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. 2021 Aug 19;12:582200. doi: 10.3389/fphar.2021.582200

TABLE 1.

Pictograms in the pharmaceutical care of chronically ill patients.

Study N Study setting and population characteristic Methods and interventions Result
Asthma
Almomani et al. (2018) 219 • Jordan • Randomised, controlled trial • A statistically significant difference between the two groups regarding improvement in inhaler techniques after 3 months was observed for 2/4 devices: Metered dose inhaler (MDI) (p < 0.001) and turbohaler (p = 0.005)
• Patients from an outpatient hospital pharmacy, with a diagnosis of bronchial asthma by a respiratory specialist, who used an inhaler device regularly for at least 3 months • Intervention: Verbal consultation on the proper use of the inhalers plus pictogram medals attached to the devices • Patients from the intervention group who used MDI and turbohaler were 7 and 5 times more likely to have improved their inhaler techniques as compared to the control group, respectively
• ≥18 years of age • Control: Verbal consultation only • All intervention patients were satisfied with pictogram medals
• Assessment at baseline and after 3 months, evaluating the inhaler techniques with a standard checklist • No significant differences in other asthma related clinical outcomes such as adherence to medication, asthma control, or unscheduled medical intervention was observed between the two groups at study end
Wrench et al. (2019) 55 • South Africa • Pre-post intervention study • A statistically significant increase in the mean number of correct steps was observed: 4.6 ± 2.2 at baseline and 7.9 ± 2.7 at follow-up (p < 0.05)
• Patients from a rural primary healthcare clinic, dependent on the public healthcare sector, with a diagnosis of asthma, prescribed an MDI for at least 1 month, speaking either English or isiXhosa • Intervention: a Structured assessment of inhaler technique with the use of a 12-step checklist and a demonstration and patient education of the correct inhaler technique supported and facilitated by the illustrated study leaflet on MDI use (English or isiXhosa version) • Statistically significant improvement of correct technique was observed in 10/12 steps controlled in the checklist
• ≥18 years of age • The intervention process was repeated 4 weeks later • All except one patient enjoyed the study pictograms
Diabetes
Doucette et al. (2014) 17 • Canada • Pre-post intervention study • High interpretation of each of the 8 “heart disease and stroke” pictograms (85% or higher) for initial and follow-up interviews was noted
• Patients from of primary care physicians’ offices under the auspices of the Regional Health Authority’s Diabetes Education Centre diagnosed with type 2 diabetes mellitus • Intervention: Patients were shown pictograms relating to diabetes complications, prevention, and treatment: “heart disease and stroke” (n = 8) and pictograms relating to “nerve damage’ (n = 7). Assessment of the pictogram meaning was made with a structured interview tool. Correct answers were recorded. Incorrect answers lead to patient education • Correct interpretation of 28.6% (2/7) of “nerve damage” pictograms during the initial interview and 100% during the follow-up interview
• 18–85 years of age • A follow-up assessment of the recall of pictograms was planned within 8 weeks. The number of correct responses was recorded • Overall, correct pictogram interpretation was significantly higher at the second interview (94.9 vs 82.8%; 12.2% difference; 95% confidence interval [CI], 4.7–19.7; p < 0.003)
• A significant improvement in interpretation of the individual pictograms at the second interview was noted for two of the pictograms “pain medication” and “slow digestion”.
• Among 13 participants who assessed their satisfaction with the pictograms, 11 (84.6%) were satisfied and 2 (15.4%) were neutral
Chan and Hassali, (2014) 110 • Malaysia • Randomised, controlled trial • All 3 groups demonstrated within-group increase of total adherence score after 4 weeks
• Patients from outpatient pharmacy in a major general hospital with refill prescriptions of selected oral antihypertensive or antidiabetic drugs • Intervention 1: font-enlarged labels • Total comprehension score of pictogram-incorporated label group was significantly higher after 4 weeks (mean change 0.37, p = 0.010)
• Intervention 2: pictogram-enriched labels • Significantly higher scores for a few items in both adherence and comprehension measurements after 4 weeks were observed in the two intervention groups
• Control: Standard labels, or pictogram-incorporated labels • F tests indicated that all 3 groups did not significantly differ in the changes of both total adherence and comprehension scores (p = 0.573 and 0.069, respectively) when subjects’ age was adjusted
• Assessment of baseline adherence, comprehension, and preferences was conducted upon recruitment; follow-up telephone interviews—after 4 weeks • Pictogram-incorporated labels over font-enlarged labels were preferred by the elderly and those with a higher number of morbidities
Mohan et al. (2014) 200 • United States • Randomized, controlled trial • Patients in the PictureRx group had an overall better understanding of their medications (MUQ difference 9.9; 95% CI 5.7–14.2; p < 0.01)
• Patients from a safety net clinic in Nashville, TN in a predominantly Spanish-speaking area. Patients were eligible if they were Latino, at least 18 years old, had a diagnosis of diabetes, and were prescribed at least 1 chronic medication • Intervention: A PictureRx illustrated medication list depicted the medication, indication, and dosing instructions accompanied by plain-language bilingual text • Each point increase in BHLS was associated with an increase of 1.1 in MUQ overall score (95% CI 0.3–2.0)
• Patients were excluded if they could not locate their medications or had a visual acuity >20/50, had hearing deficit, dementia, psychosis, disorientation, unable to communicate in English or Spanish, lacked a regular phone number, or belonged to a special population (e.g. pregnant or prisoner) • Control: Usual care, where patients received a written list of their medications in their preferred language, with indication but no images • Self-reported adherence was 0.5 points higher in ARMS score n the intervention group, though not statistically significant (95% CI, -0.1–1.1)
• 59% of patients had low health literacy tested by BHLS (Brief Health Literacy Screen) • Outcomes were assessed by telephone 1 week later. The Medication Understanding Questionnaire was used to assess the patient’s ability to report indication, strength, dosing and frequency for their medication regimen • Patients who received the PictureRx intervention reported very high satisfaction. 99% reported that the tool was easy clear, easy to read, and helped them remember which medicines to take (96.9%) and when to take them (96.9%)
• 71% of patients had not graduated high school • Secondary outcomes assessed were self-reported adherence and satisfaction. Medication adherence was assessed by the Adherence to Refills and Medications Scale (ARMS)
Negarandeh et al. (2013) 127 • Iran • Randomized, controlled trial • Mean scores of knowledge, adherence to medication and adherence to dietary regimen were significantly higher in both intervention groups compared to control (p < 0.05)
• Patients recruited from a secondary level diabetes clinic in Saqqez, Kurdistan with a diagnosis of type 2 diabetes for more than 6 months and had low health literacy (defined by a score of 59 or lower on TOFHLA), were at least 18 years old, and had no visual, mental, or learning disabilities • Intervention 1: Education based on a teach-back strategy during three weekly sessions lasting 20 min each. The patient also received written instructions of important information • There were no significant differences in knowledge or adherence between the two intervention groups
• Patients were excluded if they had participated in previous diabetes education research • Intervention 2: Patients received education with illustrated content during three weekly sessions lasting 20 min each
• Control: Patients received usual care which involved diabetes education presented in a brochure. Questions were answered by a community health nurse, similarly to the intervention groups
AIDS
Mansoor and Dowse, (2006) 120 • South Africa • Randomised, controlled trial • In the group receiving materials incorporating simple text and pictograms a significant increase in adherence to therapy was noted, whereas a non-significant increase in adherence was observed in the group receiving more complex information (measured both by the self-report and the tablet count)
• Patients from local primary healthcare out-patient clinics, HIV-positive patients on chronic cotrimoxazole therapy, from a variety of educational backgrounds, able to read and understand either English or isiXhosa • Two different PILs were designed for co-trimoxazole tablets and were available in both English and isiXhosa • Combined results from the self-report and tablet count found that the overall mean percentage adherence of the participants receiving Intervention 2 (88.3%) was significantly higher than those receiving Intervention 1 (73.6%), and the control group (67.7%) (p < 0.05)
• > 16 years of age • Intervention 1: Longer text-only PIL • Significantly more participants receiving Intervention 2 (92.5%) obtained 100% adherence when compared with the control group (70.0%) (p < 0.05)
• Intervention 2: Simple PIL with pictograms • The results from the tablet count showed that the mean percentage adherence was significantly higher in participants who received Intervention 2 (86.5%) when compared with the controls (65.1%) or Intervention 1 (70.1%) (p < 0.05)
• Control: No PIL
• Adherence to therapy was assessed using two methods: Self-report and tablet count ∼14 days later
Mansoor and Dowse, (2007) 120 • South Africa • Randomised, controlled trial • The mean percentage for knowledge of medicines was significantly higher in the group that received the simple PIL incorporating pictograms (76.3%), compared with both the control group (43.3%) and the group who received the longer, text-only PIL (50.9%) (p < 0.05)
• Patients from local primary healthcare out-patient clinics, HIV-positive patients on chronic cotrimoxazole therapy, able to read and understand either English or isiXhosa • Intervention 1: Text-only PIL, longer and more complex
• > 16 years of age • Intervention 2: a simple, shorter PIL that incorporated pictograms and text
• Control: No PIL
• Medicines knowledge was investigated in an interview ∼14 days later
Wilby et al. (2011) 82 • Canada • Randomised, controlled trial • Majority of the targeted pieces of information (88%) in the intervention group were correctly identified at follow-up, while only 2% in the controls (p < 0.0001)
• Patients from an ambulatory pharmacy, HIV-positive patients who are receiving a new prescription for an antiretroviral medication • Intervention: pictogram-enhanced information • Majority of the intervention patients (79%) recalled properly all targeted information versus none of patients in the control group (p < 0.0001)
• ≥19 years of age • Control: Standard counselling • The results were dependent of the fact that each pictogram was explained to patients prior to use
• Evaluation of recall at first follow-up visit
• Evaluation of the recall at the next follow-up appointment at the ambulatory pharmacy
• Correct/incorrect response were recorded
Kalichman et al. (2013) 446 • United States • Randomized clinical trial • Participants with marginal health literacy receiving Intervention 1 and Intervention 2 demonstrated greater adherence and undetectable HIV viral loads compared to controls
• Patients from AIDS services and community outreach, with HIV and receiving antiretroviral therapy, with marginal and lower health literacy levels • Intervention 1: Pictograph-guided adherence counselling • Participants with lower health literacy skills in the control group demonstrated greater adherence compared to the two adherence counselling groups
• Intervention 2: Standard adherence counselling
• Control: general health improvement counselling
• Unannounced assessment: pill count adherence and blood plasma viral load 9-months post-intervention
Dowse et al. (2014) 116 • South Africa • Randomised, controlled study • Intervention patients presented a significant knowledge increase over the 6-month period (62.0–94.4%), and an improvement at each subsequent interview was noted. No improvement was observed in the control group
• Patients from rural clinics, HIV/AIDS patients who had been taking a first-line ARV regimen for less than 3 months, had isiXhosa as their home language, and had a maximum of 10 years of schooling • Intervention: Standard care plus simple pre-tested PIL containing both text and illustrations • Side effect knowledge, which was the lowest (50–56%) at baseline increased in the intervention group to 92%
• ≥18 years of age • Control: Standard care • Other medicine-related knowledge at baseline (57–67%) improved significantly (93%), which was sustained over 6 months
• HIV and medicines-related knowledge was evaluated at baseline, one, three, and 6 months post-intervention; self-efficacy was assessed over 6 months • A large intervention effect was observed (Cohen’s d values post-baseline were 1.36–2.18)
• A significant improvement over 6 months in self-efficacy was observed in the intervention group but not in controls
• At baseline, patients with ≤3 years of education had lower knowledge and self-efficacy. However, this was not reported post-intervention, which was attributed by the authors to the PIL mitigating the limited education effect
• In the intervention group knowledge and self-efficacy were significantly correlated
Monroe et al. (2018) 46 • United States • Randomized controlled study • There was a trend towards higher adherence to medications for HIV as compared with hypertension/diabetes medications (p = 0.07)
• Patients from the johns Hopkins HIV clinic, patients with HIV and diabetes and/or hypertension attending a clinic for underserved patients and those at risk for poor health outcomes • Intervention: Pictorial aid: a photographic representation of the medications, the indications, and the dosing schedule • The intervention was feasible to implement and satisfaction with the intervention was high
• Patients using the HIV clinic pharmacy for all prescriptions, being prescribed medications for HIV and diabetes and/or hypertension for ≥6 months, and being prescribed ≥5 different medications per day total (for any condition); speaking English • Control: Standard clinic visit discharge medication list
• ≥ 18 years of age • Assessment of the adherence to antiretroviral therapy (ART) for HIV and therapy for diabetes or hypertension was compared
Browne et al. (2019) 116 • South Africa • Randomised, controlled study • The mean side effect knowledge increased from 45.9% (baseline) to 95.7% (after 3 months) in the intervention group (p < 0.0001)
• Patients from local public sector clinics, HIV patients taking antiretroviral drugs, patients with limited literacy, isiXhosa-speaking • Intervention: Standard care plus illustrated information: Side-effect pictograms, combined with simple text, incorporated into a side effects panel within an ARV information leaflet • Knowledge did not change significantly in the control group
• Control: Standard care • Pictogram interpretation was good
• Side-effect knowledge was assessed at baseline. Interpretation of side-effect pictograms was evaluated after 1 month. Knowledge was re-tested after one and 3 months • All patients found the pictograms clear and useful, and endorsed their routine use
Chronic kidney Disease
Mateti et al. (2015) 81 • India • Quasi-experimental pre- and post-test • The overall user testing knowledge assessment mean scores significantly improved from 44.25 to 69.62 (p < 0.001)
• Patients from haemodialysis (HD) units of academic, government, and corporate hospitals, HD patients on pharmaceutical care group with minimum primary educational background, patients undergoing HD continuously for 3 months • Without control group
• 18–75 years of age • Usability testing of the pictogram-based PILs
 Cardiac disorders
Zerafa et al. (2011) 80 • Malta • Randomised, controlled trial (although called a case-controlled study in the manuscript) • Patients in the intervention group had a higher mean percentage compliance score (88%) than the controls (66%) (p < 0.05)
• Patients who underwent coronary artery bypass or heart valve surgery at the cardiac Surgical Ward and Medical outpatients clinic of Mater Dei Hospital, Birkirkara, Malta, able to communicate with the investigator; mentally competent • Intervention: a chart with pictorial explanation of the time of day together with a colourful photograph of each tablet prescribed and counselled to comply to oral analgesia and exercise and also on the avoidance of alcohol and smoking during the recovery period
• >18 years of age • Control: Usual care without the pharmacist intervention
• All patients were re-interviewed 8 weeks after discharge
Kripalani et al. (2012) 435 • United States • Randomised, controlled trial • Among those that CMG could be calculated 138 (32.9%) had CMG<0.20 during follow-up and were considered adherent
• Patients from an inner-city primary care clinic, adults with coronary heart disease • 2 × 2 factorial design: Usual care, refill, reminder postcards, illustrated medication schedules, or both interventions for 1 year • Overall, adherence rate did not differ significantly across treatments: 31.2% in usual care, 28.3% with mailed refill reminders, 34.2% with illustrated medication schedules, and 36.9% with both interventions
• Cardiovascular medication refill adherence was assessed by the cumulative medication gap (CMG) • In post-hoc analyses, illustrated medication schedules were found to led to significantly greater odds of adherence among patients who at baseline had >8 medications (OR = 2.2; 95% CI, 1.21–4.04) or low self-efficacy for managing medications (OR = 2.15; 95% CI, 1.11–4.16); a trend was found among patients who reported non-adherence at baseline (OR = 1.89; 95% CI, 0.99–3.60)
Hawkins and Firek, (2014) 27 • United States • Crossover study • Patients medication adherence significantly improved from pre-intervention to post-intervention (t (26) = 2.16, p < 0.05)
• Patients from a large Veterans’ Administration facility in southern California who presented to the VA outpatient heart failure clinic, with congestive heart failure (CHF) and cognitive impairment • Pre-intervention: Subjects brought their prescribed medications for a pill count, and returned after 30 days for a repeat pill count to assess baseline adherence • Patient acceptance of the intervention was high, with 74.1% of participants indicating the medication sheet was very helpful in remembering to take medications and filling medication boxes
• Participants 18 years old or older, had a diagnosis of CHF, and screened positive for cognitive impairment using the Saint Louis University Mental Status (SLUMS) exam • Post-intervention: customized pictorial medication sheet with brief instructions on use, and optional CADEX Pocket Pill Box with vibrating alarms. Pictorial medication sheets included images on the participant’s current medications printed in full colour and dose range, arranged in columns for morning, noon, and evening. A brief description of the medication name, indication, and dose were included. Pill count was assessed after 30 and 60 days
• Patients excluded if they had severe functional limitations, acutely decompensated CHF, dementia requiring a caregiver, severe mental illness such as schizophrenia, or a life expectancy of less than 6 months
Machtinger et al. (2007) 147 • United States • Randomized, controlled trial • Intervention subjects achieved anticoagulation control more rapidly than control subjects (median 28 vs 42 days; hazard ratio [HR] 1.43; CI 1.00, 2.06)
• Patients from a pharmacist-staffed anticoagulation clinic at San Francisco General Hospital (SFGH) receiving chronic warfarin • Intervention: Visual medication schedule at each visit with digitized images of the patient’s warfarin regimen printed on a weeklong calendar, plus standard care • The intervention showed significant benefit in subjects with baseline regimen discordance (median 28 vs 49 days; HR 1.92; CI 1.08, 3.39) but the benefit was not significant among subjects with baseline concordance (median 28 vs 35 days; HR 1.14; CI 0.71–1.83)
• At least 18 years old, spoke English, Spanish or Cantonese, were taking warfarin for at least 3 months, had an INR outside the therapeutic range (either 2.0–3.0 or 2.5–3.5) within 5 days prior to enrolment • Control: Standard care, which included standard medication counselling and follow-up in the anticoagulation clinic and consultation and medication management by pharmacists with expertise in anticoagulation
• Patients excluded if they had a psychiatric disorder, dementia, blindness, aphasia, were too ill to participate, could not communicate independently, had corrected vision of 20/100 or worse, used pill boxes filled by health care professionals, managed their warfarin by telephone, expected to stop taking warfarin within 90 days, or were not using warfarin preparations on the SFGH formulary

TOFHLA, Test of Functional Health Literacy in Adults.