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      The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals

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          Abstract

          Introduction

          Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.e., respondents’ awareness and understanding of the communication) of a targeted educational brochure distributed to health-care professionals (HCPs) as a risk minimization strategy for the communication of new rare and important adverse events (AEs).

          Methods

          A prospective, non-interventional, online survey was performed following distribution of a specifically designed brochure highlighting new and important adverse events to a targeted HCP population, consisting of known users of the target medicine, as represented by a commercial database. Predefined multiple-choice survey questions assessed overall HCP awareness of the brochure and understanding and retention of information in those HCPs who reported receiving the brochure.

          Results

          The educational brochure was sent to a total of 565 HCPs; 121 (21.4%) responded to the survey. The majority of respondents (95.0%) had previously prescribed or dispensed the target medicine. In all, 88 (72.7%) respondents said they had received the educational brochure, of whom 95.5% stated they had at least scanned the main points. More participants who had received the brochure (86.4% to 96.6%) answered the five individual survey questions correctly compared with those who did not (51.5% to 97.0%); this was significant for four out of five questions ( P ≤ 0.005). Significantly more HCPs who received the brochure achieved the predefined pass rate (at least four of five questions answered correctly) compared with HCPs who did not receive the brochure (93.2% vs 57.6%, respectively; P = 0.000003).

          Conclusions

          Distribution of targeted educational brochures may be an effective risk minimization strategy to raise HCP awareness of new rare and important AEs; educational brochures may also be an effective channel for sharing information on how these AEs can be best managed and on the importance and means of reporting AEs.

          Funding

          Celgene Pty Ltd, Melbourne, Australia.

          Electronic supplementary material

          The online version of this article (doi:10.1007/s12325-016-0284-y) contains supplementary material, which is available to authorized users.

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          Most cited references10

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          Response rates in postal surveys of healthcare professionals between 1996 and 2005: An observational study

          Background Postal surveys are a frequently used method of data collection in health services research. Low response rates increase the potential for bias and threaten study validity. The objectives of this study were to estimate current response rates, to assess whether response rates are falling, to explore factors that might enhance response rates and to examine the potential for non-response bias in surveys mailed to healthcare professionals. Methods A random sample of postal or electronic surveys of healthcare workers (1996-2005) was identified from Medline, Embase or Psycinfo databases or Biomed Central. Outcome measures were survey response rate and non response analysis. Multilevel, multivariable logistic regression examined the relationship between response rate and publication type, healthcare profession, country and number of survey participants, questionnaire length and use of reminders. Results The analysis included 350 studies. Average response rate in doctors was 57.5% (95%CI: 55.2% to 59.8%) and significantly lower than the estimate for the prior 10 year period. Response rates were higher when reminders were sent (adjusted OR 1.3; 95%CI 1.1-1.6) but only half the studies did this. Response rates were also higher in studies with fewer than 1000 participants and in countries other than US, Canada, Australia and New Zealand. They were not significantly affected by publication type or healthcare profession (p > 0.05). Only 17% of studies attempted assessment of possible non-response bias. Conclusion Response rates to postal surveys of healthcare professionals are low and probably declining, almost certainly leading to unknown levels of bias. To improve the informativeness of postal survey findings, researchers should routinely consider the use of reminders and assess potential for non-response bias.
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            Why are response rates in clinician surveys declining?

            To understand why response rates in clinician surveys are declining. Cross-sectional fax-back survey. British Columbia. Random sample of family physicians and all gynecologists in the College of Physicians and Surgeons of British Columbia's registry. Accuracy of the College of Physicians and Surgeons of British Columbia's registry, and the prevalence and characteristics of physicians with policies not to participate in any surveys. Of 542 physicians who received surveys, 76 (14.0%) responded. On follow-up we found the following: the College of Physicians and Surgeons of British Columbia's registry was inaccurate for 94 (17.3%) listings; 14 (2.6%) physicians were away; 100 (18.5%) were not eligible; and 197 (36.3%) had an office policy not to participate in any surveys. Compared with the respondents, physicians with an office policy not to participate in any surveys were more likely to be men, less likely to be white, more likely to have urban-based practices, and more likely to have been in practice for more than 15 years. Many physicians have an office policy not to participate in any surveys. Owing to the trend of lower response rates, recommendations of minimum response rates for clinician surveys by many journals might need to be reassessed.
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              Evaluation of the effectiveness of risk minimization measures.

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                Author and article information

                Contributors
                nbester@specialisedtherapeutics.com.au
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                23 January 2016
                23 January 2016
                2016
                : 33
                : 167-177
                Affiliations
                [ ]Specialised Therapeutics Australia, Melbourne, Australia
                [ ]Celgene Pty Ltd, Melbourne, Australia
                [ ]Celgene Europe Ltd, Uxbridge, UK
                [ ]Celgene Corporation, Summit, NJ USA
                Article
                284
                10.1007/s12325-016-0284-y
                4769727
                26801772
                ff019a11-e91c-4d48-a67a-ecf29f58a1cf
                © The Author(s) 2016
                History
                : 26 November 2015
                Funding
                Funded by: Celgene Pty Ltd
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare 2016

                abraxane,australia,brochure,education,health-care professionals,nab-paclitaxel,risk management plans,risk minimization

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