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. 2009 Apr 15;2009(2):CD002104.
doi: 10.1002/14651858.CD002104.pub3.

Written information about individual medicines for consumers

Donald Nicolson  1 , Peter Knapp, D K Theo Raynor, Pat Spoor
Affiliations

Written information about individual medicines for consumers

Donald Nicolson et al. Cochrane Database Syst Rev. .

Abstract

Background: Medicines are the most common intervention in most health services. As with all treatments, those taking medicines need sufficient information: to enable them to take and use the medicines effectively, to understand the potential harms and benefits, and to allow them to make an informed decision about taking them. Written medicines information, such as a leaflet or provided via the Internet, is an intervention that may meet these purposes.

Objectives: To assess the effects of providing written information about individual medicines on relevant patient outcomes (knowledge, attitudes, behaviours and health outcomes) in relation to prescribed and over-the-counter medicines.

Search strategy: We searched MEDLINE, EMBASE, CINAHL, The Cochrane Library, PsycINFO and other databases to March 2007. We handsearched five journals' tables of contents, and the reference lists of included studies, and contacted experts in the field.

Selection criteria: Randomised controlled trials (RCTs) of medicine users, comparing written medicines information with no written medicines information; or trials that compared two or more styles of written medicines information. We only included trials that measured a knowledge, attitudinal or behavioural outcome. There were no language restrictions.

Data collection and analysis: Two review authors independently extracted data relating to the interventions, methods of the trials, and outcome measures; and reconciled differences by discussion. Heterogeneity of interventions and outcomes measured meant that data synthesis was not possible. The results are presented in narrative and tabular format.

Main results: We included 25 RCTs involving 4788 participants. Six of twelve trials showed that written information significantly improved knowledge about a medicine, compared with no written information. The inability to combine results means we cannot conclude whether written information was effective for increasing knowledge. The results for attitudinal and behavioural outcomes were mixed. No studies showed an adverse effect of medicines information.

Authors' conclusions: The combined evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking. There is some evidence that written information can improve knowledge. The trials were generally of poor quality, which reduces confidence in the results. Trials examining the effects of written information need to be better designed and use consistent and validated outcome measures. Trials should evaluate internet-based medicines information. It is imperative that written medicines information be based on best practice for its information design and content, which could improve its effectiveness in helping people to use medicines appropriately.

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Conflict of interest statement

PK and DKR were directors of Luto Research Ltd until 2009​, a company ​which provides patient information leaflet testing services to the pharmaceutical industry.​ However, this review was funded by Health Technology Assessment UK, carried out in their academic roles, and they did not benefit financially from the success of patient information leaflets.​ PK has not been a director of Luto since 2009 and has no financial interest in the company. DKR is no longer a director but maintains a role with the company as an Academic Advisor.​

Update of

References

References to studies included in this review

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Smith 1998 {published data only}
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Stratton 1984 {published data only}
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Sukkari 2001 {published data only}
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Suppatiporn 2005 {published data only}
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Swanson 1990 {published data only}
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Sweileh 2004 {published data only}
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Temple 1997 {published data only}
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Tymchuk 1990 {published data only}
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Udkow 1979 {published data only}
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Whiteside 1983 {published data only}
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Winkler 1981 {published data only}
    1. Winkler JD, Kanouse DE, Berry SH, Hayes‐Roth B, Rogers WH, Garfinkle JB. Informing Patients About Drugs: Analysis of Alternative Designs for Erythromycin Leaflets. RAND Corporation, 1981.
Wise 1986 {published data only}
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Wiseman 1989 {published data only}
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Worsley 1989 {published data only}
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Young 2006a {published data only}
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Young 2006b {published data only}
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Zion 1989 {published data only}
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Zweifler 1989 {published data only}
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References to studies awaiting assessment

Fuchs 2007 {published data only}
    1. Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts. Patient Education and Counseling 2007;67:157‐68. - PubMed
Gundogar 2007 {published data only}
    1. Gundogar D, Demirci S, Uluhan F. How should we inform patients aboutantidepressants? A study comparing verbal and written information. International Journal of Pharmacy Practice 2007;11:212‐7. - PubMed
McDonald 2007 {published data only}
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Ziklund‐Fisher 2008 {published data only}
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MeSH terms