An audit of clinical outcomes and client and referrer satisfaction with a mood and anxiety Disorders unit

Objective To evaluate outcome and client and referrer satisfaction with the service provided by a Mood and Anxiety Disorders Unit (MADU).

Method MADU was a specialized clinical service for the assessment and management of individuals suffering with affective and anxiety disorders. Clients were referred to MADU from a variety of health service providers. A telephone survey of 30 clients and 20 referrers who have used the services of MADU was conducted, investigating outcome satisfaction with the service provided by MADU.

Results Clients and referrers reported a high level of satisfaction with the service provided by MADU. There was a high degree of adherence to treatment recommendations. The mean Patient Global Impression of Improvement (PGI) rating by the clients before the MADU assessment was 2.74 (SD = 1.27). In comparison the mean PGI rating at the time of follow-up was 6.64 (SD = 1.91).

Conclusions Specialist mood disorders units are a useful and potentially cost-effective additional service included as a part of a mental health service.

MAAGs: the next generation. A study of the development of medical audit advisory groups and the arrangements for supporting clinical audit in primary care

Background: MAAGs have, historically, been disparate organisations with a lack of central direction, albeit with the same goal: to develop and support the performance of audit in primary care. This goal has been (and is being) achieved in a number of ways all over the country. In the last two years, MAAGs have witnessed many changes in primary care and are adapting themselves to suit these new arrangements at a local level.

Aim: To formalise our knowledge of where MAAGs are going, how they are getting there and the support they are receiving.

Method: A postal questionnaire to the 104 MAAGs in England and Wales, addressing 6 main issues of relevance to the development of MAAGs and the support they are receiving.

Results: At least two MAAGs have dissolved, leaving a possible total of 102 still in existence. Of these, 76 (74.5%) responded to the survey. The composition of the MAAG committee has changed dramatically since the inception of MAAGs in 1990, and staffing levels appear to have risen substantially. MAAGs appear to be more adequately funded by their health authorities than has previously been reported and many are actively seeking additional sources of funding. There is still large variation in levels of MAAG funding. Furthermore, funding is unrelated to the number of GPs or practices served. Security for MAAG staff appears to have been addressed in many areas, with 84% of MAAGs having at least one member of staff on a permanent employment contract. Many MAAGs are developing rolling programmes in an attempt to eliminate the short-sighted approach to the development of clinical audit that has existed since MAAGs were first set up.

Conclusion: Many MAAGs (with the obvious exception of those that have been dissolved) appear to be thriving without central direction or initiative. It is now evident that we were a little hasty in our concerns for the future of MAAGs beyond April 1996. It would seem that many organisations have taken the situation which arose two years ago as an opportunity to grow and develop in ways that may not have been possible within the confines of the Health Circular.

The suitability of polycystic ovary syndrome-specific questionnaires for measuring the impact of PCOS on quality of life in clinical trials

Objectives: Generic patient-reported outcome (PRO) measures underestimate the impact of polycystic ovary syndrome (PCOS) on quality of life (QoL). The aim of this review was to identify PCOS-specific QoL measures and establish whether their development history and measurement properties support their use in clinical trials.

Methods: A systematic search was conducted using terms synonymous with “PCOS” and “QoL.” Following identification of measures, further searches were undertaken using the questionnaire name and abbreviation to explore its use, development history, and demonstrated measurement properties.

Results: Of 56 abstracts screened, 21 reported using PRO measures. One PCOS-specific QoL measure was identified: the PolyCystic Ovary Syndrome Questionnaire (PCOSQ). Nine papers show that the PCOSQ’s development history is somewhat incomplete, and that it does not have good content validity. The PCOSQ subscales demonstrate acceptable levels of reliability (0.70–0.97) and partial known-groups validity as well as convergent/divergent validity with other PRO instruments. Responsiveness
to change is variable and minimally important differences have not been established.

Conclusions: The PCOSQ is the only condition-specific measure of the impact of PCOS on QoL. Additional research is required to ensure its comprehensiveness, sensitivity, and to guide interpretation prior to including in clinical trials.

Mixed methods evaluation research for a mental health screening and referral clinical pathway

Rationale: This study is an exemplar of mixed method evaluation research for development of a clinical pathway.

Aim: To develop and evaluate an evidence-based, feasible mental health screening and referral clinical pathway for Department of Veterans’ Affairs-funded community nursing care of war veterans and war widows in the Australian context.

Methods: Mixed methods were applied to formulate and clinically evaluate an appropriate pathway. The pathway was applied at urban and rural sites for the nursing care of 97 war veteran and war widow clients. Evaluative data were collected from clients, their informal carers, community nurses, and general practitioners. Chart auditing and pre-post measures were undertaken. Collaboration occurred with an interdisciplinary design team.

Results: The final modified six-page pathway includes use of validated screening tools (Kessler Psychological Distress Scale [K10]) and Alcohol Use Disorder Identification Test, appropriate referral information, directions for support and health-promoting education, and evidence-based guidelines. Implications for Practice: The clinical pathway is a useful, tested, evidence-based guide for generalist community nurses to identify and suitably respond to common mental healthcare needs of war veterans and war widows. The pathway provides outcomes acceptable to clients and their carers, nurses and doctors.

Conclusions: This study provides an evaluated clinical pathway for generalist community nurses to screen for mental health difficulties, make appropriate referrals as required and to support war veteran and war widow clients. However, the study also shows how research can be used to develop and evaluate
practical, evidence-based clinical pathways.

Predicting changes in lifestyle and clinical outcomes in preventing diabetes : The Greater Green Triangle Diabetes Prevention Project

Objectives : To analyse how psychosocial determinants of lifestyle changes targeted in the Greater Green Triangle Diabetes Prevention Project conducted in Southeast Australia in 2004–2006 predict changes in dietary behaviour and clinical risk factors.

Methods : A longitudinal pre-test and post-test study design was used. The group program was completed by 237 people at high risk of type 2 diabetes. Associations between changes in the variables were examined by structural equation modelling using a path model in which changes in psychological determinants for lifestyle predicted changes in dietary behaviours (fat and fibre intake), which subsequently predicted changes in waist circumference and other clinical outcomes. Standardised regression weights are presented, with β = ± 0.1 and β = ± 0.3 representing small and medium associations, respectively.

Results : Improvements in coping self-efficacy and planning predicted improvements in fat (β = − 0.15, p < 0.05 and β = − 0.32, p < 0.001, respectively) and fibre intake (β = 0.15, p < 0.05 and β = 0.23, p < 0.001, respectively) which in turn predicted improvements in waist circumference (β = 0.18, p < 0.01 and β = − 0.16, p < 0.05, respectively). Improvements in waist circumference predicted improvements in diastolic blood pressure (β = 0.13, p < 0.05), HDL (β = − 0.16, p < 0.05), triglycerides (β = 0.17, p < 0.01), and fasting glucose (β = 0.15, p < 0.05).

Conclusions : Psychological changes predicted behaviour changes, resulting in 12-month biophysical changes. The findings support the theoretical basis of the interventions.

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians : a model process

Background
The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients.

Methods
The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug.

Results
Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug.

Conclusions
Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.

Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).

Clinical and economic burden of emergency department presentations for neutropenia following outpatient chemotherapy for cancer in Victoria, Australia

Objective. To examine the clinical characteristics and financial charges associated with treating adult cancer patients receiving chemotherapy in outpatient clinics who presented to the emergency department (ED) with neutropenia.
Design and Setting. A retrospective audit was conducted across two health services involving ED episodes and subsequent hospital admissions of patients who received chemotherapy through day oncology from January 1 to December 31, 2007 and presented to the ED with neutropenia. ED data were collected from the Victorian Emergency Minimum Dataset and charges were collected from Health Information Services. Descriptive and bivariate statistics were used to describe the patient and clinical characteristics and financial outcomes, and to explore associations between these factors.
Results. In total, 200 neutropenic episodes in 159 outpatients were seen in the ED over the survey period. The mean patient age was 56.6 years (standard deviation, 13.2 years) and 47.2% were male. Overall, 70.0% of ED episodes were triaged as Australasian Triage Scale 2 (emergency). The median ED wait time was 10 minutes and the median ED length of stay was 6.8 hours. The median charge for each ED episode was $764.08 Australian dollars. The total combined ED and inpatient charge per episode was in the range of $144.27-$174,732.68, with a median charge of $5,640.87.
Conclusions. This study provides important insights into the clinical and economic burden of neutropenia from both the ED and inpatient perspectives. Alternative treatment models, such as outpatient treatment, early discharge programs or prophylactic interventions to reduce the clinical and economic burden of neutropenia on our health system, must be explored.

Balanced efficacy, safety, and tolerability recommendations for the clinical management of bipolar disorder

Objective:  To provide practical and clinically meaningful treatment recommendations that amalgamate clinical experience and research findings for each phase of bipolar disorder.

Methods:  A comprehensive search of the literature was undertaken using electronic database search engines (Medline, PubMed, Cochrane reviews) using key words (e.g., bipolar depression, mania, treatment). All relevant randomised controlled trials were examined, along with review papers, meta-analyses, and book chapters known to the authors. In addition, the recommendations from accompanying papers in this supplement have been distilled and captured in the form of summary boxes. The findings, in conjunction with the clinical experience of international researchers and clinicians who are practiced in treating mood disorders, formed the basis of the treatment recommendations within this paper.

Results:  Balancing clinical experience with evidence informed and lead to the development of practical clinical recommendations that emphasise the importance of safety and tolerability alongside efficacy in the clinical management of bipolar disorder.

Conclusions:  The current paper summarises the treatment recommendations relating to each phase of bipolar disorder while providing additional, evidence-based, practical insights. Medication-related side effects and monitoring strategies highlight the importance of safety and tolerability considerations, which, along with efficacy information, should be given equal merit.

Can a targeted psychological intervention be effective for young people following a first manic episode? Results from an 18-month pilot study

Aim: There is a scarce literature describing psychological interventions for a young, first-episode cohort who have experienced psychotic mania. This study aimed to assess whether a manualized psychological intervention could be effective in reducing symptomatology and relapse, and improve functional outcome in this population.

Methods: The study was an open-label design, drawn from a larger pharmacotherapy trial. All participants in the pharmacotherapy trial were offered a manualized psychological intervention in addition to case management. Inclusion in the psychotherapy group was based on participant's choice, and on completion of four or more of the eight modules offered. All clinical files were audited to ensure accuracy of group allocation. Forty young people aged 15 to 25 years old who had experienced a manic episode with psychotic features were recruited into the study, with 20 people in the combined treatment as usual plus psychotherapy group (P+TAU), and an equal number of matched control participants who received treatment as usual (TAU) within the same service. All participants were prescribed antipsychotic and mood-stabilizing medication. Symptomatic, functional and relapse measures were taken both at baseline and at 18-month follow-up.

Results: Manic symptoms improved significantly for both groups, with no differences between groups. Depression scores and overall symptom severity were significantly lower in the P + TAU group. No differences were evident between groups with regard to numbers or type of relapse. The P + TAU group had significantly better social and occupational functioning after 18 months.

Conclusion: This study suggests that a manualized psychological intervention targeted to a first-episode population can be effective in reducing depression and overall symptom severity, and can improve functional outcome following a first episode of psychotic mania.

Clinical outcomes associated with screening and referral for depression in an acute cardiac ward

Aim.  The aim of this paper is to describe the implementation of a depression screening and referral tool in two cardiac wards of a major metropolitan public hospital. The tool consisted of two sections: (1) screening for depression risk (Cardiac Depression Scale-5) and (2) consequential referral actions.

Background.  Prior research has shown that depression in patients with heart disease is associated with significantly impaired quality of life, decreased medication adherence, increased morbidity and increased use of healthcare services.

Design.  A prospective in-patient study design.

Method.  A consecutive sample of 202 patients admitted to either the cardiac medical (n = 145) or surgical (n = 57) wards of a major Melbourne metropolitan hospital were recruited into the study over an 18-week period.

Results.  Just over half (54%) of the patients were identified as ‘at risk’ of depression. Of these, 19% were assessed as moderate risk and 35% high risk. Of those patients, 91% had the risk score documented in their medical history, 90% had engaged in discussions with clinicians regarding their risk score, 85% had their risk score communicated formally to the medical team and 25% were formally referred for appropriate follow-up – significantly more than prior to implementation of the screening and referral tool.

Conclusions.  By providing a formalised mechanism for detecting depression, documented screening and referral rates improved for those with comorbid depression and heart disease affording an opportunity for early intervention. These findings support a move towards integrated approaches to screening of depression to become standard practice in the acute cardiac setting.

Relevance to clinical practice.  Such mechanisms also have the potential to initiate the development of new models of care that acknowledge the complexity of comorbid depression and heart disease and provide pathways from speciality to primary care which integrate the physical and psychosocial domains inclusive of screening, referral, systematic monitoring and streamlined behavioural and physical care.

Social support and clinical depression in China

Introduction It has been recognised for many years that in Western contexts social support is associated with depression. However, relatively few studies have investigated this association in non-Western countries, and few, if any, in a clinical population. The present study aimed to establish how the perceived quality of social support provided by their spouse, their family and their friends to people in China who have a clinical diagnosis of depression is associated with aspects of their illness.

Methods The sample comprised 50 males and 50 females ranging in age from 19 to 62 years. All participants had a clinical diagnosis of depression. They completed the Beck Depression Inventory and a scale assessing perceived social support.

Results Contrary to predictions and previous research findings, no significant association was found between perceived quality of social support and level of depression, length of depression, and number of episodes of depression.

Discussion A variety of cultural factors may be associated with the quality of social support provided to patients with depression. Further research is required to investigate if these findings generalise across other non-Western populations, and also, to explore other factors that may influence the onset and continuation of depression among people in China.

Preparing interprofessional clinical learning sites : what the literature tells us

Purpose: Infusing an interprofessional perspective into healthcare education in the university setting instils a collaborative approach in the provision of patient-centred care concepts for students. The purpose of this paper is to describe how one Australian health science faculty is modernising their healthcare education curriculum to develop this approach.

Method: As part of the development process, a systematic literature review was undertaken to determine the elements required for the development of interprofessional clinical learning (IPCL) sites, including but not limited to, necessary organisational and professional considerations to effect interprofessional education (IPE).

Results: The results of this review identified four key factors for IPE development: 1) shared culture, 2) support and leadership, 3) strategic facilitation and planning, and 4) effective feedback, evaluation and dissemination of curriculum intent.

Discussion: These elements are discussed in association with curriculum change in this faculty to promote interprofessional collaboration and teaching.

Conclusion: As a result of the review, the modernisation of our IPE curriculum is being underpinned by shared understandings between faculty and clinical site health providers about IPE. Our joint goal is for appropriate preparation and sustainability of IPCL sites.

Clinical performance of an innovative back surface multifocal contact lens in correcting presbyopia

Purpose: This prospective study was designed to subjectively and objectively evaluate the performance of an aspheric multifocal back surface rigid gas permeable (RGP) contact lens. The multifocal element of this lens design consisted of an aspheric optical zone that varied according to the patient's ametropia, corneal topography, and required reading addition.

Methods: We fit 28 presbyopic subjects with an aspheric multifocal back surface RGP contact lens (age range: 45 to 68 years). Reading additions ranged from +0.75 D to +2.50 D. Subjects were assessed initially and at 2, 6, and 12 weeks for ocular changes, visual performance, and subjective responses.

Results: We required 116 RGP lenses to achieve an acceptable fit and visual acuity in 28 subjects (55 eyes). At the final visit, the distance logMAR acuity with the multifocal contact lens (+0.12 +/-0.10) was not statistically different (t=-0.623, P= 0.5388) from spectacle acuity at the initial visit (+0.10 +/-0.12). The near logMAR acuity with the multifocal contact lens at the final visit (0.36 +/- 0.12) was not statistically different from that for near acuity with spectacles at the initial visit (0.33 +/- 0.13). No slit lamp signs worsened during the study. A reduction in myopia of 0.67 D was noted by the final visit. Spectacle blur was noted if the acuity at the initial refraction was compared to the acuity with the same refraction at the final visit (t= -3.287, P= 0.0028) but not when the refractive changes were incorporated (t= 1.058, P= 0.3127). All subjects rated the performance of the lenses very highly: comfort, 86%; distance acuity, 83%; near acuity, 73%; and stability of vision, 74%. Twenty-four subjects (86%) chose the multifocal contact lens as their preference.

Conclusion: We demonstrated that a multifocal design is able to provide acceptable distance and near correction for presbyopic patients. The aspheric geometry required can be optimized for a given patient by considering his/her degree of ametropia, as well as the corneal topography.

Amyloid formation results in recurrence of hyperglycaemia following transplantation of human IAPP transgenic mouse islets

Aims/hypothesis Islet transplantation is a potential cure for diabetes; however, rates of graft failure remain high. The aim of the present study was to determine whether amyloid deposition is associated with reduced beta cell volume in islet grafts and the recurrence of hyperglycaemia following islet transplantation.

Methods We transplanted a streptozotocin-induced mouse model of diabetes with 100 islets from human IAPP (which encodes islet amyloid polypeptide) transgenic mice that have the propensity to form islet amyloid (n = 8–12) or from non-transgenic mice that do not develop amyloid (n = 6–10) in sets of studies that lasted 1 or 6 weeks.

Results Plasma glucose levels before and for 1 week after transplantation were similar in mice that received transgenic or non-transgenic islets, and at that time amyloid was detected in all transgenic grafts and, as expected, in none of the non-transgenic grafts. However, over the 6 weeks following transplantation, plasma glucose levels increased in transgenic but remained stable in non-transgenic islet graft recipients (p < 0.05). At 6 weeks, amyloid was present in 92% of the transgenic grafts and in none of the non-transgenic grafts. Beta cell volume was reduced by 30% (p < 0.05), beta cell apoptosis was twofold higher (p < 0.05), and beta cell replication was reduced by 50% (p < 0.001) in transgenic vs non-transgenic grafts. In summary, amyloid deposition in islet grafts occurs prior to the recurrence of hyperglycaemia and its accumulation over time is associated with beta cell loss.

Conclusions/interpretation Islet amyloid formation may explain, in part, the non-immune loss of beta cells and recurrence of hyperglycaemia following clinical islet transplantation.

Clinical evaluation of long-term users of two contact lens care preservative systems

Purpose: To clinically evaluate long-term users of two different contact lens care preservative systems and to investigate whether prolonged use is associated with an increase in the prevalence of dry eye.

Methods: Eighty-nine wearers of group IV hydrogel or silicone hydrogel lenses participated in this one-visit, investigator-masked study. Subjects were required to have consistently used a polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) based solution for 2 years. Consistent use was defined as 80% for the past 2 years and 100% for the past year. Clinical assessments included: average and comfortable wear time; overall and end-of-day comfort; signs of dryness, discomfort, burning or stinging, grittiness or scratchiness and visual changes; non-invasive and fluorescein break-up-time; pre-ocular tear film lipids, tear meniscus height, Schirmer and fluorescein clearance tests; limbal and bulbar hyperemia; palpebral roughness; corneal and conjunctival staining; lens front surface wetting; and lens film deposits.

Results: Significantly more grittiness or scratchiness was reported by subjects using a PHMB-containing system (67% vs. 44%; P = 0.02). Palpebral roughness and hyperemia were significantly greater in the PHMB group wearing group IV lenses (P = 0.01 and P = 0.05, respectively). Corneal staining was significantly higher in the PHMB users in all four peripheral sectors (P < 0.01). Nasal and temporal conjunctival staining was also significantly higher for users of PHMB-containing systems (P < 0.05). Front surface lens wettability was significantly better for group IV PQT users compared to PHMB users (P = 0.008), with 84% vs. 72%, respectively, with lenses graded by the investigator as having good or excellent wettability. Significantly higher levels of lens front surface film deposits were noted with PHMB users (P = 0.007), with 58% of group IV lenses treated with PHMB compared with 38% of group IV lenses treated with PQT showing some lens front surface film deposition. No significant differences between the two preservative system groups were noted for the range of dry eye evaluations nor the remaining clinical assessments.

Conclusions: Differences in both ocular and lens characteristic were observed between long-term users of two preservative systems used in many contact lens multi-purpose solutions. The findings from this study did not support the hypothesis that prolonged use of PHMB-containing solutions leads to dry eye. Additional studies including a larger sample size and perhaps longer use of the systems could help to further elucidate differences in clinical performance between systems.