Scandinavian Journal of Gastroenterology. 2014; 49: 909–916
ORIGINAL ARTICLE
Patient-reported outcomes after acute nonvariceal upper gastrointestinal hemorrhage
Scand J Gastroenterol Downloaded from informahealthcare.com by University of Nebraska on 02/25/15 For personal use only.
PALLE BAGER & JENS F. DAHLERUP Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark
Abstract Objective. Nonvariceal acute upper gastrointestinal bleeding (AUGIB) is often associated with significant blood loss and anemia. Both the bleeding episode itself and the subsequent anemia are likely to significantly impact a patient’s health-related quality of life (HRQoL). Treating the anemia is essential to increase the hemoglobin levels. The HRQoL impact has not been investigated. This longitudinal study aimed to determine the relationship between anemia, HRQoL, and fatigue in patients after nonvariceal AUGIB. Materials and methods. A total of 97 patients (51 males and 46 females; mean age 70 years) were followed in a longitudinal study with a 6-month follow-up. All patients had AUGIB and were anemic at inclusion. Anemia, HRQoL (EQ-5D-3L), and fatigue (using the Multidimensional Fatigue Inventory) were assessed at baseline, and at 1, 3, and 6 months. The patients were initially included in an iron supplementation study. Results. The patients’ HRQoL increased and their fatigue levels decreased from baseline to month 3 and month 6. Approximately half of the patients had full health at month 3; similar results were observed in the general population. Three and six months after the bleeding episodes, neither the HRQoL nor fatigue was affected by the anemia. Conclusion. This study did not uncover relationships between anemia and HRQoL or anemia and fatigue after nonvariceal AUGIB.
Key Words: anemia, fatigue, gastrointestinal hemorrhage, health-related quality of life
Introduction Acute upper gastrointestinal bleeding (AUGIB) is a common disorder that is associated with a high mortality rate (3–15%) [1–6]. Both pharmacological and endoscopic therapies are recommended to treat the condition, and hospital admission is essential. Prior to the endoscopic therapy, most AUGIB patients experience significant blood loss. Blood loss can be ameliorated to some extent by blood transfusions. However, a recently published randomized study revealed that a restrictive transfusion strategy was associated with improved clinical outcomes, including fewer complications and reduced mortality, compared with a more liberal transfusion strategy [7]. Unfortunately, no patient-reported outcomes have been reported regarding AUGIB and anemia.
Anemia commonly develops after AUGIB. A retrospective study demonstrated that more than 80% of the patients admitted to hospital with nonvariceal AUGIB were anemic after being discharged from a semi-intensive care unit [8]. Furthermore, the study revealed that systematic follow-up procedures were lacking, most likely because of the limited focus of the existing guidelines on this aspect of patient care [2]. As AUGIB has been estimated to have an annual incidence rate of approximately 160 admissions per 100,000 inhabitants, post-discharge anemia will affect many patients globally [9]. Furthermore, older individuals are well represented in the patient group that experiences AUGIB, thereby leading to a higher risk of comorbidities [10]. Anemia can be sustained for a longer period and can have greater impact on an individual if comorbidity is present. If a patient is anemic after AUGIB, the impact on his health-related
Correspondence: Palle Bager, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Noerrebrogade 44, 8000 Aarhus C, Denmark. Tel: +45 78493897. Fax: +45 78492860. E-mail: [email protected]
(Received 24 January 2014; revised 26 March 2014; accepted 27 March 2014) ISSN 0036-5521 print/ISSN 1502-7708 online 2014 Informa Healthcare DOI: 10.3109/00365521.2014.910544
910
P. Bager & J. F. Dahlerup
Scand J Gastroenterol Downloaded from informahealthcare.com by University of Nebraska on 02/25/15 For personal use only.
quality of life (HRQoL) is unknown. A small study monitoring patient-reported outcomes for all types of AUGIB at baseline and 1 month later determined that the patients’ physical HRQoL improved; however, these results were not stratified for anemia [11]. Our substudy was part of a larger study investigating iron supplementation in anemic nonvariceal AUGIB patients [12]. The primary aim of our substudy was to determine the relationship between anemia, HRQoL, and fatigue in this patient group using a longitudinal design with a 6-month follow-up. Materials and methods Study overview Patients in the study were recruited from the Department of Surgery (Section for Upper Gastrointestinal and Hepato-pancreato-biliary Surgery), Aarhus University Hospital, Denmark. The study was approved by the regional ethics committee and registered at ClinicalTrials.gov (number NCT00978575). The included patients were randomized 1:1:1 to one of the following treatment arms: oral iron treatment for 3 months, a single dose of intravenous iron at baseline, or no treatment. There was a 3-month double-blinded treatment period. The results of the main study are described elsewhere [12]. Patients Patients with nonvariceal AUGIB were included in the study approximately 48 h after the bleeding source was stabilized and an endoscopic evaluation was performed. The eligible patients were men and women older than 18 years who were admitted to the hospital with nonvariceal AUGIB. All patients were anemic at the time of inclusion according to the anemia definitions of the World Health Organisation (WHO): Hemoglobin (Hb) levels
ORIGINAL ARTICLE
Patient-reported outcomes after acute nonvariceal upper gastrointestinal hemorrhage
Scand J Gastroenterol Downloaded from informahealthcare.com by University of Nebraska on 02/25/15 For personal use only.
PALLE BAGER & JENS F. DAHLERUP Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark
Abstract Objective. Nonvariceal acute upper gastrointestinal bleeding (AUGIB) is often associated with significant blood loss and anemia. Both the bleeding episode itself and the subsequent anemia are likely to significantly impact a patient’s health-related quality of life (HRQoL). Treating the anemia is essential to increase the hemoglobin levels. The HRQoL impact has not been investigated. This longitudinal study aimed to determine the relationship between anemia, HRQoL, and fatigue in patients after nonvariceal AUGIB. Materials and methods. A total of 97 patients (51 males and 46 females; mean age 70 years) were followed in a longitudinal study with a 6-month follow-up. All patients had AUGIB and were anemic at inclusion. Anemia, HRQoL (EQ-5D-3L), and fatigue (using the Multidimensional Fatigue Inventory) were assessed at baseline, and at 1, 3, and 6 months. The patients were initially included in an iron supplementation study. Results. The patients’ HRQoL increased and their fatigue levels decreased from baseline to month 3 and month 6. Approximately half of the patients had full health at month 3; similar results were observed in the general population. Three and six months after the bleeding episodes, neither the HRQoL nor fatigue was affected by the anemia. Conclusion. This study did not uncover relationships between anemia and HRQoL or anemia and fatigue after nonvariceal AUGIB.
Key Words: anemia, fatigue, gastrointestinal hemorrhage, health-related quality of life
Introduction Acute upper gastrointestinal bleeding (AUGIB) is a common disorder that is associated with a high mortality rate (3–15%) [1–6]. Both pharmacological and endoscopic therapies are recommended to treat the condition, and hospital admission is essential. Prior to the endoscopic therapy, most AUGIB patients experience significant blood loss. Blood loss can be ameliorated to some extent by blood transfusions. However, a recently published randomized study revealed that a restrictive transfusion strategy was associated with improved clinical outcomes, including fewer complications and reduced mortality, compared with a more liberal transfusion strategy [7]. Unfortunately, no patient-reported outcomes have been reported regarding AUGIB and anemia.
Anemia commonly develops after AUGIB. A retrospective study demonstrated that more than 80% of the patients admitted to hospital with nonvariceal AUGIB were anemic after being discharged from a semi-intensive care unit [8]. Furthermore, the study revealed that systematic follow-up procedures were lacking, most likely because of the limited focus of the existing guidelines on this aspect of patient care [2]. As AUGIB has been estimated to have an annual incidence rate of approximately 160 admissions per 100,000 inhabitants, post-discharge anemia will affect many patients globally [9]. Furthermore, older individuals are well represented in the patient group that experiences AUGIB, thereby leading to a higher risk of comorbidities [10]. Anemia can be sustained for a longer period and can have greater impact on an individual if comorbidity is present. If a patient is anemic after AUGIB, the impact on his health-related
Correspondence: Palle Bager, Department of Hepatology and Gastroenterology, Aarhus University Hospital, Noerrebrogade 44, 8000 Aarhus C, Denmark. Tel: +45 78493897. Fax: +45 78492860. E-mail: [email protected]
(Received 24 January 2014; revised 26 March 2014; accepted 27 March 2014) ISSN 0036-5521 print/ISSN 1502-7708 online 2014 Informa Healthcare DOI: 10.3109/00365521.2014.910544
910
P. Bager & J. F. Dahlerup
Scand J Gastroenterol Downloaded from informahealthcare.com by University of Nebraska on 02/25/15 For personal use only.
quality of life (HRQoL) is unknown. A small study monitoring patient-reported outcomes for all types of AUGIB at baseline and 1 month later determined that the patients’ physical HRQoL improved; however, these results were not stratified for anemia [11]. Our substudy was part of a larger study investigating iron supplementation in anemic nonvariceal AUGIB patients [12]. The primary aim of our substudy was to determine the relationship between anemia, HRQoL, and fatigue in this patient group using a longitudinal design with a 6-month follow-up. Materials and methods Study overview Patients in the study were recruited from the Department of Surgery (Section for Upper Gastrointestinal and Hepato-pancreato-biliary Surgery), Aarhus University Hospital, Denmark. The study was approved by the regional ethics committee and registered at ClinicalTrials.gov (number NCT00978575). The included patients were randomized 1:1:1 to one of the following treatment arms: oral iron treatment for 3 months, a single dose of intravenous iron at baseline, or no treatment. There was a 3-month double-blinded treatment period. The results of the main study are described elsewhere [12]. Patients Patients with nonvariceal AUGIB were included in the study approximately 48 h after the bleeding source was stabilized and an endoscopic evaluation was performed. The eligible patients were men and women older than 18 years who were admitted to the hospital with nonvariceal AUGIB. All patients were anemic at the time of inclusion according to the anemia definitions of the World Health Organisation (WHO): Hemoglobin (Hb) levels
