Inajara Rotta

Effectiveness of clinical pharmacy services: an overview of systematic reviews (2000–2010)

Background Multiple reviews have evaluated the impact of pharmacist-delivered patient care on health-related outcomes. However, it is unclear which of the pharmacist-delivered interventions in these services are the most effective. Aim of the review To gather the evidence of the impact of clinical pharmacy services on the medication use process or on patient outcomes using an overview of systematic reviews. Methods PubMed was searched to retrieve systematic reviews published between 2000 and 2010 that assessed the impact of clinical pharmacy services on the medication use process or patient outcomes. Two independent reviewers evaluated the study eligibility and one extracted the description and results of the services. The methodological quality of each review was assessed with the R-AMSTAR tool. Results Of the 343 potentially relevant records identified, 49 systematic reviews, comprising a total of 269 randomized controlled trials, met the selection criteria. Clinical pharmacy services that focused on specific medical conditions, such as hypertension or diabetes mellitus, revealed a positive impact of pharmacists’ interventions on patient outcomes. For other medical conditions, however, the results were inconclusive (e.g., dyslipidemia or thromboprophylaxis). Interventions that targeted medication adherence and assessed the impact of clinical pharmacy services in prescription appropriateness also produced inconclusive results because of the variability of methods used to assess both medication adherence and medication appropriateness. Conclusions Systematic reviews that assessed clinical pharmacy services targeting specific conditions were more conclusive given that the intervention was well defined, and the measured outcomes were unequivocal and tangible. Conversely, the results were inconclusive for interventions with a broader target and with monitoring parameters that were unclearly established or inconsistently assessed across studies. These findings emphasize the need to better define clinical pharmacy services and standardize methods that assess the impact of these services on patient health outcomes.

Efficacy of Topical Antifungals in the Treatment of Dermatophytosis: A Mixed-Treatment Comparison Meta-analysis Involving 14 Treatments

IMPORTANCE Considering that most randomized controlled trials compare antifungals with placebo instead of other antifungals, conventional meta-analysis is insufficient to define superiority between the evaluated strategies. To our knowledge, this is the first mixed-treatment comparison meta-analysis on antifungal treatments in the literature and shows all the evidence available at the time of the study. OBJECTIVE To evaluate and compare the efficacy of topical antifungals used in dermatophytosis treatment, using mixed-treatment comparisons. EVIDENCE ACQUISITION We performed a comprehensive search (up to July 31, 2012) for all entries in MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Literatura Latino Americana e do Caribe em Ciências da Saúde, and International Pharmaceutical Abstracts. Randomized controlled trials that compared topical antifungals with one another or with placebo in dermatophytosis treatment were selected for analysis. Methodologic quality of the trials was assessed using the Jadad scale. We excluded studies that scored less than 3 points. The outcomes evaluated were mycologic cure at the end of treatment and sustained cure. A random-effects Bayesian mixed-treatment comparisons model was applied to combine placebo-controlled and direct topical antifungals comparison trials. RESULTS Pooled data of the 65 trials identified did not show any statistically significant differences among the antifungals concerning the outcome of mycologic cure at the end of treatment. Regarding the sustained cure outcome, butenafine hydrochloride and terbinafine hydrochloride were significantly more efficacious than were clotrimazole, oxiconazole nitrate, and sertaconazole nitrate. Terbinafine also demonstrated statistical superiority when compared with ciclopirox (ciclopiroxolamine), and naftifine hydrochloride showed better response compared with oxiconazole. No inconsistency was detected in the network of evidence for both outcomes, sustaining the validity of the mixed-treatment comparisons results. CONCLUSIONS AND RELEVANCE With the outcome mycologic cure at the end of treatment, there was no significant difference among the antifungals. Butenafine, naftifine, and terbinafine might be the best strategies for maintaining cured status. Because of the different costs of the antifungals, pharmacoeconomic analysis is required to identify the most efficient strategy for dermatophytosis management.

A Tool to Characterize the Components of Pharmacist Interventions in Clinical Pharmacy Services: The DEPICT Project

BACKGROUND The complexity of clinical pharmacy services usually leads to an inconsistent or even poor description of their interventions in scientific reports. To ensure comparability and reproducibility of the evidence, an in-depth description of pharmacist interventions is required. OBJECTIVE To validate a new tool called DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) to characterize clinical pharmacy services. METHODS We developed a 3-phase study. First, to create a theoretical framework, an overview of systematic reviews was performed in PubMed between 2000 and 2010. Then, an in-depth analysis of the included studies was carried out to identify a list of components in order to create the instrument. Finally, 2 independent raters separately applied the tool to a random sample of 28 randomized clinical trials extracted from the systematic reviews. Interrater agreement was evaluated using PABAK (prevalence-adjusted bias-adjusted κ) coefficient or intraclass correlation coefficient (ICC). RESULTS We included 49 systematic reviews in our overview. Analysis of these studies resulted in 58 intervention components, with 57 dichotomous variables and 1 discrete variable. These items resulted in a preliminary version of the instrument. The reliability analysis showed that 8 binary items of this version had a PABAK less than or equal to 0.60. These items were then excluded or modified, resulting in a final version of the tool, with 54 items organized into 12 domains. DEPICT showed an average PABAK of 0.85 (95% CI 0.81 to 0.88) and an ICC of 1.0. Twenty items presented a PABAK value between 0.61 and 0.80 (substantial agreement) and 33 had a value between 0.81 and 1.0 (almost perfect agreement). CONCLUSIONS DEPICT is a reproducible instrument for describing the components of pharmacist interventions performed as part of clinical pharmacy services. It allows retrospective analysis of published studies and can be used as a reference guide to report pharmacist interventions in future studies.

Comparative efficacy of oral nucleoside or nucleotide analog monotherapy used in chronic hepatitis B: a mixed-treatment comparison meta-analysis.

To compare the efficacy of nucleoside or nucleotide analog monotherapy for the treatment of chronic hepatitis virus B (HBV) with adefovir dipivoxil, entecavir, lamivudine, telbivudine, and tenofovir disoproxil fumarate.

Ensuring consistent reporting of clinical pharmacy services to enhance reproducibility in practice: an improved version of DEPICT

RATIONALE, AIMS AND OBJECTIVES DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) was created in response to the frequently reported issue of poor intervention description across studies assessing the impact of clinical pharmacy activities. The aim of this study was to create an improved version of DEPICT (i.e. DEPICT 2) to better characterize clinical pharmacy services in order to ensure consistent reporting, therefore enhancing reproducibility of interventions in practice. METHOD A qualitative approach through a thematic content analysis was performed to identify components of pharmacist interventions described in 269 randomized controlled trials. A preliminary version of DEPICT 2 was applied independently by two authors to a random sample of 85 of the 269 RCTs and reliability determined by the prevalence-adjusted bias-adjusted kappa (PABAK) or the intraclass correlation coefficient (ICC). The final version of DEPICT 2 was compared against DEPICT 1. RESULTS The final version of DEPICT 2 comprised 146 items and 11 domains. The inter-rater agreement analysis showed that DEPICT presented good to optimal reproducibility, with a mean PABAK value of 0.87 (95% CI 0.85-0.89) and a mean ICC value of 0.88 (95% CI 0.62-1.14). The mean difference between items checked in the two versions (DEPICT 2 - DEPICT 1) was 10.58 (95% CI 9.55-11.61), meaning that approximately 11 more components were identified in the new version of DEPICT. CONCLUSIONS DEPICT 2 is a reliable tool to characterize components of clinical pharmacy services, which should be used to ensure consistent reporting of interventions to allow their reproducibility in practice.

Efficacy of topical antifungal drugs in different dermatomycoses: a systematic review with meta-analysis

OBJECTIVE To evaluate and compare the efficacy of topical antifungal drugs applied to the treatment of each dermatomycosis. METHODS A systematic review of randomized clinical trials, published in Portuguese, Spanish and English until July 2010, which compared the use of azole and allylamine antifungal drugs among themselves and with placebo in the treatment of cutaneous candidiasis and T. versicolor, T. pedis, T. cruris and T. corporis was performed. The efficacy outcomes evaluated were mycological cure at the end of treatment and sustained cure. RESULTS Of the 4,424 studies initially identified, 49 met the selection criteria and were included in the meta-analyses. The grouped efficacy data evidenced the superiority of antifungal drugs compared to placebo, regardless of the dermatomycosis under evaluation, with odds ratio values ranging from 2.05 (95% CI 1.18-3.54) to 67.53 (95% CI 11.43-398.86). Allylamines were better than azoles only for the outcome sustained cure (OR 0.52 [95% CI 0.31-0.89]). CONCLUSION There is consistent evidence of the superiority of antifungal drugs over the use of placebo, and placebo-controlled studies are no longer justifiable. Allylamines maintain the mycological cure for longer periods compared to azole drugs. Given the significant cost difference among the classes, pharmacoeconomic analyses should be performed.

A Systematic Review of Evidence-Based Community Pharmacy Services Aimed at the Prevention of Cardiovascular Disease.

BACKGROUND Cardiovascular disease (CVD) is the leading cause of death worldwide and has a substantial impact on peoples health and quality of life. CVD also causes an increased use of health care resources and services, representing a significant proportion of health care expenditure. Integrating evidence-based community pharmacy services is seen as an asset to reduce the burden of CVD on individuals and the health care system. OBJECTIVES To (a) identify community pharmacy evidence-based services designed to help prevent CVD and (b) provide fundamental information that is needed to assess their potential adaptation to other community pharmacy settings. METHODS This review used the DEPICT database, which includes 488 randomized controlled trials (RCT) that address the evaluation of pharmacy services. Articles reviewing these RCTs were identified for the DEPICT database through a systematic search of the following databases: MEDLINE, Scopus, SciELO (Scientific Electronic Library Online), and DOAJ (Directory of Open Access Journals). The DEPICT database was reviewed to identify evidence-based services delivered in the community pharmacy setting with the purpose of preventing CVD. An evidence-based service was defined as a service that has been shown to have a positive effect (compared with usual care) in a high-quality RCT. From each evidence-based service, fundamental information was retrieved to facilitate adaptation to other community pharmacy settings. RESULTS From the DEPICT database, 14 evidence-based community pharmacy services that addressed the prevention of CVD were identified. All services, except 1, targeted populations with a mean age above 60 years. Pharmacy services encompassed a wide range of practical applications or techniques that can be classified into 3 groups: activities directed at patients, activities directed at health care professionals, and assessments to gather patient-related information in order to support the previous activities. CONCLUSIONS This review provides pharmacy service planners and policymakers with a comprehensive list of evidence-based services that have the potential to be adapted to different settings from which they were originally implemented and evaluated in order to reduce the burden of CVD. DISCLOSURES Funding for this review was provided by the University of Technology Sydney Chancellors Postdoctoral Fellowship awarded to Sabater-Hernández. No other potential conflict of interest was declared. Study concept and design were contributed by Sabater-Hernández, Fernandez-Llimos, Rotta, and Correr. Sabater-Galindo and Sabater-Hernández took the lead in data collection, along with Franco-Trigo and Rotta. Data interpretation was performed by Sabater-Hernández, Durks, and Lopes. The manuscript was written primarily by Sabater-Hernández, along with Hossain, and revised by Fernandez-Llimos, Rotta, and Benrimoj, with assistance from Durks, Sabater-Galindo, Franco-Trigo, and Correr.

Eficácia de antifúngicos tópicos em diferentes dermatomicoses: uma revisão sistemática com metanálise

OBJECTIVE: To evaluate and compare the efficacy of topical antifungal drugs applied to the treatment of each dermatomycosis. METHODS: A systematic review of randomized clinical trials, published in Portuguese, Spanish and English until July 2010, which compared the use of azole and allylamine antifungal drugs among themselves and with placebo in the treatment of cutaneous candidiasis and T. versicolor, T. pedis, T. cruris and T. corporis was performed. The efficacy outcomes evaluated were mycological cure at the end of treatment and sustained cure. RESULTS: Of the 4,424 studies initially identified, 49 met the selection criteria and were included in the meta-analyses. The grouped efficacy data evidenced the superiority of antifungal drugs compared to placebo, regardless of the dermatomycosis under evaluation, with odds ratio values ranging from 2.05 (95% CI 1.18-3.54) to 67.53 (95% CI 11.43-398.86). Allylamines were better than azoles only for the outcome sustained cure (OR 0.52 [95% CI 0.31-0.89]). CONCLUSION: There is consistent evidence of the superiority of antifungal drugs over the use of placebo, and placebo-controlled studies are no longer justifiable. Allylamines maintain the mycological cure for longer periods compared to azole drugs. Given the significant cost difference among the classes, pharmacoeconomic analyses should be performed.

Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45 mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45 mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.Conduziu-se uma revisao sistematica e metaanalise de ensaios clinicos randomizados em pacientes com psoriase moderada a grave, tratados com biologicos ou placebo por 10 a 14 semanas. Foram incluidos 41 estudos, com escore de Jadad medio de 4,4, totalizando 15.586 pacientes. Para os desfechos de eficacia PASI 50, 75 e 90 os resultados nao sao conclusivos para definir qual e o melhor agente biologico no curto prazo. Nao houve diferenca estatistica entre placebo e biologicos para ocorrencia de infeccoes e eventos ad-versos serios. Ustequinumabe 45mg foi o biologico com menor ocorrencia de descontinuacao por conta de eventos adversos. Baseado na evidencia ate entao disponivel, nao e possivel determinar qual agente biologico e o melhor para se atingir resposta PASI 50, 75 e 90 apos 10-14 semanas de tratamento. Para o mesmo intervalo, a seguranca global parece ser a mesma para todos os biologicos e ustequinumabe 45mg o tratamento melhor tolerado. Para melhor compreender a eficacia e seguranca, meta-analise indireta comparando droga-a-droga sao necessarias ja que ensaios clinicos randomizados podem nao ser viaveis.

Pharmacist-led discharge medication counselling: A scoping review

RATIONALE, AIMS, AND OBJECTIVES Discharge medication counselling has produced improved quality of care and health outcomes, especially by reducing medication errors and readmission rates, and improving medication adherence. However, no studies have assembled an evidence-based discharge counselling process for clinical pharmacists. Thus, the present study aims to map the components of the pharmacist-led discharge medication counselling process. METHODS We performed a scoping review by searching electronic databases (Pubmed, Scopus, and DOAJ) and conducting a manual search to identify studies published up to July 2017. Studies that addressed pharmacist-led discharge medication counselling, regardless of the population, clinical conditions, and outcomes evaluated, were included. RESULTS A total of 1563 studies were retrieved, with 75 matching the inclusion criteria. Thirty-two different components were identified, and the most prevalent were the indication of the medications and adverse drug reactions, which were reported in more than 50% of the studies. The components were reported similarly by studies from the USA and the rest of the world, and over the years. However, 2 differences were identified: the use of a dosage schedule, which was more frequent in studies published in 2011 or before and in studies outside the USA; and the teach-back technique, which was used more frequently in the USA. Poor quality reporting was also observed, especially regarding the duration of the counselling, the number of patients, and the medical condition. CONCLUSION Mapping the components of the pharmacist-led discharge counselling studies through a scoping review allowed us to reveal how this service is performed around the world. Wide variability in this process and poor reporting were identified. Future studies are needed to define the core outcome set of this clinical pharmacy service to allow the generation of robust evidence and reproducibility in clinical practice.