Table 3. Assessment of the intervention in the included articles.
| Source | BoT as the primary endpoint | Burden of treatment measurement tool | Impact on BoT | Results |
|---|---|---|---|---|
| Reimer (2008) | NO | DETAILED RESULT ONLY | Positive | • ease of carrying around daily (p <0.001) • discreteness for public use (p = 0.018) • effort required to perform injections (p <0.001) • overall ease of use (p = 0.012) |
| • dedicated questions in the various questionnaires | ||||
| Koek (2009) | NO | DETAILED RESULT ONLY | Positive | • treatment method (i.e. radiation modalities): 2 [1.5–2.4] vs 3.2 [2.6–3.8] (p <0.001) • time lost: 1.4 [1–1.8] vs 4.4 [3.8–5] (p <0.001) • ultraviolet B phototherapy: 2 [1.5–2.3] vs 3.6 [3.1–4.2] (p <0.001) • entire treatment (including topic treatments): 2.6 [2.1–3.2] vs 4.2 [3.6–4.8] (p <0.001) |
| • Ad hoc Questionnaire: 4 items assessed using a Visual Analog Scale from 0 (low BoT) to 10 (high BoT) | ||||
| Oude Elberink (2009) | NO | OVERALL BoT RESULT | Non-significant | • improvement with VIT (randomised subjects): 93.3% • improvement with EpiPen (randomised subjects): 41.7% |
| • 1 item ranging from 1 to 7 (1–3 = positive / 4–7 = negative) | ||||
| Ishii (2011) | YES | OVERALL BoT RESULT + DETAILED RESULT | Positive | • Overall BoT result: score from 64.54 to 67.49 (p = 0.041) • Detailed results: 2 questions with p <0.005: “How bothered have you been by the need to adjust the dosing of your medication?”/“not at all” answer from 36.6% to 51.2%, and “How satisfied have you been with the ease and convenience of your diabetes medication”/positive answer from 40.7% to 53.8% |
| • “treatment burden” domain of the DiabMedSat (0–100 scale) | ||||
| Martin (2013) | NO | OVERALL BoT RESULT | Positive | • Overall BoT result: difference in the change from baseline between groups (weekly Albiglutide vs. three times daily insulin): 6.8 (p <0.001) |
| • "Treatment burden" domain of the DiabMedSat (0–100 scale) | ||||
| Bilton (2014) | NO | OVERALL BoT RESULT | Positive | • Not described in the article |
| • CQF-R with 1 domain on BoT | ||||
| Quittner (2015) | NO | OVERALL BoT RESULT | Positive | • Improvement with Ivacaftor by 4.3 vs 1.3 with placebo (p = 0.042) |
| • CQF-R with 1 domain on BoT | ||||
| Garg (2016) | NO | OVERALL BoT RESULT + DETAILED RESULT | Positive | • TRIM-D–BoT domain: mean transformed score: 5.3 (FlexTouch pen better than FlexPen pen, p <0.001) • TRIM-D DQ–"Device bother" domain: mean transformed score: 8.4 (FlexTouch pen better than FlexPen pen, p <0.001) • ITSQ–"Inconvenience" domain: “FlexTouch pen score–FlexPen pen score” difference: 4.6, (p <0.001) |
| • "Burden of treatment" domain (6–30 scale) and "Device bother" domain of the TRIM-D (3–15 scale), "Inconvenience" domain of the ITSQ (5–35 scale) | ||||
| Kabul (2016) | YES | OVERALL BoT RESULT | Positive | • TRIM-D–BoT domain: difference in the change from baseline (three times daily insulin–Twice daily insulin) between groups: 5.03 [95%CI: 0.99–9.06] |
| • "Burden of treatment" domain of the TRIM-D (5-point Likert scale) | ||||
| Salisbury (2018) | NO | OVERALL BoT RESULT | Non-significant | • MTBQ: adjusted difference in means (Intervention group–usual care group): -0.46 (p = 0.49) |
| • MTBQ (5-point Likert scale) | ||||
| Ishii (2019) | YES | DETAILED RESULT ONLY | Non-significant | • DTR-QOL–“burden on social activities and daily activities” domain: difference in the change from baseline (Trelagliptin–daily DPP4-inhibitors) between groups: 1.938 (p = 0.4536) • DTR-QOL–“anxiety and dissatisfaction with treatment” domain: difference in the change from baseline (Trelagliptin–daily DPP4-inhibitors) between groups: 4.160 (p = 0.896) |
| • “Burden on social activities and daily activities”, “anxiety and dissatisfaction with treatment” domains of the DTR-QOL (7-point Likert scale) |
95% confidence intervals are presented within brackets. BoT = Burden of Treatment, VIT = Venom-Specific Immunotherapy, DiabMedSat = Diabetes Medication Satisfaction questionnaire, CQF-R = Cystic Fibrosis Questionnaire-Revised, TRIM-D = Treatment-Related Impact Measure for Diabetes, ITSQ = Insulin Treatment Satisfaction Questionnaire, MTBQ = Multimorbidity Treatment Burden Questionnaire, DTR-QoL = Diabetes Therapy-Related Quality of Life, DPP-4 = Dipeptidyl Peptidase-4