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All students are required to complete this assignment as a DP requirement. The assignment accounts for 10% of the final GEMP 4 integrated block mark. Evidence-based medicine is the practice of child health care based on the best available evidence. Doctors and other health professionals caring for children need to be aware of the evidence about the benefits and harms of preventive manoeuvres, diagnostic strategies, and treatment and rehabilitation techniques in order to provide optimal care to their patients and their families. Objective of this assignment On completion of the assignment the student should have: Identified a suitable clinical question Improved her/his literature searching skills Collected relevant evidence in a clear, coherent way Gained practice and skill in critically appraising original research articles Assessed the relevance of the evidence to his/her patient Task You should identify a clinical question or problem related to a real-life patient you encounter in any of the rotations you undertake in GEMP 4 (ward, outpatients, clinic setting). You are expected to formulate an answerable question that can be answered by means of a focussed, systematic literature search. A description of the literature search, a critical appraisal of the relevant studies identified, and the relevance of the search to your patient must be presented. Format Typed assignments are preferred. Neat, handwritten assignments are acceptable. Students are expected to present their evidence-based search in a standardised format. This BETS (Best Evidence Topics) format (available at http://www.bestbets.org/) is favoured. An example is copied below. Further examples can be found at the BETS website. YOU ARE URGED TO USE THE TEMPLATE PRESENTED AT THE END OF THIS DOCUMENT. This has been prepared to: - save you time (no need to format document yourself), - indicate the length of the response sought to questions, and - ensure that you do not miss answering critical questions. Your assignment should not exceed 8 pages (the template is 6 pages long). Examples of appropriate questions or problems: 1. 2. 3. 4. 5. 6. 7. 8. Is ibuprofen better than paracetamol in reducing fever in a child? What is the diagnostic value of a physical examination in chest trauma? Comparison of digital versus metacarpal blocks for repair of finger injuries Does speculum examination have a role in assessing bleeding in early pregnancy? Do restraints help in patients with dementia? Is supplemental Oxygen therapy necessary in acute strokes? What is the diagnostic utility of CT scan in patients presenting with a first fit? Ultrasonography or diagnostic peritoneal lavage in abdominal trauma?

Due date: Friday, 7 September 2012 by 16:00. Any assignments handed in after this time will be penalised at 5% per day.) To be handed in at the CHSE: Mrs Natashya Bennett in Academic Administration Some hints: You are expected to get the full-text of each of the papers you select for review. Only use the abstract if you are unable to acquire the full-text. If you find that there are too many relevant papers on a particular topic, you should select the best 4-6 papers to include in your review. You must, however, justify why you selected these 4-6 papers (e.g. most recent, largest sample size, availability, etc) As you rule, you should not select topics for which a good systematic review or meta-analysis already exists; unless the original review is dated, and you find more recent data that update the conclusion of the original metaanalysis. Common problems noted with this assignment: Hypothetical patient presented instead of one of your own patients Highly technical or irrelevant topic choice Patient details omitted Clinical scenario too detailed with irrelevant information (this is not a case report) Vague (unanswerable) question selected Structured question not in PICO format Search strategy not described in detail (see mark sheet) Incomplete search Citing unavailability of full paper (electronically) as a reason for excluding relevant studies Relying only on abstracts rather than reviewing original papers Summarising less than four papers, unless a limited number of relevant publications exist Inadequate study patient details in summary table (e.g. number, age, sex, distinguishing traits) Failure to provide study level in summary table Lack of understanding of what is meant by outcome Study results presented as numbers or percentages with no detail of statistical tests of significance (e.g. p-values, relative risk, odds ratio) or other pertinent statistics (e.g. sensitivity, likelihood ratio, absolute risk reduction, number needed to treat) No use of EBM knowledge in identifying study weaknesses No attempt to integrate and critically reflect on the results of different studies in Commentary section. Rather commentary is mainly a repetition of results. Relevance of evidence found to your patient is not made clear (remember the critical fifth and final step of the EBM process!) Failure to follow Vancouver reference system exactly (e.g. not providing names of six authors before using et al., abbreviating journal titles inappropriately)

GEMP 4 EBM Assignment marking sheet Final Mark: Criteria Choice of Topic Presentation ____ Components Originality Relevance to block Completed all sections Neatness Spelling check completed Grammar check completed Short description of the clinical situation Relevant and interesting Clear, convincing Patient/Intervention/Comparison/Outcome Resources used (2) Search terms used (2) Hits found (1) Hits relevant, details of why other hits excluded (3) Explanation of why 4-6 papers selected for review chosen (3) Completeness of search (1) ID (2) Patients (4) Study design and level (2) Outcomes (4) Study results (7) Weaknesses (6) Summation of the evidence Strengths and weaknesses of evidence Conclusion/s Clear, concise, correct Relevance of evidence search to index (your) patient Did the evidence make a difference? Cited correctly in text (1) Vancouver system followed (4) Max Mark 4 4 Student Mark

Scenario Explanation for choice of topic Structured Clinical Question Search strategy

5 5 4 12

Summary of Relevant papers


Commentary Clinical bottom line/s Applicability to patient Patient outcome References Total Marker: Comments:

20 5 6 5 5 100

Note: This is an example from the BETs web page http://www.bestbets.org/database/search.html and does not exactly reflect the detail required in your assignment. Review the mark sheet provided to obtain exact details of the assignments requirements.

BET (best evidence topic) Title Ask a snappy question Inhaled steroids in the treatment of mild to moderate persistent asthma in children: once or twice daily administration? Scenario Short description of the clinical situation. Make it readable and interesting. Your patient has to be a real patient (not a hypothetical one). A six year old girl comes to your outpatient pediatric clinic with a two-month history of cough and shortness of breath, requiring, nearly three times a week, administration of beta 2 agonists by jetnebulizer. She has often been noticed to wheeze at school during the gymnastic class and when she's laughing or crying; almost once a week she awakes during the night complaining of cough and respiratory difficulties. Explain why you chose this topic Justify your choice Your diagnosis is persistent asthma (1) and after a short course of nebulized salbutamol (albuterol) and oral steroids you decide to start, twice a day, a prophylaxis with inhaled steroids, via a spacer device. As her mother is working outside home till late afternoon, she asks you if a once-daily administration would have the same efficacy Structured Clinical Question Three or four part clinical question (PICO format preferred) In [children with mild to moderate persistent asthma] does [once daily and twice daily administration of inhaled steroids] have [the same efficacy]? Search Summary of searches performed. Start with secondary resources (e.g. Cochrane) and then primary resources. Describe search strategy used, hits found and hits relevant. Why others excluded? Medline 1966-12/01 using OVID interface, Cochrane Library (2001), PubMed clinical queries. "Inhaled steroids" OR glucocorticoids OR glucocorticosteroids OR budesonide OR mometasone OR flunisolide OR fluticasone propionate OR beclomethasone dipropionate AND ( once versus twice OR once with twice daily OR OD OR BID administration ) AND asthma. Limits: All Children:0-18 years, Randomized Controlled Trial. Search outcome No systematic reviews. 31 studies found, 9 were relevant. (Papers available in abstracts only and studies including both adults and children aged > 12 were excluded). Summary of Relevant paper(s) Use this table to fill in for your own studies. Each study may be accompanied by a longer, fuller, critical appraisal (in the commentary section). Ensure you understand what each column heading means, e.g. Outcomes.

Author, date Patient group and country

Study type (level Outcomes of evidence)

Key results

Study weaknesses

24 children, age 5.612.5 yrs, with mild Significant reduction of lower leg asthma,outpatient clinic Lower leg growth, growth rate (p=.04) and markers of Small study Heuck C et Double blind OD vs BID Budesonide PEF, symptom score,collagen turnover with BID. No other al, RCT (level by Metered Dose albuterol use, significant differences between OD The trial did not 1998, 1b) Jadad Inhaler + spacer markers of collagen and BID:Morning PEF (95% CI 4 include a placebo Denmark score: 3 crossover trial, 2 turnover to+15 L/min ), in evening PEF(95% period treatment periods of 4 CI 3 to +16 L/min) wks. PEF, FEV1, 163 children, age 7-16 Patients with nearJonasson G Double blind FVC,symptom score, No significant differences between yrs , with mild asthma, normal lung et al, RCT (level beta agonist use, OD vs BID Budesonide:FEV1% -0.05 outpatient clinic OD vs function: FEV1 at 1998, 1b) Jadad metacoline (95% CI 3.3 to +3.0); PEF 2.9 L/min BID Budesonide by baseline >100%, Norway score: 3 challenge, exercise (95% CI 10.8 to +16.6) Dry Powder for 12 wks reversibility of 3% test,adverse events Ten patients excluded from the Peak Expiratory all-patients-treated 167 children, age 5-12 Flow(PEF), Forced population yrs with symptomatic Expired volume in 1 OD >BID for evening PEF:+19.7 Campbell asthma, multicenter Double blind second (FEV1), l/min vs + 8.3 l/min (p=0.013), no A greater number LM et al, study O RCT (level Forced Vital other significant differences (morning of patients 1998, 1b) Jadad Capacity (FVC), PEF: +24.6 l/min vs +15.2 l/min, randomised to the UK OD vs BID Budesonide score: 2 well-being and p=0.059) BID arm: 90 vs 77 by Dry Powder for 8 symptom score, wks albuterol use, Patients adverse events compliance not assessed 480 children, age 6 months-8 yrs, with Lost to follow-up: moderate persistent 27% asthma, multicenter Improvement in FEV1 significant study. FEV1, PEF, between Budesonide 0.50 mg BID and Baker JW Double blind Differences in % symptom score, placebo (0.17 / 0.04 L/min), but not et al, RCT (level patients using Budesonide inhalation adverse events and significant between Budesonide 0.1 1999, 1b) Jadad inhaled steroids suspension by jet in a subgroup mg OD and placebo (0.11/0.04 USA score: 2 before entering nebulizer :0.25 mg OD cortisol testing L/min). For the other outcomes: 0,50 into the study vs. 0.25 mg BID vs. mg BID >1 mg OD, but not significant between OD and 0,50 mg BID vs.1 mg BID groups OD vs. Placebo for 12 wks FEV1, FVC, Forced Difference in expiratory flow patients 206 children, age 5-15 No significant differences between Moller C et Double blind between 25 and 75% demographic yrs, with stable asthma, OD and BID: Morning PEF 2.8 al, RCT (level of Forced Vital characteristics multicenter study OD L/min (90% CI 10.4 to + 4.5); 1999, 1b) Jadad Capacity (FEF 25(duration of asthma vs BID Budesonide by Absolute Reduction for FEV1% 0.08 Sweden score: 3 75), PEF, symptom in months) Dry Powder for 12 wks (95% CI 3.4 to + 0.9) score, albuterol use, between OD and adverse events BID FEV1, FEF 25-75, 122 children, age 7-16 PEF, exercise test, Jonasson G Double blind yrs, with mild asthma, metacoline et al, RCT (level No significant differences between Compliance outpatient clinic OD vs challenge, symptom 2000, 1b) Jadad BID and OD declined rapidly BID Budesonide by score, growth rate, Norway score: 3 Dry Powder for 27 wks eosinophil count, compliance 242 children, age 4-11 Asthma had to yrs, with persistent FEV1, PEF LaForce Double blind BID > OD for FEV1 change in % remain stable for stable asthma, symptom score, CF et al, RCT (level (95% CI 11.28 to 0.124); no other all the study multicenter study OD nightime awakening, 2000, 1b) Jadad significant differences: for morning period; high rate of vs BID Fluticasone albuterol use, USA score: 3 PEF (95% CI 27.26 to + 9.26) discontinuation in propionate by Dry adverse events the placebo group Powder for 12 wks 262 children, age 4-11 Change in FEV1 in L/min from Lost to followPurucker et yrs, with persistent Double blind FEV1, PEF baseline : OD fluticasone 0.08 (NS), up:35%. al, stable asthma, single RCT (level symptom score, BID fluticasone 0.13 (NS) and placebo 2003, study 1b) Jadad nightime awakening, 0.05 (NS). BID Fluticasone vs. No details about USA score: 2 albuterol use Placebo: Absolute Reduction for how randomisation Fluticasone propionate morning PEFR in L/min 27.8 was performed and

by Dry Powder 0,05 mg OD vs 0.1 mg BID vs placebo X 12 wks 242 children, age 4-11 yrs, with persistent (more severe than that of Study FLTA 2007) Purucker et stable asthma. al, 2003, Single study. USA Fluticasone propionate by Dry Powder 0.1 mg OD vs 0.2 mg BID vs placebo X 12 wks

(p<.050)). OD Fluticasone vs. about demographic Placebo: Absolute Reduction for characteristics of morning PEFR in L/min 15.3 L/min the three groups. (NS) BID Fluticasone vs. Placebo: Absolute Reduction for FEV1 in L/min 0.27 (p< .001). 100 micrograms OD Lost to followFluticasone vs. Placebo: Absolute up:45%. Reduction for FEV1 in L/min 0.16 Double blind FEV1, PEF (p<.001). No significant difference No details about RCT (level symptom score, between the two FP arms. BID how randomisation 1b) Jadad nightime awakening, Fluticasone vs. Placebo: Absolute was performed and score: 2 albuterol use Reduction for morning PEFR in L/min about demographic 22.8 (p<.050)). 100 micrograms OD characteristics of Fluticasone vs. Placebo: Absolute the three groups. Reduction for morning PEFR in l/min 13.3 l/min (NS)

Commentary Time for a short summation of the evidence, its strengths and weaknesses, and any conclusions As Baker's study evaluate the efficacy of different doses of Budesonide (4 Groups) compared to placebo, 8 studies were found that specifically compare the once-daily vs twice-daily administration of inhaled steroids. Overall the methodological quality of the included studies was not always satisfactory: even if the majority of the references mentioned the number of patients excluded from the study, withdrawals and drop-outs were described and commented only in Heuck's and in Moller's articles; in Baker's and in both Purucker's studies "lost to follow-up" was > 20%. Intention to treat analysis was reported to be used by Jonasson, by LaForce and by Purucker; allocation concealment was unclear in most of the cases and often details of methods used to generate the random allocation sequence were lacking. This overview found a heterogenous group of trials with different results; although the majority of studies reported not significant difference between the two regimens the overall findings of the seven studies are not sufficient to support the evidence that administering inhaled steroids once-daily and twice daily has the same efficacy. Clinical bottom lines Snappy one line answers to the questions posed In mild to moderate persistent asthma, in children, inhaled steroids should continue to be given twicedaily. Applicability to patient Briefly describe the implications of your search and your conclusion to your index patient Once daily administration might have a similar efficacy at least in some subgroups of patients with more stable asthma, but further well conducted randomized controlled studies are needed. References Provide these in the Vancouver format Visit this site to get the format guidelines: http://www.nlm.nih.gov/bsd/uniform_requirements.html 1. 2. Warner JO, Naspitz CK, Cropp GJA. Third International Pediatric Consensus Statement on the management of childhood asthma. Pediatr Pulmonol 1998;25(1):1-17. Heuck C, Wolthers OD, Kollerup G, et al. Adverse effect of inhaled budesonide (800 &#956;gr) on growth and collagen turnover in children with asthma: a double-blind comparison of once-daily versus twice-daily administration. Journal of Pediatrics 1998;133(5):608-612. Jonasson G, Carlsen KH, Blomqvist P. Clinical efficacy of low-dose inhaled budesonide once or twice daily in children with mild asthma not previously treated with steroids. Eur Respir J 1998;12(5):1099-1104.



Campbell LM, Bodalia B, Gogbashian CA, et al. Once-daily budesonide:400 ugr once daily is as effective as 200 ugr twice daily in controlling childhood asthma. Int J Clin Pract 1998;52(4):213-219. 5. Baker JW, Mellon M, Wald J, et al. A multipledosing, placebocontrolled study of budesonide inhalation suspension given once or twice daily for treatment of persistent asthma in young children and infants. Pediatrics 1999;103(2):414-21. 6. Moller C, Stromberg L, Oldaeus G, et al. Efficacy of once-daily versus twice-daily administration of budesonide by turbuhaler in children with stable asthma. Pediatric Pulmonology 1999;28(5):337-343. 7. Jonasson G, Carlsen KH, Jonasson C, et al. Low-dose inhaled budesonide once or twice daily for 27 months in children with mild asthma. Allergy 2000;55(8):740-8. 8. LaForce CF, Pearlman DS, Ruff ME, et al. Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma. Ann Allergy Asthma Immunol 2000;85(5):407415. 9. Purucker ME, Rosebraugh CJ, Zhou F, Meyer RJ. Inhaled fluticasone propionate by Diskus in the treatment of asthma. A comparison of the efficacy of the same nomimal dose given either once or twice a day. Study FLTA 2007. Chest 2003;124(4):1584-1593. 10. Purucker ME, Rosebraugh CJ, Zhou F, Meyer RJ. Inhaled fluticasone propionate by Diskus in the treatment of asthma. A comparison of the efficacy of the same nomimal dose given either once or twice a day. Study FLTA 2008. Chest 2003;124(4):1584-1593.