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1.  Leadership and leadership development in healthcare settings – a simplistic solution to complex problems? 
There is a trend in health systems around the world to place great emphasis on and faith in improving ‘leadership’. Leadership has been defined in many ways and the elitist implications of traditional notions of leadership sit uncomfortably with modern healthcare organisations. The concept of distributed leadership incorporates inclusivity, collectiveness and collaboration, with the result that, to some extent, all staff, not just those in senior management roles, are viewed as leaders. Leadership development programmes are intended to equip individuals to improve leadership skills, but we know little about their effectiveness. Furthermore, the content of these programmes varies widely and the fact that many lack a sense of how they fit with individual or organisational goals raises questions about how they are intended to achieve their aims. It is important to avoid simplistic assumptions about the ability of improved leadership to solve complex problems. It is also important to evaluate leadership development programmes in ways that go beyond descriptive accounts.
doi:10.15171/ijhpm.2014.101
PMCID: PMC4204740  PMID: 25337595
Leadership; Evaluation; Training
2.  Donor and recipient size mismatch in adolescents undergoing living donor renal transplantation affect long-term graft survival 
Transplantation  2013;96(6):555-559.
Context
Controversies exist in the adult literature regarding the use of kidneys from small donors into larger recipients. Little is known regarding this issue in pediatric kidney transplantation.
Objective
To assess the impact of donor/recipient size mismatch on long-term renal graft survival in pediatric patients undergoing living donor renal transplantation.
Study Design
We reviewed the United Network for Organ Sharing database from 1987 through 2010 for adolescent (11-18 years old) patients who underwent primary living donor renal transplantation. According to donor/recipient body surface area (BSA) ratio, patients were stratified into 2 categories: BSA ratio <0.9 and BSA ratio ≥0.9. Graft survival rates were compared between these 2 groups using Kaplan-Meier survival curves and Cox proportional hazards models.
Results
Of the 1880 patients identified, 116 (6.2%) had a donor/recipient BSA ratio <0.9 and 1764 (93.8%) had a donor/recipient BSA ratio ≥0.9 group. BSA ratio of <0.9 conferred an increased risk of graft loss (adjusted hazard ratio [HR] 1.61, 95% CI 1.13-2.27, p=0.008). Patients with a donor/recipient BSA ratio ≥0.9 group had a significantly longer graft survival compared to those with a donor/recipient BSA ratio <0.9, after adjustment for: donor age and gender, recipient age, gender, ethnicity, cause of renal failure as well as clinical factors: cold and warm ischemia time and HLA mismatch.
Conclusion
We conclude that low donor/recipient BSA ratio was associated with an increased risk of graft loss. Appropriate size matching confered better long-term graft survival in adolescents receiving live donor kidney transplants.
doi:10.1097/TP.0b013e31829d672c
PMCID: PMC4141076  PMID: 23838999
Body Surface Area; Renal Transplantation; Pediatrics and Living donor
3.  A Five-Gene Peripheral Blood Diagnostic Test for Acute Rejection in Renal Transplantation 
Monitoring of renal graft status through peripheral blood (PB) rather than invasive biopsy is important as it will lessen the risk of infection and other stresses, while reducing the costs of rejection diagnosis. Blood gene biomarker panels were discovered by microarrays at a single center and subsequently validated and cross-validated by QPCR in gthe NIH SNSO1 randomized study from 12 US pediatric transplant programs. A total of 367 unique human PB samples, each paired with a graft biopsy for centralized, blinded phenotype classification, were analyzed (115 acute rejection (AR), 180 stable and 72 other causes of graft injury). Of the differentially expressed genes by microarray, Q-PCR analysis of a five gene-set (DUSP1, PBEF1, PSEN1, MAPK9 and NKTR) classified AR with high accuracy. A logistic regression model was built on independent training-set (n=47) and validated on independent test-set (n=198)samples, discriminating AR from STA with 91% sensitivity and 94% specificity and AR from all other non-AR phenotypes with 91% sensitivity and 90% specificity. The 5-gene set can diagnose AR potentially avoiding the need for invasive renal biopsy. These data support the conduct of a prospective study to validate the clinical predictive utility of this diagnostic tool.
doi:10.1111/j.1600-6143.2012.04253.x
PMCID: PMC4148014  PMID: 23009139
acute allograft rejection; transplantation genomics; transplantation; transplant rejection; translational research; renal transplantation; renal allograft rejection; biomarker; bioinformatics
4.  Immunostimulatory Oligonucleotides Attenuate Airways Remodeling in Allergic Monkeys 
To determine whether inhaled immunostimulatory DNA sequence oligonucleotides containing CpG motifs mitigate the pathophysiologic manifestation of the asthmatic phenotype (airways hyperresponsiveness and airways remodeling), rhesus monkeys with experimentally induced allergic airways disease were treated seven times with inhaled immunostimulatory oligonucleotides (or sham) periodically for 33 weeks. Airways hyperresponsiveness was reduced twofold in immunostimulatory DNA sequence–treated compared with sham-treated monkeys. Airways from immunostimulatory oligonucleotide-treated monkeys had thinner reticular basement membranes, fewer mucous cells, fewer eosinophils, and fewer mast cells than sham-treated allergic monkeys. We conclude that inhaled immunostimulatory oligonucleotides can attenuate the magnitude of airway hyperreactivity and airways remodeling produced in nonhuman primates with experimentally induced allergic airways disease.
doi:10.1164/rccm.200404-533OC
PMCID: PMC3927836  PMID: 15306532
airway wall alterations; allergic asthma; immunostimulatory DNA sequence oligonucleotides; nonhuman primate
5.  Paying for performance in healthcare organisations 
Aligning Financial Incentives (FIs) to health policy goals is becoming increasingly popular. In many cases, such initiatives have failed to deliver anticipated benefits. Attributing this to the actions of self-interested and resistant professionals is not an entirely helpful approach. It is important to avoid simplistic assumptions to build knowledge of how and why schemes are implemented in practice to inform future policy in this area.
doi:10.15171/ijhpm.2014.14
PMCID: PMC3952536  PMID: 24639977
Incentives; Professionals; Quality Improvement
6.  COMPLETE STEROID AVOIDANCE IS EFFECTIVE AND SAFE IN CHILDREN WITH RENAL TRANSPLANTS: A MULTICENTER RANDOMIZED TRIAL WITH 3 YEAR FOLLOW UP 
To determine whether steroid avoidance in pediatric kidney transplantation is safe and efficacious, a randomized, multicenter trial was performed in 12 pediatric kidney transplant centers. One hundred thirty children receiving primary kidney transplants were randomized to steroid-free (SF) or steroid-based (SB) immunosuppression, with concomitant tacrolimus, mycophenolate, and standard dose daclizumab (SB group) or extended dose daclizumab (SF group). Follow-up was 3 years post-transplant. Standardized height Z score change after 3 years follow-up was −0.99±2.20 in SF vs. −0.93±1.11 in SB; p=0.825. In subgroup analysis, recipients under 5 years of age showed improved linear growth with SF compared to SB treatment (change in standardized height Z score at 3 years −0.43±1.15 vs. −1.07±1.14; p=0.019). There were no differences in the rates of biopsy-proven acute rejection at 3 years after transplantation (16.7% in SF vs. 17.1% in SB; p=0.94). Patient survival was 100% in both arms; graft survival was 95% in the SF and 90% in the SB arms (p=0.30) at 3 years follow-up. Over the three year follow-up period, the SF group showed lower systolic BP (p=0.017) and lower cholesterol levels (p=0.034). In conclusion, complete steroid avoidance is safe and effective in unsensitized children receiving primary kidney transplants.
doi:10.1111/j.1600-6143.2012.04145.x
PMCID: PMC3681527  PMID: 22694755
Pediatric; kidney transplantation; growth; corticosteroids; graft function; side effects
7.  Determining the optimal model for role-substitution in NHS dental services in the United Kingdom 
BMC Oral Health  2013;13:46.
Background
Role-substitution describes a model of dental care where Dental Care Professionals (DCPs) provide some of the clinical activity previously undertaken by General Dental Practitioners. This has the potential to increase technical efficiency, the capacity to care and reduce costs. Technical efficiency is defined as the production of the maximum amount of output from a given amount of input so that the service operates at the production frontier i.e. optimal level of productivity. Academic research into technical efficiency is becoming increasingly utilised in health care, although no studies have investigated the efficiency of NHS dentistry or role-substitution in high-street dental practices. The aim of this study is to examine the barriers and enablers that exist for role-substitution in general dental practices in the NHS and to determine the most technically efficient model for role-substitution.
Methods/design
A screening questionnaire will be sent to DCPs to determine the type and location of role-substitutive models employed in NHS dental practices in the United Kingdom (UK). Semi-structured interviews will then be conducted with practice owners, DCPs and patients at selected sites identified by the questionnaire. Detail will be recorded about the organisational structure of the dental team, the number of NHS hours worked and the clinical activity undertaken. The interviews will continue until saturation and will record the views and attitudes of the members of the dental team. Final numbers of interviews will be determined by saturation.
The second work-stream will examine the technical efficiency of the selected practices using Data Envelopment Analysis and Stochastic Frontier Modeling. The former is a non-parametric technique and is considered to be a highly flexible approach for applied health applications. The latter is parametric and is based on frontier regression models that estimate a conventional cost function.
Discussion
Maximising health for a given level and mix of resources is an ethical imperative for health service planners. This study will determine the technical efficiency of role-substitution and so address one of the key recommendations of the Independent Review of NHS dentistry in England.
doi:10.1186/1472-6831-13-46
PMCID: PMC3849722  PMID: 24063247
8.  Experience of contractual change in UK general practice: a qualitative study of salaried GPs 
The British Journal of General Practice  2012;62(597):e282-e287.
Background
General practice in the UK underwent major change in 2004, with the introduction of new contracts and a significant element of pay for performance. Although salaried GPs form an increasing proportion of the general practice workforce, little is known of their experiences.
Aim
To explore the views and experiences of salaried GPs working in English general practice.
Design and setting
Qualitative study using semi-structured interviews in 17 practices across England, between July 2007 and September 2009.
Method
Interviews were conducted with 23 salaried GPs. A topic guide included questions on motivations for a career in general practice, descriptions of their daily working environment and duties, practice relationships, and future aspirations.
Results
The new ability to opt out of out-of-hours responsibilities was deemed positive for the profession but not a major driver for choosing medical speciality. Views regarding the impact of the Quality and Outcomes Framework were ambivalent. Differences in pay were regarded as largely reflective of differences in responsibility between salaried GPs and principals. Most participants reported conducting varied work in collaborative practices. Participants held varying career aspirations.
Conclusion
Salaried GPs' working experiences were dependent upon personal aspirations and local context. Most salaried GPs were reportedly content with their current position but many also had aspirations of eventually attaining GP principal status. The current lack of available partnerships threatens to undo recent positive workforce progress and may lead to deep dissatisfaction within the profession and a future workforce crisis. Further large-scale quantitative work is required to assess the satisfaction and future expectations of those in salaried posts.
doi:10.3399/bjgp12X636128
PMCID: PMC3310035  PMID: 22520916
general practice; primary care; workforce
9.  Persistent frequent attenders in primary care: costs, reasons for attendance, organisation of care and potential for cognitive behavioural therapeutic intervention 
BMC Family Practice  2012;13:39.
Background
The top 3% of frequent attendance in primary care is associated with 15% of all appointments in primary care, a fivefold increase in hospital expenditure, and more mental disorder and functional somatic symptoms compared to normal attendance. Although often temporary if these rates of attendance last more than two years, they may become persistent (persistent frequent or regular attendance). However, there is no long-term study of the economic impact or clinical characteristics of regular attendance in primary care. Cognitive behaviour formulation and treatment (CBT) for regular attendance as a motivated behaviour may offer an understanding of the development, maintenance and treatment of regular attendance in the context of their health problems, cognitive processes and social context.
Methods/design
A case control design will compare the clinical characteristics, patterns of health care use and economic costs over the last 10 years of 100 regular attenders (≥30 appointments with general practitioner [GP] over 2 years) with 100 normal attenders (6–22 appointments with GP over 2 years), from purposefully selected primary care practices with differing organisation of care and patient demographics. Qualitative interviews with regular attending patients and practice staff will explore patient barriers, drivers and experiences of consultation, and organisation of care by practices with its challenges. Cognitive behaviour formulation analysed thematically will explore the development, maintenance and therapeutic opportunities for management in regular attenders. The feasibility, acceptability and utility of CBT for regular attendance will be examined.
Discussion
The health care costs, clinical needs, patient motivation for consultation and organisation of care for persistent frequent or regular attendance in primary care will be explored to develop training and policies for service providers. CBT for regular attendance will be piloted with a view to developing this approach as part of a multifaceted intervention.
doi:10.1186/1471-2296-13-39
PMCID: PMC3390898  PMID: 22607525
High utilisers of care; Primary care; Cognitive behavior therapy; Hypochondriasis; Somatoform disorders; Health care economics and organizations
10.  The medium-term sustainability of organisational innovations in the national health service 
Background
There is a growing recognition of the importance of introducing new ways of working into the UK's National Health Service (NHS) and other health systems, in order to ensure that patient care is provided as effectively and efficiently as possible. Researchers have examined the challenges of introducing new ways of working--'organisational innovations'--into complex organisations such as the NHS, and this has given rise to a much better understanding of how this takes place--and why seemingly good ideas do not always result in changes in practice. However, there has been less research on the medium- and longer-term outcomes for organisational innovations and on the question of how new ways of working, introduced by frontline clinicians and managers, are sustained and become established in day-to-day practice. Clearly, this question of sustainability is crucial if the gains in patient care that derive from organisational innovations are to be maintained, rather than lost to what the NHS Institute has called the 'improvement-evaporation effect'.
Methods
The study will involve research in four case-study sites around England, each of which was successful in sustaining its new model of service provision beyond an initial period of pilot funding for new genetics services provided by the Department of Health. Building on findings relating to the introduction and sustainability of these services already gained from an earlier study, the research will use qualitative methods--in-depth interviews, observation of key meetings, and analysis of relevant documents--to understand the longer-term challenges involved in each case and how these were surmounted. The research will provide lessons for those seeking to sustain their own organisational innovations in wide-ranging clinical areas and for those designing the systems and organisations that make up the NHS, to make them more receptive contexts for the sustainment of innovation.
Discussion
Through comparison and contrast across four sites, each involving different organisational innovations, different forms of leadership, and different organisational contexts to contend with, the findings of the study will have wide relevance. The research will produce outputs that are useful for managers and clinicians responsible for organisational innovation, policy makers and senior managers, and academics.
doi:10.1186/1748-5908-6-19
PMCID: PMC3063189  PMID: 21396135
11.  The present state and future direction of primary care: a qualitative study of GPs' views 
Background
Over the past decade there has been a sharp increase in the number of non-profit-sharing salaried doctors employed by practices. This has been accompanied by the introduction of mechanisms to facilitate the entry of other providers into the primary care market.
Aim
To explore the views of GP principals and salaried doctors on current working practices and the future direction of primary care in England.
Design of study
Qualitative study using semi-structured interviews.
Setting
Twenty-two nationally representative practices across England, between February and August 2007.
Method
Interviews were conducted with 22 principals and seven salaried doctors. A topic guide included questions on motivations for working in primary care, descriptions of working lives, the way in which clinical time was spent, and predictions for future working conditions.
Results
Significant changes to GP working arrangements were identified, including increasing pursuit of specialist clinical interests by GP principals and increasing employment of salaried GPs. These developments were reported as improving the working lives of principals but also creating a hierarchical structure at practice level that led to resentment among salaried doctors. Many of the salaried GPs felt disenfranchised and disillusioned by the difference in status and autonomy in decision making and the type of work they performed in the practice. Almost all GPs felt uncertain about the future of primary care and were concerned about the potential threat of private providers delivering primary care within the NHS through a largely salaried workforce.
Conclusion
By failing to recognise the problems of employing an increasingly disenfranchised salaried labour force, GP principals may be undermining the very ethos of general practice they otherwise advocate and recreating smaller versions of the private provider organisations they suggest threaten to corrode NHS primary care.
doi:10.3399/bjgp09X473060
PMCID: PMC2784528  PMID: 19889257
primary care; salaried GP; workforce
12.  Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder 
BMC Psychiatry  2010;10:100.
Background
Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived.
Methods/design
Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ≥ 16 and global assessment of function (GAF) ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis incuding the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study.
Discussion
This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and implementation.
Trial registration
Clinical trials.gov identifier NCT01047124
doi:10.1186/1471-244X-10-100
PMCID: PMC3001706  PMID: 21114826
13.  Sirolimus pharmacokinetics in pediatric renal transplant recipients receiving calcineurin inhibitor co-therapy 
Pediatric transplantation  2006;10(8):914-919.
We have previously reported sirolimus (SRL) pharmacokinetics (PK) in pediatric renal transplant recipients on a calcineurin inhibitor (CNI)-free protocol. We now report pediatric SRL PK in pediatric renal transplant patients receiving SRL + CNI. SRL was dosed to achieve target trough levels between 10 and 20 ng/mL. We performed 49 SRL PK profiles in pediatric renal transplant recipients receiving SRL in combination with either cyclosporine (CsA; 25 profiles), or tacrolimus (TCL; 24 profiles). Ten of the SRL + TCL profiles were obtained from children receiving SRL on a b.i.d. dosing regimen. All other SRL profiles were q.d. regimens. We calculated, the maximum concentration (Cmax), AUC, apparent clearance (aCL; dose/AUC) for dose in mg/m2, and mean residence time (MRT). SRL levels were measured at 6 and 7 time points for b.i.d. and q.d. dosing, respectively. Regression analysis of SRL trough values vs. AUC showed good correlation in the SRL q.d. + CsA, SRL q.d. + TCL, and SRL b.i.d. + TCL groups (r2 = 0.95, 0.68, and 0.44, respectively). SRL aCL corrected for body surface area was higher in children aged 0-5 yr receiving SRL with either CsA or TCL. SRL dosing schedule should be tailored to each patient. Higher SRL aCL may be present in younger children when administered with CNI.
doi:10.1111/j.1399-3046.2006.00541.x
PMCID: PMC1636453  PMID: 17096757
sirolimus; pharmacokinetics; calcineurin inhibitors; cyclosporine; tacrolimus; children; kidney transplantation
14.  Impact of financial incentives on clinical autonomy and internal motivation in primary care: ethnographic study 
BMJ : British Medical Journal  2007;334(7608):1357.
Objective To explore the impact of financial incentives for quality of care on practice organisation, clinical autonomy, and internal motivation of doctors and nurses working in primary care.
Design Ethnographic case study.
Setting Two English general practices.
Participants 12 general practitioners, nine nurses, four healthcare assistants, and four administrative staff.
Main outcome measure Observation of practices over a five month period after the introduction of financial incentives for quality of care introduced in the 2004 general practitioner contract.
Results After the introduction of the quality and outcomes framework there was an increase in the use of templates to collect data on quality of care. New regimens of surveillance were adopted, with clinicians seen as “chasers” or the “chased,” depending on their individual responsibility for delivering quality targets. Attitudes towards the contract were largely positive, although discontent was higher in the practice with a more intensive surveillance regimen. Nurses expressed more concern than doctors about changes to their clinical practice but also appreciated being given responsibility for delivering on targets in particular disease areas. Most doctors did not question the quality targets that existed at the time or the implications of the targets for their own clinical autonomy.
Conclusions Implementation of financial incentives for quality of care did not seem to have damaged the internal motivation of the general practitioners studied, although more concern was expressed by nurses.
doi:10.1136/bmj.39238.890810.BE
PMCID: PMC1906646  PMID: 17580318
15.  Innovation sustainability in challenging health-care contexts: embedding clinically led change in routine practice 
The need for organizational innovation as a means of improving health-care quality and containing costs is widely recognized, but while a growing body of research has improved knowledge of implementation, very little has considered the challenges involved in sustaining change – especially organizational change led ‘bottom-up’ by frontline clinicians. This study addresses this lacuna, taking a longitudinal, qualitative case-study approach to understanding the paths to sustainability of four organizational innovations. It highlights the importance of the interaction between organizational context, nature of the innovation and strategies deployed in achieving sustainability. It discusses how positional influence of service leads, complexity of innovation, networks of support, embedding in existing systems, and proactive responses to changing circumstances can interact to sustain change. In the absence of cast-iron evidence of effectiveness, wider notions of value may be successfully invoked to sustain innovation. Sustainability requires continuing effort through time, rather than representing a final state to be achieved. Our study offers new insights into the process of sustainability of organizational change, and elucidates the complement of strategies needed to make bottom-up change last in challenging contexts replete with competing priorities.
doi:10.1177/0951484812474246
PMCID: PMC3667693  PMID: 23554445
16.  PUBLIC HEALTH ASPECTS OF LYMPHOGRANULOMA VENEREUM 
California Medicine  1949;71(3):178-186.
The clinical symptoms of lymphogranuloma venereum with the serious pathologic changes often occurring in the late stages of the disease warrant greater attention to the disease.
The reported ratio of cases of lymphogranuloma venereum to cases of syphilis and gonorrhea is much higher in San Francisco than in other metropolitan ports of western United States, apparently because of greater use of diagnostic tests for the disease.
Tests of persons likely to be exposed and other persons not likely to be exposed to venereal diseases indicate that a positive reaction to a Frei test implies past or present infection with lymphogranuloma venereum.
Positive reactions to complement fixation tests are notably more frequent than positive response to Frei tests. The complement fixation test appears to be an unreliable diagnostic aid.
The frequency of positive reactions associated with other venereal diseases, and their infrequency otherwise, suggests that lymphogranuloma venereum may exist, unrecognized, in many persons, who may be, potentially at least, carriers of the disease.
PMCID: PMC1520193  PMID: 18147525

Results 1-16 (16)