between senior leaders. Each of these was linked to a set of underlying drivers, with the strongest support for drivers with interpersonal roots. Effective strategies for resolving tensions involved significant effort by leaders at improving the interpersonal dynamics associated with everyday interaction and forging relational connections through enhanced trust within the leadership team. CONCLUSION: This study outlines the organizational and individual characteristics that lend to effective collaboration among senior health care leadership and the types of collaborative tensions likely to be experienced by senior health care leaders. PRACTICE IMPLICATIONS: Organizations should provide greater role clarity for senior leadership roles, promote "soft" interpersonal competencies within them, and better assess potential leaders for success in senior roles. Organizational support in the form of facilitation, time, and spaces to learn together can provide a better context for collaborative decision-making.

The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial.

BACKGROUND: Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. METHODS: This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. DISCUSSION: It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience. TRIAL REGISTRATION: ISRCTN, ISRCTN14678860 , Registered on 6 June 2016.

An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol.

BACKGROUND: Cellular-based therapies represent a platform technology within the rapidly expanding field of regenerative medicine and are distinct from conventional therapeutics-offering a unique approach to managing what were once considered untreatable diseases. Despite a significant increase in basic science activity within the cell therapy arena, alongside a growing portfolio of cell therapy trials and promising investment, the translation of cellular-based therapeutics from "bench to bedside" remains challenging, and the number of industry products available for widespread clinical use remains comparatively low. This systematic review identifies unique intrinsic and extrinsic barriers in the cell-based therapy domain. METHODS/DESIGN: Eight electronic databases will be searched, specifically Medline, EMBASE (OvidSP), BIOSIS & Web of Science, Cochrane Library & HEED, EconLit (ProQuest), WHOLIS WHO Library Database, PAIS International (ProQuest), and Scopus. Addition to this gray literature was searched by manually reviewing relevant work. All identified articles will be subjected for review by two authors who will decide whether or not each article passes our inclusion/exclusion criteria. Eligible papers will subsequently be reviewed, and key data extracted into a pre-designed data extraction scorecard. An assessment of the perceived impact of broad commercial barriers to the adoption of cell-based therapies will be conducted. These broad categories will include manufacturing, regulation and intellectual property, reimbursement, clinical trials, clinical adoption, ethics, and business models. This will inform further discussion in the review. There is no PROSPERO registration number. DISCUSSION: Through a systematic search and appraisal of available literature, this review will identify key challenges in the commercialization pathway of cellular-based therapeutics and highlights significant barriers impeding successful clinical adoption. This will aid in creating an adaptable, acceptable, and harmonized approach supported by apposite regulatory frameworks and pertinent expertise throughout the respective stages of the adoption cycle to facilitate the adoption of new products and technologies in the industry.

Medicine authentication technology as a counterfeit medicine-detection tool: a Delphi method study to establish expert opinion on manual medicine authentication technology in secondary care.

OBJECTIVES: This study aims to establish expert opinion and potential improvements for the Falsified Medicines Directive mandated medicines authentication technology. DESIGN AND INTERVENTION: A two-round Delphi method study using an online questionnaire. SETTING: Large National Health Service (NHS) foundation trust teaching hospital. PARTICIPANTS: Secondary care pharmacists and accredited checking technicians. PRIMARY OUTCOME MEASURES: Seven-point rating scale answers which reached a consensus of 70-80% with a standard deviation (SD) of <1.0. Likert scale questions which reached a consensus of 70-80%, a SD of <1.0 and classified as important according to study criteria. RESULTS: Consensus expert opinion has described database cross-checking technology as quick and user friendly and suggested the inclusion of an audio signal to further support the detection of counterfeit medicines in secondary care (70% consensus, 0.9 SD); other important consensus with a SD of <1.0 included reviewing the colour and information in warning pop up screens to ensure they were not mistaken for the 'already dispensed here' pop up, encouraging the dispenser/checker to act on the warnings and making it mandatory to complete an 'action taken' documentation process to improve the quarantine of potentially counterfeit, expired or recalled medicines. CONCLUSIONS: This paper informs key opinion leaders and decision makers as to the positives and negatives of medicines authentication technology from an operator's perspective and suggests the adjustments which may be required to improve operator compliance and the detection of counterfeit medicines in the secondary care sector.

Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study.

OBJECTIVES: To identify the authentication and detection rate of serialised medicines using medicines authentication technology. DESIGN AND INTERVENTION: 4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit. SETTING: A site within a large UK National Health Service teaching hospital trust. PARTICIPANTS: Accredited checking staff, pharmacists and dispensers in a pharmacy department. PRIMARY OUTCOME MEASURES: Authentication and detection rate of counterfeit expired and recalled medicines. RESULTS: The operational detection rate of counterfeit, recalled and expired medicines scanned as a combined group was 81.4% (stage 1 (S1)) and 87% (stage 2 (S2)). The technology's technical detection rate (TDR) was 100%; however, not all medicines were scanned and of those that were scanned not all that generated a warning message were quarantined. Owing to an operational authentication rate (OAR) of 66.3% (over both stages), only 31.8% of counterfeit medicines, 58% of recalled drugs and 64% of expired medicines were detected as a proportion of those entered into the study. Response times (RTs) of 152 ms (S1) and 165 ms (S2) were recorded, meeting the falsified medicines directive-mandated 300 ms limit. CONCLUSIONS: TDRs and RTs were not a limiting factor in this study. The suboptimal OAR poses significant quality and safety issues with this detection approach. Authentication at the checking stage, however, demonstrated higher OARs. There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this technology in preparation for the incumbent European Union regulative deadline.

A global call for action to include gender in research impact assessment.

Global investment in biomedical research has grown significantly over the last decades, reaching approximately a quarter of a trillion US dollars in 2010. However, not all of this investment is distributed evenly by gender. It follows, arguably, that scarce research resources may not be optimally invested (by either not supporting the best science or by failing to investigate topics that benefit women and men equitably). Women across the world tend to be significantly underrepresented in research both as researchers and research participants, receive less research funding, and appear less frequently than men as authors on research publications. There is also some evidence that women are relatively disadvantaged as the beneficiaries of research, in terms of its health, societal and economic impacts. Historical gender biases may have created a path dependency that means that the research system and the impacts of research are biased towards male researchers and male beneficiaries, making it inherently difficult (though not impossible) to eliminate gender bias. In this commentary, we - a group of scholars and practitioners from Africa, America, Asia and Europe - argue that gender-sensitive research impact assessment could become a force for good in moving science policy and practice towards gender equity. Research impact assessment is the multidisciplinary field of scientific inquiry that examines the research process to maximise scientific, societal and economic returns on investment in research. It encompasses many theoretical and methodological approaches that can be used to investigate gender bias and recommend actions for change to maximise research impact. We offer a set of recommendations to research funders, research institutions and research evaluators who conduct impact assessment on how to include and strengthen analysis of gender equity in research impact assessment and issue a global call for action.

Collective action for implementation: a realist evaluation of organisational collaboration in healthcare.

BACKGROUND: Increasingly, it is being suggested that translational gaps might be eradicated or narrowed by bringing research users and producers closer together, a theory that is largely untested. This paper reports a national study to fill a gap in the evidence about the conditions, processes and outcomes related to collaboration and implementation. METHODS: A longitudinal realist evaluation using multiple qualitative methods case studies was conducted with three Collaborations for Leadership in Applied Health Research in Care (England). Data were collected over four rounds of theory development, refinement and testing. Over 200 participants were involved in semi-structured interviews, non-participant observations of events and meetings, and stakeholder engagement. A combined inductive and deductive data analysis process was focused on proposition refinement and testing iteratively over data collection rounds. RESULTS: The quality of existing relationships between higher education and local health service, and views about whether implementation was a collaborative act, created a path dependency. Where implementation was perceived to be removed from service and there was a lack of organisational connections, this resulted in a focus on knowledge production and transfer, rather than co-production. The collaborations' architectures were counterproductive because they did not facilitate connectivity and had emphasised professional and epistemic boundaries. More distributed leadership was associated with greater potential for engagement. The creation of boundary spanning roles was the most visible investment in implementation, and credible individuals in these roles resulted in cross-boundary work, in facilitation and in direct impacts. The academic-practice divide played out strongly as a context for motivation to engage, in that 'what's in it for me' resulted in variable levels of engagement along a co-operation-collaboration continuum. Learning within and across collaborations was patchy depending on attention to evaluation. CONCLUSIONS: These collaborations did not emerge from a vacuum, and they needed time to learn and develop. Their life cycle started with their position on collaboration, knowledge and implementation. More impactful attempts at collective action in implementation might be determined by the deliberate alignment of a number of features, including foundational relationships, vision, values, structures and processes and views about the nature of the collaboration and implementation.

Open Access Could Transform Drug Discovery: A Case Study of JQ1.

INTRODUCTION: The cost to develop a new drug from target discovery to market is a staggering $1.8 billion, largely due to the very high attrition rate of drug candidates and the lengthy transition times during development. Open access is an emerging model of open innovation that places no restriction on the use of information and has the potential to accelerate the development of new drugs. AREAS COVERED: To date, no quantitative assessment has yet taken place to determine the effects and viability of open access on the process of drug translation. This need is addressed within this study. The literature and intellectual property landscapes of the drug candidate JQ1, which was made available on an open access basis when discovered, and conventionally developed equivalents that were not are compared using the Web of Science and Thomson Innovation software, respectively. EXPERT OPINION: Results demonstrate that openly sharing the JQ1 molecule led to a greater uptake by a wider and more multi-disciplinary research community. A comparative analysis of the patent landscapes for each candidate also found that the broader scientific diaspora of the publically released JQ1 data enhanced innovation, evidenced by a greater number of downstream patents filed in relation to JQ1. The authors' findings counter the notion that open access drug discovery would leak commercial intellectual property. On the contrary, JQ1 serves as a test case to evidence that open access drug discovery can be an economic model that potentially improves efficiency and cost of drug discovery and its subsequent commercialization.

The role of hospital managers in quality and patient safety: a systematic review.

OBJECTIVES: To review the empirical literature to identify the activities, time spent and engagement of hospital managers in quality of care. DESIGN: A systematic review of the literature. METHODS: A search was carried out on the databases MEDLINE, PSYCHINFO, EMBASE, HMIC. The search strategy covered three facets: management, quality of care and the hospital setting comprising medical subject headings and key terms. Reviewers screened 15,447 titles/abstracts and 423 full texts were checked against inclusion criteria. Data extraction and quality assessment were performed on 19 included articles. RESULTS: The majority of studies were set in the USA and investigated Board/senior level management. The most common research designs were interviews and surveys on the perceptions of managerial quality and safety practices. Managerial activities comprised strategy, culture and data-centred activities, such as driving improvement culture and promotion of quality, strategy/goal setting and providing feedback. Significant positive associations with quality included compensation attached to quality, using quality improvement measures and having a Board quality committee. However, there is an inconsistency and inadequate employment of these conditions and actions across the sample hospitals. CONCLUSIONS: There is some evidence that managers' time spent and work can influence quality and safety clinical outcomes, processes and performance. However, there is a dearth of empirical studies, further weakened by a lack of objective outcome measures and little examination of actual actions undertaken. We present a model to summarise the conditions and activities that affect quality performance.

The Hidden Complexity of Long-Term Care: how context mediates knowledge translation and use of best practices.

PURPOSE: Context is increasingly recognized as a key factor to be considered when addressing healthcare practice. This study describes features of context as they pertain to knowledge use in long-term care (LTC). DESIGN AND METHODS: As one component of the research program Translating Research in Elder Care, an in-depth qualitative case study was conducted to examine the research question "How does organizational context mediate the use of knowledge in practice in long-term care facilities?" A representative facility was chosen from the province of Saskatchewan, Canada. Data included document review, direct observation of daily care practices, and interviews with direct care, allied provider, and administrative staff. RESULTS: The Hidden Complexity of Long-Term Care model consists of 8 categories that enmesh to create a context within which knowledge exchange and best practice are executed. These categories range from the most easily identifiable to the least observable: physical environment, resources, ambiguity, flux, relationships, and philosophies. Two categories (experience and confidence, leadership and mentoring) mediate the impact of other contextual factors. Inappropriate physical environments, inadequate resources, ambiguous situations, continual change, multiple relationships, and contradictory philosophies make for a complicated context that impacts care provision. IMPLICATIONS: A hidden complexity underlays healthcare practices in LTC and each care provider must negotiate this complexity when providing care. Attending to this complexity in which care decisions are made will lead to improvements in knowledge exchange mechanisms and best practice uptake in LTC settings.

Challenges to using evidence from systematic reviews to stop ineffective practice: an interview study.

OBJECTIVES: To examine the challenges to using systematic review evidence to develop guidance for decommissioning ineffective health services, and the problems experienced by clinicians and commissioners when they attempt to implement the evidence from this guidance. METHODS: Interviews with 23 clinicians and 15 commissioners from nine commissioning organizations (Primary Care Trusts) in the south of England. RESULTS: Participants identified generic and intervention-specific barriers to using systematic review evidence to develop and implement decommissioning. Generic barriers included: contradictions within the health care system arising from policy; managing a high volume of evidence; difficulty in applying the evidence to the local context; and patient or parent expectations. Intervention-specific factors included: the influence of industry; an absence of systems for monitoring local implementation of guidance; and the availability of different codes for the same procedure which made monitoring some practices unreliable. CONCLUSIONS: The micro practices of commissioners are shaped by the wider system of health policy, the knowledge producing and delivery agencies associated with health care, and power dynamics within the health care system. If decommissioning is to be guided by evidence, then adequate resources to support the process are necessary. This includes long-term engagement of clinicians, providing alternatives to the decommissioned activity and tackling perverse incentives. An important precursor to decommissioning is obtaining data on the nature and extent of current clinical practice and using these data to monitor variation in the implementation of guidance.

The role of chief executive officers in a quality improvement : a qualitative study.

OBJECTIVES: To identify the critical dimensions of hospital Chief Executive Officers' (CEOs) involvement in a quality and safety and to offer practical guidance to assist CEOs to fulfil their leadership role in quality improvement (QI). DESIGN: Qualitative interview study. SETTING: 20 organisations participating in the main phase of the Safer Patients Initiative (SPI) programme across the UK. PARTICIPANTS: 17 CEOs overseeing 19 organisations participating in the main phase of the SPI programme and 36 staff (20 workstream leads, 10 coordinators and 6 managers) involved in SPI across all 20 participating organisations. MAIN OUTCOME MEASURE: Self-reported perceptions of CEOs on their contribution and involvement within the SPI programme, supplemented by staff peer-reports. RESULTS: The CEOs recognised the importance of their part in the SPI programme and gave detailed accounts of the perceived value that their involvement had brought at all stages of the process. In exploring the parts played by the CEOs, five dimensions were identified: (1) resource provision; (2) staff motivation and engagement; (3) commitment and support; (4) monitoring progress and (5) embedding programme elements. Staff reports confirmed these dimensions; however, the weighting of the dimensions differed. The findings stress the importance of particular actions of support and monitoring such as constant communication through leadership walk rounds and reviewing programme progress and its related clinical outcomes at Board meetings. CONCLUSIONS: This study addressed the call for more research-informed practical guidance on the role of senior management in QI s. The findings show that the CEOs provided key participation considered to significantly contribute towards the SPI programme. CEOs and staff identified a number of clear and consistent themes essential to organisation safety improvement. Queries raised include the tangible benefits of executive involvement in changing structures and embedding for sustainability and the practical steps to creating the 'right' environment for QI.

Sanitary pad interventions for girls' education in Ghana: a pilot study.

BACKGROUND: Increased education of girls in developing contexts is associated with a number of important positive health, social, and economic outcomes for a community. The event of menarche tends to coincide with girls' transitions from primary to secondary education and may constitute a barrier for continued school attendance and performance. Following the MRC Framework for Complex Interventions, a pilot controlled study was conducted in Ghana to assess the role of sanitary pads in girls' education. METHODS: A sample of 120 schoolgirls between the ages of 12 and 18 from four villages in Ghana participated in a non-randomized trial of sanitary pad provision with education. The trial had three levels of treatment: provision of pads with puberty education; puberty education alone; or control (no pads or education). The primary outcome was school attendance. RESULTS: After 3 months, providing pads with education significantly improved attendance among participants, (lambda 0.824, F = 3.760, p<.001). After 5 months, puberty education alone improved attendance to a similar level (M = 91.26, SD = 7.82) as sites where pads were provided with puberty education (Rural M = 89.74, SD = 9.34; Periurban M = 90.54, SD = 17.37), all of which were higher than control (M = 84.48, SD = 12.39). The total improvement through pads with education intervention after 5 months was a 9% increase in attendance. After 3 months, providing pads with education significantly improved attendance among participants. The changes in attendance at the end of the trial, after 5 months, were found to be significant by site over time. With puberty education alone resulting in a similar attendance level. CONCLUSION: This pilot study demonstrated promising results of a low-cost, rapid-return intervention for girls' education in a developing context. Given the considerable development needs of poorer countries and the potential of young women there, these results suggest that a large-scale cluster randomized trial is warranted. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201202000361337.

Implementing health research through academic and clinical partnerships: a realistic evaluation of the Collaborations for Leadership in Applied Health Research and Care (CLAHRC).

BACKGROUND: The English National Health Service has made a major investment in nine partnerships between higher education institutions and local health services called Collaborations for Leadership in Applied Health Research and Care (CLAHRC). They have been funded to increase capacity and capability to produce and implement research through sustained interactions between academics and health services. CLAHRCs provide a natural 'test bed' for exploring questions about research implementation within a partnership model of delivery. This protocol describes an externally funded evaluation that focuses on implementation mechanisms and processes within three CLAHRCs. It seeks to uncover what works, for whom, how, and in what circumstances. DESIGN AND METHODS: This study is a longitudinal three-phase, multi-method realistic evaluation, which deliberately aims to explore the boundaries around knowledge use in context. The evaluation funder wishes to see it conducted for the process of learning, not for judging performance. The study is underpinned by a conceptual framework that combines the Promoting Action on Research Implementation in Health Services and Knowledge to Action frameworks to reflect the complexities of implementation. Three participating CLARHCS will provide in-depth comparative case studies of research implementation using multiple data collection methods including interviews, observation, documents, and publicly available data to test and refine hypotheses over four rounds of data collection. We will test the wider applicability of emerging findings with a wider community using an interpretative forum. DISCUSSION: The idea that collaboration between academics and services might lead to more applicable health research that is actually used in practice is theoretically and intuitively appealing; however the evidence for it is limited. Our evaluation is designed to capture the processes and impacts of collaborative approaches for implementing research, and therefore should contribute to the evidence base about an increasingly popular (e.g., Mode two, integrated knowledge transfer, interactive research), but poorly understood approach to knowledge translation. Additionally we hope to develop approaches for evaluating implementation processes and impacts particularly with respect to integrated stakeholder involvement.