Effectiveness of a printed leaflet for enabling patients to use digoxin side-effect information. Evaluation of drug information for cardiology patients. Evaluation of information given to rheumatology patients using non-steroidal anti-inflammatory drugs. Randomized trial of psychotropic medication information leaflets for people with intellectual disability. The benefits of prescription information leaflets (1). Application of psychological principles to the design of written patient information. Presenting risks and benefits to patients. Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial. An assessment of drug information sheets for diabetic patients: only active involvement by patients is helpful. Do undereducated patients read and understand written education materials? A pilot study in Isparta, Turkey. Comparison of two methods of presenting risk information to patients about the side effects of medicines. A randomized double blind trial of verbal NSAID education compared to verbal and written education. An evaluation of four methods of pharmacist-conducted patient education. [Comparative study of a new package insert for benzodiazepines adapted for patients]. The effects of a psychiatric patient education to medication program on post-discharge compliance. Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. Evaluation of the use of programmed instruction for patients maintained on Warfarin therapy. Manufacturer's information insert and subjective theophylline side-effects. The impact of a drug information sheet on the understanding and attitude of patients about drugs.
The effectiveness of a printed leaflet designed to inform patients about digoxin was evaluated. The printed leaflet alone was compared to the verbal consultation alone and the verbal consultation in addition to the printed leaflet. The study assessed patients' decisions about the appropriate course of action to take if side-effect symptoms occurred. Patients receiving the printed leaflet alone scored higher than patients receiving the verbal consultation; however, they scored lower than patients receiving both the printed leaflet and verbal consultation together. Patients receiving both verbal and printed information scored significantly higher than those receiving verbal consultation only. The findings suggest that printed materials together with verbal consultation are essential for enabling patients to make appropriate decisions with respect to side effects. There is not enough evidence to support the use of printed materials in place of verbal consultation. Health practitioners should use printed materials as an adjunct to verbal information. 1. Cardiologists and pharmacists at the University Hospital of Wales collaborated to write 20 individual leaflets incorporating guidelines for a range of drugs used in the treatment of cardiology patients. The Plain English Campaign advised on the intelligibility and presentation of the information. 2. One hundred and twenty-five patients from the Regional Cardiology Unit, University Hospital of Wales were randomly allocated to receive usual verbal counselling about their drug treatment with or without an individualised drug information wallet. Two weeks after discharge from hospital patients completed a postal questionnaire to determine their satisfaction with the information about their drug treatment and their understanding of it. Forty-nine questionnaires were returned from the leaflet group and 52 from the control group. 3. The provision of written guidelines resulted in significant improvements in patients' satisfaction with their drug treatment (chi 2 = 33.3, P less than 0.001) and their understanding of it (P less than 0.001, Mann-Whitney test). Overall, patients who received leaflets were more likely to be aware of the potential side effects of their drugs but less likely to be apprehensive about them. Succinct guidelines concerning drug therapy can be assimilated by cardiology patients and provide them with a permanent record for future reference. This paper reports the findings of a study of information given to rheumatology patients using non-steroidal anti-inflammatory drugs. One hundred and twenty patients were randomized to three groups. Group A received an information leaflet, Group B received both a leaflet and a verbal explanation and Group C received only a verbal explanation. Information was gathered on demography, knowledge base, sources of information, satisfaction with the leaflet and further information requirements. Data were collected by questionnaires which were completed before randomization and 8-12 weeks later. Analysis indicates the potential benefits of giving information to patients although the full implications of these benefits are not clear and further research is indicated in this important area. People with intellectual disability (ID), like other patient groups, are known to have a limited knowledge of medication. Leaflets are seen as an appropriate means of providing patient information. To test the hypothesis that medication information leaflets would improve the knowledge and care of the target group, the present authors designed a randomized trial and planned to do subgroup analyses where appropriate. The participants were individually randomized to two groups. A control group was given verbal medication information by their nurse or psychiatrist, and a study group was given specifically designed leaflets in addition to verbal information. The present authors recruited 54 people with mild to moderate ID and mental illness, aged 18 years and older, who were taking psychiatric medications. Questionnaires administered by a blind interviewer recorded outcomes such as medication knowledge and satisfaction at two time points. The participants with mild ID in the leaflet group had significantly reduced medication knowledge and understanding. There were no significant differences in satisfaction with clinicians and medication. Patient information leaflets may confuse people with mild ID in the short term. Other patient groups with cognitive deficits may have similar outcomes. Evaluation of outcomes of health education initiatives is important. 1. Prescription information leaflets (PILs) giving information about non-steroidal anti-inflammatory drugs (NSAIDs), beta-adrenoceptor antagonists and inhaled bronchodilators were evaluated in three small Hampshire towns, while a fourth, in which no leaflets were distributed, acted as a control. 2. Seven hundred and nineteen (82%) patients prescribed one of these medicines agreed to be interviewed in their homes, 1 to 2 weeks after the medicine had been prescribed. Four hundred and nineteen of them had received leaflets, while 300 received no written information. Two hundred and sixty patients received their leaflets from a pharmacist while 159 were given them by their general practitioner. 3. Patients who received leaflets were better informed about every item of knowledge tested, except for the name of the medicine. Awareness of the side effects showed the greatest improvement, but there was no evidence that these leaflets produced spurious side effects. 4. Much improved levels of satisfaction were recorded amongst patients who received leaflets, especially those for NSAIDs (P less than 0.001) and for beta-adrenoceptor antagonists (P less than 0.01). 5. Subsequently, three hundred and fifty-eight (77%) of the patients prescribed either a NSAID or a beta-adrenoceptor antagonist 1 year earlier responded to a postal questionnaire. The benefits in terms of knowledge and satisfaction were still apparent, although less marked than previously. Of the patients still taking beta-adrenoceptor antagonists 70% had retained their leaflets over the intervening 12 months. 6. Ninety-seven per cent of patients read their leaflet regardless of whether it was distributed by a general practitioner or pharmacist. However, those who obtained it from a pharmacist tended to be more knowledgeable and satisfied. 7. We conclude that patients welcome the idea of receiving PILs. They improve patients' knowledge of how to take their medicines correctly and their awareness of potential side effects. Importantly, patients who receive leaflets are more satisfied than those who do not. These overall benefits justify the use of leaflets on a routine basis. nan To investigate whether patients are influenced by the order in which they learn the risks and benefits of a treatment and whether this effect is attenuated by a treatment's associated risk and/or benefit.
                Subjects were randomized to review 1 of 6 medical treatment information brochures.
                Waiting rooms of primary care physicians at an academic health center.
                Six hundred eighty-five subjects, ages 18 to 70 years.
                Subjects reviewed 1 of 3 treatments for symptomatic carotid artery disease. The first (aspirin) was low-risk/low-benefit, the second (carotid endarterectomy surgery) was high-risk/high-benefit, and the third (extracranial-to-intracranial bypass surgery) was high-risk but of unknown benefit. Patients were also randomized to receive information about risk either before or after benefit. Patients were asked to rate the favorability of the treatment on a scale of 0 to 100 and whether they would consent. Finally, subjects rated how their decisions were influenced by the risk and benefit information.
                Subjects evaluating aspirin therapy were influenced by the order of the risk/benefit information. Those learning about risks after benefits had a greater drop in their favorability ratings than subjects learning about risks before benefits (-10.9 vs -5.2 on a 100-point scale; P = .02) and were less likely to consent (odds ratio, 2.27; P = .04). In contrast, subjects evaluating carotid endarterectomy and extracranial-to-intracranial bypass were not influenced by information order. When subjects were influenced by the order of information, they also reported that the treatment's risk had less influence on their decision making (P < .01).
                When patients evaluate low-risk medical interventions, they may form less favorable impressions of the treatment and be less likely to consent to the treatment when they learn about the risks after the benefits. Order effects were not observed with high-risk treatments regardless of potential benefits. To assess whether provision of educational leaflets or questions on contraception improves knowledge of contraception in women taking the combined contraceptive pill.
                Randomisation of women into three groups according to type of educational leaflet on contraceptive information. These groups were subdivided into two on the basis of questions on contraception asked by the doctor or practice nurse. The women were followed up by postal questionnaire 3 months later.
                15 general practices in South and West region.
                636 women attending check up appointment for repeat prescription of the combined contraceptive pill.
                Knowledge of: factors causing pill failure, subsequent action, emergency contraception, and all the rules (pill rules) that apply to the contraceptive pill.
                523 women returned completed questionnaires (response rate 82%). Knowledge of contraception with no intervention was low with only 10 (12%) women knowing all the pill rules. Educational intervention had a highly significant effect on knowledge of: factors causing pill failure (likelihood ratio chi2=22); subsequent action (21); emergency contraception (24); and all the pill rules (22) (P<0.01 in all cases). Improvement in knowledge of all the pill rules occurred with provision of the summary leaflet (28% knew all the rules, adjusted odds ratio 4.04, 95% confidence interval 1.68 to 9.75), the Family Planning Association's leaflet (27%, 3.43, 1.45 to 8.09), and asking questions (26%, 3.03, 1.30 to 7.00). Asking questions in addition to provision of leaflets improved knowledge of contraception further for the summary leaflet (39%, 6.81, 2.85 to 16.27) but not for the Family Planning Association leaflet (21%, 2.58, 1.07 to 6.18).
                Women attending check ups for repeat prescriptions of the contraceptive pill should be provided with educational leaflets on contraception or asked relevant questions to help improve their knowledge of contraception. Asking questions in addition to providing a summary leaflet is time consuming, but results in the most knowledge gained. Insulin/sulphonylurea-treated diabetics attending a busy university diabetic clinic were studied to determine whether issuing drug information sheets and/or age influenced understanding and behaviour regarding their disease and its treatment, especially with respect to avoiding hypoglycaemia. Patients were each asked 10 basic questions (each correct answer scoring 1), stratified by age (20 were less than or equal to 45 years and 91 greater than 45 years). According to a single-blind randomised protocol, they were issued or not issued with drug information sheets (providing information to correctly answer all 10 questions). After 2-3 months, 107 (88 aged greater than 45 years) were retested and asked whether they recalled an information sheet, read it themselves or had it read to them. Whether or not patients received sheets, corresponding mean aggregate scores were very similar in both age groups and there was no correlation with age. Second test scores yielded clinically and statistically significant increments in both the sheet and no sheet groups, respective mean aggregate scores increasing from 4.48 to 5.80 and 5.14 to 6.27 (P less than 0.001). Among patients issued with sheets, 32 who recalled reading them achieved the greatest improvement in mean scores (4.53 to 6.16, P less than 0.001). Active interaction/communication (participation in first test, recall and reading of information sheet) had a favourable educational impact irrespective of age, but merely issuing drug information sheets had no benefit. The aim of our study is to evaluate the effect of written information in improving the knowledge of the undereducated nonsteroidal anti-inflammatory drug (NSAID) users about the side effects of NSAIDs and to investigate the compliance of patients with the written information materials.
                Thirty patients received only verbal information, 38 patients received only written, and 40 patients received both verbal and written information. After seven or ten days a questionnaire was administered to the patients on the phone to assess the patients' knowledge.
                Sixty one (78.2%) patients read the leaflets. Higher number of correct answers was obtained with both verbal and written information. Written information better informed than verbal information alone (p=0.02).
                We conclude that the undereducated patients will read and understand written education materials especially when the materials are written simple and short. To determine whether the use of verbal descriptors suggested by the European Union (EU) such as "common" (1-10% frequency) and "rare" (0.01-0.1%) effectively conveys the level of risk of side effects to people taking a medicine.
                Randomised controlled study with unconcealed allocation.
                120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction.
                Cardiac rehabilitation clinics at two hospitals in Leeds, UK.
                A written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, "common" or 2.5%; for pancreatitis, "rare" or 0.04%).
                The estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine.
                The mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors.
                Patients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine. We performed a double blind randomized controlled trial to investigate whether patients taking nonsteroidal antiinflammatory drugs (NSAID) knew more about these drugs at followup depending on whether they were randomized to receiving or not receiving an NSAID information sheet. The patients were unaware they were in a study.
                All patients received verbal education on the side effects of NSAID that was standardized and always given by the same rheumatologist. Thirty patients randomly received an NSAID information sheet and 26 patients did not. At next clinic followup, after reading a letter of explanation about the study and signing a consent form, patients completed a questionnaire asking about their knowledge of NSAID.
                Outcome variables assessed within the questionnaire included whether NSAID : (1) can decrease inflammation; (2) help with pain; (3) cause stomach upset and bleeding in the bowels. None of these variables were statistically significant. The only variable that was statistically significantly different between the groups was their report of whether they had received an information sheet about NSAID (p<0.00004). A greater proportion of patients who received the NSAID information sheet correctly reported they had received one compared to those who had not received one and who said they had not received one (85% in the former group, 70% in the latter group). The group who received the NSAID information sheet were more apt to say that NSAID can help with their pain (odds ratio 6.1, p<0.05). Education level was positively correlated with knowledge (p<0.04). However, level of education explained only 11% of the variance in overall knowledge scores (r=0.34) among all patients.
                An information sheet may not add educational value over verbal information by a physician in a clinic setting. nan A standardized, patient-oriented package insert for benzodiazepines has been compared with four package inserts printed by manufacturers for these drugs. The leaflets were submitted to 222 hospitalized patients randomly allocated to two groups; 108 received a manufacturer's notice and 114 the standardized notice. The patients were interviewed two or three days later and found the standardized notice more comprehensible than those of the manufacturers. Two independent experts assessed the adequacy of the notices and also found the standardized notice more appropriate for patients. The patients answered a questionnaire about the effects of the drugs and the precautions while using them. Those who had read the standardized notice were significantly better informed than those who had read manufacturers' notices. However, the level of understanding varied largely from one item to another, and depended on the level of education and age. The effect of a structured program of education on subsequent psychiatric patient compliance with medication-taking was investigated. The subjects consisted of 150 hospitalized patients housed on four acute-care receiving wards and ready for discharge from Fallsview Psychiatric Hospital in Ohio. They were randomly assigned to one of three groups. Results indicated that subjects who received written information with verbal reinforcement were significantly more compliant than the control subjects. These findings suggest that, if the hand-out is discussed with them, the patients given medication handouts similar to those used in the study will comply with medication-taking after discharge at a higher rate than those given no hand-out. Implications of these findings for increased psychiatric patients' post-discharge compliance with medications are discussed. To evaluate two different methods of improving adherence to antidepressant drugs.
                Factorial randomised controlled single blind trial of treatment leaflet, drug counselling, both, or treatment as usual.
                Primary care in Wessex
                250 patients starting treatment with tricyclic antidepressants.
                Adherence to drug treatment (by confidential self report and electronic monitor); depressive symptoms and health status.
                66 (63%) patients continued with drugs to 12 weeks in the counselled group compared with 42 (39%) of those who did not receiving counselling (odds ratio 2.7, 95% confidence interval 1.6 to 4.8; number needed to treat=4). Treatment leaflets had no significant effect on adherence. No differences in depressive symptoms were found between treatment groups overall, although a significant improvement was found in patients with major depressive disorder receiving drug doses of at least 75 mg (depression score 4 (SD 3.7) counselling v 5.9 (SD 5.0) no counselling, P=0.038).
                Counselling about drug treatment significantly improved adherence, but clinical benefit was seen only in patients with major depressive disorder receiving doses >/=75 mg. Further research is required to evaluate the effect of this approach in combination with appropriate targeting of treatment and advice about dosage. nan In Western Europe medicine packages contain an insert prepared by the manufacturer which enumerates the drug side-effects. We investigated the influence of this insert on alleged theophylline side-effects. Forty literate adult asthmatics were randomly allocated into two groups (n = 20 each): theophylline packages contained the manufacturer's insert in group A but not in group B. Theophylline was prescribed (10 mg.kg-1 body weight qd) for one week. During this period the patients filled a diary grading 13 different symptoms from 0 to 3; 5 of these symptoms were listed on the insert as theophylline side-effects. On the eighth day the patients were interviewed and theophylline blood levels measured. Theophylline side-effects were significantly more marked in group A than in group B, whereas the other symptoms were of similar magnitude. Eight patients prematurely stopped their treatment in group A vs 3 in group B, because of alleged intolerance. Theophylline blood levels did not differ significantly in the two groups; neither did they in the subgroup which stopped treatment and in the one which complied to prescription. We conclude that side-effects were suggested to the patients by the insert and/or that the insert increased their awareness of side-effects, with a subsequent detrimental influence upon compliance to therapy. A proposed Food and Drug Administration program to require written information with prescription drugs could cost $500 million annually; the American Medical Association has implemented a similar, voluntary program costing more than $3 million. However, the educational impact of written drug information has not been studied. We evaluated one-page drug information sheets using an objective examination. The baseline score of 71 patients was 3.9 of 6.0. Patients tested before and one day after receiving the drug sheet improved their score by +1.4. In the second phase, patients randomized to receive the drug sheet improved their score after one month by +1.1; those not given the sheet had no improvement. Changes in attitudes and incidence of reported adverse effects seemed to be random and unrelated to the information sheet. Thus, a drug information sheet may be a useful adjunct to patient education.
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.