Research partnerships in a project assessing the role of treatments used for women

with cervical cancer

A systematic review and meta-analysis of individual patient data

Claire Vale, Jayne TierneyMeta-analysis Group

Why do we need to do systematic reviews?

• Even randomised controlled trials don’t always give clear answers• Small differences difficult to spot• May need many hundreds of patients

• Randomised controlled trials might give different answers from each other• Important to look at all of them • Consider all of the ‘evidence’

What are systematic reviews and meta-analyses?

• Combining information from all the trials might give a clearer answer • Gather together all relevant trials

(a systematic review)• Fit all of their results together

(a meta-analysis) • Often (e.g. Cochrane systematic reviews)

rely on information given in the reports of trials• Can be limited

Example data from a trial report

Trial 1 Treatment Group

Control Group

Number of patients randomised

102 103

Average age of patients 46 47

Stage of cancer: 23-4

7032

69 34

Grade of cancer: 23

8121

8023

% Recurred 20 15

What is a systematic review and meta-analyses of IPD?• First look for and gather all of the trials

(systematic review) published and unpublished • Instead of using information from the reports we:

• ask each investigator to provide up-to-date information on each patient who took part

• collect, check and re-analyse the data supplied (meta-analysis)

• present results at collaborators meeting • present and report results in the name of the

collaborative group

Example individual patient data

Patient ID

Date randomised

Treatment

allocated

Age Stage

Grade

Recurrence

001 23 June 1990

Control 46 2b 3 Yes

002 19 Oct 1988 Treatment

39 4 2 No

003 01 Feb 1991

Treatment

51 2a 2 No

004 09 April 1987

Control 32 3 3 No

203 11 Nov 1989

Control 40 2b 2 No

204 03 Jan 1990 Treatment

35 2a 3 Yes

205 15 Mar 1992

Control 56 3 2 No

What is this IPD meta-analysis about?• IPD meta-analysis to compare:

• radiotherapy alone • chemotherapy given with radiotherapy

(chemoradiation)

in the treatment of women with cervical cancer

• Chemoradiation is already standard care in many countries• BUT some important questions unanswered

What will this project add?• Answer additional questions, e.g.

• Do all types of women get the same benefit from chemoradiation?

• Do different doses or durations of treatment give similar effects?

• What are the side-effects of treatment? • Use all the evidence: 28 trials, >5000 women

• A more reliable estimate of treatment effect • Up-to-date information (long-term picture)

• Allow women and their doctors to make more informed treatment choices

Why involve women with cervical cancer?

• To ensure we: • Think about important issues• Interpret the results appropriately• Disseminate the results to women affected

by cervical cancer• And give them the opportunity to:

• Learn more about research process• Make an active contribution• Take up opportunities for training• Help us to improve our research

IPD meta-analysis timescale

Invite participation

Data collection

Data checking

Plan Collaborators’ meeting

Check all data

Do first analyses

Collaborators’ meeting

Sept 2004 Apr 2005 May 2006

Finalise results

Write findings

Disseminate

? 2007

Potential areas of involvement for partners• 4 main areas:

1. Development2. Data collection and analyses3. Prepare for the Collaborators’ Meeting4. Write up and disseminate the findings

• Variety of tasks within each of these• Chance for research partners to be involved• As much or as little as happy to do

Enlisting help from Experts

• First we set up a Reference group:• Bec Hanley (TwoCan Associates)• Pamela Morton (Director, Jo’s Trust)• Tony Stephens (NCRN Consumer Liaison lead)• David Wright (Macmillan Fellow, Southampton)• Karen Handscomb (Gyn cancer specialist nurse)• Cathy Hughes (Gyn cancer specialist nurse)• Nicolette Spera (Research Partner)

Role of the Reference Group

• Help to recruit Research Partners• Oversee and advise us on involvement of

the Research Partners• Suggest training/support needs

• Help develop training materials

• Opportunity to learn / impact on our research• May continue working with us our future

projects?

Recruiting research partners

• Reference group helped • Terms of Reference / Job description • Leaflets and detailed information for Research

Partners

• Ways we tried:• 1. Reference group contacts • 2. INVOLVE database • 3. Macmillan “CancerVOICES” • 4. Letters to support groups • 5. Word of mouth

Who are the Research Partners?

• Alison, Andrea, Jane, Nicolette and Sue• 5 women all of whom have had cervical cancer• 3 women had chemoradiation / 1 radiotherapy

alone / 1 surgery alone• 2 London /1 South-East /1 Midlands /1 North-West• 2 previous involvement

• e.g. patient representative for cancer networks• 1 researcher

• First meeting in April 2005• Described project and potential areas of involvement

Research Partners contributions so far

• Helped recruit other research partners• Directly• Input into advertisements

• Feedback and input into patient friendly information on project

• Help to track down contact details• Contribute to project newsletters

• Research and plan the social event at the Collaborators’ Meeting

• Attend the Collaborators’ Meeting• Comments and feedback on:

• How their involvement is going• Meetings / communication• The Collaborators’ Meeting• What we might do differently / better next

time

Research Partners contributions so far

Next stages of the IPD meta-analysis

• Update searches to check for any new trials

• Finalise the analyses• Interpret final results • Present results at gynaecological oncology

conference• Write the paper for medical journal• Disseminate more widely

Research Partners future contributions

• Help us to interpret the results• Different priorities to the doctors?

• Identify ways to disseminate results to women affected by cervical cancer• Discuss and plan with Reference Group

and Research Partners• Producing accessible information• Reaching the appropriate audiences

Research Partners future contributions

• Report back to the Reference Group• Suggest other things we might do / areas

you’d like to be involved in• Write up / publish experiences of

partnership• Training workshops / seminars• Present to women affected by cervical

cancer

Feedback from the Research Partners

• Information on the project• “pitched at the right level for someone like

me with a reasonable level of understanding about cervical cancer, but not about research processes and clinical trials”

• “short sentences, clear explanations and use of colour in highlighting key word/ideas was very helpful”

• Could do with extra sections explaining the results

Feedback from the Research Partners

• Day spent looking at the data • Helped in understanding the project and

the results• Part of the general training or induction for

research partners

Feedback from the Research Partners

• Meetings / communications• Well organised and informative• Expenses paid (in advance) and DoH payment

rate for attendance• But maybe plan all meetings at outset• Hold a meeting to describe the results of meta-

analyses • better understanding of results when presented

at Collaborators’ meeting

• Allow more time for input / comments

Feedback from the Research Partners

• Attending the Collaborators’ Meeting• Enjoyed the opportunity (“privilege”)• “Research Partners”

• “wasn’t clear to the doctors who we were”

• Not enough preparation • Weren’t sure what to expect • Clinical discussions “a bit blunt”

• Dedicated question and answer session• Dedicated doctor that they know for support• Seating plans

Feedback from the research partners

• Not sure what use they have been • Down to us to provide better feedback

What else we have learned

• Resources• Financial• Time

• Expert advice• Researchers – don’t be scared!• It can be done!

Plans for involvement of consumers in future IPD meta-analyses

• Involve consumers in new projects being done by our group• From the earliest stage• Include suggestions of Research Partners• Current Research Partners as “buddies” or

mentors and or part of the Reference Group

• Provide training for others to involve consumers in IPD meta-analysis

• Do it better!