CLEO: a multidimensional tool to assess clinical, economic and organisational impacts of pharmacists' interventions.

OBJECTIVES: Clinical pharmacists' interventions (PIs) are an important element in ensuring good pharmaceutical care. We aimed to develop and validate a comprehensive multidimensional tool for assessing the potential impact of PIs for daily practice of medication review. METHODS: Experts of the French Society of Clinical Pharmacy (SFPC) developed the CLinical, Economic and Organisational (CLEO) tool, consisting of three independent dimensions concerning clinical, economic and organisational impact. They were asked to analyse 30 scenarios of PIs, and re-rated 10 PIs with a washout of 1 month (internal validation). Then, seven external experts not involved in the development of the tool rated 60 scenarios collected when using the CLEO in daily practice. Inter- and intra-rater reliabilities were determined by calculation of the intra-class correlation (ICCA,1). Users' satisfaction and acceptability of the tool were assessed on a 7-level Likert scale with a 17-item questionnaire. RESULTS: For internal reliability, the inter-rater reliability for the CLEO tool was good for clinical dimensions (ICCA,1=0.693), excellent for economic dimensions (ICCA,1=0.815) and fair for organisational dimensions (ICCA,1=0.421); and the intra-rater reliability was good for clinical dimensions (ICCA,1=0.822), excellent for economic dimensions (ICCA,1=0.918) and good for organisational dimensions (ICCA,1=0.738). For external reliability, the inter-rater reliability was good for clinical dimensions (ICCA,1=0.649), excellent for economic dimensions (ICCA,1=0.814) and fair for organisational dimensions (ICCA,1=0.500). CLEO was viewed as relevant (mean±SD 4.93±1.27), acceptable (4.81±1.78), practicable (5.56±1.45) and precise (5.38±1.47). CONCLUSIONS: CLEO is a comprehensive tool assessing clinical, economic and organisational impacts of PIs which has been developed, validated and was reliable and feasible for use in routine clinical practice.

Comparison of two commercial quantitative PCR assays for EBV DNA detection and their correlation with the first WHO International Standard for EBV.

PURPOSE: There are few data on the performance of automated Epstein-Barr virus (EBV) PCR assays. This study compared EBV quantification for the kPCR PLX EBV DNA (kPCR; Siemens, France) and the EBV R-gene (R-gene; Argene, Biomerieux, France) assays and their correlation with the World Health Organization (WHO) standard. METHODOLOGY: WHO International Standard for EBV (WHO standard) dilution panels in different matrices were submitted to nucleic acid extraction with Versant kPCR Molecular Systems SP followed by the kPCR assay, or to nucleic acid extraction with the MagNA Pure LC System or NucliSENS easyMag followed by the R-gene assay. Seventy-four clinical specimens were tested in both assays. Bland-Altman analysis and linear regression analysis were performed. RESULTS: The correlation between the WHO standard diluted in different matrices and the R-gene and kPCR assays was good (R2 >0.96 and R2 >0.92, respectively). A matrix effect was observed. The correlation of quantitative results between both assays yielded a coefficient of determination R2 higher than 0.74. The quantification differences were within one log10 of the averaged results for 34 of the 38 specimens (89 %). Calibration to the WHO standard did not increase the comparability of quantitative results. CONCLUSIONS: The quantitative results of both assays showed reasonable correlation with each other and a good correlation with the WHO standard.

Tools for Assessing Potential Significance of Pharmacist Interventions: A Systematic Review.

INTRODUCTION: Assessing the significance of pharmacist interventions (PIs) is essential to demonstrate the added value of pharmacists. Methods and tools for assessing the potential significance of PIs are diverse and their properties are questionable. OBJECTIVES: We aimed to systematically review the tools available to assess the potential significance of PIs. METHODS: We conducted a systematic search for English- or French-language publications from 1986 to 2013 in PubMed, PsycINFO, PASCAL, and CINAHL. Studies were screened by two independent reviewers based on inclusion/exclusion criteria and were abstracted for content, structure of tools, and validation process. RESULTS: Of 873 citations screened, 82 distinct tools were identified from 133 studies. While clinical aspects were often defined quite clearly, terminology regarding humanistic, economic, and process-related aspects of PIs was omitted, incomplete, or ambiguous in most tools. The probabilities of consequences of PIs/drug-related problems were evaluated in 20/82 tools. Few tools simultaneously measured economic, clinical, humanistic, and process-related variables. Structure of the tools varied from an implicit, mono-dimensional tool to an explicit, multi-dimensional algorithm. Validation processes were diverse in terms of quantification and number of raters, rating method, and psychometric parameters. Of 133 identified studies, there was limited evidence of validity (8/133, 6.0%), inter-rater reliability (49/133, 36.8%), and intra-rater reliability (2/133, 1.5%). CONCLUSIONS: The majority of tools focused primarily on assessing clinical aspects and failed to detect comprehensive impacts. The heterogeneity of tools and assessment processes hindered our ability to synthesize the results of evaluations. Limited results for their validity and reliability cast doubt on the credibility of this methodology for justification of the value of PIs. Recommendations for development of tools with optimal theoretical, pragmatic, and psychometric properties are proposed.

Assessment of clinical pharmacists' interventions in French hospitals: results of a multicenter study.

BACKGROUND: The development of clinical pharmacy activities in most European countries is underway; however, data on these activities are still poorly reported. Multicenter studies are necessary to standardize and demonstrate the value of clinical pharmacy activities in these countries. OBJECTIVE: To document clinical pharmacists' daily routine interventions (PIs) to identify trends of intervention, drugs, and situations most frequently associated with drug-related problems (DRPs) and to estimate physicians' acceptance of PI. METHODS: A prospective study of PIs was conducted in 6 French hospitals. The sample consisted of 300 randomized PIs per hospital, recorded during the medication order validation process when a DRP was identified. We recorded patients' demographic characteristics, drugs involved, wards, DRP description, pharmacists' recommendations, and whether or not the recommendations were accepted by the physicians. RESULTS: A total of 38,626 medication orders were analyzed by 28 clinical pharmacists, leading to 1800 PIs (4.66 PIs per 100 medication orders). Of the 1800 PIs, 25.9% targeted psychotropic drugs, 15.9% targeted antithrombotic drugs, 15.5% targeted digestive and metabolic drugs, and 15.0% targeted cardiovascular drugs. The most commonly identified DRPs were nonconformity to guidelines or contraindication (21.3%), followed by improper administration (20.6%), supratherapeutic dose (19.2%), and drug interaction (12.6%). Nearly half (42.2%) of the pharmacists' recommendations were related to drug choice (drug switch 22.2%, drug discontinuation 16.3%, addition of a new drug 3.7%) followed by dose adjustment (23.8%), optimization of administration (21.9%; change of administration route 10.3%, administration modalities 11.6%), and need for drug monitoring (12.2%). The rate of physicians' acceptance was 73.4% (15.3% refusals, 11.3% not assessable). CONCLUSIONS: In French hospitals, pharmacists contribute to preventing DRPs during medication order validation. This study suggests that a few types of drugs and errors constitute a substantial proportion of PIs. Knowledge of the most frequent DRPs could significantly increase the efficiency of clinical PIs.