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Rationale, aims and objectives Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. Method A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Results Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Conclusions Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Clinical nurse specialists ( CNSs) are major providers of transitional care. This paper describes a systematic review of randomized controlled trials ( RCTs) evaluating the clinical effectiveness and cost-effectiveness of CNS transitional care. Methods We searched 10 electronic databases, 1980 to July 2013, and hand-searched reference lists and key journals for RCTs that evaluated health system outcomes of CNS transitional care. Study quality was assessed using the Cochrane Risk of Bias and Quality of Health Economic Studies tools. The quality of evidence for individual outcomes was assessed using the Grading of Recommendations Assessment, Development and Evaluation ( GRADE) tool. We pooled data for similar outcomes. Results Thirteen RCTs of CNS transitional care were identified ( n = 2463 participants). The studies had low ( n = 3), moderate ( n = 8) and high ( n = 2) risk of bias and weak economic analyses. Post-cancer surgery, CNS care was superior in reducing patient mortality. For patients with heart failure, CNS care delayed time to and reduced death or re-hospitalization, improved treatment adherence and patient satisfaction, and reduced costs and length of re-hospitalization stay. For elderly patients and caregivers, CNS care improved caregiver depression and reduced re-hospitalization, re-hospitalization length of stay and costs. For high-risk pregnant women and very low birthweight infants, CNS care improved infant immunization rates and maternal satisfaction with care and reduced maternal and infant length of hospital stay and costs. Conclusions There is low-quality evidence that CNS transitional care improves patient health outcomes, delays re-hospitalization and reduces hospital length of stay, re-hospitalization rates and costs. Further research incorporating robust economic evaluation is needed. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The management of rheumatoid arthritis ( RA) usually entails regular hospital reviews with a specialist often when the patient is well rather than during a period of exacerbation. An alternative approach where patients initiate appointments when they need them can improve patient satisfaction and resource use whilst being safe. This service evaluation reports a system-wide implementation of a patient-initiated review appointment system called Direct Access ( DA) for people with RA. The aim was to establish the impact on patient satisfaction of the new system versus usual care as well as evaluate the implementation processes. Methods As all patients could not start on the new system at once, in order to manage the implementation, patients were randomly allocated to DA or to usual care. Instead of regular follow-up appointments, DA comprised an education session and access to a nurse-led telephone advice line where appointments could be accessed within two weeks. Usual care comprised routine follow-ups with the specialist. Data were collected on patient satisfaction, service use and outcomes of any contact to the advice line. Results Three hundred and eleven patients with RA were assessed as being suitable for DA. In terms of patient satisfaction, between-group differences were found in favour of DA for accessibility and convenience, ease of contacting the nurse and overall satisfaction with the service. Self-reported visits to the general practitioner were also significantly lower. DA resulted in a greater number of telephone contacts (incidence rate ratio = 1.69; 95% confidence interval 1.07 to 2.68). Hospital costs of the two different service models were similar. Mean waiting time for an appointment was 10.8 days Conclusion This service evaluation found that DA could be implemented and it demonstrated patient benefit in a real-world setting. Further research establishing the broader cost-consequences across the whole patient pathway would add to our findings. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Frequent use and serious adverse effects related to non-steroidal anti-inflammatory drugs ( NSAIDs) underscore the need to raise patient awareness about potential risks. Partial success of patient- or provider-based interventions has recently led to interest in combined approaches focusing on both patient and physician. This research tested a shared decision-making intervention for increasing patient-reported awareness of NSAID risk. Methods A group randomized trial was performed in Alabama from 2005 to 2007. Intervention group doctor practices received continuing medical education ( CME) about NSAIDs and patient activation tools promoting risk assessment and communication during visits. Comparison group doctor practices received only CME. Cross-sectional data were collected before and after the intervention. Generalized linear latent and mixed models with logistic link tested relationships among the intervention, study phase, intervention by study phase interaction and patient-reported awareness of risks with either prescription or over-the-counter ( OTC) NSAIDs. Results Three hundred and forty-seven patients at baseline and 355 patients at follow-up participated in this study. The intervention [adjusted odds ratio ( AOR) = 0.74, P = 0.248], follow-up study phase ( AOR = 1.31, P = 0.300) and intervention by study phase interaction ( AOR = 0.98, P = 0.942) were not significantly associated with patient-reported awareness of any prescription NSAID risk. Follow-up study phase was associated with increased odds of reporting any OTC NSAID risk awareness ( AOR = 2.99, P < 0.001), but the patient activation intervention and intervention by study phase interaction were not significantly associated with patient-reported awareness of any OTC NSAID risk ( AOR = 0.98, P = 0.929; AOR = 0.87, P = 0.693, respectively). Conclusions Our point-of-care intervention encouraging shared decision making did not increase NSAID risk awareness. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. Method A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. Results Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension ( P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension ( P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. Conclusions The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs. [ABSTRACT FROM AUTHOR]