IMPLEMENTING AN ACTION PROTOCOL ON PROSTATIC DISEASE IN PRIMARY CARE AND IMPACT ON REFERRALS TO UROLOGY

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1 General Urology Arch. Esp. Urol. 2012; 65 (8): IMPLEMENTING AN ACTION PROTOCOL ON PROSTATIC DISEASE IN PRIMARY CARE AND IMPACT ON REFERRALS TO UROLOGY Angel Tejido-Sanchez, Felipe Villacampa-Auba, Jose Maria Molero-Garcia 1, Gabriela Garcia- Alvarez 2, Juan Passas-Martinez and Rafael Diaz-González. Servicio de Urología. Hospital Universitario 12 de Octubre. 1 Centro de Salud San Andrés. Madrid. 2 Dirección Asistencial Centro. Hospital Universitario 12 de Octubre. Madrid. España. Summary.- OBJECTIVES: To determine the impact of implementing a joint action protocol on prostatic disease on the referrals to Urology from Primary Care in a health care area. METHODS: We drafted a protocol for managing patients consulting for clinical signs and symptoms associated to benign prostatic hyperplasia (BPH) and to test PSA in asymptomatic males. At the same time, three addresses were opened for consultations generated from Primary Care, and joint sessions were carried out in the primary health care centers. We measured the impact of the protocol by assessing the adequacy of prostatic disease referrals to Urology, as well as by determining the course of the total number of referrals in three peripheral specialized health care centers (PSHCC). RESULTS: From January 2011, a better compliance to the referrals to Urology protocol for prostatic disease has been produced, going from 47% (assessment prior to implementing the protocol) to 64%. These results are especially good when we consider referrals associated to PSA, which went from a compliance of 33% to 84%. Regarding the course of the referrals to Urology, the referral rate (referrals per 1000 inhabitants) has decreased by 15% (from 13,8 to 11,7). CONCLUSIONS: The collaboration between Urology and Primary health care, by means of implementing joint protocols, and also by establishing new communication channels ( , joint sessions), achieves a better adequacy of patients referred for prostatic disease, as well as a reduction in the total number of referrals. Keywords: Benign prostatic hyperplasia. PSA. Primary Care. Referrals to Angel Tejido Sánchez Avda. Julio Fuentes, 9 portal 2-2 A Boadilla del Monte Madrid (Spain). a_tejido@yahoo.com CORRESPONDENCE Accepted for publication: July 6 th, 2012 Resumen.- OBJETIVO: Determinar el impacto sobre las derivaciones a Urología desde Atención Primaria, de un protocolo de actuación conjunta en patología prostática en un área sanitaria. MÉTODOS: Se elaboró un protocolo para el manejo del paciente que consulta por clínica relacionada con hiperplasia prostática y para la realización de PSA en varón asintomático. Al mismo tiempo, se abrieron tres direcciones de correo electrónico para consultas generadas desde Atención Primaria y se realizaron sesiones conjuntas en los Centros de Salud. Medimos el impacto del protocolo valorando la adecuación de las deriva-

2 738 A. Tejido-Sánchez, F. Villacampa-Aubá, J. M. Molero-García, et al. ciones a Urología por patología prostática, así como determinando la evolución del número total de derivaciones en tres centros de especialidades periféricas. RESULTADOS: Desde enero de 2011, se ha producido una mejor adecuación de las derivaciones a Urología por patología prostática, que han pasado de un 47% de adecuación (valoración previa a la implantación del protocolo) a un 64%. Estos resultados son especialmente buenos cuando consideramos las derivaciones relacionadas con el PSA, que han pasado de un 33% a un 84% de adecuación. En cuanto a la evolución de las derivaciones a Urología, la tasa de derivación (derivaciones por 1000 habitantes) ha descendido en un 15% (de 13,8 a 11,7). CONCLUSIONES: La colaboración entre Urología y Atención Primaria, mediante la implantación de protocolos conjuntos, así como estableciendo nuevos medios de comunicación (correo electrónico, sesiones conjuntas), consigue una mejor adecuación de los pacientes derivados por patología prostática, así como una disminución en el número total de derivaciones. Palabras clave: Hiperplasia prostática benigna. PSA. Atención Primaria. Derivaciones a Urología. INTRODUCTION Benign prostatic hyperplasia (BPH) is the most frequent urological disease in men, and the main cause of outpatient consultation in specialized health care centres. Its incidence is increasing mainly because of two reasons; the population s progressive aging and a massive use of PSA testing in men over 50 years of age. For these reasons, the involvement of the Primary Care (PC) Physician in the management of this pathology is essential, as more than half of these patients can be followed at this level of care (1,2). The establishment of clear criteria for action in these patients, and the establishment of new channels for communication between levels of care may improve the management of this pathology significantly, as the Primary Care Physician can manage many of the cases that arise in his/her daily clinical practice, if he/she has the adequate tools, favouring the efficiency of the care process. To this end, we jointly carried out a protocol (Urology-PC), attempting to adapt the action norms in this pathology to the best scientific evidence available, always taking the characteristics of our health area into account. At the same time, we established new pathways of communication with PC. For this, we started a program of consultations via and we carried out joint sessions in the health care centres. With this study, we attempted to assess the impact of these measures on the referrals from PC to Urology, both in the compliance to the referral criteria and in the number of referred patients. MATERIAL AND METHODS Drafting of the protocol From January until October 2010, a working group was conformed that was composed of two urologists, a PC physician and two members of the Board of Directors (BoD) of the old area 11 of the SERMAS ( Servicio Madrileño de Salud, Madrid Health Service). A broad bibliographic review was carried out, and the conclusions were adapted to the means available in our setting, in order to issue a series of recommendations for managing patients who consult for prostatic disease (symptomatic BHP and use of PSA in asymptomatic males). The recommendations were based on the the consensus document drafted by the Spanish Urology Association (AEU, Asociación Española de Urología ), jointly with scientific societies on Primary Care (3), European Association of Urology (EAU) guidelines on BPH (4), results of the ERSPC and PLCO (5,6) studies and the recomentadions of EAU and American Cancer Society on screening for prostate cancer (7-9). These recommendations were summarized in 2 algorithms to make their use easier (Figures 1 and 2), including the clinical assessment and the necessary complementary tests, the criteria for referral and the treatment recommended in each case. Moreover, we drafted an informative sheet about the advantages and risks of screening for prostate cancer, to hand out to the patient who consults in PC for this reason. Geographic scope of the application 3 peripheral specialized health care centres (PSHCCs) were selected and the health care centres depending on these for implementing the protocol (a total of 15 health care centres), with an assigned population of 387,215 inhabitants. The PSHCCs included were Carabanchel (PSHCC1; population), Orcasitas (PSHCC2; population) and Villaverde (PSHCC3; population).

3 IMPLEMENTING AN ACTION PROTOCOL ON PROSTATIC DISEASE Protocol implementation phases Once the protocol was drafted in October 2010, it was submitted to the direction of the 12 de octubre University Hospital, and was approved on November 11, Subsequently, a meeting was carried out with the directors of health care centres, in which the protocol was presented, and the phases of implementation were established. Next, meetings were carried out in each of the health care centres with their doctors during November and December, so that the protocol started being applied in January, From this date onwards, three addresses were opened (one for every PSHCC), where the Primary Care physicians are able to send their consultations. Since then, different joint sessions are being carried out in health care centres about different topics associated to Urology. In each PSHCC, a urologist was designated to be in charge of the coordination with the directors of health care centres and of supervising the answering of s and of proposing, together with those in charge of education in the health care centres, joint sessions and courses in the different centres. Evaluation of the protocol s results We established two parameters to assess the impact of the protocol after its implementation. These were the adequacy of the patients referred to Urology in accordance with the protocol s recommendations and the course of the total referrals to Urology from PC. In order to assess the adequacy of the referrals, we chose three time periods of one month, during which the indications of referral due to prostatic disease in consults carried out by 10 urologists of FIGURE 1. Algorithm of the diagnostic-therapeutic management of patients with BPH-associated symptoms of the lower urinary tract.

4 740 A. Tejido-Sánchez, F. Villacampa-Aubá, J. M. Molero-García, et al. the three PSHCCs (always the same urologists) were collected. During the month of November, 2010, we reviewed referrals attended in the three PSHCCs chosen for implementing the protocol. In 2011, this assessment was repeated during May and November. We used the chi-square test to determine whether variation in the appropriateness of referrals obtained statistical significance. The reason for choosing the referral rate and not the total number of referrals was that the population assigned to the CEPs changed in June 2010 from 462,286 to 387,215 inhabitants. This variation in the population was particularly important in the Carabanchel PSHCC1, which went from 155,604 to 86,066 people assigned. The course of the referrals to Urology was determined by comparing the referral rate (referrals per 1,000 assigned inhabitants) during two 10-month periods (relative risk reduction and 95% confidence interval). We compared the referrals during the periods of time between January and October 2010 and 2011, in such a way that we avoided the months of November and December 2010, during which the protocol was presented to the Health care Centres. Data for the total number of referrals, and the population assigned to each center, we were provided by the Admissions Service and the Department of 12 de octubre University Hospital respectively. The reason for choosing the referral rate and not the total number of referrals was that the population FIGURE 2. Algorithm of the recommendations for the management of patients who request prostate cancer screening.

5 IMPLEMENTING AN ACTION PROTOCOL ON PROSTATIC DISEASE TABLE I. COMPLIANCE OF THE REFERRALS WITH THE CRITERIA INCLUDED IN THE PROSTATIC DISEASE PROTOCOL. Patient with symptomatic BPH Screening for prostate cancer Total November, /71 (54%) 10/30 (33%) 48/101 (47%) May, /38 (55%) 18/24 (75%) 39/64 (61%) November, /45 (58%) 11/13 (84%) 37/58 (64%) assigned to the PSHCCs changed in June, 2010, going from 462,286 to 387,215 inhabitants. This variation in the population was especially important in the Carabanchel PSHCC1, which went from 155,604 to 86,066 of the assigned inhabitants. Other parameters measured during 2011 were the number of s sent by Primary Care physicians and the number of sessions carried out at the Health care Centres. RESULTS Adequacy of the referrals We analysed a total of 223 referrals carried out form PC due to prostatic disease (Table I). The first assessment was carried out before the protocol was presented in the health care centres, which allowed us to ascertain the initial situation of referrals due to prostatic disease. We assessed 101 referrals; 71 due to BPH-associated symptoms and 30 for prostate cancer screening. Out of the 71 referrals for symptomatic BPH, 38 (54%) followed the protocol, whereas only 10 out of the 30 (33%) referrals for prostate cancer screening complied with the established criteria. In May 2011, we collected 64 referrals; 38 for symptomatic BPH and 24 for prostate cancer screening. Regarding referrals due to HBP symptoms, the results remained unchanged compared to the previous assessment, as 21 out of the 38 referrals (55%) followed the protocol. However, out of the 24 patients referred for prostate cancer screening, 18 (75%) met the referral criteria. TABLE II. COMPARISON OF REFERRAL RATES (REFERRALS CARRIED OUT PER 1,000 ASSIGNED INHABITANTS TO EACH PSHCC) IN THE PERIODS JANUARY-OCTOBER 2010 AND PSHCC Referral rate (January-October 2010) Referral rate (January-October 2011) Variation % Carabanchel CEP1 14, % Orcasitas CEP % Villaverde CEP3 16,1 10,1-37% OVERALL 13,8 11,7-15%

6 742 A. Tejido-Sánchez, F. Villacampa-Aubá, J. M. Molero-García, et al. In November 2011, the third assessment was carried out. In it, a total of 58 referrals were analysed (45 for symptomatic BPH and 13 for prostate cancer screening). The results associated to symptomatic BPH improved as compared to the previous analyses, with 26 referrals that followed the protocol (58%), although not statistically significant (p=0,65). On the contrary, 11 out of 13 (84%) patients referred for prostate cancer screening met the established criteria, obtaining a p=0.002 when compared with the first results. Therefore, the overall compliance to the protocol went from 47% in November 2010 (48/101) to 64% in November 2011 (37/58), which entails an improvement of 36% in the first year of implementation, with a p=0,048. Course of the referrals to Urology from Primary Care The total number of referrals to Urology from Primary Care, in the period between January and October 2010, was of 5,970, as compared to 4,547 carried out during the same period in the year However, the attended population went from 462,286 to 387,215 inhabitants throughout Therefore, when we calculate the referral rate, we find that in the first period (2010), 13.8 referrals were carried out per 1,000 inhabitants, compared to 11.7 that were produced in the same period of These results entail a 15% decrease in the referral rate (Table II), with a relative risk reduction of 0.15 and a 95% confidence interval 0.11 to 0.18 at 95%. and joint sessions Starting in January 2011, 3 s (one per PSHCC) for sending consultations were made available to the Primary Care physicians of the area. During the first year of implementation, 16 consultations about patients with urological diseases were received. During the months of November and December 2010, the protocol was presented in most of the health care centres (12 out of 15 centres), while in the remaining centres, it was presented during the first months of 2011 due to agenda issues. Moreover, during 2011, a total of 5 joint sessions were carried out in health care centres, as well as a certified course of 16 training hours, which included the most frequent urological diseases (prostatic disease, haematuria, lithiasis, incontinence, erectile dysfunction and catheter management). DISCUSSION The population s progressive aging and the use of PSA in males over 50 years of age make prostatic disease the first cause of outpatient consultation in Urology. However, the PC physician has the necessary means for its diagnosis and followup in a large percentage of the patients (1,2). For these reasons, during 2010, we conformed a working group for Prostatic Disease in Primary Care that included urologists from the 12 de Octubre University Hospital, PC physicians and members of Primary Care BoD of the old Area 11 of the SERMAS. Our aims were to establish criteria for improving the care of the patients who consulted for prostatic disease in the PC consult, as well as to create new channels of communication between the different levels of care. As a result of this working group, a protocol for the management of prostatic disease in Primary Care was established, which included recommendations for the diagnosis, treatment and follow-up for the two most frequent reasons: patients who consult for symptomatic BPH, and the symptomatic men who request a PSA test (prostate cancer screening). The guidelines for managing patients with symptomatic BPH are mostly based on the recommendations by scientific societies, especially the consensus document drafted by the Spanish Urology Association (AEU, Asociación Española de Urología ), jointly with scientific societies on Primary Care (3-5). Just like in this document, within our objectives we aim to promote the optimal treatment of patients with BPH in the settings of Primary Care and Urology, as well as to provide unified and concise criteria for referring patients with BPH to the urologist that can be assumed by all the levels of care (3). There are few differences between our guidelines and those established by the AEU and AP societies. The patient s initial assessment is the same, and the referral criteria are similar. Free PSA is not used in routine Primary Care visits, so we established a criterion for referral PSA greater than 4 mg / dl. Another difference is that the rise in creatinine is not a criterion for referral, unless it is associated with obstructive uropathy. The recommendations in treating and monitoring patients are also similar. However, the use of inhibitors of 5 alpha reductase inhibitor monotherapy is limited, since it is necessary prescriptions for Urology. In prostate cancer screening, we insist on the importance of the information about the potential

7 IMPLEMENTING AN ACTION PROTOCOL ON PROSTATIC DISEASE benefits and risks, as well as in individualizing the risk. As in patients with BPH, action norms are based on the recommendations found in literature (5,6) and on the ones made by scientific societies (7-11). The joint drafting of this protocol is essential, as it allows to adapt its recommendations to the means available to the PC physician, and to improve the results. Furthermore, we established new forms of communication between Urology and Primary Care. In this sense, aside from sessions for presenting the protocol in each health care centre, we offer the possibility of carrying out joint sessions or courses. During 2011, five sessions and one course of 16 training hours were carried out; their development was one of the objectives that were to be consolidated, with new courses and sessions, as well as introducing other forms of teaching, as are the presence of Primary Care physicians in Urology consults. Another route of communication is the availability of s where the PC physicians can address their consults to the reference urologists in the PSHCCs. The s allow for a rapid resolution of the doubts that may arise in the management of urological patients in the Primary Care consult. Even if the number of consults in the first year was of 16, this number is expected to grow progressively. In order to measure the impact of this protocol in urological patients, we assessed its effect in the referrals to the Urology consults of three PSHCCs that depend on the 12 de Octubre University Hospital. In this study we found a better compliance to the protocol, both overall and according to the reason for consultation (symptomatic BPH and prostate cancer screening). We went from 54 to 58% in symptomatic BPH, while in prostate cancer screening, these results are much better (from 33 to 84%). Overall, the adequacy of the referrals due to prostatic disease went from 47% to 61% in the first assessment after the protocol was started, and later to 64%, which confirms that the results are progressively improving, although there still is great room for improvement. Furthermore, the impact of these initiatives has also been reflected on the number of referrals to Urology from PC. We have evidenced a reduction of 15% in the request of first consultations, when we considered the three PSHCCs jointly. However, as can be noted in Table II, there are important differences among the centres. The PSHCCs of Orcasitas (PSHCC2) and Villaverde (PSHCC3) presented with important reductions (21 and 37%, respectively), while the PSHCC of Carabanchel (PSHCC1) presented with an increase of 8%. These differences can be explained by the important reduction in the population assigned to the PSHCC of Carabanchel (PSHCC1), which has cause for an important amount of first consults to be referred to this PSHCC that should have been attended at Orcasitas (PSHCC2) and Villaverde (PSHCC3). CONCLUSIONS The involvement of the Primary Care physician, jointly with the urologist, is essential in the management of prostatic disease. Carrying out joint action protocols, as well as establishing new routes of communication ( s, joint sessions), achieves a better adequacy of referrals to Urology, as well as a reduction in their number. REFERENCES AND RECOMMENDED READINGS (*of special interest, **of outstanding interest) **3. **4. *5. 6. *7. *8. Brenes FJ., Pérez N., Pimienta M., Dios JM.: Hiperplasia benigna de próstata. Abordaje por el médico de Atención Primaria. SERMERGEN. 2007;33: Carballido JA., Badia X., Gimeno A., Regadera L., Dal-Ré R., Guilera M.: Validez de las pruebas utilizadas en el diagnóstico inicial y su concordancia con el diagnóstico final en pacientes con sospecha de hiperplasia benigna de próstata. Actas Urol Esp. 2006;30: Castiñeiras J., Cozar JM., Fernández-Pro A., Martín JA., Brenes FJ., Naval E., Molero JM., Pérez D.: Criterios de derivación en hiperplasia benigna de próstata para atención primaria. Actas Urol Esp. 2010;34: Madersbacher S., Alivizatos G., Nordling J., Sanz CR., Emberton M., De la Rosette JJ.: EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004;46: Schröder FH., Hugosson J., Roobol MJ., Tammela TL., Ciatto S., Nelen V., y cols.: Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012;366: Andriole GL., Crawford ED., Grubb RL 3rd., Buys SS., Chia D., Church TR., y cols.: Mortality results from a randomized prostate-cancer screening trial. N Eng J Med. 2009;360: Heidenreich A., Aus G., Bolla M., Joniau S., Matveev VB., Schmid HP., y cols.: EAU guidelines on prostate cancer. Eur Urol. 2008;53: Wolf AMD., Wender RC., Etzioni RB., Thompson IM., D Amico AV., Volk RJ., y cols.: American Cancer Society guideline for the early detection of prostate cancer. CA Cancer J Clin. 2010;60:70-98.

8 744 * Abrahamsson PA., Artibani W., Chapple CR., Wirh M.: European Association of Urology position statement on screening for prostate cancer. Eur Urol. 2009;56(2): Páez A.: Al fin ERSPC y PLCO. Actas Esp Urol. 2009;33: Morote J.: Impacto del cribado del cáncer de próstata sobre la mortalidad. Actas Esp Urol. 2009;360:

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