randomising every patient you see: software for clinic seat research
DESCRIPTION
Randomising every patient you see: Software for clinic seat research. Bruce Arroll Douglas Kingsford Antonio Fernando III 2010 Department of General Practice & Primary Health Care Faculty of Medical & Health Science University of Auckland, Auckland, New Zealand. The problem with RCTs. - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/1.jpg)
Randomising every patient you see:Software for clinic seat research
Bruce Arroll
Douglas Kingsford
Antonio Fernando III
2010
Department of General Practice & Primary Health Care
Faculty of Medical & Health Science
University of Auckland, Auckland, New Zealand
![Page 2: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/2.jpg)
The problem with RCTs
Expensive Exclude many of the patients we see
May not be the patients we usually see-restrictive Expensive Time consuming Huge amount of paperwork If paper based need data entry
How generalisable are they How to get a cheap computer generated randomisation
code to ensure concealed allocation.
![Page 3: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/3.jpg)
McVickers paper
– Vickers AJ, Scardino PT. The clinically integrated randomised trial proposed novel method for conducting large trials at low cost. Trials (Biomed Central 5/3/2009)
Integrate RCT in to clinical practice Randomise every eligible patient Eligible if clinician uncertain-broad-crucial point Adverse effects, me too drugs; lifestyle Patients could enter own data eg adverse effects
![Page 4: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/4.jpg)
Randomisation “daily”
20 starter packs of Varenicline (Champix)
Give them out haphazardly or systematically
“Pressured” my colleagues to be systematic Mailed a letter to 40 Maori smokers offering 4 free visits
with or without a starter pack of Champix 4/20 with starter pack replied and 0/20 in control Conclusion “don’t send out letters to Maori patients”
Without a starter pack
Better way would be phone call or face to face
![Page 5: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/5.jpg)
Pediatric Oncology-the challenge
Every child with a malignancy in the (developed
world) is in a randomised controlled trial
Contributed to increase in survival for leukemia from about 30% to 90%
![Page 6: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/6.jpg)
Generalisability RCT
300 patients from 250 GPs
300 consecutive patients from 3 GPs
Which has the most generalisability?
![Page 7: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/7.jpg)
Office RCT
Internet based software
Make RCTs from office chair simple
Answer simple research questions as part of every day clinical work
![Page 8: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/8.jpg)
Ideas for RCT
Gratitude diaries
Telephone call from practice nurse
![Page 9: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/9.jpg)
Gratitude diaries 3 things grateful for and what did to cause them daily for
one week. Control group writes down early life memories. ? Then once per week
RCT done with internet sample had an effect up to 6 months later. CES-D 13 vs 10.5 Seligman ME, American psychologist 2005;60;5:410-21
Once per week enough Lyubomirsky S.The How of Happiness: Penguin
No trials in primary care Anecdote 90%+ patients happy to do them.
![Page 10: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/10.jpg)
Research Question Does giving depressed patients a gratitude diary vs
control writing improve their PHQ outcomes at 4 (?) months
Inclusion criteria broad Any one with PHQ ≥ 10 (600 pts in 4000 patients) Excl Bipolar; severe drug/alcohol;dementia; personality
disorder; eating disorder; persisting psychotic illness; life expectancy < 2 years; patient unreliable at attending appointments
![Page 11: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/11.jpg)
Research Issues ? Follow up as they come in versus attempt a formal
follow up
A sample size of 98 patients in each arm will be required to demonstrate a 2 point reduction on the PHQ from 13 to 11 with a standard deviation of 5
![Page 12: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/12.jpg)
Issues Follow up and analysis
Stop trial at 4 months and do last value carried forward
Or
Stop trial at 4 months and take data as found (akin to Kaplan Meir)
– Analyse using random coefficients which would compare the gradient of the intervention group and the control group
![Page 13: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/13.jpg)
Develop office based software Able to get randomisation code from clinic computer
Data gets stored on web No extra data entry required
Multiple doctors/nurses can submit data from different clinics-international collaboration possible
Privacy assured as each clinic uses own patient file identifier Simple entry criteria and simple outcome criteria Eg 600 patients with PHQ ≥ 10
![Page 14: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/14.jpg)
Doug Kingsford-sleep deprived
![Page 15: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/15.jpg)
![Page 16: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/16.jpg)
![Page 17: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/17.jpg)
![Page 18: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/18.jpg)
![Page 19: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/19.jpg)
![Page 20: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/20.jpg)
Validated in primary care In NZ Arroll et al 2010 (not published)
Short Gives a “diagnosis” categorical Also continuous score to monitor improvement Free from June 2010 Currently been used in decision support in our district
health board therefore familiar and used
Why PHQ-9 and GAD-7
![Page 21: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/21.jpg)
Data collected after randomisation-next slide
Previous psych contact and admissions asked after
randomisation
Done to simplify recruiting
Not part of primary outcome
Used for exploring for future studies
? Cause any bias
![Page 22: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/22.jpg)
Spectrum
No gold standard ie post mortem won’t tell you if the
person is depressed.
Sadness →→→→→→→→→→Depression
↓
Consider Treatment if severe or
persistent
![Page 23: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/23.jpg)
DSM IVDiagnostic and statistical manual of mental disorders
![Page 24: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/24.jpg)
![Page 25: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/25.jpg)
What is in paper form?
Consent form –need to be kept/scanned
Information sheet
Intervention instructions
![Page 26: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/26.jpg)
Follow up data entry
Less than 1 minute
![Page 27: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/27.jpg)
PHQ
9 questions over past month
Score 10-14 mild major depression
Score 15-19 moderate major depression
Score 20+ severe major depression
Advantage a dichotomous score and a continuous scale
to monitor improvement
![Page 28: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/28.jpg)
PHQ 2009
Total = 19 Below 10 = 16 people 10-14 = 1 person 15-19 = 2 person 20+ nil
![Page 29: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/29.jpg)
GAD
Below 8 =14 persons 8 or more = 5 persons
![Page 30: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/30.jpg)
Missed consent tick
![Page 31: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/31.jpg)
![Page 32: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/32.jpg)
![Page 33: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/33.jpg)
![Page 34: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/34.jpg)
![Page 35: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/35.jpg)
Analysis
Both ways i.e. all at 4 months –send out/phone for follow up At 4 months according how they have come in
– Using random coefficients analysis of slopes
Analyse all Analyse by PHQ 10-14 and >14
>14 more difficulty with functioning and may be less able to do Gratitude diaries
–
![Page 36: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/36.jpg)
Start testing July 2010
Ethics underway
Beta test in own clinic
–
![Page 37: Randomising every patient you see: Software for clinic seat research](https://reader035.vdocument.in/reader035/viewer/2022062500/5681572c550346895dc4c872/html5/thumbnails/37.jpg)
Advice
Control activity ? 3 memories of past
Ok to collect data over randomisation
Follow all at 4 months or as they have come in