Development and Pilot-Testing of Key Questions to Identify Patients’ Difficulties in Medication Administration

Figures & data

Table 1 Sociodemographic Data of Participants in Step 2) and 3) of the Development Process and of Participants in the Pilot-Testing

	Step 2) Assessment of Comprehensibility	Step 2) Re-Testing	Step 3)	Pilot-Testing
Number of patients	12	5	27	36
Average Age ± SD [years]	56.3 ± 16.5	45.6 ± 9.6	62.1 ± 16.4	56.2 ± 20.5;1 Ma
Number of women (%)	7 (58.3)	4 (80.0)	14 (51.9)	21 (58.3)
Average Number of drugs ± SD	3.8 ± 3.4	2.2 ± 1.1	5.1 ± 2.7	4.3 ± 2.9; 5 Ma
Number of participants having a medical background (%)	3 (25.0)	1 (20.0)	3 (11.1)	4 (11.1)
Percentage of participants having received a training in the use of the respective dosage form [%] (n/total)^a	Na	Na	Na	65.4 (17/26)
Percentage of participants using dosage form/splitting tablets regularly for more than three years [%] (n/total)^b	Na	Na	Na	52.9 (18/34); 1 Ma

Notes: ^aOnly participants using any inhalers, ophthalmic preparations, or injection devices considered; ^bonly participants using any inhalers, ophthalmic preparations, or injection devices or splitting tablets considered.

Abbreviations: Ma, missing answer(s); Na, not applicable.

Table 2 Description of Pilot-Testing of Exemplary Key Questions

	Key Question	Second Key Question^a	Description
Inhalers (Metered dose inhaler)	Many patients find it difficult to pull the trigger of their inhaler and to inhale at the same time. Are you having any trouble using your inhaler?	For how many seconds after inhalation do you hold your breath?	● Demonstration of inhalation using placebo or own device. ● Placebo were ensured to be equal to own drug.
Inhalers (Capsule-based/Other inhalers)	For how many seconds after inhalation do you hold your breath?	Do the capsules contain powder residues after inhalation?^b	● Demonstration of inhalation using placebo or own device. ● Placebo were ensured to be equal to own drug.
Ophthalmic preparations (drops)	Do you always succeed in inserting a drop into the conjunctival sac at the first attempt?	Do you always keep both eyes closed after the drop?	● Demonstration of eye drop installation using eye drops for moistening. ● Different eye drops (and bottles were available).
Injection devices (prefilled)	How frequently do you change the injection site?	Na	● Demonstration of injection technique using a placebo insulin pen. ● Injection in puppet. ● Patients were asked to show the injection site of the following 7 days.
Tablet splitting	Do you find it difficult to split your tablets consistently into pieces that have the same size?	Na	● Patients were asked to choose a tablet that resembles their own tablet from a selection of tablets. ● Patients were offered different tools (eg a knife, a tablet splitter, a scissor etc.) that might be used for splitting tablets. ● Patients were asked to split tablets if it would be their own. ● Patients were asked if splitting their own tablets was different. ● Demonstration of splitting own tablet was also possible.
Meal-dependent administration	Do you find it difficult to coordinate the daily use of your medication with your meals?	Na	● Patients were asked which drugs have to be taken. ● Patients were asked to mark their usual time for meals and their usual times for drug administration on two time frames (one for weekdays and one for the weekend).

Notes: ^aOnly applied when first key question did not lead to disclosure of difficulties; ^bonly applied in case of capsule-based inhalers.

Abbreviation: Na, not applicable.

Figure 1 Percentage of errors in medication administration identified by key questions and general questions per complexity factor.