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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]

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]

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]

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 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]

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]

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]