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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: Establishing the relationship between various doses of an exposure and a response variable is integral to many studies in health care. Linear parametric models, widely used for estimating dose–response relationships, have several limitations. This paper employs the optimal discriminant analysis (ODA) machine‐learning algorithm to determine the degree to which exposure dose can be distinguished based on the distribution of the response variable. By framing the dose–response relationship as a classification problem, machine learning can provide the same functionality as conventional models, but can additionally make individual‐level predictions, which may be helpful in practical applications like establishing responsiveness to prescribed drug regimens. Method: Using data from a study measuring the responses of blood flow in the forearm to the intra‐arterial administration of isoproterenol (separately for 9 black and 13 white men, and pooled), we compare the results estimated from a generalized estimating equations (GEE) model with those estimated using ODA. Results: Generalized estimating equations and ODA both identified many statistically significant dose–response relationships, separately by race and for pooled data. Post hoc comparisons between doses indicated ODA (based on exact P values) was consistently more conservative than GEE (based on estimated P values). Compared with ODA, GEE produced twice as many instances of paradoxical confounding (findings from analysis of pooled data that are inconsistent with findings from analyses stratified by race). Conclusions: Given its unique advantages and greater analytic flexibility, maximum‐accuracy machine‐learning methods like ODA should be considered as the primary analytic approach in dose–response applications. [ABSTRACT FROM AUTHOR]

Background Systematic reviews ( SR) of clinical evidence are rightfully considered the basis for developing recommendations to support decisions in current practice. To avoid bias, SRs are expected to be systematic in their research strategy and are exhaustive. The drawback of the latter criteria relies in the substantial work needed to conduct and keep SRs updated. The objective of this paper is to compare a research strategy based on the review of a selected number of core journals, which we consider a 'pragmatic review' ( PR), with that derived by an SR in estimating the efficacy of treatments. Methods Five clinical areas were considered for the comparison between the two strategies: chronic obstructive pulmonary disease, dermatology, heart failure, renal diseases and stroke. We extracted a systematic sample from all the Cochrane SRs pertaining to each area and were published before April 2010. Two groups of journals were considered in the PR: six general journals that commonly published research for the five clinical areas, and five specialist journals with the highest impact factor in each area. To assess the agreement in the findings of SRs and PRs, we considered both the direction of the estimates and P-values. Results A sample of 27 SRs included 171 overall analyses and 259 subgroup analyses related to primary outcomes. The PR captured one or more clinical trials in 24 of the 27 SRs (89%), and 118 of the 171 overall analyses (69%) were replicated. The PR supported the recommendations to use (or not) the study treatment in 11 of the 13 SRs (85%), which ended with a clinical recommendation. Conclusions We verified in a sample of SRs that the conclusion of a research strategy based on a pre-defined set of general and specialist medical journals is able to replicate almost all the clinical recommendations of a formal SR. [ABSTRACT FROM AUTHOR]

Background Colorectal cancer (CRC) is one of the most common types of cancer in European countries and associated with a high mortality rate. A 16% relative risk reduction (RRR) of mortality was found in a meta-analysis based on four randomized controlled trials (RCT) on CRC screening. The aim of this paper was to scrutinize these trials for potential biases and assess their influence on the screening trials. Methods The four RCTs were reviewed based on the principles of 'Critical Appraisal of the Medical Literature'. Principal investigators of the four RCTs were contacted to clarify uncertainties in their study. Data were collected from The Danish Data Archives. Authors of the Cochrane review were contacted. Results Six biases were identified, of which five favour screening. Three of the biases identified were specific to CRC screening: type of diagnostic method, place of surgery and diagnostic delay. Conclusion The 16% RRR in CRC mortality found in the updated Cochrane review's meta-analysis is overestimated. [ABSTRACT FROM AUTHOR]

The aim of this paper was to compare selected indication parameters for patients scheduled for hip and knee replacement at orthopaedic units in Sweden. Swedish orthopaedic clinics performing joint replacement were invited to enrol in the study. The study time was set to 2 years (from June 2006 to June 2008). The study subjects were patients undergoing hip or knee replacement for osteoarthritis (OA). For data collection, we used a Swedish priority criteria tool based on a translation from a form used in Canada with minor changes. The reliability and validity of the Swedish tool were investigated, with good reproducibility. The questionnaires (one for the doctor and one for the patient) were completed during decision making for surgery. Eleven hospitals enrolled in the study. In total, 2961 patients were included during the study period. Among these, 1662 were hip replacement patients and 1299 were knee replacement patients. The vast majority of patients undergoing hip or knee replacement had findings indicating severe OA, both clinically and radiologically according to the clinical priority tool. Statistically significant self-reported problems with pain at rest, walking and impaired activities of daily living were also observed. There were statistically significant differences in reported indications between the hospitals, both for hip OA patients and for knee OA patients. A clinical priority criteria tool is a useful means of following changes in indications for certain procedures. It could also contribute to explaining differences in case mix when evaluating clinical outcome and patient satisfaction. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives: The Hamilton depression rating scale (HDRS) is seen as an international gold standard for the measurement of depression. High rates of untreated depression, including perinatal depression, support the rationale to adapt and validate a structured version of the HDRS to be used by non‐clinicians in low‐income settings. Methods: Using previous structured versions of the HDRS as a foundation, the tool was adapted, translated, and then validated with an isiXhosa speaking perinatal population in South Africa (n = 187), using cognitive testing, test‐retest reliability, and inter‐rater assessments. The AFFIRM‐HDRS was compared with the Edinburgh postnatal depression scale (EPDS) using the non‐parametric Spearman Rho test to assess concurrent validity. Internal consistency was examined using Cronbach's Alpha, and inter‐rater and test‐retest reliability were assessed with the intra‐class coefficient (ICC). Cohen's Kappa was used to assess the overall percentage agreement for each individual item of the AFFIRM‐HDRS. Results: The AFFIRM‐HDRS showed good construct and content validity had significant associations with the EPDS (Rho = 0.60 and 0.43, P <.001), and acceptable internal consistency (Cronbach's alpha = 0.74.). Inter‐rater reliability and test‐retest scores were excellent, with intraclass correlations ranging from 0.97 (0.94‐0.99) to 0.98 (0.97‐0.99) between raters, and test‐retest reliability being 0.90 (95% CI: 0.86‐0.93). The tool performed similarly to previous structured versions. Individual item‐rest correlations suggest that the items "Weight loss or gain," "Insight," and "Libido" did not fit well with the overall instrument, but that the rest of the items performed well. Conclusion: The AFFIRM‐HDRS is adequately structured to be used by non‐clinicians in an isiXhosa speaking perinatal population. It is hoped that this structured tool can be used to assist with identification and referral of these at‐risk populations by non‐clinicians in resource‐constrained environments, thereby playing a role in addressing the treatment gap for perinatal depression in LMICs. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives Long-term exposure to glucocorticoids can cause adverse drug reactions of long latency ( ADRLLs), including glucocorticoid-induced diabetes mellitus ( GID). Providers can monitor for GID using the glycosylated haemoglobin blood ( HbA1C) test. This study examined the utility of decisional support to improve HbA1C-based screening for GID. US veterans were identified as chronic users of oral glucocorticoids (>120 days of oral glucocorticoids in the last 2 years). The primary care providers caring for these patients were the target of the intervention. Providers were randomized to receive automatic HbA1C orders for their patients receiving chronic glucocorticoid or usual care. Methods This study was a pilot two-arm, group-randomized, controlled trial ( n = 12 providers, n = 38 patients). Data collection occurred from 5 May 2013 until 10 January 2014. A pharmacist generated the order for an HbA1C through the electronic medical record. The time between the intervention start date and the date on which an HbA1C order was signed were compared using Cox proportional and hierarchical linear regression. Results The time to sign HbA1C orders (mean 12.0 days for the intervention arm; 104.0 days for control arm) was associated with significant differences favouring the intervention [ HR (Hazard Ratio) 50.2, P < 0.001, confidence interval ( CI) 6.3 to 398.7]. For the intervention group, 95% of orders were signed, whereas only 12% of control providers signed orders (odds ratio 150, P < 0.001, CI 12.4 to 1812.9). Conclusions The results of this study strongly suggest that the clinical pharmacist-triggered order intervention is effective. This method of computerized decisional support may be useful in improving screening for GID and ADRLLs. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Meta-analyses of diagnostic test accuracy are important elements in evidence-based medicine. However, currently there is no overview of related quantitative findings that were obtained in a large number of real meta-analyses. This study aimed at providing such empirical summary. Methods From the literature 50 meta-analyses were randomly selected that had reported their 2 × 2 count data of sensitivity and specificity. Descriptive statistics, assessment of between-study heterogeneity and bivariate random-effects meta-analysis of sensitivity and specificity were performed with a novel Bayesian program code. The bivariate model parameters were also converted to the parameters of the closely related hierarchical summary receiver operating characteristic ( HSROC) model. Results Among the 50 meta-analyses, the studies per meta-analysis ranged from 5 to 45 and the disease prevalence from 2.3 to 71%. Significant between-study heterogeneity was found in 43 of 50 meta-analyses, favouring a random-effects model over a fixed-effects model. Empirical distributions of sensitivity and specificity, positive and negative likelihood ratios, and other model results are presented in the full text numerically and graphically. Conclusions Studies of diagnostic test accuracy can be well meta-analysed within a Bayesian framework, and the presented quantitative findings provide an orientation when interpreting the results of the standard bivariate/ HSROC model. [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 Responding to safety concerns, the American Heart Association ( AHA) published guidelines for non-steroidal anti-inflammatory drug ( NSAID) use in patients with pre-existing cardiovascular disease ( CVD) during 2005 and revised them in 2007. In the revision, a stepped approach to pain management recommended non-selective NSAIDs over highly selective NSAIDs. This research evaluated NSAID prescribing during and after guideline dissemination. Method A cross-sectional sample of 8666 adult, community-based practice visits with one NSAID prescription representing approximately 305 million visits from the National Ambulatory Medical Care Survey ( NAMCS) from 2005 to 2010 was studied. Multivariable logistic regression controlling for patient, provider and visit characteristics assessed the associations between diagnosis of CVD and NSAID type prescribed during each calendar year. Visits were stratified by arthritis diagnosis to model short-term/intermittent and long-term NSAID use. Results Approximately one-third (36.8%) of visits involving a NSAID prescription included at least one of four diagnoses for CVD (i.e. hypertension, congestive heart failure, ischaemic heart disease or cerebrovascular disease). Visits involving a CVD diagnosis had increased odds of a prescription for celecoxib, a highly selective NSAIDs, overall [adjusted odds ratio ( AOR) = 1.29, 95% confidence interval ( CI): 1.06-1.57] and in the subgroup of visits without an arthritis diagnosis ( AOR = 1.45, 95% CI: 1.11-1.89). Results were not statistically significant for visits with an arthritis diagnosis ( AOR = 1.10, 95% CI: 0.47-2.57). When analysed by year, the relationship was statistically significant in 2005 and 2006, but not statistically significant in each subsequent year. Conclusion National prescribing trends suggest partial implementation of AHA guidelines for NSAID prescribing in CVD from 2005 to 2010. [ABSTRACT FROM AUTHOR]

Rationale Despite the availability of various prevention guidelines on acute coronary syndrome ( ACS), secondary prevention practice utilizing aspirin, beta-blockers, angiotensin converting enzyme inhibitors and statins still can be sub-optimal. Aims and objectives To review and document the utilization of pharmacotherapy for the secondary prevention of ACS in patients discharged from a Malaysian hospital. Methods A retrospective cross-sectional study was conducted at a tertiary hospital in Penang, Malaysia. Patients with a primary diagnosis of ACS were identified from medical records over a 4-month period. A range of clinical data was extracted from medical records, including medical history, clinical presentation and pharmacotherapy both on admission and at discharge. This audit focused on the use of four guideline-recommended therapies: aspirin±clopidogrel, beta-blockers, statins and angiotensin-converting enzyme inhibitor ( ACEI)/angiotensin II receptor blockers ( ARBs). Results Data pertaining to a total of 380 ACS patients was extracted and reviewed, the mean age of the study population was 57.49 years and 73.9% of population was males. Patients with unstable angina accounted for 56.6% of the admissions whereas 23.4% and 20% of the patients were admitted for ST-elevation myocardial infarction and non-ST-segment elevation infarct respectively. 95.7% of the patients received antiplatelets comprising of at least aspirin, and 82% received aspirin plus clopidogrel. Furthermore, 80.3% of the patients received a beta-blocker at discharge, 95% a statin and 69.7% received either an ACEI or ARB. Compared with patients who presented with myocardial infarction (with or without ST-segment elevation), those presenting with unstable angina were less likely to receive the combination of aspirin plus clopidogrel or an ACEI/ ARB at discharge. Patients over 65 years of age were also less likely to receive a beta-blocker at discharge, compared with younger patients. Conclusions There is a good adherence to evidence-based guidelines for the secondary prevention of ACS in this local setting. However, there is some potential underutilization in the older population and patients presenting with unstable angina. [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]

Rationale, aims and objectives The accurate reporting of the trial methodology and results is essential for accurate judgement on the quality of the research. This review aims to assess the impact of the adequacy of allocation concealment on treatment effect estimates. Methods A search was performed in MEDLINE (via the Ovid platform) to identify all randomized controlled trials ( RCTs) indexed in January 2011 within its set of 'core clinical journals'. Meta-regression was undertaken on a subset of two arm trials to quantify the association between adequacy of allocation concealment and effect size. Results Adequate allocation concealment methods were used in 27% ( n = 23) of included trials. There was insufficient information given in 68% ( n = 58) of trials to make a judgement on allocation concealment. Meta-regression showed that there was a trend, not statistically significant, towards a smaller effect size between adequacy of allocation concealment and effect sizes. Conclusion This review highlighted that research needs to be reported to a higher standard and there are many trials reporting poor methods of allocation concealment within the small sample of trials included in this review. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Drug-eluting coronary stents (DES) rapidly dominated the marketplace in the United States after approval in 2003, but utilization rates were initially lower among African American patients. We assess whether racial differences persisted as DES diffused into practice. Methods Medicare claims data were used to identify coronary stenting procedures among elderly patients with acute coronary syndromes (ACS). Regression models of the choice of DES versus bare mental stent controlled for demographics, ACS type, co-morbidities and hospital characteristics. Diffusion was assessed in the short run (2003-2004) and long run (2007), with the effect of race calculated to allow for time-varying effects. Results The sample included 381 887 Medicare beneficiaries treated with stent insertion; approximately 5% were African American. Initially (May 2003-February 2004), African American race was associated with lower DES use compared to other races (44.3% versus 46.5%, P < 0.01). Once DES usage was high in all patients (March-December 2004), differences were not significant (79.8% versus 80.3%, P = 0.45). Subsequent concerns regarding DES safety caused reductions in DES use, with African Americans having lower use than other racial groups in 2007 (63.1% versus 65.2%, P < 0.01). Conclusions Racial disparities in DES use initially disappeared during a period of rapid diffusion and high usage rates; the reappearance of disparities in use by 2007 may reflect DES use tailored to unmeasured aspects of case mix and socio-economic status. Further work is needed to understand whether underlying differences in race reflect decisions regarding treatment appropriateness. [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]

Rationale, aims and objectives In 2005, the US Preventive Services Task Force issued recommendations for one-time abdominal aortic aneurysm (AAA) screening using abdominal ultrasonography in men aged 65 to 75 years with a history of smoking. However, despite a mortality rate of up to 80% for ruptured AAAs, providers order the screening for a minority of patients. We examined AAA screening rates among providers and investigated the role of visit duration and other factors in whether patients received screening. We also looked for potential interventions to improve compliance. Methods We retrospectively reviewed the records of patients who visited our clinic over a 4-month period and met the US Preventive Services Task Force criteria for AAA screening when our practice had a real-time decision support tool implemented to identify patients due for the screening. We also surveyed our clinic's providers about their knowledge and attitudes regarding AAA screening. Results Despite the use of physician reminders, providers ordered screening for only 12.9% of eligible patients. Screening was more likely to be ordered during longer visits versus shorter ones (24% vs. 6%). When surveyed, most providers (70.6%) indicated that a nurse-directed ordering system would improve compliance. Conclusions This study illustrates that physician reminders alone are not sufficient to improve care and that more time is needed for preventive services. This provides additional support for the use of a multidisciplinary approach to preventive screening, as in a patient-centred medical home. In a patient-centred medical home, a care team of physicians, nurses and office staff use technology such as clinical decision support to provide comprehensive, coordinated patient care. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Until now, the evaluation of the effectiveness of guideline implementation in nursing and allied health professions has received relatively little attention. The aims of this study were (i) to describe the development process of guidelines concerning the management of peripheral venous catheters (PVCs) implemented in an Italian hospital; and (ii) to evaluate the effectiveness of guideline dissemination in terms of both clinical outcomes (signs of infection) and process outcomes (measures of appropriateness of PVC management). Methods An observational study was conducted before and after the adoption of a new protocol in the CTO-CRF-Maria Adelaide Hospital. Data from 306 PVCs (153 before and 153 after) were collected. For each PVC, a wide range of outcome measures was collected, including: data on fixation system type of dressing; visibility of the insertion site; registration of the insertion date; duration of catheter insertion; presence of connectors, taps and needles; and signs of infection. The effect of guideline implementation was evaluated using a logistic regression model to adjust for the confounding variable represented by the nurses' average years of working experience. Results The risk of using inappropriate dressing was significantly reduced [odds ratio (OR) 0.43; 95% confidence interval (CI) 0.27-0.70], while the use of transparent dressing increased (OR 2.39; 95% CI 1.46-3.89). Conclusion Our study shows significant improvement in practices relevant to the correct management of PVCs 2 months after guideline implementation. A second survey (after a minimum of 6 months) is necessary to assess persistence of improvement in clinical practices. [ABSTRACT FROM AUTHOR]

Objectives Blood tests are requested for approximately 50% of patients attending the emergency department (ED). The time taken to obtain the results is perceived as a common reason for delay. The objective of this study was therefore to investigate the turnaround time (TAT) for blood results and whether this affects patient length of stay (LOS) and to identify potential areas for improvement. Methods A time-in-motion study was performed at the ED of the John Radcliffe Hospital (JRH), Oxford, UK. The duration of each of the stages leading up to receipt of 101 biochemistry and haematology results was recorded, along with the corresponding patient's LOS. Results The findings reveal that the mean time for haematology results to become available was 1 hour 6 minutes (95% CI: 29 minutes to 2 hours 13 minutes), while biochemistry samples took 1 hour 42 minutes (95% CI: 1 hour 1 minute to 4 hours 21 minutes), with some positive correlation noted with the patient LOS, but no significant variation between different days or shifts. Conclusions With the fastest 10% of samples being reported within 35 minutes (haematology) and 1 hour 5 minutes (biochemistry) of request, our study showed that delays can be attributable to laboratory TAT. Given the limited ability to further improve laboratory processes, the solutions to improving TAT need to come from a collaborative and integrated approach that includes strategies before samples reach the laboratory and downstream review of results. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The accuracy of health care professionals in reporting safety events determines their usefulness for both system improvement and research. The study objectives were to: (1) validate (assess the accuracy of) the reasons recorded by doctors and pharmacists for discontinuing medication orders at discharge in a hospital's electronic patient records (EPR); (2) investigate the causes of any detected recording inaccuracy; and (3) collect preliminary data on the frequency and types of medication discontinuation. Methods This was a validation study in one English hospital. The study comprised two steps: extraction of discontinued medication orders from the EPR followed by short structured interviews with doctors and pharmacists who made the discontinuation. A total of 104 discontinued orders were discussed during 15 face-to-face and six telephone interviews. The software package spss was used for data analysis. Results Duplication of therapy (27, 25.2%), omission of drug (23, 21.5%) and dosage regimen change (19, 17.8%) were the three most frequent reasons given for discontinuing medications. The majority of recorded discontinuation reasons were correct (100, 96.2%) and complete (101, 97.1%), and hence were judged accurate (97, 93.3%). The difference in accurate recording between doctors (15, 88.2%) and pharmacists (82, 94.3%) was not statistically significant. Potential causes of recording inaccuracy included: slip or lapse, lack of training, carelessness and electronic system rigidity. Conclusion This study showed that doctors and pharmacists recorded accurate reasons for the majority of the discontinued medication orders. It also showed that utilizing pharmacists' recorded reasons during clinical interventions using EPR was beneficial in understanding and characterizing prescribing errors. Although they require further research, the reasons identified present preliminary data about the most prevalent types of pharmacists' interventions during hospital discharge. [ABSTRACT FROM AUTHOR]

Many women are prescribed oestrogen-containing contraceptives for whom oestrogen-containing methods may be less suitable. Two surveys examining contraceptive prescription practices among doctors ( n = 419) and attitudes towards contraception among women ( n = 1623) in France, Germany, Spain, Italy and Russia were evaluated. Progestin-only pills and hormone-free intrauterine devices were the most commonly prescribed contraceptives for women with medical conditions for which oestrogen-containing methods are not preferred (40% and 20%, respectively), those suffering from oestrogen-related side effects (32% and 21%) and those with concerns about the safety of oestrogen-containing methods (28% and 24%). Combined oral contraceptives (COC) were prescribed to ≥10% in these two groups. One-quarter of contraceptive users had asked to be switched from one COC to another because of oestrogen-related side effects; a similar proportion had been switched by their doctor for this reason. Half of the women surveyed did not want or had concerns about foreign/additional oestrogen, and about 80% said that they would consider switching to a different hormonal contraceptive to minimize oestrogen exposure. Although most doctors were aware of the World Health Organization medical eligibility criteria for contraceptive use, they still prescribed COCs or other oestrogen-containing contraceptives to women with medical conditions for which oestrogen-containing options are not favoured, suggesting a need for additional education. By complying with guidelines and heeding women's concerns, doctors can individualize their contraceptive recommendation to improve safety, acceptance and compliance and, ultimately, reduce the risk of an unintended pregnancy. [ABSTRACT FROM AUTHOR]

The cause of increased post-AMI (acute myocardial infarction) mortality associated with depression remains poorly elucidated. The objective of this study was to examine the extent to which self-reported cardiac functional status accounted for depression-mortality associations following AMI. Using a prospective cohort design ( n = 1941), the authors obtained self-reported measures of depression and developed profiles of the patients' pre-hospitalization cardiac risks, co-morbid conditions and drugs and revascularization procedures during or following index AMI hospitalization. To create these profiles, the patients' self-reports were retrospectively linked to no less than 12 years' worth of previous hospitalization data. Mortality rates 2 years after acute MI were examined with and without sequential risk adjustment for age, sex, income, cardiovascular risk, co-morbid conditions, selected process-of-care factors and self-reported cardiac functional status. Depression was strongly correlated with 2-year mortality rate [crude hazard ratio (HR) of severe vs. minimal depression category, 2.48 (95% CI 1.20-5.15); P = 0.01]. However, after sequential adjustment for age, sex, income and self-reported cardiac functional status, the effect of depression was greatly attenuated [adjusted HR for severe vs. minimal depression category, 1.35 (95% CI 0.63-2.87); P = 0.44]. Cardiac risk factors and non-cardiac co-morbidities had negligible explanatory effect. The main factor determining the increased mortality rate in depressed patients is self-reported cardiac functional status. Efforts to address increased mortality in depressed patients with cardiovascular illnesses should focus on processes that impact cardiac functional status. [ABSTRACT FROM AUTHOR]

Variability in indications for total hip replacement (THR) and unequal waiting times may limit health care access. To analyse the relationship between appropriateness and previously developed surgical priority instruments. Multicentre cross-validation study of patients placed on the waiting list for THR. Information on surgical priority, surgeons' evaluation of priority through a visual analogue scale (VAS) and health-related quality of life (HRQOL) (Health Utilities Index mark 3, EQ-5D, Western Ontario McMaster Osteoarthritic Index) was collected. THR indications were considered appropriate, uncertain or inappropriate according to appropriateness criteria. Statistical differences and clinically important differences in surgical priority, VAS and HRQOL between appropriateness categories were analysed with the Mann-Whitney U-test and effect size (ES), respectively. Surgical priority score's ability to discriminate appropriate and inappropriate indications was evaluated through the area under the receiver-operating characteristic curve (AUC) and its 95% confidence interval (95% CI). 49.4% (87) of the THR indications were deemed appropriate, 39.8% (70) uncertain and 10.8% (19) inappropriate. Differences in surgical priority score, VAS and HRQOL between appropriateness categories were statistically significant. Clinically important differences were generally small (ES, 0.2-0.5) between inappropriate and uncertain, moderate (ES, 0.5-0.8) between uncertain and appropriate, and large (ES > 0.8) between inappropriate and appropriate categories. The AUC to discriminate appropriate and inappropriate indications was 0.97 (95% CI: 0.96-0.99) and 0.90 (95% CI: 0.83-0.97), respectively. The relationship between the surgical priority and appropriateness instruments reinforces their validity and could improve waiting list management by establishing maximum waiting periods based on patients' characteristics. [ABSTRACT FROM AUTHOR]

Time series analysis has seen limited application in the biomedical Literature. The utility of conventional and advanced time series estimators was explored for intensive care unit (ICU) outcome series. Monthly mean time series, 1993-2006, for hospital mortality, severity-of-illness score (APACHE III), ventilation fraction and patient type (medical and surgical), were generated from the Australia and New Zealand Intensive Care Society adult patient database. Analyses encompassed geographical seasonal mortality patterns, series structural time changes, mortality series volatility using autoregressive moving average and Generalized Autoregressive Conditional Heteroscedasticity models in which predicted variances are updated adaptively, and bivariate and multivariate (vector error correction models) cointegrating relationships between series. The mortality series exhibited marked seasonality, declining mortality trend and substantial autocorrelation beyond 24 lags. Mortality increased in winter months (July-August); the medical series featured annual cycling, whereas the surgical demonstrated long and short (3-4 months) cycling. Series structural breaks were apparent in January 1995 and December 2002. The covariance stationary first-differenced mortality series was consistent with a seasonal autoregressive moving average process; the observed conditional-variance volatility (1993-1995) and residual Autoregressive Conditional Heteroscedasticity effects entailed a Generalized Autoregressive Conditional Heteroscedasticity model, preferred by information criterion and mean model forecast performance. Bivariate cointegration, indicating long-term equilibrium relationships, was established between mortality and severity-of-illness scores at the database level and for categories of ICUs. Multivariate cointegration was demonstrated for {log APACHE III score, log ICU length of stay, ICU mortality and ventilation fraction}. A system approach to understanding series time-dependence may be established using conventional and advanced econometric time series estimators. [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]

To evaluate the extensive use of peripheral venous catheters (PVCs), including catheter-related complications, a reliable tool for PVC assessment is needed. The aim of this study was to develop such a tool to evaluate PVCs in relation to management, documentation and signs and symptoms of thrombophlebitis (TH), as well as to determine its inter-rater and test-retest reliability. The tool development included confirmation of content and face validity. Two groups of registered nurses used the new tool (PVC ) to assess PVC management and signs of TH independently. Group A ( n = 3) assessed 26 items in 67 PVCs bedside (inter-rater reliability). Group B ( n = 3) assessed photographs (67 PVCs, 21 items) of the same PVCs as those in Group A with a 4-week interval (test-retest reliability). Proportion of agreement P(A) and Cohen's kappa were calculated to evaluate inter-rater and test-retest reliability. Among nurses assessing PVCs at bedside, the P(A) was good to excellent (0.80-1) in 96% of the items in PVC . In 80% of the items kappa was substantial to almost perfect (0.61-1). TH sign erythema fell into the fair range (kappa = 0.40). In test-retest reliability analysis the P(A) was within the good and excellent range (0.80-1.0) and kappa varied from moderate to almost perfect (0.41-1.0) in 95% of the items. One item 'outer dressing is clean' was in fair range (0.21-0.40). The PVC instrument shows satisfactory inter-rater and test-retest reliability. Reliability tests on reviewing documentation remain to be performed. [ABSTRACT FROM AUTHOR]

Assessment of the quality of care is a key element in current diabetes care. However, the quality of care for diabetes patients in Japan has rarely been reported. To assess the quality of diabetes care in two communities in Japan by using National Health Insurance claims data. We analysed claim data of 13 650 beneficiaries of National Health Insurance in two communities in Japan from May 2006 to April 2007. Diabetes cases were identified by using a case detection algorism. Our main outcome measures were three process quality indicators: (1) haemoglobin A1c (HbA1c) testing; (2) annual eye examination; and (3) annual nephropathy screening, recommended in the existing clinical guidelines. We calculated the performance rate of each quality indicator and examined the effects of demographic characteristics and co-morbid conditions. We identified 636 diabetes cases. Of these, 97.0% had at least one HbA1c test, and 69.8% had ≥4 tests during the study period. The odds ratios (ORs) for ≥4 HbA1c tests were lower in subgroups aged 75-79 (OR 0.58, 95% confidence interval 0.35-0.96), and aged ≥80 (OR 0.54, 95% confidence interval 0.32-0.88) compared with the subgroup aged <70 after adjusting for other patient characteristics. The annual rate for eye examinations and nephropathy screenings were 20.8% and 5.8% respectively. We found high performance rates for HbA1c testing, while the annual rates for eye examinations and nephropathy screenings were suboptimal. Using administrative data would facilitate more comprehensive assessment of the quality of care in Japan. [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]

Improving pain management is important in pre-hospital settings. We aimed to investigate how pain was managed in pre-hospital suspected acute myocardial infarction (AMI) or fracture and how this could be improved. We conducted a cross-sectional study in Lincolnshire using recorded suspected AMI and fracture between April 2005 and March 2006. Outcomes included pain assessment, improvement in pain scores and administration of Entonox, opiates or GTN (in AMI). We accessed 3654 patients with suspected AMI or fracture. Pain was assessed in over three quarters of patients but analgesics administered in under two-fifths. Assessment was more likely in patients with suspected AMI (OR 2.05, 95% CI [1.70, 2.47]), and who were alert (OR 3.55, 95% CI [2.32, 5.43]). Entonox was less likely to be administered for suspected AMI (OR 0.11, 95% CI [0.087, 0.15]) or by paramedic crews (OR 0.56, 95% CI [0.45, 0.68]) but more likely to be given when pain had been assessed (OR 3.54, 95% CI [2.77, 4.52]). Opiates were more likely to be prescribed for suspected AMI (OR 1.30, 95% CI [1.07, 1.57]), in alert patients (OR 1.35, 95% CI [0.71, 2.56]) assessed for pain (OR 2.20, 95% CI [1.73, 2.80]) by paramedic crews. This exploratory study showed shortfalls in assessment and treatment of pain, but also demonstrated that assessment of pain was associated with more effective treatment. Further research is needed to understand barriers to pre-hospital pain management and investigate mechanisms to overcome these. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The Sheehan Disability Scale (SDS) is a three-item instrument that measures disability in three inter-related domains: work, family life/home responsibilities and social/leisure activities. The main objective of the present study was to examine the factor structure, reliability and construct validity of the SDS in a wide Spanish sample of primary care (PC) patients. Methods One phase cross-sectional survey. A total of 3815 patients, aged 18 years or older attending PC for a medical visit, were interviewed between October 2005 and March 2006. The interviews included the Structured Clinical Interview for DSM-IV Axis I Disorders for depressive and anxiety disorders, the Mini-International Neuropsychiatric Interview for the rest of mental disorders, a medical conditions checklist, the 2.0 version of the 12-item Short-Form Health Survey (SF-12) for measuring quality of life and the SDS. Results The principal component analysis and the subsequent confirmatory factor analysis indicated that the SDS is one-dimensional (normed fit index = 0.990, non-normed fit index = 0.987, comparative fit index = 0.991, goodness-of-fit index = 0.993, standardized root mean-square residual = 0.037, root mean-square error of approximation = 0.053). The internal consistency of the scale was good (α = 0.83) and it was significantly associated with the physical and mental component of the SF-12. Concerning discriminative validity, patients with major depression or panic disorder scored higher on the SDS than patients with chronic medical conditions or with no chronic pathology. We also found that a cut-off point of 8 in the SDS adequately discriminated between patients with and without depression (area under the curve = 0.814, sensitivity = 81.60%, specificity = 70.60%). Conclusions The SDS seems a reliable, valid and useful clinical tool for measuring disability in Spanish PC patients. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Teratology Information Services (TIS) provide health care professionals and the public with information regarding the safety and/or risk of exposures during pregnancy and lactation, mainly via telephone consultations. An international comparison of clinical practices at TIS has never been conducted. The survey objective was to compare international TIS to North American TIS, with an aim to identify strengths and challenges that can lead to service improvement. Methods Twenty-two international TIS were approached for participation during an international conference. TIS were surveyed on information in six categories: services, staffing, operations, data collection, knowledge transfer activities and additional information. Data were summarized using descriptive statistics. Statistical tests were conducted using SPSS®. Results Sixteen TIS from 12 countries participated. Survey results were compared with previously reported results from a similar survey of North American TIS (16 US, two Canadian). TIS exist in a variety of departments and settings, but most commonly are in university hospitals. Pregnant women were the most commonly counselled group worldwide. International TIS spent significantly more time fielding inquiries regarding medications, while North American TIS had a wider variety of inquiry categories. All TIS could improve budget tracking. Conclusions Overall, service practices and goals were similar, although international TIS conducted more follow-up with service users than North American TIS. This report offers TIS the first ever opportunity to compare practices. Increased dialogue between TIS encourages sharing of best practices and improves the ability of these important public health programmes to support women and health care providers. [ABSTRACT FROM AUTHOR]

Objective Constructing categories based on probabilities is not unusual in defining the outcome or the exposure. We compare the threshold approach and the simulation approach in making inferences. Method We used a simple structured example as well as published data to illustrate the difference between the simulation and the threshold approaches. Results We demonstrated that simulation results were different from the threshold approach in estimating the effect of a high-deductible health plan. For repeat visits, we estimated a statistically significant ratio of incident rate ratio (IRR) 0.78 (95% CI: 0.64, 0.93) for non-preventable emergency department visits using the simulation approach while the high-severity category showed no statistical significance with the ratio of IRR 0.98 (95% CI: 0.64, 1.49) using a threshold of 75%. We also demonstrated that none of the threshold values could achieve the results of the simulation approach. Conclusions The simulation approach is preferred over the threshold one when analysing data with probability-based outcome, exposure and/or other covariates if the size of the data permits. [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]