Trial reportBMC family practice2021
Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial.
Trial report in BMC family practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01610817 (Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled 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.
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.
Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives : InPAct Study (Information for Participating Actively in Cardiovascular Treatment)
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.
- Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact.British journal of clinical pharmacology · 2026Pooled it
- Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025Pooled it
- Protocol for a stepped wedge randomized controlled trial to optimize antibiotics prescription in Nepal.Contemporary clinical trials communications · 2026Article
- Expanding Family Health History to Include Family Medication History.Journal of personalized medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbout 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs.
methodsA cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used.
resultsSixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC
conclusionA booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status.
trial registrationTrial registry identifier NCT01610817 (2012/05/30).
Indexed as
Identifiers
What OpenQuestion holds
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.