scholarly journals Readability and Suitability of COPD Consumer Information

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Kathryn Fullmann ◽  
David F. Blackburn ◽  
Mark E. Fenton ◽  
Holly Mansell
Keyword(s):  
Drug Product ◽  
Premature Death ◽  
Reading Level ◽  
Consumer Information ◽  
Information Leaflets ◽  
Suitability Assessment ◽  
Medication Information ◽  
Serious Injury ◽  
Health Canada ◽  
Acceptability Threshold

Background. Information leaflets have been shown to positively or negatively impact adherence, depending on their content. The objective of this study was to perform an appraisal of the consumer information provided in COPD inhaler monographs. Methods. COPD inhalers were identified from the Health Canada Drug Product Database. Medication information and instructions for inhaler use were analyzed for readability by seven formulas, with an acceptability threshold of grades 6–8. Three researchers rated suitability using a modified Suitability Assessment of Materials (SAM) tool and assessed leaflets for explicit warnings. Results. Twenty-six inhalers with a COPD indication were evaluated. Medication information sections were rated as “difficult to read” or “hard,” and 85% (22/26) had a reading level above grade 8. The instructions for inhaler use were rated as “easy” or “fairly easy” to read and 63% (16/26) met the threshold by all formulas. While all leaflets achieved superior suitability ratings, extreme warnings included risk of premature death (n=12), risks of serious injury (n=26), serious interactions (n=26), and statements that convey a serious consequence to therapy (n=26). Conclusion. While COPD information leaflets in Canada performed well in terms of readability and suitability, overemphasis on side effects, warnings, and precautions may contribute to patient fear and nonadherence.

Medication Information Leaflets Assessment Questionnaire

2009 ◽  
Author(s):  
Di Hirsh ◽  
Rosemary Clerehan ◽  
Margaret Staples ◽  
Richard H. Osborne ◽  
Rachelle Buchbinder
Keyword(s):  
Information Leaflets ◽  
Medication Information ◽  
Assessment Questionnaire

scholarly journals Development of consumer information leaflets for deprescribing in older hospital inpatients: a mixed-methods study

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033303 ◽  
Author(s):  
Natali Jokanovic ◽  
Parisa Aslani ◽  
Sophie Carter ◽  
Mai Duong ◽  
Danijela Gnjidic ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Professionals ◽  
Medication Management ◽  
Consumer Information ◽  
Transitions Of Care ◽  
User Testing ◽  
Structured Interviews ◽  
Convenience Sample ◽  
Information Leaflets ◽  
System Usability Scale

ObjectiveTo develop information leaflets for older inpatients and/or their carers to support deprescribing of antipsychotics, benzodiazepines/Z-drugs and proton pump inhibitors (PPIs).DesignAn iterative mixed-methods approach involving face-to-face user testing and semi-structured interviews was performed over three rounds with consumers and hospital health professionals.SettingSydney, New South Wales, Australia.ParticipantsThirty-seven consumers (or their carers) aged 65 years or older admitted to hospital in the previous 5 years and taking at least one regular medicine (not the medicine tested) completed user testing. Health professionals included a convenience sample of seven pharmacists and five doctors.MethodsThe antipsychotic leaflet was tested in round 1 (consumers, n=10) and revised and retested in round 2 (consumers, n=9; health professionals, n=5). Findings from rounds 1 and 2 informed the design of the benzodiazepine/Z-drug and PPI leaflets tested in round 3 (benzodiazepine/Z-drug consumers, n=9; health professionals, n=7; PPI consumers, n=9). Findings from round 3 informed the final design of all leaflets. Consumer user testing involved 12–13 questions to evaluate consumers’ ability to locate and understand information in the leaflet. Usability by health professionals was assessed using the System Usability Scale (SUS).ResultsAt least 80% of consumers correctly found and understood the deprescribing information in the leaflets (9 of 12 information points in round 1 (antipsychotic); 10 of 12 in round 2; 12 of 13 (benzodiazepine/Z-drug) and 11 of 12 (PPI) in round 3). Consumers perceived the leaflets to be informative, well-designed and useful aids for ongoing medication management. The SUS scores obtained from health professionals were 91.0±3.8 for the antipsychotic leaflet and 86.4±6.6 for the benzodiazepine/Z-drug leaflet, indicating excellent usability.ConclusionsUnderstandable and easy-to-use consumer information leaflets were developed and tested by consumers and health professionals. The feasibility and utility of these leaflets to support deprescribing at transitions of care should be explored in clinical practice.

Development and assessment of a low-health-literacy, pictographic adrenal insufficiency action plan

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Patrick T. Reeves ◽  
Ashley C. Packett ◽  
Carolyn Sullivan Burklow ◽  
Sofia Echelmeyer ◽  
Noelle S. Larson
Keyword(s):  
Patient Education ◽  
Adrenal Insufficiency ◽  
Assessment Tool ◽  
Action Plan ◽  
Consumer Information ◽  
Care Plan ◽  
Endocrine Society ◽  
Readability Score ◽  
Suitability Assessment ◽  
Individualized Care

Abstract Objectives Adrenal insufficiency (AI) is an overall rare disorder characterized by the chronic need for pharmacotherapy to prevent threat to life. The Pediatric Endocrine Society has recommended the use of clinical action tools to improve patient education and help guide acute management of AI. We aimed to develop and assess an easy-to-use, patient-friendly, evidence-based, personalized pictogram-based adrenal insufficiency action plan (AIAP) to aid in the management of AI in children. Methods Patients/caregivers (P/Cs) responded to surveys which measured the concepts of transparency, translucency, and recall in order to assess the pictograms. Readability was assessed using six formulas to generate a composite readability score. Quality was graded by P/Cs using the Consumer Information Rating Form (CIRF) (>80% rating considered acceptable). Understandability and actionability was assessed by medical librarians using the Patient Education Materials Assessment Tool-Printable (PEMAT-P) (>80% rating was acceptable). Suitability was evaluated by clinicians using the Suitability Assessment of Materials (SAM) instrument (>70% rating considered superior). Results All pictograms met criteria for inclusion in the AIAP. Composite readability score=5.4 was consistent with a fifth-grade level. P/Cs (n=120) judged the AIAP to be of high quality with CIRF rating=85.2%. Three medical librarians rated the AIAP to have 100% understandability and 100% actionability. Thirty-three clinicians completing the SAM generated a suitability rating of 90.0%. Conclusions The AIAP visually highlights individualized care plan components to facilitate optimized preventative and acute AI care. Further investigation will determine if AIAP improves clinical outcomes for patients with AI.

Jurisdictional Guidance on DOAC Use—Will It Affect Practice? A Comparison of European, American, and Canadian Product Monographs

2019 ◽  
Vol 54 (3) ◽  
pp. 277-282
Author(s):  
Darcy A. Lamb ◽  
Tammy J. Bungard ◽  
Jennifer Lowerison ◽  
William M. Semchuk ◽  
Peter Thomson ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Renal Dysfunction ◽  
Product Information ◽  
Drug Product ◽  
Data Extraction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hepatic Function ◽  
The United States ◽  
Health Canada

Objective: To identify clinically relevant areas of concordance and discordance between product monographs for 4 direct oral anticoagulants (DOACs) approved by regulatory authorities in Europe, the United States, and Canada. Data Sources: For each DOAC (apixaban, dabigatran, edoxaban, rivaroxaban), manufacturer product monographs were retrieved from the European Medicines Database, US Food and Drug Administration, and Health Canada Drug Product Database. Data Extraction: Monographs for each DOAC were independently reviewed by 2 investigators to identify areas of concordance and discordance. Discordance existed if it was deemed that a potentially clinically relevant difference existed. A heat map summarizing the data was created to identify areas of complete concordance, partial concordance (concordance between 2 of 3 monographs), and complete discordance. Data Synthesis: The areas of concordance were indications for use, use in extremes of weight, and switching to/from the DOAC. Areas of discordance included the following: differing recommendations for use/dosing with renal dysfunction; contraindication or use with caution with drug interactions, pregnancy, and hepatic/renal dysfunction; and timing of DOAC with spinal/epidural anesthesia after a procedure or traumatic puncture. Relevance to Patient Care and Clinical Practice: Concordance was most evident for uncomplicated patients with atrial fibrillation or venous thromboembolism, whereas discordance emerged for those having characteristics/factors wherein clinicians may seek clarification within product monographs (eg, impaired renal/hepatic function, drug interactions). As such, clinicians must be familiar with product information within their country of practice. Conclusion: Variability between jurisdictions was evident, and variability of DOAC use is likely to increase with expanding worldwide uptake.

Patient assessment of medication information leaflets and validation of the Evaluative Linguistic Framework (ELF)

2009 ◽  
Vol 77 (2) ◽  
pp. 248-254 ◽  
Author(s):  
Di Hirsh ◽  
Rosemary Clerehan ◽  
Margaret Staples ◽  
Richard H. Osborne ◽  
Rachelle Buchbinder
Keyword(s):  
Patient Assessment ◽  
Information Leaflets ◽  
Medication Information ◽  
Linguistic Framework

scholarly journals Cross-comparison of cancer drug approvals at three international regulatory agencies

2016 ◽  
Vol 23 (5) ◽  
pp. 454 ◽  
Author(s):  
N. Samuel ◽  
S. Verma
Keyword(s):  
Antineoplastic Agents ◽  
Drug Product ◽  
Drug Approval ◽  
Primary Objective ◽  
Cancer Drug ◽  
European Medicines Agency ◽  
Cancer Drugs ◽  
Regulatory Bodies ◽  
Drug Approvals ◽  
Health Canada

Background The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies—Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)—and to explore differences in the drug approval processes that might contribute to any disparities.Methods The publicly available Health Canada Drug Product Database was surveyed for all marketed antineoplastic agents approved between 1 January 2005 and 1 June 2013. For the resulting set of cancer drugs, public records of sponsor submission and approval dates by Health Canada, the fda, and the ema were obtained.Results Overall, the tta for the 37 antineoplastic agents that met the study criteria was significantly less for the fda than for the ema (X̄ = 6.7 months, p < 0.001) or for Health Canada (X̄ = 6.4 months, p < 0.001). The tta was not significantly different for Health Canada and the ema (X̄ = 0.65 months, p = 0.89). An analysis of the review processes demonstrated that the primary reason for the identified discrepancies in tta was the disparate use of accelerated approval mechanisms.Summary In the present study, we systematically compared cancer drug approvals at 3 international regulatory bodies. The differences in tta reflect several important considerations in the regulatory framework of cancer drug approvals. Those findings warrant an enhanced dialogue between clinicians and government agencies to understand opportunities and challenges in the current approval processes and to work toward balancing drug safety with timely access

scholarly journals Adaptation of the European Commission-recommended user testing method to patient medication information leaflets in Japan

2017 ◽  
Vol Volume 9 ◽  
pp. 39-63 ◽  
Author(s):  
Michiko Yamamoto ◽  
Hirohisa Doi ◽  
Ken Yamamoto ◽  
Kazuhiro Watanabe ◽  
Tsugumichi Sato ◽  
...  
Keyword(s):  
European Commission ◽  
User Testing ◽  
Testing Method ◽  
Information Leaflets ◽  
Medication Information ◽  
Patient Medication
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