ABSTRACT
INTRODUCTION: The prevalence of penetrating complications in Crohn's disease (CD) increases progressively over time, but evidence on the medical treatment in this setting is limited. The aim of this study was to evaluate the effectiveness of biologic agents in CD complicated with internal fistulizing disease. METHODS: Adult patients with CD-related fistulae who received at least 1 biologic agent for this condition from the prospectively maintained ENEIDA registry were included. Exclusion criteria involved those receiving biologics for perianal disease, enterocutaneous, rectovaginal, anastomotic, or peristomal fistulae. The primary end point was fistula-related surgery. Predictive factors associated with surgery and fistula closure were evaluated by multivariate logistic regression and survival analyses. RESULTS: A total of 760 patients from 53 hospitals (673 receiving anti-tumor necrosis factors, 69 ustekinumab, and 18 vedolizumab) were included. After a median follow-up of 56 months (interquartile range, 26-102 months), 240 patients required surgery, with surgery rates of 32%, 41%, and 24% among those under anti-tumor necrosis factor, vedolizumab, or ustekinumab, respectively. Fistula closure was observed in 24% of patients. Older patients, ileocolonic disease, entero-urinary fistulae, or an intestinal stricture distal to the origin of the fistula were associated with a higher risk of surgery, whereas nonsmokers and combination therapy with an immunomodulator reduced this risk. DISCUSSION: Biologic therapy is beneficial in approximately three-quarters of patients with fistulizing CD, achieving fistula closure in 24%. However, around one-third still undergo surgery due to refractory disease. Some patient- and lesion-related factors can identify patients who will obtain more benefit from these drugs.
Subject(s)
Crohn Disease , Fistula , Rectal Fistula , Adult , Humans , Crohn Disease/complications , Crohn Disease/drug therapy , Crohn Disease/surgery , Ustekinumab/therapeutic use , Treatment Outcome , Biological Therapy , Necrosis , Retrospective Studies , Rectal Fistula/etiology , Rectal Fistula/therapyABSTRACT
NETs (neuroendocrine tumors) constitute a heterogeneous group of epithelial-type neoplasms with a predominantly neuroendocrine differentiation. Although the most common locations are the pancreas, digestive tract, and lung, this type of neoplasm can arise in virtually any organ in the body. They are rare tumors with a wide variety of clinical presentations. Symptomatic tumors are more frequent in younger patients and present at more advanced pathological stages. We present the case of a 42-year-old male with idiopathic splenomegaly and bicytopenia (anaemia and thrombocytopenia) under study by haematology department who was admitted due to an episode of melena and hemoglobin of 4.5 mg/dl. Isolated gastric varices (IGV1) with red spots were confirmed at gastroscopy and endoscopic variceal obturation using cyanoacrylate was performed in two sessions. An endoscopic ultrasonography was performed, showing thrombosis of the splenic vein extending towards the splenoportal confluence with anechoic serpiginous structures outside and inside the gastric wall suggestive of collateral circulation with gastric varices (GV). An increase in portal caliber was observed, with no signs of liver cirrhosis. Computed tomography confirms the findings. Two months/week/days later he was readmitted with rebleeding signs after starting anticoagulant treatment, so it was decided to perform a splenectomy due to failure of the endoscopic treatment. Histology revealed infiltration of the spleen by a well-differentiated neuroendocrine tumor (NET). Gallium PET/CT and Octreotid scan showed uptake in the body and tail of the pancreas with positivity for somatostatin receptors previously undetected by other means. Finally, treatment was completed with distal pancreatectomy and splenoportal axis trombectomy with vascular esplenic resection and the patient was discharged from hospital.
Subject(s)
Esophageal and Gastric Varices , Neuroendocrine Tumors , Pancreatic Neoplasms , Male , Humans , Adult , Gastrointestinal Hemorrhage/surgery , Esophageal and Gastric Varices/diagnostic imaging , Esophageal and Gastric Varices/etiology , Neuroendocrine Tumors/complications , Neuroendocrine Tumors/diagnostic imaging , Neuroendocrine Tumors/surgery , Positron Emission Tomography Computed Tomography , Treatment Outcome , Neoplasm Recurrence, Local , Pancreatic Neoplasms/complications , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/surgeryABSTRACT
An 80-year-old female with a mechanic mitral valve treated with acenocumarol was admitted to the hospital due to tarry stools over the last two days and hemoglobin levels of 5.6 g/dl. She had not biliary pathology. An emergency esophagogastroduodenoscopy showed lots of fresh clots over the second part of the duodenum that seemed to come from the major papilla. A duodenoscopy was performed in order to obtain a direct view, showing a huge clot near the papilla. Its removal with a polypectomy snare revealed a large duodenum diverticulum with little saculations inside, one of which showed a visible, actively bleeding vessel. Sclerosis with epinephrine was performed and subsequently, two through-the-scope Cook® 11 mm clips were placed, achieving the cessation of the hemorrhage. Several attempts with different clips were needed since they were separated by the elevator nail of the duodenoscope. No complications developed during the procedure or once anticoagulation was restarted.
Subject(s)
Diverticulum , Thrombosis , Aged, 80 and over , Diverticulum/complications , Diverticulum/diagnostic imaging , Duodenoscopy/adverse effects , Duodenum , Female , Gastrointestinal Hemorrhage/therapy , Humans , Thrombosis/complicationsABSTRACT
BACKGROUND: Patients with inflammatory bowel disease (IBD) may present extraintestinal manifestations (EIMs) that affect the joints, skin, eyes, and hepatobiliary area, among others. AIMS: Our aim was to analyse the prevalence and characteristics of EIMs in patients with IBD and to identify the possible risk factors associated with the development of EIMs in the largest series published to date. METHODS: Observational, cross-sectional study including patients from the Spanish ENEIDA registry promoted by GETECCU. We retrospectively identified all cases of EIMs in the ENEIDA registry until January 2018. RESULTS: The study included 31,077 patients, 5779 of whom had at least one EIM (global prevalence 19%; 95% CI 18.2-19.0). Among the different types of EIMs, rheumatic manifestations had a prevalence of 13% (95% CI 12.9-13.7; 63% of EIMs), with a prevalence of 5% (95% CI 4.7-5.2) for mucocutaneous manifestations, 2.1% (95% CI 1.9-2.2) for ocular manifestations, and 0.7% (95% CI 0.6-0.8) for hepatobiliary manifestations. The multivariable analysis showed that the type of IBD (Crohn's disease, p < 0.001), gender (female, p < 0.001), the need for an immunomodulator (p < 0.001) or biologic drugs (p < 0.001), a previous family history of IBD (p < 0.001), and an extensive location of IBD (p < 0.001) were risk factors for the presence of EIMs. CONCLUSIONS: One-fifth of patients with IBD may have associated EIMs, with rheumatic manifestations as the most frequent (> 60% of EIMs). Female patients with severe Crohn's disease represent the group with the highest risk of developing EIMs. These patients should therefore be specially monitored and referred to the corresponding specialist when suggestive symptoms appear.
Subject(s)
Inflammatory Bowel Diseases/diagnosis , Inflammatory Bowel Diseases/epidemiology , Registries , Adult , Cross-Sectional Studies , Digestive System Diseases/diagnosis , Digestive System Diseases/epidemiology , Female , Humans , Joint Diseases/diagnosis , Joint Diseases/epidemiology , Male , Middle Aged , Prospective Studies , Retrospective Studies , Spain/epidemiology , Young AdultABSTRACT
We present the case of a 47-year-old male with a personal history of radically removed malignant melanoma (pT3bN2M0) who was receiving adjuvant nivolumab for the prevention of recurrence. He was admitted to our service complaining of epigastric pain and hyporexia after receiving the ninth dose of nivolumab. He underwent a preferential esophagogastroduodenoscopy, which showed intense inflammation limited to the stomach.
Subject(s)
Gastritis , Melanoma , Skin Neoplasms , Gastritis/chemically induced , Gastritis/drug therapy , Humans , Male , Melanoma/drug therapy , Melanoma/pathology , Middle Aged , Nivolumab/adverse effects , Skin Neoplasms/drug therapyABSTRACT
Secukinumab is a monoclonal antibody that inhibits interleukin-17A. It is currently prescribed for the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis, which are immune-mediated diseases that show significant co-heritability with inflammatory bowel disease (IBD). Although this treatment appears to be well tolerated by patients, several cases of new-onset IBD after secukinumab have been reported during the last years.
Subject(s)
Arthritis, Psoriatic , Inflammatory Bowel Diseases , Psoriasis , Spondylitis, Ankylosing , Antibodies, Monoclonal, Humanized/adverse effects , Arthritis, Psoriatic/drug therapy , Chronic Disease , Humans , Inflammatory Bowel Diseases/drug therapy , Psoriasis/drug therapy , Spondylitis, Ankylosing/drug therapyABSTRACT
We present the case of an 81-year-old male with a history of surgically resected colorectal and bladder cancer, who was admitted to our hospital with a urinary infection. A routine renal ultrasound showed a pelvic cyst and a CT scan confirmed a non-complicated cyst, but a lesion was observed in the left lung. He underwent a PET-CT in which an unexpected enhancement of the small bowel attracted our attention.
Subject(s)
Adenocarcinoma , Duodenal Neoplasms , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/surgery , Aged, 80 and over , Duodenal Neoplasms/diagnostic imaging , Duodenal Neoplasms/surgery , Duodenum , Humans , Male , Positron Emission Tomography Computed Tomography , UltrasonographyABSTRACT
BACKGROUND: The adenoma detection rate (ADR) is the most important marker of colonoscopy quality. Devices to improve adenoma detection have been developed, such as the Endocuff and transparent cap.âThe aim of the current study was to examine whether there was a difference in ADR between Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC). METHODS: A randomized prospective trial was conducted. Eligible patients included adults ≥â18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP). The primary outcome measure was ADR. Secondary outcomes included mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation. Procedural measures, device removal rate, and adverse events were also recorded. RESULTS: A total of 711 patients (51.1â% men; median age 63 years) were included, of whom 357 patients were randomized to EAC and 354 patients to CAC. In the intention-to-treat analysis, the ADR was similar in both groups: EAC 50.4â% (95â% confidence interval [CI] 45.1â-â55.7) vs. CAC 50.6â% (95â%CI 45.2â-â55.9). Similar results were obtained in the per-protocol analysis: EAC 51.6â% (95â%CI 46.2â-â57) vs. CAC 51.4â% (95â%CI 46â-â56.8). There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation. Device removal rate and adverse events were also similar. CONCLUSION: In this randomized study, no differences in ADR were found between Endocuff- and cap-assisted colonoscopy.
Subject(s)
Adenoma/diagnostic imaging , Colonic Polyps/diagnostic imaging , Colonoscopy/methods , Colorectal Neoplasms/diagnostic imaging , Early Detection of Cancer/methods , Adolescent , Adult , Aged , Aged, 80 and over , Colonoscopes , Female , Humans , Male , Middle Aged , Prospective StudiesABSTRACT
OBJECTIVE. During colonoscopy, advancing the endoscope can sometimes be difficult due to the appearance of loops or bends in the insertion tube. Therefore, research continues toward improving colonoscope technology. The aim of this study is to compare the use of colonoscopes equipped with "responsive insertion technology" (RIT) versus regular non-RIT colonoscopes. MATERIALS AND METHODS. Prospective, comparative and randomized trials that included patients submitted to colonoscopy. In group I, RIT colonoscopes were used, while in group II, colonoscopies with variable stiffness but without the other components of the RIT technology were used. Demographic variables and variables related to colonoscopy, as well as the pain perceived by the patient and the difficulty in performing endoscopy were recorded. RESULTS. A total of 122 patients were included in group I and 120 patients in group II. The cecal intubation rate was similar in both groups. The use of the RIT colonoscopes was associated with a lower cecal intubation time (4.4 ± 2.0 vs. 5.4 ± 3.5, p = 0.005) and a lower difficulty in performing examinations for both the endoscopist (19.1 ± 20.0 vs. 27.7 ± 22.2, p = 0.002) and the nursing staff (20.8 ± 17.0 vs. 26.3 ± 19.6, p = 0.04). No significant differences were found between both groups in the need for ancillary maneuvers or in the pain perceived by the patient. CONCLUSIONS. RIT colonoscopes allow cecal intubation in a shorter time compared to variable stiffness colonoscopes, and are associated with a greater level of ease of the procedure.
Subject(s)
Colonoscopes , Colonoscopy/instrumentation , Adolescent , Adult , Aged , Aged, 80 and over , Cecum , Colonoscopy/adverse effects , Equipment Design , Female , Humans , Male , Middle Aged , Pain/diagnosis , Pain/etiology , Pain Measurement , Prospective Studies , Young AdultABSTRACT
Objective: Psychological factors, such as stress, anxiety, and depression, are frequently related to inflammatory bowel disease (IBD). However, few studies have examined these factors in patients newly diagnosed with IBD. The aim of the present study was to test the psychological burden in patients with a recent diagnosis of IBD and the factors related to this psychological burden. Methods: We performed a prospective, multi-center, observational study in patients with a new diagnosis of IBD (≤6 months). The patients were recruited from four different Spanish hospitals. Clinical and demographic characteristics were collected. Patients were evaluated using the Hospital Anxiety and Depression Scale and quality of life questionnaire for patients with inflammatory bowel disease (IBDQ-32). The Scale of Stress Perceived by the Disease was used to assess stressful life events. Results: We included 156 patients newly diagnosed with IBD [69 women; 80 Crohn's disease (CD) and 76 ulcerative colitis (UC)], with a mean age of 42.3 (SD 16.21) years. A total of 37.2% of patients had symptoms of anxiety and 17.3% had symptoms of depression. Quality of life was affected in 30.1% of patients. Factors related to anxiety in early IBD were being a woman and having CD. The only factor related to depression was the presence of comorbidity. Being a woman and having suffered previous stressful life events were factors related to impaired quality of life. Conclusion: Anxiety, depression, and impaired quality of life are frequent in patients with a recent diagnosis of IBD. This psychological burden is greater in women.
ABSTRACT
BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.
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(1) Scant information is available concerning the characteristics that may favour the acquisition of COVID-19 in patients with inflammatory bowel disease (IBD). Therefore, the aim of this study was to assess these differences between infected and noninfected patients with IBD. (2) This nationwide case−control study evaluated patients with inflammatory bowel disease with COVID-19 (cases) and without COVID-19 (controls) during the period March−July 2020 included in the ENEIDA of GETECCU. (3) A total of 496 cases and 964 controls from 73 Spanish centres were included. No differences were found in the basal characteristics between cases and controls. Cases had higher comorbidity Charlson scores (24% vs. 19%; p = 0.02) and occupational risk (28% vs. 10.5%; p < 0.0001) more frequently than did controls. Lockdown was the only protective measure against COVID-19 (50% vs. 70%; p < 0.0001). No differences were found in the use of systemic steroids, immunosuppressants or biologics between cases and controls. Cases were more often treated with 5-aminosalicylates (42% vs. 34%; p = 0.003). Having a moderate Charlson score (OR: 2.7; 95%CI: 1.3−5.9), occupational risk (OR: 2.9; 95%CI: 1.8−4.4) and the use of 5-aminosalicylates (OR: 1.7; 95%CI: 1.2−2.5) were factors for COVID-19. The strict lockdown was the only protective factor (OR: 0.1; 95%CI: 0.09−0.2). (4) Comorbidities and occupational exposure are the most relevant factors for COVID-19 in patients with IBD. The risk of COVID-19 seems not to be increased by immunosuppressants or biologics, with a potential effect of 5-aminosalicylates, which should be investigated further and interpreted with caution.
ABSTRACT
BACKGROUND AND AIMS: Immunomediated adverse events [IAEs] are the most frequently reported infliximab [IFX]-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. We aimed to compare the rates of IFX-related IAEs and loss of response [LOR] in elderly and younger patients. METHODS: Adult patients in the ENEIDA registry who had received a first course of IFX therapy were identified and grouped into two cohorts regarding age at the beginning of treatment [over 60 years and between 18 and 50 years]. The rates of IAEs and LOR were compared. RESULTS: In total, 939 patients [12%] who started IFX over 60 years of age and 6844 [88%] below 50 years of age were included. Elderly patients presented a higher proportion of AEs related to IFX [23.2% vs 19%; p = 0.002], infections [7.1% vs 4.3%; p < 0.001] and neoplasms [2.2% vs 0.5%; p < 0.001]. In contrast, the rates of IAEs [14.8% vs 14.8%; p = 0.999], infusion reactions [8.1% vs 8.1%; p = 0.989], late hypersensitivity [1.3% vs 1.2%; p = 0.895], paradoxical psoriasis [1% vs 1.5%; p = 0.187] and drug-induced lupus erythematosus [0.6% vs 0.7%; p = 0.947] were similar in elderly and younger patients. LOR rates were also similar between the two groups [20.5% vs 19.3%; p = 0.438]. In the logistic regression analysis, IFX monotherapy, extraintestinal manifestations and female gender were the only risk factors for IAEs, whereas IFX monotherapy, extraintestinal manifestations and Crohn's disease were risk factors for LOR. CONCLUSIONS: Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.
Subject(s)
Inflammatory Bowel Diseases , Adult , Aged , Chronic Disease , Cohort Studies , Female , Gastrointestinal Agents/adverse effects , Humans , Inflammatory Bowel Diseases/chemically induced , Inflammatory Bowel Diseases/drug therapy , Infliximab/adverse effects , Middle Aged , Registries , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND AND AIMS: Crohn's disease [CD] can develop penetrating complications at any time during the disease course. Enterocutaneous fistulae [ECF] are disease-related complications with an important impact on quality of life. Our aim was to describe the outcomes of this complication, including its medical and/or surgical management and their temporal trends. The primary endpoint was fistula closure, defined as the absence of drainage, with no new abscess or surgery, over the preceding 6 months. METHODS: Clinical information from all adult patients with CD and at least one ECF-excluding perianal fistulae-were identified from the prospectively-maintained ENEIDA registry. All additional information regarding treatment for this complication was retrospectively reviewed. RESULTS: A total of 301 ECF in 286 patients [January 1970-September 2020] were analysed out of 30 088 records. These lesions were mostly located in the ileum [67%] and they had a median of one external opening [range 1-10]. After a median follow-up of 146 months (interquartile range [IQR], 69-233), 69% of patients underwent surgery. Fistula closure was achieved in 84%, mostly after surgery, and fistula recurrence was uncommon [13%]. Spontaneous and low-output fistulae were associated with higher closure rates (hazard ratio [HR] 1.51, 95% confidence interval [CI] 1.17-1.93, pâ =â 0.001, and HR 1.49, 95% CI 1.07-2.06, pâ =â 0.03, respectively); this was obtained more frequently with medical therapy since biologics have been available. CONCLUSIONS: ECF complicating CD are rare but entail a high burden of medical and surgical resources. Closure rates are high, usually after surgery, and fistula recurrence is uncommon. A significant proportion of patients receiving medical therapy can achieve fistula closure.
Subject(s)
Crohn Disease , Intestinal Fistula , Rectal Fistula , Adult , Crohn Disease/drug therapy , Humans , Intestinal Fistula/etiology , Intestinal Fistula/surgery , Quality of Life , Rectal Fistula/etiology , Rectal Fistula/surgery , Retrospective Studies , Treatment OutcomeABSTRACT
(1) Aims: Patients receiving antitumor necrosis factor (anti-TNF) therapy are at risk of developing tuberculosis (TB), usually due to the reactivation of a latent TB infection (LTBI). LTBI screening and treatment decreases the risk of TB. This study evaluated the diagnostic performance of different LTBI screening strategies in patients with inflammatory bowel disease (IBD). (2) Methods: Patients in the Spanish ENEIDA registry with IBD screened for LTBI between January 2003 and January 2018 were included. The diagnostic yield of different strategies (dual screening with tuberculin skin test [TST] and interferon-×¥-release assay [IGRA], two-step TST, and early screening performed at least 12 months before starting biological treatment) was analyzed. (3) Results: Out of 7594 screened patients, 1445 (19%; 95% CI 18−20%) had LTBI. Immunomodulator (IMM) treatment at screening decreased the probability of detecting LTBI (20% vs. 17%, p = 0.001). Regarding screening strategies, LTBI was more frequently diagnosed by dual screening than by a single screening strategy (IGRA, OR 0.60; 95% CI 0.50−0.73, p < 0.001; TST, OR 0.76; 95% CI 0.66−0.88, p < 0.001). Two-step TST increased the diagnostic yield of a single TST by 24%. More cases of LTBI were diagnosed by early screening than by routine screening before starting anti-TNF agents (21% [95% CI 20−22%] vs. 14% [95% CI 13−16%], p < 0.001). The highest diagnostic performance for LTBI (29%) was obtained by combining early and TST/IGRA dual screening strategies in patients without IMM. (4): Conclusions: Both early screening and TST/IGRA dual screening strategies significantly increased diagnostic performance for LTBI in patients with IBD, with optimal performance achieved when they are used together in the absence of IMM.
ABSTRACT
We aim to describe the incidence and source of contagion of COVID-19 in patients with IBD, as well as the risk factors for a severe course and long-term sequelae. This is a prospective observational study of IBD and COVID-19 included in the ENEIDA registry (53,682 from 73 centres) between March-July 2020 followed-up for 12 months. Results were compared with data of the general population (National Centre of Epidemiology and Catalonia). A total of 482 patients with COVID-19 were identified. Twenty-eight percent were infected in the work environment, and 48% were infected by intrafamilial transmission, despite having good adherence to lockdown. Thirty-five percent required hospitalization, 7.9% had severe COVID-19 and 3.7% died. Similar data were reported in the general population (hospitalisation 19.5%, ICU 2.1% and mortality 4.6%). Factors related to death and severe COVID-19 were being aged ≥ 60 years (OR 7.1, 95% CI: 1.8-27 and 4.5, 95% CI: 1.3-15.9), while having ≥2 comorbidities increased mortality (OR 3.9, 95% CI: 1.3-11.6). None of the drugs for IBD were related to severe COVID-19. Immunosuppression was definitively stopped in 1% of patients at 12 months. The prognosis of COVID-19 in IBD, even in immunosuppressed patients, is similar to that in the general population. Thus, there is no need for more strict protection measures in IBD.
ABSTRACT
BACKGROUND: The effectiveness of the switch to another anti-tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. METHODS: We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. RESULTS: A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8-3; P < 0.0001) and ulcerative colitis vs Crohn's disease (HR, 1.6; 95% CI, 1.1-2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. CONCLUSIONS: Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.
Subject(s)
Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Tumor Necrosis Factor Inhibitors/therapeutic use , Adalimumab/administration & dosage , Adalimumab/therapeutic use , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , Infliximab/administration & dosage , Infliximab/therapeutic use , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Prospective Studies , Registries , Remission Induction , Spain , Tumor Necrosis Factor Inhibitors/adverse effects , Young AdultABSTRACT
Colonoscopy services working in colorectal cancer screening programs must perform periodic controls to improve the quality based on patients' experiences. However, there are no validated instruments in this setting that include the two core dimensions for optimal care: satisfaction and safety. The aim of this study was to design and validate a specific questionnaire for patients undergoing screening colonoscopy after a positive fecal occult blood test, the Colonoscopy Satisfaction and Safety Questionnaire based on patients' experience (CSSQP). The design included a review of available evidence and used focus groups to identify the relevant dimensions to produce the instrument (content validity). Face validity was analyzed involving 15 patients. Reliability and construct and empirical validity were calculated. Validation involved patients from the colorectal cancer screening program at two referral hospitals in Spain. The CSSQP version 1 consisted of 15 items. The principal components analysis of the satisfaction items isolated three factors with saturation of elements above 0.52 and with high internal consistency and split-half readability: Information, Care, and Service and Facilities features. The analysis of the safety items isolated two factors with element saturations above 0.58: Information Gaps and Safety Incidents. The CSSQP is a new valid and reliable tool for measuring patient' experiences, including satisfaction and safety perception, after a colorectal cancer screening colonoscopy.
Subject(s)
Colonoscopy/standards , Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Patient Safety , Patient Satisfaction/statistics & numerical data , Aged , Colonoscopy/adverse effects , Female , Focus Groups , Humans , Male , Middle Aged , Occult Blood , Principal Component Analysis , Reproducibility of Results , Spain , Surveys and QuestionnairesABSTRACT
To assess inflammatory bowel disease (IBD) patients' experience of chronic illness care and the relationship with demographic and healthcare-related characteristics.This cross-sectional survey used the Instrument to Evaluate the EXperience of PAtients with Chronic diseases (IEXPAC) questionnaire to identify parameters associated with a better healthcare experience for IBD patients. IEXPAC questionnaire responses are grouped into 3 factors - productive interactions, new relational model, and patient self-management, scoring from 0 (worst) to 10 (best experience). Scores were analyzed by bivariate comparisons and multiple linear regression models.Surveys were returned by 341 of 575 patients (59.3%, mean age 46.8 (12.9) years, 48.2% women). Mean (SD) IEXPAC score was 5.9 (2.0); scores were higher for the productive interactions (7.7) and patient self-management factors (6.7) and much lower for the new relational model factor (2.2). Follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines were associated with higher (better) overall patient experience score, and higher productive interactions and self-management factor scores. A higher productive interactions score was also associated with patients receiving medication subcutaneously or intravenously. Higher new relational model scores were associated with follow-up by a nurse, affiliation to a patients' association, receiving help from others for healthcare, a lower number of medicines and a higher educational level.In patients with IBD, a better overall patient experience was associated with follow-up by a nurse, being seen by the same physician, and being treated with a lower number of medicines.