Evidence map›Paper›PMID 40202573›Full record

ArticleInternational journal of clinical pharmacy2025

Guidelines for reporting artificial intelligence studies in medicines, pharmacotherapy, and pharmaceutical services: MedinAI development, validation and statement.

Wallace Entringer Bottacin, Thais Teles de Souza, Walleri Christini Torelli Reis, Ana Carolina Melchiors

Abstract readValidation Study
PubMed Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Wallace Entringer BottacinPostgraduate Program in Pharmaceutical Services and Policies, Federal University of Paraná, Avenida Prefeito Lothário Meissner, 632 - Jardim Botânico, Curitiba, PR, CEP 80210-170, Brazil. wallace.bottacin@gmail.com.ORCID http://orcid.org/0000-0001-7721-5876
Thais Teles de SouzaDepartment of Pharmaceutical Sciences, Federal University of Paraíba, João Pessoa, PB, Brazil.ORCID http://orcid.org/0000-0002-6820-4259
Walleri Christini Torelli ReisPostgraduate Program in Health Decision Modeling, Federal University of Paraíba, João Pessoa, PB, Brazil.
Ana Carolina MelchiorsPostgraduate Program in Pharmaceutical Services and Policies, Federal University of Paraná, Avenida Prefeito Lothário Meissner, 632 - Jardim Botânico, Curitiba, PR, CEP 80210-170, Brazil.ORCID http://orcid.org/0000-0001-6911-4792

Funding

PROPESQ/PRPG/UFPB PVG 13392-2020
6 · The paper itself

Abstract

backgroundArtificial intelligence (AI) applications in medicines, pharmacotherapy, and pharmaceutical services are expanding, yet the lack of standardized reporting guidelines for scientific studies hinders transparency, comparability, and reproducibility in evidence-based healthcare decision-making.

aimTo develop and validate comprehensive reporting guidelines for AI studies in these fields through expert consensus.

methodFollowing the Guidance for Developers of Health Research Reporting Guidelines (Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217 , 2010), this study was conducted between May and October 2024 in two phases. Phase 1 involved drafting the initial guidelines through literature reviews and structured expert discussions by an internal committee. Phase 2 employed the Delphi method for validation and refinement. Twenty-six experts from nine countries, representing clinical pharmacy, pharmaceutical services, computer science, and AI, participated in the first round, with 21 completing the second round. Items were included if they received a median ≥ 7 on a 9-point evaluation scale, with ≥ 75% agreement defining publication consensus.

resultsThe final MedinAI guidelines comprise 14 items and 78 sub-items across four domains: core aspects, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. All items achieved consensus (median = 8, with 95.2% agreement on publication readiness). MedinAI's items adapt to different AI development stages, and its structure operates in parallel with EQUATOR Network reporting guidelines for most study designs (CONSORT, STROBE, PRISMA, SPIRIT, etc.), ensuring versatility.

conclusionMedinAI provides validated reporting guidelines for AI studies in medicines, pharmacotherapy and pharmaceutical services, promoting transparency, comparability, reproducibility, responsible and ethical AI development for these fields.

Indexed as

Artificial IntelligenceDrug TherapyGuidelines as TopicPharmaceutical ServicesResearch DesignConsensusDelphi TechniqueHumansReproducibility of ResultsArtificial intelligenceDigital healthDrug therapyPharmaceutical servicesPublishing

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.