Intervention of pharmaceutical care on the quality-adjusted life years in diabetic foot ulcer patients-A randomized...

Diabetic foot ulcer (DFU) is one of the reasons for hospitalization among diabetic patients. The objective is to study the impact of pharmaceutical care on quality-adjusted life years (QALY) in DFU patients.

The eligible DFUs patients were randomized into the General Care (GC) and Pharmaceutical Care (PC) Group in a 1:1 ratio using the block design method. The study was carried out for 2 years at a tertiary care teaching hospital. The PC group received pharmaceutical care from the clinical pharmacist along with general care. The sociodemographics, health-related quality of life (HRQoL), and economic data were collected from the both groups at baseline, 6^th month, and 12^thmonth. The changes in the outcomes within groups were analyzed using repeated measures of ANOVA.

Out of 174 DFU patients, 87 each were allocated to PC and GC groups. At baseline, there was no statistically significant difference in HRQoL scores; in contrast, during 6^th and 12^thmonth, follow-ups showed a statistically significant improvement in domains like dependence/daily life (P = 0.006), negative emotions (P = 0.030) and bothered by ulcer care (P = 0.024) in the PC group compared to the GC group. The PC group gained (-) Rs. 9984.3 and (-) US$.119.83 QALY at less cost when compared with the GC group DFU patients.

The clinical pharmacist who provided structured pharmaceutical care services had significant positive impact on the HRQoL and economic outcomes in the PC group compared to the GC group. The study intervention was cost effective based on India's GDP per capita of 2022.