Indications and hemoglobin thresholds for red blood cell transfusion and iron replacement in adults with gastrointestinal bleeding: An algorithm proposed by gastroenterologists and patient blood management experts.

Gastrointestinal (GI) bleeding is associated with considerable morbidity and mortality. Red blood cell (RBC) transfusion has long been the cornerstone of treatment for anemia due to GI bleeding. However, blood is not devoid of potential adverse effects, and it is also a precious resource, with limited supplies in blood banks. Nowadays, all patients should benefit from a patient blood management (PBM) program that aims to minimize blood loss, optimize hematopoiesis (mainly by using iron replacement therapy), maximize tolerance of anemia, and avoid unnecessary transfusions. Integration of PBM into healthcare management reduces patient mortality and morbidity and supports a restrictive RBC transfusion approach by reducing transfusion rates. The European Commission has outlined strategies to support hospitals with the implementation of PBM, but it is vital that these initiatives are translated into clinical practice. To help optimize management of anemia and iron deficiency in adults with acute or chronic GI bleeding, we developed a protocol under the auspices of the Spanish Association of Gastroenterology, in collaboration with healthcare professionals from 16 hospitals across Spain, including expert advice from different specialties involved in PBM strategies, such as internal medicine physicians, intensive care specialists, and hematologists. Recommendations include how to identify patients who have anemia (or iron deficiency) requiring oral/intravenous iron replacement therapy and/or RBC transfusion (using a restrictive approach to transfusion), and transfusing RBC units 1 unit at a time, with assessment of patients after each given unit (i.e., "don't give two without review"). The advantages and limitations of oral versus intravenous iron and guidance on the safe and effective use of intravenous iron are also described. Implementation of a PBM strategy and clinical decision-making support, including early treatment of anemia with iron supplementation in patients with GI bleeding, may improve patient outcomes and lower hospital costs.

Cost-minimization analysis favours intravenous ferric carboxymaltose over ferric sucrose or oral iron as preoperative treatment in patients with colon cancer and iron deficiency anaemia.

BACKGROUND: Ferric Carboxymaltose (FCM), Iron Sucrose (IS) and Oral Iron (OI) are alternative treatments for preoperative anaemia. OBJECTIVE: To compare the cost implications, using a cost-minimization analysis, of three alternatives: FCM vs. IS vs. OI for treating iron-deficient anaemia before surgery in patients with colon cancer. METHODS: Data from 282 patients with colorectal cancer and anaemia were obtained from a previous study. One hundred and eleven received FCS, 16 IS and 155 OI. Costs of intravenous iron drugs were obtained from the Spanish Regulatory Agency. Direct and indirect costs were obtained from the analytical accounting unit of the Hospital. In the base case mean costs per patient were calculated. Sensitivity analysis and probabilistic Monte Carlo simulation were performed. RESULTS: Total costs per patient were 1827® in the FCM group, 2312® in the IS group and 2101® in the OI group. Cost savings per patient for FCM treatment were 485® compared to IS and 274® compared to OI. A Monte Carlo simulation favoured the use of FCM in 84.7% and 84.4% of simulations when compared to IS and OI, respectively. CONCLUSIONS: FCM infusion before surgery reduced costs in patients with colon cancer and iron-deficiency anaemia when compared with OI and IS.

Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia.

PURPOSE: The purpose of the study was to evaluate the efficacy of preoperative intravenous (IV) ferric carboxymaltose (FCM) administration vs. no-IV iron in colon cancer (CC) anemic patients undergoing elective surgery with curative intention. METHODS: This was a multicenter, observational study including two cohorts of consecutive CC anemic patients: the no-IV iron treatment group was obtained retrospectively while FCM-treated patients were recorded prospectively. RESULTS: A total of 266 patients were included: 111 received FCM (median dose 1000 mg) and 155 were no-IV iron subjects. Both groups were similar in terms of demographic characteristics, tumor location, surgical approach, and intra-operative bleeding severity. The FCM group showed a significant lower need for red blood cell (RBC) transfusion during the study (9.9 vs. 38.7%; OR: 5.9, p < 0.001). In spite of lower hemoglobin levels at baseline diagnosis and lower transfusion rates in the FCM group, the proportion of responders was significantly higher with respect to the no-IV group both at hospital admission (48.1 vs. 20.0%, p < 0.0001) and at 30 days post-surgery (80.0 vs. 48.9%, p < 0.0001). The percentage of patients with normalized hemoglobin levels was also higher in the FCM group (40.0 vs. 26.7% at 30 days, p < 0.05). A lower number of reinterventions and post-surgery complications were seen in the FCM group (20.7 vs. 26.5%; p = 0.311). The FCM group presented a significant shorter hospital stay (8.4 ± 6.8 vs. 10.9 ± 12.4 days to discharge; p < 0.001). CONCLUSIONS: Preoperative ferric carboxymaltose treatment in patients with CC and iron deficiency anemia significantly reduced RBC transfusion requirements and hospital length of stay, reaching higher response rates and percentages of normalized hemoglobin levels both at hospital admission and 30 days post-surgery.

[Prevalence and characteristics of anemia and iron deficiency in patients hospitalized for gastrointestinal diseases in Spain]. / Prevalencia y características de la anemia y ferropenia en pacientes hospitalizados por enfermedades digestivas en España.

OBJECTIVE: To determine the prevalence and characteristics of anemia and iron deficiency in patients hospitalized for gastrointestinal diseases. METHODS: An epidemiological, multicenter, mixed design study (retrospective review of randomized clinical records and prospective visits) conducted between February 2010 and March 2011 in 22 Spanish gastroenterology departments. Severe anemia was defined as Hb < 10g/dL, mild/moderate as Hb ≥ 10g/dL, and iron deficiency as ferritin < 30ng/ml or transferrin saturation < 16%. RESULTS: We included 379 patients. The mean±SD age was 57±19 years and 47% were men. The prevalence of anemia at admission was 60% (95% CI 55 to 65), and anemia was severe (Hb <10g/dl) in half the patients. The prevalence of iron deficiency was 54% of evaluable patients (95% CI 47 to 61). Gastrointestinal bleeding at admission was found in 39% of the patients, of whom 83% (121/146) were anemic. At discharge, the proportion of anemic patients was unchanged (from 60% at admission to 58% at discharge) (95% CI 53 to 63) and iron deficiency was found in 41% (95% CI 32 to 50): anemia was severe in 17% and mild/moderate in 41%. During follow-up, at 3-6 months after admission, 44% (95% CI 39 to 50) of evaluable patients continued to have iron deficiency and 28% (95% CI 23 to 32) were still anemic: 5% severe and 23% mild/moderate. The prevalence of iron deficiency was 44% (95% CI: 39-50). During admission, 50% of patients with anemia did not receive treatment. At discharge, 55% were untreated. CONCLUSION: The prevalence of anemia in patients hospitalized for gastroenterological diseases was very high. Anemia persisted in over a quarter of patients at the follow-up visit. Only half of hospitalized patients received treatment for anemia, even when the anemia was severe.

SureClick® (Darbepoetin alfa) can improve perceived satisfaction and competence for anemia treatment and increase self-administration in non-dialyzed patients with chronic kidney disease.

BACKGROUND AND AIMS: SureClick® is a prefilled pen for administration of darbepoetin alfa (DA) that is ready-to-use. We explored patient satisfaction with SureClick® compared with prefilled syringes (PFS). METHODS: Multicenter, prospective, 6-months, observational study in non-dialyzed patients with chronic kidney disease (CKD) treated with DA in PFS who switched to SureClick® at baseline. Main outcomes were: change in Anemia Treatment Satisfaction Questionnaire (ATSQ-S), Perceived Competence for Anemia Scale (PCAS) and self-administration rate. RESULTS: We enrolled 132 patients with a mean(SD) age of 71.3 (14.6) years, 57.6% women. Mean(SD) ATSQ-S scores at baseline and final records were 25.5 (7.9) and 31.6 (4.9) (on a scale from 0 to 36 maximum satisfaction-, mean change: 6.2, 95%CI: 4.6-7.8, p<0.0001). The PCAS also increased significantly (4.3 (2.0) vs 5.6 (1.6), on a scale from 1 to 7 maximum competence, p<0.0001). At baseline 47.7% of patients self-administered DA with PFS, vs 74.2% with SureClick® (p<0.001). No significant changes in hemoglobin were observed (11.4 (0.5) vs 11.6 (1.3) g/dl, p=0.193). Two patients (1.5%) had adverse reactions to SureClick® (pain on application). CONCLUSIONS: Our results suggest that the change from PFS to SureClick® could increase patient satisfaction and perceived competence in anemia management in non-dialyzed CKD patients, and could increase the self-administration rate, thereby reducing use of health resources.

Impact of upper digestive symptoms in patients with irritable bowel syndrome.

BACKGROUND: Functional digestive disorders constitute a sizable proportion of gastroenterology and primary healthcare consultations, and have a negative impact on health-related quality of life. Dyspepsia and heartburn are often associated with irritable bowel syndrome (IBS); however, the incidence of these symptoms and their effect on IBS patients have not been evaluated. AIM: To investigate the clinical, psychological and health-related quality of life impact of upper digestive symptoms on IBS patients. METHODS: A prospective, observational, multicentered study was conducted in Spain: 517 IBS patients (Rome II criteria), grouped according to predominant symptoms of constipation (IBS-C), diarrhea (IBS-D) or alternating bowel habit (IBS-A) and 84 controls without IBS were recruited. Upper digestive symptoms were recorded in a 30-day diary. Health-related quality of life was evaluated by Irritable Bowel Syndrome Quality of Life and Euro-Quality of Life Five-Dimension Questionnaires; psychological well-being was evaluated by the Psychological General Well-Being Index. RESULTS: IBS patients had greater frequencies of upper digestive symptoms (72.3 vs. 6.0%), dyspepsia (21.1 vs. 4.8%) and heartburn (40.0 vs. 13.1%) (all P < 0.05) than controls. Prevalence of upper digestive symptoms was lower in patients with IBS-D than in those with IBS-C or IBS-A (P < 0.05). Health-related quality of life and psychological status were significantly worse in IBS patients with upper digestive symptoms than in those without. CONCLUSIONS: Upper digestive symptoms, frequently present in IBS patients, impair health-related quality of life and psychological status. This effect is greater in patients with IBS-C and IBS-A than in those with IBS-D. These data emphasize the importance of evaluating the presence of upper digestive symptoms in IBS patients.

Satisfaction survey with DNA cards method to collect genetic samples for pharmacogenetics studies.

BACKGROUND: Pharmacogenetic studies are essential in understanding the interindividual variability of drug responses. DNA sample collection for genotyping is a critical step in genetic studies. A method using dried blood samples from finger-puncture, collected on DNA-cards, has been described as an alternative to the usual venepuncture technique. The purpose of this study is to evaluate the implementation of the DNA cards method in a multicentre clinical trial, and to assess the degree of investigators' satisfaction and the acceptance of the patients perceived by the investigators. METHODS: Blood samples were collected on DNA-cards. The quality and quantity of DNA recovered were analyzed. Investigators were questioned regarding their general interest, previous experience, safety issues, preferences and perceived patient satisfaction. RESULTS: 151 patients' blood samples were collected. Genotyping of GST polymorphisms was achieved in all samples (100%). 28 investigators completed the survey. Investigators perceived patient satisfaction as very good (60.7%) or good (39.3%), without reluctance to finger puncture. Investigators preferred this method, which was considered safer and better than the usual methods. All investigators would recommend using it in future genetic studies. CONCLUSION: Within the clinical trial setting, the DNA-cards method was very well accepted by investigators and patients (in perception of investigators), and was preferred to conventional methods due to its ease of use and safety.

Splitting irritable bowel syndrome: from original Rome to Rome II criteria.

OBJECTIVES: Diagnosis of irritable bowel syndrome (IBS) and other functional bowel disorders (FBD) is based on symptom evaluation. Clinical criteria have changed over time, yielding different proportions of subjects fulfilling diagnostic requirements. According to new diagnostic criteria (Rome II), subjects considered some years ago to have IBS no longer do so. The aim of this article is to evaluate how patients diagnosed as having IBS according to original Rome criteria have been split, and to which clinical diagnosis they belong today. METHODS: Two hundred and eleven subjects meeting original Rome IBS diagnostic criteria were studied: 65 also met Rome II criteria while 146 did not. Subjects were extracted from an epidemiological survey, using home-based personal interviews, on 2000 subjects randomly selected as representative of the Spanish population. Clinical complaints, personal well-being, resource utilization, and health-related quality of life (HRQOL) were compared. RESULTS: Of the subjects meeting original Rome but not Rome II criteria, the present diagnosis should be: 40%"minor" IBS (IBS symptoms of less than 12 wk duration), 37% functional constipation, 12% alternating bowel habit, 7% functional diarrhea, 3% functional abdominal bloating, and 1% unspecified functional bowel disorder (FBD). Thus, 52 subjects (36%) should not be diagnosed with IBS because they really had other FBD, 59 (40%) because of symptoms consistent with IBD diagnosis but not the required duration or frequency, and 35 (24%) because of symptoms consistent with some other FBD diagnosis but not meeting the required duration. Clinical complaints, personal well-being, resource utilization, and HRQOL were more severely affected in IBS than in other FBD as a group, and in "major" rather than in "minor" forms. CONCLUSIONS: Many subjects meeting original Rome criteria for IBS do not meet Rome II criteria: approximately one quarter of subjects do not have sufficient symptom duration or frequency to be diagnosed with IBS and almost half are now considered as having other ("major" or "minor") FBD.

Irritable bowel syndrome subtypes according to bowel habit: revisiting the alternating subtype.

BACKGROUND: Disturbed bowel habit, diarrhoea or constipation is a key manifestation of irritable bowel syndrome (IBS). In some patients, diarrhoea and constipation alternate, giving rise to the so-called alternating subtype. AIMS: To assess IBS subtype breakdown (constipation (C-IBS), diarrhoea (D-IBS) or alternating (A-IBS)) according to the Rome II criteria and patients' self-assessment, the predominance in the alternating subtype (i.e. constipation, diarrhoea or neither), and the medical and personal impact, including health-related quality of life (HRQoL), of the different IBS subtypes. SUBJECTS AND METHODS: Two thousand individuals selected randomly to represent the general population were classified as potential IBS subjects (n = 281) or as non-potential IBS subjects (n = 1719) according to a validated questionnaire. Bowel habit classification was determined using the Rome II IBS supportive symptoms. RESULTS: Among 201 subjects meeting the Rome I criteria, 15% presented with D-IBS, 44% presented with C-IBS, 19% presented with A-IBS, and 22% presented with normal bowel habit. Among the 63 subjects meeting the Rome II criteria, 23% presented with A-IBS. According to the subjects' self-assessment, of those meeting the Rome I criteria, 16% considered themselves to have D-IBS, 66% to have C-IBS and 18% to have A-IBS. In subjects meeting the Rome II criteria, 24% considered themselves to have A-IBS. Among those classified with A-IBS by the Rome II criteria, most considered themselves to be constipated. Regardless of the subtype self-classification, most subjects reported a normal frequency of bowel movements. Clinical manifestations in A-IBS were very similar to those of C-IBS but with the added presence of defecatory urgency. Abdominal discomfort/pain and frequency of visits to physicians were greater in the A-IBS subtype than in the other two IBS subtypes. HRQoL was affected similarly in all IBS subtypes. CONCLUSIONS: Approximately one-quarter of subjects with IBS belong to the A-IBS subtype by the Rome II criteria, although the majority consider themselves to be constipated; indeed, clinical manifestations are more akin to the C-IBS subtype than to the D-IBS subtype. Abdominal discomfort/pain and frequency of visits to physicians are greater in the A-IBS subtype than in the other two IBS subtypes, while HRQoL is impaired similarly.

Burden of illness in irritable bowel syndrome comparing Rome I and Rome II criteria.

OBJECTIVES: To evaluate the burden of illness in irritable bowel syndrome (IBS), in terms of resource utilisation (direct and indirect) and health-related quality of life (HR-QOL), in individuals with IBS who meet Rome I and Rome II criteria. METHODS: A cross-sectional study, carried out by personal interview, on a representative sample (n = 2000) of the Spanish population. Individuals with suspected IBS were identified via a screening question and subsequently given an epidemiological questionnaire to complete. The questionnaire collected information on IBS symptoms, resource utilisation, and HR-QOL [Medical Outcomes Study 36-item Short Form (SF-36)]. RESULTS: Sixty-five individuals met Rome II criteria for IBS, while 146 individuals met exclusively Rome I criteria. Of Rome II individuals, 67.7% had consulted some type of healthcare professional in the previous 12 months, compared with only 41.8% of those individuals meeting exclusively Rome I criteria (p vs 17.1%); 'drug consumption' (70.8 vs 45.2%); and 'reduced performance in main activity' (60 vs 27.4%). Compared with the general population, the study sample reported significantly worse HR-QOL scores in four dimensions of the SF-36 ('bodily pain', 'vitality', 'social functioning' and 'role-emotional'. Additionally, individuals meeting Rome II criteria reported worse HR-QOL scores than those individuals meeting exclusively Rome I criteria, especially in the 'bodily pain' and 'general health' dimensions. CONCLUSIONS: The burden of illness in IBS is important and correlated to the diagnostic criteria employed. Individuals who met Rome II criteria reported a higher level of resource utilisation and worse HR-QOL than individuals meeting exclusively Rome I criteria.