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INTRODUCTION: With the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments' efficacy and toxicity is drawing more attention. Mobile phone interventions may be a practical solution to support patients taking OAMs at home, yet evidence to inform the efficacy of these interventions is lacking. The safety and adherence to medications and self-care advice in oncology (SAMSON) pilot randomised control trial (RCT) aims to evaluate the acceptability, feasibility and potential efficacy of a novel digital solution to improve medication adherence (MA) among people with cancer. METHODS AND ANALYSIS: This is a two-arm, 12-week, pilot RCT aiming to enrol 50 adults with haematological, lung or melanoma cancers at an Australian metropolitan specialised oncology hospital, who are taking oral anti-cancer medicines. Participants will be randomised (1:1 allocation ratio) to either the intervention group (SAMSON solution) or the control group (usual care). The primary outcomes are the acceptability and feasibility of SAMSON. The secondary outcomes are MA, toxicity self-management, anxiety and depressive symptoms, health-related quality of life, and parameters relating to optimal intervention strategy. Quantitative data will be analysed on a modified intention-to-treat basis. SUMMARY: While multicomponent interventions are increasingly introduced, SAMSON incorporates novel approaches to the solution. SAMSON provides a comprehensive, patient-centred, digital MA intervention solution with seamless integration of a mobile platform with clinical consultations that are evidence-based, theory-based, co-designed and rigorously tested. The pilot trial will determine whether this type of intervention is feasible and acceptable in oncology and will provide a foundation for a future full-scale RCT. ETHICS AND DISSEMINATION: Primary ethics approvals were received from Peter MacCallum Cancer Centre and Swinburne University of Technology Human Research Ethics Committees (HREC/95332/PMCC and 20237273-15836). Results will be disseminated via peer-reviewed publications and presentations at international and national conferences. TRIAL REGISTRATION NUMBER: The protocol has been prospectively registered on the Australian New Zealand Clinical Trials Registry with trial registration number (ACTRN12623000472673).
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Antineoplásicos , Cumplimiento de la Medicación , Neoplasias , Autocuidado , Humanos , Proyectos Piloto , Autocuidado/métodos , Neoplasias/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Antineoplásicos/efectos adversos , Australia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Telemedicina , Teléfono CelularAsunto(s)
Dolor en Cáncer/tratamiento farmacológico , Dolor Crónico/tratamiento farmacológico , Ketamina/administración & dosificación , Ketamina/economía , Ketamina/uso terapéutico , Cuidados Paliativos/economía , Administración Cutánea , Adulto , Anciano , Australia , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Efecto Placebo , Distribución Aleatoria , Aguas Salinas/administración & dosificación , Aguas Salinas/uso terapéuticoRESUMEN
BACKGROUND: Providing care at end of life has consequences for caregivers' bereavement experience. 'Difficulty moving on with life' is an informative and unbiased symptom of prolonged grief disorder. Predictors of bereaved caregivers' ability to 'move on' have not been examined across the population. AIM: To identify the characteristics of bereaved hands-on caregivers who were, and were not, able to 'move on' 13-60 months after the 'expected' death of someone close. DESIGN: The South Australian Health Omnibus is an annual, random, cross-sectional community survey. From 2000 to 2007, respondents were asked about providing care for someone terminally ill and their subsequent ability to 'move on'. Multivariable logistic regression models explored the characteristics moving on and not moving on. SETTING: Respondents were aged ⩾15 years and lived in households within South Australia. They had provided care to someone who had died of terminal illness in the preceding 5 years. RESULTS: A total of 922 people provided hands-on care. In all, 80% of caregivers (745) had been able to 'move on'. Closeness of relationship to the deceased, increasing caregiver age, caregiver report of needs met, increasing time since loss, sex and English-speaking background were significantly associated with 'moving on'. A closer relationship to the deceased, socioeconomic disadvantage and being male were significantly associated with not 'moving on'. CONCLUSION: These results support the relevance of 'moving on' as an indicator of caregivers' bereavement adjustment. Following the outcomes of bereaved caregivers longitudinally is essential if effective interventions are to be developed to minimise the risk of prolonged grief disorder.
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Adaptación Psicológica , Actitud Frente a la Muerte , Aflicción , Cuidadores/psicología , Cuidadores/estadística & datos numéricos , Pesar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Australia del Sur , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND/OBJECTIVES: Patients with psoriasis experience higher rates of depression, anxiety and suicidal ideation than the general population. With effective treatment, there is evidence that with the initial decrease in the psoriasis area and severity index (PASI) score, patients' quality of life (QoL), measured by the dermatology life quality index (DLQI) improves. However, to date, there have been no studies demonstrating that patients' QoL remains improved. We investigated the association between the DLQI and PASI of patients with psoriasis on biologic agents for an extended period of time of up to 6.5 years. METHODS: The data for this longitudinal, retrospective study was collected from a large tertiary teaching hospital in South Australia. Data was collected from all patients with psoriasis who had been on biologic agents for 2 or more years (n = 54). RESULTS: PASI and DLQI were highly correlated over all time points (ρ = 0.50), P < 0.001. DLQI scores significantly decreased by 0.8 (95% CI: 0.30, 1.26) units per year from 12 months to 6.5 years, P = 0.002. After 12 months, PASI scores declined by 0.19 (95% CI: 0.13, 0.52) units per year, P = 0.24. CONCLUSION: This study demonstrates that DLQI and PASI remain low after 12 months, and, in fact, both gradually decline further with time. Patients on biologic agents for prolonged periods maintained their improvement in QoL for up to 6.5 years.
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Productos Biológicos/uso terapéutico , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Calidad de Vida , Índice de Severidad de la Enfermedad , Adulto , Australia , Productos Biológicos/farmacología , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Psoriasis/psicología , Estudios Retrospectivos , Medición de Riesgo , Perfil de Impacto de Enfermedad , Centros de Atención Terciaria , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND/OBJECTIVES: With the increase in rates of methicillin-resistant Staphylococcus aureus (MRSA) skin infections in the general population, there may be a similar increase of such infections in patients with atopic dermatitis (AD). There are few studies on MRSA prevalence in the AD population, and no previous studies in Australia. This study investigated the prevalence of MRSA and other organisms in the paediatric AD population over the previous 15 years. METHODS: Skin swab results and other significant data, including patients' characteristics and comorbidities, were collected on patients with AD aged 0-18 years, admitted to a large teaching hospital in South Australia from 1999 to 2014 (N = 298). This longitudinal, retrospective study investigated, using logistic regression, the change of prevalence of MRSA, methicillin-sensitive S. aureus (MSSA) and Streptococcus spp. in AD over the past 15 years. RESULTS: Compared with 1999-2002, in 2003-2006 patients were approximately threefold more likely (P = 0.350), in 2007-2010 they were approximately 13-fold more likely (P = 0.030) and in 2011-2014 they were approximately 24-fold more likely to test positive for MRSA (P = 0.008), despite low absolute MRSA numbers. There was a positive association between the number of previous hospital admissions per patient and MRSA (OR = 1.16 [1.08-1.25], P = 0.000). In contrast, there was no change in the prevalence of MSSA or Streptococcus spp. over time. CONCLUSION: The prevalence of MRSA in children with AD is clearly on the rise. This has negative consequences for individuals with AD and is also a major public health problem.
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Dermatitis Atópica/epidemiología , Staphylococcus aureus Resistente a Meticilina/aislamiento & purificación , Infecciones Cutáneas Estafilocócicas/epidemiología , Infecciones Estreptocócicas/epidemiología , Streptococcus/aislamiento & purificación , Adolescente , Niño , Preescolar , Comorbilidad , Femenino , Hospitalización , Humanos , Lactante , Estudios Longitudinales , Masculino , Prevalencia , Estudios Retrospectivos , Piel/microbiología , Australia del Sur/epidemiología , Infecciones Cutáneas Estafilocócicas/microbiología , Infecciones Estreptocócicas/microbiologíaRESUMEN
BACKGROUND: Assessing risk and weighing the potential benefits from evidence-based therapies are essential in the clinical decision making process of optimizing care and outcomes for patients presenting with acute coronary syndromes (ACS). Such practices are advocated in international clinical guidelines of ACS care. While the GRACE risk score (GRS) is a guideline advocated, well-validated risk stratification tool, its utility in improving care and outcomes remains unproven, and its application has been limited in routine clinical practice. OBJECTIVE: This study will assess the effectiveness using the GRS tool and treatment recommendations during patient assessment on improving the application of guideline-recommended therapies in ACS care. DESIGN: This study employs a PROBE (prospective cluster [hospital-level] randomized open-label, blinded endpoint) design to evaluate objective measures of hospital performance, with clinical events adjudicated by a blinded event committee. This randomized study is nested within the established CONCORDANCE registry of ACS patients, with existing methods for data collection and monitoring of care and clinical outcomes. The hospital-level intervention is the integration of the GRS into routine ACS patient assessment process. The study will assess the use of early invasive management, prescription of guideline recommended pharmacology and referral to cardiac rehabilitation by hospital discharge; with the key composite clinical endpoint of cardiovascular death, new or recurrent myocardial infarction, in-hospital heart failure or cardiovascular readmission at 12 months. Health economic impacts of risk stratification implementation will also be evaluated. The study will recruit 3000 patients from 30 hospitals. SUMMARY: The AGRIS trial will establish the effect of routine objective risk stratification using the GRACE risk score on ACS care and clinical outcomes.
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Síndrome Coronario Agudo/terapia , Manejo de la Enfermedad , Sistema de Registros/estadística & datos numéricos , Medición de Riesgo/métodos , Anciano , Australia , Femenino , Humanos , Masculino , Estudios Prospectivos , Factores de RiesgoRESUMEN
PURPOSE: To assess the feasibility of a physiotherapy intervention using an interactive gaming program compared with conventional physiotherapy for hospitalised older people. METHODS: Randomised controlled pilot study in a geriatric rehabilitation unit within an acute public hospital. Participants were randomly allocated to physiotherapy using an interactive gaming program (n = 22) or conventional physiotherapy in a ward-based gym (n = 22). Feasibility was assessed by comparing the effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by the Timed Up and Go test, secondary outcomes: safety, adherence levels, eligibility and consent rates). RESULTS: Participants (n = 44) had a mean age of 85 years (SD 4.5) and the majority (80%) were women. Univariable analyses showed no significant difference between groups following intervention. However, multivariable analyses suggested that participants using the interactive gaming program improved more on the Timed Up and Go test (p = 0.048) than participants receiving conventional physiotherapy. There were no serious adverse events and high levels of adherence to therapy were evident in both groups. Only a small proportion of patients screened were recruited to the study. CONCLUSIONS: In this feasibility study, the use of a commercially available interactive gaming program by physiotherapists with older people in a hospital setting was safe and adherence levels were comparable with conventional therapy. Preliminary results suggest that further exploration of approaches using games as therapy for older people could include commonly used measures of balance and function.
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Terapia por Ejercicio/métodos , Equilibrio Postural , Rehabilitación/métodos , Juegos de Video , Actividades Cotidianas , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Hospitalización , Hospitales Públicos , Humanos , Masculino , Cooperación del Paciente , Proyectos Piloto , Distribución por Sexo , Australia del Sur , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine the associations between serum levels of vitamin D, sunlight exposure, and knee cartilage loss cross-sectionally and longitudinally in older adults. METHODS: A total of 880 randomly selected subjects (mean age 61 years [range 51-79 years], 50% women) were studied at baseline, and 353 of these subjects were studied 2.9 years later. Serum levels of 25-hydroxyvitamin D (25[OH]D) were assessed by radioimmunoassay, and sunlight exposure was assessed by questionnaire. T1-weighted fat-suppressed magnetic resonance imaging (MRI) of the right knee was performed to determine knee cartilage volume and defects. Knee radiographic osteoarthritis (OA) and knee pain were also assessed. RESULTS: The mean 25(OH)D serum level was 52.8 nmoles/liter at baseline (range 13-119 nmoles/liter). Winter sunlight exposure and serum 25(OH)D level were both positively associated with medial and lateral tibial cartilage volume, and a serum 25(OH)D level<50 nmoles/liter was associated with increased medial tibiofemoral joint space narrowing (all P<0.05). Longitudinally, baseline serum 25(OH)D level predicted change in both medial and lateral tibial cartilage volume (beta=+0.04% per annum per nmole/liter for both; P<0.05), and change in serum 25(OH)D level was positively associated with change in medial tibial cartilage volume. These associations were consistent in subjects with radiographic OA and knee pain and/or in women, but not in men or in subjects without radiographic OA or knee pain. CONCLUSION: Sunlight exposure and serum 25(OH)D levels are both associated with decreased knee cartilage loss (assessed by radiograph or MRI). This is best observed using the whole range of 25(OH)D levels rather than predefined cut points and implies that achieving vitamin D sufficiency may prevent and/or retard cartilage loss in knee OA.
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Cartílago Articular/patología , Articulación de la Rodilla/patología , Luz Solar , Vitamina D/sangre , Anciano , Estudios de Cohortes , Exposición a Riesgos Ambientales , Femenino , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Osteoartritis de la Rodilla/patología , Radioinmunoensayo , Encuestas y Cuestionarios , Tasmania , Vitamina D/análogos & derivadosRESUMEN
Susceptibility to early-onset periodontitis (EOP) appears to be attributable to a gene inherited in an autosomal dominant pattern. This explains why EOP clusters in families and why about half of the family members develop periodontal disease early in life. Manifestation of EOP is variable, with some patients having a localized form restricted to first molars and incisors (LJP) and others with a severe generalized form of periodontitis (SP). The extent and severity of disease is less in patients who are seropositive for Actinobacillus actinomycetemcomitans than in seronegative patients, and this relationship prompted the hypothesis that anti-A. actinomycetemcomitans helps limit disease. The dominant antibody is an IgG2 reactive with the serotypespecific carbohydrate. The incidence of the LJP form of EOP is about 10 times higher in blacks than in whites. Interestingly, blacks have higher levels of serum IgG2, a higher frequency of anti-A. actinomycetemcomitans antibody, and higher serum titers of IgG2 anti-A. actinomycetemcomitans which may help explain why the disease is localized. Studies in progress suggest that smoking reduces serum IgG2 levels in SP patients and is associated with more severe periodontal destruction. In marked contrast, IgG2 does not appear to be reduced in LJP patients who smoke, and smoking does not appear to increase periodontal destruction. We think that IgG2 anti-A. actinomycetemcomitans is playing a role in limiting the extent and severity of disease in patients genetically susceptible to EOP. J Periodontol 1996;67:317-322.