June 2016 | AIMS

AIMS Newsletter Issue 12 June 2016

Thanks

AIMS Trial

Team

Inside this issue:

Message from CI 1

AIMS New Team Members 2

Randomisation Rankings 2

News Flash 3

AIMS in the Spotlight 4

AIMS Stars 4

AIMS on facebook 5

FAQ’s 6

Dear Friends Welcome to the Inspirational 12th issue of the AIMS newsletter.

The biggest thank you from the bottom of our hearts for your hard work and dedication. We are OVER HALF WAY

To celebrate this a few nice treats are winging their way to you soon.

We hope the changes to the database are proving straight forward. Don’t forget Amie is contactable at all times for support! Stay Wonderful

WE ARE OVER HALF WAY!!!!

June ISSUE 2016

Page 1

THE AIMS TEAM

Target Randomisation Rankings

As most sites have different targets – these rankings are based on % target met since recruitment began at each site

Sites Status Quo

Malawi: 1160 clients

Uganda: 376 clients

Pakistan: 208 clients

Tanzania: 127 clients

Page 2

The AIMS Team Welcome New Members

Dr Watts

BRONZE is awarded to:MALAWI - QECH

With a target of 60 per month, you have been recruiting since Jun 14 with an average of 47 per month.

Your average monthly recruitment to target is 78%

SILVER is awarded to: UGANDA

With a target of 20 per month, you have been recruiting since Aug 14 with an average of 16.9 per month.

Your average monthly recruitment to target is 84%

GOLD is awarded to: PAKISTAN

With a NEW target of 10 per month (prev 36), you have been recruiting since Dec 14 with an average of 12.6 per month since the new target. Since the new target (Jan 16) your average monthly recruitment to target

is 126%

RECRUITMENT GRAPHS Which months did we do well?

Which months need improvement?

UGANDA – 20/month MALAWI – 60/month

PAKISTAN – 10/month* TANZANIA– 20/month

0

5

10

15

20

25

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

RUST is awarded to:MALAWI - ZOMBA

With a target of 30 per month, you have been

recruiting since Dec 15 with an average of 15.6 per month. Your average monthly recruitment to

target is 52%

ZOMBA – 30/month

RUST is awarded to: TANZANIA

With a target of 20 per month, you have been

recruiting since Nov 14 with an average of 6.6 per month. Your average monthly recruitment to target

is 33%

SOROTI SITE TO OPEN

CONGRATS TO: Dr Jane Daniels who has been promoted to Reader in Women’s Health Trials

***Please let us know if you have any good news***

NEWS FLASH

SOROTI we are looking forward to having you in the team.

James – thank you for your help so far in the set up, and Dr Tom Otim, thank you for your continued

support. Amie will come and visit soon!

Page 4 ****AIMS STARS****

Who Will Be The Next AIMS Star?

Thank you EVERYONE!

Dr Iffat from AIMS Team Pakistan

Dr Noreen at Karimabad is with us from the get-go while Dr Nigar looked after the trial well at Hyderabad campus. Now Dr Sidra and Dr Arshia are keeping the momentum at Kharadar and Garden sites respectively. Here I also want to appreciate the administrative support from the management of all these hospitals.

The research officers (RO) are in fact running the show by directly interacting with the patients. Dr Sara is the most successful RO so far, as she recruited the maximum number of patients at Karimabad campus under direct supervision of Dr Noreen, till Jan 2015. Ms Erum replaced her recently. Dr Reeta did well at Hyderabad. Dr Jaivanti started at AKUH and then Dr Rabia successfully continued the process, while Ms Mehtab at Garden and Ms Kishwar at Kharadar showed a promising start. The AIMS trial Pakistan is centered at The Aga Khan University Hospital (AKUH) in Karachi. AKUH is Pakistan's largest private medical institute and hospital, established in 1985 and is the primary teaching site of the Aga Khan University’s (AKU) Faculty of Health Sciences. This 599 bed hospital is a tertiary facility providing multidisciplinary care to ensure continuum of patient care with passion and confidence providing high quality services through four secondary hospitals,

including Karimabad, Garden and Kharadar campuses in Karachi and one in Hyderabad. The trail commenced in Dec 2014 with the recruitment of first patient at AKUH, and concurrently started at Hyderabad and Karimabad campuses. In the preliminary stages it wasn’t a smooth ride and we faced lots of challenges, the biggest one is being switching practices from surgical to medical options for the management for miscarriages, which negatively impacted patient recruitment enormously. This made us to close the trial at our Hyderabad site within a year. Subsequently trial was launched at Garden and Kharadar campuses from March 01, 2016, and the results have been very promising so far. I also want to mention the support of OBGYN faculty—my friends and colleagues, who showed their confidence in me and willingly encouraged their patients to partake in the trial. The research department and the clinical trial unit (CTU) are the main supporters for us had it be the planning or the nitty-gritty’s of the processes. Mr. Asghar and Ms Salima from the research department of women and child health division and Dr Erum and Ms Laila form CTU are worth mentioning. Ms

Afshan from the pharmacy in CTU is taking care of IMPs from storage to dispensing and from receiving to incineration. Mr. Ishrat from the finance and Mr Shakeel form the admission department played their part well. I would also like to mention hard work of data management team and the collegiality of Anaesthesia group, nursing staff and lab personnel. These are only few worth mentioning but in essence there is crew working back stage to make this show a great success. The support from Birmingham was highly motivational and encouraging throughout the process. My goal at this stage is to be more proactive with integrated efforts of my entire team to jointly achieve our targets with the rest of trial centers.

I am pleased to avail this opportunity of sharing my AIMS experience here with you. My journey as a member of this wonderful team started in the year 2012 when I was nominated as the Principle Investigator (PI) for Pakistan site. I am grateful to Dr Rahat Qureshi, the Chairperson of the department of OBGYN, the Aga Khan University,

for showing this confidence in me and for her continuous guidance throughout my venture till date. This is not my story alone, if it wasn’t for my entire team we wouldn’t have succeeded in sailing through the rough seas. First and foremost the research specialists (RS) are worth mentioning here who worked hard to make this venture possible. Initially it was Dr Fozia and now Ms Humera Ismail is fulfilling these responsibilities well. The RS is actually the backbone of team and coordinating all the activities. Secondly my co-investigators for each site are looking after the logistics of trial and processes at their respective site.

Dr Iffat

Humera

DID YOU KNOW THAT AIMS HAS A WONDERFUL FACEBOOK PAGE REGULAR UPDATES ON RECRUITMENT

& AIMS TEAM SUCCESS STORIES

PLEASE ‘LIKE’ US TODAY

https://www.facebook.com/aimstrial

AIMS IS ALSO ON TWITTER

PLEASE ‘FOLLOW’ US TODAY

https://www.twitter.com/AIMSTrial

PLEASE ‘LIKE’ US!

Contact us: Amie a.wilson.5@bham.ac.uk

David d.m.lissauer@bham.ac.uk

Phone AIMS UK +44 (0) 1216236835 Mobile +44 (0) 7816174170

Page 7

Q: ‘If a participant develops a pelvic infection does she need to be unblended so we know if she was given antibiotics or placebo’? A: No, she does not need to be unblinded. She should be treated for the pelvic infection (with antibiotics, WCC, vaginal swab). It should be documented on form 4 and form 6 that a pelvic infection developed (positive primary outcome) and the treatment should be documented on forms 4 and 6 Q: ‘If a patient has participated in AIMS in a previous pregnancy, can she participate again in subsequent pregnancies?’ A: YES she can be randomised in subsequent pregnancies. She should be given a new study ID number for each pregnancy. Q: ‘What should I do if I cannot get a participant to return to follow up despite best efforts to encourage her to return.’ A: If the participant will allow you to visit her at home then we would encourage this. If she will not but you are able to speak to her on the phone, then please complete form 4 (telephone contact), please also complete form 6 by taking the participants history on the phone. Please then inform Amie that this participant did not return. Amie will email a note to file about the participant. Q: ‘But what if the participant cannot be reached by phone?’ A: Please complete do not complete form 4, please complete form 6 only using the hospital records. Q: ‘If I use only emergency randomizations will it be a problem?’ A: YES! This could create an imbalance in minimization between sites. Please try to make sure emergency randomization is kept strictly for emergencies Q: ‘Should I file copies of the lab reports in the patient CRF folders?’ A: This is not a requirement for AIMS, however many sites do file them in the patient CRFs as there is not a system to trace such reports once the hospital notes are archived. Q: ‘I have randomized a patient but no pack numbered has been given on the database’ A: Contact the trial coordinator. All of the remaining packs may have been allocated to the other arm of the trial. This usually occurs when only a few packs are remaining at the clinic store for randomization. More packs need to be added to the store and added on the database under the ‘transfer IMP’ tab, as available for randomization. Please inform Amie if this issue. See Flowchart 4a ‘IMP unavailable’ for guidance. Q: ‘The patient does not have a phone or a personal phone number that I can call her on’ A: Is the patient able to provide a phone number of a relative or friend that she is in close communication with e.g. Sister or Neighbor Q: ‘I want to practice using the database. Is this possible?’ A: Yes AIMS has a test database. You can enter as many pretend patients as you wish. http://www.medscinet.net/AIMSTest/ The log in details are: User name: aimstest Password: aims Q: ‘A patient wants to take part in the trial but cannot return for the follow up appointment. Can she be included?’ A: No. It is essential that patients return for follow up. This is the only true way of assessing the primary outcome. Patients that do not return are classed as lost to follow up.’ Q: ‘When should I perform a white cell count?’ A: When one or more of the following symptoms is reported: UTERINE TENDERNESS, PURULENT VAGINAL DISCHARGE or if the patient has a temperature above 38.0 oC Q: ‘If a white cell count has already been taken at a previous appointment and the patient has one or more symptom again should I repeat the white cell count?’ A: Yes. A white cell count should be taken at every appointment when the patient has one or more symptom. If the patient is an inpatient and has one or more symptoms daily, this will require daily white cell counts. A white cell count should be taken every day that the patient has one or more of the specified symptoms. Q: ‘The patient did not return for follow up until 30 days after the surgery. Should I still complete her assessment?’ A: Yes. Although the participant will be classed as lost to follow up if she is assessed after day 28 post surgery, it is still important to conduct and record this assessment as this data will be analyzed in a further analysis. Q: The participant declined to take the medication after being randomized. What should I do?’ A: The participant should be followed up as per protocol, as if the participant had taken the medication. Participants will be analyzed on an intention to treat basis so it is important that she is followed up as normal. Q: ‘If a participant uses multiple methods of transport to get to the hospital, which method should I select on form 1?’ A: Select the method of transport that the participant used for the greatest amount of time during the journey. Q: ‘What should I do if the database does not give a pack number when I press ‘randomise’? A: This may mean that there are not enough pack numbers for the database to randomize between. More pack numbers will need adding to the ‘IMP transfer’ section in the database. You can the select ‘reallocate pack’ and a pack number should be produced. Please contact Amie if this happens. See flow chart 4a

AIMS is on TWITTER

Please FOLLOW us.

www.twitter.com/aimstrial

AIMS is on FACEBOOK Please LIKE ‘AIMS Trial’

www.facebook.com/aimstrial

Got a Question?

Email Amie

AIMS is on the Web. Check out the website for current form versions and all other useful documents. www.aimstrial.org