Because of the recurrent course, significant burden, and intergenerational impact of depression, there is a great need for interventions for depressed parents and their children. This article reviews eight interventions that 1) aim to impact the functioning and well-being of 18-month to 18-year old children of depressed parents and 2) have been evaluated in controlled studies. The interventions are described and the empirical evidence of their efficacy is reviewed and critiqued. Existing research points to several promising intervention strategies, such as psychoeducation about parental depression, addressing parenting in adult depression treatment, promoting positive parent-child interactions, and teaching coping skills to children. Common limitations of the research in this area are small sample sizes, homogenous samples, and lack of replication. Implementation problems within the mental healthcare system are highlighted. Multi-component interventions seem to be a promising approach to address the complex impact parental depression has on children and the parent-child relationship. This review illustrates the need for more research on intervention models that can be implemented with children at various developmental levels.
Parental depression; interventions; prevention; children
Health systems around the world are struggling to meet the needs of aging populations and increasing numbers of clients with complex health conditions. Faced with multiple health system challenges, governments are advocating for team-based approaches to health care. Key descriptors used to describe health care teams include “interprofessional,” “multiprofessional,” “interdisciplinary,” and “multidisciplinary.” Until now there has been no review of the use of terminology relating to health care teams. The purpose of this integrative review is to provide a descriptive analysis of terminology used to describe health care teams.
An integrative review of the literature was conducted because it allows for the inclusion of literature related to studies using diverse methodologies. The authors searched the literature using the terms interprofessional, multiprofessional, interdisciplinary, and multidisciplinary combined with “health teams” and “health care teams.” Refining strategies included a requirement that journal articles define the term used to describe health care teams and include a list of health care team members. The literature selection process resulted in the inclusion of 17 journal articles in this review.
Multidisciplinary is more frequently used than other terminology to describe health care teams. The findings in this review relate to frequency of terminology usage, justifications for use of specific terminology, commonalities and patterns related to country of origin of research studies and health care areas, ways in which terminology is used, structure of team membership, and perspectives of definitions used.
Stakeholders across the health care continuum share responsibility for developing and consistently using terminology that is both common and meaningful. Notwithstanding some congruence in terminology usage, this review highlights inconsistencies in the literature and suggests that broad debate among policy makers, clinicians, educators, researchers, and consumers is still required to reach useful consensus.
descriptors; interprofessional; multiprofessional; interdisciplinary; multidisciplinary
The new forms of organization of healthcare services entail the development of new clinical practices that are grounded in collaboration. Despite recent advances in research on the subject of collaboration, there is still a need for a better understanding of collaborative processes and for conceptual tools to help healthcare professionals develop collaboration amongst themselves in complex systems. This study draws on D'Amour's structuration model of collaboration to analyze healthcare facilities offering perinatal services in four health regions in the province of Quebec. The objectives are to: 1) validate the indicators of the structuration model of collaboration; 2) evaluate interprofessional and interorganizational collaboration in four health regions; and 3) propose a typology of collaboration
A multiple-case research strategy was used. The cases were the healthcare facilities that offer perinatal services in four health regions in the province of Quebec (Canada). The data were collected through 33 semi-structured interviews with healthcare managers and professionals working in the four regions. Written material was also analyzed. The data were subjected to a "mixed" inductive-deductive analysis conducted in two main stages: an internal analysis of each case followed by a cross-sectional analysis of all the cases.
The collaboration indicators were shown to be valid, although some changes were made to three of them. Analysis of the data showed great variation in the level of collaboration between the cases and on each dimension. The results suggest a three-level typology of collaboration based on the ten indicators: active collaboration, developing collaboration and potential collaboration.
The model and the typology make it possible to analyze collaboration and identify areas for improvement. Researchers can use the indicators to determine the intensity of collaboration and link it to clinical outcomes. Professionals and administrators can use the model to perform a diagnostic of collaboration and implement interventions to intensify it.
Most shared decision-making (SDM) models within healthcare have been limited to the patientphysician dyad. As a first step towards promoting an interprofessional approach to SDM in primary care, this article reports how an interprofessional and interdisciplinary group developed and achieved consensus on a new interprofessional SDM model. The key concepts within published reviews of SDM models and interprofessionalism were identified, analysed, and discussed by the group in order to reach consensus on the new interprofessional SDM (IP-SDM) model. The IP-SDM model comprises three levels: the individual (micro) level and two healthcare system (meso and macro) levels. At the individual level, the patient presents with a health condition that requires decision-making and follows a structured process to make an informed, value-based decision in concert with a team of healthcare professionals. The model acknowledges (at the meso level) the influence of individual team members' professional roles including the decision coach and organizational routines. At the macro level it acknowledges the influence of system level factors (i.e. health policies, professional organisations, and social context) on the meso and individual levels. Subsequently, the IP-SDM model will be validated with other stakeholders.
Interprofessionalism; shared decision-making; conceptual models; theories; primary care
The scientific literature continues to advocate interprofessional collaboration (IPC) as a key component of primary care. It is recommended that primary care groups be created and configured to meet the healthcare needs of the patient population, as defined by patient demographics and other data analyses related to the health of the population being served. It is further recommended that the improvement of primary care services be supported by the delivery of feedback and performance measurements. This paper describes the theory underlying an interprofessional educational intervention developed in Quebec’s Montérégie region (Canada) for the purpose of improving chronic disease management in primary care. The objectives of this study were to explain explicitly the theory underlying this intervention, to describe its components in detail and to assess the intervention’s feasibility and acceptability.
A program impact theory-driven evaluation approach was used. Multiple sources of information were examined to make explicit the theory underlying the education intervention: 1) a literature review and a review of documents describing the program’s development; 2) regular attendance at the project’s committee meetings; 3) direct observation of the workshops; 4) interviews of workshop participants; and 5) focus groups with workshop facilitators. Qualitative data collected were analysed using thematic analysis.
The theoretical basis of the interprofessional education intervention was found to be work motivation theory and reflective learning. Five themes describing the workshop objectives emerged from the qualitative analysis of the interviews conducted with the workshop participants. These five themes were the importance of: 1) adopting a regional perspective, 2) reflecting, 3) recognizing gaps between practice and guidelines, 4) collaborating, and 5) identifying possible practice improvements. The team experienced few challenges implementing the intervention. However, the workshop’s acceptability was found to be very good.
Our observation of the workshop sessions and the interviews conducted with the participants confirmed that the objectives of the education intervention indeed targeted the improvement of interprofessional collaboration and quality of care. However, it is clear that a three-hour workshop alone cannot lead to major changes in practice. Long-term interventions are needed to support this complex change process.
Interprofessional continuing education; Quality improvement; Primary care practice; Program theory-driven evaluation
More than half of all Canadians use some form of complementary and alternative medicine (CAM) every year. The way CAM is being used, the magnitude of its use and the lack of clarity on standards of evidence make CAM a rising healthcare issue. A recent research priority-setting exercise by the Canadian Interdisciplinary Network for CAM Research (IN-CAM) identified three research priority areas: (1) healthcare delivery and policy research, including (a) exploring if and how CAM should be regulated, (b) defining what constitutes acceptable evidence of safety and efficacy, (c) investigating the organization and delivery of integrative healthcare; (2) methodological research, including exploring how best to assess whole systems of care and how to choose patient-, practitioner- and policy-relevant outcome measures; and (3) knowledge transfer, including formal education strategies, the provision of information and dialogue with those who use information in decision-making. The high use of CAM products and therapies leads to many questions from patients, practitioners and policy makers. The research agenda presented here provides a guide to begin programs of research that will answer these questions.
Due to the complexity of human health, emphasis is increasingly being placed on the need for and conduct of multidisciplinary and/or interdisciplinary health research. Yet many academic and research organizations--and the discipline-specific associations and journals--may not yet be prepared to adopt changes necessary to optimally support interdisciplinary work. This article presents an ongoing interdisciplinary research project's efforts to investigate mechanisms and pathways that lead to occupational health disparities among healthcare workers. It describes the promises and pitfalls encountered during the research,and outlines effective strategies that emerged as a result. Lessons learned include: conflict resolution regarding theoretical and methodological differences; establishing a sense of intellectual ownership of the research, as well as guidelines for multiple authorship; and development and utilization of protocols, communication systems, and tools. This experience suggests a need for the establishment of supportive structures and processes to promote successful interdisciplinary research.
The implementation of evidence-based infection control practices is essential, yet challenging for healthcare institutions worldwide. Although acknowledged that implementation success varies with contextual factors, little is known regarding the most critical specific conditions within the complex cultural milieu of varying economic, political, and healthcare systems. Given the increasing reliance on unified global schemes to improve patient safety and healthcare effectiveness, research on this topic is needed and timely. The ‘InDepth’ work package of the European FP7 Prevention of Hospital Infections by Intervention and Training (PROHIBIT) consortium aims to assess barriers and facilitators to the successful implementation of catheter-related bloodstream infection (CRBSI) prevention in intensive care units (ICU) across several European countries.
We use a qualitative case study approach in the ICUs of six purposefully selected acute care hospitals among the 15 participants in the PROHIBIT CRBSI intervention study. For sensitizing schemes we apply the theory of diffusion of innovation, published implementation frameworks, sensemaking, and new institutionalism. We conduct interviews with hospital health providers/agents at different organizational levels and ethnographic observations, and conduct rich artifact collection, and photography during two rounds of on-site visits, once before and once one year into the intervention. Data analysis is based on grounded theory. Given the challenge of different languages and cultures, we enlist the help of local interpreters, allot two days for site visits, and perform triangulation across multiple data sources.
Qualitative measures of implementation success will consider the longitudinal interaction between the initiative and the institutional context. Quantitative outcomes on catheter-related bloodstream infections and performance indicators from another work package of the consortium will produce a final mixed-methods report.
A mixed-methods study of this scale with longitudinal follow-up is unique in the field of infection control. It highlights the ‘Why’ and ‘How’ of best practice implementation, revealing key factors that determine success of a uniform intervention in the context of several varying cultural, economic, political, and medical systems across Europe. These new insights will guide future implementation of more tailored and hence more successful infection control programs.
Trial number: PROHIBIT-241928 (FP7 reference number)
Implementation; Infection control; Catheter-related bloodstream infections; Hand hygiene; Intensive care units; Best practice; Organizational culture; Organizational case studies; Organizational innovation; Organizational decision making; Patient safety
Natural experimental studies are often recommended as a way of understanding the health impact of policies and other large scale interventions. Although they have certain advantages over planned experiments, and may be the only option when it is impossible to manipulate exposure to the intervention, natural experimental studies are more susceptible to bias. This paper introduces new guidance from the Medical Research Council to help researchers and users, funders and publishers of research evidence make the best use of natural experimental approaches to evaluating population health interventions. The guidance emphasises that natural experiments can provide convincing evidence of impact even when effects are small or take time to appear. However, a good understanding is needed of the process determining exposure to the intervention, and careful choice and combination of methods, testing of assumptions and transparent reporting is vital. More could be learnt from natural experiments in future as experience of promising but lesser used methods accumulates.
The overall goal of our research agenda is to contribute to improved quality of healthcare by identifying factors that foster or inhibit the use of healthcare information by patients to make informed healthcare decisions. We propose to study the natural history of the use of healthcare information by women with breast cancer to support decisions about health care. To do so in this paper we propose a conceptual model developed based on an extensive literature review and critique that describes patients' health information use over the disease course. It will guide our further investigation of the complex relationships among patients' personal circumstances, the progress of their medical treatment, and their satisfaction and empowerment as informed decision-makers. The model will help policy makers and health professionals identify the best means to provide patients with useful information, and help all stakeholders in health care acquire information needed to improve healthcare quality.
Cultural Consultation is a clinical process that emerged from anthropological critiques of mental healthcare. It includes attention to therapeutic communication, research observations and research methods that capture cultural practices and narratives in mental healthcare. This essay describes the work of a Cultural Consultation Service (ToCCS) that improves service user outcomes by offering cultural consultation to mental health practitioners. The setting is a psychiatric service with complex and challenging work located in an ethnically diverse inner city urban area. Following a period of 18 months of cultural consultation, we gather the dominant narratives that emerged during our evaluation of our service.
These narratives highlight how culture is conceptualized and acted upon in the day-to-day practices of individual health and social care professionals, specialist psychiatric teams and in care systems. The findings reveal common narratives and themes about culture, ethnicity, race and their perceived place and meaningfulness in clinical care. These narratives express underlying assumptions and covert rules for managing, and sometimes negating, dilemmas and difficulties when considering “culture” in the presentation and expression of mental distress. The narratives reveal an overall “culture of understanding cultural issues” and specific “cultures of care”. These emerged as necessary foci of intervention to improve service user outcomes.
Understanding the cultures of care showed that clinical and managerial over-structuring of care prioritises organisational proficiency, but it leads to inflexibility. Consequently, the care provided is less personalised and less accommodating of cultural issues, therefore, professionals are unable to see or consider cultural influences in recovery.
Cultural consultation; Cultural formulation; Ethnography; Institutional racism; Culture and mental health
Interprofessional education is a collaborative approach to develop healthcare students as future interprofessional team members and a recommendation suggested by the Institute of Medicine. Complex medical issues can be best addressed by interprofessional teams. Training future healthcare providers to work in such teams will help facilitate this model resulting in improved healthcare outcomes for patients. In this paper, three universities, the Rosalind Franklin University of Medicine and Science, the University of Florida and the University of Washington describe their training curricula models of collaborative and interprofessional education.
The models represent a didactic program, a community-based experience and an interprofessional-simulation experience. The didactic program emphasizes interprofessional team building skills, knowledge of professions, patient centered care, service learning, the impact of culture on healthcare delivery and an interprofessional clinical component. The community-based experience demonstrates how interprofessional collaborations provide service to patients and how the environment and availability of resources impact one's health status. The interprofessional-simulation experience describes clinical team skills training in both formative and summative simulations used to develop skills in communication and leadership.
One common theme leading to a successful experience among these three interprofessional models included helping students to understand their own professional identity while gaining an understanding of other professional's roles on the health care team. Commitment from departments and colleges, diverse calendar agreements, curricular mapping, mentor and faculty training, a sense of community, adequate physical space, technology, and community relationships were all identified as critical resources for a successful program. Summary recommendations for best practices included the need for administrative support, interprofessional programmatic infrastructure, committed faculty, and the recognition of student participation as key components to success for anyone developing an IPE centered program.
interprofessional; healthcare teams; collaboration; interprofessional education; interprofessional curricula models
The Department of Veterans Affairs (VA) has been at the vanguard of information technology (IT) and use of comprehensive electronic health records. Despite the widespread use of health IT in the VA, there are still a variety of key questions that need to be answered in order to maximize the utility of IT to improve patient access to quality services. This paper summarizes the potential of IT to enhance healthcare access, key gaps in current evidence linking IT and access, and methodologic challenges for related research. We also highlight four key issues to be addressed when implementing and evaluating the impact of IT interventions on improving access to quality care: 1) Understanding broader needs/perceptions of the Veteran population and their caregivers regarding use of IT to access healthcare services and related information. 2) Understanding individual provider/clinician needs/perceptions regarding use of IT for patient access to healthcare. 3) System/Organizational issues within the VA and other organizations related to the use of IT to improve access. 4) IT integration and information flow with non-VA entities. While the VA is used as an example, the issues are salient for healthcare systems that are beginning to take advantage of IT solutions.
access to care; medical informatics; veterans
There is an increasing need both to understand the translation of biomedical research into improved healthcare and to assess the range of wider impacts from health research such as improved health policies, health practices and healthcare. Conducting such assessments is complex and new methods are being sought. Our new approach involves several steps. First, we developed a qualitative citation analysis technique to apply to biomedical research in order to assess the contribution that individual papers made to further research. Second, using this method, we then proposed to trace the citations to the original research through a series of generations of citing papers. Third, we aimed eventually to assess the wider impacts of the various generations. This article describes our comprehensive literature search to inform the new technique. We searched various databases, specific bibliometrics journals and the bibliographies of key papers. After excluding irrelevant papers we reviewed those remaining for either general or specific details that could inform development of our new technique. Various characteristics of citations were identified that had been found to predict their importance to the citing paper including the citation’s location; number of citation occasions and whether the author(s) of the cited paper were named within the citing paper. We combined these objective characteristics with subjective approaches also identified from the literature search to develop a citation categorisation technique that would allow us to achieve the first of the steps above, i.e., being able routinely to assess the contribution that individual papers make to further research.
Research assessment; Citation categorisation; Methodology; Wider impacts of research; Citation generations
The paradigm shifts in healthcare delivery now more than ever call for interdisciplinary teamwork to deliver the best patient care. The lessons from the Institute of Medicine's To Err Is Human: Building a Safer Health System report are painful but elucidate the problems with training and working in silos and the consequent inconsistent communication between healthcare providers. We review the literature regarding interprofessional training and describe some strategies and innovations. This article proposes that healthcare professional schools embed interprofessional education into the curriculum to meet the challenges of providing high-quality, efficient, and safe patient care.
Interprofessional training; professional development; quality improvement teamwork
Process evaluations are recommended to open the ‘black box’ of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.
We reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.
The developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.
There is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.
Process evaluation; Complex intervention; Cluster-randomised controlled trial; Qualitative; Quantitative; Reporting
Rigorous evaluation of an intervention requires that its allocation be unbiased with respect to confounders; this is especially difficult in complex, system-wide healthcare interventions. We developed a short survey instrument to identify factors for a minimization algorithm for the allocation of a hospital-level intervention to reduce emergency department (ED) waiting times in Ontario, Canada.
Potential confounders influencing the intervention's success were identified by literature review, and grouped by healthcare setting specific change stages. An international multi-disciplinary (clinical, administrative, decision maker, management) panel evaluated these factors in a two-stage modified-delphi and nominal group process based on four domains: change readiness, evidence base, face validity, and clarity of definition.
An original set of 33 factors were identified from the literature. The panel reduced the list to 12 in the first round survey. In the second survey, experts scored each factor according to the four domains; summary scores and consensus discussion resulted in the final selection and measurement of four hospital-level factors to be used in the minimization algorithm: improved patient flow as a hospital's leadership priority; physicians' receptiveness to organizational change; efficiency of bed management; and physician incentives supporting the change goal.
We developed a simple tool designed to gather data from senior hospital administrators on factors likely to affect the success of a hospital patient flow improvement intervention. A minimization algorithm will ensure balanced allocation of the intervention with respect to these factors in study hospitals.
Analysis of consumer decision making in the health sector is a complex process of comparing feasible alternatives and evaluating the levels of satisfaction associated with the relevant options. This paper makes an attempt to understand how and why consumers make specific decisions, what motivates them to adopt a specific health intervention, and what features they find attractive in each of the options.
The study used a descriptive-explanatory design to analyze the factors determining the choices of healthcare providers. Information was collected through focus group discussions and in-depth interviews.
The results suggest that the decision making related to seeking healthcare for Kala Azar (KA) treatment is a complex, interactive process. Patients and family members follow a well-defined road map for decision making. The process of decision making starts from the recognition of healthcare needs and is then modified by a number of other factors, such as indigenous knowledge, healthcare alternatives, and available resources. Household and individual characteristics also play important roles in facilitating the process of decision making. The results from the group discussions and in-depth interviews are consistent with the idea that KA patients and family members follow the rational approach of weighing the costs against the benefits of using specific types of medical care.
The process of decision making related to seeking healthcare follows a complex set of steps and many of the potential factors affect the decision making in a non-linear fashion. Our analysis suggests that it is possible to derive a generalized road map of the decision-making process starting from the recognition of healthcare needs, and then modifying it to show the influences of indigenous knowledge, healthcare alternatives, and available resources.
Kala Azar; Decision-making process; Utilization; Nepal
A gap continues to exist between what is known to be effective and what is actually delivered in the usual course of medical care. The goal of implementation research is to reduce this gap. However, a tension exists between the need to obtain generalizeable knowledge through implementation trials, and the inherent differences between healthcare organizations that make standard interventional approaches less likely to succeed. The purpose of this paper is to explore the integration of participatory action research and randomized controlled trial (RCT) study designs to suggest a new approach for studying interventions in healthcare settings.
We summarize key elements of participatory action research, with particular attention to its collaborative, reflective approach. Elements of participatory action research and RCT study designs are discussed and contrasted, with a complex adaptive systems approach used to frame their integration.
The integration of participatory action research and RCT design results in a new approach that reflects not only the complex nature of healthcare organizations, but also the need to obtain generalizeable knowledge regarding the implementation process.
Researchers and clinicians acknowledge today that the contribution of both cerebral hemispheres is necessary to a full and adequate verbal communication. Indeed, it is estimated that at least 50% of right brain damaged individuals display impairments of prosodic, discourse, pragmatics and/or lexical semantics dimensions of communication. Since the 1990's, researchers have focused on the description and the assessment of these impairments and it is only recently that authors have shown interest in planning specific intervention approaches. However, therapists in rehabilitation settings still have very few available tools. This review of recent literature demonstrates that, even though theoretical knowledge needs further methodological investigation, intervention guidelines can be identified to target right hemisphere damage communication impairments in clinical practice. These principles can be incorporated by speech and language pathologists, in a structured intervention framework, aiming at fully addressing prosodic, discursive and pragmatic components of communication.
A consistent theme running through the healthcare debate is the need for new care models that include collaborative, team-based care. There is also growing recognition that interprofessional education is critical to achieving collaborative, patient-centered care. Not unlike conventional, biomedical professions, CAM (complementary and alternative medicine) professions have also educated students in silos with little interaction between various disciplines. Northwestern Health Sciences University, under their NIH NCCAM-funded R-25 grant, is breaking new ground in requiring that their students in chiropractic, massage, and OAM complete a common course in evidence informed practice. A previous Explore column described the core competencies that the students are required to achieve. This column focuses on the practicalities and challenges of offering a course to students enrolled in three different degree programs. Perhaps it will stimulate readers to consider how we might achieve interprofessional education that brings together all health professional students, biomedical and CAM.
There is a need for formal evaluation in the development of any computer-based expert systems. This may be quite difficult when judging a critiquing system, that is, a system which responds to a proposed management strategy with an explanatory prose discussion of the advisability of that approach. DxCON is an expert system which produces prose critiques discussing the radiologic workup of obstructive jaundice. This paper briefly describes DxCON, and then focuses on a study performed to validate its knowledge. The need to confront subjective as well as objective criteria in the evaluation of expert critiquing systems is explored.
Pharmacists must collaborate with other health professionals to promote the optimal use of medications, relying on coordinated, interprofessional communication and care to do so. In 2003, the Institute of Medicine (IOM) recommended “all health professionals should be educated to deliver patient-centered care as members of an interdisciplinary team, emphasizing evidence-based practice, quality improvement approaches, and informatics.”2 At the University of Washington, the Center for Health Sciences Interprofessional Education (CHSIE) was established in 1997 to promote interprofessional curricular and clinical innovation in education, faculty development, and student activities, and to conduct evaluative research regarding the impact of interprofessional innovations. In this manuscript, we will describe the Center for Health Sciences Interprofessional Education, and highlight key projects that serve as examples of pharmacy involvement in interprofessional education, research, and service.
If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention.
The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of pragmatism.
We have concrete suggestions for improving PRECIS and a growing list of enthusiastic individuals interested in contributing to this work. By early 2014 we expect to have a validated PRECIS-2.
Pragmatic; Explanatory; Clinical trials; Trial design; Applicability
Errors in health care that compromise patient safety are tied to latent failures in the structure and function of systems. Teams of people perform most care delivered today, yet training often remains focused on individual responsibilities. Training programmes for all healthcare workers need to increase the educational experience of working in interdisciplinary teams. The complexities of team training require a multifunctional (systems) approach, which crosses organisational divisions to allow communication, accountability, and creation and maintenance of interdisciplinary teams. This report identifies challenges for medical education in performing the research, identifying performance measurements, and modifying educational curricula for the advancement of interdisciplinary teams, based on the complexity of team training identified in commercial aviation.