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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 Fibromyalgia ( FM) is challenging to diagnose, especially in primary care settings. The Fibromyalgia Diagnostic Screen was developed to facilitate the diagnosis of FM in clinical practice. The objectives of this study were to assess the performance of the Fibromyalgia Diagnostic Screen in primary care and specialty clinics, using the 1990 American College of Rheumatology ( ACR) diagnostic criteria as the gold standard, and comparing the Fibromyalgia Diagnostic Screen with the London Fibromyalgia Epidemiology Study Screening Questionnaire ( LFESSQ) and the modified 2010 ACR Fibromyalgia Diagnostic Criteria ( ACR-FDC). Methods This multicenter, cross-sectional study included 150 adult chronic pain patients who underwent a physician-administered structured history and physical exam and completed the Fibromyalgia Diagnostic Screen, the LFESSQ and the modified ACR-FDC. The analyses determined the predictive ability of the Fibromyalgia Diagnostic Screen for FM. Results Item-level analyses provided support for the response categories and predictive ability of most of the Fibromyalgia Diagnostic Screen items. Additionally, the evaluation of the Fibromyalgia Diagnostic Screen scoring models demonstrated the greatest accuracy in predicting an FM diagnosis with a combination of patient items and clinician items that included an abbreviated tender point exam (sensitivity 0.68, specificity, 0.82). Sensitivity of the modified ACR-FDC and the LFESSQ was 0.87 and 0.86, respectively, with specificity 0.62 and 0.49, respectively. Conclusions The Fibromyalgia Diagnostic Screen is a useful new clinical tool to aid in the evaluation of FM in clinical practice. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The inappropriate use and overcrowding of emergency departments ( EDs) by walk-in patients are well-known problems in many countries. The current study aimed to determine whether ambulatory walk-in patients could be treated more efficiently in a new hospital-integrated general practice ( HGP) for emergency care services compared to a traditional ED. Methods We conducted a pre-post comparison before and after the implementation of a new HGP. Participants were walk-in patients attending the ED of a city hospital in Zurich. Main outcome measures were differences in total process time, time intervals between stages of care and diagnostic resources used. Results The median process time from admission to discharge was 120 minutes in the ED [interquartile range ( IQR): 80-165] versus 60 minutes in the HGP ( IQR: 40-90) ( P < 0.001). The adjusted odds ratio of receiving any additional diagnostics was 1.86 (95% confidence interval 1.06-3.27; P = 0.032) for ED doctors versus general practitioners ( GPs) when controlling for patients' age, sex and injury-related medical problems. Conclusion The HGP is an efficient way to manage walk-in patients with regard to process time and utilization of additional diagnostic resources. The involvement of GPs in the HGPs should be considered as a promising model to overcome the inappropriate use of resources in EDs for walk-in patients who can be treated by ambulatory care. [ABSTRACT FROM AUTHOR]

Objectives This study aimed to examine the performance of the Global Trigger Tool and to investigate characteristics associated with the occurrence of adverse events ( AEs). Study design Retrospective medical record review. Setting A tertiary teaching hospital, Korea. Method We employed two-stage review of a random sample of 630 charts for patients discharged between January and June 2011. Two quality improvement specialists reviewed the presence of AEs using 53 triggers developed by the Institute for Healthcare Improvement. Two physicians reviewed and validated the findings of adverse events. Positive predictive values for individual triggers were calculated. Logistic regression analysis was performed to determine factors associated with AEs. Results Of 629 patients, 45 (7%) experienced at least one AE during their hospitalization. Among the observed AEs, 61% were preventable. The frequent types of AEs were 'procedure-related' and 'medication-related'. Six triggers had positive predictive values of greater than 50.0%: 'health care-associated infection', 'any procedure complication', 'medication: other', 'return to surgery', 'occurrence of any operative complication' and 'intubation/reintubation'. Significant factors associated with the occurrence of AEs were length of stay ( OR 1.13; 95% CI 1.07 to 1.20) and the number of triggers ( OR 1.49; 95% CI 1.11 to 1.98). Conclusion The Global Trigger Tool was useful for the detection of adverse events in a Korean hospital setting. Triggers with high positive predictive values should have priority for incorporation into routine screening systems. Furthermore, patients who stay longer in the hospital need to be closely monitored using triggers to improve patient safety. [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]

Rational, aims and objective The aim of the present study was to compare the ease of use and the capability of four approaches [Medication Appropriateness Index (MAI), the Beers' criteria 2003, the Improved Prescribing in the Elderly Tool (IPET) and Health Plan Employer Data and Information Set (HEDIS)] in assessing changes in medication appropriateness in elderly patients over a period of hospitalization. Methods A retrospective observational study in two hospitals in Northern Ireland using the four measures was undertaken, involving a cohort of 192 patients (aged > 65 years). Medication appropriateness assessments were made at three stages during the patients' hospital 'journey', that is, at admission, during their inpatient stay and at discharge. The identifying rates of inappropriate prescribing in elderly patients in hospital used validated screening tools: MAI, the Beers' criteria 2003, the IPET and HEDIS. Results The MAI was the most comprehensive approach but was also the most time consuming to apply. Data derived using the MAI indicated clearly that there was improved medication appropriateness over the three hospital stay stages ( P < 0.001). Although this trend was also significant for the Beers' criteria 2003 ( P < 0.05) and the IPET ( P < 0.05) approaches, the HEDIS was unable to differentiate changes in appropriateness over time. There was a good correlation between data derived using the MAI and the Beers' criteria 2003 and the IPET approaches; this correlation was not evident for the HEDIS. Conclusions The MAI is the most convincing tool in evaluating medication appropriateness, but is very time consuming to apply. Beers' criteria 2003 and the IPET perform to an acceptable standard within the clinical setting and are more practical in their application. The HEDIS, although simplest to apply, does not have the sensitivity to measure change in appropriateness over time. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Previous service development work in the area of integrated medicines management (IMM) has demonstrated clear quality improvements in a targeted group of patients within a hospital in Northern Ireland. In order to determine whether this programme could be transferable to routine practice and thereby assess its generalizability, research has been carried out to quantify the health care benefits of incorporating the concept of IMM as routine clinical practice. Method The IMM programme of care was delivered to all eligible patients (subject to inclusion criteria) across two hospital sites in Northern Ireland during normal pharmacy opening hours. All patients were followed up for a period of 12 months from their time of hospital admission. All patient data were collected using the custom-designed Electronic Pharmacist Intervention Clinical System at each stage of their hospital journey, that is, admission, inpatient stay and discharge. Results Patients who received the IMM service benefited from a reduced length of hospital stay on their reference admission (1.42 days; P = 0.020) as well as a reduced length of stay during the first rehospitalization (5.86 days; P = 0.013). There was also a trend of a reduced number of readmissions and a longer time to readmission during the 12-month follow-up period. Potential significant opportunity cost savings were demonstrated as well as a significant improvement in medication appropriateness (discharge vs. reference admission). Conclusions The IMM programme of care has proven to be transferable to routine hospital care within two hospitals in Northern Ireland. It is anticipated that this current research will further inform the development of IMM as routine clinical practice across Northern Ireland and beyond. [ABSTRACT FROM AUTHOR]

Objectives The safety of drug-eluting stent (DES) use was called into question in 2006. However, the attitudes towards DES use after DES safety concerns were expressed and the distribution of chronic motivation type among interventional cardiologists are unknown. This study aims to examine the current attitudes towards DES use among interventional cardiologists and to investigate the distribution of chronic motivation type among these doctors. Methods A questionnaire survey of interventional cardiologists was conducted in New York State from October 2008 to April 2009. The questionnaire included face valid items to measure the attitudes towards DES use, valid Regulatory Focus Questionnaire to measure the chronic motivation type, and items collecting demographic information. Results A total of 119 valid responses were received (response rate: 47%). There were no statistically significant differences regarding the demographic factors between the respondents and the non-respondents. The vast majority of interventional cardiologists (92%) agreed that 'DES is a revolutionary technology' and that 'DES use will increase in the future' (70%). The chronic motivation type of the respondents was predominantly sensitive to positive outcomes (89%). Conclusions Interventional cardiologists had a very positive attitude regarding DES technology and predicted future growth of DES use. The vast majority of interventional cardiologists were found to be concerned about achieving positive outcomes and wanted to prevent errors of omission. To the best of our knowledge, this is the first study to report the distribution of chronic motivation type among doctors. [ABSTRACT FROM AUTHOR]

The purpose of this study is to examine Electronic Health Record (EHR) adoption among Florida doctors who treat the elderly. This analysis contributes to the EHR adoption literature by determining if doctors who disproportionately treat the elderly differ from their counterparts with respect to the utilization of an important quality-enhancing health information technology application. This study is based on a primary survey of a large, statewide sample of doctors practising in outpatient settings in Florida. Logistic regression analysis was used to determine whether doctors who treat a high volume of elderly (HVE) patients were different with respect to EHR adoption. Our analyses included responses from 1724 doctors. In multivariate analyses controlling for doctor age, training, computer sophistication, practice size and practice setting, HVE doctors were significantly less likely to adopt EHR. Specifically, compared with their counterparts, HVE doctors were observed to be 26.7% less likely to be utilizing an EHR system (OR = 0.733, 95% CI 0.547-0.982). We also found that doctor age is negatively related to EHR adoption, and practice size and doctor computer savvy-ness is positively associated. Despite the fact that EHR adoption has improved in recent years, doctors in Florida who serve the elderly are less likely to adopt EHRs. As long as HVE doctors are adopting EHR systems at slower rates, the elderly patients treated by these doctors will be at a disadvantage with respect to potential benefits offered by this technology. [ABSTRACT FROM AUTHOR]

A recent trend in health care system is to provide more choices to the patients. This study surveyed the general public's choices for primary care in Hong Kong which has the setting of free choices for private or public service and also direct access to specialists. We used a combined qualitative and quantitative approach. We held five focus group interviews with participants of different socio-economic categories. Information from the focus groups helped to design a questionnaire for random telephone interviews with members of the public aged 18 or above. There were 37 participants in the focus groups and 1647 respondents in the telephone survey. The most important factor for choosing a doctor was proximity to home or workplace, followed by quick relief from the illness. Once continuity of care had been established, distance was of less importance but comprehensive care was valued. Nearly 70% of the public had regular doctors. About 93% of the public would consult specialists directly when they thought they needed a specialist's opinion. Nearly 30% chose specialists for any medical care and 38% preferred specialists to also look after their primary care problems. Convenient accessibility was the most important factor for the initial choice of primary care doctors by the general public. The perceived clinical proficiency of the doctor determined future continuity of care. Patients liked to have direct access to specialists. Though some chose to see the specialists even for primary care problems, most people had regular doctors who were likely to have the attributes of family doctors. [ABSTRACT FROM AUTHOR]

Rationale If the complexity of the patient's medical problems increases or the complexity of the interactions between the doctor and the patient, the staff or the health care system increase, then complexity of patient care will increase. This study examined trends in patient complexity, and identified doctor, practice and improvement strategy characteristics associated with perceived complexity. Methods This secondary analysis used data from three Community Tracking Surveys with 22 134 primary care doctors completing surveys about themselves, their practice setting, practice improvement strategies and complexity of care in three consecutive 2-year time periods (1996–1997, 1998–1999, 2000–2001). Data were analysed using hierarchical logistic regression. Results The proportion of primary care doctors who perceived that complexity of care had increased over the past 2 years rose from 31.5% to 35.9%. Perceived complexity of patient care was consistently related to being in solo practice and the belief that they could not frequently obtain high-quality services and referrals for patients. As availability of services increased, complexity decreased whereas as use of practice improvement strategies increased, complexity also increased. Conclusions Understanding that we cannot determine whether respondents understood care as ‘complicated’ or ‘complex’, potential consequences of this increase in complexity include an increase in medical errors and referral rates along with decreased quality of patient care and career satisfaction. [ABSTRACT FROM AUTHOR]