The United Kingdom Glaucoma Treatment Study:a multicenter, randomized, placebo-controlled clinical trial: design and methodology

Elevated intraocular pressure (IOP) is a major risk factor for the deterioration of open-angle glaucoma (OAG); medical IOP reduction is the standard treatment, yet no randomized placebo-controlled study of medical IOP reduction has been undertaken previously. The United Kingdom Glaucoma Treatment Study (UKGTS) tests the hypothesis that treatment with a topical prostaglandin analog, compared with placebo, reduces the frequency of visual field (VF) deterioration events in OAG patients by 50% over a 2-year period.

A Novel Dried Blood Spot-LCMS Method for the Quantification of Methotrexate Polyglutamates as a Potential Marker for Methotrexate Use in Children

Objective: Development and validation of a selective and sensitive LCMS method for the determination of methotrexate polyglutamates in dried blood spots (DBS).

Methods: DBS samples [spiked or patient samples] were prepared by applying blood to Guthrie cards which was then dried at room temperature. The method utilised 6-mm disks punched from the DBS samples (equivalent to approximately 12 μl of whole blood). The simple treatment procedure was based on protein precipitation using perchloric acid followed by solid phase extraction using MAX cartridges. The extracted sample was chromatographed using a reversed phase system involving an Atlantis T3-C18 column (3 μm, 2.1x150 mm) preceded by Atlantis guard column of matching chemistry. Analytes were subjected to LCMS analysis using positive electrospray ionization.

Key Results: The method was linear over the range 5-400 nmol/L. The limits of detection and quantification were 1.6 and 5 nmol/L for individual polyglutamates and 1.5 and 4.5 nmol/L for total polyglutamates, respectively. The method has been applied successfully to the determination of DBS finger-prick samples from 47 paediatric patients and results confirmed with concentrations measured in matched RBC samples using conventional HPLC-UV technique.

Conclusions and Clinical Relevance: The methodology has a potential for application in a range of clinical studies (e.g. pharmacokinetic evaluations or medication adherence assessment) since it is minimally invasive and easy to perform, potentially allowing parents to take blood samples at home. The feasibility of using DBS sampling can be of major value for future clinical trials or clinical care in paediatric rheumatology. © 2014 Hawwa et al.

Interventions to improve the appropriate use of polypharmacy in older people: a Cochrane systematic review

Objective: To summarise the findings of an updated Cochrane review of interventions aimed at improving the appropriate use of polypharmacy in older people. Design: Cochrane systematic review. Multiple electronic databases were searched including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (from inception to November 2013). Hand searching of references was also performed. Randomised controlled trials (RCTs), controlled clinical trials, controlled before-and-after studies and interrupted time series analyses reporting on interventions targeting appropriate polypharmacy in older people in any healthcare setting were included if they used a validated measure of prescribing appropriateness. Evidence quality was assessed using the Cochrane risk of bias tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation).
Setting: All healthcare settings. 
Participants: Older people (≥65 years) with ≥1 long-term condition who were receiving polypharmacy (≥4 regular medicines).
Primary and secondary outcome measures: Primary outcomes were the change in prevalence of appropriate polypharmacy and hospital admissions. Medication-related problems (eg, adverse drug reactions), medication adherence and quality of life were included as secondary outcomes.
Results: 12 studies were included: 8 RCTs, 2 cluster RCTs and 2 controlled before-and-after studies. 1 study involved computerised decision support and 11 comprised pharmaceutical care approaches across various settings. Appropriateness was measured using validated tools, including the Medication Appropriateness Index, Beers’ criteria and Screening Tool of Older Person’s Prescriptions (STOPP)/ Screening Tool to Alert doctors to Right Treatment (START). The interventions demonstrated a reduction in inappropriate prescribing. Evidence of effect on hospital admissions and medication-related problems was conflicting. No differences in health-related quality of life were reported.
Conclusions: The included interventions demonstrated improvements in appropriate polypharmacy based on reductions in inappropriate prescribing. However, it remains unclear if interventions resulted in clinically significant improvements (eg, in terms of hospital admissions). Future intervention studies would benefit from available guidance on intervention development, evaluation and reporting to facilitate replication in clinical practice.

Cuidar da pessoa com esquizofrenia em processo de reabilitação psicossocial

Este ensino clínico permitiu-nos prestar cuidados de enfermagem especializados a 16 homens com esquizofrenia em processo de reabilitação psicossocial. Na sua maioria são: adultos, solteiros, da região sul de Portugal, com uma média de 9 anos de escolaridade, com história de consumo de substâncias (álcool, tabaco, haxixe, cocaína, heroína e anfetaminas), institucionalizados na Casa de Saúde do Telhal (CST) há mais de 11 anos. Todos apresentam diagnósticos de enfermagem das várias dimensões do adoecer, com exceção da dimensão comportamental excitatória, sendo os de maior prevalência: “Conhecimento sobre Processo de doença/Cuidados na doença/Tratamento, Não Demonstrado”; Cognição, Comprometida”; “Processo Social, Alterado”; “Autoestima, Diminuída”. Foram desenvolvidos 4 programas de intervenção: consulta de enfermagem de saúde mental e psiquiatria (CESMP); atelier de estimulação cognitiva (AEC); programa de desenvolvimento de competência intrapessoais, interpessoais e profissionais (PDCIIP); programa de psicoeducação (SABER+). A satisfação global com os programas foi superior a 7 (numa escala de 1 a 10) e os resultados que foram percebidos pela maioria dos reabilitandos situaram-se acima das suas expectativas iniciais. De uma forma geral, todos registaram ganhos: no desempenho cognitivo (em particular os que beneficiaram do AEC); na adaptação psicossocial – nomeadamente ao nível do insight; os reabilitandos que beneficiaram do programa SABER+ melhoraram ainda os comportamentos demonstrados de aceitação do estado de saúde; no bem-estar psicológico – nomeadamente ao nível da autoestima (sobretudo os que beneficiaram da CESMP e/ou do PDCIIP), dos afetos positivos e dos comportamentos de motivação; nos vários domínios da qualidade de vida (QdV) medidos pelo WHOQOL-Bref em particular o domínio ambiental; todos elevaram o seu nível de conhecimentos nos 3 eixos em que que se estruturou o programa de psicoeducação (processo da doença, cuidados na doença, tratamento da doença); na adesão à medicação, sobretudo os que integraram o programa de psicoeducação, contudo todos tendem a necessitar de ajuda parcial para conseguir demonstrar conhecimento no cumprimento do esquema terapêutico e estão envolvidos em treinos supervisionados de preparação e autoadministração; ABSTRACT: This clinical training allowed us to provide skilled nursing care to 16 men with schizophrenia in a psychosocial rehabilitation setting. Most of these individuals are: adults, singles, from the southern region of Portugal, with an average of 9 years of schooling, with a history of substance abuse (alcohol, tobacco, cannabis, cocaine, heroin and amphetamines), institutionalized in Casa de Saúde do Telhal (CST) for over 11 years. We find nursing diagnoses from all of the disease dimensions with the exception of excitatory behavioral dimension, being the most prevalent: "knowledge about disease process / care / treatment, not stated"; cognition, impaired", "social process, impaired”, “self-esteem, decreased". We developed 4 intervention programs: psychiatry and mental health nursing consultation (CESMP); atelier of cognitive stimulation (AEC); intrapersonal, interpersonal and professional competences training (PDCIIP); psychoeducation (SABER+). The overall satisfaction with the programs was above 7 (on a scale of 1 to 10) and the results noticed by most patients were above their initial expectations. All registered nursing results were: in cognitive performance (particularly those who benefited from the AEC); in psychosocial adaptation - especially in terms of insight; patients who benefited from the SABER+ program demonstrated improved further acceptance of their health condition, psychological well-being, particularly in terms of self-esteem (especially those who benefited from the CESMP and/or the PDCIIP), positive affects and motivation; in the different domains of quality of life (QoL) measured by WHOQOL-Bref in particular the environmental domain; every patients raised their level of knowledge in the 3 axes in which the psychoeducational program (SABER+) was structured (disease process, care and treatment); in medication adherence, especially those who benefited of the psychoeducational program, however all the patients tend to need partial help to demonstrate knowledge in meeting the therapeutic regimen and are involved in supervised training programs for preparation and self administration.

L’assurance médicaments et son impact sur l’adhésion des patients à leurs médicaments

L’assurance médicaments est un des facteurs qui peuvent influencer l’adhésion aux médicaments. Les objectifs de ce mémoire étaient d’évaluer l’impact du type d’assurance médicaments (publique versus privée) sur l’adhésion et le coût des antihypertenseurs et d’évaluer l’impact des procédures de remboursement et de la contribution du patient sur l’adhésion aux médicaments prescrits pour traiter une maladie chronique. Afin de répondre à ces objectifs, deux cohortes rétrospectives ont été construites à partir des bases de données de la RAMQ et reMed : une cohorte appariée d’utilisateurs d’antihypertenseurs couverts par une assurance médicaments privée ou publique et une cohorte de patients couverts par une assurance médicaments privée ayant rempli au moins une ordonnance pour un médicament traitant une maladie chronique. Les résultats montrent que le niveau d’adhésion aux antihypertenseurs était similaire entre les deux types d’assurance médicaments et que le coût des antihypertenseurs était 28,9 % plus élevé au privé. De plus, il a été observé que les procédures de remboursement n’affectaient pas l’adhésion, alors que le niveau de contribution des patients l’affectait. Les patients qui déboursaient un plus grand montant à l’achat de leurs médicaments étaient moins adhérents (différence : -19,0 %, Intervalle de confiance [IC] à 95 % : -24,0 à -13,0), alors que les patients qui n’avaient rien à débourser étaient moins adhérents (différence : -9,0 %, IC à 95 % : -15,0 à -2,0), que ceux qui devaient débourser une petite somme. Les résultats présentés dans ce mémoire montrent que l’assurance médicaments influence l’adhésion par l’entremise des caractéristiques des plans d’assurance.

Prevalencia y factores asociados a la no adherencia en el tratamiento farmacológico de mantenimiento en adultos con trastorno afectivo bipolar

La prevalencia de no adherencia en el tratamiento de mantenimiento en el Trastorno Afectivo Bipolar esta en los rangos de 20% y un 60%, interviniendo diversos factores relacionados con el paciente, la enfermedad, el tratamiento, y la relación con el terapeuta, asociándose a una mayor morbilidad, mortalidad y riesgo de reingresos hospitalarios. Objetivos: Determinar la prevalencia y factores asociados a la no adherencia en tratamiento de mantenimiento de pacientes adultos con diagnóstico de trastorno afectivo bipolar. Métodos: Estudio de corte transversal incluyo 124 paciente que asistieron a consulta los meses de noviembre y diciembre , se aplicó cuestionario estructurado, que contenía las variables de factores asociados, demográficos, relacionadas con el paciente, con la enfermedad, el tratamiento, relación terapéutica y el sistema de salud, relacionados con la familia; la Escala de Impresión Global Para el Trastorno Bipolar Modificado (CGI – BPM -M) y apgar familiar Resultados: La prevalencia de no adherencia al tratamiento farmacológico de mantenimiento fue del 29.8%. Siendo esta mayor para las mujeres (64.9%) que para los hombres (35.1%), aunque esta diferencia no fue estadísticamente significativa (p= 0.17). Los factores asociados que estadísticamente significativos fueron mayor gravedad de la enfermedad OR 1.9 , antecedente de no adherencia (38% P=0.001), percepción negativa del terapeuta, menor insight( 87% RP4.65), mayor estigma(50% RP 6.2), no tener familiar que le recuerde toma del medicamento(73%). Conclusiones: La prevalencia estuvo en el rango de otros estudios realizados por Scott, Vieta et al, los factores asociados como estigma, antecedente de no adherencia, no tener apoyo familiar, un insight pobre y el habito de fumar ,pueden ser identificados desde el abordaje del paciente y modificados para mejorar la adherencia terapéutica

La experiencia de los receptores en el trasplante de órganos y tejidos

El trasplante de órganos y/o tejidos es considerado como una opción terapéutica viable para el tratamiento tanto de enfermedades crónicas o en estadios terminales, como de afectaciones no vitales, pero que generen una disminución en la calidad de vida percibida por el paciente. Este procedimiento, de carácter multidimensional, está compuesto por 3 actores principales: el donante, el órgano/tejido, y el receptor. Si bien un porcentaje significativo de investigaciones y planes de intervención han girado en torno a la dimensión biológica del trasplante, y a la promoción de la donación; el interés por la experiencia psicosocial y la calidad de vida de los receptores en este proceso ha aumentado durante la última década. En relación con esto, la presente monografía se plantea como objetivo general la exploración de la experiencia y los significados construidos por los pacientes trasplantados, a través de una revisión sistemática de la literatura sobre esta temática. Para ello, se plantearon unos objetivos específicos derivados del general, se seleccionaron términos o palabras claves por cada uno de estos, y se realizó una búsqueda en 5 bases de datos para revistas indexadas: Ebsco Host (Academic Search; y Psychology and Behavioral Sciences Collection); Proquest; Pubmed; y Science Direct. A partir de los resultados, se establece que si bien la vivencia de los receptores ha comenzado a ser investigada, aún es necesaria una mayor exploración sobre la experiencia de estos pacientes; exploración que carecería de objetivo si no se hiciera a través de las narrativas o testimonios de los mismos receptores

Recovering from an acute cardiac event – the relationship between depression and life satisfaction

Aims. This study sought to measure the rates and trajectory of depression over six months following admission for an acute cardiac event and describe the relationship between depression and life satisfaction.
Background. Co-morbid depression has an impact on cardiac mortality and is associated with the significant impairment of quality of life and well-being, impairments in psychosocial function, decreased medication adherence and increased morbidity.
Design. This was a descriptive, correlational study.
Method. The study was undertaken at a large public hospital in Melbourne. Participants were asked to complete a survey containing the cardiac depression scale (CDS) and the Personal Well-being Index.
Results. This study mapped the course of depression over six months of a cohort of patients admitted for an acute cardiac event. Significant levels of depressive symptoms were found, at a level consistent with the literature. A significant correlation between depressive symptoms as measured by the CDS and the Personal Well-being Index was found.
Conclusions. Depression remains a significant problem following admission for an acute coronary event. The Personal Wellbeing Index may be a simple, effective and non-confrontational initial screening tool for those at risk of depressive symptoms in this population. Relevance to clinical practice. Despite the known impact of depression on coronary heart disease (CHD), there is limited research describing its trajectory. This study makes a compelling case for the systematic screening for depression in patients with CHD and the importance of the nursing role in identifying at risk individuals.

Dialysis residential care : a future dialysis service model

People with chronic kidney disease are ageing and have increasing co-morbidities. The current delivery of renal replacement therapy, dialysis and transplantation, needs to adjust to changing patient needs. This paper proposes a potential future service delivery model featuring a dialysis residential care facility and a care coordination focus. The residential care facility would be composed of four levels of care; high, hostel, independent and outpatient. The paper argues that this model may result in decreased morbidity, improved patient quality of life and may prove cost effective. Patients' nutritional status, medication adherence and transport efficiency may be improved. We propose this model to stimulate further debate in order to meet the needs of current and future chronic kidney disease patients.

Olanzapine / fluoxetine combination for treatment resistant depression : efficacy and clinical utility

Antidepressant monotherapy is a first-line treatment for depression; however, not all sufferers will adequately respond to treatment. When treating a patient with treatment-resistant depression, the clinician needs to consider all factors which may contribute to an inadequate response to an antidepressant. These include accuracy of diagnosis and medication adherence, as well as the patient’s personality, lifestyle, life events and social circumstances. If it is determined that treatment resistance is due to failure of efficacy of antidepressant monotherapy, then an augmentation strategy using an atypical antipsychotic may be considered. Treatment using olanzapine/fluoxetine combination (OFC) is one of many options. Four randomized, acute-phase trials have suggested OFC is useful for reducing Montgomery–Åsberg Depression Rating Scale scores after inadequate response to antidepressant monotherapy. OFC has been useful at doses of olanzapine/fluoxetine 6/25, 6/50, 12/25 and 12/50 mg/day, with 1/5 mg/day suggested to be an ineffective dose. Treatment with OFC has been associated with some side effects, including weight gain and the metabolic syndrome, somnolence, dry mouth, increased appetite and headache. Treatment decisions therefore need to be made to balance the risks and benefits.

Health beliefs - what role do they play in outcomes research?

Lay beliefs about health and illness are individual and social, influenced by prevailing social and medical ideologies. Health beliefs clearly influence self-care motivation and have an effect on health-promoting behaviour (e.g. attendance at a screening program, food choices, adherence to prescribed medication). Further, the beliefs and attributions that people hold can directly affect physiological systems (e.g. the immune system). Health beliefs have been shown to influence a variety of patient-reported outcomes, including medication adherence, satisfaction and health-related quality of life. It is widely acknowledged that when the patient's beliefs are acknowledged and incorporated, rather than ignored, optimal biomedical patient-reported outcomes are more likely to be achieved. Several psychological models have been developed to predict health behaviours and may be utilised to identify the beliefs that inform such behaviours. These models consider the social milieu, personality, demographic, political and economic predictors of health beliefs. They demonstrate the impact of beliefs such as the causes of illness, effectiveness of healthcare and acceptability of health services, and how manipulating these can result in actual or intended behaviour change. This workshop will introduce health beliefs and discuss the psychological models that underpin the translation of belief into behaviour. The session is interactive, with participants defining health beliefs and their impact on behaviour. Participants will be invited to critique the models and apply their chosen model to a health indication of their choice.

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.

A randomised, feasibility trial of a tele-health intervention for acute coronary syndrome patients with depression (‘MoodCare’): study protocol

Background Coronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare) for depression and CHD secondary prevention, with Usual Care (UC).

Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group). The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake), medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1), 6 months (post-intervention) (Time 2), 12 months (Time 3) and 24 months follow-up for longer term effects (Time 4). We are comparing depression (Cardiac Depression Scale [CDS]) and HRQOL (Short Form-12 [SF-12]) scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government.

Discussion This manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression.

Exploring motivation and confidence in taking prescribed medicines in coexisting diseases: a qualitative study

Aims and objectives: To explore the motivation and confidence of people with coexisting diabetes, chronic kidney disease (CKD) and hypertension to take their medicines as prescribed. Background: These comorbidities are major contributors to disease burden globally. Self-management of individuals with these coexisting diseases is much more complicated than that of those with single diseases and is critical for improved health outcomes. Design: Motivational interviewing telephone calls were made with participants with coexisting diabetes, CKD and hypertension. Methods: Patients aged ≥18 years with diabetes, CKD and systolic hypertension were recruited from outpatient clinics of an Australian metropolitan hospital between 2008-2009. An average of four motivational interviewing telephone calls was made with participants (n = 39) in the intervention arm of a randomised controlled trial. Data were thematically analysed using the modified Health Belief Model as a framework. Results: Participants' motivation and confidence in taking prescribed medicines was thwarted by complex medicine regimens and medical conditions. Participants wanted control over their health and developed various strategies to confront threats to health. The perceived barriers of taking recommended health action outweighed the benefits of taking medicines as prescribed and were primarily related to copious amounts of medicines. Conclusion: Taking multiple prescribed medicines in coexisting diabetes, CKD and hypertension is a perpetual vocation with major psychosocial effects. Participants were overwhelmed by the number of medicines that they were required to take. The quest for personal control of health, fear of the future and the role of stress and gender in chronic disease management have been highlighted. Participants require supportive emotional interventions to self-manage their multiple medicines on a daily basis. Relevance to clinical practice: Reducing the complexity of medicine regimens in coexisting diseases is paramount. Individualised psychosocial approaches that address the emotional needs of patients with regular follow-up and feedback are necessary for optimal chronic disease self-management. © 2013 John Wiley & Sons Ltd.

A collaborative approach to the treatment alliance in bipolar disorder.

The treatment alliance is the arena in which psychopharmacological and other therapeutic interventions occur. The nature and quality of the treatment alliance may affect adherence to treatment and the realization of the benefits of effective pharmacological treatment in clinical practice. It is an area that has attracted little systematic study, despite the available evidence suggesting that it plays a measurable role in clinical outcomes.