General practice-based clinical trials in Germany - a problem analysis

Trials

Volumn 13, Issue , 2012, Pages

  Hummers Pradier, Eva ^a   Bleidorn, Jutta ^b   Schmiemann, Guido ^c   Joos, Stefanie ^d   Becker, Annette ^e   Altiner, Attila ^f   Chenot, Jean François ^g   Scherer, Martin ^h  

^a UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c UNIVERSITY OF BREMEN   (Germany)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e PHILIPPS UNIVERSITY MARBURG   (Germany)

^f UNIVERSITY OF ROSTOCK   (Germany)

^g UNIVERSITY OF GREIFSWALD   (Germany)

^h UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

Author keywords

Barriers; Clinical trials; Comparative effectiveness research; General practice; Research support

Indexed keywords

ARTICLE; CHECKLIST; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; FUNDING; GENERAL PRACTICE; GENERAL PRACTITIONER; GERMANY; HEALTH CARE SYSTEM; HUMAN; PILOT STUDY; PRACTICE GUIDELINE; PRIMARY MEDICAL CARE;

CLINICAL TRIALS AS TOPIC; COMPARATIVE EFFECTIVENESS RESEARCH; GENERAL PRACTICE; GERMANY; HEALTH CARE COSTS; HUMANS; MODELS, ORGANIZATIONAL; PRIMARY HEALTH CARE; RESEARCH DESIGN; RESEARCH SUPPORT AS TOPIC; TIME FACTORS; WORKLOAD;

EID: 84868458218     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-205     Document Type: Article

References (45)

1. Van Weel C. Research for Care, Care for Research. Reflections on the Challenges of Multi-Morbidity for General Practice. Keynote, EGPRN-Conference Dubrovnik 2009, [http://www.egprn.org/index.php/presentations/keynote-lectures/finish/15-keynotes/613-2009-dubrovnik-croatia-keynote-speaker] (accessed on Oct.15, 2012).
2. Hummers-Pradier E, Beyer M, Chevallier P, Eilat-Tsanani S, Lionis C, Peremans L, Petek D, Rurik I, Soler JK, Stoffers HE, Topsever P, Ungan M, van Royen P. The research agenda for general practice/family medicine and primary health care in Europe. Part 4. Results: specific problem solving skills. Eur J Gen Pract 2010, 16:174-181. 10.3109/13814788.2010.504982, 20825274.
3. Sullivan F, Norbury M. Commentary on: 'The research agenda for general practice/family medicine and primary health care in Europe. Part 4. Specific problem solving skills'. Eur J Gen Pract 2010, 16:131-132. 10.3109/13814788.2010.504258, 20670081.
4. Gágyor I, Bleidorn J, Wegscheider K, Hummers-Pradier E, Kochen MM. Practices, patients and (im)perfect data-feasibility of a randomised controlled clinical drug trial in German general practices. Trials 2011 Apr 1, 12:91.
5. Vickers AJ, Scardino PT. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost. Trials 2009, 10:14. 10.1186/1745-6215-10-14, 2656491, 19265515.
6. VanLare JM, Conway PH, Sox HC. Five next steps for a new national program for comparative-effectiveness research. N Engl J Med 2010, 362:970-973. 10.1056/NEJMp1000096, 20164480.
7. Sox HC. Comparative effectiveness research: a progress report. Ann Intern Med 2010, 153:469-472.
8. Westfall JM, Ingram B, Navarro D, Magee D, Niebauer L, Zittleman L, Fernald D, Pace W. Engaging communities in education an d research: PBRNs, AHEC, and CTSA. Clin Transl Sci 2012, 5:250-258. 10.1111/j.1752-8062.2011.00389.x, 22686202.
9. Shaw SE, Greenhalgh T. Best research-for what? Best health-for whom? A critical exploration of primary care research using discourse analysis. Soc Sci Med 2008, 66:2506-2519. 10.1016/j.socscimed.2008.02.014, 18378371.
10. Royal College of General Practitioners Research Ready self-accreditation http://www.rcgp.org.uk/researchready (accessed on Oct. 18, 2012), Royal College of General Practitioners.
11. National Institute for Health Research Clinical research network http://www.crncc.nihr.ac.uk (accessed on Oct. 18, 2012), National Institute for Health Research.
12. The Netherlands rural information network of general practitioners (linh) http://www.nivel.nl/en/linh-zorgregistratie-huisartsen (accessed on Oct. 18, 2012), The Netherlands rural information network of general practitioners (linh).
13. American Academy of Family Physicians Federation of practice based research networks http://www.aafp.org/online/en/home/clinical/research/fpbrn.html (accessed on Oct. 18, 2012), American Academy of Family Physicians.
14. TRANSFoRm Translational research and patient safety in Europe TRANSFoRm Translational research and patient safety in Europe http://www.transformproject.eu (accessed on April 30, 2012), TRANSFoRm Translational research and patient safety in Europe.
15. Delaney B. General practice at the cutting edge of information technology, or failing to keep pace?. Br J Gen Pract 2010, 60:239-240. 2845484, 20353667.
16. German Research Foundation (DFG) Clinical Trials http://www.dfg.de/en/research_funding/programmes/individual/clinical_trials/index.html (accessed on Oct. 18, 2012), German Research Foundation (DFG).
17. Altiner A, Brockmann S, Sielk M, Wilm S, Wegscheider K, Abholz HH. Reducing antibiotic prescriptions for acute cough by motivating GPs to change their attitudes to communication and empowering patients: a cluster-randomized intervention study. J Antimicrob Chemother 2007, 60:638-644. 10.1093/jac/dkm254, 17626023.
18. Chenot JF, Leonhardt C, Keller S, Scherer M, Donner-Banzhoff N, Pfingsten M, Basler HD, Baum E, Kochen MM, Becker A. The impact of specialist care for low back pain on health service utilization in primary care patients: a prospective cohort study. Eur J Pain 2008, 12:275-283. 10.1016/j.ejpain.2007.06.004, 17681811.
19. Bleidorn J, Gágyor I, Wegscheider K, Kochen MM, Hummers-Pradier E. Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection? - results of a randomized controlled pilot trial. BMC Med 2010, 8:30. 10.1186/1741-7015-8-30, 2890534, 20504298.
20. Loh A, Simon D, Wills CE, Kriston L, Niebling W, Harter M. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Patient Educ Couns 2007, 67:324-332. 10.1016/j.pec.2007.03.023, 17509808.
21. Schneider A, Tilemann L, Schermer T, Gindner L, Laux G, Szecsenyi J, Meyer FJ. Diagnosing asthma in general practice with portable exhaled nitric oxide measurement-results of a prospective diagnostic study. Respir Res 2009, 10:15. 10.1186/1465-9921-10-15, 2660901, 19254389.
22. Peters-Klimm F, Campbell S, Hermann K, Kunz C, Muller-Tasch T, Szecsenyi J, . (on Behalf of the Competence Network Heart Failure) Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial. Trials 2010, 11:56. 10.1186/1745-6215-11-56, 2882359, 20478035, (on Behalf of the Competence Network Heart Failure).
23. Freund T, Peters-Klimm F, Rochon J, Mahler C, Gensichen J, Erler A, Beyer M, Baldauf A, Gerlach FM, Szecsenyi J. Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]. Trials 2011, 12:163. 10.1186/1745-6215-12-163, 3141533, 21714883.
24. German Research Foundation (DFG) Scientific networks http://www.dfg.de/en/research_funding/programmes/individual/scientific_networks/index.html (accessed on Oct. 18, 2012), German Research Foundation (DFG).
25. Schneider A, Großmann N, Linde K, . DFG Network Clinical Trials in General Practice The development of general practice as an academic discipline in Germany-an analysis of research output between 2000 and 2010. BMC Fam Pract 2012, 13:58. 10.1186/1471-2296-13-58, 3489844, 22702476, DFG Network Clinical Trials in General Practice.
26. Herrmann M, Lichte T, Von Unger H, Gulich M, Waechtler H, Donner-Banzhoff N, Wilm S. Faculty development in general practice in Germany: experiences, evaluations, perspectives. Med Teach 2007, 29:219-224. 10.1080/01421590701299231, 17701636.
27. Rosemann T, Szecsenyi J. General practitioners' attitudes towards research in primary care: qualitative results of a cross sectional study. BMC Fam Pract 2004, 5:31. 10.1186/1471-2296-5-31, 545488, 15613246.
28. Hummers-Pradier E, Beyer M, Chevallier P, Eilat-Tsanani S, Lionis C, Peremans L, Petek D, Rurik I, Soler JK, Stoffers HE, Topsever P, Ungan M, van Royen P. The research agenda for general practice/family medicine and primary health care in Europe 2009, European General Practice Research Network (EGPRN) Maastricht, http://www.egprn.org/files/userfiles/file/research_agenda_for_general_practice_family_medicine.pdf (accessed on Oct. 18, 2012).
29. Timmer A. Postgraduate training: Plea for evidence-based medicine [in German]. Dtsch. Ärzteblatt 2012, 109:A1418-A1420.
30. van der Zee J, Kroneman M, Bolíbar. Conditions for research in general practice. Can the Dutch and British experiences be applied to other countries, for example Spain?. Eur J Gen Pract 2003, 9:41-47. 10.3109/13814780309160401, 14611015.
31. Koch K, Miksch A, Schürmann C, Joos S, Sawicki PT. The German health care system in international comparison: the primary care physicians' perspective. Dtsch Arztebl Int 2011, 108:255-261. 3088170, 21556263.
32. Sawicki PT, Bastian H. German health care: a bit of Bismarck plus more science. BMJ 2008, 337:a1997. 10.1136/bmj.a1997, 18996937.
33. Hummers-Pradier E, Scheidt-Nave C, Martin H, Heinemann S, Kochen MM, Himmel W. Simply no time? Barriers to GPs' participation in primary health care research. Fam Pract 2008, 25:105-112. 10.1093/fampra/cmn015, 18417465.
34. Williamson MK, Pirkis J, Pfaff JJ, Tyson O, Sim M, Kerse N, Lautenschlager NT, Stocks NP, Almeida OP. Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study. BMC Med Res Methodol 2007, 7:42. 10.1186/1471-2288-7-42, 2147023, 17875219.
35. Peters-Klimm F, Hermann K, Gágyor I, Haasenritter J, Bleidorn J, . for the Network Group Clinical Studies in General Practice Experiences and attitudes regarding practice-based clinical trials: Results of a survey among German primary care physicians [in German]. Gesundheitswesen 2012, Aug. 14, epub ahead of print, for the Network Group Clinical Studies in General Practice.
36. Gágyor I, Haasenritter J, Hummers-Pradier E, Peters-Klimm F, Bleidorn J. GCP-Training for family physicians participating in practice-based clinical drug trials [in German]. Z Allg Med in press.
37. Federal ministry of health The act on the reform of the market for medicinal products (AMNOG) http://www.bmg.bund.de/ministerium/english-version/amnog.html (accessed on Oct. 18, 2012), Federal ministry of health.
38. Götte D. Consequences of the German AMNOG for the identification of study objectives to demonstrate clinical efficacy and cost effectiveness of innovative drugs [in German]. Dtsch Med Wochenschr 2012, 137:274-280.
39. Ovhed I, van Royen P, Håkansson A. What is the future of primary care research? Probably fairly bright, if we may believe the historical development. Scand J Prim Health Care 2005, 23:248-253. 10.1080/02813430500316692, 16272075.
40. Hummers-Pradier E. General practice research in Germany-development and current situation [in German]. Z Allg Med 2006, 82:409-414.
41. Glanville J, Kendrick T, McNally R, Campbell J, Hobbs FD. Research output on primary care in Australia, Canada, Germany, the Netherlands, the United Kingdom, and the United States: bibliometric analysis. BMJ 2011, 342:d1028. 10.1136/bmj.d1028, 3050436, 21385804.
42. Advisory Council for the Assessment of Developments in the Health Care System Coordination and integration-health care in an ageing society. Special Report 2009, http://www.svr-gesundheit.de/Informationen/PM09-SVR.pdf (accessed on Sept. 12, 2012), Advisory Council for the Assessment of Developments in the Health Care System.
43. Bösner S, Haasenritter J, Becker A, Karatolios K, Vaucher P, Gencer B, Herzig L, Heinzel-Gutenbrunner M, Schaefer JR, Abu Hani M, Keller H, Sönnichsen AC, Baum E, Donner-Banzhoff N. Ruling out coronary artery disease in primary care: development and validation of a simple prediction rule. CMAJ 2010, 182:1295-1300. 10.1503/cmaj.100212, 2934794, 20603345.
44. Gágyor I, Hummers-Pradier E, Kochen MM, Schmiemann G, Wegscheider K, Bleidorn J. Immediate versus conditional treatment of uncomplicated urinary tract infection-a randomized-controlled comparative effectiveness study in general practices. BMC Inf Dis 2012, 12:146.
45. Hauswaldt J, Bleidorn J, Kersting M, Hummers-Pradier E. Harmonizing electronic data from a German GP based research network [abstract]. Eur J Gen Pract 2012, 18:30-49.