How experiences become data: The process of eliciting adverse event, medical history and concomitant medication reports in antimalarial and antiretroviral interaction trials

BMC Medical Research Methodology

Volumn 13, Issue 1, 2013, Pages

  Allen, Elizabeth N ^a   Mushi, Adiel K ^b   Massawe, Isolide S ^b   Vestergaard, Lasse S ^c,d   Lemnge, Martha ^b   Staedke, Sarah G ^e   Mehta, Ushma ^a   Barnes, Karen I ^a   Chandler, Clare I R ^e  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b NATIONAL INSTITUTE FOR MEDICAL RESEARCH   (Tanzania)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d Mental Health Services CPH   (Denmark)

^e LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

Clinical trial; Elicitation; Harm; HIV; Malaria; Pharmacovigilance; Safety; Social context; South Africa; Tanzania

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTIMALARIAL AGENT; ARTEMETHER PLUS BENFLUMETOL; ARTEMISININ DERIVATIVE; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE;

ADULT; ARTICLE; CLINICAL TRIAL (TOPIC); DRUG COMBINATION; DRUG INTERACTION; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; INTERVIEW; MALARIA; MALE; MIDDLE AGED; SELF REPORT; SOUTH AFRICA; TANZANIA; TREATMENT OUTCOME;

ADULT; ANTI-HIV AGENTS; ANTIMALARIALS; ARTEMISININS; CLINICAL TRIALS AS TOPIC; DRUG COMBINATIONS; DRUG INTERACTIONS; ETHANOLAMINES; FEMALE; FLUORENES; FOCUS GROUPS; HIV INFECTIONS; HUMANS; INTERVIEWS AS TOPIC; MALARIA; MALE; MIDDLE AGED; SELF REPORT; SOUTH AFRICA; TANZANIA; TREATMENT OUTCOME; TRUTH DISCLOSURE;

EID: 84887352873     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/1471-2288-13-140     Document Type: Article

References (45)

1. Adverse events: the more you search, the more you find. Ioannidis JP, Mulrow CD, Goodman SN, Ann Intern Med 2006 144 4 298 300 10.7326/0003-4819-144- 4-200602210-00013 16490917 (Pubitemid 46768214)
2. Systematic reviews of adverse effects: framework for a structured approach. Loke YK, Price D, Herxheimer A, Cochrane adverse effects methods group, BMC Med Res Methodol 2007 7 32 10.1186/1471-2288-7-32 17615054 (Pubitemid 47206824)
3. CIOMS, Management of safety information from clinical trials: report of CIOMS working group VI Geneva 2005
4. Pitfalls in meta-analyses on adverse events reported from clinical trials. Huang HY, Andrews E, Jones J, Skovron ML, Tilson H, Pharmacoepidemiol Drug Saf 2011 20 10 1014 1020 10.1002/pds.2208 21858897
5. Generic assessment of side effects. Rief W, Glombiewski JA, Barsky AJ, [ http://gase-scale.com/Instruction-GASE.pdf ]
6. Brief communication: better ways to question patients about adverse medical events: a randomized, controlled trial. Bent S, Padula A, Avins AL, Ann Intern Med 2006 21 257 261 (Pubitemid 46768208)
7. Relating spontaneous adverse experience reports to scores on a questionnaire querying tolerability. Barber BL, Santanello NC, Int J Clin Pharmacol Ther 1995 33 11 598 604 8688984
8. Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill LL, Vitiello B, Fisher P, Levine J, Davies M, Abikoff H, Chrisman AK, Chuang S, Findling RL, March J, Scahill L, Walkup J, Riddle MA, J Am Acad Child Adolesc Psychiatry 2004 43 12 1488 1496 10.1097/01.chi.0000142668.29191.13 15564818 (Pubitemid 40468623)
9. Detecting treatment emergent adverse events in clinical trials: a comparison of spontaneously reported and solicited collection methods. Wernicke JF, Faries D, Milton D, Weyrauch K, Drug Saf 2005 28 11 1057 1063 10.2165/00002018-200528110-00006 16231957 (Pubitemid 41483709)
10. Residual antimalarials in malaria patients from Tanzania-implications on drug efficacy assessment and spread of parasite resistance. Hodel EM, Kabanywanyi AM, Malila A, Zanolari B, Mercier T, Beck HP, Buclin T, Olliaro P, Decosterd LA, Genton B, PLoS One 2009 4 12 8184 10.1371/journal.pone.0008184 20011529
11. Validity of pharmacoepidemiology drug and diagnosis data. West SL, Strom BL, Poll C, Pharmacoepidemiology Chichester, England: John Wiley & Sons Ltd, Strom BL, 4 2005 709 765
12. Questionnaire design and the recall of pharmacological treatments: a systematic review. Gama H, Correia S, Lunet N, Pharmacoepidemiol Drug Saf 2009 18 3 175 187 10.1002/pds.1703 19116956
13. Culture and psychopharmacology. Lin KM, Smith MW, Ortiz V, Psychiatr Clin North Am 2001 24 3 523 538 10.1016/S0193-953X(05)70245-8 11593861 (Pubitemid 32912068)
14. CIOMS/WHO, Drug Development Research in Resource-Limited Countries Geneva: Draft report of the Joint CIOMS/WHO working group 2005
15. Neuroticism, side effects, and health perceptions among HIV-infected individuals on antiretroviral medications. Johnson MO, Neilands TB, J Clin Psychol Med Settings 2007 14 1 69 77 10.1007/s10880-007-9056-9 18568088 (Pubitemid 46553897)
16. Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Nestoriuc Y, Orav EJ, Liang MH, Horne R, Barsky AJ, Arthritis Care Res 2010 62 6 791 799 10.1002/acr.20160
17. Patients' perceptions of the side-effects of prostate cancer treatment-a qualitative interview study. Korfage IJ, Hak T, de Koning HJ, Essink-Bot ML, Soc Sci Med 2006 63 4 911 919 10.1016/j.socscimed.2006.01.027 16798130
18. Beyond literacy and numeracy in patient provider communication: focus groups suggest roles for empowerment, provider attitude and language. Brugge D, Edgar T, George K, Heung J, Laws MB, BMC Public Health 2009 21 9 354
19. The impact of gender dyads on doctor-patient communication: a systematic review. Sandhu H, Adams A, Singleton L, Clark-Carter D, Kidd J, Patient Educ Couns 2009 76 3 348 355 10.1016/j.pec.2009.07.010 19647969
20. Doctor-patient communication: a review of the literature. Ong LML, de Haes JCJM, Hoos AM, Lammes FB, Soc Sci Med 1995 40 903 10.1016/0277-9536(94) 00155-M 7792630
21. "Side effects": cultural constructions and reinterpretations of Western pharmaceuticals. Etkin NL, Med Anthropol Q 1992 6 99 113 10.1525/maq.1992.6.2.02a00010
22. Multinational clinical trials: breaking language and cultural barriers. Stober M, [ http://appliedclinicaltrialsonline.findpharma.com/ appliedclinicaltrials/article/ ]
23. The influence of the nocebo effect in clinical trials. Colloca L, Open Access J Clin Trials 2012 4 61 68
24. The consent form as a possible cause of side effects. Myers MG, Cairns JA, Singer J, Clin Pharmacol Ther 1987 42 3 250 253 10.1038/clpt.1987.142 3621780 (Pubitemid 17155727)
25. The ACT consortium. [ http://www.actconsortium.org/ ]
26. Auerbach CF, Silverstein LB, Qualitative Data: an introduction to coding and analysis New York: New York University Press 2003
27. Strauss A, Corbin J, Basics of qualitative research: Grounded theory procedures and techniques London: Sage 1990
28. International Conference on Harmonisation. 'Guideline for Good Clinical Practice E6 (R1) 1996 http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Efficacy/E6-R1/Step4/E6-R1-Guideline.pdf Accessed 14th November 2013
29. Recall of drug utilization depends on subtle structural questionnaire characteristics. Lunet N, Bastos J, Cumaio F, Silva P, Dias E, Barros H, Pharm World Sci 2008 30 2 175 181 10.1007/s11096-007-9161-8 17882533 (Pubitemid 351311413)
30. Mode of questionnaire administration can have serious effects on data quality. Bowling A, J Public Health (Oxf) 2005 27 3 281 291 10.1093/pubmed/ fdi031 15870099 (Pubitemid 41298086)
31. Forging convictions: the effects of active participation in a clinical trial. Scott C, Walker J, White P, Lewith G, Soc Sci Med 2011 72 2041 2048 10.1016/j.socscimed.2011.04.021 21636195
32. "Playing their parts": the experiences of participants in a randomized sham-controlled acupuncture trial. Paterson C, Zheng Z, Xue C, Wang Y, J Altern Complement Med 2008 14 2 199 208 10.1089/acm.2007.0682 18315508 (Pubitemid 351364407)
33. Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention. Heaven B, Murtagg M, Rapley T, May C, Graham R, Kaner E, Thomson R, Patient Educ Couns 2006 62 260 270 10.1016/j.pec.2005.07.013 16181766 (Pubitemid 43975710)
34. Biological citizenship. Rose N, Novas C, Collier S.J, Ong A. Global Assemblages Anthropological Problems, in Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems Oxford, UK: Blackwell Publishing Ltd, Ong A, Collier SJ, 2005 439 463
35. Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Molyneux CS, Peshu N, Marsh K, Soc Sci Med 2004 59 12 2547 2559 10.1016/j.socscimed.2004.03.037 15474208 (Pubitemid 39345760)
36. The lay public's explicit and implicit definitions of drugs. Björnsdóttir I, Almarsdóttir AB, Traulsen JM, Res Social Adm Pharm 2009 5 1 40 50 10.1016/j.sapharm.2008.04.003 19285288
37. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda: limitations of diagnostic testing in the reality of diagnosis. Chandler CI, Hall-Clifford R, Asaph T, Pascal M, Clarke S, Mbonye AK, Soc Sci Med 2011 72 6 937 944 10.1016/j.socscimed.2011.01.009 21349623
38. What do we mean by partnership in making decisions about treatment? Charles C, Whelan T, Gafni A, BMJ 1999 319 780 782 10.1136/bmj.319.7212.780 10488014 (Pubitemid 29431540)
39. Combining prevention, treatment and care: lessons from South Africa. Achmat Z, Simcock J, AIDS 2007 21 Suppl 4 11 20 10.1097/01.aids.0000279702. 71062.52 (Pubitemid 47051745)
40. How the psychosocial context of clinical trials differs from usual care: a qualitative study of acupuncture patients. Barlow F, Scott C, Coghlan B, Lee P, White P, Lewith GT, Bishop FL, BMC Med Res Methodol 2011 11 79 10.1186/1471-2288-11-79 21612644
41. Helman CG, Culture, Health and Illness London: Hodder Arnold 5 2007
42. Power issues in the doctor-patient relationship. Goodyear-Smith F, Buetow S, Health Care Anal 2001 2001 9 449 462 (Pubitemid 34123643)
43. Designing adverse event forms for real-world reporting: participatory research in Uganda. Davies EC, Chandler CIR, Innocent SHS, Kalumuna C, Terlouw DJ, Lalloo DG, Staedke SG, Haaland A, PLoS ONE 2012 7 3 32704 10.1371/journal.pone.0032704 22479335
44. A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the microbicides development programme. Pool R, Montgomery CM, Morar NS, Mweemba O, Ssali A, Gafos M, Lees S, Stadler J, Crook A, Nunn A, Hayes R, McCormack S, PLoS ONE 2010 5 7 11600 10.1371/journal.pone.0011600 20657778
45. Weaving a multimethodology and mixed methods praxis into randomized control trials to enhance credibility. Hesse-Biber S, Qual Inq 2012 18 10 876 889 10.1177/1077800412456964