An observational study in Overdose and Adverse Event, sponsored by Universidad Miguel Hernandez de Elche. Completed at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by Universidad Miguel Hernandez de Elche · Observational
Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.
Basement: Overuse subjected patients to unnecessary risk without promoting a sufficient clinical benefit and over-cost. The Less is More Medicine movement has led to the identification of Do not do in different specialties, also in primary care.
Objective: To analyze the impact of errors (overuse rates based in Do not do recommendations) in clinical practice.
Method: Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them. Retrospective study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.
Setting. Primary care in Andalucía, Aragón, Castilla La Mancha, Comunidad Valenciana, Madrid, Murcia, Navarra y País Vasco, eight autonomous communities in Spain.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
This study's enrollment of 750,000 is above the median of 450 across 26 observational studies indexed under Drug Overdose.
Browse Drug Overdose studies →Universidad Miguel Hernandez de Elche is the lead sponsor of 88 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients data codified in the primary care databases (BDCAP and BIFAP)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Drug: Benzodiazepines · Drug: Non-steroidal anti-inflammatory drugs · Drug: paracetamol · Drug: Antimicrobial agent · Drug: Lipid-lowering drug · Diagnostic Test: Prostate cancer · Radiation: Lumbago
All patients visiting pediatricians (0 to 14 years old). The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Drug: Antimicrobial agent · Drug: Mucolytic · Drug: Ibuprofen and paracetamol
Benzodiazepines for insomnia, agitation or delirium in people older than 65
Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis
paracetamol 1g for more than 3 days
antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy
Also known as: Antibiotics
Lipid-lowering drugs in patients older than 75 years without previous cardiovascular events
Screening for prostate cancer in asymptomatic patients
image tests in non-specific lumbago
antibiotics for pharyngitis (infants)
Also known as: Antibiotics
mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
Also known as: Mucolytics
Drug pages: Ibuprofen · Acetaminophen
treatment with ibuprofen and paracetamol (infants)
Medical overuse
Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse
Time frame: Three years
Medical overuse
Inadequate test for lumbalgia or prostate cancer
Time frame: Three years
Adverse events as consequence of inadequate clinical decision [Safety]
Patients suffering hurt due to inadequate prescription or inadequate test. Inadequate prescriptions or tests as defined by Do-not-Do recommendations. These were defined by Spanish Primary Care Scientific Societies
Time frame: Three years
Plan to share: Yes — Public and safety patient researchers
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: December 2019
Access criteria: http://www.nohacer.es
Data sharing details ↗ · www.nohacer.es
Ran from Oct 2018 to primary completion in Dec 2019, 13 months.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Universidad Miguel Hernandez de Elche