SUPPORT Summaries
Evidence of the effects of health system interventions
for low- and middle-income countries
Evidence of the effects of health system interventions
for low- and middle-income countries
January, 2017 - SUPPORT Summary of a systematic review | print this article | download PDF
Medicines are the most common intervention used in most health systems. As with any treatment, patients need sufficient information to make informed decisions about their use. Written information, such as leaflets or online information, is the most common way of providing this information.
Key messages
People making decisions concerning patient information and pharmaceutical policies
Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.
A summary of studies addressing a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise the relevant research, and to collect and analyse data from the included studies.
SUPPORT – was an international project to support the use of policy relevant reviews and trials to inform decisions about maternal and child health in low- and middle-income countries, funded by the European Commission (FP6) and the Canadian Institutes of Health Research.
| Review objectives: To assess the effects of providing written information about prescribed and over-the-counter medicines on patient outcomes. | ||
| Type of | What the review authors searched for | What the review authors found |
|---|---|---|
| Study designs & interventions | Randomised trials, nonnrandomised trials, controlled before after and interrupted time series studies in which the effects of written information were compared with a control group or alternative intervention. | 25 randomised trials were included. |
| Participants | Patients of any age receiving written information about a prescribed or over-the-counter medicine in any setting (hospital in- and out-patients and primary care) | 4788 participants were enrolled in the included trials. 19 studies involved patients with chronic conditions (using NSAIDs or cardiovascular medicines), 5 trials were focused on patients with acute conditions, and 1 on both. |
| Settings | Any setting | The trials were conducted in 9 countries: USA (8 trials), UK (8), Belgium (2), Canada (2), Finland (1), France (1), Hong Kong (1), Switzerland (1) and Turkey (1). |
| Outcomes | Patient knowledge about the medicine, patients’ attitudes towards taking the medicine, patients’ medicine-taking behaviour, and patients’ health outcomes | Patients’ knowledge: recall of information about the medicine, recall of side effects; patients’ attitudes towards taking medicines; and patients’ medicine-taking behaviour |
| Date of most recent search: March 2007 | ||
| Limitations: This review had important limitations related to the assessment of the risk of bias for included studies and the analysis of heterogeneity. Additionally, it has not been updated since 2007. | ||
Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.
High: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different† is low.
Moderate: This research provides a good indication of the likely effect. The likelihood that effect will be substantially different† is moderate.
Low: This research provides some indication of the likely effect. Howevver, the likelihood that it will be substantially different† is high.
Very low: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different† is very high.
* This is sometimes referred to as 'quality of evidence' or 'confidence in the estimate'.
† Substantially different = a large enough difference that it might affect a decision.
See last page for more information.
The review included 25 trials. All of them were conducted in high income countries except for one carried out in Turkey. The two comparisons assessed by the review are detailed below.
There was an important variation in the content of the interventions used in the included trials, but most of the interventions (19 trials) included information about ‘What this medicine is and what it is used for’ and ‘Possible side effects’.
The outcomes assessed were measured with many different methods. For instance, measures of knowledge and satisfaction were often developed for individual trials and appeared to be measuring different components of those outcomes.
1) Written medicine information versus no written information
Twenty trials assessed this comparison: 12 of them compared written medicine information to no information and in the other 8 trials both groups were given additional verbal information. Seventeen of the 20 trials measured a change in knowledge, 3 a change in attitudes, and 8 assessed a behavioural outcome.
Written medicine information compared to no written information |
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| People: patients in treatment for suspected late onset neonatal sepsis Settings: Hospital and primary care in middle- and high-income countries Intervention: Written medicine information Comparison: No written medicine information |
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| Outcomes | Impact | Certainty of the evidence (GRADE) |
|
| Knowledge about the medicine and its side effects (measured with different instruments) |
Findings were mixed, although most studies measuring knowledge found that either the written medicine information increased knowledge (recall of information or recall of side effects) or made little or no difference |
Low |
|
| Attitudes towards the information provided (scales of satisfaction with the information provided) | In 1 trial assessing attitudes regarding the usefulness and ease of comprehension of the written medicine information, there were differences favouring the intervention group. In the other 2 trials participants given written medicine information expressed greater satisfaction with the information provided. |
Low |
|
| Behaviour (self-reported adherence scales and biological markers of adherence) | In the trials examining adherence to instructions, adherence was higher among people given written medicine information. However, little or no difference was found when biological markers were used to assess adherence. |
Low |
|
| Health outcomes | No studies assessed this outcome | - | |
| GRADE: GRADE Working Group grades of evidence (see above and last page) | |||
Eight trials compared the effect of presenting written medicine information in different ways. The comparisons assessed included ‘easy to read’ leaflets versus standard manufacturer’s leaflets, numerical versus text descriptions of risks, and the order of presentation of the information (benefits and risks). Five of the studies measured a knowledge outcome, 4 an attitudinal outcome, and 2 assessed behaviour change. Because of the diversity of comparisons it was not possible to prepare a single Summary of Findings table for this group of comparisons.
| Findings | Interpretation* |
|---|---|
| APPLICABILITY | |
| All the trials – except one conducted in Turkey - were carried out in high-income countries. |
Implementation of written medicine information depends on the health systems’ regulatory context. For instance in high-income countries there are specific laws that already govern the use of written medicine information. The implementation and impact in low-income countries without similar laws could be different from the findings from this review.
|
| EQUITY | |
| Overall, the review provides little data regarding differential effects of the interventions for disadvantaged populations. |
Interventions requiring skills unequally distributed in the population (such as reading) could increase inequalities regarding information about medicines and other health issues.
|
| ECONOMIC CONSIDERATIONS | |
| There was no information about the cost or cost effectiveness of the interventions |
Although the cost of scaling up the intervention could be affordable (written materials are relatively inexpensive), costs will depend on the regulatory context of the specific health system in which the intervention is implemented. |
| MONITORING & EVALUATION | |
| The certainty of the available evidence is low and no evidence was found for some comparisons and outcomes. |
Consideration should be given to monitoring and evaluating the effects of changes in policies regarding the provision of information about medicines to patients on knowledge and behaviours. Randomised trials or interrupted time series studies should be used to evaluate the effects of changes in these policies when there is important uncertainty about the effects. |
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*Judgements made by the authors of this summary, not necessarily those of the review authors, based on the findings of the review and consultation with researchers and policymakers in low-income countries. For additional details about how these judgements were made see: http://www.support-collaboration.org/summaries/methods.htm |
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Ciciriello S, Johnston RV, Osborne RH, et al. Multimedia educational interventions for consumers about prescribed and over the counter medications. Cochrane Database Syst Rev 2013; 4: CD008416.
Ryan R, Santesso N, Lowe D, et al. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. Cochrane Database Syst Rev 2014; 4: CD007768.
Tomás Pantoja, Unit of Health Policy & Systems Research, School of Medicine, Pontificia Universidad Católica de Chile, Chile.
None declared. For details, see: www.supportsummaries.org/coi
This summary has been peer reviewed by: Peter Knapp and Fatima Suleman.
Nicolson DJ, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev 2009; 2: CD002104.
Pantoja T. What are the effects of written information about medicines for consumers? A SUPPORT Summary of a systematic review. January 2017. www.supportsummaries.org
evidence informed health policy, evidence based, systematic review, health systems research, health care, low and middle income countries, developing countries, primary health care, medicines, consumers, access, information, pharmaceuticals
