Domains:

Self-assessment (subjective by patients)

Application quality

§  Confidence in the beginninga/at DOT/at the endb?

§  Degree of effort required in the beginning/at the end?

§  Difficulties with removal of needle shield in the beginning/at the end?

§  Puncture painful in the beginning/at the end/throughout therapy?

§  Injection painful in the beginning/at the end/throughout therapy?

§  Self-injection or injections administered by another person in a future s.c. therapy?

Assistance quality

§  Sufficiently informed about injection site?

§  Sufficiently informed about injection technique?

Adherence

§  Difficulties with regular application of LMWH?

§  Degree of personal responsibility concerning adherence of LMWH?

§  Skipped injections (and how many)?

§  Degree of adherence concerning prescribed injection time?

Domains:

Reality (objective by investigators)

Application quality (DOT)

§  Pre-filled syringe/alcohol swab/cotton swab/plaster/sharps collector within easy reach?

§  Washing or disinfection of hands right before injection?

§  Injection site?

§  Disinfection of the skin area (e.g. by a single wipe; rubbing; no disinfection)?

§  Waited for the alcohol to evaporate/let it dry?

§  No contact with disinfected skin area?

§  Difficulties to remove needle shield?

§  Horizontal removal of the needle shield by pulling it straight off the syringe using both hands?

§  Need of a new pre-filled syringe due to wrong removal of needle shield?

§  Reattachment of needle shield?

§  Removal of air bubble?

§  Drop on the needle (e.g. shaken off; wiped off; left; no drop)?

§  Pinched a skin fold (e.g. an inch; less than an inch; no skin fold)?

§  Puncture into cleansed skin area?

§  Full length of the needle inserted into the skin?

§  Waited a second before withdrawing the needle?

§  Thumb grip pressed when withdrawing the needle?

§  Needle withdrawn at the same angle that it was inserted?

§  Skin fold released after withdrawing the needle?

§  Skin area swabbed after injection (e.g. swabbing gently; rubbing; no swabbing)?

§  Investigator’s assessment of patient’s confidence

§  Syringe disposed immediately after withdrawing the needle?

§  Recapping?

Assistance qualityc

Adherenced

Knowledge

§  Consistency with prescribed therapy duration?

§  Consistency with prescribed daily injections?

§  Consistency with prescribed injection time?

§  Injection site?

§  Recapping?

§  Reason for LMWH treatment?

§  Potential interactions with over-the-counter medication?

§  Potential adverse drug reactions?

§  Action taken if mild injection site irritation, burning or hematoma at injection site occurred?

§  Action taken if sudden malaise occurred?