WP 8: Launching the clinical platform

Workpackage 8: Determinants of antibiotic use and resistance in primary care (and definitions development)

Chris Butler, Cardiff University (WP 8 leader)Theo Verheij, University of Utrecht; co-PIPaul Little, Southampton University; co-PI Herman Goossens, Project leader

And the team

WP 8: Launching the clinical platform The ‘GRACE' Spirit

1. The Network will live on to serve science for the benefit of patients in the EU and beyond

2. Multidisciplinary; molecule to management to policy

3. Dialogue

4. Synergy

WP 8: Launching the clinical platform Antibiotic use and resistance

Correlation between penicillin use and prevalence of penicillin non-susceptible S pneumoniae

Gossens H, Lancet2005:365:579-587

Comparisons of national aggregate data• No indications data• No data on infections incidence• No data on thresholds for consulting• No severity data• No data on outcomes• Voices of patients and clinicians not heard• Does not tell us what to do about the problem

WP 8: Launching the clinical platform Limitations of the famous graphs

A GPs voice from the South Wales Valleys…You read all this literature and they do say that frequent

antibiotic prescription, they develop resistance …. They say ‘oh… you are prescribing more of those antibiotics’… but then we are on the front line …it is an old mining area, a lot of them get so many chest infections here, and living in the small houses, infection is passed over so quickly … you have to treat them before it is too late … if you have not given antibiotics for a chest infection and if the patient develops pneumonia later on, you can not justify why you have not given an antibiotic …I know that I want my patient to get better quickly…our big problem is to help the hospital…we start ourselves a little bit stronger antibiotic to prevent the hospital load

Butler, Simpson, Wood: submitted

WP 8: Launching the clinical platform Antibiotic use and resistance

Improved living conditions with time

Infections, complications

Antibiotic Prescribing

?

Aim to narrow this gap, but what is the optimal size? e.g. What about antibiotics for AECOPD in Valleys?

Where is my country, region, practice?

Ongoing partnership is require to ‘mind the gap’

?

WP 8: Launching the clinical platform Time, social determinants of health, prescribing, complications

WP 8: Launching the clinical platform Objectives

1. Establishing a primary care clinical network to serve the objectives of GRACE

2. Describe presentation, investigation, management, outcomes of community acquired LRTI in Europe

3. To describe and achieve a deep understanding of the micro-level determinants of antibiotic resistance; e.g. beliefs, knowledge, appraisals of resistance and contextual factors

4. To develop definitions for use throughout GRACE

WP 8: Launching the clinical platform: 1 Objective 1: Establishing the clinical platform

Networks selected on basis of invitations of expressions of interest against explicit criteria

WP 8: Launching the clinical platform: 1We’ve already got (a lot of) Europe covered!

Country N° practices/ Co-ordinator Facilitator N° GPs

Belgium 25/50 Samuel Coenen Samuel Coenen

Finland 5-10/50-150 Ulla-Maija Rautakorpi Ulla-Maija Rautakorpi

Germany 15-25/15-25 Tom Schaberg Konstanze Voigt

Hungary 25/20 Bernadette Kovacs Bernadette Kovacs

Italy 20/15 Francesco Blasi Francesco Blasi

Netherlands 7/35 Theo Verheij Eelko Hak

WP 8: Launching the clinical platform: 1Networks 1

Country N° practices/ Co-ordinator Facilitator N° GPs

Norway 8/32 Carol Pascoe Hasse Melbye

Poland 5/10 Maciek Godycki-Cwirko Maciek Godycki-Cwirko

Spain 20/6 Jordi Almirall Jordi Almirall

15/6 Antoni Torres Ruano Nuria Sanchez

Sweden 10/40 Bo-Eric Sigvard MölstadMalmvall Futurum

UK 25/60 Christopher Butler Richard Hibbs

8/24 Michael Moore Michael Moore

WP 8: Launching the clinical platform: 1Networks 2

Objective 2. Describing presentation, investigation, management and outcomes of community acquired LRTI (registration study)

Each network– Minimum of 8 GP practices, 20 000 patients per network– 2 x one month recruitment periods

• October 2006• February 2007

– 150 patients per network per recruitment month– 3600 LRTI patients in total at end of WP8

WP 8: Launching the clinical platform: 2

CRF and clinician registration form• Demographics• History• Presentation• Clinical findings• Usual investigations • Management • Referral• Perceived expectations• Advice, including OTC meds, sick leave

WP 8: Launching the clinical platform: 2 Clinicians

Diary: 28 days• More detailed demographics inclusion, smoking, duration

of illness, reasons for consulting, education, other household members

• Expectations and hopes for antibiotics• Beliefs about antibiotics• Reasons for consulting• Daily symptoms• Taking of medicines• Work absence and interference with normal activities• Help seeking for this illness

WP 8: Launching the clinical platform: 2Patients

WP 8: Launching the clinical platform: 2General flow

WP8 eligible patient goes to GP and signs informed consent

GP completes registration form and CRF GP enters data into GRACE-platform

Patient completes diary and sends it to NNF

NNF enters diary data into GRACE-platform and tracks missing diaries and CRF’s

For each patient the GP receives a file with:1. Information leaflet

2. Informed consent

3. Registration form

4. CRF

5. Diary (in local language)

6. Envelop to send diary back to NNF

7. Sticker page with patient specific study numbers

WP 8: Launching the clinical platform: 2Patient packs

WP 8: Launching the clinical platform: 2Informed consent

Patient goes to GP

GP checks in- and exclusion criteria (e.g. cough)

GP informs patient about WP8

Patient signs informed consent

GP stores consent local, in patient specific file

WP 8: Launching the clinical platform: 2Patient registration

GP completes registration form on paper

GP stores registration form local in patient specific file

GP enters ASAP into GRACE-platform: Study ID, GP ID, Incl. Date, DOB and Gender

GP faxes registration form to NNF

WP 8: Launching the clinical platform: 2CRF

GP completes CRF on paper

GP enters data from CRF into GRACE-platform within 2 days

GP stores CRF local in patient specific file

NNF contacts GP in case of missing CRF data

WP 8: Launching the clinical platform: 2Patient diary

GP gives diary to patient

Patient sends diary to NNF

NNF contacts patient in case of missing diary

Patient fills in diary (28 days)

NNF contacts patient about diary 4 days

after inclusionNNF enters data of diary

into GRACE-platform

WP 8: Launching the clinical platform: 2General flow

Patient signs informed consent GP stores informed consent local in patient specific file

GP completes registrationform on paper

GP completes CRF on paper

GP gives diary to patient

Patient fills in diary (28 days) Patient sends diary to NNF

GP enters data from CRF intoGRACE-platform within 2 days

NNF enters data of diaryinto GRACE-platform

GP enters ASAP into GRACE-platform:Study number, GP number, Inclusion Date, DOB, Gender

NNF contacts GPin case of missing

CRF data

NNF contactspatient in caseof missing diary

NNF contactspatient about diary 4days after inclusion

GP stores registration form local in patient specific file

GP faxes registration form to NNF

Objective 3: To describe and achieve a deep understanding of the micro-level determinants of antibiotic resistance; e.g. beliefs, knowledge, appraisals of resistance and contextual factors

• Qualitative study in 6 networks• Second recruitment period• Interviews with clinicians and patients• Based on variation identified in first month of registration

study, maximum variation sample of clinicians; recruit patients from those who have recently consulted with LRTI

• NNF to recruit and do/oversee interviews

WP 8: Launching the clinical platform: 3

WP 8: Launching the clinical platform: 3 Why qualitative research?

• Generates themes that researchers may not have yet considered

• Generates hypotheses• Gets inside the heads of the people who

really matter• The goal is not to find statistical validity but

common or important themes

“I think when I was a young fiery GP trainee I used to try and not give antibiotics and now I’m softening ... I’m quite well aware of the lack of firm evidence that antibiotics treat URTIs and that in terms of evidence based medicine we over prescribe antibiotics, but my own view is that I don’t really care ... you're goals at the end of the consultation is for you and the mother to be satisfied.”

WP 8: Launching the clinical platform: 3 An example of the power of qualitative research

• Their perceptions of their own and others’ antibiotic prescribing

• Their perceptions of antibiotic resistance• Barriers to change• Opportunities for improvement

WP 8: Launching the clinical platform: 3Qualitative study: clinicians’ topic guide

•Help seeking; thresholds, cultural influences•Perceptions of problem of antibiotic resistance•Beliefs about causes of LRTI and management•Beliefs about antibiotics

WP 8: Launching the clinical platform: 3Qualitative study: patients’ topic guide

• Training of interviewers (NNF)• Translation of transcripts• Integration to develop a Europe-wide,

‘grounded theory’

WP 8: Launching the clinical platform: 3Qualitative study: process and challenges

Objective 4: Developing definitions

Empirical research (the quantitative study will provide the platform todescribe syndromes and clinical presentation)

↓Literature searching

↓Expert opinion to enhance the empirical research and literaturesearching

↓Consensus groups (using modified Delphi technique)

↓Face validity

WP 8: Launching the clinical platform: 4

• Finalize protocol and all materials and data collection tools: April

• Ethics and governance approval; April, May• Site visits: May, June• Pilot IT and recruitment processes: June, July• Training meeting: Grace platform September • First recruitment period: October 2006 (f/u Nov)• Evaluation: December• Second recruitment period: February 2007 (f\u March)• Qualitative study: February, March 2007• WPs 9 and 10 planning

WP 8: Launching the clinical platformTimetable

Lower respiratory tract infection is not the commonest thing managed in general practice (News, July 19) and 807 patients is a scandalous lack of evidence on which to base research, especially as the result is not what we see in hospital and general practice.

Doctors taking notice of Government propaganda about not using antibiotics in the NHS have caused an increase in LRTI and death.

My evidence is based on 30 years in general and hospital practice. If antibiotics don't work in LRTI perhaps these academics could explain why, when patients get an LRTI after being denied antibiotics for URTI, they get better on antibiotics in hospital.

Could Professor Paul Little and his colleagues consider doing something useful....

Dr Searle, Pulse Aug 2 2004Dr Searle, Pulse Aug 2 2004 Pulse August 2 2004

WP 8: Launching the clinical platform Why antibiotics propaganda may cause extra deaths

Most likely to benefit

Least likely to benefit

Always prescribe

Uncertainty

Never prescribe

•Physical findings•Expectations of effectiveness of antibiotics•Tests•Perceived expectations•Relationships•Parents need to return to work•Concern about adverse outcomes in untreated patients•Duration and worsening of symptoms•Physician demographics and speciality•Financial/reimbursement •Time

Enhanced communication

McFarlane, Davey

WP 8: Launching the clinical platformFill in in evidence gaps to enhance clincial practice

WP 8: Launching the clinical platformMulti-faceted innovation to address real problems

Infrastructure innovation• Integrating primary care networks across Europe • Integrating primary care clinical platform with disciplines ranging from the

molecular geneticists to the health economists• Durable clinical platform for existing Grace studies and for new studies,

Research Methods innovation• Describing practice across countries, languages and health care settings• Qualitative research integration across languages and settings

Scientific innovation• Description of variation in presentation, management and outcome• Understand the variation• Preparing the ground for future studies• Targets for intervention• Health economics and modeling studies