Valeur en termes de données probantes des informations ... - KCE

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14 Written information from pharmaceutical companies KCE reports 55 References were classified into one of five categories: review article (with a scale for rating methodologic quality - 26%), clinical trial of treatment (also with a scale for rating methodologic quality - 64%); basic laboratory experiment, survey or governmentgenerated statistics, secondary data source (e.g., book, product monograph or entry in the CPS), data on file (unpublished material), all these categories accounting for 10%. A methodologic quality scale was applied to the first two categories but not if it belonged to the third category nor if it was a secondary source (except if it was unreferenced, i.e. considered as author’s opinion, in this case, it received the lowest score). References received as "data on file" were classified into one of the first four categories and then treated accordingly. 15 Adequacy of references Adequacy was either complete or incomplete according to the standard bibliographic norms. 23 The majority was found to be incomplete. Type of references According to a study, type of references could be tertiary literature (books – 2%), editorials (1%), primary literature (human or non human research, epidemiologic research, review articles, all these categories accounting for 97%) 5 Type of study referenced It could be a clinical study (50% of cases) or a laboratory study or there could be no scientific study (34% of cases). 8 Another author classified the type of articles referenced as original research, review article, letter or editorial. 31 The type of study design of referenced studies was presented as well as details like the number and characteristics of study subjects. 2 Study design was classified as controlled (42% of cases), uncontrolled (8%), prospective (1%) or retrospective (3%). 5 Outcome in the study referenced The outcome could concern either clinical endpoints (43,1%), surrogate endpoints (37,2%) or pathophysiological endpoints (19,6%). 19 Data supporting the references A study defined the academic status of data supporting references as follows: published report, presented at meeting only, data on file only, no scientific study, no response of company. The data could be considered as high quality or low quality. Claims were assessed as well supported or unsupported, based on the review of the data. The validity of the claims was assessed by the rating of the data and they were considered as well supported, possibly supported (here meaning not the same validity rating by al reviewers), unsupported or no response from company. Fourteen % of the claims were well supported, 34% were possibly supported, 44% were unsupported and there was no response for 8% of them. 8 Another classification was the following: well supported, poorly supported or misleading. 21 The validity of an article was also determined by a list of six questions that addressed evidence-based principles. 9 The level of supporting evidence of each reference was determined as follows: metaanalysis or systematic review = level 1 evidence (10% for unambiguous clinical outcome; 14% for vague clinical outcome), at least one randomised controlled trial = level 2 evidence (respectively 45 and 25%), other study (such as a cohort study) = level 3 evidence (9% for both types of outcome), claims with references not searchable on Medline, unreferenced claims. 29 The response for information for data on file was either no response (64% for generic data; 47% for specific data), response to initial request (29 and 37%, respectively) or
KCE reports 55 Written information from pharmaceutical companies 15 response after repeat request (7 and 16%, respectively). The type of response was either a decline (14 and 34%, respectively), study data that were unpublished (12 and 7%, respectively) and/or journal reprint (4 and 3%, respectively). 31 Link with the claim A comparison was performed between the data presented in the document studied and the data presented in the original study to determine consistency. 9 A study assessed the link between claims and references and considered claims as either well supported or poorly supported by the reference(s) or misleading. The distribution into these categories was 17, 74 and 9%, respectively. 21 Referenced statements were also classified as correct (46,1%), incorrect/inaccurate (4,2%), misleading (15,3%) or taken from abstract, discussion or conclusion of a study (5,4%). 5 Another one used a series of criteria to determine if claims were supported or not (44,1%). 19 One study used a scale (score 1 to 5: complete support, limited or partial support, not directly relevant, irrelevant, contradictory) to rate the degree to which references support statements. 15 Financial source of study Funding sources were searched for in each referenced study as well as affiliation of 2, 31, 9 authors with manufacturer of product. Acceptability of references References cited as data on file or available upon request were considered unacceptable (65%). 28 2.3.5.6 Final classification of the advertisement The advertisement was classified as «accept» (4%), «accept contingent upon minor revisions» (35%), «accept contingent upon major revisions» (34%) or «reject the advertisement» (28%). 6 Reasons for revisions or rejections were lack of information (on safety, efficacy, populations, side effects and contraindications or references), presence of misleading information (references, statements, graphs and tables or images), or need of another 6, 1 correction A simple final classification was proposed as acceptable or unacceptable, this last category being further classified according to the Australian Pharmaceutical Manufacturer Association (APMA) Code of Conduct into advertisement containing unacceptabe reference or making unacceptable claims. 28 2.4 DISCUSSION The aim of the literature search was to obtain a support for the choice of the methodology for the exploratory inventory as well as a support for the choice of the domain and of the methodology of the content analysis of the material chosen from the exploratory inventory. From the literature search, it appeared that there was a great variability regarding the methods used for the inventory as well as for the content analysis of written information from the pharmaceutical industry. However, for the latter, some methods were used several times, like the use of a checklist or of a score. The duration of studies was variable; the domains covered in the studies were also variable, as presented in the results section (class of medication).
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Dépôt légal : D/2007/10.273/13
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35. Etude relative aux coûts poten
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Valeur en termes de données probantes des informations ... - KCE

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