The aim of this study was to investigate the HRQoL of patients with ITP and the factors associated with HRQoL. The updated international consensus report indicates that there are differences in the clinical presentation of ITP, clinical outcomes and response to treatment (20). Therefore, the assessment of HRQoL, complications of corticosteroid treatment, and the impact of corticosteroid side effects on the HRQoL of ITP patients plays an important role in the quality of outcomes and measuring the success of treatment. The most common clinical presentation at diagnosis of ITP was epistaxis and wet purpura (mucosal bleeding) (77.6%), followed by fatigue (73.4%), skin manifestations (petechiae and ecchymosis) (56.1%), and heavy menstrual bleeding (27.6%). This was similar to studies conducted in Mexico (8, 34), in Spain (35), in France (36), and in Turkey (37).
Corticosteroid side effects may affect HRQoL or treatment response, and in this study population, 71.5% of study participants had chronic ITP. There is a significant association between the duration of corticosteroid treatment and the average number of adverse events experienced (24). Emotional corticosteroid side effects, such as insomnia, restlessness, and/or sleep disturbances (32.7%), physical symptoms, including general weakness/fatigue (47.7%), and muscle weakness (14.0%), accounted for the largest proportion. In a study conducted in the United States, patients treated with corticosteroids reported that the number and severity of corticosteroid side effects increased significantly when the treatment duration was extended from 3 months to 12 months (24). According to the ITP World Impact Survey, approximately 50% of study participants suffered from fatigue during the survey (8), and in this study, general weakness/fatigue (47.7%) was also the most common corticosteroid side effect in ITP patients. This can severely affect HRQoL domains, such as energy levels to perform activities. On the other hand, 56.5%, 46.7%, and 21.0% of the study participants took CPT, PPI, and calcium with vitamin D3, respectively. This supportive treatment reduced the immunosuppression and gastrointestinal side effects of corticosteroids as well as the extent of osteoporosis. In general, to decrease corticosteroid-related side effects, prednisone should be rapidly tapered and usually stopped in responders, and non-responders stop the medications after 4 weeks of initiation (38).
In this study, the total impact of ITP on HRQoL is 35.41 ± 9.27, and the impact of ITP on work or study is 50.01 ± 2.17, which is greater than the impact of ITP on daily life (31.69 ± 7.38); this is consistent with the ITP World Impact Survey data (8, 39) and survey data reported from Switzerland, Austria, and Belgium (40). Our study is also similar to the studies conducted in China (41), the United States of America (11), and Serbia (9), in which physical function was more impaired than in the other domains of HRQoL. On the other hand, an Indian study showed that the impact of ITP on patients' work/study was less than the impact of ITP on their daily lives (42). A systematic review conducted in 2018 suggests that patients with ITP experience negative effects on their sexual activities, including decreased libido and bruising and bleeding during intercourse (17). In this study, the mean impact of ITP on patients’ sex life was rated as 1.04 ± 0.71, which is lower than all other IQLI domains, and the result is similar to a qualitative study in the United Kingdom, which found that the impact of ITP on sex life was less relevant (43).
Predictive factors for a higher impact of ITP on HRQoL included emotional-related corticosteroid side effects, fatigue during the assessment, not taking CPT, epistaxis and wet purpura (mucosal bleeding), place of residence, and skin symptoms (petechiae and ecchymosis). These were significantly correlated with a greater impact of ITP on HRQoL, with emotion-related corticosteroid side effects accounting for the highest value with 15.4% of the variance (adjusted R-squared = 0.154, β = 0.392). When the number of patients experiencing emotional-related corticosteroid side effects increased by one, the impact of ITP on patients' HRQoL increased by 0.392 (β = 0.392, 95% CI: 5.160–9.961, P < 0.001). This might be due to the emotional side effects of steroids, such as insomnia, depression, anxiety, restlessness, and anger, which directly affect work capacity and concentration in daily activities and reduce the energy capacity to perform a given activity, greatly affecting HRQoL. In addition, the number of patients with epistaxis and wet purpura (mucosal bleeding) during diagnosis increased by one, the impact of ITP on patients' HRQoL increased by 0.191 (β = 0.191, 95% CI: 0.091–4.259, P = 0.001), and the number of patients with clinical presentations of skin symptoms (petechiae and ecchymosis) of ITP patients increased by 0.041 (β = 0.041, 95% CI: 0.091–4.259 P = 0.041), which is in line with other studies conducted in China and Serbia (9, 27).
A study conducted in the United States of America (44) and China (41) showed that fatigue was one of the most debilitating aspects of the HRQoL of ITP. Moreover, in this study, the number of patients with fatigue during assessment also increased by one, and the impact of ITP on patients' HRQoL increased by 0.236 (β = 0.326, 95% CI: 4.394–9.475, P < 0.001). The number of patients who did not take CPT increased by one, and the impact of ITP on patients' HRQoL increased by 0.236 (β = 0.236, 95% CI: 2.236–6.570, P < 0.001). This may be because immunosuppressive therapy, especially high-dose corticosteroids, predisposes patients to infections, which may also affect HRQoL in ITP patients. A study conducted in China found that infections are a common problem in patients with primary ITP, with an incidence of 24% in the first month of treatment, possibly due to immunosuppressive therapy. The number of patients living far from the clinic of hematology (out of Addis Ababa) increased by one, and the impact of ITP on patients' HRQoL increased by 0.166 (β = 0166, 95% CI: 1.107–5.114 P = 0.003), which is in line with a study conducted in Serbia (9).
This study evaluated the impact of ITP on HRQoL in the Ethiopian population. In addition, the study assessed the impact of corticosteroid side effects on the HRQoL of ITP patients. The authors recommended that in this study the use of corticostriod was not limited and that it strongly affected HRQoL domains. To reduce corticosteroid-related side effects, prednisone should be rapidly tapered and usually discontinued in responders, and in non-responders, medication should be discontinued after 4 weeks of initiation. Finally, this study had certain limitations. The maximum time period (4 months) was used to recruit the study participants, but the event is rare; therefore, the sample size was small, and it is difficult to generalize the whole population.