ENTREVISTA-Asia enfrenta amenaza enfermedad por animales, virus

ENTREVISTA-Asia enfrenta amenaza enfermedad por animales, virus
miércoles 31 de marzo de 2010 10:38 GYT Por Tan Ee Lyn

SINGAPUR (Reuters) - Asia enfrenta una doble amenaza para la salud pública por las enfermedades infecciosas provenientes de animales y la emergencia de cepas de virus resistentes a fármacos que dificultan el tratamiento, dijo un funcionario de la Organización Mundial de la Salud (OMS).

Henk Bekedam, jefe del sector de desarrollo de la agencia de Naciones Unidas, dijo que el 75 por ciento de las nuevas enfermedades como H1N1, H5N1 y el síndrome respiratorio agudo severo (SARS por sus siglas en inglés) provienen de animales y que la mejor manera de prevenir su propagación es separar adecuadamente a los animales de los humanos.

"En China, Camboya, Tailandia, Laos, Vietnam, los animales siguen estando muy cerca de las personas", dijo Bekedam a Reuters en una entrevista el miércoles, al margen de una conferencia de salud en Singapur.

"Estas son cuestiones que tenemos que afrontar y, luego del SARS, sabemos acerca de la necesidad de compartir la información", añadió.

La cercana proximidad entre humanos y animales permite que los virus y otros microorganismos salten la barrera de las especies. Un ejemplo de esto fue lo ocurrido con el virus del SARS, que se propagó por todo el mundo en el 2003 y causó la muerte de más de 800 personas.

Los expertos temen desde hace tiempo que el virus H5N1 de la gripe aviaria desate una pandemia, aunque aún sigue siendo una enfermedad mayormente confinada a las aves.

El contacto cotidiano de las personas con aves de corral permitió que el H5N1 salte la barrera de las especies e infecte a humanos, que tienen una tasa de mortalidad del 60 por ciento por el virus.

La OMS declaró una pandemia cuando el aún vigente virus H1N1 de la gripe porcina comenzó a expandirse por todo el mundo el año pasado, pero muchas personas tendieron a minimizar el evento porque su tasa de mortalidad es relativamente baja y las personas que lo contraen sufren síntomas leves.

Sin embargo, Bekedam dijo que el virus sigue causando un número sustancial de muertes, muchas de ellas entre niños y personas con condiciones médicas subyacentes, como asma y obesidad, que hubieran sobrevivido de no ser por el virus.

En Asia, el uso incorrecto de fármacos contra enfermedades críticas como el VIH y la tuberculosis (TB) también está generando una resistencia a los medicamentos, una peligrosa tendencia que, según Bekedam, debe ser controlada por los estados miembros.

"En los países pobres, la gente compra lo que puede y a menudo no termina el tratamiento, por eso, estas enfermedades se tornan muy peligrosas, como la TB resistente a los fármacos", dijo.

Los fármacos para combatir la TB y el VIH tienen que tomarse a tiempo. Y si no se completa el tratamiento, los productos suelen no tener buenos resultados en el paciente, lo que provoca la necesidad de recurrir a medicamentos más fuertes que pueden no estar disponibles.

Si bien Bekedam se negó a citar países específicos que sufren este problema, dijo: "La resistencia al VIH es muy importante y la OMS aconseja a los estados miembros que sigan de cerca el tema".

En cuanto a la TB, el funcionario sostuvo que el tipo resistente a los fármacos era prevalente en lugares donde los programas contra la enfermedad habían fracasado en el pasado.

"Estamos pagando las consecuencias porque varios sistemas de salud no pudieron ofrecer los programas adecuadamente. No fueron lo suficientemente efectivos, (los pacientes) no terminaron el tratamiento", dijo.
(Editado en español por Gabriela Donoso)
© Thomson Reuters 2010 All rights reserved.

Recommended adult immunization schedule: United States, 2010.

GUIDELINE TITLE
Recommended adult immunization schedule: United States, 2010.

BIBLIOGRAPHIC SOURCE(S)
Advisory Committee on Immunization Practices. Recommended adult immunization schedule: United States, 2010. Ann Intern Med 2010 Jan 5;152(1):36-9. PubMed


Centers for Disease Control and Prevention (CDC). Recommended adult immunization schedule - United States, 2010. MMWR Morb Mortal Wkly Rep 2010 Jan 15;59(1):1-4.

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: Advisory Committee on Immunization Practices. Recommended adult immunization schedule: United States, 2009*. Ann Intern Med 2009 Jan 6;150(1):40-4.

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=15493&nbr=&string=

First-line Systemic Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer: Bevacizumab Treatment: Guideline Recommendations

Evidence-Based Series #7-10 Version 2.2010: Section 1
First-line Systemic Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer: Bevacizumab Treatment: Guideline Recommendations
J. Goffin, N, Coakley, C. Lacchetti, P.M. Ellis, Y.C. Ung, W.K. Evans,
and the Lung Cancer Disease Site Group (DSG)

A Quality Initiative of the Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO)

The guideline recommendations contained in Section 1 of this Evidence-based Series replace recommendations in previous versions of guideline #7-10. These updated recommendations are based on a new systematic review of the relevant data from January 2007 to October 2009 (Section 2A) plus the original evidence up to July 2005 (Section 2B).

Current Report Date: February 3, 2010
Original Report Date: May 22, 2009

open here to see the full-text: [pdf, 10 pages]
http://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=45735

SOLUTIONS® wound care algorithm.

GUIDELINE TITLE
SOLUTIONS® wound care algorithm.

BIBLIOGRAPHIC SOURCE(S)
ConvaTec. SOLUTIONS wound care algorithm. Princeton (NJ): ConvaTec; 2008. 8 p.

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: ConvaTec. SOLUTIONS wound care algorithm. Princeton (NJ): ConvaTec; 2005. 8 p.

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=13559&nbr=&string=

Guidelines of care for the management of psoriasis and psoriatic arthritis

Guidelines of care for the management of psoriasis and psoriatic arthritis

Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy

Alan Menter, MD,a Neil J. Korman, MD, PhD,b Craig A. Elmets, MD,c Steven R. Feldman, MD, PhD,d Joel M. Gelfand, MD, MSCE,e Kenneth B. Gordon, MD,f Alice Gottlieb, MD, PhD,g John Y. M. Koo, MD,h Mark Lebwohl, MD,i Henry W. Lim, MD,j Abby S. Van Voorhees, MD,k Karl R. Beutner, MD, PhD,l,m and Reva Bhushan, PhDn Dallas, Texas; Cleveland, Ohio; Birmingham, Alabama; Winston-Salem, North Carolina; Philadelphia,
Pennsylvania; Chicago, Illinois; Boston, Massachusetts; San Francisco and Palo Alto, California; New York, New York; Detroit, Michigan; and Schaumburg, Illinois

Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this fifth of 6 sections of the guidelines of care for psoriasis, we discuss the use of ultraviolet (UV) light therapy for the treatment of patients with psoriasis.

Treatment should be tailored to meet individual patients’ needs.We will discuss in detail the efficacy and safety as well as offer recommendations for the use of phototherapy, including narrowband and broadband UVB and photochemotherapy using psoralen plusUVA, alone and in combination with topical and systemic agents.

We will also discuss the available data for the use of the excimer laser in the targeted treatment of psoriasis.

Finally, where available, we will summarize the available data that compare the safety and efficacy of the different forms of UV light therapy. ( J Am Acad Dermatol 2010;62:114-35.)

open here to see the full-text, pdf, 22 pages:
http://www.aad.org/research/guidelines/_doc/pso5phototherapy.pdf

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): PULMONARY REHABILITATION

NATIONAL GUIDELINE CLEARINGHOUSE™ (NGC)
GUIDELINE SYNTHESIS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): PULMONARY REHABILITATION
GUIDELINES BEING COMPARED

1. American College of Chest Physicians/American Association of Cardiovascular and Pulmonary Rehabilitation (ACCP/AACVPR). Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based clinical practice guidelines. Chest 2007 May;131(5 Suppl):4S-42S. [211 references]
http://www.guideline.gov/summary/summary.aspx?doc_id=10856&nbr=005669

2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda (MD): Global Initiative for Chronic Obstructive Lung Disease (GOLD); 2008. 94 p. [435 references]
http://www.guideline.gov/summary/summary.aspx?doc_id=14175&nbr=007082

3. Singapore Ministry of Health (SMOH). Chronic obstructive pulmonary disease. Singapore: Singapore Ministry of Health; 2006 Oct. 84 p. [155 references]
http://www.guideline.gov/summary/summary.aspx?doc_id=10223&nbr=005386

4. Department of Veterans Affairs, Department of Defense (VA/DoD). VA/DoD clinical practice guideline for management of outpatient chronic obstructive pulmonary disease Washington (DC): Department of Veteran Affairs, Department of Defense; 2007. 138 p.
http://www.guideline.gov/summary/summary.aspx?doc_id=12925&nbr=006639


open here to see the full-text:
http://www.guideline.gov/Compare/comparison.aspx?file=COPD_Pulmonary_Rehab4.inc

Faecal incontinence: the management of faecal incontinence in adults.

GUIDELINE TITLE
Faecal incontinence: the management of faecal incontinence in adults.

BIBLIOGRAPHIC SOURCE(S)
National Collaborating Centre for Acute Care. Faecal incontinence: the management of faecal incontinence in adults. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007. 146 p. [444 references]

GUIDELINE STATUS
This is the current release of the guideline.

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=10951&nbr=&string=

ambrisentan - EPARs for human use

FICHA FARMACOLÓGICA de ambrisentan. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MARZO 31, 2010.-

abrir aquí para acceder al documento EMA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/volibris/volibris.htm

Active Substance
ambrisentan
International Nonproprietary Name or Common Name
ambrisentan
Pharmaco-therapeutic Group
Other anti-hypertensives
ATC Code
CO2KX02

Therapeutic Indication:
Volibris is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.


Date of issue of Marketing Authorisation valid throughout the European Union
21 April 2008

Orphan medicinal product designation date
11 April 2005


EPARs for authorised medicinal products for human use

Docetaxel - EPARs for human use [REVISIÓN Y ACTUALIZACIÓN MONOGRÁFICA]

FICHA FARMACOLÓGICA de Docetaxel. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MARZO 31, 2010.-

abrir aquí para acceder al documento EMA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/taxotere/taxotere.htm

Active Substance
Docetaxel
International Nonproprietary Name or Common Name
Docetaxel
Pharmaco-therapeutic Group
Taxanes
ATC Code
L01CD 02

Therapeutic Indications:
Breast cancer

TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node‑positive breast cancer.

TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer

TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

TAXOTERE in combination with cisplatin and 5‑fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

TAXOTERE in combination with cisplatin and 5‑fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.


Date of issue of Marketing Authorisation valid throughout the European Union
27 November 1995

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use

Iloprost - EPARs for human use

FICHA FARMACOLÓGICA de Iloprost. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MARZO 31, 2010.-

abrir aquí para acceder al documento EMA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/ventavis/ventavis.htm

Active Substance
Iloprost
International Nonproprietary Name or Common Name
Iloprost
Pharmaco-therapeutic Group
Platelet aggregation inhibitiors excluding heparin
ATC Code
B01AC11

Therapeutic Indication:
Treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.

Date of issue of Marketing Authorisation valid throughout the European Union
16 September 2003

Orphan medicinal product designation date
29 December 2000


EPARs for authorised medicinal products for human use

clopidogrel hydrogen sulphate / acetylsalicylic acid [2] - EPARs for human use

FICHA FARMACOLÓGICA de clopidogrel hydrogen sulphate / acetylsalicylic acid. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MARZO 31, 2010.-

abrir aquí para acceder al documento EMA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/duocover/duocover.htm

Active Substance
clopidogrel hydrogen sulphate / acetylsalicylic acid
International Nonproprietary Name or Common Name
clopidogrel hydrogen sulphate / acetylsalicylic acid
Pharmaco-therapeutic Group
Platelet aggregation inhibitors excl. heparin
ATC Code
B01AC30

Therapeutic Indication:
DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoCover is a fixed-dose combination medicinal product for continuation of therapy in:
• Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention

• ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

Date of issue of Marketing Authorisation valid throughout the European Union
15 March 2010

Orphan medicinal product designation date
n/a


EPARs for authorised medicinal products for human use

clopidogrel hydrogen sulphate / acetylsalicylic acid - EPARs for human use

FICHA FARMACOLÓGICA de clopidogrel hydrogen sulphate / acetylsalicylic acid. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MARZO 31, 2010.-

abrir aquí para acceder al documento EMA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/duoplavin/duoplavin.htm

Active Substance
clopidogrel hydrogen sulphate / acetylsalicylic acid

International Nonproprietary Name or Common Name
clopidogrel hydrogen sulphate / acetylsalicylic acid

Pharmaco-therapeutic Group
Platelet aggregation inhibitors excl. heparin


ATC Code
B01AC30

Therapeutic Indication:
DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in:

Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy


Date of issue of Marketing Authorisation valid throughout the European Union
15 March 2010

Orphan medicinal product designation date
n/a


EPARs for authorised medicinal products for human use

DIRECTORIO DE DOCUMENTOS EDITADOS EN MARZO 2010

DIRECTORIO DE DOCUMENTOS EDITADOS EN MARZO 2010

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 108. Strontium ranelate - EPARs for authorised medicina...
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A High Proportion of DNA Variants of BRCA1 and BRCA2 Is Associated with Aberrant Splicing in Breast/Ovarian Cancer Patients

A High Proportion of DNA Variants of BRCA1 and BRCA2 Is Associated with Aberrant Splicing in Breast/Ovarian Cancer Patients
David J. Sanz1, Alberto Acedo1, Mar Infante1, Mercedes Durán1, Lucía Pérez-Cabornero1, Eva Esteban-Cardeñosa2, Enrique Lastra3, Franco Pagani4, Cristina Miner1 and Eladio A. Velasco1
+ Author Affiliations

Authors' Affiliations:1Grupo de Genetica del Cancer, Instituto de Biologia y Genetica Molecular, Consejo Superior de Investigaciones Cientificas-Universidad de Valladolid, Valladolid, Spain; 2Laboratorio de Biologia Molecular, Servicio de Biopatologia Clinica, Hospital La Fe, Valencia, Spain; 3Servicio de Oncologia, Complejo Hospitalario de Burgos, Burgos, Spain; and 4International Centre of Genetic Engineering and Biotechnology, Trieste, Italy

Corresponding Author:
Eladio A. Velasco, Grupo de Genética del Cáncer (B-7), Instituto de Biología y Genética Molecular, CSIC-UVa, Sanz y Forés s/n, 47003 Valladolid, Spain. Phone: 34-98318480; Fax: 34-983184800; E-mail: eavelsam@ibgm.uva.es.
Abstract
Purpose: Most BRCA1/2 mutations are of unknown clinical relevance. An increasing amount of evidence indicates that there can be deleterious effects through the disruption of the splicing process. We have investigated the effect of aberrant splicing of BRCA1/2 on hereditary breast/ovarian cancer (HBOC).

Experimental Design: DNA variants were analyzed with splicing prediction programs to select putative splicing mutations. Splicing assays of 57 genetic variants were done by lymphocyte reverse transcription-PCR and/or hybrid minigenes in HeLa and nontumor breast epithelial cells.

Results: Twenty-four BRCA1/2 variants of Spanish HBOC patients were bioinformatically preselected. Functional assays showed that 12 variants induced anomalous splicing patterns, 6 of which accounted for 58.5% of BRCA1 families. To further evaluate the defective splicing of BRCA1/2, we analyzed 31 Breast Cancer Information Core Database (BIC) and two artificial variants that were generated by mutagenesis. Sixteen variants induced different degrees of aberrant splicing. Altogether, anomalous splicing was caused by 28 BRCA1/2 variants of all types, indicating that any DNA change can disrupt pre-mRNA processing. We show that a wide range of regulatory elements can be involved, including the canonical and cryptic splice sites, the polypyrimidine tract, and splicing enhancers/silencers. Twenty mutations were predicted to truncate the BRCA proteins and/or to delete essential domains, thus supporting a role in HBOC.

Conclusions: An important fraction of DNA variants of BRCA1/2 presents splicing aberrations that may represent a relevant disease-causing mechanism in HBOC. The identification of splicing disruptions by functional assays is a valuable tool to discriminate between benign polymorphisms and pathogenic mutations. Clin Cancer Res; 16(6); 1957–67
open here please:
http://clincancerres.aacrjournals.org/content/16/6/1957.abstract

Applying the GRADE Approach: Perspective from the Canadian Agency for Drugs and Technologies in Health

Expert Commentary
Perspective

Applying the GRADE Approach: Perspective from the Canadian Agency for Drugs and Technologies in Health

By: Denis Bélanger, B.Sc.Phm., ACPR

Dr. Ned Calonge raises some very good points in his Expert Commentary on the GRADE approach. In addition to the groups he identified that use GRADE, the Canadian Agency for Drugs and Technologies in Health (CADTH) also applies GRADE for generating recommendations. To date, recommendations on insulin analogues and self-monitoring of blood glucose (SMBG) have been developed by our expert review committee, known as COMPUS Expert Review Committee (CERC). CERC develops recommendations and advice with the aim of promoting optimal drug therapy and fostering a sustainable health care system for Canadians. CERC considers the practical needs of policy makers, health care providers, and consumers who will be implementing and using the recommendations.

While applying GRADE, CADTH researchers and CERC members have encountered both advantages and challenges that we would like to share.

From our perspective, the early engagement of the expert committee in identifying critical outcomes for generating a recommendation is a significant advantage. As CERC is responsible for making a recommendation, it is useful for members to be involved in determining what evidence will be required for the committee to fulfill its mandate, and the list of outcomes helps CADTH researchers compile all relevant information from available evidence. With this step in place, the research team avoids guessing about which outcomes should be reported or excluded from the analyses.

Traditional means of assessing quality of evidence focus on individual studies. In contrast, the GRADE process appraises the overall quality of evidence available for each outcome of interest. Quality of evidence can vary across outcomes reported in the same study, since some outcomes may be more prone to bias than others. For example, ascertainment bias due to lack of blinding is more likely for a subjective outcome, such as quality of life, than for an objective outcome, such as plasma glucose concentration. The GRADE approach provides a clear picture of the confidence that the expert committee has in the results for each outcome.

For CADTH, the clarification of how evidence is presented to CERC and how CERC arrives at a specific recommendation is an additional benefit of the GRADE process. The fact that CERC must discuss and visibly disclose the values and preferences around its recommendation helps our audiences better understand the recommendation. This explanation also helps the reader compare his or her values against those of the committee. A reader who places more importance on a value that is aligned with CERC is more likely to adopt the recommendation. For example, a recommendation encouraging the use of a specific agent because of improved safety profile (e.g., significantly less weight gain than the comparators) would be more appealing to consumers who place more value on avoiding the specific side effect. Likewise, a reader with values and preferences that differ from CERC can better judge whether he or she wishes to adopt the recommendation.

While the process for developing GRADE evidence profiles is very well documented by the GRADE Working Group, the process a committee uses to move from evidence to recommendations is not as well defined. The challenge faced by groups and organizations who want to adopt GRADE is how to operationalize GRADE at the Panel/Committee level. To address this challenge, CADTH describes the process that CERC used to generate recommendations in our published optimal therapy recommendation reports on insulin analogues (1) and self-monitoring of blood glucose (2). With each project, we identify opportunities for improved transparency and efficiencies for developing and presenting the evidence, as well as developing, documenting and presenting recommendations.

In our experience, the GRADE process has provided CADTH with a sound and consistent way of approaching the development of recommendations. Regular contact between GRADE Working Group members, CERC members, and CADTH researchers so that they may exchange ideas and share challenges, opportunities, and lessons learned proves invaluable to the successful implementation of GRADE in our work.

Author

Denis Bélanger, B.Sc.Phm., ACPR
Canadian Agency for Drugs and Technologies in Health (CADTH)

Disclaimer

The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Guideline Clearinghouse™ (NGC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.

Potential Conflicts of Interest

Denis Bélanger is the Director, Topics and Research for the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition, he lists the Canadian Association for Population Therapeutics as a professional affiliation. He states no financial or personal conflicts of interest.

References

Canadian Agency for Drugs and Technologies in Health. Optimal therapy recommendations for the prescribing and use of insulin analogues. Optimal Therapy Report - COMPUS 2009;2(7). Available: http://www.cadth.ca/media/pdf/compus_IA_OT_rec_report.pdf (accessed 2010 Mar 12).
Canadian Agency for Drugs and Technologies in Health. Optimal therapy recommendations for the prescribing and use of blood glucose test strips. Optimal Therapy Report - COMPUS 2009;3(6). Available: http://www.cadth.ca/media/pdf/compus_BGTS_OT_Rec_e.pdf (accessed 2010 Mar 12).

American Society of Clinical Oncology Titles

American Society of Clinical Oncology

1. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. This updates a previously published guideline summary.

GUIDELINE TITLE
American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants.

BIBLIOGRAPHIC SOURCE(S)
Hensley ML, Hagerty KL, Kewalramani T, Green DM, Meropol NJ, Wasserman TH, Cohen GI, Emami B, Gradishar WJ, Mitchell RB, Thigpen JT, Trotti A 3rd, von Hoff D, Schuchter LM. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. J Clin Oncol 2009 Jan 1;27(1):127-45. [50 references] PubMed

GUIDELINE STATUS
This is the most current release of the guideline.

This guideline updates a previously released version: Schuchter LM, Hensley ML, Meropol NJ, Winer EP. 2002 update of recommendations for the use of chemotherapy and radiotherapy protectants: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2002 Jun 15;20(12):2895-903. [28 references] PubMed

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=15228&nbr=&string=


2. American Society of Clinical Oncology clinical practice guideline update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction. This updates a previously published guideline summary.

GUIDELINE TITLE
American Society of Clinical Oncology clinical practice guideline update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction.

BIBLIOGRAPHIC SOURCE(S)
Visvanathan K, Chlebowski RT, Hurley P, Col NF, Ropka M, Collyar D, Morrow M, Runowicz C, Pritchard KI, Hagerty K, Arun B, Garber J, Vogel VG, Wade JL, Brown P, Cuzick J, Kramer BS, Lippman SM, American Society of Clinical Oncology. American Society of Clinical Oncology clinical practice guideline update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction. J Clin Oncol 2009 Jul 1;27(19):3235-58. [127 references] PubMed

GUIDELINE STATUS
This is the current release of the guideline.

This guideline updates a previous version: Chlebowski RT, Col N, Winer EP, Collyar DE, Cummings SR, Vogel VG 3rd, Burstein HJ, Eisen A, Lipkus I, Pfister DG. American Society of Clinical Oncology technology assessment of pharmacologic interventions for breast cancer risk reduction including tamoxifen, raloxifene, and aromatase inhibition. J Clin Oncol 2002 Aug 1;20(15):3328-43. [119 references] PubMed

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=15229&nbr=&string=


3. Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology-American Urological Association 2008 Clinical Practice Guideline.

GUIDELINE TITLE
Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology-American Urological Association 2008 Clinical Practice Guideline.

BIBLIOGRAPHIC SOURCE(S)
Kramer BS, Hagerty KL, Justman S, Somerfield MR, Albertsen PC, Blot WJ, Ballentine Carter H, Costantino JP, Epstein JI, Godley PA, Harris RP, Wilt TJ, Wittes J, Zon R, Schellhammer P, American Society of Clinical Oncology Health Services Committee, American Urological Association Practice Guidelines Committee. Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline. J Clin Oncol 2009 Mar 20;27(9):1502-16. [51 references] PubMed

GUIDELINE STATUS
This is the current release of the guideline.

open here to see the full-text:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=15227&nbr=&string=

Alcohol Consumption & Cancer Risk

Alcohol Consumption & Cancer Risk
Full Title: Alcohol Consumption and Cancer Risk: Understanding the Possible Causal Mechanisms Explaining the Increased Risk of Breast and Colorectal Cancer with Alcohol Consumption
Evidence-based Practice Center Systematic Review Protocol
Expected Release Date: late 2010

Contents
Background
Scope
Key Questions
Analytic Framework
Objective
Disposition of the Documents Identified by Literature Searches
Methods
References
Summary of Protocol Amendments
Appendix 1



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Background

Alcohol consumption is highly prevalent in the general U.S. population. The 2008 prevalence and trends data from the Behavioral Risk Factor Surveillance System indicated that about 54% of U.S. adults had consumed alcohol within the past 30 days.1 Though moderate alcohol consumption may have some potential health benefits, worldwide, alcohol consumption has been identified as one of the major risks for increasing the burden of disease.2 Several epidemiologic studies have reported moderate to strong associations between the level of alcohol consumption and the incidence of cancers of the mouth, pharynx, larynx, esophagus, and liver.3-7 Observed associations of alcohol consumption and cancer, however, can be confounded by other risk factors for cancer, such as age, smoking, family history, physical condition, and race or ethnicity.8-11

Although the association between alcohol and breast and colorectal cancer is comparatively less strong than the association with the cancers named above, given the high prevalence and incidence of breast and colorectal cancer, reducing the effect of any contributing factor may have a large overall impact on cancer incidence and prevalence.4-6,8,12-17 Because of the high prevalence of alcohol consumption, exploring the potential underlying mechanism(s) of the association between alcohol consumption and breast and colorectal cancers is essential in developing primary preventive measures. Since alcohol consumption is a modifiable behavior,18 recommending and promoting changes in behavior and appropriate preventive interventions may help reduce cancer risks in the general population.



Scope
The purpose of this report is to systematically and objectively synthesize evidence from the basic science literature to clarify the possible causal mechanisms by which alcohol could contribute to cancer risk, focusing on breast cancer and colorectal cancer. Although an integration of typical epidemiological studies with more basic biological literature has value, the scope of this project is confined to potential pathophysiological/toxicological mechanisms of action and not on the societal determinants of drinking alcohol. Epidemiological data, however, may provide insight into the dose/response relationship.

Apart from alcohol and water, the exact composition of most drinks on the market remains confidential and is not available to the general public.18 Therefore, the scope of this report is limited to ethanol. Other compounds (or contaminants) found in various alcoholic beverages that may play a role in the development of breast and colorectal cancers are outside the scope of this report. These compounds include nitrosamines, aflatoxins, polyphenols, ethyl carbamate (urethane), asbestos, and arsenic compounds, and more.3,16,19,20



Key Questions
1. What are the likely causal mechanisms by which alcohol contributes to the development of breast cancer? Which of the possible mechanisms (e.g., induction of p450 cytochromes and carcinogen metabolism, effects on blood hormone concentrations, effect of acetaldehyde or other alcohol metabolite on apoptosis and DNA repair, interactive effects on other nutritional factors, or others) are likely to be most important in breast cancer development?

2. For the most likely mechanisms of action involving alcohol and the development of breast cancer, how might other factors modify the effect of alcohol on breast cancer (for example, age, latency of effect, intensity, duration, and recency of exposure, presence of co-carcinogens, presence of threshold effect)? Do the causal mechanisms vary by cell type or other tumor characteristics?

3. What are the likely causal mechanisms by which alcohol contributes to the development of colorectal cancer? Which of the possible mechanisms (e.g., induction of p450 cytochromes and carcinogen metabolism, effects on blood hormone concentrations, effect of acetaldehyde or other alcohol metabolite on apoptosis and DNA repair, interactive effects on other nutritional factors, or others) are likely to be most important in colorectal cancer development?

4. For the most likely mechanisms of action involving alcohol and the development of colorectal cancer, how might other factors modify the effect of alcohol on colorectal cancer (for example, age, latency of effect, intensity, duration, and recency of exposure, presence of co-carcinogens, presence of threshold effect)? Do the causal mechanisms vary by cell type or other tumor characteristics?


Analytic Framework
Figures 1 and 2 are analytic frameworks that diagram the linkage between alcohol and cancer induction of either breast or colorectal cancer in humans or animals. The linkage between alcohol and cancer induction is through either risk factors related to alcohol (KQ 2 for breast cancer and KQ4 for colon cancer) or through alcohol metabolites (KQ1 for breast cancer and KQ3 for colorectal cancer). The mechanism of the relationship is to be examined within studies of human or animal isolated organs and cells, which may include studies of whole humans or animals or through studies on cell lines.



Alcohol Consumption & Cancer Risk
Figure 1: Analytical Framework for Breast Cancer (Text Description)
The Analytical Framework begins with two text boxes captioned "Whole Human or Whole Animal" and "Cell lines." Arrows point from these two boxes to a third box captioned "Human or Animal Isolated Organs and Cells"; an arrow points from this box to another captioned "Alcohol."

Three arrows point away from "Alcohol." The uppermost of these is a broken grey line, pointing to a box that reads "Other Risk Factors" and captioned KQ (Key Question) 2. The middle arrow is also a broken grey line, pointing to a box that reads "Cancer induction." The lowest arrow is a solid black line, pointing to a box that reads "Alcohol metabolites" and captioned KQ 1. Broken grey line ending in arrows also point from "Other Risk Factors" and "Alcohol metabolites" to "Cancer induction."

An arrow with a solid black line points away from "Cancer induction" to an ovoid captioned "Breast Cancer."



Alcohol Consumption & Cancer Risk
Figure 2: Analytical Framework for Colorectal Cancer (Text Description)
The Analytical Framework begins with two text boxes captioned "Whole Human or Whole Animal" and "Cell lines." Arrows point from these two boxes to a third box captioned "Human or Animal Isolated Organs and Cells"; an arrow points from this box to another captioned "Alcohol."

Three arrows point away from "Alcohol." The uppermost of these is a broken grey line, pointing to a box that reads "Other Risk Factors" and captioned KQ (Key Question) 4. The middle arrow is also a broken grey line, pointing to a box that reads "Cancer induction." The lowest arrow is a solid black line, pointing to a box that reads "Alcohol metabolites" and captioned KQ 3. Broken grey line ending in arrows also point from "Other Risk Factors" and "Alcohol metabolites" to "Cancer induction."

An arrow with a solid black line points away from "Cancer induction" to an ovoid captioned "Colorectal Cancer."





Objective
The purpose of our assessment is not to determine the exact extent to which alcohol is a risk factor for breast and colorectal cancers, but instead to explore the possible underlying causal mechanism(s) of the association between alcohol consumption and breast and colorectal cancers (see broken arrows from alcohol to cancer induction in analytical framework above).


Disposition of the Documents Identified by Literature Searches
Figure 3 is a flow chart depicting the pathway by which identified documents may be excluded at various levels, including the abstract or full document level, before being included in the report. Of those documents included in the report, some may be included in background or future research sections, such as those describing mechanisms of basic cancer, breast cancer, or colorectal cancer, alcohol metabolism, epidemiology of alcohol or cancer, or other components of alcoholic drinks. The remaining documents that would be included in the evidence base would be comprised of human studies with tissue/biochemical/histopathology analysis, whole animal models, animal tissue, human cell lines, non-human cell lines.




Alcohol Consumption & Cancer Risk
Figure 3: Flow chart depicting the pathway by which identified documents may be excluded at various levels (Text Description)
The flow chart begins with "Documents identified"; an arrow points down to a rhombus labeled "Abstracts Screened." Two arrows point from "Abstracts Screened," one to "Documents excluded at the abstract level" and the other to "Full documents retrieved."

An arrow points down from "Full documents retrieved" to a rhombus labeled "Full documents reviewed." Two arrows point from "Full documents reviewed," one to "Documents excluded at the full document level" and the other to "Documents to be included in the report."

An arrow points down from "Documents to be included in the report" to a rhombus labeled "Full documents reviewed for inclusion in the evidence base." Two arrows point from "Full documents reviewed," one to "Documents to be included in the background or future research sections of the report: Basic cancer mechanisms; Breast cancer mechanisms; Colorectal cancer mechanisms; Alcohol metabolism; Epidemiology studies of alcohol and cancer; Other components of alcoholic drinks." The other arrow points down to "Studies addressing the key questions; this constitutes the evidence base of the report: Human studies with tissue/biochemical/histopathology analysis; Whole animal models; Animal tissue; Human cell lines; Non-human cell lines."



Study Selection
We will use the following formal criteria to determine which studies will be included in our analysis.

Any study, regardless of design, that provides data on the possible causal mechanism(s) of any association between alcohol consumption and breast and colorectal cancers in any population setting, including humans, animals and in vitro experimental studies.


Methods
Given that this report will be examining proposed hypotheses rather than testing them, we will be providing an overview of the evidence on physiological and biochemical mechanisms by categorizing and synthesizing information on identified causal mechanisms in order to determine which mechanisms have the most supporting evidence.

The members of the Technical Expert Panel (TEP) proposed several methods for evaluating studies using animals, tissues, or cells as the primary experimental model.

^ Evidence from interventional studies offer the most compelling evidence that a mechanism/pathway is directly involved in increasing cancer risk with alcohol intake.
º Interventional studies that directly interfere with a pathway or mechanism suspected of linking alcohol intake to an increase in cancer risk will be considered of higher internal validity than observational studies describing an association between alcohol intake and cancer. An interventional study would test the hypothesis that alcohol intake would increase cancer risk when a particular pathway is intact, but not when the pathway is blocked.
^ Use of alcohol concentration levels in animal studies that far exceed levels that occur in humans will be considered of low applicability.
^ Cell lines should be appropriate to the study of breast and colorectal cancer in humans.
^ The use of carcinogens, co-carcinogens, and other agents should be appropriate to the study of breast and colorectal cancer in humans.


References
1. Prevalence and trends data. Nationwide (states, DC, and territories) [internet]. Altanta (GA): Centers for Disease Control and Prevention (CDC); 2008. [accessed 2009 Aug 21]. 2008 alcohol consumption: adults who have had at least one drink of alcohol within the past 30 days. [2 p]. Available: http://apps.nccd.cdc.gov/brfss/index.asp.

2. WHO. Global status report on alcohol 2004. Geneva: World Health Organization (WHO); 2004. 94 p.

3. Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri A, Cogliano V, WHO International Agency for Research on Cancer Monograph Working Group. Carcinogenicity of alcoholic beverages. Lancet Oncol 2007 Apr;8(4):292-3. PMID: 17431955

4. Poschl G, Seitz HK. Alcohol and cancer. Alcohol Alcohol 2004 May-Jun;39(3):155-65. PMID: 15082451

5. Giovannucci E. Alcohol, one-carbon metabolism, and colorectal cancer: recent insights from molecular studies. J Nutr 2004 Sep;134(9):2475S-81S. PMID: 15333745

6. Hamajima N, Hirose K, Tajima K, Rohan T, Calle EE, Heath CW Jr, Coates RJ, Liff JM, Talamini R, Chantarakul N, Koetsawang S, Rachawat D, Morabia A, Schuman L, Stewart W, Szklo M, Bain C, Schofield F, Siskind V, Band P, Coldman AJ, Gallagher RP, Hislop TG, Yang P, Kolonel LM, Nomura AM, Hu J, Johnson. Alcohol, tobacco and breast cancer—collaborative reanalysis of individual data from 53 epidemiological studies, including 58,515 women with breast cancer and 95,067 women without the disease. Br J Cancer 2002 Nov 18;87(11):1234-45. PMID: 12439712

7. O'Hanlon LH. Studies seek molecular clues on alcohol's role in cancer. J Natl Cancer Inst 2005 Nov 2;97(21):1563-4. PMID: 16264173

8. Cho E, Smith-Warner SA, Ritz J, van den Brandt PA, Colditz GA, Folsom AR, Freudenheim JL, Giovannucci E, Goldbohm RA, Graham S, Holmberg L, Kim DH, Malila N, Miller AB, Pietinen P, Rohan TE, Sellers TA, Speizer FE, Willett WC, Wolk A, Hunter DJ. Alcohol intake and colorectal cancer: a pooled analysis of 8 cohort studies. Ann Intern Med 2004 Apr 20;140(8):603-13. PMID: 15096331

9. Key TJ, Schatzkin A, Willett WC, Allen NE, Spencer EA, Travis RC. Diet, nutrition and the prevention of cancer. Public Health Nutr 2004 Feb;7(1A):187-200. PMID: 14972060

10. Schatzkin A, Longnecker MP. Alcohol and breast cancer. Where are we now and where do we go from here? Cancer 1994 Aug 1;74(3 Suppl):1101-10. PMID: 8039145

11. Seitz HK, Stickel F. Molecular mechanisms of alcohol-mediated carcinogenesis. Nat Rev Cancer 2007 Aug;7(8):599-612. PMID: 17646865

12. Zhang Y, Kreger BE, Dorgan JF, Splansky GL, Cupples LA, Ellison RC. Alcohol consumption and risk of breast cancer: the Framingham Study revisited. Am J Epidemiol 1999 Jan 15;149(2):93-101. PMID: 9921953

13. Feigelson HS, Jonas CR, Robertson AS, McCullough ML, Thun MJ, Calle EE. Alcohol, folate, methionine, and risk of incident breast cancer in the American Cancer Society Cancer Prevention Study II Nutrition Cohort. Cancer Epidemiol Biomarkers Prev 2003 Feb;12(2):161-4. PMID: 12582027

14. Smith-Warner SA, Spiegelman D, Yaun SS, van den Brandt PA, Folsom AR, Goldbohm RA, Graham S, Holmberg L, Howe GR, Marshall JR, Miller AB, Potter JD, Speizer FE, Willett WC, Wolk A, Hunter DJ. Alcohol and breast cancer in women: a pooled analysis of cohort studies. JAMA 1998 Feb 18;279(7):535-40. PMID: 9480365

15. Purohit V, Khalsa J, Serrano J. Mechanisms of alcohol-associated cancers: introduction and summary of the symposium. Alcohol 2005 Apr;35(3):155-60. PMID: 16054976

16. Seitz HK, Simanowski UA. Alcohol and carcinogenesis. Annu Rev Nutr 1988;8:99-119. PMID: 3060182

17. Singletary K. Ethanol and experimental breast cancer: a review. Alcohol Clin Exp Res 1997 Apr;21(2):334-9. PMID: 9113272

18. Lilla C, Koehler T, Kropp S, Wang-Gohrke S, Chang-Claude J. Alcohol dehydrogenase 1B (ADH1B) genotype, alcohol consumption and breast cancer risk by age 50 years in a German case-control study. Br J Cancer 2005 Jun 6;92(11):2039-41. PMID: 15886702

19. US Department of Health and Human Services, Public Health Service, National Toxicology Program. Alcoholic beverage consumption. Known to be a human carcinogen. Rockville (MD): U.S. Department of Health and Human Services; 2000. 2 p.

20. Monteiro R, Calhau C, Silva AO, Pinheiro-Silva S, Guerreiro S, Gartner F, Azevedo I, Soares R. Xanthohumol inhibits inflammatory factor production and angiogenesis in breast cancer xenografts. J Cell Biochem 2008 Aug 1;104(5):1699-707. PMID: 18348194



Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will be accompanied by a description of the change and the rationale.

Note: The following protocol elements are standard procedures for all protocols.

Review of Key Questions
For Comparative Effectiveness reviews the key questions were posted for public comment and finalized after review of the comments. For other systematic reviews, key questions submitted by partners are reviewed and refined as needed by the EPC and the Technical Expert Panel (TEP) to assure that the questions are specific and explicit about what information is being reviewed.

Technical Expert Panel (TEP)
A TEP panel is selected to provide broad expertise and perspectives specific to the topic under development. Divergent and conflicted opinions are common and perceived as health scientific discourse that results in a thoughtful, relevant systematic review. Therefore study questions, design and/or methodological approaches do not necessarily represent the views of individual technical and content experts. The TEP provides information to the EPC to identify literature search strategies, review the draft report and recommend approaches to specific issues as requested by the EPC. The TEP does not do analysis of any kind nor contribute to the writing of the report.

Peer Review (Standard Language)
Approximately five experts in the field will be asked to peer review the draft report and provide comments. The peer reviewer may represent stakeholder groups such as professional or advocacy organizations with knowledge of the topic. On some specific reports such as reports requested by the Office of Medical Applications of Research, National Institutes of Health there may be other rules that apply regarding participation in the peer review process. Peer review comments on the preliminary draft of the report are considered by the EPC in preparation of the final draft of the report. The synthesis of the scientific literature presented in the final report does not necessarily represent the views of individual reviewers. The dispositions of the peer review comments are documented and will, for Comparative Effectiveness Reviews (CERs) and Technical Briefs, be published three months after the publication of the Evidence Report.

It is our policy not to release the names of the peer reviewers or TEP panel members until the report is published so that they can maintain their objectivity during the review process.


Evidence-based Practice Center: ECRI Institute

Current as of March 2010


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Internet Citation:

Alcohol Consumption and Cancer Risk, Review Protocol. March 2010. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/tp/alccantp.htm
http://www.ahrq.gov/clinic/tp/alccantp.htm