SOBRINA: Consequences of Doing What Should Not be Done in Primary Care
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients visiting GP All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed. |
Drug: Benzodiazepines
Benzodiazepines for insomnia, agitation or delirium in people older than 65
Drug: Non-steroidal anti-inflammatory drugs
Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis
Drug: paracetamol
paracetamol 1g for more than 3 days
Drug: Antimicrobial agent
antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy
Other Names:
Drug: Lipid-lowering drug
Lipid-lowering drugs in patients older than 75 years without previous cardiovascular events
Diagnostic Test: Prostate cancer
Screening for prostate cancer in asymptomatic patients
Radiation: Lumbago
image tests in non-specific lumbago
|
| Patient visiting pediatricians 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
antibiotics for pharyngitis (infants)
Other Names:
Drug: Mucolytic
mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
Other Names:
Drug: Ibuprofen and paracetamol
treatment with ibuprofen and paracetamol (infants)
|
Outcome Measures
Primary Outcome Measures
- Medical overuse [Three years]
Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse
- Medical overuse [Three years]
Inadequate test for lumbalgia or prostate cancer
Secondary Outcome Measures
- Adverse events as consequence of inadequate clinical decision [Safety] [Three years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients visiting GPs
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | FISABIO | Elche | Alicante | Spain | 03202 |
| 2 | Universidad Miguel Hernández | Elche | Alicante | Spain | 03202 |
Sponsors and Collaborators
- Universidad Miguel Hernandez de Elche
- Osasunbidea
- Servicio Madrileño de Salud, Madrid, Spain
- Fondo de Investigacion Sanitaria
- AQuAS
- Agencia de Calidad Sanitaria de Andalucía
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Servicio Aragones De Salud
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Generalitat Valenciana
- MurciaSalud
- Osakidetza
- Castilla-La Mancha Health Service
Investigators
- Principal Investigator: JOSE J MIRA, PhD, UNIVERSIDAD MIGUEL HERNANDEZ
Study Documents (Full-Text)
None provided.More Information
Publications
- Aranaz-Andrés JM, Aibar C, Limón R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.
- Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, Nagpal S, Saini V, Srivastava D, Chalmers K, Korenstein D. Evidence for overuse of medical services around the world. Lancet. 2017 Jul 8;390(10090):156-168. doi: 10.1016/S0140-6736(16)32585-5. Epub 2017 Jan 9. Review. Erratum in: Lancet. 2022 Mar 5;399(10328):908.
- Gibson R. The human cost of overuse. BMJ. 2014 May 6;348:g2975. doi: 10.1136/bmj.g2975.
- Grady D, Redberg RF. Less is more: how less health care can result in better health. Arch Intern Med. 2010 May 10;170(9):749-50. doi: 10.1001/archinternmed.2010.90.
- Newton EH, Zazzera EA, Van Moorsel G, Sirovich BE. Undermeasuring Overuse--An Examination of National Clinical Performance Measures. JAMA Intern Med. 2015 Oct;175(10):1709-11. doi: 10.1001/jamainternmed.2015.4025.
- Rosenberg A, Agiro A, Gottlieb M, Barron J, Brady P, Liu Y, Li C, DeVries A. Early Trends Among Seven Recommendations From the Choosing Wisely Campaign. JAMA Intern Med. 2015 Dec;175(12):1913-20. doi: 10.1001/jamainternmed.2015.5441. Erratum in: JAMA Intern Med. 2015 Dec;175(12):2003.
- Segal JB, Bridges JF, Chang HY, Chang E, Nassery N, Weiner J, Chan KS. Identifying possible indicators of systematic overuse of health care procedures with claims data. Med Care. 2014 Feb;52(2):157-63. doi: 10.1097/MLR.0000000000000052.
- PI16/00816