Should patients in a randomized, pragmatic health economics trial be allowed to switch therapy in mid-trial to that pro- vided in the other arm? Specifically, should patients in the treatment arm (T) ...be allowed to switch to the therapy of the comparator arm (C) if they need a change of therapy—that is, should TC switches be allowed? Also, should patients in the comparator arm be allowed to switch to the therapy of the treatment arm if they need changes of therapy—should CT switches be allowed? This is a nontrivial issue in study design that has been debated in the clinical trials literature and is currently being handled inconsistently in the health economics literature. In this article, the authors argue that TC switches should always be allowed and that CT switches should be allowed or not depending on the economic question. They further argue that the most common economic question is one that would lead to CT switches not being al- lowed.
To evaluate the cost effectiveness of a new product, oral ganciclovir, in comparison to a current therapy, intravenous (i.v.) ganciclovir, in the maintenance treatment of newly diagnosed ...cytomegalovirus (CMV) retinitis in patients with AIDS.
This was a retrospective economic study of a prospective non-blinded randomised clinical trial. The model included i.v. ganciclovir induction, i.v. or oral ganciclovir maintenance and i.v. ganciclovir reinduction for patients whose CMV retinitis progressed. Safety and efficacy data were derived from the trial. A panel of Canadian infectious disease physicians and family physicians estimated the following in relation to i.v. ganciclovir treatment for CMV retinitis and related adverse events: healthcare resource utilisation, clinical practice patterns, patient out-of-pocket expenses and time loss from work. The incremental cost-effectiveness analysis is reported from a societal and a Ministry of Health perspective.
The trial was conducted in Canada (2 centres) and the US (13 centres) between March 1991 and November 1992. The model assumed that patients received either inpatient or outpatient care, or both. The model provided an analysis in a Canadian setting.
Participants were patients with AIDS and newly diagnosed CMV retinitis.
All patients received induction therapy with i.v. ganciclovir 5 mg/kg, twice daily for 14 days then once daily for 7 days. Patients whose CMV retinitis stabilised were randomised to maintenance therapy with either i.v. ganciclovir (5 mg/kg/day; n = 57) or oral ganciclovir (3000 mg/day; n = 60) and were followed for up to 140 days after the start of maintenance therapy.
The trial demonstrated that the mean time to progression of CMV retinitis was 57 days for oral ganciclovir compared with 62 days for i.v. ganciclovir maintenance therapy, as measured by masked fundus photography, and 96 days with i.v. ganciclovir compared with 68 days with oral ganciclovir according to the funduscopy results. There were more adverse events in the i.v. ganciclovir group compared with the oral ganciclovir group. The cost-effectiveness results provide the dollar amount expended in order to continue to provide additional benefit using i.v. ganciclovir compared with oral ganciclovir. The incremental cost-effectiveness (C/E) ratio was 482 Canadian dollars ($Can: 1993 to 1995 values) per progression-free day gained with i.v. ganciclovir. Sensitivity analysis using funduscopy, rather than fundus photography, to document progression of CMV retinitis resulted in a C/E ratio of $Can42.
This analysis found that i.v. ganciclovir provided additional days free of progression of CMV retinitis when compared with oral ganciclovir, but the costs were higher.
A total of 651 depressed patients completed self-administered health-related quality-of-life (HRQOL) questionnaires during treatment with moclobemide in order to evaluate whether general and ...psychopathology-specific HRQOL questionnaires could detect changes in depressed patients receiving treatment. Patients were treated with moclobemide on an outpatient basis over an 8-week period; questionnaires were completed at weeks 0, 2, 4, and 8. At each assessment, patients completed one of two HRQOL questionnaires: namely, the General Health Questionnaire (GHQ), a psychopathology-specific HRQOL questionnaire, or the Short-Form 36 (SF-36), a general HRQOL instrument. Physicians were randomized to one of the two HRQOL questionnaires for all of their patients. Because the French version of the SF-36 was not available in the public domain, the patients of all Francophone physicians completed the GHQ, whereas the patients enrolled by Anglophone physicians completed either the SF-36 or the GHQ. The GHQ provides an overall score that measures the emotional dimensions of HRQOL, whereas the SF-36 provides scores in the following eight domains: physical functioning (PF), physical role functioning (PRF), emotional role functioning (ERF), social functioning (SF), bodily pain (BP), mental health (MH), vitality (VT), and general health perceptions (GHP). The GHQ and seven domains of the SF-36 detected a statistically significant linear trend (improvement) over time (p < 0.05). The change in the BP domain of the SF-36 was not statistically significant (p = 0.29).
To describe surgical management and associated outcomes for dogs with primary spontaneous pneumothorax.
110 client-owned dogs with primary spontaneous pneumothorax that underwent surgical management.
...Medical records at 7 veterinary teaching hospitals were reviewed. Data collected included signalment, history, clinical signs, radiographic and CT findings, surgical methods, intraoperative and postoperative complications, outcomes, and histopathologic findings. Follow-up information was obtained by contacting the referring veterinarian or owner.
110 dogs were included, with a median follow-up time of 508 days (range, 3 to 2,377 days). Ninety-nine (90%) dogs underwent median sternotomy, 9 (8%) underwent intercostal thoracotomy, and 2 (2%) underwent thoracoscopy as the sole intervention. Bullous lesions were most commonly found in the left cranial lung lobe (51/156 33% lesions) and right cranial lung lobe (37/156 24% lesions). Of the 100 dogs followed up for > 30 days, 13 (13%) had a recurrence of pneumothorax, with median time between surgery and recurrence of 9 days. Recurrence was significantly more likely to occur ≤ 30 days after surgery, compared with > 30 days after surgery. Recurrence > 30 days after surgery was rare (3 3%). No risk factors for recurrence were identified.
Lung lobectomy via median sternotomy resulted in resolution of pneumothorax in most dogs with primary spontaneous pneumothorax. Recurrence of pneumothorax was most common in the immediate postoperative period, which may have reflected failure to identify lesions during the initial thoracic exploration, rather than development of additional bullae.
Unprecedented Arctic ozone loss in 2011 Manney, Gloria L; Santee, Michelle L; Rex, Markus ...
Nature (London),
10/2011, Volume:
478, Issue:
7370
Journal Article
Peer reviewed
Chemical ozone destruction occurs over both polar regions in local winter-spring. In the Antarctic, essentially complete removal of lower-stratospheric ozone currently results in an ozone hole every ...year, whereas in the Arctic, ozone loss is highly variable and has until now been much more limited. Here we demonstrate that chemical ozone destruction over the Arctic in early 2011 was--for the first time in the observational record--comparable to that in the Antarctic ozone hole. Unusually long-lasting cold conditions in the Arctic lower stratosphere led to persistent enhancement in ozone-destroying forms of chlorine and to unprecedented ozone loss, which exceeded 80 per cent over 18-20 kilometres altitude. Our results show that Arctic ozone holes are possible even with temperatures much milder than those in the Antarctic. We cannot at present predict when such severe Arctic ozone depletion may be matched or exceeded.
Objectives
To determine the impact of genetic muscle disorders and identify the sociodemographic, illness, and symptom factors influencing quality of life.
Methods
Adults (aged 16–90 years) with a ...confirmed clinical or molecular diagnosis of a genetic muscle disorder identified as part of a nationwide prevalence study were invited to complete an assessment of the impact of their condition. Quality of life was measured using the World Health Organization Quality of Life questionnaire. Impact was measured via the prevalence of symptoms and comparisons of quality of life against New Zealand norms. Multivariate regression models were used to identify the most significant predictors of quality of life domains.
Results
490/596 participants completed the assessment (82.2% consent rate). Quality of life was lower than the general population on physical (
t
= 9.37
p
< 0.0001,
d
= 0.54) social (
t
= 2.27
p
= 0.02,
d
= 0.13) and environmental domains (
t
= 2.28
p
= 0.02,
d
= 0.13), although effect sizes were small. No difference was found on the psychological domain (
t
= − 1.17
p
= 0.24,
d
= 0.07). Multivariate regression models (predicting 42%–64% of the variance) revealed personal factors (younger age, being in employment and in a relationship), symptoms (lower pain, fatigue, and sleep difficulties), physical health (no need for ventilation support, fewer activity limitations and no comorbidities), and psychosocial factors (lower depression, anxiety, behavioural dyscontrol and higher self-efficacy, satisfaction with health care and social support) contributed to improved quality of life.
Conclusions
A range of factors influence the quality of life in adults diagnosed with a genetic muscle disorder and some may serve as targets for multi-faceted intervention.
Meeting the needs of acute geriatric patients is often challenging, and although evidence shows that older patients need tailored care, it is still unclear which interventions are most appropriate. ...The objective of this study is to systematically evaluate the hospital-wide acute geriatric models compared with conventional pathways. The design of the study includes hospital-wide geriatric-specific models characterized by components including patient-centered care, frequent medical review, early rehabilitation, early discharge planning, prepared environment, and follow‐up after discharge. Primary and secondary outcomes were considered, including functional decline, activities of daily living (ADL), length-of-stay (LoS), discharge destination, mortality, costs, and readmission. A systematic review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A total of 20 studies reporting on 15 trials and acutely admitted patients with an average age of 79, complex conditions and comorbidities to acute geriatric-specific pathways (
N
= 13,595) were included. Geriatric-specific models were associated with lower costs (weighted mean difference, WMD = − $174.98, 95% CI = -$332.14 to − $17.82;
P
= 0.03), and shorter LoS (WMD = − 1.11, 95% CI = − 1.39 to − 0.83;
P
< 0.001). No differences were found in functional decline, ADL, mortality, case fatalities, discharge destination, or readmissions. Geriatric-specific models are valuable for improving patient and system-level outcomes. Although several interventions had positive results, further research is recommended to study hospital-wide geriatric-specific models.
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