Artificial intelligence applied in human health technology assessment: a scoping review protocol.

OBJECTIVE: This scoping review aims to map studies that applied artificial intelligence (AI) tools to perform health technology assessment tasks in human health care. The review also aims to understand specific processes in which the AI tools were applied and to comprehend the technical characteristics of these tools. INTRODUCTION: Health technology assessment is a complex, time-consuming, and labor-intensive endeavor. The development of automation techniques using AI has opened up new avenues for accelerating such assessments in human health settings. This could potentially aid health technology assessment researchers and decision-makers to deliver higher quality evidence. INCLUSION CRITERIA: This review will consider studies that assesses the use of AI tools in any process of health technology assessment in human health. However, publications in which AI is a means of clinical aid, such as diagnostics or surgery will be excluded. METHODS: A search for relevant articles will be conducted in databases such as CINAHL (EBSCOhost), Embase (Ovid), MEDLINE (PubMed), Science Direct, Computer and Applied Sciences Complete (EBSCOhost), LILACS, Scopus, and Web of Science Core Collection. A search for gray literature will be conducted in GreyLit.Org, ProQuest Dissertations and Theses, Google Scholar, and the Google search engine. No language filters will be applied. Screening, selection, and data extraction will be performed by 2 independent reviewers. The results will be presented in graphic and tabular format, accompanied by a narrative summary. DETAILS OF THIS REVIEW CAN BE FOUND IN OPEN SCIENCE FRAMEWORK: osf.io/3rm8g.

Efficacy and safety of onasemnogene abeparvovec for the treatment of patients with spinal muscular atrophy type 1: A systematic review with meta-analysis.

BACKGROUND: Onasemnogene abeparvovec has been approved for the treatment of spinal muscular atrophy 5q type 1 in several countries, which calls for an independent assessment of the evidence regarding efficacy and safety. OBJECTIVE: Conduct a meta-analysis to assess the efficacy and safety of onasemnogene abeparvovec in patients diagnosed with SMA type 1, based on the available evidence. METHODS: This article results from searches conducted on databases up to November 2022. Outcomes of interest were global survival and event-free survival, improvement in motor function and treatment-related adverse events. Risk of bias assessment and certainty of evidence were performed for each outcome. Proportional meta-analysis models were performed when applicable. RESULTS: Four reports of three open-label, non-comparative clinical trials covering 67 patients were included. Meta-analyses of data available in a 12-month follow-up estimate a global survival of 97.56% (95%CI: 92.55 to 99.86, I2 = 0%, n = 67), an event-free survival of 96.5% (95%CI: 90.76 to 99.54, I2 = 32%, n = 66) and a CHOP-INTEND score ≥ 40 points proportion of 87.28% (95%CI: 69.81 to 97.83, I2 = 69%, n = 67). Proportion of 52.64% (95%CI: 27.11 to 77.45, I2 = 78%, n = 67) of treatment-related adverse events was estimated. CONCLUSION: The results indicate a potential change in the natural history of type 1 SMA, but the methodological limitations of the studies make the real extent of the technology's long-term benefits uncertain.

Efficacy and Safety of Once-Weekly Subcutaneous Semaglutide in Overweight or Obese Adults: A Systematic Review with Meta-Analysis.

BACKGROUND: To evaluate the efficacy and safety of once-weekly subcutaneous semaglutide treatment in overweight or obese patients without type 2 diabetes. METHODS: Randomized clinical trials that assessed the impact of once-weekly semaglutide on body weight and safety outcomes in overweight or obese patients were retrieved from PubMed, EMBASE, and Lilacs up to November 2023. Risk of bias was assessed with RoB 2.0, and certainty of evidence (CoE) with GRADE. A random-effects meta-analysis was conducted. RESULTS: Ten publications, with 22.155 patients, were included. Semaglutide decreased relative body weight (MD: -11.80; 95%CI: -13.53 to -10.07; CoE: High), absolute body weight (MD: -11.58; 95%CI: -13.25 to -9.90; CoE: High) and BMI (MD: -4.15; 95%CI: -4.85 to -3.45; CoE: High). Semaglutide also increased the proportion of patients who achieved 5%, 10%, and 15% of weight loss ([weight loss≥5%: RR 2.29, 95% CI: 1.88 to 2.80; CoE: High]; [weight loss≥10%: RR 4.54, 95% CI: 3.45 to 5.98; CoE: High]; [weight loss≥15%: RR 8.29, 95%CI: 5.54 to 12.39; CoE: High]). Semaglutide leads to small risk to adverse events (RR: 1.03; 95%CI: 1 to 1.06; CoE: High), no difference in the serious adverse events (RR: 1.07; 95%CI: 0.70 to 1.62; CoE: Low), but increases in the risk to discontinued treatment (RR: 2.03; 95%CI: 1.87 to 2.20; CoE: High) and gastrointestinal adverse events (RR: 3.26; 95%CI: 1.99 to 5.34; CoE: Moderate). CONCLUSION: This up-to-date systematic review highlights that once-weekly semaglutide treatment resulted in clinically important weight loss, becoming a promising adjuvant therapy for obesity.

Key performance indicators for pharmaceutical services: A systematic review.

Background: Key performance indicators (KPIs) are a set of indicators that improve the quality of services provided by pharmacists. They enable the monitoring and evaluation of result progress and optimize decision-making for stakeholders. Currently, there is no systematic review regarding KPIs for pharmaceutical services. Objectives: To identify and assess the quality of KPIs developed for pharmaceutical services. Methods: A systematic review was conducted in PubMed, Scopus, EMBASE, and LILACS from the inception of the database until February 5th, 2024. Studies that developed a set of KPIs for pharmaceutical services were included. The indicators were evaluated using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. Two independent reviewers performed the study selection, data extraction, and quality assessment. Results: Fifteen studies were included. The studies were conducted in different regions, most of which were developed for clinical services in hospitals or ambulatory settings, and used similar domains for the development of KPIs such as medication review, patient safety, and patient counseling. Literature review combined with the Delphi technique was the method most used by the studies, with content validity by inter-rater agreement. Regarding methodological quality, most studies described information on the purpose, definition, and stakeholders' involvement in the set of KPIs. However, little information was observed on the strategy for risk adjustment, instructions for presenting and interpreting the indicator results, the detailed description of the numerator and denominator, evidence scientific, and the feasibility of the set of KPIs. Only one study achieved a high methodological quality in all domains of the AIRE tool. Conclusion: Our findings showed the potential of KPIs to monitor and assess pharmacy practice quality. Future studies should expand KPIs for other settings, explore validity evidence of the existing KPIs, provide detailed descriptions of evidence, formulation, and usage, and test their feasibility in daily practice.

Cost-Effectiveness of Onasemnogene Abeparvovec Compared With Nusinersen and Risdiplam in Patients With Spinal Muscular Atrophy Type 1 in Brazil: Custo-Efetividade do Onasemnogeno Abeparvoveque (AVXS-101) em Comparação ao Nusinersena e Risdiplam em Pacientes com Atrofia Muscular Espinhal Tipo 1 no Brasil.

OBJECTIVES: This study aimed to evaluate the cost-effectiveness of the onasemnogene abeparvovec in relation to nusinersen and risdiplam in the treatment of spinal muscular atrophy type 1 from the perspective of the Brazilian Unified Health System. METHODS: A Markov model was built on a lifetime horizon. Short-term data were obtained from clinical trials of the technologies and from published cohort survival curves (long term). Costs were measured in current 2022 local currency (R$) values and benefits in quality-adjusted life-years (QALYs). Utility values were derived from type 1 spinal muscular atrophy literature, whereas costs related to technologies and maintenance care in each health state were obtained from official sources of reimbursement in Brazil. Deterministic and probabilistic, as well as scenario, sensitivity analyses were performed. RESULTS: Compared with the less costly strategy (nusinersen), the use of onasemnogene abeparvovec resulted in an incremental cost of R$2.468.448,06 ($975 671.169 - purchasing power parity [PPP]) and a 3-QALY increment and incremental cost-effectiveness ratio of R$742.890,92 ($293 632.774 - PPP)/QALY. Risdiplam had an extended dominance from other strategies, resulting in an incremental cost-effectiveness ratio of R$926.586,22 ($366 239.612 - PPP)/QALY compared with nusinersen. Sensitivity analysis showed a significant impact of the follow-up time of the cohort and the cost of acquiring onasemnogene abeparvovec. CONCLUSIONS: Over a lifetime horizon, onasemnogene abeparvovec seems to be a potentially more effective option than nusinersen and risdiplam, albeit with an incremental cost. Such a trade-off should be weighed in efficiency criteria during decision making and outcome monitoring from the perspective of the Brazilian Unified Health System.

Ensino experiencial na farmácia universitária: um estudo de perspectiva etnográfica na educação / Experiential learning in a university pharmacy: a study adopting the ethnographic approach to education / Enseñanza experiencial en la farmacia universitaria: un estudio de perspectiva etnográfica en la educación

O objetivo deste estudo foi refletir sobre o desafio da formação de identidade profissional do farmacêutico clínico em um contexto de currículo não integrado e em um ambiente tradicional e especializado. Desenvolveu-se uma pesquisa qualitativa orientada pelos pressupostos da perspectiva etnográfica na educação, empregando-se múltiplos métodos de coleta de dados entre abril e julho de 2019. O cenário de ensino experiencial foi uma Farmácia Universitária da região Sul do Brasil. Por meio de uma descrição densa e com uso da reflexividade teórica e intertextual, é apresentada uma narrativa utilizando a voz dos participantes como âncora para dar visibilidade ao processo vivenciado. A ausência de um padrão para o cuidado na profissão farmacêutica, o currículo tradicional e a desarticulação entre teoria e prática constituem desafios para os estudantes de Farmácia legitimarem a prática profissional farmacêutica centrada no usuário.(AU)

The aim of this study was to reflect on the challenge of forming the professional identity of clinical pharmacists in the context of non-integrated curriculums and a traditional specialized environment. We conducted a qualitative study between April and July 2019 guided by the ethnographic approach to education, employing multiple data collection methods. The experiential learning setting was a university pharmacy in the south of Brazil. By means of a thick description and through the use of theoretical and intertextual reflexivity, we present a narrative using the voice of the participants as an anchor to provided visibility to the experienced process. The absence of a standard for the care process in the pharmacy profession, the traditional curriculum, and the lack of connection between theory and practice are challenges facing pharmacy students in legitimizing patient-centered professional practice.(AU)

El objetivo de este estudio fue reflexionar sobre el desafío de la formación de la identidad profesional del farmacéutico clínico en un contexto de currículum no integrado y en un ambiente tradicional y especializado. Se desarrolló una investigación cualitativa orientada por las presuposiciones de la perspectiva etnográfica en la educación, utilizándose múltiples métodos de colecta de datos entre abril y julio de 2019. El escenario de la enseñanza experiencial fue una Farmacia Universitaria de la región sur de Brasil. Por medio de una descripción densa y con el uso de la reflexividad teórica e intertextual se presenta una narrativa que utiliza la voz de los participantes como ancla para dar visibilidad al proceso vivido. La ausencia de un estándar para el proceso de cuidado en la profesión farmacéutica, el currículum tradicional y la desarticulación entre teoría y práctica se constituyen en desafíos para que los estudiantes de Farmacia legitimen la práctica profesional farmacéutica centrada en el usuario.(AU)

Pharmacists' contribution to benzodiazepine deprescribing in older outpatients: a systematic review and meta-analysis.

BACKGROUND: Consolidated and reliable evidence regarding the effectiveness of pharmacist interventions for deprescribing benzodiazepines in older outpatients is lacking. AIM: This study evaluated and summarized the impact of pharmacist interventions on benzodiazepine deprescribing among older outpatients. METHOD: A literature search was conducted until August 2022 in PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials databases. The review included randomized controlled trials that assessed the impact of pharmacist interventions on deprescribing benzodiazepine in older outpatients. Two independent investigators conducted the study selection, data extraction, and risk of bias assessment. Meta-analyses were conducted using random-effect models in the RStudio software. RESULTS: A total of 893 records were identified. Five studies, including 3,879 patients, met the inclusion criteria and were included in the systematic review. All five studies used health education as an intervention strategy, and three also conducted medication reviews. There was no evidence of the pharmacist's authority to modify prescriptions during benzodiazepine deprescribing. One study was classified as having a low risk of bias, whereas the other had some concerns or a high risk of bias. Three studies were included in the meta-analysis and a significant impact of pharmacist interventions on benzodiazepines deprescribing rates in older outpatients was observed (RR = 2.75 [95%CI 1.29; 5.89]; p = 0.04; I2 = 69%; low certainty of evidence). CONCLUSION: Pharmacists may contribute to deprescribing benzodiazepines in older outpatients. Further studies are needed to increase the reliability of these findings. PROSPERO registration number: CRD42022358563.

Factors Associated With PIM use in the Frail Elderly: A Cross-sectional Study.

Background: The use of potentially inappropriate medications (PIM) by the elderly is commonly studied, but studies evaluating the use of PIM by frail elderly covered by prepaid health plans are still lacking. Objective: To identify the prevalence of use and the factors associated with the use of PIM by the elderly patients with high and moderate risk of clinical-functional vulnerability, according to the Beers criteria 2019. Methods: A cross-sectional study was developed with elderly people from a private health plan in Vitória-ES, Brazil. Socioeconomic, demographic and clinical data were collected through a digital platform and a structured questionnaire through an interview, from October 2018 to June 2019. The association between the use of PIM and independent variables was verified by univariate logistic regression with their respective confidence intervals (CI) 95%. The Multiple Model included the variables with P ≤ .20. Results: 332 elderly patients were interviewed (mean age 81.5 years, gender 237 female, 95 male). A 65% prevalence of PIM use was identified. In the multiple logistic regression model, the variables associated with the use of PIM were self-medication (P = .004), high risk of clinical-functional vulnerability (P = .022), use of psychotropic medications (P = .000001), musculoskeletal medications (P = .04) and alimentary tract medications (P = .03). Physical exercises were considered a protection factor (P = .02). Conclusion: The high prevalence of PIM use indicates the need for improvement in elderly private health care, to increase pharmacotherapy safety for this population.

Implementation of Medication Reconciliation conducted by hospital pharmacists: A case study guided by the Consolidated Framework for Implementation Research.

BACKGROUND: Medication reconciliation (MR) implementation in hospital care transitions has proved to be a challenge for health professionals and managers. It points to the need to conduct Implementation Research with a view to understanding the tasks of the real world and knowing how they impact this process. Guided by the Consolidated Framework for Implementation Research (CFIR), this study aims to analyze the factors that influenced the MR implementation process conducted by pharmacists at a hospital setting. METHODS: A qualitative case study was carried out in the cardiology and gastroenterology units of a teaching hospital in Brazil, involving participant observation and semi-structured interviews with physicians, pharmacists, nurses, nutritionists and a social worker. The CFIR was used to guide data collection and thematic analysis. The constructs were classified according to their influence and strength. RESULTS: Sixteen health professionals involved directly or indirectly with MR implementation participated in the study. Based on the analysis of the participants' quotes and of the field diary, 18 constructs of the CFIR were identified as influencing MR implementation. The constructs that most strongly influenced MR implementation concerned "Inner Setting", "Characteristics of Individuals" and "Characteristics of Intervention". The participating professionals showed little knowledge of MR and had different points of view on its scope, weakly relating MR to patient safety. The tools used to conduct MR were adapted according to the hospital's needs, thus facilitating its implementation. However, MR proved to be complex and require clinical knowledge and aligned teamwork to identify and resolve undocumented medication discrepancies, being as well intertwined with culture and organizational communication. CONCLUSIONS: The results point to implementation failures and highlight that MR is a complex intervention, requiring specific knowledge from the multidisciplinary team and alignment with other existing workflows. The barriers and facilitators identified may serve to design and test implementation improvement strategies.

Application and utility of geographic information systems in pharmacy specific health research: A scoping review.

BACKGROUND: Geographic Information Systems (GIS) are considered essential tools to analyze spatially referenced health data. OBJECTIVES: The purpose of this scoping review is to describe how GIS is used in pharmacy specific health research. METHODS: During July 2020, the following databases were searched: EMBASE, MEDLINE (PubMed), Web of Science and Scopus. The search strategy included terms relating to spatial analysis and pharmacy. Studies were considered eligible if they involved the use of GIS and focused on pharmacies. A narrative and tabular synthesis of the results was carried out, structured around the spatial analysis methods utilized across studies, as well as the characteristics of pharmacies evaluated in studies. RESULTS: After a review of 6967 sources, 48 studies were included in this review. Twenty-nine studies were conducted in the United States (60.4%) and thirty-six focused on accessibility (75.0%; n = 36). Twenty-two studies investigated the relationship between sociodemographic aspects of the population and the accessibility and availability of pharmacies (45.8%). Twelve studies (25.0%) performed distance analysis and six studies (12.5%) performed geostatistical analysis. Community pharmacies were the setting evaluated most frequently, with over-the-counter selling products being the most evaluated pharmacy variable (13.3%; n = 6). Population density (58.3%; n = 28), income indicators (43.8%; n = 21) and minority community composition rates (41.7%; n = 20) were the most used population variables. CONCLUSIONS: GIS have been increasingly used in pharmacy specific health research. Generally, research has sought to identify potential barriers to access and their effects on the population. Future research may benefit by utilizing robust spatial methods and applications across countries outside of the United States. Doing so could help to confirm the impact of sociodemographic characteristics on the availability and/or accessibility of pharmacies globally.

Factors influencing the implementation of pharmaceutical care in outpatient settings: A systematic review applying the Consolidated Framework for Implementation Research.

BACKGROUND: Pharmaceutical care in outpatient settings is a type of health service that has been shown to contribute to decreasing drug-related morbidity and mortality rates. However, every process of implementing a new service brings about changes and transformations in the work routine, thus posing challenges. OBJECTIVES: This systematic review aims to identify barriers to and facilitators for the implementation of pharmaceutical care in outpatient settings by applying the CFIR method, a framework based on the theory of health services, used to analyze and synthesize research data, which can direct strategies for the service to work as planned. METHODS: A systematic review was conducted exploring the barriers to and facilitators for the implementation of pharmaceutical care in outpatient settings. The MEDLINE, EMBASE, CINAHL, COCHRANE, and LILACS databases were consulted. RESULTS: Eight studies were included: five qualitative ones, two mixed-method ones, and a quantitative one. The most frequent CFIR constructs identified were Patient Needs and Resources (n = 30, 10.75%), Knowledge and Beliefs about the Intervention (n = 31, 11.11%), Networks and Communications (n = 34, 12.19%), and Available Resources (n = 56, 20.07%). The most cited barriers were: insufficient human resources, patients' unawareness of the existence of the pharmaceutical care service, and pharmacists' resistance to changes. Facilitators included: the opportune presentation of the service to the healthcare team; the use of electronic devices for specific guidance; and the assessment of patient satisfaction. CONCLUSIONS: This systematic review allowed detecting key guidelines to improve the implementation process, including (1) defining an implementation method and exploring it extensively during the pre-implementation phase, (2) ensuring human and financial resources, (3) determining how the new service will interact with other existing services. More research is needed to understand how these factors can affect the implementation of clinical services.

Medication Reconciliation at hospital admission and discharge: Evaluation of fidelity and process outcomes in a real-world setting.

OBJECTIVES: The study aimed to assess the fidelity of Medication Reconciliation (MR) delivered by the pharmacist at hospital admission and discharge, and the process outcomes. METHODS: Prospective study conducted in cardiology and cardiovascular surgery unit of a university hospital between September 2019 and January 2020. Independent observers collected data to measure MR fidelity, related to coverage, sources of information used to collect medication history and presence of outstanding and resolved Undocumented Discrepancies (UD). Process outcomes included medication errors and their potential to cause harm, identified by the pharmacist during the formal MR process. RESULTS: Of the eligible patients, 122 (69.7%) had their medications reconciled in a timely manner at hospital admission and 50 (43.8%) at discharge. The pharmacist consulted 2.76 (±0.8) sources of information to build the medication history, on average. At least one outstanding UD was found in 101 (82.8%) patients at admission and in 41 (82.0%), at discharge. The average number of outstanding UD per patient at admission and discharge was 3.0 (±2.6) and 2.4 (±1.9), respectively. The UD communicated to the physician by the pharmacist during the formal MR process, involved mainly omission errors and were classified as requiring monitoring or potentially necessary intervention. In the univariate analysis, the number of drugs pre-admission and admission, the reason for admission and non-elective readmission in 30 days were associated with the presence of medication errors at admission. CONCLUSIONS: This study found a high number of UD, suggesting flaws in the implementation of MR and highlight the importance of quality measurement.

Tools to prioritize outpatients for pharmaceutical service: A scoping review.

BACKGROUND: The performance of pharmacists in clinical services contributes to improving outcomes in patient drug therapy. In the context of streamlined resources and high health services' demand, the use of patient selection tools can screen those who would benefit more from a pharmaceutical service. OBJECTIVE: This review aims to map and describe tools developed for patient selection for pharmaceutical services delivered in primary health care and outpatient settings. METHODS: The search was conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and the Latin American and Caribbean Health Sciences. The search strategy included terms relating to patient selection and outpatient pharmaceutical service. We included papers on outpatient settings, and which described the tool developed for the selection of a patient for pharmaceutical service. Two reviewers extracted data of each study concerning the types and items making up the tool. The items composing the tools were grouped into categories. RESULTS: Twelve studies were included in the literature. Most of the studies were developed in the United States (53.8%), followed by Canada (30.8%). Approximately half of the studies developed tools for selecting patients for a medication review (46.2%), and only 15.4% for drug therapy management. Identification of patients at risk of drug-related problems, the need for pharmaceutical service follow-up, and patients at risk of hospital readmission were the main objective to develop the tools. In total, 92.3% of the developed tools had items related to drug therapy complexity, 76.9% to comorbidities and 61.5% to adherence/subjective aspects. Statistical methods were employed to evaluate the validation parameters, such as the ROC curve and internal consistency. CONCLUSIONS: Few studies that developed tools to select outpatients for pharmaceutical services were found. However, many tools showed unsatisfactory validation parameters. Thus, it is necessary to improve the development of instruments that can identify patients who would benefit from the pharmaceutical service accurately.

Pharmacist-led medication reconciliation at patient discharge: A scoping review.

BACKGROUND: One of the strategies to promote patient safety in care transitions is medication reconciliation (MR), which is conducted by the pharmacist at the patient's discharge from hospital. However, there are divergences about this process and about the pharmacist's role in conducting such intervention. OBJECTIVE: To systematically review the literature that reports the MR process led by pharmacists at patient discharge and map the different methods, strategies and tools used in the process. METHODS: Relevant studies were searched in the following databases: EMBASE, MEDLINE (PubMed), The Cochrane Library, and LILACS. No language restriction or publication date was applied. The studies considered eligible were those involving and describing pharmacist-led MR processes at acute patient discharge from hospital, with an experimental, quasi-experimental, or observational design. The characteristics of the studies and the MR processes were identified and then a qualitative synthesis was performed. RESULTS: Fifty studies were included. The majority of them were observational ones (82%), and the main outcome was medication discrepancies (42%). The studies were mostly conducted in university hospitals (70%) and in internal medicine wards (54%). Pharmacists were responsible mainly for gathering medication histories (72%), and identifying (96%) and solving (98%) pharmacotherapeutic problems. The main sources of information on pre-admission medications were patient/caregiver interviews (66%) and records from other care providers (40%). Only 30% of the studies described a patient discharge plan, and 14% shared information of the patient's pharmacotherapy with community pharmacists. CONCLUSION: The concept of MR and the pharmacist-led activities in the process varied in the literature, as well as the pharmacotherapy assessment focus and the communication strategies towards patients and other care providers, showing that standardization of the process and concepts is necessary.