M O N T H L Y N E W S L E T T E R F R O M T H E D E P A R T M E N T O F P E D I A T R I C E M E R G E N C Y M E D I C I N E

PEM

COUNTING ON KIDSThe difficulties of conducting Pediatric research - is it worth it?

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The Pediatric Predicament

Events and Updates

Recent publications

Study updates

PEMMREP

Volunteer appreciation

Contacts

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By using evidence-based medicine, physicians can combine clinical judgement with up-to-date research developments to provide their patients with the best care possible.  Instead of extrapolating adult research data, generating and developing pediatric research helps answers questions regarding safety and efficacy.  This is especially important in the pediatric emergency medicine field where decision making is constrained by time.  Therefore, the impact of pediatric research should be clearly obvious.

In an article being published in the Scientific American (https://goo.gl/AZCZyL) , the value of pediatric research is being called into question.  In the article, Harvard University researchers conducted a systematic review of over 550 pediatric clinical trials between 2008 to 2011 and found that greater than 40% of those studies were never finished or never published.  More than 77,500 children enrolled in these studies, to find out that their sacrifice and commitment were not fully realized.  

What are some of these hindrances?  The physiology of children as well as the exponential changes in growth affects the type, dosage and safety profile of drugs.  The lack of enrollment is also still a challenge. It is not only the child that partakes in the study, but the parent(s) and/or the caregiver(s).  Issues such as communication, time, location, and understanding of the study also affects enrollment.

Schmidt, Charles. “Pediatric Predicament.” Scientific American, vol. 317, no. 3, Sept. 2017, pp. 24–25.,  www.scientificamerican.com/article/many-pediatric-studies-are-a-waste-of-time/.

Parents are often worried that their kids might end up on standard of care rather than the investigational product, which can be quite disheartening.  

So how are these obstacles being addressed?  The article states that at a medical centre level, more oversight should be established by identifying roadblocks in enrollment and maintaining participation.  In the US, the National Institutes of Health (NIH) is working alongside various experts in government, hospitals, and industry to make trial results readily available.  This will help disseminate information from tertiary research centers to primary care facilities and hopefully increase accessibility.

What can we do here to implement better research practices at PEM and to support pediatric research? By actively thinking about research studies that patients are eligible for during patient encounters, notifying Research Assistants and the PEMMREP volunteers regarding interested patients, using the tracking board to note missed and declined patients, and educating patients on the importance of research in the pediatric population, can impact the landscape of medicine for tomorrow’s generation.

Plus, it doesn't hurt to get a free cup of coffee in the process!                                 Dr. April Kam (kama@mcmaster.ca)

Events & Updates

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Events & Updates

R E S E A R C H R O U N D T A B L E

We are excited to announce this new Royal College accredited series in the

Department of Pediatrics!

This hybrid of former Work-in-Progress and Research Seminars is an informal,

interactive forum for researchers, trainees, allied health staff and research staff to

share knowledge and exchange ideas. Some sessions will be project-focused,

while others will focus on current research issues/topics; all sessions will provide a

collaborative learning experience! Research Roundtable sessions are open to all in

the Department of Pediatrics and will be held the first and third Tuesday of every

month from 8-9 am in 3A14 unless otherwise communicated.

We want to hear from YOU! Interaction and knowledge sharing are key to the

spirit of Research Roundtable, so bring your great ideas.

Upcoming Research Roundtable sessions will be advertised in the Department

Digest, on the Pediatrics website, and on the television in 3A, and postings in high-

traffic hospital areas (e.g. near elevators). If you would like to receive Outlook

meeting requests that populate the date, time, location, and topic of upcoming

Seminars in your calendar, email Lindsay Akrong (lakrong@mcmaster.ca) to be

added to our distribution list.

Questions? Interested in presenting at a future Research Roundtable session?

Contact Karen Choong (choongk@mcmaster.ca).

Research Roundtable Rounds will resume in September 2017! 

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Recent PublicationsObjective:

To systematically review the literature and determine frequencies of adverse drug

events (ADE) associated with pediatric asthma medications.  

Methods:

Following PRISMA guidelines, we systematically searched six bibliographic databases

between January 1991 and January 2017.  Study eligibility, data extraction and quality

assessment were independently completed and verified by two reviewers.  We

included randomized control trials (RCT), case-control, cohort, or quasi-experimental

studies where the primary objective was identifying ADE in children 1 month – 18

years old exposed to commercial asthma medications. The primary outcome was ADE

frequency.

Findings:

Our search identified 14,540 citations.  46 studies were included: 24 RCT, 15 cohort, 4

RCT pooled analyses , 1 case-control, 1 open-label trial and 1 quasi-experimental

study.  Studies examined the following drug classes: inhaled corticosteroids (ICS)

(n=24), short-acting beta-agonists (n=10), long-acting beta-agonists (LABA) (n=3), ICS +

LABA (n=3), Leukotriene Receptor Antagonists (n=3)  and others (n=3).  29 studies

occurred in North America, and 29 were industry funded.  We report a detailed index

of 406 ADE descriptions and frequencies organized by drug class.  The majority of data

focuses on ICS, with 174 ADE affecting 13 organ systems including adrenal and growth

suppression.  We observed serious ADE, although they were rare, with frequency

ranging between 0.9-6% per drug.   There were no confirmed deaths, except for 13

potential deaths in a LABA study including combined adult and pediatric participants.

We identified substantial methodological concerns, particularly with identifying ADE

and determining severity.  No studies utilized available standardized causality, severity

or preventability assessments.    

Conclusion:

The majority of studies focus on ICS, with adrenal and growth suppression described.

Serious ADE are relatively uncommon, with no confirmed pediatric deaths.  We identify

substantial methodological concerns, highlighting need for standardization with future

research examining pediatric asthma medication safety.

Dr. James Leungleungj16@mcmaster.ca 

A S Y S T E M A T I C R E V I E W O F A D V E R S E D R U G E V E N T S A S S O C I A T E D W I T H A D M I N I S T R A T I O N O F C O M M O N

A S T H M A M E D I C A T I O N S I N C H I L D R E N

H A V E A R E C E N T P U B L I C A T I O N T H A T Y O U W A N T T O S H O W C A S E H E R E ?   S E E C O N T A C T S S E C T I O N T O S U B M I T .

05Reference:

Leung, James S., et al. “A Systematic Review of Adverse Drug Events Associated with Administration of Common Asthma Medications in Children.”       PLOS One, vol. 12, no. 8, 9 Aug. 2017, pp. 1–25., doi:10.1371/journal.pone.0182738.

Research so far...Video AOM

MISSED (in August)

ENROLLED (in August)

32 2PATIENTS

ENROLLED

TOTAL

21

Between 6 - 59 months of age

Primary diagnosis of non-severe AOM

Eligible for watchful waiting prior to

filling antibiotic prescription

PAGE #4545 if your patient:

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Did your patient decline to

participate or is ineligible?

Please fill out the PINK REFUSAL TO

PARTICIPATE form located near the ED

physician space

Required information includes: PATIENT

LABEL, HOUSE-STAFF CONTACT and REASON

FOR REFUSAL

Redjana Carciumaru carciur@mcmaster.ca

x 75821

+200%(since last month)

Research so far...

TOTAL

50

5MISSED

(in August)ENROLLED (in August)

1PATIENTS

ENROLLED

SAFER

PAGE #4545 if your patient:Between 6 months - 10 years presenting with CAP:

Fever (>37.5 C axillary, >37.7 C oral, >38 rectal) recorded

in ED or home in the 48h prior to presentation

Any one of: tachypnea on exam, cough on exam/history,

increased work of breathing on exam, auscultatory

findings consistent with pneumonia

Infiltrates on CXR consistent with bacterial CAP as judged

by ED physician

Attending ED physician diagnoses the child with primary

CAP

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Did your patient decline to participate

or is ineligible?Please fill out the MANILA REFUSAL TO

PARTICIPATE form 

Required information includes: PATIENT LABEL,

HOUSE-STAFF CONTACT and REASON FOR

REFUSAL

Was the RA unavailable?If the patient would like to hear more about the

study but the RA/Volunteer is unavailable -

Please fill out the GREEN RECRUITMENT

TRACKING form

Required information includes: PATIENT

LABEL, CAREGIVER & HOUSE-STAFF CONTACT 

Research so far...QAPPE

140TOTAL

Primary objectives are: Decreasing

unnecessary appendectomies (negative

appendectomies), Decreasing unnecessary

abdominal U/S and or CT scans, Decreasing

unnecessary hospital admissions for serial

examinations

Secondary objective is: Acting as a guide for

other centers in resource allocation and

referral patterns

Population: Pediatric patients (0-18 years)

presenting to the ED at MCH with abdominal

pain and suspected appendicitis

PATIENTS ENROLLED

ENROLLED (in August)

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SQUEEZE

PAGE #4552 if your patient:Between 29 days to < 18 years of age

Persistent shock (abnormal perfusion OR low

blood pressure OR on a vasoactive infusion

like dopamine, epinephrine, or

norepinephrine

Suspected or confirmed septic shock

Has received 40 mL/kg of IV fluid (2L for

children > or equal to 50 kgs)

*On-call hours: 4:30 pm to 8:30 AM, please dial x76443 to request page. Do not use 87*

to send page during on-call hours. If SQUEEZE Trial pager unavailable page

Dr. Melissa Parker #2073

TOTAL

10PATIENTS

ENROLLED

0ENROLLED (in August)

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PEMMREPI N T E R V I E W S , R E V I E W S & P R E V I E W S

PEMMREP Interviews are underway!  As of the release of this

newsletter, we have 30 students who have applied.  Interviews for

this program will focus on several key areas – commitment to

pediatric research, mock consent role-playing, and unique skills and

talents each student bring to the program.  If you have or know of an

undergrad, grad, or medical student, who would be interested in this

program, scan the QR code below or have them send an email to

sign-up.  Flyers for the program can be seen throughout MUMC,

MDCL, and IAHS, as well as OSCARplus and Learnlink.

How will you identify PEMMREP volunteers?  Just like the HHSC

volunteers, PEMMREP students will also be equipped with a

fashionable vest!  The vests will make it easier for house-staff,

nursing, support staff, and patients to identify volunteers during their

shifts.

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Mohammed  

Hassan-Ali

hassam5@mcmaster.ca

x 73864

T O S I G N U P , V I S I T h t t p s : / / g o o . g l / o h G Q C H

Volunteer AppreciationR E C O G N I Z I N G P E M M R E P V O L U N T E E R S S I G N I F I C A N T L Y I N V O L V E D I N

R E S E A R C H E N G A G E M E N T

Dr. Shayan Bashir is a medical graduate from Allama Iqbal Medical College in

Lahore, Pakistan.  He received his MD in 2006.  Since finishing his internship,

Shayan has been actively involved in different disciplines of healthcare.  He

has worked in various parts of the world, and worked with multi-disciplinary

teams in tertiary care hospitals.

Embarking onto a goal of advancing his career, Shayan came to Canada with

an aim to secure residency training in North America.  Since coming to

Canada, Shayan has participated in volunteer work ranging from Clinical

Research at SickKids (in Pediatric Hematology on Thalassemia patients) to

Hematology Clinics at Princess Margret Hospital (in the Healing Beyond Body

patient support program) so that he can strengthen his credentials, as well as

gain hands-on knowledge in the Canadian healthcare system.   Shayan was

also a co-author in a manuscript submitted for publication titled, "Pregnancy

Associated Arbovirus Infections".

Currently, Shayan is working as Clinical Assistant at a Family Practice in

Brampton, which is not only very busy but allows exposure to a wide of

variety of medical illnesses .  Concurrently, Shayan started volunteering here

at McMaster Children’s Hospital in the Pediatric Emergency Department since

June 2017.  He has been very passionate about learning about clinical

research and contributing to the advancement in healthcare while pursuing

his goal towards becoming a licensed physician in Canada.

Shayan plans to apply to CARMS this year to be able to become a primary

care physician in Canada.

Thank you Shayan for your contribution and continued support in PEMMREP!

Shayan Bashir

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Shayan Bashir

Have something to say in the next newsletter?Mohammed Hassan-Ali, MD, MSc Clinical Research Coordinator Division of Emergency Medicine Department of Pediatrics MUMC 2N49B-I hassam5@mcmaster.ca 905-521-2100 x 73864

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