Thanks for being on-board

Thanks for being on board and for your support this year. We have more projects open and trials taking enrolments than any other year and we couldn’t do that without your support.  What a year!

Supporting your research is why we come to work each day. Here are some of the highlights in our year:

• over 1,480 patients were randomised using Spinnaker
• Deb Gilbertson joined the team at Spiral in the role of development support
• we entirely rewrote the user-permissions module for Spinnaker ready for more complex studies
• we started work on ANZ’s first response adaptive platform trial (REMAP-CAP)

Like you we have been working hard through the year. To recharge and get ready for 2017 we will close on the 22nd of December and reopen on the 16th of January 2017.   

OUR SUPPORT FOR YOU NEVER STOPS. While you are playing cricket on the beach or eating too much ham, our infrastructure team will be monitoring Spinnaker, making sure everything is running smoothly and that your trials can be accessed when you need them. 

Merry Xmas from everyone @ Spiral

Self-learning trial to use Spinnaker software

I am excited to announce Spiral have joined the team working on the first response adaptive platform trial to be based in Australia and New Zealand(REMAP-CAP).  The self-learning design for this clinical trial is an exciting new methodology that significantly reduces the time and number of patients needed to test treatments while increasing safety for trial participants.

For this project our Spinnaker software will be used in Australian and New Zealand ICUs to test questions related to community acquired pneumonia.  Spinnakers adaptability is a key factor in this self-learning/adaptive trial.

Trial funding

The trial is funded by the Health Research Council of New Zealand(HRC) and the National Health and Medical Research Council of Australia(NHMRC).

Read the NZ HRC summary and funding details »

General Characteristics of a Platform Trial

• A novel and innovative trial design that is highly adaptive and utilises frequent Bayesian interim analyses to answer as many questions as possible from the available sample
• Simultaneously evaluates the effectiveness of multiple alternative treatment options in a heterogeneous population including identifying any interactions between treatments
• Evaluates treatment effects in sub-groups
• Allows modification of key trial parameters in response to accumulated information and predefined rules
• Preferentially randomises participants to treatments that are likely to be more effective, leading to better outcomes for patients within the trial. 

Self-learning trial to use Spinnaker software

I am excited to announce Spiral have joined the team working on the first response adaptive platform trial to be based in Australia and New Zealand(REMAP-CAP).  The self-learning design for this clinical trial is an exciting new methodology that significantly reduces the time and number of patients needed to test treatments while increasing safety for trial participants.

For this project our Spinnaker software will be used in Australian and New Zealand ICUs to test questions related to community acquired pneumonia.  Looks like Spiral really does have the most adaptable clinical trial software in ANZ!

Trial funding

The trial is funded by the Health Research Council of New Zealand(HRC) and the National Health and Medical Research Council of Australia(NHMRC).

Read the NZ HRC summary and funding details »

General Characteristics of a Platform Trial

• A novel and innovative trial design that is highly adaptive and utilises frequent Bayesian interim analyses to answer as many questions as possible from the available sample
• Simultaneously evaluates the effectiveness of multiple alternative treatment options in a heterogeneous population including identifying any interactions between treatments
• Evaluates treatment effects in sub-groups
• Allows modification of key trial parameters in response to accumulated information and predefined rules
• Preferentially randomises participants to treatments that are likely to be more effective, leading to better outcomes for patients within the trial. 

Self-learning trial to use Spinnaker software

I am excited to announce Spiral have joined the team working on the first response adaptive platform trial to be based in Australia and New Zealand(REMAP-CAP).  The self-learning design for this clinical trial is an exciting new methodology that significantly reduces the time and number of patients needed to test treatments while increasing safety for trial participants.

For this project our Spinnaker software will be used in Australian and New Zealand ICUs to test questions related to community acquired pneumonia.  Looks like Spiral really does have the most adaptable clinical trial software in ANZ! 

Trial funding

The trial is funded by the Health Research Council of New Zealand(HRC) and the National Health and Medical Research Council of Australia(NHMRC).

Read the NZ HRC summary and funding details »

General Characteristics of a Platform Trial

• A novel and innovative trial design that is highly adaptive and utilises frequent Bayesian interim analyses to answer as many questions as possible from the available sample
• Simultaneously evaluates the effectiveness of multiple alternative treatment options in a heterogeneous population including identifying any interactions between treatments
• Evaluates treatment effects in sub-groups
• Allows modification of key trial parameters in response to accumulated information and predefined rules
• Preferentially randomises participants to treatments that are likely to be more effective, leading to better outcomes for patients within the trial. 

3 local ICU researchers receive 2017 HRC awards

The 2017 New Zealand Health Research Council general career development awards were announced on Monday and 3 of our favourite researchers received awards.

Shay McGuinness, Auckland District Health Board, received a Clinical Practitioner Research Fellowship for Improving outcomes after cardiothoracic surgery.

Paul Young, Capital & Coast District Health Board, received a Clinical Practitioner Research Fellowship for Prevention and treatment of fever in the intensive care unit.

Diane Mackle, Medical Research Institute of New Zealand, received a Clinical Research Training Fellowship for Knowledge translation in the management of oxygen therapy in intensive care.

Nga mihi nui

Read the HRC press release

Paracetamol wins Wellington researchers $20,000 prize

Congratulations to Dr Paul Young for winning the Medicines New Zealand’s 2016 Value of Medicines Award for his work on the HEAT Trial.

Read more about the HEAT Trial and how we support researchers with our study management software

Media release as follows............
Monday, 10 October 2016, 9:48 am
Press Release: Medicines New Zealand
Paracetamol wins Wellington researchers $20,000 prize

Dr Paul Young will be presented with Medicines New Zealand’s 2016 Value of Medicines Award for leading a world-class study into the effects paracetamol has on patients in intensive care units (ICU) this evening.

“We are impressed with the range and high standard of entries for this year’s Award. The Value of Medicines Award supports innovative research that improves the understanding, effectiveness or safety of the use of medicines, and Dr Young’s research is a worthy winner” said Hon Heather Roy, Medicines New Zealand Chair.

Paracetamol, the world’s most commonly administered medicine, has never been tested on critically ill patients, until now.

Dr Young, a leading member of the New Zealand ICU research community, and his team at the Medical Research Institute of New Zealand, collaborated with over 200 ICU doctors and 3000 ICU nurses to answer a simple clinical question that is faced each day with the patient: should the fever be treated with paracetamol or not?

“Dr Young’s study will have a considerable impact on clinical practice in a contentious area of research” said Mrs Roy.

The Value of Medicines Award will help Dr Young collaborate with researchers from Scandinavia and Australia in the area of fever management in the ICU.

The results from this study have shown:

· Paracetamol was safe and well tolerated in ICU patients with fever or infection
· The medicine reduced body temperature by around a quarter of a degree
· Patients who survived spent less time in ICU if they were given paracetamol, but patients who died spent more time in ICU before death if given paracetamol.

Dr Paul Young will be presented the 2016 Value of Medicines Award by Simon O’Connor, Member of Parliament for Tamaki and Chair of Parliament’s Health Select Committee, this evening.

Spinnaker Tip #4 - Save time with "Quick Entry" on changes

Spinnaker tracks changes that people make to your database. At the most basic level we track who made the change, what day/time they made it, and the before and after snapshots of each data point changed.

We know this can be a pain and we are here to help not hinder. So look out for the "Quick Entry" option.  When you have multiple changes on a form AND they are all for the same reason, click the Quick Entry link to shrink that list down to just a single entry explaining the changes for all the data points.

Congratulations TARGET

Congratulations to all the team on TARGET which opened for enrolments last week and has already enrolled 23 patients across Australia and New Zealand. It’s a privilege working with so many dedicated people. The offline conditions and hold ups on this trial challenged us all but we got there in the end, on budget and all still talking to each other. Kudos to the project manager.   

TARGET stands for "The Augmented versus Routine approach to Giving Energy Trial". TARGET is a 4,000 patient, multicentre, double-blinded, randomised, controlled, parallel-group, phase III clinical trial designed primarily to determine if augmentation of calorie delivery improves 90 day survival in mechanically ventilated patients.  Don’t hold your breathe waiting for the results, they are 4 years away. 

Tip #2: DIY locations

Some software makes it hard to add locations. With Spinnaker the Project Manager can easily add locations and control access to the software. Part of the "Manage" section in Spinnaker.

Case study: CAMERA2: A novel way of treating MRSA

I’d like to recognise the work done by the CAMERA team in getting the CAMERA Trial off the ground and flying. It's 6 months since the study started taking enrolments. Recruitment is on target, hospitals in Singapore and Israel have recently joined the multiple sites across Australia.

The CAMERA Trial - Combination Antibiotic therapy for Methicillin Resistant Staphylococcus Aureus - is a multi-centre RCT to determine if 7 days of intravenous β-lactam in combination with standard therapy will lead to better complication-free survival 90-days after randomisation, compared to standard therapy alone in adult patients with methicillin-resistant S. aureus (MRSA) bloodstream infection.

We are fortunate to work with people making a difference to our future and support Josh, Steve and the CAMERA team with our Spinnaker software. We have written a case study on the trial which you can read here. 

The case study will become part of a suite of trials coming to our new information rich Spinnaker website later this year.

Hope you enjoy the read.

Audrey 

Download the case study

Tip #1: Quickly see the status of any patient

CRF status from NovelSTART

Use the “Find a patient” page to quickly see the status of the data entry on the CRF for any patient. Heres what those status icons mean:

A tick means all the data required for this form has been entered into the database (the study project manager will define the requirements)

A question mark means some of the data has been entered into this form. The database is waiting for more data.

A cross means no data has been entered for this form.

2016 goals

Each year I spend some time around January thinking about and setting some goals for the year. I don't usually share these publicly but there is some appeal to writing them down, Making them public and eventually being held accountable (in December?). I find goals exciting and fun to begin,  the real trick is finishing or completing them. A real sense of achievement comes when they are done and I can tick them off my list. Here's my list ...

Redevelop the Spinnaker website

Some of the folks out there who know about our software, Spinnaker, don't know much about our company, Spiral, and vice versa. Time to overhaul the Spinnaker website and get clear on all our messages. We already have design concepts for the new website so this goal is underway.  As part of this process the Spinnaker logo has been reworked to reflect a fresher, more confident product and we have started using the new logo.

The new objectives for the website are:

• to have content that accurately reflects our work and helps people understand what we do
• to be a resources for clients, including videos, and how-to's
• to be responsive and display nicely across all devices
• to make connections across to the Spiral website, to tell the story of our history and out team

Which brings me to my next goal ...

Update the content on the Spiral website

Our company website has been in its current form for around 4 years. The design is still relevant but the content is very out of date. In the interests of keeping life a simple as possible I have elected to retain the existing layout/design and rewrite the content. Still a big job but a job that can be actioned incrementally.  During the year each part of the website will have a content audit and overhaul.  My next goal relates to the previous two goals ...

Create a video resource for Spinnaker

Along with videos about how to use Spinnaker and how Spinnaker works there will be interviews with clients, friends and team members. The response I have received from the short instructional video's I have created so far suggests this is a great medium for training.  The video's will also be a part of telling our story so people know more about us, decide if they want to work with us or find out more. Part of telling our story is writing more so the next goal addresses this ...

Create a content calendar for the whole year

Our approach to content has typically been haphazard and reactionary. Not only will I have a content calendar, to drive our writing for the year, we will be efficient and reuse our content across multiple media. For example when we write a blog post we will re-use that same material for videos, twitter etc.

Along with these promotional related goals we will deliver on all our projects and ...

Continue to improve Spinnaker

We are  fortunate to work with some talented, thoughtful people who have given us really useful feedback on how they work, how they use Spinnaker and what they wish it had! As soon as we get any downtime we use that feedback to improve Spinnaker and ultimately bring out a new version for the next clinical trial we are work on. This year we will bring out at least one new version of Spinnaker. My next goal relates to the new project that will use the next version of Spinnaker ...

Work on another project in Melbourne

Ive enjoyed my visits to Melbourne this year, working with the team at Monash. This goal is simply to have another project, based out of Melbourne and continue those visits. There is something about Melbourne. My final goal is around delivery of our projects ...

Document our QA testing process

We have some great tools that help us to test that our software does the job it was designed to do. How we do that mostly resides in one persons head. It's time we documented how, what and where we test. Its time to spread the load with testing and involve more heads.

So thats it, thanks for being interested and reading my goals. I am looking forward to an interesting year. I hope you have a happy, healthy and prosperous 2016.

Audrey
twitter.com/nzaudrey