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WP 8: Launching the clinical platform

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-PI Paul Little , Southampton University; co-PI

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WP 8: Launching the clinical platform

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  1. 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-PI Paul Little, Southampton University; co-PI Herman Goossens, Project leader And the team

  2. WP 8: Launching the clinical platform The ‘GRACE' Spirit The Network will live on to serve science for the benefit of patients in the EU and beyond Multidisciplinary; molecule to management to policy Dialogue Synergy

  3. 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

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

  5. WP 8: Launching the clinical platform Antibiotic use and resistance 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

  6. WP 8: Launching the clinical platform Time, social determinants of health, prescribing, complications 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’ ? Improved living conditions with time

  7. 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

  8. 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

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

  10. WP 8: Launching the clinical platform: 1 Networks 1 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

  11. WP 8: Launching the clinical platform: 1 Networks 2 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 Mölstad Malmvall Futurum UK 25/60 Christopher Butler Richard Hibbs 8/24 Michael Moore Michael Moore

  12. WP 8: Launching the clinical platform: 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

  13. WP 8: Launching the clinical platform: 2 Clinicians CRF and clinician registration form • Demographics • History • Presentation • Clinical findings • Usual investigations • Management • Referral • Perceived expectations • Advice, including OTC meds, sick leave

  14. WP 8: Launching the clinical platform: 2 Patients 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

  15. 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

  16. WP 8: Launching the clinical platform: 2 Patient packs • For each patient the GP receives a file with: • Information leaflet • Informed consent • Registration form • CRF • Diary (in local language) • Envelop to send diary back to NNF • Sticker page with patient specific study numbers

  17. 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

  18. WP 8: Launching the clinical platform: 2Patient registration GP enters ASAP into GRACE-platform: Study ID, GP ID, Incl. Date, DOB and Gender GP completes registration form on paper GP faxes registration form to NNF GP stores registration form local in patient specific file

  19. WP 8: Launching the clinical platform: 2CRF GP enters data from CRF into GRACE-platform within 2 days NNF contacts GP in case of missing CRF data GP completes CRF on paper GP stores CRF local in patient specific file

  20. WP 8: Launching the clinical platform: 2Patient diary GP gives diary to patient Patient fills in diary (28 days) Patient sends diary to NNF NNF contacts patient about diary 4 days after inclusion NNF enters data of diary into GRACE-platform NNF contacts patient in case of missing diary

  21. WP 8: Launching the clinical platform: 2General flow

  22. WP 8: Launching the clinical platform: 3 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

  23. WP 8: Launching the clinical platform: 3Why 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

  24. WP 8: Launching the clinical platform: 3An example of the power of qualitative research “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.”

  25. WP 8: Launching the clinical platform: 3 Qualitative study: clinicians’ topic guide • Their perceptions of their own and others’ antibiotic prescribing • Their perceptions of antibiotic resistance • Barriers to change • Opportunities for improvement

  26. WP 8: Launching the clinical platform: 3 Qualitative study: patients’ topic guide Help seeking; thresholds, cultural influences Perceptions of problem of antibiotic resistance Beliefs about causes of LRTI and management Beliefs about antibiotics

  27. WP 8: Launching the clinical platform: 3 Qualitative study: process and challenges • Training of interviewers (NNF) • Translation of transcripts • Integration to develop a Europe-wide, ‘grounded theory’

  28. WP 8: Launching the clinical platform: 4 Objective 4: Developing definitions Empirical research (the quantitative study will provide the platform to describe syndromes and clinical presentation) ↓ Literature searching ↓ Expert opinion to enhance the empirical research and literature searching ↓ Consensus groups (using modified Delphi technique) ↓ Face validity

  29. WP 8: Launching the clinical platform Timetable • 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

  30. WP 8: Launching the clinical platform Why antibiotics propaganda may cause extra deaths 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 2004Pulse August 2 2004

  31. WP 8: Launching the clinical platformFill in in evidence gaps to enhance clincial practice Most likely to benefit • 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 Always prescribe Enhanced communication Uncertainty Never prescribe Least likely to benefit McFarlane, Davey

  32. 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

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