Understanding the medicines information-seeking behaviour and information needs of South African long-term patients with limited literacy skills.

BACKGROUND: Although much health information-seeking behaviour (HISB) research has been reported in patients with good literacy skills, little is known about HISB in patients with limited literacy skills served by under-resourced health-care systems. OBJECTIVE: To investigate medicine information-seeking behaviour and information needs in patients with limited literacy. METHODS: Using a question guide, four focus group discussions (FGDs) were conducted to explore themes related to information needs, information-seeking practices and awareness of and ability to utilize information sources. Twenty-two isiXhosa-speaking long-term patients with limited formal education were recruited from a primary health-care clinic in South Africa. Discussions were audio-recorded and transcribed verbatim. NVivo(®) was used for initial coding of transcripts. Codes were analysed, and potential themes and subthemes in the entire data set were identified and refined. FINDINGS: The results of this study reflect a passive, disempowered patient. Poor awareness of information sources, lack of health-related knowledge and stigma contributed to a lack of information-seeking practice, thus potentially adversely influencing patient-provider interactions. Patients neither asked questions nor were encouraged to ask questions. All expressed an unmet need for information and a desire for receiving the illustrated written medicines-related information displayed in the FGDs. The main sources of information were health-care professionals, followed by family and friends. CONCLUSION: The significant level of patient disempowerment and passivity reported amongst patients underpinned their inability to actively seek information. Neither sources of information nor types of appropriate medicines information could be identified. Unmet information needs and a desire for information were reported.

Pharmacy students' opinion of the routine use of pharmaceutical pictograms on a health care train serving rural limited literacy patients.

OBJECTIVES: To assess pharmacy student opinion of the routine use of pictograms for counselling and communicating medicine-related information. METHODS: A Google Forms survey was sent to co-ordinators at five Pharmacy Schools who distributed the link to 152 students following their 5-day work placement. The survey included Likert Scale and open questions on prior pictogram exposure, their usefulness in practice and their design. KEY FINDINGS: Opinion of pictogram usefulness in facilitating communication with patients was positive, with 104 (95.4%) rating their usefulness as good/excellent. Students noted language and low literacy as communication barriers which pictograms helped to mitigate. Only 24.8% (N = 27) reported that using pictograms required extra time during the dispensing process. Most students reported that patients liked the pictograms and found it easy to teach patients the pictogram meaning to clarify verbal and written medicine-related information. Pictograms were regarded by most students as simple, clear, culturally acceptable and able to communicate their core message clearly. A third agreed that they should have additional detail and be more realistic, some offered suggestions for modification. Many suggested expanding pictogram use to primary care clinics and hospitals. CONCLUSIONS: This study presents unique finding relating to the role and value of pictograms in practice. Opinion of routine pictogram use was largely positive, particularly given significant language and literacy barriers in this rural population. The extra time taken using pictograms was generally not regarded as a barrier to their adoption. Pictogram quality and design were considered to be good, with expanded use of pictograms suggested.

Pharmaceutical indication pictograms for low literacy viewers: Health literacy and comprehension.

Background: Poor comprehension of pharmaceutical pictograms used on medicine labels or leaflets can compromise understanding of medicine-taking information, potentially causing negative health outcomes. Aim: The aim was to assess association of health literacy (HL) with comprehension of pictograms displaying indication and side effect information in a lower literacy, limited English proficiency (LEP) population. Setting: Community centre, Makhanda, South Africa. Methods: This was a quantitative cross-sectional study using simple random probability sampling. Ninety isiXhosa-speaking adults with a maximum of 12 years schooling, attending primary healthcare clinics were interviewed using structured interviews. Health literacy was assessed using the Health Literacy Test for Limited Literacy populations. Comprehension of 10 locally developed pictograms was evaluated. Results: The mean pictogram comprehension score was 7.9/10, with 8/10 pictograms complying with the International Organization for Standardization criterion of 66.7% correct comprehension. Only 15.6% of participants had adequate HL. A significant association of HL with pictogram comprehension was established (p = 0.002). Pictogram misinterpretation was higher in those with lower HL; adequate HL was associated with superior comprehension. Pictogram comprehension was negatively associated with age (p < 0.006), and positively associated with education (p < 0.001) and English proficiency (p < 0.001). Conclusion: Higher HL was associated with better pictogram comprehension. Low HL, LEP and low education levels are regarded as potential indicators for possible pictogram misinterpretation. Contribution: This study observed the potential for misinterpretation of medication pictograms. Health professionals should be aware that low HL, limited schooling and limited English proficiency could signal difficulty in fully comprehending pictogram content.

Methodology of an approach for modifying pictograms showing medication side effects or indication.

BACKGROUND: Pictograms may improve user-friendliness and comprehension of written or verbal health information. This paper describes a method to modify pictograms to improve their visual clarity, appeal and overall interpretive complexity in order to reduce the cognitive load on the viewer during comprehension. METHODOLOGY: Nine pictograms previously tested for comprehension were selected for modification. In phase 1, two participatory design workshops were conducted with (a) three limited literacy, first-language isiXhosa-speaking participants and (b) four university students. Opinions and ideas for improving interpretation were discussed. In phase 2, revised visuals were generated by the graphic artist and subsequently modified in an intensive, multistage, iterative process. RESULTS: As no guidelines for pictogram modification exist, a modification schema was developed based on the process described in this study. Adopting a participatory approach combined with a systematic, intensive modification process enabled the opinions and preferences of the end-users to be heard, ensuring cultural relevance and contextual familiarity of the final product. Careful scrutiny of all individual visual elements of each pictogram, considerations of space, and thickness of lines all contributed to improving the legibility of visuals. CONCLUSIONS: The methodology for designing and modifying existing pictograms using a participatory process resulted in nine final pictograms that were approved by all design team members and considered good candidates for subsequent comprehension testing. The methodological schema presented in this paper provides guidance to researchers intending to design or modify pictograms.

Designing and reporting pictogram research: Problems, pitfalls and lessons learnt.

Research describing the design, evaluation or use of pictograms for various health-related applications is receiving increasing attention in the literature. However, recent reviews of this body of literature have commented adversely on the overall quality of the research, highlighting problems with the pictogram design process, as well as calling for improvement in both the methodology and reporting of all aspects of designing, developing, modifying, evaluating and applying pictograms in practice. The heterogeneity in study design, as well as in the interventions and outcomes measured, prevents overall conclusions being drawn about the effectiveness of pictograms on comprehension and medicine-taking behaviour such as adherence and self-care. The reporting of such research should provide adequate detail to enable reproducibility and replicability of the research. This article offers guidance in designing and reporting pictogram-based research, highlighting areas that are often problematic or inadequately addressed.

Pharmacists, are words enough? The case for pictograms as a valuable communication tool.

Despite living in a visually saturated world, with visual content permeating seemingly every aspect of our lives, an area in which visuals are still under-represented is health communication. Written health information, including medicines information, has generally been reported as being reader-unfriendly, offering challenges and barriers to even the most literate of readers with its often lengthy, detailed documents, use of medical jargon, and densely packed small text. The inclusion of visual content in the form of pictograms offers the potential to enhance the attractiveness and reader-friendliness of the information as well as improving comprehension and recall of medicines and general health information. This commentary presents the case of pictograms as a valuable tool in medicines information, urging pharmacists to consider their adoption in practice, but also sounding a note of caution when using pictograms.

Applicability of the REALM health literacy test to an English second-language South African population.

OBJECTIVE AND SETTING: To investigate health literacy in an English second language population using the REALM test, to evaluate its appropriateness and to compare health literacy between four different education categories. SETTING: Primary healthcare clinics and participant homes in Grahamstown, South Africa. METHOD: The REALM test, a US-developed test, was administered via an interpreter to 125 Xhosa-speaking, English second language participants from a range of educational backgrounds. Participants were asked to read all 66 words (three lists of 22 words each), and pronunciation was assessed. In a deviation from the standard method, an explanation for each word was requested to evaluate comprehension. Results were classified into four categories: adequately pronounced and comprehended; neither adequately pronounced nor comprehended; adequately pronounced but not comprehended; not adequately pronounced but comprehended. The first two categories were rated as "applicable". The percentage of "applicable" cases of the total of 8250 cases (125 participants; 66 words each) was calculated. The association between education and both pronunciation and comprehension was investigated using chi-square tests, with a significance level of P < 0.05. MAIN OUTCOME MEASURES: Average grade-equivalent reading level; number of words adequately pronounced and comprehended; applicability of the REALM to individual words. RESULTS: Average grade-equivalent reading level of the study population according to the REALM test was grade 7-8. An average of 46 of 66 words were adequately pronounced, whereas less than half this number (20) were adequately comprehended. Comprehension ability was 57% lower than the ability to adequately pronounce the words, a finding that highlights the inability of pronunciation data to predict comprehension of a health-related text. Examples of poor comprehension include antibiotics (16.0%), fatigue (6.4%), nausea (8.0%), anaemia (2.4%), osteoporosis (0.8%), hepatitis (0.8%), haemorrhoids (0%), impetigo (0%) and colitis (0%). Both pronunciation (P = 0.016) and comprehension (P = 0.001) were significantly influenced by education. Applicability of the REALM to individual words ranged from 20.8 to 96.0%, with an average of 59.1%. Given that the REALM was deemed inapplicable for an average of four out of every 10 words, it appears to be unsuitable for use in its current form for assessing health literacy of the study population.

Acceptance of ambulatory blood pressure monitoring in a semi-rural population in South Africa.

BACKGROUND: Ambulatory blood pressure monitoring is a valuable tool that helps in providing an insight into the diagnosis and management of hypertension; however, no evidence exists of its acceptance in the diverse South African population. AIM: We assessed the acceptance of an ambulatory blood pressure monitor in patients attending public sector primary health care (PHC) clinics. SETTING: Five PHC clinics in the Makana subdistrict in the Eastern Cape. METHOD: A cross-sectional study was conducted with 70 hypertensive patients. Eligible patients were between 40 and 75 years old, taking either enalapril and hydrochlorothiazide or enalapril, hydrochlorothiazide and amlodipine. Socio-demographic, clinical and acceptance data were collected. The monitor cuff remained in place for 24 h. Acceptance was assessed after the monitor was removed. An overall acceptance score was generated to classify acceptance as either good or poor. RESULTS: The mean years of schooling was 5.9 years, with 22 reporting no school attendance. Generally, acceptance was good, with 70% of the population rating the technique as 'acceptable' (acceptance score of > 23/30). Most participants reported minimal discomfort with only 13.3% reporting that it hindered normal daily activities. Night readings interrupted sleep in 43%, with extreme sleep disturbance (≥ 3 awakenings) reported in just over half the patients. Increased years of schooling was the only variable associated with acceptance score (r = -0.243, p = 0.042). CONCLUSION: Ambulatory blood pressure monitoring was generally well-accepted, with few adverse effects being reported. Use of this technique at PHC facilities could reduce the incidence of misdiagnosis and uncontrolled hypertension.

Preferences of Resettled Refugees on Pictograms Describing Common Symptoms of Illness.

Illustrated health resources are useful for people who have limited English linguistic ability. The aim was to compare the preferences of resettled refugees from Africa and non-African countries, on pictograms describing common symptoms of illness. Data were collected in two cities in Queensland, Australia. Participants indicated their preference for three types of pictograms depicting seven symptoms. Pictogram sources included the International Pharmaceutical Federation, royalty-free stock images, and pictograms designed in South Africa. For all ailments, participants (n = 81) from Africa preferred the African pictograms more than participants not from Africa (n = 61). A significant association was found between pictogram preference and where respondents were from for each ailment except headache (p = 0.375). African refugees showed a significant preference for pictograms which had been culturally adapted for an African population; however, some other refugees also preferred certain African pictograms. Pictograms for resettled refugees should be pre-tested to determine acceptability, as they should be culturally relevant.

Outcome of illustrated information leaflet on correct usage of asthma-metered dose inhaler.

BACKGROUND: Research globally has shown that metered dose inhaler (MDI) technique is poor, with patient education and regular demonstration critical in maintaining correct use of inhalers. Patient information containing pictorial aids improves understanding of medicine usage; however, manufacturer leaflets illustrating MDI use may not be easily understood by low-literacy asthma patients. AIM: To develop and evaluate the outcome of a tailored, simplified leaflet on correct MDI technique in asthma patients with limited literacy skills. SETTING: A rural primary health care clinic in the Eastern Cape, South Africa. METHODS: Pictograms illustrating MDI steps were designed to ensure cultural relevance. The design process of the leaflet was iterative and consultative involving a range of health care professionals as well as patients. Fifty-five rural asthma patients were recruited for the pre-post design educational intervention study. Metered dose inhaler technique was assessed using a checklist, and patients were then educated using the study leaflet. The principal researcher then demonstrated correct MDI technique. This process was repeated at follow-up 4 weeks later. RESULTS: The number of correct steps increased significantly post intervention from 4.6 ± 2.2 at baseline to 7.9 ± 2.7 at follow-up (p 0.05). Statistically significant improvement of correct technique was established for 10 of the 12 steps. Patients liked the pictograms and preferred the study leaflet over the manufacturer leaflet. CONCLUSION: The tailored, simple, illustrated study leaflet accompanied by a demonstration of MDI technique significantly increased correct MDI technique in low-literacy patients. Patients approved of the illustrated, simple text leaflet, and noted its usefulness in helping them improve their MDI technique.

The impact of illustrated side effect information on understanding and sustained retention of antiretroviral side effect knowledge.

BACKGROUND: Prompt management of side effects is critical to supporting adherence to antiretroviral (ARV) medication. OBJECTIVE: This study examines the impact of presenting side effect information using simple text combined with pictograms on sustained knowledge of ARV side effects over three months. METHOD: Previously designed side effect pictograms, combined with simple text, were incorporated into a side effects panel within an ARV information leaflet. In a randomised controlled study, 116 limited literacy HIV patients taking ARVs were randomly allocated to either control (standard care) or intervention groups (standard care plus illustrated information). Side effect knowledge was assessed at baseline, and intervention patients received the illustrated leaflet. Knowledge was re-tested at one and three months. Interpretation of side effect pictograms was evaluated at one month. RESULTS: In intervention patients, mean side effect knowledge increased from 45.9% (baseline) to 95.7% (three months; p<0.0001), and pictogram interpretation was good. Knowledge did not change significantly in the control group. All found the pictograms clear and useful, and endorsed their routine use. CONCLUSIONS: Providing patients with simple written information containing pictograms on ARV side effects significantly improved side effect knowledge, sustained over time, in limited literacy, rural South African HIV patients.

'Yummy or crummy?' The multisensory components of medicines-taking among HIV-positive youth.

The global rollout of Antiretroviral Treatment (ART) has revealed an urgent need to understand the medicines-taking practices of HIV-positive adolescents. In the last decade, the literature on the social determinants of health has broadened the evidence-base on ART adherence. Interdisciplinary studies have expanded conceptions of medicines-taking beyond clinical or health systems frameworks, recognising the importance of socio-structural conditions and of patients' beliefs and experiences. Participatory research techniques which foreground the perspectives of adolescents provide greater insights still into their adherence. This article explores the use of participatory methods within a broader study on the social determinants of ART adherence among HIV-positive adolescents in South Africa. We describe how participatory methods were incorporated into this study (n = 1,059 in the quantitative baseline). We focus on an exercise, 'Yummy or crummy?', that explored the multisensory dimensions of medicines-taking, including their colour, smell, shape, and delivery mechanism. We describe two principal findings: first, adolescents' preference for greater understanding of the chemical workings of medicines, manifested in their preferences for colour, taste and shape of medicines; and second, the vital relationship between sensory preferences and the social imperatives of discretion and confidentiality regarding HIV-status.

Knowledge and practice of healthcare professionals relating to oral medicine use in swallowing-impaired patients: a scoping review.

OBJECTIVES: Swallowing impairment is a growing problem that affects 16% of the overall population and can significantly affect medicine-taking. However, little is known about the knowledge and practice of healthcare professionals (HCPs) relating to swallowing-impaired (SI) patients. The aim of this scoping review was to investigate the knowledge and practice of HCPs in supporting SI patients with their medicine-taking, to identify their reference sources, and to describe their training and information needs. METHOD: Databases searched included Scopus, Web of Science, Medline and Google Scholar from inception to August 2017. Qualitative and quantitative studies describing knowledge and practice of HCPs relating to medicine use in SI patients were included. KEY FINDINGS: The nine included studies, from an initial 142, involved nurses (nine studies), pharmacists (one study) and doctors (two studies) in hospitals or aged-care facilities. A knowledge deficit linked to lack of training was revealed, particularly with identification of modified-release dosage forms, medication that can/cannot be crushed, vehicle for safe dispersion, consequences of inappropriate modification, drug stability and legal aspects. Written information sources were named, but not used in practice. Pharmacists were the primary experts for consultation, and were involved in nurse education, and were members of multidisciplinary teams. CONCLUSIONS: Knowledge in nurses was inadequate, with practice indicating potentially serious medication-related errors. Additional training, either undergraduate or as continuing professional development, is recommended. Information to guide safe medicine modification practice should be accessible to all practitioners. Pharmacists could take the lead role in offering training to nurses.

An illustrated booklet for reinforcing community health worker knowledge of tuberculosis and facilitating patient counselling.

BACKGROUND: Community health workers (CHWs) have facilitated the move to decentralise tuberculosis (TB) management, but lack access to information appropriate both for personal use and in patient interaction and education. AIM: To explore the impact of a pictorial-based TB booklet on reinforcing CHW knowledge and facilitating patient counselling. SETTING: This study was conducted in local primary health care clinics and the Hospice in Grahamstown, Eastern Cape Province in South Africa. METHODS: Quantitative and qualitative methods were used. A simple, 17-page, A5 booklet containing pictograms and simple text was designed in collaboration with CHWs who advised on preferred content. Its influence on knowledge was assessed in 31 CHWs using a 17-item questionnaire in a before-and-after study. The experiences of CHWs using the booklet were qualitatively explored using focus group discussions (FGD) and semi-structured interviews. RESULTS: Overall knowledge increased significantly from 70.6% to 85.3% (p < 0.001) with 8 of 17 questions significantly better answered at follow-up. These addressed meaning of side effects and side effect advice for patients, cause and prevention of TB, action if a dose is forgotten, timing of dose in relation to food intake and the possibility that not all patients are cured.Community health workers reported using the booklet during patient interactions, commenting that it enhanced their confidence in their own TB-related knowledge, improved recall of information and reduced uncertainty. They appreciated the simplicity of the text and its userfriendliness because of the inclusion of pictograms. The booklet was perceived to be valuable as a tool for both patient education as well as improved communication with patients. CONCLUSION: A simple, user-friendly TB booklet containing pictograms improved CHWknowledge and acted as a valuable tool in patient communication and education.

Medicine labels incorporating pictograms: do they influence understanding and adherence?

The objective was to determine the influence of medicine labels incorporating pictograms on the understanding of instructions and on adherence. Eighty-seven Xhosa participants attending an outpatient clinic who had been prescribed a short course of antibiotics were randomly allocated to either a control group (41 participants given text-only labels), or an experimental group (46 participants given text + pictogram labels). All participants had a maximum of 10 years of formal schooling. Follow-up home visits were conducted after 3-5 days to assess understanding of instructions and to evaluate adherence. A high adherence of greater than 90% was found for 54% of the experimental group, compared with only 2% of the control group. Average percentages for understanding in the control and experimental groups were 70 and 95%, respectively, and average adherence was 72 and 90%, respectively. The presence of pictograms was found to contribute positively to both understanding of instructions and adherence.

Reflecting on patient-centred care in pharmacy through an illness narrative.

Patient-centred care (PCC) is rapidly adopting a central position in discussions on the quality of healthcare, with patient-centredness deemed essential to transforming the healthcare system. PCC speaks to the quality of patient-provider relationships and has been defined as an approach to providing care that is respectful of and responsive to individual patient preferences, needs, and values, while ensuring that patient values guide all clinical decisions. However its place within pharmacy practice is unclear and is as yet undefined, particularly in relation to pharmaceutical care. Through my personal illness narrative, I briefly explore the visibility and evidence of PCC in the pharmacy literature as well as from personal experience of pharmacy care, and find it lacking. I conclude that an integrated, seamless understanding of PCC and the use of shared language within the health professions is essential in successful teamwork with both the patient and with other health professions.

Development and evaluation of pictograms on medication labels for patients with limited literacy skills in a culturally diverse multiethnic population.

BACKGROUND: Much of the migrant workforce in Qatar is of low literacy level and does not understand Arabic or English, presenting a significant challenge to health care professionals. Medicine labels are typically in Arabic and English and are therefore poorly understood by these migrant workers. OBJECTIVE: To develop pictograms illustrating selected medicine label instructions and to evaluate comprehension of the pictograms or conventional text supported with verbal instructions in foreign workers with low literacy skills. METHODS: A range of common labeling instructions were identified and pictograms depicting these were developed using visual concepts and ideas from the literature. The process involved a consultative approach with input from the researchers, a local graphic artist, and members of the target population. The final set was evaluated for comprehension in participants who were randomized to one of three study groups: text plus verbal instructions, pictogram-only label, and pictogram with verbal instructions. One-way ANOVA and Chi-square tests were used to assess differences between group variables. Statistical significance was set at P ≤ 0.05. RESULTS: Of 23 label instructions screened, 11 were selected for the study. A total of 123 participants took part in this study. Pictogram plus verbal instructions group achieved better results in interpreting the majority of the label instructions (P ≤ 0.05). The best interpreted pictograms with verbal instructions included: "Take two tablets three times a day," "Take one tablet in the morning and one tablet at night," and "Instill one drop in the eye." The worst interpreted pictograms with verbal instructions were: "Do not take with dairy products" and "Do not use by mouth." Some pictograms were difficult to interpret even when accompanied with verbal instructions, suggesting the need to thoroughly pilot them among users prior to implementation. CONCLUSION: Medication labels consisting of simple pictorials supported by verbal instructions were better comprehended by individuals with low literacy skills than labels with written plus verbal instructions in a language that the individual did not understand. Further, pictogram-only labels were the least comprehended types of medicine labels among the participants.

An illustrated leaflet containing antiretroviral information targeted for low-literate readers: development and evaluation.

OBJECTIVE: To apply a dual visual/textual modal approach in developing and evaluating a medicine information leaflet with pictograms suitable for low-literate HIV/AIDS patients. To identify and recommend best practices in this type of information design. METHODS: A simple leaflet incorporating pictograms was designed for an antiretroviral regimen. Cognitive testing for understanding was conducted in 39 low-literate, South African, antiretroviral-naïve adults. Participants were required to locate and explain the information, and were questioned on their opinion of leaflet layout and contents. RESULTS: Average understanding of the leaflet was 60%. Basic medication information was the best understood. An overall lack of knowledge of HIV/AIDS and its core concepts was found. Only half the participants considered this simple leaflet "easy" to read. All endorsed the inclusion of pictograms. CONCLUSION: This testing method used in ARV-naïve individuals was invaluable in identifying areas needing modification before its use in patients. Text associated with pictograms was more noticeable and better understood, but only if they were closely juxtaposed. PRACTICE IMPLICATIONS: Leaflet design should consider culture and literacy skills, be informed by learning theory and design principles, include visuals to enhance appeal and improve understanding, and involve end-users. Verbal counseling should accompany written information.

Developing visual images for communicating information aboutantiretroviral side effects to a low-literate population.

The side effects of antiretroviral (ARV) therapy are linked to altered quality of life and adherence. Poor adherence has also been associated with low health-literacy skills, with an uninformed patient more likely to make ARV-related decisions that compromise the efficacy of the treatment. Low literacy skills disempower patients in interactions with healthcare providers and preclude the use of existing written patient information materials, which are generally written at a high reading level. Visual images or pictograms used as a counselling tool or included in patient information leaflets have been shown to improve patients' knowledge, particularly in low-literate groups. The objective of this study was to design visuals or pictograms illustrating various ARV side effects and to evaluate them in a low-literate South African Xhosa population. Core images were generated either from a design workshop or from posed photos or images from textbooks. The research team worked closely with a graphic artist. Initial versions of the images were discussed and assessed in group discussions, and then modified and eventually evaluated quantitatively in individual interviews with 40 participants who each had a maximum of 10 years of schooling. The familiarity of the human body, its facial expressions, postures and actions contextualised the information and contributed to the participants' understanding. Visuals that were simple, had a clear central focus and reflected familiar body experiences (e.g. vomiting) were highly successful. The introduction of abstract elements (e.g. fever) and metaphorical images (e.g. nightmares) presented problems for interpretation, particularly to those with the lowest educational levels. We recommend that such visual images should be designed in collaboration with the target population and a graphic artist, taking cognisance of the audience's literacy skills and culture, and should employ a multistage iterative process of modification and evaluation.

Development of written information for antiretroviral therapy: comprehension in a Tanzanian population.

OBJECTIVE: To design and develop a simple, easily readable patient information leaflet (PIL) for a commonly used antiretroviral (ARV) regimen and to evaluate its readability and acceptability in a Tanzanian population. METHOD: A PIL incorporating simple text and pictograms was designed for the antiretroviral regimen of stavudine, lamivudine and efavirenz. The PIL was designed according to established good design guidelines, modified during a multi-stage iterative testing process and piloted in a South African Xhosa population. The PIL was made available in both English and Kiswahili. Sixty Tanzanian participants who were not taking ARVs were interviewed. They were asked to read the PIL in the language of their choice and were then asked a series of two-part questions; the first part required participants to locate the information in the PIL, after which they were asked to explain the information in their own words. Acceptability was assessed through close-ended questions and open-ended feedback. The influence of selected patient characteristics on comprehension of the PIL was investigated using one-way ANOVA and t-tests for independent samples with a significance level set at 0.05. MAIN OUTCOME MEASURE: Comprehension of the written information in an overall percentage understanding. RESULTS: The overall average percentage comprehension of the PIL was 95%. The target set by the EC guideline that at least 80% of participants correctly locate and understand the information was achieved for 19 of the 20 questions. Five of the six instructions illustrated by pictograms were correctly understood by all participants. The only patient characteristics significantly associated with comprehension were educational level and self-reported ease of reading the PIL. Acceptability of the PIL was high and positive comments were associated with simplicity, good design, easy readability and user-friendliness, the latter enhanced by the inclusion of pictograms. CONCLUSION: The PIL designed for this study was shown to be effective in communicating information about ARVs. Patient characteristics must be taken into account when developing written information, and the final document must be tested for comprehension in the target population.