Reports on problems encountered in the implementation of complex interventions are scarce in psychotherapy literature. This is remarkable given the inherent difficulties of such enterprises and the associated safety risks for patients involved.A case study of the problematic implementation process of Mentalization- Based Treatment for Adolescents (MBT-A), a new therapy for 14 to 18 year old youngsters with severe personality disorders, is presented. The implementation process is described and analyzed at an organizational, team and therapist level.Our analysis shows that problems at all three levels contributed and interacted to make the implementation cumbersome and hazardous.The implementation of complex psychotherapeutic programs for difficult patients could benefit from a structured attention to processes at multiple levels. We therefore propose a new comprehensive heuristic model of treatment integrity. This new model includes organisational, team and therapist adherence to the treatment model as necessary components of treatment integrity in the implementation of complex interventions. The application of this new model of treatment integrity potentially increases the chance of successful implementations and reduces safety risks for first patients enrolling in a new program. The last two decades have yielded new and promising interventions for the treatment of borderline personality disorder (BPD). For example, several studies support the effectiveness of various psychosocial interventions for BPD in adults, including Mentalization-Based Treatment (MBT) , DialectFor that purpose, we will describe a case study of a problematic implementation of Mentalization- Based Treatment for Adolescents (MBT-A), i.e. a new treatment program for 14 to 18 year old youngsters with severe personality disorders, at de Viersprong, Netherlands institute for personality disorders. This case study revealed an intriguingly ambivalent result, i.e. patient outcomes were favourable in terms of symptom reduction and improvement of personality functioning and quality of life , while ta.As far as we know, this manuscript is the first published report on a failed implementation of a psychotherapy program. The problems described in this case are not likely to be specific to the implemented treatment model or specific setting, but instead might include various commonly encountered problems and thus are likely relevant for other treatment models and settings as well. Below, we will first introduce the case and describe the precursors to the implementation problems. Second, we will systematically analyze the encountered problems at an organizational, team and therapist level, respectively. Third, this analysis is used to reformulate the concept of treatment integrity in a way that could be useful to understand successes and failures in the dissemination of evidence based treatment models. This model might help to increase the chance of successful implementation of treatment programs and reduce safety risks for involved patients, staff and organizationDe Viersprong has approximately 40 years of experience in treating adolescents with personality problems in a long term inpatient setting. Traditionally, mildly to moderately disturbed adolescents entered this intensive and supportive treatment program and typically showed large improvements with effect sizes in the range between 1.0 and 1.5. Due to recent major organizational changes in mental health services in the Netherlands, including (a) the transition from supply- to demand-focused health care, (b) the differentiation between first , second  and third  echelon mental health care, and (c) the introduction of stepped care as the basic principle in assignment to each of these echelons, de Viersprong – as a highly specialised, third echelon organization – started to attract a new population of more severely disordered adolescents. The inclusion of these more severely disordered adolescents posed new challenges to the therapists and organization. In particular, they were more sensitive to crisis, and displayed a wider range of externalizing problems. The prevailing treatment model – even with major adaptations – failed to adapt to the needs of these more severely disordered patients, leading to a sharp increase of dropout rates to almost half of the patients. It was obvious and recognized that the old program required substantial reorganization to be able to face the challenges this new patient group presented. In the process of reorganizing, part of the treatment program in the existing clinic was substituted for a new treatment program, i.e. MBT-A.The challenge was to design a treatment program that would be able to deal with the problems of severe borderline adolescents, often including behavioural problems, substance abuse, extreme self-injurious behaviour, extreme sensitivity to crisis, absenteeism, and severe family conflicts. At that time, our intention was to keep the inpatient setting and solve these problems by choosing a method aimed at dealing with the borderline symptoms. However, no randomized controlled studies on personality disorders (PD) in adolescents had been published nor were there guidelines on how to treat these adolescents. Eventually, MBT was chosen as the theoretical and methodological base for the new program. MBT is a psychodynamically oriented treatment program developed by Bateman and Fonagy ,12 for ab. Furthermore, the team attended several congresses and presentations about MBT and discussed the manual and other relevant literature. Finally, the team was trained by experienced MBT trainers and the manual was revised and supplemented by the supervisors and team.About nine months passed between the choice for MBT and the actual implementation of the new program. During this period, a manual was written with some adaptations of the model to make it suitable for adolescents within an inpatient setting. This mainly included the addition of school and family therapy to the program and supporting developmental tasks, like structuring free timeAlthough the new therapy was hardly announced in professional journals or other media, many patients were admitted and almost immediately a waiting list developed. During the information sessions before the start of the new program, patients and their families reported that they had been waiting for a new specialized therapy and expressed high expectations. This apparent demand strengthened the belief that the clinical team had made the right choice in adapting their inpatient therapy into a specialized inpatient treatment for severe and/or resistant BPD in adolescents. All these factors further increased the already motivated and enthousiastic team spirit at the start of the new program in March 2008. However, it turned out that this high morale was quickly put to the test.It soon became clear that the implementation did not develop as expected. Signs were twofold and came from staff as well as from patients. Several staff members, particularly nurses, became overwhelmed and overburdened by the severity of the pathology they had to deal with combined with the ambiguity of their new tasks and role and uncertainty about MBT interventions. This left many nurses feeling powerless, resulting in a loss of authority and an increase of conflicts with patients. The resulting loss of morale and decreasing job satisfaction contributed to conflicts in the team and a burn out among several staff members. This interacted with increasing turmoil among the patient group, who also had to deal with major changes, including a new therapy schedule, a new therapeutic approach, and different rules. A vicious circle developed, with increasingly frustrated and overburdened staff and the youngsters feeling increasingly misunderstood, neglected and angry. All this resulted in an increase in acting out behaviour, more crossings of behavioural boundaries and a general grim and brutal atmosphere. Several nurses took sick leave due to stress and exhaustion, leaving the program understaffed, increasing the work load for the remaining staff. It became impossible to run daily therapy program five days a week. The program had to be limited to initially two and later three days a week. Parents were confronted with their children being at home most of the week, while they counted on them only being home in the weekend. Parents’ dissatisfaction escalated in an information meeting with the board of the management of de Viersprong, leading them to inform the National Health Care Inspection, several other organizations, the press and patients’ sites on the web. With all the negative press and pressure from patients and parents, the implementation problems reached their climax.At that time, the board of management of de Viersprong intervened, although it would take some time before the measures would have some effect. The most important interventions were a stop in patient admissions and the quick recruitment of additional personnel creating an ‘overstaffing’ of the team. Overstaffing was necessary, to bring the staff at operational strength given the many sick leaves. Bringing the staff back to its intended operational strength restored the balance staff/patients and helped to regain a sense of control over the acting out behaviour of patients. Furthermore, the frequency of the supervision by experienced MBT therapists from within the institution was substantially increased. More time was scheduled to train new personnel and to discuss problematic team processes during intervision.Looking back, the implementation turned out to be almost catastrophic, given the actual risks for patients, staff, and institution. It is therefore remarkable that dropout rates displayed a large improvement (less than 15 %) over the preceding treatment program  and patient outcomes were actually not poor at all: symptom level and personality dysfunctioning decreased significantly with effect sizes ranging from medium to large . NeverthGiven these high costs, risks and burdens, it was considered very important to analyze the encountered problems thoroughly. During and after the efforts of regaining control at the ward, many meetings were organised and several reports were written in an effort to understand ‘what went wrong’. From these efforts, it became clear that there was no ‘magic bullet’ which could be pinpointed as responsible for all encountered problems. In the next paragraph, we will discuss in more detail the several interacting factors leading to the implementation failure.As in many circumstances of medical failure, it became clear that the failure could only be understood from a complex of interacting problems at different levels. Heuristically, we choose to differentiate between factors at the organizational, team and therapist level that contributed to the failed implementation. This analysis is completed with a discussion of factors related to the specific choice of method (inpatient MBT for adolescents). Finally, we discuss from a mentalizing perspective how all these levels have interacted to create a cascade-effect leading to the major problems as mentioned before.The following organizational factors have contributed to the implementation problems: organizational structures, institutional culture and support, lack of structures to support change management, and staffing, logistics, and budget planning.· Organizational structuresFirst, as in many institutions, the organization was divided in an adult and youth ward. Both were organizationally separated and managed by different managers. Expertise on the treatment of BPD with MBT was available in the adult ward and through these organizational barriers less easily accessible in the youth ward. Second, the organization had recently gone through a reorganization: management responsibilities were decentralized toward lower hierarchical levels in the organization. As a consequence, most of the managerial setup of the new program was assigned to psychotherapists, lacking relevant managerial experience and expertise. As such, the reorganization contributed to an insufficiently prepared project.· Institutional culture and supportThe organization was in transition from a traditional therapeutic community with relatively little interest in research and evidence based thinking towards a modern, science-oriented organization, resembling the processes described by Chiesa and Healy . At the · Lack of structures to support change managementThe existing program at the ward had been more or less unchanged for more than 40 years. Several staff members worked for more than 20 years at the ward and were strongly attached to the old program. The existing program was rooted in a Therapeutic Community tradition which had been for decades the core landmark of the institution. The amount and degree of change for all involved parties implied by treating a different population with a different method demanding a different team culture had been largely underestimated. No specific structures to support these changes had been established. As a result, many implementation issues had to be dealt with while already running the program and problems had to be solved ‘on the spot’. Further on, potential risks and pitfalls involved in these major changes had not been sufficiently identified at forehand, based upon an analysis of the existing situation and the desired changes.· Staffing, logistics and budget planningDue to a lack of experience and a hasty and premature start of the new program, the implementation plan showed major shortcomings. Among the shortcomings were: insufficient staffing due to two vacant positions, insufficient logistics and facilities as the building had to serve two different programs instead of one unified program, a selection of staff members with insufficient competencies to deal with the complex needs of the new group of patients, and insufficient budget planning and evaluation. The new program not only required budget for training and supervision, but also an increase in personnel, and a financial buffer for unexpected expenses. Once the problems arose and absent staff had to be replaced in order to be able to continue the program, financial expenses exceeded the planned budget, raising even more the organizational pressure on staff.The following team factors have contributed to the implementation problems: team problems prior to the implementation, resistance toward change, lack of clear leadership, communication difficulties, and lack of clear supervisory structures.· Team problems prior to the implementationA major reason for changing treatment methods was the experienced shortcomings of the existing model to deal with the new population of crisis-sensitive adolescents. In the absence of a clear method, this had lead to differences in opinions within the old team about how to deal with crisis. Thus, even before the new program started, there was an imminent split in the team, mainly between psychotherapists and nurses. This split was partly due to the nature of the patients in treatment, and their tendency to split their projections on staff members. The psychotherapists were often idealized by the patients, whereas the psychosocial nurses (whom were ´available´ 24 hours a day) frequently had to deal with the negative projections partially due to their pedagogical role. This strengthened the wish to quickly implement the new program as a possible solution for these differences in opinions. However, as the split wasn’t well enough understood, it re-emerged quickly when the arousal increased at the ward due to all unexpected difficulties with the implementation. Old team dynamics kept influencing the new way of working.· Resistance toward changeThe new program required changes within the team at different levels. The traditional therapeutic community was characterized by much democracy without a clear demarcation of leadership. The new model required a new hierarchical order with psychotherapists being in lead as the primary clinicians. Further on, the members of the new and old team were identical. Many therapists found it hard to give up their ´old´ theoretical model and routine way of treatment. Despite huge efforts to use the new concepts and philosophy, a subtle mixture of old and new ways of thinking and handling was inevitable, leading to minor and larger inconsistencies in applying the MBT model. With the increase of stress at the ward came an increase in inconsistencies in treatment and an increase in patient (and staff) crisis.· Lack of clear leadershipPartly due to the old ‘democratic’ culture of the prior therapeutic community, the team lacked clear and broadly supported leadership in this moment of change. This meant that the team was not only experimenting with a new therapy, but at the same time experimenting with its own management.· Communication problemsThe team was large and it turned out - due to the  working schedules - to be impossible for the whole team to attend intervision-supervision on a regular basis. These factors made it difficult to communicate relevant patient information well enough between the team members, Relevant patient information got ‘lost’ between shifts, leading to increasing arousal among patients whom felt ‘forgotten’ by the staff. Moreover, the inability to attend intervision also partially denied staff members the emotional support and learning opportunity in talking over the difficult cases and problematic situations encountered.· Lack of clear supervisory structuresSupervision and training were offered, but due to the organizational barriers, from a distance. More generally, the treatment manual was experienced as too abstract, and the team lacked an experienced supervisor who could help translate theory into practice, guide and monitor interventions and help manage team processes from a mentalizing perspective. What was lacking, was supervision ‘on the spot’, highly needed given the lack of experience in the team and the challenging population.The following therapist factors have contributed to the implementation problems: personnel selection, and lack of experience with the model.· Personnel selectionThe old team – selected and trained for the purpose of treating a different population of adolescents – was re-educated in the new model. There had been no explicit selection of personnel based upon their abilities to treat a more severe BPD-population, using a different method, focussing strongly on affective and relational issues. Soon after the start, some personnel felt less comfortable with the new demands that were put upon them by the new program.· Lack of experience with the modelNone of the therapists had previous experience with the new model. Although therapists were trained in the model, had read the books and manual, and received classic supervision by experienced trainers, they still felt insufficiently prepared to apply their new knowledge and skills to deal with everyday changing situations. Therapists from all disciplines experienced a lack of concrete supportive protocols to deal with frequent clinical problems like youngsters being absent from therapy or school, engaging in or threatening with self-injurious behaviour, staying in bed, insulting and provoking team members or peers, or refusing to obey general rules of the unit. This lead among several therapists to increased uncertainty about how to apply the model on a daily basis. Especially when problems increased, the team morale dropped as did the belief in the usefulness of the model to face the challenges met in their work with these patients. This further hindered the use of this new theoretical framework in a consistent way from the start, and to use the mentalizing method as a new cornerstone for team functioning and interactions.Finally, implementation problems could in part also been explained by the specific choice of model and setting. Three issues contributing to the problems at this level are the choice for MBT, the choice for an inpatient setting, and the necessary adaptations for adolescents. All three added to the complexity of the innovation.· MBTCompared to the existing program, the MBT-model required a totally different sort of stance and range of interventions, requiring different skills from therapists. MBT emphasizes the development of an attachment relationship with patients, staying mentally close even in times of crisis and adopt a not-knowing stance. It requires a level of transparency from therapists unlike other models and aims at focussing on affective issues within the therapist-patient relationship. All these core characteristics of MBT required to some degree different personality characteristics from staff members.· Inpatient settingThe amount and intensity of contact among patients within an inpatient setting is much greater than in an outpatient setting, leading to (hyper)activation of the attachment system and correspondingly higher levels of stress at the ward . Also, w· Adolescent populationMBT had originally been developed for adult BPD patients. Therefore, it required adaptation to meet the specific needs of adolescents. For example, pedagocial limit setting turned out to be an important issue which was insufficiently covered by the manual and trained in the classic training. Further on, some characteristics of adolescents seemed to make  group therapy more complex. Their decreased capacity to mentalize contributed to their difficulties to differentiate from peers, leading to high levels of arousal within group therapy and strong loyalty towards each other. This sometimes led them to cover up each other’s boundary crossings and to try managing each other’s complex problems without discussing them with adult staff members.In sum, we believe an important contributing factor to the implementation problems, was the amount of innovation involved. Treating adolescents for their underlying personality pathology was new at that time; adapting MBT to an inpatient setting was new as was treating adolescents with MBT. There was a lack of (published) experiences on the ‘shoulds’ and ‘shouldn’ts’ in adapting MBT to an inpatient adolescent BPD population. The high level of innovation in itself created major challenges that should have been addressed more extensively prior to the start in the implementation plan.It should be clear that all these factors interacted to create a snowballing effect, leading to increasing levels of arousal at the ward and demoralization and anxiety among staff. The huge amount of changes implied by the new program combined with the lack of experience with the new model and the insufficient guided implementation increased feelings of uncertainty and incompetence among staff. In a team that was lacking clear leadership and clear supervisory structures, this lead to inconsistencies in the approach of youngsters. Especially staff members whom felt less comfortable with the new demands from the model, felt uncertain and insecure in an unstable and already conflicted team. Their mentalizing abilities reduced, leaving them more vulnerable to act out towards youngsters, like withdrawing from contact. In turn, the experienced unreliability increased anxiety, activated the attachment system, reduced mentalizing capacity and increased acting out among youngsters , often using the more uncertain staff members to project their anxieties and anger upon. Again, this further reduced the mentalizing abilities of these staff members, further increased by the lacking competencies of the team to adopt a mentalizing stance towards team interactions, leading to insufficient support for staff members under stress. In turn, these processes increased splitting within the team, making it even more difficult to maintain a mentalizing stance towards each other. The resulting splitting further contributed to inconsistencies in the approach of youngsters, which again further increased their arousal. Under the influence of the arising problems, previous scepticism from the broader context turned into severe criticism, leading to a defensive withdrawal of the team. The relation between the team and the rest of the organisation got infected by increasing mutual distrust and resulting problematic communication. This not only denied the team from further emotional and supervisory support but also hindered regaining a mentalizing perspective on team functioning. This contributed to the split within the team, the lack of experienced emotional support and the increasing stress. As a result, a cascade of negative interactions and effects finally lead to exhaustion and complete demoralization of several team members.As has been described earlier, the implementation crisis warranted immediate action from board of management of de Viersprong, including a temporary patient stop, the addition of specific MBT expertise to the program, and the recruitment of new personnel. These interventions helped to regain basic control, diminish the turbulence, and improve the quality of the program. However, our extensive analysis of the implementation problems inevitably led to a radical reorganisation of the program in line with the resulting conclusions of this analysis. This reorganisation has been designed along the following lines:Reducing the complexity of the program. A major contributing factor turned out to be the high level of innovation, complexity and intensity implied in treating BPD adolescents with MBT for longer periods of time in an inpatient setting. Therefore the inpatient setting was replaced by an outpatient setting. It was assumed that this would reduce the burden of staff members, increasing their ability to maintain a mentalizing stance, individually and as a team. The format of the intensive outpatient version of MBT for adults was used, as has been described in detail and studied by Bateman and Fonagy [1. d Fonagy . TherebyEmbedding the new program within existing expertise. As has been described, the lack of organizational embedding led to missed opportunities to use existing expertise from within the institution. Therefore, the new program was organizationally embedded within a newly formed MBT unit that integrated the formerly existing adolescent and adult MBT programs. This enabled us to integrate MBT and adolescent expertise in the organization.2. Designing a new implementation plan for the new program. In contrast to the cumbersome start of the first version of the adolescent MBT program, the new version was started ‘de novo’. An implementation plan was designed addressing the various issues mentioned before in this article, including referral process, personnel recruitment, logistics, facilities, and so on. The implementation plan was discussed at all organizational levels, ensuring enough support within the institution.3. Embedding the program within the development of a quality system. One of the major issues was the lack of familiarity with the model on a daily base and the associated difficulties to maintain a reflective, mentalizing stance within the team interactions. This led to reduced therapist adherence to the model and increased interfering team processes. To increase adherence to the working mechanisms of the model and to decrease potentially damaging processes, a quality monitoring system is now being developed. For example, each treatment program has a supervisor who is not a therapist working in that team. The supervisor is an experienced MBT therapist needing several skills: he of she has to be able to measure and reflect on MBT interventions and adherence, to enhance therapist’s mentalizing stance, and to signal and manage destructive team processes like unnoticed or unrevealed splits.4. Developing an organizational manual. The organizational manual is a manual on management and service organization in which the managerial aspects of designing and maintaining a MBT service are described. Management focus is on organizing and facilitating the clinical processes as written up in the treatment guide and monitored within the quality system and is thus an important part of the quality system.5. The program now runs in this new format. The implementation has been remarkably smoother. Results are being monitored. Although we do not have research-based results yet, the first clinical impressions support the effectiveness of the program in line with our previous findings of the old MBT program for adolescents.In this paper, we have argued that the escalating implementation problems in this case study could best be understood from the interaction of three levels of application: organization, team and therapist. At an organizational level, the organizational barriers and recent reorganisation, lack of support within the institution due to the institutional culture, lack of structures to support change management and the shortcomings in the implementation plan, were considered to be the dominant problem factors. At team level, the team problems prior to implementation, the resistance toward change, lack of clear leadership, communication problems and lack of supervisory structures were important determinants. At therapist level, the lack of selection of personnel and the lack of experience with the new model contributed to the implementation problems. These problems were further magnified due to the level of innovation implied in adapting MBT for an inpatient adolescent population. Together, these factors led to increasing impotence and frustration in staff, interacting with increasing levels of arousal and distrust in the patient group related to experienced unreliability. Increased patient turmoil, staff exhaustion and safety risks for patients, staff and the institution ended up resulting in ending the inpatient treatment program.1 adherence, 2 competence, 3 differentiation) at three levels of application  level, 2 team (meso) level, and 3 therapist (micro) level). Examples of these components of treatment integrity, applied to the model of Mentalization-Based Treatment, are provided in TableIn our view, the analysis of this case study might have implications for the conceptualization of treatment integrity to explain successful implementation of evidence-based programs. In psychotherapy outcome research, treatment integrity refers to the extent to which the intervention was implemented as intended . It usuaAdherence refers to the degree to which processes and the procedures that help to optimize the working mechanisms of the model are utilized, i.e. (in case of MBT) what should therapists, teams and organisations do to enhance mentalizing among patients? At therapist level, adherence refers to the basic attitude and interventions that are described in the treatment manual. For example, referring to MBT, therapist adherence refers to the interventions described to enhance mentalizing in patients from a ‘not-knowing’ mentalizing stance. At team level, adherence refers to necessary team processes enabling the working of the model. For example, MBT requires coherence, consistency and continuity in team work. Inconsistencies (and possible splitting) in team functioning will cause confusion, destabilization, and subsequently an increase in crisis and other destructive behaviour. A consistent approach on the other hand creates reliability and safeness, while continuity helps to reconnect the fragmented experiential world of BPD patients. At organisational level, adherence refers to the managerial and organisational procedures that ensure the necessary conditions to implement and maintain the treatment program successfully. For example, to implement MBT, it is necessary that the organisation creates support for the new program within the own institution as the new, ‘difficult’, patients might interfere with the working of other wards. Another example of organisational adherence is the designing of a sufficiently detailed implementation plan, in which the innovative character of the program needs to be thought and worked through.Competence refers to the level of skill and judgement shown in the delivering of the treatment, i.e. what basic qualities and skills should therapists, teams and organization should have in order to be able to perform the procedures as outlined in the ‘adherence’ section. At therapist level, competence for MBT refers to the basic qualities of therapists to work with the most complex BPD patients, including their ability to keep a reflective, mentalizing stance under high pressure. At team level, competence in MBT refers to the qualities a team should have to be able to maintain a consistent approach. This includes a well balanced team with clear roles and leadership qualities among at least one team member. At organisational level, finally, competence refers to the organisational and managerial qualities necessary to provide the organisational conditions for delivering this particular treatment. An evident example is sufficient budget to run the new program as it is intended. Another example, related to the complexity of the MBT population, is the ability of  people in charge to stay calm and intervene constructively after major crisis among the patients .Differentiation refers to what makes this program ‘unique’. As a concept, there is some overlap with the concept of adherence. At therapist level, differentiation refers to the interventions specific for this model and to the ‘forbidden’  interventions. For example, in contrast to Dialectical Behaviour Therapy, MBT will focus much less on behavioural sequences and will instead focus on underlying mental states. At team level, differentiation should describe the specifics of the team functioning and communication within the particular model. For example, within MBT, communication among team members should be focused at helping each other to restore mentalizing. At organisation level, differentiation refers to the specific managerial issues and challenges for this model. For example, MBT might in the future encourage organisations to implement a quality control system, which requires organisational embedding and funding different from other treatment models for BPD.We do not suggest this multilevel model of treatment integrity to be necessary to understand successes and failures in all treatment programs. However, the more complex a treatment model and the more complex the patient population, the more relevant it might be to use this more extended heuristic model of treatment integrity to have an overview of all procedures and qualities that should be provided in order to implement and maintain the treatment program successfully. For example, team adherence becomes a relevant issue when the treatment model requires an integrated (multidisciplinary) team to deliver a consistent treatment. Organisational adherence will be especially relevant when the new program is highly innovative for the organisation where it will be run. If this analysis is correct, this might also imply that the broadening of the concept of treatment integrity could have important implications for developers of complex treatment models. For example, a treatment manual might be a necessary, but insufficient tool to promote adherence in cases of complex (psychotherapeutic) interventions. Developers should also describe how the model should be implemented successfully at local settings within existing teams and existing organisations. This proposal is consistent to the approach taken by the developers of Multisystemic Therapy (MST) , who havaThe WMO  does not cover retrospective case studies like the one described in this report. The report does not describe a medical scientific experiment nor does it report on any additional action by patients in order to collect the data for this study. As a consequence no written informed consent was collected from the patients involved in the treatment described.bAs our aim is not the discussion of a treatment program for adolescents, but the illustration of a failed implementation, we limit ourselves for this purpose to this short description.BPD : Borderline personality disorder; CBT : Cognitive behaviour therapy; DBT : Dialectical behaviour therapy; MBT : Mentalization-based treatment; MBT-A : Mentalization-based treatment for adolescents; MST : Multisystemic therapy; PD : Personality disorder; SFT : Schema-focused therapy; STEPPS : Systems training for emotional predictability and problem solving; TFP : Transference-focused psychotherapy.All authors are currently working for the organization. Three authors  were directly involved in the implementation process of the treatment program. The organization is financing the manuscript.JH was a involved in the MBT-A program and made the draft for the manuscript. DB was supervisor for the program, read the first draft and added several points of discussion. JB introduced the quality perspective in the article and edited the second draft. RV edited the last draft. All authors read and approved the final manuscript.


The concepts and standard practices of implementation, largely originating in developed countries, cannot necessarily be simply transferred into diverse cultural contexts. There has been relative inattention in the implementation science literature paid to the implementation of interventions targeting minority Indigenous populations within developed countries. This suggests that the implementation literature may be bypassing population groups within developed countries who suffer some of the greatest disadvantage. Within the context of Aboriginal Australian health improvement, this study considers the impact of political and cultural issues by examining the transfer and implementation of the Family Wellbeing program across 56 places over a 20-year period.A theoretical model of program transfer was developed using constructivist-grounded theory methods. Data were generated by conducting in-depth interviews with 18 Aboriginal and non-Aboriginal research respondents who had been active in transferring the program. Data were categorised into higher order abstract concepts and the core impetus for and process of program transfer were identified.Organizations transferred the program by using it as a vehicle for supporting inside-out empowerment. The impetus to support inside-out empowerment referred to support for Aboriginal people's participation, responsibility for and control of their own affairs, and the associated ripple effects to family members, organizations, communities, and ultimately reconciliation with Australian society at large. Program transfer occurred through a multi-levelled process of embracing relatedness which included relatedness with self, others, and structural conditions; all three were necessary at both individual and organizational levels.Similar to international implementation models, the model of supporting inside-out empowerment by embracing relatedness involved individuals, organizations, and interpersonal and inter-organizational networks. However, the model suggests that for minority Indigenous populations within developed countries, implementation approaches may require greater attention to the empowering nature of the intervention and its implementation, and multiple levels of relatedness by individuals and organizations with self, others, and the structural conditions. Key elements of the theoretical model provide a useful blueprint to inform the transfer of other empowerment programs to minority Indigenous and other disadvantaged populations on a case-by-case basis. There has been an accelerated growth in implementation science literature in western countries in recent decades based on the insight that research findings should be more widely implemented in health practice . ResearcThe significant gaps in health and wellbeing equity between Indigenous and non-Indigenous populations in Canada, North America, New Zealand, and Australia have been well described; as has been evidence of achievement of health targets that has shown that it is possible to improve health . Howeveret al. has been an extraordinarily useful part of thinking about health services for disempowered people more broadly. And also some of the workforce issues, it’s been highly influential in my thinking about where we should go.’Another Aboriginal facilitator commented: '… it just really opened my eyes—it’s bigger than a program. This is also about influencing change around policy.’For individual FWB agents, embracing relatedness with the structural conditions also required grappling to make sense of their personal histories and to enact personal change processes. For example, an Aboriginal FWB facilitator reflected:'You’re a product of past history, of what happens. I guess when I stand up as an Aboriginal person and go through my life’s experiences and my childhood and teenage years, and more times out of none, every Aboriginal student in that class is going to comprehend what I’m saying because they’ve had the same journey.’Despite the success of program transfer efforts through iterative enactment of the three dimensions of embracing relatedness to support inside-out empowerment, program delivery in the majority of sites was not sustained beyond a pilot phase. A non-Aboriginal researcher and advocate reflected:'… to try and get that level of sustainability is quite difficult for a program of the sort that we’re talking about, very difficult really. If you look across public sector programs… which are non-mainstream, to survive 10 years is quite a challenge, when you’re looking at… at least three governments in a period of time like that.’Research respondents indicated that despite the frustrations of short term funding and their inability to sustain program delivery in many settings, program delivery had resulted in sustained benefits for individual participants. Additionally, the program’s empowerment principles had been incorporated within organizational systems and services to add value to organizational and community processes.The theoretical model was based on the transfer of only one program. The inherent characteristics of the FWB program and the crucial importance of the Aboriginal Australian political and cultural conditions may make it difficult to generalize the findings of this study. However, the theoretical model was considered trustworthy. A diversity of people  was interviewed; systematic comparisons were made between data and between categories; strong logical links were made between the gathered data and the argument and analysis; and those active in FWB program transfer provided feedback that the analytical interpretations made sense and offered them deeper insights about program transfer.The model of program transfer and implementation, grounded in the naturally occurring process of FWB, is consistent with aspects of international implementation models. As documented in the international literature, program transfer and implementation involved individuals, organizations and interpersonal and inter-organizational networks, partnerships, and collaborations ,4,37. InHowever, the findings of this study suggest that the implementation of innovations targeting minority Indigenous populations within developed countries may require attention to the empowering nature of the innovation and its implementation, and consideration of the multiple levels of relatedness—with self, others, and the structural conditions. First, the impetus for program transfer of supporting inside-out empowerment suggests that the relative disempowerment of Indigenous populations makes empowerment a particularly relevant attribute of the nature of interventions and the processes of their implementation. In the case of FWB, the empowering nature of the program and its implementation process made it infectious, influencing the impetus for and process of program transfer. FWB provided a framework or set of principles for engaging and empowering work with Aboriginal people at individual, group, organizational, community, and/or policy levels. These empowerment principles and attributes contributed to experiential change processes that drove participants to advocate for transfer to other settings in order to support other people’s empowerment, fostering a sense of control and ownership over the implementation process. Benefits included the development of personal empowerment, agency, capacity, a ripple effect to others, engagement in organizational and community change processes, program transfer, and value-adding to organizational, service- and policy-related endeavors at local levels. This finding suggests a need for recognition of empowerment as an impetus for program transfer and implementation and the embedding of empowering processes as an active component within processes of implementation.Second, program transfer occurred through an organic, informal process of embracing relatedness within and between individuals and organizations, and with the broader structural conditions. FWB agents used their enhanced sense of agency from program participation and their interpersonal (family) and inter-organizational networks to influence the transfer and implementation process. The Aboriginality of providers and participants was perceived as a critical success factor for the relevance and credibility of the program. The provider hubs interacted with implementing organizations and funders to respond to demand for the program. The Western and Aboriginal structural conditions both enabled and constrained transfer, but regardless, program transfer required an active process of engagement with these broader conditions. Thus, the processes of relatedness resulted in individual agency, strengthened organizational capacity and further program transfer. The finding, however, that the program was not sustained in the majority of sites to which it was transferred suggests that recognition and sustained resourcing for coordination and linkage roles of the provider hubs could strengthen capacity for sustained program spread.Although the indicators of Aboriginal disadvantage remain daunting, program transfer and implementation offer one pragmatic and potentially cost-effective approach for incrementally improving a range of Aboriginal Australian health, wellbeing, and educational outcomes. The model of supporting inside-out empowerment by embracing relatedness suggests that factors important in the transfer and implementation of interventions to disadvantaged populations such as Aboriginal Australians, are the empowering nature of the intervention and its implementation, and the relatedness of individuals and organizations through networks and with the broader structural conditions. The theoretical model provides a new conceptual rendering of multi-levelled-relatedness as a process for transferring programs across Aboriginal Australian sites and situations. The key elements of the theoretical model provide a useful blue print to inform the transfer of empowerment-based programs on a case-by-case basis, and may be relevant beyond Indigenous populations to other disadvantaged minority populations.aTechnical and Further Education, South Australia (TAFESA) in Adelaide and Berri; Batchelor College in Alice Springs, Northern Territory; and James Cook University in Cairns and Townsville, Queensland.The author declares that she has no competing interests.The author conceptualized and designed the study as a doctoral research study, and acquired, analyzed, and interpreted the data. She wrote the manuscript and was responsible for its intellectual content.


Plasma derived medicines (PDM) including immunoglobulins, clotting factors and albumin are life saving medicines which due to their high costs are inaccessible for many patients living in developing countries. By contrary substantial volume of plasma as raw materials for production of these medicines are discarded worldwide. Good quality recovered plasma, as a result of separation of donated blood into its components, could be used for production of PDM. In 2011 Iranian donors donated about 2 million units of blood. A shift from administration of whole blood to components therapy has resulted in the generation of over 250,000 liters of surplus of recovered plasma. This created a good opportunity for Iran’s health care system to use this plasma for production of PDM. Therefore Iran national transfusion service has started a contract fractionation program for converting recovered plasma into PDM. This program not only provided essential PDM for Iran pharmaceutical market but also has created a direct saving of about 8.5 million Euros in 2011 for national health sector. In addition this program has drastically contributed to improvement of overall quality of working procedures and services provided by Iran national blood transfusion organization. WHO Model List of Essential Medicine emphasizing their clinical importance. Primary immune deficiencies (PID) and bleeding disorders such as haemophilia are among the most important disease require PDM for their management. The majority of patients with haemophilia or PID are currently not receiving adequate treatment, and the numbers of these patients being diagnosed are increasing.Although blood as a very precious human resource has been used for direct transfusion for centuries it has recently become increasingly important to separate the manufacturing aspect of blood as a source of pharmaceutical “raw material”. The process of separating blood into its components will result to plasma as a rich source of human proteins for further manufacturing of plasma derived medicines (PDM). Fractionation of plasma could provide a wide range of medicines essential for management of patients with bleeding and immunological disorders. Coagulating factors including factor VIII (FVIII), factor IX (FIX), von willebrand factor, fibrinogen, fibrin sealants, prothrombin complex concentrate, albumin and immunoglobulins (IG) are among the most used PDM around the world. Some of these medicines including coagulation factors concentrates and IG are on the Global need for PDM have been increasing almost geometrically over the last decade and based on evidences for new indications of this medicines it seems that administration of PDM will increase for years to come. DespiteHigh costs and low availability of PDM in middle and low income economies resulted to under treatment of patients living in these countries. Based on data presented by patient oriented organizations,5 the maLocal fractionation of plasma and contract fractionation are two main options for using recovered plasma as an Active Pharmaceutical Ingredient (API) for production of PDM. Although both options will provide means to improve quality of the transfusion system and availability of PDM, local fractionation requires substantial investment of time and money due to the very high level of complexity of the plasma fractionation technology and regulatory issues. HoweverIn addition to other advantages of contract fractionation including tangible effects on quality of the blood transfusion system and transfusion safety it couldHowever, success of any contract fractionation program requires some essential pre requisites. A contract fractionation agreement is a mutual activity that should follow transparent and well-established agreements between plasma supplier and fractionator company. Among other items volume and quality of plasma and costs of fractionation are of the utmost importance. Range of the products should be well-balanced based on the country’s needs to PDM. Therefore, successful contract fractionation programs could serve as a ramp-up phase for establishment of local fractionation facility, wherever feasible. That is why some developing countries with contract fractionation program have established a long term plan for establishment of local fractionation facility in their national policy for plasma. However, due to practical difficulties regarding transfer of plasma fractionation technology this major move should be done only after a very careful assessment and feasibility study based on presence of strong government endorsement and in particular the volume of plasma available. Since building a high tech GMP-compliant plasma fractionation facility require considerable investment, contract fractionation activity could be considered a valuable training activity for national staff to build a team of skilled manpower.Despite presence of considerable number of fractionation facilities worldwide, there are only few countries which have reached full self sufficiently for providing PDM for their own market and most of the countries have to rely on importation of PDM in order to response to the patients’ need. Although more than 50% of global fractionators are located in the Asia-Pacific region, many fractionation plants in this region have small capacity or produce short range of the products. The total plasma volume fractionated in 2010 in this region is close to 6.4 million liters. The coverage of local needs by products prepared from domestic Japanese plasma is about 25% for factor VIII, 58% for albumin and 95% for IG in 2010. The volume of plasma fractionated in Korea is about 870,000 liters. China with over 25 plasma fractionation in 2010 fractionated about 3.4 million liters of plasma which has been collected exclusively by plasmapheresis from remunerated donors[Iran, a country with a population of over 74 millions, has one of the largest pharmaceutical market in the Middle East. Blood transfusion In Iran is an integral part of the national health system. In 1974 based on a parliamentary law, Iran Blood Transfusion Organization (IBTO) was established in order to centralize all blood transfusion activities from donor recruitment to production of blood components in one organization. IBTO is a public and non-profit organization that relies on the government of Iran for its budget and delivers all its basic services including blood components free of charge both to the public and private hospitals. Self sufficiently of country for blood and blood components has always been the main objective of IBTO. Since 2007 Iran has reached to 100% voluntary donation and IBTO collects blood only from non remunerated voluntary blood donors. In 2011 Iranian donors donated about 2 million units of blood to IBTO. In Iran in addition to the screening of the donors through interviewing of the donors all donated bloods undergo lab testing for possible presence of important and known blood borne diseases including hepatitis B virus (HBV), hepatitis c virus (HCV), human immunodeficiency virus (HIV) and syphilis. Percent of confirmed HBsAg positive samples in blood donated by Iranian donors has drastically decreased from 0.8% in 2002 to 0.25% in 2010. Prevalence of confirmed HCV positive results has also decreased from 0.18% in 2002 to 0.07% in 2010. Despite increasing prevalence of HIV in general population IBTO succeeded to reduce confirmed positive HIV samples in donated bloods to 0.004 in 2010[In recent decade administration of whole blood in health centers of Iran has drastically declined and therefore majority of donated blood >95%) are now converted to blood components including packed red blood cells, platelets and plasma. A shift from administration of whole blood to component therapy has resulted in the generation of surplus of recovered plasma from donated blood. This created a good opportunity for Iran's health care system to use this plasma for production of PDM. In the other hand due to the improvement of standards of care, consumption of PDM in Iran shows a steady rise causing a significant burden on limited resources available in national health sector[5% are noBased on annual number of whole blood donation, IBTO is able to produce about 250,000 liters of surplus plasma annually. Therefore in order to use this plasma for improving availability and affordability of PDM and due to lack of any national fractionation facility, since 2005 IBTO and its sister company Iran Blood Research and Fractionation Co. (IBRF) initiated a contract fractionation program. Although improving the blood safety profile of the country through improving quality assurance system has been one of the main objectives of this project, the program has also significantly improved availability of PDM in the country. IBTO haObviously the medicines produced from this volume of plasma plays a critical role in providing essential PDM to Iranian patients. Plasma is a very valuable raw material and should be converted to as much medicines as practically possible. It has been reported that the cost of one liter of plasma, meeting the requirements for fractionation, is worth between 60–100 Euros. TherefoIn contrary to blood and blood components which are currently provided by IBTO free of charge for all Iranian patients, PDM in Iran are regarded as medicines and should be paid for. Except for antihemophilic factors VIII and IX which are highly subsidized by the government and are free of charge for hemophilia patients, cost of IG and albumin should be borne by either insurance companies or patient. IBTO and IBRF are non-profit organizations which have to recover their operational costs for contract fractionation including costs for plasma preparation from donated bloods, its transportation and fractionation costs through products provided. As expected, the price of PDM prepared by this program is still notably lower than those of commercially available in the market Table.Despite strong support of the activity by governmental officials especially Iran Ministry of Health, Iran contract fractionation program does not receive any financial support from the government and operates based on cost recovery approach. Therefore average prices of PDM produced through the national fractionation activity consists of contract fractionation costs, overhead and administration costs, operational costs and costs for running and expanding the program . IBRF has recently constructed a new 50,000 liters capacity cold warehouse devoted to the program. Based on data presented in TableHowever, in addition to substantial direct effect of this project on saving of resources allocated for importation of PDM, indirect influence of the IBTO project on reducing costs of imported commercial medicines is worth mentioning. Availability of medicines produced from Iranian plasma in the market has inevitably forced the importers to offer more reasonable prices for their products in order to hold their shares in Iran’s market. In fact, the presence of the products produced from contract fractionation in the market, through improving bargaining power of the national authorities on commercial products, has contributed greatly to maintain a downward pressure on the price of the commercially available PDM in Iran’s market.Although treatment of patients such as hemophilia and PID patients with PDM is a life saving intervention, in developing countries mainly due to limited resources available in their national health sector, most of these patients are not diagnosed or properly treated. Therefore use of PDM in these countries is much lower than the actual needs of patients,5. DespiBy improving standards of practice in transfusion medicine many countries even in developing countries turned to components therapy instead of administration of whole blood. Therefore as a consequence, millions of additional plasma units could be generated which unfortunately under current conditions are discarded. Wastage of plasma in these countries is not only could be considered as a human tragedy but also is an economic misfortune for their heath sector. Based on number of donated blood globally it is estimated that every year at least 9 million liters of recovered plasma discarded worldwide. Therefore based on current prices for one liter of plasma such wasted plasma has a market value of about 650–900 million USD. Use of this volume of plasma theoretically could result in about 1.4 billion International Unit (IU) of FVIII. Based on annual use of 20,000 IU per patient this quantity of FVIII would allow an additional 70,000 children with haemophilia A to be treated each year. In addition, the same volume of plasma can generate an additional 2.3 billion IU of FIX necessary for treatment of an additional 57,500 haemophilia B children each year, assuming an annual consumption of 40,000 IU/year/patient. More importantly the same volume of recovered plasma could produce at least 37 tons of IG. This quantity would be used to manage hundred thousand of PID patients. Finally, 230 tons of albumin calculated on a mean recovery of 25 g/L, could be produced from this volume of plasma. This quantity would cover the needs of billion inhabitants based on a consumption of 200 kg/million population. It should also be kept in mind that plasma can be fractionated to yield other PDM as well.Therefore it is both ethical and economically feasible for these countries to take measures to preserve and use this plasma as API for production of PDM. Recovering this plasma and turning it into essential medicines would meet a substantial unmet health need. Additionally such program will eventually improve national capability to provide all blood components of higher quality and safety through upgrading blood collecting facilities to the status of pharmaceutical manufacturers with acceptable GMP. CurrentContract fractionation of locally produced plasma could substantially improve affordability of PDM especially in developing countries. In addition to saving on the budget a contract fractionation program could also protect the country from product shortages. In majority of cases the contract fractionation program will provide a reliable and affordable supply of PDM. However, it should be mentioned that contact fractionation could attract hostility from importers of PDM and the program can be exposed to competition from temporarily low prices for PDM in national market as result of “dumping” by the importers. Therefore, contract fractionation programs should be considered as a long term activity and should not be reconsidered based on short term fluctuation of PDM prices in the market.According to the WHO Secretariat Report in 2010 “a large percentage of the plasma collected in developing countries is categorized as waste material and destroyed. This wastage occurs because appropriate technology, regulatory controls, quality systems and good manufacturing practices are all lacking, thereby rendering the plasma unsuitable for conversion into fractionated medicinal”. TherefoIt is obvious that successful fractionation programs require commitment and investment to establish, both on the part of the blood collection service and the contract fractionator. In any cases success of contract fractionation activity requires strong and reliable governmental commitment, effective framework, balanced products basket and long term planning.In order to be viable any contract fractionator program needs to recover the establishment costs. Well planned contract fractionation programs which rely on large enough volume of plasma is a cost effective approach. Iran, as a country faced with increasing demand for PDM relies on its centralized blood transfusion system for producing plasma for fractionation and has successfully implemented this approach in past years to improve availability and affordability of these medicines. Iran contract fractionation program has enjoyed strong government commitment and support which should be considered as one the main success elements of this program. Iran experience has shown that contract plasma fractionation through direct and indirect effects on price of PDM could substantially improve availability and affordability of such medicines in national health market. In conclusion it is obvious that there is a need for increased global plasma collection and fractionation into PDM and enhanced regulatory capacity in developing countries to make the best use of recovered plasma. Therefore, contract fractionation projects for the production of PDM remain a practical approach to respond to the needs of patients to PDM.The author declare that he/she has no competing of interests.Professor Abdol Majid Cheraghali is advisor to Managing Director of IBTO, board member of IBRF and a key person for Iran national plasma contract fractionation program.


Several residency program characteristics have been suggested as measures of program quality, but associations between these measures are unknown. We set out to determine associations between these potential measures of program quality.Survey of internal medicine residency programs that shared an online ambulatory curriculum on hospital type, faculty size, number of trainees, proportion of international medical graduate (IMG) trainees, Internal Medicine In-Training Examination (IM-ITE) scores, three-year American Board of Internal Medicine Certifying Examination (ABIM-CE) first-try pass rates, Residency Review Committee-Internal Medicine (RRC-IM) certification length, program director clinical duties, and use of pharmaceutical funding to support education. Associations assessed using Chi-square, Spearman rank correlation, univariate and multivariable linear regression.Fifty one of 67 programs responded (response rate 76.1%), including 29 (56.9%) community teaching and 17 (33.3%) university hospitals, with a mean of 68 trainees and 101 faculty. Forty four percent of trainees were IMGs. The average post-graduate year (PGY)-2 IM-ITE raw score was 63.1, which was 66.8 for PGY3s. Average 3-year ABIM-CE pass rate was 95.8%; average RRC-IM certification was 4.3 years. ABIM-CE results, IM-ITE results, and length of RRC-IM certification were strongly associated with each other (p < 0.05). PGY3 IM-ITE scores were higher in programs with more IMGs and in programs that accepted pharmaceutical support (p < 0.05). RRC-IM certification was shorter in programs with higher numbers of IMGs. In multivariable analysis, a higher proportion of IMGs was associated with 1.17 years shorter RRC accreditation.Associations between quality indicators are complex, but suggest that the presence of IMGs is associated with better performance on standardized tests but decreased duration of RRC-IM certification. There is no generally accepted single measure that defines the quality of an internal medicine residency training program -3. "QualIn addition to ABIM-CE pass rate, there are also other potential candidates for program quality indicators. The Internal Medicine In-Training Exam (IM-ITE), administered by nearly all internal medicine residency training programs, serves as a self-assessment tool for residents and as a program evaluation tool for program directors ,7. IM-ITThe associations and causality between most proposed indicators of program quality are unknown. We surveyed internal medicine residency training programs on specific proposed indicators of program quality with the objective to determine potential associations among them, serving as a basis for future study on causality.A survey was developed using indicators of program quality as defined by literature review  ,8-14. Vand and 3rd year residents as well as the number of years of program certification (RRC-IM) were examined by the Spearman rank correlation.The distribution of program types  that responded to the mailed questionnaire was compared to the distribution of nationally accredited internal medicine programs. National data were obtained from the American Medical Association's (AMA) Fellowship and Residency Electronic Interactive Database (FREIDA) . ProgramThe main dependent variables of interest were IM-ITE percentile scores and years of RRC certification. The independent variables of interest were program characteristics. The distribution of IM-ITE percentile scores and years of RRC certification were approximately normal, and modeled as continuous outcomes. Percentage of IMG, percentage of program director's clinical duty, number of faculty and number of residents were analyzed as both continuous variables and dichotomized variables using median values. To evaluate the associations between program characteristics and quality indicators, univariate linear regressions were used first, to compare the mean IM-ITE percentile score and mean years of RRC certification with each program characteristic. Factors associated with IM-ITE and mean years of program certification with a pre-specified p-value of 0.2 in the univariate analysis were subsequently included in the multivariable models to assess the associations with quality indicators after adjustment for potential covariates.All tests of significance were two-tailed, with an alpha level of 0.05. Analyses were performed using Stata/SE .Of the total 67 surveys sent, 51 internal medicine residency training programs completed and returned the questionnaires (response rate 76.1%). Six programs (9%) declined to participate, and no response was received from 10 programs (14.9%). Of the 51 responding programs, 17 (33.3%) were university hospitals and 34 (67.7%) were other types of hospitals. This distribution of program type is similar to non-participating programs in the nationally accredited internal medicine training programs, of which 106 (32.2%) are university hospitals, and 223 (67.8%) are other types of hospitals (chi-square p = 0.93) .Of the 51 responding programs, nine (17.7%) had a primary care track and 34 (66.7%) had the majority of graduates enter subspecialty fellowship training. Twenty seven programs (52.9%) used funds supplied by pharmaceutical companies to support resident education. On average, 44% of residents were international graduates. The proportion of IMGs was higher in the non-university hospitals than in the university hospitals . Program directors spent 30% of time in weekly clinical duty and 14% of time on annual clinical activities. The mean IM-ITE raw score for PGY2s was 63.1%, and the mean rank percentile was 61.3. For PGY3s, the mean raw score on the IM-ITE was 66.8%, and the mean rank percentile was 58.8  and 0.49 (p = 0.002) for PGY2 and PGY3, respectively. A positive association was also shown between shorter RRC-IM certification and lower ABIM-CE pass rates, with correlation of 0.29 (p = 0.04).Mean PGY3 IM-ITE scores relative to selected program characteristics are depicted in Table Length of RRC-IM certification relative to selected program characteristics is also shown in Table th percentile vs. 56.6th percentile; p = 0.08); no other differences were statistically significant.When ABIM-CE pass rates were compared relative to program characteristics, there were no significant differences in these pass rates based on selected program characteristics. Mean PGY2 IM-ITE rank scores were also compared relative to program characteristics. Mean PGY2 IM-ITE rank scores were higher in programs at which program directors had lower clinical workloads, although this association was not statistically significant  was observed at university hospitals relative to all other hospital types , were associated with lower program director weekly clinical duties , and a lower proportion of IMG graduates .Pair-wise associations among potential program quality indicators and program characteristics are summarized in Figure th percentile vs. 49th percentile), consistent with the findings of others [In looking for associations between program quality indicators, our results confirm the association between IM-ITE scores, ABIM-CE pass rates, and years of RRC certification, and extends knowledge of associations between other program quality indicators. When looking for associations between ABIM-CE pass rates and other indicators of program quality, there were no significant differences in ABIM-CE pass rates relative to hospital type, proportion of IMG graduates, program director workload, program size, faculty size, or acceptance of pharmaceutical funding. Since the range of ABIM-CE pass rates in our surveyed programs was so narrow, our study may have lacked the power to detect any meaningful associations between ABIM-CE pass rates and other indicators. The range of IM-ITE scores (both raw scores and percentile rank scores) in surveyed programs was wider, and we were able to demonstrate associations between IM-ITE scores and other quality indicators. We found that programs with larger percentages of IMG graduates had higher PGY3 IM-ITE rank scores . Programs with higher numbers of residents and programs with higher number of faculty had longer RRC certification than did smaller programs and in those with fewer faculty. We did not, however, find an association between hospital type and length of RRC certification, which contrasts with the findings of others . Larger Among the strongest associations demonstrated was the negative association between a high proportion of IMG graduates and longer RRC certification. This negative association was also present in our multivariable model, in which we corrected for number of residents, number of faculty, and IM-ITE scores. We found that programs with higher proportions of IMGs tend to be non-university hospitals with fewer full-time faculty, and that accept pharmaceutical funding to support training. This may suggest fewer resources to comply with ACGME certification requirements, even though these programs demonstrate successful medical knowledge outcomes among trainees .Strengths of our study include survey results from a group of internal medicine training programs whose distribution mirrors that of all internal medicine residency training programs, and with a satisfactory response rate on the survey. Nevertheless, several limitations deserve mention. First, the small variation of ABIM-CE pass rates among surveyed programs limited our ability to detect associations between program quality indicators and ABIM-CE pass rates. In addition, that the average ABIM-CE pass rates and IM-ITE scores in responding programs was greater than 50% suggests that although the distribution of responding programs mirrored that of all programs, responding programs differed in some way from all programs, and results may not be generalizable to all residency programs. Our survey was limited to those potential indicators suggested by the medical literature, and may have missed other program characteristics that are associated with quality, yet were not identified. Our survey also used self-reported ABIM-CE pass rates and IM-ITE performance, which may have been less accurate. Some of the quality indicators studied were aggregate results of individual data , which is a limitation of this and related studies. Finally, we studied associations, not causality. We do not know whether addressing a program characteristic such as program director workload or faculty size or faculty-to-resident ratios will improve educational outcomes such as IM-ITE scores or ABIM-CE pass rates or length of RRC certification, but our results may form the basis for future study.In conclusion, we found that commonly cited indicators of program quality  are closely associated, and that the associations between other potential indicators of program quality are complex. Even when correcting for other variables, programs with a high percentage of IMG graduates have a shorter length of RRC certification. Further study is needed to understand the factors underlying the associations observed in this study.ABIM-CE: American Board of Internal Medicine Certifying Examination; ACGME: Accreditation Council for Graduate Medical Education; AMA: American Medical Association; FREIDA: Fellowship and Residency Electronic Interactive Database; IMG: International Medical Graduate; IM-ITE: Internal Medicine In-Training Examination; PGY: Post-Graduate Year; RRC-IM: Residency Review Committee in Internal MedicineThe authors declare that they have no competing interests.Data collection was performed by SS and DD. Data interpretation, preparation and critical revision of manuscript and approval of final manuscript were performed by all authors.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6920/11/30/prepub


This study reports the results of the qualitative process evaluation (PE) of the Isfahan Healthy Heart Program (IHHP), an integrated community-based trial for prevention and control of non-communicable diseases in Iran.The study explored the overall quality of program implementation. The participants, including designers of IHHP, stakeholders and community members (n = 60) were purposefully recruited from the intervention areas. Data collected from semi-structured interviews and field notes were analyzed using a modified thematic analysis.Four main themes were identified. Our findings highlighted the key role of the resources as both facilitating and hindering factors. IHHP directors faced incompatibilities arising from negative perceptions/attitudes which resulted in decreased adherence to the program. Hence various strategies were used to motivate, strengthen and organize the human workforce implementing the program.Recommendations arising from evaluation of the program were used in subsequent stages of implementation. Qualitative research is an important component of community trials which can improve their implementation. The high prevalence of cardiovascular diseases and their associated mortality worldwide, including in Iran, have made them a major health concern -3. As a This program has provided an opportunity to assess the effectiveness of lifestyle interventions designed for non-communicable diseases (NCDs) prevention and control in a developing country setting. The long-term objectives of IHHP were to decrease the incidence of NCDs and their related disability/mortality. Improving of the knowledge and awareness of the general population and health professionals about NCDs, and improvement of the skills of health professionals in controlling NCD risk factors constituted the short-term objectives of IHHP .Study communities were two intervention counties (Isfahan and Najafabad) and a reference area (Arak), all located in Central Iran. The program had three phases. The first phase, that was conducted in intervention and reference areas in 2000 to study the existing situation of cardiovascular diseases and it's risk factors as well as the knowledge, attitude and practice of the population about the disease and healthy life style. The second-phase, that included multidisciplinary interventions, began in 2001 based on the results of the situation analysis and needs assessment in the community; this phase targeted the whole community and environmental changes in Isfahan and Najafabad . The thiIHHP evaluation protocol targeted the impact, process and outcome of the program with work beginning in 2002 . We repoUsing a qualitative approach, this study revealed the perceptions of program implementers/targets during IHHP interventions. This is an acceptable method in complex and context-dependent community-based programs.This study was conducted in intervention areas. Initially, a process evaluation committee (PEC) consisting of an independent team of researchers was assembled. The PEC members were five health professionals with previous experience in qualitative research. They became familiar with IHHP goals, objectives, strategies and interventional projects through 8 meetings in the presence of PEC members and IHHP board of directors (and some key stakeholders and program designers). The study participants consisted of key informants and others who had some experience with topics of interest to the targeted population, and included policy makers, stakeholders, projects administrators, local leaders, the community members etc. They were purposefully selected on the basis of their role in the interventional projects and information about the program areas, as well as recommendations from those already interviewed. A total of 60 participants were included in the study. Subsequently, feedback gained from the initial meetings was used to make decisions about the study's leading questions.Data collection involved in-depth semi-structured interviews and obtaining field notes during completion of the research over 3 years 2004-2006). This provided a source of formative data with which to identify issues and experiences gained during the implementation stage of the IHHP. Ten open-ended questions were used  approved the study. Informed consent was obtained from the participants prior to interviews; the participants were ensured about confidentiality and anonymity. All data were protected and were made available only to the authors; tapes of interviews were kept in a locked drawer.Collection and analysis of qualitative data were done simultaneously. A modified thematic analysis was used to analyze the data obtained from the transcripts, as well as relevant field notes; it was used to identify explicit and implicit themes, and essences or patterns within the text in relation to the study aims and objectives . TranscrThe reliability and validity of the study was strengthened by including adequate participants, conducting the analytical process actively, and reaching a level of saturation. Relevance of these strategies has been supported . Audio rThere were several interventions in each project, hence a variety of themes and sub-themes emerged from this study. IHHP was performed in multiple settings (Annex 1), however, the main target groups who underwent interventions were the general population, health professional and cardiovascular patients. Here we present the results obtained from the HLCP, HPEP and WIP projects. Most of the project managers were selected from amongst policymakers, stockholders and academics. Hence, most of the participants in the current quantitative research had positive attitudes to the planned interventions, which resulted in higher commitment to the program. They felt more responsible and adjusted their performance using feedbacks. Data emerging from this qualitative study produced several themes and related sub-themes, as follows:Accessibility of resources was emphasized by the participants; it affected the implementation of interventions. Adequate and appropriate allocation of resources yielded satisfactory results in line with program goals. Lack or shortage of resources, limitations in material and human resources, increased personnel responsibility, and changes in management, led to serious problems. Availability of human resources critically affected the implementation of IHHP interventions. The participants said they faced considerable shortage of human resources. The IHHP board of directors had relied on the participants themselves to appropriately respond to this challenge, i.e. the program aimed to make the participants self-enterprising, for instance, many of the educational materials prepared in IHHP projects were used by nurses for peer education; here the resource was not supplied directly by IHHP directors, rather by program stakeholders and the community. This reflects improvement of culture in a community-oriented health program. Educational technology was found to be of great importance second to human resources.We defined 'attitude' as any positive or negative belief about the program's effectiveness, feasibility and rationale, as well as feelings about program designers/directors. We found from the participants' experiences that positive attitudes, especially those of project managers strengthened their commitment to the interventions, enabling them to achieve a higher level of program acceptance. Another finding related to the lack of awareness of program goals, and negative attitude to program effectiveness among some health professionals/policy makers. Project managers spent much time and energy solving this conflict. Our analysis suggests that a key barrier to implementation was the stakeholders' negative attitude to IHHP.Project managers arranged meetings with stakeholders to draw their compliance with planned IHHP activities. Based on the participants' experiences, some of these activities were helpful and were accepted by the stakeholders as a "pleasant experience". The factors perceived as being "enabling" are:The trainees were pleased with their education program and found it in line with their occupational needs.Program planners found more incentives to encourage the acceptance/continuation of desirable behaviors. For example, one method used to encourage smoking cessation was to establish a reward system.We indentified activities within the programs for prevention, treatment and rehabilitation of cardiovascular disease which increased motivation and enhanced the stakeholder's push toward program goals.Gaining appreciation was a great challenge in implementing interventions, especially in hospitals. Behaviors related to program objectives need not only recognition, but also appreciation.It attempts to build an acceptable atmosphere where the stakeholders learn the educational concepts underlying IHHP. We found that improving people's knowledge improved their behaviors.The implementation of interventions requires advocacy and cooperation of other organizations. Communication with stakeholders is essential to the continuum of interventions. Participation included formal and/or informal relations to the program's multidisciplinary background. In addition, the quality of relations predicted agreeable outcomes.Our findings supported the notion expressed as "more staff, more training, more skills and strengthened health systems" ; financiBased on our participants' experiences, enabling factors were the most interesting ones. We found that readiness of stakeholders and the community to accept new changes was considerably grounded in their motivation. The various educational sessions drawn up by program designers were part of a core strategy to achieve this goal. To make these sessions more effective, social, environment and contextual factors were taken into account. The participants in IHHP i.e. program planners, stakeholders, and the community joined in a collaborative approach of both intra- and inter-sectoral nature. Some of the problems faced in the process were caused by traditional, professional, and organizational values and/or interpersonal incompatibilities. The emphasis on collaboration is consistent with the efforts encouraging a collaborative approach to health services delivery . This isIn summary, most of the participants expressed satisfaction with the program. This may have been due to IHHP's integration with existing systems/facilities at the community level. The PEC found that IHHP designers had developed strategies to provide accessible and useful services to all users. Notably, they could overcome resource shortages through appropriate management. They employed various strategies, such as training and information programs to assess the special needs/opinions of target groups, risk sensitization programs, inter-sectoral collaboration, alliance formation, and behavioral change through inductive approaches etc; this way, they tackled some of the negative attitudes to practicality/usefulness of program.This study highlights the important role of resource availability, as well as facilitating/hindering factors. Acceptance of interventions and compliance were determined by attitudes/perceptions about the feasibility/effectiveness of the program. Face-to-face meetings and distribution of educational materials in the community reduce resistance to the program.Organized planning and consistent participation are essential to success of interventions and adherence to the program. Successful strategies and interventions were officially integrated into the health system. The findings and recommendations of evaluation were used in subsequent program planning. We propose that simple IHHP-type interventions be adapted for implementation and integration in communities with limited financial and/or human resources.The authors declare that they have no competing interests.NS: director of the project and design the study and rewrote the article to its present form. KR: coordinated the project and responded to the comments of the referees. MA: drafted the original version of the manuscript. HAA: performed the qualitative analysis and commented on the qualitative design of the study. SZ: help to coordinate of the project. All authors have read and approved the final manuscript.