Summary
Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit. We evaluated the response to ...testosterone in men with borderline hypogonadism. A randomized double‐blind placebo‐controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level (total testosterone <10 nmol/L or free androgen index <30%). Patients were randomized to Testoderm®TTS body patch (5 mg/day, n = 20) or a placebo patch (n = 19) for 6 months, followed by open‐label testosterone replacement for a further 6 months in all patients. During the placebo‐controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment (p = 0.004); this was associated with a decrease in total body fat mass (p = 0.019) and increase in haemoglobin level (p = 0.036). There were no significant changes in lean body mass, markers of bone turnover, and measures of bone mineral density (BMD). There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life questionnaire (MEDQoL score, p = 0.017), mainly accounted for by deterioration in the placebo arm. When the active treatment period was combined for placebo and testosterone groups, the within‐patient analysis showed a significant effect of testosterone to decrease markers of bone resorption (uNTX/Cr, p = 0.007; iFDPD/Cr, p = 0.0006) and to increase lean body mass (p = 0.001). There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction. However, there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD.
Quality of life is an important patient-reported outcome of rheumatoid arthritis (RA) in addition to structural and functional outcomes. The RAQoL (Rheumatoid Arthritis Quality of Life questionnaire) ...was developed in the UK and the Netherlands as a disease-specific tool. It was adapted for use in the Australian social context and the reliability and validity was tested. A lay panel assessed the UK version and adapted the wording for use within Australia. Reliability and validity were assessed by a postal survey of the RAQoL and comparator questionnaires to 100 patients with RA. The RAQoL was easily adapted into Australian-English. Test-retest reliability was high with a Spearman rank correlation coefficient of 0.93. RAQoL scores correlated well with patient-perceived disease activity and severity--indicating good validity. The Australian version of the RAQoL is a valid and reliable tool for the assessment of quality of life. It is practical, easy to administer and has good potential for use in clinical settings and trials in Australia.
Abstract
BACKGROUND
Gliomas are associated with great societal burden through both direct (health and social care) and indirect (e.g., productivity loss) costs, but socioeconomic reports are scarce. ...We describe costs in a sample of glioma patients at high risk for depression and their family caregivers, and explore relationships between costs and treatable symptoms (depression; fatigue; cognitive complaints).
MATERIAL AND METHODS
Data from a nationwide randomised trial comparing internet-based therapy for depressive symptoms with waitlist controls were used.
Healthcare utilization, medication use, and productivity loss based on the
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P) were described and costs in the past 4 weeks were calculated. Caregivers reported on their own costs and wellbeing
We used generalized linear regression models to predict costs using multiple observations per participant and robust standard errors. We included depressive symptoms (CES-D), fatigue (CIS), cognitive complaints (MOS), tumour grade (low-/high-grade), and disease status (stable/progression/active treatment).
RESULTS
Data from 91 glioma patients and 46 caregivers were used with multiple assessments from baseline through 12 months follow-up. Baseline data showed that over a 4 week period, 64.8% of patients (M=€394.99, sd=856.83) and 41.3% of caregivers (M=€131.11, sd=392.89) had used healthcare services. Medication was used by 90.1% of patients (M=€100.83, sd=191.07) and 43.5% of caregivers (M=€13.19, sd=21.03). Productivity loss resulted in M=€1231.19, sd=2185.35 for patients and M=€310.92, sd=841.36 for caregivers. In total, mean direct and indirect costs were €1632.22 (sd=2314.25) for patients and €447.85 (sd=1002.94) for caregivers. In patients, more depressive symptoms and cognitive complaints were associated with increased healthcare use costs; higher tumour grade and active disease were linked with higher medication costs (all p<.05). Active treatment was related to higher overall costs (p<.05). In caregivers, increased caregiver fatigue was associated with higher productivity loss and overall costs; more caregiver cognitive complaints were associated with higher total costs; higher tumour grade was associated with higher healthcare use and total costs; and patient active treatment was linked with higher healthcare use costs (all p<.05).
CONCLUSION
Direct and indirect costs are substantial in glioma patients and caregivers. This indicates that the true cost of brain tumours is a burden shared between patients, caregivers, the healthcare system, and society more widely. Tentative links between costs and symptoms of depression, fatigue, and cognitive complaints indicate that adequate support may lead to cost reductions. Multivariable regression models are currently being prepared.
BackgroundIt is suggested that the use of patient reported outcome measure (PROMs) can enhance patients’ consultations with clinicians and improve clinical management. However, existing systematic ...reviews have found it difficult to reach firm conclusions about the impact of PROMs feedback on the process and outcomes of patient care, largely due to the heterogeneity and complexity of the intervention itself and the wide range of indicators used to assess its impact. This suggests a lack of consensus or even clarity about how this interventions is expected to work.MethodsWe conducted a realist synthesis to explore the contexts in which and processes through which PROMs enable patients to share concerns with clinicians and change clinicians’ communication practices within the consultation. We identified the ideas and assumptions (program theories) underlying how PROMs use was intended to work and developed an overall model to act as a framework for the review. Electronic databases were searched and backwards and forward citation tracking were carried out on key systematic reviews. We selected papers relevant to testing our theories and 36 papers were included.ResultsPROMs completion prompts patients to engage in self-reflection and identify then prioritise issues of importance to them. Whether PROMs supported or constrained patients in sharing issues with clinicians depended on the structure of the PROM and existing clinician-patient relationship. Patients valued PROMs but preferred to share information with clinicians when they had established a trusting relationship with them. Clinicians preferred to develop rapport through their verbal interactions with patients. Clinicians perceived standardised PROMs constrained their relationship with patients and were difficult to incorporate into the flow of consultations. Clinicians avoided using them or adapted the PROM, which may compromise their validity. Individualised PROMs supported consultations by allowing patients to ‘tell their story’ but were less useful as an outcome measure to measure change over time.DiscussionIt is the process of PROMs completion which helps patients to reflect on their health and raise issues with clinicians. The structure of the PROM was a key determinant of the extent to which the use of PROMs supported or constrained the clinician-patient relationship. PROMs may support the care of individual patients through acting as a ‘conversation opener’ rather than as a standardised, quantified summary of patients’ problems.
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