Evidence map›Paper›PMID 27038611›Full record

Trial reportTrials2016

Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial.

Marise Oliveira-Santos, José Fernando de Souza Verani, Luiz Antônio Bastos Camacho, Carlos Augusto Ferreira de Andrade, Rosele Ferrante-Silva, Evandro Mendes Klumb

Erratum issued Registry-linked trialAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02330250 (Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT02330250 nacompletednot on this map

Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial

TypeinterventionalSponsorOswaldo Cruz FoundationRan2014 to 2016Enrolled131ConditionsSystemic Lupus Erythematosus, Medication AdherenceArmsPharmaceutical Care, Control
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Marise Oliveira-SantosSergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rua Leopoldo Bulhões, 1480, Manguinhos, Rio de Janeiro, Brazil. mariseo@uerj.br.
José Fernando de Souza VeraniSergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rua Leopoldo Bulhões, 1480, Manguinhos, Rio de Janeiro, Brazil.
Luiz Antônio Bastos CamachoSergio Arouca National School of Public Health, Oswaldo Cruz Foundation, Rua Leopoldo Bulhões, 1480, Manguinhos, Rio de Janeiro, Brazil.
Carlos Augusto Ferreira de AndradeEvandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil n° 4.036, Manguinhos, Rio de Janeiro, Brazil.
Rosele Ferrante-SilvaLagoa Federal Hospital, Ministry of Health, Rua Jardim Botânico n° 501, Jardim Botânico, Rio de Janeiro, Brazil.
Evandro Mendes KlumbPedro Ernesto University Hospital, State University of Rio de Janeiro, Boulevard 28 de Setembro n° 77, Vila Isabel, Rio de Janeiro, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment adherence is a primary determinant of the success and effectiveness of healthcare. Lack of adherence can lead to treatment failure and death. Although studies have shown that pharmaceutical intervention can improve drug treatment for patients with chronic diseases, studies on pharmaceutical care are not only inconsistent, they are scarce and limited to developed countries, include few patients, and are not studied in randomized clinical trials. Systemic lupus erythematosus is an autoimmune disease with high hospitalization and case-fatality rates. The adherence rate is low (31.7 %) in this group of patients in Brazil, and drug treatment for the disease is complex. Our objective is to evaluate the effectiveness of pharmaceutical care in drug treatment adherence in patients with systemic lupus erythematosus treated at a rheumatology outpatient clinic in Rio de Janeiro, Brazil.

methodsA randomized clinical trial (pragmatic trial) will be conducted. Adult participants (women) from a public hospital in Rio de Janeiro with a diagnosis of systemic lupus erythematosus will be followed for 12 months. A total of 120 patients will be randomized to two groups: intervention (Dader method for pharmaceutical care) and control (health/dietary counseling and risk reduction). The primary outcome will be drug treatment adherence evaluated by the eight-item Morisky Medication Adherence Scale. Secondary outcomes will be clinical improvement and quality of life. DISCUSSION: Patients with systemic lupus erythematosus present with low treatment adherence, thus justifying the mobilization of human resources to optimize their clinical management. Despite the proven effectiveness of pharmaceutical care for various diseases, there are still no studies evaluating its effectiveness in systemic lupus erythematosus. Our hypothesis is that the intervention will also be effective in this patient group.

trial registrationClinicalTrials.gov identifier: NCT02330250 .

Indexed as

Medication AdherencePharmaceutical ServicesBrazilClinical ProtocolsCounselingFemaleHealth Knowledge, Attitudes, PracticeHospitals, PublicHumansLupus Erythematosus, SystemicOutpatient Clinics, HospitalPatient Care TeamPharmacistsQuality of LifeRemission InductionResearch DesignAdherenceLupus nephritisPharmaceutical careRandomized clinical trialSystemic lupus erythematosus

Identifiers

PMID27038611
PMCPMC4818901

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Registered trials

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.