JMIR Publications

ABSTRACT

Background:

Introduction: The clinical activities developed by pharmacists in a hospital environment can improve health outcomes and generate savings for hospitals. However, to determine whether pharmaceutical interventions are cost-effective, it is essential to define a method according to which cost-effectiveness is intended to be measured. In addition, the quality of economic assessments and the amount of information present in systematic reviews in the literature make it difficult to analyse the effects of this intervention. Therefore, we describe a protocol for an overview of systematic reviews on the pharmacoeconomic impact of the performance of clinical pharmacists in hospitals. Methods and analysis. A systematic search of the Cochrane Library databases, PubMed/MEDLINE, LILACS, Scopus, Web of Science, Google Scholar, and Open Thesis will be performed using the PRISMA statement. The search will involve the use of keywords determined using the Medical Subject Headings (MeSH) database to define the search terms and include the following terms: ‘pharmacoeconomics’, ‘clinical pharmacy services’, and ‘hospital’. The study designs to be included will be systematic reviews of good quality. The primary result will be the ratio of cost, in monetary units, to the outcome, in monetary units or natural units. The secondary economic results will be determined based on factors associated with drugs and translated into benefit, effectiveness, or usefulness. Ethics and dissemination. The review will be performed under Master's research approved by the Ethics Committee of the University Hospital of the Federal University of Sergipe. The results will be submitted to indexed journals and national and international meetings. Registration number: PROSPERO CRD420191406665. Keywords: pharmacoeconomics; service clinical pharmacy; hospital.

Objective:

Provir an overview of systematic reviews on the pharmacoeconomic impact of the performance of clinical pharmacists in hospitals

Methods:

METHODS AND ANALYSIS This study protocol is reported according to the reporting guidelines provided in the Statement of Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P)17 (see attached file). The review protocol was registered in the International Prospective Registry of Systematic Reviews (PROSPERO) [CRD420191406665]. Information sources and search strategy A systematic search of the Cochrane database, PubMed, MEDLINE, Latin American Literature in Health Sciences (LILACS), Scopus, Web of Science, Google Scholar, and Open Thesis will be conducted. The search strategy will use terms from the Medical Subject Headings (MeSH) and Descriptores en Ciencias de la Salud (DeCS) databases: (pharmacoeconomics); (‘Pharmaceutical economics’) (‘pharmacy economics’); (‘Pharmacy economic’); (‘Pharmaceutical economics’); and (‘Clinical pharmacy services’), (‘clinical pharmacy service’), (‘pharmacy service, hospital’), (hospital), (hospitals) (Table 1). Inclusion criteria The eligibility criteria were defined according to the PICO strategy (population-intervention-comparison-result) with the following variables: pharmacoeconomic studies (cost-minimisation, cost-benefit, cost-effectiveness, and cost-utility analyses), (ii) studies that evaluated clinical pharmaceutical services in hospitals, and (iii) studies published in Portuguese, English, or Spanish. Exclusion criteria Systematic reviews in which the interventions performed by pharmacists in the health team are not clearly distinguishable (i); overviews (ii); and systematic reviews that analysed non-clinical activities such as medication handling, storage, administration (including vaccines), or other logistical activities (iii) were excluded. Study design The present study will provide an overview of systematic reviews. The overview seeks to meet the need for evaluating and synthesising the results of systematic reviews, optimising and improving access to information, and decision making.18 Thus, the following publications obtained from a systematic search of more than one database of literature will be considered: publications that clearly specify the review question, eligibility criteria, and selection of the studies involved; in which data collection was performed by two or more reviewers; in which the risk of bias in the included studies was evaluated, and in which information is synthesised using a quantitative or qualitative approach. Population of the included studies Studies that included hospitalised patients who were using at least one medication will be considered. Scenarios of the included studies Studies conducted in hospitals anywhere in the world will be considered as long as they meet the inclusion criteria. Intervention/comparison Studies comparing the clinical results of patients receiving clinical pharmaceutical services to those of patients for whom there were no pharmacist interventions will be considered. Outcomes of interest The primary result will be the ratio of cost (currency unit) to the outcome (currency unit or natural units, for example, years of life or quality-adjusted life-years [QALYs]). This is usually presented as an outcome. The secondary economic results will be the determinants or factors associated with medications translated into benefits (such as days of hospitalisation avoided; days of work that will be lost; and materials, labour, and equipment that could be relocated), effectiveness (in terms of parameters such as years of life gained, lives saved, cholesterol reduction, mmHg of reduced blood pressure, number of cases prevented, time of symptoms, and reduction of recurrence rates), and usefulness (Years of Life Adjusted by Quality - AVAC or QALY). Screening and selection of studies All articles identified in the literature search will be screened by two reviewers, regardless of duplicate removal using EndNote. The titles and abstracts of the articles returned from the initial searches will be selected based on the eligibility criteria described above (section "Inclusion criteria"). The full texts will be examined in detail and selected for eligibility. The references of all articles considered will be searched manually to identify any relevant reports lost in the search strategy. Any disagreements will be resolved by discussion, if necessary. A PRISMA flow chart showing details of included and excluded studies at each stage of the study selection process will be provided. Data extraction and management A data extraction form will be designed using the online platform Google Forms. Google Forms will allow the management of articles and allow authors to collaborate simultaneously. The review team will receive training on how to use Google Forms before the start of the study to ensure calibration of the forms and methods of data collection. The data to be collected in this overview will be in accordance with the items described in Table 2. Study characteristics The following data will be extracted from the studies selected: name of the first author, study design, year of publication, journal, year (or period) of the study, sample size, scenario, geographic location of the study, among others. Data relevant to the evaluation of the methodological quality of the studies will be collected. Methodological quality assessment The evaluation of the methodological quality of systematic reviews will be performed using the Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) instrument. R-AMSTAR is a revised version of AMSTAR, which consists of 11 items with good content validity for measuring the methodological quality of systematic reviews. It is widely accepted and used because of its reliability and reproducibility. Before the start of the assessment, the items that make up the list will be widely discussed and a manual will be created to guide the interpretation of the R-AMSTAR items to ensure consistency in the analysis. For the evaluation of systematic reviews, the following items will be considered: conducting a project; the selection of studies and data extraction search in pairs; scope of the bibliographic research; analysis of the type of publication (for example, theses, dissertations, and book chapters), availability of included and excluded studies, providing the characteristics of the included studies, evaluation and documentation of the scientific quality of the included studies, use of the scientific quality of the studies included in the formulation of the conclusions; suitability of the methods used to combine the findings of the studies; assessment of the likelihood of publication bias; and inclusion of conflict of interest. Summary of the data Data from each study will be used to create tables of evidence for a general description of the included studies. Monetary values will be presented as mean and standard deviation, and natural outcomes will be presented by descriptive methods. We will also establish a model of quality effects to examine how the quality of each study changes the average result. A comparison of the review methods will be performed in terms of the eligibility criteria (criteria used to identify eligible patients, study designs, and endpoints of interest), details of bibliographic search (dates, databases, main differences in the strategies employed, taking into account language restrictions), endpoint definitions used, and rigorous review methods (as reflected by variations in R-AMSTAR assessments and other aspects of the study methodology). The statistical program SPSS version 17.0 will be used to calculate the kappa index to verify the agreement in the selection of studies included among the authors, thus decreasing the chance of missing out on a study and the possibility of bias. In addition to the above, the Risk of Bias in Systematic Reviews (ROBIS) will be used. ROBIS assesses both the risk of bias and the relevance of the research question to be answered.19 Ethics and dissemination The review will be performed under Master's research approved by the Ethics Committee of the University Hospital of the Federal University of Sergipe. The results will be submitted to indexed journals. We will present at national and international meetings.

Results:

DISCUSSION This overview will determine the pharmacoeconomic impact of clinical pharmacist interventions in the hospital environment. In addition, this study will point out which clinical outcomes in natural units are impacted by the performance of clinical pharmacists. Although studies have shown the positive clinical, economic, and human benefits of the interventions of clinical pharmacists for patients and institutions, the subject is not yet exhausted, and the analysis of robust scientific evidence can improve the significance of the results. This work will identify and fill the knowledge gaps in the field.20 According to De Rijdt et al. (2008)21, the economic evaluations of clinical pharmacy services, for the most part, have a series of methodological limitations related to the absence of a control group without clinical pharmaceutical interventions, limited scope of costs and results, focus limited to direct health costs, exclusion of the cost of employing pharmacists, use of intermediate outcomes, exclusion of health benefits, and absence of incremental cost analysis. Perez et al. (2005)22, in their assessment of clinical pharmacy services, reported that most studies were conducted in hospitals with the most common types of pharmacotherapeutic monitoring and disease management services. The authors highlight the variation in the quality of studies, with less than half being considered good or reasonable.19 In this sense, it is necessary to better understand the effects of these pharmaceutical interventions will make it possible to define strategies to facilitate their implementation and integration in hospital care. Consequently, it is possible to overcome their negative effects and optimise the positive ones to use them to their full potential as a tool to support clinical pharmacy services and ultimately improve results. Any changes made to this protocol during the course of the study will be reported in the final manuscript and reported in PROSPERO. The results will be made public through publication in a peer-reviewed journal. There are several limitations to our planned systematic review. We plan to identify reviews that are indexed in specific databases, which may restrict the inclusion of systematic reviews that are not in the selected databases. Furthermore, there is a limitation related to the language, since the search for manuscripts will be performed in three languages (Portuguese, English, and Spanish), which restricts the selection in other languages. Contributors Concept and design of study: FJRA, FVF, CASS, IMCB and DPLJ. Refining the methodology and data extraction tools: FJRA, MCR, CASS and ADOF. Drafting the manuscript: FJRA, FVF, MCR, CASS and DPLJ. Revising manuscript critically for content: IMCB, ADOF and DPLJ. Final approval of the version to be published: FJRA, FVF and DPLJ. Competing interests None declared. Funding This research received no specific grant from any funding agency in the public commercial or not-for-profit sectors.

Conclusions:

Not applicable Clinical Trial: PROSPERO CRD420191406665.