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Background: Dysphagia, a common complication after stroke, significantly hampers the recovery process of patients, both due to dysphagia itself and the additional complications it causes. Although a large number of articles have been published on post‐stroke dysphagia (PSD), bibliometric analysis in this field is still lacking. This study aimed to provide a comprehensive understanding of the research hotspots and trends in PSD, thereby guiding future research efforts. Methods: The Web of Science Core Collection (WoSCC) database was searched for articles related to PSD from 2003 to 2022. Data were visualised and analysed using CiteSpace and VOSviewer. Results: A total of 3102 publications were included in the scientometric analysis, with a gradual increase in the number of papers published each year. The United States emerged as the country with the highest number of publications (625 articles), while the University of Manchester led with the most publications among institutions (67 articles). Notably, Dysphagia was both the most published (254 articles) and the most cited journal (11,141 citations). Among authors, Hamdy S emerged as the most prolific (52 articles), with Martino R being the most cited (1042 citations). Conclusion: Based on our findings, we anticipate that research hotspots in PSD will mainly focus on complications due to PSD such as stroke‐associated pneumonia, stroke‐related sarcopenia. Additionally, exploration into the mechanisms and parameters of noninvasive brain stimulation techniques for the treatment of PSD, as well as the rehabilitation needs of patients with PSD, are expected to be key focal points in future research endeavours. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: Most frailty assessments have been developed for people aged over 65 years. However, there is growing evidence that frailty is detectable in younger people. This paper tests the hypothesis that the Fried frailty phenotype and the CFS categories identify the same people in age‐gender subgroups in community‐dwelling 40 to 75‐year‐olds. Method: Participants were recruited via comprehensive community‐sampling strategies. They self‐reported frailty using the Clinical Frailty Scale (CFS), and frailty was also estimated using the Fried phenotype (self‐reported unintended weight loss, exhaustion and low regular exercise; observed slow gait speed and poor grip strength). CFS and Fried scores were compared overall, and for age‐gender subgroups (40‐49 years, 50‐59 years, 60‐69 years, and 70‐75 years). Spearman rho and differences in mean integer Fried scores were calculated across CFS categories using ANOVA. Correlations were determined between Fried categories of not‐frail, pre‐frail, and frail and ranked CFS categories, using ranked scores (tau‐c) and Cochran‐Mantel‐Haenszel (C‐M‐H) tests. Results: Of 656 participants (67% female; mean age 59.9 years, SD 10.6), Fried phenotype classified 59.2% not frail, 39.0% pre‐frail, and 1.8% frail, with no gender or age differences. CFS data were missing for 25 participants, with N = 631 reporting categories of very well (24.6%), well (44.6%), managing well (21.9%), vulnerable (6.3%), mildly frail (0.5%), and moderately frail (0.2%). Overall, the mean Fried frailty scores increased incrementally and significantly across ranked CFS categories (P <.01), with weak linear correlation (rho = 0.09). There were variable correlations in age‐gender groups, with the best correlation found for women aged 50 years or older, and men aged 60 to 69 years. Conclusion: Frailty assessments using the two assessments became more consistent, as age increased. Pre‐frailty was identified by both assessments in all age‐gender groups. The validity of self‐reported CFS, and of pre‐frailty criteria relevant to people younger than 65 years, needs investigation. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: Missing data represent a challenge in longitudinal studies. The aim of the study is to compare the performance of the multivariate normal imputation and the fully conditional specification methods, using real data set with missing data partially completed 2 years later. Method: The data used came from an ongoing randomized controlled trial with 5‐year follow‐up. At a certain time, we observed a number of patients with missing data and a number of patients whose data were unobserved because they were not yet eligible for a given follow‐up. Both unobserved and missing data were imputed. The imputed unobserved data were compared with the corresponding real information obtained 2 years later. Results: Both imputation methods showed similar performance on the accuracy measures and produced minimally biased estimates. Conclusion: Despite the large number of repeated measures with intermittent missing data and the non‐normal multivariate distribution of data, both methods performed well and was not possible to determine which was better. [ABSTRACT FROM AUTHOR]

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: Defensive caesarean section (CS) has become one of the most common medical procedure worldwide. Additionally, performing CS in accordance with the patient's choice is an appropriate professional practice. Aims and Objective: This paper reports a prospective, observational, multicenter study to quantify the use of this type of practice that is performed by obstetricians to avoid medico‐legal complaints and decrease the frequency of malpractice litigations. Methods: We interviewed 73 obstetricians from three distinct units of obstetrics and gynaecology, to assess their opinion regarding defensive caesarean delivery and caesarean delivery performed upon maternal request. We conducted an opinion‐based survey using questionnaires based on nine, close‐ended questions. Results: Out of 73 respondents, 51 (69.9%) stated that they perform defensive CS; 63 (86.3%) declared that their choice of birth delivery is influenced by the risk of being accused of malpractice; 60 (82.2%) indicated that it is normal for the patient to be able to decide on the type of delivery; and 63 (86.3%) declared that they consult their patients regarding their delivery preferences. We found statistically significant differences between the respondents who declare that they perform defensive CS (69.9%) and those who said that they are influenced by the risk of malpractice when they choose the method of delivery for their patients (86.3%) (P < .001; McNemar Test). Conclusions: The results of our study indicate that defensive caesarean section is a widespread practice among obstetrics practitioners in Romania. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives: The Patient Assessment of Chronic Illness Care (PACIC) instrument assesses patient care in alignment with the chronic care model. The aim of the study was to comprehensively validate the PACIC using the Rasch model. A special focus was placed on the investigation of local dependence (LD), differential item functioning (DIF) and targeting. Method: This secondary analysis utilized data of 760 patients with a diagnosis of diabetes who had participated in the Swiss CoDiab‐VD cohort study. The psychometric properties of the French PACIC‐version were evaluated using the Rasch model. DIF was investigated in relation to age, gender, education, year of recruitment into the CoDiab‐VD cohort study, type of diabetes and whether patients got an injectable antidiabetic drug or not. Results: The initial analysis of the PACIC revealed poor fit to the Rasch model (χ2‐p < 0.001) with response dependency being the most prominent problem. After combining the items into two testlets (testlet 1: Items 1–11; testlet 2: Items 12–20), good overall model fit was found (χ2‐p = 0.77) as well as good reliability (Person Separation Index = 0.85) and targeting. DIF with regard to whether patients got an injectable antidiabetic drug or not was found for testlet 2. However, the size of this DIF was regarded as not being substantial. Conclusion: The PACIC is a well‐targeted, reliable unidimensional instrument to assess patient care in alignment with the chronic care model in patients with diabetes. It is free of substantial DIF. The PACIC‐20 sum score can hence be used in clinical practice for individual diagnostic. For evaluation purposes like assessment of change or group evaluations, the usage of the interval‐scale level person parameters is recommended as it permits using parametric statistical analyses and provides a more accurate picture about the actual amount of change. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The basic single-group interrupted time series analysis (ITSA) design has been shown to be susceptible to the most common threat to validity--history --the possibility that some other event caused the observed effect in the time series. A single-group ITSA with a crossover design (in which the intervention is introduced and withdrawn 1 or more times) should be more robust. In this paper, we describe and empirically assess the susceptibility of this design to bias from history. Method Time series data from 2 natural experiments (the effect of multiple repeals and reinstatements of Louisiana's motorcycle helmet law on motorcycle fatalities and the association between the implementation and withdrawal of Gorbachev's antialcohol campaign with Russia's mortality crisis) are used to illustrate that history remains a threat to ITSA validity, even in a crossover design. Results Both empirical examples reveal that the single-group ITSA with a crossover design may be biased because of history. In the case of motorcycle fatalities, helmet laws appeared effective in reducing mortality (while repealing the law increased mortality), but when a control group was added, it was shown that this trend was similar in both groups. In the case of Gorbachev's antialcohol campaign, only when contrasting the results against those of a control group was the withdrawal of the campaign found to be the more likely culprit in explaining the Russian mortality crisis than the collapse of the Soviet Union. Conclusions Even with a robust crossover design, single-group ITSA models remain susceptible to bias from history. Therefore, a comparable control group design should be included, whenever possible. [ABSTRACT FROM AUTHOR]

This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine‐learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods—advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data. [ABSTRACT FROM AUTHOR]

Abstract: Rationale, aims and objectives: Interrupted time series analysis (ITSA) is an evaluation methodology in which a single treatment unit's outcome is studied serially over time and the intervention is expected to “interrupt” the level and/or trend of that outcome. The internal validity is strengthened considerably when the treated unit is contrasted with a comparable control group. In this paper, we introduce a robustness check based on permutation tests to further improve causal inference. Method: We evaluate the effect of California's Proposition 99 for reducing cigarette sales by iteratively casting each nontreated state into the role of “treated,” creating a comparable control group using the ITSAMATCH package in Stata, and then evaluating treatment effects using ITSA regression. If statistically significant “treatment effects” are estimated for pseudotreated states, then any significant changes in the outcome of the actual treatment unit (California) cannot be attributed to the intervention. We perform these analyses setting the cutpoint significance level to P > .40 for identifying balanced matches (the highest threshold possible for which controls could still be found for California) and use the difference in differences of trends as the treatment effect estimator. Results: Only California attained a statistically significant treatment effect, strengthening confidence in the conclusion that Proposition 99 reduced cigarette sales. Conclusions: The proposed permutation testing framework provides an additional robustness check to either support or refute a treatment effect identified in for the true treated unit in ITSA. Given its value and ease of implementation, this framework should be considered as a standard robustness test in all multiple group interrupted time series analyses. [ABSTRACT FROM AUTHOR]

Aims and objectives: The aim of this paper is to determine the influence of do not attempt cardiopulmonary resuscitation (DNACPR) orders and the Universal Form of Treatment Options (‘UFTO’: an alternative approach that contextualizes the resuscitation decision within an overall treatment plan) on nurses' decision making about a deteriorating patient. Methods: An online survey with a developing case scenario across three timeframes was used on 231 nurses from 10 National Health Service Trusts. Nurses were randomised into three groups: DNACPR, the UFTO and no‐form. Statements were pooled into four subcategories: Increasing Monitoring, Escalating Concern, Initiating Treatments and Comfort Measures. Results: Reported decisions were different across the three groups. Nurses in the DNACPR group agreed or strongly agreed to initiate fewer intense nursing interventions than the UFTO and no‐form groups (P < 0.001) overall and across subcategories of Increase Monitoring, Escalate Concern and Initiate Treatments (all P < 0.001). There was no difference between the UFTO and no‐form groups overall (P = 0.795) or in the subcategories. No difference in Comfort Measures were observed (P = 0.201) between the three groups. Conclusion: The presence of a DNACPR order appears to influence nurse decision making in a deteriorating patient vignette. Differences were not observed in the UFTO and no‐form group. The UFTO may improve the way nurses modulate their behaviours towards critically ill patients with DNACPR status. More hospitals should consider adopting an approach where the resuscitation decisions are contextualised within overall goals of care. [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: Program evaluations often utilize various matching approaches to emulate the randomization process for group assignment in experimental studies. Typically, the matching strategy is implemented, and then covariate balance is assessed before estimating treatment effects. This paper introduces a novel analytic framework utilizing a machine learning algorithm called optimal discriminant analysis (ODA) for assessing covariate balance and estimating treatment effects, once the matching strategy has been implemented. This framework holds several key advantages over the conventional approach: application to any variable metric and number of groups; insensitivity to skewed data or outliers; and use of accuracy measures applicable to all prognostic analyses. Moreover, ODA accepts analytic weights, thereby extending the methodology to any study design where weights are used for covariate adjustment or more precise (differential) outcome measurement. Method: One‐to‐one matching on the propensity score was used as the matching strategy. Covariate balance was assessed using standardized difference in means (conventional approach) and measures of classification accuracy (ODA). Treatment effects were estimated using ordinary least squares regression and ODA. Results: Using empirical data, ODA produced results highly consistent with those obtained via the conventional methodology for assessing covariate balance and estimating treatment effects. Conclusions: When ODA is combined with matching techniques within a treatment effects framework, the results are consistent with conventional approaches. However, given that it provides additional dimensions and robustness to the analysis versus what can currently be achieved using conventional approaches, ODA offers an appealing alternative. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives: Interventions with multivalued treatments are common in medical and health research; examples include comparing the efficacy of competing interventions and contrasting various doses of a drug. In recent years, there has been growing interest in the development of methods that estimate multivalued treatment effects using observational data. This paper extends a previously described analytic framework for evaluating binary treatments to studies involving multivalued treatments utilizing a machine learning algorithm called optimal discriminant analysis (ODA). Method: We describe the differences between regression‐based treatment effect estimators and effects estimated using the ODA framework. We then present an empirical example using data from an intervention including three study groups to compare corresponding effects. Results: The regression‐based estimators produced statistically significant mean differences between the two intervention groups, and between one of the treatment groups and controls. In contrast, ODA was unable to discriminate between distributions of any of the three study groups. Conclusions: Optimal discriminant analysis offers an appealing alternative to conventional regression‐based models for estimating effects in multivalued treatment studies because of its insensitivity to skewed data and use of accuracy measures applicable to all prognostic analyses. If these analytic approaches produce consistent treatment effect P values, this bolsters confidence in the validity of the results. If the approaches produce conflicting treatment effect P values, as they do in our empirical example, the investigator should consider the ODA‐derived estimates to be most robust, given that ODA uses permutation P values that require no distributional assumptions and are thus, always valid. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Declining capacity to function safely and independently in the community is a manifestation of ageing. Multiple measures are used to define and predict functional decline. This paper explores the use of partial least squares ( PLS) analysis to understand the interaction between overtime measures of functional decline. Methods Comprehensive information was captured on individuals aged 65+ who presented at a large metropolitan Australian hospital Emergency Department ( ED) for a complaint, which did not result in a hospital admission. They were followed-up by telephone 1 and 3 months, post- ED discharge. Information was collected each time on home situations (living alone, using community services, using a gait aid and having a formal carer), recent falls, hospitalizations and instrumental activities of daily living ( IADLs). PLS analysis was applied to identify overtime relationships between measures. Results Valid information was provided by 147 individuals at all three time points. The eight individual IADL items clustered clearly around physical, mental or combined mental and physical IADLs. These clusters were strongly related to increased use of community supports, gait aid and carer, and living alone. The relationship was less convincingly for hospitalizations, and falls were not explained well. Conclusion PLS analysis offers a novel and comprehensive way of analysing complex health data, which allows sense to be made of relationships over a 3-month period. This analysis provides a better understanding of declining function over time, than could be provided by current health modelling methods. [ABSTRACT FROM AUTHOR]

In health care, particularism asserts the primacy of the individual case. Moral particularists, such as Jonsen and Toulmin, reject deduction from universal moral principles and instead seek warrants for action from the multiple sources unique to a given patient. Another kind of health care particularism, here referred to as the knowledge of particulars, is offered as a corrective to evidence-based medicine ( EBM), its influence on health care practice and policy, and specifically to EBM's reliance on the aggregate. This paper describes the knowledge of particulars and identifies strategies for its legitimation in health care policy and practice. First, the paper documents the ascendancy of the aggregate through EBM's definition of 'what works' in health care. Second, it delineates the limits of health care knowledge based on the analysis of aggregates, not only for the care of individual patients but for the formulation of policies about patient care. Third, the paper analyses prominent rejections of the particular in contemporary health policy discourse and relates them to larger political purposes. Finally, it depicts the knowledge of particulars as the basis for clinical prudence and offers three potential strategies for promoting particularism as essential to high-quality care. [ABSTRACT FROM AUTHOR]

Background of Study: Like most healthcare disciplines, the physiotherapy profession has embraced the concept of evidence‐based practice (EBP) worldwide. However, there is a discrepancy between the amount of research evidence that exists and its use in clinical decision making. Aims: To investigate the barriers physiotherapists in Nigeria encounter in implementing EBP in stroke management. Methods: This was a cross‐sectional survey involving consecutively recruited 170 physiotherapists (mean age = 29.92 ± 5.72 years) from conveniently sampled centres in the six geopolitical zones in Nigeria. The Practitioner and Organizational Barriers to Evidence‐based Stroke Rehabilitation Questionnaire was used to collect data on EBP among the physiotherapists. Data was summarized using frequency, percentage, mean, and SD and analysed using Spearman rank order, Kruskal‐Wallis and Mann‐Whitney U tests at alpha level of 0.05. Results: Insufficient time (47.6%), lack of information resources (42.9%), lack of organizational mandate (42.9%), lack of research skills (30.6%), and poor ability to critically appraise literature (29.4%) were the mostly reported barriers. Most participants had received formal training about EBP, had positive attitude and beliefs about EBP, were highly confident in their abilities to implement EBP, were aware of their roles in EBP, and were interested in acquiring and improving the skills necessary to implement EBP. There was unavailability of resources and support to promote evidence‐based practice. EBP uptake was significantly facilitated by having more education on EBP, higher academic degree, less daily workload, more years of experience in stroke rehabilitation, more participation time in research and teaching, and belonging to professional association (P <.05). Conclusion: Insufficient time, lack of organizational mandates, lack of research skills, poor ability to critically appraise literature and unavailability of resources and organizational support are key barriers to EBP among Nigerian physiotherapists. Nigerian physiotherapists, their regulatory board, and Government need to work in tandem to improve EBP among Nigerian physiotherapists. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives An essential requirement for ensuring the validity of outcomes in matching studies is that study groups are comparable on observed pre-intervention characteristics. Investigators typically use numerical diagnostics, such as t-tests, to assess comparability (referred to as 'balance'). However, such diagnostics only test equality along one dimension (e.g. means in the case of t-tests), and therefore do not adequately capture imbalances that may exist elsewhere in the distribution. Furthermore, these tests are generally sensitive to sample size, raising the concern that a reduction in power may be mistaken for an improvement in covariate balance. In this paper, we demonstrate the shortcomings of numerical diagnostics and demonstrate how visual displays provide a complete representation of the data to more robustly assess balance. Methods We generate artificial datasets specifically designed to demonstrate how widely used equality tests capture only a single-dimension of the data and are sensitive to sample size. We then plot the covariate distributions using several graphical displays. Results As expected, tests showing perfect covariate balance in means failed to reflect imbalances at higher moments (variances). However, these discrepancies were easily detected upon inspection of the graphic displays. Additionally, smaller sample sizes led to the appearance of covariate balance, when in fact it was a result of lower statistical power. Conclusions Given the limitations of numerical diagnostics, we advocate using graphical displays for assessing covariate balance and encourage investigators to provide such graphs when reporting balance statistics in their matching studies. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives In 2004, the pharmaceutical company Warner- Lambert paid US $430 million to resolve criminal and civil legal liability for aggressive off-label marketing of gabapentin. Perhaps surprisingly, however, regulatory and legal concerns regarding the marketing of gabapentin has not significantly impacted upon the attitude of doctors towards using gabapentin for neuropathic pain. In this paper, we attempt to understand the reasons for this discrepancy between clinical practice and regulatory/legal concerns through an analysis of published discussions about gabapentin prescribing. Methods We performed a qualitative empirical analysis of the published clinical debate surrounding the use of gabapentin for the management of neuropathic pain. Results The ongoing use of gabapentin for neuropathic pain was primarily driven by the perception that it was a safe, non-addictive drug with few drug interactions, by possible similarities between the physiology of chronic pain and other neurological conditions, by the well-established clinical precedent of using antiepileptic drugs in pain management, and by the lack of alternative options available in the market. Emerging evidence of lack of effectiveness and controversies about the integrity of the scientific record appeared to be of relatively little importance to practising clinicians. Conclusions Those who want to promote 'rational' prescribing need to recognize that prescribing is driven by many factors other than epidemiological data and regulatory indications and that even intensely negative publicity about medicines may not penetrate clinical reasoning. This suggests that a range of measures may be needed to 'incentivize' rational prescribing and to promote research integrity. Regulators must be more sensitive to the contextual issues that are relevant to clinical practice when evaluating drugs for approval and developing guidelines. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. Methods The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. Results During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. Conclusions Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Person-centred health care is prominent in international health care reforms. A shift to understanding and improving personal care at the point of delivery has generated debates about the nature of the person-centred research agenda. This paper purviews research paradigms that influence current person-centred research approaches and traditions that influence knowledge foundations in the field. It presents a synthesis of the emergent approaches and methodologies and highlights gaps between static academic research and the increasing accessibility of evaluation, informatics and big data from health information systems. Findings Paradigms in health services research range from theoretical to atheoretical, including positivist, interpretive, postmodern and pragmatic. Interpretivist (subjective) and positivist (objectivist) paradigms have been historically polarized. Yet, integrative and pragmatic approaches have emerged. Nevertheless, there is a tendency to reductionism, and to reduce personal experiences to metrics in the positivist paradigm. Integrating personalized information into clinical systems is increasingly driven by the pervasive health information technology, which raises many issues about the asymmetry and uncertainty in the flow of information to support personal health journeys. The flux and uncertainty of knowledge between and within paradigmatic or pragmatic approaches highlights the uncertainty and the 'unorder and disorder' in what is known and what it means. Transdisciplinary, complex adaptive systems theory with multi-ontology sense making provides an overarching framework for making sense of the complex dynamics in research progress. Conclusion A major challenge to current research paradigms is focus on the individualizing of care and enhancing experiences of persons in health settings. There is an urgent need for person-centred research to address this complex process. A transdisciplinary and complex systems approach provides a sense-making framework. [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]

Objective: To evaluate the Patient Participation in Rehabilitation Questionnaire (PPRQ) according to Rasch measurement theory. Method: Five hundred twenty‐two post‐discharge patients from a neurological rehabilitation unit were included. The PPRQ questionnaire comprises 20 items rated by a cohort of 522 patients about their experiences of participating in rehabilitation. The measurement properties of the PPRQ were evaluated by Rasch analysis of the responses. Results: The Rasch analysis of 20 items showed some major misfits, particularly three items addressing the involvement of family members. After removing those items, the model fit improved and no significant DIF remained. Despite improvements, person values (−2.96 to 4.86 logits) were not fully matched by the item values (−0.61 to 0.77 logits). Neither did the t test for unidimensionality meet the criterion of 5%, and local dependency was present. The unidimensionality and local dependency could, however, be accommodated for by four testlets. Conclusion: The PPRQ‐17 showed that a ruler with a reasonable and clinical hierarchy can be constructed, although the expectations of dimensionality and local dependency need to be evaluated further. Despite room for further development, PPRQ‐17 nevertheless shows improved measurement precision in terms of patient leniency compared with previous evaluations with classical test theory. In turn, this can play a crucial role when comparing different rehabilitation programs and planning tailored care development activities. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Differences in the performance of medical care may be due to variation in the introduction and diffusion of medical innovations. The objective of this paper is to compare seven European countries ( United Kingdom, the Netherlands, West Germany, France, Spain, Estonia and Sweden) with regard to the year of introduction of six specific pharmaceutical innovations (antiretroviral drugs, cimetidine, tamoxifen, cisplatin, oxalaplatin and cyclosporin) that may have had important population health impacts. Methods We collected information on introduction and further diffusion of drugs using searches in the national and international literature, and questionnaires to national informants. We combined various sources of information, both official years of registration and other indicators of introduction (clinical trials, guidelines, evaluation reports, sales statistics). Results and conclusions The total length of the period between first and last introduction varied between 8 years for antiretroviral drugs and 22 years for cisplatin. Introduction in Estonia was generally delayed until the 1990s. The average time lags were smallest in France (2.2 years), United Kingdom (2.8 years) and the Netherlands (3.5 years). Similar rank orders were seen for year of registration suggesting that introduction lags are not only explained by differences in the process of registration. We discuss possible reasons for these between-country differences and implications for the evaluation of medical care. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives There is an international imperative to implement research into clinical practice to improve health care. Understanding the dynamics of change requires knowledge from theoretical and empirical studies. This paper presents a novel approach to testing a new meta theoretical framework: the Consolidated Framework for Implementation Research. Method The utility of the Framework was evaluated using a post hoc, deductive analysis of 11 narrative accounts of innovation in health care services and practice from England, collected in 2010. A matrix, comprising the five domains and 39 constructs of the Framework was developed to examine the coherence of the terminology, to compare results across contexts and to identify new theoretical developments. Results The Framework captured the complexity of implementation across 11 diverse examples, offering theoretically informed, comprehensive coverage. The Framework drew attention to relevant points in individual cases together with patterns across cases; for example, all were internally developed innovations that brought direct or indirect patient advantage. In 10 cases, the change was led by clinicians. Most initiatives had been maintained for several years and there was evidence of spread in six examples. Areas for further development within the Framework include sustainability and patient/public engagement in implementation. Conclusion Our analysis suggests that this conceptual framework has the potential to offer useful insights, whether as part of a situational analysis or by developing context-specific propositions for hypothesis testing. Such studies are vital now that innovation is being promoted as core business for health care. [ABSTRACT FROM AUTHOR]

When a randomized controlled trial is not feasible, investigators typically turn to matching techniques as an alternative approach to evaluate the effectiveness of health care interventions. Matching studies are designed to minimize imbalances on measured pre-intervention characteristics, thereby reducing bias in estimates of treatment effects. Generally, a matching ratio up to 4:1 (control to treatment) elicits the lowest bias. However, when matching techniques are used in prospective studies, investigators try to maximize the number of controls matched to each treated individual to increase the likelihood that a sufficient sample size will remain after attrition. In this paper, we describe a systematic approach to managing the trade-off between minimizing bias and maximizing matched sample size. Our approach includes the following three steps: (1) run the desired matching algorithm, starting with 1:1 (one control to one treated individual) matching and iterating until the maximum desired number of potential controls per treated subject is reached; (2) for each iteration, test for covariate balance; and (3) generate numeric summaries and graphical plots of the balance statistics across all iterations in order to determine the optimal solution. We demonstrate the implementation of this approach with data from a medical home pilot programme and with a simulation study of populations of 100 000 in which 1000 individuals receive the intervention. We advocate undertaking this methodical approach in matching studies to ensure that the optimal matching solution is identified. Doing so will raise the overall quality of the literature and increase the likelihood of identifying effective interventions. [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]

High-grade glioma profoundly affects patients and their families. The best ongoing care for patients completing radical treatment is uncertain. To address this issue a UK-wide audit surveying the follow-up practices of multidisciplinary cancer teams was conducted. An online survey package was used with a paper version available. Of 102 clinicians approached 86 replied, a response rate of 84%. Three-monthly outpatient department appointments led by an oncologist and a specialist nurse were the norm, but more controversially, some centres conduct joint clinics with the whole neurosurgical/oncology team present or available. Nurse-led telephone follow-up in place of hospital visits is uncommon. Regular scanning is conducted despite the clinical benefits being contentious. Access to a range of allied services providing supportive care is considered, but the actual levels of need and the efficiency with which they are delivered require further investigation. The picture of UK follow-up practices revealed by this survey demonstrates that research is now needed to determine what preferences patients and families have for follow-up and their satisfaction with these. [ABSTRACT FROM AUTHOR]

Research on relationships often does not refer to a single person but rather to two persons. Nonetheless, such data has been often analysed by examining individuals in isolation, which falls short of capturing their truly interpersonal and non-independent nature. This paper highlights and illustrates some analytic tools for such dyadic data that are essential for theories about dyadic relationships to be tested adequately. The methodology is applied to clinical trial data from male patients treated for their erectile dysfunction and data from their partners with respect to treatment satisfaction. Multi-level modelling was used to analyse the data. The approaches outlined allow researchers to assess both individual effects and companion effects (e.g. of baseline intercourse satisfaction on subsequent treatment satisfaction), role of participant (e.g. patient or partner) or treatment condition (e.g. test or placebo) on outcome (e.g. treatment satisfaction), and differences on individual and companion effects when couples differ on important variables (e.g. differences on the individual and companion effects of baseline intercourse satisfaction on treatment satisfaction when couples differ with respect to treatment condition). Researchers are encouraged to consider implementing dyadic data analysis in their own work. [ABSTRACT FROM AUTHOR]

Health management programmes are generally evaluated as point treatment studies in which only a baseline and outcome measurement are used in the analysis, even when multiple observations for each individual are available. By summarizing observations into two distinct measurements the evaluator loses any ability to discern patterns of change in the outcome variable over time in relation to the intervention. There are several statistical models available to evaluate longitudinal data that are typically regression-like in form and designed to adjust for clustering at the individual level. Most evaluators of longitudinal studies tend to adjust for the effect of time-dependent confounding by including these covariates as independent variables in the model. However, this standard adjustment approach is likely to provide biased estimates. In this paper we describe the application of the propensity score-based weighting technique to longitudinal data to estimate the effect of treatment on an outcome. This method reweights each treatment pattern to represent the entire population at each time point and provides an unbiased treatment effect. We illustrate the technique using data from a disease management programme and demonstrate its superiority over standard analytical adjustments in correcting for time-dependent confounding for each time period under study. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The potential bias introduced by surgeons' lack of comparable, relevant experience when performing the procedures in different arms of randomized controlled trials (RCTs) is arguably not well‐managed or reported. The aim of this work was to review the frequency and nature with which surgeons' relevant experience is reported in RCTs of total hip (THA) and total knee arthroplasty (TKA), and to relate this to other risk of bias domains for this study design. Methods: A systematic review of RCTs comparing different minimally invasive procedures for TKA and comparisons of THA and hemiarthroplasty (HA). We searched MEDLINE, EMBASE, Science Citation Index, The Cochrane Library, Conference Proceedings Citation Index‐Science (CPCI‐S), Current Controlled Trials, and Clinical Trials.gov. Results: Seventy‐five relevant RCTs were identified, 65 RCTs comparing minimally invasive with standard or other minimally invasive approaches to TKA, and 10 for THA compared with HA. Risk of bias based on the reported details of surgeons' relevant experience was categorized as low, high, or unclear. There was a clear distinction before and after 2009, with a substantial decrease in trials at high or unclear risk of bias after this date. There were no strong associations between this domain and other, standard risk of bias domains for RCTs. Conclusion: The surgeons' relevant experience in an evaluated procedure is often poorly reported but has improved since 2009. The variable is not adequately captured by any other risk of bias domain. Future work should concentrate on conducting research on a much larger sample of studies and in procedures other than knee and hip arthroplasty. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The application of resilience in health care requires the shift from a cause‐effect approach to a systemic approach, yet few tools have been developed to measure resilience potential in this specific context. This study tests a resilience assessment grid (RAG) questionnaire to measure the resilience of anaesthesiologists, with a cross‐country survey. Method: A study was conducted with an analytic hierarchy process (AHP) questionnaire containing 57 detailed questions; 16 nations and 172 respondents were involved in the study. The data were statistically analysed to identify insights from the questionnaire, main improvements for further assessment, and confirmation of the design of the questionnaire. The questionnaire reliability was assessed by Cronbach analysis. Weak items were identified by a detailed correlations analysis and through a weight‐polarization matrix. Construct validity was confirmed by principal component analysis (PCA) and factor analysis (FA). Results: The α level of Cronbach analysis is 0.910. PCA and FA confirmed the absence of underlying unexpected factors, with less than 8% from the first factor and a total of just 54% of variability explained by 17 factors. Suggestions for revising the questionnaire ensue from the analysis, with improvements for the questionnaire's significance. Conclusion: The questionnaire shows the potential to assess proxy measures of resilience, even confirming the relevance of a structured weighting approach based on the AHP. The exemplar statistical cross‐country analyses encourage the widespread use of a centralized resilience questionnaire to support standardized analyses and the diffusion of best practices among organizations. [ABSTRACT FROM AUTHOR]

Rationale Despite their inherently pervasive limitations, data from observational studies are increasingly relied upon by health care decision makers to fill critical information gaps created by lack of evidence from randomized controlled trials. Aim and objective The aim and objective of this article was to revisit the major issues associated with observational studies from secondary data sources. Method The method of this article was canvass of the literature. Results Sources of bias are highlighted and steps intended to minimize bias are summarized. Conclusion Efforts should be made to improve causal inference of treatment effects from observational studies found in secondary data sources. Extra care and caution should be exercised in the interpretation and reporting of results from these studies. [ABSTRACT FROM AUTHOR]

Rationale Electronic medical record (EMR) systems are commonly included in health care reform discussions. However, their embrace by the health care community has been slow. Methods At Addiction Research and Treatment Corporation, an outpatient opioid agonist treatment programme that also provides primary medical care, HIV medical care and case management, substance abuse counselling and vocational services, we studied the implementation of an EMR in the domains of quality, productivity, satisfaction, risk management and financial performance utilizing a prospective pre- and post-implementation study design. Results This report details the research approach, pre-implementation findings for all five domains, analysis of the pre-implementation findings and some preliminary post-implementation results in the domains of quality and risk management. For quality, there was a highly statistically significant improvement in timely performance of annual medical assessments ( P < 0.001) and annual multidiscipline assessments ( P < 0.0001). For risk management, the number of events was not sufficient to perform valid statistical analysis. Conclusions The preliminary findings in the domain of quality are very promising. Should the findings in the other domains prove to be positive, then the impetus to implement EMR in similar health care facilities will be advanced. [ABSTRACT FROM AUTHOR]

Much of medical research involves large-scale randomized controlled trials designed to detect small differences in outcome between the study groups. This approach is believed to produce reliable evidence on which the management of patients is based. But can we be sure that the demonstration of a small, albeit statistically significant, difference is sufficient to infer the presence of a causal relationship between the drug and the outcome? A study is claimed to have internal validity when other explanations for the observed difference - namely, inequalities between the groups, bias in the assessment of the outcome and chance - have been excluded. Despite the various processes that are put into place - including, for example, randomization, allocation concealment, double-blinding and intention-to-treat analysis - it remains doubtful whether the groups are equal in terms of all factors relevant to the outcome and whether bias has been excluded. As for the exclusion of chance, not only may inappropriate statistical tests be used, but also frequentist statistics has been subjected to serious criticisms in recent years that further bring internal validity into question. But the problems do not end with the flaws in internal validity. The philosophical basis of large-scale randomized controlled trials and epidemiological studies is unsound. When examined closely, many obstacles emerge that threaten the inference from a small, statistically significant difference to the presence of a causal relationship between the drug and the outcome. Given the influence of statistics-based research on the practice of medicine, it is of the utmost importance that the flaws in this methodology are brought to the fore. [ABSTRACT FROM AUTHOR]

Rationale The complexity of end-of-life care, represented by a large number of units caring for dying patients, of different types of organizations motivates the importance of measure the quality of provided care. Despite the law 38/2010 promulgated to remove the barriers and provide affordable access to palliative care, measurement, and monitoring of processes of home care providers in Italy has not been attempted. Aims and objectives Using data drawn by an institutional voluntary observatory established in Italy in 2013, collecting home palliative care units caring for people between January and December 2013, we assess the degree to which Italian home palliative care teams endorse a set of standards required by the 38/2010 law and best practices as emerged from the literature. Methods The evaluation strategy is based on Rasch analysis, allowing to objectively measuring both performances of facilities and quality indicators' difficulty on the same metric, using 14 quality indicators identified by the observatory's steering committee. Results Globally, 195 home care teams were registered in the observatory reporting globally 40 955 cured patients in 2013 representing 66% of the population of home palliative care units active in Italy in 2013. Rasch analysis identifies 5 indicators ('interview' with caregivers, continuous training provided to medical and nursing staff, provision of specialized multidisciplinary interventions, psychological support to the patient and family, and drug supply at home) easy to endorse by health care providers and 3 problematic indicators (presence of a formally established Local Network of Palliative care in the area of reference, provision of the care for most problematic patient requiring high intensity of the care, and the percentage of cancer patient dying at Home). Conclusions The lack of Local Network of Palliative care, required by law 38/2010, is, at the present, the main barrier to its application. However, the adopted methodology suggests that a clear roadmap for health facilities to afford future quality and normative challenges. [ABSTRACT FROM AUTHOR]

Rationale, Aims and Objectives Errors in hospitals during the preparation and administration of intravenous drugs to infants and children have been reported to a rate of 13% to 84%. This study aimed to investigate the potential for hazardous events that may lead to an accident for preparation and administration of drug injection in a pediatric department and to describe a reduction plan of risks. Methods The preliminary hazard analysis (PHA) method was implemented by a multidisciplinary working group over a period of 5 months (April-August 2014) in infants aged from 28 days to 2 years. The group identified required hazard controls and follow-up actions to reduce the error risk. To analyze the results, the STATCART APR software was used. Results During the analysis, 34 hazardous situations were identified, among 17 were quoted very critical and drawn 69 risk scenarios. After follow-up actions, the scenarios with unacceptable risk declined from 17.4% to 0%, and these with acceptable under control from 46.4% to 43.5%. Conclusion The PHA can be used as an aid in the prioritization of corrective actions and the implementation of control measures to reduce risk. The PHA is a complement of the a posteriori risk management already exists. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Single-group interrupted time series analysis (ITSA) is a popular evaluation methodology in which a single unit of observation is studied; the outcome variable is serially ordered as a time series, and the intervention is expected to "interrupt" the level and/or trend of the time series, subsequent to its introduction. The most common threat to validity is history--the possibility that some other event caused the observed effect in the time series. Although history limits the ability to draw causal inferences from single ITSA models, it can be controlled for by using a comparable control group to serve as the counterfactual. Method Time series data from 2 natural experiments (effect of Florida's 2000 repeal of its motorcycle helmet law on motorcycle fatalities and California's 1988 Proposition 99 to reduce cigarette sales) are used to illustrate how history biases results of single-group ITSA results--as opposed to when that group's results are contrasted to those of a comparable control group. Results In the first example, an external event occurring at the same time as the helmet repeal appeared to be the cause of a rise in motorcycle deaths, but was only revealed when Florida was contrasted with comparable control states. Conversely, in the second example, a decreasing trend in cigarette sales prior to the intervention raised question about a treatment effect attributed to Proposition 99, but was reinforced when California was contrasted with comparable control states. Conclusions Results of single-group ITSA should be considered preliminary, and interpreted with caution, until a more robust study design can be implemented. [ABSTRACT FROM AUTHOR]

Rationale In Canada, Aboriginal people, particularly First Nations experience significant health disparities and a lower health status compared with the non-Aboriginal population. Aims and Objectives The purpose of this study was to examine the demographic and clinical characteristics of First Nations patients admitted to hospitals in Saskatchewan, and the acute care services used by First Nations compared with non-First Nations, specifically hospital length of stay. Primary residence of patients was also mapped to determine geographic patterns that would inform health service provision. Methods A retrospective medical chart audit was carried out to collect data on patient demographics and clinical characteristics of 203 First Nations and 200 non-First Nations patients admitted to two urban hospitals in Saskatchewan from 2012 to 2014. Results The most common reason for admission of First Nations and non-First Nations patients was infection (24.6%) and cardiology conditions (19.5%), respectively. There was no significant difference in mean length of stay for First Nations (10.44 days) compared with non-First Nations (10.57 days). After adjusting for age, mean length of stay for First Nations was nearly 3 days longer than non-First Nations. First Nations patients' residence was from across the broad geography of Saskatchewan, with 45% living in rural communities or on reserve. Conclusions The outcomes of this study are clinically meaningful and support the need for research, in collaboration with Aboriginal patients and families, to further examine and improve the care experience in order to decrease health disparities for Aboriginal patients in Canada. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Theories of decision making are divided between those aiming to help decision makers in the real, 'large' world and those who study decisions in idealized 'small' world settings. For the most part, these large- and small-world decision theories remain disconnected. Methods We linked the small-world decision theoretic concepts of signal detection theory ( SDT) and evidence accumulation theory ( EAT) to the threshold model and the large world of heuristic decision making that rely on fast-and-frugal decision trees ( FFT). Results We connected these large- and small-world theories by demonstrating that seemingly different decision-making concepts are actually equivalent. In doing so, we were able (1) to link the threshold model to EAT and FFT, thereby creating decision criteria that take into account both the classification accuracy of FFT and the consequences built in the threshold model; (2) to demonstrate how threshold criteria can be used as a strategy for optimal selection of cues when constructing FFT; and (3) to show that the compensatory strategy expressed in the threshold model can be linked to a non-compensatory FFT approach to decision making. We also showed how construction and performance of FFT depend on having reliable information - the results were highly sensitive to the estimates of benefits and harms of health interventions. We illustrate the practical usefulness of our analysis by describing an FFT we developed for prescribing statins for primary prevention of cardiovascular disease. Conclusions By linking SDT and EAT to the compensatory threshold model and to non-compensatory heuristic decision making ( FFT), we showed how these two decision strategies are ultimately linked within a broader theoretical framework and thereby respond to calls for integrating decision theory paradigms. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Balancing administrative demands from the medical school while providing patient support and seeking academic advancement can cause personal hardship that ranges from high stress to clinically recognizable conditions such as burnout. Regarding the importance of clinical faculties' burnout and its effects on different aspects of their professional career, this study was conducted and aimed to evaluate the relationship between willingness to change teaching approaches as characterized by a modified stage-of-change model and measures of stress and burnout. Methods This descriptive analytic study was conducted on 143 clinical faculty members of Tehran University of Medical Sciences in Iran. Participants were asked to complete three questionnaires: a modified stages of change questionnaire the Maslach Burnout Inventory and the General Health Questionnaire. Data were analysed by SPSS: 16 using non-parametric statistical tests such as multiple regression and ICC (intra-class coefficient) and Spearman correlation coefficient test. Result A significant relationship was found between faculty members' readiness to change teaching approaches and the subscales of occupational burnout. Specifically, participants with low occupational burnout were more likely to be in the action stage, while those with high burnout were in the attitude or intention stage, which could be understood as not being ready to implement change. There was no significant correlation between general health scores and stage of change. Conclusions We found it feasible to measure stages of change as well as stress/burnout in academic doctors. Occupational burnout directly reduces the readiness to change. To have successful academic reform in medical schools, it therefore would be beneficial to assess and manage occupational burnout among clinical faculty members. [ABSTRACT FROM AUTHOR]

The article discusses the importance of small data in the development of big data in medicine and research. Topics covered include some proposed ways to generate a learning health care system, the barriers that may slow big data development, and how the doctor-patient encounter presents as the link between clinical research and medical care. Also discussed are the use of small data to generate knowledge and the use of big data to benefit individual patients.

Rationale, aims and objectives Evidence and consensus-based guidelines for nutrition management of maple syrup urine disease ( MSUD) were developed as part of a project to create nutrition guidelines for inherited metabolic disorders identified through newborn screening. The objective of this study was to describe and evaluate the role of evidence analysts in the systematic review phase of guideline development to improve quality of process and output and inform future guideline development projects. Methods Recruitment, training and output of evidence analysts were documented throughout the MSUD project. The role of analysts was to critically review and rate the scientific quality of published literature and abstract pertinent information using quality checklists and abstraction worksheets. A secure, web-based application was developed to standardize the process and establish permanent documentation. Analysts completed a post-project survey on perceptions of their role, training and the evidence analysis process. Results Of 23 recruits, 65% (15) completed evidence analyst training; 73% of those (11) participated in the analysis of 98 literature articles. Analysts reviewed a median of four articles (range 1-16) with median productivity of 1.1 articles per month. All analysts surveyed ( n = 9) understood their role and agreed that training was adequate; 100% agreed that analyst involvement was critical in developing guidelines for MSUD. Conclusion Evidence analysts played a key role in appraising and abstracting evidence to develop nutrition guidelines for MSUD. With critical improvements to the process, particularly more stringent and systematic evaluation and documentation of analyst performance related to productivity and quality, we will continue to recruit, train and support evidence analysts in evidence-based guideline development projects. [ABSTRACT FROM AUTHOR]

Rationale aims and objectives The increasing amount of the clinical research conducted in the primary health care has enabled extending research beyond traditional settings, but this transfer has implied some trade-offs. Health care professionals who conduct research with trusted patients require assuming the ethical standards of research and communication skills to enable patients' autonomy and freedom of choice. This study aims to measure the opinions of health professionals and patients on issues of communication in clinical research. Method A cross-sectional study with health care professionals and patients from primary health care centres in Barcelona ( Spain). Each group completed a similar self-administered questionnaire. A Rasch model was fitted to data. After examination of goodness-of-fit, differences between groups were compared using analysis of variance, and patients' measures were calibrated to professionals' measures to compare overall mean measures. Results Professionals and patients found the ethical attitudes most difficult to endorse related to trust in clinical researchers and conflicts of interest. Patients' perceptions of professional ethical behaviour were significantly lower than professionals'. Different item functioning between nurses and family doctors was found in the item on seeking ethical collaboration when collaborating in clinical research. Effective knowledge of ethical norms was associated with greater perceived ethical values in clinical research and confidence in health care professionals among patients. Conclusions Differences in the views of the communication process between patients and professionals could alert research boards, health care institutions and researchers to the need for greater transparency, trust and ethical instruction when patients are involved in clinical research. [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 There is evidence that health and well-being of the National Health Service ( NHS) workforce affects organizational and patient outcomes. A Cochrane review of the effectiveness of clinical audit to improve quality of care has shown great variation between studies, depending on the design and intensity of support offered. This study evaluates the effectiveness of an organizational audit methodology with (1) action-planning workshops and follow-up and (2) audit feedback alone, to support the implementation of the National Institute for Health and Care Excellence ( NICE) workplace guidance. Methods Two rounds of audit using a self-administered online questionnaire were conducted. An overall implementation score was devised for each trust. Following round 1, interviews were conducted with a cohort of trusts with high scores. The interviews used a theory-based framework to identify predictors of and barriers to successful implementation. From this, the content for action-planning workshops was devised and workshops held with lower scoring trusts. The remaining trusts received only written feedback on their audit results. Changes in the implementation score between rounds 1 and 2 were compared within and between cohorts. Results The median improvement in scores between rounds 1 and 2 was statistically significant except where baseline score was high. The improvement for trusts who received workshops was very much better than those who did not ( P < 0.001). This difference remained after adjustment using stratification by baseline score ( P = 0.001). Conclusions Audit, combined with action-planning workshops and follow-up, appears to be more effective in improving implementation of NICE workplace health and well-being guidance than audit with feedback alone. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives The aim of this study was to examine the validity of the Health of the Nation Outcome Scales ( HoNOS) in terms of change in relation to sex, clinical characteristics and level of clinical change as assessed using other measures. Methods The sample consisted of N = 690 admissions from one Swiss psychiatric hospital who were assessed at admission and discharge using the HoNOS and the clinical global impression ( CGI) scale. Repeated measures analyses of variance were conducted to compare changes in HoNOS scores over time stratified by sex, diagnostic category and CGI level of change, controlled for age and previous hospitalizations. Two-way interactions between time and these factors were calculated and post hoc t-tests were conducted to compare changes in HoNOS scores between admission and discharge at factor levels. Results HoNOS scores significantly decreased from admission to discharge in bivariate analyses although no main effect of time was found in multivariate models. Sex was found to moderate change in HoNOS behavioural subscale scores; primary diagnosis at admission moderated change in HoNOS total scores, the behavioural subscale and the social subscale; and CGI level of change moderated the change in all HoNOS scales. Conclusions Our findings confirmed the sensitivity to change of the HoNOS in psychiatric settings from admission to discharge. Furthermore, we found that this change reflected similar changes in the CGI, a well-established measure for the evaluation of clinical outcomes, which, in turn supports the validity of the HoNOS. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives This study aimed to determine the value of using a mix of clinical pharmacy data and routine hospital admission spell data in the development of predictive algorithms. Exploration of risk factors in hospitalized patients, together with the targeting strategies devised, will enable the prioritization of clinical pharmacy services to optimize patient outcomes. Methods Predictive algorithms were developed using a number of detailed steps using a 75% sample of integrated medicines management ( IMM) patients, and validated using the remaining 25%. IMM patients receive targeted clinical pharmacy input throughout their hospital stay. The algorithms were applied to the validation sample, and predicted risk probability was generated for each patient from the coefficients. Risk threshold for the algorithms were determined by identifying the cut-off points of risk scores at which the algorithm would have the highest discriminative performance. Clinical pharmacy staffing levels were obtained from the pharmacy department staffing database. Results Numbers of previous emergency admissions and admission medicines together with age-adjusted co-morbidity and diuretic receipt formed a 12-month post-discharge and/or readmission risk algorithm. Age-adjusted co-morbidity proved to be the best index to predict mortality. Increased numbers of clinical pharmacy staff at ward level was correlated with a reduction in risk-adjusted mortality index ( RAMI). Conclusions Algorithms created were valid in predicting risk of in-hospital and post-discharge mortality and risk of hospital readmission 3, 6 and 12 months post-discharge. The provision of ward-based clinical pharmacy services is a key component to reducing RAMI and enabling the full benefits of pharmacy input to patient care to be realized. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Defensive medical practice represents an increasing concern in European countries and is reported to account for rising health care expenditures. Malpractice liability, current jurisdiction and the increasing claim for accountability appear to result in additional diagnostic requests with marginal clinical benefit. Investigations that evaluate the national Austrian prevalence and contextual principles and consequences of defensive medicine are lacking so far. Method Orthopaedic and trauma surgeons as well as radiologists from public hospitals in Austria were invited to complete a study questionnaire retrieving personal estimation of the quantity of patient contacts and defensive requests in a typical month, subjective judgement of medico-legal climate, evolving defensive trends, working time usage for defensive considerations and prior confrontations with malpractice liability claims. Results The prevalence of defensive medicine was found to be 97.7%. The average orthopaedic or trauma surgeon requests 19.6 investigations per month for defensive reasons, which represents 28% of all diagnostic examinations. High-quality imaging modalities and short-term admissions yield increasing defensive significance. Participants are confronted with 1.4 liability claims per month. During the treatment of high-risk patients, 81% of doctors request additional diagnostic procedures for defensive considerations. Expenditure of time for defensive practice amounts to 9.2 hours/month in radiology and to 17 and 18% of total working time, respectively, in orthopaedic and trauma surgery. Conclusion Defensive medical practice represents a serious and common challenge in Austria. Our results indicate the urgent necessity for confrontation with and solution for the increasing effort of self-protection within the health care system. [ABSTRACT FROM AUTHOR]