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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
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To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference between tertiary and primary care for patients with stable benign prostatic hyperplasia (BPH) symptoms.
The effectiveness of the use of teleconsultation will be evaluated by the initial international prostate symptom score (IPSS) in patients randomized to the standard monitoring (tertiary hospital) and teleconsultation monitoring (primary care) and after twelve months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconsultation | Experimental | Tele consultation (experimental) - after the randomization the patient is guided to seek primary care under teleconsultation supervision to keep his treatment. One year later the patient's symptoms are reassessed in a medical consultation. |
|
| Hospital | Active Comparator | Hospital (control) - after the randomization the patient is guided to keep his treatment in the tertiary care as usual. One year later the patient's symptoms are reassessed in a medical consultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleconsultation | Other | Teleconsultation - the teleconsultation usage in chronic diseases, such as benign hyperplasia, seems to be a promising scenario. Once the patient symptoms are evaluated and diagnosed as a stable disease he is able to keep his treatment annually. In a way to do not overload de tertiary system, such monitoring could be done under a teleconsultation with a urological supervision in the primary care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Low Urinary Tract Symptoms (LUTS) | Low urinary tract symptoms are assessed through International Prostate Score System (IPSS) which includes seven main important symptoms of benign prostate hyperplasia, validated to portuguese. Each symptom is graduated from zero to five. This score classifies the symptoms of the lower urinary tract that will be assessed at randomization and after twelve months in each arm of the study. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Acute Urinary Retention (AUR) | The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia. | 12 months |
| Change from baseline Serum Creatinine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brasil S Neto, MdPg | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital De Clinicas De Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12657354 | Background | Carson C 3rd, Rittmaster R. The role of dihydrotestosterone in benign prostatic hyperplasia. Urology. 2003 Apr;61(4 Suppl 1):2-7. doi: 10.1016/s0090-4295(03)00045-1. | |
| 7650822 | Background | Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 1995 Sep 6;274(9):700-5. doi: 10.1001/jama.274.9.700. |
| Label | URL |
|---|---|
| Portaria Ministério Da Saúde | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| D006761 | Hospitals |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Hospital (control) | Other | The patient will keep his usual care at the tertiary care. |
|
Serum creatinine values will be assessed at randomization and after twelve months
| 12 months |
| Change from baseline Serum Urea | Serum urea values will be assessed at randomization and after twelve months | 12 months |
| Change from baseline Prostatic Specific Antigen (PSA) | Prostatic specific antigen serum values will be assessed at randomization and after twelve months. | 12 months |
| Occurrence of Urinary infection | Occurrence of urinary tract infection during the study will be assessed through urine cultures | 12 months |
| Adhesion to Medications | The adhesion to prescribed medications will be assessed after 12 months of the randomization | 12 months |
| Background | Ferreira, J. B. B. et al. O complexo regulador da assistência à saúde na perspectiva de seus sujeitos operadores. Interface (Botucatu), Botucatu, v. 14, n. 33, June 2010 |
| Background | Fratini, J. G.; Sauoe, R.; Massaroli, A. Referência e contra referência: contribuição para a integralidade em saúde. Cienc Cuid Saude, Itajaí, v. 7, n. 1, p. 65-72, Jan/Mar 2008 |
| Background | Gusso, G.; Lopes, J. M. C. Tratado de Medicina de Família e Comunidade - 2 Volumes: Princípios, Formação e Prática. Artmed, 1ed., Porto Alegre, 2012 |
| 11074195 | Background | Kirby RS. The natural history of benign prostatic hyperplasia: what have we learned in the last decade? Urology. 2000 Nov 1;56(5 Suppl 1):3-6. doi: 10.1016/s0090-4295(00)00747-0. |
| Background | Mattos, L. A. P. et al. Desfechos clínicos aos 30 dias do registro brasileiro das síndromes coronárias agudas (ACCEPT). Arq. Bras. Cardiol., São Paulo, v.100, n. 1, Jan. 2013 |
| 12031373 | Background | Platz EA, Smit E, Curhan GC, Nyberg LM, Giovannucci E. Prevalence of and racial/ethnic variation in lower urinary tract symptoms and noncancer prostate surgery in U.S. men. Urology. 2002 Jun;59(6):877-83. doi: 10.1016/s0090-4295(01)01673-9. |
| 22265645 | Background | Starfield B. Primary care: an increasingly important contributor to effectiveness, equity, and efficiency of health services. SESPAS report 2012. Gac Sanit. 2012 Mar;26 Suppl 1:20-6. doi: 10.1016/j.gaceta.2011.10.009. Epub 2012 Jan 21. |
| 15195324 | Background | Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783. |
| Background | Berger, Milton ; LUZ JR, Pedro Nery da ; SILVA NETO, Brasil ; KOFF, Walter José . Validação estatística do escore internacional de sintomas prostáticos (IPSS) na língua portuguesa. Jornal Brasileiro de Urologia, Rio de Janeiro/RJ, v. 25, n. 2, p. 225-234, 1999. |
| D052801 |
| Male Urogenital Diseases |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |