Abstract:

A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a VMP to Competent Authorities at defined time points post-authorisation. At these times, MAHs are expected to provide succinct summary information on all adverse events together with a critical evaluation of the benefit-risk balance of the VMP in the light of any new or changing pharmacovigilance information. This evaluation is necessary to ascertain whether further investigations need to be carried out and/or whether changes should be made to the SPC or other product information. For VMPs:

• purely nationally authorized;
• authorized within the scope of Directive 87/22/EEC (ex-concentration procedure);
• that have benefited from the MRP or the DCP in accordance with Directive 2001/82/EC;
• that have been subject to referrals considered under Articles 36, 37 and 38 of Directive 2001/82 

PSURs should be submitted to DGV in accordance with point 2 of Article 110.º of Decreto-Lei n.º 148/2008, from 29^th July, as amended by Decreto-Lei n.º 314/2009, from 28^th October. The requirement for the submission of a PSUR applies irrespective of whether the VMP is marketed or not.

Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health. A pragmatic approach that will avoid or minimise these pitfalls includes the following: adequate resource planning, training, development of 'scripts' designed to maximize the capture of key information for medically important reactions, standardized and harmonized Medical Dictionary for Regulatory Activities (MedDRA) coding procedures, pre-specified search criteria for data retrieval, ongoing medical review, and metrics to evaluate the effectiveness and efficiencies of these processes. With these quality measures in place, the utility of the PSUR as an effective pharmacovigilance tool is enhanced

References:

[1.] Holm, G., Snape, J R., Murray-Smith, R., Talbot, J., Taylor.D., & Sörme. P.,(2013). Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities. Drug Safety, 36(7): 533–546. [doi:10.1007/s40264-013-0049-3,available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3691479/, accessed March 25, 2014]

[2.] Hoffmann, E., Fouretier, A., Vergne, C., et al. (2012). "Pharmacovigilance Regulatory Requirements in Latin America". Pharm Med 26 (3): 153–164.doi:10.1007/bf03262389.

[3.] Ruhoy, I.S., & Daughton, C.G., (2008). Beyond the medicine cabinet: An analysis of where and why medications accumulate. Environment International, 34 (8): 1157-1169.

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[5.] Herper, M., (2012). Why Big Pharma Won't Get Its Piece Of The $1.2 Trillion Global Drug Market. Available from http://www.forbes.com/sites/matthewherper/2012/07/12/the-global-drug-market-will-swell-to-1-2-trillion-while-big-pharma-treads-water/, accessed March 28, 2014.

[6.] Rahman, S.Z., Khan, R.A., Gupta, V., Misbah Uddin, (2008). "Pharmacoenvironmentology – Ahead of Pharmacovigilance". In Rahman, S.Z., Shahid, M., & Gupta, A., An Introduction to Environmental Pharmacology (1st ed.). Aligarh: Ibn Sina Academy. pp. 35–52.

[7.] Rahman., S.Z., Khan, R.A., (2006). "Environmental pharmacology: A new discipline". Indian J Pharmacol. 38 (4): 229–30. doi:10.4103/0253-7613.27017.

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[10.]   Sackman, J.E., (2013). Navigating Emerging Markets -Latin America: Latin America's diverse growing market seeks regulatory harmonization. BioPharm International 26(4), 60-63.

[11.]   Sara Gambrill, (2011). China's Pharmacovigilance System: The Hunger For Safety Insights, Clinical Leader,

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Abstract:

Patient safety has received growing attention worldwide sin last decade or two in clinical research. Identification and immediate reporting of an Adverse Event (AE) has always been one of the key parameters to assess and observer patient’s safety in clinical research. Compromise to the patient safety was evident as critical violation of the International Harmonization Conference (ICH) - Good Clinical Practice (GCP) requirements of clinical research.

This review was written after comprehensive and critical assessment of the research conducted by G. Ross Baker et.al. This review provided a synthesis of key principles of identification of AEs and determination of their preventability. It examined detail article structure considering the sample size, research population and relevance to the research topic. The review further critiqued on the article authority and creditability of the journal to authenticate the research. This review also commented on the other relevant advance researches conducted in the area of AEs within clinical research as a detail comparison.

It was concluded in this review that research conducted by G. Ross Baker et.al was critical in terms of improving attention towards patient safety in clinical research and community services.

References:

[1.] Agoritas, T., Bovier P.A., & Perneger T.V.,(2005).Patient reports of undesirable events during hospitalization. J Gen Intern Med; 20: 922-928.

[2.] Aranaz-Andrés, J.M., Aibar-Remón, C., Vitaller-Murillo, J., Ruiz-López P., Limón-Ramírez, R., & Terol-García E; (2008). ENEAS work group. Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events. J Epidemiol Community Health. ;62(12):1022-9.

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[4.] Canadian Medical Association Journal, http://www.cmaj.ca/ retrieved on 29 January 2014.

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[7.] Masotti, P., Green, M., Shortt, S., Hunter, D., Szala-Meneok, K., Adverse events in community care: developing a research agenda. Healthc Q. 2007;10(3):63-9.

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[13.]   preliminary retrospective record review [published erratum in BMJ 322:1395.

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Abstract:

Background: Bias might occur due to the clinical research study structures, endogenous bias, and to the investigators’ intention, external bias, on selecting only the positive outcomes and published them. So the publication bias still widespread in TCM clinical, but TCM are not unique cases, therefore study conclusions ought to be interpreted with caution.

Objective: to review the article ‘’Prospective registration, bias risk and outcome-reporting bias in randomized clinical trials of traditional Chinese medicine: an empirical methodological’’ regarding the contents, strengths, structures and limitations of Traditional Chinese Medicine (TCM) Clinical trials. In addition to outcome-reporting bias in randomized clinical trials.

Results: The number of Chinese randomized trials registration increases from 1999 to 2012, as well as the countries where these Chinese trials registered. As well as the frequency of the type of TCM intervention included in each registry. Classification of disease based on the International Classification of Diseases (ICD-10) has been used to classify medical conditions. Only (46.1%)= 505 out of 1096 registered randomized trials were completed studies. Only has found 29% of registered TCM trials presented selective outcome-reporting bias in between the outcomes registered and the outcomes published.

Conclusions: The quality of TCM clinical trials have developed through prospective international trial registration compared with previous methodological studies. Although there are some inconsistencies between the registered trial protocols and subsequent publications and inadequate reporting .Nevertheless it is indistinct how the study designs have got better-quality.

References:

[1.] Song, F., Parekh, S., Hooper, L., Loke, Y.K.,, Ryder, J., Sutton, A.J., Hing, C., Kwok, C.S., Pang, C., &Harvey, I., (2010). Dissemination and publication of research findings: an updated review of related biases.. Health Technology Assessment; Vol. 14: No. 8.(14(8):iii, ix-xi, 1-193. doi: 10.3310/hta14080.): 1-193.

[2.] Cao, H., Pan, X., Liu, J.,(2009). Acupuncture for Treatment of Insomnia, 15 (11:)-171-186- doi: 10.1089/acm.2009.0041 ed. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3156618/#__ffn_sectitl: Journal of Alternative and Complementary Medicine.

[3.] Jiang, M., Lu C., Zhang, C., Yang, J., Tan, Y., Lu, A., & Chan, K., (2012). Syndrome differentiation in modern research of traditional Chinese medicine, volume 140, Issue 3, 10, Pages 634–642. ed.: Journal of Ethnopharmacology.

[4.] Liu., Jian-Ping., Han., Mei; Li., Xin-Xue; Mu, Yu_Jie; Lewith, George; Wang, Yu-Yi; Witt, Claudia; Yang, Guo-Yan; Manheimer, Eric; Snellingen, Torkel; Berman, Brian.,&Christian,G., Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine : an empirical methodological study. B M J Open 2013; , vol 3, no. 7, (2044-6055): pp. e002968.

[5.] Maggie, B., &Covington, M.,(2001) Traditional Chinese Medicine in the Treatment of Diabetes, vol. 14 no. 3 pages 154-159. ed. Diabetes Spectrum: doi: 10.2337/diaspect.14.3.154.

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[11.]   http://creativecommons.org/licenses/by-nc/3.0/

[12.]   http://en.wikipedia.org/wiki/BMJ. 

Abstract:

The term ‘Stakeholder’ is a broad term that applies to: People inside the organization, but usually outside of the project team, who are in some way affected by the project. Typically Stakeholders will be users of the output from a project or benefit from its introduction. They may also have to change their role, function or method of working as users of new systems, processes or products.

Stakeholders might also be external customers and suppliers, as they might be directly affected by the changes resulting from a project. Stakeholders could include those who identified the need for project activity.

References:

[1.] http://www.healthit.gov/sites/default/files/cds/3_5_14_stakeholder_responsibilities_and_role_descriptions.pdf.

Abstract:

A systematic review is a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question. Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine. An understanding of systematic reviews and how to implement them in practice is becoming mandatory for all professionals involved in the delivery of health care. Besides health interventions, systematic reviews may concern clinical tests, public health interventions, social interventions, adverse effects, and economic evaluations. Systematic reviews are not limited to medicine and are quite common in other sciences where data are collected, published in the literature, and an assessment of methodological quality for a precisely defined subject would be helpful.

With an ever-increasing plethora of studies being published in the health sciences, it is challenging if not impossible for busy clinicians and researchers alike to keep up with the literature. Reviews summarizing the outcomes of various intervention trials are therefore an extremely efficient method for obtaining the “bottom line” about what works and what doesn’t. In his review we cover the basic principles of Systemic review and meta-analysis. The important issues that needs to consider while doing systematic reviews and meta-analysis are outlined and some of the terms used in the reporting of systematic reviews and meta-analysis such as odds ratio, relative risk, confidence interval and forest plot

References:

[1.] Akobeng, AK,(2003). The Cochrane Database of SystematicReviews; issue 4.

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[4.] Baldassano, R.,(2003) et al; Am J Gastroenterol;98:833–8.

[5.] Clarke, M., Oxman, AD., (2001). eds. Cochrane Reviewers’ Handbook 4.1.4 (updated October 2001). In: The Cochrane Library, Issue 4, Oxford: Update software.

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[7.] D’haens, G., et al; (1999). Gastroenterology. Germany, Springer.

[8.] Elnicki. DM., et al. (1999). Evidence based endocrinology. Am J Med Sci, 317:243–6

[9.] Green ML;(2000).J Eval Clin Pract;6:121–38.

[10.]   Greenhalgh,T., Milbank Quarterly 87 (4): 729–88.

[11.]   Jadad, AR.,(1996).et al. Control Clin Trials;17:1–12.

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[15.]   Isabelle,S., et al; Journal of Technology Assessment in Health Care 19 (1): 168–78.

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Abstract:

The article "Serological Assessment of Samples from Patients Complaining of Dyspepsia" by Dr. Stephen Mortlock is current article published in the Journal of Gastrointestinal and Digestive Systems in October 2013. This review analyses the article's structure, authority, currency, stability, objectivity and it relevance to students and the health care industry. The review first summarize the article. it then analysis the structure of the article, taking into consideration the concept, methodology of the research, it accessible and the technical flow of the article. The review will also critique the article on the basis of its authority, currency, accuracy, objectivity and it stability. The relevance of the article to in the academia and healthcare industry will also be analyzed in the review. The review will analyze all the relevant data and information (including diagrams) provided by the article before judging on the credibility and the reliability of the article. In entirety, the article is very well written, well structured, clear and relevant in to first year medical students and general practitioners.

References:

[1.] Agréus, L., Kuipers, EJ., Kupcinskas, L., Malfertheiner, P., & Di Mario, F., et al (2012). Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers. Scand J Gastroenterol 47: 136-147.

[2.] Agréus, L., Kuipers, EJ., Kupcinskas, L., Malfertheiner, P., & Di Mario, F., et al. (2012). Rationale in diagnosis and screening of atrophic gastritis with stomach-specific plasma biomarkers. Scand J Gastroenterol 47: 136-147.

[3.] Axon, A.,(2002) Management of uninvestigated dyspepsia: review and commentary. Gut 50 Suppl 4: iv51-55.

[4.] Brun, R., & Kuo, B., (2010). Functional dyspepsia. Therap Adv Gastroenterol 3: 145-164.

[5.] Dai, YC., Tang, ZP.,& Zhang ,YL (2011). How to assess the severity of atrophic gastritis. World J Gastroenterol 17: 1690-1693.

[6.] ErdoÄŸan, A.,& Yilmaz, U., (2011). Is there a relationship between Helicobacter pylori and gastric autoimmunity? Turk J Gastroenterol 22: 134-138.

[7.] Harmon, RC., & Peura, DA., (2010). Evaluation and management of dyspepsia. Therap Adv Gastroenterol 3: 87-98.

[8.] Iijima, K., Abe, Y., Kikuchi, R., Koike, T., & Ohara, S., et al. (2009). Serum biomarker tests are useful in delineating between patients with gastric atrophy and normal, healthy stomach. World J Gastroenterol 15: 853-859.

[9.] Kamangar, F., Sheikhattari, P., & Mohebtash, M., (2011). Helicobacter pylori and its effects on human health and disease. Arch Iran Med 14: 192-199.

[10.]   Mason, JM., Delaney, B., Moayyedi, P., Thomas, M.,& Walt, R., et al. (2005). Managing dyspepsia without alarm signs in primary care: new national guidance for England and Wales. Aliment Pharmacol Ther 21: 1135-1143.

[11.]   Mortlock, S., Nikulin, M., & Arnold-Maclean, C., (2012). ‘External quality assessment of a non-standard gastric assay panel.’ The Biomedical Scientist 56: 533-534.

[12.]   Nasrollahzadeh, D., Aghcheli, K., Sotoudeh, M., Shakeri, R., & Persson,EC., et al. (2011). Accuracy and cut-off values of pepsinogens I, II and gastrin 17 for diagnosis of gastric fundic atrophy: influence of gastritis. PLoS One 6: e26957.

[13.]   Oustamanolakis, P.,& Tack, J., (2012). Dyspepsia: organic versus functional. J Clin Gastroenterol 46: 175-190.

[14.]   Penston, JG., & Pounder, RE., (1996). A survey of dyspepsia in Great Britain. Aliment Pharmacol Ther 10: 83-89.

[15.]   Spiegel, BM., Vakil, NB., & Ofman, JJ., (2002) Dyspepsia management in primary care: a decision analysis of competing strategies. Gastroenterology 122: 1270-1285.

[16.]   Sudraba, A., Daugule, I., Rudzite, D., Funka, K., & Tolmanis, I., et al. (2011). Performance of routine Helicobacter pylori tests in patients with atrophic gastritis. J Gastrointestin Liver Dis 20: 349-354.

[17.]   Sugano, K .,(2011). Should we still subcategorize helicobacter pylori-associaed dyspepsia as functional disease? J Neurogastroenterol Motil 17: 366-371.

[18.]   Taniyama, K., Shimbo, T., Iwase, H., Tanaka, S., & Watanabe, N., et al. (2011). Evidence-based therapy according to the guideline for gastric ulcers is cost-effective in Japan. J Physiol Pharmacol 62: 627-635.

[19.]   Wallander, MA., Johansson, S., Ruigómez, A., García Rodríguez, LA., & Jones, R., (2007). Dyspepsia in general practice: incidence, risk factors, comorbidity and mortality. Fam Pract 24: 403-411.

[20.]   Yakoob, J., Abbas, Z., Khan, R., Naz, S., & Ahmad, Z., et al. (2012). Prevalence of non Helicobacter pylori species in patients presenting with dyspepsia. BMC Gastroenterol 12: 3.

Abstract:

This review would critically review the article, “Cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: a systematic review and meta- analysis”, published in BMC Psychiatry. The review would introduce the article with a brief summary on the basis of available literature and further critique the overall structure of the article. The review would provide information on the accessibility of the article and highlights on current activities that are ongoing in the area of research. In addition, it would also provide information on the article by critically evaluating it on the basis of accuracy, relevance, stability, objectivity and ultimately the credibility of the article set to be reviewed. The cited references would also be critiqued on the basis of the authenticity of the article and presentation of references for future citations.

References:

[1.] Ball, J., Thinking your way out of Depression, New South Wales, Retrieved January 31, 2014: http://www.blackdoginstitute.org.au/docs/cbt_jillianball.pdf

[2.] Beltman, M., Richard, W., Voshaar, V., & Speckens,O., (2010). Cognitive Behavioral therapy for depression in people with a somatic disease: meta-analysis of randomised controlled trials. BJP, 197, pp 11 -19. Retrieved from: http://bjp.rcpsych.org/content/197/1/11.long

[3.] Buchanan, R., Freedman, W., Javitt, R., Abi-Dargham, DC., & Liberman, A.,(2007). Recent advances in the development of novel pharmacological agents for the treatment of cognitive impairment in schizophrenia. Schizophrenia Bulletin, 33, 5, pp 1120 – 1130. Retrieved from: http://schizophreniabulletin.oxfordjournals.org/content/33/5/1120.full.pdf+html

[4.] Cooper, CL., Hind, D., Parry, GD., Isaac, CL., Dimairo1,M.,O'Cathain,A.,Rose,A., Freeman, JV., Martin, L., Kaltenthaler, EC., Thake, A.,& Sharrack, B.,(2011). Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial. Trials, 12, 259. Retrieved from: http://www.trialsjournal.com/content/12/1/259

[5.] Duke Geriatrics. Clinical Research. Retrieved January 31, 2014: http://geriatrics.medicine.duke.edu/research/clinical-research.

[6.] Hind, D., Cotter, J., Thake, A., Badburn,M., Cooper, C., Issac, C., & House,A.,(2014). “Cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: a systematic review and meta-analysis”, BMC Psychiatry, 14, 5, Retrieved from: http://www.biomedcentral.com/1471-244X/14/5.

[7.] Medline Plus. X–Plain, Multiple Sclerosis. Retrieved January 15, 2014: http://www.nlm.nih.gov/medlineplus/tutorials/multiplesclerosis/htm/_no_50_no_0.html.

[8.] Morris, RM., Dennison, L., & Chalder, T., (2010). Supportive Adjustments for Multiple Sclerosis. Multiple Sclerosis Society. Retrieved January 28, 2014: http://www.mssociety.org.uk/sites/default/files/Documents/Professionals/SAMS%20Manual%20GI22%201210%20-%20web.pdf.

[9.] Murray, A., (2014). BMC Psychiatry. Retrieved January 30, 2014: http://www.biomedcentral.com/bmcpsychiatry/about.

[10.]   National Multiple Sclerosis Society. Retrieved January 15, 2014: http://www.nationalmssociety.org/about-the-society/index.aspx

[11.]   NHS choices. Cognitive Behavioural Therapy. Retrieved January 28, 2014: http://www.nhs.uk/conditions/Cognitive-behavioural-therapy/Pages/Introduction.aspx.

[12.]   Shaddy, A., (2007). Understanding and treating depression in Multiple Sclerosis, recognising the symptoms and learning the solutions. Multiple Sclerosis Association of America. Retrieved from: http://www.mymsaa.org/PDFs/MSAA.Depression.0507.pdf.

[13.]   Siegert, RJ., & Abernethy, DA., (2005). Depression in multiple sclerosis: a review, Journal of Neurol Neurosurg Psychiatry, 7, pp: 469–475. Retrieved from: http://jnnp.bmj.com/content/76/4/469.short.

[14.]   Wallin, MT., Wilken, JA., Turner, AP., Williams,RM., & Kane, R., (2006). Depression and multiple sclerosis: Review of a lethal combination. Journal of Rehabilitation Research and Development, 43, 1, pp 45-62.

[15.]   Whitefield, G.,&Williams, C., (2003). The evidence base for cognitive – behavioural therapy in depression: delivery in busy clinical settings. Advances in Psychiatric Treatment, 9, pp 21 – 30. Retrieved from: http://apt.rcpsych.org/content/9/1/21.full.

Abstract:

This review critically reviews the article monoclonal antibodies therapy in neuro oncology The Brain tumors In applying mAb therapy to brain tumors, both expectations and interpretation are seems difficult due to blood-brain barrier (BBB).It prevents the antibodies from entry into the brain but in case of brain tumors their entry is more complex. Brain tumors (the target), antibodies (the magic), how antibodies attack tumor (the bullet) and how they reach it (through blood brain barrier) are reviewed .With this as introduction, practical experience with mAbs for brain tumor targets is by Clinical experience with mAbs in brain tumor therapy indicates that it is less inherently toxic than the conventional therapies and far safer for widespread delivery

Three of the best-studied antibody/target combinations Bevacizumab and GBM. It hard to define the effect of the antibody itself on tumor growth bevacizumab primarily reduces edema. Other questions concern response criteria. How to weigh overall survival as opposed to progression-free survival; Rituximab and PCNSL Rituximab targets the common B-cell marker CD20 PCNSL, which is typically a B-cell lymphoma. Trastuzumab and metastastic breast cancer Monoclonal antibodies (mAbs) serve as tumor-specific magic bullets in two ways. As bullets, they would move through the blood to reach and attack tumor targets and specificity of a single antibody would provide the magic , breast cancer patients respond to systemic mAb treatment, but then metastases appear in the brain. Limitations of clinical trials and drawbacks of pre-clinical models interpretation of clinical results difficult - increase in overall or progression-free survival, or simply an improved quality of life, are certainly of benefit to brain tumor patients- delivery strategies and tumor sites

References:

[1.] Beduneau, A., Saulnier, P., & Benoit, JP., (2007). Active targeting of brain tumors using nanocarriers. Biomaterials. 28:4947–4967.

[2.] Cheng, X., & Hung, MC., (2007). Breast cancer brain metastases. Cancer Metastasis 26:635–643.

[3.] Choi, YK., & Kim, KW.,(2008). Blood-neural barrier: its diversity and coordinated cell-to-cell communication.

[4.] Deeken, JF.,& Loscher, W., (2007). The blood-brain barrier and cancer: transporters, treatment and Trojan horses.

[5.] Ferreri, AJ., & Reni, M.,( 2007). Primary central nervous system lymphoma. Crit Rev Oncol Hematol.

[6.] Gerstner, ER., & Fine, RL.,( 2007). Increased permeability of the blood-brain barrier to chemotherapy in metastatic brain tumors: establishing a treatment paradigm.

[7.] Kim, WY.,& Lee, HY.,( 2009).Brain angiogenesis in developmental and pathological processes: mechanism and therapeutic intervention in brain tumors.

[8.] Neelapu, SS., Kwak, LW., Kobrin, CB., Reynolds, CW., Janik, JE., & Dunleavy, K,, et al.( 2005).Vaccine-induced tumor-specific immunity despite severe B-cell depletion in mantle cell lymphoma.

[9.] Poulsen, HS., Grunnet, K., Sorensen, M., Olsen, P., Hasselbalch, B., & Nelausen, K,, et al. . (2009). Bevacizumab plus irinotecan in the treatment patients with progressive recurrent malignant brain tumours.

[10.]   Rubenstein, JL., Kim, J., Ozawa, T., Zhang, M., Westphal, M.,& Deen, DF., et al(2000).Anti-VEGF antibody treatment of glioblastoma prolongs survival but results in increased vascular cooption. Neoplasia.

[11.]   Sathornsumetee, S., Rich, & JN.,( 2007).Antiangiogenic therapy in malignant glioma: promise and challenge. Pubmed-NCBI.

[12.]   Saunders, NR., Ek, CJ.,& Habgood, MD.,( 2008). Dziegielewska KM, Barriers in the brain: a renaissance.

[13.]   Strome, SE., Sausville, EA., & Mann, D.,(2007)A mechanistic perspective of monoclonal antibodies in cancer therapy beyond target-related effects. Oncologist12:1084–1095.

[14.]   Takahashi, JA., Llena, JF., & Hirano, A.,(1996) Pathology of cerebral metastases. Neurosurg Clin N Am.7:345–367.

Abstract:

The review of the article identifies Tuberculosis (TB) as an infectious disease which is known worldwide with reference to India being the second largest populated country in the world. Secondly it identifies Acid Fast Bacilli using Zielh-Neelson (Z-N) staining in a clinical laboratory for the identification of TB using the best possible method to obtain secretions from the lower airways of patients as compared to bacterial identification which is normally used.

Various diagnostic methods and materials used to evaluate the article authority and accuracy will be outlined which includes sample study, period of examination, ethical practices prior starting the study, study protocol, study design, inclusion and exclusion criteria carried out systematically under sterile conditions.

Analysis of AFB smear will be explained and presented using tables which are instrumental in the identification of other diagnostic methods like sputum smear microscopy and X-ray method. Conclusion of the study will be based on the safest method for identification of the organism, which is cost effective and has the potential to offer treatment to the suspected patients. On the other hand, the article has obtained its objectivity and coverage by using various ethical committees and by declaring no conflict of interest among the authors who have contributed equally to the study.

Finally, the evaluation of the article will be carried through the use of well designed and précised questionnaires, a case sheet proforma plus relevant referees attached to the article to aid more understanding.

References:

[1.] Andrew, L., diagnostic surgical pathology of the head and neck, 2009, 2nd edition, 647 – 727.

[2.] Alexander, JrC., (2010). differential diagnosis in surgical pathology of the lung and pleura, 2^nd edition, 217 – 280.

[3.] Barnard, R., & AM, J., (2008) Rapid Molecular Screening for multidrug- resistant tuberculosis in a high volume public health laboratory, 177:787 – 792, South Africa.

[4.] Brooks, GF et al (1995): Jawetz, Melnick, & Adelberg’s Medical Microbiology, 21ST International Edition, Prentice Hall International Limited, London, UK, 134 – 144.

[5.] Caviedes, L., & LEE, TS., (2000). Rapid efficient detection and drug susceptibility testing of Mycobacterium Tuberculosis in sputum by microscopic observation of broth cultures; 38; 1203 – 1208, tuberculosis working groups in Peru.

[6.] Centres for Disease Control and Prevention, MMWR Recomm, 2002, sexually transmitted diseases treatment guidelines, 51(RR – 6): 1 – 78.

[7.] Gavino, M., &Wang, E., (2007)., a comparison of a new rapid real – time polymerase chain reaction system to traditional culture in determining group B streptococcus colonization.

[8.] Goldman’s Cecil medicine,(2012), non tuberculous mycobacteria, volume 2, pages 1948 – 1950, 24th edition, Steven M. Holland.

[9.] Margret, S., et al, 2009, nonsquamous pathological diseases of the hypophyarnx, larynx and trachea, chapter 5, 2nd edition and pages 309 – 411.

[10.]   Mitnick, CD., & S.S. (2008)., comprehensive treatment of extensively drug – resistant tuberculosis. N. Engl. J. MED, 359; 563 – 54.

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[12.]   Rutala, W.A., & D.J. (2002)., draft guideline for disinfection and sterilization in healthcare facilities, centres for disease control and prevention, Atlanta.

[13.]   Steven, L., (2014). microbiology of waterborne diseases, second edition, chapter nine pages 177 – 207. Mycobacterium.

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Abstract:

The review will assess the article: ‘Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial’, published in 2012 by Xue et al. in the E-journal, Trials, volume 12 number 164. The assessment will focus on the knowledge contribution of the article to the field of translational medicine and evidence based research for use of Complementary and Alternative Medicine (CAM).

Translational medicine, a research dissemination tool for advancing gains of basic laboratory discoveries to populations via clinical studies, has come to be a very useful tool for the practice of conventional medicines. This paradigm has also found usefulness as an emerging trend in the development and practice of CAM. CAM, though older than conventional medicine, have found rebirth in the healing sphere owing to public demand and based on successful psychometric evaluations using various rigorous study designs of Randomised Controlled Trials (RCT).

The goal of designing a study protocols is to obtain a tool for measuring and evaluating how an intervention, medical device or diagnostic contribute to improvement in health status or knowledge. Hence, this review will assess the scientific rigour and proof of principles demonstrated by the author in developing the study design. The article will be summarised, assessed on presentation effectiveness and the depth of literature on current knowledge. A critique on authority, currency, relevance, accuracy, objectivity and stability will be carried out and the conclusion will present the statement of scientific value of the article.

References:

[1.] Brownson, R. C., Kreuter, M. W., Arrington, B. A., & True, W. R., (2006). Translating Scientific Discoveries Into Public Health Action: How Can Schools Of Public Health Move Us Forward? Public Health Reports Volume 121, 97-103

[2.] Elder, C., Aickin, M., Bauer, V., Cairns, J., & Vuckovic, N., (2006). Randomized trial of a whole-system ayurvedic protocol for type 2 diabetes. Altern Ther Health Med. 12(5), 24-30.

[3.] Ernst, E., Cohen, M. H., & Stone, J., (2004). Ethical problems arising in evidence based complementary and alternative medicine. J Med Ethics, 30, 156–159. doi: 10.1136/jme.2003.007021

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[5.] Frenkel, M. A., & Borkan J. M., (2003). An approach for integrating complemetary–alternative medicine into primary care. Family Practice, 20(3), 324–332. Doi: 10.1093/fampra/cmg315, available online at www.fampra.oupjournals.org.

[6.] Gross, D., Shenkman, Z., Bleiberg, B., Dayan, M., Gittelson, M., & Efrat, R., (2002). Ginseng improves pulmonary functions and exercise capacity in patients with COPD. Monaldi Arch Chest Dis. 57(5-6), 242-246.

[7.] Halbert, R. J., Natoli, J. L., Gano, A., Badamgarav, E., Buist, A. S., & Mannino, D. M., ( 2006). Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 28(3), 523-532.

[8.] Ludbrook, J., (2000). Multiple inferences using confidence intervals. Clin Exp Pharmacol Physiol. 27(3), 212-215.

[9.] Price, D., Freeman, D., Cleland, J., Kaplan, A., & Cerasoli, F., (2011). Earlier diagnosis and earlier treatment of COPD in primary care. Prim Care Respir J. 20(1), 15-22. doi: 10.4104/pcrj.2010.00060.

[10.]   Rabe, K. F., Hurd, S., Anzueto, A., Barnes, P. J., Buist, S. A., Calverley, P., Fukuchi, Y., Jenkins, C., Rodriguez-Roisin, R., van Weel, C., & Zielinski, J.,(2007). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 176(6), 532-555.

[11.]   Shergis, J. L., Parker, S., Coyle, M. E., Zhang, A. L., & Xue C. C., (2013), ‘Key considerations for conducting Chinese medicine clinical trials in hospitals’. Chinese Medicine vol. 8, no. 3 http://www.cmjournal.org/content/8/1/3.

[12.]   Sun, X. G., Lin, D., Wu, W., & Lv,. Z.(2011). Translational Chinese Medicine: A Way for Development of Traditional Chinese Medicine. Chinese Medicine, 2, 186-190 doi:10.4236/cm.2011.24029.

[13.]   Terzic A., & Waldman S. A., (2010) Translational medicine: path to personalized and public health Biomarkers Med. 4(6), 787–790.

[14.]   Verhoef, M. J., Vanderheyden, L. C., Dryden,T., Mallory, D., & Ware M. A., (2006). Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures. BMC Complementary and Alternative Medicine, 6(38) doi:10.1186/1472-6882-6-38.

[15.]   Waldman S. A., & Terzic A., (2009). Translational medicine in the era of health care reform. Clin. Transl. Sci. 2, 96–97.

[16.]   Walker, L. G. & Anderson, J., (1999). Testing complementary and alternative therapies within a research protocol. Eur J Cancer. 35(11).